Summary:
Summary Statement of Deficiencies D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on the review of laboratory quality assessment (QA) records and interview with testing personnel (TP) #1 the laboratory director (LD) failed to ensure QA programs were maintained for 2 of 24 months from 2018 and 2019. Findings Include: 1. On the day of survey, 01/09/2020, the review of QA activities revealed, the LD did not maintain QA activities for the following months (2 of 24) from 2018 and 2019: a. November 2018 - not signed until February of 2019. b. April 2019 - not signed by LD or designee. 2. TP #1 confirmed the findings above on 01/09/2020 around 11:50 am. 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 review of testing personnel records and interview with the testing personnel (TP) #1, the technical consultant (laboratory director) failed to evaluate 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 -- competency of the 1 of 2 technical consultants in 2018. Findings Include: 1. On the date of survey, 01/09/2020, review of testing personnel annual competency assessments records revealed, 1 of 2 TC (TC #2) was not assessed for competency in 2018. 2. The TP #1 confirmed the findings above on 01/09/2020 around 09:30 am D6051 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(v) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. This STANDARD is not met as evidenced by: Based on review of competency assessment records, proficiency testing (PT) records and interview with testing personnel (TP) #1, the technical consultant (Laboratory director) failed to assess the competency of 3 of 5 TP through internal blind testing samples or external PT samples in 2018 and 2019. Findings Include: 1. On the day of survey, 01/09/2020, review of competency assessment and PT records revealed, the laboratory did not assess the annual test performance for 3 of 5 TP through internal blind testing samples or external PT samples for the following personnel in 2018 and 2019: a. 3 of 5 TP in 2018 (TP #3, #4 and #5). b. 2 of 5 TP in 2019 (TP #1 and TP #2). 2. TP #1 confirmed the findings above on 01/09/2020 around 10:15 am. -- 2 of 2 --