D.13 Policy and Procedures for Ancillary Testing Quality Management, 36C25522R0052.pdf

Pathology & Laboratory Medicine Service Department: POC VA Medical Center, Columbia, MO

POC.5 POLICY AND PROCEDURES FOR

ANCILLARY TESTING QUALITY MANAGEMENT

INTRODUCTION

Quality assurance parameters ensure that the information generated by the laboratory is accurate, reliable, and reproducible. This ensures quality throughout the pre-analytic, analytic, and post-analytic phases of testing. This is accomplished by assessing the quality of the specimens; monitoring the performance of the test procedures, reagents, media, instruments, and personnel; reviewing test results; and documenting the validity of the test method.

SPECIMEN COLLECTION AND TRANSPORT

• A guideline for collection, preservation and transport of specimen is provided to the floor through the hospital’s information system (VISTA and CPRS) and a procedure for the techs to refer to in the department.

• Specimens are processed and tested as soon as possible.

QUALITY CONTROL REVIEW POLICY

• Each batch of reagents is checked for appropriate reactivity.

• Quality control of commercial products is performed according to manufacturer’s instructions or CAP Checklist requirements.

• Control specimens are tested in the same manner as patient samples and analyzed by personnel who routinely perform patient testing.

• Control results must be reviewed acceptable before reporting patient results.

• Testing personnel are responsible for recording quality control data on the appropriate forms provided in the department.

• Testing personnel are responsible for notifying the ATC when controls are out of range and filling out a corrective action form.

• The ATC is responsible for monthly periodic review of the quality control data and documentation of the review by initial and date.

• Quality control for tests performed less frequency than once per month will be reviewed when the tests are performed.

• The ATC is responsible for maintaining quality control records in an organized manner available for inspection.

• All quality control records and patient reports will be retained for a period of at least two years.

• Any error in reporting quality control results, tech will draw a line through the incorrect results and initial. The correct results will be circled on the document.

D.13 Policy and Procedures for Ancillary Testing Quality Management, 36C25522R0052

REAGENTS

• All reagents utilized in this laboratory are commercially obtained.

• Reagents are stored as recommended by the manufacturer and used within their indicated expiration date.

• Reagents will be labeled with a received date.

• Each shipment of reagents comes with a package slip that lists the lot number, expiration date and a statement that all lots meet CLSI standards.

• The package slip is filed away and kept for two years.

• Reagents or kits that have not been QC’d will have a sticker that states “Do Not

Use”. When reagents or kits have been QC’d, a “Ready For Use” sticker will be placed over the “Do Not Use” sticker..

• There is no mixing of reagents from other lot numbers when there are multiple components in a reagent kit.

• All reagents are tested according to manufacturer specifications.

• Company controls (external controls) or known CAP surveys are used to check reagents and test methods.

• A positive and negative external control is tested and documented with each kit new lot number/shipment date. If controls come with the kit, the controls are tested and documented on the QC log sheet or in RALS. Any discrepancies from expected results must be investigated and corrective action completed.

• The” put in use” date for all reagents and kits will be documented on QC log sheets or RALS.

PROCEDURE REVIEW POLICY:

• Procedure manuals will be reviewed, dated and initialed by ATC every two years.

• All procedures will be reviewed and approved by a new Director when there is a change in directorship.

• New procedures, policies, worksheets and log sheets will be reviewed and approved by Director before implementation.

• Instructions for every procedure routinely performed in the laboratory are included in the manuals.

• New testing personnel will review and sign-off on procedures according to his/her job duties.

• New procedures or major testing changes made on a current procedure will be reviewed, dated and initialed by the director and signed-off by all testing personnel.

• Procedure manuals will be available at all times in the laboratory and on Sharepoint.

• Quick references are allowed at the workbench for testing personnel.

• Procedures in the manual will be referenced to a published source.

• Retired procedures will be retained for two years with a recorded date of retirement.

TEST PROCEDURE

• Testing personnel should be familiar with the principle, specimen, reagents and material, procedure of the test, and reporting results before performing a test.

• Testing personnel should promptly correct any errors detected.

ORDERS

• Clinical standing orders, order sets, and protocols are dated, timed, authenticated, and included in the patient’s clinical record.

• Upon verbal orders for POC testing, the laboratory requests electronic authorization within 30 days

PROFICIENCY TESTING (PT):

• For proficiency surveys see PT shipping calendar and laboratory activity menu.

