Bullitt County Family Practioners

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 October 28, 2019, the laboratory failed to monitor and document the humidity in the laboratory using the correct reference range where the testing was performed from January 11, 2018 through October 27. 2019. Findings include: 1. The Manufacturer's operations manual for the Act Diff analyzer lists an operating range for humidity for the analyzer between twenty percent (20%) to eighty percent (80 %). 2. Review of Maintenance log revealed the humidity was not monitored and document from January 11, 2018 through October 27, 2019. 3. Testing personnel acknowledged in an interview at 3:20 PM on October 28, 2019, the laboratory failed to have a system in place to ensure the humidity was monitored and documented daily, using the manufacturer's recommended range. 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 October 28, 2019, the Technical Consultant failed to perform and document annual competency using the 6 mandated competency assessment requirements for testing personal. Competency assessment was not performed using six (6) methods of assessment for two (2) out of two (2) employees from January 19, 2018 through October 27, 2019 This is a repeat deficiency from January 10, 2018. Findings include: 1. Record review on October 28, 2019 revealed there was no documented competency assessments between January 19, 2019 and October 27, 2019, for two (2) employee that included the following: competency assessments failed to include direct observation of routine patient test performance, direct observation of performance of instrument maintenance function checks and calibration, monitoring the recording and reporting of test results, review of worksheets, review of quality control records, review of proficiency test results, review of maintenance records, assessment of testing external proficiency testing samples and problem solving skills. An interview with the staff on October 28, 2019 at 03:20 PM revealed the facility failed to have a system in place between January 19, 2018 and October 27, 2019 to ensure competency was performed using all six (6) mandated competency assessment requirements. -- 2 of 2 --

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 01/10/2018, the technical consultant failed to perform there outlined quality assurance plan. Findings include: No quality assurance was performed from June 14, 2016 though January 10,2018 The staff acknowledged in an interview on 1/10/2018 at 10:05am 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 01/10/2018 , 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 three out of three employees from Jan 1, 2016 through December 31, 2016. 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: 30 am on 01/10/2016 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 --