American Health S, Llc

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review survey of proficiency testing (PT) scores obtained from the Certification and Survey Provider Enhanced Reporting (CASPER) 0155 report and the College of American Pathologists (CAP) PT agency. 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: 493.803 Condition: Successful participation. D6000: 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: 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 -- Based on a desk review of the CASPER 0155 report and the 2025 CAP PT records, the laboratory failed to successfully participate in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in the subspecialty of Endocrinology and for the Thyroid-Stimulating Hormone (TSH) analyte. Refer to D2107 and D2108. D2107 ENDOCRINOLOGY CFR(s): 493.843(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 desk review of the CASPER 0155 report and the 2025 CAP PT records (Events 1 and 3), the laboratory failed to achieve satisfactory performance (80% or better) for the same analyte in two of three consecutive testing events in the subspecialty of Endocrinology for the TSH analyte. The findings include: 1. A review of the CASPER 0155 report revealed a 0% score for the TSH analyte for 2025 Events 1 and 3. 2. A review of the CAP PT records confirmed the laboratory received the above results. D2108 ENDOCRINOLOGY CFR(s): 493.843(g) (g) 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 desk review of the CASPER 0155 report, CAP PT 2025 records (Events 1 and 3), and interviews, the laboratory failed to achieve an overall satisfactory performance (80% or greater) for two out of three consecutive testing events in the subspecialty of Endocrinology. The findings include: 1. A review of the CASPER 0155 report revealed that the laboratory received the following scores for the Endocrinology subspecialty: 2025 Event 1: 37% 2025 Event 3: 72% 2. A review of the 2025 CAP PT records (Events 1 and 3) revealed the laboratory received the following scores for the Endocrinology subspecialty: 2025 Event 1 (K-A Ligand- General): 38% 2025 Event 3 (Parathyroid Hormone (PTH)-C): 73% 3. A phone interview with the CAP customer support specialist on 01/05/2026 at 3:00 pm 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. -- 2 of 3 -- This CONDITION is not met as evidenced by: Based on a desk review of the CASPER 0155 report and the 2025 CAP PT records, the laboratory director failed to provide overall management and direction of the laboratory services. The laboratory director failed to ensure proficiency testing samples were tested as required. 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 desk review of the CASPER 0155 report and the 2025 CAP PT records (Events 1 and 3), the laboratory director failed to ensure proficiency testing samples were tested as required. The laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2107 and D2108. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing (PT) scores obtained from the Certification and Survey Provider Enhanced Reporting (CASPER) 0155 report and verified with the College of American Pathologists (CAP) PT agency. The facility was found to be out of compliance with the following CONDITION LEVEL DEFICIENCIES: 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: 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 -- Based on a desk review of PT scores from the CASPER 0155 report and the CAP PT 2025 records, the laboratory failed to successfully participate in a PT program approved by the Health and Human Services (HHS), for each specialty, subspecialty, and analyte or test in which the laboratory is certified under Clinical Laboratory Improvement Amendments (CLIA). The laboratory failed to successfully participate in the specialty of Routine Chemistry and for the analyte Triiodothyronine. Refer to D2097 and D2107. . D2097 ROUTINE CHEMISTRY CFR(s): 493.841(g) (g) 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 desk review of the CASPER 0155 and the laboratory's CAP PT evaluation reports, the laboratory failed to achieve satisfactory performance for the overall specialty of Routine Chemistry in two of three PT events in 2025. The findings include: 1. A review of the CMS 155 report revealed the following unsatisfactory Routine Chemistry PT event scores: -2025 Event 1: 12% -2025 Event 2: 12% 2. A review of the CAP 2025 PT records (Ligand General K-A 2025 and K-B 2025) confirmed that the laboratory received the above results. . D2107 ENDOCRINOLOGY CFR(s): 493.843(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 desk review