• Do not refer or communicate information about a proficiency specimen to another lab or coworker.

• Do not refer a proficiency specimen to a reference lab.

• All samples are potentially infectious and must be handled according to Standard precautions at all times.

• The PT specimens are handled and processed according to the instructions provided in the kit.

• A rotation schedule has been incorporated so that all testing personnel are involved in the proficiency testing program.

• Samples are analyzed using the same testing method as for patient samples.

• Testing personnel will fill out the result forms and turn in any worksheets or log sheets that were used for recording results.

• Testing personnel will not share information about the assessment until the results have been graded.

• The ATC will enter results using CAP web site. A copy of the entry will be double checked by another ATC or tech before approval on the web site.

• The ATC or tech that double checks the electronic copy will check each entry and initial.

• CAP survey evaluation report will be reviewed by the ATC and Director.

• Unacceptable results will be investigated by the testing personnel that performed the survey along with the ATC and a proficiency survey response will be completed. Problems identified by unacceptable proficiency testing results will be corrected.

• Re-assessment of failed survey will be graded by the ATC and reviewed by the director.

• For incorrect results of re-assessed samples, testing personnel is given a reeducation session and then given a second unknown. If the result is correct, no further assessment is needed. If the second result is incorrect, the tech is given a reeducation session and third unknown.

• If there is a second failure on the assessment, the tech will not be able to perform the test on patient samples until he/she has shown 100% competence.

• Proficiency survey response will be reviewed by the Director.

• ATC will respond to any comments, questions, or suggestions that are made by the Director on the proficiency survey response for unacceptable results.

• Ungraded results will be investigated and ATC will document response on evaluation form.

• Proficiency testing challenges that were not graded will be identified and the acceptability of performance will be assessed and documented through the use of peer results.

• CAP proficiency evaluations are reported to the VA Regional Commissioner.

ALTERNATIVE PERFORMANCE ASSESSMENT

• For tests that CAP does not require PT, semi-annual assessment will be performed.

• KOH and Scabies are the only tests that are assessed by an alternative method in this department.

LABORATORY SAFETY

• Wear gloves while performing testing on the patient and follow all precautions for bloodborne pathogens.

• Hand Hygiene: Using antimicrobial soap and water to cleanse hands or gel or foam product that contains no less than 60% isopropyl alcohol, designed to disinfect healthcare providers' hands.

• Use standard biohazard precautions when handling any blood specimen during collection, testing, and disposal.

• Dispose of needles in appropriate puncture resistant containers.

• Dispose of specimen and testing materials in appropriate biohazard containers.

• Lancets and needles are considered a single use item.

• Single use items are disposed in appropriate puncture resistant biohazard containers.

INSTRUMENTS AND EQUIPMENT

• All instruments and equipment are properly operated, maintained, serviced and monitored by trained personnel.

• Each instrument and equipment is inspected by the Biomedical Engineering Department before it is put into use. After the safety inspection, a dated inspection sticker is placed on the equipment.

• Each item of equipment in the laboratory meets the manufacturer’s claims and specifications.

• The Temp Trak Monitoring System electronically records temperature of the refrigerators, and freezer.

• On a monthly basis, each temperature sensor will be checked against a NIST certified thermometer which is kept in each refrigerator and freezer. The sensor and thermometer readings must be within acceptable range. The monthly check is documented by the testing personnel and reviewed by the ATC or designee monthly.

• Preventive maintenance and cleaning are performed by the testing personnel and recorded on a log sheet, when applicable.

• The eyewashes are checked weekly.

• Microscopes are serviced once a year.

• All field service maintenance records on equipment are kept for the life of the instruments.

REPORTING OF RESULTS

• Control results must be reviewed as acceptable before reporting patient results.

• Results are automatically reported in CPRS (with appropriate reference ranges when applicable). The results are entered in the lab report section of the patient electronic medical record (EMR) via the RALS-Web3 interface. The operator performing the test is responsible for proper evaluation, documentation of results, and treatment necessary for the patient.

VERIFICATION OF MANUAL ENTRIES

• All results manually entered into the computer are checked against the log sheet for transcription errors. This is documented on the log sheet by the ATC or tech.

• A patient’s computer report is checked for accuracy each day except on weekends and holidays. In case of a long absence of the ATC, another testing personnel in the department checks results.

