36C24121Q0569.docx

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36C24121Q0569 08-03-2021 Tom Neubelt 802-296-5102 08-16-2021 16:00

EDT

Department of Veterans Affairs VAMC White River Junction 215 North Main Street White River Junction

VT

05009 X 621511 $35 Million N/A X Department of Veterans Affairs VAMC White River Junction 215 North Main Street White River Junction

VT

05009 Department of Veterans Affairs VAMC White River Junction 215 North Main Street White River Junction

VT

05009

Department of Veterans Affairs Financial Services Center Per VAR clause 852-232-72 http://www.fsc.va.gov/einvoice.asp

See CONTINUATION Page This solicitation is an RFQ for services to perform off-site thyroid sequencing to detect variants/mutations and gene fusion for indeterminate thyroid fine needle aspirates FNAs) for the Department of Veterans Affairs Medical Center, VISN 1 Laboratories (herein referred to as VAMC). This will be a firm fixed price BPA with a five (5) year period of performance to run from 9/1/21-8/31/26, with yearly funded task orders. Contractor shall provide all necessary personnel, supervision, labor, equipment, materials and necessary to provide these services for the VISN 1 Labs pursuant to the Performance Work Statement contained herein.

Quotes are due by 8/13 Submit to thomas.neubelt@va.gov See CONTINUATION Page X X Julie Lemire Table of Contents

Performance Work Statement (PWS) General:

Services are required to perform off-site thyroid sequencing to detect variants/mutations and gene fusions for indeterminate thyroid fine needle aspirates (FNAs) for the Department of Veterans Affairs Medical Center, VA VISN 1 Laboratories (herein referred to as VAMC). The services shall be provided in a state-of-the-art civilian medical facility. The standard of services shall be of quality; meeting or exceeding those outlined in the licensing and accreditation section of this PWS. Contactor policies and procedures shall comply with Health Insurance Portability and Accountability Act (HIPAA).

Description of Services/Introduction:

This request is for a 5-year firm-fixed price BPA with a base period of performance 8/1/2021 through 7/31/22. The contractor shall provide all personnel, equipment, supplies, facilities, tools, materials, supervision, and other items and services necessary to provide services as defined in this PWS except for those items specified as government furnished property and services. The contractor shall perform to the standards in this contract.

Scope:

The contractor shall provide testing as outlined in this PWS. The VAMC will send a contractor provided requisition form or manifest containing at a minimum the patient’s full name, hospital identification number, tests to be performed, sample collection date/time, ordering provider, sample type and date of birth (second identifier). For specialized testing, the VAMC will provide a brief clinical history when necessary. The annual quantity is only an estimate. Volumes may vary during the life of the agreement.

Testing Services:

FNA of the thyroid is performed to distinguish benign thyroid lesions from malignant ones. In the case of an indeterminate thyroid FNA, genetic sequencing testing is needed to more accurately classify whether a patient would need further surgery, and how extensive that surgery may be. This is important because it reduces the rate of unnecessary thyroid surgery for patients with benign nodules. Ability to test for the following mutations is preferred: TERT and ALK.

Locations:

VA Connecticut Healthcare System West Haven Campus, POC: Dana Towle, Phone:203-932-5711 x2965, Email: Dana.Towle@va.gov, 950 Campbell Avenue West Haven, CT 06516

VA Boston Healthcare System West Roxbury Campus, POC: Arthur Mcgee, Phone:857-203-5993, Email: Arthur.Mcgee@va.gov 1400 VFW Parkway West Roxbury, MA 02132

VA White River Junction POC: Susan Webber, Phone:802-295-9363 x 5512, Email: Susan.Webber@va.gov, 215 North Main Street White River Junction, VT 05009-001

VA Manchester POC: Monica Zukovic, Phone: 603-624-4366 x6639, Email: Monica.Zukovic@va.gov, 718 Smyth Road, Manchester, NH 03104

VA Providence POC: Amanda Fitzgerald, Phone:401-273-7100 x 3127, Email: Amanda.Fitzgerald@va.gov, Providence, RI 02908

VA Maine POC: Dennis Arbour, Phone: 207-623-8411 x 5613, Email: Dennis.Arbour@va.gov, 1 VA Center Augusta, ME 04330

The Government reserves the right to add additional VISN 1 Lab sites during the life of this agreement.

The Contractor Laboratory shall:

1. Accept the unique facility National Provider Identifier (NPI) number and not require an NPI for each individual ordering practitioner.

