Augusta State Medical Prison

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on November 17, 2022. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 laboratory competency policy review and staff interview, competecies were not performed on 1 out of 1 Testing Personnel per policy requirement. The Findings include: 1. Competency document review revealed compentency was not performed on 1 out of 1 Testing Personnel (TP) for 2021 as required by policy. 2. During an interview on November 17, 2022, with the Testing Personnel#1 (CMS-209), at approximately 12:45 PM, in an office, near the laboratory, confirmed the lack of competency assessment in 2021 for the Testing Personnel. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) 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)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical 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 -- phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on review of testing personnel (TP) documents and staff interview, the Laboratory Director(LD) failed to ensure the Testing Personnnel (TP) competency was performed. The Findings include: 1. Competency document review revealed that the Laboratory Director failed to perform the Testing Personnel (TP)competency for 2021. 2. During an interview with the Testing Personnel#1(CMS-209) on November 17, 2022 at approximately 12:45 PM, in an office near the laboratory, confirmed that the Laboratory Director(LD) did not perform a competency assssment on the Testing Personnel (TP) for 2021. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on February 22, 2022. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two of three consecutive events (3rd event of 2020 and 1st event of 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 -- 2021), resulting in the first unsuccessful occurrence for Hematology # 760 including: cell ID or WBC differential (DIFF) # 765, red blood cell count (RBC) #775, hematocrit(HCT) # 785, hemoglobin (HGB) # 795, white blood cell count (WBC) # 805 and platelets (PLT) # 815, PTT #835, PT #845; Chemistry #245 including: ALT (SGPT) #255, albumin #265, alk phos #275, AST (SGOT) #295, TOTAL BILIRUBIN (TBIL) #305, Calcium (CA) #345, Chloride (CL) #355, creatine #405, glucose #415, Potassium (K) #465, Sodium (Na) #475, total protein #485, BUN #505. Findings include: Refer to D 2130 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two of three events (3rd event of 2020 and 1st event of 2021), resulting in the first unsuccessful performance for Chemistry #245 including: ALT (SGPT) #255, albumin #265, alk phos #275, AST (SGOT) #295, TOTAL BILIRUBIN (TBIL) #305, Calcium (CA) #345, Chloride (CL) #355, creatine #405, glucose #415, Potassium (K) #465, Sodium (Na) #475, total protein #485, BUN #505. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analytes Chemistry #245 including: ALT(SGPT) #255, albumin #265, alk phos #275, AST (SGOT) #295, TOTAL BILIRUBIN (TBIL) #305, Calcium (CA) #345, Chloride (CL) #355, creatine #405, glucose #415, Potassium (K) #465, Sodium (Na) #475, total protein #485, BUN #505. on event 3 of 2020 with a score of 0% and event 1 of 2021 with a score of 0%. 2. Desk review of the laboratory's proficiency testing reports from American Association of Bioanalyts (AAB) confirmed the laboratory failed the aforementioned analytes on Event 3 of 2020 and Event 1 of 2021 resulting in the first unsuccessful performance. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports from the American Association of Bioanalysts (AAB), the laboratory failed to maintain satisfactory performance in two consecutive events (3rd event of 2020 and 1st event of 2021), resulting in the first unsuccessful occurrence for Hematology # 760 including: Cell ID or white blood cell differential (WBC DIFF) # 765, red blood cell count (RBC) #775, hematocrit (HCT) # 785, hemoglobin (HGB) # 795, white blood cell count (WBC) # 805, platelets (PLT) # 815, PT #845, and PTT #835. Findings include: 1. Desk review of Casper Reports 153 -- 2 of 4 -- and 155 disclosed the laboratory failed with the following scores: Hematology #760 Event 3 of 2020 and 1 of 2021 a score of 0% on both events WBC DIFF # 765 Event 3 of 2020 and 1 of 2021 a score of 0% on both events RBC # 775 Event 3 of 2020 and 1 of 2021 a score of 0% on both events HCT # 785 Event 3 of 2020 and 1 of 2021 a score of 0% on both events HGB # 795 Event 3 of 2020 and 1 of 2021 a score of 0% on both events WBC # 805 Event 3 of 2020 and 1 of 2021 a score of 0% on both events PLT # 815 Event 3 of 2020 and 1 of 2021 a score of 0% on both events PT #845 Event 3 of 2020 and 1 of 2021 a score of 0% on both events PTT #835 Event 3 of 2020 and 1 of 2021 a score of 0% on both events 2. Desk review of the laboratory's proficiency testing reports from AAB confirmed the laboratory failed event 3 of 2020 and 1 of 2021 resulting in the first unsuccessful performance. 