• Any major clerical or analytical errors found that could affect patient treatment are immediately corrected in the computer and reported to the provider as soon as possible and an Internal laboratory incident report form will be filled out by ATC or tech and given to Lab Manager. The computer report will show both the correct result and in the comment field, the incorrect result is noted with

“INCORRECTLY REPORTED AS . . .”

VERIFICATION/CORRELATION OF INSTRUMENT/METHOD ASSESSMENT

• When more than one instrument/method is used to test a given analyte, correlation will be performed against each instrument/method twice a year.

• CAP surveys or patient samples will be used for comparison.

• Instrument verifications are performed twice a year using matrix appropriate materials. (See specific procedures for calibration/verification/linearity studies instructions.)

• Calibration/verification/linearity samples are ran in duplicate and acceptability criteria are defined for each analyte.

• When results fail, a corrective action form is filled out. Affected lot numbers cannot be used for patient testing until errors are resolved.

• If repeat calibration/verification fails, contact technical support.

PERFORMANCE (AMR) VERIFICATION

Verification and/or validations will be performed on any new test instrument or equipment before implementation. All manufacturers’ guidelines for verification will be followed to ensure that all testing equipment/instrumentation is performing according to expectation. Performance of all instruments and equipment is verified upon installation, after major maintenance, or after major service. Verification will be performed before the introduction of a new point of care ystem; when adding a new test to an existing point of care system; or before reporting patient test results. The instrument has to meet performance specifications defined by the manufacturer for that system. Verification generally involves testing clinical samples with the new system and comparing results to those obtained with an established reference method or a system that has been previously verified. Testing clinical samples may be done concurrently with the two systems. Verification results must be approved and signed off by the Laboratory Director prior to any patient testing.

ANALYTICAL MEASUREMENT RANGE VERIFICATION

Analytic measurable range (AMR) by analyte are as follow:

Glucose – 10 to 600 mg/dL tHb – 3.0 to 23.0 g/dL %O2Hb – -10.0 to 110% Creatinine – 0.2 to 20.0 mg/dL pH – 6.50 to 8.20 pCO2 – 5 to 130 mmHg pO2 – 5 to 800 mmHg ACT – 50 to 1000

AMR is defined by each manufacturer and when results fall outside of testing range and a value is needed, samples are recollected and tested by the main lab. The AMR is verified semi-annually by performing linearity studies with matrix-appropriate materials of known values. Creatinine and ABG uses i-STAT Tricontrols Calibration Verification.

tHb and %O2Hb uses Performance Verification Product. Glucose uses Accu-Chek Inform II Linearity Test Kit. Each manufacturer includes a package insert detailing acceptability criteria for each specific analyte. Refer to manufacturers’ guidelines for ranges.

ANALYTIC INTERFERENCES

Each test has stated specimen limitations or analytical interferences per manufacturer’s guidelines. Review each procedure for listing. If a known or suspected interfering agent is present in a patient’s sample, the sample will be referred to the main lab for continued patient testing using an alternate test methodology.

GUIDELINES FOR RETENTION OF RECORDS

The following records are retained for at least 2 years:

• Patient’s test results and reports

• Printouts for QC and Calibration/Linearities

• Accession Log sheets and patient requisitions

• Quality control reports

• Instrument maintenance records-records will be retained for the life of the instrument and two years after the discontinuation of instrument.

• Proficiency testing records

• Quality management records

• Discontinued Policies/procedures will be held for 2 years after date of discontinuation.

QUALITY CONTROL

Procedures performed by point-of-care testing staff must have Quality Control (QC) samples run whenever such a sample is available. These control materials will be tested as closely to the procedural patient testing to mimic the processes. This includes the instrument, reagents, and general operator steps (competency assessments will ensure each operator’s individual technique is appropriate). Use of electronic quality control must ensure the instrument is in good working order and simulate the process of the test patient within the instrument.

All quality control results are recorded either electronically or on a log sheet with a copy available in the Pathology Laboratory and kept for a minimum of two years.

