PURPOSE: This policy provides an overview of SHANDS Jacksonville Laboratory s commitment to the care and safety of the patients we serve.

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PAGE 1 of 5 TITLE: Provision of Care Regarding Laboratory Services PURPOSE: This policy provides an overview of SHANDS Jacksonville Laboratory s commitment to the care and safety of the patients we serve. POLICY: The goal of SHANDS Jacksonville Clinical Laboratories is to provide timely, accurate clinical laboratory test results for the physicians use in the diagnosis, monitoring, and treatment of patients. Efforts toward that goal include variable staffing to meet volume demand, utilization of modern, high-throughput clinical analyzers, and fostering a culture of process improvement. SCOPE OF SERVICES: The Laboratory offers a full range of services, including anatomic pathology, cytology, transfusion services, microbiology, chemistry, and hematology. Additional esoteric services include flow cytometry, prognostic tumor markers, fluorescent in-situ hybridization, neuropathology (muscle and nerve biopsies), electron microscopy, molecular diagnostics, virology (including viral load testing), mycology and Factor VIII inhibitor titers. The Laboratory responds to physician complaints and invites feedback from medical staff. There is a standing Thursday morning Quality Management meeting to which physicians, nurses or staff may bring concerns. The Microbiology director and supervisor attend rounds with Infectious Disease faculty and housestaff. Laboratory personnel periodically meet with Emergency Department and Nursing Services to address concerns and problems specific to those areas. The Laboratory is licensed by the State of Florida, accredited by The College of American Pathologists and American Association of Blood Banks, and holds a CLIA certificate to perform highly complex testing. Laboratories to which tests are referred must be accredited, licensed by the State of Florida, and approved by the Medical Executive Committee. Clinical laboratory tests are performed by nationally credentialed medical technologists licensed by the State of Florida, under the direction of board certified faculty of the University of Florida. Details of the tests, collection instructions, reference ranges, and services offered are published in the SHANDS Jacksonville Laboratory Guidelines and also are available on-line through the SHANDS Jacksonville Infonet.

PAGE 2 of 5 Staffing and Hours of Operation: Transfusion Services, Microbiology, Chemistry and Hematology are staffed and operational 24 hours per day, 7 days per week. Pathology, Cytology and other specialty areas are staffed 8 hours per day, 5 days per week. Supervisors are on duty 24 hours per day, 5 days per week and are on-call on the weekend. Pathologists, laboratory directors, and managers are available on-call, 24 hours per day, 7 days per week. LABORATORY ORDERS: Laboratory testing is performed only in response to requests made by healthcare professionals licensed by the State of Florida. Laboratory orders for inpatients and on-campus outpatients are transmitted through the hospital information system. Off-campus physicians must complete a request form or provide the required information on a prescription pad. The following information is required as part of any order for a laboratory test: 1. Patient name 2. One of the following: Hospital number, account number, resus number, birth date, or any other unique identifier 3. Ordering physician s name and ordering location 4. Test(s) requested 5. Date 6. Time of collection (required for some tests and always recommended) 7. Initials of collector (required for some tests and always recommended) 8. For PAP smears, the source of the smear, the date of the last menstrual period, previous history of abnormal results, treatment, or biopsies. 9. For pathology specimens, the specimen site, date and time of collection, and any relevant clinical history or findings, such as diagnoses for pre- and post-operative surgical specimens. 10. Billing information for unregistered outpatients 11. Diagnosis codes consistent with ordered procedures. Omission of any of these components may delay testing and/or compromise the integrity of the report. An attempt is made to obtain the required information on critical specimens. However, if the essential information is not available, the procedure may be performed, but the missing information is noted in the report. If the procedure cannot be performed without the information that is unavailable, the ordering physician or the nursing unit caring for the patient is notified, and the reason for cancellation of the order is documented in the laboratory computer system. ORDER PRIORITIES:

