MINIMAL SERVICE DELIVERY STANDARDS (MSDS) FOR LABORATORY COLLECTION POINTS 2024 Abbreviations and Acronyms BSBS Biosafety and Bio Security BSL Biosafety Level CPD Continuing Professional Development CQI Continuous Quality Improvement DCGT Directorate of Clinical Governance and Trainings EQA External Quality Assurance HCE Health Care Establishment IMS Information Management System IQC Internal Quality Control ISO International Standards Organization JD Job Description LQMS Laboratory Quality Management System M. Phil Master of Philosophy MER Management of Equipment and Reagents MSDS Minimum Service Delivery Standards PCR Polymerase Chain Reaction PEP Post-Exposure Prophylaxis PhD Doctor of Philosophy PMDC Pakistan Medical & Dental Council PPE Personal Protective Equipment QA Quality Assurance QC Quality Control RMP Registered Medical Practitioner SHCC Sindh Health Care Commission SOP Standard Operating Procedure TAT Turn Around Time UPS Uninterrupted Power Supply WHO World Health Organization

2 MINIMAL SERVICE DELIVERY STANDARDS (MSDS) FOR LABORATORY COLLECTION POINTS 2024 Members of SHCC Standards Development Team Dr. Syed Ahmed Raza Kazmi, Director, Clinical Governance &Trainings Dr. Faiza Bhutto, Deputy Director, Clinical Governance & Trainings Dr. Zainab Hasan, Deputy Director, Clinical Governance & Trainings Members of Technical Working Group Dr. Naila Tariq Dr. Erum Khan Dr. Aamir Mirza Dr. Farhan Essa Abdullah Dr. Ghulam Fatema Dr. Rafiq Khanani Dr. Ashraf Memon Dr. Aga Umer Daraz Khan Dr. Adnan Mustafa Participants of Finalization Meeting Name Institute Dr. Naila Tariq National Medical Center/ Alkhidmat Laboratories Dr. Rafiq Khanani Advanced Lab/ CitiLabs Dr. Jawaid Jabbar Tabba Heart Institute Dr. Khwaja Muhammad Nauman Sind Lab Dr. Syed Mehmood Hasan Jinnah Sindh Medical University Dr. Agha Umer Daraz Hussaini Laboratories Dr. Adnan Zuberi Indus Health Network Dr. Shaheen Sharafat Liaquat National Hospital Dr. Ashraf Memon Kharader General Hospital Syed Mehak Naz Chughtai Lab Mohd. Imran Awan Chughtai Lab Mr. Zahid Hussain SKMCH & RC Laboratories Dr. Shaheen Javed Rahila Laboratories Mr. Faisal Imran LUMHS Laboratories Dr. Amtul Qudoos Rafiq Jinnah Postgraduate Medical Center Dr. Usman Ali Dr. Ziauddin Hospital Dr. Kamran Dawood Memon Medical Institute Dr. Erum Khan Aga Khan Hospital

3 MINIMAL SERVICE DELIVERY STANDARDS (MSDS) FOR LABORATORY COLLECTION POINTS 2024 Table of Contents Introduction ............................................................................................................................................ 4 Standard Development Process ............................................................................................................ 5 Scope ...................................................................................................................................................... 5 Normative References ............................................................................................................................ 5 Summary of Standards .......................................................................................................................... 6 1. Responsibilities of Management (ROM) ......................................................................................... 7 2. Facility Management and Safety (FMS) .......................................................................................... 7 3. Human Resource Management (HRM) ........................................................................................... 8 4. Management of Equipment and Reagents (MER).......................................................................... 9 5. Recording and Reporting System (RRS)........................................................................................ 9 6. Quality Assurance (QA)................................................................................................................. 10 7. Biosafety and Biosecurity (BSBS) ................................................................................................ 11 8. Access, Assessment and Continuity of Care (AAC) ................................................................... 12 9. Care of Patients (COP)................................................................................................................... 12 10. Patient Rights and Education (PRE) .............................................................................................. 13 Appendix 1 ............................................................................................................................................ 14 Laboratory Collection Point Personnel Specifications .................................................................. 14 References ............................................................................................................................................ 14

