AGENDA Quality, Patient Care and Patient Experience Committee Meeting

Transcription

1 AGENDA Quality, Patient Care and Patient Experience Committee Meeting Monday, September 16, 2013, 5:30 7:40 p.m. Conference Room E & F, ground floor El Camino Hospital 2500 Grant Road, Mountain View, California Purpose: The purpose of the Quality, Patient Care and Patient Experience Committee ( Quality Committee ) is to advise and assist the El Camino Hospital (ECH) Board of Directors ( Board ) in constantly enhancing and enabling a culture of quality and safety at ECH, and to ensure delivery of effective, evidence-based care for all patients. The Quality Committee helps to assure that excellent patient care and exceptional patient experience are attained through monitoring organizational quality and safety measures, leadership development in quality and safety methods and assuring appropriate resource allocation to achieve this purpose. A copy of the agenda for the Regular Meeting will be posted and distributed at least seventy-two (72) hours prior to the meeting. In observance of the Americans with Disabilities Act, please notify us at forty-eight (48) hours prior to the meeting so that we may provide the agenda in alternative formats or make disability related modifications and accommodations. PRESENTED BY I. CALL TO ORDER/ROLL CALL David Reeder, Chair Quality Committee 5:30-5:31 p.m. II. POTENTIAL CONFLICT OF INTEREST DISCLOSURES David Reeder, Chair Quality Committee 5:31-5:32 III. CONSENT CALENDAR All items listed on the Consent Calendar are considered to be routine matters or are considered formal documents covering previous Committee instructions. One motion, a second and a vote may approve, accept, or recommend all of the items listed on the Consent Calendar. There will be no separate discussion of Consent Calendar items unless members of the Committee, Hospital staff or the public request discussion on a specific item at the beginning of the consideration of the Consent Calendar. Approval: a. Minutes of Regular Meeting Open Session July 22, 2013 Policies: b. Code Green: Patient Elopment c. Code Green: Elopment Checklist d. Temperature and Humidity in the Operating Room and MV Interventional Services e. Physics Quality Assurance General Program f. Physics Quality Assurance For Trilogy / Liniac g. Physics Quality Assurance - Measurement of Equipment h. Physics Quality Assurance - Eclipse Treatment Planning System i. Physics Quality Assurance - Systemic Page 1/219 David Reeder, Chair Quality Committee public comment motion required 5:32-5:33

2 Agenda: El Camino Hospital Quality Committee of the Board September 16, 2013 Page 2 Clinical Review of Medical Records j. Physics Quality Assurance - Cyberknife Program k. Physics Quality Assurance for High Dose Rate (HDR) Brachytherapy Quality Management Program (QMP) l. High Dose Rate (HDR) Operating and Safety Procedures m. Emergency Response Procedures for Nulcetron HDR-IR-192 If the Source Fails to Return to the Safe n. High Dose Rate (HDR) Calibration Procedures o. High Dose Rate (HDR) Inventory of Sealed Sources p. High Dose Rate (HDR) Transportation of Sealed Sources q. Radiation Safety Training Procedures r. Quality Assurance Responsibilities for Oversight of Physics in Radiation Oncology Information: s. FY 2014 Committee Goals: Status to Complete t. Quality Summary ATTACHMENT 1 IV. INFORMATIONAL AND POSSIBLE MOTION ITEMS A. Patient Story ATTACHMENT 2 Eric Pifer, MD Chief Medical Officer information 5:33-5:43 B. Review Corporate Scorecard ATTACHMENT 3 Eric Pifer, MD Chief Medical Officer information 5:43-5:48 C. Final FY 2014 Organizational Goals with Targets ATTACHMENT 4 Eric Pifer, MD Chief Medical Officer public comment possible motion 5:48-6:08 D. Quality Program: C. Difficile Infections ATTACHMENT 5 Eric Pifer, MD Chief Medical Officer information 6:08-6:23 E. Quality Program: Readmissions ATTACHMENT 6 Eric Pifer, MD Chief Medical Officer information 6:23-6:33 F. Public Communication David Reeder, Chair Quality Committee 6:33-6:36 Page 2/219

3 Agenda: El Camino Hospital Quality Committee of the Board September 16, 2013 Page 3 V. ADJOURN TO CLOSED SESSION The Committee will adjourn to a Closed Session, pursuant to the sections of the California codes noted below: 1. Conflict of Interest disclosures relating to Items 2-7 on the Closed Session agenda pursuant to the code provisions listed below. 2. Approval of the Closed Session Minutes of the Quality Committee Meeting of the Board (July 22, 2013) Govt. Code Section Report involving health care facility trade secrets, Health and Safety Code Section 32106(b) - Pacing Plan 4. Report of Medical Staff Quality Assurance Committee, Health and Safety Code Section and report involving health care facility trade secrets, Health and Safety Code Section 32106(b) - Quality Council Minutes 5. Report involving health care facility trade secrets, Health and Safety Code Section 32106(b) - Action Item Status Spreadsheet 6. Report involving health care facility trade secrets, Health and Safety Code Section 32106(b) - IT Case for Change 7. Report involving health care facility trade secrets, Health and Safety Code Section 32106(b) - CMS and EMTALA Update 8. Adjourn to Open Session motion required information information information information information VI. RECONVENE OPEN SESSION To report any required disclosure regarding permissible actions taken during Closed Session. David Reeder, Chair Quality Committee 7:38-7:39 VII. ADJOURNMENT David Reeder, Chair Quality Committee 7:40 p.m. PLEASE NOTE: The CLOSED SESSION is limited to Quality Committee Members and invited Hospital staff only. Page 3/219

4 Separator Page Att 1a - BQC Open Minutes docx Page 5/219

5 DRAFT Minutes of the Open Session Quality, Patient Care and Patient Experience Committee Of El Camino Hospital Monday July 22, 2013 The Open Session meeting of the Quality, Patient Care and Patient Experience Committee of El Camino Hospital (the Committee ) was called to order by Chair David Reeder, at 5:40 p.m. on Monday, July 22, 2013, Conference Rooms E&F, at El Camino Hospital, 2500 Grant Road, Mountain View, California. 1. Call to Order. Roll call was taken. Committee members present were David Reeder; Katherine Anderson; Jeffrey Davis, MD; Patricia Einarson, MD; Lisa Freeman; and Robert Pinsker, MD. 2. Potential Conflict of Interests Disclosures. Committee Chair Reeder asked if any Committee member or anyone in the audience believes that a Committee member may have a conflict of interest on any of the items on the agenda. No conflict of interest was reported. 3. Consent Calendar. The Committee reviewed the items on the Consent Calendar. Action: Dr. Einarson asked that the Proposal for Absent Members be removed from the consent calendar for discussion. A motion was made by Dr. Davis and seconded by Ms. Freeman, and adopted by a vote of six Committee members in favor to approve the following items on the Consent Calendar: Minutes of June 17, 2013 Committee meeting and Save the Date October 23, 2013 and April 23, Dr. Einarson (1) requested and received clarification that the Proposal for Absent Members was meant to be applicable to all committee members, not only Board members, (2) requested that section 1 be amended to provide that the Committee Chair be copied on requests to the management team for additional information and on responses to those requests, and (3) that members notify both Dr. Pifer and the Committee Chair at least one week in advance if they will be absent from a meeting. A motion was made by Dr. Davis and seconded by Ms. Anderson and adopted by a vote of six Committee members in favor to approve the proposal for Absent Committee Members with the amendments proposed by Dr. Einarson. Member R. Cary Hill, MD joined the meeting at 5:47 pm. Page 6/219

6 Minutes: Quality Patient Care and Patient Experience Committee July 22, 2013 Page 2 4. Informational and Possible Motion Items A. Patient Story Dr. Pifer commented that the goal of this portion of the agenda is to bring a patient story that ties in with a key topic of the meeting to the attention of the committee members. The committee members discussed the actions taken by staff in response to the situation presented in the story. Ms. Reinking informed the committee that nursing staff, student nursing instructors, and environmental services were all engaged in reviewing the situation and developing processes to insure better service and embed preventing situations like these from occurring in staff training. Ms. Reinking also reported that this patient will now be part of the Patient Advisory Council. The committee members discussed incorporating service orientation into hiring practices and the need to get physicians, not just nursing staff, involved in providing good service. Ms. Reinking noted that the Hospital is looking at hiring practices and that RN s have incentives around service built into the collective bargaining agreement this year. Dr. Hill asked the committee to consider whether the Hospital has the right procedures and processes in place that allow the right people to spend adequate face to face time with the patients and function well. No action was taken. B. Accomplishment of Current Goals Dr. Pifer commented that as reflected in the materials, all of the Committee s goals for FY 2013 were complete. No objection was stated. No action was taken. C. Review Corporate Scorecard Dr. Pifer introduced the topic by asking the members to consider whether the Corporate Scorecard reflects the correct metrics and whether management is doing enough to demonstrate to the committee that they are doing the right things to improve the metrics. Dr. Pifer pointed out the areas in which the Hospital is doing well and the areas that still require improvement. The members discussed whether the metric goals for FY 2014 should be complete now, as opposed to waiting until September when all FY 2013 data is in. Following discussion, the Committee members identified four metrics they would like to drill down on at upcoming meetings: Readmissions, C. Difficile Infections, the Mortality Page 7/219

7 Minutes: Quality Patient Care and Patient Experience Committee July 22, 2013 Page 3 Index, and Achieving and Maintaining Zero Stage 3 and 4 Hospital Acquired Pressure Ulcers. Chair Reeder asked Dr. Pifer to be prepared to address C. Difficile infections and Readmissions with visual presentations at the next Committee meeting. The members also discussed benchmarking C. Difficile incidence against other hospitals and the difficulty of doing that when different facilities employ different methods of assessing their incidence rates. The members also discussed how to engage skilled nursing facilities in preventing C. Difficile infections. The members also discussed the need for both the Committee and the Hospital to focus on defining what is quality in addition to attending to the measures reflected on the Corporate Scorecard, and to get the staff on the patient care units engaged in contributing to that definition. No action was taken. D. Reconsideration of FY 2014 Committee Goals Chair Reeder noted that the Governance Committee s recommended change to Goal #1 was appropriate, but that Goals #3 and #6 should remain as stated. The committee members discussed the Governance Committee s recommendations and expressed views similar to those views expressed by Chair Reeder, who indicated he would report back to the Governance Committee. No action was taken. E. Communication with ECH Board from the Quality Committee The Committee members discussed the various methods that Board members have of receiving information regarding what the Quality Committee is doing. Chair Reeder reported that the Board members have access to committee materials through the Board portal and to updates and Committee minutes in the Board meeting packet. The members suggested there be a minute live presentation at Board meetings that includes visuals to be used as a lead in to discussing how Quality is affecting strategic priorities. The members discussed the importance of and methods for educating Board members who are not connected to the clinical environment. No action was taken. F. Quality Summary and Quality Council Minutes Dr. Pifer noted that he had asked these items to come off the consent calendar so that the Committee would have a fuller opportunity to discuss them and to understand how the Medical Staff is taking time to participate in Quality activities. He gave an overview of Page 8/219

8 Minutes: Quality Patient Care and Patient Experience Committee July 22, 2013 Page 4 each topic on the Quality Summary, and pointed out that the organization did not reach its readmissions goal in Q4 FY 2013, but did meet the overall FY 2013 goal for that metric. No action was taken. 5. Adjourn to Closed Session. A motion was made by Dr. Davis, seconded by Ms. Anderson, and approved by a vote of seven members in favor, to adjourn the Open Session to Closed Session at 7:12 p.m. pursuant to Gov t Code Section for approval of the minutes of the Closed Session (June 17, 2013); and pursuant to Health and Safety Code Section (b) for reports involving health care facility trade secrets for development of new services and programs: Update on CMS Survey and Pacing Plan. Closed Session: The Committee completed its business of the Closed Session at 7:25 p.m. 6. Reconvene Open Session. The Committee reconvened Open Session at 7:25 p.m. Closed Session Report. Chair Reeder reported on the following action taken in Closed Session, which is required to be reported in Open Session: Consent Calendar: The Committee reviewed and approved the Consent Calendar Closed Session items as follows: Approval of the minutes of the Closed Session of the Regular Committee Meeting (June 17, 2013) by a vote of seven members in favor. 7. Closing Comments Summary. Topics around ICD-10 Training and Continuity of Care to get agendized in a future meeting. Chair Reeder commented he will be out of town and will be calling in for the October meeting. Chair Reeder noted that he would like to hear more about the LEAN program. 8. Call Out of Deliverables. Dr. Pifer indicated he would be prepared with a drill down on C. Difficile Infections and Readmissions at the September meeting and on Risk Adjusted Mortality at a future meeting. Page 9/219

9 Minutes: Quality Patient Care and Patient Experience Committee July 22, 2013 Page 5 9. Adjournment There being no further business, the meeting was adjourned at 7:29 p.m. David Reeder Chair, ECH Quality, Patient Care And Patient Experience Committee Patricia A. Einarson, MD ECH Board Secretary Page 10/219

10 Separator Page Att 1b Policies Memo and Summary Report.pdf Page 11/219

11 DATE: Quality, Patient Care and Patient Experience Committee Meeting, September 16, 2013 TO: El Camino Hospital Quality, Patient Care and Patient Experience Committee FROM: Elizabeth Pepe Greenlee, DHA, RN, Director of Accreditation and Regulatory Compliance, Quality/Risk Manager SUBJECT: COMMITTEE ACTION: New Policies for Approval Motion Required Policies: EC 2.34 Code Green Patient Elopement Code Green is a new emergency code adopted by the Hospital to alert staff of a missing or eloped adult patient. The policy, EC 2.34 Code Green Patient Elopement was written to ensure an appropriate and standardized response in dealing with a patient who is missing or has eloped. EC Code Green Elopement Checklist The checklist is to be completed whenever a Code Green is called to provide information to aid in locating the patient as quickly as possible. These two documents will reside in the Security Management section of the Environment of Care policies and the policy owner is Steve Weirauch. Temperature and Humidity in the Operating Room and MV Interventional Services This is a new policy/ procedure to ensure compliance with AORN standards for temperature and humidity. It was identified that while the Hospital had a practice in place for monitoring the temperature and humidity in these procedural areas, there was nothing in writing regarding the process for what to do if there were issues when these items were out of range. 1 Page 12/219

12 This document will reside in the Nursing Services manual and the policy owners are Mary Rivera, Cindy Harmer, and Ken King Radiation Oncology Department Policies and Procedures The Hospital Radiation Oncology Department recently contracted with a new Physics group. The 14 policies listed below are new and were developed to support the work flow of the new Physics group and ensure accuracy of treatment delivery, equipment, and safety of patients. These documents will reside in the Imaging Services manual and the policy owner is Judy D Eliscu Physics Quality Assurance - General Program 6.03 Physics Quality Assurance For Trilogy / Liniac 6.04 Physics Quality Assurance - Measurement of Equipment 6.05 Physics Quality Assurance - Eclipse Treatment Planning System 6.06 Physics Quality Assurance - Systemic Clinical Review of Medical Records 6.07 Physics Quality Assurance - Cyberknife Program 6.08 Physics Quality Assurance for High Dose Rate (HDR) Brachytherapy Quality Management Program (QMP) 6.09 High Dose Rate (HDR) Operating and Safety Procedures 6.10 Emergency Response Procedures for Nulcetron HDR-IR-192 If the Source Fails to Return to the Safe 6.11 High Dose Rate (HDR) Calibration Procedures 6.12 High Dose Rate (HDR) Inventory of Sealed Sources 6.13 High Dose Rate (HDR) Transportation of Sealed Sources 6.14 Radiation Safety Training Procedures 6.15 Quality Assurance Responsibilities for Oversight of Physics in Radiation Oncology Next Steps: Upon recommendation from the Quality, Patient Care, and Patient Experience Committee, these policies will go to the El Camino Hospital Board for review and approval at its October 9, 2013 meeting. Page 13/219

13 Separator Page Att 1b.2 - Summary Report for BOD Sept 2013 meeting.xlsx Page 14/219

14 SUMMARY OF POLICIES/PROTOCOLS FOR REVIEW AND APPROVAL NEW POLICIES Policy Number Policy Name Department Date Summary of Policy Changes Physics Quality Assurance - Radiation New policy from new Physicist group to ensure regulatory 6.02 General Program Oncology 7/13 compliance Physics Quality Assurance For 6.03 Trilogy / Liniac Radiation Oncology 7/13 New policy from new Physicist group to ensure regulatory compliance Physics Quality Assurance Measurement of Equipment Radiation Oncology 7/13 New policy from new Physicist group to ensure regulatory compliance Physics Quality Assurance - Eclipse Treatment Planning 6.05 System Physics Quality Assurance - Systemic Clinical Review of 6.06 Medical Records Physics Quality Assurance Cyberknife Program Radiation Oncology 7/13 Radiation Oncology 7/13 Radiation Oncology 7/13 New policy from new Physicist group to ensure regulatory compliance New policy from new Physicist group to ensure regulatory compliance New policy from new Physicist group to ensure regulatory compliance 6.08 Physics Quality Assurance for High Dose Rate (HDR) Brachytherapy Quality Management Program (QMP) Radiation Oncology 7/13 New policy from new Physicist group to ensure regulatory compliance 6.09 High Dose Rate (HDR) Operating and Safety Procedures Radiation Oncology 7/13 Emergency Response Proceures for Nulcetron HDR-IR-192 If the Source Fails to Return to the 6.10 Safe Radiation Oncology 7/13 High Dose Rate (HDR) Radiation 6.11 Calibration Procedurs Oncology 7/13 High Dose Rate (HDR) Radiation 6.12 Inventory of Sealed Sources Oncology 7/13 New policy from new Physicist group to ensure regulatory compliance New policy from new Physicist group to ensure regulatory compliance New policy from new Physicist group to ensure regulatory compliance New policy from new Physicist group to ensure regulatory compliance Page 15/219

15 High Dose Rate (HDR) Transportation of Sealed 6.13 Sources Radiation Safety Training 6.14 Procedures Radiation Oncology 7/13 Radiation Oncology 7/13 New policy from new Physicist group to ensure regulatory compliance New policy from new Physicist group to ensure regulatory compliance 6.15 Quality Assurance Responsibilities for Oversite of Physics in Radiation Oncology Radiation Oncology 7/ Code Green: Patient Elopment Safety Program 7/ Code Green: Elopment Checklist Safety Program 7/13 Temperature and Humidity in the Operating Room and MV Interventional Services Procedureal Areas 7/13 New policy from new Physicist group to ensure regulatory compliance This policy provides an appropriate response to locate a missing/eloped adult in-patient. Form to be completed whne elopment occurs New policy to ensure compliance with AORN standards for the temperature and humidity POLICIES WITH MAJOR REVISIONS Policy Number Policy Name Department Review or Revised Date Summary of Policy Changes POLICIES WITH MINOR REVISIONS Policy Number Policy Name Department Review or Revised Date Summary of Policy Changes POLICIES WITH NO REVISIONS - REVIEWED Policy Number Policy Name Department Review or Revised Date POLICIES TO ARCHIVE Policy Number Policy Name Department DATE ARCHIVE Page 16/219

16 Separator Page Att 1b Code Green - Elopement.docx Page 17/219

17 EL CAMINO HOSPITAL SAFETY PROGRAM FOR MANAGEING THE ENVIRONMENT OF CARE SAFETY MANAGEMENT POLICIES 2.34 Code Green: Patient Elopement A. Coverage: All El Camino Staff, Volunteers and Physicians B. Reviewed/Revised: New Policy, 2013 C. Policy Summary: This policy provides an appropriate response to locate a missing/eloped adult in-patient. D. Definitions 1. Patient Elopement: A patient is considered to have eloped when s/he cannot be found, has not been discharged and has not notified anyone of his/her intent of leaving. 2. High Risk Patient for Elopement: A patient is at high risk for elopement if s/he is: E. Policy: a. On a legal hold (danger to themselves or others). b. Having active suicidal/homicidal ideation c. On a patient watch or has a safety attendant d. Confused, disoriented, lacking mental capacity, altered mental status, has a history of dementia/alzheimer s or a history of traumatic brain injury. e. On a Lanterman Petris-Short (LPS) conservatorship. f. Undergoing detoxification or substance abuse treatment 1. All reasonable measures will be taken to prevent the elopement of patients from the hospital. 2. The hospital will take all reasonable steps necessary to safely retrieve/locate a high risk eloped patient as quickly as possible. 3. At no time during an elopement, should anyone without a valid need to know be informed of the incident. 4. The hospital s response will be limited to the hospital campus as defined by the EMTALA policy Responding to Requests for Emergency Medical Assistance for Individuals within 250 yards of the Hospital. Security shall coordinate notification to law enforcement, who will be notified for assistance beyond the hospital campus. Approved: 1DODD_QVDV6F-04C72397C0A80BB022F42D5357CDEE04.DocxDRAFT Code Green - Elopement.Docx El Camino Hospital Created: 08/20/2013 Page 18/219

