Pocahontas Community Hospital

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was completed on June 3, 2025. The laboratory was found to be out of compliance with the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R 493.803 Condition: Successful Participation D6076 - 42 C.F.R 493.1441 Condition: Laboratory Director, High Complexity 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) 155 report and graded results from the American Proficiency Institute (API), the laboratory failed to successfully participate in two consecutive testing 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 -- events in the subspecialty of compatibility testing. The laboratory had unsatisfactory scores for 2024 event 3 and 2025 event 1. Refer to D2181. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) (e) Failure to achieve an overall testing event score of satisfactory for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) 155 report and graded results from the American Proficiency Institute (API), the laboratory failed to achieve satisfactory performance (100% or greater) for two consecutive testing events in the subspecialty, compatibility testing. The findings include: 1. For 2024 event 3, the laboratory received an unsatisfactory performance score of zero for the subspecialty, compatibility testing. 3. For 2025 event 1, the laboratory received an unsatisfactory performance score of 80% for the subspecialty, compatibility testing. 3. The CASPER 155 report and graded results from API confirm the findings listed above. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) 155 report and graded results from the American Proficiency Institute (2024 event 3 and 2025 event 1), the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under subpart H of this part; This STANDARD is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) 155 report and graded results from the American Proficiency Institute (API), the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2181. -- 2 of 2 --

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of proficiency testing records and confirmed by interview with general supervisor (GS) #1 at 8:40 am on 05/16/2025, the laboratory failed to verify the accuracy of post-vasectomy (qualitative semen analysis) examinations twice annually for four out of four time periods from 01/01/2023 - 12/31/2024. The findings include: 1. GS #1 stated the laboratory performs post-vasectomy (qualitative semen analysis) examinations. 2. At the time of the survey, GS #1 confirmed the laboratory did not enroll in proficiency testing or perform twice annual accuracy testing for post- vasectomy (qualitative semen analysis) examinations by another method from 01/01 /2023 - 12/31/2024. D5781

