COMMUNICATION OF PATHOLOGY RESULTS

Transcription

1 Principle To define provide guidelines for notification and documentation of critical values, corrected results, and significant or unexpected surgical pathology results. Policy Statement A critical laboratory value is a test result that is significantly outside of normal limits, and that has significant medical implications for the patient requiring immediate attention and action by the patient s providers. A list of tests for which critical values exist, and the critical values themselves (Appendix A), has been established by the BIDMC clinical laboratory, and are, annually, reviewed, with modifications as needed, and approved by the Core Clinical Services Committee (CCSC). The critical value list is published in the BIDMC laboratory manual (available on the CareGroup website). Federal regulations require that the laboratory maintain accurate and reliable test results and that remedial action be applied and documented when errors in the reported patient test results are detected. The laboratory must promptly notify a provider, issue a corrected report and maintain the original data as a permanent record. Reports that display "corrected" results must clearly indicate that the new result is a change from a previously reported result. As clinical decisions or actions may have been based on the previous report, it is important to replicate previous information (data, interpretations, reference intervals) together with the revised information. The previous information and the revised information must be identified as such. Certain surgical pathology diagnoses may be considered particularly significant or unexpected. Diagnoses to be defined as significant or unexpected should be determined by the pathology department in cooperation with the clinical medical staff. Scope This procedure applies to all sections of the Pathology Department. Definitions Critical Values - are laboratory results which indicate a condition likely to require prompt clinical intervention. It is the responsibility of the laboratory to communicate these results immediately to a health care provider. Significant or Unexpected results are results or diagnoses which indicate a condition requiring prompt communication of such results to the clinician. Corrected/Changed results any result or diagnosis that has been amended from the original finding Page 1 of 18

2 PROCEDURE Critical Values I. Critical Values must be called back immediately to a health care provider. II. When reporting a critical value, state that you are calling from the laboratory with a critical value and give the patient s name, medical record number, test name(s) and result(s). Ask the provider to read back the patient s name, medical record number [as long as the provider is able to read back the name without violating HIPAA rules], test name(s), and result(s). The following script should be used to ensure compliance with JCAHO s National Patient Safety Goal [Improve the effectiveness of communication among caregivers]: III. Tech: This is Joe from the Lab. I have a critical value to report. Please write this down and read it back. Jane Doe, MRN , has a potassium of 7.2. MD: Jane Doe, MRN , potassium 7.2. Tech: That is correct. Thank you. As a practical matter, you are not responsible for verifying that the provider actually wrote anything down. You need only verify that the information coming back out of the earpiece of the phone matches what is being reported out of the lab. Calls will be made according to the following guidelines: A. For: INPATIENTS and EMERGENCY DEPARTMENT (ED) 1) Call the floor or unit or ED to report the critical value. 2) Critical values may be communicated to a unit coordinator, nurse or physician. 3) Unless the patient has been admitted all critical values (including those delayed by more than 24 hours such as blood cultures) are called to the ED unit coordinator at B. For: OUTPATIENTS/OUTREACH (see Appendix B for details for some outpatient and outreach areas) 1) Outpatients/Outreach Medical Technologist Protocol: a. The ordering provider (physician or nurse practitioner) listed on the requisition will be paged. If no page is available, or the provider doesn t respond to the page within 15 minutes, the medical technologist will call the practice/office number or listed in the Appendix of this SOP. The will indicate the name of the covering physician. b. If it is not possible to contact the ordering provider, or no ordering provider s name is listed the (next) calls will go to the responsible physician, using the page number and/or office number, as needed. It is preferable to page the physician whenever possible. c. If it is not possible to contact the responsible physician, the medical technologist will page the clinical pathology resident on call (beeper #32093). 2) Outpatients/Outreach Clinical Pathology (CP) Resident protocol: Page 2 of 18

