SOLICITATION NOTICE
Q -- FY21: VISN 08 Reference Laboratory Testing Services
- Notice Date
- 8/14/2021 10:34:36 AM
- Notice Type
- Presolicitation
- NAICS
- 621511
— Medical Laboratories
- Contracting Office
- 248-NETWORK CONTRACT OFFICE 8 (36C248) TAMPA FL 33637 USA
- ZIP Code
- 33637
- Solicitation Number
- 36C24821R0112
- Response Due
- 8/25/2021 7:00:00 AM
- Archive Date
- 11/23/2021
- Point of Contact
- Paul A Jarrett, Contract Specialist, Phone: 813-972-2000 Ext 3107
- E-Mail Address
-
Paul.Jarrett@va.gov
(Paul.Jarrett@va.gov)
- Awardee
- null
- Description
- DRAFT STATEMENT OF WORK Reference Laboratories Testing 1.0 INTRODUCTION Veterans Integrated Services Network 8 (VISN 8) has a requirement for reference laboratory testing for all esoteric tests from the associated VISN 8 Veterans Affairs Medical Facilities and the transportation of clinical laboratory specimens to the contractor s laboratory(s) as well as courier service between facilities within VISN 8. The associated Veterans Affairs Medical Facilities include the following: Veterans Affairs Medical Center (VAMC) Bay Pines, VAMC Tampa, VAMC Orlando, VAMC West Palm Beach, VAMC Miami, VAMC Lake City, VAMC Gainesville, VAMC San Juan, and their associated community-based outpatient clinics (CBOCs). These facilities encompass the entire state of Florida (except for the western edge of the Florida Panhandle and a clinic in Pensacola) and Puerto Rico. 2.0 BACKGROUND Anatomic and surgical pathology tests and clinical laboratory tests are essential diagnostic tools for the physicians to use to improve patient care. A reference laboratory is required to provide the testing services that cannot be performed within the facilities of the VISN, to provide confirmation of tests that are performed within the facilities of the VISN, and to provide consultations on pathology specimens. 3.0 SCOPE OF WORK Services shall include reference laboratory testing for all esoteric tests as defined by the contractor s reference test manual, the transportation of clinical laboratory specimens to the contractor s laboratory(s) as well as provide courier service between facilities within VISN 8 daily (with the exceptions of weekend and holidays), the reporting of clinical and anatomic analytical test results and consultative services as required to assimilate the full scope of its laboratory operations to the VISN 8. All requirements and provisions defined in this scope of work will apply to any laboratory, i.e. branch, division, sub-contractor, etc. performing reference testing on behalf of the contractor and will include any and all new facilities acquired into VISN 8 during the contract period at a negotiated cost per coverage. 4.0 APPLICABLE STANDARDS AND SPECIFICATIONS 4.1 The associated VISN 8 Veterans Affairs Medical Facilities will prepare specimens for shipping by the contractor to the reference laboratory in accordance with all State and Federal shipping rules and regulations. 4.2 The courier service and the shipping initiator must comply with all transportation, shipping rules and regulations, employee training and infection control guidelines established by State and Federal agencies. 4.3 VA Information Security Requirements 4.3.1 The contractor must meet all Enterprise Cyber Security Infrastructure Project (ECSIP) requirements in order to establish an interconnection with the VA for transfer of laboratory test results directly into a VA computer system via the appropriate Laboratory Electronic Data Interchange protocol. There are three basic types of authorized connections. The ECSIP team will have the ultimate decision on which connection type is appropriate. The connection types are described below. More information can be obtained from the VA Information Security Officer at any facility. 4.3.2 External users shall be classified in one of three distinct categories: 1) client-to-site virtual private network (VPN), 2) site-to-site VPN, or 3) Business Partner Gateways. The items below can be utilized in assisting users to determine which category a particular connection may best be identified. 4.3.3 Client-to-Site VPNs satisfy remote connectivity for small groups of external users (IE <50) that require access to VA internal resources. Non VA users are restricted to specific internal IP addresses identified by the Contracting Officer Representative (COR). External business partners should have access to the minimum resources required to meet contractual obligations. 4.3.4 Site-to-Site VPNs are connections to external business partners, which terminate in an ECSIP gateway. These connections will then be routed across the VA WAN to the requisite VA facility resources as defined by firewall policy. 4.3.5 Business Partner Gateways (BPGs) are connections to external business partners, which terminate at the requisite VA facility and do not traverse the VA WAN. These connections will be limited in number based on the definitions of the Chief Information Officer requirements. 