Haywood County Community Hospital, Inc

Summary Statement of Deficiencies D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on a review of the Ortho Transfusion Services test log, laboratory observation, and staff interview, the laboratory failed to ensure the specimen integrity and identification of patient samples was maintained throughout the testing process in transfusion medicine testing for patient number 512663, tested on 11/03/25. The findings include: 1. A review of the Ortho Transfusion Services test log revealed compatibility testing performed for patient number 512663 on 11/03/25 for unit numbers W0408 25 117335, W0408 25 105606, and W0408 25 117341. 2. Observation of gel test cards on 11/13/25 at 12:10 p.m., revealed a card that was labeled with unit numbers W0408 25 117335, W0408 25 105606, and W0408 25 117341. The gel test card was not labeled with the patient's name, identifier, or date of testing. 3. Testing Person Four stated the gel cards with the unit number stickers attached were for the compatibility testing for patient 512663 and confirmed the survey findings during an interview on 11/13/25 at 12:15 p.m. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) (a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (a)(1) Patient preparation. (a)(2) Specimen collection. (a)(3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (a)(4) Specimen storage and preservation. (a)(5) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- Conditions for specimen transportation. (a)(6) Specimen processing. (a)(7) Specimen acceptability and rejection. (a)(8) Specimen referral. This STANDARD is not met as evidenced by: Based on a review of the laboratory's specimen collection policy for Transfusion Medicine samples, and staff interviews, two of three persons interviewed failed to state the correct labeling process for samples collected for Transfusion Medicine testing. The findings include: 1. A review of the laboratory procedure titled "Blood Bank Specimen Identification" revealed that the Tempenex armband is put on at the time of collection for specimens collected for Transfusion Medicine Testing. 2. Staff interviews revealed the following: Testing person two stated the armband is put on the patient after the testing is completed during interview on 11/12/25 at 9:55 a.m. Phlebotomist number one stated the armband is put on the patient after testing during interview on 11/12/25 at 10:50 a.m. 3. The Regional Laboratory Supervisor/Technical Consultant confirmed the survey findings during interview on 11/13/25 at 5:00 p.m. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: CITATION ONE: Based on a review of the laboratory's wet prep procedure and staff interviews, the laboratory failed to follow the policy for the correct amount of saline to add to the wet prep specimen when received in the laboratory. The findings include: 1. A review of the wet prep procedure revealed that after the specimen is received in the laboratory that 0.5 mL of saline is added to the tube. 2. Testing person number four failed to state the amount specified in the procedure during an interview on 11/13/25 at 9:00 a.m. 3. The Regional Laboratory Director/Technical Consultant Two confirmed the survey findings during an interview on 11/13/25 at 5:35 p.m. mL=milliliter CITATION TWO: Based on a review of the laboratory procedure manual, a review of laboratory records and staff interview, the laboratory failed to perform calibration verification every six months as required by procedure for analytes performed on the Beckman Coulter AU700 chemistry instrument in 2024 and 2025 (two of four were not performed when due). The findings include: 1. A review of the laboratory's procedure for Calibration Verification (PolicyStat ID 16406177) revealed that calibration verifications were to be performed every six months for all analytes performed on the Beckman Coulter AU700 Chemistry instrument. 2. A review of the laboratory's calibration verification records revealed that the laboratory failed to perform calibration verifications every six months, as outlined in the laboratory's Calibration Verification (PolicyStat ID 16406177) procedure. The calibration verification that was due in January 2024 was not performed until February 2024. The calibration verification that was due in August of 2025 were not completed until October of 2025. 3. Testing person four confirmed the survey findings during an interview on 11/13/25 at 3:35 p.m. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) -- 2 of 5 -- (b) The procedure manual must include the following when applicable to the test procedure: (b)(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. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies 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)

Summary Statement of Deficiencies D0000 During a recertification survey that was completed on 09/22/23, the laboratory was found out of compliance with the following conditions: 42 CFR 493.1240 Preanalytic systems D2005 ENROLLMENT CFR(s): 493.801(a)(4) Authorize the proficiency testing program to release to HHS all data required to-- (i) Determine the laboratory's compliance with this subpart; and (ii) Make PT results available to the public as required in section 353(f)(3)(F) of the Public Health Service Act. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of manufacturer package insert, the patient test report comment, the laboratory's proficiency testing records, the Centers for Medicare and Medicaid Casper Report 0155D (CMS 155), and interview with the laboratory supervisor, the laboratory failed to ensure the proficiency testing results for the non-waived direct antigen test for Respiratory Syntial Virus (RSV) was reported to Centers for Medicare and Medicaid Services (CMS) for 2023 event one and 2023 event two. The findings include: 1. Observation of the laboratory on 09/18/23 at 8:30 am revealed the Quidel Sophia RSV test in use for patient testing. 2. Review of the manufacturer package insert for the Quidel Sophia RSV revealed the following: "The Sophia RSV FIA employs immunofluorescence for detection of respiratory Syncytial virus (RSV) nucleoprotein antigen in nasopharyngeal swab and nasopharyngeal aspirate/wash specimens taken directly form symptomatic patients." The test is moderately complex when performed on patients from the age of seven to less than nineteen years of age. 3. Review of the patient test report comment revealed the following: "This test is intended for use with symptomatic pediatric patients under 19 years of age." 4. Review of the laboratory's proficiency testing records revealed the laboratory reported the non-waived Quidel Sophia RSV test to their PT provider as 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 5 -- waived test for 2023 event one and 2023 event two. 5. Review of the laboratory's CMS 155 report revealed no scores were reported to CMS for virology. 6. Interview with the laboratory supervisor on 09/19/23 at 4:30 pm confirmed the laboratory failed to ensure the non-waived RSV proficiency testing results were reported to CMS in 2023. 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 the laboratory's proficiency testing (PT) records and interview with the lab supervisor, the laboratory director failed to sign two of seven PT attestation statements reviewed for 2023. The findings include: 1. Review of the laboratory's proficiency testing records revealed that the attestation statement was not signed by the lab director for two of seven events reviewed (2023 event one for microbiology, 2023 event two for chemistry). 2. Interview with the lab supervisor on 09/19/23 at 4:30 pm confirmed the lab director had not signed the PT attestation statements for two of seven PT events in 2023. 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 procedure manual, the testing personnel competency assessment forms, and interview with the general supervisor, the forms used by the laboratory for assessing testing personnel competency were not in compliance with laboratory policy in 2023. The findings include: 1. Review of the laboratory's testing personnel competency evaluation policy revealed that "Recording /Reporting of Results" would be included as part of assessing competency. 2. Review of the forms used for assessing testing personnel competency revealed that recording and reporting of test results was not included as part of the competency assessment evaluation. 3. Interview with the general supervisor on 09/19/23 at 4:00 pm confirmed the forms used for performing and recording competency assessment did not include the required element of recording and reporting of test results for any of the test systems in use. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) 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 general laboratory systems requirements specified at 493.1231 through 493.1236. -- 2 of 5 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's test menu, review of patient test reports, the laboratory's proficiency testing policy, proficiency testing records and interview with the lab supervisor, the laboratory failed to ensure it followed its' own policy for participation in proficiency testing for the Ammonia and Fibrin Degradation Product (D-Dimer) analyte in 2023, with no