Red River Women's Clinic

Summary Statement of Deficiencies D0000 The Red River Women's Clinic laboratory was found to be out of compliance with the regulations of the Clinical Laboratory Improvement Amendments of 1988 (42 C.F.R. part 493) upon completion of the recertification survey performed on September 19, 2024. The following standard-level deficiencies were cited: 493.1254 Maintenance and function checks - (a)(2) and (b)(2) . 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: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to perform and document function checks (calibration) for 2 of 2 digital thermometers in 2024. Findings are as follows: 1. The laboratory performed Rhesus (Rh) typing as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory at 10:00 a.m. on 09/19/24. 2. The following digital thermometers were observed as in use during the tour: ML traceable thermometer Serial #: 221203375 Calibration Expiration Date: 01/31/24 Location: Refrigerator Use: Rh quality control material and patient specimen storage temperature monitoring Marketlab thermometer and hygrometer Serial #: 221551149 Calibration Expiration Date: 05/31/24 Location: Countertop Use: Daily room temperature and humidity monitoring 3. Function check documentation for this equipment was not found in laboratory records. The laboratory was unable to provide current certificates of calibration or function check documentation for the equipment upon request. 4. A procedure defining equipment 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 -- function check activities and frequency was not found during review of laboratory policies and procedures. See D5435 5. In an interview at 10:05 a.m. and 11:30 a.m. on 09/19/24, TP1 confirmed the above finding. . D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(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: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to establish a function check procedure and perform function checks for general laboratory equipment . Findings are as follows: 1. The laboratory performed Rhesus (Rh) typing as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory at 10:00 a.m. on 09/19/24. 2. The following ONiLAB mechanical pipettes were observed as present and available for use during the tour: Serial # YE224AX0255086 Type: Single channel, 5-50 ul Serial # YE224AX0255090 Type: Single channel, 5-50 ul The calibration date found on the manufacturer certificates was 05/22/22 for both pipettes. The manufacturer's operator's manual did not provide calibration frequency requirements. 3. Function check documentation for this equipment was not found in laboratory records. The laboratory was unable to provide function check documentation for the equipment upon request. 4. Function check requirements for laboratory equipment were not included in the CLIA Notebook policies and procedures found in the CLIA Log manual. 5. In an interview at 10:10 a.m. on 09/19/24, TP1 confirmed the above finding. . -- 2 of 2 --

Summary Statement of Deficiencies D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) 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 observation, document review, and interview with laboratory personnel, the laboratory failed to complete a performance verification (PV) for the single non- waived test implemented by the laboratory in 2022. Findings are as follows: 1. The laboratory performed Rhesus (Rh) typing as confirmed by Testing Personnel 2 (TP2) during a tour of the laboratory at 1:05 p.m. on 03/28/23. 2. Eldon Biologicals EldonCard Blood Typing Kits were observed as present and available for use during the tour of the laboratory. Rh testing using the EldonCard kits was implemented on 08 /10/22 as indicated by TP2 and confirmed in laboratory patient testing records. 3. PV documentation for EldonCard Rh testing was not found during review of laboratory records. The laboratory was unable to provide PV documentation upon request. 4. The patient testing log found in the Lab Log manual indicated 118 patients received Rh testing since implementation on 08/10/22 through date of survey, 03/28/23. See below Year Number of patients tested 2022 68 2023 50 5. In an interview at 1:20 p.m. on 03 /28/23, TP2 confirmed the above finding. . 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 --