David C Wynecoop Memorial Clinic

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 review of the laboratory's competency assessment records, the laboratory's policies and procedure manual and interview with the laboratory supervisor (TP#1) on April 18, 2022, the laboratory failed to establish and follow written policies and procedures to assess employee and consultant competency. Findings Include: 1. The laboratory hired a new laboratory supervisor (TP#1) start date May 23, 2021. The laboratory has testing records of a contracted Testing personnel )TP#2) on January 10, 2022. 2. The laboratory's Quality Assessment (QA) Policy (page 11) states "the Clinical Consultant or designee will conduct an ongoing evaluation of employee competence." 3. The laboratory has no documentation of ongoing evaluation of competency for TP#1 or TP#2, or annual competency for the Technical Consultant or Clinical Consultant. The laboratory does not have a designee identified for the Clinical Consultant responsibilities as listed in the QA Policy. 4. The laboratory's QA policy and procedures does not include annual consultant competency or six month competency assessment for new testing personnel. 5. The laboratory supervisor confirmed by interview on April 18, 2022 at 12:30 PM, the laboratory did not perform six month competency evaluation for TP#1 or TP#2. 6. The laboratory testing records identifies 18 test being performed annually by the laboratory. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the 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 -- effectiveness of

Summary Statement of Deficiencies 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: A review of chemistry calibration records and interview of laboratory personnel revealed that the laboratory failed to document the required calibrations for the Reichert Unistat Bilirubinometer. Findings: 1. The laboratory was unable to produce documentation, during the survey, of the manufacturer required every 6 months calibration of the Reichert Unistat Bilirubinometer for 2017 & 2018. 2. An interview with the laboratory manager on 05/24/2018 at 1:00 PM confirmed the lack of calibration documentation. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: A review of chemistry records and interview of laboratory personnel revealed that the laboratory failed to document the required every 6 months calibration verification of the Reichert Unistat Bilirubinometer. Findings: 1. No documentation was available for review, during the survey, for the every 6 months calibration verification on the Reichert Unistat Bilirubinometer for 2017 and 2018. 2. An interview of the laboratory manager on 05/24/2018 at 1:00 PM confirmed the lack of calibration verification documentation. -- 2 of 2 --