Summary:
Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Based on review of the Laboratory Procedure Manual and interview with the Laboratory Supervisor determined the laboratory failed to have a procedure for the performance of manual urine microscopic testing and for the performance of six month and annual competency assessments in 2018. The findings include: 1. Review of the Laboratory Procedure Manual revealed no documented procedure for the performance of manual urine microscopic testing, six month competency assessments, and annual competency assessments. 2. Interview with the Laboratory Supervisor on September 25, 2018, at 10:20 AM confirmed the Laboratory Procedure Manual failed to include a procedure for the performance of manual microscopic testing and procedure for the performance of six month and annual competency assessments in 2018. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: 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 -- Based on review of the competency assessment records for the two Medical Assistants (numbers one and two) and interview with the Technical Consultant number one determined the Technical Consultant failed to evaluate the competency of the two Medical Assistants(numbers one and two) using the six competency assessment criteria in 2018. The findings include: 1. Based on review of the competency assessment records for the two medical assistants (numbers one and two) failed to include the six competency assessment criteria . 2. Interview with Technical Consultant number one on September 25, 2018, at 11:00 AM confirmed the Technical Consultants failed to include the six competency assessment criteria in the competency assessments for the two Medical Assistants(numbers one and two) in 2018. -- 2 of 2 --