Kilby Correctional Facility

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 reviews of personnel records and an interview with the Laboratory Director/ Technical Consultant, the laboratory failed to implement a mechanism and procedures to assess five of the six minimal competency assessment criteria required for moderate complexity testing. This was noted for one of one testing personnel since before the previous survey on 3/11/2021. The findings include: 1. A review of the electronic quality assurance records revealed the Laboratory Director/ Technical Consultant documented the competency assessments for the testing personnel by using the proficiency testing scores in 2021-2023. All scores were 100%, so the Director deemed the Testing Personnel #1 competent. 2. During an interview with the Laboratory Director on 8/3/2023 at 10:45 AM, the surveyor reviewed the six competency assessment criteria required for moderate complexity testing, as follows: a) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. b) Monitoring the recording and reporting of test results. c) Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. d) Direct observation of performance of instrument maintenance and function checks. e) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples, or external proficiency testing samples. f) Assessment of problem solving skills. 3. As the interview continued on 8/3 /2023 at approximately 10:50 AM, the surveyor explained the current system failed to include assessments for five of the six minimal competency assessment criteria. The 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 -- Laboratory Director confirmed he had no other means for assessing competency, and had not realized there were other requirements. SURVEYOR ID# 32558 and 46292 Licensure and Certification Surveyors -- 2 of 2 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of the 2016 - 2018 CAP (College of American Pathologists) Proficiency Testing records and an interview with the Technical Supervisor (also the Testing Personnel), the laboratory failed to ensure attestation statements for seven out of twelve surveys were signed by the Laboratory Director and testing personnel. The findings include: 1. A review of the CAP Syphilis Serology and Viral Marker Proficiency Testing (PT) records revealed no signatures of the Laboratory Director (LD) and/or the Testing Personnel (TP) on attestation statements for the following surveys: A) 2016-3rd Event RPR Survey: No LD B) 2017-1st Event Viral Markers: No LD C) 2017-2nd Event Viral Markers: No TP D) 2017-1st Event RPR Survey: No LD or TP E) 2017-3rd Event RPR Survey: No LD F) 2018-1st Event Viral Markers: No LD G) 2018-2nd Event Viral Markers: No LD 2. In an interview on 7/3/2018 at 11: 30 AM, the Technical Supervisor reviewed the PT records with the surveyor, and confirmed the above noted findings. . 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. 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 -- (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 a lack humidity records, a review of the Vitros Operator's Guide and an interview with the Technical Supervisor (also the Testing Personnel), the surveyor determined the laboratory failed to monitor humidity in the room where testing was performed. The findings include: 1. During the initial laboratory tour, the Technical Supervisor listed Anti-HIV 1/2 performed on the Vitros EciQ on the laboratory test menu. 2. A review of the Vitros Operator's Guide on page 1-11 included these instructions, "...Environment Specifications ... Site Relative Humidity [RH]: 15-75 % RH non-condensing...". 3. A review of the environmental monitoring records revealed the laboratory only recorded the daily room temperatures for the testing area. There was no documentation of the daily room humidity. 4. During an interview and review of the above records on 7/3/2018 at 1:00 PM, the Technical Supervisor confirmed the laboratory has not been monitoring and recording the daily room humidity. SURVEYOR: Laura T. Williams, BS, MT (ASCP) Licensure and Certification Surveyor -- 2 of 2 --