2. Perform analytical testing for VAMC patients for the tests defined in the test menu included in this PWS. The Contractor shall bill only for the tests specified in the request sent by the VAMC Laboratory service and that are contained in the test menu found in this PWS.

3. Provide test results in a turnaround time of 15 days or less.

4. Provide a reference test manual, and report of analytical test results and consultative services as required assimilating the full scope of its laboratory operations.

5. Provide VAMC with appropriate laboratory supplies (collection tubes and shipping kits) not customarily utilized by the VAMC. These supplies are to be used by the VAMC only in connection with specimens being sent for testing to the contractor.

6. Provide the VAMC with a means of transportation of specimens to the performing laboratory at no additional cost. (i.e. Prepaid shipping labels, or courier services.)

7. Carry out its functions hereunder in full compliance with all local, state, and federal laws or regulations.

8. Provide test result reports/consults by fax to the send-out office of the sending VA or make results available within an online web portal for review. Contact information to be provided upon contract award.

9. Provide a consultation/laboratory result report that at a minimum shall contain the following information:

· CPT Code for testing performed

· VAMC Lab accession number, if supplied

· VAMC submitting facility name

· Patient location if supplied

· Date/time specimen receipt

· Abnormal intervals

· Any other information the laboratory has that may indicate a questionable validity of test results.

· VAMC facility account number

· Contractor accession number

· Contractor address

· Contractor CLIA number

· Reference intervals

· Testing laboratory name

10. Consult with VAMC on test results by telephone as needed.

11. Provide a printed or electronic Laboratory Manual containing the following information:

· Testing methodology for a test must be defined in the laboratory user’s manual

· Department hours of operation

· Accreditation

· Technical Staff

· Service Departments (Method of contacting, phone numbers, hours of availability)

· Quality Assurance Information

· Billing Procedures & fee schedules for services provided

· Procedures and criteria for phoning reports and other important information

· Report forms

12. Provide telephone number(s) and contact person(s) to be used by the VA Medical Center to make specimen problem inquiries and problem solving on weekdays. *NOTE: Also include names and telephone number(s) of Technical Directors and Pathologists available for consultation.

13. Maintain the minimum acceptable service, reporting systems, and quality control as specified herein. Immediate (within 24 business hours) notification must be given to VA upon adverse action by a regulatory agency.

14. Assign a specific local account representative.

15. Advise VAMC facility of any planned changes in methodology, procedure, or reference ranges at least 14 days prior to changes. If two-week notification is not possible due to emergency, contractor shall notify VAMC as soon as possible.

16. Not release patient’s records that include test results to any person other than the ordering healthcare provider or VA Pathology and Laboratory Medicine staff member. All member records shall be treated as confidential to comply with all state and federal laws regarding the confidentiality of patient’s records. This provision shall survive termination of the resulting contract award.

17. Certify and ensure that all employees, officers, or agents do not use Protected Health Information received from any VAMC site that would constitute a violation of any applicable provision in standards set forth in the Health Insurance Portability and Accountability Act (HIPAA).

18. Provide 4 quarterly (Oct- December, January- March, April-June, July- September) utilization/cost reports and an annual report (for contract performance period) to the sending VA site laboratory administration and to the VISN1 Network Consolidated Laboratory office (NCL) at no additional cost to the Government. The reports will be in Microsoft excel format and include at a minimum the following column header: patient name, date of service, CPT code, test name/procedure, volume, cost per test, total cost. The data will be in the rows. These reports shall be forwarded to the sending VA site and NCL within 30 days of the end of the quarter.

Licensing and accreditation – Contractor Laboratory:

1. Shall have all licenses, permits, accreditation certificates required by Federal law and State law.

2. Shall be accredited by the Department of Health and Human Services Clinical Laboratory Improvement Amendments (CLIA) and the College of American Pathologists (CAP) or The Joint Commission (TJC). Copies of all professional certifications, licensures and renewal certifications shall be provided upon submission of a proposal and be updated as needed to the Contracting Officer to include the contractor laboratory’s Laboratory Director(s) and/or Medical Director(s).

3. Medical Director(s) must have suitable qualifications and experience to direct a laboratory providing consultation services under this contract according to CLIA and CAP or TJC standards.

4. Personnel assigned to perform the services covered by this contract shall be eligible to provide the services of this contract and licensed in a State, Territory, or Commonwealth of the United States or the District of Columbia. All licenses held by Contractor personnel working on this contract shall be full and unrestricted licenses. Contractor Personnel assigned by the Contractor to work under this BPA shall be licensed to the extent required by the applicable licensing board.

