Bio-Tech Clinical Laboratories Inc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at BIO-TECH CLINICAL LABORATORIES from 10/06/2025 to 10/29/2025 The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiencies cited are as follows: D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory was not in compliance with Federal licensure requirements to perform testing for the ABO Group and Rh Factor since 02/15/2024. The findings included: 1-The Clinical Laboratory Improvement Amendments (CLIA) Application for Certification (Form CMS-116) signed by the owner on 09/30/2025, obtained during survey showed the laboratory performed testing in the following specialties/subspecialties: Microbiology (Bacteriology, Mycology, Parasitology and Virology), Diagnostic Immunology (Syphilis Serology and Diagnostic Immunology), Chemistry (Routine Chemistry, Urinalysis and Toxicology), Hematology and Immunohematology. 2-Review of the laboratory test menu showed the laboratory performed testing for the analytes ABO typing and Rh Factor. 3-Review of the Food and Drug Administration (FDA) web site for CLIA testing complexity showed that since 2007, the FDA has classified the reagents: ALBAclone Blood Grouping Reagent ABO group and Rh Factor as moderate complexity under Immunohematology specialty. 4-Review of the Certificate of Compliance for this laboratory revealed that the laboratory did not have included the Immunohematology specialty/subspecialty ABO Group & Rh Group. 5-During an 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 -- interview on 10/08/2025 at 02:30 PM, Testing Personnel #1 confirmed the laboratory did not have the Immunohematology specialty/ subspecialty ABO Group & Rh Group. 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) 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 record review and staff interview, the laboratory failed to test 2 out of 5 patients reviewed within the acceptable timeframe for urine culture. Findings included: 1-Review of the Microbiology Procedure Manual signed by the Laboratory Director on 10/06/2025 in section "BIO-TECH CLINICAL LABORATORY"," Patient instructions for Urine Collection (Routine Urinalysis and Culture" revealed, that in section "Storage" stated "Specimen should be delivered as soon as possible to Biotech Clinical Laboratory, if a delay of more than two hours is expected, refrigerate the sample. Maximum refrigeration time for routine urinalysis and routine culture is 24 hours." 2-Review of policy: "SPECIMEN TRANSPORT GUIDE", in section" SPECIMEN REJECTION CRITERIA" in section "Unacceptable specimens" stated: "... Twenty-four hours specimens are unacceptable for bacterial culture." 3-Review of patient reports, worklist reports, and final patient reports revealed that the following cases were tested outside of the acceptable timeframe established in the procedure: Patient #1 (Collected 10/25/2023, received 10/27/2023, plated 10/28/2023 final 10/30 /2023). This patient was plated at 72 hours of collection date. Patient #2 (Collected 10 /26/2023, received and plated 10/30/2023, final 11/01/2023). This patient was plated 96 hours after collection) 4-Review of Microbiology rejection log for October 2023, revealed that the laboratory had no specimens rejected. 5-During an interview on 10/06 /2025 at 12:20 PM, the Testing Personnel #5 confirmed that the patients listed above were tested outside of the acceptability criteria for urine culture. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (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 D5300 PREANALYTIC SYSTEMS CFR(s): 493.1240 Each laboratory that performs nonwaived testing must meet the applicable preanalytic system(s) requirements in 493.1241 and 493.1242, 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 preanalytic systems and correct identified problems as specified in 493. 1249 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on observation, review of the procedure manual and test results, and interview, the laboratory failed to correct identified problems in the Preanalytic Systems. Findings included: The laboratory failed to follow their written policy for specimen integrity for five of 46 samples observed on 11/16/2023. This deficiency was not corrected from the recertification survey. Refer to D5311 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D0000 An unannounced complaint survey for #2023000754 was conducted from 01/30/2023 through 08/01/2023. The allegations were substantiated, no deficiencies were cited. D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of the test menu and proficiency testing (PT) records, and interview, the laboratory failed to enroll in an approved PT program for the three analytes in 2021 and 2022. Findings included: Review of the test menu provided with Clinical Laboratory Improvement Amendments (CLIA) Application for Certification indicated American Association of Bioanalysts (AAB) was the PT provider for the following analytes: Immunoglobulin (Ig) G, IgA, and IgM. Review of the PT records from AAB showed that there was no PT performed on IgG, IgA, and IgM. On 02/01/2023 at 4:25 PM, Testing Personnel A stated they were not doing PT on the above mentioned analytes. D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 15 -- receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on review of American Association of Bioanalysts (AAB) proficiency testing (PT) records and the procedure manual, and interview, the laboratory failed to treat PT samples in the same manner as patients for five (2021 1st, 2nd, 3rd and 2022 1st, 2nd) of six (2021 1st, 2nd, 3rd and 2022 1st, 2nd, 3rd) testing events reviewed in the speciality of Hematology. Findings included: Review of the policy titled Reporting Results Using LIS (laboratory information system) noted the "results transmit automatically. On 04/12/2023 at 6:40 PM, Testing Personnel A stated the laboratory information system (LIS) reports patient results after testing personnel approved the results and that rerun patient specimens are reported from one set of results and does not combine results from the two separate runs. Results are reported out for the following analytes: Leukocytes, Erythrocytes, Hemoglobin, Hematocrit, Platelets, Neutrophil %, Lymphocyte %, Monocyte %, Eosinophil %, and Basophil %. Review of the hematology instrument printout and the AAB attestation with the test results that were reported revealed the follow discrepancies. 1. 2021 1st event 2021 1st event sample "Vial 2" Results reported to AAB for Platelets - 480 Results from instrument printout run on 02/15/2021 at 13:33:51 reported Platelets - 429 Results from instrument printout run on 02/15/2021 at 13:47:30 reported Platelets - 480 All other test results for 2021 1st event vial 2 were reported from the first run on 02/15/2021 at 13:33:51 . 2. 2021 2nd event 2021 2nd event sample "Vial 7" Results reported to AAB for Lymphocyte % - 18.5% Results from instrument printout run on 05/20/2021 at 12:10:37 reported Lymphocyte % - 19.6% Results from instrument printout run on 05/20/2021 at 12:28:25 reported Lymphocyte % - 18.0% No other instrument printouts were saved. 2021 2nd event sample "Vial 7" Results reported to AAB for Monocyte % - 8.0% Results from instrument printout run on 05/20/2021 at 12:10:37 reported Monocyte % - 5.6% Results from instrument printout run on 05/20/2021 at 12:28:25 reported Monocyte % - 8.5% No other instrument printouts were saved. All other test results for 2021 2nd event vial 7 were reported from the second run on 05/20 /2021 at 12:28:25. 2021 2nd event sample "Vial 9" Results reported to AAB for Erythrocytes - 4.14 Results from instrument printout run on 05/20/2021 at 12:20:21 reported Erythrocytes - 4.12 Results from instrument printout run on 05/20/2021 at 12: 38:11 reported Erythrocytes - 4.12 Results from instrument printout run on 05/25 /2021 at 10:36:36 reported Erythrocytes - 4.14 2021 2nd event sample "Vial 9" Results reported to AAB for Hemoglobin - 11.8 Results from instrument printout run on 05/20/2021 at 12:20:21 reported Hemoglobin - 11.8 Results from instrument printout run on 05/20/2021 at 12:38:11 reported Hemoglobin - 11.7 Results from instrument printout run on 05/25/2021 at 10:36:36 reported Hemoglobin - 11.8 2021 2nd event sample "Vial 9" Results reported to AAB for Hematocrit - 37.2 Results from instrument printout run on 05/20/2021 at 12:20:21 reported Hematocrit - 37.0 Results from instrument printout run on 05/20/2021 at 12:38:11 reported Hematocrit - 36.7 Results from instrument printout run on 05/25/2021 at 10:36:36 reported Hematocrit - 37.2 2021 2nd event sample "Vial 9" Results reported to AAB for Platelets - 300 Results from instrument printout run on 05/20/2021 at 12:20:21 reported Platelets - 296 Results from instrument printout run on 05/20/2021 at 12:38: -- 2 of 15 -- 11 reported Platelets - 286 Results from instrument printout run on 05/25/2021 at 10: 36:36 reported Platelets - 300 2021 2nd event sample "Vial 9" Results reported to AAB for Lymphocyte % - 28.3 Results from instrument printout run on 05/20/2021 at 12:20:21 reported Lymphocyte % - 25.3 Results from instrument printout run on 05/20 /2021 at 12:38:11 reported Lymphocyte % - 26.8 Results from instrument printout run on 05/25/2021 at 10:36:36 reported Lymphocyte % - 26.8 No other instrument printouts were saved. 