Summary:
Summary Statement of Deficiencies 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 surveyor review of the Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to enroll in an approved PT program for Complete Blood Count (CBC) tests from August 2017 to the date of survey. The TP # 1 listed on CMS form 209 confirmed on 2/6/19 at 11:45 am the laboratory was not enrolled in PT for CBC tests. D3011 FACILITIES CFR(s): 493.1101(d) 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 of the Laboratory equipment and interview with the Laboratory Director (LD), the laboratory failed to ensure protection from physical Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- hazards at the time of the survey. The finding includes: 1. Observation of the Power Spin centrifuge revealed the table it was placed on was not level, the table had a downward slant and the centrifuge was placed at the low end. 2. The LD confirmed on 2/5/19 at 1:10 pm that the laboratory did not ensure protection from physical hazards. D3029 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(2) Test procedures. Retain a copy of each test procedure for at least 2 years after a procedure has been discontinued. Each test procedure must include the dates of initial use and discontinuance. This STANDARD is not met as evidenced by: Based on surveyor review of Coagulation Tests and interview with the Testing Personnel (TP), the laboratory failed to retain the test procedure for Prothrombin Tests (PT) performed on the Sysmex CA 600 Series Analyzer from 8/8/ 17 to 1/29/19. The finding includes: 1. The test procedure includes the International Sensitivity Index (ISI) used to calculate the International Normalized Ratio (INR) for PT tests. 2. The laboratory used an ISI value of .99 to calculate the INR in the time period stated above but there was no documented evidence found to verify the value. 2. The TP confirmed on 2/5/19 at 1:00 pm that test procedures were not retained. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on lack of the Competency Assessment (CA) records, review of the personnel files and interview with the Laboratory Director (LD), the laboratory failed to perform a CA on one out of one Testing Personnel (TP) in the calendar year 2018. The LD confirmed on 2/6/19 at 11:25 am that CA was not performed on TP. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing records and interview with the Laboratory Director (LD), the laboratory failed to evaluate coded results obtained for Endocrinology tests in 2 and 3 event of 2018 performed with the College of American Pathologists (CAP). The findings include: 1. The laboratory did not evaluate code 20 (No appropriate target) for Triiodothyronine, Free Triiodothyronine and Thyroxine -- 2 of 6 -- tests. 2. The LD confirmed on 2/6/19 at 10:50 am that the laboratory failed to evaluate coded results. D5309 TEST REQUEST CFR(s): 493.1241(e) If the laboratory transcribes or enters test requisition or authorization information into a record system or a laboratory information system, the laboratory must ensure the information is transcribed or entered accurately. This STANDARD is not met as evidenced by: Based on surveyor review of the Test Requisitions (TR), Procedure Manual (PM) and interview with the Laboratory Director (LD), the laboratory failed to ensure that information from the TR was transcribed accurately into the laboratory information system from November 13, 2018 to December 29, 2018. The findings include: 1. A review of 29 out of 29 TR revealed that all 29 TR were not reveiwed by another technical staff. 2. The