5. Must comply with the regulatory requirements of Health and Human Services, Centers for Medicare and Medicaid (CMS).

6. Must notify the Contracting Officer immediately (within 24 business hours), in writing, upon its loss (or any of its subcontractors) of any required certification, accreditation, or licensure.

7. Shall maintain safety and health standards consistent with the requirements set forth by the Occupational, Health, and Safety Administration (OSHA), and the Center for Disease Control (CDC) and Prevention.

Contract Performance Monitoring:

Quality Control:

1. The contractor must operate a successful quality control program as required by CLIA and CAP or TJC. Services are to be performed in accordance with this PWS. The quality control program must include procedures to identify, prevent, and ensure non-recurrence of defective services. The contractor’s quality control program is the means by which the contracting laboratory assures that work complies with the requirement of the contract. A quality control program will be submitted as part of an offer and put into place upon final contract award. After acceptance of the quality control plan the contractor shall receive the contracting officer’s acceptance in writing of any proposed change to this QC system.

2. The VA will maintain an Internal Quality Control Program to monitor the quality of test results received from the Contracting Laboratory.

Quality Assurance:

1. The contractor shall comply with all applicable OSHA, Federal and State laws, CAP or TJC regulations as required for performing the testing services in this PWS.

2. The VA Medical Center will maintain an Internal Quality Control Program to monitor the quality of test results received from the contractor. The method used for monitoring is at the discretion of the VA Medical Center and may include, but is not limited to , unidentified split specimens sent periodically to the contractor for testing, split specimen sent to another reference laboratory for comparison, or monitoring of turn-around-time.

3. The contractor’s facilities, methodologies (defined as the principal of the method and the references), and quality control procedures may be examined by representatives of the VAMC during the life of the contract.

Hours of Operation:

The contractor is responsible for providing services 8:00 am - 4:30 pm EST Monday – Friday. The Contractor must always maintain an adequate workforce for the uninterrupted performance of all tasks defined within this PWS. When hiring personnel, the Contractor shall keep in mind that the stability and continuity of the workforce are essential. All certifications must be kept current with any change of personnel assigned to this contract. Federal Holidays: (The contractor does not have to perform on these holidays) New Year’s Day, Labor Day, Martin Luther King Jr.’s Birthday, Columbus Day, President’s Day, Veteran’s Day, Memorial Day, Thanksgiving Day, Independence Day, Christmas Day.

Physical Security:

The contractor shall be responsible for safeguarding all government equipment, information and property provided to the contractor laboratory. Each specimen that is lost by the contractor laboratory will incur a charge of $100.00 and will be credited to the Government on the monthly invoice.

Post Award Conference/Periodic Progress Meetings:

The Contractor agrees to attend a post award conference convened by the contracting activity in accordance with Federal Acquisition Regulation Subpart 42.5. The contracting officer, Contracting Officers Representative (COR), and other Government personnel, as appropriate, may meet periodically with the contractor to review the contractor's performance. At these meetings, the contracting officer will apprise the contractor of how the government views the contractor's performance and the contractor will apprise the Government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional cost to the government.

Government Personnel: The follow personnel are Program Managers for this effort:

· Janet Lane, Program Manager, VISN 1 Network Consolidated Laboratory

· Jacqueline Dang, Quality Manager, VISN 1 Network Consolidated Laboratory

· David McElwee, Program Support Medical Technologists, Network Consolidated Laboratory

· Holly Charpentier, Program Support Medical Technologists, Network Consolidated Laboratory

Contractor Program Manager:

The contractor shall provide a contract manager who shall be responsible for the performance of the work. The name of this person and an alternate who shall act for the contractor when the manager is absent shall be designated in writing to the contracting officer. The contract manager or alternate shall have full authority to act for the contractor on all contract matters relating to daily operation of this contract. The contract manager or alternate shall be available between 8:00 a.m. to 4:30p.m EST/EDT, Monday thru Friday, except Federal holidays or when the government facility is closed for administrative reasons.

Identification of Contractor Employees:

All contract personnel attending meetings, and working in other situations where their contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression in the minds of members of the public that they are Government officials. They must also ensure that all documents or reports produced by contractors are suitably marked as contractor products or that contractor participation is appropriately disclosed.

Contractor Furnished Items and Responsibilities:

The Contractor shall furnish all supplies, equipment, facilities, and services required to perform work as outlined in this contract.

