Summary:
Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on review of 2018 and 2019 API (American Proficiency Institute) proficiency testing records and interview with TP (testing personnel) 2/25/20, the laboratory failed to retain all proficiency testing records for at least two years. Review of 2018 and 2019 API proficiency testing records revealed: 1. The laboratory did not have copies of signed attestation statements available for the 2018 Hematology 3rd event, the 2019 Hematology 1st, 2nd, and 3rd events, and the 2019 Microbiology 1st, 2nd, and 3rd events. 2. The laboratory did not have a copy of the comparative evaluation for the 2018 Microbiology 2nd event. 3. The laboratory did not have copies of the report forms used to record results, the signed attestation statement, or the graded results for the 2018 Microbiology 3rd event. During interview at approximately 10:45 a.m., TP #1 stated she was unaware they needed to keep attestation statements. 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 review of the laboratory's policies and procedures and review of personnel records 2/25/20, the laboratory failed to follow established policies and procedures for evaluating the competency of testing personnel. Findings: The laboratory's "Clinical Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- Laboratory Point-of-Care Testing Competency Assessment for Non-Waived Testing" policy states "... 3) Policy: Personnel that perform tests of moderate and/or high complexity (non-waived) in a CLIA-certified laboratory or point-of-care testing area must have documented competency. A. New Testing Staff Members will have competency assessment: 1. Initially 2. 6-Months 3. Annually B. After the first year, each staff member is required to have documented annual competency on each method used by the staff member. C. The following six (6) procedures are the minimal regulatory requirements for assessment of competency for all personnel performing laboratory testing for each test that the individual is approved by the laboratory director to perform: 1. Direct observations of routine patient test performance ... 2. Monitoring the recording and reporting of test results. ... 3. Review of intermediate test results or worksheets, quality control records, ... 4. Direct observations of performance of instrument maintenance and function checks. ... 5. Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. ... 6. Assessment of problem solving skills. ... E. Competency Observation: Must be completed by a qualified individual, meeting CLIA Technical Consultant requirements. ..." Review of personnel records revealed: 1. Competency evaluations for TP #1 conducted in May and November 2019 did not include a competency evaluation for post vasectomy semen analysis. Competency evaluations for TP #2 conducted in July 2019 and January 2020 did not include a competency evaluation for post vasectomy semen analysis. Both TP #1 and TP #2 had documentation of an on- line "TRAINING TEST" for post vasectomy semen analysis from June 2019. The test consisted of three images which required the participant to determine presence or absence of sperm. It was unclear whether the test was used for training or to determine competency. 2. Competency evaluations for TP #1 and TP #2 did not include all six procedures included in the minimal regulatory requirements for assessment of competency. The "COMPETENCY ASSESSMENT FORM" used to document urine microscopic competency states "... COMPETENCY ELEMENTS INCLUDE TWO (2) OF THE FOLLOWING COMPONENTS: 1. Assessment of problem solving skills. ... 2. Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. ... 3. Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. ..." 3. The May 2019 urine microscopic competency assessment for TP #1 was signed by TP #2. There were no records available to indicate that the laboratory director had delegated the responsibility for the performance of competency evaluations to TP #2. TP #1's November 2019 urine microscopic competency evaluation was not signed, so it was unclear who performed the evaluation. 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)