Lake Martin Community Hospital

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. In addition, retain the following: This STANDARD is not met as evidenced by: Based on a review of the Alere Triage Quality Control records for D-Dimer testing and an interview with the Technical Supervisor (TS), it was determined the laboratory failed to retain the manufacturer's QC assay information sheets (package inserts) for all but the current lot numbers in use from the date of the last survey, 05-19-2023, to the date of the current survey 07-02-2025. The findings include: 1. A review of D- Dimer QC records revealed no retention of the manufacturer's assay information sheets (package inserts) except the sheets for the current lot number of controls in use which were posted on the wall where the Alere Triage analyzer was located. 2. During Day 2 exit conference with the CEO, Hospital Administrator, TS and Testing Personnel #5 on 07-02-2025 at 4:00 PM, the TS confirmed the above findings. D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a 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 general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. 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 -- This CONDITION is not met as evidenced by: Based on the review of the American Proficiency Institute (API) Proficiency Testing (PT) records, the laboratory failed to ensure: A) Submission of PT results before the postdate (Refer to D5215). B) Failed to implement effective

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the laboratory's proficiency testing provider, American Proficiency Institute (API). The laboratory was found to be out of compliance with CONDITION LEVEL DEFICIENCIES, as follows: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director . D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on proficiency testing (PT) desk reviews of the CASPER Reports 0153D and 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 -- 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and PT evaluation reports from the American Proficiency Institute (API), the laboratory failed to successfully participate (achieve scores of 100%) in proficiency testing for Compatibility Testing, an analyte in the specialty of Immunohematology. The laboratory failed two consecutive PT events in 2024, resulting in initial unsuccessful proficiency testing performance. Refer to D2181. . D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory for 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 (PT) desk reviews of the CASPER Reports 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and PT evaluation reports from the American Proficiency Institute (API), the laboratory failed to successfully participate (achieve scores of 100%) in proficiency testing for Compatibility Testing. The laboratory failed two consecutive PT events in 2024, resulting in initial unsuccessful proficiency testing performance. The findings include: 1. A review of the CASPER Reports revealed the laboratory received failing scores for Compatibility Testing in two consecutive API PT events, as follows: A) 2024 Immunology / Immunohematology Event #1: 80% B) 2024 Immunology / Immunohematology Event #2: 80% 2. A review of the laboratory's proficiency testing evaluation reports from the API website confirmed these findings. . 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 (PT) desk reviews of the CASPER Reports 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and proficiency testing evaluation reports from the American Proficiency Institute (API), the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. 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; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on proficiency testing (PT) desk reviews of the CASPER Reports 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and PT evaluation reports from the American Proficiency Institute (API), the laboratory director failed to ensure the laboratory had successful participation in an HHS approved proficiency testing program for Compatibility Testing in two consecutive 2024 API PT events. Refer to D2181. SURVEYOR ID #32558 Licensure and Certification Surveyor -- 3 of 3 --

Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of the American Proficiency Institute (API) Proficiency Testing (PT) records and an interview with the Technical Consultant and the Laboratory Director, the laboratory failed to document reviews of returned PT results for seven of eighteen 2022-2023 survey events. The findings include: 1. A review of the API PT records revealed no documentation of a review from the Laboratory Director, or designee, for the following surveys: a) 2022 Chemistry 2nd Event. b) 2022 Hematology 2nd Event. c) 2022 Hematology 3rd Event. d) 2022 Microbiology 3rd Event. e) 2022 Chemistry Miscellaneous 2nd Event. f) 2023 Chemistry 1st Event. g) 2023 Microbiology 1st Event. 2. During an interview on May 17, 2023, at 12:58 PM, the Technical Consultant and Laboratory Director confirmed the above findings. 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 the CASPER reports and American Proficiency Institute (API) Proficiency Testing (PT) records, the laboratory failed to successfully particiapte in compatibility testing for two consecutive events, Events #2 and #3, 2022. These failures constitute an initial unsuccessful PT participation. The findings include: Refer to D2173. D2173 COMPATIBILITY TESTING CFR(s): 493.863(a) Failure to attain an overall testing event score of at least 100 percent is unsatisfactory 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 -- performance. This STANDARD is not met as evidenced by: Based on the CASPER reports and American Proficiency Institute (API) Proficiency Testing (PT) records, the laboratory failed to satisfactorily perform in compatibility testing (Immunohematology) for two consecutive events, Events #2 and #3, 2022. The findings include: 1. The CASPER reports revealed the laboratory scored: a) Event #2, 2022 Compatibility Testing 80% b) Event #3, 2022 Compatibility Testing 80% 2. A review of the API PT records revealed the above noted findings. -- 2 of 2 --

