Mena Regional Health System

Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) (b)The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based upon a review of American Proficiency Institute (API) proficiency testing preformance evaluation for Immunology/Immunohematology proficiency testing events in 2025, and interviews with laboratory staff, the laboratory did not test compatability for samples SER-07 and SER-08 in the 2nd proficiency testing event in 2025 in the same manner as patient testing. Findings follow: A) Review of the API Immunology/Immunohematology Antibody Screen result comparative evaluation for the second event in 2025 revealed samples SER-07 and SER-08 were resulted as "unexpected antibody detected" and the results were evaluated as acceptable. B) Review of the API Immunology/Immunohematology Compatability result comparative evaluation for the second event in 2025 revealed samples SER-07 and SER-08 were resulted as compatible and the results were evaluated as unacceptable. C) In an interview on 11/5/25 at 02:30 p.m., when asked what caused the failure for compatability testing on the 2nd API Immunology/Immunohematology event in 2025, the laboratory staff member (#10 on the form CMS 209) stated that samples SER-07 and SER-08 had positive antibody screens and the testing personnel performed and reported the samples as compatible based upon an immediate spin crossmatch. The laboratory's policy is to refer compatibility testing for all patients with positive Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- antibody screens to a reference laboratory, but "the techs thought because it was proficiency testing they had to report it" and they did not treat the proficiency testing samples in the same manner as patients. 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 2025 CMS Casper Reports 0153D and 0155D, and the American Proficiency Institute (API) proficiency testing results, the laboratory failed to have successful participation in proficiency testing for the test compatibility testing. 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 unsuccessful performance as cited at 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 2025 CMS Casper Reports 0153D and 0155D, and the American Proficiency Institute (API) proficiency testing results, the laboratory failed to achieve satisfactory performance in two consecutive proficiency testing events for the test compatibility testing as evidenced by: A) The Laboratory received a score of 0.0% for compatibility testing in the third proficiency testing event of 2024. B) The Laboratory received a score of 60% for compatibility testing in the second proficiency testing event of 2025. C) The scores identified above resulted in a "long term" evaluation of "unsuccessful" by the API proficiency testing agency. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) -- 2 of 5 -- (d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on a review of the laboratory procedure manual, lack of documentation, and interviews with laboratory staff, the laboratory director failed to approve, sign, and date all the laboratory procedures. Survey findings include: A. During a review of the laboratory procedures, it was determined the laboratory director failed to sign the procedure manual and individual policies (Titled procedures NOT signed by the Laboratory Directory: Guidelines for Manual Differential & Scanning a Peripheral Blood Smear, Blood Cell Differential & Smear Review, Red Blood Cell Indices, Platelet Clumping Cold Agglutinin Procedure, Policy & Procedure for Hematology Analyzer, Corrected Reference Laboratory Report, MMA Corrected report, Hematology QC Lot Verification, Quality Assessment Plan, Quality Assessment Report Criteria, Specimen Collection Manual, HcG Dipstick rapid Test, Quickvue RSV, Stat Flu A&B, Coagulation Quality Control and Corrective, Coagulation Sysmex CA-620, Coagulation Sysmex 2500, Coag Lot Rollover, Coag IRN Calculation Verification.) B. In an interview at 1:54 pm on 11/03/2025, Technical Consultant (TC) as listed on the 209 form, confirmed the laboratory director's written approval of the laboratory procedures was not available. D5409 PROCEDURE MANUAL CFR(s): 493.1251(e) (e) The laboratory must maintain a copy of each procedure with the dates of initial use and discontinuance as described in 493.1105(a)(2). This STANDARD is not met as evidenced by: Based upon the review of the laboratory policy and procedure "Quality Assurance of Blood Bank Procedures", and interview with laboratory staff, the laboratory did not document the discontinuance of performing AHG crossmatches on IgG cards on patients with positive antibody screens. Findings follow: A) Review of the policy and procedure "Quality Assurance of Blood Bank Procedures" effective 6/14/24, reviewed and approved by the laboratory director on 9/25/24, revealed that patients with a positive antibody screen will have samples sent to the reference blood bank for antibody identification and the provision of antigen negative blood units. "After receiving the antidody negative units the units will be retyped, immediate spin crossmatched in buffer cards and AHG crossmatched in IgG cards". B) In an interview on 11/5/25 at 02:00 p.m., the laboratory staff member (# 10 on the form CMS 209) stated that policy is no longer in use and that all patients with positive antibody screens are referred to the reference blood bank who performs the crossmatches. