Summary:
Summary Statement of Deficiencies D0000 The validation survey was performed on 02/14/2020. The findings were reviewed with technical consultant #1 at the conclusion of the survey. The laboratory was found in compliance with standard-level deficiencies cited. 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 a review of records and interview with technical consultant #1, the laboratory failed to have established safety procedures, which were accessible to laboratory staff, to ensure the protection from physical, chemical, biochemical, electrical hazards, and biohazardous materials. Findings include: (1) At the beginning of the survey, the surveyor reviewed the laboratory's written procedures and was not able to locate the laboratory's safety procedures; (2) The surveyor asked technical consultant #1 if the laboratory had established safety procedures, which were accessible to the laboratory staff, to ensure the protection from physical, chemical, biochemical, electrical hazards, and biohazardous materials; (3) Technical consultant #1 stated to the surveyor, the laboratory had not established 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. 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 -- This STANDARD is not met as evidenced by: Based on a review of records and interview with technical consultant #1, the laboratory failed to have a written competency policy for the clinical consultant based on the job responsibilities as listed in Subpart M. Findings include: (1) At the beginning of the survey, the surveyor reviewed personnel records for competency assessments performed during 2018 and to date in 2019. There was no evidence competencies had been performed for the clinical consultant based on their job responsibilities; (2) The surveyor asked technical consultant #1 if a written policy to evaluate the positions based on job responsibilities was available, and if competencies had been performed during the review period. Technical consultant #1 stated a policy to evaluate the clinical consultant based on job responsibilities had not been written; and competencies had not been performed. -- 2 of 2 --