of the CASPER 0155 and the laboratory's 2025 CAP PT evaluation reports (Events 1 and 2), the laboratory failed to achieve satisfactory performance (80% or better) for the same analyte in two consecutive testing events for the Triiodothyronine analyte in 2025. The findings include: 1. A review of the CASPER 0155 report revealed the following results: - 2025 Event 1: The laboratory received a 0% score for Triiodothyronine. - 2025 Event 2: The laboratory received a 0% score for Triiodothyronine 2. A review of the CAP PT records (Ligand General K- A 2025 and K-B 2025) confirmed that 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 PT desk review of the CASPER 0155 report and CAP PT 2025 records, -- 2 of 3 -- the laboratory director failed to provide overall management and direction of the laboratory services. The laboratory director failed to ensure PT samples were tested as required. 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 PT desk review of the CASPER 0155 report and CAP PT 2025 records, the laboratory director failed to ensure PT samples were tested as required. The laboratory director failed to ensure successful participation in an HHS-approved PT program. Refer to D2097 and D2107. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing (PT) scores obtained from the Certification and Survey Provider Enhanced Reporting (CASPER) 0155 report and verified with the College of American Pathologists (CAP) PT agency. The facility was found to be out of compliance with the following CONDITION LEVEL DEFICIENCIES: 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: 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 -- Based on a desk review of PT scores from the CASPER 0155 report and the CAP PT 2025 records, the laboratory failed to successfully participate in a PT program approved by the Health and Human Services (HHS), for each specialty, subspecialty, and analyte or test in which the laboratory is certified under Clinical Laboratory Improvement Amendments (CLIA). The laboratory failed to successfully participate in the subspecialty of Toxicology and for the analytes Carbamazepine, Digoxin, Gentamicin, Phenobarbital, Phenytoin, Theophylline, Tobramycin, Valproic Acid, Alanine Aminotransferase (ALT) (SGPT), Albumin, Alkaline Phosphatase (Alk. Phos), Amylase, Aspartate Aminotransferase (AST) (SGOT), Bilirubin (Bili Total), Calcium (Ca Total), Chloride (Cl), Cholesterol Total, Cholesterol High-density lipoprotein (HDL) (Cholesterol, HDL), Creatine Kinase (CK Total), Creatinine, Glucose (Non-waived), Iron Total, Lactate Dehydrogenase (LDH Total), Magnesium (Mg), Potassium (K), Sodium (NA), Total Protein, Triglyceride (TRIGL), Blood Urea Nitrogen (BUN), and Uric Acid. Refer to D2096, D2118, and D2119. 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 PT desk review survey of the CASPER 0155 report and the CAP PT 2025 records (Events one and two), the laboratory failed to achieve satisfactory performance (80% or better) for the same analytes for two consecutive testing events in Routine Chemistry for the ALT (SGPT), Albumin, Alk. Phos, Amylase, AST (SGOT), Bili Total, Ca Total, Cl, Cholesterol Total, Cholesterol HDL, CK Total, Creatinine, Glucose (Non-Waived), Iron Total, LDH Total, Mg, K, Na, Total Protein, TRIGL, BUN, and Uric Acid analytes. The findings include: 1. A review of the CASPER 0155 report revealed the following results: 2025- Event One: The laboratory received an unsatisfactory score of 0% for ALT (SGPT), Albumin, Alk. Phos, Amylase, AST (SGOT), Bili Total, Ca Total, Cl, Cholesterol Total, Cholesterol HDL, CK Total, Creatinine, Glucose (Non-Waived), Iron Total, LDH Total, Mg, K, Na, Total Protein, TRIGL, BUN, and Uric Acid analytes. 2025- Event Two: The laboratory received an unsatisfactory score of 0% for ALT (SGPT), Albumin, Alk. Phos, Amylase, AST (SGOT), Bili Total, Ca Total, Cl, Cholesterol Total, Cholesterol HDL, CK Total, Creatinine, Glucose (Non-Waived), Iron Total, LDH Total, Mg, K, Na, Total Protein, TRIGL, BUN, and Uric Acid analytes. 2. A review of the CAP PT records (General Chemistry/Therapeutic Drugs C-A 2025 and C-B 2025) confirmed that the laboratory received the above results. Word Key: % - percent D2118 TOXICOLOGY CFR(s): 493.845(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 PT desk review survey of the CASPER 0155 report and the CAP PT 2025 -- 2 of 4 -- records (Events one and two), the laboratory failed to achieve satisfactory performance (80% or better) for the same analytes for two consecutive testing events in the subspecialty of Toxicology for the Carbamazepine, Digoxin, Gentamicin, Phenobarbital, Phenytoin, Theophylline, Tobramycin, and Valproic Acid analytes. The findings include: 1. A review of the CASPER 0155 report revealed the following results: 2025- Event One: The laboratory received an unsatisfactory score of 0% for the Carbamazepine, Digoxin, Gentamicin, Phenobarbital, Phenytoin, Theophylline, Tobramycin, and Valproic Acid analytes. 