Screven County Hospital, Llc

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification Survey was completed on June 12, 2025. 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: 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: A review of 2023 - 2025 API Proficiency Testing Records confirmed that the Laboratory failed to investigate and perform

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on December 16, 2024. 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] D6076 - 42 CFR 493.1441 Condition: HIGH 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 Compatibility testing in 2024 event 2, resulting in an initial unsuccessful participation. Refer to D 2173 D2173 COMPATIBILITY TESTING CFR(s): 493.863(a) Failure to attain an overall testing event score of at least 100 percent is unsatisfactory 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 the 2nd event of 2024 resulting in an initial unsuccessful participation for compatibility testing. Findings: 1. A review of Casper Report 155 revealed the laboratory failed Compatibility testing on the following: 2024 Event 2 Score 80% 2. A review of the laboratory's API Report confirmed the laboratory failed compatibility testing with the aforementioned score. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of the CMS CASPER 155 report and review of American Proficiency Institute (API) report, the laboratory director failed to provide overall management and direction for proficiency testing performance. The laboratory director failed to ensure proficiency testing samples were tested as required. Refer to D6089 D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure 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 CMS CASPER Report 155 and the American Proficiency Institute (API) 2024 event # 2 PT evaluation report, the laboratory director failed to ensure successful proficiency testing performance in compatibility testing. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on December 7, 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 level deficiencies were cited: D2016 - 42 C.F.R. 493.803 Successful participation [proficiency testing] D6000 - 493.1403 Laboratory Director, Moderate Complexity 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 Centers for Medicare and Medicaid (CMS) 155 Report and review of the American Proficiency Institute (API) proficiency testing reports, the 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 -- laboratory failed to successfully participate in 2 consecutive proficiency testing events resulting in the initial unsuccessful participation in Sodium (NA). 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 CMS 155 report and review of API PT reports, the laboratory failed to demonstrate satisfactory performance in 2 consecutive testing events for NA, resulting in the initial unsuccessful participation for NA. Findings: 1. Desk review of CMS 155 reports disclosed the laboratory failed NA with the following scores: 2023 event 2 = 60% 2023 event 3 = 60% 2. Desk review of the laboratory's proficiency testing reports from API confirmed the laboratory failed the aforementioned analyte. 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 CMS 155 report and review of API reports, the laboratory director failed to provide overall management and direction for successful participation in PT. The laboratory director failed to ensure PT samples were tested as required. 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 CMS 155 Report and the API PT evaluation reports, the laboratory director failed to ensure successful PT participation. Refer to D 2096 -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on May 11, 2023. 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 competency document review and staff interview, the Laboratory Director failed to ensure competency was reviewed and signed for 2021. Findings include: 1. Competency document review revealed the Laboratory Director did not review or sign the competency documents for Testing Personnel #5 (CMS-209) in 2021. 2. During an interview with the General Supervisor (CMS-209) on May 11, 2023 at 2:30 PM, in the GS office, confirmed the lack of the Laboratory Director's review and signature of the competency document for 2021. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on November 12, 2020. 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 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 -- proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in 2 out of 3 events (1st and 3rd events of 2020), resulting in the first unsuccessful occurrence for Thyroxine (TY) #0595. Findings include: Refer to D2107 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 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 out of three events (1st and 3rd events of 2020), resulting in the first unsuccessful occurrence for Thyroxine (TY) #0595. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed #0595 TY on event 1 of 2020 with a score of 60% and event 3 of 2020 with 0%. 2. The criteria for acceptable performance for the specialty of Endocrinology is 80%. 3. Desk review of the laboratory's proficiency testing reports from American Proficiency Institute (API) confirmed the laboratory failed TY #0595 Events 1 and 3 of 2020 resulting in the first unsuccessful performance. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on an in-office desk review of proficiency testing (PT) records, the Laboratory Director failed to ensure the laboratory successfully participated in two out of three proficiency testing events (Events 1 and 3 of 2020) for analyte # 0595, Thyroxine (TY) in the specialty of Endocrinology. The findings include: Refer to: D2016 D2107 D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure 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 failed to maintain satisfactory performance in two out of three events (1st and 3rd events of 2020), resulting in the first unsuccessful occurrence for Thyroxine (TY) #0595. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed #0595 TY on -- 2 of 3 -- event 1 of 2020 with a score of 60% and event 3 of 2020 with 0%. 