Subject Objectives and Organization Pathology and Laboratory Medicine Index Number Lab-0175 Section Laboratory Subsection General Category Departmental Contact Ekern, Nancy L Last Revised 10/25/2016 References Required document for Laboratory Accreditation by the College of American Pathologists (CAP), Centers for Medicare and Medicaid Services (CMS) and/or COLA. Applicable To Employees of Gundersen Health System clinical laboratories, Gundersen St. Joseph s Hospital laboratories, Gundersen Boscobel Area Hospital and Clinics laboratories, Gundersen Tri-County Hospital laboratories and Gundersen Palmer Lutheran Hospital and Clinics laboratories. Detail MISSION STATEMENT: The Gundersen Health System Laboratory is committed to excellence by providing quality service with integrity, efficiency and compassion. OVERVIEW: The Gundersen Health System Laboratory is a system of hospital and clinic laboratory services designed to provide timely, state-of-the art services to meet the health care needs of outpatients and inpatients as requested by licensed Physicians, Doctors of Osteopathy, Dentists, Podiatrists or other members of House Staff, Physicians Assistants, Nurse Practitioners and other approved care providers who work with physicians. Diagnostic laboratory services are performed as requested by members of the medical staff upon written order. Services are ordered through the Hospital Information System or by written requisition for out of network lab orders. Considering the health care needs of the patient, the ordering providers must specify the appropriate priority for collection and testing of diagnostic laboratory services, i.e. STAT, Routine. (See Lab-0235 Laboratory Procedures Turnaround Time.) All Gundersen Health System laboratories operate with a Certificate under the provisions of the Clinical Laboratory Improvement Amendments (CLIA) Program of the Department of Health and Human Services (DHHS) and Centers for Medicare & Medicaid Services (CMS). All Gundersen Health System laboratories comply with state and local laws and regulations. Laboratory leadership coordinates practice and policy with other internal and external departments and agencies to assure compliance. Page 1 of 9
Additionally, all sites within the Gundersen Health System Laboratory system which provide non-waived diagnostic services are also accredited by the College of American Pathologists (CAP), Centers for Medicare and Medicaid Services (CMS) and/or COLA. Laboratory staff work with medical and nursing staff to ensure that Point-of-Care testing and quality control is performed in accordance with procedures, documented and within appropriate limits. All staff performing laboratory testing undergo competency testing as defined by CLIA guidelines. Proficiency samples are obtained from several sources and tested at intervals throughout the year to verify the quality of testing performed. Proficiency samples are tested in a manner identical to patient samples, rotated among staff responsible for testing, and results are not compared prior to submission deadline. (See Lab-0135 Quality Assurance for Laboratory Testing.) A quality program is in place for the laboratory, and the program guides and defines the quality activities for all testing sections of the laboratory. The program ensures quality throughout all phases of testing: pre-analytic, analytic, and post-analytic. Data will be collected and monitored to include Patient Identification and Preparation; specimen collection, identification, handling, processing, and transport; and accurate, timely result reporting. Appropriate monitors will be used for detecting problems in laboratory systems and identifying opportunities for improvement. Critical, core functions are selected or monitors for each section of the laboratory, i.e. turnaround time, proficiency testing, critical calls, amended, RL6 and incident reports. In addition, monitors are selected when an opportunity for improvement is identified based on event reporting and improvement and corrective action plans, i.e. order entry errors. Data from regional clinics will be reviewed on a quarterly basis by the supervisor, manager and lab director. This data will also be summarized on an annual basis and included in the quality management plan. SCOPE OF CARE: The La Crosse hospital laboratory provides diagnostic services on a twenty-four hour and seven-day-per week basis with on-site and on-call staff. The diagnostic services provided by the hospital laboratory include: Hematology, Coagulation, Flow Cytometry, Cytology, POCT, Urinalysis, Chemistry, Transfusion Medicine, Immunology, Microbiology, Virology, Anatomic Pathology and Histology. Hospital Affiliates provide basic testing in Hematology, Coagulation, POCT, Urinalysis, Chemistry, Transfusion Medicine, and Microbiology. Clinic laboratory services vary by location and may include limited Hematology, Chemistry and Urinalysis. STAFFING PLAN: The laboratory is staffed by physicians, doctoral level scientists, medical technologists, medical laboratory technicians, histology technicians, medical transcriptionists, cytotechnologists and support staff. Technical staff are assigned according to test complexity. MEDICAL LEADERSHIP: Implementation Page 2 of 9