2025- Event Two: The laboratory received an unsatisfactory score of 0% for the Carbamazepine, Digoxin, Gentamicin, Phenobarbital, Phenytoin, Theophylline, Tobramycin, and Valproic Acid analytes. 2. A review of the CAP PT records (General Chemistry/Therapeutic Drugs C-A 2025 and C-B 2025) confirmed that the laboratory received the above results. D2119 TOXICOLOGY CFR(s): 493.845(g) (g) 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 PT desk review of the CASPER 0155 report and the CAP PT 2025 records (Events one and two), the laboratory failed to achieve an overall satisfactory performance (80% or greater) for two consecutive testing events in the subspecialty of Toxicology. The findings include: 1. A review of the CASPER 0155 report revealed the following: 2025 Event One: The laboratory received an overall unsatisfactory score of 0% for Toxicology. 2025 Event Two: The laboratory received an overall unsatisfactory score of 0% for Toxicology. 2. A review of the CAP PT records (General Chemistry/Therapeutic Drugs C-A 2025 and C-B 2025) confirmed that 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 PT desk review of the CASPER 0155 report and CAP 2025 records, the laboratory director failed to provide overall management and direction of the laboratory services. The laboratory director failed to ensure PT samples were tested as required. 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; -- 3 of 4 -- This STANDARD is not met as evidenced by: Based on a PT desk review of the CASPER 0155 report and CAP 2025 records, the laboratory director failed to ensure PT samples were tested as required. The laboratory director failed to ensure successful participation in an HHS-approved PT program. Refer to D2096, D2118, and D2119. -- 4 of 4 --

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of test system policy's and procedures, review of the laboratory's Quality Assurance and Improvement Plan, lack of records, and staff interview, the laboratory failed to retain the complete blood count (CBC) quality control (QC) manufacturer assay sheets used to establish Quality Control (QC) ranges for the Beckman Coulter UniCel DxH 900 in 2021, 2022, or 2023. The findings include: 1. Observation of the laboratory on 11/13/23 at 8:30 a.m. revealed the following: - Two Beckman Coulter UniCel DxH 900 (SNs BD09124 & BD09125) test systems in use for hematology patient testing. - Beckman Coulter 6C commercial controls, current lots 5140 (exp 12/24/23) and 3510 exp 11/28/23 were in use for performing quality control on the DxH 900 test systems. 2. Review of the laboratory's "UniCel DxH Coulter Cellular Analysis System" policy revealed "When using the recommended Beckman Coulter commercial controls, refer to the package insert." 3. Review of the laboratory's Quality Assurance and Improvement Plan revealed "All routine laboratory records are kept for 2 years and the current one." 4. Review of laboratory records revealed no Beckman Coulter 6C commercial controls package inserts had been retained for lots used in 2021, 2022 or 2023. 5. Interview with the Technical Consultant and Director of Quality on 11/13/23 at 4:30 p.m. confirmed the manufacturer assay sheets used to establish Quality Control (QC) ranges for the Beckman Coulter UniCel DxH 900 test systems were not retained in 2021, 2022, or 2023. 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 -- 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 of the laboratory's procedure manual, testing personnel (TP) records, and staff interview, the laboratory failed to follow its own policy for documenting competency assessments for 2 of 5 testing personnel in 2021 and 2022. The findings include: 1. Review of the General Laboratory Personnel policy revealed "Competencies will be performed upon initial hire, at 6 months and annually thereafter". 2. Review of competency assessment documents for testing personnel revealed the following: - No documented initial or 6-month competency assessments for TP2 in 2022. - No documented annual competency for TP1 in 2021 and 2022. 3. Interview with the Technical Consultant and Director of Quality on 11/13/23 at 4:30 p. m. confirmed the laboratory did not follow their own policy for documenting initial, 6- month, and annual competency assessments for 2 of 5 testing personnel in 2021 and 2022. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedure manual, Laboratory Personnel Report (Form CMS-209), and staff interview, the current laboratory director failed to approve the laboratory's procedures. The findings include: 1. Review of the laboratory's written policy and procedure manuals revealed no signature or date indicating approval by the current laboratory director as listed by the laboratory on form CMS- 209. 2. Interview with the Laboratory Director on 11/13/23 at 4:30 p.m. confirmed the current laboratory director began on 09/22/2023 and had not approved the policies and procedures. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the Sysmex CS2500 operator's -- 2 of 4 -- manual, humidity logs, and staff interview, the laboratory failed to maintain appropriate operating humidity levels in the laboratory for the Sysmex CS2500 test system used in patient testing in 2021, 2022, and 2023 for a total of 279 days. The findings include: 1. Observation of the laboratory on 11/13/23 at 8:30 a.m. revealed two Sysmex CS2500 (SNs 21643 & 21650) coagulation analyzers in use for coagulation patient testing. 2. Review of the Sysmex CS2500 operator's manual revealed the operating humidity range for the test system to be 30% - 85%. 3. Review of the humidity logs revealed that the humidity was out of range for 96 of 365 days in 2021, 101 of 365 days in 2022, and 82 of 317 days in 2023. 4. Interview with the Technical Consultant and Director of Quality on 11/13/23 at 4:30 p.m. confirmed the laboratory failed to ensure the humidity was within manufacturer's acceptable range for the Sysmex CS2500 test system used for patient testing in 2021, 2022 and 2023 for a total of 279 days. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Citation #1 Based on observation of the laboratory and staff interview, the laboratory failed to label containers of staining reagents used for preparing patient peripheral blood smears with contents, lot numbers, preparation dates, and expiration dates. The findings include: 1. Observation of the laboratory on 11/13/23 at 08:30 a.m. revealed containers of staining solutions in use for staining patient peripheral blood. The containers were not labeled with contents, lot numbers, storage requirements or preparation and expiration dates. 2. Interview with the Technical Consultant and Director of Quality on 11/13/23 at 4:30 p.m. confirmed the laboratory did not label containers of staining reagents with contents, lot numbers, storage requirements or preparation and expiration dates. Citation #2 Based on observation of the laboratory, review of manufacturer's instructions for use, the laboratory's policies and procedure manual, and staff interview, the laboratory failed to label Beckman Coulter 6C commercial control with open dates and updated expiration dates. The findings include: 1. Observation of the laboratory on 11/13/23 at 08:30 a.m. revealed the Beckman Coulter UniCel DxH 900 (SN: BD09124 & BD09125) test systems using Beckman Coulter 6C commercial controls (lot: 5140 exp.: 12/24/23 and Lot: 3510 exp.: 11/28/23). The control vials lacked an open and an updated expiration date. 2. The Coulter 6C Control instructions for use states the controls have a 16 day open vial stability and will be "performed a maximum of 18 times within 16 days." 3. Review of the laboratory policies and procedure manual revealed the following statement under the "Laboratory Policies: General Laboratory" section: "1. All reagents, standards, controls, etc. must be labeled with Date Received, Date Opened, Expiration Date" 4. Interview with the Technical Consultant and Director of Quality on 11/13/23 at 4:30 p.m. confirmed the laboratory did not label the Beckman Coulter 6C commercial controls used for quality control of the Beckman Coulter UniCel DxH 900 hematology test systems with opened and updated expiration dates. D6004 LABORATORY DIRECTOR RESPONSIBILITIES -- 3 of 4 -- CFR(s): 493.1407(a)(b) 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. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on review of the Clinical Laboratory Improvement Amendments (CLIA) certificate of compliance, CLIA Application for Certification (form CMS-116), Laboratory Personnel Report CLIA (form CMS-209), and staff interview, the laboratory director failed to ensure compliance with regulation 493.51(a)(4) by not notifying the department of Health and Human Services (HHS) state agency within 30 days of when the laboratory director personnel changed on 09/22/23. The findings include: 1. Review of the CLIA certificate of Compliance revealed the laboratory director was not the same as the laboratory director listed on the forms CMS-116 and CMS-209 completed for the survey conducted on 11/13/2023. 2. Interview on 11/13 /2023 at 4:30 p.m. with the Laboratory Director, Technical Consultant, and Director of Quality confirmed the laboratory failed to notify the HHS state agency within 30 days of when the laboratory director changed on 09/22/23. -- 4 of 4 --