2021 2nd event sample "Vial 9" Results reported to AAB for Monocyte % - 4.9 Results from instrument printout run on 05/20/2021 at 12:20:21 reported Monocyte % - 7.4 Results from instrument printout run on 05/20/2021 at 12: 38:11 reported Monocyte % - 6.4 Results from instrument printout run on 05/25/2021 at 10:36:36 reported Monocyte % - 4.9 All other test results for 2021 2nd event vial 9 were reported from the second run on 05/20/2023 at 12:38:11. 2021 2nd event sample "Vial 10" Results reported to AAB for Eosinophil % - 5.4 Results from instrument printout run on 05/20/2021 at 12:22:46 reported Eosinophil % - 5.4 Results from instrument printout run on 05/20/2021 at 12:36:19 reported Eosinophil % - 5.2 2021 2nd event sample "Vial 10" Results reported to AAB for Basophil % - 0.5 Results from instrument printout run on 05/20/2021 at 12:22:46 reported Basophil % - 0.3 Results from instrument printout run on 05/20/2021 at 12:36:19 reported Basophil % - 0.7 No other instrument printouts were saved. All other test results for 2021 2nd event vial 10 were reported from the second run on 05/20/2021 at 12:36:19. 3. 2021 3rd event 2021 3rd event sample "Vial 11" Results reported to AAB for Neutrophil % - 54.5 Results from instrument printout run on 09/23/2021 at 14:39:45 reported Neutrophil % - 50.5 No other instrument printouts were saved. 2021 3rd event sample "Vial 11" Results reported to AAB for Lymphocyte % - 33.3 Results from instrument printout run on 09/23/2021 at 14:39:45 reported Lymphocyte % - 39.3 No other instrument printouts were saved. 2021 3rd event sample "Vial 11" Results reported to AAB for Monocyte % - 4.0 Results from instrument printout run on 09/23/2021 at 14: 39:45 reported Monocyte % - 2.0 No other instrument printouts were saved. All other test results for 2021 3rd event vial 11 were reported from 09/23/2021 at 14:39:45. 2021 3rd event sample "Vial 12" Results reported to AAB for Neutrophil % - 59.5 Results from instrument printout run on 09/20/2021 at 11:12:07 reported Neutrophil % - 59.1 No other instrument printouts were saved. 2021 3rd event sample "Vial 12" Results reported to AAB for Lymphocyte % - 28.2 Results from instrument printout run on 09/20/2021 at 11:12:07 reported Lymphocyte % - 26.2 No other instrument printouts were saved. 2021 3rd event sample "Vial 12" Results reported to AAB for Monocyte % - 5.8 Results from instrument printout run on 09/20/2021 at 11:12:07 reported Monocyte % - 7.0 No other instrument printouts were saved. 2021 3rd event sample "Vial 12" Results reported to AAB for Eosinophil % - 6.2 Results from instrument printout run on 09/20/2021 at 11:12:07 reported Eosinophil % - 6.8 No other instrument printouts were saved. 2021 3rd event sample "Vial 12" Results reported to AAB for Basophil % - 0.3 Results from instrument printout run on 09/20 /2021 at 11:12:07 reported Basophil % - 0.9 No other instrument printouts were saved. All other test results for 2021 3rd event vial 12 were reported from 09/20/2021 at 11:12:07. 2021 3rd event sample "Vial 14" Results reported to AAB for Leukocytes (White Blood Cells - WBC) - 9.1 Results from instrument printout run on 09/20/2021 at 11:17:18 reported WBC - 9.4 Results from instrument printout run on 09/23/2021 at 14:35:50 reported WBC - 8.8 No other instrument printouts were saved. 2021 3rd event sample "Vial 14" Results reported to AAB for Neutrophil % - 58.8 Results from instrument printout run on 09/20/2021 at 11:17:18 reported Neutrophil % - 56.3 Results from instrument printout run on 09/23/2021 at 14:35:50 reported Neutrophil % - 58.2 No other instrument printouts were saved. 2021 3rd event sample "Vial 14" Results reported to AAB for Lymphocyte % - 30.2 Results from instrument printout run on 09/20/2021 at 11:17:18 reported Lymphocyte % - 30.5 Results from instrument -- 3 of 15 -- printout run on 09/23/2021 at 14:35:50 reported Lymphocyte % - 30.2 2021 3rd event sample "Vial 14" Results reported to AAB for Monocyte % - 4.4 Results from instrument printout run on 09/20/2021 at 11:17:18 reported Monocyte % - 3.6 Results from instrument printout run on 09/23/2021 at 14:35:50 reported Monocyte % - 3.2 No other instrument printouts were saved. 2021 3rd event sample "Vial 14" Results reported to AAB for Eosinophil % - 6.0 Results from instrument printout run on 09/20 /2021 at 11:17:18 reported Eosinophil % - 8.8 Results from instrument printout run on 09/23/2021 at 14:35:50 reported Eosinophil % - 7.8 No other instrument printouts were saved. 2021 3rd event sample "Vial 14" Results reported to AAB for Basophil % - 0.6 Results from instrument printout run on 09/20/2021 at 11:17:18 reported Basophil % - 0.8 Results from instrument printout run on 09/23/2021 at 14:35:50 reported Basophil % - 0.6 All other test results for 2021 3rd event vial 14 were reported from 09/20/2021 at 11:17:18. 2021 3rd event sample "Vial 15" Results reported to AAB for Leukocytes - 3.5 Results from instrument printout run on 09/23 /2021 at 14:37:32 reported WBC - 3.4 No other instrument printouts were saved. 2021 3rd event sample "Vial 15" Results reported to AAB for Neutrophil % - 53.8 Results from instrument printout run on 09/23/2021 at 14:37:32 reported Neutrophil % - 51.8 No other instrument printouts were saved. 2021 3rd event sample "Vial 15" Results reported to AAB for Lymphocyte % - 34.4 Results from instrument printout run on 09 /23/2021 at 14:37:32 reported Lymphocyte % - 38.0 No other instrument printouts were saved. 2021 3rd event sample "Vial 15" Results reported to AAB for Monocyte % - 3.9 Results from instrument printout run on 09/23/2021 at 14:37:32 reported Monocyte % - 1.9 No other instrument printouts were saved. 2021 3rd event sample "Vial 15" Results reported to AAB for Eosinophil % - 7.6 Results from instrument printout run on 09/23/2021 at 14:37:32 reported Eosinophil % - 7.7 No other instrument printouts were saved. 2021 3rd event sample "Vial 15" Results reported to AAB for Basophil % - 0.3 Results from instrument printout run on 09/23/2021 at 14: 37:32 reported Basophil % - 0.6 No other instrument printouts were saved. All other test results for 2021 3rd event "Vial 15" were reported from 09/23/2021 at 14:37:32. 4. 2022 1st event 2022 1st event sample "Vial 1"through "Vial 5" Results reported to AAB came from two laboratories, Lab A and Lab B (a sister lab that has their own Clinical Laboratory Improvement Amendments (CLIA) Certificate of Accreditation) Results that were reported from Lab A instrument printouts on 02/11/2022 for Leukocytes, Erythrocytes, Hemoglobin, Hematocrit, and Platelet Count Results that were reported from Lab B instrument printouts on 02/16/2022 for Neutrophil %, Lymphocyte %, Monocyte %, Eosinophil %, and Basophil %. 5. 2022 2nd event 2022 2nd event sample "Vial 6" to Vial 10" Results reported to AAB from instrument printout run on 05/20/2022 for Leukocytes, Erythrocytes, Hemoglobin, Hematocrit, and Platelet Count No other instrument printouts were saved. Results reported to AAB for Neutrophil %, Lymphocyte %, Monocyte %, Eosinophil %, and Basophil % where hand written on the instrument printout dated 05/20/2022. On 02/01/2023 at 11:00 AM, Testing Personnel A stated that they may have rerun some samples and then threw away the printouts. On 02/01/2023 at 11:11 AM, Testing Personnel A stated that the 2022 1st event must have been run over there (Lab B). On 02/01/2023 at 11: 30 AM, Testing Personnel A verified that the oldest records stored in the hematology instruments memory was from 11/17/2022 and that they don't backup the data on the instrument. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the -- 4 of 15 -- laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and interview, the laboratory failed to have all testing personnel rotate through PT samples for PT in the specialties of Diagnostic Immunology, Chemistry and Hematology for six of six (2021 1st, 2nd, 3rd, and 2022 1st, 2nd, 3rd) events. Findings included: Review of the Laboratory Personnel Report, signed and dated by the Laboratory Director on 1/30/2023, listed five testing personnel. Testing Personnel (TP) A, B, D, and E all worked in the first floor laboratory (Diagnostic Immunology, Chemistry, and Hematology) and TP-C is the only TP who works in the second floor laboratory (Microbiology). Review of the policy titled "Proficiency Testing" noted "The educational purpose and documentation of proficiency is best served by a rotation that allows involvement of all technologists in the proficiency testing program." 