1. Medical staff assigned wholly or partially to the laboratory will be led and managed by the Medical Director Laboratory, department chairperson. The Medical Director Laboratory is selected by advisory election by members of the department and approved by the Board of Governors. 2. The Medical Director Laboratory: a. Serves as department chairperson and heads the department. b. Satisfies the personnel requirements of the College of American Pathologists (CAP), Centers for Medicare and Medicaid Services (CMS) and/or COLA. c. Serves as Medical Director for no more than 5 laboratory sites performing moderately complex to highly complex testing. There is no limit to the number of waived labs an individual may direct. d. Will still assume overall responsibilities for all operation aspects of the laboratory although he/she has reapportioned his/her responsibilities to the appropriate person. e. Will be accessible to the laboratory to provide on-site, telephone or electronic consultation as needed. On-site consults will be conducted annual, or as needed and documented by the laboratory director/designee for all clinic and affiliate locations outside La Crosse. Visits will be documented using form Lab-0175.5 f. May perform the duties of the technical/clinical consultant. g. If the laboratory director delegates these responsibilities, the personnel are qualified under CLIA Regulation: 193.1409, 493.1415, and 493.1421, respectively. The following personnel have been designated to review employee skill rosters and assessment, analyzer/equipment maintenance and calibration records, quality control data, proficiency attestation sheets and result reports. They also resolve technical problems and take remedial action when necessary: i. Clinical/Technical Consultants ii. Laboratory Manager iii. General Supervisor iv. Technical Leaders All electronic POCT records are reviewed by Lab POC Technical Leader v. POCT: Department Clinical Manager and Operations Lead ES Active review and corrective action for paper records: maintenance and temperature charts Staff communication and documentation of lab POCT procedural changes h. Reviews and approves all new lab policies and procedures, as well as substantial changes to existing documents, before implementation. i. Reviews or delegates review of all lab policies and procedures at least every 2 years. j. Reviews and is involved in the laboratory quality management program. j. The laboratory director or his/her representative will ensure through direct observation: i. Evaluation of PT results, consistency of patient test results, QC review, and complaints raised by other staff and patients that the testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and post analytic phase of testing. Page 3 of 9
ii. The physical plant and environmental conditions of the laboratory are appropriate for the testing performed and provide a safe environment in which employees are protected from physical, chemical and biological hazards. iii. The test methodologies selected have the capability of providing the quality of results required for patient care, verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; and laboratory personnel are performing the test methods as required for accurate and reliable results. This will again be a function QA, QC, review of patient test results, etc. iv. The laboratory is enrolled in an approved proficiency testing program for the testing performed and that the proficiency testing samples will be tested as required. The laboratory director, or designee (section director or technical consultant), will be responsible for signing the transfusion medicine proficiency testing attestation sheet. v. The results are returned within the timeframes established by the proficiency testing program. Furthermore, all proficiency testing reports received will be reviewed by laboratory director or his/her representative and the appropriate staff to evaluate the laboratory s performance and to identify any problems that require corrective action. vi. That an approved corrective action plan will be followed when any proficiency testing results are found to be unacceptable or unsatisfactory, and all documentation will be retained for a period of two years. vii. That the quality control and quality assurance programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. viii. Establishment and maintenance of acceptable levels of analytical performance for each test system. ix. That all necessary remedial actions are taken and documented whenever significant deviations from the laboratory s established performance specifications are identified, and that patient test results are reported only when the system is functioning properly. x. That reports of test results include pertinent information required for interpretation. The lab director or designee will review and, at least every 2 years, approve the content and format of patient reports to ensure effective communication of patient results that will meet the needs of the medical staff. That consultation is available to the laboratory s clients on matters relating to the quality of the test results reported and their interpretation concerning specific patient conditions. xi. Through review of the required standards and or direct observation as previously indicated, that a sufficient number of laboratory personnel are employed with the appropriate education and either experience or training to provide appropriate consultation, properly supervise ad accurately perform tests and report test results in accordance with the personnel responsibilities described. xii. Through review of the required standards and or direct observation as previously indicated, that prior to testing patients specimens, all personnel have the Page 4 of 9
appropriate education and experience, receive the appropriate training for the type and complexity of the services provided and report accurate results. xiii. That policies and procedures are established for monitoring individuals who conduct pre analytical, analytical, and post analytical phases of testing to assure that they are competent and maintain their competency to process specimen, preform test procedures and report test results promptly and proficiently and, whenever necessary, identify needs for remedial training or continuing education to improve skills. xiv. That an approved procedure manual is available to all personnel responsible for any aspect of the testing process. xv. Specify, in writing, the responsibilities and duties of each consultant and each person engaged in the performance of the pre analytic, analytic, and post analytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. 3. Section Directors: a. Physicians or doctoral level scientists qualified by training, expertise and experience in their areas of responsibility. b. Available to other members on the medical staff for consultation. c. A pathologist is available at all times. d. Additional responsibilities of the Blood Bank Medical Director: i. Participates and reviews documentation of processes, procedures, and policies regarding patient consent for transfusion. ii. iii. Establishes and reviews criteria for transfusion. Actively involved in reviewing transfusion data such as usage, patient cases, and compliance. 