4.3.6 Specifications outlining the requirements of this computer interface including computer hardware, maintenance, and supply requirements are defined in the telecommunication requirements listed below. Connectivity Requirement Client-to-Site VPN Site-to-Site VPN Business Partner Gateway Small Number of Users If the number of user accounts the ISO must administer is manageable, a client-to-site connection will usually suffice. X Numerous Users Having a significant number of client-to-site user accounts to manage may justify a site-to-site VPN. X Persistent Connection Required The need to maintain continuous connectivity can usually be supported with a site-to-site VPN. X X High Bandwidth A large volume of traffic may be a valid need to establish or maintain a Business Partner Gateway (BPG) connection to prevent certain traffic from traversing the VA WAN. As an example, a medical teaching University supported by a VA Hospital that sends large radiological images on a regular basis. This could have a detrimental impact on the VA WAN if that traffic traverses the WAN through a VPN connection. X Service Level Agreements SLAs that guarantee specific levels of support to contracted agencies that could not be provided using a One-VA VPN may also justify a BPG connection. X High Availability Availability of critical business processes, such as financial and medical applications, may justify maintaining a BPG to minimize the risk of financial and personal health data loss. X Data Sensitivity Data Sensitivity Every effort should be made to protect sensitive information. Although protection mechanisms are in place, there are still risks associated with transmitting sensitive data across any network, to include the VA WAN. Although the One-VA VPN satisfies this requirement, the sensitivity of the data may be such that additional precautions are warranted. X X Server-to-Server Connections In most cases, a site-to-site VPN can be used to support external server connections. X X LAN Extensions LAN extensions to the VA WAN may be supported with a site-to-site VPN. In order to qualify for a LAN extension, VA must control both physical AND logical security at the site. X Requirements A requirement for protocols not currently supported in the VA firewall policy and would be a significant security risk to the VA WAN is a candidate for a site-to-site VPN connection. X X Data protection - Requirements - The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated, per VA policy. Non-VA Owned Systems Contractors will not access, transmit, or store remotely any VA sensitive information that is not encrypted using VA approved encryption per VA policy HB 6500. X (Vendor needs to ensure client workstations are FIPS encrypted) X (VA VPN tunnel is FIPS compliant) 5.0 PERFORMANCE REQUIREMENTS 5.1 The contractor shall provide to the associated VISN 8 Veterans Affairs Medical Facilities a current list of all tests available through their laboratory and keep the associated VISN 8 Veterans Affairs Medical Facilities current of all new tests as they become available. 5.1.2 The following general test information shall be provided to the Government in hard copy test catalog format and available electronically as requested; 2-3 copies for each facility: Requisition form requirements Alphabetized test name list Reference lab test number Specimen collection requirements Test method used (indicate if testing performed in duplicate) Test reference intervals Test critical values, if any Policy for critical value notification CPT coding Test turnaround times (minimum and maximum times indicated); where the turnaround time is defined as the time between pick-up of specimen by the contractor and receipt of results by a VISN 8 facility LOINC Codes Frequency of test performance (specific days of week indicated) Location of test performance by test name (i.e. name and address of primary laboratory, name of separate branch/division of primary lab, name and address of secondary (sub-contracted) laboratory must be cited) 5.1.3 The contractor shall notify in writing each VISN 8 facility when any modifications to this information occur during the contract award period or minimally on an annual basis. 5.2 The contractor will provide the associated VISN 8 Veterans Affairs Medical Facilities with Anatomic and Surgical Pathology consultations. The consultants are nationally and internationally recognized pathologists, subspecialty-qualified clinicians, and board-certified clinical scientists and are available for consultation regarding appropriate test ordering, additional recommended testing, disease management, and patient results. A pathologist shall be on call at all times and available for emergency consultation after hours. Complex issues that cannot be resolved by the resident pathologist on call will be referred immediately to the medical director specializing in the appropriate area. The specialty areas for consultation include but are not limited to; Amyloid testing, Lung and Mediastinum, Soft tissue tumors and Surgical Oncology, GYN pathology, Breast, Bone Pathology, Prostate and Urinary pathology, Gastrointestinal Pathology, Neuropathology, Endocrine Pathology, Hematopathology, General Surgical Pathology, Head and Neck Pathology, Uropathology, Dermatopathology, and Pulmonary. 5.3 The contractor shall be responsible to perform no less than 80% of the requested testing within facilities wholly owned by the contractor. 5.4 The contractor will be responsible to furnish the associated VISN 8 Veterans Affairs Medical Facilities with an electronic/computerized method to request tests and receive results. 