1. Review of the proficiency testing records from American Association of Bioanalysts (AAB) showed that each PT event was performed by one to three testing personnel . Proficiency testing for Blood Cell Identification, Cardiac Markers / Isoenzymes, Hematology with Diff C, Hepatitis Markers, and HIV Markers, was performed by TP-A for six of six events (2021 1st, 2nd, 3rd, and 2022 1st, 2nd, 3rd). Proficiency testing for Antinuclear Antibody, Antistreptolysin O, Basic Chemistry, Infectious Mononucleosis, and Rubella, was performed by TP-B for six of six events (2021 1st, 2nd, 3rd, and 2022 1st, 2nd, 3rd). Proficiency testing for Coagulation was performed by TP-A for five (2021 1st, 2nd, and 2022 1st, 2nd, 3rd) of six events (2021 1st, 2nd, 3rd, and 2022 1st, 2nd, 3rd) and by TP-E for three (2021 1st, 3rd, and 2022 2nd) of six events (2021 1st, 2nd, 3rd, and 2022 1st, 2nd, 3rd). Proficiency testing for Comprehensive Chemistry was performed by TP-A for three (2021 1st, 3rd, and 2022 2nd) of six events (2021 1st, 2nd, 3rd, and 2022 1st, 2nd, 3rd) and by TP-B for six of six events (2021 1st, 2nd, 3rd, and 2022 1st, 2nd, 3rd). Proficiency testing for Therapeutic Drugs was performed by TP-A for five (2021 1st, 3rd, and 2022 1st, 2nd 3rd) of six events (2021 1st, 2nd, 3rd, and 2022 1st, 2nd, 3rd), and by TP-B for six of six events (2021 1st, 2nd, 3rd, and 2022 1st, 2nd, 3rd). 2. Review of the proficiency testing records from College of American Pathologists (CAP) showed that each PT event was performed by one testing personnel . Proficiency testing for Mycobacterium Tuberculosis was performed by TP- B for four of four events (2021 1st, 2nd, and 2022 1st, 2nd). 3. On 02/01/2022 at 10: 24 AM, Testing Personnel A acknowledged they did not rotate the performance of PT testing amongst all testing personnel. 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 proficiency testing (PT) records and interview, the Laboratory Director and the Testing Personnel failed to sign the attestation form for PT in the specialties of Chemistry, Diagnostic Immunology Hematology, and Microbiology for 6 of 6 (2021 1st, 2nd, 3rd, 2022 1st, 2nd, 3rd) testing events. Findings included: Review of the policy titled "Proficiency Testing" noted "PT result is reviewed by the Medical Director upon report submission and the attestation letter must be signed." -- 5 of 15 -- The American Association of Bioanalysts (AAB) attestation form states "In addition to the analysts' signature, one of the following must sign once for all analytes reported on this form. Director or Technical Consultant (moderate complexity) or Technical Supervisor (high complexity)." The College of American Pathologists (CAP) stated "the individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient work load using the laboratory's routine methods. The laboratory director or designee and the testing personnel must sign on the results form." 1. Review of the AAB PT records showed the attestation statements were not signed by the Laboratory Director for the following: 2022 1st event for Basic Chemistry, Hematology with Diff C, and Therapeutic Drugs. 2022 2nd event for Antinuclear Antibody, Antistreptolysin O, Bacteriology, Basic Chemistry, Blood Cell Identification, Cardiac Markers / Isoenzymes, Coagulation, Comprehensive Chemistry, Hematology with Diff C, Hepatitis Markers, HIV (Human Immunodeficiency Virus) Markers, Infectious Mononucleosis, Rubella, Syphilis Serology, and Therapeutic Drugs. 2022 3rd event for Comprehensive Chemistry and HIV Markers. 2. Review of the AAB PT records showed the attestation statements were not signed by the Testing Personnel for the following: 2022 3rd event for Bacteriology, Hepatitis Markers, HIV Markers, and Parasitology. 3. On 02/01/2023 at 10:35 AM, the Testing Personnel A acknowledged that not all the attestations were not signed by the Laboratory Director or the testing personnel. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, 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 proficiency testing (PT) records and interview, the laboratory failed to retain the Hematology instrument printout when they reran PT samples for two (2021 3rd, 2022 2nd) of six (2021 1st, 2nd, 3rd, and 2022 1st, 2nd, 3rd) events. Findings included: 2021 3rd event sample "Vial 11" Results reported to AAB for Neutrophil % - 54.5 Results from instrument printout run on 09/23/2021 at 14:39:45 reported Neutrophil % - 50.5 No other instrument printouts were saved. 2021 3rd event sample "Vial 11" Results reported to AAB for Lymphocyte % - 33.3 Results from instrument printout run on 09/23/2021 at 14:39:45 reported Lymphocyte % - 39.3 No other instrument printouts were saved. 2021 3rd event sample "Vial 11" Results reported to AAB for Monocyte % - 4.0 Results from instrument printout run on 09/23/2021 at 14:39:45 reported Monocyte % - 2.0 No other instrument printouts were saved. 2021 3rd event sample "Vial 12" Results reported to AAB for Neutrophil % - 59.5 Results from instrument printout run on 09/20/2021 at 11:12:07 reported Neutrophil % - 59.1 No other instrument printouts were saved. 2021 3rd event sample "Vial 12" Results reported to AAB for Lymphocyte % - 28.2 Results from instrument -- 6 of 15 -- printout run on 09/20/2021 at 11:12:07 reported Lymphocyte % - 26.2 No other instrument printouts were saved. 2021 3rd event sample "Vial 12" Results reported to AAB for Monocyte % - 5.8 Results from instrument printout run on 09/20/2021 at 11: 12:07 reported Monocyte % - 7.0 No other instrument printouts were saved. 2021 3rd event sample "Vial 12" Results reported to AAB for Eosinophil % - 6.2 Results from instrument printout run on 09/20/2021 at 11:12:07 reported Eosinophil % - 6.8 No other instrument printouts were saved. 2021 3rd event sample "Vial 12" Results reported to AAB for Basophil % - 0.3 Results from instrument printout run on 09/20 /2021 at 11:12:07 reported Basophil % - 0.9 No other instrument printouts were saved. 2021 3rd event sample "Vial 15" Results reported to AAB for Leukocytes - 3.5 Results from instrument printout run on 09/23/2021 at 14:37:32 reported WBC - 3.4 No other instrument printouts were saved. 2021 3rd event sample "Vial 15" Results reported to AAB for Neutrophil % - 53.8 Results from instrument printout run on 09 /23/2021 at 14:37:32 reported Neutrophil % - 51.8 No other instrument printouts were saved. 2021 3rd event sample "Vial 15" Results reported to AAB for Lymphocyte % - 34.4 Results from instrument printout run on 09/23/2021 at 14:37:32 reported Lymphocyte % - 38.0 No other instrument printouts were saved. 2021 3rd event sample "Vial 15" Results reported to AAB for Monocyte % - 3.9 Results from instrument printout run on 09/23/2021 at 14:37:32 reported Monocyte % - 1.9 No other instrument printouts were saved. 2021 3rd event sample "Vial 15" Results reported to AAB for Eosinophil % - 7.6 Results from instrument printout run on 09/23 /2021 at 14:37:32 reported Eosinophil % - 7.7 No other instrument printouts were saved. 2021 3rd event sample "Vial 15" Results reported to AAB for Basophil % - 0.3 Results from instrument printout run on 09/23/2021 at 14:37:32 reported Basophil % - 0.6 No other instrument printouts were saved. 2022 2nd event sample "Vial 6" to Vial 10" Results from instrument printout run on 05/20/2022 for Leukocytes, Erythrocytes, Hemoglobin, Hematocrit, and Platelet Count No other instrument printouts were saved. Results for Neutrophil %, Lymphocyte %, Monocyte %, Eosinophil %, and Basophil % were hand written on the instrument printout dated 05/20/2022. On 02/01 /2023 at 11:00 AM, Testing Personnel A stated that they may have rerun some samples and then threw away the printouts. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of American Association of Bioanalysts (AAB) proficiency testing (PT) records and interview, the previous Laboratory Director or the designee failed to document the review and evaluation of proficiency testing (PT) results for one (2022 1st event) of six (2021 1st, 2nd, 3rd & 2022 1st, 2nd, 3rd events) PT events. Findings included: Review of the AAB Proficiency Testing Performance Evaluation" revealed that the performance evaluation is grouped into two categories, Chemistry and Non- Chemistry. Chemistry includes the PT for Basic Chemistry, Cardiac Markers / Isoenzymes, Clinical Microscopy, Comprehensive Chemistry, Fertility - Endocrinology, Glycohemoglobin, High Sensitivity C-Reactive Protein, Immunochemistry, Iron Binding, Pregnancy, Therapeutic Drugs, Tumor Markers, Urinalysis, and Urine Drug Screening. Non-Chemistry includes the PT for Antinuclear Antibody, Antistreptolysin O, Blood Cell Identification, Chlamydia-GS- Strep Group B Antigen Screen, C (Clostridium) Difficile, Coagulation, C-Reactive -- 7 of 15 -- Protein, Erythrocyte Sedimentation Rate, Helicobacter Pylori, Hematology with Diff C, Hepatitis Markers, Rubella, and Syphilis Serology. Review of the performance reviews showed there was no signature indicating the PT results were reviewed. On 02 /01/2023 at 10:05 AM, the Previous Laboratory Director (prior to 01/02/2023) acknowledged the performance reviews were not signed. 