Jackson Hospital & Clinic, Inc

Summary Statement of Deficiencies D0000 A recertification survey was conducted on 3/28/2024 and the following conditions were not met: D2016 - 42 C.F.R 493.803 Condition: Successful participation D6000 - 42 C.F.R. 493.1403 Condition: 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 a review of Proficiency Testing records and an interview with the Technical Consultant, the laboratory failed to achieve satisfactory performance in two of three consecutive testing events for the specialty of Hematology for White Blood Cell Differential (WBC), Red Blood Cell (RBC), Hematocrit (HCT), Hemoglobin (HGB), and Platelets (PLT). The findings include: 1. Refer to D2130 2. Refer to D2131 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 -- 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 a review of Proficiency Testing (PT) records and an interview with the Technical Consultant, the laboratory failed to achieve satisfactory performance for two out of three consecutive PT events. This was noted for Hematology 3rd Event in 2022 and Hematology 1st Event in 2023. The findings include: 1. A review of PT records revealed the laboratory received a score of 0% for White Blood Cell Differential (WBC), Red Blood Cell (RBC), Hematocrit (HCT), Hemoglobin (HGB), and Platelets (PLT) for the Hematology 3rd PT event in 2022. The laboratory received no score for the Hematology 1st event in 2023 as a result of not submitting results to the PT provider. 2. During an interview on 3/28/2024 at 12:00 PM, the Technical Consultant confirmed the above findings. D2131 HEMATOLOGY CFR(s): 493.851(g) Failure to achieve an overall testing event score of satisfactory performance 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 a review of Proficiency Testing (PT) records and an interview with the Technical Consultant, the laboratory failed to achieve satisfactory performance for two out of three consecutive PT events. This was noted for Hematology 3rd Event in 2022 and Hematology 1st Event in 2023. The findings include: 1. A review of PT records revealed the laboratory received a score of 0% for White Blood Cell Differential (WBC), Red Blood Cell (RBC), Hematocrit (HCT), Hemoglobin (HGB), and Platelets (PLT) for the Hematology 3rd PT event in 2022. The laboratory received no score for the Hematology 1st event in 2023 as a result of not submitting results to the PT provider. 2. During an interview on 3/28/2024 at 12:00 PM, the Technical Consultant confirmed the above 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 a review of Proficiency Testing (PT) records and an interview with the Technical Consultant, the Laboratory Director failed to provide overall management and direction of laboratory services as required under Subpart H. The findings include: 1. Refer to D6016 -- 2 of 3 -- 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 review of Proficiency Testing (PT) records and an interview with the Technical Consultant, the Laboratory Director failed to ensure PT samples were performed as required under Subpart H. This was noted for two consecutive PT events reviewed in 2022 and 2023. The findings include: 1. A review of PT records revealed the laboratory received a score of 0% for White Blood Cell Differential (WBC), Red Blood Cell (RBC), Hematocrit (HCT), Hemoglobin (HGB), and Platelets (PLT) Hematology 3rd PT event in 2022. The laboratory received no score for the Hematology 1st event in 2023 as a result of not submitting results to the PT provider. 2. During an interview on 3/28/2024 at 12:00 PM, the Technical Consultant confirmed the above findings. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on a review of Personnel records and an interview with the Technical Consultant, the Technical Consultant failed to assess competency six months after initial training on the Beckman Coulter DxH 520 Hematology analyzer for Testing Personnel #2 and Testing Personnel #3. This was noted for two out of two previously qualified Testing Personnel from the date of the last survey, 7/20/2022, to the date of the current survey, 3/28/2024. The findings include: 1. A review of Personnel records revealed initial training for the Beckman Coulter DxH 520 for Testing Personnel #2 and #3 dated 9/14/2022. No evidence of a six month competency assessment was available for either Testing Personnel at the time of survey. 2. During an interview on 3/28/2024 at 12:00 PM, the Technical Consultant confirmed the above findings. -- 3 of 3 --

Summary Statement of Deficiencies 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 reviews of the 2019-2022 temperature records, the Beckman Coulter AcT diff 2 Complete Blood Count (CBC) Hematology analyzer Users Manual, the storage requirements for Coulter 4C-ES Cell Controls, the Policy and Procedures Manual, and an interview with the Laboratory Manager of the main hospital, the laboratory failed to monitor and document environmental parameters to ensure: 1) the Hematology analyzer was operated within the manufacturer's specifications for temperature and humidity, and 2) the Hematology quality control (QC) was stored as per the manufacturer's temperature requirements. The surveyor noted 10 (May 2021 through February 2022) out of 34 months (October 2019 through July 2022) when the laboratory failed to monitor and record room temperature and humidity, and 13 out of 34 days (during March and April 2022) when QC refrigerator temperatures were not documented. The findings include: 1. A review of the 2019-2022 environmental records revealed the following: A. 2021 May through December: no documentation of room temperature and humidity B. 2022 January and February: no documentation of room temperature and humidity C. 2022 March: no documentation of the QC refrigerator temperatures 7 out of 18 days D. 2022 April: no documentation of the QC refrigerator temperatures 6 out of 16 days 2. A review of the Beckman Coulter AcT diff 2 Hematology analyzer Users Manual on page 1-2 "Preinstallation Checks" 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 -- revealed, "... Keep room temperature between 16 degrees and 35 degrees C [Celsius] (61 degrees and 95 degrees F [Fahrenheit]) and humidity to between 20 and 85 percent...". 3. A review of the packaging for Coulter 4C-ES Cell Controls for CBCs revealed storage requirements of 2-8 degrees C. 4. A review of the policy and procedure manual revealed the following: A. Page 2, "The AcT diff 2 analyzer operates at an ambient temperature of 16-35 degrees Celsius and at a humidity of less than 85 percent...". B. Page 6, "The controls must be stored at 2-8 degrees Celsius when not in use...". 5. During an interview on July 20, 2022, at 12:12 PM, the Manager confirmed the above findings. 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 a review of the API (American Proficiency Institute) proficiency testing (PT) records, and an interview with the Laboratory Manager of the main hospital, the Laboratory Director failed to ensure results were submitted before the PT provider's cutoff date. This affected one of three 2021 API PT surveys. The findings include: 1. A review of the CMS (Center for Medicare and Medicaid Services) CASPER Report 0096D revealed the laboratory received a 0% score for the third survey event in 2021, due to "Failure to Participate". 2. A review of the API PT records for the 2021 Event #3 Hematology survey revealed the survey samples were shipped on 11/1/2021, however the survey testing was not performed until 1/17/2022. The laboratory had not kept a record of the required submission date for Event 3-2021, however the surveyor noted third event surveys performed in 2019 and 2020 were due in late November. 3. A review of the investigation on the

Summary Statement of Deficiencies 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 a review of the 2018 - 2019 API (American Proficiency Institute) Proficiency Testing records and an interview with Testing Personnel #1, the laboratory failed to document reviews of three out of six of the returned survey evaluations results, and failed to document

Summary Statement of Deficiencies No Tags No deficiency details available. 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 --