Clinical Laboratory Inc

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The facility was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director 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: This CONDITION is not met as evidenced by: Based on a proficiency testing desk 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 -- review of the Certification and Survey Provider Enhanced Reporting (CASPER) 0155 report and American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) 2025 records, the laboratory failed to successfully participate in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in the sub-specialty of Routine Chemistry for the Follicle Stimulating Hormone (FSH) analyte, in the sub-specialty of Hematology for the Prothrombin Time (PT) analyte and in the sub-specialty of Immunohematology for the Antibody Detection (Ab-detection) analyte. Refer to D2096, D2130, and D2164. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (f) Failure to achieve satisfactory performance for the same analyte or test in 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 a proficiency testing desk review of the CASPER 0155 report and AAB- MLE 2025 proficiency testing records, the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two of two consecutive testing events (2025 Events 2 and 3) in the sub-specialty of Routine Chemistry for the FSH analyte. Findings: 1. A review of the CASPER 0155 report revealed the following results: AAB-MLE 2025- 2nd Event The laboratory received an unsatisfactory score of 60% for FSH. AAB-MLE 2025- 3rd Event The laboratory received an unsatisfactory score of 40% for FSH. 2. A review of AAB-MLE 2025 proficiency testing records confirmed the laboratory received the above results. D2130 HEMATOLOGY CFR(s): 493.851(f) (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 a proficiency testing desk review of the CASPER 0155 report and AAB- MLE 2025 proficiency testing records, the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two of three testing events (2025 Events 1 and 3) in the sub-specialty of hematology for the Prothrombin Time (PT) analyte. Findings: 1. A review of the CASPER 0155 report revealed the following results: AAB-MLE 2025- 1st Event The laboratory received an unsatisfactory score of 60% for PT. AAB-MLE 2025- 3rd Event The laboratory received an unsatisfactory score of 60% for PT. 2. A review of AAB-MLE 2025 proficiency testing records confirmed the laboratory received the above results. D2164 UNEXPECTED ANTIBODY DETECTION CFR(s): 493.861(a) (a) Failure to attain an overall testing event score of at least 100 percent is unsatisfactory performance. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155 report and AAB- MLE 2025 proficiency testing records, the laboratory failed to achieve satisfactory performance (100% or greater) for the same analyte in two of three testing events (2025 Events 1 and 3) in the sub-specialty of Immunohematology for the Antibody Detection (Ab-detection) analyte. Findings: 1. A review of the CASPER 0155 report revealed the following results: AAB-MLE 2025- 1st Event The laboratory received an unsatisfactory score of 80% for Ab-detection. AAB-MLE 2025- 3rd Event The laboratory received an unsatisfactory score of 80% for Ab-detection. 2. A review of AAB-MLE 2025 proficiency testing records confirmed the laboratory received the above results. 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 a proficiency testing desk review of the CASPER 0155 report and AAB- MLE 2025 proficiency testing records, the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155 report and AAB- MLE 2025 proficiency testing records, the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2096, D2130, and D2164. -- 3 of 3 --

Summary Statement of Deficiencies D5317 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(d) (d) If the laboratory accepts a referral specimen, written instructions must be available to the laboratory's clients and must include, as appropriate, the information specified in paragraphs (a)(1) through (a)(7) of this section. This STANDARD is not met as evidenced by: Onsite Revisit 8/27/2025 Based on review of the laboratory's procedures, manufacturer's instructions, four of four patient test requisitions, patient final test reports, and interview with the technical supervisor, the laboratory failed to have a client services manual for referred specimens. Findings included: 1. The laboratory's client services manual lacked: a) Patient preparation b) Conditions of specimen transport c) Specimen storage/preservation d) Acceptability/rejection criteria 2.. Review of the laboratory's procedures and manufacturer's instructions for a random sampling of testing that the laboratory performed included the following for specimen stability: a) The laboratory's written procedure for Sickle Cell testing stated, "Specimens