Summary:
Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of laboratory quality control (QC) Levey-Jennings (LJ) records and interview with general supervisor (GS) 1/7/20, the laboratory failed to retain all daily QC records for the hematology and chemistry testing performed. Findings: The laboratory performs hematology testing on the Medonic M-series analyzer and chemistry testing on the Medica Easy RA analyzer. The laboratory prints LJ reports as documentation of daily QC for the hematology and chemistry analyzers. 1. Review of LJ reports for the Medonic M-series hematology analyzer revealed the following dates in which LJ reports were not printed and retained: a. June 18 through June 24, 2019. b. July 26, through August 2, 2019. August 2, 2019. 2. Review of LJ reports for the Medica Easy RA chemistry analyzer revealed the following dates in which LJ reports were not printed and retained: a. October 30 through December 10, 2018. b. January 18 through January 21, 2019. c. May 10 through May 18, 2019. d. June 19 through June 24, 2019. e. July 26 through August 4, 2019. Interview with GS at approximately 3:00 p.m. confirmed the LJ reports were not printed and retained, she stated that some of the dates in question may have been on the weekend in which daily QC would not have been run as the laboratory was closed on weekends. 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, 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 -- consultant competency. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, review of personnel records, and interview with clinical consultant (CC) 1/7/20, the laboratory failed to establish written policies and procedures for evaluating the competency of providers who perform microscopy and the GS. Findings: 1. Review of the laboratory's procedure manual revealed it did not include a written policy or procedure for evaluating the competency of providers who perform microscopic examinations of synovial fluid for the presence of crystals. During interview at approximately 12:40 p. m., the CC confirmed the laboratory did not have a written competency evaluation policy for providers. 2. Review of personnel records revealed the GS had a performance review in February 2019 which included items such as communication, dependability, job knowledge, and teamwork. The GS also had a competency evaluation of her technical skills in April 2019. There was no written policy or procedure for evaluation of the GS delegated responsibilities, and there was no documentation the laboratory director evaluated her competency as a general supervisor in 2019. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, review of 2017, 2018, and 2019 American Proficiency Institute (API) proficiency testing records and interview with GS 1/7/20, the laboratory failed to evaluate ungraded proficiency testing results. The laboratory's "Proficiency Testing" procedure states "... 12. ... d. All ungraded challenges must be reviewed against the Participant Summary to evaluate the lab's performance, with comments made on the result form indicating acceptability of results. ..." Review of 2017, 2018, and 2019 API proficiency testing results revealed the laboratory failed to document evaluation of ungraded samples on the following test events: 1. 2017 Immunology 3rd event; 2. 2018 Immunology 1st and 3rd events; 3. 2019 Immunology 1st, 2nd, 3rd events. During interview at approximately 3:00 p.m. the GS stated they review all proficiency testing results, but she was unaware they needed to document evaluation of ungraded results. 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. This STANDARD is not met as evidenced by: Based on review of a random patient test report (#8945), review of 2018 and 2019 American Proficiency Institute (API) and College of American Pathologists (CAP) proficiency testing records, the absence of verification records, and interview with the GS 1/7/20, the laboratory failed to enroll in proficiency testing or establish a system to -- 2 of 5 -- verify the accuracy of the microscopic synovial fluid examinations at least twice a year. Review of a random patient test report (ID #8945) revealed the test report included a synovial fluid examination. The test report stated "Assessment and Plan ... s /p inj right knee 1/7/20 - no crystals seen ...". Review of 2018 and 2019 API and CAP proficiency testing records revealed the laboratory was not enrolled in proficiency testing for the microscopic synovial fluid examinations for the presence of crystals performed by providers. There were no records available to demonstrate that the laboratory had a system in place to verify the accuracy of the microscopic synovial fluid examinations for the presence of crystals at least twice a year. During interview at approximately 3:30 p.m., the GS confirmed that the providers perform microscopic synovial fluid examinations for the presence of crystals. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) 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)