The contractor shall follow all Government rules and regulations regarding information security to prevent disclosure of sensitive information to unauthorized individuals or organizations, and shall adhere to all VA Privacy and Security, the Privacy Act and HIPAA requirements when obtaining and reviewing information.

BAA and BI not required, this is a covered entity. Laboratory is not required to have a business associate contract to disclose health info to a reference lab for treatment of the individual. See 45CFR 164.502 (e), exceptions to Business Associate Standard.

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DEPARTMENT OF VETERANS AFFAIRS VISN 1

VA NEW ENGLAND HEALTHCARE SYSTEM

NCL Memorandum No.: 523-008 September 2020 NCL New Instrument/New Test Policy

1. Policy: All laboratories within the Network Consolidated Laboratory (NCL) will follow the guidelines described in the New Instrument/New Test Protocol before placing new instrumentation in use or before adding new methodologies to their test repertoire.

2. Definitions:

a. The Network Consolidated Laboratory (NCL) consists of all clinical laboratory operations in the VA New England Healthcare System, including facilities associated with VA Boston, Bedford, VA Connecticut, Manchester, Northampton, Providence, White River Junction, Togus and the community-based outpatient clinics.

b. The NCL Executive Council (NCL EC) is an advisory board to the NCL Program Director and consists of all VISN 1 Clinical Laboratory Service Chiefs and Administrative Officers, as well as the NCL Program Director, Quality Manager/HSS and Program Support Medical Technologist.

c. The NCL New Instrument/New Test Protocol is a document written by the New Instrument/New Test Task Force and approved by the NCL EC for use by all NCL laboratories. The protocol is in the form of a checklist, and defines all processes for introducing new instrumentation and/or new test methodologies into the lab. Portions of this protocol may not be applicable to all instrumentation or tests implemented in the laboratory. Those portions determined to be non-applicable should be marked N/A in the checklist (i.e. linearity studies are N/A for tissue processors and stainers).

d. Functional Group Chairs are those individuals that chair one of the NCL Functional Groups: (e.g. Chemistry, Hematology, and Microbiology).

e. Designee: For the purpose of this document, designee refers to an individual who meets CAP director qualifications.

f. AMR: Analytic Measurement Range

g. Establish/establishment refers to when the laboratory must perform a robust study to determine the performance specifications of a test method or instrument. Performance specifications must be established for any modified FDA-cleared or approved test, tests not cleared or approved by the FDA, or a test system developed in-house (laboratory developed test).

h. IQCP: Individualized Quality Control Plan

i. LDT: Laboratory Developed Test

j. Method performance specification studies are either verification studies or establishment studies that are performed to produce evidence that a test method or instrument provides acceptable results when used in your laboratory or by your staff for patient testing.

k. POC: Point of Care

l. Verify/Verification: refers to when the laboratory confirms the manufacturer’s established performance specifications and analytical claims when the test method or instrument is used by the laboratory and its staff. Verification is done for unmodified, FDA-cleared or approved test systems (instrumentation, equipment, reagents, and supplies needed to perform an assay or examination and generate test results).

3. Responsibilities:

a. Each NCL Laboratory Chief is responsible for ensuring their staff utilizes the NCL New Instrument/New Test Protocol when introducing new instrumentation or new test methodologies into their laboratory.

b. Where applicable, (i.e. when instrumentation is chosen via functional group standardization efforts), the functional group chair will ensure that all NCL labs utilize the NCL New Instrument/New Test Protocol when introducing the new instrumentation or new test methodology.

4. Procedure:

Where applicable, the following method performance specification procedures will be performed before placing a new instrument or new test methodology in service at VA New England Network Consolidated Laboratory.

VA New England Network Consolidated Laboratory New Instrument/New Test Protocols

The procedures outlined below refer to Waived and non-Waived testing introduced into the laboratory and represent minimum requirements.

A. Documented Protocol

1. Based on guidance in the VHA Handbook 1106.01, the VA requires that performance specifications for both waived and non-waived test methods are verified (or established) and documented prior to implementation.

2. Prior to the start of each performance specification study the laboratory medical director or designee will determine and document the following on a signed NCL Method Performance Specification Protocol: (Attachment B; also available on the NCL Functional Group share drive: NCL Policies\NCL Memorandum 523-008 New Instrument-New Test\NCL Method Performance Specification Protocol Attachment B.docx)

i. The applicable parameters to be included in the study (e.g. AMR, Accuracy, Specificity, Sensitivity, Reference Range, etc.). Any parameters required by the manufacturer for validation must also be included in the laboratory’s method performance specification protocol.

ii. For each applicable parameter, the number and type of specimens to be analyzed and any other paramaters applicable to the test, such as concentration/dilution/reactivity, etc.

iii. For each applicable parameter, the limits of acceptability to be used when evaluating your data. Data falling outside the limits of acceptability will be documented by the laboratory director or designee in the Summary Statement.

