Dimmit Regional Hospital

Summary Statement of Deficiencies D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(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 preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on review of a sampling of patient test records from August 29, 2022 to September 6, 2022, and staff interview, it was revealed the laboratory's quality assessment program failed to identify when the time of collection was listed as occurring after the sample was received in the laboratory for 1 of 24 reports. The findings include: 1. A sampling of patient test records from August 29, 2022 to September 6, 2022 identified 1 of 24 reports where the collection time for the sample was listed as occurring after the samples were received in the laboratory. It was: Date: 09/04/2022 Patient ID: 10241937 Collection time: 0040 Receipt time: 0037 2. An interview with the compliance person on 09/06/2022 at 1500 hours in the break room - after his review of the records- confirmed the findings. 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. 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: Based on review of the laboratory's RPR Quality Control Sheets from May 2022 to July 2022, review of the laboratory's RPR test records from May 2022 to July 2022, and staff interview, it was revealed the laboratory failed to have documentation of performing needle volume checks with each new ampule of antigen opened for 2 of 3 events. The findings include: 1. A review of the laboratory's RPR Quality Control Sheets from May 2022 to July 2022 revealed the laboratory defined the frequency of verifying the dispensing volume of the needle with each new antigen ampule. 2. A review of the laboratory's RPR test records from May 2022 to July 2022 revealed the laboratory documented changing the antigen ampule on the following days: May 27, 2022 July 1, 2022 July 29, 2022 3. Further review of the laboratory's RPR Quality Control Sheets from May 2022 to July 2022 revealed the laboratory failed to document verifying the needle volume on May 27, 2022 and July 29,2022. 4. A interview with the team lead tech on 09/06/2022 at 1600 hours in the laboratory - after his review of the records- confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted August 23-27, 2021. An exit conference was held on August 27, 2021. In attendance was the Laboratory Director, Chief Executive Officer, the Technical Consultant (Laboratory Manager), and the Executive Director of Outpatient Operations. The facility was informed that an unannounced revisit will be conducted. The following condition level deficiencies were found out of compliance: D5300 - 42 C.F.R 493.1240 Condition: Pre-Analytic Systems D5400 - 42 C.F.R. 493.1250 Condition: Analytic systems; D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director; D6033 - 42 C.F.R. 493.1409 Condition: Laboratories performing moderate complexity testing; technical consultant; Noted deficiencies and plans of correction were discussed with the laboratory representative at the exit conference. The facility representatives were given an opportunity to provide evidence of compliance with noted deficiencies and no such evidence was provided prior to survey exit. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on review of the laboratory's test menu, review of patient test records from November 2020 - July 2021 and staff interview, it was revealed the laboratory failed to report 643 SARS-COV-2 negative antigen test results as required by 400.200 for 259 of 328 days reviewed. Findings include: 1. Review of the laboratory's test menu revealed the facility started testing for COVID antigen utilizing the QIAstat-Dx Respiratory SARS-COV-2 panel in October 2020. 2. Review of the laboratory policies available revealed no documentation of a policy/procedure related to reporting COVID antigen test results. 3. Review of the laboratory's SARS-COV-2 patient test records from November 1, 2020 to August 24, 2021 revealed no documentation the laboratory reported 643 negative SARS-COV-2 antigen results 259 of 328 days reviewed. Refer to SARS-COV-2 IgM antibody Patient Alias list. a) November 2020 35 negative results not reported 19 test days b) December 2020 75 negative results not reported 28 test days c) January 2021 71 negative results not reported 31 test days d) February 2021 73 negative results not reported 28 test days e) March 2021 93 negative results not reported 31 test days f) April 2021 52 negative results not reported 22 test days g) May 2021 45 negative results not reported 25 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 -- days h) June 2021 53 negative results not reported 27 test days i) July 2021 91 negative results not reported 29 test days j) August 2021 55 negative results not reported 19 test days 4. An interview with the general supervisor on 08/23/2021 at 1500 in his office revealed the laboratory only reported positive COVID results. He stated the facility was unaware that negative results were also to be reported. This confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Based on surveyor observation and confirmed in interview of facility personnel, the laboratory failed to identify 3 of 3 reagents found in Coplin jars with lot number and expiration date. The findings were: 1. Surveyor observation on January 18, 2021 at 13: 52 hours in the laboratory found three (3) Coplin jars that contained reagents. The jars were not labeled with lot number or expiration date. Jar 1: Fixative Solution I No Lot Number No Expiration Date Jar 2: Fixative Solution II No Lot Number No Expiration Date Jar 3: Deionized Water No Lot Number No Expiration Date: 2. Reagent Log posted in the Hematology Department documented when reagents were changed but also did not include lot numbers or expiration dates. 