3 a. The resident will confirm the identity of the patient s provider, and responsible physician, and then make every reasonable attempt to contact one of these individuals using information from the hospital information system, and the assistance of hospital operators to call an appropriate provider at home. b. If it is not possible to contact the ordering provider or responsible physician, the resident must call the CP physician on call for the relevant laboratory. c. The CP physician will review the result, and the patient s computer record, and determine whether the patient should be contacted directly for emergent medical care. If, in the opinion of the CP physician, the patient needs to be called, the CP physician will contact the ED to review with a physician there. If both physicians are in agreement about the need for the patient to receive evaluation and care, the CP physician will call the patient. d. Every call from a medical technologist to the CP resident will be recorded and presented at the Clinical Pathology Clinical Case Conference the following week. e. The Operations Director will investigate all such calls and determine whether the lab followed the SOP and associated appendices. Calls that the lab should have been able to handle will be reviewed by the Operations Director with the appropriate manager. Calls that were appropriately handled by the lab but the lab was unable to contact a provider will be documented in the Patient Safety Reporting System. f. Lab Medicine will report to the CCSC the number of times that the medical technologist was unable to contact the ordering provider and summarize what additional actions were taken to correct the problem based on response the Patient Safety Reporting System follow up. C. BLOOD GAS RESULTS 1) All results for the OR, L&D, or for an arrest must be called to originating location. D. SEND OUT TESTS 1) Any send out test result identified as a critical value (established by the reference lab); will be called back according to the guidelines within this procedure. IV. All critical value calls must be documented. In most cases (except as noted below) the documentation will be entered into the computer as a comment with the critical value. The comment must include the last name and first initial of the person taking the information, and the date and time (be precise) of the call. Example: Notified Dr. M. Jones at 2:15pm 2/29/96 Exceptions: At present, BLOOD GAS call backs will be documented on the requisition slip and BLOOD BANK call backs will be documented on the worksheet if unable to enter in computer. Documentation must include: a. date and time of call b. name of person called c. technologist s initials Page 3 of 18

4 Corrected Reports Procedure I. The technologist who realizes that a test result needs to be changed is responsible for changing the result in the computer and notifying the appropriate provider. The corrected test result should be entered into the patient record with the following comment: Corrected result, previously reported as. Notified, date, time. ECEPTION: Due to the nature of the Blood Bank computer system the comment Corrected Report will be added to the patient s record. Blood Bank reporting errors will be followed up with a deviation report according to the Error Management SOP with appropriate documentation. ECEPTION: Given that Point of Care Prothrombin Time testing is performed and resulted by the patient s provider, it is not necessary to note who was notified. The corrected test result should be entered into the patient s record with the following comment: Corrected from. ECEPTION: Due to the nature of the Anatomic Pathology system the following will be added to the report: ***** CORRECTED REPORT***** Date of Change is recorded along with the actual revision II. III. If more than one correction is made to a patient report, all corrections must be listed in sequential order, including dates and results of corrections made on subsequent reports. Documentation must be maintained for two years. Page 4 of 18

5 Significant and Unexpected Diagnoses Procedure I. The attending pathologist or designee will contact an attending physician (or physician s office) by telephone under the following circumstances: Any diagnosis of malignancy in an uncommon location, uncommon specimen type (i.e. hernia sac, intervertebral disc material, tonsil, etc.) or unexpected clinical situation Any definitive diagnosis of specific infection or other severe medical condition requiring immediate therapy (i.e. temporal arteritis) Absence of chorionic villi when clinically expected Any significant discrepancy between the permanent section and frozen section diagnoses Any case labeled rush or in which an urgent result is specifically requested II. All calls will be documented in the final surgical pathology report and the date/time of call will be noted along with the name of the person called. The call can be made by either the resident or the attending pathologist on the case. An example of this report is: "Dr. was notified of the diagnosis via telephone on June 22, 2007 at 8:45 a.m." Page 5 of 18