3. For any FDA approved tests that are modified by your laboratory and/or any non-FDA approved tests (i.e. any LDT, ASR, RUO) the laboratory must establish as opposed to verify the parameters listed below in accordance with CLIA ’88 guidelines.

4. When there is a change in main laboratory instrumentation, an abbreviated study, as determined by the laboratory medical director or designee, is performed for any associated POC testing instruments/methods. The requirements for a signed method performance specification protocol and Summary Statement apply.

5. Retain this document with your study data and signed Summary Statement for a period of two years after the method or instrument is no longer in use, ten years for Transfusion Medicine.

6. Current Performance Specification Resources for modified FDA approved tests or laboratory developed tests can be located in 42 CFR §493.1253 of the CLIA Interpretive Guidelines and in the CLIA Brochure #2 “Verification of Performance Specifications” on the CLIA/CMS website: https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/CLIA_Brochures

7. Refer to the Test Method Validation/Verification and Method Performance Specifications section of the most recent applicable checklist provided by your Laboratory Accreditation Agency for additional requirements.

B. Method Performance Specification Studies

1. Studies should be performed by lab staff or POC testing personnel (those who will normally perform the patient testing). Vendors may provide assistance. However, if studies are performed by someone other than the laboratory staff or POC testing staff (e.g. manufacturer representative), the laboratory or POC testing staff must demonstrate that study results correlate with in-house test performance. This may be accomplished by VA testing staff participating in the QC and patient correlation studies which in turn can be used to assess and document initial competency for the individual performing the testing.

2. For non-waived tests, performance specification studies must be performed at the CLIA location where the instrument/method will be in use for patient testing. For example, the main laboratory for a facility cannot perform establishment/verification studies for a CBOC located at a different address.

3. For waived testing under the same Laboratory System or Ancillary Testing Program, the primary performance specification studies may be performed at one site (as in the main facility) provided that additional smaller studies, as determined by the laboratory director or designee, are performed at the actual testing location and by the intended testing personnel to ensure that performance specifications equivalent to those obtained during the primary study are achieved. The primary performance specification study data must be available to the all sites.

C. Summary Statement

1. Final approval of the method performance specification study data will be documented in a Summary Statement signed by the laboratory medical director or designee. The summary must include a written assessment of the method performance specification study including the acceptability of the data and a statement approving each test for clinical use before patient testing begins. Example of an acceptable summary statement: “This method performance specification study has been reviewed and the method is considered acceptable for patient testing."

2. A Summary Statement has been incorporated into the NCL Method Performance Specification protocol. See Attachment B.

3. Retain this Summary Statement and written assessment of the method performance specification study with your signed documented protocol and study raw data for a period of two years (ten years for Transfusion Medicine) after the method or instrument is no longer in use.

4. For a non-modified FDA-cleared/approved test, a summary of the study data must address analytic performance specifications, including analytic accuracy, precision, interferences, and reportable range, as applicable.

5. In addition, for modified FDA-cleared/approved tests or LDTs, the summary must address analytical sensitivity, analytical specificity and any other parameter that is considered important to assure that the analytical performance of a test (e.g. specimen stability, reagent stability, linearity, carryover, and cross-contamination, etc.), is appropriate and applicable.

6. If the laboratory makes clinical claims about its tests, the summary must address the verification of these claims.

D. Manufacturer’s Instructions must be followed. This applies to waived and non-waived tests. If instructions are modified, the test is considered a laboratory developed test in which case the laboratory must establish performance specifications in accordance with this policy.

E. Accuracy (Correlation) – Required for waived and non-waived testing.

1. For all non-Waived testing, except for hard-to find analytes such as CSF protein, a minimum of twenty (20) patient samples will be run on both the current and replacement instrument. For quantitative results, the Slope, Intercept, and Correlation Coefficient will be calculated and evaluated for acceptability.

2. For Waived testing the minimum number of specimens will be determined by the Laboratory Director or designee.

F. Linearity – If applicable to the method (i.e. N/A for qualitative methods) linearity studies will be conducted using material with matrix characteristics appropriate for the method and the specimens being tested. The material chosen will span the entire Analytic Measurement Range (AMR) and will be run three (3) or (4) times each and averaged. Recovery within 50% of the lower end and within 10% of the upper end can be considered acceptable verification of clinical performance of the test, but this determination is ultimately up to the discretion of the laboratory director or designee.