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 review of the laboratory test menu and proficiency testing (PT) records, and interview, the laboratory failed to verify the accuracy (PT) of ten analytes at least twice annually in 2021 and 2022, and two analytes at least twice annually in 2021. Findings included: 1. Review of the test menu provided with Clinical Laboratory Improvement Amendment (CLIA) Application for Certification indicated American Association of Bioanalysts (AAB) was the PT provider for the following analytes: Homocysteine, Low-Density Lipoprotein (LDL), Microalbumin, Prolactin, Sickle Cell, Testosterone, Total Iron Binding Capacity (TIBC), and Treponema Pallidium Particle Agglutination (T Pallidium-PA). Review of the PT records from AAB showed that there was no proficiency performed on Homocysteine, LDL, Microalbumin, Prolactin, Sickle Cell, Testosterone, TIBC, and T Pallidium PA in 2021 and 2022. Review of the test menu indicated PT was to be performed using the PT provider College of American Pathologists (CAP) for Haptoglobin. Review of the PT records from CAP showed that there was no proficiency performed on Haptoglobin in 2021 and 2022. Review of test menu indicated the PT for Lupus Erythematosus (LE) Latex was to be performed "In House." No documentation of "In House" testing for LE Latex was available for review. On 02/01/2023 at 4:25 PM, Testing Personnel A stated they did not do PT on the above mentioned analytes. 2. Review of the test menu indicated PT was to be performed using the PT AAB for Prostate Specific Antibody (PSA) and Vitamin B12. Review of the PT records from AAB showed that there was no proficiency performed on PSA) and Vitamin B12 in 2021. On 04/12/2023 at 6:30 PM, Testing Personnel A stated she was unable to locate the PT for PSA and Vitamin B12 for 2021. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on observation, review of the procedure manual and test results, and interview, the laboratory failed to follow their written policy for specimen integrity for seven patient (patient #1-7 from 01/30/2023) samples observed on 01/30/2023. Findings -- 8 of 15 -- included: On 01/30/23 at 10:30 AM during a tour of the laboratory seven patient specimens were found with only one patient identifier on the tubes. Review of the procedure titled "Specimen Integrity Qualification for Processing noted "Specimen container is clearly labeled with at least two patient identifiers." Review of patient test report showed that all seven patients samples were run and reported out. According to the Clinical Laboratory Improvement Amendments (CLIA) Application for Certification signed and dated by the Laboratory Director on 01/30/2023, the laboratory had an estimated annual test volume of 193,513 tests per year. On 01/30 /2023 at 11:00 AM, Testing Personnel A acknowledged the specimens only had the patients name on the tubes. 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. This CONDITION is not met as evidenced by: Based on record review and staff interview, the laboratory did not meet the condition for Analytic Systems. Findings included: -Failure to evaluate if the IMMULITE 2000 XPi meet the performance specifications as per manufacturer instructions before patient testing. Refer to D5421. 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 An unannounced complaint survey for #2023000754 was conducted from 01/30/2023 through 08/01/2023. The allegations were substantiated, no deficiencies were cited. D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of the test menu and proficiency testing (PT) records, and interview, the laboratory failed to enroll in an approved PT program for the three analytes in 2021 and 2022. Findings included: Review of the test menu provided with Clinical Laboratory Improvement Amendments (CLIA) Application for Certification indicated American Association of Bioanalysts (AAB) was the PT provider for the following analytes: Immunoglobulin (Ig) G, IgA, and IgM. Review of the PT records from AAB showed that there was no PT performed on IgG, IgA, and IgM. On 02/01/2023 at 4:25 PM, Testing Personnel A stated they were not doing PT on the above mentioned analytes. D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 15 -- receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on review of American Association of Bioanalysts (AAB) proficiency testing (PT) records and the procedure manual, and interview, the laboratory failed to treat PT samples in the same manner as patients for five (2021 1st, 2nd, 3rd and 2022 1st, 2nd) of six (2021 1st, 2nd, 3rd and 2022 1st, 2nd, 3rd) testing events reviewed in the speciality of Hematology. Findings included: Review of the policy titled Reporting Results Using LIS (laboratory information system) noted the "results transmit automatically. On 04/12/2023 at 6:40 PM, Testing Personnel A stated the laboratory information system (LIS) reports patient results after testing personnel approved the results and that rerun patient specimens are reported from one set of results and does not combine results from the two separate runs. Results are reported out for the following analytes: Leukocytes, Erythrocytes, Hemoglobin, Hematocrit, Platelets, Neutrophil %, Lymphocyte %, Monocyte %, Eosinophil %, and Basophil %. Review of the hematology instrument printout and the AAB attestation with the test results that were reported revealed the follow discrepancies. 1. 2021 1st event 2021 1st event sample "Vial 2" Results reported to AAB for Platelets - 480 Results from instrument printout run on 02/15/2021 at 13:33:51 reported Platelets - 429 Results from instrument printout run on 02/15/2021 at 13:47:30 reported Platelets - 480 All other test results for 2021 1st event vial 2 were reported from the first run on 02/15/2021 at 13:33:51 . 2. 2021 2nd event 2021 2nd event sample "Vial 7" Results reported to AAB for Lymphocyte % - 18.5% Results from instrument printout run on 05/20/2021 at 12:10:37 reported Lymphocyte % - 19.6% Results from instrument printout run on 05/20/2021 at 12:28:25 reported Lymphocyte % - 18.0% No other instrument printouts were saved. 2021 2nd event sample "Vial 7" Results reported to AAB for Monocyte % - 8.0% Results from instrument printout run on 05/20/2021 at 12:10:37 reported Monocyte % - 5.6% Results from instrument printout run on 05/20/2021 at 12:28:25 reported Monocyte % - 8.5% No other instrument printouts were saved. All other test results for 2021 2nd event vial 7 were reported from the second run on 05/20 /2021 at 12:28:25. 2021 2nd event sample "Vial 9" Results reported to AAB for Erythrocytes - 4.14 Results from instrument printout run on 05/20/2021 at 12:20:21 reported Erythrocytes - 4.12 Results from instrument printout run on 05/20/2021 at 12: 38:11 reported Erythrocytes - 4.12 Results from instrument printout run on 05/25 /2021 at 10:36:36 reported Erythrocytes - 4.14 2021 2nd event sample "Vial 9" Results reported to AAB for Hemoglobin - 11.8 Results from instrument printout run on 05/20/2021 at 12:20:21 reported Hemoglobin - 11.8 Results from instrument printout run on 05/20/2021 at 12:38:11 reported Hemoglobin - 11.7 Results from instrument printout run on 05/25/2021 at 10:36:36 reported Hemoglobin - 11.8 2021 2nd event sample "Vial 9" Results reported to AAB for Hematocrit - 37.2 Results from instrument printout run on 05/20/2021 at 12:20:21 reported Hematocrit - 37.0 Results from instrument printout run on 05/20/2021 at 12:38:11 reported Hematocrit - 36.7 Results from instrument printout run on 05/25/2021 at 10:36:36 reported Hematocrit - 37.2 2021 2nd event sample "Vial 9" Results reported to AAB for Platelets - 300 Results from instrument printout run on 05/20/2021 at 12:20:21 reported Platelets - 296 Results from instrument printout run on 05/20/2021 at 12:38: -- 2 of 15 -- 11 reported Platelets - 286 Results from instrument printout run on 05/25/2021 at 10: 36:36 reported Platelets - 300 2021 2nd event sample "Vial 9" Results reported to AAB for Lymphocyte % - 28.3 Results from instrument printout run on 05/20/2021 at 12:20:21 reported Lymphocyte % - 25.3 Results from instrument printout run on 05/20 /2021 at 12:38:11 reported Lymphocyte % - 26.8 Results from instrument printout run on 05/25/2021 at 10:36:36 reported Lymphocyte % - 26.8 No other instrument printouts were saved. 2021 2nd event sample "Vial 9" Results reported to AAB for Monocyte % - 4.9 Results from instrument printout run on 05/20/2021 at 12:20:21 reported Monocyte % - 7.4 Results from instrument printout run on 05/20/2021 at 12: 38:11 reported Monocyte % - 6.4 Results from instrument printout run on 05/25/2021 at 10:36:36 reported Monocyte % - 4.9 All other test results for 2021 2nd event vial 9 were reported from the second run on 05/20/2023 at 12:38:11. 