Summary:
Summary Statement of Deficiencies D6049 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. This STANDARD is not met as evidenced by: Based on review of laboratory testing records from 2/5/20 through the day of survey and interview with clinic office manager at 2:30 p.m. on 5/10/22, maintenance, QC (quality control), calibration, temperature and proficiency records listed below had not been documented as reviewed by the technical consultant (TC). Findings Include: 1. Review of the laboratory records from 2/27/21 through 5/10/22 revealed the following records were not documented as reviewed by the TC: a. Boule Medonic M Series hematology maintenance records from 2/27/21 through 5/10/22. b. Temperature records (room, refrigerator, freezer) from 2/27/21 through 5/10/22. c. Boule Medonic M Series hematology QC records from 2/27/22 through 5/10/22. d. Boule Medonic M Series hematology calibration on 12/17/21. e. Proficiency records (2nd and 3rd events of 2021 and 1st event of 2022). 2. Interview with the clinic office manager at 2:30 p. m. on 5/10/22 confirmed there was no documented review of these records by the TC during this time period. D6053 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 semiannually during the first year the individual tests patient specimens. 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 review of testing personnel records from February 2021 through 5/10/22, the Centers for Medicare and Medicaid Services (CMS) 209 personnel form and interview with the clinic office manager, the technical consultant (TC) failed to evaluate and document the performance of testing personnel (TP) #2 at least semiannually during the first year of employment. Findings include: 1. Review of the personnel records indicated that TP #2 was hired in February 2021 and began performing testing on patients. 2. On 5/10/22 there was no documented semiannual evaluation/competency available for review on TP #2 performed by the technical consultant during the first year of testing patients. 3. The clinic office manager confirmed in an interview at 3:30 p.m. on 5/10/22 that there was no 6 month evaluation/ competency performed on TP #2. 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 review of laboratory testing personnel (TP) records including the Centers of Medicare and Medicaid Services (CMS) 209 personnel form and interview with the clinic office manager, the technical consultant (TC) failed to evaluate annually and document the performance of TP #1 and #2 who are responsible for performing moderate complexity testing. Findings include: 1. Based on laboratory personnel records available for review on the day of survey, there was no annual evaluations /competencies performed by the technical consultant on TP #1 since the last survey on 2/5/20. 2. Based on laboratory personnel records available for review on 5/10/22 there was no annual evaluation/competency performed by the technical consultant on TP #2 for 2022. 2. The office manager confirmed no annual evaluation/competencies had been documented as performed by the technical consultant for the years 2021 and 2022. -- 2 of 2 --