4. Clinical/Technical Consultant If the laboratory technical consultant delegates these responsibilities, the personnel are qualified under CLIA regulation 49.31415, and 493.1421, respectively. The following personnel have been designated to review employee skill rosters and assessment, employee competency assessment, analyzer/equipment maintenance and calibration records, quality control data, proficiency testing performance. They also resolve technical problems and take remedial action when necessary. Each Technical Consultant is responsible for: a. Selecting test methodologies that are capable of providing quality results and are appropriate for clinical use. b. Verifying the test procedures performed and establishing the laboratory s test performance characteristics and that these are adequate to determine the accuracy, precision and other pertinent performance characteristics of each test method. c. Ensuring that the laboratory enrolls and participates in an HHS approved PT program commensurate with the services offered and that the laboratory tests the PT samples as required under subpart H of the regulations and returns the results within the established time frames. The technical consultant must also ensure that all PT reports are reviewed by the appropriate staff and that any problems are identified and the appropriate corrective action is initiated when results are found to be unacceptable. Page 5 of 9
d. Establishing a QC program appropriate for each test system performed and establishing the parameters for acceptable levels of analytic performance for each. Ensuring that these levels are maintained throughout the entire process from receipt of specimen through sample analysis and the reporting of test results to assure the quality to the laboratory services provided and to identify failures in quality as they occur. e. Resolving technical problems and ensuring that all necessary remedial actions are taken and documented whenever significant deviations from the laboratory s established performance specifications are identified, and those patient results are reported only when the test system is functioning properly. f. Ensuring that prior to testing patient specimens, all personnel have the appropriate training, education and experience for the type and complexity of services offered and have demonstrated that they can perform all testing operations reliable and can provide and report accurate results. Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for type of testing performed. g. Evaluating the competency of all testing personnel and assuring that the staff maintain their competency by establishing policies and procedures for monitoring individuals conducting all phases of testing from processing specimens through reporting results and identifying those who need remedial training or continuing education. These may include, but are not limited to: i. Direct observation of routine test performance including patient preparation, specimen handling, processing and testing. ii. Monitoring the recording and reporting of test results. iii. Review of intermediate test results or worksheets, QC records, PT results and preventive maintenance records. iv. Direct observation of performance of instrument maintenance and function checks. v. Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external PT samples. vi. Assessment of problem solving skills. vii. Evaluation and documentation of the performance of individuals responsible for moderate complexity testing at least semiannually during their first year and annually thereafter, unless there are test methodology changes in which each individual s performance must be re-evaluated to include the use of the new test method. viii. Ensure that an approved procedure manual is available to all testing personnel responsible for any aspect of the testing process. ADMINISTRATIVE LEADERSHIP AND ORGANIZATION OF LABORATORY STAFF 1. The department will be staffed by physicians, doctoral level scientists, medical technologists and technicians, histology technicians, medical transcriptionists, cytotechnologist and other support staff as needed. 2. Technical and support staff employed by the laboratory report directly or indirectly to the administrative director of the department. LABORATORY ACCREDITATION Page 6 of 9
The Gundersen Health System Laboratories are accredited by the College of American Pathologists (CAP) Clinical Laboratory Improvement Amendments (CLIA), Centers for Medicare and Medicaid Services (CMS) and/or COLA. Accreditation is valid for two-year period and is maintained on a continuous basis by: 1. Timely application for inspection prior to anniversary date. 2. Successfully participating in the CAP surveys, COLA approved surveys, or a CAP/COLA approved 3. Alternative proficiency testing program. 4. Notifying the Accreditation agency (CAP, COLA, CMS) of changes in location, ownership or directorship of the laboratory; prior to the change, or within two working days if an unexpected change occurs. 5. Notifying the Accreditation agency (CAP, COLA, CMS) of test menu changes, prior to starting a new patient testing. 6. Notifying the Accreditation agency (CAP, COLA, CMS) within two working days of the laboratory finding itself the subject of an investigation by the state or federal agency or adverse media attention related to the laboratory performance. 7. Notifying Accreditation agency (CAP, COLA, CMS) (if applicable) as soon as possible if subject to validation inspection. 8. Cooperate with Accreditation agency (CAP, COLA, CMS) (if applicable) when the laboratory is subject an inspection or investigation. 9. Providing an inspection team to perform at least one inspection during the two-year cycle (CAP only). 10. Submitting a completed Self-Evaluation Verification form in the interim year (CAP and COLA). 