Honeycomb Medical Group,Plc

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 observation of the laboratory, review of the laboratory procedure manual, review of testing personnel competency assessment records, and staff interviews, the laboratory failed to follow the competency assessment policy for eight of eight competency assessments reviewed that were performed for three of three testing personnel in 2022, 2023, and 2024. The findings include: 1. Observation of the laboratory on 10/21/24 at 9 a.m. revealed the Beckman Coulter AU 480 used for chemistry testing, the Beckman Coulter Access 2 used for immunoassay and chemistry testing, the Tosoh G8 used for performing glycated hemoglobin (Hgb A1c) testing and the Beckman Coulter DxH 560 used for performing patient testing for Complete Blood Count with automated White Blood Cell Differential (CBC w/Diff). 2. A review of the laboratory policy titled "Employee Competency Validation Policy" under section V., number three, item f. revealed the following "Competency assessment, which includes the six procedures, must be performed for testing personnel for each test that the individual is approved by the laboratory director to perform." The six required elements were included in the policy. 3. A review of testing personnel competency assessments revealed the following: Testing person one: Annual competency performed on 05/23/23 Direct observation of routine patient test performance did not include the Beckman Coulter DxH 560, the Beckman Coulter Access 2, or the Tosoh G8 instruments. Review of worksheets, QC, PT, and maintenance records did not include the Beckman Coulter AU 480 or the Beckman Coulter Access 2. Direct observation of instrument maintenance and function checks did not include the Beckman Coulter AU 480 or the Beckman Coulter Access 2. Blind Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- testing did not include the Tosoh G8, the Beckman Coulter AU 480 or the Beckman Coulter Access 2. Assessment of problem solving skills did not include the Beckman Coulter AU 480, the Beckman Coulter Access 2 or the Tosoh G8. Annual competency performed 04/17/24: Blind testing not evaluated for the Beckman Coulter AU 480, the Beckman Coulter Access 2, or the Tosoh G8. Assessment of problem solving skills did not include the Beckman Coulter AU 480, Beckman Coulter Access 2, the Tosoh G8, or the Beckman Coulter DxH 560. Testing person two: Six month competency assessment performed 10/07/22 did not include: Direct observation of routine patient testing not documented for the Tosoh G8 Hgb A1c instrument, the Beckman Coulter DxH 560 CBC w/Diff instrument, and the Beckman Coulter AU 480 chemistry instrument. Review of worksheets, QC, PT and Maintenance records not documented for the Tosoh G8 Hgb A1c instrument or the Beckman Coulter DxH 560 CBC w/Diff instrument. Direct observation of instrument maintenance and function checks not documented for the Beckman Coulter Access 2 instrument, the Tosoh G8 instrument or the Beckman Coulter DxH 560 instrument. Blind testing not evaluated for the Beckman Coulter DxH CBC w/Diff instrument. Assessment of problem solving skills not documented for the Beckman Coulter DxH 560 instrument, the Tosoh G8 instrument or the Beckman Coulter Access 2 instrument. Annual competency performed on 04/28/23 did not include: Direct observation of routine specimen handling and processing for the Beckman Coulter Access and the Tosoh G8 Hgb A1c instrument. Direct observation of instrument maintenance for the Beckman Coulter AU480, the Tosoh G8 Hgb A1c, and the Beckman Coulte rDxH 560 CBC instrument. Blind testing for the Beckman Coulter DxH 560 CBC instrument, the Tosoh G8 Hgb A1c instrument, and the Beckman Coulter Access 2 chemistry and immunoassay instrument. Annual competency performed 10/08/24 did not include: Direct observation of routine specimen handling and processing for the Beckman Coulter CBC instrument and the Tosoh G8 glycated hemoglobin (Hgb A1c) instrument. Review of worksheets, QC, PT and Maintenance Records for Beckman Coulter AU 480 instrument, the Tosoh G8 Hgb A1c instrument, and the Beckman Coulter DxH Complete Blood count (CBC) instrument. Blind testing for the Complete Blood Count. Testing person three: 6 month competency performed on 08/15/22 Direct observation of routine patient test performance not evaluated for the Beckman Coulter AU 480, the