Summary:
Summary Statement of Deficiencies D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on lack of training documentation for one testing personnel who performs testing in the sub-specialty of Histopathology and interview with the facility personnel, the laboratory director failed to ensure that all testing personnel receive the appropriate training and demonstrate that they can perform all testing operations reliably and accurately prior to testing patients' specimens. Findings include: 1. The laboratory performs testing under the sub-specialty of Histopathology, with an approximate annual test volume of 10,000. 2. No initial training documentation was presented for review for one testing personnel hired in January 2020, who performs the gross evaluation on patient specimens in the sub-specialty of Histopathology. 3. The facility personnel confirmed that the laboratory failed to have documentation of initial training for the testing personnel indicated above. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high 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 lack of documentation of a semi-annual competency evaluation for one testing personnel and interview with the facility personnel, the technical supervisor failed to evaluate and document the performance of individuals responsible for high complexity testing at least semiannually during the first year the individuals tested patient specimens. Findings include: 1. No semi-annual competency evaluation documentation was presented for review for one testing personnel who began grossing patient specimens in January 2020. 2. The facility personnel confirmed that the technical supervisor failed to document a semi-annual competency evaluation for the testing personnel indicated above. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on lack of testing personnel competency evaluation documentation and interview with the facility personnel, it was determined that the technical supervisor did not evaluate and document the performance of one testing personnel at least annually. Findings include: 1. During the survey conducted on 10/05/2021, no documentation of an annual competency assessment for was presented for review for one testing personnel who performs the gross description on patients' specimens. The testing personnel began testing patient specimens in January 2020. 2. The facility personnel confirmed that no annual competency evaluation was performed for the testing personnel indicated above. -- 2 of 2 --