Big Sandy Medical Center

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on August 1, 2025. At the time of the desk review, it was determined that the laboratory was not in compliance with all conditions required by the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 Code of Federal Regulations, Part 493 (42 C.F.R. 493). The following condition level deficiencies were cited: 493.803 Condition: Successful participation. 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 an off-site review of the CMS-155 reports of proficiency testing performance, American Proficiency Institute (API) proficiency testing (PT) scores, corresponding laboratory records, and email communication with the laboratory 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 -- director (LD) #1, the laboratory failed to achieve satisfactory performance for routine chemistry for two consecutive testing events, resulting in unsuccessful proficiency testing performance in 2025. See 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 review of American Proficiency Institute (API) proficiency testing (PT) scores, laboratory records and email communication with the laboratory director (LD) # 1, the laboratory failed to achieve a score of at least 80% for two consecutive proficiency testing events for aspartate aminotransferase (AST) in the year 2025. Findings: 1. A review of API's Routine Chemistry PT scores and laboratory records for AST on August 1, 2025, revealed the laboratory failed to achieve a satisfactory performance score of 80% or greater for the following PT events: 2025, Event 1 scored 60% 2025, Event 2 scored 60% 2. An email from LD #1 on August 1, 2025, at 3:19 PM confirmed the two consecutive failed 2025 PT events for the analyte AST. -- 2 of 2 --

Summary Statement of Deficiencies D5425 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(3) (b)(3) The laboratory must determine the test system's calibration procedures and control procedures based upon the performance specifications verified or established under paragraph (b)(1) or (b)(2) of this section. This STANDARD is not met as evidenced by: Based on a review of microbiology records and an interview with Laboratory Director (LD) #1, it was found that the laboratory failed to include a verification study in their Individualized Quality Control Plans (IQCP) to support its quality control (QC) practices for new lots of agar media used for patient urine cultures from July 22, 2023, to July 22, 2025. Findings: 1. A review of microbiology's IQCP lacked records of a QC verification study for new lots of trypticase soy agar (TSA)-5% Sheep Blood agar and MacConkey agar biplates to support the manufacturer's QC frequency. 2. A review of the test volume sheet revealed 124 urine cultures using TSA-5% Sheep Blood agar and MacConkey agar biplates were performed in the last 12 months (July 1, 2024, to July 1, 2025). 3. An interview with the LD #1 on July 22, 2025, at 3:00 PM, confirmed the laboratory failed to perform a verification study to support its quality control (QC) practices for new lots of agar media used for patient urine cultures from July 22, 2023, to July 22, 2025. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on March 25, 2025. At the time of the desk review, it was determined that the laboratory was not in compliance with all conditions required by the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 Code of Federal Regulations, Part 493 (42 C.F.R. 493). The following condition level deficiencies were cited: 493.803 Condition: Successful participation. 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 an off-site review of the CMS-155 reports of proficiency testing Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- performance, American Proficiency Institute (API) proficiency testing (PT) scores, corresponding laboratory records, and email communication with the laboratory director (LD) #1, the laboratory failed to achieve satisfactory performance for routine chemistry for three consecutive proficiency testing events, resulting in subsequent unsuccessful proficiency testing performance in 2024 and 2025. See 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 review of American Proficiency Institute (API) proficiency testing (PT) scores, laboratory records and email communication with the laboratory director (LD) # 1, the laboratory failed to achieve a score of at least 80% for three consecutive proficiency testing events for magnesium (Mg) in the years 2024 and 2025. Findings: 1. A review of API's Routine Chemistry PT scores and laboratory records for Mg on March 24, 2025, revealed the laboratory failed to achieve a satisfactory performance score of 80% or greater for the following PT events: 2024, Event 2 scored 60% 2024, Event 3 scored 20% 2025, Event 1 scored 60% 2. An email from LD #1 on March 18, 2025, at 3:47 PM confirmed the findings, with the laboratory director self-reporting the third unsuccessful magnesium proficiency testing event. 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 an off-site review of 2024 and 2025 American Proficiency Institute (API) proficiency testing (PT) scores and corresponding laboratory records, and email communication with the laboratory director (LD) #1, the laboratory director failed to provide overall management and direction for the laboratory to ensure an effective

