Bradley County Medical Center

Summary Statement of Deficiencies D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Review of laboratory policies and procedures, observations made during a tour of the laboratory, and interviews with staff, determined the laboratory failed to follow procedures to ensure positive identification of a urine specimen. Survey findings include: A) Laboratory policies and procedures for "Labelling of Samples" (approved 11/15/22) stated "Every specimen brought to the laboratory must have a label on the container in which it is held. It is not acceptable to label on the lid, transport bag or other container used to trasnport the specimen. The label must contain the following legible information: Two Unique Identifiers - Patient name and medical record number, encounter number, or date of birth; collection date and time; speciment type and/or source." B) During a tour of the laboratory, at 3:45pm. on 9/3/25, the surveyor observed 1 of 12 urine specimens labelled with only the patient name on the cup. C) In an interview, at 3:47 on 9/2/25, general supervisor #4 (as listed on the form CMS- 209) confirmed the specimen identified above lacked information as required by laboratory policy and procedure. . D5463 CONTROL PROCEDURES CFR(s): 493.1256(d)(7)(g) (d)(7) Over time, rotate control material testing among all operators who perform the test. 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 -- This STANDARD is not met as evidenced by: Through a review of the Microbiology QC (Quality Control) Laboratory Report for the VITEK 2 systems, and interviews with laboratory staff, it was determined the laboratory failed to document rotational testing of control material among all testing personnel. Survey findings include: A. Through a review of the Microbiology QC logs for the VITEK 2 system for 2025 and 2024, the surveyor determined that all quality control (19 of 19) was performed by laboratory employees utilizing the same system username. B. Upon request, information showing which employee(s) performed QC for the Vitek 2, none was provided. C. In an interview at 1:06pm on 9/3/25, general supervisor #4 (as listed on the form CMS-209) confirmed that there is no documentation showing who was performing the Vitek 2 QC runs. -- 2 of 2 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(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: Through a review of the proficiency test attestation records for nine events in 2022 and 2023, lack of documentation, and interviews with laboratory staff, it was determined that required signatures to attest to the routine integration of proficiency test samples in the patient workload were not present on 4 of the nine events reviewed. Survey findings follow: A) Review of the attestation forms for the following proficiency test events for arterial blood gas determinations revealed that they were not signed by the testing personnel: First Chemistry Core Event 2022; Third Chemistry Core Event 2022; and First Chemistry Core Event 2023. B) Review of the second Chemistry Core event of 2022 revealed that it lacked an attestation form signed by any testing personnel or the laboratory director. C) In an interview, at 01:23 p.m. on 11/7/23, the laboratory staff member (# 13 as listed on the form CMS-209) confirmed the attestation form was not available for Chemistry Core event # 2 in 2022 and required testing personnel signatures were not available for arterial blood gas events identified above. 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 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 -- 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: Through observation, review of temperature records, lack of documentation and interview it was determined that the laboratory failed to monitor the temperature on each day of operation in one of six rooms in which supplies with storage temperature requirements were stored. . Findings follow: A) During a tour of the laboratory on 11/7 /23 at 10:45 a.m., six separate rooms (main lab, microbiology lab, blood bank, phlebotomy room, respiratory therapy and emergency room) containing laboratory items with a temperature storage requirement were observed. B) During a review of the laboratory's temperature records it was noted that no temperature records were presented for the microbiology lab area. C) During a tour of the laboratory on 11/9/23 at 11:00 a.m. 3 cartons of BacTAlert FA Plus blood culture bottles lot 00044181675, expiration date 2024-03-31 with a storage temperature requirement of 15 to 30 degrees C. were observed in the microbiology lab. D) Upon request, the laboratory could not present the temperature records for the microbiology lab in which the supplies identified above were stored. E) In an interview on 11/9/23 at 11:05 a.m. , the laboratory staff member (# 13 on form CMS 209) confirmed that temperature records for the micorbiology lab were not kept. 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 11:00 a.m.on 11/9 /23, two bottles of stain (3 Step Solution A lot # 114823 and 3 Step Solution B lot # 114824) with expiration date of 1/2023 were observed available for use when they had exceeded their expiration date. B) In an interview on 11/9/23 at 11:05 a.m., the laboratory staff member (# 13 on the CMS 209 form) confirmed that the stains identified above had exceeded the expiration date and were available for use. 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. -- 2 of 3 -- This STANDARD is not met as evidenced by: Through a review of the laboratory individualized quality control plan (IQCP) for arterial blood gas assays, lack of documentation, and interviews with laboratory staff, it was determined the laboratory failed to perform control procedures using the frequency established by the laboratory. Survey findings follow: A) The IQCP for arterial blood gas assays states "the laboratory is following manufacturer's recommended quality control procedure by testing external quality control material for each shipment of a new kit lot number".. B) During a tour of the laboratory on 11/9 /23 at 11:10 a.m. the RAPIDPoint 1200 series arterial blood gas analyzer was observed in the emergency room with the analysis cartridge lot # 3320902717 loaded on the instrument. C) Upon request, the laboratory was unable to provide the external quality control results for cartridge lot # 3320902717. D) In an interview at 11:12 on 11/9/23, laboratory employee #19 (as listed on the form CMS-209) confirmed the lot number and instrument , identified above, did not have external quality control performed and stated "I do not recall running external quality control on this machine". -- 3 of 3 --