2. The criteria for acceptable performance for the specialty of Endocrinology is 80%. 3. Desk review of the laboratory's proficiency testing reports from American Proficiency Institute (API) confirmed the laboratory failed TY #0595 Events 1 and 3 of 2020 resulting in the first unsuccessful performance. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on April 9, 2019. 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: D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on review of the laboratory director's credentials, education and experience as well as interview with the laboratory supervisor and hospital administrator, the laboratory director (LD) failed to meet the qualifications required by the state of Georgia to direct the laboratory. Findings include: 1. Review of the laboratory director's state license revealed it is a restricted license and was granted only to director the hospital laboratory in a nearby county. 2. Review of the the laboratory director's credentials revealed no documentation or evidence of certification by one of the credentialing boards required by the State of Georgia for laboratory directors. 3. Interview with the laboratory supervisor and hospital administrator on April 9, 2019 at approximately 11 am in the conference room confirmed the laboratory director is not certified by one agencies accepted by the State of Georgia, the LD has a restricted license and, therefore, is not qualified to direct this hospital laboratory. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves 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 6 -- procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of the laboratory's 2017, 2018 and 2019 quality control (QC) records for testing performed on the Beckman Coulter DXC600 chemistry & toxicology analyzers (DXC) , Beckman Coulter Access 2 Immunoassay analyzer (Access 2), and ACL coagulation analyzer (ACL) and review of the laboratory's 2017, 2018 & 2019 calibration verification documentation for testing performed on the DXC analyzers, the laboratory failed to monitor and evaluate the overall quality of the analytic systems and correct identified problem. Findings include: Refer to: D 5439 & D 5469 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 the initial opening comments and staff interview, it was stated that the laboratory had received a loaner analyzer for the Opti CCA TS Arterial Blood Gas (ABG) analyzer and also received a new ABG analyzer. There were no documents to show that the laboratory performed Accuracy, Precision, Reportable Range determination, and verification if the manufacturer's reference intervals were appropriate for the laboratory's patient population. Findings: 1. During the initial opening comments, it was stated that the laboratory had received a loaner ABG analyzer, and a replacement analyzer, when their analyzer was not working. I ask if they had the implementation documents and it was stated that they did not have any implementation documents. The only documents they could produce were two Quality Certificates, one for the loaner, and one for the new analyzer provided by the manufacturer. The blood gas supervisor was asked if they had any documents where they had verified the accuracy, precision, report range, and reference intervals, it was stated that they did not perform any verification on the analyzers. 2. Interview with the Blood Gas supervisor, on April 9, 2019 at approximately 12:15pm in the chapel, confirmed that the above aforementioned statement was correct. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as -- 2 of 6 -- acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on review of the laboratory's 2017, 2018 & 2019 calibration verification records, lack of documents and records to review and staff interview, the laboratory failed to document calibration verification of testing performed on the DXC 600 chemistry and toxicology analyzers. Findings include: 1. Review of calibration verification records revealed the only documentation available is a spread sheet showing the date of completion, name of the analyte, analytical range, and a low, mid- range and high value. No graphs, charts, instrument printouts or other documentation showing the actual values obtained during testing is available. 2. Review of calibration verification spread sheets revealed the analytical range recorded on the spread sheet does not correspond with the low and high values listed on the charts for some analytes. 3. Interview with the general supervisor on April 9, 2019 at approximately 4 pm in the conference room revealed the laboratory uses a combination of proficiency testing samples, calibrators and patient samples to perform calibration verification. No documentation or records showing the identity of the samples used, how values for the calibration verification material were established, or the acceptable limits for the difference between the measured value obtained, versus the actual concentration of the materials. 4. Review of the laboratory's procedure manuals revealed no procedure or instructions are available for performing calibration verification. 5. Interview with the general supervisor on April 9, 2019 at approximately 4:30 pm in the conference room confirmed the laboratory does not have documentation to support the values recorded on spreadsheets labeled DXC 600 Calibration Verification and does not have a procedure for performing calibration verification. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. -- 3 of 6 -- This STANDARD is not met as evidenced by: Based on review of the Quality Control logs for the OPTI CCA TS blood gas (ABG) analyzer, the ABG Quality Control (QC) procedure and staff interview, the laboratory failed to document for the month of January 2018 and February 2018, that liquid controls were performed as stated in their ABG QC procedure as recommended by the manufacturer. Findings: 1. Review of the QC logs for the ABG analyzer showed that for the month of January and February in 2018, the laboratory did not document that liquid controls were performed in either month. 