American Health Associates, Inc

Summary Statement of Deficiencies D0000 An announced onsite CLIA recertification survey was conducted on May 19, 2026, at American Health Associates, LLC dba American Health Associates of Spartanburg by the South Carolina Department of Public Health (SC DPH) Bureau of Nursing Homes and Medical Services. The laboratory was found to be out of compliance with Medicare condition 42 CFR Part 493, CLIA requirements for laboratories. The following are a list of STANDARD LEVEL deficiencies cited as a result of recertification survey conducted on May 19, 2026: D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on record review, lack of documentation of written procedures, and staff interview, the laboratory failed to have updated written policies and procedures to follow that ensure optimum integrity of patient's specimen from the time of collection or receipt of the specimen through completion of testing and the reporting of results for 3 out of 3 specialties/subspecialities reviewed (Diagnostic Immunology, Chemistry, and Hematology). Findings included: 1. Review of CMS 116 application reveals the laboratory performs testing in the specialty and subspecialty of diagnostic immunology, chemistry, and hematology. 2. A review of random patient chemistry results revealed the following: a. Instrument printout dated October 31, 2023, 06:02, S. No.0048 S.ID B1969744, Na/l 129, GLUC 58, K/L 3.8, BUN 16, Cl/1 105, CRE 0.75, CO2 28 b. Instrument printout dated October 31, 2023, 06:02, S. No. H0007 S. ID B1969692 c. Instrument printout dated October 31, 2023, 06:02, S.No.0052 S. ID B1969750, Na/l 143, k/L 4.3, Cl/1 105, co2 24, ALT 4, GLUC 62, BUN 29, CRE 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 -- 0.98, TP 6.3, ALB 2.87 d. Instrument printout dated October 31, 2023, 06:02, S. No. 0053 S. ID Na/2 141, K/2 4.5, Cl/l 100, co 28,GLUC 68, BUN 17, CRE 0.94 e. Instrument printout dated October 31, 2023, 06:02, S. No.0057 S. ID B1969755, Na/2 135, K/2 4.5, cl/2 95, co2 31, GLUC 79, BUN 16, CRE 0.75 f. Instrument printout dated July 18, 2025, 06:02, S. No. H0006 S. ID B2100168, Na/l 147, GLUC 41 The above test results are examples of tests that were potentially affected due to a lack of updated policies and procedures (last updated June 2010) for current analyzers following the manufacturer's instructions for processing of clinical specimens. 3. In an interview on May 19, 2026, at 3:07 pm in the office with the testing personnel (TP) TP2 the above findings were confirmed. 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 records review, lack of documentation and staff interview, the laboratory failed to document twice annual accuracy accessment of the Laboratory Information System (LIS) as part of the Quality Assurance Plan (QA). Findings including: 1. Review of the laboratory's QA plan (dated June2010) reveals a lack of policy and procedure requirement for twice annual accuracy assessment for the LIS. 2. Review of laboratory records reveals a lack of documentation for twice annual accuracy assessments for the LIS.(signed off 6/17/10) 3. In an interview with the testing personnel (TP2) on May 19, 2026, in the office at 3:08pm, the findings were confirmed. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) (a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (a)(1) Patient preparation. (a)(2) Specimen collection. (a)(3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (a)(4) Specimen storage and preservation. (a)(5) Conditions for specimen transportation. (a)(6) Specimen processing. (a)(7) Specimen acceptability and rejection. (a)(8) Specimen referral. This STANDARD is not met as evidenced by: Based on records review, lack of documentation, and staff interview, the laboratory failed to establish and/or follow written policies and procedures based on manufacturer's instructions for specimen submission, handling, referral requirements, preservation, and transportation as outlined by the manufacturer as required 493.1242 (a) (4) (5) (6) in the for 4 out of 4 (Calcium, Glucose, Potassium, and Activated Partial Thrombin Time) analytes requiring specified specimen handling prior to testing. Findings included: 1. Review of Beckman Coulter 5800 user manual reveals specific specimen requirements for the following analytes: a. Calcium -separate from the red cells as soon as possible b. Glucose-separate red cells rapidly to minimize loss of glucose through glycolysis c. Potassium-sample free from hemolysis; separate red cells from serum as soon as possible 2. A review of Siemens Healthcare Diagnostics Sysmex CS-2500 System Installation Package Rev 1.0 reveals Activated Partial -- 2 of 4 -- Thromboplastin Time (APTT)- use heparinized sample, centrifuge within 1 hour, 18- 24 Celsius, test within 4 hours of collection. 3. The surveyor requested from the laboratory and the laboratory failed to provide written procedures for staff/specimen collectors, and/or clients noting the specific specimen requirements for 4 out of 4 (Calcium, Glucose, Potassium, and APTT) analytes on the day of inspection. 