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 review of American Proficiency Institute records and an interview with the laboratory director, the laboratory failed to achieve satisfactory performance for magnesium, total iron binding capacity, and triiodothyronine for two consecutive testing events, resulting in unsuccessful proficiency testing performance. (See D2096 and D2107). D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 2 -- 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 American Proficiency Institute (API) proficiency testing (PT) scores and interview with laboratory director (LD) # 1, the laboratory failed to achieve a score of at least 80% for two consecutive PT events (routine chemistry 2024 Events 2 and Event 3) for magnesium (Mg) and total iron binding capacity (TIBC), measured. Findings: 1. A review of API's Routine Chemistry PT scores for Mg revealed that in 2024, Event 2 scored 60% and Event 3 scored 20%. 2. A review of API's Routine Chemistry PT scores for TIBC, measured revealed that in 2024, Event 2 scored 60% and Event 3 scored 60%. 3. An interview with LD #1 on November 12, 2024, at 4:49 PM confirmed the failed PT events were due to results running higher than expected. D2107 ENDOCRINOLOGY CFR(s): 493.843(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 American Proficiency Institute (API) proficiency testing (PT) scores and interview with laboratory director (LD) # 1, the laboratory failed to achieve a score of at least 80% for two consecutive PT events (Endocrinology 2024 Events 2 and Event 3) for triiodothyronine (Free T3). Findings: 1. A review of API's Endocrinology PT scores for Free T3 revealed that in 2024, Event 2 scored 40% and Event 3 scored 60%. 2. An interview with LD #1 on November 12, 2024, at 4:49 PM confirmed the failed PT events were due to results running higher than expected. -- 2 of 2 --

Summary Statement of Deficiencies D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of coagulation records, procedures, and interview with technical supervisor (TS) #1, the laboratory failed to verify the performance specifications of new lots of Activated Partial Thrombin Time (aPTT) reagents performed on Sysmex CA-660 from July 25, 2021, to July 25, 2023. Findings: 1. A review of coagulation procedure revealed the laboratory failed to have a step-by-step procedure for verifying new lots of Dade Actine FSL aPTT reagent. 2. No crossover studies to verify the performance specifications for new lots of aPTT reagents prior to patient testing were available for review. 3. A review of the test volume sheet revealed 37 aPTT tests were resulted from July 25, 2022, to July 25, 2023 (12-month period). 4. An interview with the TS #1 on July 25, 2023, at 1:04 PM, confirmed the laboratory failed to verify the performance specifications of new lots of Dade Actine FSL aPTT reagents from July 25, 2021, to July 25, 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 1 --

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 routine desk audit of CMS-155 reports of proficiency testing (PT) performance, review of American Proficiency Institute (API) records and interview with the technical supervisor (TS) #1, the laboratory failed to achieve satisfactory performance for total bilirubin for two out of three PT events (2022 Event 2 and 2023 Event 1) performed on the Siemens Dimension EXL, resulting in unsuccessful proficiency testing performance. (See D2096) D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 2 -- 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 proficiency testing (PT) scores and interview with technical supervisor (TS) # 1, the laboratory failed to achieve a score of at least 80% for two out of three consecutive PT events (2022 Event 2 and 2023 Event 1) for total bilirubin. Findings: 1. A review of the API total bilirubin PT scores revealed that in 2022, Event 2 scored 40% and in 2023, Event 1 scored 40%. 2. An interview with (TS) #1 on April 11, 2023, at 10:34 AM confirmed the failed total bilirubin PT events were due to the lack of QC and Calibration acceptability and monitoring. -- 2 of 2 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on record review and interview with Testing Personnel (TP) #1, the laboratory failed to ensure the laboratory was enrolled in an HHS-approved proficiency testing program for Mycology (KOH Preps) and Parasitology (Wet Mount) from January 1, 2020 to January 26, 2022. Findings: 1. Review of Test Volume Report revealed six KOH Preps and six Wet Preps were performed for 2021. 2. Review of Order Choice Utilization Report for 01/01/2020-12/31/2020 showed two KOH Preps and six Wet Preps had been performed. 3. Review of 2020 and 2021 American Proficiency Institute (API) Testing Program records lacked documentation of proficiency testing for KOH Preps and Wet Preps. 4. Interview on January 26, 2022 at 3:00 PM with the TP#1 confirmed the laboratory failed to enroll in an HHS-approved proficiency testing program for Mycology (KOH Preps) and Parasitology (Wet Preps) from January 1, 2020 to January 26, 2022. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including 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 -- 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 record review, procedure and interview with Testing Personnel (TP) #1, the laboratory failed to retain patient test records and quality control (QC) records of rheumajet RF Latex Agglutination Test for Rheumatoid Factor (RF) from January 1, 2020 to March 31, 2021. Findings: 1. No patient test records or QC records of rheumajet RF Latex Agglutination Test were available for review from January 1, 2020 to March 31, 2021. 2. Review of Order Choice Utilization Report for 01/01 /2020-12/31/2020, revealed 21 RF patient tests ordered. 3. Review of Rheumajet RF- NCCLS procedure revealed, "Quality Control 1. Prior to each set of determinations, the latex reagents should be tested with each run using the positive and negative controls provided in the kit." 4. Review of Rheumajet RF-NCCLS procedure included a blank template log to document "date, patient id & name, external pos control, external neg control, lot no. exp date, test result, and tech." 5. Interview on January 26, 2022 at 2:00 PM with (TP)#1 confirmed the laboratory failed to retain patient test records and quality control (QC) records of rheumajet RF Latex Agglutination Test from January 1, 2020 to March 31, 2021. -- 2 of 2 --