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: =================================== The laboratory failed to maintain satisfactory participation in two out of three events for the Blood Urea Nitrogen (BUN) analyte resulting in the initial unsuccessful proficiency testing (PT) occurrence for BUN (Refer to 2087) =================================== D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) 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 -- 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 a desk review survey of the CMS CASPER Report 0155D, the laboratory's 2021 and 2022 Proficiency Testing (PT) performance summary records from the College of American Pathologists (CAP) Proficiency Testing program, and phone interview with the lab manager, the laboratory failed to maintain satisfactory performance for the Blood Urea Nitrogen (BUN) analyte for the 3rd event 2021 and the 2nd event 2022, resulting in the initial unsuccessful PT occurrence. The findings include: 1. A review of the CMS 0155D report revealed unsatisfactory BUN analyte scores of 60% for the 3rd event of 2021 and 60% for the 2nd event of 2022. 2. A review of the laboratory's CAP Proficiency Testing records revealed unsatisfactory BUN analyte scores of 60% for the 3rd event of 2021 and 60% for the 2nd event of 2022, resulting in the initial unsuccessful PT occurrence. 3. Phone interview with the laboratory manager on November 8, 2022 at approximately 10:00 am confirmed the survey findings. =================================== -- 2 of 2 --

Summary Statement of Deficiencies D0000 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: The laboratory failed to maintain satisfactory performance in 3 out of 4 proficiency testing (PT) events for the analyte Triiodothyronine (T3) resulting in a 2nd unsuccessful PT. (Refer to D2107) D2107 ENDOCRINOLOGY CFR(s): 493.843(f) 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 -- 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 review of the Centers for Medicare and Medicaid Services (CMS) CASPER report 155/153 and the College of American Pathologist (CAP) performance summary revealed the laboratory failed to achieve successful performance for the analyte Triiodothyronine (T3) in the 3rd event 2019, 1st and 3rd event 2020 resulting in the 2nd unsuccessful PT occurrence. The findings include: 1. Review of the CMS CASPER report 155/153 revealed a score of 0% for the 3rd event 2019, a score of 20% for the 1st event 2020 and a score of 0% for the 3rd event 2020 for the analyte T3. 2. Review of the CAP performance summary report revealed a score of 0% for the 3rd event 2019, a score of 20% for the 1st event 2020 and a score of 0% for the 3rd event 2020 for the analyte T3. 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: The Laboratory Director failed to ensure the laboratory follow the May 15, 2020

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 a Proficiency Test (PT) Desk review of the Centers for Medicare and Medicaid Services CASPER report 155/153 and the proficiency testing agency, College of American Pathologist (CAP) performance summary determined the laboratory failed to maintain successful performance for the analyte Triiodothyronnine (T3) in the 3rd event 2019 and 1st event 2020 resulting in the 1st unsuccessful PT occurrence. (Refer to 2096). D2096 ROUTINE CHEMISTRY Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- CFR(s): 493.841(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 review of the CMS CASPER report 155/153 and the CAP performance summary revealed the laboratory failed to achieve successful performance for the analyte Triiodothyronnine (T3) in the 3rd event 2019 and the 1st event 2020 resulting in the 1st unsuccessful PT occurrence. The findings include: 1. Review of the CMS CASPER report 155/153 revealed a score of 0% for the 3rd event 2019 and a score of 20% for the 1st event 2020 for the analyte T3. 2. Review of the CAP performance summary report revealed a score of 0% for the 3rd event 2019 and a score of 20% for the 1st event 2020 for the analyte T3. -- 2 of 2 --