Summary:
Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on staff interview and record review on 05/25/2018, the laboratory failed to monitor and document the humidity of the laboratory where the testing was performed. Humidity was not recorded from May 3, 2016 through May 24, 2018. Findings include: The Manufacturer's operations manual for the Cobas b 221 lists an operating range for humidity for the anayzer between twenty percent (20%) and eighty-five percent (85%). Review of Maintenance log revealed no documented evidence the humidity had been monitored from May 3, 2016 through May 24, 2018. Testing personnel acknowledged in an interview at 10:15 am on 05/25/2018 the laboratory failed to have a system in place to ensure the humidity was monitored and documented daily. 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. 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 staff interview and record review on 05/25/2018, the Technical Consultant failed to perform and document annual competency using the 6 mandated competency assessment requirements for testing personel. Competency assessment was performed using Two (2) of Six (6) methods of assessment for nineteen (19) out of nineteen (19) employees from May 3, 2016 through May 24, 2018. Findings include: Record review revealed competency assessments failed to include monitoring the recording and reporting of test results, review of worksheets, review of quality control records, review of proficiency test results, review of maintence records and assessment of testing external proficiency testing samples. An interview with the staff on 05/25/2018 at 10:05 AM, revealed the facility failed to have a system in place to ensure competency was performed using all six mandated competency assessment requirements. -- 2 of 2 --