Ambulatory Surgery Center: CMS Regulations and Survey Findings
Sue Reuss, RN Minnesota Department of Health
Ambulatory Surgery Center (ASC) Key Characteristics - distinct entity - exclusively operates for the purpose of providing surgical services to patients who do not require hospitalization, and - the expected duration of services does not exceed 24 hours following an admission.
Distinct Entity Wholly separate and clearly distinguishable OR Temporally Distinct: using the same physical premises with another entity as long as separated in usage by time or space. -In the case of an Adjacent physician office: The waiting room, restroom, and reception area can be shared as long as they are never used by more than one of the entities at any given time.
Survey Findings An ASC and adjacent physician eye clinic were open at the same hours of operation. The clinic physician determined on his own to utilize a laser machine at the ASC for a clinic patient who required a procedure. The patient was not on the surgery schedule and had not been admitted through the ASC.
Survey Findings A Central waiting room was observed to serve as an ASC and adjacent clinic. There were two front desk receptionists, one checked in ASC patients and one checked in the clinic patients. The waiting area was shared space between the ASC and Clinic with each entity open during concurrent hours.
Temporally Separated 416.2 CMS considers an ASC to be a distinct entity if it shares spaces: So long as it is temporally separated i.e., same physical premises used by the ASC and another entity, however, both are not open at the same time
Medical Records ASC records must be: Separate from physician office records Secure and non accessible by non-asc personnel
Survey Findings While observing a patient being admitted to an ASC for a procedure, a staff member accessed the patient s electronic medical record and noticed the H&P was missing. The staff opened the patient s clinical electronic medical record and printed out the H&P, stating, I go to the clinic record to obtain information needed for the ASC and when I work in the clinic I go to the ASC record, as needed, for the clinic.
Survey Findings The ASC did not assure that only ASC designated personnel had access to the ASC medical record. The ASC s electronic medical records were not kept separate from the clinic electronic medical records.
Distinct Entity 416.2 references the ASC must maintain separate medical records that are secure and not accessible to non-asc personnel.
Electronic Health Records (EHR) Ref: Memorandum Summary S&C-09-53 Provider Choice: - Providers/suppliers have the right to use whatever system of medical records they choose as long as that system complies with its Medicare participation requirements.
Electronic Records (S&C-09-53) Medicare Participation Requirements: HIPPA Privacy Rule and the HIPPA Security Rule. These rules are found at 45 CFR Parts 160 and 164.
Governing Body
Governing Body Responsibilities 416.41 Determines, implements and monitors policies governing the ASC s total operation. Ongoing and direct oversight and accountability of QAPI program (See 416.43) Ensures quality healthcare is provided in a safe environment Develops and maintains a disaster preparedness plan Oversees the delivery of the ASC contracted services, credentials, privileges, evidence of training, periodic evaluation, etc.
Governing Body: Quality Assessment and Performance Improvement (QAPI) The governing body must ensure that the QAPI program: -Is defined, implemented and maintained by the ASC Addresses the ASC s priorities and evaluates all improvements for effectiveness. Specifies data collection methods, frequency, and details Clearly establishes expectations for safety
Survey Findings Review of the QAPI and Governing Body minutes, the Governing Body did not provide leadership and review of the QAPI program. QA reports were not given to the Governing Body for review. The Governing Body minutes did not reflect QAPI activity and did not reflect QAPI activity had been presented to the board.
Survey Findings Review of QAPI minutes and the governing board minutes, neither minutes addressed the safety and effectiveness of the services provided by each contracted service and did not ensure contracted services were part of the QAPI program.
Disaster Preparedness 416.41(c) (1) The governing body must assure the ASC has a policy and procedure and maintains a written disaster preparedness plan. (2) The ASC coordinates with the State and local authorities, as appropriate (3) The ASC conducts drills, at least annually, to test the plans effectiveness. The ASC must complete written evaluation of each drill.
Disaster Preparedness Plan Hazard identification: Any potential hazards that could affect the facility directly and indirectly for the area it is located in. Activities taken to eliminate or reduce the probability of the event or reduce the severity of the event. Preparedness, Response, Recovery Testing, Evaluating and updating the plan.
Survey Findings Review of the facility s emergency drill logs, annual emergency drills had not been conducted. Review of QAPI minutes lacked identification of a disaster preparedness program.
