Summary:
Summary Statement of Deficiencies D0000 An announced, on site, initial certification survey was conducted at Chapmanville Primary Care Clinic on January 20, 2021, by the West Virginia Office of Laboratory Services. The laboratory was surveyed to assess compliance with the Federal Clinical Laboratory Improvement Amendment (CLIA) regulations under 42 CFR 493. Specific deficiencies are explained below. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of the laboratory written policies and procedures (P&P) and an interview with laboratory manager, the laboratory failed to establish written P&P to assess employee competency and initial training of testing personnel (TP). Findings: 1. A review of written P&P could not locate a written policy or procedure for assessing employee competency or initial training of testing personnel. 2. A review of written P&P identified an initial training and competency performed for the 2 testing personnel of the laboratory. 3. During an interview with the laboratory manager, on 1 /20/2021 at approximately 8:30 AM, the laboratory manager stated that there was no written policy or procedure for employee competency or initial training of testing personnel. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- This STANDARD is not met as evidenced by: Based on a review of the laboratory test menu, written policies and procedures (P&P), and an interview with the laboratory manager, the laboratory failed to enroll in a commercial proficiency testing program or establish a policy or procedure to verify accuracy at least twice per year of the analytes, not included in Subpart I, Amphetamine, Methamphetamine, Barbiturate, Benzodiazapine, Cocaine, EDDP, Opiate, THC, and TCA. Findings: 1. A review of the laboratory test menu and testing records identified no enrollment in a commercial proficiency testing program for the analytes Amphetamine, Methamphetamine, Barbiturate, Benzodiazapine, Cocaine, EDDP, Opiate, THC, and TCA tested on the Quidel Triage Meter Pro and not included in Subpart I. 2. A review of the written P&P identified no written policy or procedure to verify accuracy at least twice a year for the analytes Amphetamine, Methamphetamine, Barbiturate, Benzodiazapine, Cocaine, EDDP, Opiate, THC, and TCA tested on the Quidel Triage Meter Pro and not included in Subpart I. 3. During an interview with the laboratory manager, on 1/20/2021 at approximately 8:30 AM, the laboratory manager stated there were no analytes from the test menu enrolled in a commercial proficiency testing program and no written policy or procedure to verify the accuracy of them. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on a review of laboratory written policies and procedures (P&P) and an interview with the laboratory manager, the laboratory failed to establish a written P&P for (3) Specimen labeling, including patient name or unique patient identifier (7) Specimen acceptability and rejection and (8) Specimen referral. Findings: 1. A review of the laboratory written P&P identified the manufacturer instructions being utilized as the P&P for the testing of Amphetamine, Methamphetamine, Barbiturate, Benzodiazapine, Cocaine, EDDP, Opiate, THC, and TCA on the Quidel Triage Meter Pro. 2. A review of the Quidel Triage Meter Pro manufacturer instructions revealed no P&P for (3) Specimen labeling, including patient name or unique patient identifier (7) Specimen acceptability and rejection and (9) specimen referral to LabCorp for confirmation testing. 3. During an interview with the laboratory manager, on 1/20 /2021 at approximately 8:45 AM, the laboratory manager stated that the manufacturer instructions were being used as the laboratory P&P for the Quidel Triage Meter Pro testing. The laboratory manager also stated there was not a written P&P for specimen labeling, specimen acceptability and rejection, and specimen referral to LabCorp for confirmation testing when ordered by the physician. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) -- 2 of 5 -- The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)