Central Georgia Infectious Diseases, Llc

Summary Statement of Deficiencies D0000 A proficiency testing (PT) desk review was completed on March 23, 2023. 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 condition deficiencies were cited: D2016 - 42 CFR 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 CFR 493.1403 Condition: Moderate Complex 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 review of the CASPER 155 report and review of the American Proficiency Institute (API) reports, the laboratory failed to maintain satisfactory proficiency 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 -- testing (PT) participation for chloride (CL) in 2022 event 3 and 2023 event 1, resulting in an initial unsuccessful participation for CL. Refer to D 2096 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 review of the Centers for Medicare and Medicaid (CMS) CASPER 155 report and review of American Proficiency Institute (API) reports, the laboratory failed to maintain satisfactory participation in two consecutive testing events ( 3rd event of 2022 and 1st event of 2023), resulting in an initial unsuccessful participation for chloride (CL). Findings: 1. A review of Casper Report 155 revealed the laboratory failed CL on the following: 2022 Event 3 CL Score 40% 2023 Event 1 CL Score 40% 2. A review of the laboratory's API Reports confirmed the laboratory failed CL with the aforementioned scores. 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 review of the Centers for Medicare and Medicaid (CMS) CASPER 155 report and review of the American Proficiency Institute (API) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in two consecutive testing events ( 3rd event of 2022 and 1st event of 2023), resulting in the initial unsuccessful participation in chloride (CL). 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 review of the Centers for Medicare and Medicaid (CMS) CASPER 155 report and review of the American Proficiency Institute (API) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in two consecutive testing events ( 3rd event of 2022 and 1st event of 2023), resulting in the initial unsuccessful participation in chloride (CL). Refer to D 2096 -- 2 of 2 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on March 29,2022. 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: The laboratory failed to maintain satisfactory proficiency testing (PT) performance for Chloride (CL) analyte #355 in 2020 event 1 & 3, 2021 event 2, and 2022 event 1 resulting in the second unsuccessful occurrence for Chloride. Findings include: Refer to D2096. 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 -- 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 four (4) of seven (7) events (1st and 3rd events of 2020, 2nd event of 2021, and 1st event of 2022 ), resulting in the second unsuccessful performance for chloride (CL), analyte # 355. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte # 355 CL: - event 1 of 2020 with a score of 40% - event 3 of 2020 with a score of 60% - event 2 of 2021 with a score of 60% - event 1 of 2022 with a score of 60% 2. Desk review of the laboratory's proficiency testing reports from American Proficiency Institute (API) confirmed the laboratory failed CL on Events 1 & 3 of 2020, Event 2 of 2021, and Event 1 of 2022 resulting in the second 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: The laboratory director failed to ensure the laboratory maintained satisfactory proficiency testing (PT) performance for Chloride (CL) analyte #355 in 2020 event 1 & 3, 2021 event 2, and 2022 event 1 resulting in the second unsuccessful occurrence for Chloride. Findings include: Refer to D6016 D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of the Centers for Medicare and Medicaid Casper Report 155 (CMS 155) and the laboratory's 2020, 2021, and 2022 proficiency testing (PT) evaluation reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance for four (4) proficiency testing events for the Chloride (CL) #355 resulting in the second unsuccessful PT occurrence for Chloride (CL) #355 . The -- 2 of 3 -- findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte # 355 CL: - event 1 of 2020 with a score of 40% - event 3 of 2020 with a score of 60% - event 2 of 2021 with a score of 60% - event 1 of 2022 with a score of 60%. 2. Desk review of the laboratory's proficiency testing reports from American Proficiency Institute (API) confirmed the laboratory failed CL on 2020 Events 1 & 3, 2021 Event 2 , and 2022 event 1, resulting in the second PT occurrence for CL. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on January 25, 2021. 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 153 and 155 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two out of three events (Events 1 & 3 of 2020), resulting in the first 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 -- unsuccessful occurrence for CL analyte #0355 in the specialty of Routine Chemistry. Findings include: Refer to D2096 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 153 and 155 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two out of three events (Events 1 & 3 of 2020), resulting in the first unsuccessful occurrence for CL analyte #0355 in the specialty of Routine Chemistry. 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte #0355 CL, on Event 1 of 2020 with a score of 40%, and Event 3 of 2020 with a score of 60%. 2. The criteria for acceptable performance for the specialty of Routine Chemistry is 80%. 