18 Safety Program: Policies & Procedures 1DODD_QVDV6F-04C72397C0A80BB022F42D5357CDEE04.docxDRAFT Code Green - Elopement.docx Page 2 of 3 5. Patients who have the capacity to make medical decisions have the right to leave the hospital against medical advice. The physician shall be contacted about patient s decision with appropriate documentation. Refer to Patient Care Policy Leaving against Medical Advice for further guidance. 6. Any recommended external communication to the public shall be coordinated with Marketing/Communications. F. Procedure: 1. Elopement Prevention Measures: Nursing staff shall follow department procedures to help decrease elopement risk for patients. 2. Identification and Response to Patient Elopement a. Response by Unit/Department 1) If the adult patient cannot be immediately located, staff on the unit/department shall search the immediate area to locate the patient. If a pediatric patient, (including a newborn), cannot be located, staff shall follow the Code Pink/Purple procedures. 2) If the adult patient still cannot be found after a thorough search of the immediate area, staff shall do the following: a) Immediately dial 55 and report to the Call Center, who will initiate a Code Green to all users using Vocera. b) Provide name, age, gender, and physical description of patient and patient care unit where the patient was last seen to the Call Center. c) Begin completing Elopement Checklist ( Code Green - Elopement Checklist). Give the completed checklist (or a copy) to the Code Green Response team for review. After the incident, send a copy of the checklist to Security for inclusion in the event documentation. d) Notify physician. e) Document incident and outcome in medical record. b. Call Center Operator 1) Initiate Code Green over Vocera via text message to all staff. 2) If known, provide age and gender of patient and last known location. Sample text Code Green, 45 year old, male, 2C c. All Personnel 1) Upon the announcement of Code Green, available staff shall search for the patient at entry and exit points including elevators, lobbies, stairwells and fire doors for persons appearing to be a patient from another unit leaving the facility. If person appearing to be a patient is located, contact Security immediately. Staff shall search units and open areas for patient. Remember to look outside windows to see if patient is outside. Approved: 1DODD_QVDV6F-04C72397C0A80BB022F42D5357CDEE04.docxDRAFT Code Green - Elopement.docx El Camino Hospital Created: 08/20/2013 Page 19/219

19 Safety Program: Policies & Procedures 1DODD_QVDV6F-04C72397C0A80BB022F42D5357CDEE04.docxDRAFT Code Green - Elopement.docx Page 3 of 3 2) For inpatient rehabilitation patients who are brain-injured with agitation and cognitive deficits, staff will utilize the Brain-Injury protocol to approach the patient, using a quiet voice in a non-threatening manner. It is usually preferred for someone known to the patient to approach first. It is better not to touch the patient suddenly. d. Security 1) Begin reviewing video footage in search of missing patient. 2) Initiate search of campus. 3) Review the Elopement Checklist (Appendix A) that the staff completed. 4) In discussion with Code Green leader, notify law enforcement if needed. e. Code Green Response Team The Code Green response team shall convene at the location where patient was last seen. The Code Green response team consists of: Unit Manager Primary Nurse Charge Nurse Hospital Supervisor Security Officer of the Day Clinical Effectiveness Staff (when available) The unit manager shall serve as the team leader when available. All other times, the hospital supervisor shall serve as team leader. 1) Response team shall coordinate notification to physician, family, Administrator on Call, Clinical Effectiveness and police. 2) The response team shall determine when patient will be effectively discharged if patient cannot be located. 3) The response team shall determine where patient shall be examined if found inside the hospital. If the patient has left the hospital, the patient must be screened through the Emergency Department. 3. Documentation a. Staff shall complete a QRR. b. Unit staff will complete the Elopement Checklist and provide it to the Code Green Response Team. After the incident a copy shall be given to Security for inclusion in the incident after action report. G. Approvals: Central Partnership Council, June 2013 Approved: 1DODD_QVDV6F-04C72397C0A80BB022F42D5357CDEE04.docxDRAFT Code Green - Elopement.docx El Camino Hospital Created: 08/20/2013 Page 20/219

20 Safety Program: Policies & Procedures 1DODD_QVDV6F-04C72397C0A80BB022F42D5357CDEE04.docxDRAFT Code Green - Elopement.docx Page 4 of 4 Patient Care Management Council, July 2013 Approved: 1DODD_QVDV6F-04C72397C0A80BB022F42D5357CDEE04.docxDRAFT Code Green - Elopement.docx El Camino Hospital Created: 08/20/2013 Page 21/219

21 Separator Page Att 1c Code Green - Elopement Checklist.docx Page 22/219

22 Code Green: Elopement Checklist (to be completed by Staff and Security) Time Now: AM PM Date: Person reporting the incident: PATIENT DESCRIPTION: Name: Age: Height: Weight: Gender: Hair Color: Ethnicity: Black Caucasian Hispanic Asian Other: Clothing Description: Patient gown: Shirt/Blouse: Color: Pants/Slacks/Dress/Jacket: Other characteristics (tattoo(s), piercing(s), etc.) _ Color: ELOPEMENT INFORMATION Patient Last Seen: Time: (use military time) Date: Location: With Whom: How did they leave the floor? Unknown (Check box) Which direction? Unknown (Check box) Mental Status when last seen: Medications last taken: \ Substance Abuse Yes No Memory problems Yes No FAMILY CONTACT Name of Emergency Contact: Patient s Home Address: Emergency Contact Phone: Alternative Phone #: Distance to Patient s Home Address: Approved: 1DODD_QVDV6F-04C72450C0A80BB022F42D53ECBF3A80.DocxDRAFT Code Green - Elopement Checklist- 1.Docx El Camino Hospital Created: 08/20/2013 Page 23/219

23 Safety Program: Policies & Procedures 1DODD_QVDV6F-04C72450C0A80BB022F42D53ECBF3A80.docxDRAFT Code Green - Elopement Checklist-1.docx Page 2 of 2 PLEASE SEND COMPLETED CHECKLIST TO SECURITY SERVICES Approved: 1DODD_QVDV6F-04C72450C0A80BB022F42D53ECBF3A80.docxDRAFT Code Green - Elopement Checklist- 1.docx El Camino Hospital Created: 07/24/2013 Page 24/219

24 Separator Page Att 1d - PolProc_Temp Humidity.doc Page 25/219

25 EL CAMINO HOSPITAL POLICY/PROCEDURE: TEMPERATURE AND HUMIDITY IN PROCEDURAL AREAS, MONITORING OF (OPERATING ROOM, INTERVENTIONAL RADIOLOGY, LABOR & DELIVERY, INTERVENTIONAL SERVICES- MV) OUTCOMES: 1. The departments where procedures are performed will be within the set range for temperature and humidity as outlined in the AORN standards of recommended practice. 2. The chain of command will be initiated so appropriate measures are taken to ensure patient safety. SUPPORTIVE DATA: 1. The temperature and humidity must be within a certain range to avoid condensation from forming on sterile items 2. Infection risk increases in environments which are outside the prescribed temperature and humidity ranges. 3. Fire hazard risk increases in environments which are outside the prescribed range. CONTENT: 1. The temperature of the procedural areas should be monitored and recorded daily using a log or electronic documentation of the heating, ventilation and air conditioning (HVAC) system. The recommended temperature range in an operating room is between 68 F and 73 F (20 C to 23 C). If the temperature becomes out of range, the chain of command will be initiated within the department. The decision will be made whether to continue to perform procedures, or cancel & reschedule cases until proper range is re-established. This will be done in collaboration with O.R., Labor & Delivery, Interventional Radiology or Interventional Services management, Chief Nursing Officer, Infection Control, and Facility staff. 2. The humidity of the procedural areas should be monitored and recorded daily using a log or electronic documentation of the heating, ventilation and air conditioning (HVAC) system. The recommended humidity range in a procedural room is between 20% to 60%. If the humidity becomes out of range, the chain of command will be initiated with the procedural area. The decision will be made whether to continue to perform procedures, or cancel and reschedule cases until proper range is re-established. This will be done in collaboration with O.R., Labor & Delivery, Interventional Radiology or Interventional Services management, Chief Nursing Officer, Infection Control, and Facility staff. REFERENCES: 1. Recommended practices for sterilization. In: Perioperative Standards and Recommended Practices. Denver, CO: AORN, Inc; 2012:e1-e Per addendum d to ANSI/ASHRAE/ASHE Standard , an acceptable range for humidity in an operating room is between 20% to 60%. C:\utilities\distiller\temp\1DODD_QVDV6F- 04C72510C0A80BB022F42D53337BEFFE.doc\\san01\Department\OR\OR Document\ZZZZZZ OR POLICIES, PROCEDURES AND PROTOCOLS--DONT NOT ALTER WITHOUT APPROVAL\PolProc_Temp & Humidity.doc El Camino Hospital Page 26/219

26 Policy/Procedure: Diode, Green Light or Holmium Laser Page 2 of 2 3. Recommended practices for sterilization. In: Perioperative Standards and Recommended Practices. Denver, CO: AORN, Inc; 2012:e1-e36 4. ANSI/ASHRAE/ASHE Addendum d to Standard : Ventilation of Health Care Facilities Accessed November 30, AUTHOR: M. Rivera, RN 7/13 APPROVAL: O.R. Committee MV, LG, 7/13 REVIEW/REVISION: DISTRIBUTION: OR, Labor & Delivery, Interventional Radiology, Interventional Services- MV, Infection Control, Facilities \\San01\policies & procedures\clinical Procedures Committee\PolProc_Diode or Holmium Laser.doc El Camino Hospital Page 27/219

27 Separator Page Att 1e RadOnc - QA General Program docx Page 28/219

28 EL CAMINO HOSPITAL RADIATION ONCOLOGY DEPARTMENT POLICIES AND PROCEDURES 6.02 PHYSICS QUALITY ASSURANCE - GENERAL PROGRAM A. Coverage: Radiation Oncology B. Reviewed/Revised: June 2013 C. Policy Summary: Quality Assurance Program These audits serve to provide proper management oversight as required by regulatory authorities The QA program has clinical, physical, and administrative components, thus its successful implementation requires the teamwork of all personnel. The QA program shall cover the quality of all aspects of patient care services (such as taking patient data, making appointments, diagnosis, treatment planning, treatment, and follow-up), products (e.g., customized beam blocks, immobilization devices), equipment used (accelerators, simulators), and the records of all aspects of diagnosis, planning, treatment, and followup. The responsibilities for performing various tests are divided among physicists and therapists. The medical director and clinical manager are responsible for assuring that the process is implemented and documented. State and federal regulations require that certain QA (e.g., checks and measurements described in the spot-check procedures) be reviewed by a physicist within a specified time interval. The clinical manager will provide a report on QA activities to the medical director on a quarterly basis, at a minimum. The medical director will review this report to assure compliance with written policies. D. Policy and Procedure: 1. Procedure: a. Chief physicist takes the lead in the process of overseeing the Quality Assurance and Radiation Safety measure in the department. b. Each member of the team has competencies related to their role in the QA process. c. Quality Assurance and Radiation Safety Audits may be performed periodically by the appropriate qualified staff, including the Chief Radiation Expert. d. Additionally, a comprehensive review of radiation oncology s entire QA and Radiation Safety Program is conducted at intervals not to exceed twelve months depending on state and federal agencies. e. A mailed thermoluminescent dosimeter (TLD) service is used to verify that the treatment unit calibration is consistent throughout the company and within national standards. Page 29/219

29 Cancer Center Policies & Procedures 6.02 Physics QA General Program Page 2 of 2 E. Approvals: 1. A physicist must review (i.e., sign and date) all daily, weekly, and monthly QA tests, checks, or measurements that are not performed by the physicist on the respective QA forms. 2. This review shall be done on a weekly basis to ensure the QA has been performed as required. 3. QA checks and the performance of patient dose calculations/checks by the physicist must be documented by signing and dating the Quality Assurance Checklist form on a weekly frequency. 4. It is a violation of regulatory requirements if the results of certain QA tests described in the facility s spot-check procedures (i.e., daily, weekly, and monthly machine checks) are not reviewed (i.e., signed and dated) by a physicist within 7 days if the measurements were not performed by a physicist. Approved By: Robert Sinha Radiation Oncology Medical Director 6/28/13 Judy D Eliscu Radiation Oncology Clinical Manager 6/28/13 Radiation Safety Committee 7/10/13 Page 30/219

30 Separator Page Att 1f RadOnc - Trilogy Linac docx Page 31/219

31 EL CAMINO HOSPITAL RADIATION ONCOLOGY DEPARTMENT POLICIES AND PROCEDURES 6.03 PHYSICS QUALITY ASSURANCE FOR TRILOGY/LINIAC A. Coverage: Radiation Oncology contracted Physicists and Radiation Therapists B. Reviewed/Revised: June 2013 C. Policy Summary: Quality Assurance of Trilogy Linear Accelerator All radiation therapy machines must be calibrated and monitored to ensure appropriate performance as mandated by state and federal regulatory agencies to ensure safe and correct patient treatments. QA of radiation therapy equipment is primarily an ongoing evaluation of functional performance characteristics. These characteristics ultimately influence the geometrical and dosimetric accuracy of the applied dose to the patients. The functional performance of radiotherapy equipment can change suddenly due to electronic malfunction, component failure or mechanical breakdown, or can change slowly due to deterioration and aging of the components. Therefore, two essential requirements emerge: The goal of these procedures is to assure that the performance characteristics, defined by physical parameters and established during commissioning of the equipment, demonstrate no serious deviations. Additionally, these procedures shall ensure the radiation safety of both the patient and the worker when operating therapy equipment. The overall responsibility for a machine QA program is assigned to the physicist. However, a QA program for radiation therapy equipment is very much a team effort, and the responsibilities of performing various tasks are divided among physicists, and therapists. It is very important that test procedures are well documented for all units under the QA program. The results of initial baseline testing (commissioning) and future periodic testing must be recorded and dated. Records documenting the frequency of performance and the results of QA tests are important, both in retrospective analysis of trends, and in documenting current status. Additionally, numerous QA tests are required to be documented by regulatory authorities. D. Policy and Procedure: 1. PROCEDURE: QA measurements shall be performed periodically on all therapy equipment, including the dosimetry and other QA measurement devices themselves; and there shall be regular preventive maintenance monitoring and correction of the performance of the therapy machines and measurement equipment. Page 32/219

32 Cancer Center Policies & Procedures Physics Quality Assurance for Trilogy/Liniac Page 2 of 2 2. Test Frequency: a. Performance tests are distributed among daily, monthly, and annual tests.b. Daily tests include those, which could seriously affect patient positioning or patient and worker safety. b. Monthly tests include more refined testing of parameters, which will have a lower likelihood of changing over a month. c. A comprehensive test is performed on an annual basis. 3. Tolerance Values: a. The tolerance values for radiological, geometrical, and mechanical parameters are based on the TG-40. b. If a parameter either exceeds the tolerance value parameters may need to be adjusted to correct the problem and appropriate individuals, including the medical director, need to be notified to correct the problem. 4. Linear Accelerator QA: a. Daily: Therapist The therapists are required to perform a number of daily machine checks before treating patients. b. Monthly: Physics The Physicist is responsible for a number of monthly checks. c. Annual: Physicist The physicist is responsible for performing a comprehensive annual review. E. Attachments: None F. Approval: Committee and Board Approved By: Robert Sinha Radiation Oncology Medical Director 6/28/13 Judy D Eliscu Radiation Oncology Clinical Manager 6/28/13 Radiation Safety Committee 7/10/13 Page 33/219

33 Separator Page Att 1g RadOnc - Measurement of Equipment docx Page 34/219

34 EL CAMINO HOSPITAL RADIATION ONCOLOGY DEPARTMENT POLICIES AND PROCEDURES 6.04 PHYSICS QUALITY ASSURANCE - MEASUREMENT OF EQUIPMENT A. Coverage: B. Reviewed/Revised: June 2013 C. Policy Summary: All radiation therapy machines must be calibrated and monitored to ensure appropriate performance as mandated by state and federal regulatory agencies to ensure safe and correct patient treatments. D. Policy and Procedure: 1. PROCEDURE: Policy and procedure; various types of electronic equipment and software applications are used in the quality measurement of each machine. There is calibration and spot check technology utilized in the maintenance and checking of this equipment. 2. Chamber and Electrometer System: a. Calibration: 1. The physicist is responsible for ensuring the timely calibration of the electrometer and ion chambers. 2. The electrometer and ion chambers must be sent to an Accredited Dosimetry Calibration Laboratory at intervals not to exceed 24 months or after any servicing that may affect its calibration. 3. When sending out the electrometer and chamber for calibration, ensure that another electrometer and chamber are available within the department during the time the electrometer and chamber are gone. b. Constancy Check: 1. The chamber and electrometer system must be checked for constancy by the physicist or dosimetrist at intervals not to exceed 12 months. 3. Survey Meter: a. Calibration: 1. The physicist is responsible for ensuring the timely calibration of all survey meters. Survey meters must be sent to an Accredited Dosimetry Calibration Laboratory or equivalent at intervals not to exceed 12 months or after any servicing that may affect its calibration. Page 35/219

35 Cancer Center Policies and Procedures Physics Quality Assurance - Measurement of Equipment Page 2 of 2 2. When sending out the meter for calibration, ensure that another meter is available within the department during the time the electrometer and chamber are gone. 4. Barometer/Thermometer: 5. General: a. The physicist is responsible for inter-comparing thermometers with each other and with a certified thermometer at intervals not to exceed 12 months. b. The physicist is responsible for inter-comparing the barometer with a mercury system at intervals not to exceed 12 months. a. Source-to-film distance (SFD) standardization A standard SFD (140 cm) is used whenever possible in order to minimize the chance for error. Arc Software Check Map Software Check Water Phantom E. Attachments: None F. Approvals: Robert Sinha Radiation Oncology Medical Director 6/28/13 Judy D Eliscu Radiation Oncology Clinical Manager 6/28/13 Radiation Safety Committee 7/10/13 Page 36/219

36 Separator Page Att 1h RadOnc - Eclipse Treatment Planning System docx Page 37/219

37 EL CAMINO HOSPITAL RADIATION ONCOLOGY DEPARTMENT POLICIES AND PROCEDURES 6.05 PHYSICS QUALITY ASSURANCE ECLIPSE TREATMENT PLANNING SYSTEM A. Coverage: Radiation Oncology B. Reviewed and Revised: June 2013 C. Policy Summary: QA TREATMENT PLANNING COMPUTER SYSTEM Software for Varian Trilogy Varian Accelerator To ensure the treatment-planning computer is calculating the appropriate beams and doses for patient treatment. A phantom is used to approximate the body of a person that is being treated. The computer software shall be commissioned for each treatment machine, energy, and modality at the time of purchase of the software with accuracy verified annually and every time a software upgrade is installed. D. Policy and Procedure 1. PROCEDURE: a. Program Documentation The physicist and dosimetrist is responsible for ensuring that the program d d documentation is complete and readily available in the following categories b. Beam Data Library 1) The beam data shall be acquired by a qualified radiation oncology physicist using a water tank with an automated dose acquisition system. 2) The standard generated beam data (% depth doses, output factors, scatter factors, tissue phantom ratios and combinations of these) shall be kept in digital form and/or in a beam data or dosimetry notebook for use in hand calculations and for comparisons. c. Operating Instructions and Data I/0 The complete operating instructions, including procedures for entering individual patient data and machine parameters into the system in order to carry out a treatment plan, are contained in the Treatment Planning System technical manuals. 2. Test Procedures: a. Initial User Test Procedures The computer software shall be commissioned for each treatment machine, energy, and modality at the time of purchase of the software with accuracy verified annually and every time a software upgrade is installed. Page 38/219

38 Cancer Center Policies and Procedures Physics Quality Assurance Eclipse Treatment Planning System Page 2 of 2 b. Acceptance Testing 1) All digitizers on the planning system will be checked by entry of a standard outline, plotting the outline and comparing the plot to the original. 2) The CT phantom will be scanned and the CT numbers will be measured and used for entering relative electron density curves and comparisons. 3) The computer calculated dose distributions for a selected set of conditions in standard phantoms are compared to measured dose distributions for equivalent phantoms. 4) The dose at selected points in phantom shall be independently calculated by hand. 5) The calculated dose distributions for a selected set of summation conditions in standard phantoms will be made to be compared to the distributions calculated for the annual quality control test of the treatment planning system. 6) A standard irregular field will be calculated for the initial test and results compared for the annual tests. c. Tests after Program Modification/Upgrade 1) QA tests must be performed on the treatment planning system after program modification/upgrade. 2) The physics staff will decide if program modifications are small enough to allow only limited testing. 3) The limited tests will use a reference set of QA treatment plans and the results will be compared to the initial acceptance test results. d. Ongoing Tests 1) Monthly QA a) On a Monthly basis the physics staff must verify that the data and applications files have not changed. b) Results will be compared with results from the initial test and/or previous monthly tests. c) The monthly QA procedures and results are located in the Treatment Planning System QA binder. 2) Annual Verification a) The physics staff is responsible for performing the yearly check of the treatment planning system. b) The calculated dose distributions for a selected set of treatment conditions in standard phantoms will be compared to the results of the initial acceptance testing or the prior year s data. c) The yearly QA procedures are located in the Treatment Planning System QA binder. Page 39/219

39 Cancer Center Policies and Procedures Physics Quality Assurance Eclipse Treatment Planning System Page 3 of 3 E. Attachments: None F. Approvals: Robert Sinha Radiation Oncology Medical Director 6/28/13 Judy D Eliscu Radiation Oncology Clinical Manager 6/28/13 Radiation Safety Committee 7/10/13 Page 40/219

