Summary:
Summary Statement of Deficiencies 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: A Follow-up survey was performed at Ochsner American Legion Hospital, LLC, CLIA # 19D0663961, on January 31, 2024 through February 1, 2024. Based on review of the laboratory's CMS 209 form (Laboratory Personnel Report), competency assessment forms, laboratory policies, and interview with personnel, the Technical Consultants failed to perform annual competencies in 2023 for two (2) of two (2) testing personnel reviewed. Findings: 1. Review of the laboratory's CMS 209 form revealed two (2) testing personnel were listed that were not previously included on CMS 209 form completed for the validation survey conducted April 17, 2023 through April 21, 2023. 2. Review of the laboratory's "Laboratory Training and Competency" policy revealed the following "competency is assessed at the following frequency: at least annually after an individual has performed assigned duties for one year. The annual assessment of competency can be performed throughout the entire year to minimize impact on workload. Only those delegated in writing (delegation chart) by the laboratory director may perform competency assessments." 3. Review of the 2023 competency assessments for Testing Personnel 1 and Testing Personnel 2 revealed the Technical Consultant who performed the assessments was not documented. 4. In interview on February 1, 2024 at 9:55 am, the Laboratory Supervisor confirmed the Technical Consultant did not document their performance of the 2023 competency assessment for the identified two (2) Testing Personnel. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. This STANDARD is not met as evidenced by: A Follow-up survey was performed at Ochsner American Legion Hospital, LLC, CLIA # 19D0663961, on January 31, 2024 through February 1, 2024. Based on record review and interview with personnel, the Laboratory Director failed to ensure policies and procedures for assessing personnel competency were maintained. Refer to D6120. D6112 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451 The technical supervisor is responsible for the technical and scientific oversight of the laboratory. The technical supervisor is not required to be on site at all times testing is performed; however, he or she must be available to the laboratory on an as needed basis to provide supervision as specified in (a) of this section. This STANDARD is not met as evidenced by: Based on observation by surveyors, record review, and interview with personnel, the Technical Supervisor failed to provide technical and scientific oversight for the laboratory. Findings: 1. The laboratory failed to ensure Gram Stain decolorizer reagent was not used past its expiration date for quality control testing for two (2) of five (5) weeks reviewed in January 2024. Refer to D5417 I. 2. The laboratory failed to ensure Gram Iodine reagent used for gram stain testing was not used past its expiration date for two (2) of four (4) months reviewed. Refer to D5417 II. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (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: A Follow-up survey was performed at Ochsner American Legion Hospital, LLC, CLIA # 19D0663961, on January 31, 2024 through February 1, 2024. Based on review of the laboratory's CMS 209 form (Laboratory Personnel Report), competency assessment forms, laboratory policies, and interview with personnel, the Technical Supervisor failed to ensure the performance of annual competencies in 2023 for two (2) of two (2) testing personnel reviewed. Findings: 1. Review of the laboratory's CMS 209 form revealed two (2) testing personnel were listed that were not previously included on CMS 209 form completed for the validation survey conducted April 17, -- 2 of 3 -- 2023 through April 21, 2023. 2. Review of the laboratory's "Laboratory Training and Competency" policy revealed the following "competency is assessed at the following frequency: at least annually after an individual has performed assigned duties for one year. The annual assessment of competency can be performed throughout the entire year to minimize impact on workload. Only those delegated in writing (delegation chart) by the laboratory director may perform competency assessments." 3. Review of the 2023 competency assessments for Testing Personnel 1 and Testing Personnel 2 revealed the Technical Supervisor or General Supervisor who performed the assessments was not documented. 4. In interview on February 1, 2024 at 9:55 am, the Laboratory Supervisor confirmed the Technical Supervisor or General Supervisor did not document their performance of the 2023 competency assessment for the identified two (2) Testing Personnel. -- 3 of 3 --