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on a review of Vitamin B12 records, Proficiency Testing records, and an interview with the General Supervisor, the laboratory failed to verify the accuracy of Vitamin B12 at least twice annually. This was noted from July 2020 (when analyte was added to the Dimension EXL 200) to October 2021. The findings include: 1. A review of the Vitamin B12 records revealed a lack of accuracy verification being performed at least twice annually. 2. A review of Proficiency Testing records revealed the laboratory did not add Vitamin B12 when patient testing started in July of 2020. 2. During an interview on 10/20/2021 at 04:15 PM, the General Supervisor confirmed accuracy was not being verified at least twice annually for Vitamin B12. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on a review of the Chemistry Procedure Manual, Blood Bank Procedure Manual, and an interview with the General Supervisor, the current Laboratory Director 1) failed to document approval of the Policies and Procedures when he assumed the responsibilities as the Laboratory Director, and 2) failed to document approval of new Policies and Procedures before patient testing began. This was noted 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 -- from August 2020 to September 29, 2021 for Blood Bank and August 2020 to October 14, 2021 for Chemistry when the procedures were signed by the current Laboratory Director. The findings include: 1. A review of the Chemistry Procedure Manual revealed that the former Laboratory Director signed the Policy and Procedure Manual on 12/19/2019. The current Laboratory Director started in August 2020 and did not sign the Chemistry Procedure Manual until 10/14/2021. 2. A review of the Chemistry menu revealed 3 new analyte procedures, as follows: A) Hemoglobin A1c: started patient testing on 08/18/2020 and procedure was not signed by previous Laboratory Director and was not signed by the current Laboratory Director until 10/14 /2021. B) Vitamin B12: started patient testing on 07/01/2020 and procedure was not signed by previous Laboratory Director and was not signed by the current Laboratory Director until 10/14/2021. C) Vitamin D: started patient testing on 06/11/2021 and procedure was not signed by Laboratory Director until 10/14/2021. 3. A review of the Blood Bank Procedure Manual revealed most procedures were updated by the General Supervisor in February 2021 and was not reviewed by the Laboratory Director until 09 /29/2021. 4. During an interview on 10/21/2021 at 10:00 AM, the General Supervisor confirmed the above findings. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a review of the temperature records, a walk through of the laboratory, and an interview with the General Supervisor, the laboratory's criteria for Refrigerator temperatures failed to be consistent with the manufacturer's instructions. This was noted from February 2021 to October 2021. The findings include: 1. A review of the temperature records revealed the acceptable range for the Chemistry Refrigerator and Special Refrigerator was changed from 2 - 8 degrees Celsius to 0 - 8 degrees Celsius in February 2021. The temperatures recorded from February 2021 to October 2021 for both refrigerators fell below 2 degrees Celsius on multiple days. 2. During a walk through of the laboratory the Special Refrigerator contained the following items with their manufacturer's temperature requirements: a) Siemens Ci-Trol controls: 2 - 8 degrees Celsius b) C. Diff Quik Chek Complete: 2 - 8 degrees Celsius c) Triage D- Dimer Test: 2 - 8 degrees Celsius d) Quantify Plus Controls Bio-Rad: 2 - 8 degrees Celsius. 3. During a walk through of the laboratory the Chemistry Refrigerator contained the following items with their manufacturer's temperature requirements: a) Siemens Dimension reagents cartridges (multiple reagents): 2 - 8 degrees Celsius b) Siemens Calibrators (multiple calibrators): 2 - 8 degrees Celsius. 4. During an interview on 10/21/2021 at 1:45 PM, the General Supervisor confirmed he changed the range of both refrigerators because controls/reagents were running ok. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) -- 2 of 3 -- 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 a review of the validation study for the Dimension EXL 200 Vitamin B12 and Hemoglobin A1C and an interview with the General Supervisor (GS), the laboratory failed to review and evaluate the verification data prior to patient testing starting. This was noted on two out of three validations reviewed by the surveyor. The findings include: 1. A review of the validation for the Dimension EXL 200 Vitamin B12 revealed the validation was performed on 06/14/2019 and patient testing started on 07/01/2020. The General Supervisor approved by signature on 09/20/2020 and the Laboratory Director approved by signature on 10/14/2021. 2. A review of the validation for the Dimension EXL 200 Hemoglobin A1C revealed the validation was performed on 07/17/2020 and patient testing started on 08/18/2020. The General Supervisor approved by signature on 09/20/2020 and the Laboratory Director approved by signature on 10/14/2021. 3. During an interview on 10/21/2021 at 10:00 AM, the General Supervisor confirmed the laboratory failed to review and evaluate the verficiation data for Vitamin B12 and Hemoglobin A1C prior to patient testing starting. 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 a review of the Chemistry Quality Control (QC) records for the Dimension EXL 200 and an interview with the General Supervisor, the laboratory failed to ensure at least two levels of QC were run and acceptable, prior to analyzing patient specimens and reporting the results. This was noted one day out of 3 months reviewed (January 2020, October 2020, and May 2021) by the surveyor. The findings include: 1. A review of the QC records for the Dimension EXL 200 analyzer revealed only the High control was run and acceptable for all analytes on 10/27/2020; there was no evidence the Low control was run on this date. 2. During an interview on 10/21/2021 at 12:45 PM, the General Supervisor confirmed chemistry patient testing would have been performed on 10/27/2020, when only one level of QC was run. -- 3 of 3 --