Summary Statement of Deficiencies D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Through review of maintenance and background count records for the Sysmex XN 1000 analyzers serial numbers 30598 and 30523 and interview with laboratory staff members it was determined that the laboratory did not follow the protocol for daily maintenance and background counts as prescribed to ensure the acccuracy of complete blood cell counts (CBC) in one of one month reviewed. Findings follow: A) Review of the maintenance and background count records for the Sysmex XN 1000 analyzers, serial numbers 30598 and 30523, conducted on December 2, 2021 at 10:00 AM revealed that daily maintenance and background counts were recorded for both analyzers for the dates of 12/1/21, 12/2/21, 12/3/21, 12/4/21, 12/5/21 and 12/6/21. B) In an interview on 12/2/21 at 10:00 AM the laboratory staff member, identified as number thirteen on the CMS 209 form, when asked what the current date was replied December 2nd, and that they have no idea why maintenance and background counts were recorded for the dates of 12/3/21 through 12/6/21. D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of 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 -- alarm system must be documented. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Through review of Bradley County Medical Center records of continuous temperature monitoring system, back-up thermometer temperatures recorded every four hour by laboratory personnel and interview with laboratory staff, it was determined that the blood bank freezer, used for the storage of fresh frozen plasma (FFP), failed to maintain the required temperature of equal to or below -18 degrees C. on one of one month reviewed. Findings follow: A) Review of the Bradley County Medical Center records of continuous temperature monitoring system for the month of November 2020 revealed that the upper limit was defined as -14 Degrees C. and the temperature was recorded as warmer than -18 degrees C. on 111 occasions. B) Review of the back- up thermometer temperature records monitored every four hours by laboratory personnel for the blood bank FFP freezer revealed that temperatures were recorded as greater then - 18 degrees C. on 77 of 210 documented recordings in November 2020. C) In an interview on 12/2/21 at 01:00 PM the laboratory staff member, identified as number thirteen on the CMS 209 form, stated that the laboratory did not participate in the determination of acceptable ranges set in the automated temperature and humidity monitoring system, that the acceptable ranges for some parameters measured by the system were incorrect, that it was not known if the automated system was monitored and if policies and procedures required that laboratory personnel be notified if acceptable ranges were exceeded and that temperature in the blood bank freezer exceeded acceptable limits on the occasions identified above. -- 2 of 2 --

Summary Statement of Deficiencies D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: . Through a review of the manufacturer's instructions for the analyte Lactic Acid (LA), patient medical records, lack of documentation as well as interviews with staff, it was determined the laboratory failed to ensure the optimum integrity of patient specimens from the time of collection and receipt of the specimen through completion of testing and reporting of results. As evidenced by: A. A review of manufacturer's instructions for Lactic Acid revealed "Specimens for Lactic Acid analysis must be centrifuged and separated within fifteen minutes and analyzed immediately. If the test cannot be performed immediately, refrigerate the separate plasma for up to 24 hours or freeze specimen up to 30 days." B. A review of Lactic Acid patient results for February and March (two of three months) of 2019 revealed three of fifty-one patient results were not performed according to manufacturer' instructions. Patient #651335 Lactic acid collected at 1851 completed at 2035; Patient #6519329 Lactic acid collected at 0700 completed at 0805 and patient #653060 Lactic acid collected at 2336 completed 0040. C. Upon request the laboratory could not provide documentation that the specimens had been refrigerated or frozen for future analysis. D. In an interview at 1030 on 3/14/2019, the general supervisor ( as listed on form CMS 209) confirmed the laboratory did not analyzed the specimens immediately. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) 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 -- For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: . Through a review of the Blood Bank policy and procedure manual, Helmer Plasma Thawer maintenance log for 2018, lack of documentation, as well as interviews with staff, it was determined the laboratory failed to ensure function checks for the Helmer Plasma Thawer were within laboratory's established guidelines before patient testing: As evidenced by: A. A review of the Blood Bank policy and procedure manual revealed the maintenance protocol for the Helmer Plasma Thawer: "Quarterly function checks should be performed for the alarm and the lubrication of the rail." B. A review of the maintenance log for Helmer Plasma Thawer for January-December of 2018 revealed the quarterly function checks were not performed in four of four quarters for 2018. C. In an interview on 03/15/2019 at 11:30, general supervisor (as listed on the form CMS-209) confirmed the function checks were not performed for four of four quarters in 2018. -- 2 of 2 --