Summary:
Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on record review and interview with the staff on 03/27/2018 the technical consultant failed to perform quality assurance from January 1, 2016 through March 27, 2017. Findings include: No quality assurance was performed from January 1,2016 thru March 26, 2018 The staff acknowledged in an interview on 03/27/2018 at 1: 00pm, that the they did not have a system in place to document quality assurance. 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: Based on record review and staff interview on 03/27/2018, the Technical Consultant failed to perform and document annual competency using the 6 mandated competency assessment requirements for testing personel. No Competency assessment was performed for 8 out of 8 employees from Jan 1, 2016 through March 27, 2018. Findings include: Record review revealed competency assessments failed to include monitoring the recording and reporting of test results, review of worksheets, review of 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 -- quality control records, review of proficiency test results, review of maintence records, assessment of testing external proficiency testing samples, and assessing the skills for solving problems. An interview with the office manager at 12:30 pm on 03 /26/2018, revealed the facility failed to have a system in place to ensure competency was performed using the six mandated competency assessment requirements. -- 2 of 2 --