Examples of acceptable materials include:

1. Linearity material of appropriate matrix, e.g., CAP Calibration Verification/Linearity Survey material or Calibration Verification/Linearity Survey Validated Material,

2. Proficiency testing survey material or proficiency testing survey-validated material,

3. Previously tested patient specimens, unaltered,

4. Previously tested patient specimens, altered to elevated analyte concentrations by spiking in known amounts of an analyte,

5. Previously tested patient specimens, altered to lower analyte concentrations by dilution or other technique,

6. Primary or secondary standards or reference materials with matrix characteristics appropriate for the method,

7. Calibrators used to calibrate the analytic measurement system. Note: Be sure to use a different lot of calibrator than what was used to calibrate the test.

8. Control materials (either kit-provided controls or those purchased from an external source are acceptable)

G. Reference Intervals – Required for waived and non-waived testing.

1. If unable to transfer the manufacturer’s or literature-based reference range, the laboratory must establish its own reference range. The recommended sample size is 120. Further guidance can be obtained from the most current CLSI C28-A document, “Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory”.

2. Except for hard to find analytes, a minimum of twenty (20) normal patients/individuals will be used to verify (transfer) a manufacturer’s or literature based recommended range.

i. Verify that the manufacturer’s subject population is similar to your laboratory’s patient population and that specimens used in the manufacturer’s study are congruent with the specimens you will be testing (source, collection tube additives, etc.)

ii. Carefully select a pool of “normal” individuals keeping in mind exclusion and partitioning criteria that when present may affect test results and add bias to your reference range. Chart reviews may be necessary to rule in or out selected study candidates.

iii. The lab medical director or designee is responsible for approving candidate selection/omission criteria.

3. Data will be evaluated against the limits of acceptability as determined in the Method Performance Specification Protocol, using standard statistical means or programs (i.e. EP Evaluator) where appropriate.

4. The functional groups in conjunction with the laboratory medical directors may establish common reference ranges to be used throughout the VISN. In this instance each NCL site will run a minimum of twenty (20) normal patients/individuals selected using the criteria outlined in section G.2., above. The data will be combined to verify the manufacturer’s recommended reference range, a literature-based reference range or reference range currently in use. The functional group(s) will evaluate the data and recommend ranges in conjunction with the laboratory medical director(s) or designee(s).

5. If an individual site wishes to begin reporting patient results before the collaborative study has been completed, the site must:

i. Have verified their own reference range using a minimum of twenty (20) normal patients as stated above and below in Item 6 or

ii. Use the manufacturer’s suggested range as long as the manufacturer’s study population is congruent with your patient population. If using the manufacturer’s suggested range you must then monitor this range and make adjustments as necessary to reflect the characteristics of your patient population.

6. Both instances might also result in a second reference range change for that site once the collaborative study is completed. Approval and acceptance of reference intervals as determined by the collaborative study ultimately rests with the local laboratory medical director or designee. When results (such as PT/INR) are used as part of a treatment protocol and treatment is based on the result reported, it would not be required to include a normal reference range with the patient result.

7. The laboratory medical director or designee will determine if additional studies are needed prior to adopting a therapeutic or literature-based reference range and will outline the parameters of any required study in the Method Performance Specification Protocol. Regardless of whether additional studies are needed, documentation of acceptance of the reference range to be used will be included in the summary statement signed by the laboratory medical director or designee. Note: Appropriate therapeutic ranges determined by various treatment protocols would not be required to be reported with the patient results, if this information is maintained by the individual clinical departments or pharmacy.

8. Some analytes, such as Hepatitis assays and PTT, have specific method performance specification study requirements that must be followed by NCL laboratories instituting such tests.

9. Reference range studies for analytes that are difficult to obtain will be conducted and evaluated according to the discretion of the laboratory medical director(s) or designee.

H. Precision (Within-Run, Between-Run, Within-Day, Day-to-Day) – Required for non-waived testing. For waived testing the study protocol is at the discretion of the laboratory medical director or designee, but at minimum must include any requirements as specified by the manufacturer.