40 Separator Page Att 1i RadOnc - Systematic Clinical Review of Med Rec docx Page 41/219

41 EL CAMINO HOSPITAL RADIATION ONCOLOGY DEPARTMENT POLICIES AND PROCEDURES 6.06 PHYSICS QUALITY ASSURANCE - SYSTEMATIC CLINICAL REVIEW OF MEDICAL RECORDS A. Coverage: B. Reviewed/Revised: June 2013 C. Policy Summary: The QA of clinical aspects includes monitoring of the documentation in the treatment plan, the electronic medical record and the chart rounds. Multidisciplinary as well as a intradepartmental patient conference to discuss and plan the patient treatment the current status on treatment plan, side effects, problems, changes in treatment plan, social and nutrition needs. Clinical aspects are defined as chart review and film review, and can be combined into one conference called chart rounds. Chart rounds will be conducted on a weekly basis. In addition, charts must be checked by physics and by therapists on a weekly basis. The detailed protocol for chart checking is discussed below. The radiation oncologist, physicist or and therapist should each review the chart before the fifth fraction following the start of each new treatment field or field modification, on a weekly basis, and at the completion of treatment. D. Policy and Procedure: 1. PROCEDURE a. Basic Components of a Chart Review 1. The patient chart consists of the following components 2. Patient Information and History: Patient identification, such as the patient s name, ID number, and photograph. Pertinent clinical information, such as the initial physical evaluation of patient (consultation note), diagnosis of disease, stage of disease, history and physical, pathology report, diagnostic imaging reports, diagnostic laboratory reports, outside correspondence and other medical information. 3. Treatment Delivery: All of the parameters related to the treatment received by the patient are included in this section. Page 42/219

42 Cancer Center Policies and Procedures Physics Quality Assurance Systematic Clinical Review of Medical Records Page 2 of Treatment Plan: A prescription page, The simulation fields and setup instructions, MU calculations, isodose plans, TLD diode results, and special physics consultations (e.g., non-routine field abutment, dose to critical organs, etc.). signed and witnessed consent form must be in this section. 5. Treatment Field Definitions: The treatment field definitions must include detailed descriptions of patient setup position, location of treatment field relative to external patient anatomy, special treatment devices, beam modifiers, etc a photograph of the patient in the setup position. All relevant treatment field parameters (e.g., gantry angle, collimator angle, etc.) including diagrams of each treatment portal and photographs of the field marking on the patient must be documented in this section. 6. Daily Treatment Record: a. The daily record documenting the daily and cumulative doses to all prescription, critical organ, and anatomical reference points must also be included in the chart. b. This record also includes a daily record documenting treatment aids (e.g., compensating filter, wedge) and portal and verification films, and the chronology of treatment changes and remarks. 7. Clinical Data a. This section contains all of the clinical information gathered from the patient during the treatment process. This includes the clinical assessment during treatment (OTV notes) and the periodic weight, blood count, etc. with the dose to date. This section also contains the completion note containing: treatment summary and follow-up, summary of clinical problem, summary of treatment delivery, summary of patient s tolerance to treatment, summary of tumor response, and follow up plan. Page 43/219

43 Cancer Center Policies and Procedures Physics Quality Assurance Systematic Clinical Review of Medical Records Page 3 of 10 b. Overview of Chart Checking 1. The radiation oncologist, physicist or and therapist should each review the chart before the fifth fraction following the start of each new treatment field or field modification, on a weekly basis, and at the completion of treatment. 2. The review should be signed and dated by the reviewer. 3. All unintended deviations shall be documented. The unintended deviations should be promptly corrected and discussed with the appropriate staff and radiation oncologist (if applicable). 4. The document should also include corrective action(s) and suggestions for avoiding errors of this type in the future. 5. All unintended deviations must be reviewed and evaluated by the Quality Assurance Committee. 6. The committee must determine whether the error was simply an isolated mistake or whether it reflects a programmatic problem or weakness in the policies and procedures. 7. The committee should make recommendations as needed. c. Chart Check Protocol 1. Review of New or Modified Treatment Field a. The first task of the chart reviewer if to identify any changes in the treatment (e.g., change in field size, dose per fraction, etc.)or new treatment fields since the previous weekly chart review. b. The recurrent chart checking theme is to verify that all parameters are consistent from written prescription to treatment plan to simulator sheet to dose calculation to ACCESS treatment field definitions to the daily treatment record. c. The chart reviewer should check the paper chart, and record and verify system and search for: 1) new written prescriptions, Page 44/219

44 Cancer Center Policies and Procedures Physics Quality Assurance Systematic Clinical Review of Medical Records Page 4 of 10 d. Written Prescription 2) new fields or field parameter modifications (field size, gantry angle, etc.) indicated on, for example, the simulator/setup sheet, 3) an indication of modified fields on the computer treatment planning printouts or hand calculation work sheets, isodose distributions, etc., 4) MU changes under a particular field indicated in the daily record, 5) simulator and/or portal films and prints (Photos) of the field markings to identify new fields or field modifications. 6) an indication of a change in, for example, a changes or remarks section of the treatment chart. d. The chart reviewer should be especially alert to the parameters listed below; a discrepancy in any of these would cause a serious error in dose delivery: 1) wedge orientation or wedge angle, 2) source surface distance (SSD) vs. source axis distance (SAD), 3) interfield separation (e.g., using separation instead of depth for monitor unit calculations), 4) number of fields per fraction, 5) treatment unit, energy, and modality, 6) dose prescription 1. The written prescription for each site and field in the paper chart or EMR, should be reviewed to determine whether: a. written prescription has been signed and dated by the radiation oncologist. a. all written prescription changes have been signed and dated by the radiation oncologist. c. all treatment techniques are indicated (AP/PA, arc rotation, etc.). d. treatment machine, mode, and energy are identified. e. prescription (treatment) points or isodose levels are defined and conform to departmental guidelines for prescribed technique and modality. f. written prescription indicates the daily dose, total dose, and fractionation scheme. g. all beam modifying devices are identified (wedges, bolus, blocks). Page 45/219

45 Cancer Center Policies and Procedures Physics Quality Assurance Systematic Clinical Review of Medical Records Page 5 of 10 h. there is a treatment plan narrative contained in each chart which is consistent with the written prescription on the dose prescription page. i. written prescription dose is reasonable (this is a filter for gross errors such as prescribing 15,000 cgy instead of 1500 cgy). j. previously treated fields (discontinued) are clearly indicated in chart, and hidden in (EMR). k. dose would overlap with the current treatment volume. If so: 1)simulator films should be reviewed to locate such potential overlap, 2) past isodose distributions should be reviewed to locate such potential overlap and obtain the maximum cumulative dose in the overlap region. 3) separation between adjacent fields should be calculated. 4) cumulative dose to all standard points defined by department policy (e.g., dose maximum, critical organ doses, etc.) has been calculated. l. Cumulative dose to any other special points has been calculated. m. in-vivo measurements have been requested, where appropriate. e. Simulator Instructions 1. The simulator/setup page should be reviewed for each field in the paper chart and (EMR) to determine whether the following information is accurately and clearly indicated a. all physical beam parameters (e.g., SSD, gantry angle, collimator angle, field size, table vertical, electron applicator size), b. source surface distance or isocentric treatment technique, c. patient treatment position, d. patient support and immobilization devices, e. patient separation. f. reviewer should also evaluate whether the patient separation for the treatment and site is reasonable (e.g., a separation of 7.5 cm for a lateral brain is not reasonable and should alert the reviewer that something is wrong). f. Isodose Distributions, Special Dose Calculations and Measurements Page 46/219

46 Cancer Center Policies and Procedures Physics Quality Assurance Systematic Clinical Review of Medical Records Page 6 of The reviewer should determine in the paper chart or EMR, as applicable, whether: a. an isodose distribution was calculated as requested or specified by department policy. b. special calculations were performed as requested or specified by department policy (e.g., specific dose calculations, irregular fields, special equivalent square calculations, etc.). c. patient data and beam parameters used for isodose calculations, irregular field dose or point dose calculations are consistent with those specified in the simulator/setup section of the chart. For such calculations the reviewer should evaluate whether: g. MU Calculation d. the beam weight for each field agrees with the MU calculation for that particular field. e. hot spots, critical organ doses, are consistent between the calculation sheet (isodose distribution) and the treatment record, and that all parameters used in the calculation reflect those stated in the simulator/setup section (e.g., field size, gantry angles, wedge number, blocking, bolus, etc.). f. contours used for calculating isodose distributions are consistent with the separation and depth indicated in the simulator/setup sheet and used for the MU calculation. g. algorithm used for each calculation is appropriate to the modality and particular geometry of the treatment technique. 1. The reviewer should determine in the paper chart or EMR, as applicable, whether a. The daily dose calculated for each field is consistent with the total dose and fractionation scheme for that site according to the written prescription and treatment plan. b. All beam and patient parameters used for the calculation are consistent with those listed on the simulator/setup sheet and treatment plan. Special care should be given to: wedge type (if any), SSD vs. SAD treatment, patient separation, and treatment machine (modality, energy). c. Beam weighting (dose per fraction for the particular field) is consistent with the treatment plan (isodose distribution). d. MU calculations have been reviewed. If not, they should be checked immediately. Page 47/219

47 Cancer Center Policies and Procedures Physics Quality Assurance Systematic Clinical Review of Medical Records Page 7 of 10 e. All factors and parameters used for the calculation of MU are correct according to the data tables (e.g., PDD, TMR, field size factor, tray transmission factor, wedge transmission factor, etc.). f. Beam blocking is extensive, and if so, whether appropriate equivalent square (or equivalent) calculations have been made. g. Patient separation varies significantly within the treatment area, and if so, whether the separation used for the calculation corresponds to the separation at the actual clinical point of interest. h. Significant areas of high dose (hot spots) have been calculated and documented in the chart. i. For a multi-field treatment, the MU setting indicated on the daily record for a particular field corresponds to the correct MU calculation for that particular field. j. Special dose modifying devices have been used (to be ascertained by review of daily treatment record, isodose distributions, or simulator/setup sheet). Such devices include tissue compensators, special trays, transmission blocks, and occasionally a customized patient support system. If so, the reviewer should check that dose calculations have been appropriately modified. k. In the case of electron beam treatments, special block cutouts were used, and whether treatment is at extended SSD, and whether appropriate measurements (or tabulated data) were used to account for these special cases. h. Special Dosimetry Measurements 1. The physicist will determine whether the summary reports of special dosimetry measurements (e.g., TLDs, diodes, electron cutout measurements, etc.) are fully documented in the chart and lie within expected limits. i. Daily Treatment Record Page 48/219

48 Cancer Center Policies and Procedures Physics Quality Assurance Systematic Clinical Review of Medical Records Page 8 of The reviewer should determine in the paper chart or EMR, as applicable, whether a. The Monitoring Units settings indicated for each field are consistent with both the calculation work sheet and the data in the simulator/setup parameters sheet. b. Correct treatment machine, modality, and beam energy are used for each field and correctly indicated on the daily record. c. Each field treated has been signed after treatment by the therapist. d. There is definitive documentation in the treatment record (using codes, abbreviations, etc.) that the planned modifying devices (blocks, wedges, bolus, compensators, etc.) are being used. e. Cumulative total dose for each site has been correctly recorded, taking into consideration the appropriate contributions from each field in the treatment plan. f. Cumulative doses to the special calculation points (points of interest), critical organs, etc. have been correctly recorded. j. Verification of Treatment Parameters 1. The reviewer must determine whether the printed Patient Treatment Fields have been initialed and dated by the therapist on the first day of treatment (before engaging the treatment machine), indicating agreement between the treatment field parameters in the paper chart and EMR. k. Weekly Chart Review 1. As part of the weekly chart review, the reviewer should determine for each patient whether any new fields have been created or any previously treated fields modified. This can be ascertained using the methods described in the previous section. All modified and new treatment fields should be carefully reviewed in the paper chart and EMR as described in the previous section. l. Review of Previous Fields 1. For each patient, the reviewer should determine in the paper chart or EMR a. date of the previous weekly chart review b. whether the interval between chart reviews has been appropriate according to departmental policy. c. whether the chart and the calculations have been reviewed by more than one physicist. If not, every effort should be made Page 49/219

49 Cancer Center Policies and Procedures Physics Quality Assurance Systematic Clinical Review of Medical Records Page 9 of 10 to have a second pair of eyes review the chart at least once during the course of therapy. d. whether the monitor unit calculations and data entry have been reviewed by a person other than the one who performed the original calculation and data input. m. Cumulative Dose 1. The chart reviewer should determine in the paper chart or (EMR) whether: a. all doses have been correctly summed since the previous chart review. This should include the dose to the written prescription site and all additional sites such as critical organs, dose to dmax, etc. b. total dose to the written prescription point will reach the total prescribed dose prior to the next weekly chart review (if so, a note to the therapist should be written in the chart noting the last treatment). c. total dose to the written prescription point (and critical structures) exceeds the prescribed value. n. Review at Completion of Treatment 1. As a final review before the chart is placed in a file, the following items must be checked in the paper chart and EMR, within one week of completion of treatment: a. prescribed dose delivered, b. chart properly documented according to department policy, c. treatment summary included. o. Film Review: 1. Initial Portal Imaging a. The purpose of portal images is twofold: to verify that the radiation field isocenter (or other reference point) is correctly registered with respect to the patients anatomy, and that the aperture (blocks) has been properly produced and registered with respect to the radiation field isocenter. Portal films must be obtained for all treatment field at the time of treatment. Where oblique or non-coplanar fields are used, orthogonal films imaging the isocenter should be obtained, in addition to images of the treatment fields. 2. Ongoing Portal and Verification Images Page 50/219

50 Cancer Center Policies and Procedures Physics Quality Assurance Systematic Clinical Review of Medical Records Page 10 of 10 b. Portal or verification films of all fields must be obtained at least once per week, or more often for special cases. These must be reviewed by the radiation oncologist in a timely manner. 3. Film Review Conference/Chart Rounds c. Weekly treatment film review conferences will be attended by the entire planning team and the nursing staff. Inconsistencies between actual and intended treatment (e.g., between simulation images and portal images) may be more easily identified when different observers from different disciplines review the films. When a discrepancy is identified, it may be possible to determine its cause (e.g., a block cutting error, a patient positioning error, etc.) The action needed to correct the discrepancy can be discussed and directly communicated to the appropriate staff member. Written notes of the recommended corrective actions and patients reviewed, should be maintained in a file. Treatment plans and graphical dose distributions should be reviewed. It is useful to discuss the rationale for the current approach and alternate techniques, field arrangements, patient positioning, etc. E. Attachments None F. Approval Robert Sinha Radiation Oncology Medical Director 6/28/13 Judy D Eliscu Radiation Oncology Clinical Manager 6/28/13 Radiation Safety Committee 7/10/13 Page 51/219

51 Separator Page Att 1j RadOnc - CyberKnife Program (6 07).doc Page 52/219

52 EL CAMINO HOSPITAL RADIATION ONCOLOGY DEPARTMENT POLICY AND PROCEDURES 6.07 PHYSICS QA CYBER KNIFE PROGRAM A. Coverage: El Camino Hospital Physician, Physicist, and Radiation Therapists B. Reviewed/Revised: June 2013 C. Policy Summary: It is the policy at El Camino Radiation Oncology Center to provide safe operation and control of radiation producing devices. D. Policy and Procedure: 1. PROCEDURE: a. Definitions: 1) Authorized User - A board-certified Radiation Oncologist who meets the qualifications as defined by the medical staff office policy. 2) Radiation Safety Officer: An individual who has a knowledge of and the authority and responsibility to apply appropriate radiation protection rules, standards, and practices, who must be specifically authorized on a radioactive material license, and who is the primary contact with the agency. The roles and the responsibilities of the position are defined in Radiation Oncology policy ) Radiation Safety Committee: A committee to advise the administration an all matters relating to the procurement, preparation, use, storage, and disposal of radioisotopes and/or radiation producing devices that are used for the diagnosis or treatment of disease. The duties and responsibilities of the RSC are defined by Ca Code Title 17. b. Quality Assurance Frequency: 1) Daily: a) System Status Check (attachment 1) b) Linac Output Constancy Check (attachment 2) c) Safety Interlock Check (attachment 3) 2) Monthly: a) Beam Parameters Check (attachment 4) b) Robot Mastering Check (visual) (attachment 5) c) Visual Targeting Check (attachment 6) d) Imaging Alignment (Image iso-post with treatment software) (attachment 7) Page 53/219

53 Radiation Oncology Department Procedures Quality assurance responsibilities Cyber Knife Page 2 of 33 e) Beam Energy (TPR20 10 or PDD20 10) (attachment 8) f) Film Phantom Targeting Test (or 2 month interval) (attachment 9) g) Axum positioning accuracy (attachment 10) 3) Quarterly: a) Target Locating System Tracking Test (or after significant change due to maintenance or repair). b) Linac Laser Mechanical alignment check (Accuray PM procedure) (attachment 11) c) Linac Laser/Radiation Field alignment check (Accuray PM procedure) (attachment 12) 4) Annually: a) Full Calibration Report including Beam Commissioning Spot Checks as defined in California Code of Regulations, Title 17, Section b) Treatment Planning System Tests c) Beam Calibration Check d) Safety Systems Tests e) Robot Mastering (electronic) c. Instrumentation: 5) Equipment Included with CyberKnife a) Ion chamber holder Birdcage PN b) Anthropomorphic head phantom PN c) Ball-cube film cassette (with fiducials) PN d) Gafchromic film MD-22 (pre-notched) PN ) Commissioning Equipment supplied by user a) 3D Scanning Water Phantom System (Scanditronix/Wellhöfer) b) 0.6cc Farmer ion chamber c) micro ion chamber or Solid State Detector (water proof) d) Survey Meter Victoreen 450P (or equiv.) 7) Periodic Quality Assurance Equipment a) Radiochromic film ISP Gafchromic MD-22 (Accuray P/N or MD-22 prenotched by Accuray (P/N ) b) Dedicated 0.6cc Farmer chamber with 6MV buildup cap c) Small Water Phantom OR Solid Water for TG51 calibration Page 54/219

54 Radiation Oncology Department Procedures Quality assurance responsibilities Cyber Knife Page 3 of 33 d) Electrometer e) Thermometer f) Barometer g) Vidar Film Scanner Scanner h) Film analysis software ImageJ - Approved By: Robert Sinha Radiation Oncology Medical Director 6/28/13 Judy D Eliscu Radiation Oncology Clinical Manager 6/28/13 Radiation Safety Committee 7/10/13 Page 55/219

55 Radiation Oncology Department Procedures Quality assurance responsibilities Cyber Knife Page 4 of 33 (Attachment 1) Certain Parameters should be checked daily to make sure that the CyberKnife is running well and to monitor any operating parameter drift. It is recommended that the parameters in Table 1 be checked on a daily basis and the values recorded and saved. This data is extremely useful to Accuracy Field Service when diagnosing problems. Parameter Location Acceptable Range SF6 Pressure (psi) J-Box 30 psi Water Pressure (psi) Chiller side 80 ± 5 psi Water Temperature ( C) Chiller front panel 19 ± 2 C Water Flow Rate (gpm) Chiller flow meter 0.6 gpm Steering Coil 1 (amps) MCC Front Panel No drift Steering Coil 2 (amps) MCC Front Panel No drift Steering Coil 3 (amps) Inside MCC No drift Steering Coil 4 (amps) Inside MCC No drift Magnetron Heater (VAC) Modulator 9.5 ± 0.2 Gun Heater (VAC) Modulator 5.8 ± 0.2 Ion Pump (μa) MCC Front Panel N/A Magnetron Tuner MCC Front Panel or SGI N/A Dose Rate (R/min) MCC Front Panel or SGI 300 R/min Page 56/219

56 Radiation Oncology Department Procedures Quality assurance responsibilities Cyber Knife Page 5 of 33 Physics Mode (use one or the 400 R/min other, do not alternate) Express version Humidity globally 30% - 80% ParameteTable1.TTr Location Acceptable Range Table 1. CyberKnife operating parameters The acceptable range for the parameters above are somewhat machine dependant and our particular machine may be set up differently. If any of the parameters above drift substantially from their expected values, contact Accuracy Field Service. (Attachment 2) Linac Output Constancy Check/Calibration 1) The CyberKnife uses ion chambers that are vented to atmosphere. So, changes in atmospheric pressure and x-ray head temperature can affect output. It is recommended that the output be checked at least daily. If the environment where the CyberKnife is installed changes dramatically throughout a day, you may have to check more often. 2) It is also recommended that a dedicated Farmer chamber be used for this check. This is to ensure that the chamber is set up the same way each time. At the time of the initial beam calibration, attach a Farmer chamber to the birdcage chamber holder. Insert the 60mm secondary collimator. Screw the birdcage onto the CyberKnife collimator. Connect the Farmer chamber to the birdcage so that the center of the chamber is aligned with the front pointing laser. Put a 6 MV buildup cap on the chamber. Attach the triax cable to the chamber. Take note of the temperature and pressure inside the treatment room. Turn on the electrometer and verify the correct bias voltage Login to the CKS workstation and proceed to the Physics Module. Warm-up the linac by giving at least 5000 monitor units Take several chamber readings of 100 monitor units Page 57/219

