Jenkins County Medical Center

Summary Statement of Deficiencies D0000 A recertification survey was performed on .April 29, 2025. The facility was found to be NOT in compliance with all applicable CLIA requirements for specialties /subspecialties for 42 CFR. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) Proficiency Testing (PT) Provider and staff interview, the laboratory failed to provide completed Attestation Statements for 6 out of the 18 events for 2024 and 2025. Findings: 1. Review of the API PT documents for 2024 and 2025 confirmed that the following attestation statements were not complete as follows: 2024 Specialty Chemistry-Core Event 3, was not signed by the Laboratory Director(LD) Specialty Chemistry-Miscellaneous Event 1, was not available. Specialty Chemistry-Miscellaneous, Event 2, was not signed by the LD 2025 Specialty Chemistry-Core Event 1, was not available Specialty Microbiology Event 1, was not signed by the LD Immunohematology Event 1, was not signed by LD 2. Interview with the Laboratory Supervisor, on 04/29/2025 at approximately 2 pm in the conference room, confirmed the findings above. D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) 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 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 -- and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) Proficiency Testing (PT) Provider and staff interview, the Laboratory Director (LD) failed to provide total oversight of the Laboratory. The laboratory did not provide complete Attestation Statements for 6 out of the 18 events for 2024 and 2025. Findings: 1. Review of the API PT documents for 2024 and 2025 confirmed the following attestation statements were not complete as follows: 2024 Specialty Chemistry-Core Event 3, was not signed by the Laboratory Director(LD) Specialty Chemistry-Miscellaneous Event 1, was not available. Specialty Chemistry-Miscellaneous, Event 2, was not signed by the LD 2025 Specialty Chemistry-Core Event 1, was not available Specialty Microbiology Event 1, was not signed by the LD Immunohematology Event 1, was not signed by LD 2. Interview with the Laboratory Supervisor, on 04/29/2025, at approximately 2 pm, in the conference room, confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on May 28, 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] 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 Centers for Medicare and Medicaid (CMS) CASPER 155 report and review of the American Proficiency Institute (API) reports, the laboratory 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 -- failed to successfully participate in proficiency testing (PT) in 2 consecutive testing events for Activated Partial Thromboplastin Time (APTT) resulting in the initial unsuccessful participation for APTT. Refer to D 2130 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 review of the CMS CASPER 155 report and review of API PT reports, the laboratory failed to demonstrate satisfactory performance in 2 consecutive testing events for APTT resulting in the initial unsuccessful participation for APTT. Findings: 1. A review of Casper Report 155 disclosed the laboratory failed for APTT on the following: 2023 Event 3 Score 40% 2024 Event 1 Score 40% 2. A review of the laboratory's API Reports confirmed the laboratory failed for APTT 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 CMS CASPER 155 report and review of the 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 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 review of the CMS CASPER Report 155 and the API PT evaluation reports, the laboratory director failed to ensure successful PT participation in 2 consecutive testing events. Refer to D 2130 -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on May 10, 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: 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 Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on February 12, 2019. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiency was cited: D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on maintenance documents review, tour observation, and an interview with the General Supervisor (TP # 3 CMS 209), the laboratory failed to perform and document annual maintenance as defined by the manufacturer in 2018. Findings include: 1. Upon initial tour of the laboratory, it was observed the following instruments did not not have up to date annual maintenance: i.) The Clay Adams Sero-fuge 11 Centrifuge for urine's had last RPM calibration on November 2017. ii.) The Urine's and Hematology Microscopes were last serviced in December 2016. iii.) Blood Bank Centrifuge had last RPM calibration in November 2017. iv.) Three (3) Quest Model 642 E Horizon blood Centrifuges were last calibrated November 2017. 2. An interview with the General Supervisor, TP #3 (CMS 209) at approximately 12:15 p.m. on February 12, 2019 in the review room confirmed the above instruments and testing equipments were not serviced or calibrated in 2018. 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 --