1. For the majority of non-waived testing and where applicable, the following protocol should be followed:

i. Within Run/Within-Day Precision studies: Run a sample that has a value that approximates the mean of the reference interval for an assay a minimum of twenty (20) times, calculate the SD and CV and evaluate.

ii. Between-Run/Day-to-Day Precision Studies – Run a sample that has a value that approximates the mean of the reference interval for an assay a minimum of twenty (20) times over a minimum of five (5) days (unless the sample/analyte is unstable). Calculate the SD and CV and evaluate.

2. For areas where availability of specimens is rare, (i.e. molecular validation of genetic mutations) the laboratory medical director or designee will determine the protocol for validation/verification studies and ensure the studies meet applicable accreditation agency requirements.

I. Carryover –Required for non-waived testing if applicable (check manufacturer’s statements). Follow manufacturer’s instructions for waived testing. For waived testing the study protocol is at the discretion of the laboratory medical director or designee, but at minimum must include any requirements as specified by the manufacturer.

1. If applicable to the method, the following protocol should be used to determine if there is a significant carryover effect for a given analyte:

i. Run three replicates of a low control, followed by

ii. One replicate of a high control, followed by

iii. One replicate of a low control.

iv. The following table illustrates run set-up:

v. Determine the mean of the first three low control replicate values and subtract from the low control value obtained after running the high control, then divide by the high control value and multiply by 100 to obtain the percent carryover.

2. For molecular assays, positive, low positive and negative samples should be interspersed. Positivity in a negative control result would indicate carryover has occurred.

3. The criteria for pass/fail are based on clinical significance of each analyte. The laboratory medical director (or designee) will determine the pass/fail for each analyte based on clinical relevance.

J. Interferences – Required for non-waived testing, if applicable. Follow manufacturer’s instructions for waived testing. For waived testing the study protocol is at the discretion of the laboratory medical director or designee, but at minimum must include any requirements as specified by the manufacturer. Due to the intricacies and time-consuming nature of the testing, instrument manufacturers will be required to provide as much information as possible to address substances that might interfere with assays available on their system.

K. Analytical Measurement Range (AMR) – Required for non-waived testing, if applicable. Follow manufacturer’s instructions for waived testing. For waived testing, the study protocol is at the discretion of the laboratory medical director or designee, but at minimum, must include any requirements as specified by the manufacturer. The laboratory will verify the AMR determined by the manufacturer. The laboratory medical director or designee or the laboratory medical director/designee in conjunction with the applicable functional group will create procedures for detecting results that are outside the AMR.

L. Maximum Dilution/Concentration (formerly referred to as Clinically Reportable Range (CRR)) – Required for non-waived testing, if applicable. For waived testing the study protocol is at the discretion of the laboratory medical director or designee but at minimum must include any requirements as specified by the manufacturer. The laboratory medical director or designee (and applicable functional group for VISN-wide standardized protocols) will establish a documented protocol that outlines the maximum allowable concentration or dilution of samples that will yield a credible result for analytes having results falling outside the limits of the AMR.

M. Sensitivity – Required for non-waived testing, if applicable. For waived testing the study protocol is at the discretion of the laboratory medical director or designee, but at minimum, must include any requirements as specified by the manufacturer. US laboratory regulations require that the detection limit (or analytical sensitivity) be verified only for high complexity methods, modified moderate complexity methods, and moderate complexity methods that have not been cleared by FDA as meeting the CLIA requirements for quality control. However, good laboratory practice should dictate that detection limits be verified, when relevant (e.g., all forensic and therapeutic drug tests; TSH and similar immunoassay tests; PSA and other cancer markers – but, not glucose, cholesterol, enzymes, and constituents where reference range is more relevant for interpretation of the test results). Sites may access the Westgard website (https://www.westgard.com/basic-method-validation.htm) and follow the protocols described in the lesson entitled “Method Validation – The Detection Limit Experiment,” or use another acceptable protocol to verify analytical sensitivity.

N. Quality Control

1. For non-waived testing, establish an Individual Quality Control Plan for IQCP eligible tests/methods, if CLIA default QC requirements given in 42CFR 493.1256 will not be followed.

i. When considering an IQCP, the following must be true for the instrument/test system:

The test system must be FDA-approved (not modified by the laboratory).

a) The test system must be eligible for IQCP. See CMS Interpretive Guidelines, page 200. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_c_lab.pdf

b) An IQCP is created and documented for the instrument/test system. An example of an IQCP can be found on the PLMS web page “Procedure for Individualized Quality Control Plan”. Page 8 displays the CAP Default QC Requirements http://vaww.lab.med.va.gov/Education_Material_P.asp

ii. The IQCP must include a risk assessment, quality control plan, and quality assessment.