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) (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. -- 3 of 5 -- This STANDARD is not met as evidenced by: Based upon review of the package insert for Dade Innovin reagent for Prothrombin Time (PT) assays, lack of documentation, observation of instrument settings, and interview, the laboratory failed to determine the normal patient mean (MNPT) value for the laboratory's patient population used in the calculation of International Normalized Ratio (INR) values in accordance with manufacturer's instruction. Findings follow: A) Review of the package insert for Dade Innovin revealed that the MNPT used in the calculation of the INR "must be determined specifically for each thromboplastin lot using the method to analyze the patient samples using the coagulation analyzer used for the analysis. Follow appropriate laboratory guidelines for establishing MNPT for US customers the appropriate CLSI guideline is recommended". B) When asked to present the data used to establish the MNPT with the change to Dade Innovin lot # 564677, the data was available with no demographic presented of 20 normal health subjects. Laboratory could not provide the number of males and females, free of known illnesses and medications. C) In an interview at 01: 22 pm on 11/4/25, the Technical Consultant (TC), listed on the CMS 209 form, stated the data could not be located. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) (d)(3)(i) Each quantitative procedure, include two control materials of different concentrations; This STANDARD is not met as evidenced by: Based upon a review of chemistry quality control (QC) documentation for September 2025, the laboratory policy for "General Quality Control", and interview with laboratory staff, the laboratory documented running only one level of quality control on one of thirty-one days of testing in September 2025. Survey findings follow: A) Review of the laboratory policy and procedure for "General Quality Control" revealed "for each quantitative procedure include at least two levels of control material of different concentrations". B) The surveyor reviewed quality control for September 2025. On 9/4/25 the laboratory documented quality control results for the High chemistry Control (lot #3923) for the analyte Thyroid Stimulating Hormone (TSH) but did not document results for the Normal (lot # 3921) C) A review of patient TSH test results for 9/4/25 revealed sixteen patients ( identified as number 1 through 16 on a separate patient identification list) had TSH assays performed and reported on the day that only one control was documented. D ) During an interview at 01:00 p.m.on 11 /5/2025, laboratory staff member (#11 on the form CMS 209) confirmed that sixteen patients were tested on 9/4/25 when only one control was documented for TSH assays. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. -- 4 of 5 -- This CONDITION is not met as evidenced by: Based on review of 2024 and 2025 proficiency testing results, the laboratory director failed to ensure that the proficiency testing samples are tested as required under Subpart H of this part. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(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 the 2024 and 2025 proficiency testing event results, the laboratory director failed to ensure the laboratory successfully participated in proficiency testing for the immunohematology analyte compatability testing. Refer to D2181. -- 5 of 5 --

Summary Statement of Deficiencies D0000 This is the complaint survey conducted on 2/25/2025 through 2/26/2025. The complaint was not substantiated but standard level deficiencies were cited. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratorys and, as applicable, the manufacturers test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of Chemistry Policies and Procedures, Chemistry Quality Control Report By Assay for November 2024, patient test records for 11/10/2024, and interviews with laboratory staff, the laboratory failed to ensure results of control materials meet the laboratory's criteria for acceptability before reporting patient test results. Survey findings include: A. Chemistry Policies and Procedures listed laboratory tests that each type of quality control is used for. Multiqual is used to determine acceptability of Comprehensive Metabolic Profile (CMP), Basic Metabolic Profile (BMP), Lipids, Salicylates, Phosphorous, Iron, Total Iron Binding Capacity (TIBC), Magnesium, Valproic Acid, Creatine Kinase (CK), Acetaminophen, Lipase, and Uric Acid; Cardiac Control is used for Troponin, Creatine Kinase MB Fractions (CKMB), and B-type Natriuretic Peptide (BNP); and CRP Control is used for C- Reactive Protein (CRP). B. A review of Chemistry Quality Control Reports By Assay revealed Multiqual Levels 1, 2, and 3 were not run until 8:21 a.m., Cardiac Quality Control Levels 1 and 3 were run at 8:37 a.m., and CRP Quality Control Levels 1 and 2 were run at 8: 32 a.m. on 11/10/2024. C. A review of a patient test list from 11/10 /2024 determined that seven patients had tests reported before quality control was acceptable: Patient Account #1579910 CMP result reported 3:51 a.m. and a BNP and Troponin at 4:03 a.m.; Patient Account #1579911 had a CMP reported at 5:43 a.m.; Patient Account #1579912 had a BMP reported at 5:25 a.m.; Patient Account 1579914 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 -- had a BMP reported at 6:39 a.m.; Patient Account #1579915 had a CMP reported at 6: 26 a.m.; Patient Account #1579916 had a CMP and CK reported at 5:43 a.m., Troponin and CKMB at 5:46 a.m. and BNP reported at 5:47 a.m.; and Patient Account #1579917 had a CMP reported at 6:40 a.m. D. In an interview at 10:25 a.m. on 2/26/2025, laboratory employee #1 (as listed on the form CMS-209) confirmed the lack of acceptable quality control results before patients were reported on 11/10/2024. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A CLIA conplaint investigation was performed on 10/17/2022 through 10/27/2022. The laboratory was not in compliance with the following conditions: 493.1250 Analytic Systems 493.1441 Laboratory Director (High Complexity) 493.1487 Testing personnel (High Complexity) D3015 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103 A facility that provides transfusion services must meet all of the requirements of this section and document all transfusion-related activities. This STANDARD is not met as evidenced by: Through a review of Rules and Regulations for Hospitals and Related Institutions in Arkansas 2016, Medical Staff Bylaws, and Blood and Tissue Committee Meeting Minutes, and through interviews with staff, it was determined the facility failed to comply with Rules and Regulations for Hospitals and Related Institutions in Arkansas 2016 requirements for blood utilization committee that includes documenting all transfusion activities in 2022. This was previously cited as a deficiency in the validation survey conducted in January 2020. Findings follow: A) The Rules and Regulations for Hospitals and Related Institutions in Arkansas 2016 stated in Chapter 19 (Laboratory) that "a committee of the Medical Staff shall fulfill the following responsibilities: Establish criteria for the proper use of blood and its components; Monitor the transfusion of blood and its components to ensure the established criteria for proper use are met; Review the reports of suspected transfusion reactions; and Establish criteria for therapeutic phlebotomies". B) The Medical Staff Bylaws last amended on July 11 2017 stated the following: "The blood and tissue committee shall consist of a chairman, who is an associate or active member of the medical/dental /podiatric staff , director of medical records, director of laboratory, and the operating room supervisor." and "In addition, the committee shall provide a mechanism that ensures the review of blood transfusions for proper utilization and evaluation of all Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- confirmed transfusion reactions." C) A review of Blood and Tissue Committee Meeting Minutes dated 2/5/20 stated under the heading of "policy" "The blood and tissue committee will meet quarterly under the blood utilization section to review transfusion services including pre-analytical, analytical, and post analytical processes these processes include but are not exclusive to the following transfusion services: 1. Rates of transfusions. 2. Adherence to Policy of Criteria to Tranfuse and use of blood products. 3. Documentation of variances thereof. 4. Use of emergent released units. 5. Possible transfusion reaction work ups. 6. Review of transfusion services policies. 7. Quality monitors which should be congruent and periodical". D) In an interview on 10 /17/22 at 11:10 a.m. when asked for the Blood and Tissue Committee meeting minutes the personnel (#1 and #2 as listed on the entrance conference attendance record) stated the committee minutes "whereabouts" are unknown since the last laboratory manager left. E) At 03:17 p.m. staff member (#1 as listed on the entrance conference attendance record) presented copies of Transfusion Committee reports for 2/5/20, 3/9/15/20, 12/14/20, 3/24/21, 6/24/21 and 9/23/21. When asked for Blood and Transfusion Committee minutes since 9/23/21 the staff member stated that the committee had stopped meeting at the instruction of the laboratory manager "due to covid". F) Review of the Blood and Tissue Committee minutes presented contained no reports concerning the adherence to policy, criteria to transfuse, and use of blood products or documentation of variances thereof. In an interview at 3:17 p.m. on 10/17 /22 staff member (#1 as listed on the entrance conference attendance record), when asked if quality assurance monitors for the adherence criteria to transfuse and use of blood products were documented ,stated that she had never seen those criteria in writing. Without written protocol for transfusion and regular meetings the committee cannot ensure that transfusions meet established criteria as required by the Rules and Regulations for Hospitals and Related Institutions in Arkansas 2016. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic 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: Through a review of the policy titled, "Receiving and Storage of Blood Products", a review of the Blood Bank Log book, "Request for Investigation of Transfusion Reaction" from September 2020 through September 2022, the Root Cause Analysis Incident Investigation Tool, patient blood type results, personnel records, and interviews with laboratory staff, it was determined the laboratory failed to meet analytic systems requirements as evidenced by: D5553 - The laboratory failed to document the release and visual inspection of two units of packed red blood cells immediately before the blood was distributed for infusion to the patient. D5559 - The laboratory failed to document pathologist's final judgement and signature on five of fifteen transfusion reaction workups D5787 - The laboratory failed to maintain a record system with dates of all specimen testing D5791 - The laboratory used incorrect data and failed to identify the problem when ABO incompatible blood was transfused to a patient. -- 2 of 9 -- 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: Through a review of the policy titled, "Receiving and Storage of Blood Products", a review of the Blood Bank Log book, and interviews with laboratory staff, it was determined the laboratory failed to document the release and visual inspection of two units of packed red blood cells immediately before the blood was distributed for infusion to the patient on 9/19/2022. Survey findings include: A. The