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 using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in two of three consecutive events (3rd event of 2020 and 1st event of 2021), resulting in the first unsuccessful occurrence for Hematology # 760 including: cell ID or WBC differential (DIFF) # 765, red blood cell count (RBC) #775, hematocrit(HCT) # 785, hemoglobin (HGB) # 795, white blood cell count (WBC) # 805 and platelets (PLT) # 815, PTT #835, PT #845; Chemistry #245 including: ALT(SGPT) #255, albumin #265, alk phos #275, AST (SGOT) #295, TOTAL BILIRUBIN (TBIL) #305, Calcium (CA) #345, Chloride (CL) #355, creatine #405, glucose #415, Potassium (K) #465, Sodium (Na) #475, total protein #485, BUN #505. Findings include: Refer to D 6016 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 using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in two of three consecutive events (3rd event of 2020 and 1st event of 2021), resulting in the first unsuccessful occurrence for Hematology # 760 including: cell ID or WBC differential (DIFF) # 765, red blood cell count (RBC) #775, hematocrit(HCT) # 785, hemoglobin (HGB) # 795, white blood -- 3 of 4 -- cell count (WBC) # 805 and platelets (PLT) # 815, PTT #835, PT #845; Chemistry #245 including: ALT(SGPT) #255, albumin #265, alk phos #275, AST (SGOT) #295, TOTAL BILIRUBIN (TBIL) #305, Calcium (CA) #345, Chloride (CL) #355, creatine #405, glucose #415, Potassium (K) #465, Sodium (Na) #475, total protein #485, BUN #505. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analytes Hematology # 760 including: cell ID or WBC differential (DIFF) # 765, red blood cell count (RBC) #775, hematocrit(HCT) # 785, hemoglobin (HGB) # 795, white blood cell count (WBC) # 805 and platelets (PLT) # 815, PTT #835, PT #845; Chemistry #245 including: ALT(SGPT) #255, albumin #265, alk phos #275, AST (SGOT) #295, TOTAL BILIRUBIN (TBIL) #305, Calcium (CA) #345, Chloride (CL) #355, creatine #405, glucose #415, Potassium (K) #465, Sodium (Na) #475, total protein #485, BUN #505. on event 3 of 2020 with a score of 0% and event 1 of 2021 with a score of 0%. 2. Desk review of the laboratory's proficiency testing reports from American Association of Bioanalyts (AAB) confirmed the laboratory failed the aforementioned analytes on Event 3 of 2020 and Event 1 of 2021 resulting in the first unsuccessful performance. D6017 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(ii) 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)(ii) Ensure that results are returned within the timeframes established by the proficiency testing program. This STANDARD is not met as evidenced by: Based on proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory director (LD) failed to ensure PT results are returned within the timeframes established by the proficiency testing program. Findings include: 1. Review of PT records for 2020 event 3 and 2021 event 1 revealed the laboratory received a score of 0% for "no results received". 2. Desk review of the laboratory's proficiency testing reports from American Association of Bioanalyts (AAB) confirmed the laboratory failed the aforementioned analytes on Event 3 of 2020 and Event 1 of 2021 resulting in the first unsuccessful performance due to "no results received". -- 4 of 4 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on January 13, 2021. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on proficiency test (PT) document review and staff interview, the laboratory failed to document

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on September 13, 2018. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D6017 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(ii) 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)(ii) Ensure that results are returned within the timeframes established by the proficiency testing program. This STANDARD is not met as evidenced by: Based on review of the 2018 AAB (American Association of Bioanalysts) Proficiency Testing (PT) documents and an interview with the laboratory's supervisor (TP # 2 CMS 209) and the Clinic's administrator, the laboratory director failed to ensure Proficiency Testing results were submitted within the timeframes established by the PT program. Findings include: 1.) A review of the 2018 AAB PT records revealed Events # Q1 and Q2 of the Chemistry survey received a score of 0% "Failure to Participate" because results were not submitted to AAB on a timely basis. 2.) An interview with the laboratory's Supervisor (TP# 2 CMS 209) and the Clinic's administrator at approximately 03:50 pm on September 13, 2018 in the conference room confirmed the laboratory failed to submit AAB PT Chemistry events Q1 and Q2 results before the cut off dates. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) 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 -- (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of personnel competency assessment records and an interview with the laboratory's supervisor (TP# 2 CMS 209) and the Clinic's administrator, the laboratory failed to include the six required competency assessment criteria when evaluating annual competency on testing personnel for the Sysmex Hematology analyzer and Vitros 250 Chemistry analyzer. The findings include: 1. Review of testing personnel (TP # 2, 3, 4 and 5 CMS 209) competency assessment records for 2017 and 2018 revealed the assessment did not include the six competency assessment criteria required by CLIA. 2. An interview with the laboratory's supervisor TP (#2 CMS 209) and Clinic's administrator in the conference room on September 13, 2018 at approximately 03:55 PM confirmed that annual competency assessment for testing personnel (TP# 2, 3, 4 and 5 CMS 209) did not contain the six required criteria by CLIA. -- 2 of 2 --