United Laboratory Services Corp

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at UNITED LABORATORY SERVICES CORP from 04/22/2025 to 05/15/2025. The laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D2075 GENERAL IMMUNOLOGY CFR(s): 493.837(a) (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 record review and staff interview, the laboratory failed to score at least 80 % in the following analytes: Complement C3 protein (C3), Complement protein (C4), Immunoglobulin A (IgA), Immunoglobulin G (IgG) and Immunoglobulin M (IgM) in the first event of 2024 and for Rheumatoid antibody test in 3rd event of 2024. Findings included: 1- Review of proficiency testing records for American American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) revealed that the laboratory had unsatisfactory scores for the following analytes of the immunology specialty: - 60 % score of C3, C4, IgA, IgG and IgM tests in the 1st event of 2024. - 0 % score in the Rheumatoid antibody test in the 3rd event of 2024 2- During an interview on 05/15/2025 at 9:05 AM, the owner confirmed the laboratory failed proficiency testing score of the analytes of reference. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) (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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- event. This STANDARD is not met as evidenced by: Based on records review and staff interview, the laboratory failed to score at least 80% in Proficiency Testing (PT) for the following analytes Cholesterol Total, Cholesterol-HDL, Iron Total, Bilirubin Total, Prostate-Specific Antigen (PSA) Total, Folate and Uric Acid for Routine Chemistry reviewed for 2024 and 2025. Findings include: 1- Review of American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) records for 2024 (1st, 2nd and 3rd) and 2025 (1st event) revealed the following failing scores: - 1st event 2024: 60% Total Bilirubin; - 2nd event 2024: 60% Cholesterol Total, 40% Iron Total; - 3rd event 2024: 40% Cholesterol-HDL; - 1st event 2025: 20% Creatinine, 20% PSA total. 2- During an interview on 05/15/2025 at 09:20 AM, the owner confirmed the failing PT score for the analytes of reference in Routine Chemistry. D2098 ENDOCRINOLOGY CFR(s): 493.843(a) (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 records review and staff interview, the laboratory failed to score at least 80% in Proficiency Testing (PT) for the following analytes: Cortisol, Free Thyroxine (Free TY), Luteinizing Hormone, Follicle Stimulating Hormone (FSH), Thyroxine (TY) for Endocrinology specialty reviewed for 2024 and 2025. Findings included: 1- Review of American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) records for 2024 (1st, 2nd and 3rd) and 2025 (1st event) revealed the following failing scores: - 1st event 2024: 20% Cortisol; - 3rd event 2024: 0% T3 Uptake, 20% TY; - 1st event 2025: 20% Folate serum, 60% Free TY, 0% LH, 0% Prolactin (PRL). 2- During an interview on 05/15/2025 at 09:22 AM, the owner confirmed the failed PT score for the analytes of reference in Endocrinology specialty. D2121 HEMATOLOGY CFR(s): 493.851(a) (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 review of proficiency testing (PT) records and staff interview, the laboratory failed to score at least 80% on the Platelets in the second event of 2024. Findings included: 1-Review of American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) records for 2024 and 2025 revealed that the laboratory received a score of 40% for the Platelets in the second event of 2024. 2-During an interview on 05/15/2025 at 09:26 AM, the laboratory owner confirmed the failling PT score for the Platelet analyte in the event of reference. -- 2 of 5 -- D2122 HEMATOLOGY CFR(s): 493.851(b) (b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and staff interview, the laboratory received an unsatisfactory score in the first event of 2024 and in the first event of 2025 for the specialty of Hematology. Findings included: 1-Review of American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) records for 2024 and 2025 revealed the following results: 1st event 2024: 0% Hematocrit, 40% Hemoglobin (HGB), 0% Partial Thromboplastin Time (PTT) and 0% Prothrombin Time (PT) resulting in an overall score of 55% in the first event of 2024. 1st event 2025: 0% Red Blood Cells (RBC), 0% Hematocrit, 0% Hematocrit and 60% PT resulting in an overall score of 71% in the first event of 2025 2-During an interview on 05/15/2025 at 09:25 AM, the laboratory owner confirmed the laboratory failed the PT testing for the Hematology events of reference. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (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 review of Beckman Coulter Access 2 Analyzer Manual, instrument printouts review and staff interview the laboratory failed to follow manufacturer instructions using expired reagents, controls and calibrations for Carcinogen Embryonic Antigen (CEA2), Cortisol, Folate, Free Triiodothyronine (FreeT3), Prostatic Antigen (PSA- Hyb), Progesterone, Thyroid Stimulating Hormone (TSH3), Testosterone, Total T3, Human Folicle Stimulating Hormone (hFSH), Human Luteinizing Hormone (hLH) on 05/27/2024. Findings included: 1-Review of Access 2 Analyzer Manual on pages 93 to 95 revealed on section "Test Result Flags" "If something occurs while a sample is running, the system associates a flag to the test result. Use the Sample details to read the flag description associated with a result. Select Troubleshoot F2 to find troubleshooting information about the flag. There are two types of test results Flags. Fatal Flags- no calculated result is given, Non-Fatal Flags a result was calculated but a condition exists for the result". And corrections are required. Listed of Non-Fatal Flags: CEX: Calibration expired, LEX Reagent Lot expired, PEX reagent Pack expired, QEX Quality Control lot expired, QCF Quality Control Failure. 2-Review of Quality Control (QC) instrument printouts for the Access 2 for testing date 05/27 /2024 revealed that the QC results printed on 05/29/2024 at 4:29 PM for the Biorad 1, 2 and 3 Q. The results showed flags for the following analytes: Control 1, 2 and 3: - CEA2 with CEX, PEX and QEX -Cortisol: QEX -Folate: QEX; FT3: CEX, PEX, QEX - PSA-Hyb: QEX - Progesterone QEX; TSH3: QEX -Testosterone: CEX, PEX, QEX -Total T3: QEX - hFSH: QEX - hLH: CEX, PEX, QEX. 3-Review of another set of printouts of the QC records with same time and date (05/27/2024) printed on 01/21 /2025 at 12:15 PM and had the Supervisor signature did not have any flag. 4-Review of American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) -- 3 of 5 -- Proficiency Testing (PT) samples (PT#6, PT#7, PT#8 and PT#10) tested on 05/27 /2024 and printed on 05/29/2024 at 4:29 PM, revealed that the FT3 test had the flags CEX and PEX. The laboratory reported the results. 5- During an interview on 04/23 /2025 at 11:24 AM with a laboratory assistant, she confirmed that there were two sets of results for the QC for 05/27/2024. During a phone call on 05/15/2025 at 09:05 AM the owner confirmed that the laboratory reported the FT3 results with the flag. 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 record review and staff interview, the laboratory failed to perform maintenance for the CellDyn Emerald 22 and ACL Elite as specified by the manufacturer for period reviewed January through December of 2024 and January through April of 2025. Findings included: 1- Review of maintenance records for the CellDyn Emerald 22 serial number 310321-OD0292, initially revealed that the laboratory did not record the quarterly and semiannually maintenance recommended by the manufacturer in 2024 and 2025. The laboratory did not use the correct log as per manufacturer. 2- Review of the CellDyn Emerald 22 operator's manual PN 9141000 F Table E1. Maintenance Log procedure listed weekly, quarterly and semiannually maintenance that the laboratory did not follow. a. Weekly - Bleach cleaning b. Quarterly - Lubricate the Pistons, Inline Filter Cleaning, and Barcode Reader Cleaning c. Semiannually - Particle Air Filter Cleaning, Needle Replacement, O-ring Replacement. 3- Review of maintenance records ACL ELITE Pro serial number 06110501, revealed that the laboratory did not perform monthly Air filter check and monthly clean in June, July and August 2024 as per manufacturer Maintenance Log PN 774413 AA (Nov 2010) 4- Interview on 04/23/2025 at 2:10 PM the Laboratory Risk Management consultant admitted that the maintenance for the CellDyn Emerald 22 and ACL Elite Pro were not performed and recorded as per the manufacturer's frequency. D5781