laboratory policy titled, "Receiving and Storage of Blood Products", "To release a unit: Only those employees authorized to perform blood bank testing may release blood or blood products. To verify the correct patient/unit is being released, the Blood Bank Log book and the Unit Tag must match. The Tech may read the Log and the Nurse may read the unit (or vise versa). Tech and Nurse must identify the patient using name, D. O.B., and Blood Bank Identification Band, as well as the Unit number, Blood Type and Rh, and expiration date. The Blood Bank Log book, product hang tag, and labels all must match before issuing and releasing. The Tech must also review the test results, including the antibody and crossmatch interpretations to insure they are negative and compatible, and the blood band number on the worksheet for errors and omissions prior to release of the unit. If there is a discrepancy, the unit cannot be released until the problem is fixed. The tech must document the visual inspection of the unit in provided space in the Blood Bank log book. Fill in the release section, including the date and time, on both the worksheet and the Blood Bank log book." B. A review of the Transfusion Service Testing Logs for 2021 and 2022 revealed that on 9/19/2022 two units of blood were signed out for patient #1500289 by a registered nurse without documentation that the authorized testing person from the laboratory performed any of the required procedures listed in the policy. C. In an interview, at 2: 32 p.m. on 10/17/2022, laboratory employee #3 (as listed on the personnel worksheet) confirmed the lack of laboratory documentation at the time the blood was taken from the laboratory on 9/19/2022. D5559 IMMUNOHEMATOLOGY CFR(s): 493.1271(e)(f) (e) Investigation of transfusion reactions. (e)(1) According to its established procedures, the laboratory that performs compatibility testing, or issues blood or blood products, must promptly investigate all transfusion reactions occurring in facilities for which it has investigational responsibility and make recommendations to the medical staff regarding improvements in transfusion procedures. (e)(2) The laboratory must document, as applicable, that all necessary remedial actions are taken to prevent recurrences of transfusion reactions and that all policies and procedures are reviewed to assure they are adequate to ensure the safety of individuals being transfused. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. -- 3 of 9 -- This STANDARD is not met as evidenced by: Through a review of all "Request for Investigation of Transfusion Reaction" from September 2020 through September 2022 and through interviews with laboratory staff, it was determined the laboratory failed to document pathologist's final judgement and signature on five of fifteen transfusion reaction workups. Survey findings include: A. Through a review of "Request for Investigation of Transfusion Reaction" it was determined that the forms included a section for the Pathologists Final Judgement and the Clinical Laboratory Director's signature. On five of the fifteen forms completed for possible transfusion reactions in the last 24 months (Patient #1 as listed on the Patient Identification Worksheet dated 9/28/2020, Patient #2 as listed on the Patient Identification Worksheet dated 1/21/2021, Patient #3 as listed on the Patient Identification Worksheet dated 9/2/2021, Patient #4 as listed on the Patient Identification Worksheet dated 9/19/2022, and Patient #5 as listed on the Patient Identification Worksheet dated 9/29/2022), the Pathologists Final Judgement and the Clinical Laboratory Director's signature were not completed. B. In an interview, at 2:38 p.m. on 10/17/2022, laboratory personnel #3 (as listed on the personnel worksheet) confirmed the pathologist failed to complete his section of the transfusion reaction workups on five of fifteen possible transfusion reactions. C. Without the pathologist's final judgement documented, the laboratory was unable to make recommendations to the medical staff regarding improvements in transfusion procedures, to take necessary remedial actions to prevent recurrences of transfusion reactions, or to ensure that all policies and procedures are reviewed and updated to ensure the safety of individuals being transfused. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Through a review of the Transfusion Reaction Request for Investigations, the Blood Bank Log book, and interviews with laboratory staff, it was determined the laboratory failed to maintain a record system with dates of all specimen testing for one of fifteen. Survey findings include: A. A review of fifteen Transfusion Reaction Request for Investigation forms included one 9/29/2022 for patient #129564. The form was completed with results from laboratory testing of pre and post transfusion samples. B. The laboratory used a manually documented Blood Bank Log to document all blood bank test results. A review of the Blood Bank Log book revealed that the pre and post transfusion testing performed as a response to the Transfusion Reaction Request for Investigation were not documented in the Blood Bank Log. There was no documentation in the Log to support the results documented on the transfusion reaction form for one (Patient #5 from the Patient Identification Worksheet) of fifteen patients reviewed . C. In an interview, at 2:29 p.m. on 10/17/2022, employee #3 (as listed on Entrance Conference Sign In Sheet) confirmed the lack of documented test results in the Blood Bank Log to support the findings on the Transfusion Reaction forms. -- 4 of 9 -- D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Through a review of the Root Cause Analysis Incident Investigation