Horizon Internal Medicine

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. In addition, retain the following: This STANDARD is not met as evidenced by: Based on review of manufacturer's package inserts, review of 2023, 2024 and 2025 calibration records, and interview with testing personal (TP) #1 on 04/17/25, the laboratory failed to retain documentation of calibrations for the Sensitive Estradiol (SNSE2), Luteinizing Hormone (LH) and Dehydroepiandrosterone Sulfate (DHEA-S) testing performed on the Access 2 analyzer. Findings: Review of manufacturer's package inserts for SNSE2, LH and DHEA-S testing revealed calibrations are required to be performed every 28 days. Review of 2023, 2024 and 2025 calibration records for SNSE2, LH and DHEA-S testing revealed the following: 1. SNSE2, Lot # 272206, calibration expired on 05/15/23, there was no documentation of calibration until 06/12/23. 2. LH, Lot # 338139, calibration expired on 10/06/23, there was no documentation of calibration until 11/03/23. 3. DHEA-S, Lot # 439360, calibration expired on 11/12/24, there was no documentation of calibration until 12/05/24. Interview with TP #1 at approximately 1:15 p.m. confirmed the laboratory failed to retain documentation of the calibrations. TP #1 stated the Access 2 analyzer does not allow you to perform testing if calibrations are expired and they must have misplaced the documentation of the calibrations. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and 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 -- other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on surveyor observations and interview with TP #1 on 04/17/25, the laboratory failed to ensure expired reagents were not available for use. Findings: At approximately 2:30 p.m. surveyor observed the following expired reagents in the laboratory refrigerator: 1. One box of "Natrol FLU/RSV/SARS-COV-2 Negative Control", Lot # 331569, expiration date 07/31/24. 2. One box of "Natrol FLU/RSV /SARS-COV-2 Positive Control", Lot # 330992, expiration date 05/08/24. 3. One "BUN Flex Reagent Cartridge", Lot # FA4325, expiration date 11/20/24. 4. One "BUN Flex Reagent Cartridge", Lot # BB5008, expiration date 01/08/25. At approximately 3:00 p.m. surveyor observed the following expired reagents in the laboratory freezer: 1. One box of "Access Prolactin Calibrators", Lot # 43913, expiration date 02/28/25. Interview with TP #1 at approximately 3:15 p.m. confirmed the reagents were expired. The reagents were disposed of at time of discovery. This deficiency was cited on the previous survey 9/27/22. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on review of operator's manual and review of 2023, 2024 and 2025 maintenance logs 04/17/25, the laboratory failed to perform and/or document weekly maintenance on the Access 2 analyzer approximately 3 of 52 weeks in 2023 and 1 of 52 weeks in 2024. Findings: Review of operator's manual for the Access 2 analyzer page 6-5 revealed "Weekly Maintenance...In order to keep the Access 2 system running properly, perform weekly maintenance once every seven days." Page 6-6 revealed the following weekly maintenance steps; "Clean Instrument Exterior, Inspect the Liquid Waste Bottle for Wear, Check for Fluid in the Waste Bottle, Inspect and Clean the Primary Probe, Replace and Clean the Aspirate Probes, Run Daily Maintenance, Run Systems Check...Initial Maintenance Log". Review of 2023 and 2024 Access 2 maintenance logs revealed the following weeks in which weekly maintenance was not performed and/or documented: 1. Weekly maintenance was performed 04/10/23 and not performed again until 04/24/23, a period of approximately 14 days. 2. Weekly maintenance was performed 05/01/23, and not performed again until 05/22/23, a period of approximately 21 days. 3. Weekly maintenance was performed 08/21/24, and not performed again until 09/09/24, a period of approximately 21 days. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) (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 -- 2 of 4 -- 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 the laboratory's policies and procedures, review of 2023, 2024, and 2025 Bio-Rad D-10 records, and interview with the technical consultant (TC) 4/17 /25, the laboratory failed to perform and document calibration verification for the Hemoglobin A1c testing performed on the Bio-Rad D-10 analyzer at least once every 6 months. Findings: Review of the laboratory's Bio-Rad D-10 procedure for Hemoglobin A1c testing revealed " ... Calibration Calibration must be performed once, following the installation and priming of every new analytical cartridge. Additional calibration may be performed at the discretion of the laboratory. ..." The procedure describes the use of two calibrators: HbA1c Calibrator Level 1 and HbA1c Calibrator Level 2. Review of the laboratory's "Quality Control Policy" revealed on page 4 "... Calibration and Calibration Verification ... Calibration Verification will be performed at least every six months for those tests which are not routinely calibrated with a minimum of 3 levels of calibration material. ..." Review of 2023, 2024, and 2025 Bio-Rad D-10 records revealed no documentation of calibration verification. During interview at approximately 2:25 p.m., the TC confirmed that the laboratory routinely uses only two levels of calibrator to calibrate the Bio-Rad D-10 analyzer. The TC stated they did not perform calibration verification during 2023 and 2024, and they have not performed it yet in 2025. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur; This STANDARD is not met as evidenced by: Based on review of personnel records, review of the laboratory's quality assessment plan, review of 2023, 2024, and 2025 quality assessment records, and interview with the technical consultant (TC) 4/17/25, the laboratory director failed to ensure the quality assessment program was utilized effectively to identify and correct problems and prevent their recurrence. Findings: Review of personnel records revealed the laboratory delegated "the responsibility for Quality Assessment, Quality Control, Policy and Procedure Manual, and Proficiency Testing review to the laboratory Technical Consultant/Supervisor" effective 12/1/22. Review of the laboratory's quality assessment plan revealed "... Key aspects of service are ultimately identified through either employee recognition of recurring problems identified (to include pre and post analytical information), department Action Logs (to include analytical information), -- 3 of 4 -- maintenance logs, quality control logs and at least 6 internal audits per year in which recurring problems have been identified through these monitoring processes. ... Additionally, the technical consultant will review all systems within the laboratory on a monthly basis. ... Expired reagents will be discarded. ... Quality controls are run according to CLIA requirements. If patients are tested with controls not acceptable, a patient remediation chart audit may be done if deemed necessary. ... Quality Control requirements are designated and written for each procedure within the lab. ... Occasionally upon review by the Technical Consultant or Director, these limits may not be met or problems encountered. ... Steps to follow when QC is out of limits are usually listed for each procedure. Having exhausted these suggestions, the supervisor or consultant will launch an extensive investigation including, but not limited to the following. ... 6. Check QC records for trends, shifts, etc. After problem has been identified,

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions, review of the FDA (Food and Drug Administration) website, and interview with TP (testing personnel) 9/27/22, the laboratory failed to include Fact Sheets with patient Cepheid Xpert Xpress and Abbott BinaxNOW SARS-CoV-2 test results. Findings: 1. Review of manufacturer's Instructions for Use for the Cepheid GeneXpert Xpress SARS-CoV-2/Flu/RSV revealed the "Conditions of Authorization for Laboratory and Patient Care Settings" specify "... Authorized laboratories using your product will include with result reports of the Xpert Xpress SARS-CoV-2/Flu/RSV test, all authorized Fact Sheets. ..." Review of the FDA website revealed a "FACT SHEET FOR PATIENTS" and a "FACT SHEET FOR HEALTHCARE PROVIDERS". 2. Review of manufacturer's Instructions for Use for the Abbott BinaxNOW COVID-19 Ag Card revealed the "Conditions of Authorization for Laboratory and Patient Care Settings" specify "... Authorized laboratories using your product will include with test result reports, all authorized Fact Sheets. ..." Review of the FDA website revealed a "FACT SHEET FOR PATIENTS" and a "FACT SHEET FOR HEALTHCARE PROVIDERS". During interview at approximately 11:10 a.m., TP #1 confirmed that the Fact Sheets were not provided with their laboratory's SARS-CoV-2 test results. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures and review of 2021 CAP (College of American Pathologists) proficiency testing records 9/27/22, the laboratory failed to maintain copies of all proficiency testing records for at least two years from the date of the proficiency testing event for 12 of 12 proficiency testing events reviewed. Findings: Review of the laboratory's "Proficiency Testing" policy revealed on page 2 " ... Submission of Proficiency Testing Results 1. CLIA Laboratory director or designee must sign the result form when testing is complete in the attestation line marked 'director or designee'. 2. All personnel who performed the testing of survey materials must sign the attestation page. 3. A copy of the result form, including the attestation, must be retained in the department for the appropriate amount of time per Retention Policy. ..." Review of 2021 CAP proficiency testing records revealed the laboratory failed to maintain copies of report forms used to record proficiency testing results, instrument printouts, or attestation statements signed by the analyst and the laboratory director for the following events: 1. 2021 C-A event - no report forms, no attestation statement 2. 2021 C-B event - no report forms 3. 2021 C-C event - no report forms, no attestation statement 4. 2021 UDS-A event - no report forms, attestation not signed 5. 2021 UDS-B event - no report forms 6. 2021 GH5-A event - no report forms, no instrument printouts, no attestation statement 7. 2021 GH5-B event - no report forms, no instrument printouts 8. 2021 K-A event - no report forms 9. 2021 K-B event - no report forms 10. 2021 VITD-A event - no instrument printouts 11. 2021 BNP5-A event - no report forms, no instrument printouts, no attestation statement 12. 2021 BNP5-B event - no report forms, no instrument printouts, no attestation statement 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 review of the laboratory's policies and procedures, review of 2021 CAP (College of American Pathologists) proficiency testing records, and the absence of accuracy verification records 9/27/22, the laboratory failed to verify the accuracy of the Hemoglobin A1c and BNP (B-type Natriuretic Peptides) testing at least twice a year in 2021. Findings: Review of the laboratory's "Proficiency Testing" policy revealed "Addendum A Actions Laboratories take when a PT Result is Not Graded". -- 2 of 9 -- According to Addendum A, the "Action Required" for ungraded results based on Exception Code 11 includes "Perform and document alternative assessment (Semi- Annual Verification) for the period that commercial PT was not tested to the same level and extent that would have been tested." Review of 2021 CAP proficiency testing records revealed the laboratory was enrolled for Hemoglobin A1c in 2021. Review of proficiency testing records revealed all five samples on both the GH5-A and the GH5-B test events were ungraded based on Exception Code 11 - unable to analyze. In the comments section on the Attestation Statement page for test event GH5-B, the laboratory had noted "Instrument gives high pressure issue when PT is processed, issued notified to Bio Rad. Code 11 probably issue with sample handling /delivery." Review of 2021 CAP proficiency testing records revealed the laboratory was enrolled for BNP. Review of proficiency testing records revealed all five samples on both the BNP5-A and the BNP5-B test events were ungraded based on Exception Code 11 - unable to analyze. There was no documentation of any other activities performed to verify the accuracy of the Hemoglobin A1c and BNP testing in 2021. 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)