6 Appendix A Critical Values are laboratory results which indicate a condition likely to require prompt clinical intervention. It is the responsibility of the laboratory to communicate these results immediately to a health care provider. Note: Additional results, although not critical, may be considered significant or unusual and will be communicated to the patient s provider at the discretion of the Laboratory Director. This list was approved by Core Clinical Services Committee at the January 27, 2009 meeting. Chemistry Test Name Critical Value Frequency (if not each time) Acetaminophen High: > 50 µg/ml Bicarbonate Low: < 15 mmol/l High: > 40 mmol/l Bilirubin (in neonate) High: > 16 mg/dl Calcium, free Low: < 1.00 mmol/l High: > 1.45 mmol/l Calcium, total (serum) Low: < 6.0 mg/dl High: > 13.0 mg/dl Carbamazepine High: > 13.5 µg/ml (Tegretol) Carboxyhemoglobin High: > 15 % Chloride Low: < 80 mmol/l High: >120 mmol/l Digoxin High: > 2.5 ng/ml Gentamicin High: > 12.0 µg/ml Glucose Low: < 50 mg/dl High: > 450 mg/dl Lactate High: > 4.0 mmol/l No repeat calls for critical values within same day Lithium High: > 2.0 mmol/l Magnesium (serum) Low: < 1.0 mg/dl High: > 4.5 mg/dl Methemoglobin High: >5% Osmolality Low: < 250 mmol/kg High: > 326 mmol/kg pco 2 (arterial) Low: < 20 mm Hg High: > 60 mm Hg New Value No repeat calls for critical values within same day. ph (arterial) Low: < 7.26 High: > 7.55 New Value No repeat calls for critical values within same day. po 2 (arterial) Low: < 60 mm Hg High: > 600 mm Hg New Value No repeat calls for critical values within same day. Phenobarbital High: > 60 µg/ml Phenytoin (Dilantin) High: > 25 µg/ml Phosphate (serum) Low: < 1.0 mg/dl Potassium (serum) Low: < 3.0 mmol/l High: 6.0 mmol/l Page 6 of 18

7 Test Name Critical Value Frequency (if not each time) Primidone High: > 15 µg/ml Procainamide (Pronestyl) High: > 12 µg/ml Quinidine High: > 10 µg/ml Salicylate High: > 30 mg/dl Sodium Low: < 125 mmol/l High: > 150 mmol/l Theophylline High: > 22 µg/ml Tobramycin High: > 12 µg/ml Troponin T High: >0.10 ng/ml New Value No repeat calls for critical values within one week.. Valproic acid (Depakene) High: > 125 µg/ml Vancomycin High: > 45 µ g/ml Blood Bank Test Name Critical Value Frequency (if not each time) Antibody screen / crossmatch Positive antibody screen or incompatible crossmatch following emergency release of blood or urgent request for crossmatched blood. Direct anti-globulin test Positive (in neonate) Heparin antibody test Positive Antibody screens Positive (Labor and Delivery only) first time positive Hematology Test Name Critical Value Frequency (If not each time) Leukemic cells Presence of any leukemic cells in blood or body fluid CSF cell count Fibrinogen Low: < 100 mg/dl For OB patients between the ages 14 and 52, < 200 mg/dl High: WBC s > 20/µL Hematology physician will call new results after smear review. No repeat calls for critical values within 3 months unless prior result was normal and new result is critical. Page 7 of 18

8 Test Name Critical Value Frequency (if not each time) Hematocrit Low: < 15 % (inpatients) High: >60 % (outpatients) New Value No repeat calls for critical values <25 % (outpatients) within 3 months unless prior result was normal and new result is critical. (no calls to 11R, 7F, Hem/Onc) Malaria smear Positive Initial Detection Platelet count Low: < 10K/µL (inpatients) <50K/µL (outpatients) <50K/µL (NICU patients) High: >999 K/µL INR >4.9 (corresponds to a PT of approximately seconds) Partial thromboplastin time >50 secs (outpatients) >100 (inpatients) New Value No repeat calls for critical values within 3 months unless prior result was normal and new result is critical. (no calls to 11R, 7F, Hem/Onc) White blood cell count Low: < 5.0 K/µL (neonate) < 2.0 K/µL (outpatients) High: >30.0 K/µL (outpatients) New Value No repeat calls for critical values within 3 months unless prior result was normal and new result is critical. (no calls to 11R, 7F, Hem/Onc) Microbiology Test Name Critical Value Frequency (if not each time) Acid fast smear Positive Initial Detection No repeat calls for critical values within two weeks. Respiratory Viral screen, Positive DFA Bacterial antigens Positive (CSF) Blood culture Positive Initial Detection of organism by Gram stain No repeat calls for critical values within one week. Page 8 of 18