4. In an interview on May 19, 2026, at 3:07 pm in the office with the testing personnel (TP) TP2 the above findings were confirmed. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on record review, lack of documentation, and staff interview, the laboratory failed to have an established written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified as required 493.1241 through 493.1242 for the 3 out of 3 years reviewed (2023, 2024, and 2025). Findings included: 1. Review of policy and procedure titled "Quality Assurance and Improvement Plan"(dated 6/17/2010) reveals section IV, Quality Assurance Plan, A. Procedure Manuals, lack a section and/or procedure for collection/transportation of specimens. 2. Review of patient results reveals the following results were potentially affected due to specimen handling and /or transportation. a. Instrument printout dated October 31, 2023, 06:02, S.No.0048 S. ID B1969744, Na/l 129, GLUC 58, K/L 3.8, BUN 16, Cl/1 105, CRE 0.75, CO2 28 b. Instrument printout dated October 31, 2023, 06:02, S. No. H0007 S. ID B1969692 c. Instrument printout dated October 31, 2023, 06:02, S.No.0052 S. ID B1969750, Na/l 143, k/L 4.3, Cl/1 105, co2 24, ALT 4, GLUC 62, BUN 29, CRE 0.98, TP 6.3, ALB 2.87 d. Instrument printout dated October 31, 2023, 06:02, S. No. 0053 S. ID Na/2 141, K/2 4.5, Cl/l 100, co 28,GLUC 68, BUN 17, CRE 0.94 e. Instrument printout dated October 31, 2023, 06:02, S. No.0057 S. ID B1969755, Na/2 135, K/2 4.5, cl/2 95, co2 31, GLUC 79, BUN 16, CRE 0.75 f. Instrument printout dated July 18, 2025, 06:02, S. No. H0006 S. ID B2100168, Na/l 147, GLUC 41 Sodium=Na/ Potassium= K /l Chloride=Cl Carbon Dioxide= CO2 Alanine Transaminase=ALT Glucose=GLUC Blood urea nitrogen=BUN Creatinine=CRE TOTAL PROTEIN=TP ALBUMIN=ALB 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 direct observation, lack of documentation, and staff interview, the laboratory failed to establish approved procedures for new/current analyzers in use, and date the initial use and discontinuance of procedures not in use as required 493.1251 for 3 out -- 3 of 4 -- of 3 years reviewed (2023, 2024, and 2025). Findings included: 1. During a laboratory tour on May 19, 2026, at 11:20 am the following instrumentation was observed: a. Beckman Coulter AU5800 Chemistry Analyzer b. Beckman Coulter DXH 900 Hematology Analyzer c. iSED ESR Analyzer d. Sysmex Coagulation CS-2500 Analyzer e. Beckman Coulter Automated Urinalysis Solution DXU Iris 2. The surveyor requested and the laboratory failed to provide procedures approved by laboratory director for the following instrumentation: a. Beckman Coulter AU5800 Chemistry Analyzer b. Beckman Coulter DXH 900 Hematology Analyzer c. iSED ESR Analyzer d. Sysmex Coagulation CS-2500 Analyzer e. Beckman Coulter Automated Urinalysis Solution DXU Iris 3. In an interview on May 19, 2026, at 3:07 pm in the office with the testing personnel (TP) TP2 the above findings were confirmed. D5409 PROCEDURE MANUAL CFR(s): 493.1251(e) (e) The laboratory must maintain a copy of each procedure with the dates of initial use and discontinuance as described in 493.1105(a)(2). This STANDARD is not met as evidenced by: Based on direct observation, lack of documentation, and staff interview, the laboratory failed to date the initial use and discontinuance of procedures not in use as required 493.1251 for 3 out of 3 years reviewed (2023, 2024, and 2025). Findings included: 1. During a laboratory tour on May 19, 2026, at 11:20 am the following instrumentation was observed: a. Beckman Coulter AU5800 Chemistry Analyzer b. Beckman Coulter DXH 900 Hematology Analyzer c. iSED ESR Analyzer d. Sysmex Coagulation CS- 2500 Analyzer e. Beckman Coulter Automated Urinalysis Solution DXU Iris 2. Review of the procedure manual reveals a lack of documentation for the new instrumentation observed and noted in the laboratory on the day of inspection. 3. In an interview on May 19, 2026, at 3:07 pm in the office with the testing personnel (TP) TP2 the above findings were confirmed. D6045 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(7) (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; This STANDARD is not met as evidenced by: Based on records review (testing personnel competency records) and staff interview, the TC failed to document initial and annual competency assessments for 2 out of 2 TP. Findings included: 1. Review of the Quality Assurance and Improvement Plan dated 6/17/10 reveals the requirement of initial and annual competency for staff 2. Review of competency documentation reveals a lack of initial and annual competency assessments for TP1 and TP2. 3. Review of personnel competency documentation identifies each competency evaluation as being semiannaul. 4. In an interview with the TP2 on May 19, 2026 at 3:08pm in the office, the findings were confirmed. -- 4 of 4 --