57 Radiation Oncology Department Procedures Quality assurance responsibilities Cyber Knife Page 6 of 33 Average the readings and calculate the output using the temperature and pressure readings and the adjustment factor from the last calibration. Adjust the Calibration Factors to attain 1.00 MU/cGy (within 1%). Confirm the calibration by taking one or two more readings and recalculating output. Press the Save Calibration Factors Button to save the adjustments for treatment. Turn off the electrometer and remove the birdcage from the collimator. (Attachment 3) Safety Interlock Check It is important to check that some of the most important safety interlocks on a daily basis. At a minimum, it is recommended that the door interlock and the operator panel E-stop button be checked daily. In the Physics Module, run 100 monitor units. While the beam is on, open the treatment room door. The radiation should stop and a red E-stop banner should appear on the SGI screen describing the error. Close the door, recover from the error, and continue to run the radiation. Again, while the beam is on, press the operator panel E-stop mushroom switch. Once again, you should notice that the radiation stops and an error message is displayed on the SGI screen. This process can be repeated to check other interlocks if desired. (Attachment 4) Beam Parameters Check It is important to monitor a few beam characteristics on a monthly basis. It is recommended that beam symmetry, flatness, and penumbra be monitored monthly. Use the following procedure: Set up a piece of Ready-Pack film similarly to the above procedure. However, place the film under 5cm of buildup that is setup to 80cm SSD. Install the 40mm collimator. Page 58/219

58 Radiation Oncology Department Procedures Quality assurance responsibilities Cyber Knife Page 7 of 33 Expose the film with an appropriate amount of monitor units so as to not cause saturation. Develop the film. Analyze the film flatness. It should be less than 18% in both orthogonal directions. Analyze the beam symmetry using the TG 45 method (comparing profile heights at 80% of the beam width to each other). Analyze the penumbra. The 80% - 20% penumbra should be less than 4.5mm in both directions. Note: Equivalent methods such as water phantom scanning may be used. Beam energy should also be checked, for example by means of TPR 20/10 or PDD 20/10 ratio. (Attachment 5) Robot Mastering Check Move the robot to the perch position, and verify that all six witness marks on the robot arm line up. Since the Kuka robot has no witness marks it is necessary to mark each axis with a permanent pen to use as a reference alignment. (Attachment 6) Visual Targeting Check (v3.2.0 and later) (Optional) This is a quick visual check to see that all subsystems are working properly. This test is sometimes referred to as the BB test. Because this test is qualitative it is most useful for the early stages of targeting alignment, usually during acceptance and commissioning. It is included here as an optional test also useful for demonstrations of CyberKnife capability. Be sure that the linac laser is properly aligned. Use procedure Power-on the system. Place a small metal BB on the headrest and line it up close to isocenter using the wall lasers. A 2mm Beekley Y-spot works very nicely for this purpose. Create a new plan (from any CT set of which phantom CTs have been loaded). Select a body/fiducial treatment. Locate one fiducial at its default location. Select single center and locate the center to be at the default location (robot coordinates 0,0,0). Page 59/219

59 Radiation Oncology Department Procedures Quality assurance responsibilities Cyber Knife Page 8 of 33 Calculate and Save the plan. Create phantom DRRs. Select simulation and advance to the patient alignment interface and align the BB close to (0,0,0). Note: it will be necessary to turn the x-ray technique way down since there is no phantom material around the fiducial. Go to the imaging parameters interface and select the BB test mode. Follow the prompts on the screen and teach pendant to advance through the BB test. (Kuka) On the teach pendant, sim node will advance to the next node and pause there. Sim all will go through all the nodes in the path, pausing briefly at each node. The linac laser should consistently hit the BB at its center from all non-dummy nodes. (Attachment 7) Imaging Alignment (Optional) It is sometimes advisable to check the imaging system mechanical alignment. This is especially important if there has been an earthquake or other significant perturbation of the camera stands or ceiling mounted x-ray sources. To do so, use the following procedure: Attach the isopost to the camera stand. Exit the treatment room and close the door. Turn the Key on the ESCC to Service. On the ESCC, bypass all the interlocks except the door switch and E stop buttons, On the TLSPC, start the TlsController Software Turn on the imaging system and set the mode to fiducial Take an image. You may have to adjust the X-ray parameters so that you get a good image of the isocrystal. Verify that the isocrystal is at the center pixel ± 2 pixels. Close the TlS Controller program. Un-bypass the ESCC interlocks. Remove the isopost Alternately an image of the isopost can be acquired using the treatment delivery system. Page 60/219

60 Radiation Oncology Department Procedures Quality assurance responsibilities Cyber Knife Page 9 of 33 With isopost installed, acquire image, use zoom to 400%, center cross-hairs and snapshot image. Confirm that isocrystal is with 1 mm of center of cross-hairs. (Attachment 8) Film Targeting Test This test, often referred to as the end-to-end test is designed to show that CyberKnife, as a system, is highly accurate. That is, we show that the system, which integrates treatment planning, robot, image processing, linac, and the safety subsystem, performs as a whole with a high degree of accuracy. See the appendices at the end of this document for details on how to perform this test. (Attachment 9) Axum position accuracy checks This test is designed to show that the Axum treatment couch calibration is still within specifications for rotations and translations. Use the following procedure to check table calibration: Press the Home button on the hand controller while pressing the enable switches. Continue to hold the button until the table has stopped moving. Using a digital level, check the Head U/D and Roll L/R angles and confirm that they are 0 ± 0.3. Inspect the right side of the couch to ensure that the couch has fully retracted and the movement stop limit switch has been engaged on the vertical bar, see Figure 1. Page 61/219

61 Radiation Oncology Department Procedures Quality assurance responsibilities Cyber Knife Page 10 of 33 Figure 1. Axum Inferior Movement Stop Limit Switch On the forward portion of the vertical lift, confirm that the interrupter blade is positioned between the two arms of the sensor, see Figure 2. The top of the blade may not be flush with the top of the black sensor Figure 2. Axum Posterior Movement Stop Limit Switch For left/right travel, use a tape measure or other measuring device to check that the center of the vertical lift is positioned to within 5 mm of the center of the couch base. It may be convenient to Page 62/219

62 Radiation Oncology Department Procedures Quality assurance responsibilities Cyber Knife Page 11 of 33 make a mark on the base of the couch that matches up with one of the retractable covers and just check that the mark continues to line up with the cover. If any position is out of specification, manually move the axis approximately five cm for a translation or approximately 3 for a rotation and then press the Home switch again until motion stops. Recheck to see if the position is in specification. If the position is still out of specification, contact Accuray. (Attachment 10) Quarterly Quality Assurance 1. Perform all Daily and Monthly Checks as well as the checks listed below. TLS Tracking 2. The TLS subsystem is responsible for measuring and reporting patient motion. Obtain a CT of a phantom. Create a plan. Make DRR s Make a Prescription. Place a phantom on the treatment table. Advance through the Treatment menus to the patient alignment interface. Re-align the phantom to get the couch offsets close to zero. Using the couch digital readouts, move the phantom to several different positions in all three translational axes. At each position, take an image and compare the TLS estimate to the actual couch offset. The RMS of all the errors should be no more than 2mm. Remember to subtract the zero-position offsets from the data. (Attachment 11) Linac Laser Mechanical alignment check The CyberKnife uses a point laser that is coincident with the radiation field as a QA tool. The laser is reflected off an adjustable mirror. The alignment must be checked periodically. Use the following procedure to check the mechanical alignment: Install the laser secondary collimator. Move the robot so that the collimator is approximately 40cm from a flat surface (floor or table). Place a piece of paper on the surface. Allow the collimator to rotate by releasing the stop pin and hold. Page 63/219

63 Radiation Oncology Department Procedures Quality assurance responsibilities Cyber Knife Page 12 of 33 Rotate the collimator housing through its full range and mark the furthest extent of the laser as it walks across the paper. It should walk no more than 1mm. Although this is a subjective test, the next section describes a more quantitative technique. (Attachment 12) Linac Laser/Radiation Field alignment check Once the mechanical alignment is verified (above), it is important to verify that the laser is indeed coincident with the radiation field. Use for example the following procedure: Install the laser secondary collimator. Place a sheet of Ready-Pack diagnostic film on a flat surface. With a mirror, adjust the robot trajectory so it is perpendicular with the film by reflecting the laser back to the hole in the collimator. Using the front pointer, adjust the SAD to 80cm. Remove the front pointer and install the 60mm collimator. Expose the film with the appropriate number of monitor units so as to not saturate the film. For XV film, Use about 25 monitor units (without buildup). Using a sharp pin, poke a hole in the film where the laser hits. This must be done very carefully so as to not shift the film inside the envelope. Develop the film and measure the location of pin hole with respect to the radiation field. This can be done using the software tool ImageJ This should not differ more than 2mm from the center of the radiation field. (Attachment 13) Annual Quality Assurance 1. Full Calibration including Beam Commissioning Spot Checks Accuracy recommends performing the full beam data analysis on an annual basis to make sure nothing has drifted. Spot check TPR, Profile, and output factor data as necessary. See the first section of this document for beam data collection procedures. 2. Treatment Planning System Tests Accuracy recommends performing selected items from the system acceptance tests on an annual basis to make sure that nothing has changed. 3. TPS Display Page 64/219

64 Radiation Oncology Department Procedures Quality assurance responsibilities Cyber Knife Page 13 of 33 This test will verify that the CT image is displayed correctly in TPS. In addition to performing this test annually, this test should be performed anytime a new CT machine is commissioned. Place a distinguishing metal pin or BB on the side of a phantom. Record the relative anatomical position of the pin. (e.g., Left, Anterior, Superior) Obtain a CT Import the CT into the CyberKnife System and display the CT in TPS. Verify that pin appears in the appropriate place on the displayed CT. 4. TPS Distance Measurement This test will verify that TPS correctly interprets the geometrical distances from the CT. In addition to performing this test annually, this test should be performed anytime a new CT machine is commissioned. Obtain a CT of a phantom with pins or BBs distributed in three dimensions. Import the CT into the CyberKnife System and display the CT in TPS. Measure the distances between the pins on the phantom and also on the displayed images using the TPS ruler (or use the displayed coordinates). Verify that the distances do not differ more than 1mm or one pixel. 5. TPS calculations This test verifies the accuracy of calculating dose due to a single beam based on the beam central axis properties. Open and display a block phantom CT. Display an axial slice that has a flat surface in the CT at the top of the window. Create a tumor of 1 vertex at 15mm depth. Select SINGLE CENTER and choose a collimator size, for example 60. Adjust the center of the sphere to coincide with the tumor vertex, recording its coordinates in the robot coordinate system. Change files tmt_node.dat, path1.dt.good, and error_list.dat in the directory /accuray/tmp/tmp_robot_data to add a beam whose coordinates are vertically above the center and at a distance that is equal to the SAD when the PDD was collected. Select SINGLE CENTER DOSE ASSIGNMENT and NEXT. Assign some cgy to the isocenter dose, and select NEXT. Choose FINETUNE menu and turn off all the beams except the one that was added. Select this beam and, in the ACTION OPTIONS list, SET BEAM CGY to 100 cgy. Select CALCULATE. Page 65/219

65 Radiation Oncology Department Procedures Quality assurance responsibilities Cyber Knife Page 14 of 33 Verify from file /accuray/tmp/tmp_tps/plan_file that depth is 15 mm and the SAD is correct. If not, adjust the center of the sphere and the beam, and repeat the previous steps. Record dose values (using the point-dose method) at various depths, for example 15, 100, 200 mm, along the beam axis, this can be conveniently done by placing more vertices of the tumor at the specified depths. Record, similarly, dose values at various Off-Center locations, for example at 25, 50, 75 percent of the collimator size, at a certain depth. Using the commissioned beam data, do hand calculations to verify the above measurements. The accuracy should be within 1%. 6. Beam Calibration Check Using an established protocol (AAPM: TG51), check the calibration of the beam and calculate a cross calibration factor for the birdcage chamber. Usually, either solid water or a small water phantom is used for this. The 60mm collimator is usually used for calibration, so a standard 0.6cc calibrated ion chamber can be used. 1. Target Locating System Tracking Test a) The TLS subsystem is responsible for measuring and reporting patient motion. Obtain a CT of a phantom. Create a plan. Make DRR s Make a Prescription. Place a phantom on the treatment table. Advance through the Treatment menus to the patient alignment interface. Re-align the phantom to get the couch offsets close to zero. Using the couch digital readouts, move the phantom to several different positions in all three translational axes. At each position, take an image and compare the TLS estimate to the actual couch offset. The RMS of all the errors should be no more than 2mm. Remember to subtract the zero-position offsets from the data. 7. Safety Systems Checks a) On an annual basis, test the following safety interlocks: All the EPO buttons All the EMO (Estop) buttons Door Interlock Pause button on SGI display Page 66/219

66 Radiation Oncology Department Procedures Quality assurance responsibilities Cyber Knife Page 15 of 33 SF6 pressure interlock Water Flow Interlock A spot check of the PDP model and interlock For more details on any of the above tests, see the Acceptance Test Procedures. 8. Robot a) On Kuka robots perform mastering check. b) On all Robots perform Search2 calibration. Draft Testing Procedures Phantom Targeting Test Procedure using 4-piece Ball-Cube 1. Purpose. The end-to-end test is designed to show that the CyberKnife II system, which integrate treatment planning, robot, image processing, linac, and the safety subsystem can deliver radiation so that the centroid of the planned dose distribution matches the centroid of the actual delivered dose distribution within the desired error. This procedure shows how to perform the end-to-end test using either the standard 2.5 inch ball-cube accessory (Accuray part # ) or the mini 1.25 inch ball-cube accessory loaded with radiochromic film. Since the procedure for using the standard and mini ball-cubes are similar, we present the procedure for standard ball-cube and note where there are differences for the mini ball-cube. Due to the importance of the images in this document we recommend that it be reproduced in color. 2. Scope. This procedure is intended for Medical Physicists, Radiation Technologists and Accuray personnel. A CyberKnife II treatment procedure involves scanning a patient for a CT, importing the patient s CT into CyberKnife II, identifying the treatment target, designing a treatment plan, generating DRRs, and delivering the plan. The end-to-end test mimics this entire treatment process by including all these steps. During installation commissioning of CyberKnife II the end-to-end test should be Page 67/219

67 Radiation Oncology Department Procedures Quality assurance responsibilities Cyber Knife Page 16 of 33 performed for each treatment modality available at that site. These can include: 6-D Skull Tracking and a 3-D Skull Tracking mode. An anthropomorphic head phantom with film cube inside should be used for skull tracking. Consult Accuray before using a Sheila phantom for skull tracking tests. Film analysis can be performed either visually using just a ruler and graph paper or digitally using a transparency scanner and the Accuray film analysis software End to end test tool. Visual film analysis can be performed in minutes and gives accuracy of about 1 mm. Digital analysis takes about 15 minutes and has accuracy of 0.3 mm. This Appendix does not include digital film analysis. However, digital film analysis using the End to end test tool is described in the End-to-End Automation Tool Product Manual. 3. Materials 3.1. Phantoms The anthropomorphic head phantom, shown in Figure 4 can be used for both 6-D and 3-D skull tracking modes. A neck attachment is available which allows placement of a miniature film cassette anterior of the C7 vertebra. The advantage of the anthropomorphic head is that it demonstrates the ability to track a humanlike skull. Figure 4. Accuray anthropomorphic head phantom with cavity for holding ball-cube Standard ball-cube targeting tool (Accuray part # ) shown in Figure 5. This tool is made of four pieces which connect together using threaded nylon rods and nuts. A mm diameter acrylic ball is placed in the center of the cube. The standard ball-cube is placed in the cranium cavity of the head phantom. Page 68/219

68 Radiation Oncology Department Procedures Quality assurance responsibilities Cyber Knife Page 17 of 33 Figure 5. Standard ball-cube and pre-cut Gafchromic film connected together along slots Mini ball-cube targeting tool (Accuray part # ) shown in Figure 6. This tool is made of four pieces which connect together using nylon locator pins. A 19 mm diameter acrylic ball is placed in the center of the cube. The mini ball-cube can be placed in the neck phantom and using the spacer accessory it can be placed in the head phantom. Page 69/219

69 Radiation Oncology Department Procedures Quality assurance responsibilities Cyber Knife Page 18 of 33 Figure 6. Lower right: Mini ball-cube with Gafchromic film connected together along slots. Upper left: spacer block to allow the mini ball-cube to be used in the standard 2.5 inch phantom cavities. Lower Right: Mini ball-cube with Gafchromic film connected together along slots. Upper left: spacer block to allow the mini ball-cube to be used in the standard 2.5 inch (63.5 mm) phantom cavities Neck Phantom Accessory. The standard (CIRS Type) head phantom can be fitted with a neck attachment (Accuray part # , includes phantom) which replaces the standard base plate. The Neck Accessory allows the mini-ball-cube to be placed just inferior to the C7 vertebra (Figure 7). base Figure 7. Neck phantom Accessory. cover plate 3.2. Radiochromic film. Accuray recommends either Gafchromic MD-22 (Accuray part #019366) precut film, Gafchromic MD-22 pre-notched (Accuray part #017895) or Gafchromic MD-55 (Accuray part #014921), which comes in 5 inch square sheets. The larger MD-55 films must be cut down to 2.5 inch square pieces with corners removed. Unless the pre-notched film is used, slots must be cut along the center line of the film as shown in Figure 8 so the films can be placed together in the film cube Optical transparency scanner (required for digital film analysis). One option is to use a 16-bit (or 48-bit color) scanner with the ability to generate consistent and accurate density and position measurements. One example is the Epson Expression 1680 Professional - E1680-PRO. When using a photography scanner, one must be careful to perform regular calibration since these scanners do not guarantee spatial accuracy. A preferred option is to use a medical imaging scanner such as the Vidar VXR-12 or VXR-16. To use the Vidar scanner, the small pieces of radiochromic film must be placed in clear plastic pockets or taped to blank x-ray films or clear plastic sheets. Page 70/219

70 Radiation Oncology Department Procedures Quality assurance responsibilities Cyber Knife Page 19 of 33 axial film sagittal film Figure 8. Pre-cut pieces of exposed (30 Gy, 30 mm collimator) Gafchromic film, slotted to fit together. Here the reference edges were superior (one dot), Anterior (two dots) and left (three dots). 4. Procedure to use Ball-Cube to test CyberKnife II accuracy 4.1. Cut a slot on each film. The slot can be cut by marking a line on the film with a permanent marker and then cutting around the line with scissors. The best way to locate the line on the film is to trace it from a template. Figure 9 shows the dimensions and location of the slot. The cutting line should extend along the center of the film about 2 mm past the center of the film. Prenotched films (Accuray P/N ) have a smaller slot since they use a more precise cutting process. Figure 9. Sample film cutting template for standard 2.5 inch film, not to scale. Mini films should becut with slot length of / inch and the same slot width. Page 71/219

71 Radiation Oncology Department Procedures Quality assurance responsibilities Cyber Knife Page 20 of Load film cube with two pieces of film as shown in Figure 10. Standard Figure 10. How to load film into four-piece ball-cube Be sure that the axial film is aligned precisely with the anterior and left edges of the film cube. Be sure that the sagittal film is aligned with the anterior and superior edges of the film cube. Label the film reference edges with a permanent marker. Mini Standard Mini Page 72/219

72 Radiation Oncology Department Procedures Quality assurance responsibilities Cyber Knife Page 21 of 33 Figure 11. To determine if the film is aligned with the reference edges, view the cube surface at an angle and look for the light blue edge of the film. If you can see the film edge as a uniform line, even at small angles, then the film is aligned with the edge of the cube One way to align the films with the edge of the cube is to first install the films in the cube without tightening the nuts. Next, tap the reference edges of the film cube on a hard flat surface so the films slide to these edges. Sometimes the film gets stuck and it is necessary to push the film from the opposite side using a piece of paper or a business card To determine if the films are aligned with the edges of the assembled film cube, look at the reference edges from about a 45 degree angle with respect to the surface. The edge of the unexposed film should appear as a black line. If the film is below the surface the line will not appear. If it is sticking out too far you can see it sticking out and you can also feel it with your fingers. (This may take some practice.) Figure 11 shows what a loaded ball-cube looks like when the film is properly aligned with the reference edges. Figure 12. Insertion of the mini-ball cube into the neck phantom. The standard ball-cube is not compatible with the neck phantom Load the ball-cube into the phantom. It is important that the reference edges of the film cube are labeled corresponding to the labels on the films. Make sure that the cube is properly oriented within the phantom. Figure 13 shows the proper orientation of the film cube in the phantom If performing neck QA use the neck phantom accessory (021090). Figure 12 shows how to insert the mini-ball-cube in the neck phantom The edge marked superior should be at the superior edge of the phantom, etc. Page 73/219

73 Radiation Oncology Department Procedures Quality assurance responsibilities Cyber Knife Page 22 of 33 Figure 13. Proper orientation of the film cube. The anterior face of the film cube is engraved with marking to show its proper orientation in the phantom. When placed in the phantom the writing should face forward (anterior). The other directions are labeled in this photo. The mini ball-cube is unlabeled, before using it place the cube in the orientation shown and label at least the anterior, left and superior faces Generate a CT scan of the phantom containing a film cube loaded with film. To minimize measurement error due to localization, use 1.5 mm slice thickness or less, and use prospective axial slices. Follow the appropriate Accuray procedure for CT scanning. One procedure is given in the CyberKnife II User s Guide Load the CT for patient. CyberKnife II treatment software allows CTs to be loaded as PATIENT or PHANTOM. We recommend using PATIENT so you will test the TREATMENT mode instead of the SIMULATION mode ENTER TPS and OPEN the CT. We should emphasize that CT move should be adjusted to make proper DRR images. The spaces at the anterior and superior edges of DRR should be between 10 and 15 mm Move the CT center to achieve a space of 5-10 mm on the anterior and superior edges of the phantom. Too much or too little space may lead to unstable tracking Use 3-path treatment to achieve the best accuracy, for example, when performing a CyberKnife calibration (deltaman) adjustment. The dose distribution from 3-path treatments is better than for single path and this improves the targeting accuracy Set axial, sagittal and coronal view to the center of the ball and zoom in as much as possible while including the whole ball Use the Ball-cube test tool from the hidden TPS hidden menu to plan the treatment to the ball target. Refer to Appendix 2 for details on planning the treatment. Page 74/219