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on a review of quality assurance (QA) and control records (QC) for Coagulation testing [Prothrombin (PT) / International Normalized Ratio (INR)], a review of the laboratory's policies and procedures, and an interview with the laboratory manager, the surveyor determined the laboratory failed to follow its policies to manually verify the accuracy of the INR calculation, and failed to validate the platelet poor plasma, at least every six months. The findings include: 1. A review of the policies and procedures revealed the laboratory should verify the platelet poor plasma and accuracy of the INR calculation every six months. 2. A review of the QA and QC records for Coagulation revealed: a) The laboratory validated the platelet poor plasma on 11/07/16, and not again until 11/01/17, a one year time lapse. b) The laboratory performed the PT/INR manual verifications on 11/07/16 and not again until 11/01/17, a one year time lapse. 3. The above noted findings were discussed with the laboratory manager on 1/18/19 at 11:30 AM. The laboratory manager confirmed the policy and procedure to perform these verification every six months; and confirmed the verifications were not performed between November 2016 and November 2017. 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-- 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 -- (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. This STANDARD is not met as evidenced by: Based on a review of the laboratory's test menu and installation records with the laboratory manager, a review of policies and procedures, a review of quality control (QC) records and patient test logs, and an interview with the laboratory manager, the surveyor determined the laboratory failed to ensure an IQCP (Individualized Quality Control Plan) for CDiff (Clostridium Difficile) was completed, prior to reducing the frequency of testing quality control to every thirty days. In the absence of an acceptable and complete IQCP, the laboratory failed to perform quality control testing each day of patient testing. The findings include: 1. On January 17, a review of the installation records revealed the laboratory installed CDiff testing (via an Alere non- waived test kit) on October 24, 2017. At 2:00 PM, the laboratory manager, along with the surveyor, reviewed the records and confirmed the installation and patient testing. 2. At 2:00 PM, the laboratory manager stated the laboratory had established an IQCP for the CDiff testing. 3. The surveyor's review of the IQCP, with the laboratory manager, revealed the plan did not include risk assessments of potential risks, associated with the five elements; Specimen, Test System, Reagent, Environment, and Testing Personnel. At this time, the surveyor confirmed with the laboratory manager, potential risks associated with the above mentioned elements had not been considered; and the IQCP only included a Quality Assurance Plan and a Quality Control Plan (to test two levels of quality control at least every thirty days). 4. Further review of the manufacturer's package insert included the following: External positive and negative controls - the reactivity of CDiff kit should be verified upon receipt... Additional tests can be performed with the controls to meet the requirements of local, state and/or federal regulations. 5. A review of the QC records for 2018 and 2017 (October) for CDiff revealed the laboratory performed two levels of quality control testing at least once per month, with the controls being testing twice in April and June of 2018. 6. At 2:40 PM, A review of the patient logs and QC records revealed the laboratory performed patient testing on days when at least two levels of quality control were not tested. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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 qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of the laboratory's test menu and installation records with the laboratory manager, a review of policies and procedures, a review of quality control (QC) records and patient test logs, and an interview with the laboratory manager, the surveyor determined the laboratory failed to test at least two levels of QC for CDiff -- 2 of 3 -- (Clostridium Difficile) each day of patient testing, in the absence of a completed (acceptable) IQCP (Individualized Quality Control Plan). The findings include: 1. On January 17, a review of the installation records revealed the laboratory installed CDiff testing (via an Alere non-waived test kit) on October 24, 2017. At 2:00 PM, the laboratory manager, along with the surveyor, reviewed the records and confirmed the installation and patient testing. 2. At 2:00 PM, the laboratory manager stated the laboratory had established an IQCP for the CDiff testing. 3. The surveyor's review of the IQCP, with the laboratory manager, revealed the plan did not include risk assessments of potential risks, associated with the five elements; Specimen, Test System, Reagent, Environment, and Testing Personnel. At this time, the surveyor confirmed with the laboratory manager, potential risks associated with the above mentioned elements had not been considered; and the IQCP only included a Quality Assurance Plan and a Quality Control Plan (to test two levels of quality control at least every thirty days). 4. Further review of the manufacturer's package insert included the following: External positive and negative controls - the reactivity of CDiff kit should be verified upon receipt... Additional tests can be performed with the controls to meet the requirements of local, state and/or federal regulations. 5. A review of the QC records for 2018 and 2017 (October) for CDiff revealed the laboratory performed two levels of quality control testing at least once per month, with the controls being testing twice in April and June of 2018. 6. At 2:40 PM, A review of the patient logs and QC records revealed the laboratory performed patient testing on days when at least two levels of quality control were not tested. -- 3 of 3 --