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 on lack of competency assessment written procedure and an interview with the office manager, the laboratory failed to establish a written procedure for competency assessment for the testing personnel performing KOH and fungal cultures. FINDINGS: The office manager confirmed on March 12, 2020 at approximately 10: 30 AM, that the laboratory failed to establish and follow written procedures for competency assessment based on specific skills for personnel performing KOH and fungal culture testing. 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 the lack of twice yearly verification and confirmed at survey with the office manager, the laboratory failed to verify the accuracy for KOH and fungal culture testing at least twice per year. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on surveyor's review of records and an interview with the office manager, the laboratory failed to ensure that the: 1. laboratory followed the manufacturer's temperature requirements for the fungal media, refer to D5413; 2. laboratory established and followed policies and procedures, refer to D5403; 3. laboratory discontinue the use of the expired KOH reagent, refer to D5417; 4. laboratory follow the established microscope maintenance policy, refer to D5433; 5. laboratory perform and document quality control for the fungal media, refer to D5445. 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)