Beckman Coulter DxH 560, or the Tosoh G8. Review of worksheets, QC, PT and maintenance records was not evaluated for the Beckman Coulter DxH560, the Beckman Coulter AU480, the Beckman Coulter Access 2, or the Tosoh G8. Direct observation of instrument maintenance and function checks was not evaluated for the Beckman Coulter Access 2, the Beckman Coulter DxH560 or the Tosoh G8. Blind testing was not evaluated for the Beckman Coulter AU 480, the Beckman Coulter Access 2, or the Tosoh G8. Problem solving was not evaluated for the Beckman Coulter DxH 560, the Tosoh G8 or the Beckman Coulter Access 2. Annual competency performed on 02/21/23 Monitoring the recording/reporting of results was not evaluated for the Tosoh G8, the Beckman Coulter AU 480 or the Beckman Coulter Access 2 Review of worksheets, QC, PT and maintenance records not documented for the Tosoh G8, the Beckman Coulter AU 480, or the Beckman Coulter Access 2 Direct observation of instrument maintenance and function checks not documented for the Beckman Coulter DxH560, the Beckman Coulter Access 2 or the Tosoh G8. Blind testing not evaluated for the Beckman Coulter DxH 560. Assessment of problem solving skills not documented for the Beckman Coulter AU480, the Beckman Coulter Access 2, or the Beckman Coulter DxH 560. Annual competency performed on 02/19/24 Direct observation of routine patient test performance was not documented for the Tosoh G8, the Beckman Coulter AU 480, or the Beckman Coulter DxH 560. Direct observation of instrument maintenance and function checks was not evaluated for the Tosoh G8, the Beckman Coulter AU 480, or -- 2 of 6 -- the Beckman Coulter Access 2 instruments. Blind testing was not evaluated for the Tosoh G8, the Beckman Coulter AU 480, or the Beckman Coulter Access 2. Assessment of problem solving skills was not evaluated for the Beckman Coulter AU480, the Beckman Coulter Access 2, the Beckman Coulter DxH 560 or the Tosoh G8. 4. Technical consultants one and two confirmed the survey findings during an interview on 10/21/24 at 2:30 p.m. 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 D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of

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 the laboratory proficiency testing (PT) records and interview with the technical consultant, the testing personnel and lab director/designee failed to sign attestation statements for seven of seven PT events in 2021 and 2022. The findings include: 1. Review of the laboratory's PT records revealed the following: No attestation statements signed by testing personnel for seven of seven events (urine chemistry events 2021 one and two, chemistry 2021 event three and 2022 event one, hematology 2021 events two and three, 2022 event one). No attestation statements signed by lab director/designee for six of seven events (urine chemistry events 2021 one and two, chemistry- 2022 event one, hematology 2021 events two and three, 2022 event one). 2. Interview with the technical consultant on 05/09/2022 at approximately 6 pm confirmed testing personnel and lab director/designee failed to sign attestation statements for seven of seven PT events in 2021 and 2022. D5201 CONFIDENTIALITY OF PATIENT INFORMATION CFR(s): 493.1231 The laboratory must ensure confidentiality of patient information throughout all phases of the total testing process that are under the laboratory's control. This STANDARD is not met as evidenced by: Based on review of the laboratory procedure manual and interview with the technical Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 11 -- consultant, the laboratory failed have any policies and procedures to ensure the confidentiality of patient information. The findings include: 1. Review of the laboratory's quality assessment plan revealed the laboratory did not have any procedures in place to ensure the confidentiality of patient information. 2. Interview with the technical consultant on 05/09/2022 at 6 pm confirmed the laboratory did not have policies and procedures in place to ensure confidentiality of patient information. D5205 COMPLAINT INVESTIGATIONS CFR(s): 493.1233 The laboratory must have a system in place to ensure that it documents all complaints and problems reported to the laboratory. The laboratory must conduct investigations of complaints, when appropriate. This STANDARD is not met as evidenced by: Based on review of the laboratory procedure manual and interview with the technical consultant, the laboratory failed a process in place for investigation of complaints. The findings include: 1. Review of the laboratory procedure manual revealed the quality assessment plan did not include a procedure/process in place for documentation and investigation of complaints. 