3. Desk review of the laboratory's proficiency testing reports from the American Proficiency Institute (API) confirmed the laboratory failed analyte #0355 CL for Events 1 and 3 of 2020 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 American Proficiency Institute (API) proficiency testing (PT) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in two out of three consecutive events (Events 1 & 3 of 2020), resulting in the first unsuccessful occurrence for #0355 CL (Chlorine) in the specialty of Routine Chemistry. The findings include: Refer to D6016 D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: -- 2 of 3 -- 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 American Proficiency Institute (API) proficiency testing (PT) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in two out of three consecutive events (Events 1 & 3 of 2020), resulting in the first unsuccessful occurrence for #0355 CL (Chlorine) in the specialty of Routine Chemistry. The findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte #0355 CL, on Event 1 of 2020 with a score of 40%, and Event 3 of 2020 with a score of 60%. 2. The criteria for acceptable performance for the specialty of Routine Chemistry is 80%. 3. Desk review of the laboratory's proficiency testing reports from the American Proficiency Institute (API) confirmed the laboratory failed analyte #0355 CL (Chlorine) for Events 1 and 3 of 2020 resulting in the first unsuccessful performance. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An initial Clinical Laboratory Improvement Amendments (CLIA) survey was completed on October 28, 2020. The laboratory was not in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following Condition and Standard deficiencies were cited: 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 review of the American Proficiency Institute (API) Proficiency Testing (PT) provider documents, test list, and staff interview, the laboratory did not order the correct Chemistry PT, for the year 2020, to cover all analytes that are tested and reported out at the facililty. Findings: 1. Review of the test list for chemistry, the facility performs the following test: ALT/SGPT Creatinine AST/SGOT Glucose Total Bilirubin Potassium Blood Unea Nitrogen Sodium Calcium Triglycerides Chloride Uric Acid Cholesterol Alkaline Phosphatase Cholesterol/HDL Albumin CO2 Total Protein 2. Review of the API documents the selected Basic Chemistry Program does not include testing for Alkaline Phosphatase, Albumin, and Total Protein. 3. Interview with staff #2 (CMS form 209), on October 29, 2020 at approximately 5:30 pm, in the conference room confirmed the aforemention information. 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 -- 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 review of the American Proficiency Institute (API) Proficiency Testing (PT) documents the laboratory failed to participate successfully (100%) in PT for 2020 first event and third event for the analyte Chloride. Reference D2087 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 review of the American Proficiency Institute (API) Proficiency Testing (PT), the laboratory failed to attain a score of at least 80% for the first event and third event for 2020, analyte Chloride. Findings: 1. Review of the API, PT evaluation reports for 2020, the first and third events, showed that the laboratory scored a 40% on Chloride for the first event and 60% on the third event. 2. Interview with staff #2 (CMS-209) on October 28, 2020, at approximately 6pm in the conference room, confirmed that the scores for the analyte Chloride for 2020 PT for the first event was 40%, and the third event was 60%. 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 Employee Competency documents, and staff interview the -- 2 of 4 -- laboratory failed to provide training and competency documents, for both of the testing personal(TP).. Findings: 1. Based on review of the Employee Competency documents, for the two TP, one had no training documents or competency documents, and one had an Initial training and competency documents but did not have a 6 month competency. 2. Interview with staff #2(CMS 209 form) on October 28, 2020, at approximately 5pm in the conference room confirmed that one TP did not have any training or competency records, and one TP did not have a 6 month competency. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the Quality Control (QC) documents for the Pentra Micro 60 (Pentra 60) Hematology analyzer, the laboratory failed to monitor the accuracy and precision of the complete analytic process. Findings: 1. Based on review of the QC documents for the Pentra 60, the laboratory failed to routinely print the Levy Jennings (LJ) charts for each Lot of QC material. From November 2019, to September 2020, the laboratory only printed LJ charts for January and February 2020, for hematology QC.. 2. Interview with staff #2 (CMS-209 form) on October 28, 2020 at approximately 4:30 pm in the conference room, confirmed that the laboratory had not printed LJ charts from November 2019 to September 2020, except for January and February 2020 for hematology QC. D6024 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(7) 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)(7) Ensure that all necessary remedial actions are taken and documented whenever significant deviations from the laboratory's established performance specifications are identified, This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute(API) Proficiency Testing(PT) documents for 2020, and staff interview, the Laboratory Director (LD) failed to ensure that all necessary remedial actions was taken and documented. Findings: 1. Based on the API documents for 2020, for Chemistry event one, the laboratory scored a 40% on Chloride, and a 60% on Glucose, and the third event scored a 60 % on Chloride. -- 3 of 4 -- There was no