Tool, patient blood type results, and the "Request for Investigation of Transfusion Reaction", personnel records, and through interviews with staff, it was determined the laboratory used incorrect data and misidentified the problem when ABO incompatible blood was transfused to a patient. Survey findings follow: A. A review of the Root Cause Analysis Incident Investigation Tool and supporting data revealed the laboratory test results that the team used in the investigation were incorrect and caused the team to make incorrect assumptions. The data used by the root cause analysis team included a pre-transfusion and post-transfusion blood type. The data used included an A positive result for pre-transfusion and an O positive result for post-transfusion and the team concluded the pre-transfusion sample was mislabeled. B. A review of the "Request for Investigation of Transfusion Reaction" for Patient #5 (as listed on the Patient Identification Worksheet) revealed the patient's pre-transfusion sample tested as O positive and the post-reaction sample tested as O positive. Personnel #5 documented these results on a Laboratory Problem / Error form that stated, "patient was Typed and Screened as A positive on 9/28 and was assigned a unit of A positive blood. During transfusion 9-29, she began to have a transfusion reaction. Protocol was immediately implemented and following a Type and Screen of both her Pre-transfusion and Post- Transfusion blood draws, it was determine the patient is O positive." C. A review of the printouts of test results that the root cause analysis team had used in their investigation revealed the pretransfusion result used was tested by employee #3 (as listed on the personnel worksheet) who originally mistyped and miscrossmatched the patient. This result was the original result of A positive that was an error and caused the O positive patient to get A positive blood. D. The root cause analysis stated, "Labeling of blood product - wrong label that reflected the wrong blood type being tagged for patient" and "The incident was R/T human error of mislabeling the blood" but the transfusion reaction investigation performed on 9/29/2022 documents retyping of the patient samples and the unit of blood. Patient samples typed as O positive and the unit (which was labeled as A positive) typed as A positive. The samples and the blood were all labeled correctly in order for employee #5 to obtain these results. E. In a review of the Request For Investigation of Transfusion it was observed that the Pathologist's Final Judgement stated, "Dr Wang remented [sic] for more tranning [sic] of Med teck [sic] in the lab" F. A review of the personnel records for laboratory employee #3 (as listed on a separate personnel identification list) revealed that the employee began employment on 7/1/19, training records were not presented, and the only competency evaluation was dated 10/22/21. On the Blood Bank section of that competency the employee was scored as "needs work" on "Fetal Cell Screens" and "Verifies Expiration Dates of Reagents and Controls" and the employee was not scored for "Performs as Needed for All Tests" and "Accurately Reports and Records Patient Results". G. The root cause analysis failed to document the recommendation on the transfusion reaction investigation for more training or that the employee involved lacked training documentation and competency assessment for blood bank. -- 5 of 9 -- 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 a review of facility records and staff interviews, it was revealed the laboratory director failed to provide overall management for the laboratory (refer to citations at D6102, D6103, and D6107). 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: Through a review of personnel records, proficiency testing results for 2021 and 2022, cease testing letter from accreditation agency, transfusion reaction investigation documents and interviews with laboratory staff, it was determined the director failed to ensure that personnel have received appropriate training prior to testing patient specimens. Survey findings follow: A) Review of American Proficiency Institute (API) Immunohematology proficiency testing results for 2021 and 2022 revealed: - that the laboratory scored 80% (unacceptable) for compatability testing on the 2nd testing event of 2021 the root cause/

Summary Statement of Deficiencies D0000 This is the validation survey of the laboratory conducted on 1/21/2020 through 1/23 /2020. At the time of the validation survey the laboratory was not in compliance with the following conditions with immediate jeopardy: 493.1100 Facility Administration (Immediate Jeopardy) 493.1217 Immunohematology (Immediate Jeopardy) 493.1250 Analytic Systems 493.1441 Laboratory Director High Complexity (Immediate Jeopardy) 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: Through a review of Rules and Regulations for Hospitals and Related Institutions in Arkansas 2016, Medical Staff Bylaws, Blood and Tissue Committee Meeting Minutes, Mena Regional Health System transfusion statistics, Mena Regional Health System / Laboratory Blood Bank Department "Transfusion Reaction Policy", Mena Regional Health System "Blood Components Administration" policy, Perry & Potter current edition "Clinical Nursing Skills & Techniques", MRHS Employee In Service "Skills for Administering Parenteral Fluids and Blood Products" Power-Point slide summary, the Mena Regional Health System "Transfusion Reaction:Request for Investigation" form, patient blood administration records for October and November Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 21 -- 2019, lack of documentation, and interview it was determined the facility failed to meet