4 MINIMAL SERVICE DELIVERY STANDARDS (MSDS) FOR LABORATORY COLLECTION POINTS 2024 Introduction Primary purpose of a clinical diagnostic laboratory is to provide accurate, reliable and timely results to clinicians. The main objective of producing these Minimal Service Delivery Standards (MSDS) is to provide a common understanding of what is expected from the laboratory to ensure provision of consistently high-quality service delivery and to provide a roadmap for improving the quality, safety and reliability of clinical laboratories and collection centers across province of Sindh. In line with global Good Clinical Lab Practices (GCLP), these standards cover all key aspects of laboratory management, technical operations, biosafety and quality systems. It is advised that all categories of labs adopt or start to adopt digital systems and processes including for test booking, reporting, Laboratory Information Management System (LIMS) and Laboratory Quality Management System (LQMS). The lab must strive to provide services and diagnostic tests to meet the needs of patients and clinicians it serves and must periodically review its scope of services based on population/clinician needs and advances in diagnostic techniques. It is important that each step of the Total Testing Process is correctly performed. Areas most vulnerable to error are pre-analytical and post analytical phases. High and consistent quality standards in the pre-analytical and post analytical phase are hence extremely important. Incorrect or incomplete registration of patient details can lead to incorrect sample identification and issuance of incorrect reports that apart from causing mental anguish to patients, can significantly impact patient care and may result in unintended harm to the patient. Incorrect identification of required tests, obtaining incorrect type of sample, incorrectly obtained or inadequately stored and transported sample runs a risk of incorrect results due to contamination, specimen damage or need for retesting. Similarly, timely and correct reporting and record keeping in the post analytical phase is critical to assure valid reporting and patient satisfaction. Therefore, this document provides the pre-analytical and post-analytical standards extracted from the MSDS for Clinical Diagnostic Laboratories which are applicable to the Laboratory Collection Points (CP). It is required that the main parent laboratory is licensed on the MSDS before its associated CP/s.

5 MINIMAL SERVICE DELIVERY STANDARDS (MSDS) FOR LABORATORY COLLECTION POINTS 2024 Standard Development Process  Stakeholder consultative meeting with representatives of public and private sector laboratories and teaching hospitals  Formation of Working Group  National Health Policy recommendations reviewed and followed as guiding principal for development of draft standards  Review of available standards for clinical laboratories  Final draft reviewed by Working Group  Stakeholder consultation meeting for finalization  Standards put up on website for public review  Standards notified by cabinet and published in gazette Scope These standards are applicable to following categories of laboratory services as registered with Sindh Health Care Commission: 1. Laboratory Collection Point (CP)/Centers: No tests conducted on site; only phlebotomy and non-invasive sample collection, storage, transport and reporting; Reference/parent laboratory must be licensed with SHCC If any Kit Based Rapid Diagnostic Screening Tests using capillary blood are conducted at the Collection Point, the used kit with printed result on Lab Header is immediately provided to the patient, clearly mentioning the details of the Kit, its expiry, the obtained result and declaration that it is RDT for screening purposes only and further tests and clinical correlation is advised for confirmation. Example as for Pregnancy, Dengue etc. Normative References Normative references are those documents that contain material that must be understood and used to implement the standard and are an indispensable resource when applying the standards. For implementation of these standards, the following are recommended: • Good Clinical Laboratory Practices in Pakistan. Pakistan Academy of Sciences 2019, Islamabad, Pakistan https://www.nih.org.pk/wp-content/uploads/2019/04/HANDBOOK-for- Good-Clinical-Lab.pdf • MSDS and Reference Manual for Clinical Laboratories, Punjab Health Care Commission

6 MINIMAL SERVICE DELIVERY STANDARDS (MSDS) FOR LABORATORY COLLECTION POINTS 2024 Summary of Standards S. No. Domain Standards Measurable Criteria 1 Responsibilities of management (ROM) 1 5 2 Facility Management and Safety (FMS) 3 13 3 Human Resource Management (HRM) 6 19 4 Management Of Equipment and Reagents 2 5 5 Recording and Reporting System (RRS) 2 12 6 Quality Assurance 2 10 7 Biosafety and Biosecurity (BSBS) 6 20 8 Access, Assessment and Continuity of Care (AAC) 3 7 9 Care of Patients (COP) 3 7 10 Patient Rights and Education (PRE) 3 9 Total 31 107