2021 2nd event sample "Vial 10" Results reported to AAB for Eosinophil % - 5.4 Results from instrument printout run on 05/20/2021 at 12:22:46 reported Eosinophil % - 5.4 Results from instrument printout run on 05/20/2021 at 12:36:19 reported Eosinophil % - 5.2 2021 2nd event sample "Vial 10" Results reported to AAB for Basophil % - 0.5 Results from instrument printout run on 05/20/2021 at 12:22:46 reported Basophil % - 0.3 Results from instrument printout run on 05/20/2021 at 12:36:19 reported Basophil % - 0.7 No other instrument printouts were saved. All other test results for 2021 2nd event vial 10 were reported from the second run on 05/20/2021 at 12:36:19. 3. 2021 3rd event 2021 3rd event sample "Vial 11" Results reported to AAB for Neutrophil % - 54.5 Results from instrument printout run on 09/23/2021 at 14:39:45 reported Neutrophil % - 50.5 No other instrument printouts were saved. 2021 3rd event sample "Vial 11" Results reported to AAB for Lymphocyte % - 33.3 Results from instrument printout run on 09/23/2021 at 14:39:45 reported Lymphocyte % - 39.3 No other instrument printouts were saved. 2021 3rd event sample "Vial 11" Results reported to AAB for Monocyte % - 4.0 Results from instrument printout run on 09/23/2021 at 14: 39:45 reported Monocyte % - 2.0 No other instrument printouts were saved. All other test results for 2021 3rd event vial 11 were reported from 09/23/2021 at 14:39:45. 2021 3rd event sample "Vial 12" Results reported to AAB for Neutrophil % - 59.5 Results from instrument printout run on 09/20/2021 at 11:12:07 reported Neutrophil % - 59.1 No other instrument printouts were saved. 2021 3rd event sample "Vial 12" Results reported to AAB for Lymphocyte % - 28.2 Results from instrument printout run on 09/20/2021 at 11:12:07 reported Lymphocyte % - 26.2 No other instrument printouts were saved. 2021 3rd event sample "Vial 12" Results reported to AAB for Monocyte % - 5.8 Results from instrument printout run on 09/20/2021 at 11:12:07 reported Monocyte % - 7.0 No other instrument printouts were saved. 2021 3rd event sample "Vial 12" Results reported to AAB for Eosinophil % - 6.2 Results from instrument printout run on 09/20/2021 at 11:12:07 reported Eosinophil % - 6.8 No other instrument printouts were saved. 2021 3rd event sample "Vial 12" Results reported to AAB for Basophil % - 0.3 Results from instrument printout run on 09/20 /2021 at 11:12:07 reported Basophil % - 0.9 No other instrument printouts were saved. All other test results for 2021 3rd event vial 12 were reported from 09/20/2021 at 11:12:07. 2021 3rd event sample "Vial 14" Results reported to AAB for Leukocytes (White Blood Cells - WBC) - 9.1 Results from instrument printout run on 09/20/2021 at 11:17:18 reported WBC - 9.4 Results from instrument printout run on 09/23/2021 at 14:35:50 reported WBC - 8.8 No other instrument printouts were saved. 2021 3rd event sample "Vial 14" Results reported to AAB for Neutrophil % - 58.8 Results from instrument printout run on 09/20/2021 at 11:17:18 reported Neutrophil % - 56.3 Results from instrument printout run on 09/23/2021 at 14:35:50 reported Neutrophil % - 58.2 No other instrument printouts were saved. 2021 3rd event sample "Vial 14" Results reported to AAB for Lymphocyte % - 30.2 Results from instrument printout run on 09/20/2021 at 11:17:18 reported Lymphocyte % - 30.5 Results from instrument -- 3 of 15 -- printout run on 09/23/2021 at 14:35:50 reported Lymphocyte % - 30.2 2021 3rd event sample "Vial 14" Results reported to AAB for Monocyte % - 4.4 Results from instrument printout run on 09/20/2021 at 11:17:18 reported Monocyte % - 3.6 Results from instrument printout run on 09/23/2021 at 14:35:50 reported Monocyte % - 3.2 No other instrument printouts were saved. 2021 3rd event sample "Vial 14" Results reported to AAB for Eosinophil % - 6.0 Results from instrument printout run on 09/20 /2021 at 11:17:18 reported Eosinophil % - 8.8 Results from instrument printout run on 09/23/2021 at 14:35:50 reported Eosinophil % - 7.8 No other instrument printouts were saved. 2021 3rd event sample "Vial 14" Results reported to AAB for Basophil % - 0.6 Results from instrument printout run on 09/20/2021 at 11:17:18 reported Basophil % - 0.8 Results from instrument printout run on 09/23/2021 at 14:35:50 reported Basophil % - 0.6 All other test results for 2021 3rd event vial 14 were reported from 09/20/2021 at 11:17:18. 2021 3rd event sample "Vial 15" Results reported to AAB for Leukocytes - 3.5 Results from instrument printout run on 09/23 /2021 at 14:37:32 reported WBC - 3.4 No other instrument printouts were saved. 2021 3rd event sample "Vial 15" Results reported to AAB for Neutrophil % - 53.8 Results from instrument printout run on 09/23/2021 at 14:37:32 reported Neutrophil % - 51.8 No other instrument printouts were saved. 2021 3rd event sample "Vial 15" Results reported to AAB for Lymphocyte % - 34.4 Results from instrument printout run on 09 /23/2021 at 14:37:32 reported Lymphocyte % - 38.0 No other instrument printouts were saved. 2021 3rd event sample "Vial 15" Results reported to AAB for Monocyte % - 3.9 Results from instrument printout run on 09/23/2021 at 14:37:32 reported Monocyte % - 1.9 No other instrument printouts were saved. 2021 3rd event sample "Vial 15" Results reported to AAB for Eosinophil % - 7.6 Results from instrument printout run on 09/23/2021 at 14:37:32 reported Eosinophil % - 7.7 No other instrument printouts were saved. 2021 3rd event sample "Vial 15" Results reported to AAB for Basophil % - 0.3 Results from instrument printout run on 09/23/2021 at 14: 37:32 reported Basophil % - 0.6 No other instrument printouts were saved. All other test results for 2021 3rd event "Vial 15" were reported from 09/23/2021 at 14:37:32. 4. 2022 1st event 2022 1st event sample "Vial 1"through "Vial 5" Results reported to AAB came from two laboratories, Lab A and Lab B (a sister lab that has their own Clinical Laboratory Improvement Amendments (CLIA) Certificate of Accreditation) Results that were reported from Lab A instrument printouts on 02/11/2022 for Leukocytes, Erythrocytes, Hemoglobin, Hematocrit, and Platelet Count Results that were reported from Lab B instrument printouts on 02/16/2022 for Neutrophil %, Lymphocyte %, Monocyte %, Eosinophil %, and Basophil %. 5. 2022 2nd event 2022 2nd event sample "Vial 6" to Vial 10" Results reported to AAB from instrument printout run on 05/20/2022 for Leukocytes, Erythrocytes, Hemoglobin, Hematocrit, and Platelet Count No other instrument printouts were saved. Results reported to AAB for Neutrophil %, Lymphocyte %, Monocyte %, Eosinophil %, and Basophil % where hand written on the instrument printout dated 05/20/2022. On 02/01/2023 at 11:00 AM, Testing Personnel A stated that they may have rerun some samples and then threw away the printouts. On 02/01/2023 at 11:11 AM, Testing Personnel A stated that the 2022 1st event must have been run over there (Lab B). On 02/01/2023 at 11: 30 AM, Testing Personnel A verified that the oldest records stored in the hematology instruments memory was from 11/17/2022 and that they don't backup the data on the instrument. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the -- 4 of 15 -- laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and interview, the laboratory failed to have all testing personnel rotate through PT samples for PT in the specialties of Diagnostic Immunology, Chemistry and Hematology for six of six (2021 1st, 2nd, 3rd, and 2022 1st, 2nd, 3rd) events. Findings included: Review of the Laboratory Personnel Report, signed and dated by the Laboratory Director on 1/30/2023, listed five testing personnel. Testing Personnel (TP) A, B, D, and E all worked in the first floor laboratory (Diagnostic Immunology, Chemistry, and Hematology) and TP-C is the only TP who works in the second floor laboratory (Microbiology). Review of the policy titled "Proficiency Testing" noted "The educational purpose and documentation of proficiency is best served by a rotation that allows involvement of all technologists in the proficiency testing program." 