Summary Statement of Deficiencies D0000 Recertification survey was conducted from 7/17/2023 to 01/09/2024. United Laboratory Services Corp clinical laboratory was not in compliance with 42 CFR Part 493, requirements for clinical laboratories. The following Conditions were not met: 5300 Preanalytic Systems 5400 Analytic Systems 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 for specialty of Chemistry, Diagnostic Immunology Hematology, and Microbiology in 2022. Findings included: Review of the Proficiency Testing Policy noted "The Medical Director and employees performing PT will sign off an attestation form of all survey before leaving the laboratory." 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)." 1. Review of the AAB PT records showed the attestation statements were not signed by the Laboratory Director for the following: 2022 2nd event for Hepatitis Markers, HIV (Human Immunodeficiency Virus), and Immunoproteins. 2022 3rd event for Antinuclear Antibody, Antistreptolysin O, Blood Cell Identification, Coagulation, COVID-19/SARS Antigen, C-Reactive Protein, Erythrocyte Sedimentation Rate, Fertility - Endocrinology, Glycohemoglobin, Helicobacter Pylori, Hematology with Diff C, Hepatitis Markers, HIV (Human Immunodeficiency Virus) Markers, Immunochemistry, Immunoprotein, Infectious Mononucleosis, Iron Binding, Lipids, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- Parasitology, Reticulocyte Count Manual, Rheumatoid Factor, Syphilis Serology, Therapeutic Drugs, Tumor Markers, and Urine Microalbumin. 2. Review of the AAB PT records showed the attestation statements were not signed by the Testing Personnel for the following: 2022 1st event for Blood Cell Identification, Hepatitis Markers, Immunochemistry, and Iron Binding. 2022 2nd event for Hepatitis Markers, HIV (Human Immunodeficiency Virus), Immunoproteins, and Urine Microalbumin. 2022 3rd event for Antinuclear Antibody, Antistreptolysin O, Basic Chemistry, Blood Cell Identification, Coagulation, Comprehensive Chemistry, COVID-19/SARS Antigen, C-Reactive Protein, Erythrocyte Sedimentation Rate, Fertility - Endocrinology, Glycohemoglobin, Helicobacter Pylori, Hematology with Diff C, Hepatitis Markers, HIV (Human Immunodeficiency Virus) Markers, Immunochemistry, Immunoprotein, Infectious Mononucleosis, Iron Binding, Lipids, Reticulocyte Count Manual, Rheumatoid Factor, Syphilis Serology, Therapeutic Drugs, Tumor Markers, and Urine Microalbumin. On 07/17/2023 at 2:05 PM, General Supervisor acknowledged that some of the attestations were not signed. 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. This STANDARD is not met as evidenced by: Based on review of quality control (QC) records, maintenance records, and interview, the laboratory failed to retain the hematology daily QC records for 19 (July 1, 4, 5, 6, 7, 9, 11, 12, 13, 14, 15, 16, 18, 19, 20, 21, 22, 23, 25 2022) of 20 (July 1, 4, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 16, 18, 19, 20, 21, 22, 23, 25 2022) days of patient testing, and failed to retain the hematology patient's instrument test records for 16 (February 1, 2, 3, 4, 5, 7, 8, 9, 10, 11, 12, 14, 15, 16, 17, 18 2022) of 23 (February 1, 2, 3, 4, 5, 7, 8, 9, 10, 11, 12, 14, 16, 17, 18, 19, 21, 22, 23, 24, 25, 26, 28 2022) days of patient testing, Findings Included: 1. Review of the log for titled DxH800 Maintenance Log for July 2022 showed that maintenance on the hematology analyzer was performed on July 1, 4, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 16, 18, 19, 20, 21, 22, 23, and 25 2022. The laboratory was not able to provide the daily QC printouts for July 1, 4, 5, 6, 7, 9, 11, 12, 13, 14, 15, 16, 18, 19, 20, 21, 22, 23, 25 2022. On 07/20/2023 at 3:30 PM, General Supervisor stated she was unable to find the hematology daily QC records. 2. Review of the logs for hematology titled QC Monthly Log and DxH800 Maintenance Log (hematology analyzer) for February showed daily QC was performed on February 1, 2, 3, 4, 5, 7, 8, 9, 10, 11, 12, 14, 15, 16, 17, 18, 19, 21, 22, 23, 24, 25, 26, and 28, 2022. Review of patient's CBC printouts for February 2022 revealed the patients instrument test records from February 1st to February 18th were missing. On 07/20 /2023 at 4:24 PM, General Supervisor stated she was unable to find the hematology patient's printouts. 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 -- 2 of 8 -- 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, record review, and interview, the laboratory failed to run blood serum specimens within manufacturer's instructions for Antinuclear Antibody (ana) screen, Anti-double-stranded deoxyribonucleic acid antibodies (dsDNA) testing, Helicobacter pylori (H.pylori) testing, , Hsv-1 IgG, and Herpes Type II (HSV-2 Ig G) 12 (PT#1-12) out of 12 patients (PT) reviewed (D5311) D5305 TEST REQUEST CFR(s): 493.1241(c) The laboratory must ensure the test requisition solicits the following information: (1) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values. (2) The patient's name or unique patient identifier. (3) The sex and age or date of birth of the patient. (4) The test(s) to be performed. (5) The source of the specimen, when appropriate. (6) The date and, if appropriate, time of specimen collection. (7) For Pap smears, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy. (8) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable. This STANDARD is not met as evidenced by: Based on review patient test requisitions and interview, the laboratory failed to ensure the test requisition included the specimen collection time for 13 (#1 - #9, #12- #15) of 15 (#1 - #15 patients reviewed. Findings Included: Review of the patient test requisitions showed Patients #1 - #4 were collected on 2/22/2022, Patients #5 - #7 were collected on 2/28/2022, Patient #8 was collected on 01/05/2023, Patient #9 was collected on 01/06/2023, Patients #12 - #14 were collected on 05/18/2023, and Patient #15 was collected on 05/19/2023. No time of collection were recorded on the requisitions. On 07/26/2023 at 5:06 PM, General Supervisor acknowledged the test requisitions were missing the collection times. 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, record review, and interview, the laboratory failed to run blood -- 3 of 8 -- serum specimens within manufacturer's instructions for Antinuclear Antibody (ana) screen, Anti-double-stranded deoxyribonucleic acid antibodies (dsDNA) testing, Helicobacter pylori (H.pylori) testing, , Hsv-1 IgG, and Herpes Type II (HSV-2 Ig G) 12 (PT#1-12) out of 12 patients (PT) reviewed. Findings Included: Review of Ana Screen Test System procedure signed by laboratory director (LD) on 11/29/2021 package insert read, "Store sample at room temperature for no longer than 8 hours. If testing is not performed within 8 hours, sera may be stored between 2-8 Celsius (C) for no longer than 48 hours. If delay in testing is anticipated, store test sera at -20 C or lower." Review of DsDNA Test System procedure signed by laboratory director (LD) on 11/29/2021 package insert read, "Store sample at room temperature for no longer than 8 hours. If testing is not performed within 8 hours, sera may be stored between 2- 8 Celsius (C) for no longer than 48 hours. If delay in testing is anticipated, store test sera at -20 C or lower." Review of H. Pylori Test System procedure signed by laboratory director (LD) on 11/29/2021 package insert read, "Store sample at room temperature for no longer than 8 hours. If testing is not performed within 8 hours, sera may be stored between 2-8 Celsius (C) for no longer than 48 hours. If delay in testing is anticipated, store test sera at -20 C or lower." Review of Hsv-1 IgG Test System procedure signed by laboratory director (LD) on 11/29/2021 package insert read, "Store sample at room temperature for no longer than 8 hours. If testing is not performed within 8 hours, sera may be stored between 2-8 Celsius (C) for no longer than 48 hours. If delay in testing is anticipated, store test sera at -20 C or lower." Review of HSV-2 Ig G Test System procedure signed by laboratory director (LD) on 11/29/2021 package insert read, "Store sample at room temperature for no longer than 8 hours. If testing is not performed within 8 hours, sera may be stored between 2-8 Celsius (C) for no longer than 48 hours. If delay in testing is anticipated, store test sera at -20 C or lower." Review of Herpes I (HSV-1) and Herpes II (HSV-2) testing worksheet revealed the following: A. PT# 1 blood specimen was collected on 5/27 /2023 for HSV-1 and HSV-2. B. PT#2 blood specimen was collected on 6/14/2023 for HSV-1 and HSV-2. C. PT#3 blood specimen was collected on 12/16/2022 for HSV-1 and HSV-2. Review of Dynex (DSX) HSV I and HSV II instrument printouts revealed the following: a. PT#3 blood specimen tested for HSV-1 and HSV-2 on 12/30/2022. b. PT #1 and PT#2 blood specimens tested for HSV-1 and HSV-2 on 6/22/2023. Review of Ana Screen testing worksheet revealed the following: A. PT#4 blood specimen was collected on 12/14/2021 for Ana Screen B. PT#5 blood specimen was collected on 12/15/2021 for Ana Screen. C. PT#6 blood specimen was collected on 6 /29/2023 for Ana Screen. D. PT#7 blood specimen was collected on 6/30/2023 for Ana Screen. E. PT#8 blood specimen was collected on 7/5/2023 for Ana Screen. F. PT#9 blood specimen was collected on 7/6/2023 for Ana Screen. Review of DSX Ana Screen instrument printouts revealed the following: a. PT#4 and PT#5 blood specimen tested for Ana Screen on 1/5/2022. b. PT #6, PT#7, PT#8, and PT#9 blood specimens tested for Ana Screen on 7/11/23. Review of H. Pylori testing worksheet revealed the following: A. PT#10 blood specimen was collected on 5/23/2023 for H. Pylori testing. B. PT#11 blood specimen was collected on 7/6/2023 for H. Pylori testing. C. PT#12 blood specimen was collected on 7/7/2023 for H. Pylori testing. Review of DSX H. Pylori testing instrument printouts revealed the following: a. PT#10 blood specimen tested for H. Pylori on 6/6/2023. b. PT#11 and PT#12 blood specimens were tested for H. Pylori on 7/11/23. On 7/26/2023 at 3:53PM, there was a freezer in the room which went from -10 to -30C. There were no blood tubes located in this freezer for long term storage of blood specimens. Review of 2023 Temperature Log Freezer an Area General (samples Freezer) revealed the following days temperatures above -20 C: a. 25 out of 31 days in January b. 23 out of 28 days in February c. 27 out of 31 days in March d. 25 out of 30 days in April e. 25 out of 31 days in May f. 25 out of 30 days in June g. 24 out of 31 days in July h. 23 out of 31 days in August i. 21 out of 30 days in -- 4 of 8 -- September j. 20 out of 31 days in October k. 22 out of 30 days in November l. 22 out of 31 days in December On 7/18/2023 at 2PM Consultant confirmed the blood specimens were stored past their storage requirements for testing. 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 complete a performance specification for infectious Mononucleosis latex testing before testing 2 out of 2 patients in 2022. (D5423) to run positive and negative controls for 2 out of 2 patients tested for infectious mononucleosis latex testing in 2022.(5449) D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on observation, record review and interview, the laboratory failed to complete a performance specification for infectious Mononucleosis latex testing before testing 2 out of 2 patients in 2022. Findings Included: Review of Performance Specifications for Infectious Mononucleosis latex test revealed the following laboratory had no performance specifications including accuracy, precision, analytical, sensitivity, reportable ranges for infectious mononucleosis latex test. Review of Infectious Mononucleosis(mono) results revealed the following: a. Patient 1 was collected on 5 /10/22 and resulted as negative for mono. b. Patient 2 was collected on 9/10/2022 and resulted as negative for mono. On 7/26/2023 at 2:30 PM, Consultant confirmed performance specifications or validation could not be located. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- -- 5 of 8 -- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview, the lab failed to run positive and negative controls for 2 out of 2 patients tested for infectious mononucleosis latex testing in 2022. Findings Included: Review of Infectious Mononucleosis (IM) latex test read, " use of positive and negative control will permit monitoring of reagent performance. Place one drop each of the IM positive and negative control onto separate test well. IM positive and Negative should be included in each test series." Review of IM Test control serology Quality Control Log revealed no positive and negative controls were done for May and September in 2022. Review of Infectious Mononucleosis(mono) results revealed the following: a. Patient 1 was collected on 5/10/22 and resulted as negative for mono. b. Patient 1 was collected on 9/10/2022 and resulted as negative for mono. On 7/26/2023 at 2:30 PM, Consultant confirmed IM positive and negative controls were not done for 2 patients. 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 review of the instrument printouts and interview, the Laboratory failed to perform daily quality controls (QC) prior to Patient test samples on the Cell-Dyn Emerald 22 AL Hematology analyzer for 2 of 2 months (February 2022, January 2023) reviewed, and on the ACL Elitepro Coagulation analyzer for 2 of 2 month (Novemenber 2022, March 2023) reviewed. 1. CBC (Complete Blood Count) 02/23 /22 - No controls were run, and 26 Patients were run at 9:14 AM, 9:38 AM, 9:39 AM, 10:59 AM, 11:00 AM, 11:32 AM, 12:19 PM, 1:08 PM (2 Patients), 1:09 PM, 1:10 PM, 9:02 PM, 9:08 PM, 9:29 PM, 9:30 PM (2 Patients), 9:31 PM, 9:32 PM (2 Patients), 9:33 PM, 9:34 PM, 9:35 PM (2 Patients), 9:36 PM, and 9:37 PM. 02/25/22 - Level 1 control was run at 12:50 PM, Level 2 control was run at 12:51 PM, and Level 3 control was run at 12:51 PM. 1 of 32 Patients run before running QC. The patient was run at 12:02 PM. 01/03/2023 - No controls were run, and 4 Patients were run at 10:06 AM, 11:25 AM, 11:27 AM, and 11:53 AM. 01/06/2023 -Level 1 control was run at 11:58 AM, Level 2 control was run at 12:00 PM, and Level 3 control was run at 12:01 PM. 2 of 25 Patients were run before running QC. Patients were run at 8:58 AM and 11:42 AM. 01/07/2023 - No controls were run, and 2 Patients run at 2:10 PM and 2:12 PM. 01/11/2023 - Level 1 control was run at 8:59 AM, Level 2 control was run at 9:00 AM, and Level 3 control was run at 9:02 AM. 11 of 35 Patients run before running QC. Patients were run at 8:33 AM, 8:34 AM, 8:36 AM, 8:37 AM, 8:39 AM, 8: 40 AM, 8:42 AM, 8:43 AM, 8:45 AM, 8:46 AM, and 8:49 AM 01/14/2023 - No controls were run, and 9 Patients run at 2:47 PM, 2:48 PM, 2:50 PM, 2:52 PM, 2:53 PM, 2:54 PM, 2:56 PM, 2:58 PM, and 3:55 PM. 01/18/2023 - Level 1 control was run at 3:02 PM, Level 2 control was run at 12:19 PM and 3:04 PM, and Level 3 control was run at 12:21 PM and 3:05 PM. 10 of 35 Patients run before running QC. Patients were run at 8:39 AM, 8:41 AM, 8:42 AM, 8:44 AM, 8:45 AM, 8:47 AM, 8:48 AM, 8: -- 6 of 8 -- 50 AM, 8:52 AM, and 8:53 AM. 01/21/2023 - No controls were run, and 12 Patients run at 1:54 PM, 1:55 PM, 1:57 PM, 1:58 PM, 2:00 PM, 2:01 PM, 2:41 PM, 2:06 PM, 2:07 PM, 2:09 PM, 2:30 PM, and 2:50 PM. 01/24/2023 - Level 1 control was run at 9: 00 AM, Level 2 control was run at 9:01 PM, and Level 3 control was run at 9:03 PM. 10 of 42 patients run before running QC. Patients were run at 8:15 AM, 8:17 AM, 8: 28 AM, 8:29 AM, 8:31 AM, 8:32 AM, 8:34 AM, 8:35 AM, 8:37 AM and 8:38 AM. 01 /26/2023 - Level 1 control was run at 10:49 AM, Level 2 control was run at 10:42 AM, and Level 3 control was run at 10:44 AM. 2 of 2 Patients were run before running QC. Patients were run at 8:19 AM, and 8:21 AM. 01/28/23 - No controls were run, and 14 Patients were run at 5:14 PM, 5:15 PM, 5:16 PM, 5:18 PM, 5:19 PM, 5:21 PM, 5:23 PM, 5:24 PM, 5:26 PM, 5:27 PM, 5:29 PM, 5:30 PM, 5:32 PM, and 5:33 PM. 2. Reticulocyte Count 02/23/22 - No controls were run, and 11 Patients were run at 10:26 AM, 10:28 AM, 10:29 AM, 10:45 AM, 10:46 AM, 10:47 AM, 10:48 AM, 10: 49 AM, 10:51 AM, and 10:52 AM. 3. PT (Prothrombin Time) and PTT (Partial Thromboplastin Time) 11/05/2022 - No controls were run, and 1 Patients PT/PTT was run at 2:47 PM/3:06 PM. 11/05/2022 - No controls were run, and 1 Patients PT/PTT was run at 2:27 PM/2:36 PM. 11/05/2022 - No controls were run, and 1 Patients PT /PTT was run at 10:07 AM/10:21 PM 03/09/2023 - No controls were run, and 1 Patients PT/PTT was run at 7:59 AM/7:54 AM. 03/11/2023 - No controls were run, and 1 Patients PT/PTT was run at 1:32 PM/1:25 PM. 03/17/2023 - No controls were run, and 5 Patients PT/PTT were run at 7:52 AM/7:48 AM, 11:31 AM/11:26 AM (2 Patients), and 1:57 PM/1:53 PM (2 Patients). 03/21/2023 - Two levels of controls for PT/PTT were run at 12:55 PM/12:51 PM and 1 of 2 patients was run at 8:12 AM/8:08 AM. 03/23/2023 - Two levels of controls for PT/PTT were run at 7:46 PM/7:42 PM and 4 of 5 patients were run at 7:38 AM/7:33 AM(4 Patients). On 07/26/2023 at 3:10 PM, General Supervisor acknowledged that patient specimens were run before daily qc was run and on days where no qc was run. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on review of worklist's and interview, the laboratory failed to identify the personnel who performed the testing for Chemistry for 1 of 19 days, Hematology for 20 of 20 days, Immunology for 5 of 5 days, and Microbiology for 3 of 19 days in May 2023. Findings Included: The worklist's included a list of the patients run, the date, and a place for the tech who performed the test to initial. Review of the Chemistry Worklist showed testing was performed on 19 days in May 2023 (1, 2, 3, 4, 8, 9, 11, 12, 15, 16, 17, 18, 19, 24, 25, 26, 29, 30, and 31). The worklist's failed to indicate who performed the testing on one day (05/11/2023). Review of the Hematology Worklist showed testing was performed on 20 days in May 2023 (1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15, 16, 17, 18, 22, 24, 25, 26, 29, and 30). The worklist's failed to indicate who performed the testing for all twenty days. Review of the Immunology Worklist showed testing was performed on 5 days in May 2023 (1, 2, 17, 19, and 26). The worklist's failed to indicate who performed the testing for all five days. Review of the -- 7 of 8 -- Microbiology Worklist showed testing was performed on 19 days in May 2023 (1, 2, 4, 5, 8, 9, 10, 11, 12, 15, 16, 17, 18, 19, 22, 24, 25, 26, 29, and 31). The worklist's failed to indicate who performed the testing on three days (05/19/23, 05/24/23, 05/25 /2023). On 07/26/2023 at 3:32 PM, General Supervisor acknowledged that some of the worklists were missing the information on who performed the test. -- 8 of 8 --