can be kept for 1 to 2 weeks at 2 to 8C." Sickledex manufacturer stated, "Blood samples stored at 1C to 10C for up to 45 days may be used for testing." b) The laboratory's written procedure for rapid plasma reagin (RPR) testing stated, "Serum samples should be tested within five (5) days of collection." The laboratory's procedure was consistent with Arlington Scientific RPR manufacturer's instructions. c) The laboratory's written procedure for Rubella Immunoglobulin G (IgG) testing stated, "If the test cannot be carried out on the same day, the serum must be stored between 2-8C for no longer than 8 days after collection." The laboratory's procedure was consistent with ASI Rubella manufacturer's instructions. d) The laboratory's written procedure for rheumatoid factor/rheumatoid arthritis (RF/RA) Latex testing stated, "If samples cannot be tested immediately, maintain them in their original tubes at 2-8C and test within 48 hours" (or can be frozen -20C or colder). The laboratory's procedure was consistent with Arlington Scientific RF/RA Latex manufacturer's Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- instructions. e) The laboratory's written procedure for human chorionic gonadotropin (hCG) testing stated, "Serum specimen may be stored at 2-8C for up to 48 hours prior to testing." The laboratory's procedure was consistent with hCG Combo kit manufacturer's instructions. Patient 00195960000 "Date: 02/27/2025" requested Sickle Cell testing, test results were reported on 02/28/2025 at 8:12 AM. Patient 0009145000 "Order Date: 02/24/2025 03:10 PM" requested RPR and Rubella IgG testing, test results were reported on 02/24/2025 at 12:33 PM. Patient 0020720000 "Order Date: 02/03/2025 at 01:02 PM" requested RA Latex testing, test results were reported on 02/04/2025 at 2:50 PM. Patient 205229 "Date: 1/27/25" requested hCG qualitative testing, test results were reported on 01/27/2025 at 12:53 PM. 3. During the exit interview on 08/27/2025 at 12:00 PM, the technical supervisor confirmed the laboratory failed to have a client services manual for referred specimens to ensure correct patient preparation, conditions of specimen transport, specimen storage /preservation, and acceptability/rejection criteria. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The facility was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity. testing; laboratory director 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 a proficiency testing desk review of the Certification and Survey Provider Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Enhanced Reporting (CASPER) 0155 report and American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) 2024 and 2025 records, the laboratory failed to successfully participate in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in the subspecialty of Routine Chemistry for the Blood Urea Nitrogen (BUN) analyte. Refer to D2096 D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (f) Failure to achieve satisfactory performance for the same analyte or test in 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 a proficiency testing desk review of the CASPER 0155 report and AAB- MLE 2024 and 2025 proficiency testing records, the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two of three consecutive testing events (2024-Event 3 and 2025-Event 2) in the subspecialty of Routine Chemistry for the BUN analyte. Findings included: 1. A review of the CASPER 0155 report revealed the following results: AAB-MLE 2024 - 3rd Event The laboratory received an unsatisfactory score of 20% for BUN. AAB-MLE 2025 - 2nd Event The laboratory received an unsatisfactory score of 60% for BUN. 2. A review of AAB-MLE 2024 and 2025 proficiency testing records confirmed the laboratory received the above results. 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 a proficiency testing desk review of the CASPER 0155 report and AAB- MLE 2024 and 2025 proficiency testing records, the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155 report and AAB- MLE 2024 and 2025 proficiency testing records, the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2096 -- 2 of 2 --

Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) (b)The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT), blood bank quality control worksheets, the laboratory's procedure manual, and in interview with the technical supervisor, the laboratory failed to test quality control (QC) before testing blood bank proficiency testing (PT) as they would with patients for 1 of 1 event in 2025. Findings included: 1. Review of American Association of Bioanalysts (AAB) Medical Laboratory Evaluation Blood Bank event 1 in 2025 included five PT samples analyzed on 02/07 /2025 (ABO Group, D Typing, and Unexpected Antibody Detection). 2. Review of Immucor CorQC Data Sheets from 02/2025 included QC performed on 02/06/2025 and 02/08/2025, but not on the day PT was tested (02/07/2025). 3. Review of the laboratory's procedure manual stated, "QUALITY CONTROL FREQUENCY: Each patient run." The laboratory failed to ensure quality control was tested before performing PT as they would with patients. 4. During an interview on 06/04/2025 at 9: 24 AM, the technical supervisor confirmed the above findings. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 14 -- Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. In addition, retain the following: This STANDARD is not met as evidenced by: Based on review of the laboratory's procedure manual, direct observation, the laboratory failed to retain Kwik-Stik package insert to ensure American Type Culture Collection (ATCC) microorganisms used for QC were maintained per manufacturer's instructions and included in their written procedure. Findings included: 1. Review of the laboratory's microbiology procedure manual revealed it did not include step-by- step procedure for plating, maintaining, and labeling QC microorganism plates. 2. During a tour of the microbiology department on 06/04/2025 at 1:36 PM, the following QC microorganism plates did not include a lot number and expiration date of the original Kwik-Stik ATCC organisms (random sampling of 17): "K. Oxytoca, 700324, 6/3" on MacConkey media "P. aeruginosa, 27853, 6/3" on MacConkey media "K. pneumoniae, 700603, 6/3" on MacConkey media "P. aeruginosa BAA, 1744, 6/3" on MacConkey media "E. coli, 35218, 6/3" on MacConkey media "S. aureus, 29213, 6 /3" on Blood Agar media "S. pneumo, 49619, 6/3" on Blood Agar media The laboratory did not have a mechanism in place to track ATCC microorganisms that had been plated and used as QC, refer to D5415. 3. During a tour of the laboratory on 06 /04/2025 at 1:36 PM, packaged unused Kwik-Stik microorganisms were observed stored in a refrigerator. 4. During an interview on 06/04/2025 at 1:36 PM, the technical supervisor confirmed the laboratory did not have Kwik-Stik package insert to follow manufacturer's instructions when inoculating the microorganisms. D5305 TEST REQUEST CFR(s): 493.1241(c) (c) The laboratory must ensure the test requisition solicits the following information: (c)(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. (c)(2) The patient's name or unique patient identifier. (c)(3) The sex and age or date of birth of the patient. (c)(4) The test(s) to be performed. (c)(5) The source of the specimen, when appropriate. (c)(6) The date and, if appropriate, time of specimen collection. (c)(7) For Pap smears, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy. (c)(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 of the laboratory's procedures, manufacturer's instructions, patient test requisitions, patient final test reports, and interview with staff, the laboratory failed to ensure collection dates and times were included in patient test requisitions when requesting tests with specimen stability requirements for 4 of 4 patients (random sampling). Findings included: 1. Review of the laboratory's procedures and manufacturer's instructions for a random sampling of testing that the laboratory performed included the following for specimen stability: a) The laboratory's written -- 2 of 14 -- procedure for Sickle Cell testing stated, "Specimens can be kept for 1 to 2 weeks at 2 to 8C." Sickledex manufacturer stated, "Blood samples stored at 1C to 10C for up to 45 days may be used for testing." b) The laboratory's written procedure for rapid plasma reagin (RPR) testing stated, "Serum samples should be tested within five (5) days of collection." The laboratory's procedure was consistent with Arlington Scientific RPR manufacturer's instructions. c) The laboratory's written procedure for Rubella Immunoglobulin G (IgG) testing stated, "If the test cannot be carried out on the same day, the serum must be stored between 2-8C for no longer than 8 days after collection." The laboratory's procedure was consistent with ASI Rubella manufacturer's instructions. d) The laboratory's written procedure for rheumatoid factor/rheumatoid arthritis (RF/RA) Latex testing stated, "If samples cannot be tested immediately, maintain them in their original tubes at 2-8C and test within 48 hours" (or can be frozen -20C or colder). The laboratory's procedure was consistent with Arlington Scientific RF/RA Latex manufacturer's instructions. e) The laboratory's written procedure for human chorionic gonadotropin (hCG) testing stated, "Serum specimen may be stored at 2-8C for up to 48 hours prior to testing." The laboratory's procedure was consistent with hCG Combo kit manufacturer's instructions. 