2. Interview with the Blood Gas supervisor on April 9, 2019 at approximately 3pm, in the chapel, confirmed that there was no documentation that the liquid ABG controls were performed in January and February of 2018. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (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) procedure and QC documents for the Opti CCA TS analyzer used for testing Arterial Blood Gases (ABG's) , and staff interview , the laboratory failed to perform two levels of controls with different concentrations at least once each day patient specimens were assayed. Findings: 1. Review of the QC procedure and QC documents for the Opti CCA TS ABG analyzer revealed the laboratory only performed external liquid control monthly or when a new lot number was placed into use and did not perform two external controls of different concentrations each day of patient testing. 2. Interview with the laboratory general supervisor and respiratory therapy supervisor on April 9, 2019 at 12:15 pm in the Chapel confirmed the laboratory was not performing two levels of different concentrations of external controls at least once each day patient specimens were assayed. They also confirmed an Individualized Quality Control Plan (IQCP) had not been performed. 34123 Based on review of QC records for D-dimer testing performed using the Alere Triage Meter and staff interview , the laboratory failed to perform two levels of controls with different concentrations at least once each day patient specimens were assayed. Findings: 1. Review of QC records for D-dimer testing performed on the Alere Triage meter revealed QC was only performed monthly and when a new kit or lot number was placed into use. 4. Interview with the laboratory general supervisor (see CMS 209) on April 9, 2019 at 6 pm in the conference room confirmed the laboratory was not performing two levels of different concentrations of controls at least once each day patient specimens were assayed and also confirmed an Individualized Quality Control Plan (IQCP) had not been performed. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When -- 4 of 6 -- control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's 2017, 2018 and 2019 quality control (QC) records for testing performed on the Beckman Coulter DXC600 chemistry & toxicology analyzers (DXC) , Beckman Coulter Access 2 Immunoassay analyzer (Access 2), and ACL coagulation analyzer (ACL), review of the package inserts for controls, review of the manufacturer's instructions for use of controls and staff interview, the laboratory failed to establish criteria for acceptability of controls. Findings include: 1. Review of 20017, 2018 & 2019 Levey Jennings charts for testing performed on the DXC chemistry analyzer, DXC toxicology analyzer, Access 2 immunoassay analyzer and ACL coagulation analyzer, review of BioRad control assay sheets including Liquid Assayed Multiqual control, Immunoassay Plus control , and Liquicheck Diabetes control , Liquicheck Cardiac Markers Plus control, Liquicheck Ethanol /Ammonia control, Liquicheck Urine Chemistry control, and review of Hemosil coagulation control assay sheets, revealed the laboratory uses the standard deviation (SD) and ranges given by the manufacturer on the assay sheet to determine the acceptable range of control values and has not adjusted their QC ranges to reflect the standard deviation obtained by their laboratory. 2. Review of control values obtained by the laboratory also revealed the standard deviations calculated on testing performed in their laboratory is much lower than the values used to determine acceptability of patient results. 3. Review of on-line instructions for Biorad controls listed above and obtained from BioRad at www.myeinserts.com and review of manufacturer's instructions for use of Hemosil coagulation controls revealed each laboratory should establish their own acceptable ranges and use the assayed ranges as a guide. 4. Interview with the general supervisor (see CMS 209) on April 9, 2019 at 12 pm in the conference room confirmed the laboratory uses the mean and SD ranges from the assay sheets supplied by the manufacturer and those ranges are not indicative of ranges obtained by their laboratory. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of laboratory records, lack of records to review and staff interview, the laboratory director failed to provide overall management and direction of the laboratory. Findings include: Refer to D 6093 & D 6106 D6093 LABORATORY DIRECTOR RESPONSIBILITIES -- 5 of 6 -- CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of the laboratory's 2017, 2018 and 2019 quality control (QC) records for testing performed on the Beckman Coulter DXC600 chemistry & toxicology analyzers (DXC) , Beckman Coulter Access 2 Immunoassay analyzer (Access 2), and ACL coagulation analyzer (ACL), review of the package inserts for controls, review of the manufacturer's instructions for use of controls and staff interview, the laboratory director failed to ensure the laboratory established criteria for acceptability of controls. Also, based on review of QC records for D-dimer testing performed using the Alere Triage Meter and staff interview , the laboratory director failed to ensure the laboratory performed two levels of controls with different concentrations at least once each day patient specimens were assayed. Refer to D 5469 & D 5447 D6106 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(14) The laboratory director must ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure manuals and staff interview, the laboratory director failed to ensure a procedure was available for performing calibration verification for testing performed on the DXC 600 chemistry and toxicology analyzers. Findings include: 1. Review of the laboratory's procedure manuals revealed no procedure or instructions available for performing calibration verification for testing performed on the DXC 600 chemistry and toxicology analyzers. 2. . Interview with the general supervisor on April 9, 2019 at approximately 4:30 pm in the conference room confirmed the laboratory does not have a procedure for performing calibration verification on the DXC analyzers. Also refer to: D 5439 -- 6 of 6 --