5.5 The contractor is responsible for providing a test report for each test requested. A report is defined as a printed final copy in duplicate of laboratory testing results or host-to-host electronic transmission of test results. This report will be received by either messenger delivery or computer interface. Each test report shall at minimum indicate the following information: Patient's name and/or identification number Physician s name (if supplied) VISN 8 medical record number or laboratory accession number (if supplied) VISN 8 submitting facility name Patient's location (clinic/ward) (if supplied) Test ordered Date/time of specimen collection (when available) Date/time test completed Test result Reference intervals Toxic and therapeutic ranges, if applicable Flagged abnormal values Reference laboratory specimen number Name and address of testing laboratory if other than contractor Any other information the laboratory has that may indicate a questionable validity of test results Comments related to the test provided by the submitting lab Unsatisfactory specimen shall be reported with documentation supporting its unsuitability for testing Anatomic and Surgical reports shall be in synoptic format 5.6 The contractor will be responsible for transporting and storing specimens in such a manner to insure the integrity of the specimen. In addition, the contractor will provide additives required for collection of specimens in unit packages to facilitate collection in CBOCs and Out Patient Clinics (OPCs). Material Safety Data Sheets will be provided to sites for supplies containing hazardous chemicals (e.g. boric acid tablets, acids). 5.7 Emergency testing services shall be available for all procedures deemed necessary on an emergent basis. The test results will be reported within four (4) hours from the time the specimen is collected/picked-up by the contractor. 5.8 The contractor shall provide timely (defined by the minimum and maximum turnaround times established for each test) and appropriate testing of patient specimens as requested by VISN 8 facilities. 5.9 The contractor shall store the specimens a minimum of seven days after the test is reported in the event that subsequent action is necessitated (i.e. problem solving and/or repeat testing). 5.10 Test definitions, test information and test requirements shall be complete, available and easily accessible. Tests requests are generated utilizing the Vista/contractor interface. For all non-interfaced tests, ordering shall be accomplished through a menu that is intuitive, has minimal options and uses a mouse or touch screen. Upon selection of the test, the computer shall alert (flag) the user to the type of specimen required and the storage conditions. It shall also alert the user to the location of the laboratory that will be performing the test. 5.11 A shipping manifest that identifies the specimens sent to the commercial reference laboratory, transportation conditions, and testing ordered shall be provided to the VA. 5.12 The contractor shall provide reference testing courier services between the VISN 8 facilities and the contracted laboratory as well as between the VISN 8 facilities themselves in accordance with the courier schedule. Courier services shall be automatically extended to any and all new VISN 8 facilities acquired during the contract period. Service shall include at least one (1) pick-up per day at each facility. 5.13 The contractor shall provide specimen pick-up services regardless of the number of specimens picked up. The contractor shall provide emergency transportation services equal to the routine level services and be available 24 hours per day, seven days per week including Government holidays. Response time for emergency transportation services shall be within 1 hour of notification of specimen availability. A unit of service is defined as a call for emergency transportation regardless of the number of specimens included in the transport. 5.14 Notification of a test result that has been identified in the commercial reference contractor laboratory as a critical value shall be communicated by telephone to the submitting VISN 8 laboratory upon verification of the critical test result. A hard copy result must follow any telephonic reporting either by fax or computer generated report. 5.15 Reserved 5.16 The ordering of specimen collection and transportation supplies is accomplished through direct on-line ordering provided by the contractor. The contractor shall provide at no additional charge an adequate supply of specimen collection materials for such testing that is destined to the commercial reference laboratory for analysis and requires specialized handling as dictated by the commercial reference laboratory s specimen collection requirements, i.e. dry ice, stabilizing tablets, ice packets, etc. 5.17 Performance Standards. The following performance standards will apply to services provided under this statement of work: Contractor shall have anatomical and surgical pathology consultants available to VISN 8 during normal business hours and on-call after business hours. Acceptable rate: 100 percent. Contractor shall perform all testing at its own facilities. Acceptable rate: 80 percent. Emergency testing is reported no later than four hours after pickup of specimen from VISN 8 Medical Facility. Acceptable rate: 100 percent. Contractor shall meet all established test turnaround times. Results for clinical test are to be received within 24 hours of specimen pickup, unless the nature of the test requires a turnaround