Coastal Southeastern United Care

Summary Statement of Deficiencies 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) -- (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: Based on review of laboratory procedure, review of 2021, 2022 and 2023 Potential of Hydrogen (PH) calibration and quality control (QC) records and interview with general supervisor (GS) 4/25/23, the laboratory failed to perform calibration verifications using minimum, mid-point and maximum values at least every 6 months for the PH testing performed for approximately 28 months.. Findings: Review of laboratory procedure "pH Detect" revealed "...CALIBRATION: The laboratory uses 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 -- both pH 3.0 and pH 11.0 calibrators to generate the calibration curve. Calibration frequency: at least every 7 days". Review of 2021, 2022, and 2023 PH calibration and QC records revealed the laboratory performed 2 point calibrations at least every 7 days and performed 4 levels of QC once a day. Interview with GS at approximately 10:30 a.m. confirmed the laboratory performed 2 point calibrations using calibration reagents with a pH 3.0 and pH 11.0. -- 2 of 2 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of 2018 and 2019 College of American Pathologists (CAP) proficiency testing (PT) records and interview with general supervisor (GS) 10/10/19, the laboratory failed to ensure attestations were signed as required by the testing personnel (TP) who performed the tests and the laboratory director (LD). Review of 2018 and 2019 CAP PT records revealed TP and LD failed to sign attestations for the following PT events: a. 2018 CAP/American Association of Clinical Chemistry (AACC), Urine Drug Screen (UDS)-B. b. 2018 CAP/AACC, UDS-C. c. 2019 CAP /AACC, UDS-A. d. 2019 CAP/AACC, UDS-B. Interview with GS at approximately 12:00 p.m. confirmed the TP and LD had not signed the attestations for the PT events in which the laboratory participated. 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 and policies, review of 2018 and 2019 staff competency records and interview with GS 10/10/19, the laboratory failed to establish 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 -- and follow policies to assess GS competency. Review of laboratory procedures and policies revealed the laboratory failed to establish competency assessment policies for the laboratory responsibilities delegated to the GS. Review of 2018 and 2019 staff competency records revealed no documentation of competency assessments for the GS. Interview with GS at approximately 11:30 a.m. confirmed the laboratory had not established or performed competency assessments for the GS. 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)