74 Radiation Oncology Department Procedures Quality assurance responsibilities Cyber Knife Page 23 of Generate DRRs for the treatment and prescribe treatment Deliver the treatment plan using the CyberKnife II TREATMENT mode. (We do not recommend using SIMULATION mode for these routine phantom tests). Check DRR images. Be sure space at anterior and superior is mm. Also the imaging technique (kv, ma, ms) should be adjusted to make the live images and DRR images look similar. Alternately, adjust image technique to make brightness and gradient gains within the range 0.9 to After the treatment is completed remove the ball-cube and the phantom. Always confirm the ball-cube was loaded properly into the phantom Remove the film from the film cube. Always confirm that the film was loaded properly into the ball-cube Check that the film is labeled properly. Remember to keep the film away from fluorescent lights and the sun as much as possible. Exposure to these will darken the film over several hours. The film is less sensitive to incandescent lights Locate the center of the exposure on each piece of film. The center of the axial film dose is measured with respect to the left and anterior edges. The center of the sagittal film dose is measured with respect to the anterior and superior edges. The center can be measured by laying the film over a cross drawn on graph paper and centering the dose spot on the cross. Figure 14 shows a method using two crosses that keeps the slot from interfering with the film alignment. The film axes are aligned with the rotated cross but the film is positioned so that the exposure is centered on the vertical cross. Using two crosses keeps the film slot away from the axes used to position the film. To measure the dose centroid: Center the exposed circle on the vertical cross (+) Mark the positions of the two reference edges of the film on the rotated cross (X), see Figure Remove the film and measure the distance from the center of the cross to the reference edge-marks This visual technique alone is not recommended for setting the targeting offset (Delta_man) during CyberKnife II commissioning. Better accuracy can be achieved using the digital method outlined below. Page 75/219

75 Radiation Oncology Department Procedures Quality assurance responsibilities Cyber Knife Page 24 of 33 Figure 14. Example of visual film analysis for standard 2.5 Gafchromic film. Reference edge marks shown in red Alternately, the film can be scanned in a calibrated optical scanner. It is important to check the distance calibration of the scanner by scanning a precise ruler in both horizontal and vertical orientation and calculating the true pixels/inch. It is good practice to also perform visual analysis as described above and compare the results as a check. Refer to the End-to-End Automation Tool Product Manual for details of how to analyze the film. Page 76/219

76 Radiation Oncology Department Procedures Quality assurance responsibilities Cyber Knife Page 25 of 33 Appendix 2: Using the TPS Ball-Cube Tool. 1. Purpose. The end-to-end test is designed to show that the CyberKnife II system, which integrates treatment planning, robot, image processing, linac, and the safety subsystem can deliver radiation so that the centroid of the planned dose distribution matches the centroid of the actual delivered dose distribution within the specified error. This procedure shows how to plan the end-to-end test. Since the procedure for using the standard and mini ball-cube is almost the same we present one procedure and note where there are differences for the mini ball-cube. Due to the importance of the images in this document we recommend that it be reproduced in color. 2. Scope. This procedure is intended for Medical Physicists and Accuray personnel. Treatment planning can be performed using the multi-isocenter feature of the planning system; this however can be time consuming. To facilitate this process Accuray developed a TPS tool which automates the major steps in creating a treatment plan aimed at the ball-cube ball. This procedure demonstrates how to use this tool. 3. Materials. DATA. Creating a treatment plan requires a CT scan of the test phantom containing a ballcube loaded with film. The CT must be acquired using the standard Accuray protocol. The preferred CT step size is 1 to 1.5 mm; however 2 mm step size scans have achieved sub-mm accuracy. 4. Procedure for planning a ball-cube test Acquire a CT scan of the Accuray head phantom containing a ball-cube loaded with film, and load this CT into CyberKnife Open a treatment plan with this phantom First use the Move CT tool (Figure 15) to get the proper space around the phantom DRRs (Figure 16). Accuray recommends 0 to 1 cm space on the anterior and superior edges of the phantom. Page 77/219

77 Radiation Oncology Department Procedures Quality assurance responsibilities Cyber Knife Page 26 of 33 F Page 78/219

78 Radiation Oncology Department Procedures Quality assurance responsibilities Cyber Knife Page 27 of 33 Figure 15. The Move CT Center tool must be used to set the correct position of the CT center. Figure 16. When the CT center is set properly, the gap at the anterior and superior edge of the phantom should be 0-1 cm Next, open the Ball-cube setup test tool from the TPS hidden menu The Delineate Ball window will pop-up (Figure 17). This window allows the user to control the auto-contouring process. This window allows window and level adjustment for the contouring routine. In most cases the default values (20 and 1025) will create a contour close to the edge of the ball. If the contour is consistently inside or outside the edge of the ball then these values should be adjusted The window instructs the user to outline the volume of the ball phantom, find a slice in which the ball is solid and select it toward the edge (Figure 17). It is best to first zoom in on the ball in all three TPS windows: axial, sagittal and coronal (Figure 18). Page 79/219

79 Radiation Oncology Department Procedures Quality assurance responsibilities Cyber Knife Page 28 of 33 Figure 17. The Delineate Ball window allows the user to control the automatic contouring of the target ball. Figure 18. It is helpful to zoom in on the target ball before starting the auto-contouring process. Page 80/219

80 Radiation Oncology Department Procedures Quality assurance responsibilities Cyber Knife Page 29 of To start the auto-contouring process, simply click the pointer (mouse) inside the ball on the axial view. It is important not to click outside the ball or in the film slot as this may cause an error forcing termination of the planning system. Figure 19 shows an autocontoured ball. Figure 19. Auto-contouring of the target ball. This example shows a vertical red line at the superior edge of the sagittal image. This indicates an unwanted region has been included in the contour The contouring process is not perfect. It will sometimes add small extraneous regions or create regions that are shifted off the axis of the circle. Page 81/219

81 Radiation Oncology Department Procedures Quality assurance responsibilities Cyber Knife Page 30 of 33 Figure 20. Example of unwanted contour generated by auto-contouring routine. The unwanted contour can be detected by vertical red line on sagittal view Remove the extraneous contour by deleting the contouring in the effected CT slice (Figure 20). Before you edit automatically drawn contours turn off Auto Draw option If the contour on a single slice is offset, this contour should be re-drawn manually after turning off the auto draw feature. Use the control drag tool to draw a circle that matches the ball. Although this problem is most apparent in the axial view, it is also visible in the sagittal view as a posterior bump in the contour of that slice (Figure 21). Page 82/219

82 Radiation Oncology Department Procedures Quality assurance responsibilities Cyber Knife Page 31 of 33 Figure 21. Example of error in auto contouring target ball Once the ball is delineated correctly, push the Continue button on the Delineate Ball window (Figure 17). The next window to appear is the Center Dose on Ball window (Figure 22). Figure 22. Center Dose on Ball window showing parameters for skull tracking. Page 83/219

83 Radiation Oncology Department Procedures Quality assurance responsibilities Cyber Knife Page 32 of The Collimator and Percent Dose to Align settings are determined by the type of treatment and size of the target. Table 1 gives guidelines on how to set these values. Enter the proper values in the Center Dose on Ball window. Treatment Target Sphere Collimator Approx. Isodose Skull 800 Standard mm 30 mm 70% Skull 650 Standard mm 35 mm 70% Skull 800 Mini 19 mm 15 mm 50% Skull 800 Mini 19 mm 20 mm 80% Table 1. Recommended collimator size and isodose line for Ball-cube test tool Next enter the value of Maximum MU. A value of 35 MU is usually appropriate. The goal is to get beams. After entering Maximum MU click Solve for Dose. If the calculation is successful the software will report the number of beams after about 30 seconds. It will take several minutes to complete the dose calculation Delete all but three contours (double click appropriate color in lower right corner of axial image to bring up contour window). Set these contours to be the desired contour plus one 10% higher and one 10% lower. Turn off the ROI and the yellow circle for each window using the buttons at the base of each window. This makes the contours easier to identify. If these contours are non-concentric this indicates a possible mistake in the previous steps. The contours shown in Figure 23are typical for this test. Page 84/219

84 Radiation Oncology Department Procedures Quality assurance responsibilities Cyber Knife Page 33 of 33 Figure 23. Example of dose distribution achieved using ball-cube test tool. It is important that contours above and below the planned contour are concentric. Significant differences in contour spacing indicate increased measurement error The treatment plan is ready for treatment, save the plan and exit TPS. Always use at least five different tests to calculate changes to the CyberKnife targeting offset (deltaman). Page 85/219

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86 EL CAMINO HOSPITAL RADIATION ONCOLOGY DEPARTMENT POLICIES AND PROCEDURES 6.08 PHYSICS QUALITY ASSURANCE FOR HIGH DOSE RATE (HDR) BRACHYTHERAPY QUALITY MANAGEMENT PROGRAM (QMP) A. Coverage: Radiation Oncology and contracted physics staff B. Reviewed/Revised: June, 2013 C. Policy Summary: It is the policy at El Camino Hospital Radiation Oncology to provide safe operation and control of radioactive materials used with the high-dose-rate (HDR) Brachytherapy afterloader and to provide proper response to emergency and abnormal situations. This procedure is applicable to the Quality Management Program for the Iridium- 192 sealed sources for the HDR afterloader. D. Policy and Procedure: PROCEDURE: a. Definitions: 1. Authorized User: physician licensed by the California State Board of Medical Examiners who meets the applicable requirements of CA Code Title 17 on the facility Radioactive Materials License. 2. Misadministration: A brachytherapy radiation dose: a. Involving the wrong individual, wrong radioisotope, or wrong treatment site; b. Involving a sealed source that is leaking; c. When, for a temporary implant, one or more seeds are not removed upon completion of the procedure; or d. When the calculated administered dose differs from the prescribed dose by more than 20 percent from the prescribed dose. 3. Recordable Event: The administration of: a. A radiopharmaceutical or radiation without a written directive where a written directive is required; b. A radiopharmaceutical or radiation where a written directive is required without daily recording of each administered radiopharmaceutical dosage or radiation dose in the appropriate record; c. A brachytherapy radiation dose when the calculated administered dose differs from the prescribed dose by more than 10 percent of the prescribed dose. Page 87/219

87 Radiation Oncology Department Procedures Quality assurance responsibilities for oversight of physics in radiation oncology Page 3 of 7 4. Radiation Safety Officer: An individual who has a knowledge of and the authority and responsibility to apply appropriate radiation protection rules, standards, and practices, who must be specifically authorized on a radioactive material license, and who is the primary contact with the agency. The roles and the responsibilities of the position are defined in CA Code Title Radiation Safety Committee: A committee to advise the administration an all matters relating to the procurement, preparation, use, storage, and disposal of radioisotopes and/or radiation producing devices that are used for the diagnosis or treatment of disease. The duties and responsibilities of the Radiation Safety Committee are defined by CA Code Title 17. b. Quality Management Items: Prescriptions: 1) No HDR brachytherapy treatment shall be administered without a dated and signed or initialed written directive from an individual named on the ECH Radioactive Material license as an authorized user of the specific radioactive material prescribed. 2) Except where a delay to provide a written directive would jeopardize the patient s health (see below), a written directive must be prepared prior to administration of any brachytherapy radiation dose. a) An oral directive is acceptable when a delay to provide a written directive would jeopardize the patient s health because of the emergent nature of the patient s condition. The information contained in the oral directive must be documented immediately in the patient s record and a written directive prepared within 24 hours of the oral directive. b) An oral revision to an existing written directive is acceptable when a delay to provide a written revision to an existing written directive would jeopardize the patient s health. The oral revision must be documented and the authorized user must sign a revised written directive within 48 hours of the oral revision. c) A written directive, which changes an existing written directive, can be made for any diagnostic or therapeutic procedure if the revision is dated and signed by an authorized user prior to the administration of the next brachytherapy dose. Patient Treatment (HDR): 1) Before administering a brachytherapy treatment, the radiation therapist(s) shall verify by patient identity by the patient s name in the computer for patient s records: birth date, the name on the patient s ID, or a photograph of the patient s face. This verification is documented on the Microselectron Patient QA Checklist. 2) Before administering an HDR brachytherapy dose, the radiation therapist(s) administering the dose shall assure that the specific details of treatment delivery are in accordance with the written prescription of the authorized Radiation Oncologist. The Therapist must verify that the isotope, treatment site, and total dose are in agreement with the written prescription and plan of treatment prior to each treatment. Page 88/219

88 Radiation Oncology Department Procedures Quality assurance responsibilities for oversight of physics in radiation oncology Page 4 of 7 3) Therapists, Physicians, and Physicists must clarify all orders when there is a question or uncertainty about the plan of treatment. Treatment Planning: 1) Prior to administration of an HDR treatment, CT simulation will be completed for use in treatment planning and source position verification. 2) Prior to treatment, an authorized user shall approve a plan of treatment that provides sufficient information and direction to meet the objectives of the written prescription. For brachytherapy procedures, a graphical plan will be produced prior to treatment which identifies the isotope used in the calculation and shows the intended source position(s), activities, and dwell times. The plan will indicate the absorbed dose calculated at the reference point (or surface) specified in the prescription. 3) Dose calculations shall be independently checked prior to the administration of the prescribed brachytherapy dose. a) The authorized user has a period of two days in which to perform the checks of dose calculations would jeopardize the patient s health or the patient s condition. b) An authorized user or a qualified person under the supervision of an authorized user (e.g. radiation therapy physicist, oncology physician, dosimetrist, or radiation therapist), who did not make the original calculations, shall check the dose calculations. c) This calculation must be performed and compared with the computer calculated total dwell time prior to each treatment. Agreement shall be within the tolerance established by the radiation oncology physicist. d) Additionally, the computer-generated dose calculations should be checked to verify that correct input data for the patient were used in the calculations (e.g. source strengths and positions). e) Computer-generated dose calculations for input into the HDR unit should be checked to verify correct transfer of data from the computer (e.g. channel numbers, source positions, and treatment times). f) The performance of these checks (and others as specified by the radiation oncology physicist) shall be documented in the quality assurance form, along with the initials of the person performing the check. Page 89/219

89 Radiation Oncology Department Procedures Quality assurance responsibilities for oversight of physics in radiation oncology Page 5 of 7 Post Treatment: 1) After the administration of the brachytherapy treatment, an authorized user shall date, sign or initial a written record of the calculated administered dose in the patient s chart or other appropriate record. 2) The auditable form will be retained for at least three years, each written prescription and a record of each administered dose where a written prescription is required. 3) After the administration of an HDR treatment, an authorized user or a person acting under the supervision of an authorized user records the calculated administered dose, the total dwell time, the treatment site, and the date of treatment, along with the initials of the individual making the record. 4) The authorized user dictates and signs or initials a treatment summary, which includes the calculated administered dose per fraction and the calculated total administered dose. c. Supervision: 1) Because ECHRO permits the receipt, possession, use and transfer of radioactive materials and the operation of radiation-producing machines by an individual under the supervision of an authorized user, ECHRO will instruct the supervised staff in principles of radiation safety appropriate to that individual s use of radioactive material and x-ray machines. 2) All employees in Radiation Oncology shall attend annual training in radiation safety and machine safety (on-site) and emergency procedure. Documentation of such training will be retained in employee file. 3) ECHRO requires the authorized user to be immediately available to communicate with the supervised individuals. 4) A Radiation Oncologist is always available for consultation in the Radiation Oncology office during working hours. 5) ECHRO requires the authorized user to be able to be physically present and available to the supervised individual within one (1) hour. Radiation Oncologists will be physically present and available within one (1) hour of notification of a clinical need that requires his/her presence. When a specific physician is out of town, that physician will make arrangements for a backup authorized user to respond. 6) ECHRO requires that only those individuals specifically designated by the authorized user be permitted to administer radionuclides or radiation to patients. Each Radiation Oncologist named as an authorized user in the ECHRO license has the right to specify which individuals they will permit to administer radiotherapy to patients under their care. Page 90/219

90 Radiation Oncology Department Procedures Quality assurance responsibilities for oversight of physics in radiation oncology Page 6 of 7 d. Review of the Quality Management Program: 1) The Radiation Safety Committee, through the Radiation Safety Officer, shall perform a periodic review of the brachytherapy QM program. 2) To verify compliance with all aspects of the quality management program the review shall include: a) An evaluation of a representative sample of patient administrations within the review p events within the review period, b) All recordable period, c) All misadministrations within the review period. 3) The review shall be conducted at intervals not to exceed twelve (12) months. 4) A record of each review shall be maintained for inspection by the State of California in auditable form for three (3) years and shall include evaluations and finding of the review. a) The number of patient cases sampled will include a representative number of patient administrations from the past twelve (12) months (or since the last review) 1) The number of patient cases to be sampled will be based on the principles of statistical acceptance sampling and should represent each treatment modality performed at the institution. The method outlined in Subpart C Quality Control Sampling Procedures in US NRC 10 CFR will be followed, with a lot tolerance percent defective of 5% or less. 2) The cases will be selected randomly LOT TOLERANCE PERCENT DEFECTIVE (PERCENT ERROR) 5.0% Lot Size Sample Size Acceptance Number 1 to 30 ALL 0 31 to to to to to Table 1. Sampling Criteria. Page 91/219

91 Radiation Oncology Department Procedures Quality assurance responsibilities for oversight of physics in radiation oncology Page 7 of 7 h. In each case, an evaluation will check for the following items: 1) A valid and complete written directive was present prior to treatment. The lack of a valid and complete written directive is unacceptable. 2) There is documentation of patient identification by more than one means prior to administering treatment. The lack of documentation is unacceptable. 3) There is documentation of patient pretreatment, treatment, and post treatment checks, i.e. patient survey, room survey, source check, positioning check, etc. The lack of documentation is unacceptable. 4) Agreement between what was administered versus what was prescribed in the written directive. Disagreement between what was prescribed and what was delivered is unacceptable. i. The number of unacceptable discoveries that are allowed for each sample size and lot tolerance percent defective will be derived from the acceptance sampling tables. j. For each case reviewed, the Committee will identify deviations from the written directive, the cause of each deviation, and the action required to prevent recurrence. 1) The actions may include new or revised policies, new or revised procedures, additional training, or increased supervisory review of work. 2) Corrective actions for deficient conditions will be implemented within a reasonable time after identification of the deficiency. k. The QM program s policies and procedures shall be reviewed after each annual review to determine whether the program is still effective or to identify actions to make the program more effective. E. Approval by: Robert Sinha Radiation Oncology Medical Director 6/28/13 Judy D Eliscu Radiation Oncology Clinical Manager 6/28/13 Radiation Safety Committee 7/10/13 Page 92/219

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93 Radiation Oncology Procedures Physics Quality Assurance High Dose Rate (HDR) Operating and Safety Procedures Page 1 of 6 EL CAMINO HOSPITAL RADIATION ONCOLOGY DEPARTMENT POLICIES AND PROCEDURES 6.09 HIGH DOSE RATE (HDR) OPERATING & SAFETY PROCEDURES A. Coverage: All Radiation Oncology/Medical Physics personnel B. Reviewed/Revised: June, 2013 C. Policy Summary: It is the policy at ECH Radiation Oncology to provide safe operation and control of radioactive materials used the highdose-rate (HDR) brachytherapy afterloader and to provide proper response to emergency and abnormal situations. D. Policy and Procedure: 1. System security: a. The system is secured from unauthorized use by removal of the keys when not in use. b. The treatment console area is a restricted area within the radiation oncology department accessible to authorized personnel only. c. The device containing the sealed source is secured within the treatment room with a cable to prevent operation beyond the designated treatment area or removal from the facility. d. Only authorized licensed personnel shall install, maintain, adjust, or repair the HDR device involving shielding or source-drive related components or install, replace, relocate, or remove a sealed source. e. The source manufacturer will have a Radioactive Materials License for source exchanges and will perform all source exchanges at intervals not to exceed six months. Page 94/219

94 Radiation Oncology Procedures Physics Quality Assurance High Dose Rate (HDR) Operating and Safety Procedures Page 2 of 6 2. Leak testing and Inventory: Sources are exchanged at less than six months. Vendor provided documentation is reviewed at the time of source installation for compliance and acceptability. All sources removed at the time of exchange are packaged by the vendor and returned to the vendor. 3. Personnel exposure: Personnel radiation exposure is monitored by a NVLAP accredited radiation badge provider. All personnel shall wear a whole body badge and a ring badges as appropriate. The badges will be exchanged on a quarterly basis. The quarterly radiation monitoring device report will be reviewed by the Radiation Safety Officer upon its arrival and sent for employee review. 4. Patient Monitoring: a. An authorized user and a licensed medical physicist with a specialty in therapeutic radiological physics shall be physically present during all patient treatments involving the HDR. b. Only a patient receiving treatment is allowed in the treatment room while the source is exposed. c. The patient shall be monitored both visually and aurally during treatment through CCTV (with backup) and intercom systems. If visual or aural communication is lost, HDR procedures will be stopped until corrective action has been performed. d. Entry into the treatment room after completion of treatment is restricted until reduction of radiation levels to ambient has been verified through use of a portable radiation survey meter. The authorized physicist, or someone under direct supervision of the authorized physicist, shall survey patients with an appropriate portable survey instrument after the treatment has been completed and prior to being released. The survey will be documented on the microselectron patient QA Checklist form. 5. System Operation: a. Access to the treatment room is controlled by a door with an interlock that prevents exposure of the source while the door is open, initiates Page 95/219

