Sedan City Hospital

Summary Statement of Deficiencies D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of the laboratory's 2022, 2023, and 2024 to date of survey American Proficiency Institute (API) proficiency testing (PT) documentation and interview with technical consultant (TC) #2, the laboratory failed to document

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on the review of proficiency testing (PT) records, the laboratory failed to successfully participate in PT from American Proficiency Institute (API) under the specialties: 1. Routine Chemistry for the regulated analyte: Sodium. See D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is 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 -- unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing (PT) from the provider API for Chemistry, and phone interview, the laboratory failed to achieve an acceptable score of 80% or higher for two of three consecutive testing events for the regulated analyte Sodium.. Findings: 1. Review of API PT scores for 2022 revealed the following performance scores for Sodium: a. Second testing event 2022 revealed a score of 60%. b. Third testing event 2022 revealed a score of 60% . 2. Phone interview with the lab manager on December 5, 2022 at 12:05 p.m. confirmed, the laboratory failed to achieve an acceptable score of 80% or higher for two of three consecutive testing events for the regulated analyte Sodium. -- 2 of 2 --

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on review of instrument type and test settings, lack of reagent lot evaluation data, manufacturer's instructions, patient testing volumes and interview, the laboratory failed to follow manufacturer's instruction on reagent lot changes for both Innovin and Actin reagent: prior to use for patient testing. Findings: 1. Prothrombin time (PT) and partial prothrombin time (PTT) testing are performed on the Sysmex CA-660. 2. Sysmex CA-600 instrument setting for PT testing showed Innovin reagent lot #557614A, expiration 10/12/2020. Mean normal patient (MNPT) set at 10.7 seconds, ISI value set at 1.05 and last modification date as 3/13/2021. 3. Review of PT reagent in use found the Innovin reagent lot was #549763, expiration 11/28/2022, ISI value for CA-600 instrument was 1.01. 4. Request was made to review the Innovin reagent lot #549763 evaluation for normal values and NPGM determination. No data was made available at the time of survey. 5. Manufacturer's instructions for Innovin contained " the mean normal PT (MNPT) is defined as the mean value of the normal range. It must be determined specifically for each thromboplastin lot using the method used to analyze the patient samples and, where appropriate, using the coagulation analyzer used for the analysis." 6. Sysmex CA-600 instrument setting for PTT testing showed Actin reagent lot #548460, expiration 1/13/2018. 7. Review of the PTT reagent in use was Actin reagent lot #55766524, expiration 11/30/2023. 8. Request was made to review the Actin reagent lot #55766524 evaluation for normal values. No data was made available at the time of survey. 9. Manufacturer's instructions for Actin contained "Reference intervals vary from laboratory to laboratory depending on 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 -- population served and the technique, method, equipment and reagent lot used. Therefore, each laboratory must establish its own reference intervals or verify them whenever one or more of the aforementioned variables are changed." 10. Review patient test volumes revealed 367 PT and 21 PTT results were reported from 1/14 /2021 to 5/9/2022. 11. Interview with testing personnel (TP) #1 5/9/2022 at 4:30 p.m. confirmed, the laboratory failed to follow manufacturer's instruction on reagent lot changes for both Innovin and Actin reagent: prior to use for patient testing. D5553 IMMUNOHEMATOLOGY CFR(s): 493.1271(b)(f) (b) Immunohematological testing and distribution of blood and blood products. Blood and blood product testing and distribution must comply with 21 CFR 606.100(b)(12); 606.160(b)(3)(ii) and (b)(3)(v); 610.40; 640.5(a), (b), (c), and (e); and 640.11(b). (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of patient transfusion records and interview, the laboratory failed to perform and document a visual inspection/appearance on seven of seven Packed Red Blood Cell (PRBC) units prior to issue for transfusion from 1/14/2020 to 5/9/2022. Findings: 1. Upon review of the blood product issue and transfusion form, there was no designated area for the documentation of a visual inspection of blood product performed immediately before issue. There was also no other entry found on these documents of this inspection. 2. A review of the patient transfusion records revealed seven units of blood were issued for transfusion from 1/14/20 to 5/9/2022. 3. Interview with TP #1 on 5/9/2022 at 1:35 p.m. confirmed, the laboratory failed to perform and document a visual inspection/appearance on seven of seven Packed Red Blood Cell (PRBC) units prior to issue for transfusion from 1/14/2020 to 5/9/2022. -- 2 of 2 --

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: Based on an absence of thermometer records, microscope maintenance records and interview with General Supervisor (GS) #1, the laboratory failed to define a function check protocol for the thermometers and microscopes. Findings were: 1. No documentation was available for function checks of thermometers for a 24 month period. No documentation was available for the certification of accuracy (NIST traceble) for thermometers, including blood bank storage thermometers for a 24 month period. 2. No documentation was available for the maintenance of microscopes during 2019. 3. Interview with GS #1 on 01/13/2020 @1:20 pm confirmed the laboratory had no records of function checks for the thermometers used in the laboratory for the past two years. 4. Interview with GS #1 on 01/13/2020 @1:20 pm confirmed the laboratory had no records of microscope maintenance during 2019. 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 D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on lack of documents and interview with the laboratory manager at 1:40 pm on October 18, 2018, the laboratory failed to have and follow policies and procedures to assess the technical consultant's competency. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Review of 2017 Sysmex CA-600 test system records and manufacturer's instructions, Dade Innovin package inserts, interview with lab manager, and direct observation reveals that the laboratory failed to follow the manufacturer's instructions for test system operation. Findings include: 1. The laboratory reports an INR ratio which is calculated using the ISI value of the reagent currently in use. According to the package insert for Dade Innovin, lot 549708 with expiration date 2/23/2020, the correct ISI value is 1.00. An incorrect value of 0.98 was observed in the Sysmex CA- 600 coagulation analyzer computer. Innovin lot 549708 was put into use September 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 -- 2017. 2. At the time of the survey, the lab failed to provide complete documentation of the normal patient mean study for the new lot of Innovin put into use during September 2017. 3. The above information was confirmed by Lab Manager and testing personnel #2, refer to Testing Personnel Report (CMS-209), at 13:40 on October 18, 2018. -- 2 of 2 --