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 laboratory personnel records and interview with the technical consultant (TC) listed on the Centers for Medicare & Medicaid Services (CMS) 209 form at 9:45 a.m. on 7/19/22, the laboratory director failed to follow written policies to assess competency of the TC at least annually. There were no annual evaluations for the TC on the day of survey for the years 2021 and 2022. Findings include: 1. Based on review of the personnel records on 7/19/22, the laboratory director failed to follow policies to evaluate the TC at least annually for the years 2021 and 2022. 2. Interview with the TC confirmed there were no competency evaluations documented by the laboratory director for the TC since the last survey on 11/12/20. D5429 MAINTENANCE AND FUNCTION CHECKS 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 the CDS Medonic M-Series Hematology analyzer maintenance logs since the last survey on 11/12/20 and confirmation by testing 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 -- personnel (TP) #1, listed on the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, the laboratory failed to document as performed monthly maintenance procedures as defined by the manufacturer with at least the frequency specified by the manufacturer. Findings include: 1. Review of the CDS Medonic M- Series Hematology analyzer maintenance logs since the last survey on 11/12/20 revealed the following monthly maintenance procedures were not documented as performed for the time frames listed: Monthly Cleaning (hypochlorite) and Clot Prevention (enzymatic): January-May 2021 and July-October 2021 2. TP #1 confirmed the monthly maintenance procedures were not documented during these time frames. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on surveyor review of the CDS Medonic M-Series Hematology analyzer calibration records, lack of calibration documentation, and interview with the technical consultant (TC), the laboratory failed to document as performed the calibration of the CDS Medonic M-Series Hematology analyzer every six months according to the manufacturer's instructions. Findings include: 1. The CDS Medonic M-Series Hematology Procedure Manual states that calibration of the analyzer must be performed upon setup of the instrument, with any major maintenance, and at a minimum of every 6 months. There was no documentation of calibration for the Hematology analyzer since the last survey on 11/12/20. 2. The TC confirmed during an interview on 7/19/22 at 10:00 a.m. that calibration had not been performed on the CDS Medonic M-Series Hematology analyzer from 11/12/20 through 7/19/22. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on surveyor review of the Centers for Medicare & Medicaid Services (CMS) 209 personnel form and personnel records since the last survey on 11/12/20, the technical consultant failed to evaluate and document the performance of Testing Personnel (TP) #5 responsible for moderate complexity testing at least annually since 11/12/20. Findings include: Review of the CMS 209 personnel form and personnel -- 2 of 3 -- records since the last survey on 11/12/20 revealed no documentation that the technical consultant evaluated and documented the performance of TP #5 responsible for moderate complexity complete blood count (CBC) testing at least annually since 11/12 /20. -- 3 of 3 --