Summary:
Summary Statement of Deficiencies D0000 An initial survey conducted on June 1, 2022 found the laboratory out of compliance with the following CONDITION LEVEL DEFICIENCIES: D5400 - 42 C.F.R. 493.1250 Condition: Analytic systems; 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 laboratory procedures, personnel records, and in interview with the laboratory director, the laboratory failed to establish written procedures to ensure competency assessment for three of five employees (supervisors and the clinical consultant for hematology). Findings included: 1. Review of the laboratory's written procedures did not include competency assessment for individuals designated as the technical supervisor, general supervisor, and clinical consultant, as required. The supervisors and clinical consultant provided oversight of hematology testing (Sperm Chromatin Dispersion Test - HaloSperm). 2. Review of the technical supervisor, general supervisor, and clinical consultant records included date of employment since 07/2021. The records did not include competency assessment performed and documented based on position responsibilities as defined in Subpart M (493.1351). 3. During an interview on 06/01/2022 at 1:00 pm, the laboratory director confirmed written procedures did not include performing and documenting competency assessments for the technical supervisor, general supervisor, and clinical consultant. 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 a review of the Centers for Medicaid and Medicare Services (CMS) form 116, laboratory quality control (QC) records, patient testing logs, laboratory documents, instructions for use, and confirmed in interviews the laboratory failed to meet the analytic system requirements in 493.1251 through 493.1283. The findings include: 1. The laboratory failed to establish the test system performance specifications for accuracy, precision, analytical sensitivity, analytical specificity to include interfering substances, reportable range of test results, and reference intervals (normal values) for the Sperm Chromatin Dispersion Test before reporting 66 of 66 patients test results from June 2021 to February 2022. Refer to D5423. 2. The laboratory failed to test staining materials for intended reactivity each day of patient testing for the Halosperm Chromatin Dispersion Test, for 16 of 66 patients tested from June 2021 to February 2022. Refer to D5473. 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)