NCL Memorandum 523-008 NEW INSTRUMENT-NEW TEST final 10-17-2016.pdf

Z:\NCL Policies\NCL Memorandum 523-008 New Instrument-New Test FY2017\NCL Memorandum 523-008 NEW INSTRUMENT-NEW TEST final 10-17-2016.docx

DEPARTMENT OF VETERANS AFFAIRS

VISN 1

VA NEW ENGLAND HEALTHCARE SYSTEM

NCL Memorandum No.: 523 -008 September 2016 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 Manager, and consists of all VISN 1 Clinical Laboratory Service Chiefs and Administrative Officers, as well as the NCL Program Manager, Quality Manager 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:

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

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.

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

A. Documented Protocol

1. Through VHA Handbook1106.01, 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 (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 particulars specific 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) 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:

http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/CLIA_Brochures.html .

7. Refer to the Test Method Validation/Verification and Method Performance Specifications section of the most recent CAP All Common Checklist 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 its 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.

file://vhav01fpc2/common$/Visn%201%20Ncl%20Functional%20Groups/NCL%20Policies/METHOD%20PERFORMANCE%20SPECIFICATION%20PROTOCOL%207-2014%20draft%20v1.docx http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/CLIA_Brochures.html

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 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. 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/Analytic Measurement Range (AMR) – If applicable to the method (ex. 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 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 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 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:

http://vaww.lab.med.va.gov/

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.

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 CAP 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:

Run Position Sample

1 Low Control 2 Low Control 3 Low Control 4 High Control 5 Low Control

v. Determine 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.

Equation: % Carryover = (Position 5 result) – (Mean of Position 1-3 results) X 100 (Position 4 result)

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 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 - and 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. The risk assessment must include an evaluation of all five components (specimen, test system, reagent, environment, testing personnel) and cover the entire testing process (preanalytic, analytic and post analytic).

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. 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.

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

iv. 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.

https://www.westgard.com/basic-method-validation.htm https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_c_lab.pdf https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_c_lab.pdf http://vaww.lab.med.va.gov/Education_Material_P.asp file://r04bednas21/V01_Groups/Common/Visn%201%20Ncl%20Functional%20Groups/NCL%20Policies/NCL%20memorandum%20523-008%20New%20Instrument-New%20Test/42%20CFR%20493.1256%20-%201278.docx

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, data will be obtained for twenty (20) points over a minimum of five (5) days.

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 instrumentation, clinicians must be informed so that proper assessment of patient results can be made.

Each facility must have a mechanism to communicate such changes to relevant clinical staff. For test changes within VISN 1 Reference Laboratories that will affect referring VISN 1 facilities, the reference laboratory will provide the NCL Quality Manager with a test change notification to be distributed to the VISN Chief of Staff and VISN 1 Lab Chiefs/AOs mail groups for local distribution to ensure providers are informed of the changes.

T. Intermittent Testing – Defined as tests that are taken out of production for a time (for example, seasonal testing such as influenza testing) and then resumed. A test is considered to be taken out of production, if: 1. Patient testing is not offered, AND 2. PT or alternative assessment is suspended. The following must be done BEFORE testing can be resumed:

1. PT or alternative assessment within 30 days prior to restart of patient testing. If a PT challenge is not offered during the 30-day period an alternative assessment approved by the lab medical director or designee is allowed but the lab must participate in the next scheduled PT event.

2. Method performance specifications verified as applicable within 30 days prior to restarting patient testing

3. Competency assessed for analysts within 12 months prior to restarting patient testing.

U. Additional laboratory responsibilities:

1. Determine if instrument training will be done on or off site and ensure appropriate staff is trained. Submit request for travel orders through CGE-Concur for off-site training, if required. Contact local Travel Clerk to verify requirements.

2. Create (or obtain from vendor) an initial training guideline specific for performance of the new test/new instrument to be used as documentation of satisfactory completion of initial training. Document training for each individual performing testing.

3. Create (or obtain from vendor) a competency assessment document that demonstrates the user’s understanding and ability to operate the new instrument or perform the new test. Document competency of employees performing testing after 6 months, if employee are within their first year of hire, or annually thereafter.