95 Radiation Oncology Procedures Physics Quality Assurance High Dose Rate (HDR) Operating and Safety Procedures Page 3 of 6 retraction of the source if the door is opened during treatment, and requires a reset after the door is closed if the interlock was activated. b. An A/B selector switch is incorporated in the interlock mechanisms to prevent dual operation of the HDR and any other radiation-producing device. c. The control console indicator and independent radiation monitor indicator is located at the entrance to the treatment room to provide a clear warning that the source is on or off. d. System operation is restricted to properly trained and licensed Radiation Therapists (RT s), authorized users, licensed medical physicists with a specialty in therapeutic radiological physics, and authorized service personnel. 6. Written Procedures: Emergency response procedures shall be developed, implemented, and available in written form at the treatment console for situations where the sealed source cannot be retracted into the shielded position by normal operation. Should the source fail to return to the safe, the unit is equipped with a manual crank for returning the source to the safe. An Emergency kit will be available near the HDR unit containing the following: 1 Wire rope and cable cutter 1 barrier tape 1 digital stopwatch 1 long handle tongs 1 12" forceps 1 Instructions to deal with each treatment procedure 7. Postings: a. A storage pig to hold the source in any extracted configuration shall be maintained in the treatment room for temporary storage of the source in the extreme case that the source cannot be returned to the safe. b. Written procedures are provided to all operational staff for securing the system. Documentation will be maintained that they have read and understood the procedures, license, and applicable state regulations. c. In the event of a malfunction of the therapy unit or safety equipment, HDR procedures will be stopped until the malfunction is corrected. If the malfunction results in unplanned exposure of a patient or other person, the RSO and/or California Bureau of Radiation Control will be notified. a. Information will be posted at the treatment console specifying the Page 96/219

96 Radiation Oncology Procedures Physics Quality Assurance High Dose Rate (HDR) Operating and Safety Procedures Page 4 of 6 location of the emergency response procedures manual, and the names, addresses, and telephone numbers of authorized users, licensed medical physicist, and RSO. b. Signs indicating Caution High Radiation Area and Caution Radioactive Materials will be posted outside the treatment room. An additional radioactive materials sign will be posted on the HDR unit. 8. Calibration, Maintenance, and Repair: a. Full calibration measurements and surveys of adjacent restricted and unrestricted areas shall be performed on the HDR afterloader by the authorized licensed medical physicists with a specialty in therapeutic radiological physics before first medical use, following replacement of the sealed source, and following repair of the unit that involves the sealed source or components related to the exposure assembly. b. A licensed vendor will calibrate survey meters annually. c. Full calibration measurements shall be performed at least as often as the minimum manufacturer s specifications and recommendations and include output measurement of the source strength to within 5% using a well chamber and electrometer calibrated within the previous two years by an ADCL. Certificates will be kept on file for review. d. Source positioning will be verified to within 1 mm. e. Source retraction with backup battery power will be verified by switching off normal power. f. Length of transfer tubes will be measured for consistency. g. Timer accuracy will be verified at typically short and long dwell times to assure linearity using an independent timer. h. Source travel time error will be measured using a two-position twodwell time comparison method. i. Lengths of all non-rigid applicators will be verified at the time of full calibration or within six months prior to use. 9. Spot Checks: a. Periodic spot checks will be performed at the beginning of each treatment day and after source exchange. The spot checks shall include verification of electrical interlocks, exposure indicator lights, viewing and intercom systems, emergency response equipment, radiation monitors, timer accuracy, clock date and time, source position and indicators to within 1 mm, condition of the transfer tubes, Page 97/219

97 Radiation Oncology Procedures Physics Quality Assurance High Dose Rate (HDR) Operating and Safety Procedures Page 5 of 6 and sealed source strength. b. Output shall be correct to within 1% of physical decay strength. c. If a system malfunction is found, the system shall be locked in the off position until corrective action is performed. d. The microselectron daily QA and Daily Patient QA Checklist form will be used to document the spot checks. 10. Treatment Times: Treatment time calculations will be independently verified using a separate method of calculation. 11. Training and Supervision: a. Device specific system operation and emergency procedures training shall be conducted initially before the first treatment and at least annually for all operators, authorized users, and licensed medical physicists. b. Emergency response drills shall be conducted before first use and at least annually. c. Records shall be kept of all training including a list of topics covered, date of instruction or drill, names of participants, and name of instructor. d. All operators without previous HDR experience of at least 10 cases will complete device specific system operation and emergency procedures and participate in 10 cases under supervision of a trained operator. Training will be conducted by a manufacturer s rep, authorized user, competent service technician, or trained licensed medical physicist with a specialty in therapeutic radiological physics. e. All system operation for patient procedures will be performed under the supervision of an authorized user and a licensed medical physicist with a specialty in therapeutic radiological physics. The licensed medical physicist will verify that established procedures are being followed. f. All other system operation will be restricted to trained personnel and will be evaluated at least annually by the RSO, authorized user, or licensed medical physicist with a specialty in therapeutic radiological physics. Ancillary personnel will be included in training regarding Page 98/219

98 Radiation Oncology Procedures Physics Quality Assurance High Dose Rate (HDR) Operating and Safety Procedures Page 6 of 6 hazardous materials and indications of radiation monitor warning signals. E. Attachments: None F. Approval: Robert Sinha Radiation Oncology Medical Director 6/28/13 Judy D Eliscu Radiation Oncology Clinical Manager 6/28/13 Radiation Safety Committee 7/10/13 Page 99/219

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100 EL CAMINO HOSPITAL RADIATION ONCOLOGY DEPARTMENT POLICIES AND PROCEDURES 6.10 EMERGENCY RESPONSE PROCEDURES FOR NUCLETRON HDR IR 192 IF THE SOURCE FAILS TO RETURN TO THE SAFE A. Coverage: Radiation Oncology and contracted physics staff B. Reviewed/Reviewed: June, 2013 C. Policy Summary: This policy details the emergency procedure to manually return a source to the safe in the event of an equipment malfunction. D. Policy & Procedure: 1. Should a system malfunction occur which affects source travel, the retract mechanism will automatically attempt to place the active source wire in the safe and parked position within 30 seconds. If retraction has not occurred after 50 seconds, the message manual retract will be indicated on the console box and the console indicates emergency procedures are required. 2. It should be noted that operation of the Manual Retract Handle will only be effective in the following case: a. The machine has failed to park the active wire and the message Retract failure, possible emergency. Check source status. is displayed. b. AND the manual retract handle is NOT turning. 3. In this case of a retract failure, users should follow the following procedures: a. This procedure should be followed if the hand wheel in not turning, radiation is present and a retract failure is indicated. 1) Enter the treatment room (Physicist) with a portable survey meter and personal dosimeter. 2) Turn the hand wheel in the direction of the arrow through at least 8 revolutions, or until the independent radiation monitor no longer detects radiation. If after at least 8 revolutions of hand wheel radiation is still detected by the room monitor or portable survey meter, continue with procedure b. outlined below. b. This procedure should be followed if the hand wheel is turning, radiation is present and a retract failure is indicated OR no retract failure is indicated and the hand wheel is not turning. Page 101/219

101 Radiation Oncology Procedures Emergency Response Procedures For Nucleotron HDR Ir 192 If the Source Fails to Return to the Safe Page 2 of 4 1) Enter the treatment room (Physicist) with a portable survey meter and personal dosimeter. 2) If an end of the wire is visually detectable in a catheter, grasp the source in the catheter with the long handled forceps. Cut the catheter above and below the source and place the removed section in the pig. 3) If the end of the wire cannot be seen or radiation is still present, if possible, all applicators/catheters should be removed from the patient (Physician) without disconnection at any point. Care should be taken in this procedure to use forceps wherever possible, and maintain the maximum distance from the patient and the HDR afterloader. Following removal, if possible, the catheters/applicators should be placed in a shielded container. c. In all cases above, 1) Remove the patient from the immediate area. 2) Survey the patient, and if safe to do so, evacuate the patient from the room. 3) A suitably qualified person must ensure that the applicator is shielded. 4) If unable to properly shield the source, leave the room. Close the door. Mark it NO ENTRY with radiation warning tape. 5) Notify all emergency contacts immediately. 4. Since ECH Radiation Oncology will be expected to report estimated exposure to staff and patient as a result of the incident, keep track of all exposure times and dose rates involved to produce a reasonable estimate of exposure to all concerned. 5. Emergency source recovery equipment consists of long hemostats and cable cutters. They will be kept on the HDR storage pig. The lead storage pig will be kept next to the HDR 6. Retain the treatment data printout and contact the following: a. Contracted Physicist: Tel: b. RSO: Ramesh Gopi, MD Tel: c. Physicians: Bob Sinha, MD Tel: d. Service: Nucleotron Tel: e. California Bureau of Radiation Control Tel: Page 102/219

102 Radiation Oncology Procedures Emergency Response Procedures For Nucleotron HDR Ir 192 If the Source Fails to Return to the Safe Page 3 of 4 7. Note: Each licensee who makes a report required by CA Code Title 17 shall submit a written follow-up report within 30 days of the initial report. Written reports prepared as required by other regulations may be submitted to fulfill this requirement if the reports contain all of the necessary information. The reports must include the following: a. A description of the event, including the probable cause and the manufacturer and model number of any equipment that failed or malfunctioned; b. The exact location of the event; c. The isotopes, quantities, and chemical and physical form of the licensed material involved; d. Date and time of the event; e. Corrective actions taken or planned and the results of any evaluations or assessments; and f. The extent of exposure of individuals to radiation or to radioactive materials without identification of the individuals by name. E. Attachments: None F. Approvals: Approved By: Robert Sinha Radiation Oncology Medical Director 6/28/13 Judy D Eliscu Radiation Oncology Clinical Manager 6/28/13 Radiation Safety Committee 7/10/13 Page 103/219

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105 EL CAMINO HOSPITAL DEPARTMENT AND PROCEDURES 6.11 HIGH DOSE RATE (HDR) CALIBRATION PROCEDURES A. Coverage: All Radiation Oncology/Medical Physics personnel B. Reviewed/Revised: June 2013 C. Policy Summary: It is the policy at ECH Radiation Oncology to provide safe operation and control of radioactive materials used with the high-dose-rate (HDR) brachytherapy afterloader and to provide proper response to emergency and abnormal situations. This procedure is applicable to calibration of Iridium-192 sealed sources for the HDR afterloader. 1. Definitions: a. Authorized User: A physician licensed by the California State Board of Medical Examiners who meets the applicable requirements of CA Code Title 17 specified on the facility Radioactive Materials License. b. Radiation Safety Officer: An individual who has a knowledge of and the authority and responsibility to apply appropriate radiation protection rules, standards, and practices, who must be specifically authorized on a radioactive material license, and who is the primary contact with the agency. The roles and the responsibilities of the position are defined in CA Code Title 17. c. Radiation Safety Committee: A committee to advise the administration an all matters relating to the procurement, preparation, use, storage, and disposal of radioisotopes and/or radiation producing devices that are used for the diagnosis or treatment of disease. The duties and responsibilities of the RSC are defined by CA Code Title 17. D. Policy and Procedure: 1. Procedure: a. Calibration Frequency: 1) The HDR source must be calibrated immediately after installation and prior to the treatment of any patients. 2) Full calibration measurements and surveys of adjacent restricted and unrestricted areas shall be performed on the HDR afterloader by the authorized licensed medical physicists with a specialty in therapeutic radiological physics before first medical use, following replacement of the sealed source, and following repair of the unit that involves the sealed source or components related to the exposure assembly. Page 106/219

106 2. Instrumentation: a. Well Chamber: 1) Standard Imaging HDR 1000 Plus well-type ion chamber, 2) Sun Nuclear Well Chamber b. Electrometer: 1) Max-4000 c. Portable Survey Meter: 1) Fluke Victoreen 451P-RYR d. Instruments used in calibration of the HDR unit must be calibrated, or cross calibrated with units calibrated by an Accredited Dosimetry Calibration Laboratory (ADCL) within the 24 months prior to the HDR calibration. The usual ADCL is at the University of Wisconsin. e. Portable survey meters must be calibrated annually by a licensed vendor. 3. Full Calibration Tests: a. Source activity will be verified within 5 %. b. Source positioning will be verified to within 1 mm. c. Source retraction with backup battery power will be verified by switching off normal power. d. Length of transfer tubes will be measured for consistency. e. Timer accuracy will be verified at typically short and long dwell times to assure linearity using an independent timer. f. Source travel time error will be measured using a two-position two-dwell time comparison method. g. Lengths of all non-rigid applicators will be verified at the time of full calibration or within six months prior to use. 4. Source Activity Calibration Guidelines: a. Place the well chamber on the tennis racket of the linear accelerator couch. This minimizes in-scatter from surrounding objects and allows use of a room scatter factor P room of Place the HDR insert in the well chamber. Place a thermometer next to the chamber. Page 107/219

107 b. Connect the well chamber to the electrometer using the triax BNC connector, passing through the wall to the HDR control console. Set the electrometer to +100% bias. Verify that the bias voltage is at least 300 V DC. Set the electrometer to measure na. c. Connect a Nucleotron quick connect to a 100 cm afterloading catheter. Place the tip of the catheter in the well chamber insert, push to make sure the tip is at the bottom, and tighten the insert. Verify the catheter is held firmly. Connect to channel 1 of the HDR indexer. d. Allow 15 minutes for the ion chamber to equilibrate to room temperature. Record the temperature of the ion chamber ( o C); record the atmospheric pressure (mmhg). 1) Calculate P TP = [( T) x 760}/(295.15*P). e. Exit the room and prepare the HDR console for exposures. f. It is necessary to find the sweet spot of the ion chamber. This is about 5 cm from the bottom of the chamber. Program an exposure from 99 to 91 cm, stepping the source in 0.5 cm steps and using a dwell time of 10 sec at each location. Record the na at each dwell position. g. Find the position of the peak reading and make a second exposure with 0.2 cm steps centered on the peak position. Record the peak na reading from this exposure as I 100. h. Switch the bias to + 150, allow a few minutes to equilibrate, and repeat the exposure. Record the na reading at the same position that was located in the previous exposure. Record this reading as I 50. i. Calculate A ion = 4/3 1/3 * (I 100 /I 50 ). Calculate P ion = 1/A ion. j. Calculate S k (air-kerma strength) in units of cgy m 2 h -1 with the formula: k. S k = I 100 * P elec * P T-P * P ion * P room * N(S k ) l. Where P elec is the electrometer calibration factor (dimensionless) and N(S k ) is the air kerma strength calibration factor for the ion chamber (Gy m 2 h -1 A -1 ). 1) Convert the S k reading to curies (Ci) by multiplying by Ci/cGym 2 h - 1 ). This value should be less than 10. m. Decay the activity for the source calibration certificate (T 1/2 = d) and compare to the measured activity. Calculate the difference. If the discrepancy is greater than 5.0%, contact the manufacture immediately. Do not give any patient treatments until the discrepancy is resolved. n. Following calibration, input the activity of the new source into the planning system and afterloader control console. 5. Source Positioning Verification Guidelines: a. Following calibration, a source should be verified. b. Remove the catheter from the well chamber. Tape the end to a ready-pack type V film. Page 108/219

108 c. Program an exposure at a series of dwell points starting at 99 cm and spaced at 3.0 cm. Use times of 16, 8, 4, 2, 1, 0.5, and 0.3 sec. d. Develop the film and examine to verify exposure uniformity. Purpose: This policy provides guidelines for the safe operation and emergency procedures for brachytherapy with the high-dose-rate afterloader. 6. Linearity Guidelines: 7. Spot Checks: a. Following activity calibration, the linearity of the HDR unit must be checked. The standard is 1.0% b. Set the electrometer to record nc. Remember to set the bias back to +100%. c. Make exposures at the sweet spot position for times of 15, 30, 60, 90, and 120 sec. Make two exposures for each time, average, and record as Q 15, Q 30, etc. d. Calculate Q 60ss1 = Q 90 Q 30 and Q 60ss2 = Q 120 Q 60. Average these to get Q 60ss. e. Calculate t = 60 * (Q 60 Q 60ss )/Q 60ss. This is the source transit time error. Expect a value between 0.3 to 0.6 sec. Tracking this value may be helpful in diagnosing a problem. f. Set up a table to check linearity. Column 1 is time, column 2 is Q, column 3 is Q/(t + t) in nc/sec, column 4 is the column 3 value relative to 60 sec. g. Average column 4 and find the deviation for each exposure time. Expected values are a. Periodic spot checks will be performed at the beginning of each treatment day and after source exchange. The spot checks shall include verification of electrical interlocks, exposure indicator lights, viewing and intercom systems, emergency response equipment, radiation monitors, timer accuracy, clock date and time, source position and indicators to within 1 mm, condition of the transfer tubes, and sealed source strength. b. Output shall be correct to within 1% of physical decay strength. c. If a system malfunction is found, the system shall be locked in the off position until corrective action is performed. d. The Microselectron daily QA checklist and the microselectron patient QA checklist will be used to document the spot checks. Page 109/219

109 E. ATTACHMENTS: NONE F. APPROVALS: ROBERT SINHA RADIATION ONCOLOGY MEDICAL DIRECTOR 6/28/13 JUDY D ELISCU RADIATION ONCOLOGY CLINICAL MANAGER 6/28/13 RADIATION SAFETY COMMITTEE 7/10/13 Page 110/219

110 Separator Page Att 1o RadOnc - (HDR) Inventory of Sealed Sources doc Page 111/219

111 EL CAMINO HOSPITAL RADIATION ONCOLOGY DEPARTMENT AND PROCEDURES 6.12 HIGH DOSE RATE (HDR) INVENTORY OF SEALED SOURCES A. Coverage: All Radiation Oncology/Medical Physics personnel B. Reviewed/Revised: June 2013 C. Policy Summary: It is the policy at El Camino Hospital Radiation Oncology to provide safe operation and control of radioactive materials. D. Policy and Procedure: 1. Procedure: a. An inventory of sealed sources, other than brachytherapy will be performed, every six months and records will be maintained, for three years for inspection. The inventory record will contain the following information: 1) Model number of each sealed source. 2) Serial number of each sealed source if one has been assigned. 3) Identify of each sealed source radionuclide. 4) Estimated activity of each sealed sources. 5) Location of each sealed source. 6) Date of the inventory 7) Signature of the Radiation Safety Officer b. The attached inventory form will be used to satisfy the requirements of the regulations or we will use an equivalent for that contains the above listed information. c. Quarterly Inventory: 1) The three-month inventory for brachytherapy sealed sources will be performed as required by Title 17, California Administrative Code. An inventory form for brachytherapy sealed sources or an equivalent form that contains the above listed information will be used. Page 112/219

112 Radiation Oncology Department Procedures Quality assurance responsibilities for Inventories of Sealed Sources Page 2 of 2 E. Attachments None F. Approvals: ROBERT SINHA RADIATION ONCOLOGY MEDICAL DIRECTOR 6/28/13 JUDY D ELISCU RADIATION ONCOLOGY CLINICAL MANAGER 6/28/13 RADIATION SAFETY COMMITTEE 7/10/13 Page 113/219

113 Separator Page Att 1p RadOnc - (HDR) Transport of Sealed Sources doc Page 114/219

114 EL CAMINO HOSPITAL RADIATION ONCOLOGY DEPARTMENT POLICY AND PROCEDURES 6.13 HIGH DOSE RATE (HDR) TRANSPORTATION OF SEALED SOURCES A. Coverage: Radiation Oncology and contracted physicists B. Reviewed/Revised: June, 2013 C. Policy Summary: It is the policy at ECH Radiation Oncology to provide safe operation and control of radioactive materials used with the high-dose-rate (HDR) brachythearapy afterloader and to provide proper response to emergency and abnormal situations. This procedure is applicable to shipping and receiving of Iridium-192 sealed sources for the HDR after-loader. D. Policy and Procedure: 1. Ordering and Receiving HDR Sources. a) HDR sources are shipped quarterly as part of the maintenance agreement for the HDR afterloader by the HDR vendor. b) The HDR vendor sends a notification when the source is shipped. c) Upon receipt of the HDR source, the package is received and surveyed by trained physics personnel and placed in the radioactive material storage area. A copy of the shipping papers is retained. d) The package will be surveyed within 3 hours of receipt and results are recorded on the HDR Ir-192 source log kept at the treatment console. 2. Opening HDR Source Containers. HDR source containers are only to be opened by certified HDR vendor service engineers at the time of source exchange. 3. Source Exchange. The manufacturer will perform all source exchanges. 4. Preparing for Shipment. It is the manufacturer s policy that HDR sources are only prepared for shipment by the manufacturer s service engineer at the time of the source exchange. 5. Copies of the return shipment documentation are retained. 6. All sealed sources will be disposed of by return to the manufacturer. It is our policy to return each source immediately after source change. Page 115/219

115 Radiation Oncology Department Procedures Quality Assurance Responsibilities High Dose Rate (HDR) Transportation of Sealed Services Page 2 of 2 E. Attachments: None F. Approvals: Approved By: Robert Sinha Radiation Oncology Medical Director 6/28/13 Judy D Eliscu Radiation Oncology Clinical Manager 6/28/13 Radiation Safety Committee 7/10/13 Page 116/219

