Noms Healthcare Eastern Ohio

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: **This is a repeat deficiency as cited on the 01/18/2018 routine, on-cite CLIA inspection** Based on record review and an interview with Technical Consultant (TC) #2, the laboratory failed to establish and follow written policies and procedures to assess the competency of TC#2, at a frequency determined by the laboratory, as specified in the personnel requirements in subpart M. All patient arterial blood gas (ABG) testing performed in this laboratory in 2018 and 2019 had the potential to be affected by this deficient practice. Findings Include: 1. Review of the laboratory's "Policy for Personnel Assessment" policy and procedure, provided on the date of the inspection, did not find any mention of the assessment of the TC based on the responsibilities of the position, at a frequency determined by the laboratory. 2. Review of the laboratory's Form CMS-209, approved, signed and dated by the Laboratory Director on 11/12/2019, revealed two individuals, including the Laboratory Director, listed and qualified by the Laboratory Director to function as TC. 3. Review of the laboratory's 2018 and 2019 competency assessment documentation, provided on the date of the inspection, did not find any assessment documentation for TC#2 based on the responsibilities of the TC position. 4. The Surveyor requested the laboratory's policy and procedure for the assessment of the TC and any competency assessment documentation for TC#2 based on the responsibilities of the position from TC#2. TC#2 confirmed the laboratory did not establish a policy and procedure for the assessment of the TC, did not assess the competency of TC#2 based on 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 -- responsibilities of the position, at a frequency determined by the laboratory and was unable to provide the requested documentation on the date of the inspection. The interview occurred on 11/20/2019 at 8:55 AM. 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 record review and an interview with Technical Consultant (TC) #2, the laboratory failed to define criteria consistent with the manufacturer's instructions and document humidity conditions for reliable arterial blood gas (ABG) testing procedures on the OPTI Critical Care Analyzer. All patient ABG testing performed in this laboratory in 2018 and 2019 had the potential to be affected by this deficient practice. Findings Include: 1. Review of the laboratory's "Lab Policy Manual", provided on the date of the inspection, did not find any instructions to monitor and document humidity conditions consistent with manufacturer's operating specifications. 2. Review of the "OPTI Critical Care Analyzer" manufacturer's "Operating Parameters" revealed the following: "Relative Humidity Range 5%-95% (non-condensing)" %; percent 3. The Inspector requested the laboratory's policy and procedure for the humidity criteria consistent with the manufacturer's instructions and the humidity documentation from 2018 and 2019 from TC#2. TC#2 confirmed the laboratory did not establish a policy and procedure to monitor and document humidity criteria consistent with the manufacturer's instructions, did not monitor and document humidity in 2018 and 2019 and was unable to provide the requested documentation on the date of the inspection. The interview occurred on 11/20/2019 at 10:25 AM. -- 2 of 2 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and an interview with Technical Consultant (TC) #2, the laboratory failed to establish and follow written policies and procedures to assess the competency of TC#2, as specified in the personnel requirements in subpart M. Findings Include: 1. Review of the laboratory's "Policy for Personnel Assessment" policy and procedure, provided on the date of the inspection, did not find any mention of the assessment of the TC based on the responsibilities of the position. 2. Review of the laboratory's Form CMS-209, approved, signed, and dated by the Laboratory Director on 01/08/2018, revealed two individuals, including the Laboratory Director, listed and qualified by the Laboratory Director to function as TC. 3. Review of the laboratory's 2016, 2017 and 2018 competency assessment documentation, provided on the date of the inspection, did not find any assessment documentation for TC#2 based on the responsibilities of the TC position. 4. The Surveyor requested the laboratory's policy and procedure for the assessment of the TC and any competency assessment documentation for TC#2 based on the responsibilities of the position from TC#2. TC#2 confirmed the laboratory did not establish a policy and procedure for the assessment of the TC, did not assess the competency of TC#2 based on the responsibilities of the position, and was unable to provide the requested documentation on the date of the inspection. The interview occurred on 01/18/2018 at 8:35 AM. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) 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 -- At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review and an interview with Technical Consultant (TC) #2, the laboratory failed to verify the accuracy of the bicarbonate (HCO3) testing procedures performed, that are not included in subpart I, at least twice annually. Findings Include: 1. Review of the laboratory's "Proficiency Testing Policy and Procedure", provided on the date of the inspection, did not find any mention of instructions for blind test accuracy verification (TAV) protocols for the HCO3 testing procedures performed and reported on the OPTI CCA-TS AVL blood gas analyzer. 2. Review of six out of six of the laboratory's 2016 and 2017 American Association of Bioanalysts (AAB) proficiency testing (PT) records, provided on the date of inspection, did not find that the laboratory was enrolled in HCO3 testing. 3. The Surveyor requested the laboratory's 2016 and 2017, twice annual, HCO3 TAV records from TC#2. TC#2 confirmed that the laboratory did not enroll in HCO3 testing via AAB or any other PT provider, did not conduct and document HCO3 TAV at least twice annually and was unable to provide the requested documentation on the date of the inspection. The interview occurred on 01/18/2018 at 10:12 AM. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on record review and an interview with Technical Consultant (TC) #2, the TC failed to evaluate and document the competency of one out of five of the testing personnel (TP) responsible for moderate complexity blood gas testing at least annually after the first year. Findings Include: 1. Review of the laboratory's "Policy for Personnel Assessment" policy and procedure, provided on the date of the inspection, found instructions to annually assess the competency of testing personnel, after the first year of testing. 2. Review of the laboratory's 2016, 2017 and 2018 competency assessment records did not find any 2016, 2017 and 2018 competency assessment documentation for TP#2. 3. The Surveyor requested the laboratory's 2016, 2017 and 2018 annual competency assessment records for TP#2 from TC#2. TC#2 confirmed that the laboratory did not follow their written policy and procedure to assess and document the competency of the TP, at least annually after the first year of testing patient specimens, as required, and was unable to provide the requested documentation on the date of the inspection. The interview occurred on 01/18/2018 at 8:35 AM. -- 2 of 2 --