Minnesota Department of Health Office of Emergency Preparedness http://www.health.state.mn.us/oep/healthcar e/index.html piecing it altogether
Quality Assessment and Performance Improvement (QAPI)
QAPI Program The ASC must establish ongoing quality indicators to measure, track, and analyze data collected. The QAPI program must include infection control, radiology services, and contract services.
Performance Improvement Project 416.43 (d)(1) Every ASC must undertake one or more specific quality improvement projects each year. 416.43 (d)(2) ASC must document the projects being conducted, include analysis and explain actions and results.
Survey Findings Review of QAPI meeting minutes, the ASC did not document and demonstrate distinct annual performance improvement projects and/or the rationale for the project. Review of minutes identified incidents of unusual occurrences had been reported, however no root cause analysis had been completed on the incidents. No evidence was found of an investigation and no interventions were put into place to minimize risks for other patients. The action plan indicated, continue to document.
Survey Findings Review of QAPI minutes identified an issue of patient s having marks on the skin after removal of a drape. The committee indicated this would be followed up on, however, review of minutes from the next meeting identified no documentation of the concern identified, no actions were taken or analysis to determine preventive strategies to promote patient safety.
Survey Findings Review of QAPI program minutes revealed: The ASC did not identify, measure, analyze and track quality indicators. Areas of concern identified in the QAPI meeting minutes lacked actions to determine the incidence, prevalence and severity of the concerns presented. The ASC s QAPI program did not provide data or analysis to determine the scope and severity of the problem or initiate the problem for on going data collection and analysis at future meetings.
Contract Services 416.41(a) Contract services must be provided in a safe and effective manner Contract services must be included in the ASC s QAPI program ASC must maintain a list of contracted services and personnel files of all contract services and personnel.
Survey Findings ASC s were not including contract services into the QAPI program. All services require assessment for safety and effectiveness. Examples of some of the contract services not included: Radiology Pharmaceutical Laundry Housekeeping Biomed Waste Management
Survey Findings Review of contracts and committee minutes, the Ambulatory Surgery Center (ASC) did not assure that all contracted services were included in the ASC's Quality Assessment and Performance Improvement (QAPI) program. Findings include: Although the ASC had written agreements with numerous third parties for the provision of services such as anesthesia services, radiology and laboratory services, cleaning services, and building management, the contracted services were not incorporated into their QAPI program to assure services were provided in a safe and effective manner.
Radiological Services The governing body must approve in writing the radiological services provided directly or by contract to the ASC. If the ASC uses radiology services, The ASC must ensure that a qualified radiologist supervise the ASC s radiology program.
Radiologic Services 416.49 (b) (1) The ASC must have procedures for obtaining radiological services from a Medicare approved facility to meet the needs of the patient. 416.49 (b) (2) Radiologic services must meet the hospital conditions of participation for radiologic services
Survey Findings A review of the ASC s policy and procedure for radiology services failed to indicate who was responsible for overseeing the ASC s radiology services. Interview revealed that no one had been appointed to oversee the service because the ASC did not consider a C-Arm to be ionizing radiation indicating it was only used during procedures to ensure proper placement of needles.
Hospitalization 416.41(b) ASC must : Have a written transfer agreement with the nearest, most appropriate local hospital ; or Ensure that every physician performing surgery at the ASC has admitting privileges at a local hospital.
Survey Findings Based on interview, review of personnel files, governing body and medical staff bylaws and governing body meeting minutes, the ASC did not assure that medical staff privileges were reappraised every two (2) years, in accordance with the Governing Body Bylaws and the Medical staff Bylaws. Findings include: The Governing Body By-Laws indicated "All appointments to the Medical staff, except "Provisional", shall be for two (2) years only and renewable by the Governing Body pursuant to a formal reapplication." The Medical Staff By-Laws indicated, "Reappointment shall be for a period of not more than two calendar years." A review of personnel files lacked any evidence of re-credentialing or reappraisal of medical staff privileges since initially approved by the Governing Body in 2005. A review of meeting minutes of the Board of Governors lacked any information regarding reappraisal of medical staff. The Clinical Director was not aware of any reappraisals of medical staff privileges.