CLIA requirements as evidenced by: D3015 - the facility failed to comply with Rules and Regulations for Hospitals and Related Institutions in Arkansas 2016 requirements for blood utilization committee D3025 - the facility failed to ensure transfusion reaction policies promptly identified, investigated and documented transfusion reactions for all blood products Failure to meet CLIA facility requirements is an immediate jeopardy to patient care. D3015 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103 A facility that provides transfusion services must meet all of the requirements of this section and document all transfusion-related activities. This STANDARD is not met as evidenced by: Through a review of Rules and Regulations for Hospitals and Related Institutions in Arkansas 2016, Medical Staff Bylaws, and Blood and Tissue Committee Meeting Minutes, and through interviews with staff, it was determined the facility failed to comply with Rules and Regulations for Hospitals and Related Institutions in Arkansas 2016 requirements for blood utilization committee. Survey and document all transfusion activities. findings follow: A. The Rules and Regulations for Hospitals and Related Institutions in Arkansas 2016 state in Chapter 19 (Laboratory) that a committee of the Medical Staff shall fulfill the following responsibilities: Establish criteria for the proper use of blood and its components; Monitor the transfusion of blood and its components to ensure the established criteria for proper use are met; Review the reports of suspected transfusion reactions; and Establish criteria for therapeutic phlebotomies. B. The Medical Staff Bylaws last amended on July 11 2017 state the following: "The blood and tissue committee shall consist of a chairman, who is an associate or active member of the medical/dental/podiatric staff , director of medical records, director of laboratory, and the operating room supervisor." and "In addition, the committee shall provide a mechanism the ensures the review of blood transfusions for proper utilization and evaluation of all confirmed transfusion reactions." This does not meet the hospital licensure requirements that suspected transfusion reactions are to be reviewed. C. A review of Blood and Tissue Committee Meeting Minutes for the three quarterly meetings in 2019 revealed three meetings were documented on March 1, 2019 (to review transfusions from fourth quarter of 2018), May 17, 2019 (to review transfusions from first quarter 2019), and August 20, 2019 (to review transfusions for the second quarter 2019). The minutes for the three meetings document only the committee chairman and the laboratory supervisor were in attendance (two of four members). There is no documentation that transfusions from the third or fourth quarter of 2019 were reviewed. In an interview at 10:46 on 1 /23/2020 the current Director of Laboratory Services (a member of the committee) who has been employed since September 2019, stated that he had never met the Blood and Tissue Committee chairman and that he was unaware of any meetings after the one dated August 20, 2019. D. The Blood and Tissue Committee Meeting Minutes for the May and August quarterly meetings stated that all transfusions "met protocols". Upon request, protocols could not be produced. The surveyor requested a copy of the transfusion protocols in use by the Blood and Tissue committee and was told that there are no written protocols. Laboratory employee #2 (as listed on the form CMS- 209), who is also in the role of Director of Laboratory Services and therefore a member of the committee, stated (1/23/2020 at 10:46) that he had no knowledge of written protocols. Employee #2 directed me to hospital administration in order to -- 2 of 21 -- obtain a copy of written protocols for transfusions but administrative personnel were unable to provide written protocol for transfusion. Without written protocol for transfusion the committee cannot ensure that transfusions meet established criteria as required by the Rules and Regulations for Hospitals and Related Institutions in Arkansas 2016. D3025 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(d) Investigation of transfusion reactions. The facility must have procedures for preventing transfusion reactions and when necessary, promptly identify, investigate, and report blood and blood product transfusion reactions to the laboratory and, as appropriate, to Federal and State authorities. This STANDARD is not met as evidenced by: 35451 . 35659 Based upon a review of Mena Regional Health System provided statistics, lack of documentation, Mena Regional Health System / Laboratory Blood Bank Department "Transfusion Reaction Policy", Mena Regional Health System "Blood Components Administration" policy, Perry & Potter current edition "Clinical Nursing Skills & Techniques", MRHS Employee In Service "Skills for Administering Parenteral Fluids and Blood Products" Power-Point slide summary, the Mena Regional Health System "Transfusion Reaction:Request for Investigation" form, patient blood administration records for October and November 2019, and interview the facility failed to ensure transfusion reaction policies promptly identified, investigated and documented transfusion reactions for all blood products. Findings follow: A) Review of the Mena Regional Health Systems transfusion statistics revealed that 438 units of blood products were transfused in 2018 and 397 units of blood products were transfused in 2019. B) Upon request, the laboratory could not provide records of transfusion reaction investigations and , in an interview on 1/22/20 at approximately 02:00 PM, the laboratory staff member, identified as number 2 on the CMS 209 form, stated there were no