4. Update your procedure manual. Obtain manufacturer’s procedure manual and any active Product Corrections or Recalls.

5. Determine the units of measurements to be used for each test.

6. Determine the formula and method of calculation, if a calculation is used to obtain a test result.

7. Determine the preferred and acceptable sample types for each assay.

8. Determine if a canned comment will be included with every result or with gender- or age-based results.

9. Determine if a test result that is not numeric will generate VA alerts.

10. Determine if a test is part of the automated QC system (BioRad)

11. Determine if proficiency testing will be part of automated Elab.

12. Update your Specimen Collection manual(s) as appropriate.

13. For CAP accredited laboratories notify CAP of change in test menu.

14. Purchase applicable Proficiency Testing material if available, or institute a CAP acceptable method for demonstrating proficiency (e.g. Semi-annual split sample analysis with reference or other laboratories, split samples with an established in-house method, assayed material, regional pools, clinical verification by chart review, or other suitable and documented means). It is the responsibility of the Laboratory Director to define such procedures.

15. Ensure that engineering checks are completed and that new instrumentation has a VA equipment bar code.

See Engineering/Mechanical Guidelines for New Instrument Start Up.

16. Ensure that the LIM has completed the necessary Information Management checks.

17. Ensure any waste streams generated meet local and federal discharge requirements.

18. Obtain applicable Safety Data Sheets (SDS).

19. Obtain Information Security Office approval for any middleware that will require connectivity to the internet and install before the equipment is installed.

20. Determine if additional Lantronix boxes and port licenses are needed and obtain them before new equipment arrives.

V. Interface Guidelines for New Instrument Start Up

1. The following items needed to interface new analyzers are provided by the manufacturer or the lab supervisor:

i. Vendor is required to submit a Manufacturer Disclosure Statement for Medical Device Security (MDS2) Form, VA Directive 6550 PRE-PROCUREMENT ASSESSMENT FOR MEDICAL DEVICES form 6550, and VHA Handbook 6500.6 Appendix A CHECKLIST FOR INFORMATION SECURITY IN THE INITIATION PHASE OFACQUISITIONS with their proposal.

ii. Host Communication Specifications/Host Interface Specifications/Host Transmissions Protocols are usually found in the analyzer’s User’s Manual.

a) Unidirectional set up (if applicable)

b) Bi-directional set up (if applicable)

c) Cable requirements

d) Connection requirements, pinning requirements

e) Bar coding requirements or capabilities

f) Examples of data stream messages and transmission protocols

iii. List of UI test codes for all tests run on the instrument. Each test must have a unique test code (numbers, abbreviations of test name, or a combination of both).

a) Defined by manufacturer (this is the more common method of assigning UI codes)

b) Defined by site (rarely done, but if done codes should be standardized across the VISN, wherever possible). Usually, but not always, applicable to calculated tests, or special site defined tests.

iv. List of all tests to be performed on the new instrument, individually and/or as a panel.

v. List of any new tests that have never been performed in the lab before that need to be created (both measured and calculated tests).

vi. List of calculated tests to be performed on instrument.

vii. List of any special linearity issues for a test that require the interface to alert the tech of special handling issues (e.g. the instrument reports result >10.0, so the interface must be able to accept a result of >10.0.) or any special comments or recheck issues that the interface might have to handle (e.g. the instrument reports an error code as a result and the interface needs to tell the user to “add a reflex test”, “rerun spec”, or the instrument reports a result >10.0 on a test that should be diluted, instead of accepting the >10.0 the interface can be programmed to change it to “dilute and rerun”.)

2. The Lab Information Manager must set up the following items for the new analyzer:

i. Contact IRM/Clinical Engineering to install cable(s) and port connection(s), as required.

ii. Create an Auto-instrument entry for the new analyzer so that the instrument method is captured on the “Summary list” after verification of test results. A modification may be made to an existing Auto-instrument entry, if the instrumentation differences are minimal, e.g. an upgraded similar analyzer.

a) All the tests run on the analyzer need to be added to this entry with the appropriate UI test code and decimal places needed.

b) Specific handling requirements per test, if required, must be added to this entry (this may require IT support).

c) For multiple same type instruments: each instrument must have its own entry and, if a cluster is being utilized, then an entry must be created for the cluster as well.

iii. A load/work list needs to be designated or created. One load list can be used for multiple instruments (even different instruments) provided the workload codes are protected on the test.

a) Profiles for different work list/verification schema can be added to the load/list, as needed.

b) All individual tests must be added to the appropriate profile, or all profiles as required.

c) All panel tests must be added to the appropriate profile or all profiles, as required.

iv. DI driver requirements and downloads to the Instrument Manager (following Security protocols). Note:

If more than one instrument of the same type is being implemented for one site (e.g. two CBC analyzers) then a “cluster driver” may also be needed, but it is not required.

v. An instrument configuration needs to be added to the DI. This is for one instrument set up or if multiple instruments are being set up as unidirectional interfaces. In addition, a connection name must be added and built in the DI that will use this new configuration. The connection name MUST be exactly the same as the Auto-instrument name created in step 2.

