Summary:
Summary Statement of Deficiencies D0000 A complaint survey was conducted June 12, 2024 to June 19, 2024. It was determined that Immediate Jeopardy existed for the following condition level deficiencies: 42 C.F. R. 493.801 Condition: Enrollment and Testing Of Samples 42 C.F.R. 493.1250 Condition: Analytic Systems D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of the procedure manual, immunohematology quality control (QC), patient test records, specialty information, 2023 and 2024 American Proficiency Institute (API) proficiency testing (PT) records, and interview with the director of laboratory quality, the laboratory failed to enroll in PT for antibody identification for weak (passive) D antibody. Findings: 1. Review of the immunohematology procedure manual showed a procedure "Antibody Identification" currently unapproved by the laboratory director as of 6/12/24. 2. 20 patients were tested for weak D antibody identification from 8/23/23 to 5/14/24. 3. The weak D antibody identification was not designated under immunohematology, performed at this lab, on the Form CMS-116. 4. Review of API PT immunohematology records for 2023 Event 3 and 2024 Event 1 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- showed no enrollment records for antibody identification, only antibody screening. 5. Interview with the director of laboratory quality on 6/13/24 at 11:45 AM confirmed the laboratory failed to enroll in proficiency testing for antibody identification. 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: Based on the lack of documentation, lack of Individual Quality Control Plan (IQCP), lack of quality control values on patient testing dates and interview with technical consultant #3, failed to perform QC every day of testing for the test AmniSure Rupture of Membrane (ROM) (refer to D5445); the laboratory failed to perform QC every 8 hours for arterial blood gases (refer to D5537) and every day of patient testing for the Epoc analyzers (refer D5447); failed to follow manufacturer's instructions on the Resolve Panel A used for antibody identification (AB ID) testing (refer to D5479); failed to perform QC every day of patient testing, with no established IQCP on two of two i-STATs test (refer to D5545); failed to periodically test the high alarm on the ultra cold freezer, Thermo Scientific TSU, since installed in April 2007 (refer to D5555). D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)