time of greater than 24 hours. In this case test results shall be received no later than one hour after test result verification. Acceptable rate: 100 percent. Contractor shall ensure test reports contain all minimum required information specified in the SOW. Acceptable rate: 100 percent. Contractor shall provide notification to VISN 8 laboratories of test results identified as critical values upon verification of the critical test result. Acceptable rate: 100 percent. Contractor shall provide VISN 8 with a daily listing of incomplete specimens received from the prior day. Acceptable rate: 100 percent. Contractor shall provide VISN 8 on a monthly basis, current performance improvement monitors that include and not limited to: demonstration of number of lost specimens, number of cancelled specimens, delays in turnaround times, and courier route delays/cancellations Contractor shall ensure test reports will be available via the VistA/Contractor interface. Acceptable rate: 95 percent. Contractor shall ensure that all employees having access to the VistA/Contractor interface or Protected Health Information have received the proper background investigation in accordance with the statement of work. Acceptable rate: 100 percent. Contractor shall provide to the respective designee for each facility, the following documentation on a monthly basis: current performance improvement monitors that include but are not limited to, demonstration of the number of lost specimens, number of cancelled specimens, delays in turnaround times, and courier route delays/cancellations. Acceptable rate: 100 percent. 6.0 CONTRACTORS QUALIFICATIONS/REQUIREMENTS 6.1 The reference laboratory and any subcontractors thereof must be licensed/accredited by the College of American Pathologists, the Nuclear Regulatory Commission, the Center for Disease Control, Medicare and other state regulatory agencies as mandated by federal and state statutes. In addition, the laboratory must be certified as meeting the requirements of the Clinical Laboratory Improvement Act of 1988 and comply with the National Standards to Protect the Privacy of Personal Health Information (HIPPA). Copies of all relevant permits/licenses and certification inclusive of any sanctions current or pending throughout the United States of America must be supplied to each of the VISN 8 facilities . In addition, as these documents are reissued or reworded, the awarded contractor must supply the revised copy to each of the VISN 8 facilities. The above documents must also be supplied for each reference laboratory that is a subcontractor of the primary contractor. 6.2 The Government reserves the right to physically inspect the reference laboratory(s) at any time to insure the reference laboratory s compliance with accreditation and quality assurance practices and requirements. 6.3 Results for clinical tests are to be received within 24 hours following specimen pick up either by hard copy or electronic report transmission. It is recognized that certain test procedures will require a longer turnaround time than the 24 hours. Under these circumstances, test results are expected to be received no later than 1 hour after the verification of the test. 6.4 The contractor shall take all precautions necessary to protect persons and property from injury or damage during the performance of this contract. Contractor personnel shall be responsible for any injury to employees or others as well as for any damage to personal or public property that occurs during the performance of this contactor that is caused by the negligence of the contractor or its employees. The contractor shall maintain personal liability and property damage insurance prescribed by the laws of the State of Florida. 6.5 Any equipment provided by the contractor to VA which contains a storage device such that when the device is powered down, VA sensitive data remains on it must become the property of the Federal Government and remain on Federal property or must be destroyed by VA and in accordance with Department of Veterans Affairs regulations at the time of removal (device decommissioning). Data required by the Health Insurance Portability and Accountability Account of 1996 (HIPAA) to remain on equipment located on contractor s property must be safeguarded in accordance with HIPAA and this information must be destroyed in accordance with VA requirements when no longer required by HIPAA to be held by the vendor. 6.6 The reference laboratory must meet HIPPA requirements. The contractor shall be required to be in compliance with the Health Insurance Portability and Accountability Act of 1996 regulations and will be required to sign a Business Associate Agreement with the VA. The signed agreement will be returned to the contracting officer and a signed copy will be returned to the contractor for their files. 