11. Adhere to the Terms of Use for the CAP Certification Mark of accreditation (if applicable). Laboratory staff should report all quality and safety concerns to Laboratory Management. Laboratory staff may also contact the Accreditation agency (CAP, COLA, and CMS) directly if they have a concern not addressed by Gundersen Health System Management. CAP, COLA, and CMS holds such communication in strict confidence. The dedicated phone line at CAP for quality and safety concerns is (866) 236-7212. The dedicated phone line for COLA is (800)981-9883. Gundersen Health System Laboratory Management prohibits any harassment or punitive action against any staff in response to a complaint or concern made to CAP, or any other regulatory agency. See GL- 3032 Non-retaliation and GL-1530 Event Reporting Patients and Visitors. SERVICE 1. Requests for inpatient services will originate from the nursing unit upon receipt of the physician s electronic order. 2. Requests for outpatient services will be generated by the electronic order of physicians. (GL- 3025 Ordering Outpatient Laboratory Tests) 3. A list of current test methods, including performance specifications will be made available to interested parties upon request. EQUIPMENT 1. A regular equipment maintenance schedule will be followed, documented, readily accessible, and reviewed. Page 7 of 9
2. A program of quality control, ensuring the accuracy of all testing procedures and equipment, will be continuously carried out. 3. Records pertaining to equipment maintenance and quality control will be retained for the life of the equipment plus two years. STANDARDIZATION OF TECHNIQUES 1. A procedure manual will be maintained to ensure that testing will be done uniformly and in accordance with accepted methods. 2. The procedure manual will be in compliance with CLSI standard GP2-A5. 3. All laboratory employees will participate in a standardized competency program. See Lab-0135 Quality Assurance for Laboratory Testing for complete details. EDUCATIONAL PROGRAMS 1. A continuing education program will be in place to provide personnel with: the latest information on techniques and equipment, correlation of laboratory results with disease states, and treatments, and the opportunity to review the principles of laboratory practice. 2. Laboratory personnel have the responsibility of keeping other health care professionals updated and proficient in point of care testing techniques and quality control. 3. Laboratory personnel provide continuing education opportunities to other laboratory professionals in the service area. PERSONNEL POLICIES 1. Gundersen Health System Human Resources Policies and Procedures Manual are applicable to all employees of Gundersen Health System and its key affiliates. 2. Employees are allowed to access the contents of the manual electronically via the intranet or by contacting any supervisor, manager or administrative director of the laboratory. 3. It is the responsibility of all Gundersen Health System managers, supervisors, administrative director and staff to administer Human Resources policies and procedures in a consistent and impartial manner. 4. La Crosse Campus and Regional Clinic Personnel Files: a. Personnel files for all laboratory employees shall be maintained by Human Resource Department. b. Color discrimination and vaccination testing records will be maintained by Employee Health Services. 5. Regional Center Partners and their Clinics Personnel Files: a. Personnel records are maintained on site in Regional Center Partners Human Resources. b. Education and Competency records are maintained either in Human Resources or in the onsite laboratory. EMPLOYEE EDUCATION RECORDS 1. All laboratory employees, including regional clinic employees and regional non-lab employees who provide lab testing will have two education folders located in the 4NW office commons. Each folder will have the employee name, start date, and termination date. All folders will be filed in alphabetical order. Page 8 of 9
2. La Crosse campus non-lab employees who provide lab testing will not have their education/competencies retained by the lab. The competency will reside in the employee home departmental file. 3. POCT competencies for non-lab employee will not be retained by the lab. The competency will reside in the employee home departmental file. 4. Each employee will have a working folder that will contain all education records for the current year. Records will include: a. Lab orientation, skills rosters and 6 month review of skills rosters, if a new employee within the calendar year. b. Annual competency for each lab section they work in. 5. Each employee will also have a permanent folder that will contain all previous years of education records with the most current in front of the folder. At the beginning of each calendar year the previous year will move from the working folder to the front of the permanent folder. Note: Regional Center Partners hospital and clinics only maintain permanent folders on each employee. 6. Records will be retained in the 4NW office commons until termination date. Upon termination the employee education records and the shadow file will be sent together to storage for an additional 3 years. Note: Regional Center Partners hospital and clinic education files will be stored on site per policy. 7. Lab managers will utilize a documentation spreadsheet on the lab share drive to track and determine employees educational needs. Organizational charts for each location can be found as an attached form to this policy: 1. Lab-0175.1 Regional Clinics 2. Lab-0175.3 Gundersen Tri County Hospital 3. Lab-0175.4 Gundersen St. Joseph s Hospital 4. Lab-0175.8 Gundersen Lutheran Medical Center La Crosse 5. Lab-0175.9 Gundersen Boscobel Area Hospital and Clinics REVIEW AND CHANGES: This document and all attached forms should be reviewed optimally on an annual basis with 2 years as the maximum review date. Review will be done by the Technical Leader, Supervisor, Manager, Medical Director or designated person. Changes require retyping the document or form and review by the Medical Director. Page 9 of 9