9 Test Name Critical Value Frequency (if not each time) C. difficile toxin Positive Initial Detection No repeat calls for critical values within one week. Cerebrospinal fluid Positive Gram stain, fungal stain or culture CMV Antigenemia Positive Initial Detection No repeat calls for critical values within one month. CMV Viral Load Positive Initial Detection No repeat calls for critical values within one month Cryptococcal antigen (CSF or Blood) Mycobacterium tuberculosis Other Mycobacterium species Tissue and Sterile fluids as specified Positive First positive and Multi-drug resistant First positive Gram Stains: Positive gram stains: Tissues except foot Sterile fluids: joint, pericardial, peritoneal, pleural & vitreous fluids will be called Cultures: Corresponding positive cultures will be called only if gram stain negative Initial Detection No repeat calls unless significant increase (4 fold) Initial Detection No repeat calls for critical values within two weeks. Initial detection; each source Initial Detection of organism by Gram stain and/or culture. No repeat calls for critical values within one week. Additional results, although not critical, may be considered significant or unusual and will be communicated to the patient s provider at the discretion of the Laboratory Director. Reviewed/Revised 2/20/2009 Page 9 of 18

10 Appendix B Notifying Providers of Critical Values for Specific Outpatient Sites Outreach Critical Value Call Information Definition of Who to call: Service Site Name Business Hour During hours After hours Adult Pediatric Allergy and Asthma Center Attleboro Dermatology Beth Israel Deaconess HealthCare- Boston Beth Israel Deaconess Chelsea OB/GYN Sonia Ordonez, MD Claire LaBelle, NP Beth Israel Deaconess Chelsea Adult Medicine Drs. Adam, Abrego, Kong, Levine, Perez- Lirio Jessica Ochs, NP Monday-Friday: 9:00-5:00 Mon, Fri: 8:00-3:40 pm; Tues, Thurs: 8:40-4:20 pm; closed Wed Monday-Friday: 8:00-5:30 pm Monday-Fri: 8:30-4:30 pm Mon-Fri: 8:30-5:00 pm (617) After 5:00 pm (617) (508) After hours (508) and page MD on-call (617) After 5:30 pm (617) (617) (617) Operator Dr. Ordonez Pager ID #38475 (617) (617) Answering Service/MASCO will page provider on call Page 10 of 18

11 Appendix B Notifying Providers of Critical Values for Specific Outpatient Sites Outreach Critical Value Call Information Definition of Who to call: Service Site Name Business Hour During hours After hours Adult Pediatric Beth Israel Deaconess Chelsea Dr. Phil Triffletti Pamela Fox, NP Beth Israel Deaconess HealthCare - Chestnut Hill IM Beth Israel Deaconess HealthCare- Sharon Beth Israel Deaconess HealthCare Upper Falls Beth Israel Deaconess HealthCare - Washington Sq Boston Endoscopy Ctr Mon-Thu: 8:30-5:00 pm Fri: 8:30 3:00 pm Monday, Tues, Wed, Fri: 8:30-5:00 Thurs: 8:30-7:00 Monday-Friday: 8:00-5:00 pm Monday-Friday: 9:00-5:00 pm Mon- Thurs: 8:30-7 Fri:8:00-5:00 pm Mon-Fri: 7:00-4:30 pm (617) (617) Answering Service (617) After 5:00 pm: (781) Lab: (781) After 6:00 pm: (781) (781) (781) (617) (617) (617) (617) Page 11 of 18

