Summary:
Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Nurse Manager (NM), the laboratory failed to ensure that Testing Personnel (TP) who performed Bacteriology Tests participated in the College of American Pathologists PT events in the calendar years 2017 and 2018. The finding includes: 1. A review of all PT event revealed that only one out of six TP performed PT events in 2017 and 2018. 2. The NM confirmed on 9/18/18 at 1:30 pm that PT events were not rotated between TP. 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 Reagent Refrigerator (RR) and interview with the Nurse Manager (NM), the laboratory failed to establish safety procedures to ensure protection from biochemical hazards at the time of the survey. The finding Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- includes: 1. Observation of agar plates and Bacitracin discs used for Bacteriology tests revealed juice was stored in the RR. 2. The NM confirmed on 9/18/18 at 1:10 pm that the laboratory did not establish safety procedures. 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 surveyor review of the Competency Assessment (CA) records and interview with the Nurse Manager (NM), the laboratory failed to perform and document CA accurately on six of six Testing Personnel (TP) in 2017 and 2018. The findings include: 1. The laboratory did not document what records were reviewed. 2. The CA was not assessed for monitoring the recording and reporting test results. 3. The laboratory did not use the procedures below but CA was assessed for them: a. Critical Values: handling and notification b. Properly documented &