Summary Statement of Deficiencies D0000 A desk review survey of the laboratory's proficiency test results was performed on October 26, 2022 for United Laboratory Services Corp. United Laboratory Services Corp is not in compliance with the Code of Federal Regulations (CFR), Part 493, Laboratory Requirements. The following conditions were not met: 493.803 (a)(b)(c) successful Participation, Condition 493.1441 Laboratory Director, Condition D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the laboratory's proficiency testing records for 2021 and 2022, the laboratory did not have successful performance in proficiency testing for analytes in the subspecialties of bacteriology and virology. Refer to D 2028 and D 2064. Findings 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 -- include: Review of the American Proficiency Institute (API) proficiency testing records and the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports, on October 26, 2022 on or about 10:00 AM, showed that the laboratory had unsatisfactory proficiency testing scores in bacteriology and in virology. The laboratory performs molecular bacteriology GI (gastrointestinal) and molecular bacteriology respiratory testing on the Biofire instrument. The laboratory performs molecular virology GI, and molecular virology respiratory testing on the Biofire instrument. D2028 BACTERIOLOGY CFR(s): 493.823(e) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports and the laboratory's proficiency testing records, the laboratory did not have successful performance for two consecutive testing events of proficiency testing in the subspecialty of bacteriology. Findings include: On October 26, 2022 on or about 10:00 AM the American Proficiency Institute (API) proficiency testing records and the CMS 153 and 155 reports were reviewed. The laboratory performs the molecular bacteriology GI panel and the molecular bacteriology respiratory panel on the Biofire instrument. The review showed that the laboratory failed to achieve satisfactory performance for the testing in the subspecialty of bacteriology, as shown below. Event #3, 2021 bacteriology-0% Event #1, 2022 bacteriology-0% D2064 VIROLOGY CFR(s): 493.831(e) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports and the laboratory's proficiency testing records, the laboratory did not have successful performance in proficiency testing for the subspecialty of virology. Findings include: On October 26, 2022 on or about 10:00 AM the American Proficiency Institute (API) proficiency testing records and the CMS 153 and 155 reports were reviewed. The laboratory performs the molecular virology GI panel and the molecular virology respiratory panel on the Biofire instrument. The review showed that the laboratory failed to achieve satisfactory performance in two consecutive testing events for testing in the subspecialty of virology, as shown below. Event #3, 2021 virology-0% Event #1, 2022 virology-0% D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. -- 2 of 3 -- 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on the review of the laboratory's proficiency testing records, the laboratory director failed to ensure that the laboratory maintained a satisfactory score in proficiency testing for analytes found in the subspecialties of bacteriology and virology. Findings include: On October 26, 2022, on or about 10:00 AM, the American Proficiency Institute (API) proficiency records and the Centers for Medicare & Medicaid Service (CMS) 153 and 155 reports were reviewed. The review showed that the laboratory had unsatisfactory testing scores for two consecutive testing events in the subspecialties of bacteriology and virology. Refer to D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on the review of the laboratory's proficiency testing scores, the laboratory director failed to ensure that the laboratory performed proficiency testing in such a manner as to achieve and maintain successful performance in proficiency testing in the subspecialties of bacteriology and virology as shown below. Findings Include: The review of the American Proficiency Institute (API) proficiency testing records and the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports on October 26, 2022, on or about 10:00 AM showed that the laboratory received unsatisfactory proficiency testing scores for two out of three testing events for the analytes shown below. The laboratory performs bacteriology and virology testing on the Biofire instrument. In bacteriology the laboratory performs the molecular bacteriology GI panel, and the molecular bacteriology respiratory panel. In the subspecialty of virology the laboratory performs the molecular virology GI panel and the molecular virology respiratory panel. Event #3, 2021 bacteriology-0% virology-0% Event #1, 2022 bacteriology-0% virology-0% -- 3 of 3 --

Summary Statement of Deficiencies D0000 A complaint survey for 2022004782, was conducted on 5/5/2022-5/6/2022 at United Laboratory Services Corp. The laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. D5813 TEST REPORT CFR(s): 493.1291(g) The laboratory must immediately alert the individual or entity requesting the test and, if applicable, the individual responsible for using the test results when any test result indicates an imminently life-threatening condition, or panic or alert values. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to report critical Prothrombin Time (PT) and International normalized ratio (INR) results to the medical provider for patient # 1 on 3/25/2022 and 3/29/2022. Findings included: A review of PT and INR testing reports revealed patient #1 test results were critical values for PT- 34.1 and INR -2.67 on 3/25/2022. Patient #1 test results were critical values for PT-27.3 and INR-2.13 on 3/29/2022. A review of March 2022 PT and INR fax reports revealed that critical PT and INR results for patient #1 were not faxed to their doctor's office on 3/25/2022 and 3/29/2022. During an interview on 5/6/2022 at 2:14 PM, the owner confirmed the staff failed to fax critical PT and INR results for patient #1 on 3/25/2022 and 3/29/2022 to their doctor. 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 desk review survey of the laboratory's proficiency test results was performed on 12 /16/2021 for United Laboratory Services Corp. The United Laboratory Service Corp laboratory is not in compliance with Code of Federal Regulations (CFR), Part 493, Laboratory Requirements. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the laboratory's proficiency testing records for 2021, the laboratory did not have successful performance in proficiency testing in the subspecialty of parasitology and the specialty of hematology. Refer to D2055 and D2130. Findings include: Review of the American Associates of Bioanalysts (AAB) 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 -- proficiency testing records and the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports, on December 16, 2021 on or about 10:00 AM, showed that the laboratory had unsatisfactory testing scores for the subspecialty of parasitology and for the analyte, fibrinogen for two consecutive testing events 2021. D2055 PARASITOLOGY CFR(s): 493.829(e) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports and the laboratory's proficiency testing records, the laboratory did not have successful performance in proficiency testing in the specialty of parasitology and hematology. Findings include: On December 16, 2021 on or about 10:00 AM the American Association of Bioanalysts (AAB) proficiency testing records and the CMS 153 and 155 reports were reviewed. The review showed that the laboratory failed to achieve satisfactory performance in the sub specialty of parasitology, as shown below. Parasitology Event # 2, 2021 parasitology-60% Event #3, 2021 parasityology-67% D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports and the laboratory's proficiency testing records, the laboratory did not have successful performance in proficiency testing in the specialty of parasitology and hematology. Findings include: On December 16, 2021 on or about 10:00 AM the American Association of Bioanalysts (AAB) proficiency testing records and the CMS 153 and 155 reports were reviewed. The review showed that the laboratory failed to achieve satisfactory performance for the analyte, fibrinogen as shown below. Hematology Event #2, 2021 fibrinogen-0% Event #3, 2021 fibrinogen-0% D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on the review of the laboratory's proficiency testing records, the laboratory director failed to ensure that the laboratory maintained a satisfactory score for proficiency testing in the subspecialty of parasitology and the specialty of hematology. Findings include: On December 16, 2021 on or about 10:00 AM, the -- 2 of 3 -- American Association of Bioanalysts (AAB) proficiency records and the Centers for Medicare & Medicaid Service (CMS) 153 and 155 reports were reviewed. The review showed that the laboratory had unsatisfactory testing scores for two consecutive testing events for the sub specialty of parasitology and the analyte, fibrinogen, in the specialty of hematology. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D2055 and D2130. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on the review of the laboratory's proficiency testing scores, the laboratory director failed to ensure that the laboratory performed proficiency testing in such a manner as to achieve and maintain successful participation in proficiency testing in the subspecialty of parasitology and the specialty of hematology. Findings Include: The review of the American Association of Bioanalysts (AAB) proficiency testing records and the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports on December 16, 2021 on or about 10:00 AM showed that the laboratory received unsatisfactory proficiency testing scores for two consecutive testing events as shown below. Parasitology Event #2, 2021 parasitology-60% Event #3, 2021 parasitology-67% Hematology Event #2, 2021 fibrinogen-0% Event #3, 2021 fibrinogen-0%. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted on 07/19/2021 to 08/11/2021, United Laboratory Services Corp clinical laboratory was found not in compliance with 42 CFR 493, Requirements for Clinical Laboratories. Based on the survey findings an Immediate Jeopardy situation was identified and the laboratory was notified of the Immediate Jeopardy on 08/11/2021 at 1:47 PM. The laboratory failed to follow Qiagen QuantiFERON - Tuberculosis (TB) Gold Plus (QFT-Plus) manufacturer instructions to ensure the quality of the blood specimens prior to testing for TB. The laboratory failed to reject specimens not incubated for 16 to 24 hours per manufacturer specimen guidelines for QFT-Plus. (D 5311)The laboratory failed to validate Advia Centaur human immunodeficiency virus (HIV) antigen (Ag) / antibody (Ab) Combo (CHIV) assay from 04/06/2020 to present and Bio-Rad Recombinant and Synthetic Peptides (GS) HIV-1/HIV-2 PLUS O Enzyme Immunoassay (EIA) from 02 /27/21 to present for use in the detection of HIV-1 and HIV-2 antibodies (D 5421). The laboratory failed to validate the Stanbio Rapid Plasma Reagin (RPR) Quicktest for use without humidifying covers, temperature ranges and revolutions per minute (rpm) outside of the Food and Drug Administration (FDA) approved manufacturer guidelines for Syphilis testing from December 2019 to present (D 5423). The laboratory failed to follow the Bio-Rad GS HIV-1/HIV-2 PLUS O EIA manufacturer's instructions for valid positive and negative controls to detect HIV-1 and HIV-2 antibodies from January 2020 to present (D 5481). The following conditions were cited: -D 2000- Enrollment and Testing of Samples -D 2016-Successful Participation - D 5200-General Laboratory Systems -D 5300-Preanalytic Systems -D 5400-Analytic Systems -D 6076- Laboratory Director 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 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 -- 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 record review and interview with General Supervisor (GS) A, the laboratory failed to enroll in a Proficiency Testing (PT) program approved by the Department of Health and Human Services (HHS) and Centers for Medicare and Medicaid Services (CMS) for anti-Human immunodeficiency antibody test (anti-HIV) and for Rubella antibody test for 2021. Findings included: -Review of test menu included in the CMS 116-form revealed that the laboratory is currently performing anti-HIV and Rubella antibody test. -Review of Casper report 96 Clinical Laboratory Improvement Amendments (CLIA) Application and Survey Summary report pulled on 07/12/2021 revealed the absence of anti-HIV and anti Rubella antibodies test results during 1st event of 2021. -Review of American Association of Bioanalysts (AAB) PT records revealed that the laboratory failed to enroll anti-HIV and Rubella antibody tests for 2021. During an interview on 07/20/2021 at 9:30 a.m. the GS A confirmed that the facility failed to enroll in PT for 2021 for the analytes of reference. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of laboratory proficiency testing records for 2019 and 2020, the laboratory did not have a successful performance for Activated Partial Thromboplastin Time (APTT). (See D 2130) D2047 PARASITOLOGY CFR(s): 493.829(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. -- 2 of 15 -- This STANDARD is not met as evidenced by: Based on record review and interview with General Supervisor A (GS A), the laboratory failed to get at least 80 % in proficiency testing for 1 out of 6 Parasitology events reviewed from 2019 to 2021. Findings included: Review of American Association of Bioanalysts (AAB) proficiency testing records from 2019 (3rd event) to 2021 (2nd event) revealed that the laboratory failed Parasitology, 2nd event of 2021 with a 60 % score resulting in a unsatisfactory event result. During an interview on 07 /26/2021 at 2:30 PM, the GS A confirmed that the laboratory failed the event of reference. D2066 SYPHILIS SEROLOGY CFR(s): 493.835(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on record review and interview with General Supervisor (GS) A, the laboratory failed to score at least 80% in proficiency testing for 1 (3rd event of 2019) out of 6 (2019 3rd event, 2021 2nd event) events for Syphilis Serology reviewed. Findings included: Review of American Association of Bioanalysts (AAB) proficiency testing records revealed a score of 60% for 3rd event of 2019 resulting in a unsatisfactory score for the Syphillis Serology subspecialty. During an interview on 07/26/2021 at 3: 30 PM, the GS A confirmed the failed proficiency testing score in Syphilis Serology. D2075 GENERAL IMMUNOLOGY CFR(s): 493.837(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 record review and interview with General Supervisor (GS) A, the laboratory failed to score at least 80 % in proficiency testing for Rheumatoid antibody test in 3rd event of 2019, anti-Human immunodeficiency antibody (anti-HIV) in 3rd event of 2020 and complement C3 protein (C3) in second event of 2021. Findings included: Review of proficiency testing records for American Association of Bioanalysts (AAB) revealed that the laboratory had unsatisfactory scores for the following analytes of the immunology specialty in the events listed below: - 60 % score in the Rheumatoid antibody test in the 3rd event of 2019 - 60 % score in the anti-HIV antibody test in the 3rd event of 2020 - 60 % score of C3 test in the 2nd event of 2021. During an interview on 07/26/2021 at 3:30 PM, the GS A confirmed the failed proficiency testing scores of the analytes referenced. D2099 ENDOCRINOLOGY CFR(s): 493.843(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. -- 3 of 15 -- This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to obtain a score of at least 80 % in proficiency testing (PT) for 1 out of 6 events reviewed (3rd event 2019 to 2nd event 2021) of the Endocrinology subspecialty. Findings included: Record review for American Proficiency Institute (API) PT, revealed that the laboratory received a score of 60 % in Cortisol and 20 % in Thyroxine test for the 1st Event of 2020 resulting in a score of 70 % for Endocrinology. During an interview on 07/26 /2021 at 1:30 PM, the General Supervisor A confirmed the laboratory received an unsatisfactory score for the subspecialty of Endocrinology in the PT event of reference. D2123 HEMATOLOGY CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to participate in proficiency testing (PT) for the 2nd event of 2021 for fibrinogen test. Findings included: Review of American Association of Bioanalysts (AAB) proficiency testing (PT) records revealed that the laboratory received a 0 % score for fibrinogen in the 2nd event of 2021. During an interview on 08/03/2021 at 12:30 PM, the General Supervisor A confirmed that the laboratory failed to notify the PT agency the laboratory was not testing fibrinogen at the time of the event of reference. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory had unsatisfactory score results for the 1st and 3rd events of 2020 for the Activated Partial Thromboplastin Time (APTT) resulting in an unsuccessful result for this analyte Findings included: - Review of American Proficiency Institute (API) proficiency testing results in 2020, showed that the laboratory had analyte unsatisfactory score for APTT of 60 % score for the 1st and 3rd event of 2020 resulting in an unsuccessful result for this analyte. - The laboratory tested 1793 patients from 03/13/2020 to 07/21/2021. During an interview on 07/19/2021 at 2:00 PM, with General Supervisor A, she confirmed that the laboratory failed the events of reference for APTT. -- 4 of 15 -- D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, 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 general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review and interview, the laboratory failed to perform blind testing at least twice a year for the nonregulated Qiagen QuantiFERON-Tuberculosis (TB) Gold Plus (QFT-Plus) test for 2 (2020 and 2021) out of 2 years to determine the accuracy and reliability of TB testing.(See D 5217) 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 interview, the laboratory failed to do a competency assessment for 1 out of 2 General Supervisors (GS) in 2021. Findings included: - Review of CMS 209 Laboratory Personnel Report dated and signed by the Laboratory Director (LD) on 07/19/2021 revealed the following: a) There were 2 GS. b) GS A, who oversees the Chemistry and Hematology section and GS B that it is the LD and oversees the Microbiology Section. -Review of personnel policy signed by the LD on 3/02/2021, revealed that the policy failed to include an evaluation for General Supervisor. -Review of Laboratory Employee records revealed that there were no records of competency assessment for GS A hired on March 2021. During an interview on 07/26/2021 at 12:30 PM with GS A, she confirmed that the laboratory's personnel policy failed to have a competency assessment for the General Supervisor. 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 record review and interview, the laboratory failed to perform blind testing at least twice a year for the nonregulated Qiagen QuantiFERON-Tuberculosis (TB) Gold Plus (QFT-Plus) test for 2 (2020 and 2021) out of 2 years to determine the accuracy and reliability of TB testing. Findings included: Review of 2019-2021 College of American Pathologists (CAP) revealed QFT-Plus blind testing was performed twice a year in 2019. For 2020 and 2021, there was no documentation that QFT-Plus blind testing was performed twice annually for the 2 years. Review of 2020-2021 American -- 5 of 15 -- Association of Bioanalysts (AAB) proficiency testing record revealed there was no written documentation of blind testing for QFT-Plus performed twice a year in 2020 and 2021. During an interview on 08/06/2021 at 1:47 PM, the owner confirmed the laboratory failed to perform blind testing at least twice a year for QFT-Plus test for 2 out of 2 years. 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, the laboratory failed to follow Qiagen QuantiFERON- Tuberculosis(TB) Gold Plus (QFT-Plus) manufacturer's instructions to ensure the quality of blood specimens prior to testing for TB. The laboratory failed to reject QFT-Plus specimens not incubated for 16 to 24 hours per manufacturer guidelines. (see D 5311) 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 follow Qiagen QuantiFERON- Tuberculosis (TB) Gold Plus (QFT-Plus) manufacturer's instructions to ensure the quality of blood specimens prior to testing for TB. The laboratory failed to reject QFT-Plus specimens not incubated for 16 to 24 hours per manufacturer guidelines. Findings included: Review of QFT-Plus Instructions for Use stated "Tubes must be transferred to a 37 Celsius (C) 1C incubator within 2 hours. If QFT-Plus Blood Collection Tubes are not incubated at 37 C directly after blood collection and shaking, invert the tubes to mix 10 times (10x) prior to incubator at 37 C. Incubate the QFT-Plus Blood collection tubes upright at 371 C for 16 to 24 hours. In order to obtain valid results from the QFT-Plus assay, the operator needs to perform specific tasks within set times. Prior to harvesting plasma, samples in QFT-Plus Blood Collection Tubes must have been incubated at 37 C for 16-24 hours." QFT-Plus Blood Collection Tubes also contain the following controls: Nil (the negative control) and mitogen (the positive control). Review of 2020-2021 QuantiFERON Incubation list revealed 20 out 30 QFT-plus specimens had no written documentation of incubator temperatures and exit incubator times from 02/12/2020 to 05/12/2020. 30 out 30 QFT- plus specimens did not have written incubator enter and exit times from 01/08/21 to 04 -- 6 of 15 -- /30/21. Review of QFT-Plus Patient Records revealed the following patient specimens removed from the incubator before the 16 to 24 hour timeframe: 1. Patient 1 QFT - Plus specimen had no written documentation of incubator entry time and was removed from the incubator 3:00 AM on 03/19/2020. 2. Patient 2 QFT -Plus specimen arrived at 10:41 PM on 03/19/2020 and was removed from the incubator 6:30 AM on 03/20 /2020. Total incubation time was 7 hours. The number of patients tested on QFT-Plus for tuberculosis was 275 from January 2020 to July 2021. During an interview on 08 /11/2021 at 1:47 PM, the owner confirmed the laboratory failed to follow QFT-Plus manufacturer's instructions to ensure the quality of blood specimens prior to testing for TB and to reject specimens not incubated within 16 to 24 hours. 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 interview, the laboratory failed to validate Advia Centaur human immunodeficiency virus (HIV) antigen(Ag)/antibody(Ab) Combo (CHIV) assay from 04/06/2020 to present and Bio-Rad Recombinant and Synthetic Peptides (GS) HIV-1/HIV-2 PLUS O Enzyme Immunoassay (EIA) from 02/27/21 to present for use in the detection of HIV-1 and HIV-2 antibody. (See D 5421) Based on observation, record review and interview, the laboratory failed to validate the Stanbio Rapid Plasma Reagin (RPR) Quicktest for use without humidifying covers, temperature ranges and revolutions per minute (rpm) outside of the Food and Drug Administration (FDA) approved manufacturer guidelines for Syphilis testing from December 2019 to present. (See D 5423) Based on record review and interview, the laboratory failed to follow the Bio-Rad GS HIV-1/HIV-2 PLUS O EIA manufacturer instructions for valid positive and negative controls to detect HIV-1 and HIV-2 antibodes from January 2020 to present. (See D 5481) 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 desk review survey of the laboratory's proficiency test results was performed on January 25, 2021 for United Laboratory Services Corp. The United laboratory Services Corp laboratory is not in compliance with Code of Federal Regulations (CFR), Part 493, Laboratory Requirements. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the laboratory's proficiency testing records for 2019 and 2020, the laboratory did not have successful performance in proficiency testing for the subspecialty/specialty of routine chemistry. Refer to D2130. Findings include: Review of the American Proficiency Institute (API) proficiency testing records and the review 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 -- of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports, on January 25, 2021 on or about 10:00 AM, showed that the laboratory had unsatisfactory testing scores for the analyte, Partial Thromboplastin Time (APTT) for two out of three testing events in 2020. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports and the laboratory's proficiency testing records, the laboratory did not have successful performance in proficiency testing in the specialty of routine chemistry. Findings include: On January 25, 2021 on or about 10:00 AM the American Proficiency Institute (API) proficiency testing records and the CMS 153 and 155 reports were reviewed. The review showed that the laboratory failed to achieve satisfactory performance for the analyte, partial thromboplastin time (APTT), as shown below. Event #1, 2020 APTT-60% Event #3, 2020 APTT-60% D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on the review of the laboratory's proficiency testing records, the laboratory director failed to ensure that the laboratory maintained a satisfactory score for proficiency testing in the specialty of hematology Findings include: On January 25, 2021 on or about 10:00 AM, the American Proficiency Institute (API) proficiency records and the Centers for Medicare & Medicaid Service (CMS) 153 and 155 reports were reviewed. The review showed that the laboratory had unsatisfactory testing scores for two out of three testing events for the analyte, partial thromboplastin time (APTT), in the specialty of hematology. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D2130. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on the review of the laboratory's proficiency testing scores, the laboratory director failed to ensure that the laboratory performed proficiency testing in such a manner as to achieve and maintain successful participation in proficiency testing for -- 2 of 3 -- the analyte, partial thromboplastin time (APTT), in the specialty of hematology. Findings Include: The review of the American Proficiency Institute (API) proficiency testing records and the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports on January 25, 2021 on or about 10:00 AM showed that the laboratory received unsatisfactory proficiency testing scores as shown below. Event #1, 2020 APTT-60% Event #3, 2020 APTT-60% -- 3 of 3 --

Summary Statement of Deficiencies D0000 An unannounced complaint survey, #2020012381 conducted on 11/5/20 to 11/10/20 at United Laboratory Services Corp. The laboratory was not in compliance with 42 CFR 493, Requirements for Clinical Laboratories. The following conditions were cited: -D3000 -D5400 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 COVID 19 tests results to the Department of Health (DOH). See 3009 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 interview with owner, the laboratory failed to follow the State of Florida Emergency Rule to report all positive and negative Coronavirus 19 (COVID-19) test results immediately to the Department of Health (DOH) for 4 positive and 59 negative out of 159 cases tested using Biofire Film Array Coronavirus 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 -- 2019 (COVID-19). Findings include: -Record review revealed that the laboratory started to report COVID 19 results using Biofire Film Array on 7/1/2020. -The laboratory tested 159 cases from 7/1/2020 to 11/2/2020. -Review of reports sent to the Health County from 7/1/2020 to 11/02/2020 revealed that the laboratory failed to report 4 positive (339789, 339883, 340338, 340349) and 59 negative (339321, 339326, 339325, 339701, 339702, 339703, 339704, 339779, 339781, 339810, 339822, 339853, 339919, 339999, 340193, 340089, 341617, 342995, 342996, 343019, 343020, 343021, 343022, 343186, 343193, 343250, 343349, 343350, 343354, 343359, 343501, 343521, 343527, 343599, 343605, 343606, 343635, 343737, 343898, 343899, 343908, 343916, 343932, 343933, 343934, 344000, 344066, 344196, 345234, 346340, 346381, 346407, 346527, 346528, 346529, 346530, 346531, 346875, 346953) COVID 19 cases. During an interview on 11/5 /2020 at 5:30 PM, the laboratory owner, confirmed that the laboratory failed to report the COVID-19 results of reference. 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 interview, the laboratory failed to complete COVID -19 antigen testing validations for Zeus Scientific Rapid SARS-CoV-2 IgM/IgG Test System, Healgen Scientific LLC COVID-19 IgG /IgM Rapid Test Cassette and FaStep COVID-19 IgG/IgM Rapid Test Device in 2020. (See 5421) Based on record review and interview, the laboratory failed to document and perform external positive and negative controls for Zeus Scientific Rapid SARS-CoV-2 IgM/IgG Test System from 5/6/2020 to 6/21/2020, Healgen Scientific LLC COVID-19 IgG /IgM Rapid Test Cassette from 5/20/2020 to 7/03/2020 and FaStep Covid-19 IgG/IgM Rapid Test Device from 7/20/2020 to 10/20/2020 . (See 5449) D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on record review and owner interview, the laboratory failed to complete COVID -19 antigen testing validations for Zeus Scientific Rapid SARS-CoV-2 IgM /IgG Test System, Healgen Scientific LLC COVID-19 IgG /IgM Rapid Test Cassette -- 2 of 4 -- and FaStep COVID-19 IgG/IgM Rapid Test Device in 2020 . Finding Included : Review of Zeus Scientific Rapid SARS-CoV-2 IgM/IgG Test System validation revealed no documentation for validating patient samples for testing since 5/6/2020. Review of Healgen Scientific LLC COVID-19 IgG /IgM Rapid Test Cassette validation revealed no documentation for validating patient samples for testing since 5 /20/2020. Review and FaStep COVID-19 IgG/IgM Rapid Test Device validation revealed no documentation for validating patient samples for testing since 7/20/2020. Review of COVID-19 testing log revealed Zeus Scientific Rapid SARS-CoV-2 IgM /IgG Test System in use from 5/6/2020 to 6/21/2020 , Healgen Scientific LLC COVID-19 IgG /IgM Rapid Test Cassette in use from 5/20/2020 to 7/03/2020 and FaStep COVID-19 IgG/IgM Rapid Test Device in use from 7/20/2020 to 10/20/2020. During an interview on 11/10/2020 at 4:49pm, the owner confirmed the validation was not completed for Zeus Scientific Rapid SARS-CoV-2 IgM/IgG Test System, Healgen Scientific LLC COVID-19 IgG /IgM Rapid Test Cassette and FaStep COVID-19 IgG/IgM Rapid Test Device in 2020. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to document and perform external positive and negative controls for Zeus Scientific Rapid SARS-CoV-2 IgM /IgG Test System from 5/6/2020 to 6/21/2020, Healgen Scientific LLC COVID-19 IgG /IgM Rapid Test Cassette from 5/20/2020 to 7/03/2020 and FaStep Covid-19 IgG /IgM Rapid Test Device from 7/20/2020 to 10/20/2020 . Findings Included : Review of COVID-19 External Quality Control for FaStep revealed that no negative and positive controls documented from 7/20/2020 to 10/20/2020. Review of COVID-19 External Quality Control for Zeus revealed that no negative and positive controls documented from 5/6/2020 to 6/21/2020. Review of COVID-19 External Quality Control for Healgen revealed that no negative and positive controls documented from 7/20/2020 to 10/20/2020. Review of COVID-19 testing log revealed Zeus Scientific Rapid SARS-CoV-2 IgM/IgG Test System in use from 5/6/2020 to 6/21/2020, Healgen Scientific LLC COVID-19 IgG /IgM Rapid Test Cassette in use from 5/20 /2020 to 7/03/2020 and FaStep COVID-19 IgG/IgM Rapid Test Device in use from 7 /20/2020 to 10/20/2020. During an interview on 11/10/2020 at 4:49pm , the owner confirmed failure to document and perform external positive and negative controls for Zeus Scientific Rapid SARS-CoV-2 IgM/IgG Test System from 5/6/2020 to 6/21 /2020, Healgen Scientific LLC COVID-19 IgG /IgM Rapid Test Cassette from 5/20 /2020 to 7/03/2020 and FaStep Covid-19 IgG/IgM Rapid Test Device from 7/20/2020 to 10/20/2020. D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) The laboratory director must ensure that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of -- 3 of 4 -- the method. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory director (LD) failed to sign and review validations that were in use for Zeus Scientific Rapid SARS-CoV-2 IgM/IgG Test System, Healgen Scientific LLC COVID-19 IgG /IgM Rapid Test Cassette and FaStep Covid-19 IgG/IgM Rapid Test Device . Findings Included : Review of Zeus Scientific Rapid SARS-CoV-2 IgM/IgG Test System validation lacked documentation of a review and signature by LD. Review of Healgen Scientific LLC COVID-19 IgG /IgM Rapid Test Cassette validation lacked documentation of a review and signature by LD. Review of FaStep COVID-19 IgG/IgM Rapid Test Device validation lacked documentation of a review and signature by LD. Review of COVID-19 testing log revealed Zeus Scientific Rapid SARS-CoV-2 IgM/IgG Test System was in use from 5 /6/2020 to 6/21/2020. Healgen Scientific LLC COVID-19 IgG /IgM Rapid Test Cassette was in use from 5/20/2020 to 7/03/2020 . FaStep COVID-19 IgG/IgM Rapid Test Device was in use from 7/20/2020 to 10/20/2020 . During an interview on 11/10 /2020 at 4:49pm , the owner confirmed the LD did not sign and review validations for Zeus Scientific Rapid SARS-CoV-2 IgM/IgG Test System, Healgen Scientific LLC COVID-19 IgG /IgM Rapid Test Cassette and FaStep COVID-19 IgG/IgM Rapid Test Device. -- 4 of 4 --