7 MINIMAL SERVICE DELIVERY STANDARDS (MSDS) FOR LABORATORY COLLECTION POINTS 2024 1. Responsibilities of Management (ROM) (1 Standards; 5 Measurable Criteria) ROM-1 The Laboratory Collection Point is easily identifiable 1.1.1 The Collection Point is identifiable with name on a sign board clearly visible from reasonable distance and mentions that it is a collection center/point 1.1.2 The Collection Point signboard conforms to the prescribed local legal/technical and safety standards 1.1.3 The Collection Point is registered/licensed with the SHCC; registration number is displayed on sign board, and license is displayed at prominent place inside lab or application receipt is available 1.1.4 Associated collection centers are reflected in the registration certificate/License issued by SHCC to the parent lab and its copy is displayed at the CP; any change is timely communicated to SHCC for record 1.1.5 Defined process flow and list of SHCC licensed reference laboratories for outsourcing of tests exists preferably with Signed valid MOU, where applicable 2. Facility Management and Safety (FMS) (3 Standards; 13 measurable criteria) FMS-1 The management complies with principles of construction and safety 2.1.1 The building construction and safety verification documents issued by relevant authority are available (updates any amendments to laws and rules) 2.1.2 The management assures that waiting area, sample collection area, sample handling areas are clearly demarcated, adequate and well maintained 2.1.3 The management assures that utilities (water supply, electric supply/backup) are available 2.1.4 The management assures that facility construction and infrastructure meet laboratory specifications such as impervious skid proof flooring, sealed walls with washable paints, impervious/chemical resistant counter tops, adequate lighting and ventilation as required for declared scope of service 2.1.5 The Collection Point provides services in a manner that pose no risk to staff, patients and public 2.1.6 The Collection Point has SOPs for reporting safety and quality concerns by all staff members without fear of formal/informal disciplinary or punitive action, thus promoting a safety culture FMS-2 Facility workflow design conforms with the scope of services 2.2.1 The basic design of facility supports scope of services and biosafety level requirements with adequate space allocation and effective clearly marked separation between administrative and sample collection areas FMS-3 The laboratory has plans for fire and non-fire emergencies 2.3.1 Plans and provisions for early detection, containment and abatement of fire and non-fire emergencies exist (policy, SOPs, equipment such as smoke detectors, alarms, security, hazard signs)

8 MINIMAL SERVICE DELIVERY STANDARDS (MSDS) FOR LABORATORY COLLECTION POINTS 2024 2.3.2 Unobstructed, functional and clearly marked emergency exit points are present 2.3.3 Mock drill plans are available and conducted at least once in a year 2.3.4 Hazards and risks are assessed and timely managed and no hazardous conditions are observable 2.3.5 Staff members are trained for their role in case of such emergencies and training is documented 2.3.6 First aid kits, Eye washes and spill kits are available in sample collection and handling areas 3. Human Resource Management (HRM) (6 Standards; 19 measurable criteria) HRM-1 Staff deployment is in accordance with the scope of laboratory work 3.1.1 Job description for every post is identified and documented 3.1.2 Eligibility criteria regarding qualification and experience for each post is available 3.1.3 Recruitments are made according to laid down eligibility criteria HRM-2 Documented personal record for each staff member exists 3.2.1 Personal files of each full/part-time staff member are maintained containing all relevant documents including educational and professional qualifications, experience, licenses, contract, JD, performance evaluations, competency assessments, trainings, health record and disciplinary actions 3.2.2 All personnel undergo a pre-deployment health check-up, regular screening and color blindness test 3.2.3 SHCC is notified in writing of any Collection Point staff misconduct in service provision for record purposes 3.2.4 All Collection Point personnel are free from any internal or external commercial, financial biases or other conflicts of interest that may adversely affect the quality and outcomes of any tests reflecting norms of professional code of ethics HRM-3 The staff members joining the laboratory collection point are oriented to the CP laboratory environment, sections and their individual jobs and the orientation is documented via handbook/checklist/attendance sheets 3.3.1 A written employee level specific orientation plan including all areas of laboratory CP exists for newly inducted employees 3.3.2 Each staff member is made aware of laboratory wide policies and procedures as well as section/unit/service/program specific policies and procedures 3.3.3 Each member of staff is made aware of his/her rights and responsibilities 3.3.4 All employees are oriented with regard to patient’s rights and responsibilities HRM-4 An appraisal system for evaluating the performance of employees exists as an integral part of the human resource management process 3.4.1 Well-documented performance appraisal tools exist for the laboratory Collection Point 3.4.2 All of the employees/consultants/students/voluntary workers are made aware of the performance appraisal tools at the time of induction 3.4.3 The appraisal is used as a tool for further professional development