Waived Testing

1. Accu-Chek Inform II Whole Blood Glucose

a. Two levels of quality control solution will be tested on each meter a minimum of once every 24 hours of patient testing. Each meter is set for “lock-out” at 0200 and no patient testing can be completed until both levels of control solutions pass the accepted ranges. Additionally, quality control is performed after any major troubleshooting or maintenance.

b. The instrument is set to accept quality control results within the limits of + 3 SD at the time of testing. The PASS/FAIL lockout will take the place of daily review of QC results.

c. New lot numbers of Accu-Chek Inform II test strips will be verified for acceptability upon arrival by use of quality control and linearity data. The manufacturer’s range will be used for 1 month, and then the data will be reviewed using the RALS-Web3 program. At this time the range will be accepted as is or updated by the Ancillary Testing Staff.

d. New lot numbers of Accu-Chek Inform II QC Solutions will be verified by quality control data of the test strips.

e. New lot numbers of Accu-Chek Inform II Linearity Solution will be verified by manufacture's provided range.

2. *Clinitek Status Connect Urine Dipstick

a. Two levels of quality control solution will be tested on the Clinitek each day the CBOC is open, regardless of patient testing. The transfer of the results via RALS-Web3 will ensure the connectivity is active for the location.

b. Results must pass the acceptable range provided by the QC solution manufacturer before starting any patient testing for the day. Each Clinitek has a lockout feature to ensure acceptable QC testing.

c. Manufacturer's ranges will verify new lot numbers of Multistix-10SG Urine Test Strips and Alta Diagnostics Urine Dipstick Control.

3. pH Test Strips for Gastric Fluid

a. New lots of pH test strips will be validated using graded CAP surveys of known values before being placed into use. No additional QC is needed unless the testing ability of the strips may have been compromised, such as the container being left open for an extended period of time or otherwise contaminated.

b. pH test strips are given a one year expiration date after date opened.

c. pH quality control testing will be recorded in the Quality Control Review binder.

d. pH quality control result limits will be set using CAP survey evaluation criteria of + 3 SD or + 0.5 pH units, whichever is greater

4. *Alere i Influenza A&B & Strep

a. New lot validation is accomplished by external quality control and completed by the Ancillary Testing Staff on each box of cartridges, using the positive and negative QC specimen provided.

b. External quality control test results are recorded in RALS with each new lot number and or in Microbiology Department.

c. The Alere i has built-in procedural controls. Controls are automatically stored and displayed on the screen. Can be reviewed by selecting Review Memory. Procedural Control Valid displayed on the instrument screen indicates that the assay reagents maintained their functional integrity and the sample did not significantly inhibit assay performance.

d. The Alere i contains an internal control that has been designed to control for sample inhibition, amplification and assay reagent function.

5. *Clinitek hCG-Urine Test

a. New lot validation will be completed in the Core Lab by external QC and before individual packaged kits are sent to the CBOC locations. Internal quality control of each patient test

b. Each test includes two procedural controls, which indicate that sufficient sample was added for capillary flow to occur and the correct procedural technique was used. If the instrument does not detect the Reference (R) and Control (C) regions within two minutes after starting the test, an error is reported and the test must be repeated

c. External QC records are in RALS.

6. i-STAT Whole Blood Creatinine

a. Creatinine quality control test will take place on one i-STAT1 to validate new lots of cuvettes when received. Results must be acceptable using the i-STAT Value Assignment Sheets before the new cuvettes are put into use. The iSTAT1 will be set for the internal electronic simulator test to take place every 24 hours. The external electronic simulator will be used to validate an internal simulator failure, to access the Calibration Verification test path, and to verify the thermal probe check. The thermal probe check will take place at least Semi-annually with records stored in RALS-Web3.

Non-waived Testing

1. I-STAT Activated Clotting Time (ACT Kaolin), ABG, and CG8+

a. Each Instrument is configured to automatically perform an Internal

Electronic Simulator Test every time a cartridge is inserted. If not, the analyzer displays “ELECTRONIC SIMULATOR FAIL”. The same cartridge can be re-inserted immediately after the FAIL message is displayed. If the analyzer fails the simulator test again, contact the Ancillary Testing Office.

b. New lot numbers of test cartridges will be verified as acceptable using i- STAT ACT Control Level 1 and Leve 2 for ACT and i-STAT Tri controls, Level 1 and Level 3 for ABG and CG8+. If more than one shipping container or lot number is received, cartridges from each container or lot number will be verified. The lot will be considered adequate for use provided the QC tests are in acceptable manufacturer’s ranges.

c. Monthly quality control testing will be completed by the Anesthesiology and Cardiac Catheterization and Respiratory Therapy staff for the instruments in their area using the i-STAT ACT controls Level 1 and 2 and TriControls quality controls, Level 1 and Level 3 for ABG and CG8+.