3. Interview with the Laboratory Manager on January 18, 2021 at 14:00 hours in the laboratory confirmed the findings. 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 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 -- they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's IQCP (Individualized Quality Control Plan) for D- Dimer, Mono, Rheumatoid Factor, Helicobacter pylori, and Leuko EZ Vue, review of the laboratory's quality control records, review of patient test logs, and confirmed in interview of facility personnel it was revealed that the laboratory failed to have documentation of a complete risk assessment that identified the sources of error and evaluate the frequency and impact of those sources on the quality of testing. The findings were: Note: Manufacturer-provided tools and templates, if available, may be helpful for laboratories implementing IQCP; however, laboratories need to supplement these materials with laboratory-specific information as part of the Risk Assessment. The manufacturer information is not sufficient in and of itself. In-house data, established by the laboratory in its own environment and by its own personnel, must be utilized to demonstrate that the stability of the test system as it is used in the laboratory supports the number and frequency of the QC documented in the Quality Control Plan (QCP). 1. A review of the laboratory's IQCP studies for D-Dimer, Mono, Rheumatoid Factor, Helicobacter pylori, Leuko EZ Vue, and Sensititre for antibiotic susceptibility found the plans were incomplete. The risk assessment failed to include the evaluation of frequency and impact of possible sources of error obtained from the laboratory's own data. 2. Review of the IQCP studies found the laboratory utilized only the manufacturer's instructions to develop the plans. The laboratory did not utilize either previous EQC (Equivalent Quality Control) plans or new studies to develop its plan to perform testing with each new lot number, new shipment, and every 30 days. 3. A review of the laboratory's quality control records from March 1, 2020 to April 30, 2020 found that the laboratory performed quality control testing procedures as follows: Mono Spot Two levels of external quality control performed on: March 1, 2020 (Kit Lot #B31960) April 1, 2020 (Kit Lot #B31960) RA Factor Two levels of external quality control performed on: March 1, 2020 (Kit Lot #B30982) March 23, 2020 (Kit Lot #B32356) new lot number April 1, 2020 (Kit Lot #B2356) April 3, 2020 (Kit Lot #B32356) Helicobacter pylori Two levels of external quality control performed on: March 1, 2020 (Kit Lot #HP8720025) April 1, 2020 (Kit Lot #HP9082011) Leuko EZ Vue Two levels of external quality control performed on: 03-01-2020 (Kit Lot #0619044) 04-01-2020 (Kit Lot #0619044 Sensititre March 2, 2020 March 9, 2020 March 16, 2020 March 23, 2020 March 30, 2020 April 6, 2020 April 13, 2020 April 20, 2020 April 27, 2020 4. Review of the laboratory's patient test logs from March 1, 2020 to April 31, 2020 found the following patients were tested when the laboratory's IQCP studies were incomplete: Mono Spot No patients tested in March or April 2020 RA Factor Accession No.: 25162 Result Date: March 6, 2020 Result: Negative Accession No.: 25399 Result Date: March 7, 2020 Result: Negative Accession No.: 28913 Result Date: March 25, 2020 Result: Negative Accession No.: 29774 Result Date: March 30, 2020 Result: Positive Accession No.: 30105 Result Date: April3, 2020 Result: Negative Helicobacter pylori Accession No.: 24363 Result Date: March 8, 2020 Result: Positive Accession No.: 27468 Result Date: March 12, 2020 Result: Positive Accession No.: 27530 Result Date: March 17, 2020 Result: Negative Accession No.: 28867 Result Date: March 24, 2020 Result: Negative Accession No.: 28801 Result Date: March 24, 2020 Result: Positive Accession No.: 28903 Result Date: March 24, 2020 Result: Negative Accession No.: 29906 Result Date: March 31, 2020 Result: Negative Accession No.: 29926 Result Date: March 31, 2020 Result: Negative Accession No.: 29874 Result Date: March 31, 2020 Result: Negative Accession No.: -- 2 of 6 -- 29988 Result Date: March 31, 2020 Result: Negative Accession No.: 30014 Result Date: March 31, 2020 Result: Negative Accession No.: 31377 Result Date: April 7, 2020 Result: Positive Accession No.: 31385 Result Date: April 7, 2020 Result: Negative Accession No.: 31430 Result Date: April 7, 2020 Result: Negative Accession No.: 32780 Result Date: April 15, 2020 Result: Negative Accession No.: 34019 Result Date: April 21, 2020 Result: Negative Accession No.: 35347 Result Date: April 27, 2020 Result: Negative Accession No.: 35510 Result Date: April 28, 2020 Result: Leuko EZ Vue Accession No.: 31689 Result Date: April 9, 2020 Result: Positive Accession No.: 34350 Result Date: April 22, 2020 Result: Positive Sensititre (See Patient Alias List) 5. An interview with the Laboratory Manager on January 19, 2021 at 12:45 hours confirmed the findings. He revealed that he used only the manufacturer's instructions to develop the IQCP studies. D5781