9 MINIMAL SERVICE DELIVERY STANDARDS (MSDS) FOR LABORATORY COLLECTION POINTS 2024 3.4.4 Performance appraisal is carried out at pre-defined intervals and is documented HRM-5 In-service staff capacity building record is documented 3.5.1 In-service training plan for staff members is available and execution verifiable through attendance records 3.5.2 All records of in-service training and education are contained in the personal files HRM-6 There is a process for collecting, verifying and evaluating the credentials (education, registration, training and experience) of laboratory CP staff 3.6.1 A system for the verification and validity of documents and certificates of employees with academic institutes, councils and accreditation bodies is present 3.6.2 Verification and validity of credential/documents is done in the laboratory CP for any newly added qualification/training certificate 4. Management of Equipment and Reagents (MER) (2 Standards;5 Measurable Criteria) MER-1 Safe handling and storage of samples is assured with correct equipment and materials 4.1.1 Documented policies and standard procedures guide the use and safe storage of color-coded collection tubes and sample collection bottles as per manufacturer instructions including temperature, light (brown coding) and humidity controls (Order of draw chart, tube identification chart and storage specifications are displayed) 4.1.2 An adequate number and up-to-date inventory of sample collection materials with expiry is maintained (includes sample collection materials, syringes, butterfly and safety needles, vacutainers, tourniquets, antiseptic wipes, gauze, band aids etc) MER-2 Comprehensive procedures for equipment management and maintenance exist in the laboratory 4.2.1 A detailed inventory of each equipment is maintained and available for review (such as refrigerator, tube rocker etc) 4.2.2 Regular periodic maintenance, calibration, breakdown and repairs record of all the equipment is available in the log book 4.2.3 Documented relevant log sheet is displayed on each equipment with emergency contact number for reporting equipment failure 5. Recording and Reporting System (RRS) (2 Standards; 12 Measurable Criteria) RRS-1: The laboratory collection point has a complete and accurate laboratory record for every patient 5..1.1 The laboratory CP has an established process for test registration that assures accuracy of patient identification and includes all relevant details for subsequent clinical correlation and surveillance reporting Information on preparation before sample collection is effectively communicated to the patient and recorded at the time of registration 5.1.2 Each test record has a unique identifier for every patient and record provides an up-to-date chronological data of patient’s investigations

10 MINIMAL SERVICE DELIVERY STANDARDS (MSDS) FOR LABORATORY COLLECTION POINTS 2024 5.1.3 Only authorized person makes entries in the laboratory record 5.1.4 There is a mechanism for internal data validation and results shall be reviewed and validated by authorized person before release 5.1.5 Every laboratory record entry is dated, timed and the data entry person can be identified 5.1.6 Digital/computerized/EMR system record of every patient is maintained for minimum 3 years; manual record maybe retained for 6 months – 1year except for histopathology and bone marrow for up to 5 years/lifetime) accessible from the Collection Point RRS-2 A comprehensive reporting system exists in the laboratory collection point 5.2.1 A computerized reporting system is available 5.2.2 Minimum reporting time for every test is documented and conveyed to patient 5.2.3 Reports are accessible to individual patients through a specific code 5.2.4 Critical results are timely reported to patient/ordering physician 5.2.5 Repeat results indicate addendum/modification clearly 5.2.6 Digital/manual records are protected from malware, unauthorized access and damage 6. Quality Assurance (QA) (2 Standards; 10 Measurable Criteria) QA-1 Internal quality assurance (IQA) is ensured in the collection area through standardized laboratory practices and procedures manual 6.1.1 There is a designated focal person responsible for quality assurance activities in the Laboratory collection point with documented assignment 6.1.2 Quality Assurance SOPs are communicated and coordinated among the staff 6.2.3 Policies and procedures guide the safe collection of specimens to avoid contamination; SOPs are available in procedure manuals with evidence of implementation 6.2.4 Policies and procedures guide the identification of patients and proper labeling of specimens; SOPs are available with evidence of implementation 6.2.5 Policies and procedures guide the safe and correct handling of specimens; SOPs are available with evidence of implementation 6.2.6 Policies and procedures guide the safe internal and external transportation of specimens; SOPs are available with evidence of implementation QA-2 Continuous laboratory improvement is documented 6.2.1 Gaps are identified through IQA and EQA reports and used as tools for improvement evident through relevant reports and documents 6.2.2 Incidents of non-conformance are investigated, and corrective actions are implemented and documented 6.2.3 Documented preventive actions are taken to minimize recurrence of errors 6.2.4 There is a system to monitor and measure the performance of all processes of the Collection point through comprehensive internal audit, preferably bi-annually

