Eastland Womens Clinic

Summary Statement of Deficiencies D3027 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(1) Test requisitions and authorizations. Retain records of test requisitions and test authorizations, including the patient's chart or medical record if used as the test requisition or authorization, for at least 2 years. This STANDARD is not met as evidenced by: . Based on record review and interview with the Laboratory Director (LD), and Testing Personnel (TP) #1, the laboratory failed to maintain 1 (#34) of 93 patient records reviewed by the laboratory for lack of quality control testing prior to patient testing. Findings include: 1. On August 2, 2023, at 12:38 pm, the surveyor requested 19 patient charts from the "QC EWC Records CLIA" excel spreadsheet to review. 2. A review of the charts requested revealed for 1 (#34) of 19 charts, the laboratory was unable to find the chart in the storage area due to a roof leak in the building. 3. An interview on 8/02/2023 at 12:38 pm, the LD and TP1 confirmed the above patient chart was not available on the day of the survey. 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 D0000 . The Department of Licensing and Regulatory Affairs has evaluated this facility during an announced recertification survey. It was determined the laboratory is not in compliance with CLIA regulations (42 CFR Part 93, effective April 24, 2003) and Immediate Jeopardy was identified. The following Conditions were not met: 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director 493.1409 Condition: Laboratories performing moderate complexity testing; technical consultant 493.1250 Condition: Analytic Systems 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: . Based on lack of documentation and interview with the Office Manager (OM) and Testing Personnel #1 (TP1), the individual testing proficiency testing samples and the Laboratory Director failed to attest to the routine integration of samples into the patient workload for 1 (1st event 2022) of 4 endocrinology serum Beta-Human Chorionic Gonadotropin (BhCG) testing. Findings include: 1. A review of the laboratory's American Proficiency Institute (API) proficiency testing records revealed a lack of the signed attestation statement sheet for 1 (1st event 2022) of 4 events reviewed. 2. An interview on 6/27/2023 at 11:28 am, the OM and TP1 confirmed the signed attestation statement sheet was not available on the day of the survey. . D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: . Based on record review and interview with the Office Manager (OM) and Testing Personnel (TP) #1, the laboratory failed to meet applicable analytic system requirements and correct identified problems. Findings include: 1. The laboratory failed to establish a test procedure for the Rh testing. Refer to D5401. 2. The laboratory failed to perform and document the traceable thermometer calibration checks. Refer to D5431. 3. The laboratory failed to perform control procedures each day of patient testing for the immunohematology Rh testing. Refer to D5445. 4. The laboratory failed to document

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: . Based on record review and interview with the Laboratory Liaison (LL), the laboratory failed to test the American Proficiency Institute (API) samples like a patient sample and record on the daily Rh Log and the serum pregnancy log for 2 (January 2020 to January 2022) of 2 years reviewed. Findings include: 1. Review of the API proficiency testing final reports revealed a lack of documentation on the Rh log and serum pregnancy log to show that testing and results of the proficiency testing samples are treated like a patient. 2. When queried on 1/24/2022 at 10:35 am, the LL stated "she was unaware that the proficiency testing samples needed to be recorded on the daily Rh and serum pregnancy logs." 3. An interview on 1/24/2022 at 10:35 am, the LL confirmed the API proficiency testing samples were not recorded on the daily Rh and serum pregnancy logs like routine patient samples for 2 of 2 years. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. 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: . Based on observation and interview with the Laboratory Liaison (LL), the laboratory failed to label the Anti-D Blend ALBA clone reagent with the open date for 1 (1/22 /2022) of 2 days of testing. Findings include: 1. During a tour of the laboratory on 1/24 /2022 at 9:28 am, the LL took 2 bottles of Anti-D Blend ALBA clone reagents from the refrigerator. The surveyor observed 1 of the 2 bottles did not have an open date recorded on the bottle. 2. When queried on 1/24/2022 at 9:32 am, the LL stated "the bottle was opened on Saturday and the date was not recorded on the bottle." 3. An interview on 1/24/2022 at 9:32 am, the LL confirmed 1 of the 2 bottles of Anti-D Blend ALBA clone reagent bottles was opened that past Saturday and the open date was not recorded on the bottle. 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 observation and interview with the Laboratory Liaison (LL), the laboratory failed to perform and document thermometer calibrations for 1 (Serial number (S/N) 10031746) of 1 thermometers before the expiration date. Findings include: 1. During a tour of the laboratory on 1/24/2022 at 9:28 am, the surveyor observed a Traceable Excursion thermometer in use in the refrigerator with an expiration date of 2/02/2019. 2. When queried on 1/24/2022 at 9:34 am, the LL was unaware the thermometer had an expiration date recorded on the back side of the thermometer. 3. An interview on 1 /24/2022 at 9:34 am, the LL confirmed the laboratory failed to perform and document thermometer calibration for the expired thermometer or replace it. ***Repeat Deficiency from 6/20/2017 survey*** D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require