Pineville Community Health Center

Summary Statement of Deficiencies D0000 A Recertification Survey was conducted on 09/20/2023. The facility was found not to be in compliance with the laboratory requirements of 42 CFR Part 493 with deficiencies cited. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on policy review, document review and interview, the laboratory failed to provide evidence of a self-evaluation for eleven (11) of twenty-six (26) proficiency testing (PT) samples scored as "not graded" by the Proficency Testing Provider. The Findings include: Review of the laboratory policy titled, "External Proficiency Testing," revised 12/01/2022, revealed "PT results that are not evaluated (for example - due to lack of consensus, incorrect method reporting or results reported after the cutoff date) will be reviewed and evaluated by the manager by comparison with the reported peer results." Review of the American Proficiency Institute Comparative Evaluation," for the "2021 Chemistry Core - 2nd Event", revealed the troponin T for samples CM-07 and CM-10 and the folate for sample IA-07 were not graded. Review of the "American Proficiency Institute Comparative Evaluation", for the "2021 Hematology/Coagulation - 2nd Event", revealed the blood cell identification for sample BCI-07 was not graded. Review of the "American Proficiency Institute Comparative Evaluation," for the "2021 Hematology/Coagulation - 3rd Event", revealed the nucleated red blood cells for sample COU-12 and the vaginal wet preparation for sample VKP-03 were not graded. Review of the "American 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 -- Proficiency Institute Comparative Evaluation," for the "2021 Immunology /Immunohematology - 3rd Event", revealed the direct antigen test - polyspecific for sample DAT-06 was not graded. Review of the "American Proficiency Institute Comparative Evaluation," for the "2022 Hematology/Coagulation - 1st Event", revealed the nucleated red blood cells for samples COU-01 and COU-02 were not graded. Review of the "American Proficiency Institute Comparative Evaluation," for the "2022 Immunology/Immunohematology - 1st Event" revealed the compatibility for sample SER-05 was not graded. Review of the "American Proficiency Institute Comparative Evaluation," for the "2022 Immunology/Immunohematology - 2nd Event", revealed the compatibility for sample SER-06 was not graded. No documentation of self-evaluation by the laboratory for any of the ungraded PT samples above was available for review. During an interview on 09/19/2023 at 2:00 PM, Technical Supervisor #1 and General Supervisor #2 confirmed that a self- evaluation of the ungraded PT samples was not performed. -- 2 of 2 --

Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on record review and staff interview on 02/18/2019, 02/19/2019, and 02/20 /2019, the laboratory failed to ensure four of six laboratory test reports contain the required information as to the name of the laboratory location where the test was performed. The facility legally changed its name effective 05/07/2018. Findings include: An ABO & Rh with Antibody Screen and Crossmatch results were reported on Patient #2 on 08/11/2018. The report failed to include the new name of the hospital. An ABO & Rh with Antibody Screen and Crossmatch results were reported on Patient #3 on 11/04/2018. The report failed to include the new name of the hospital. Urine Culture results were reported on Patient #4 on 09/17/2018. The report failed to include the new name of the hospital. Urine Culture results were reported on Patient #6 on 11/21/2018. The report failed to include the new name of the hospital. The Technical Supervisor acknowledged in an interview at 9:50 AM on 02/20/2019, the laboratory failed to have a system in place to ensure the required changes were included on patient test reports. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) 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 -- The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on record review and staff interview on 02/18/2019, 02/19/2019, and 02/20 /2019, the laboratory failed to have a postanalytic systems quality assessment mechanism to ensure required information as to the name of the current laboratory director appear on all test reports. The current laboratory director became effective 07 /01/2018. Findings include: An ABO & Rh with Antibody Screen and Crossmatch results were reported on Patient #2 on 08/11/2018. The report failed to include the name of the new director. An ABO & Rh with Antibody Screen and Crossmatch results were reported on Patient #3 on 11/04/2018. The report failed to include the name of the new director. Urine Culture results were reported on Patient #4 on 09/07 /2018. The report failed to include the name of the new director. Urine Culture results were reported on Patient #6 on 11/21/2018. The report failed to include the name of the new director. The Technical Supervisor acknowledged in an interview at 9:50 AM on 02/20/2019, the laboratory failed to establish a written policy to ensure an ongoing review process was in place to assess issues and changes related to test reports in the postanalytic phase of laboratory testing. -- 2 of 2 --