Summary:
Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on proficiency testing (PT) record review and interview with the laboratory director (LD), the laboratory did not ensure that a copy of all PT documents were maintained by the laboratory for a minimum of two years from the date of the PT testing event. Findings: 1. A review of PT records from 2019 showed that a signed attestation statement was not available at the time of the survey for the 1st PT event of 2019 in hematology; and 2. Hematology instrument printouts for 2 of 3 PT events, and PT program report forms used by the laboratory to record PT results for 1 of 3 PT events in 2019 were not available for review at the time of the survey. 3. During an interview on 11/21/19 at 3:15 PM, the LD confirmed that the laboratory did not maintain all PT documents for a minimum of two years from the date of the PT testing event. D3011 FACILITIES CFR(s): 493.1101(d) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 11 -- Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on surveyor observation and interview with the laboratory director (LD), the laboratory did not ensure that an eye wash station was located in the laboratory area where testing occurs. Findings: 1. During a tour of the laboratory at 9:10 AM, it was observed that there was no eye wash station available in the laboratory where laboratory testing is performed. 2. During an interview on 11/21/19 at 3:15 PM, the LD confirmed that the eye wash station was not located in the room where laboratory testing is performed. 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 record review and interview with the laboratory director (LD), the laboratory failed to ensure that the written procedures in the standard operating procedure manual (SOPM) accurately reflected the current practice in the laboratory (D5401); failed to ensure that there was an approved policy for all procedures performed in the laboratory (D5403); failed to ensure that the SOPM was approved, signed, and dated by the LD (D5407); failed to ensure that the date of discontinuance for written procedures that were not performed was documented (D5409); failed to define, monitor, and document laboratory reagent refrigerator temperature and room humidity to ensure proper reagent storage and reliable test system operation (D5413); failed to ensure that hematology reagents were labeled with opened and expiration dates to ensure quality testing (D5415); failed to ensure that hematology QC was not used after it exceeded its expiration date (D5417); failed to ensure that the hematology analyzer was validated for use before reporting patient results (D5421); failed to document performance of routine preventive maintenance checks on the Sysmex XP- 300 hematology analyzer (D5429); failed to ensure that daily background checks were performed and documented prior to performing patient testing on the hematology analyzer (D5431); and failed to ensure that calibrations for the hematology instrument were verified at least once every 6 months (D5439). 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. -- 2 of 11 -- This STANDARD is not met as evidenced by: Based on standard operating procedure manual (SOPM) and record review and interview with the laboratory director (LD), the laboratory did not ensure that the "Quality Assessment Program" procedure accurately reflected the current practice in the laboratory. Findings: 1. The procedure, "Patient test management/Record keeping" states that "Records of each test performed will be maintained in the lab." During an interview at 10:00 AM, the LD stated that they had stopped recording patients on the laboratory logs and that all original instrument print outs and records were stored in the patient chart. The LD stated that they were not keeping a separate record of laboratory results in the laboratory. 2. The procedure, "Quality Assessment Program" states that "A QA review is performed each month using the Monthly Quality Assurance Review Form." 3. Record review showed that there were no quality assurance (QA) forms available at the time of the survey. During an interview at 11: 45 AM, the LD stated that they had not performed QA reviews and confirmed that the SOPM did not accurately reflect the current practice of the laboratory. 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)