1. Review of the proficiency testing records from American Association of Bioanalysts (AAB) showed that each PT event was performed by one to three testing personnel . Proficiency testing for Blood Cell Identification, Cardiac Markers / Isoenzymes, Hematology with Diff C, Hepatitis Markers, and HIV Markers, was performed by TP-A for six of six events (2021 1st, 2nd, 3rd, and 2022 1st, 2nd, 3rd). Proficiency testing for Antinuclear Antibody, Antistreptolysin O, Basic Chemistry, Infectious Mononucleosis, and Rubella, was performed by TP-B for six of six events (2021 1st, 2nd, 3rd, and 2022 1st, 2nd, 3rd). Proficiency testing for Coagulation was performed by TP-A for five (2021 1st, 2nd, and 2022 1st, 2nd, 3rd) of six events (2021 1st, 2nd, 3rd, and 2022 1st, 2nd, 3rd) and by TP-E for three (2021 1st, 3rd, and 2022 2nd) of six events (2021 1st, 2nd, 3rd, and 2022 1st, 2nd, 3rd). Proficiency testing for Comprehensive Chemistry was performed by TP-A for three (2021 1st, 3rd, and 2022 2nd) of six events (2021 1st, 2nd, 3rd, and 2022 1st, 2nd, 3rd) and by TP-B for six of six events (2021 1st, 2nd, 3rd, and 2022 1st, 2nd, 3rd). Proficiency testing for Therapeutic Drugs was performed by TP-A for five (2021 1st, 3rd, and 2022 1st, 2nd 3rd) of six events (2021 1st, 2nd, 3rd, and 2022 1st, 2nd, 3rd), and by TP-B for six of six events (2021 1st, 2nd, 3rd, and 2022 1st, 2nd, 3rd). 2. Review of the proficiency testing records from College of American Pathologists (CAP) showed that each PT event was performed by one testing personnel . Proficiency testing for Mycobacterium Tuberculosis was performed by TP- B for four of four events (2021 1st, 2nd, and 2022 1st, 2nd). 3. On 02/01/2022 at 10: 24 AM, Testing Personnel A acknowledged they did not rotate the performance of PT testing amongst all testing personnel. 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 proficiency testing (PT) records and interview, the Laboratory Director and the Testing Personnel failed to sign the attestation form for PT in the specialties of Chemistry, Diagnostic Immunology Hematology, and Microbiology for 6 of 6 (2021 1st, 2nd, 3rd, 2022 1st, 2nd, 3rd) testing events. Findings included: Review of the policy titled "Proficiency Testing" noted "PT result is reviewed by the Medical Director upon report submission and the attestation letter must be signed." -- 5 of 15 -- The American Association of Bioanalysts (AAB) attestation form states "In addition to the analysts' signature, one of the following must sign once for all analytes reported on this form. Director or Technical Consultant (moderate complexity) or Technical Supervisor (high complexity)." The College of American Pathologists (CAP) stated "the individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient work load using the laboratory's routine methods. The laboratory director or designee and the testing personnel must sign on the results form." 1. Review of the AAB PT records showed the attestation statements were not signed by the Laboratory Director for the following: 2022 1st event for Basic Chemistry, Hematology with Diff C, and Therapeutic Drugs. 2022 2nd event for Antinuclear Antibody, Antistreptolysin O, Bacteriology, Basic Chemistry, Blood Cell Identification, Cardiac Markers / Isoenzymes, Coagulation, Comprehensive Chemistry, Hematology with Diff C, Hepatitis Markers, HIV (Human Immunodeficiency Virus) Markers, Infectious Mononucleosis, Rubella, Syphilis Serology, and Therapeutic Drugs. 2022 3rd event for Comprehensive Chemistry and HIV Markers. 2. Review of the AAB PT records showed the attestation statements were not signed by the Testing Personnel for the following: 2022 3rd event for Bacteriology, Hepatitis Markers, HIV Markers, and Parasitology. 3. On 02/01/2023 at 10:35 AM, the Testing Personnel A acknowledged that not all the attestations were not signed by the Laboratory Director or the testing personnel. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, 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 proficiency testing (PT) records and interview, the laboratory failed to retain the Hematology instrument printout when they reran PT samples for two (2021 3rd, 2022 2nd) of six (2021 1st, 2nd, 3rd, and 2022 1st, 2nd, 3rd) events. Findings included: 2021 3rd event sample "Vial 11" Results reported to AAB for Neutrophil % - 54.5 Results from instrument printout run on 09/23/2021 at 14:39:45 reported Neutrophil % - 50.5 No other instrument printouts were saved. 2021 3rd event sample "Vial 11" Results reported to AAB for Lymphocyte % - 33.3 Results from instrument printout run on 09/23/2021 at 14:39:45 reported Lymphocyte % - 39.3 No other instrument printouts were saved. 2021 3rd event sample "Vial 11" Results reported to AAB for Monocyte % - 4.0 Results from instrument printout run on 09/23/2021 at 14:39:45 reported Monocyte % - 2.0 No other instrument printouts were saved. 2021 3rd event sample "Vial 12" Results reported to AAB for Neutrophil % - 59.5 Results from instrument printout run on 09/20/2021 at 11:12:07 reported Neutrophil % - 59.1 No other instrument printouts were saved. 2021 3rd event sample "Vial 12" Results reported to AAB for Lymphocyte % - 28.2 Results from instrument -- 6 of 15 -- printout run on 09/20/2021 at 11:12:07 reported Lymphocyte % - 26.2 No other instrument printouts were saved. 2021 3rd event sample "Vial 12" Results reported to AAB for Monocyte % - 5.8 Results from instrument printout run on 09/20/2021 at 11: 12:07 reported Monocyte % - 7.0 No other instrument printouts were saved. 2021 3rd event sample "Vial 12" Results reported to AAB for Eosinophil % - 6.2 Results from instrument printout run on 09/20/2021 at 11:12:07 reported Eosinophil % - 6.8 No other instrument printouts were saved. 2021 3rd event sample "Vial 12" Results reported to AAB for Basophil % - 0.3 Results from instrument printout run on 09/20 /2021 at 11:12:07 reported Basophil % - 0.9 No other instrument printouts were saved. 2021 3rd event sample "Vial 15" Results reported to AAB for Leukocytes - 3.5 Results from instrument printout run on 09/23/2021 at 14:37:32 reported WBC - 3.4 No other instrument printouts were saved. 2021 3rd event sample "Vial 15" Results reported to AAB for Neutrophil % - 53.8 Results from instrument printout run on 09 /23/2021 at 14:37:32 reported Neutrophil % - 51.8 No other instrument printouts were saved. 2021 3rd event sample "Vial 15" Results reported to AAB for Lymphocyte % - 34.4 Results from instrument printout run on 09/23/2021 at 14:37:32 reported Lymphocyte % - 38.0 No other instrument printouts were saved. 2021 3rd event sample "Vial 15" Results reported to AAB for Monocyte % - 3.9 Results from instrument printout run on 09/23/2021 at 14:37:32 reported Monocyte % - 1.9 No other instrument printouts were saved. 2021 3rd event sample "Vial 15" Results reported to AAB for Eosinophil % - 7.6 Results from instrument printout run on 09/23 /2021 at 14:37:32 reported Eosinophil % - 7.7 No other instrument printouts were saved. 2021 3rd event sample "Vial 15" Results reported to AAB for Basophil % - 0.3 Results from instrument printout run on 09/23/2021 at 14:37:32 reported Basophil % - 0.6 No other instrument printouts were saved. 2022 2nd event sample "Vial 6" to Vial 10" Results from instrument printout run on 05/20/2022 for Leukocytes, Erythrocytes, Hemoglobin, Hematocrit, and Platelet Count No other instrument printouts were saved. Results for Neutrophil %, Lymphocyte %, Monocyte %, Eosinophil %, and Basophil % were hand written on the instrument printout dated 05/20/2022. On 02/01 /2023 at 11:00 AM, Testing Personnel A stated that they may have rerun some samples and then threw away the printouts. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of American Association of Bioanalysts (AAB) proficiency testing (PT) records and interview, the previous Laboratory Director or the designee failed to document the review and evaluation of proficiency testing (PT) results for one (2022 1st event) of six (2021 1st, 2nd, 3rd & 2022 1st, 2nd, 3rd events) PT events. Findings included: Review of the AAB Proficiency Testing Performance Evaluation" revealed that the performance evaluation is grouped into two categories, Chemistry and Non- Chemistry. Chemistry includes the PT for Basic Chemistry, Cardiac Markers / Isoenzymes, Clinical Microscopy, Comprehensive Chemistry, Fertility - Endocrinology, Glycohemoglobin, High Sensitivity C-Reactive Protein, Immunochemistry, Iron Binding, Pregnancy, Therapeutic Drugs, Tumor Markers, Urinalysis, and Urine Drug Screening. Non-Chemistry includes the PT for Antinuclear Antibody, Antistreptolysin O, Blood Cell Identification, Chlamydia-GS- Strep Group B Antigen Screen, C (Clostridium) Difficile, Coagulation, C-Reactive -- 7 of 15 -- Protein, Erythrocyte Sedimentation Rate, Helicobacter Pylori, Hematology with Diff C, Hepatitis Markers, Rubella, and Syphilis Serology. Review of the performance reviews showed there was no signature indicating the PT results were reviewed. On 02 /01/2023 at 10:05 AM, the Previous Laboratory Director (prior to 01/02/2023) acknowledged the performance reviews were not signed. 