Summary Statement of Deficiencies D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on review of personnel training records and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 8:15 am on 05/18/2023, the laboratory director failed to ensure that testing personnel received the appropriate training for each test system for five out of five new testing personnel (identifiers #3- #7) hired since the last survey on 08/26/2021. The findings include: 1. Personnel identifier #2 stated that testing personnel identifiers #3- #7 perform all testing in the laboratory including the following: chemistry, hematology, coagulation, microbiology, immunology, immunohematology, and serology. 2. The training records for personnel identifiers #3- #7 did not include review of coagulation test systems. 3. The training records for personnel identifiers #3, #4, and #7 did not include review of immunohematology test systems. 4. The training records for personnel identifier #7 did not include review of microbiology test systems. 5. At the time of the survey, personnel identifier #2 confirmed training records for personnel identifiers #3- #7 did not include review of the test systems listed above. 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 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 review of proficiency testing (PT) records and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 9: 00 am on 08/26/2021, the testing personnel and laboratory director failed to attest to the routine integration of PT samples into the patient workload for five out of five proficiency testing events (2020 events 1, 2 and 3; 2021 events 1 and 2) from 1/1 /2020 - 08/26/2021. The findings include: 1. For 2020 event 1, the laboratory director did not sign the miscellaneous chemistry PT attestation statement. 2. For 2020 event 2, the laboratory director did not sign the miscellaneous chemistry PT attestation statement. 3. For 2020 event 3, the following PT attestation statements were not signed: *Core chemistry- laboratory director *Hematology/coagulation- laboratory director and testing personnel *Immunology/immunohematology- laboratory director *Microbiology- laboratory director 4. For 2021 event 1, the following PT attestation statements were not signed: *Core chemistry- laboratory director *Hematology /coagulation- laboratory director *Immunology/immunohematology- laboratory director and testing personnel *Miscellaneous chemistry- laboratory director and testing personnel 5. For 2021 event 2, the following PT attestation statements were not signed: *Core chemistry- laboratory director and testing personnel *Microbiology- laboratory director and testing personnel D5026 IMMUNOHEMATOLOGY CFR(s): 493.1217 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 -- If the laboratory provides services in the specialty of Immunohematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1271, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of patient testing records, quality control records, the Micro Typing Systems Anti-Human Globulin Anti-IgG manufacturer's package insert, and confirmed by laboratory personnel identifiers #1 and #2 (refer to the Laboratory Personnel Report) at approximately 1:00 pm on 08/26/2021, the laboratory failed to perform a negative and positive control material each day of patient testing as specified in D5449. 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: A. Based on review of the Dimension EXL maintenance records from January- August 2021 and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 10:45 am on 08/26/2021, the laboratory failed to perform and document weekly maintenance on the Dimension EXL chemistry instrument for 14 out of 33 weeks of patient testing from 01/03/2021- 08/21/2021. The findings include: 1. According to the Dimension EXL Weekly /Monthly Maintenance log, the manufacturer requires the laboratory to perform and document the following weekly maintenance: *Clean outside of R2 Probe *Clean outside of HM wash probes 2. The Dimension EXL Weekly/Monthly Maintenance log indicated that the laboratory did not document weekly maintenance during the following weeks: 01/03/21, 01/17/21, 02/07/21, 02/21/21, 03/21/21, 03/28/21, 05/23 /21, 05/30/21, 06/06/21, 06/20/21, 07/04/21, 07/11/21, 08/01/21, and 08/08/21. 3. At the time of the survey, personnel identifier #2 confirmed that the laboratory failed to perform and document weekly maintenance on the Dimension EXL chemistry instrument as required by the manufacturer for the weeks listed above. B. Based on review of the Dimension EXL maintenance records from January- August 2021 and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 10:45 am on 08/26/2021, the laboratory failed to document monthly maintenance on the Dimension EXL chemistry instrument for four out of eight months of patient testing from January- August 2021. The findings include: 1. According to the Dimension EXL Weekly/Monthly Maintenance log, the manufacturer requires the laboratory to perform and document the following monthly maintenance: *Clean clot check drain on IMT port *Replace IMT pump tubing *Clean IMT system *Replace/clean air filters *Stylette HM wash probes *Replace HM pump heads *Clean R2 drain *Clean R3 drain 2. Review of the Dimension EXL Weekly/Monthly Maintenance log indicated that the laboratory did not perform the following monthly maintenance: *January 2021: Replace/clean air filters *February 2021: All maintenance activities *May 2021: Replace HM pump heads *June 2021: All maintenance activities 3. At the time of the survey, personnel identifier #2 -- 2 of 3 -- confirmed that the laboratory failed to perform and document monthly maintenance on the Dimension EXL chemistry instrument as required by the manufacturer for the months listed above. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of patient testing records, quality control (QC) records, the Micro Typing Systems (MTS) Anti-Human Globulin Anti-IgG manufacturer's package insert, and confirmed by laboratory personnel identifiers #1 and #2 (refer to the Laboratory Personnel Report) at approximately 1:00 pm on 08/26/2021, the laboratory failed to perform a negative and positive control material each day of patient testing for five out of five days of patient testing from 02/01/2021- 03/31/2021. The findings include: 1. The laboratory uses the MTS Anti- Human Globulin Anti- IgG card to perform unexpected antibody detection testing. 2. The MTS Anti- Human Globulin Anti- IgG Card instructions for use state, "To confirm the specificity and reactivity of the MTS Anti-IgG card, it is recommended that each lot be tested each day of use with known positive and negative antibody samples with the appropriate red blood cells." 3. The laboratory performed unexpected antibody detection testing on the following dates: *02/05/2021- 1 patient *02/24/2021- 1 patient *03/03/2021- 1 patient *03/16/2021- 1 patient *03/23/2021- 1 patient 4. Personnel identifiers #1 and #2 confirmed that the laboratory routinely performs a positive control on the MTS Anti- Human Globulin Anti-IgG card each day of patient testing, but not a negative control. 5. At the time of the survey, the laboratory did not have negative control records for the dates of patient testing listed above. -- 3 of 3 --