Lawrenceville Health Center

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on February 26, 2020. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on equipment maintenance document review and staff interview, the laboratory failed to perform and document equipment maintenance as required by CLIA (Clinical Laboratory Improvement Amendments). Findings include: 1. Equipment maintenance document review revealed required maintenance had not been performed for the following Quest Horizon centrifuges since 7/27/2018 (one centrifuge per health center) : Newton, Buford, Lawrenceville, and Rockdale. 2. An interview with the nursing director in the conference room on 2/26/2020 at approximately 2:30 p.m. confirmed the lack of required equipment maintenance since 7/27/2019 for the aforementioned health centers at the time of survey. . D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following 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 -- for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on laboratory quality control (QC) logs and staff interview, the laboratory failed to perform required QC for qualitative laboratory testing. FIndings include: 1. QC document review revealed the laboratory failed to provide documentation of positive and negative QC for Potassium Hydroxide (KOH) and Wet Prep (Parasitology) testing for 2018, 2019, and 2020 thus far. 2. An interview with the nursing director in the conference room on 2/26/2020 at approximately 3:45 p.m. confirmed the lack of QC for the aforementioned tests for 2018, 2019, and 2020 thus far. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on proficiency test document review and staff interview, the laboratory director (LD) failed to provide overall management and direction on the laboratories as required. Findings: For details refer to D6018. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on May 9, 2018. The laboratory was not in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) documents and staff interview, the laboratory failed to test the PT samples with the laboratory's regular workload by testing personnel (TP) who routinely perform the testing in the laboratory. Findings include: 1. American Association of Bioanalysts (AAB) PT document review revealed all three 2017 Clinical Microscopy PT events were performed by Staff #3 (CMS 209). 2. An interview with the director of nursing on May 9, 2018, in a conference room at approximately 3 p.m. confirmed all three 2017 Clinical Microscopy PT testing events were performed by the same TP. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) documents and staff interview, the laboratory director (LD) failed to attest to the routine integration of the PT samples into the patient workload. Findings include: 1. American Association of Bioanalysts (AAB) PT document review revealed the laboratory director (LD) failed to sign the attestation statements for all three Clinical Microscopy PT events in 2017 and the first two Clinical Microscopy PT events in 2018. 2. The PT attestation statements included the following testing facilities within the East Metro Health District: Norcross Health Center, Newton County Health Department, Buford Health Center, Rockdale County Health Department, and Lawrenceville Health Center. 3. An interview with the LD on 5/9/18 in a conference room at approximately 10:15 a.m. confirmed the LD did not sign the attestation statements for the aforementioned PT events for the aforementioned testing facilities. D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) 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. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on review of testing personnel (TP) competencies and staff interview, the laboratory director (LD) failed to employ qualified personnel to perform the duties of technical consultant (TC). Findings include: 1. TP competency document review revealed initial training competencies, six month competencies, and annual competencies for 2017 and 2018 thus far were performed by unqualified personnel. 2. An interview with the TC on 5/9/18 in a conference room at approximately 11:00 a.m. confirmed the aforementioned TP competencies were performed by unqualified personnel. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require