Summary Statement of Deficiencies D0000 The following deficiencies are the 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 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 College of American Pathology (CAP) 2024 records, the laboratory had not successfully participated 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 Chemistry for Endocrinology and T3 Uptake analyte. Refer to 2096 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 a PT Desk review survey performed on 12/05/2024, based on review of CASPER report 155D and graded proficiency reports from CAP, revealed that the laboratory failed to achieve a satisfactory score of 80% for Endocrinology and T3 UPTAKE on two consecutive proficiency testing events. Findings include: 1. The CASPER 155D report revealed the following results: Chemistry 2024-1st Event the laboratory received an unsatisfactory score for Endocrinology, 66% T3 Uptake, 0% Chemistry 2024-2nd Event the laboratory received an unsatisfactory score for Endocrinology, 66% T3 Uptake, 0% 2. A review of CAP Proficiency Testing records confirmed the laboratory received the above results. Scores less than 80% for the analyte indicate failure or unsatisfactory performance. A failure of the analyte for two out of three testing events is scored as unsuccessful. 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: During a PT Desk review performed on 12/05/2024, based on review of the CASPER 155D and graded report from CAP, it was determined that the laboratory failed to achieve satisfactory performance for Endocrinology and T3 Uptake in two consecutive testing events (2024, Event 1 and 2) See D2087. 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 proficiency testing desk review of CASPER 0155D report and CAP 2024 records, the laboratory director failed to provide overall management and direction of the laboratory services. Refer 6016 -- 2 of 3 -- 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 proficiency testing desk review of CASPER 0155D report and CAP Testing 2024 records, the laboratory director failed to ensure that 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. -- 3 of 3 --

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: During a PT desk review on 03/11/2021, based on the CASPER 155D report and proficency testing results review from College of American Pathologists (CAP), the laboratory failed to successfully participate in proficiency testing for the sub-specialty of hematology, the analyte partial thromboplastin time (PTT) and prothrombin time (PT), for two of three consecutive proficiency events (2020, Events 1 and 3). See D2121 and D2130. D2121 HEMATOLOGY CFR(s): 493.851(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: During a proficiency testing desk review performed on 03/11/2021, based on review of the CASPER report 155D and laboratory proficiency testing records (graded report from CAP), it was determined that the laboratory failed to attain a score of at least 80 percent in proficiency testing for the specialty of hematology, the analytes PTT, and PT for two of three consecutive proficiency testing events (2020, Events 1 and 3). The findings include: 1. Review of CASPER report 155D revealed the following proficiency scores for your laboratory for 2020 Event 1: a. PTT: 0% b. PT: 0% Review of CASPER report 155D revealed the following proficiency scores for your laboratory for 2020 Event 3: a. PTT: 0% b. PT: 0% 2. The scores were confirmed upon review of the graded CAP reports. Scores less than 80% for these analytes indicate failure or unsatisfactory performance. A failure of the analytes for two consecutive or two out of three testing events is scored as unsuccessful. A failure of the analyte for three consecutive or three out of four/five events is scored as a repeat unsuccessful. 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: During the desk review performed on 03/11/2021, based on review of CASPER report 155D and graded CAP results, it was determined that the laboratory failed to achieve satisfactory performance for the analytes PTT and PT in two consecutive testing events (2020, Events 1 and 3) resulting in unsuccessful proficiency testing performance. See D2121. -- 2 of 2 --

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: During an onsite recertification survey on 09/28/2018, based on the CASPER 155D report and proficency testing results review from American Proficiency Institute (API), the laboratory failed to successfully participate in proficiency testing for the sub-specialty of routine chemistry, the analyte digoxin, for two of three consecutive proficiency events (2017, Event A and Event C). See D2087. 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: During an onsite recertification survey performed on 09/28/2018, based on the CASPER 155D report review and onsite proficiency testing results review from College of American Pathologists (CAP) proficiency testing, the laboratory failed to attain a satisfactory score of at least 80% for digoxin for two of three consecutive proficiency testing events. Findings include: 1. The CASPER 155D report revealed the following scores for your laboratory's digoxin: a. 2017, Event A: 0% b. 2017, Event C: 0% 2. The scores were confirmed by review of the graded CAP results. Scores less than 80% for this analyte indicates unsatisfactory performance. A failure of this analyte for two consecutive or two out of three consecutive testing events is scored as unsuccessful. -- 2 of 2 --