11 MINIMAL SERVICE DELIVERY STANDARDS (MSDS) FOR LABORATORY COLLECTION POINTS 2024 7. Biosafety and Biosecurity (BSBS) (6 Standards; 20 Measurable Criteria) BSBS-1 The parent laboratory has a comprehensive and coordinated biosafety program for the collection points 7.1.1 There is a policy for ongoing bio risk assessment and mitigation 7.1.2 Laboratory biosafety manual and SOPs are available which cover bio-safe practices in pre- analytical and post analytical processes and promotion of safety culture through regular staff training and refreshers 7.1.3 Biosafety SOPs are communicated to the collection point staff as evident from record including for Universal precautions, needle stick injury and sample spillage 7.1.4 The laboratory has a designated qualified technician for ensuring biosafety activities of collection point 7.1.5 Regular monthly biosafety monitoring reports are generated in the collection point and available for review 7.1.6 Pathogen and Material Safety datasheets are available at parent lab and utilized for worker safety at its collection points BSBS-2 Continuous staff biosafety measures are ensured and documented 7.2.1 The collection point has appropriate consumables, equipment and facilities for biosafety, evident through inventory/stock registers (PPE including 70% ABHR, Gloves, Masks, face/eye shields and Aprons and antiseptic surface cleaning wipes)) 7.2.2 All staff involved in the handling and disposal of biohazard material and waste shall receive regular vaccination evident from records 7.2.3 Annual medical check-up of all staff dealing with biohazard materials and waste is documented BSBS-3 Patient and visitor biosafety is ensured and documented 7.3.1 Waiting areas for patients and visitors are properly ventilated via fans/exhaust and air from specimen collection area is directed away from waiting area 7.3.2 Only Patients are allowed in the specimen collection area and entry to sample storage and handling area is restricted with clearly marked signs BSBS-4 There is documented procedure of bio-risk management 7.4.1 All incidents of laboratory biosafety breach are reported and documented 7.4.2 Required disinfectants/spill kits are available in the laboratory with clearly marked location and SOP for use BSBS-5 Measures to ensure biosecurity in the laboratory collection point are practiced 7.5.1 Only authorized persons are permitted to enter the sample storage area and staff is identifiable through uniform/identity cards 7.5.2 Complete record of any transportation of samples is maintained BSBS-6 The collection point has well designed, comprehensive and coordinated waste management plan 7.6.1 Written collection point waste management SOPs are available

12 MINIMAL SERVICE DELIVERY STANDARDS (MSDS) FOR LABORATORY COLLECTION POINTS 2024 7.6.2 Waste management SOPs are communicated to collection point staff with adequate training 7.6.3 The laboratory has appropriate consumables, collection and handling systems and equipment for waste management including PPE, color coded bins, sharps bins, bags, trolleys and secure storage area 7.6.4 Terminal waste disposal mechanisms are available either on site or via contracts with waste disposal service organization 7.6.6 Record of date, time, type and weight of waste for final disposal is recorded, and record is available for review 8. Access, Assessment and Continuity of Care (AAC) (3 Standards; 7 Measurable Criteria) AAC-1 Laboratory collection point services are easily accessible 8.1.1 The location of sample collection point and specimen collection area within is easily accessible 8.1.2 There are clean toilets/washrooms with bolts (preferably separate for males and females) that are clearly marked for normal use and specimen collection Specimen collection bottles are stocked or provided, gloves/ alcohol wipes are provided or stocked, specimen collection instructions are displayed, and a shelf or basket is available and marked for placing samples. 8.1.3 Toilets for disabled patients are available with wheelchair accessibility and support bars or alternate sample collection methods are offered 8.1.4 Disabled patients are facilitated for phlebotomy and other sample collection 8.1.5 Directional arrows pointing towards various important areas for patients are displayed in the laboratory AAC-2 Laboratory collection point services are provided as portrayed/claimed 8.2.1 List of laboratory services being provided are displayed/available ACC-3 The laboratory record supports continuity of patient care 8.3.1 The record provides an up-to-date and chronological account of each patient’s record of tests 9. Care of Patients (COP) (3 Standards; 7 Measurable Criteria) COP-1 Emergency handling of patients is guided by protocols 9.1.1 SOPs for providing first aid/emergency care to the patients are documented 9.1.2 First aid kit is available and staff is conversant on its use 9.1.3 Relevant contact numbers for emergency services and referral are available and displayed at a prominent location in the laboratory collection point COP-2 Sentinel events are intensively analyzed 9.2.1 The collection point has defined sentinel events and written definition is available 9.2.2 Sentinel events are intensively analyzed when they occur and corrective action is taken and documented