12 Appendix B Notifying Providers of Critical Values for Specific Outpatient Sites Outreach Critical Value Call Information Definition of Who to call: Service Site Name Business Hour During hours After hours Adult Pediatric Bowdoin Street Health Center Chestnut Hill OB/GYN Dimock Community Health Center Fenway Community Health Mon:8:30-7:00 pm Tues-Thurs: 9:00-7:00 Fri:9:30-5:00 pm Sat:9:00-1:00 pm Monday-Thursday: 8:30-4:30 pm Friday: 8:30-3:00 Monday-Thursday: 8:30-7:30pm; Fri: 8:30-4:30pm; Sat/Sun: 9:00-noon Mon-Thur: 7:30-9:00 pm Friday:7:30-7:00 pm (617) if calling from inside the hosp dial x40100 After 7:00 pm: (617) (617) After 4:30 pm: (617) on call services (617) , x1592 (617) ask for doctor on call (617) , enter 0 for the operator After 9:00 Mon-Thurs After 7:00 Friday (617) , enter 0 for operator : Dana Fugelso Mon, Tues, Thurs: 9:00-5:00 Gambro Health Mon,Wed,Fri: Center - 6:00-9:30 pm Brookline Tues & Thurs: 6:00-4:30 pm Gambro GZ-5 Mon, Wed, Fri: 7:00 7:00pm Gambro Farr 701 Mon-Sat: 6:00-5:30 (617) Call BIDMC page operator (617) (617) Call BIDMC page operator at (617) Call at and ask for the Renal Fellow on-call (617) Call at and ask for the Renal Fellow on-call Page 12 of 18

13 Appendix B Notifying Providers of Critical Values for Specific Outpatient Sites Outreach Critical Value Call Information Definition of Who to call: Service Site Name Business Hour During hours After hours Adult Pediatric James Garland, MD Rene Goldberg Needham OBGYN Joan Golub, MD Rong Guan, LLC Mon:8-3,Tues: 9-5 Wed: 9-7, Thurs: 8-12 pm Friday: 8-5 pm Mon-Thurs: 9:00-4:00 pm Friday: 9:00-3:00 Monday-Thursday: 9:00-4:00 pm Friday Closed Hours vary, can always be reached (617) After hours (617) (781) Back Line until 5:30 (781) After 5:30: (617) Page M.D (617) (617) (617) MD prefers to be contacted by cell phone. (617) Cell phone number by cell phone HCA East Mon,Tue,Thurs: (617) (617) :30-8:00 pm Wed,Fri: 7:30-5:30 HCA West Mon-Fri: 8:30-5:00 (617) (617) HMFP Derm Mon-Fri: 9:00-5:00 (617) Call BIDMC page operator at (617) 632- (Chestnut Hill) 8611 HMFP Radiology Friday: (617) Call BIDMC page operator at (617) 632-9:00-1:00 pm 8611 Cindy Kobelin, Monday-Thurs: (617) After 5:00 pm MD 9:00-4:30 pm (617) Friday: 9:00-3:00 Page MD Longwood Mon-Fri: (617) (617) Otolarnygology 9:00-5:00 pm Page 13 of 18

14 Appendix B Notifying Providers of Critical Values for Specific Outpatient Sites Outreach Critical Value Call Information Definition of Who to call: Service Site Name Business Hour During hours After hours Adult Pediatric Longwood Urology Mon-Fri: 10:00-5:00 pm (617) (617) Medical Care Center-Lexington Monday-Friday: 9:00-5:00 pm IM-(781) OB (781) Adult Specialties (781) After 5:00 pm Internal Medicine: (781) OB/GYN: (781) Adult Specialties Call BIDMC Page Operator (617) Page ordering M.D. Men s Health Mon-Fri: 9:00-4:30 (617) (617) and follow instructions for contacting on-call MD Otolaryngology Mon,Thurs,Fri: (617) (617) Group PC 1:00-5:00 pm Pastor Medical Associates Suzanne Shroba Skin Care Physicians of Chestnut Hill Thurs: 9:00-11:00 Monday-Friday: 9:00-5:00 pm Mon,Wed,Thurs: 9:00-4:45 pm Tues: 11:00-6:30 pm Monday-Friday: 8:00-5:00 pm (617) After 5:00 pm: (617) (508) (508) (back line) (508) (617) x1677 Fax: (617) On call MD: (617) Page 14 of 18