possible transfusion reactions reported in 2018 or 2019. C) Review of the Mena Regional Health System/Laboratory Blood Bank Department "Transfusion Reaction Policy" revealed "in event that the reaction involves a rise in the patient's temperature of 2 degrees C or higher the following protocol must be followed: a. The RN shall immediately notify patient's physician and the blood bank, b. The registered nurse will complete the patient information portion of the transfusion reaction form and return it to the Blood Bank along with blood component bag, the attached transfusion set and IV solutions when possible, c. The registered nurse will order and collect the urine specimen for a post transfusion urinalysis and send it to the Clinical Laboratory. d. The Clinical Laboratory will collect a new, properly labeled, blood sample from the patient. D) Review of the Mena Regional Health System nursing policy and procedure for "Blood Components Administration" reveals that it refers for procedure to Potter & Perry current edition " Clinical Nursing Skills and Techniques" and "if a patient experiences a reaction at any time, STOP the transfusion immediately, stay with the patient, and notify the physician". That vital signs should be recorded prior to the transfusion, at 15 minutes, 30 minutes, and hourly until the transfusion is completed. E) Review of the MRHS In- Service "Skills for Administering Parenteral Fluids and Blood Products" Power Point presentation reveals that nursing staff is informed to "stay with pt for at least the first 15 minute (50 ml) of infusion, reaction can occur at any time, even afterwards, but usually occur in the first 15 minutes (if reaction = STOP stat), Monitor VS after first 15 minutes, then every 30 minutes after increasing rate, then every hour, Any -- 3 of 21 -- reaction: STOP the blood, run in NS to slow KVO and notify the physician and the lab" F) In an interview on 1/22/20 at approximately 1:40 PM, the hospital staff member, identified as number 1 on the separate hospital staff list who holds the position of QA Director, stated that she would recognize a possible transfusion reaction if there was a temperature increase 1 degree C above baseline, that the official nursing policy and procedure is Perry & Potter "Clinical Nursing Skills and Techniques" 9th edition, that she "doesn't know what the lab side looks like" and she "knows we have had some (possible transfusion reactions), we cut pig tails off and sent them to the lab" but she couldn't tell the number. She then called the hospital staff member, identified as number 2 on the separate staff identification list who holds the position of Nursing IT supervisor, who stated they knew of no definitions of changes in blood pressure that would trigger a possible transfusion reaction investigation. Asked if the laboratory would have access, in any form, to the vital signs registered during a transfusion the hospital staff member, identified as number 1 on the separate staff identification list, said that they didn't know. They then called the hospital staff member, identified as number 3 on the separate staff identification list who holds the position of CNO, who stated that they knew they had a possible transfusion reaction in October or November of 2019 because they were called at home and informed and they instructed staff to stop the transfusion and collect blood and urine specimens and send to lab for investigation but they couldn't remember the date or name of the patient. Surveyors requested the hospital staff member to try to identify the patient and date of the incident. G) In an interview on 1/23/2020 at 12:48 p.m. facility staff member, identified as number 6 on the staff identification list, who is a registered nurse in ICU, was asked to explain her processes when administering blood and blood products to a patient and to explain what she consider signs and syptoms of a transfusion reaction. She stated that if the patient's temperature went over 100 degrees Fahrenheit or if a significant increase or decrease in the blood pressure occurred she would suspect a transfusion reaction. When asked what a "significant" change would be she stated that there is not anything definite. She further stated that she would stop the transfusionand call the hospitalist but not the laboratory and that she would let the hospitalist decide whether to call the lab. On 1/23/2020 at 1:05 p.m. the surveyor interviewed a facility staff member identified as number 7 on the staff identification list, who is a registered nurse (charge nurse) in the med/surg unit. In the interview she stated that she would suspect a transfusion reaction if the patient's temperature changed by a degree or if the blood pressure increased or decreased by 20. She stated that she would notify the laboratory and the physician and that the laboratory would come draw blood from the patient and get a "tag" from the blood. Due to lack of specific written policies for monitoring patients during transfusion the nursing staff did not make consistent statements regarding transfusion reaction signs and symptoms. H) In an interview on 1/22/20 at approximately 02:30 PM, laboratory testing personnel, identified as number 5 on the CMS 209 form, stated that they had not received a request for transfusion reaction investigation, that they remember an instance when a unit was brought back to the laboratory but there was no transfusion reaction investigation initiated. I) In an interview on 1/23/20 at approximately 08:45 AM, the hospital staff member, identified as number 3 on the separate staff identification list, stated that they were not able to identify the possible transfusion reaction that they had mentioned on the previous day