6.7 The contractor must be able to interface with the current version of the VA VistA System, and be willing to provide technical support should the current system change. At least 95% of all test reports will be available via a VistA/Contractor interface. All hardware and software needed for the interface will be provided by the contractor and implementation will be timely. Contractor will use the manifest and test labels of the Host lab and receive orders and send results via a LEDi HL7 interface with VistA. Printed copies of results will also be made available via an in-house printer to confirm interfaced data. 6.8 The contractor shall be responsible for insuring that all transport personnel are trained and that their competency is regularly assessed in appropriate safety and packaging procedures suitable to specimen type and distances transported. This should include issues such as adherence to regulations for transport of biohazards, use of rigid containers where appropriate, temperature control, notification procedures in case of accident or spills, etc. 6.9 The contractor shall ensure the confidentiality of all patient information being transported and will be held liable in the event of a breach of confidentiality. The contractor shall comply with the provision of the Federal Privacy Act of 1974 (Public Law 93-579), HIPAA (Public Law 104-191), and the Comprehensive Alcohol Abuse and Alcoholism Prevention, Treatment and Rehabilitation Act of 1972 (Public Law 93-255), as well as any other statutes regarding confidentiality of patient information during and after the execution of the contract. The contractor shall obtain a signed confidentiality certificate from each employee that may have access to medical record information prior to allowing them to work on this contract. Any information about an individual that is maintained by the VA shall be kept confidential. A copy of a signed certificate shall be provided to the Contracting Officer (CO) upon request. 6.10 The preliminary and final deliverables, and all associated working papers, application source code, and other material deemed relevant by the VA which has been generated by the contractor in their performance are the exclusive property of the U.S. Government and shall be submitted to the CO at the conclusion of the services. The CO will be the sole authorized official to release, verbally or in writing, any data, draft deliverables, final deliverables, or any other written or printed materials. No information shall be released by the contractor. Any request for information presented to the contractor shall be submitted to the CO for response. Press releases, marketing material, or any other printed or electronic documentation related to these services shall not be publicized without the written approval of the CO. 6.10 The contractor shall provide a list of the availability of community based specimen collection sites. 6.11 The Contractor shall provide a statistical analysis of the VISN 8 facilities workload testing volumes to assist in the monitoring of ordering trends and utilization patterns. 6.12 The contractor shall provide anatomic and surgical pathology consultation regarding selection, collection, transportation and result interpretation of pathology specimens when required. The reference testing of anatomic and surgical pathology specimens includes but is not limited to: Immunohistochemistry technical only; Immunohistochemical technical and professional; In situ hybridization technical and professional; Fluorescent in situ hybridization technical and professional; Molecular PCR technical and professional 7.0 VISN 8 RESPONSIBILITIES 7.1 The associated VISN 8 Veterans Affairs Medical Facilities will ensure proper collection of the specimens for shipping. Specimens will be properly labeled and collected in the proper tube/container. 7.2 The associated VISN 8 Veterans Affairs Medical Facilities will ship specimens to the contractor in a time frame appropriate to maintain specimen integrity. All specimens will be stored in accordance with the policies and procedures of the reference lab. 7.3 The associated VISN 8 Veterans Affairs Medical Facilities will provide a secure fax line and a computer system to receive test reports from the reference laboratory. 7.4 The VISN 8 facilities reserve the right to select other testing methodologies than offered by the contractor s laboratory for appropriate reasons, i.e. better clinical quality, research studies, or those determined for performance at VISN 8 centers of excellence. VISN 8 facilities that identify such a testing methodology not meeting their testing criteria must submit a request for review to a VISN 8 adjudicating panel with sufficient justification to warrant an exemption from the contract. These rare test exemptions will be re-referred to another reference laboratory and the costs borne by VISN 8. 8.0 Deliverables 8.1 All contractors must meet the following background investigation requirements: All users with access to the data received from Department of Veterans Affairs (VA) are U.S. Citizens with a contractor s valid and current background investigation or a mutually agreed upon VA level background clearance verified to be at the National Agency Check with Inquiries (NACI) level for laboratory technical staff and business operations staff and are operating within the borders of the U.S.A. and its territories. Anyone with administrative or programmer access to a Federal computer system will have a background investigation commensurate with the level of access granted to the VA computer system as determined by the Information Security Officer in concert with Human Resources Management Staff. These staff must be operating within the borders of the U.S.A. and its territories. All contractor employees who require access to the Department of Veterans Affairs' computer systems shall be the subject of a background investigation and must receive a favorable adjudication from the VA Office of Security and Law Enforcement (OS & LE). This requirement is applicable to all tiers of subcontractor personnel requiring the same access. This screening shall be initiated prior to contract performance and the cost of the investigation will be the responsibility of the contractor. For U.S. Citizens, if the investigation has not been completed prior to the start date of the contract, the contractor will be responsible for the actions of those individuals they provide to perform work for VA. For non U.S. Citizens, the screening and investigation must be completed before that employee can begin working on this contract. 