2. Review of a random sampling of patient test requisitions did not include specimen date and time of collection to ensure specimens were not tested beyond their stability, as follows: Patient 00195960000 "Date: 02/27/2025" requested Sickle Cell testing, test results were reported on 02/28/2025 at 8:12 AM. Patient 0009145000 "Order Date: 02 /24/2025 03:10 PM" requested RPR and Rubella IgG testing, test results were reported on 02/24/2025 at 12:33 PM. Patient 0020720000 "Order Date: 02/03/2025 at 01:02 PM" requested RA Latex testing, test results were reported on 02/04/2025 at 2: 50 PM. Patient 205229 "Date: 1/27/25" requested hCG qualitative testing, test results were reported on 01/27/2025 at 12:53 PM. Reported dates and times were obtained from patient final test reports. 3. During the exit interview on 06/04/2025 at 4 PM, the laboratory staff (director of laboratory operations, the technical supervisor, billing supervisor and owner) reviewed and confirmed patient test requisitions did not include date and time of specimen collection. 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, review of procedures, manufacturer's product inserts, quality control documentation and interview, the laboratory failed to follow their own written policy for performing quality control on three screen cells for 9 of 9 days (Refer to D5401); failed to include step-by-step procedures for media quality control, setting up cultures, and performing urine colony counts in microbiology (Refer to D5403); failed to follow manufacturer's instructions for washing the needle used for rapid plasma reagin (RPR) testing for 405 tests (Refer to D5411); failed to document room and refrigerator temperatures for 107 of 107 days where testing occurred, and kits were stored, failed to define an incubator temperature range for blood bank testing for 9 of 9 months reviewed, failed to define an acceptable freezer temperature range per -- 3 of 14 -- manufacturer's instructions (Refer to D5413); failed to label 17 of 17 QC microorganism plates with a lot number and expiration dates to ensure American Type Culture Collection (ATCC) organisms were not used past their expiration dates (Refer to D5415); failed to ensure blood bank reagents were not used past their expiration date when 13 of 13 patients were tested, failed to ensure DensiChek plus Standards Kit was not used past its expiration date for 4 of 4 days (monthly frequency) in 2025, failed to ensure quality control was not used past the expiration date (Refer to D5417); failed to perform calibration verification procedures at least once every six months that included at least a minimal value, a mid-point value, and a maximum value near the upper limit to verify the laboratory's reportable range (Refer to D5439); failed to include two brain natriuretic peptide (BNP) control materials of different concentrations when patients were tested on 7 of 7 days in 2025, failed to include two controls materials of different concentrations each day of patient testing for erythrocyte sedimentation rate testing (Refer to D5447); failed to perform a positive and negative control each day of testing for moderately complex Chlamydia /Trichomonas(CT) and Neisseria gonorrhea (NG) (Refer to D5449); failed to use human chorionic gonadotropin (hCG) serum control material for the hCG Combo Rapid Test kit when used to test 5 of 5 patient serums in 2025 (Refer to D5465); and failed to check staining material each day of use (Refer to D5473). D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory's written procedure, blood bank QC data, patient worksheets, direct observation and interview with the technical supervisor, the laboratory failed to follow their own written policy for performing quality control on three screen cells for 9 of 9 days. Findings included: 1. Review of the laboratory's written procedure for blood bank stated, "Antibody Screen: REAGENTS: reagent Screening Cells I, II, III ...Antibody screening Procedure: Label 3 tubes 12 X 75 mm with Patient sample number; First three tubes add two drops of patient serum ..." 2. Review of Immucor corQC Data Sheets and patient worksheets from 2025 included the following (random sampling): 01/23/2025 - QC was performed on screening cells (lot S534) I, II, and III with "3+" results. 01/28/2025 - QC was performed on screening cells (lot S534) I, II, and III with "3+" results. Patient 3464102 antibody screen was performed with screening cells (lot S534) I and II. 02/24/2025 - QC was performed on screening cells (lot S539) I, II, and III with "3+" results. 02/26/2025 - QC was performed on screening cells (lot S539) I, II, and III with "3+" results. 02/27 /2025 - QC was performed on screening cells (lot S539) I, II, and III with "3+" results. 05/16/2025 - QC was performed on screening cells (lot S556) I, II, and II with "3+" results. 05/19/2025 - QC was performed on screening cells (lot S556) I, II, and II with "3+" results. Patient 355738 antibody screen was performed with screening cells (lot S556) I and II. 05/20/2025 - QC was performed on screening cells (lot S556) I, II, and II with "3+" results. 