Ancillary Testing Staff will complete testing for the backup instruments.

d. Results of QC passing have been set to allow a 3 day maximum grace period for the monthly control testing before QC lockout will take place.

Results will be stored in the RALS-Web3 system.

e. New lot numbers of i-STAT TriControls vials and ACT Control vials for the i-STAT will be verified against provided manufacturer's quality control ranges. Parallel testing will not take place due to the low volume of supplies available in each lot number.

2. GEM 4000 Total Hemoglobin and Oxyhemoglobin

a. 2 levels of QC will be tested to validate a new cartridge monthly by the Cath Lab staff. Results must be acceptable for the cartridge to be put into use for patient testing. Parallel testing will not take place due to the low volume of supplies available in each lot number.

b. Internal control tests are completed by the GEM 4000 with each patient sample. Results are recorded within the GEM 4000 and review by the Ancillary Testing Staff monthly. Parallel testing will not take place due to the low volume of supplies available in each lot number.

3. Provider-Performed Tests (PPT)

a. Provider-Performed Tests in the Dermatology clinic include KOH Preps and Mineral Oil Exams for Scabies. These tests are under guidelines specific to PPT and do not include test procedure quality control. Monthly checks of the reagents for expiration date and a visual check for contamination are made by the Ancillary Testing Staff or Dermatology Staff.

*These tests are not a part of the CAP accreditation process for this laboratory and will be monitored along with the hospital/clinic Joint Commission site inspections.

Suggested steps to resolve quality control problems are:

1. Retest using the same control.

2. Perform maintenance and retest the same control. If the quality control is now within the acceptable range, report the patient results. The outlier will be attributed to random error. DO NOT CONTINUE TO REPEAT THE TEST.

3. Check for correct lot number use, change to a new lot number, or recent maintenance that would affect the quality control values. Document the finding with the quality control results and notify the Ancillary Testing Coordinator of any problems not resolved.

4. Investigate whether the control solution or other reagent is bad. Try another vial of control solution, another vial of test strips, the same solution on another instrument, etc. Check for outdated or contaminated controls or other reagents.

If a problem is discovered that would affect previously reported results, notify the supervising nurse or physician immediately. The supervising nurse or physician will decide if any previous patients need to be repeated. Because of the nature of Ancillary Testing, repeat testing may not be possible, however the patient's physician(s) MUST be notified of possible erroneous results. Document the notifications according to the policy of the area of testing, (i.e. nursing, anesthesiology, and cardiac catheterization laboratory guidelines). Notify the Ancillary Testing Coordinator of the problem found and the need for any additional assistance.

Quality Control Reviews

Daily – The supervising nurse of each area using Ancillary Testing will be responsible for monitoring quality control on a daily basis where applicable as the "on-site ATC".

Monthly – The Ancillary Testing Coordinator will review quality control results of all tests for outliers and shifts. When written CV guidelines are not available for a given test, the quality control will be evaluated using the average CV from the CAP survey reports or a visual review of results for acceptability. Any problems will be investigated and actions taken will be documented.

Unacceptable lot numbers will not be used for any reason. If the unacceptable lot number is due to the fault of the manufacturer, the local sales representative will be immediately notified. All unacceptable lot numbers will be replaced and testing for acceptability will again take place before using.

REFERENCES

Westgard JO, et al. A multi-rule Shewhart chart for quality control in Clinical Chemistry.

Clin Chem; 27:493-501.

Harry S Truman Memorial Veteran's Hospital Pathology and Laboratory Medicine Service, Policy and Procedures for Chemistry Quality Control.

Accu-Chek® Inform II Operator’s Manual

Gem® 4000 Whole Blood Co-Oximeter Operator’s Manual

Clinitek Status Connect Operator’s Manual i-STAT System Manual

Alere I Operator’s Manual

College of American Pathologists POC Checklist, McPherson MD MSc, R; Pincus MD PhD, M. 2017. Henry’s Clinical Diagnosis and Management of by Laboratory Methods 23rd Edition. Pages 481-508. St Louis, MO:

Elsevier Inc.

Digital Copy link: https://www.clinicalkey.com/#!/browse/book/3-s2.0-C20130143425 https://www.clinicalkey.com/#!/browse/book/3-s2.0-C20130143425