Winner Regional Healthcare Center

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 proficiency testing (PT) record review and interview, the laboratory failed to achieve successful participation for the ABO blood typing test method. Unsatisfactory results had been received in two of three PT events (Nonchemistry Q1 and Q2 2021) resulting in unsuccessful PT participation. Refer to D2162. D2162 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 -- 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 CASPER Reports and interview, the laboratory failed to achieve satisfactory proficiency testing (PT) performance for the ABO blood typing test method in two out of three American Association of Bioanalysts (AAB) events (Nonchemistry Q1 and Q2 testing events). 1. Review of the laboratory's CASPER Reports 153D and 155D revealed the AAB PT scores for the ABO blood typing test method were less than the 100% required to pass the ABO blood typing test per Clinical Laboratory Improvement Amendments of 1988 requirements found at CFR 493.861(a): a. 2021 Nonchemistry Q1 event ABO score = 80% (ABO Group specimen 3 was graded as unacceptable). b. 202I Nonchemistry Q2 event ABO score = 0% (AAB reported laboratory failed to participate). Interview with the laboratory supervisor on 6/15/21 confirmed the failure. She stated she had investigated the initial unsatisfactory result. The individual processing the PT survey documented the incorrect interpretation of the ABO blood test results for specimen 3. The laboratory was unable to participate in the Q2 event due to an issue with late payment for the PT survey. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey for compliance with 42 CFR Part 493, Requirements for Laboratories, was conducted on 9/11/18. The Winner Regional Healthcare Center laboratory was found not in compliance with the following requirements: D5217, D5435, and D5543. 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 (PT) documentation, annual test volume form, and laboratory supervisor interview, the laboratory failed to verify and document the accuracy of the test methods used for patient direct antiglobulin testing (DAT) twice a year for 20 of 20 months reviewed (January 2017 through August 2018). Findings include: 1. Review of the laboratory's PT documentation revealed there had been no documentation the accuracy of the DAT test had been verified twice a year or included in PT modules for the time frame above. During 2017, 229 patient DAT tests had been performed without the test method being verified for accuracy twice a year or included in PT. Interview on 9/11/18 at 11:05 a.m. with the laboratory's supervisor revealed PT had not been ordered for the DAT test in the two years she had been laboratory supervisor. She was not aware that the laboratory needed to do twice a year accuracy or proficiency testing for the DAT test. 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 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 -- 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. This STANDARD is not met as evidenced by: Based on review of the immunohematology maintenance records, annual test volume survey form, and interview with the laboratory supervisor, the laboratory failed to evaluate the speed and timing of the bloodbank centrifuge to ensure the optimal length of time for the specimens to be centrifuged to provide accurate interpretation of the immediate spin crossmatch test method for 157 of 157 patient tests performed in 2017. Findings include: 1. Review of the 2017 and 2018 immunohematology maintenance records revealed the bloodbank centrifuge had not been evaluated to determine the best timing at the set speed of the bloodbank centrifuge to ensure an optimum blood cell dot formation had been formed. That test method had been used as part of the immediate spin crossmatch procedure for determining patient compatibility with donor blood units. Review of the annual test volume survey form revealed 157 immediate spin crossmatches had been performed on patient specimens during 2017. The centrifuge had not had its timing evaluated to establish the length of time necessary to produce ideal cell dot formation. Interview with the laboratory supervisor at 11:15 a.m. on 9/11/18 revealed the centrifuge calibration to determine optimum timing at the set speed had not been done during the two years she had been laboratory supervisor. She was not aware calibration of the centrifuge was necessary. D5543 HEMATOLOGY CFR(s): 493.1269(a)(d) (a) For manual cell counts performed using a hemocytometer-- (a)(1) One control material must be tested each 8 hours of operation; and (a)(2) Patient specimens and control materials must be tested in duplicate. (d) 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 body fluid procedure and interview with the laboratory supervisor, the laboratory failed to test an external quality control (QC) material with manual cell counts performed on cerebrospinal fluid for 20 of 20 months (1/1/17 to 8/31/18) reviewed using a hemocytometer. Findings include: 1. Review of the manual cell count procedure last reviewed march 2015 and signed by the laboratory director on 8 /18/18 revealed no mention of the use of an external QC material in the procedure. The procedure required the specimens to be counted in duplicate. Interview with the laboratory supervisor on 9/11/18 at 12:40 p.m. revealed the laboratory tested approximately two cerebral spinal fluid specimens in 2017 and two specimens in 2018. She was not aware external QC testing was necessary. They had not performed external QC for body fluid cell counts in the two years she had been laboratory supervisor. -- 2 of 2 --