Summary:
Summary Statement of Deficiencies 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 upon review of available written laboratory procedures and interview with the Laboratory Director (LD) , the laboratory failed to establish and follow written procedures for the assessment of employees performing PPMP and waived laboratory procedures. Findings include: 1. During an interview with the LD on 3/10/2020 at approximately 1030, the LD confirmed there were no written records of PPMP testing personnel (TP) competency for the past two (2) years. 2. No written evidence of bi- annual verification for personnel performing potassium hydroxide (KOH) wet mounts or isotonic saline wet mounts could be produced during the survey on 3/10/2020. 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 upon review of available written laboratory procedures and interview with the Laboratory Director (LD) , the laboratory failed to establish and follow written procedures for the assessment of employees performing PPMP and waived laboratory Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- procedures. Findings include: 1. No written evidence of bi-annual verification for personnel performing potassium hydroxide (KOH) wet mounts or isotonic saline wet mounts could be produced during the survey on 3/10/2020. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based upon review of the laboratory records provided and interview with Testing Personnel (TP) during survey, the Laboratory Director (LD) failed to ensure that an approved procedure manual is available to all TP. Findings include: 1. There was no written and LD approved procedure manual for PPMP testing during survey 3/10 /2020. 2. The LD confirmed during interview 3/10/2020 at approximately 1045 that there was no written and approved procedure manual available for TP review or use. 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)