2. Interview with the technical consultant on 05/09/2022 at 6 pm confirmed the laboratory did have a process in place for investigation of complaints against the laboratory. 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 observation of the laboratory, review of the laboratory procedure manual, and interview with the technical consultant, the laboratory failed to establish written policies and procedures for testing personnel training and competency. The findings include: 1. Observation of the laboratory on 05/09/2022 at approximately 9 am revealed the following moderately complex test systems in use for patient testing: Beckman Coulter AU480 (serial #2020113901) in use for general chemistry and urine chemistry Beckman Coulter Access 2 (serial #572885) in use for general chemistry and endocrinology tests Beckman Coulter DxH 560 (serial # BD110127) in use for complete blood count Tosoh G8 (serial #15551706) in use for glycosylated hemoglobin (Hemoglobin A1c) 2. Review of the laboratory procedure manual revealed no testing personnel policies and procedures. 3. Interview with the technical consultant on 05/09/2022 at 6 pm confirmed the laboratory failed to establish policies and procedures for testing personnel training and competency assessment in 2021 and 2022. 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 -- 2 of 11 -- (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 review of the laboratory's proficiency testing records and interview with the technical consultant, the laboratory failed to verify the accuracy of non-graded proficiency testing (PT) scores in 2021 and 2022, two of two events with non-graded scores. The findings include: 1. Review of the laboratory's PT records revealed the following: 2021 Event Two for Hematology/Coagulation: Non-graded scores for Basophils % for sample numbers DXH-08 and DXH-10; Non-graded scores for Lymphocytes % for sample number DXH-07 and DXH-09. 2022 Event One for Hematology/Coagulation: Non-graded scores for Monocytes % for DXH-02 and DXH-04. The non-graded scores had not been evaluated to determine the accuracy of the laboratory's results. 2. Interview with the technical consultant on 05/09/2022 at 6 pm confirmed the laboratory failed to verify the accuracy of non-graded PT scores for 2021 Event Two and 2022 Event One for Hematology (two of two PT events with non-graded scores). D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of patient test reports, request for laboratory records, and interview with the technical consultant, the laboratory failed to verify the accuracy of Vitamin D assay twice a year in 2021 and 2022, with approximately 2137 patients reported since testing began on 08/31/2021. 1. Observation of the laboratory on 05/09/2022 at approximately 9 am revealed the Beckman Coulter Access 2 (serial #572885) in use for patient testing for Vitamin D. 2. Review of random patient test reports revealed Vitamin D was reported on the following patients/dates: Patient #35342 reported on 09/30/2021 Patient #60493 reported on 01/19/2022 3. Request made to the technical consultant on 05/09/2022 at 1 pm for records verifying the accuracy of the Vitamin D test revealed no records were available. 4. Interview with the technical consultant on 05/09/2022 at 6 pm confirmed the laboratory failed to verify the accuracy of Vitamin D test twice a year in 2021 and 2022 with approximately 2137 patients reported since testing began on 08 /31/2021. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. -- 3 of 11 -- This CONDITION is not met as evidenced by: The laboratory failed to have a written procedure for the Tosoh G8 (Refer to D5401), failed to a have procedure for critical/alert values (Refer to D5403), failed to store control materials at temperatures consistent with manufacturer requirements (Refer to D5413), failed to label controls with open dates and corrected expiration dates (Refer to D5415), failed to perform calibration verification (Refer to D5439), failed to establish control ranges concurrently with current lot (Refer to D5469), failed to follow