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 review of the laboratory test menu and proficiency testing (PT) records, and interview, the laboratory failed to verify the accuracy (PT) of ten analytes at least twice annually in 2021 and 2022, and two analytes at least twice annually in 2021. Findings included: 1. Review of the test menu provided with Clinical Laboratory Improvement Amendment (CLIA) Application for Certification indicated American Association of Bioanalysts (AAB) was the PT provider for the following analytes: Homocysteine, Low-Density Lipoprotein (LDL), Microalbumin, Prolactin, Sickle Cell, Testosterone, Total Iron Binding Capacity (TIBC), and Treponema Pallidium Particle Agglutination (T Pallidium-PA). Review of the PT records from AAB showed that there was no proficiency performed on Homocysteine, LDL, Microalbumin, Prolactin, Sickle Cell, Testosterone, TIBC, and T Pallidium PA in 2021 and 2022. Review of the test menu indicated PT was to be performed using the PT provider College of American Pathologists (CAP) for Haptoglobin. Review of the PT records from CAP showed that there was no proficiency performed on Haptoglobin in 2021 and 2022. Review of test menu indicated the PT for Lupus Erythematosus (LE) Latex was to be performed "In House." No documentation of "In House" testing for LE Latex was available for review. On 02/01/2023 at 4:25 PM, Testing Personnel A stated they did not do PT on the above mentioned analytes. 2. Review of the test menu indicated PT was to be performed using the PT AAB for Prostate Specific Antibody (PSA) and Vitamin B12. Review of the PT records from AAB showed that there was no proficiency performed on PSA) and Vitamin B12 in 2021. On 04/12/2023 at 6:30 PM, Testing Personnel A stated she was unable to locate the PT for PSA and Vitamin B12 for 2021. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on observation, review of the procedure manual and test results, and interview, the laboratory failed to follow their written policy for specimen integrity for seven patient (patient #1-7 from 01/30/2023) samples observed on 01/30/2023. Findings -- 8 of 15 -- included: On 01/30/23 at 10:30 AM during a tour of the laboratory seven patient specimens were found with only one patient identifier on the tubes. Review of the procedure titled "Specimen Integrity Qualification for Processing noted "Specimen container is clearly labeled with at least two patient identifiers." Review of patient test report showed that all seven patients samples were run and reported out. According to the Clinical Laboratory Improvement Amendments (CLIA) Application for Certification signed and dated by the Laboratory Director on 01/30/2023, the laboratory had an estimated annual test volume of 193,513 tests per year. On 01/30 /2023 at 11:00 AM, Testing Personnel A acknowledged the specimens only had the patients name on the tubes. 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. This CONDITION is not met as evidenced by: Based on record review and staff interview, the laboratory did not meet the condition for Analytic Systems. Findings included: -Failure to evaluate if the IMMULITE 2000 XPi meet the performance specifications as per manufacturer instructions before patient testing. Refer to D5421. 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 A complaint survey for 2022006987 was conducted on 6/13/2022 at Bio-tech Clinical Laboratories. The laboratory was in compliance with 42 CFR Part 493, Requirements for Laboratories. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D0000 A recertification survey conducted on 09/29/2021 to 09/30/2021 found that BIO- TECH CLINICAL LABORATORIES INC clinical laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following conditions were cited: -D5400. Analytic Systems. -D6076 Laboratory Director 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. This CONDITION is not met as evidenced by: Based on observation, record review and interview, the laboratory failed to validate the use of Clinitek 500 to read the results of urine strips URS-10 from Teco. Refer to D5423 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- 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 An unannounced complaint survey, #2021009416, was conducted on 08/17/2021 to 08 /18/2021 at BIO-TECH CLINICAL LABORATORIES INC. The laboratory was not in compliance with 42 CFR 493, Requirements for Clinical Laboratories. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on record review and interview the laboratory failed to provide collection cups to a patient for the home sample collection in July 2021. Findings include: -Record review of clinical lab phlebotomy log, used to register house calls for July 2021 revealed that there was 1 patient that required urine and stool sample on 07/07/2021. - Review of July collection driver log to collect urine and stool samples pending from phlebotomist trip, revealed that on the day of reference no driver went to collect specimens for the patient of reference. - During a telephone interview on 8/18/2021 at 5:00 PM, with the phlebotomist assigned to that patient, confirmed that the patient collected the samples on disposables cups not assigned by the laboratory and she accepted the samples from the patient and later she transferred to the laboratories cup. She confirmed that she failed to notify to the laboratory of this incident. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) 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 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 An unannounced complaint survey, #2020014990, was conducted on 10/28/20 thru 10 /30/20 at BioTech Clinical Laboratories. The facility was not in compliance with 42 CFR 493, Requirement for clinical laboratories. The following Conditions were cited: D3000 Facility Administration 493.1100 D5300 Preanalytic Systems 493.1240 D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). This CONDITION is not met as evidenced by: Based on record review and staff interview the laboratory failed to follow the State of Florida Emergency Rule to report demographics COVID-19 test results immediately to the Department of Health (DOH) for 2,096 Patient reports (See D3009). D3007 FACILITIES CFR(s): 493.1101(b) The laboratory must have appropriate and sufficient equipment, instruments, reagents, materials, and supplies for the type and volume of testing it performs. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with the Laboratory Manager the laboratory failed to have sufficient equipment for the PT (Prothrombin Time) and PTT (Partial thromboplastin time) testing performed at the laboratory. The laboratory reports 1169 tests per year for PT and PTT testing. Findings Included: There are 2 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 -- laboratories located at the same physical address (separated by a door), this laboratory and another Certificate of Compliance laboratory (to be referred to as Lab B). During a tour of the laboratory on 10/28/20 at 11:28 AM it was observed there was a ACL Elite Pro coagulation instrument that was located thru the door at Lab B that was being used for this laboratory as well. There was no hours of operation for when this laboratory and Lab B would be using the instrument. Also, there was no policy in place to address if one laboratory had a different lot number and had to change the ISI number causing inaccurate PT-INR results. Interview on 10/28/20 at 6:30 PM the Laboratory Manager confirmed that there was no policies about sharing the instrument with Lab B and confirmed that another instrument is ordered but has not arrived. D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on record review and staff interview the laboratory failed to follow the State of Florida Emergency Rule to report demographics COVID-19 test results immediately to the Department of Health (DOH) for 2,096 Patient reports. Findings Included: Review of Florida Administrative Code Rule 64D-3.031 "Notification by Laboratories" revealed that "To allow follow-up of laboratory findings suggestive of or diagnostic of diseases or conditions in the Table of Notifiable Diseases or Conditions, the form upon which the information will be reported shall be furnished by the laboratory that includes the following information: (a) The Patient's: 1. First and last name including middle initial, 2. Address including street, city, state, and zip code, 3. Phone number, including area code, 4. Date of birth, 5. Sex, 6. Race, 7. Ethnicity (specify if of Hispanic descent or not of Hispanic descent), 8. Pregnancy status if applicable, 9. Social Security number." Interview on 10/29/20 at 6:30 PM with the Laboratory Manager confirmed that the laboratory did not report the necessary demographic information during reporting of COVID-19 results to the DOH. D5300 PREANALYTIC SYSTEMS CFR(s): 493.1240 Each laboratory that performs nonwaived testing must meet the applicable preanalytic system(s) requirements in 493.1241 and 493.1242, 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 preanalytic systems and correct identified problems as specified in 493. 