Mcgehee Hospital Inc

Summary Statement of Deficiencies D3023 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(c)(2) The facility must establish and follow policies to ensure positive identification of a blood or blood product recipient. This STANDARD is not met as evidenced by: Based upon review of the laboratory policy and procedure, transfusion clinical records, and interview with laboratory staff members, the laboratory failed to follow the policy to ensure positive identification of a blood product recipient. Findings follow: A) Policy "Blood/Blood Components - Transfusion" (Reference #14027, effective 9/18/23) states "After visually comparing the information on the patient's wristband with the Blood Bank Transfusion Form and on the bag tag complete information in the medical record per the EHR." B) Examination of transfusion records showed 3 of 6 "Transfusion Clinical Record" forms, the line stating "Pt's ID Number (Blood arm Band#)" did not contain the blood arm band number. C) In an interview on 7/22/25 at 2:03 pm, the General Supervisor confirmed that the transfusion clinical records did not always contain the patient's arm band identification number. 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 D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of proficiency test documentation and interviews with laboratory staff, the laboratory director failed to sign proficiency testing attestation statements for one of five CAP arterial blood gas proficiency events reviewed from 2022 and 2023. Survey findings include: A. A review of proficiency testing documentation from 2022 and 2023 revealed the laboratory director or designee and the analysts failed to sign the attestation statement on the first (CAP AQA 2023)Testing Event of 2023. B. In an interview, at 12:07 p.m. on 10/3/23, laboratory employee #3 (as listed on the form CMS-209) confirmed the attestation statement identified above had not been signed by the laboratory director/designee or analysts. D3023 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(c)(2) The facility must establish and follow policies to ensure positive identification of a blood or blood product recipient. 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 -- This STANDARD is not met as evidenced by: Through review of the laboratory policy and procedure "Blood and Blood Components - Sign Out Protocol", nursing service policy and procedure "Blood and Blood Components - Transfusion of Whole Blood or Packed Cells", and interview with hospital staff it was determined that documentation of patient identity was not required when blood for transfusion is obtained from the laboratory blood bank. Findings follow: A) Review of the laboratory policy and procedure "Blood and Blood Components - Sign Out Protocol", and nursing service policy and procedure "Blood and Blood Components - Transfusion of Whole Blood or Packed Cells", revealed that no requirement of documentation of the patient identity is specified when obtaining blood or blood components for transfusion from the laboratory blood bank. B) In an interview on 10/4/23 at 2:36 p.m., laboratory staff member (# 4 on the CMS 209 form) and hospital staff member (# 1 on a separate personnel identification list) confirmed that when nursing personnel retrieves blood and blood components for transfusion from the laboratory blood bank, they do not bring documentation of the patient/recipient identification. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Through observations made during a tour of the laboratory, it was determined the laboratory had reagents available for use when they had exceeded their expiration date. Survey findings follow: A) During a tour of the laboratory at 10:02 a.m.on 10/5 /23 22 of 22 Blod/Mac biplates microbiology media lot # 3159064 expiration date 2023-09-25 were observed available for use when they had exceeded their expiration date. B) In an interview on 10/5/23 at 10:10 a.m., the laboratory staff member (# 4 on the CMS 209 form) confirmed that the media identified above had exceeded the expirration date and was available for use. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Through a review of chemistry quality control results for January, May and September 2023, and interviews with laboratory staff, it was determined that patients were reported when results of control material failed to meet the criteria for acceptability on one of thirty days in September 2023. Survey findings follow: A) Through a review of chemistry quality control results for September 2023, it was revealed that on 9/17/23 the Biorad Multiqual Level 3 lot # 45953 Aspartate Transferase (AST) was reported as 242 with an acceptable range of 248 to 270 and -- 2 of 4 -- flagged as >3.0 SDI. There was no documentation that the control was ever in acceptable range on that date. B) Two patients (10129580, 10129587) had AST results reported on 9/17/23. C. In an interview at 15:32 on 10/4/23, laboratory employee #4 (as listed on the form CMS-209) confirmed the two patients were reported when the quality control results were outside of acceptable range and the results had not been evaluated. D5783

Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: . Through a review of the Proficiency Testing records for 2020 and 2021, Survey Exception Reports, lack of documentation, and interviews with staff, it was determined the laboratory failed to prevent the recurrence of problems in the General Laboratory Systems. Survey findings follow: A. A review of the Chemistry Core Proficiency testing records for the third event of 2020 and the first event of 2021 (two of two testing events) revealed the laboratory received a score of 60% for the analyte Lipase in each proficiency testing event. B. A review of the Survey Exception Report for the 3rd Chemistry Core proficiency testing event of 2020 revealed: "Lipase was calibrated on 9/30 and 10/02/2020, API was ran on 8/28/20. Pulled samples and reran. QC good rerun better; samples still on the positive bias but closer to the mean and within range. Testing personnel suggested to used new reagent well since Lipase is ran so infrequent." C. A review of the Survey Exception report for the first Chemistry Core proficiency testing event of 2021 revealed: "Lipase: repeated samples and still same result." D. The

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: . 1. Through a review of manufacturer's instructions for Vacuette and BD Vacutainer blood collection tubes, temperature records for 2018, lack of documentation, as well as interviews with staff it was determined the laboratory fail to define temperature criteria that was not consistent with manufacturer's instructions. As evidenced by: A. A review of the manufacturer's instruction for Vacuette and BD Vacutainer blood collection tubes revealed " the recommended storage temperature is 4-25 degrees Celsius. Exceeding the recommended storage temperature may lead to impairment of collection tube quality." B. A review of the laboratory's temperature records for 2018 revealed the room temperature for the phlebotomy room as 17-30 degrees Celsius. C. A review of phlebotomy room temperature for twelve of twelve months in 2018 revealed the room temperature exceeded 25.0 degrees Celsius on one of thirty days in June 2018; four of thirty-one days in July 2018 and two of thirty-one days in October 2018. D. In an interview on 4/09/2019 at 1030, laboratory personnel #4 (as listed on form CMS 209) confirmed the phlebotomy room temperature range was not consistent with manufacturer's storage requirements. 2. Through a review of temperature records for 2018, lack of documentation, as well as interview with staff it was determined the laboratory failed to monitor the temperature in one of one phlebotomy room. As evidenced by: A. A review of temperature records for twelve of 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 -- twelve months in 2018 revealed the laboratory failed to document phlebotomy room temperature on three of thirty days in April 2018; one of thirty-one days in May 2018; one of thirty days in June 2018; four of thirty-one days in July 2018; four of thirty-one days in August 2018; two of thirty days in September 2018 and four of thirty-one days in December 2018. B. Upon request the laboratory could not provide documentation of