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 01/08/2018, the technical consultant failed to perform there outlined quality assurance plan. Findings include: No quality assurance was performed from October 1, 2016 through December 31, 2017. The staff acknowledged in an interview on 1/08/2018 at 10:20am that the quality assurance plan oulined in their procedure manual was not followed. 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 01/08/2018 , the Technical Consultant failed to perform and document annual competency using the 6 mandated competency assessment requirements for testing personel. Findings include: No Competency assessment was performed for two out of two employees from Jan 1, 2016 through December 31, 2017. Record review revealed competency assessments failed to include monitoring the recording and reporting of test results, review of worksheets, 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 -- review of 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 09: 40am on 01/08/2016 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 --