Patient Rights, Advance Directives and Grievences
Patient Rights 416.50 The ASC must inform the patient and/or the patients representative verbally and in writing in advance of the date of the procedure, of the patient s rights. The ASC must have a policy and procedure in place regarding patient rights.
ASC Bill of Rights (BOR) There are specific State Bill of rights which apply to an ASC under licensing, identified on the MDH website. When the revised appendix L federal regulations came out for ASC s, a Condition for Patient Rights was added. Not all of the federal rights are included in the State BOR. The ASC s need to include the additional federal rights to the patients verbally and in writing in advance of the surgical procedure.
Survey Findings During tour of the facility, a posted Notice of Rights was observed in the waiting room of the Ambulatory Surgical Center. The posted notice did not include the Web site for the Office of the Medicare Beneficiary Ombudsman.
Survey Findings During interview, the ASC s Administrator reported that the Notice of Rights are given to the patient or the patient's representative, generally on the day of surgery, not prior, and indicated being unaware that the Notice of Rights needed to be given prior to the day of surgery.
Patient Rights- Posted Notice The ASC must have a written notice of the patient s rights posted in a visible location. The posted notice must include: Website for the Office of the Medicare Beneficiary Ombudsman Office of Health Facility Complaints, address and telephone number
Website and Information for Patient Rights www.medicare.gov/ombudsman/resources.asp OHFC Office of Health Facility Complaints P.O Box 64970 St. Paul, MN 55164-0970 Telephone 651-201-4201 1-800-369-7994 Fax 651-281-9796
Patient Rights-Financial Disclosure The ASC must also disclose, where applicable, physician financial interest or ownership in the ASC facility. The information must be in writing and given to the patient in advance of the date of the procedure.
Survey Findings A review of written information provided in the patient's admission packet, did not include a written notice of physician ownership nor did ASC staff who made pre-op telephone calls to the patient prior to the date of surgery disclose physician ownership. During interview, the Administrator verified that patients do not receive written notification of physician financial ownership prior to the date of procedure.
Advance Directives 416.50(a)(2) The ASC must comply with the following requirements: (i) Provide the patient, or as appropriate, the patient s representative in advance of the date of the procedure, with information regarding advance directives.
Advance Directive (cont.) 416.50(a)(2) (cont.) (ii) The ASC must have a policy and procedure for Advance Directives. (iii) Document in a prominent part of the patient s medical record, where it is readily noticeable, whether or not the individual has an advance directive.
Advance Directives, cont. Q-0224 416.50(a)(2) If a patient with advanced directives is transferred from the ASC to another healthcare facility: if there is an emergency transfer to a hospital, the ASC must ensure that a copy of the patient s advance directive is provided with the medical record when the patient is transferred.
Grievances 416.50 (a) (3) (i) The ASC must establish a grievance procedure for documenting the existence, submission, investigation, and disposition of a patient s written or verbal grievance to the ASC. (v) The grievance process must specify timeframes for review of the grievance and the provisions of a response.
Grievance (cont) Any verbal or written grievance must be investigated. The documentation of the grievance must include: Name of the ASC contact person Steps taken to investigate Results, decision, and date grievance process was completed.
Survey Findings During review of the facility's policy and procedure, no evidence was found that identified or addressed the facility's grievance policy or procedure. A form labeled "Notice of Privacy Practices" addressed complaints related to concerns regarding violations of patient's right to privacy, but no policy/ procedure was found informing patients of their rights to issue a written or verbal grievance.
Governing Body Quality Assessment and Performance Improvement Surgical Services Environment Medical Staff Nursing Services Patient Safety Contract Services Medical Records Pharmacy Services Radiology Services Lab Services Patient Rights Infection Control
Websites State Operations Manual Transmittal 56 Revised Appendix L, "Interpretive Guidelines for Ambulatory Surgery Centers" www.cms.hhs.gov/transmittals/downloads/r56soma.pdf MDH Clinical Web Window www.health.state.mn.us/divs/fpc/cww/cwwindex.html
Policy and Memos Memo # 10-20-ASC: Waiting area separation requirements Memo # 09-51:Exception to temporally separated. Memo # 10-14:Steris System Memo # 09-55: Flash sterilization clarifications- FY 2010 ASC Memo # 07-11: Use of alcohol-based skin preparations.