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 surveyor review of procedures and competence evaluation records and interview with the director of laboratory services, the laboratory did not ensure the director followed the procedures for assessing competence of two of two technical supervisors (TS) and technical consultants (TC) and one of one general supervisor (GS) reviewed. Findings include: 1. Review of the procedure, 'Training Verification and Competency Assessment for Laboratory Testing Personnel' showed, "The competence of those delegated to perform the TC, TS, or GS regulated responsibilities must also be established and documented". The procedure also stated the competence assessment forms should be reviewed annually. 2. Review of competence evaluations of two technical supervisors (staff D and E) showed the director completed evaluations for each of the two staff members' performance of the TS role in 2021 and 2023. No evaluation was available for 2022. The completed evaluations did not show the director evaluated either staff D or E in their role as technical consultants or staff D as a general supervisor. 3. Interview with the director of laboratory services on August 24, 2023, at 9:30 AM confirmed the two reviewed technical supervisors also have technical consultant responsibilities and staff D has general supervisor responsibilities. Further interview confirmed there was no documentation showing evaluation of competence in fulfilling these roles in 2022 for the two staff members reviewed and only documentation for the technical supervisor roles in 2021 and 2023. Further interviewed confirmed the director should perform the evaluation annually. D5429 MAINTENANCE AND FUNCTION CHECKS 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 -- CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on surveyor review of Sysmex hematology analyzer maintenance records and interview with the director of laboratory services, testing personnel did not document monthly maintenance for fifteen of fifteen months from May 2022 to July 2023. Findings include: 1. Review of the maintenance log for the Sysmex XNL-450 hematology analyzer showed monthly maintenance included "Print/review online BCQM (Recommended) and Print/Review QC report". Review of the logs from May 2022 through July 2023 showed no documented completion of the monthly tasks. 2. Interview with the director of laboratory services (staff A) on August 24, 2023, at 1:30 PM confirmed the laboratory did not document the monthly maintenance for the Sysmex XNL-450 hematology analyzer on the logs. This is a repeat deficiency previously cited on October 12, 2021. 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 surveyor review of laboratory procedures and records and communication with the director of laboratory services, testing personnel did not test two levels of quality control (QC) materials each day of troponin testing on the i-STAT analyzer for five of six days testing was performed from May 24 through June 15, 2023. Findings include: 1. Review of laboratory procedures provided no evidence the laboratory had developed an IQCP (Individualized Quality Control Plan). 2. Review of test records from May 24 through June 15, 2023, showed testing personnel performed i-STAT Troponin testing on patient samples on May 26 and 31 and June 1, 8, and 15 without testing control materials. 3. Email communication with the director of laboratory services (staff A) on August 31, 2023, at 1:47 PM confirmed staff could not find the laboratory's IQCP for Troponin testing with the i-STAT analyzer and confirmed patient testing was performed when control materials were not tested on the day of testing. D6072 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(3) Each individual performing moderate complexity testing must adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and procedures and communication with the director of laboratory services, testing personnel did not document performance of thermal probe checks for one of two events in 2022 and did not consistently document daily performance of the external electronic simulator from June 20, 2022, through August 11, 2023. Findings include: 1. Review of i-STAT Thermal Probe Check documentation from 2022 showed the laboratory only documented performance of the thermal probe check on June 20, 2022. Testing personnel documented the next thermal probe check on August 11, 2023. 2. The procedure, 'i-STAT 1 Handheld Analyzer', stated "The thermal probes on each analyzer need to be checked once every 6 months." The procedure also stated, "Performance of the External Simulator is completed ...once per 24 hours of patient testing...", and record PASS or FAIL on 'z Attachment Chem i-STAT thermal Probe Check'. 3. Interview with the director of laboratory services (staff A) on August 24, 2023, at 2:00 PM confirmed testing personnel did not document thermal probe checks as required. Email communication with (staff A) on August 31, 2023, at 1:47 PM confirmed the director could not find "consistent documentation of the Electronic QC Simulator". D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on surveyor review of CMS (Centers for Medicare and Medicaid Services) Forms and competence assessment documents and interview with the director of laboratory services, the technical supervisor did not document semi-annual competence evaluations at this laboratory for two of four new testing personnel. Findings include: 1. Review and comparison of the CMS Form 209, Laboratory Personnel Report, submitted for this survey and the form submitted for the survey in 2021 showed three new testing personnel. Additionally, one person (staff C) listed on the 2021 Form 209 had only an initial competence evaluation documented at the time of the 2021 survey. 2. Review of competence assessment documents for staff B and C showed: Staff B: One competence assessment form for this laboratory dated October 13, 2022. Staff C: Initial competence assessment dated May 6, 2021, annual dated May 23, 2022. 3. Interview with the director of laboratory services (staff A) on August 24, 2023, at 9:15 AM revealed staff B started at this laboratory on June 13, 2021, and confirmed the technical supervisor did not document competence evaluations at this laboratory during the first year. Further interview confirmed the technical supervisor documented competence evaluations for staff C only once during the first year staff C performed testing. -- 3 of 3 --