15 Appendix B Notifying Providers of Critical Values for Specific Outpatient Sites Outreach Critical Value Call Information Definition of Who to call: Service Site Name Business Hour During hours After hours Adult Pediatric South Cove Boston Health Center South Cove Quincy Health Center Thyroid Center (Dr. Sareh Parangi) Transplant Center (Liver) Polina Tsyvin Monday-Friday: 9:00-5:30 pm Saturday: 9:00-3:00 Mon,Wed,Thurs, Fri: 8:30-5:30 pm Tues: 8:30-7:00 pm Sat: 9:00-3:00 pm Mon, Thurs: 9:00-5:00 pm Monday Friday 8:30-5:00 pm Mon-Fri: 9:00-5:00 pm (617) (617) follow prompt press 1 for adult med; press 2 for pedi; Lab: (617) press3 for OBGYN (617) After 5:00 pm: (617) (page doctor) (617) Call BIDMC page operator at (617) Call to reach the Transplant Center (617) (617) Critical values on an outpatient from the following transplant providers (see list below) are to be called to the On-Call Transplant Coordinator, not the individual provider. Call to reach the Transplant Center before 5PM and after 5 PM, this number will reach the answering service who will contact the On-Call Transplant Coordinator. After 5 PM the On-Call Transplant Coordinator can be paged directly at # Michael Curry Doug Hanto Scott Johnson Khalid Kawaja Anthony Monaco Martha Pavlakis Page 15 of 18

16 Appendix B Notifying Providers of Critical Values for Specific Outpatient Sites Outreach Critical Value Call Information Definition of Who to call: Service Site Name Business Hour During hours After hours Adult Pediatric Urology Practice Associates Drs. Vaninov & Tandetnik Vernick,Gopal, Tran Mon-Fri: 9:00-5:00 pm Mon,Tues,Wed,Fri: 9:00-5:00 pm Thurs: 9:00-8:00 pm Monday-Fri: 8:00-4:00 pm (617) (617) (617) (617) (617) Call BIDMC page operator (617) and ask for ORL resident on-call Note: The critical values are not to be left with the ; their role is to identify the covering physician. Page 16 of 18

17 References The Joint Commission Accreditation Manual for Pathology and Clinical Laboratory Services: Standards and Scoring Guidelines. Oakbrook Terrace, Illinois. Joint Commission of Accreditation of Healthcare Organizations, Commission on Laboratory Accreditation Inspection Checklist. College of American Pathologists. Northfield, Illinois Commission of Laboratory Accreditation Inspection Checklist. College of American Pathologists. Lab General Checklist; September 2004, GEN Federal Register, Part 493. March 25, Commission on Laboratory Accreditation Inspection Checklist. College of American Pathologists. ANP 12175, Northfield, Illinois Page 17 of 18

18 Written by: Reviewed by: Approved by: Gina McCormack L. Uhl, MD and S. Schnitt, MD Lynne Uhl, MD Adopted: Supersedes: Critical Values (GE-QA-19.7) 4/07 & Corrected Reports (GE-QA-1.1) 4/07 STANDARD OPERATING PROCEDURES REVIEW/REVISION DOCUMENTATION SOP Title: Communication of Pathology Results Document ID Code: GE-QA-19.8 Adopted Date: 7/23/07 Review Action* Name Date Approved 7/12/2007 Revised Gina McCormack 11/28/2007 Approved Gina McCormack, MS, MT(ASCP) 11/28/2007 Reviewed Gina McCormack, MS, MT(ASCP) 11/01/2008 Revised (updated Critical value list).gina McCormack, MS, MT(ASCP) 02/20/2009 *Reviewed by; Revised by; or Approved by Page 18 of 18