vi. If there is more than one instrument of the same type that require bi-directional interfacing, then a cluster configuration may also be utilized for more efficient bi-directional interface handling, but it isn’t a requirement. If it is going to be used, the following steps are required. (Note: There must be an exact auto-instrument entry for each instrument and for the cluster and the following configuration names must match the entries.)

a) A “cluster” instrument configuration needs to be created.

b) An instrument configuration needs to be created for every instrument of the same type.

c) The individual instruments need to be added to the cluster configuration.

vii. Create or have IT lab support create any delta checks, result evaluation codes, linearity conditions necessary for all tests, as applicable, specified by the supervisor in section V. 1. vi. above.

3. Test the interface: Once the interface connections have been established and the files have been set up several tests need to be performed. This should be coordinated by the LIM with the supervisor/techs. The LIM must keep a record of this testing that validates that the interface is successfully transmitting accurate and timely data.

i. Run a “Test Patient” for all tests possible, including panels, calculations, and individual tests. This may require several test runs to capture the necessary information.

ii. Check for result transmission and accuracy. Parsing issues can cause results to be sequenced incorrectly when they are transmitted (usually a setting is incorrect on the instrument or the DI driver).

iii. Check for calculation accuracy (both for calculations done on the instrument and those done via the VistA computer)

iv. Check for “evaluation” accuracy of linearity issues or error codes, special codes, etc.

v. Check for accurate transmission of comments.

vi. Check transmission speed from the time the analyzer completes the test to the time of transmission across the interface to VistA.

vii. Check test order and correct, if necessary. Wherever possible the test order should mirror the instrument print out to minimize entry errors, especially if manual input is necessary during interface downtimes. Coordinate this with the supervisor; sometimes the instrument print order can be changed without impacting any other set up or calibration issues. Some instruments do NOT have this flexibility, so the possibility of making changes should be checked out first.

viii. Test any Data Innovations rules.

ix. When evaluating the interface, it is good practice to look at the results in VistA and also in CPRS.

W. Engineering/Mechanical Guidelines for New Instrument Start Up

The laboratory is responsible for notifying the Clinical Engineering Department as soon as possible that a new instrument is to be installed and for providing access to information the Engineering Department may need to perform the following functions/checks:

1. Spatial Considerations - Dimensions of equipment, measurements of intended area of location.

2. Power considerations- Perform a needs assessment for 120v/220v, uninterrupted power supply, emergency power needs, etc. Implement work order(s) as needed. Is manufacturer’s operator/service literature available?

Review technical specifications of item desired. Is leakage current specified? If not, incorporate the allowable leakage current and ground resistance limits into the technical requirements of the requisition.

3. Water needs assessment- Is filtration required? Holding tank? Deionized vs. distilled water?

4. Waste stream assessment: accommodate to meet local and federal discharge requirements. Is external waste pump needed (for shared drains)?

5. HVAC needs assessment:

i. Some instruments generate excess heat. Verify whether current system be sufficient to control the environment as necessary.

ii. Are there specific vent requirements (i.e. must vent to the outside)?

6. Ensure two complete sets of operator/service manuals will be provided (1 for user site and one for engineering).

7. Material Management enters equipment into facility equipment database and assigns a unique identifying number (VA equipment bar-code).

8. Perform incoming inspection:

i. Does equipment comply with manufacturer’s specifications, leakage current limits (NFPA codes), proper documents (manuals)

ii. Any limitations as to area of use?

iii. Any Damage? Any missing accessories?

iv. Will equipment be included in a PM program?

9. Additional Required Prerequisite Verification procedures for equipment:

i. Blood Bank incubators/refrigerators/freezers need to run and be monitored before inventory is introduced.

The laboratory director or designee will determine the timeframe for monitoring. Verify and document that unit is maintaining proper storage temperature.

ii. Blood Bank Centrifuges need to be calibrated. Vary spin times with control tubes to determine optimum spin time for agglutination. Document results.

iii. Blood Bank Cell Washers need to be performance checked to verify adequate washing and removal of serum/plasma proteins. Delivery and saline flow also need to be checked. Document results.

iv. Blood Bank Centrifuges need to be RPM checked, compare with manufacturers specifications and document results.