8.2 A direct contact(s) shall be designated for immediate response to courier service issues. This contact(s) shall be available within the timeframes covered in the courier route plan. The courier route plan shall be completed by the contractor and shall include a monthly fee for courier service between the following facilities: Bay Pines VA Tampa VA Gainesville VA Lake City VA Miami VA West Palm Beach VA Orlando VA San Juan, PR VA Bay Pines VA N/A Tampa VA N/A Gainesville VA N/A Lake City VA N/A Miami VA N/A West Palm Beach VA N/A Orlando VA N/A San Juan, PR VA N/A 8.3 STAT test results shall be reported within 4 hours or less of specimen pick-up (unless a longer test turnaround time is specifically allowed on a case-by-case basis). 8.4 Results for specialty clinical tests are reasonably expected to be available within 7 days following specimen pick up when performed by a facility that is wholly owned by the contractor, with the preference for availability of results to be within 3 to 5 days. 8.5 Results for specialty clinical tests performed by subsidiaries of the contractor are reasonably expected to be available with 10 days following specimen pick up, with the preference for availability of results to be within 5 to 7 days. 8.6 Contractor shall provide by 12:00P.M., daily, a report listing all incomplete specimens received by the reference laboratory from the previous day, and their processing status. 8.7 The contracted commercial reference laboratory shall submit evidence of their training and annual competency programs. During the term of this contract, this program may need to be updated/revised to comply with regulatory requirements. This documentation should be made available to the VISN 8 facilities upon their request. 8.8 The reference laboratory shall provide to the respective designee for each facility the following documentation on a monthly basis in accordance with CAP and JCAHO requirements: Current performance improvement monitors that include and not limited to demonstration of number of lost specimens, number of cancelled specimens, delays in turnaround times, and courier route delays/cancellations Other Quality Assurance Monitors as defined by VISN 8 8.9 The reference laboratory shall provide to the respective designee for each facility the following documentation on an annual basis in accordance with CAP and JCAHO requirements: Professional Staff Curricula Vitae Technical Staff Competency Skills Assessment Proficiency Exam Participation Proficiency Exam Exception Reports for the past two years Description of Performance Improvement (Quality Assurance) Program 8.10 The reference laboratory shall provide the following documentation; Proficiency Testing performance past 3 years CAP accreditation score CLIA inspection evaluation 8.11 One copy of the following reports shall be available to the respective designee for each facility by the 20th of the month following the close of the reporting month: A monthly summary sheet by dollar volume for each facility listing tests in descending order of dollar volume with volume of tests ordered, unit charge for each test, total charges for months and year to date. A summary sheet by test frequency of the entire VISN 8 laboratory utilization listing by facility all tests ordered, the volume of tests ordered, unit charge per tests, total charges and percent abnormal results for the period A summary sheet listing the type and volume of testing sent to a sub-contracted reference laboratory A monthly cumulative summary alphabetically by patient for each facility indicating patient s name, test ordered, date specimen received and ordering physician. A monthly summary sheet by test frequency for each facility listing patient name, volume of tests ordered, unit charge, total charges for this month and year to date. A summary sheet listing the type and volume of testing sent to a sub-contracted reference laboratory A consolidated report of the above information to include all facilities in one report that is sent to each facility. 8.12 The contractor shall provide written notification about changes to methodology, specimen requirements, turnaround times, reference ranges, and test availability 30 days in advance of the effective date. 8.13 The contractor shall provide a detailed plan describing their proposal for performance improvement activities that are specific to the VISN 8 facilities. This plan shall minimally address the quality aspects representative to the testing process, i.e. pre-analytical, analytical and post-analytical variables and include a description of monitoring and evaluation activities. This plan shall also includ...
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