1249 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review and interview with the Laboratory Manager the laboratory failed to get a Test Requisition signed by an authorized person for 15 (1, 2, 3, 4, 5, 7, 8, 10, 11, 13, 16, 17, 18, 19, and 20) out of 20 (1-20) Test Requisitions reviewed (See D5301). -- 2 of 4 -- D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: Based on record review and interview with the Laboratory Manager the laboratory failed to get a Test Requisition signed by an authorized person for 15 (1, 2, 3, 4, 5, 7, 8, 10, 11, 13, 16, 17, 18, 19, and 20) out of 20 (1-20) Test Requisitions reviewed. Findings Included: Review of Test Requisitions revealed the following not signed by an authorized person: 1 (dated 06/30/20), 2 (06/30/20), 3 (07/08/20), 4 (07/15/20), 5 (07/16/20), 7 (07/17/20), 8 (07/17/20), 10 (07/23/20), 11 (07/23/20), 13 (07/17/20), 16 (09/28/20), 17 (09/28/20), 18 (09/29/20), 19 (10/13/20), and 20 (no date). The dates of the 5 that had been signed by an authorized person were from: 6 (no date), 9 (no date), 12 (no date), 14 (08/31/20), and 15 (08/11/20). Interview on 10/29/20 at 6:30 PM the Laboratory Manager confirmed that the Test Requisitions signed by an authorized person. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with the Medical Technologist the laboratory failed to use disposable reagent tubes for the Zeus Elisa DSX analyzer per the manufacturer's instructions for an unknown amount of time. Findings Included: During a tour of the laboratory on 10/28/20 at 11:28AM it was observed a container with tubes that had been washed. Interview on 10/28/20 at 11:30 AM the Medical Technologist confirmed that they reused the plastic disposable reagent tubes for the Zeus Elisa DSX analyzer that tested for Anti-Nuclear antibody, Mumps, Measles, Rubella, COVID antibody testing, and Quantiferon for tuberculosis. Review of the bag that the tubes come in revealed that they are disposable. The Medical Technologist called Tech Support on 10/28/20 at 1:28 PM. Tech Support confirmed that the manufacturer states that they are one use and disposable. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: -- 3 of 4 -- Based on observation and interview with the Laboratory Manager it was observed Hematology stain without an open date or expiration date on the label. Findings Included: During a tour of the laboratory on 10/28/20 at 11:28 AM it was observed a Cameo Hematology Stain pak on the counter without an expiration date or a date opened. Interview on 10/28/20 at 11:45 AM the Laboratory Manager confirmed that the expiration date and the date of open were not on the bottles. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and 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 observation and interview with the Laboratory Manager the laboratory had expired KOH (Potassium Hydroxide) since 07/2020. Findings Included: During a tour of the laboratory on 10/28/20 at 11:28 AM it was observed a bottle of KOH that expired 07/2020. There was no other KOH in the laboratory for use. Interview on 10 /28/20 at 12:30 PM the Laboratory Manager confirmed that the expired KOH was used. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview with the Medical Technologist the laboratory reported patients when QC (quality control) was not acceptable for Magnesium testing for 2 days (08/18/20 and 08/19/20) out of 26 days reviewed. Findings Included: Quality Control was reviewed for August 2020 for the following days: 08/01, 08/03, 08/04, 08/05, 08/06, 08/07, 08/08, 08/10, 08/11, 08/12, 08/13, 08/14, 08/15, 08/17, 08 /18, 08/19, 08/20, 08/21, 08/22, 08/24, 08/25, 08/26, 08/27, 08/28, 08/29, and 08/31. Review of QC ran for Magnesium revealed on 08/18/20 (4.92) and 08/19/20 (4.96) the level 2 was not in the acceptable range of 3.16 to 3.58. Review of Patients ran revealed 2 patients reported on 08/18/20 and 2 patients reported on 08/19/20. Review of the "QC

Summary Statement of Deficiencies D0000 A recertification survey conducted, 11/6-7/2019 found that Bio-Tech Clinical Laboratories Inc was not in compliance with 42 CFR Part 493, Requirements for Laboratories. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of CMS 209 Laboratory Personnel form, review of American Proficiency Institute (API), College of American Pathologists (CAP) and American Association of Bioanalysts (AAB) proficiency testing (PT) records and with interview with Technical Supervisor (TS), the laboratory failed to have all testing personnel (TP) rotate through the testing of PT for the Chemistry, Diagnostic Immunology and Hematology specialties for 2 out of 2 years (2018 and 2019 ) reviewed. Findings include: 1-Review of CMS 209 form signed and dated by the Laboratory Director (LD) on 10/22/2019 had 5 testing personnel listed (TPA, TP B, TP C, TP D and TP E). 2- Review of API, CAP and AAB PT records for 2018 and 2019, revealed that for TP E, there was no documentation of PT testing in 2018 and 2019 for the specialties of Chemistry, Diagnostic Immunology and Hematology specialties. During an interview on 11/06/2019 at 2:00 PM, TS confirmed that TP E failed to participate in PT during the years of reference. D2110 TOXICOLOGY CFR(s): 493.845(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- performance. This STANDARD is not met as evidenced by: Based on review of API (American Proficiency Institute) proficiency testing (PT) records and staff interview, the laboratory failed 1 out of 3 events for Toxicology during 2018. Findings include: Review of API proficiency records revealed that the laboratory had a score of 60 % for Digoxin and 20 % for Phenytoin resulting in an overall score of 70 % for 3rd event of Toxicology sub-specialty in 2018. During an interview on 11/06/2019 at 2:30 PM, the Technical Supervisor confirmed that the laboratory failed the sub-specialty of reference in PT for the event of reference. 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 record review and staff interview, the laboratory failed to perform initial competency assessment for 1 (TP B) out of 5 testing personnel (TP) (TP A, B, C, D and E) and 1 out of 1 Technical Supervisor (TS), failed to perform semiannual competency assessment for 1 (TP D) out of 5 TP (A, B, C, D and E) in 1 out of 2 years reviewed (2018 -2019) and failed to perform annual assessment competency for 1 (TP E) out of 5 TP (A, B, C, D and E) for 2 out of 2 years reviewed (2018 and 2019) Findings include: Review of personnel files revealed that: -There was no documentation of initial competency assessment for TP B and TS in 2019. -There was no documentation of semiannual annual competency assessment for TP D in 2019 - There was no documentation of the annual competency assessment for TP E for 2018 and 2019 During an interview on 11/06/2019 at 2:30 PM, with TS, she confirmed that there was no documentation of the competency assessment for the staff listed above for the period of reference. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and 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 observation and staff interview, the laboratory failed to ensure Methylen Blue stain used for reticulocyte count, 10 % Formalin Fixative reagent and C Reactive Protein Test kit (CRP) were removed from the laboratory after the expiration date. Findings include: Observation of the laboratory on 11/6/2019 at 10:00 am, revealed the following expired reagents: -In the storage area a 1-gallon bottle of 10 % Formalin Fixative solution with lot number 82878 expired 5/16/2010. - 1 bottle of Methylene Blue lot 2709C65 expired on 9/2019 next to the Microscope. -In the reagent's -- 2 of 3 -- refrigerator 1 CRP Latex Test Kit with lot 2321 expired 11/1/2019. During an interview on 11/6/2019 at 10:30 am with TP A, she confirmed the existence of the expired reagents listed above. -- 3 of 3 --

Summary Statement of Deficiencies D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on API record review and interview with laboratory owner, the laboratory failed the analyte testing for Creatine Kinase (CK), Total Protein (TP) for the 3rd event of 2017 for the chemistry specialty. Findings include: Review of API record for 2017, showed that the laboratory failed the tests for CK, TP with a 0 % score in the 3rd event of 2017. During and interview on 7/2/2018 at 2:30 pm, the laboratory owner confirmed the laboratory failed the analytes of reference for the 3rd event of 2017 D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on API record review and interview with laboratory owner, the laboratory failed the analyte testing for activated partial thromboplastin time (PTT) for the 3rd event of 2017 for the hematology specialty. Findings include: Review of API record for 2017, showed that the laboratory failed the tests for PTT with a 0 % score for the 3rd event of 2017. During and interview on 7/2/2018 at 2:30 pm, the laboratory owner confirmed the laboratory failed the analyte of reference for the 3rd event of 2017 D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT 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 -- CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of