iii. The risk assessment must evaluate potential sources of error by and must include all of the following elements:

a) Must cover the entire testing process (preanalytic, analytic and post analytic).

b) Intended medical uses of the test and impact if inaccurate results are reported (clinical risk).

c) All five test components (specimen, test system, reagent, environment, testing personnel)

d) Variations in the components based on use of the tests (e.g. use in different environments, by different personnel, or multiple devises).

e) Data from the laboratory’s own environment, instrument/equipment performance, and testing personnel demonstrating acceptable performance over the maximum time interval between external quality control runs defined in the IQCP.

f) Manufacturer’s instructions and recommendations.

iv. The risk assessment must include a process to identify the sources of potential failures and errors for a testing process, and evaluate frequency and impact of those failures and sources of error.

2. Or, develop a Quality Control Plan based on CLIA default QC regulations.

i. With the exception of Coagulation and Blood Gas testing, which have more stringent requirements, default QC means external liquid controls must be run daily.

ii. A copy of the CLIA Default QC regulations is located on the NCL Functional Group share: NCL Policies\ NCL memorandum 523-008 New Instrument-New Test\42 CFR 493.1256 - 1278.docx.

3. Sample quality control study for verifying use of internal controls and the frequency of external controls:

i. The laboratory director must document criteria for acceptability prior to beginning the study.

ii. The QC study to assess the performance and stability of the tests must support the QC frequency and elements defined in the laboratory's quality control plan. At a minimum, the study must include laboratory data representing the maximum interval between runs of external quality control. Consecutive days of data collection are not specifically required if testing is done sporadically, or is not performed seven days a week. Laboratories may use historical data for tests already in place, and may supplement the study with data from published literature. For new tests, devices, and instruments introduced into the laboratory, the laboratory must collect inhouse data and may need to define a more frequent QC interval until sufficient data is available to support a longer time interval between runs of external QC. If in doubt, ask your accreditation vendor to review your QC plan and save their written approval in your validation documentation.

iii. Example 1: Run external controls and built-in/internal controls for at least 20 consecutive days, when patient samples are tested for the initial device/test system.

iv. Example 2: If the most stringent manufacturer requirement is external QC every 30 Days, an acceptable approach to verification could be:

a) Day 1 – 7 run every day

b) Day 14 – run QC

c) Day 21 – run QC

d) Day 28 run QC

e) Day 30 run QC

f) Switch performance of external QC to a 30-Day interval

v. The laboratory director will determine the extent of studies required for implementation of additional identical devices.

vi. Corrective action must be taken if either the internal or external control is out of acceptable range during or after the evaluation process. Repeating controls or re-evaluation of the internal control system may be necessary to achieve acceptable results.

Note 1: Method performance study records for limiting daily QC to internal controls signed, by the laboratory director as being acceptable, must be retained for 2 years (10 years for Transfusion Medicine) after the instrument/method is no longer in use.

Note 2: External controls must be run at least every thirty-one days or as recommended by the manufacturer (whichever is more frequent), for each new lot or shipment of test materials, after major system maintenance and after software upgrades. This does not apply to microbiology media and identification systems since they lack an internal quality control. For these areas, streamlined QC may be implemented, if an IQCP has been developed. If no IQCP, external QC must be performed for each batch, lot or shipment regardless of the frequency of shipment.

4. For waived testing, follow manufacturer instructions. If not specified by the manufacturer, the laboratory must assess the testing process and develop a QC plan based on risk assessment.

O. Control Ranges - Required for quantitative methods.

1. For assayed controls, at minimum, preliminary control ranges may be established using eight (8) points obtained over a minimum of three days. For statistical validity, if possible, preliminary ranges will be established using twenty (20) points obtained over as many runs/days as possible, with twenty days being the ideal.

2. For unassayed controls, statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. For example, data will be obtained for twenty (20) points over a minimum of five (5) days will satisfy this requirement. Source: 42 CFR 493.1256-1278.

P. Software - for Blood Bank and some molecular & other methods, validation of software is required. Follow VA and accreditation guidelines, as applicable. These validations must be documented and retained for a period of two years after the instrument/method is no longer in use.

Q. Review of Critical Values should be conducted with appropriate input from clinical staff and updates made at each facility as necessary.

R. Report Format Approval – print an Interim Report and CPRS screen shot of the new test display and have the director(s) sign and date it. Retain this documentation with your method performance study documentation.

S. Clinician Notification - If there is a method change, reference range change or if results will be affected by your change in…