05/23/2025 - QC was performed on screening cells (lot S556) I, II, and II with "3+" results. 3. During a tour on 06/04/2025 at 8:25 AM, two Selectogen screening cells (lot S562) were observed stored in the refrigerator. 4. During an interview on 06/04/2025 at 9:24 AM, the technical supervisor confirmed -- 4 of 14 -- there were only two screening cells and should have not been documenting QC for three screening cells. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The facility was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity. testing; laboratory director 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 a proficiency testing desk review of the Certification and Survey Provider 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 -- Enhanced Reporting (CASPER) 0155 report and American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) 2024 records, the laboratory failed to successfully participate in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in the specialty of General Immunology for the Anti-Human Immunodeficiency Virus (HIV) analyte. Refer to D2084. D2084 GENERAL IMMUNOLOGY CFR(s): 493.837(f) Failure to achieve satisfactory performance for the same analyte or test in 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 a proficiency testing desk review of CASPER 0155 report and AAB-MLE 2024 records, the laboratory failed to achieve satisfactory performance (80% or better) for two of two consecutive testing events 2024 (Events 1 and 2) in the specialty of General Immunology for the HIV analyte. Findings included: 1. Review of the CASPER 0155 report revealed the following results: Non-Chemistry 2024-2nd Event, the laboratory received an unsatisfactory score of 0% for HIV. Non-Chemistry 2024- 3rd Event, the laboratory received an unsatisfactory score of 0 % for HIV. 2. A review of AAB-MLE 2024 proficiency testing records confirmed the laboratory received the above results. 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 a proficiency testing desk review of the CASPER 0155 report and AAB- MLE 2024 proficiency testing records, the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016. 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 a proficiency testing desk review of the CASPER 0155 report and AAB- -- 2 of 3 -- MLE 2024 proficiency testing records, the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2084. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The facility was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6076 - 42 C.F.R. 493.1441 Condition: Laboratories performing high complexity testing; laboratory director; 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 a proficiency testing desk review of the Certification and Survey Provider 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 -- Enhanced Reporting (CASPER) 0155 report and American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) 2023-2024 records, the laboratory failed to successfully participate in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in the subspecialty of Bacteriology and in the subspecialty of Routine Chemistry for the Total Bilirubin analyte. Refer to D2028 and D2096. 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 a proficiency testing desk review of AAB-MLE 2023, 2024 proficiency testing records and the CASPER 0155 report, the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two of three consecutive testing events (2023 Event 2 and 2024 Event 1) in the subspecialty of Bacteriology. Findings included: 1. Review of AAB-MLE 2023 and 2024 proficiency testing records revealed the following results: AAB-MLE Non-Chemistry 2023 - 2nd Event The laboratory received an unsatisfactory score of 78.2 % for Bacteriology. AAB-MLE Non-Chemistry 2024 - 1st Event The laboratory received an unsatisfactory score of 70.9 % for Bacteriology. 2. A review the CASPER 0155 report confirmed the laboratory failed to successfully participate in the subspecialty of Bacteriology. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in 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 a proficiency testing desk review of the CASPER 0155 report and AAB- MLE 2024 proficiency testing records, the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two of two consecutive testing events (2024 Events 1 and 2) in the subspecialty of Routine Chemistry for the Total Bilirubin analyte. Findings included: 1. Review of the CASPER 0155 report revealed the following results: AAB-MLE Chemistry 2024 - 1st Event The laboratory received an unsatisfactory score of 40% for Total Bilirubin. AAB-MLE Chemistry 2024 - 2nd Event The laboratory received an unsatisfactory score of 40 % for Total Bilirubin. 2. A review of AAB-MLE 2024 proficiency testing records confirmed the laboratory received the above results. 