116 Separator Page Att 1q RadOnc - (HDR) Staff Training Procedures doc Page 117/219

117 EL CAMINO HOSPITAL RADIATION ONCOLOGY DEPARTMENT POLICIES AND PROCEDURES 6.14 RADIATION SAFETY TRAINING PROCEDURES A. Coverage: Radiation Oncology and appropriate El Camino Hospital staff B. Reviewed/Revised: June, 2013 C. Policy Summary: It is the policy at El Camino Hospital Radiation Oncology to provide safe operation and control of radioactive materials. D. Policy and Procedure: 1. PROCEDURE: a. Radioactive materials procedures involving the use of sources for brachytherapy, CA Code Title 17, will be performed at El Camino Hospital Mountain View and Los Gatos. b. General Radiation Training Program. 1) All individuals who in the course of employment are likely to receive an occupational dose in excess of 100 millirem (1mSv) in a year will be: 2) Informed about the storage, transfer, or use of sources of radiation in the facility; 3) Instructed in the health protection problems associated with exposure to radiation and the precautions or procedures to minimize such exposures, and the purposes and functions of protective devices employed; 4) Instructed in and observed to the extent applicable the provisions of these regulations and licenses for the protection of personnel from exposures to radiation; 5) Instructed of their responsibility to report promptly to the radiation safety officer (RSO) any condition that may cause a violation of the facility s license or any unnecessary exposure to radiation; 6) Instructed in the appropriate response in the event of any unusual occurrence that may involve exposure to radiation; and 7) Advised of the radiation exposure reports that workers are furnished pursuant to section CA Code Title 17. Page 118/219

118 Radiation Oncology Department Procedures Quality assurance responsibilities for oversight of physics in radiation oncology Page 2 of 2 c. All authorized users, medical physicists, radiation therapists, dosimetrists and nursing personnel as applicable will receive the training as described above. In addition the following categories of personnel will be trained: Security Ancillary Housekeeping Others d. The method of training will include the following: Lectures Videos Self-study Demonstrations Other Healthstream E. Attachments: None F. Approvals: ROBERT SINHA RADIATION ONCOLOGY MEDICAL DIRECTOR 6/28/13 JUDY D ELISCU RADIATION ONCOLOGY CLINICAL MANAGER 6/28/13 RADIATION SAFETY COMMITTEE 7/10/13 Page 119/219

119 Separator Page Att 1r RadOnc - QA Responsibilities doc Page 120/219

120 EL CAMINO HOSPITAL RADIATION ONCOLOGY DEPARTMENT PROCEDURES 6.15 QUALITY ASSURANCE RESPONSIBILITIES FOR OVERSITE OF PHYSICS IN RADIATION ONCOLOGY A. Coverage: Radiation Oncology Physicists (contracted) and Radiation Therapists B. Reviewed/Revised: New May, 2013 C. Policy Summary: This policy insures that patient safety guidelines and timely maintenance of all Radiation Therapy equipment is documented, maintained and reported to all appropriate committees/channels. D. Policy and Procedure: Physics practices in all hospitals are bound by State and Federal requirements. Clinical oversite of the Radiation Oncology Department is held by the Medical Director of Radiation Oncology. While it is the responsibility of the chief physicist to oversee the quality assurance and radiation safety process in the Radiation Oncology department, oversite for mandatory quality assurance reports and equipment used to insure the accuracy of treatment delivery will be the responsibility of the Radiation Oncology manager. 1. PROCEDURE: The following QA requirements, as outlined in detail in the State and Federal Requirements, and accompanying reporting requirements are summarized below: a. HDR: Radiation Therapist HDR treatment QA MicroSelectron Daily QA checklist MicroSelectron Patient QA checklist MicroSelectron Monthly QA checklist MicroSelectron Source Change QA Checklist Monthly QA and calibration report (computer print-out) Quarterly source change documentation (computer print-out) b. Trilogy Linear Accelerator: Monthly check by physics will include calibration and a review of the therapist s daily checks. An annual report for the accelerator will be due every June. c. CT simulator: Morning warm-up of the CT scanner will be done and documented by the therapists with daily, monthly and quarterly oversight by contracted Physicist. Page 121/219

121 Radiation Oncology Department Procedures Quality assurance responsibilities for oversight of physics in radiation oncology Page 2 of 12 d. CyberKnife: Daily morning QA (physics checks)will be done by the Radiation Therapist and kept in the CyberKnife log book located at the treatment console. Monthly checks are done by physicist. Annual report will be due each June. 2. All equipment used to insure accuracy of treatment delivery will be serviced at the appropriate date. 3. A schedule of due dates for all reports and equipment used to insure the accuracy of treatment delivery will be maintained and compliance will be checked monthly by the manager of the radiation oncology department. 4. Quarterly and annual reports will be generated and sent to the Radiation Safety Committee for review two weeks prior to each scheduled quarterly meeting. A member of the contracted Physics team in Radiation Oncology will attend all Radiation Safety meetings. 5. The Radiation Oncology Cancer Center Review and Radiation Protection Survey will be generated yearly at the end of the fiscal year by the contracted physicist. An annual summary of the HDR program will be included in this report. It will be reviewed by the Cancer Center Executive Director, Radiation Oncology Medical Director, the department manager and the Radiation Safety Committee. After review it will be sent to MEC for approval. 6. Clinical Engineering will have oversight for any machine issues. Refer to Radiation Oncology Policy All service reports for each machine are kept in the service report binder located at the appropriate machine console. 7. Remote access for physicists related to dosimetry and treatment planning procedures will be given to appropriate personnel through the IT and IS department and will comply with all ECH IT and IS policies and procedures related to HIPAA and network access. All security documents and BAA agreement will be signed prior to access. E. Attachments: State and Federal Regulations search Title 17 and 22 a. Radiation Therapist HDR treatment QA b. MicroSelectron Daily QA checklist c. MicroSelectron Patient QA checklist d. MicroSelectron Monthly QA checklist e. MicroSelectron Source Change QA checklist f. Schedule of Due dates for reports equipment maintenance Page 122/219

122 Radiation Oncology Department Procedures Quality assurance responsibilities for oversight of physics in radiation oncology Page 3 of 12 F. Approvals: a. Radiation Oncology Department b. Radiation Safety Committee c. Patient Care Management Council d. Medical Executive Committee e. Board of Directors Approved by: Robert Sinha Radiation Oncology Medical Director 6/28/13 Judy D Eliscu Radiation Oncology Clinical Manager 6/28/13 Radiation Safety Committee 7/10/13 Page 123/219

123 Radiation Oncology Department Procedures Quality assurance responsibilities for oversight of physics in radiation oncology Page 4 of 12 Patient Name: Attachment A MR #: RADIATION THERAPIST HDR TREATMENT QA CHECKLIST Rx is completed and signed by doctor. HDR Plan is signed by doctor and the physicist Verify patient ID on printed plan with control console. Daily QA reviewed/signed by physicist. Verify treatment dose matches on plan, Rx, and console. Step Size 5mm Verify Dwell time matches Console and plan. Verify catheter lengths match plan and console. Verify HDR source activity. Doctor and physicist are present and have checked patient set-up and plan. Date FinishTime Initials If any of these verifications fail, DO NOT TREAT until the parameters have been reviewed by physicist. Page 124/219

124 Radiation Oncology Department Procedures Quality assurance responsibilities for oversight of physics in radiation oncology Page 5 of 12 Attachment B El Camino Hospital Radiation Oncology microselectron Daily QA Checklist Date: Radiation Area Monitor (PrimAlert) Pass Fail TV Monitor Functioning and Focused on Patient Pass Fail IN USE Light Above door Pass Fail Intercom Pass Fail All Interlocks Pass Fail Interrupt Pass Fail Treatment Console Indicators and Status Lamps Pass Fail Self-Test Passes Pass Fail Verify Computer-Decayed Activity Pass Fail Source Position Check Ruler 1300 mm, 1400 mm, 1500 mm Pass Fail Survey Meter Operational Pass Fail Emergency Kit Complete and in Place Pass Fail In the event of an Interlock System failure, the HDR unit and treatment console shall be locked in the OFF position until such time that the Interlock System has been repaired. Test by (print) Signature File in HDR binder. Keep for three years Page 125/219

125 Radiation Oncology Department Procedures Quality assurance responsibilities for oversight of physics in radiation oncology Page 6 of 12 Attachment C El Camino Hospital Radiation Oncology microselectron Patient QA Checklist Patient Name Treatment Date Type of Treatment Physician Present MR Number Treatment Time Fraction Number Physicist Present ID Verified by two methods (circle): Picture Name SSN Birthdate Before Procedure: Review plan at treatment unit and compare times/dwell positions: Physicist MD Written Directive Complete Emergency Kit Ready Open Retractor Cover Condition of Applicators Checked Lock Brake Two Stop Watches Badges Daily QA Done Physician Approved Localization Pre-Treatment Survey (mr/hour) Fluke Model 451P-RYR, SN 4055 calibrated: Room Patient Unit Time By Record Treatment Time (seconds) Catheter connection checked by two people Yes First Dwell: Plan Total: Plan Reading Reading Room Vacated Post-Treatment Survey (mr/hour) Fluke Model 451P-RYR, SN 4055 calibrated: Room Patient Unit Time By Room Monitor indicates source is safe Disconnect catheters prior to moving HDR unit. After treatment make a copy of physics. File original in patient s chart. Page 126/219

126 Radiation Oncology Department Procedures Quality assurance responsibilities for oversight of physics in radiation oncology Page 7 of 12 Attachment D (see below) Page 127/219

127 Attachment D EL CAMINO HOSPITAL RADIATION ONCOLOGY microselectron Monthly QA Checklist Year Calibration Result Expect +/- 5% JAN FEB MAR APR MAY JUNE JULY AUG SEPT OCT NOV DEC Timer Accuracy and Linearity 10 secs 60 secs 120 secs Position Check Using Film (record location in mm) Initials Date Page 128/219

128 Radiation Oncology Department Procedures Quality assurance responsibilities for oversight of physics in radiation oncology Page 9 of 12 Attachment E EL CAMINO HOSPITAL RADIATION ONCOLOGY microselectron Source Change QA Checklist Date Initials Survey max = 3 20 cm Source Travel Time Error Positioning Check +/- 1 mm. Have Nucletron adjust, if needed. File in HDR Binder. Keep for 3 years. Page 129/219

129 Radiation Oncology Department Procedures Quality assurance responsibilities for oversight of physics in radiation oncology Page 10 of 12 Attachment F SCHEDULE OF DUE DATES FOR QA AND EQUIPMENT Machine Daily Monthly Quarterly Annually HDR - Therapist Treatment QA - MicroSelectron Daily QA Checklist - MicroSelectron Patient QA Checklist - MicroSelectron Monthly QA Checklist - MicroSelectron Source Change QA Checklist - QA and Calibration Report - Source Change Documentation - QA Report HDR included in the Annual Cancer Center/ Radiation Oncology Review and Radiation Protection Survey (due end of fiscal year) Linear Accelerator: Trilogy - Machine QA Morning Warm-Up in Mosaiq (by therapist) - Second Check (by physics) - Patient QA including treatment plan in Mosaiq (by therapist) - Physics QA Monthly Checks and review of therapist s daily QA and chart checks (done weekly) - PMI (scheduled by vendor and therapist) - Annual Report (due in June/end of fiscal year) - Physical QA for all treatments printed and put in chart for all IMRT and RapicArc plans (by physics) CyberKnife - Daily Machine QA Morning Warm-Up in logbook by console (by therapist) - Second Check (by physics) - Physics Chart Checks and QA - PMI (scheduled by vendor and therapist) - Annual Report (due in June/end of fiscal year) - Patient QA kept in patient s chart (by therapist) - All New Plans QA (Physics) CT Scan - Morning Warm-Up (by therapist) - QA - Physics oversite and Monthly QA - Physics oversite - Preventative Maintenance (scheduled by vendor and Clinical Engineering) - Annual Report Page 130/219

130 Radiation Oncology Department Procedures Quality assurance responsibilities for oversight of physics in radiation oncology Page 11 of 12 Cancer Center/Radiation Oncology Review and Radiation Protection Survey Fluke Victoreen Survey Meter 451 P- RYR - Model #4055 Electrometer and Ion Chamber - new 5/2013 Barometer and Thermometer (2) new in 5/2013 Due annually (June/end of fiscal year) Due for recalibration annually (May) Due for recalibration annually (May) Due for recalibration annually (May) Welhoffer Water Phantom Due annually (January) Page 131/219

131 Page 132/219

132 Separator Page Att 1s - FY14 Quality Comm Goals V2.doc Page 133/219

133 Quality / Patient Care and Patient Experience Committee Goals for FY 2014 (FINAL) Purpose The purpose of the Quality, Patient Care and Patient Experience Committee ( Quality Committee ) is to advise and assist the El Camino Hospital (ECH) Hospital Board of Directors ( Board ) in constantly enhancing and enabling a culture of quality and safety at ECH, to ensure delivery of effective, evidence-based care for all patients, and to oversee quality outcomes of all services of ECH. The Quality Committee helps to assure that exceptional patient care and patient experience are attained through monitoring organizational quality and safety measures, leadership development in quality and safety methods and assuring appropriate resource allocation to achieve this purpose. Staff: Eric Pifer, MD, CMO The CMO shall serve as the primary staff support to the Committee and is responsible for drafting the committee meeting agenda for the Committee Chair s consideration. Additional clinical representatives may participate in the Committee meetings upon the recommendation of the CMO and subsequent approval from both the CEO and Committee Chair. These may include the Chiefs/Vice Chiefs of the Medical Staff, VP of Patient Care Services, physicians, nurses, and members from the Community Advisory Councils or the community-at-large. The CEO is an ex-officio of this Committee. Goals Timeline by Fiscal Year (Timeframe applies to when the Board approves the recommended action from the Committee, if applicable.) Metrics 1. Review the hospital s organizational goals and scorecard and ensure that those metrics and goals are consistent with the strategic plan and set at an appropriate level as they apply to the Quality, Patient Care and Patient Experience Committee. Q1 Review, complete and provide feedback given to management, the governance committee and the board. 2. Review any updates to the hospital s PaCT performance improvement plan and ensure that they are consistent with the strategic plan. Provide expert feedback on the plan. Q2 Review, complete and provide feedback given to management and the board. Page 134/219 1 P a g e

134 Goals 3. Ensure that all committee meetings contain a patient story that reflects the main theme of the meeting. Timeline by Fiscal Year (Timeframe applies to when the Board approves the recommended action from the Committee, if applicable.) Ongoing Metrics Meeting agendas reflect patient story 4. Educate one another, members of other committees and the board on best practices in quality management and oversight. Ongoing Goal is one educational session per committee meeting (literature review, didactic etc.) and to do some crosscommittee work. 5. Develop a template to present individual programs and processes to the committee so as to promote awareness of ECH programs, processes and activities. The template should be no more than one page and should include metrics that reflect program and process performance, overall program description, tactics for improvement, challenges and riskreduction strategies. Q1: Template Ongoing Template by Q1 Ongoing program and process presentations using the template as evidenced by the agenda throughout the year. 6. Ensure that more than 50% of committee time is spent discussing specific metrics and performance against those metrics. Ongoing Meeting agendas reflect time spent discussing metrics and program performance. Page 135/219 2 P a g e

135 Separator Page Att 1t - Quality Summary_sep_bod_qual.docx Page 136/219

136 Quality Summary September Quality Meeting Quality Division Overall the quality division has had a very busy summer with CMS survey, several other on-site investigations and finalization of the annual organizational goals. Several of the specific topics in this packet refer to this work and this is still more work going on in departments and using Lean techniques for improvement. Transition to CNO role: Cheryl has transitioned to the Interim CNO position over the enterprise. Cheryl is spending time two days a week at LG to interact and meet with the nurse and clinical leaders as well as the staff of LG. Cheryl is establishing her new direct reports team which includes members of pharmacy and lab along with all the nursing directors. The nursing strategic plan is underway for FY 2014 and we foresee its adoption at the Central Partnership Council in September. This is a requirement for Magnet Designation. We are ramping up for Magnet designation now because re designation is due to occur in mid Other leadership changes have occurred including the appointment of a new Lab Director for the Enterprise, Edwina Sequira who was recruited from Seton Medical Center with 30 years of lab experience. Jina Canson, RN has transitioned as the Director of Dialysis to the Director of Patient Care Resources (float pool, staffing office, Hospital Supervisors, Flex RN s, Inpatient Dialysis). There are over 140 employees in this area. Service Report: For FY 12-13, there are three domains of the HCAHPS survey that are included on the corporate scorecard and organizational goals in which intensive improvement efforts have occurred. HCAHPS Composite Organizational Goal for each HCAHPS Domain FY 13 Nurse Communication Staff Responsiveness Communication On Medications FY 13 YTD Performance In June as per goal measurement period Page 137/219

137 Overall goal achievement is calculated using an average of the scores of all three domains. Goal Metrics Using Domain Average: Min=65.3 Target: 66.3 Max=67.3 ECH Performance Using Domain Average from QDM Methodology: (just above Minimum) The team continues to work on many of these areas and recruitment for the Director of Patient Experience is in its final phase of interviews. In FY 14 there will be a tremendous focus on improvement in the patient experience with an organizational investment in a director as well as staff training. We are currently in the process of setting next year s goals now that year end metrics are available. CMS Survey: Nursing had zero findings during the CMS survey. The nurses worked very hard to correct the problems that had been an earlier focus related to patient restraints and falls. Safety checklists were redeployed with nursing feedback to insure all safety issues were addressed. The checklists were completed each shift by charge RN s. Lab and pharmacy each had a finding that will be fully addressed in the CMS report which we have not received as yet. We will develop corrective action plans after we more fully understand the finding that will detailed in the CMS report. However, we have put some changes in place already based on surveyor feedback while they were onsite. Surgery: We have seen a 10% increase in OR volume at MV recently. More surgeons are interested in using our OR and have asked for privileges here at ECH. The OR has done a great job in accommodating their scheduling and equipment needs. OB: Obstetrics has been a leader in the LEAN work this year and has really been a pioneer for the LEAN methodology tools. They also have seen return on their investments. We have piloted a discharge process improvement that calls for a 70% discharge rate by 12N. It took only two months to reach the goal. Dialysis: Page 138/219

138 The Evergreen Dialysis Unit treated its last patient on August 5, All patients were safely and efficiently transferred to other units. All staff that wished to bid on an open position were placed in a position are going through several different training programs including 10 RN s. Emergency Room and Nursing units: The RPIW to improve door to floor continues to sustain improvements. Target goals for 286 minutes were met by fiscal year end. In order to achieve the results, RN s have changed the way nursing hand off report is given between the ER nurses and the floor RN s. The change has not been easy. But, the nurses understand the value the change brings to the patient experience. Page 139/219

139 Separator Page Att 2 - Patient Story.pdf Page 140/219

140 Date: September 16, 2013 To: From: Re: Board Quality Committee Eric Pifer, MD Patient Story Dear Committee Members, In the September meeting of the quality committee, we will be discussing some important issues including C. Diff infection, hospital readmissions, our CMS survey and the information technology platform. The patient story relates to readmissions. This is a very complicated area. To be successful requires a multidisciplinary approach to care as well as a strong relationship with our physician community. The story is related by a member of our readmissions team. Eric Pifer, M.D. Chief Medical Officer El Camino Hospital Page 141/219

141 Separator Page Att Pat_story_september.docx Page 142/219

142 Patient: JH is a 71 Year-Old-Male PMH: Diabetes Mellitus, knee arthroscopies, laser TURP, elevated cholesterol. Patient lives at home with wife, is independent, and still works as a researcher. FMH: Mother died of colon carcinoma. August 12, 2013 routine outpatient colonoscopy revealed large mass in the cecum and multiple polyps. Recommended to have a laparoscopic hemicolectomy. August 15-17, 2013 (LOS 2 days) Scheduled admission for Laparoscopic Ileo-Cecetomy and Appendectomy. Patient was NPO first 24hours postsurgery, and then clear liquid diet prior to being discharged home. Discharged home with orders for clear liquid diet and advance as tolerated. Readmission 1: August 19-23, 2013 (Elapsed time 2 days, LOS 4 days) JH was doing well on day 1 post discharge; on day 2 began having nausea and vomiting, increasing abdominal pain and abdominal distension. Surgeon recommended patient go to emergency and was admitted for postsurgical ileus versus small bowel obstruction. Patient had nasogastric tube and remained NPO for 3 days of the hospitalization. 21 hours prior to discharge, tube was discontinued and surgeon ordered clear liquid diet and 2 hours prior to discharge advanced to full liquid diet. Diagnosis on discharge was adynamic ileus. Readmission 2: August 25-30, 2013 (Elapsed time 2 days, LOS 5 days) Approximately 48 hours after discharge, patient returned to emergency department again with nausea, vomiting, abdominal pain and distension. Patient was admitted by surgeon for decompression. Patient had nasogastric tube for 3 days and remained NPO for 4 days. On day 4, patient was advanced to clear liquid diet approximately 30 hours prior to discharge. Patient was advanced to a bland, low fiber diet 8 hours prior to discharge. Discharged with a diagnosis of adynamic ileus. Page 143/219

143 Separator Page Att 3 - Review Corporate Scorecard.pdf Page 144/219

144 Date: September 16, 2013 To: From: Re: Board Quality Committee Eric Pifer, MD Corporate Scorecard Dear Committee Members, Please find attached the corporate scorecard updated through June Excellent performance continues in core measures, pressure ulcer, patient falls and errors (medication errors and mislabeled specimens). Areas for improvement include service (although good progress has been made particularly in nurse communication and medication communication) and readmissions. Today s drill down discussion will relate to readmissions and more details on the service plan will unfold throughout the year. Questions: 1. Are there areas where we have no scorecard metrics that you would like further discussion? 2. Are there areas in the current metric set where you would like further discussion at a future meeting? Eric Pifer, M.D. Chief Medical Officer El Camino Hospital Page 145/219