Summary Statement of Deficiencies D0000 A recertification survey conducted, 9/11-12/2019 found that United Laboratory Services Corp clinical laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. 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 record review and staff interview, the laboratory failed to have proficiency testing attestations with laboratory director (LD) and/or testing personnel (TP) signatures for 4 out of 6 (2017 3rd ; 2018 (1st, 2nd and 3rd) events; 2019 (1st and 2nd) events reviewed for the specialties of Microbiology, Diagnostic Immunology, Chemistry and Hematology . The findings include: -Review of the American Association of Bioanalysts (AAB) proficiency testing records for 2017 (3rd event), 2018 (1st, 2nd and 3rd) events and 2019 (1st, and 2nd) events, revealed no signed attestation for the following tests: Detection of Human Immunodeficiency Virus (HIV), Hepatitis, Cytomegalovirus, Herpes Type I and II Immunoglobulin (IgG), toxoplasma, Erythrocyte Sedimentation Rate (ESR), Leukocytes, Erythrocytes, Hemoglobin, Hematocrit, Platelets, Neutrophil, Lymphocytes, Monocyte, Eosinophil, Basophil, Prothrombin Time, International Normalized Ratio (INR), International Sensitivity Index (ISI), Normal Mean (GMNPT), Activated Partial Thromboplastin, IgG, Immunoglobulin A (IgA), Immunoglobulin M (IgM), Immunoglobulin E (IgE), Complement C3 and C4, Reticulocyte Count, antinuclear Antibody (ANA), Sickle Cell, Syphilis RPR, C reactive Protein, Rheumatoid factor, Infectious mononucleosis, Anti-streptolysin O, Hemoglobin A1c, in 2017 for 3rd event. -Review of College of American Pathologist (CAP) proficiency testing records 2017 (3rd event), 2018 (1st, 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 -- 2nd and 3rd) events and 2019 (1st and 2nd) events, revealed that there was no signed attestation for the following tests: - Syphilis, Infectious Mononucleosis and Anti- streptolysin tests by LD and TP for 3 out of 3 proficiency testing (PT) events in 2018 During an Interview on 9/11/2019 at 2:30 pm, the Technical Supervisor confirmed that the attestations were not signed by the LD or TP for the events of reference. D2076 GENERAL IMMUNOLOGY CFR(s): 493.837(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to have a score above 80 percent for 2 out of 6 proficiency testing (PT) events in the specialty of General Immunology for 2 out of 2 years reviewed. Findings Include: -Review of the American Association of Bioanalysts (AAB) proficiency testing records of 2018 and 2019 revealed a 0 % score for Complement 3(C3) and Complement 4(C4) in the second event of 2018, resulting in an overall score of 77 % for the General Immunology specialty. -Review of the College of American Pathologists (CAP) proficiency testing record in 2018 and 2019 revealed a 0 % score for Hepatitis Core Antigen Antibodies (Anti-Hbc) in the second event of 2019, resulting in a overall score of 66 % for the General Immunology Specialty During an interview on 9/11 /2019 at 12:30 pm, the Technical Supervisor confirmed that the laboratory failed the events of reference for Diagnostic Immunology. 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 record review and staff interview, the laboratory failed to ensure a proficiency testing score above 80 percent for each analyte for 1 out of 6 events reviewed in the Chemistry specialty for the last 2 years. Findings include: A review of the American Association of Bioanalysts (AAB) proficiency testing records for 2017 3rd event, 2018 (1st, 2nd and 3rd) events and 2019 (1st and 2nd) events, revealed the following: - Alanine Amino Transferase (ALT) test received a score of 40 percent in 2018 for the 3rd PT event. During an interview on 9/12/2019 at 2:30 PM, testing personnel # 3 confirmed that analyte of reference received a score of less than 80 percent for the event of reference. D2098 ENDOCRINOLOGY CFR(s): 493.843(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: -- 2 of 3 -- Based on record review and staff interview, the laboratory failed to ensure a proficiency testing score above 80 percent for each analyte for 2 out of 6 events reviewed in the Endocrinology specialty for the last 2 years. Findings include: -A review of the American Association of Bioanalysts (AAB) proficiency testing records for 2017 3rd event, 2018 (1st, 2nd and 3rd) events and 2019 (1st and 2nd) events, revealed the following: Thyroxine received a 60 % score for the 3rd event of 2017. - Review of the College of American Pathologists (CAP) proficiency testing record in 2017 3rd event, 2018 (1st, 2nd and 3rd) events and 2019 (1st and 2nd) events revealed 20 % score for Free Thyroxine analyte for the 3rd event of 2018. During an interview on 9/12/2019 at 2:30 PM, testing personnel # 3 confirmed that analytes of reference received a score of less than 80 percent for the events of reference. . 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 record review and staff interview, the Laboratory Director (LD) failed to document the review and evaluation of the proficiency testing (PT) results for 2 out of 6 events reviewed. Findings include: Review of College of American Pathologists (CAP) PT records, for 2017 1st event, 2018 1st, 2nd and 3rd events and 2019 (1st and 2nd ) events, showed that the LD failed to sign and date the results for the Special Immunology test package that includes the following tests: Haptoglobin, Immunoglonulin G (IgG), Transferrin, Helicobacter pylori, Anti Dexoribonucleic acid antibody double and single strand (Anti-DNA ds) for 1st and 2nd events during 2018. During an interview on 9/12/2019 at 2:30 PM, testing personnel # 3 confirmed that the LD failed to sign and date the results review for the events of above reference. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the laboratory's proficiency testing records for 2018, the laboratory did not have successful performance in proficiency testing for the analyte, partial thromboplastin time (PTT) in the specialty of hematology. Refer to D2130. Findings include: Review of the American Associates of Bioanalysts (AAB) proficiency testing records and the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports, on January 14, 2109 on or about 10:00 AM, showed that the laboratory had unsatisfactory testing scores for the analyte, partial thromboplastin time (PTT) for two out of three testing events in 2018. 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 -- D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports and the laboratory's proficiency testing records, the laboratory did not have successful participation in proficiency testing for the analyte, partial thromboplastin time (PTT) in the specialty of hematology. Findings include: On January 14, 2019 on or about 10:00 AM the American Association of Bioanalysts (AAB) proficiency testing records and the CMS 153 and 155 reports were reviewed. The review showed that the laboratory failed to achieve satisfactory performance for the analyte, partial thromboplastin time (PTT), as shown below. Event #2, 2018 PTT- 40% Event #3, 2018 PTT-60% D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on the review of the laboratory's proficiency testing records, the laboratory director failed to ensure that the laboratory maintained a satisfactory score for proficiency testing for the analyte, partial thromboplastin time (PTT) in the specialty of hematology. Findings include: On January 14, 2019, on or about 10:00 AM, the American Association of Bioanalysts (AAB) proficiency records and the Centers for Medicare & Medicaid Service (CMS) 153 and 155 reports were reviewed. The review showed that the laboratory had unsatisfactory testing scores for two out of three testing events for the analyte, partial thromboplastin time (PTT), in the specialty of hematology. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D2130. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on the review of the laboratory's proficiency testing scores, the laboratory director failed to ensure that the laboratory performed proficiency testing in such a manner as to achieve and maintain successful participation in proficiency testing for -- 2 of 3 -- the analyte, partial thromboplastin time (PTT) in the specialty of hematology. Findings Include: The review of the American Association of Bioanalysts (AAB) proficiency testing records and the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports on January 14, 2019 on or about 10:00 AM showed that the laboratory received unsatisfactory proficiency testing scores as shown below. Event #2, 2018 PTT-40% Event #3, 2018 PTT-60% -- 3 of 3 --