PAGE 3 of 5 Priority One: Because of the large volume of STAT tests requested in Chemistry and Hematology, a special priority is used to alert technologists to life threatening emergencies. The Priority One designation is used only for the tests listed below: Calcium Ionized (Green Top on Ice) CBC/Autodiff/PLT CBC Basic Metabolic Profile Glucose HGB and Hct PT Osmolality Serum Platelet Count Potassium PTT Electrolyte Profile For Priority One service, the specimen must be collected by unit personnel and delivered to a technologist, with the verbal request for Priority One status. Priority One requests on tests requiring whole blood are typically completed within 15 minutes of specimen delivery, and tests requiring serum or plasma are typically completed within 30 minutes of specimen delivery. Tests results are transmitted to a printer at the ordering location. RESUS specimens originating from ED areas are given Priority One status. Since overuse of the Priority One status, in order to expedite laboratory results in non-life threatening emergencies may delay real emergencies, the frequency and pattern of Priority One orders is monitored as part of quality management efforts. STAT: STAT priority is intended for use when the laboratory results are essential for making a eminent treatment or diagnostic decision regarding the patient. STAT requests on the above list of tests are typically completed within 1 hour of receipt. STAT results are transmitted to a printer at the ordering location. ASAP: ASAP priority is intended for non-urgent laboratory orders that need to be completed by a certain time, such as before rounds or prior to discharge. ASAP results are transmitted to a printer at the ordering location. ASAP requests are typically completed within 2 hours of specimen receipt. Other Priorities: Nurse Draw, Routine, and Timed specimens are processed as routine tests and are not printed at the ordering locations. COLLECTION: Instructions for collecting specimens are available in the Shands Jacksonville Laboratory Guidelines on the Infonet, and are published in hardcopy format, as well.

PAGE 4 of 5 Nursing staff collect blood from patients in the intensive care units, nurseries, the Emergency Department, and clinics. The laboratory phlebotomy staff collects blood in most of the remaining areas and in the laboratory reception station. Samples may be sent to the laboratory by the tube system (where available), delivered to the main laboratory on the first floor of the Clinical Center, or be picked up by a courier. TEST RESULTS: Results of clinical laboratory tests are available in the hospital information system when completed. Inpatients results are charted once a day by the laboratory staff. The medical technologists are responsible for examining all specimens for labeling errors, clotting, hemolysis, time of collection or receipt, appropriate pre-analytical processing, and any other features that may affect the integrity and accuracy of a particular test. Certain test results are compared to previously reported results on the same patient (delta checks). If the delta check exceeds limits established by the laboratory director, the technologist investigates, and often confers with unit personnel or the physician to determine whether a new sample will be required. This specimen integrity check provides an opportunity for discovering misidentified or contaminated specimens. Panic or Critical values are laboratory results that may have immediate life-threatening consequences for the patient and may require urgent medical intervention. In the event a laboratory result exceeds panic thresholds established by the laboratory director, the technologist will telephone the result directly to the physician or the nurse caring for the patient. The name and title of the person receiving and reading back the results is logged into the laboratory computer system. (Policy number LAB-02-220) When the laboratory tests specified in Policy LAB-02-257 will be significantly delayed or unavailable, the ED and Intensive Care Units are immediately notified Laboratory personnel monitor incomplete lists to ensure that all tests are reported in a timely manner. In areas that experience a heavy workload, such as the Core Laboratory, the incomplete lists are checked a minimum of three times per shift. If an erroneous laboratory result is discovered, a corrected report is issued. The physician is notified and the new report is printed. Any corrected result is clearly identified on the report, and technologists also include in the report the name of the person notified of the corrected result.

PAGE 5 of 5 QUALITY: The overall laboratory and each section of the laboratory have quality plans. Key indicators (such as turnaround time) are monitored and reported to the hospital Process Improvement Committee. Hospital Quality Management reviews Blood product usage not meeting criteria. Pathologists code surgical cases when the pre- and post-diagnoses are not in agreement for review by Quality Management. Policy Path 613200-215. Quality/Risk reports are completed and monitored for trends and issues. An element of the laboratory process is selected each year for a Failure Mode Effects Analysis to discover problems before they occur. Audits are used to ensure processes work as planned. Root cause analysis is used when a major problem or error is discovered. The laboratory is proactive in its pursuit of quality patient care by working closely with physicians and hospital staff to identify service areas in need of improvement, and develop quality plans to address and deficiencies. LAB ACCREDITATION: The Shands Jacksonville Clinical Laboratories are accredited by the College of American Pathologists (CAP) Laboratory Accreditation Program. A requirement of accreditation is that the CAP be notified immediately if any of the following occur: 1. Investigation of the laboratory by a government entity 2. Adverse media attention related to laboratory performance 3. Change in laboratory test menu (notification must occur prior to starting new patient testing) 4. Change in location, ownership, or directorship of the laboratory