but they thought is was a outpatient who declined the transfusion and no blood was given. When shown the "Transfusion Reaction: Request for Investigation" form, they indicated that it was not an official form and made a copy. J) A review of the Mean Regional Health System (MRHS) policy Skills for Administering Parenteral Fluids and Blood Products revealed the nursing personnel training in-service on Blood Administration and Blood Transfusion Reactions:" 1. Sign and Symptoms of Reaction: Statement of "not feeling -- 4 of 21 -- right" Chills Fever Low back pain Pruritis Hypotension N/V (Nausea/Vomiting) Decreased urine output Chest pain "Dyspnea" 2. If you suspect a reaction: STOP infusion immediately KVO (Keep vein open) with NS (Normal Saline) and notify doctor and blood bank immediately Monitor VS (Vital Signs) and urine output q15m (every 15 minutes) Provide reassurance to the patient Watch for S&S (Signs and Symptoms) of shock K) Transfusion History of Patient #80925: Source Nursing Notes from Nursing Personnel #5 On 11/14/19 patient #80925 was admitted to the hospital. On 11/15/19 at 0707 patient #80925 had a Hemoglobin of 9.4 g/dl and Hematocrit of 30%. At 0847 on 11/15/19 patient's Hemoglobin was 6.1 g/dl and Hematocrit 20%. The physician was notified by nursing personnel #4 (as identified on personnel worksheet #1) and a- Crossmatch for three units of Packed Red Blood Cells was ordered. On 11/15/19 at 1408 unit W091019361687 (A positive) was started with pre- transfusion vitals: Temperature 98.3, Pulse: 100, Blood pressure 104/61 and Respirations: 18. At 1414 on 11/15/16 patient #80925 stated "I'm burning up". Nursing personnel #5(as listed on staff identificatin list) stated" patient emphatically c /o being hot and burning up. Temperature is increased from start of transfusion. Physician notified. Blood Stopped. At 15:10 on 11/15/19 blood was restarted by nursing personnel #5 and vitals was taken: Pulse: 104, Blood Pressure: 106/49, Respirations: 18, no temperature was recorded by nursing personnel #5. At 17:22 on 11/15/19 per nursing personnel #5 "patient c/o headache and bodyaches, moaning and groaning loudly." Pain medications administered as ordered." Nursing personnel failed to notify the laboratory or Blood Bank of possible transfusion reaction as per nursing training policy. Patient #80925 received 2 more units of Packed Red Blood Cells: Unit W091019361700 (A positive) transfused on 11/16/19 at 1132 and unit W091019378528 (A positive) transfused at 2147 on 11/16/19. L) Through a review of blood administration records for October and November 2019 involving 20 patients receiving 54 units of packed red blood cell (PRBC) revealed that on 13 of 54 transfusions were missing vital sign recordings as required by policy and procedure. M) The following vital sign changes were noted: Patient ID DATE UNIT # FINDINGS NOTED 83696 11/10/19 wo91019351330 Pre systolic BP 135 15' systolic BP 118 80925 11/15/19 wo91019361687 15' pt complained "I am burning up" 132844 11/1/19 wo91019277649 Pre systolic BP 113 Post systolic BP 145 1396077 11 /20/19 wo91019350548 Presystolic BP 139,15'systolic BP 122 Post systolic BP 109 Because of inconsistencies between laboratory and nursing policy and procedure, inconsistency in understanding of changes in vital signs and other symptoms that might indicate a possible transfusion reaction, missing vital sign measurements as required by policy, and the findings upon reviewing a sample of tranfusion records it was determined that the facility transfusion reaction policies failed to promptly identify, investigate and document transfusion reactions for all blood products. This represents an immediate jeopardy to patients receiving blood and blood products at the facility. D5026 IMMUNOHEMATOLOGY CFR(s): 493.1217 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 upon a review of Mena Regional Health System transfusion statistics, lack of documentation, Mena Regional Health System / Laboratory Blood Bank Department -- 5 of 21 -- "Transfusion Reaction Policy", Mena Regional Health System "Blood Components Administration" policy, Perry & Potter current edition "Clinical Nursing Skills & Techniques", MRHS Employee In Service "Skills for Administering Parenteral Fluids and Blood Products" Power-Point slide summary, the Mena Regional Health System "Transfusion Reaction:Request for Investigation" form, Emergency Requests for Uncrossmatched Blood for 2019, patient blood administration records for October and November 2019, and interview it was determined the laboratory failed to meet the requirements for the specialty of Immunohematology. (refer to D5553 and D5559) Failure to meet CLIA Immunohematology requirements is an immediate jeopardy to patient care D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: . Through a review of the Proficiency Testing records for 2018 and 2019, Survey Exception Reports, lack of documentation, and interviews with staff, it was determined the laboratory failed to prevent the recurrence of problems in the General Laboratory Systems. Survey findings follow: A. A review of the Proficiency testing records for 2018 and 2019 Vaginal Wet Prep proficiency testing results: for the 3rd event of 2018 and 1st event of 2019 ( two of two testing events ) the laboratory scored 0% for the Urine Sediment test -Vaginal Wet Preparation. B. A review of the Survey Exception Report for the 3rd Vaginal Wet Prep proficiency testing event of 2018 revealed: "Re-educated staff." C. A review of the Survey Exception report for the 1st Vaginal Wet Prep Proficiency testing event of 2019 revealed: "Vaginal Wet Prep Clue Cells-this and the previous event done by MLS and LAB Assistants who are no longer employed here." D. The