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 a proficiency testing desk review of the CASPER 0155 report and AAB- MLE 2024 proficiency testing records, the laboratory director failed to provide overall management and direction of the laboratory services. 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 a proficiency testing desk review of the CASPER 0155 report and AAB- MLE 2024 proficiency testing records, the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2028 and D2096. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Centers for Medicare & Medicaid Services (CMS) New York CLIA Branch Location federal surveyor conducted an announced CLIA recertification survey at Clinical Laboratory Inc. on March 21, 2023. The laboratory was surveyed under 42 CFR part 493 CLIA requirements. The following deficiencies was found during the announced routine CLIA recertification survey performed on March 21, 2023. 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 review with the laboratory procedures and interview with testing personnel (TP) #1 and #5, the laboratory failed to establish a competency assessment procedure that assess the competency of testing personnel for each test procedure performed and that assesses the competency of consultants/supervisors for their supervisor responsibilities from March 2021 to March 2023. Findings Include: 1. On March 21, 2023 around 12:45 pm, review of laboratory procedures revealed, the laboratory's competency assessment procedure did not state to assesses the competency of testing personnel for each test procedure performed and to assess the of consultants /supervisors for their regulatory responsibilities. 2. TP Competencies performed from 2021 and 2022 did not assess TP for each test system they performed. 3. The Technical consultant/technical supervisor and general supervisor were not assessed for their supervisory responsibilities performed in 2021 and 2022. 4. TP#1 confirmed the above findings on March 21, 2023 around 4:00 pm D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D0000 An unannounced CLIA off-site proficiency testing (PT) desk review for Clinical Laboratory Inc. was conducted on March 7, 2022 by a federal surveyor from the Centers for Medicare and Medicaid Services, CLIA New York Operation Branch. The laboratory was inspected under 42 CFR Part 493 CLIA regulations. Specific deficiencies cited are as follows: 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 off-site review of the CASPER 0153D report (Unsuccessful proficiency testing (PT) report), CASPER 0155D report (Individual Laboratory Profile the laboratory) and performance evaluations from the proficiency testing organization Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- American Association of Bioanalysts (AAB), the laboratory failed to achieve satisfactory performance of at least 80% for three consecutive events for Parasitology and total bilirubin for the second and third testing events in 2021. Findings include: Please refer to: - D2055. - D2096. 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 off-site review of the CASPER 0153D report (Unsuccessful proficiency testing (PT) report), CASPER 0155D report (Individual Laboratory Profile the laboratory) and performance evaluations from the proficiency testing organization American Association of Bioanalysts (AAB), the laboratory failed to achieve satisfactory performance of at least 80% for two out of three consecutive events in the specialty of Parasitology for the second and third testing events in 2021. Findings include: 1. Based on an offsite PT desk review performed on 03/07/2022 at 10:30 am and review of the CASPER 0153D, 0155D, and AAB performance evaluation reports, the laboratory failed to achieve satisfactory scores for the following two out of three consecutive events in 2021: a. Analyte: 0035 Parasitology - i. AAB 2021 2nd event 60%. ii. AAB 2021 3rd event 60%. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in 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 off-site review of the CASPER 0153D report (Unsuccessful proficiency testing (PT) report), CASPER 0155D report (Individual Laboratory Profile the laboratory) and performance evaluations from the proficiency testing organization American Association of Bioanalysts (AAB), the laboratory failed to achieve satisfactory performance of at least 80% for two out of three consecutive events for the analyte Total Bilirubin which is in the specialty of Chemistry for the second and third testing events in 2021. Findings include: 1. Based on an offsite PT desk review performed on 03/07/2022 at 10:30 am and review of the CASPER 0153D, 0155D, and AAB performance evaluation reports, the laboratory failed to achieve satisfactory scores for the following two out of three consecutive events in 2021: a. Analyte: 0305 Total Bilirubin - i. AAB 2021 2nd event 20%. ii. AAB 2021 3rd event 60%. -- 2 of 2 --