Summary:
Summary Statement of Deficiencies D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) 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 review of Post-vasectomy procedure accuracy verification forms, the laboratory personnel records, and interview with Technical Consultant (TC) number two determined the Laboratory Director (LD) failed to ensure that the Licensed Practical Nurse (LPN) and the Medical Assistant (MA) received training for the performance of the post-vasectomy patient testing prior to performing the accuracy verification for the providers in 2017 and 2018. The findings include: 1. Review of Post-vasectomy procedure accuracy verification forms revealed the verification for 4 /17/17 was performed by Nurse Practitioner (NP) number one and confirmed by the LPN; 11/16/17 verification was performed by LD and confirmed by the MA; 4/24/18 verification was performed by Clinical Consultant (CC) number one and confirmed by the MA. 2. Review of the laboratory personnel records for the LPN and MA failed to include training documentation for the performance of post-vasectomy testing. 3. Interview with the TC number two on November 27, 2018, at 3:20 PM, confirmed the LD failed to ensure that the LPN and MA received training for the performance of the post-vasectomy testing prior to performing the accuracy verification for the providers in 2017 and 2018. 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 -- 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 the Laboratory Personnel Files and interview with the TC number two determined no competency assessments for the LD and CC number two were performed and documented for the Post-vasectomy patient testing performed in 2017 and 2018. The findings include: 1. Review of the Laboratory Personnel Files failed to include competency assessments for the LD and CC number two who perform Post- vasectomy testing on patient samples. 2. Interview with the TC on November 27, 2018, at 3:25 PM confirmed no competency assessments were performed and documented for the LC and CC number two who performed and reported Post- vasectomy patient testing in 2017 and 2018. -- 2 of 2 --