5. Attachment A: “NCL New Instrument/New Test Checklist”

6. Attachment B: “Method Performance Specification Protocol Template”

7. Rescission: August 2014

8. Review Date: August 2020

Mary-Ann Bridgwood, MS. Date Program Manager, NCL

Attachment A

NCL New Instrument/New Test Checklist Facility Name:

Instrument/Test:

Engineering Checks (See pages 9 &10)

Comments/Actions (N/A = not applicable)

Date Complete Initials

Pre-Delivery

Forms 6550, 6500.6, and MDS2 submitted

Spatial Considerations checked Power Considerations checked Work orders entered?

Work orders completed?

Water assessment Verify waste stream meets local and federal discharge requirements.

External waste pump needed?

HVAC assessment Additional Lantronix boxes or port licenses needed?

Approval & installation of middleware (ISO)

Post Delivery

Operator’s Manuals received?

VA Equipment Bar Code Issued?

Incoming Inspection: Specifications met? Limitations of use? Any damage? Any missing parts or accessories? PM program included?

Prerequisite verification: Blood bank incubators, refrigerators, freezers, Centrifuges, Cell Washers

Method Performance Verification/Establishment Guidelines (See pages 2-7)

Comments/Actions (N/A = not applicable)

Date Complete Initials

Method Performance Specification Protocol (signed by director/designee)

Accuracy Check (Correlation) Linearity Reference Intervals Precision Carryover Interferences Analytical Measurement Range Maximum Dilution/Concentration Quality Control Ranges

NCL New Instrument/New Test Checklist, cont.

Documented IQCP for limiting daily QC (if applicable)

Signed Summary Statement approving method Establishment/verification studies

Draft/approve SOP Training checklist/documentation Competency Units of Measurement Formulas and calculations Sample types Critical Value review For CAP accredited labs: Notify CAP of new test menu.

Proficiency Testing: Purchase or Institute CAP acceptable alternative and obtain applicable test method codes for reporting results

Obtain MSDS/SDS sheets Update Procedure Manual; obtain copies of any active product corrections or recalls

Update Specimen Collection Manual and test info in

VISTA/CPRS

Clinician Notification for new tests, method changes or changes affecting patient results.

Interface/IM Checks (See pages 8 & 9)

Comments/Actions (N/A = not applicable)

Date Complete Initials

Pre-Delivery

Enter work orders for new ports?

Work orders completed?

Post Delivery

Host Communications checks List of UI test codes List of all tests List of Calculations Special Linearity Issues IRM Work order (cables, ports etc.)

Create Auto Instrument Entry Create Load/work list DI driver requirements/downloads Configure instrument in DI Create/check delta checks, evaluation codes, linearity conditions

Report format approval.

Test interface; retain documentation

Attachment B

NCL METHOD PERFORMANCE SPECIFICATION PROTOCOL

Date:

Analyte(s):

Method/Instrument (check all that apply): � Waived �Non-waived

�FDA approved �Non-FDA approved (Lab Developed Test) �Modified FDA approved (Lab Developed Test) �ASR �Intermittent test

Action: �VERIFY Method Performance � ESTABLISH Method Performance

Parameters to be assessed:

Check all that apply

Parameter Specify Sample Type(s) to be Tested for each Parameter*

# of Samples to be Tested

Date Completed Criteria for Acceptability

Criteria Met/Not Met

Accuracy Linearity (AMR) Precision Carryover Interferences Maximum

Dilution/Concentration (CRR)

Sensitivity Specificity Reactivity Quality Control Plan or IQCP

(non-waived testing only)

Control Ranges Reference Range Other/additional actions required (i.e. cross-contamination, specimen & reagent stability for LDTs):

*When patient specimens are unavailable or cannot be used to assess a specific parameter, matrix appropriate materials must be used.

Examples of such materials include calibration, proficiency testing or QC materials, previously-tested patient specimens that have been diluted or spiked, ATCC organisms, standards, etc. Additional examples can be found in NCL Memorandum 523-008 New Instrument/New Test policy (NCL Functional Group share: NCL Memorandum 523-008 NEW INSTRUMENT-NEW TEST final 10- 17-2016.pdf)

Method Performance Specification Protocol approved by: _________________________________________________________

Laboratory Director or Qualified Designee Signature Date:

Summary statement of approval: This method performance specification study has been reviewed and the performance of the method is considered acceptable for patient testing. Approved by: ____________________________________________________ Laboratory Medical Director or Qualified Designee Date

Date instrument/method placed in use: __________________ file://vhav01fpc2/common$/NCL%20Policies/NCL%20Memorandum%20523-008%20NEW%20INST-NEW%20TEST%208-21-12.doc file://vhav01fpc2/common$/NCL%20Policies/NCL%20Memorandum%20523-008%20NEW%20INST-NEW%20TEST%208-21-12.doc