Ozarks Community Hospital At Gravette

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 review of the 2024 CMS Casper Reports 096D, 0153D, and the American Proficiency Institute (API) proficiency testing results, showed the laboratory failed to have initial successful participation in proficiency testing for the analyte ABO/RH and D(Rho) type 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 D2153. D2153 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(a) 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 -- (a) Failure to attain a score of at least 100 percent of acceptable responses for each analyte or test in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: . Based on review of 2024 CMS Casper Reports 96D, 153D and the American Proficiency Institute(API) proficiency testing results, it was determined the laboratory failed to have successful participation in proficiency testing for ABO/RH and D(Rho) type testing as evidenced by: A. A review of the proficiency testing results revealed the laboratory received a score of 80% for the test of D(Rho) type testing in the first proficiency testing event of 2024. B. A review of the proficiency testing results revealed the laboratory received a score of 80% for the test of ABO/RH type testing in the third proficiency testing event of 2024. 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 CMS 96D, 153D reports and API performance evaluation for 2024 the laboratory director failed to provide overall management and direction to the lab for successful participation in proficiency testing. 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 record review of CMS 96D, 153D, and API performance evaluation from 2024, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program for compatibility testing. Refer to D2153. -- 2 of 2 --

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Through obervation, review of policy and procedure manuals, lack of documentation and interview it was determined that policy and procedure for performing prothrombin time (PT) assays by the method currently in use by the laboratory was not available. Findings follow: A) In an initial tour of the laboratory on 6/21/23 at 08: 45 a.m. a Stago Satellite coagulation analyzer was observed in the hematology testing area of the laboratory and no other instrument capable of performing PT assays was observed. B) Review of the policy and procedure manual for coagulation testing revealed that a procedure for PT assays perfomed on the Siemans CA 500 analyzer was available but no procedure for PT testing perfomed on the Stago Satellite analyzer was present. C) In an interview 0n 6/21/23 at 11:45 a.m.the laboratory staff member ( # 2 on the CMS 209 form) stated that the Stago Satellite analyzer replaced the CA 500 analyzer in 2018, all PT assays are currently performed on the Stago Satellite analyzer, and confirmed that no procedure for PT analysis performed on the Stago Satellite analyzer could be found. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials 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 -- using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Through review of policy and procedure for quality control for hematology assays, review of hematology quality control reports for November 2022, lack of documentation, patient result reports and interviews with laboratory staff it was determined that the laboratory failed to perform quality control testing for complete blood cell counts (CBC) prior to reporting patient results in one of thirty days of patient testing in November 2022. Findings follow: A) The policy and procedure for quality control in CBC assays, # 809.709.310, states "at the hospital all levels of controls must be run every eight hours of operation per the following schedule for hospital hematology: 0600, 1400, 2200". B) Review of CBC quality control reports for November 2022 revealed that on November 17, 2022 no quality control results for CBC analysis was documented before 1353 (1:53 p.m.). C) Review of patient results revealed that on November 17, 2022 CBC results were reported on patient Y1623360 at 6:18 a.m.and on patient Y1623592 at 9:27 a.m.. D) Upon request, the laboratory could not provide quality control results for CBC analysis on November 17, 2022 performed before the patient results identified above were reported. E) In an interview on 6/21/23 at 3:24 p.m. the laboratory staff member (#2 on the CMS 209 form) confirmed that quaity control was not performed before 1: 53 p.m. on November 17, 2022 and the patients identified above were reported prior to quality control being performed. D5783

Summary Statement of Deficiencies D5551 IMMUNOHEMATOLOGY CFR(s): 493.1271(a)(f) (a) Patient testing. (a)(1) The laboratory must perform ABO grouping, D (Rho) typing, unexpected antibody detection, antibody identification, and compatibility testing by following the manufacturer's instructions, if provided, and as applicable, 21 CFR 606.151(a) through (e). (a)(2) The laboratory must determine ABO group by concurrently testing unknown red cells with, at a minimum, anti-A and anti-B grouping reagents. For confirmation of ABO group, the unknown serum must be tested with known A1 and B red cells. (a)(3) The laboratory must determine the D (Rho) type by testing unknown red cells with anti-D (anti-Rho) blood typing reagent. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Through review of the laboratory policy for "Release of Blood in Emergency Situations", review of "Release for Uncrossmatched Blood" forms, the Blood Bank Crossmatch log, lack of documentation, and interview it was determined that the laboratory failed to ensure and keep records of post release crossmatches on units released under emergency release protocol on one of one unit released since January 1, 2021. Findings follow: A) Review of the laboratory policy number 800.709.212 "release of Blood in Emergency Situations" states in paragraph 8 "complete antibody screen testing and crossmatch all units that were released that were issued uncrossmatched" and, in paragraph 9 it states "notify physician and the pathologist immediately of abnormal test results that may affect patient safety". . B) Review of emergency release forms revealed that on 3/29/21 the laboratory released two units of packed RBC's under emergency release protoocol to one patient. The receiving patient and unit numbers are documented on a separate "Blood Bank Patient and Blood Unit" identification list. C) Review of the Blood Bank log revealed that on 3/29/21 units WO 451 21 071133 and WO 451 21 124278 were released on emergency release 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 -- protocol. Unit WO 451 21 124278 was crossmatched but subsequently returned to the Blood Bank without having been given to the patient and unit WO 0451 21 171133 was given to the patient but there were no records of a crossmatch having been performed on or after 3/29/21. D) In an interview on 6/30/21 at 2:12 PM, the laboratory staff members identified as numbers 3 and 4 on the CMS 209 form, stated that there is no record of crossmatch being performed for the patient, identified on the separate "Blood Bank Patient and Blood Unit" identification list, for the unit, identified above, which had been administered to the patient. -- 2 of 2 --

Summary Statement of Deficiencies 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 review of the laboratory's policy and procedure manual, manufacturer's instrument manuals, instrument calibration records, quality control reports, patient test results, lack of documentation, and interview it was determined that the laboratory failed to meet analytic system requirements or monitor and correct problems in the analytic systems as evidenced by: D5439 - the laboratory failed to perform calibrations on the Sysmex XN 1000i hematology analyzer within six month intervals at minimum, D5441 - the laboratory failed to implement quality control procedures to monitor change over time for Erythrocyte Sedimentation Rate (ESR) assays, D5469 - the laboraatory failed to establish criteria for acceptable ranges of quality control material for ESR analysis as required by the manufacturer's product insert, D5481- the laboratory failed to ensure quality control results were acceptable before reporting patient results, D5783- the laboratory failed to evaluate patient results back to the last acceptable quality control results when quality control results failed to meet criteria for acceptability, and, failed to document