Summary:
Summary Statement of Deficiencies D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on direct observation, review of laboratory records, lack of documentation, and interview with Testing Personnel (TP1); the laboratory failed to meet the requirements for the specialty of hematology. Findings Include: 1. The laboratory failed to assess the competency of the technical supervisor. See D5209. 2. The laboratory failed to follow all aspects of the facility's testing procedure for Semen Analysis. See D5401. 3. The laboratory failed to perform two control materials of different concentrations at least once a day that Semen Analysis was performed from April 2022 through March 1, 2023, before reporting patient test results for 19 out of 33 days and affecting 25 patients test results. See D5447. 4. The laboratory failed to follow the manufacturer's test system criteria for control materials acceptability before reporting patient test results for 14 out of 14 days that Semen Analysis performed since April 2022, affecting 23 patients test results. See D5481. 5. The laboratory failed to establish, identify, and correct problems with analytical performance for Semen Analysis testing performed April 2022 through March 1, 2023. See D5791. 6. The laboratory failed to ensure two out of four patient test reports for Semen Analysis testing was accurately transcribed into the electronic medical record. See D5801. 7. The laboratory failed to follow written policies and procedures to monitor, assess, and when indicated correct problems identified in the post-analytic systems. See D5891. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 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 -- 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 records, lack of documentation, and interview with Testing Personnel (TP1); the laboratory failed to assess the competency of the technical supervisor. Findings Include: 1. Review of competency records found no competency assessments for the individual listed as the technical supervisor on the CMS-209 (Laboratory Personnel Report). 2. Review of the laboratory records found no procedure for competency assessments. 3. On survey date 03-09-2023, at 11:40 am, TP1 confirmed the laboratory failed to assess the competency for the technical supervisor. 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 on direct observation, review of laboratory records and interview with Testing Personnel (TP1); the laboratory failed to follow all aspects of the facility's testing procedure for Semen Analysis. Findings Include: 1. Direct observation on 03-09- 2023, at 8:14 am, TP1 was observed demonstrating the testing process for Semen Analysis. TP1 used a pipette dropper to place a sample of semen on a Makler counting chamber to count sperm under a microscope. TP1 was also observed using QC-Beads for the high- and low-Quality Control. 2. Review of the testing policy and procedure manual for Semen Analysis stated: a. "Place approximately 5uL of sample onto a Microcell counting chamber." b. "Quality Control (QC): Obtain two concentrations of the current lot number of Accu-beads. (High- and Low-level control.)" 3. During survey date 03-09-2023, at 10:18 am, TP1 confirmed the laboratory is not following the procedure for Semen Analysis that was provided. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and lack of documentation, the laboratory failed to perform two control materials of different concentrations at least once a day that Semen Analysis was performed from April 2022 through March 1, 2023 before reporting patient test results for 19 out of 33 days and affecting 25 patients test results. -- 2 of 6 -- Findings: 1. The facility's Semen Analysis Policy and Procedure stated, "Record on the Daily Control Count worksheet the concentration for the high- and low-level controls. Indicate if the counts fall within the acceptable range and are within 10% of each other. If counts do not meet the required limits, repeat and document