Hope Health Systems

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 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 review of instrument printouts and email communication with the laboratory director (LD), the laboratory failed to ensure that accession numbers used to identify patients were correctly transcribed into the instrument to correctly identify severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) reverse transcription polymerase chain reaction (RT-PCR) test results for each patient in four of 32 batches reviewed. Findings: 1. The laboratory's SARS-CoV-2 RT-PCR assay detected two regions from the viral nucleocapsid (N) gene (N1 and N2) and the human RNase P gene (RP). 2. Instrument printouts for Batch 20 through Batch 44 were reviewed. 3. Results for target RP in Batch 23 showed that well D12 was labeled as "Pos N1." The positive control for target N1 was not analyzed by the laboratory for RP amplification and results for the other two gene targets showed accession number 10354 in this position. 4. Results for target RP in Batch 23 showed that well G11 was labeled with "140350." The results for the other two gene targets showed accession number 10350 in this position. 5. Results for target N1 in Batch 25 showed well A4 and well A5 both labeled with "10359". The results for the other two gene targets showed accession number 10358 followed by 10359 in these positions. 6. Results for target N1 in Batch 26 showed that well E2 was labeled with "103856." The results for the other two gene targets showed accession number 10386 in this position. 7. Results for target N2 in Batch 39 showed that well B8 was labeled with "10587" and well F4 was labeled with "1058/7." The results for the other two gene targets showed accession numbers 10580 and 10587, respectively, in these positions. 8. In an email attachment received on 11 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- /08/2021 at 10:35 AM, the LD confirmed that patient specimen accession numbers were mislabeled in the RT-PCR instrument. D5783