145 Separator Page Att Corporate Scorecard FY13 through Jun.pdf Page 146/219

146 Corporate Scorecard FY13 Key Performance Indicator Status Trend vs Goal Quality Core Measures Quarterly Current Period Apr-May 2013 Previous Period Jan-Mar 2013 FY12 Baseline FY13 Goal Benchmark Benchmark Standard PNE Blood Culture in ED Before First Antibiotic NNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNN 100.0% 100.0% 95.5% 100% 100% best Decile PNE Initial Antibiotic Selection NNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNN 100.0% 100.0% 97.4% 100% 100% best Decile SCIP Prophylactic Antibiotic Selection NNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNN 100.0% 100.0% 99.0% 100% 100% best Decile SCIP Prophylactic Antibiotics Stopped within 24 Hours NNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNN 97.4% 98.0% 97.1% 100% 100% best Decile Core Measures % of Possible Performance Points NNNNNNNNNNNNNNNNNNNNNNNNNNNN 88.2% 77.3% 73.7% 86% NA Service* Monthly Apr-Jun 2013 Communication with Nurses* NNNNNNNNNNNNNNNNNNNNNNN 75.7% 75.7% 73.2% 75.0% 80.5% best Quartile Responsiveness of Hospital Staff* NNNNNNNNNNNNNNNNNNNNNNN 63.2% 63.2% 60.2% 64.0% 70.9% best Quartile Communication About Medicines* NNNNNNNNNNNNNNNNNNNNNNN 62.2% 63.5% 56.6% 60.0% 65.8% best Quartile HCAHPS % of Possible Performance Points* NNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNN 28% 33% NA 28% NA Outcomes Monthly Apr-Jun 2013 Hospital Onset C. diff Infection Rate NNNNNNNNNNNNNNNNNNNNNNN CA Mean Complications Index NNNNNNNNNNNNNNNNNNNNNN best Decile Mortality Index NNNNNNNNNN NNNNNNNNNNNNNNNNNNNNNN best Decile Mar-May Patient Safety Monthly Apr-Jun 2013 Stage 3-4 Hospital Acquired Pressure Ulcer/10,000 Acute PD NNNNNNNNNNNNNNNNNNNNNNN best Quartile Patient Falls / 1000 Adj Pt Days NNNNNNNNNNNNNNNNNNNNNNN NA 5 Rights Medication Errors / 1000 Adj Pt Days NNNNNNNNNNNNNNNNNNNNNNN NA Mislabeled Specimens per Month NNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNN NA 60 NA Mar-May 2013 Mar-May 2013 Feb-Apr Mar-May 2013 Page 147/219 * Values for this measure take a couple of months to finalize. The value displayed was accurate as of 8/16/ of 2

147 Corporate Scorecard FY13 Key Performance Indicator Status Trend vs Goal Current Period Previous Period FY12 Baseline FY13 Goal Benchmark Benchmark Standard Affordability Apr-Jun 2013 Mar-May 2013 Efficiency Monthly Medical-Surgical Length of Stay Improvement Opportunity* NNNNNNNNNNNNNNNNNNNNNNN GMLOS Observation ALOS (hours) NNNNNNNNNNNNNNNNNNNNNNN NA Minutes from ED Arrival to Admit to Unit NNNNNNNNNNNNNNNNNNNNNNN CEP Mean OR Room Turnaround within 35 min NNNNNNNNNNNNNNNNNNNNNNN 65% 66% 66% 67% NA Worked Hours per CMI Adjusted Discharge NNNNNNNNNNNNNNNNNNNNNNN median Total Operating Expense per CMI Adjusted Discharge NNNNNNNNNNNNNNNNNNNNNNN 14,090 13,827 13,045 14,332 NA Financial Viability Monthly Total Operating Margin NNNNNNNNNNNNNNNNNNNNNNN 9.2% 8.1% 10.5% 0.0% 3.3% median Inpatient Operating Margin NNNNNNNNNNNNNNNNNNNNNNNN NA NA 2.0% 1.4% NA Outpatient Operating Margin NNNNNNNNNNNNNNNNNNNNNNNN NA NA 27.4% 19.2% NA Adjusted Discharges NNNNNNNNNNNNNNNNNNNNNNN 7,949 8,145 7,826 7,438 NA 2,479 Total Days Cash on Hand NNNNNNNNNNNNNNNNNNNNNNN median Days of Accounts Receivable NNNNNNNNNNNNNNNNNNNNNNN median Continuum of Care Monthly Apr-Jun 2013 Patient Centered Medical Home Visits NNNNNNNNNNNNNNNNNNNNNNNNNNNNNN NA NA NA 1440 NA 30 Day All Cause Readmission NNNNNNNNNNNNNNNNNNNNNN 7.95% 8.00% 7.77% 7.65% 7.40% CA Top Decile 7 Day Unplanned Readmission after Discharge NNNNNNNNNNNNNNNNNNNNNNN 2.73% 2.63% 2.53% 2.28% NA Adj 7 Day Unplanned Readmission after Disch to a SNF NNNNNNNNNNNNNNNNNNNNNNN 5.46% 5.08% 4.69% 4.41% NA Employee Wellbeing Quarterly Employee Lift/Transfer Injury Rate NNNNNNNNNNNNNNNNNNNNNNNNNNNNNN NA CY12 CY13 % Employees Completing Health Risk Assessment NNNNNNNNNN 13.1% NA 7% 20% NA % Employees Completing Biometric Screening NNNNNNNNNN 20.9% NA 9% 20% NA Page 148/219 * Values for this measure take a couple of months to finalize. The value displayed was accurate as of 8/16/ of 2 Jan-Mar 2013 Mar-May 2013 Oct-Dec 2012

148 Separator Page Att 4 - Final FY 2014 Organizational Goals with Targets.pdf Page 149/219

149 Date: September 16, 2013 To: From: Re: Board Quality Committee Eric Pifer, MD Organizational Goals Dear Committee Members, Please find attached the El Camino Hospital FY 14 organizational goals with specific targets. As we have discussed target selection is complicated. In some cases it may be best to choose a long target period and moderately aggressive targets. This is generally best when you have a process you believe to be in control or where you have already made great improvement so that you are performing at a high level. Conversely, you select a short target period and a more aggressive target when you have poor overall performance and you want to drive performance during a single measurement year. We have already made a choice to move from 7 day hospital readmissions to 30 day and focus on Medicare patients. This move will force us to think more broadly past the initial post hospital period and drive different structures to be developed. Focusing on Medicare patients will emphasize the group of patients that are so critical to our success. Thus for the 30 day readmission rate goal we have chosen (INSERT). For falls, we believe we have a process that has made dramatic improvements and we are performing at a high level in the last quarter of the year: 1.22 falls per 10k patient days. So we have selected a long measurement frame, annual performance, and a moderately aggressive target. For core measures, we believe we have a process that is very nearly in control and we have selected the same targets as last year and a long (annual) measurement period. Questions: 1. Have we selected appropriately aggressive targets? 2. Have we picked the right measurement periods based on what you know? Eric Pifer, M.D. Chief Medical Officer El Camino Hospital Page 150/219

150 Separator Page Att Quality Committee pptx Page 151/219

151 FY14 Goal Setting Discussion Presentation to Quality Committee September 16 th 2013 Page 152/219

152 FY13 Performance FY 13 Corporate Goals Performance Performance Levels (% of Total) Performance Weight x % Minimum Target Maximum Level (out of a max of Performance Category Weight Goal (40%) (75%) (100%) Actual Year End Achieved 30%) 70% Organizational Goals Regulatory Pass/Fail Joint Commission Accreditation Threshold Financial Viability Pass/Fail 90% Budgeted Operating Margin Threshold Financial Performance Meet Budgeted.5% > Budgeted 1%> Budgeted 10.50% Meet Budgeted Margin Margin Margin Margin 2.80% Maximum 3.15% Quality 14.00% Core Measure Performance 84% 86% 90% 88.2% Target 3.73% Quality 14.00% Patient Fall Rate Maximum 4.20% Service 10.50% Average of Staff Communication 75%, Medication Communication 60%, Staff Responsiveness 64% 65.30% 66.30% % Minimum 1.37% Efficiency 10.50% ED Arrival to Admit to Unit Target 2.51% Continuum of Care 10.50% 7 Day Unplanned Readmission after Discharge (4th Quarter) 2.45% 2.28% 2.15% 2.59% Below Minimum 0.00% Incentive Award Multiplied by Salary 70% Corporate FY 13 Corporate Goals Sub-Total (70% of a possible 30% Bonus= 21%) 14.95% 30% Individual Note: 14.95% of 21% is 71% of the possible Corporate payout Page 153/219

153 FY14 Goal Setting Discussion What we heard from the Quality Committee discussions: Focus on fewer goals Balance between National Goals and True Indicators Benchmarked goals are preferred over internal trend goals What we are recommending for the Quality Committee to consider: Eliminate Core Measure Performance from the Organizational Goals, we will still track Core Measure performance via the Corporate Goals. Shift from All Falls, an internal trend indicator, to CALNOC s definition of Falls, a benchmarked, inpatient focused indicator. Set Service Goals based on June 2013 percentile ranking. Target 60th percentile, a dramatic improvement in percentile rank. Use All Cause MEDICARE Readmission within 30 Days as our Continuum of Care goal. Inherent challenges: planned vs unplanned readmission, unable to see data of our patients readmitted into another facility. Page 154/219

154 FY14 Goals: Organizational Goals Performance Category Regulatory Financial Viability Financial Performance 70% Pass/Fail Pass/Fail Goal 12.00% Meet Budgeted Margin Minimum (40%) Meet Budgeted Margin Performance Levels (% of Total) Target (75%) Organizational Goals.5% > Budgeted Margin Maximum (100%) 1%> Budgeted Margin Quality 0.00% Core Measure Performance: ELIMINATE Quality 12.00% Patient Falls (CALNOC, Q4) Service Weight 12.00% Average of Staff Communication, Medication Communication, and Staff Responsiveness (Q4). Minimum is substain June 2013 percentile performance of 27%ile, 45%ile, and 35%ile, respectfully. Target is 50%ile for all three, Maximum is 60%ile for all three. (note: percentile is based on June 2013 rankings) Avatar Scores: 75, 62, 63 for an average of : 66.6% Joint Commission Accreditation 90% Budgeted Operating Margin Avatar Scores: 78, 63, 66 for an average of: 69% Avatar Scores: 79, 64, 68 for an average of: 70.3% Efficiency 12.00% ED Arrival to Admit to Unit (Median Q4) Continuum of Care People 12.00% 10.00% 30 Day All Cause Readmission (Medicare) 11.80% 11.40% 11.20% Biometrics Screening Employee Participation Rate 42% 52% 54% Page 155/219

155 Falls per 1000 Patient Days FY14 Goals: Patient Falls Enterprise Patient Fall Rates Enterprise CALNOC Falls/1000 Med/Surg/CC PD Enterprise All Falls/1000 Total Adjusted PD CALNOC Best Quartile ( daily census) CALNOC Best Decile ( daily census) Jul-Sep 2011 Oct- Dec 2011 Jan- Mar 2012 Apr- Jun 2012 Jul-Sep 2012 Oct- Dec 2012 Jan- Mar 2013 Apr- Jun Page 156/219

156 FY14 Goals: Patient Falls CALNOC Fall Definition: The rate per 1000 patient days at which patients experience an unplanned descent to the floor (or extension of the floor, e.g., trash can or other equipment, including bedside mat). All falls are reported and described by level of injury or no injury, and circumstances (observed, assisted, restrained at the time of the fall). - Include Assisted Falls (when a staff member attempts to minimize the impact of the fall, it is still a fall). - Exclude Intentional Falls: When a patient (age 5 or older) falls on purpose or falsely claims to have fallen, it is considered an Intentional Fall and is NOT included. It is NOT considered a fall according to the CALNOC definition. - The Benchmarks used are for the CALNOC hospitals with an average daily census of 100 to 200. Both best quartile and best decile benchmarks are provided. Note: Only the Medical/Surgical/Critical Care unit falls are included in the numerator of the CALNOC Falls Rate. Page 157/219

157 FY14 Goals: Patient Falls Denominator Definitions CALNOC Patient Days (Med/Surg/CC ) Enterprise: The sum of all medical, surgical and critical care patient days including short stay days. Page 158/219

158 FY14 Goals: Patient Falls Recommendation The FY 2014 Corporate Scorecard will include only CALNOC Registry benchmarked falls The FY 2014 goal will be calculated based on the Enterprise CALNOC Fall rate during 4 th Quarter (April-June 2014) FY 2014 Goals - Minimum = Target = Maximum= 1.6 (CALNOC Best Quartile as of June 2013) Within 3 years the goal is to reach the CALNOC Best Decile which is currently 0.82 Page 159/219

159 FY14 Goals: 30 Day Readmission 30 Day All Cause Readmission - Medicare 14.0% 13.0% 12.6% 12.5% 12.9% 13.3% 12.0% 11.0% 10.0% 9.0% 11.4% 10.5% 11.5% 11.6% 11.4% 11.3% 10.1% 11.9% 11.4% 10.0% 11.4% 10.5% 8.0% 7.0% 6.0% 5.0% All Cause Planned Unplanned Linear (Unplanned) 4.0% 3.0% 2.0% 1.0% 0.0% 1.00% FY 12 Q1 1.1% 1.0% 1.6% 1.5% Q2 Q3 Q4 FY 13 Q1 1.5% 1.0% 1.3% Q2 Q3 Q4 Note: Planned = Elective Admission; Unplanned = Urgent/Emergent Admission Page 160/219

160 FY14 Goals: 30 Day Readmission Definition All Cause MEDICARE Readmission within 30 Days by Quarter Numerator: Denominator: Readmission is assigned to the month of the original discharge. Inpatient to Inpatient only. Medicare FFS only. Discharges during the month (MV and LG). Medicare FFS only. Numerator & Denominator Exclude: o ECH Psych patients o Initial Discharge Disposition of Death, AMA, Acute Care Transfer, LG Rehab o Patients readmitted to LG Rehab Note: Hospital-Wide All-Cause Unplanned Readmission Measure, Final Technical Report, Pages found on the QualityNet website. Our data does not reflect patients readmitted to another Acute Care Hospital which can be an additional 20%. This data includes only traditional Medicare fee for service ( Medicare A) only. Page 161/219 10

161 FY14 Goals: 30 Day Readmission Recommendation The FY 2014 Corporate Scorecard will measure CMS 30 Day All Cause Readmission The FY 2014 goal will be calculated based on the decrease of.5% between FY 12 (12.3%) and FY 13 (11.8%) Medicare 30 Day All Cause Readmission FY 2014 Goals - Minimum = 11.8% - Target = 11.4% - Maximum= 11.2% Page 162/219

162 FY14 Goal: Service Current %ile Minimum Target Maximum Staff Communication 27% Medication Communication 45% Staff Responsiveness 35% Current Performance 50%ile 60%ile as of Aug 2013 Note: We have improved performance for the first two months of this fiscal year, the minimum goal is to maintain that performance throughout the year and during the measurement period of 4 th quarter Page 163/219

163 Separator Page Att 5 - Quality Program: C. Difficile Infections.pdf Page 164/219

164 Date: September 16, 2013 To: From: Re: Board Quality Committee Eric Pifer, MD Clostridium Difficile Infection Dear Committee Members, Please find attached our progress to date on C. Diff infection. This is an infection that is exceedingly difficult to benchmark because of the differences in how the infection is identified (PCR versus culture) and attributed to one institution versus another. This infection is the bane of hospitals and skilled nursing units everywhere because it is difficult to eradicate and has a spore form that can survive outside the body for a long time. These spores can only be eliminated from surfaces with bleach and from hands with soap and water (alcohol based gels don t work). The infection tends to activate when broad spectrum antibiotics are used on an individual patient and it can be promoted by the use of proton pump inhibitors which raise the ph of the stomach. El Camino has done a great deal of work on this infection across multiple areas over the years and the result has been a decline in our overall rates. Questions: 1. From your experience are there other things we could try to reduce the risk of this infection? 2. Is it your impression that there is adequate public awareness of this infection and the risks that excessive use of antibiotics bring? 3. How can we improve public awareness? 4. Have we set our internal targets appropriately? Eric Pifer, M.D. Chief Medical Officer El Camino Hospital Page 165/219

165 Separator Page Att C_diff_Qualcom_Sep_13_fin.pptx Page 166/219

166 Clostridium Difficile Infection and Prevention Efforts Eric Pifer M.D. Chief Medical Officer El Camino Hospital Page 167/219

167 Overview C. Diff is a particularly vexing infection It forms spores and can survive outside the body for long periods of time. It is not eliminated by alcohol based hand gels. It is common and a new strain has emerged that is even more devastating and likely to cause death Attribution of having acquired the infection in the hospital is difficult as it takes days for symptoms to develop after acquisition. It is promoted by the use of broad spectrum antibiotics (and proton pump inhibitors) which have become ubiquitous in hospitals and nursing homes Page 168/219

168 FY 2013 Goal: To Decrease Hospital-Onset C. diff rate to 8.04 FY Enterprise Rate Infection Prevention and Control Team Strategies: Daily tracking of C. diff patients Notification to nursing unit when hospital-onset case identified Infection Control member on Antibiotic Stewardship Committee Education given to nursing staff and EVS staff on C. diff prevention strategies Monitor Hypervirulent cases of C. diff; report findings to Santa Clara County Public Health C.diff surveillance on admission for SNF patients (to start in September 2013) Patient: Hand hygiene education to patients on admission Hygiene: Daily bathing, clean sheets, clean hands before meals Healthcare Worker: Hand hygiene: Adhere to WHO Guidelines Proper use of PPE in patients known to be C.diff positive Place rule out C.diff patients on Contact Precautions Environment: (EVS) ATP monitoring of discharge room cleanliness: 92% pass rate of high touch areas Daily cleaning of C.diff rooms with 2 step method including bleach Page 169/219

169 Page 170/219

170 Enterprise HO C. diff rate FY FY 2013 Page 171/219

171 # Cases #Cases C.diff HV (Hypervirulent cases): 2012 total=17/ YTD=15/ Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec NonHV HV Jan Feb Mar NonHV HV Page 172/219 6

172 #Cases # Cases FY2013 : C.diff Tracking (HV hypervirulent) HV vs. Non- HV (CO: Community-onset vs. HO: Hospital-onset) C.diff HV vs. Non-HV Jan Feb Mar NonHV HV Infection Source Jan Feb Mar CONonHV CO HV HONonHV HO HV Page 173/219 7

173 Next Steps Implement the surveillance at admission program. Continue with hand hygiene efforts, room cleansing audits, antimicrobial stewardship efforts. Continue monitoring. Page 174/219

174 Separator Page Att 6 - Quality Program: Readmissions.pdf Page 175/219

175 Date: September 16, 2013 To: From: Re: Board Quality Committee Eric Pifer, MD Transitions in Care Dear Committee Members, Please find attached a presentation on our program for transitions in care. The program has come a long way in the development of specific programs aimed at reducing readmissions. However, to date, we have not yet made overall breakthroughs. We have numerous anecdotes about improvements in care, but it is not yet reflected in our overall numbers as shown in the graphs. Some of this may relate to inadequate methods for risk adjusting patients at high risk of readmission. A larger issue, however, is likely the degree of ownership that we are able to engender with our physicians and the various resources and coverage available to independently practicing physicians in the community. Questions: 1. Based on past experience do you have any thoughts about how we are going about addressing transitions and readmissions? 2. Please specifically comment on ways of engaging physicians more deeply in this process. Eric Pifer, M.D. Chief Medical Officer El Camino Hospital Page 176/219

176 Separator Page Att Board Quality 9-13_EP.ppt Page 177/219

177 Transitions of Care Program September 2013 Page 178/219

178 Timeline July 30, 2012 ECH receives a $500,000 grant from the Gordon and Betty Moore Foundation to reduce readmissions and improve transitions of care October 1, 2012 key personnel are hired December 11, 2012 Transitions of Care Program officially began Grant Goals Implementation of an evidencebased comprehensive discharge planning and after hospital care intervention for high risk patients Implementation of a transitional care program to reduce readmissions for high risk patients, leading to a 30% reduction in 30-day all cause readmission rates and a 15% reduction in 90-day all cause readmission rates compared to (2010) baseline Sustained reduced readmission rates through 2016 Page 179/219

179 Transitions of Care Program Page 180/219 3

180 Transitions of Care Team Ruth Zaltsmann, Project Manager Megan Williams, Manager Care Coordination Mae Lavente, Geriatric NP Katie Erwin, Outpatient Case Manager Evelyn Taverna, HF CNS Lynn Taylor, CT Surgery Nurse Navigator Kaye Jaramillo, ACS CNS Denise Pandya, Transition Services Liaison Jocelyn Reynoso, Transitions Pharmacist Monique Schwartz, Pharmacy Technician Stacy Burrell, Pharmacy Technician Page 181/219 4

181 Transitions of Care Workflow Daily rounds to assign team members to patients for follow up Discuss complex patients and need for additional resources (hospital or community) Once a week, review root-cause analysis of 7-day readmissions Page 182/219 5