13 MINIMAL SERVICE DELIVERY STANDARDS (MSDS) FOR LABORATORY COLLECTION POINTS 2024 COP-3 The laboratory policies and procedures clearly identify whether home-based sample collection services are available and under what conditions (days, times, prescription or patient incapacity requirements) 9.3.1 The laboratory collection point is equipped with means of communication and transport services for home-based patient sample collection if applicable; there is means of communication to parent lab for any queries 9.3.2 The laboratory has appropriate means of collection and transportation of home-based samples including secure carry case, PPE, appropriate sample collection equipment and storage containers; and appropriate means of transportation of samples to parent laboratory 10. Patient Rights and Education (PRE) (3 Standards; 9 Measurable Criteria) PRE-1 A system exists for obtaining consent when it is required 10.1.1 The laboratory has listed those situations where specific informed consent is required; form is available and there is evidence of correct utilization 10.1.2 The policy describes who can give consent when a patient is incapable of independent decision-making PRE-2 Patients and families have a right to information on expected cost 10.2.1 The tariff list is available to patients and laboratory bears the cost of sample recollection when required 10.2.2 The lab offers and informs patients of cost-effective bundles and implements cost ceilings when defined by regulatory authority PRE-3 Patient rights for appeals, complaints and confidentiality are assured 10.3.1 The laboratory collection point has a documented policy and procedure for the registering and resolution of complaints or other feedback received from clinicians, patients or other parties 10.3.2 The laboratory collection point provides contact details of management/ complaint system to public 10.3.3 Complaints are systematically investigated and corrective and remedial measures are taken and documented 10.3.4 Confidentiality of patient record is maintained 10.3.5 Disease data sharing is restricted to relevant authorities and there is strict policy on release of data directly or indirectly to unauthorized persons or media

MINIMUM SERVICE DELIVERY STANDARDS FOR CLINICAL DIAGNOSTIC LABORATORIES 14 Appendix 1 Laboratory Collection Point Personnel Specifications Position Qualifications Scope Lab Technologist/Collection Center In charge Matric/ FSc with 2-year Diploma in Lab Tech (SMF) Can collect samples and perform automated /LIC and simple auto interpreted tests Phlebotomist/In charge collection center Matric; Phlebotomy or Lab technician 1 year certificate course (SMF or internal training) Obtains blood samples, manages samples and performs administrative work Administrator/Receptionist Suitable for JD One person can perform as receptionist, administrator and phlebotomist References 1. Islamabad Health Regulatory Authority, Minimum Service Delivery Standards for Clinical Labs 2. National Laboratory Policy 2017, National Institute of Health, Ministry of Health Service Regulation and Coordination, Islamabad 3. Pakistan Academy of Sciences. 2019. Good Clinical Laboratory Practices in Pakistan. Islamabad, Pakistan. 4. World Health Organization, Regional Office for South-East Asia. Laboratory quality standards and their implementation. 2011 5. Laboratory quality management system: Handbook. World Health Organization 2011 6. Laboratory biosafety manual, 3rd edition, World Health Organization, Geneva, 2004 Available at http://www.who.int/csr/resources/publications/biosafety/Biosafety7.pdf 7. ISO 9001:2000 8. ISO 15189:2007 for clinical laboratories 9. ISO/IEC 17025:2005 10. Clinical Lab Standards Institute consensus-based medical laboratory standards 11. Joint Commission International Accreditation 4th Ed Effective January 2022

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