Burlington County Health Department

Summary Statement of Deficiencies D5803 TEST REPORT CFR(s): 493.1291(b) Test report information maintained as part of the patient's chart or medical record must be readily available to the laboratory and to CMS or a CMS agent upon request. This STANDARD is not met as evidenced by: Based on the surveyor review of Acssesion Log (AL), Final Reports (FR) and interview with the Office Manager (OM), the laboratory failed to have FR on one out of six FR reviewed on the date of survey. The OM confirmed on 9/17/24 at 11:00 am that the laboratory did not maintain all FR. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Office Manager (OM), the laboratory failed to evaluate results when they received an unacceptable score in Gram Stain tests performed with the the Collage of American Pathologists form 9/17/2021 to the date of survey. The finding include: 1. The laboratory received an "Unacceptable" result Gram Stain on samples D5-01, D5- 02 in A-2022 and D5-10 in B-2021. 2. The laboratory received an code "27" lack of participation or referee consensus. 2. There was no documented evidence that the laboratory investigated the failures. 3. The OM confirmed on 4/4/2023 at 11:10 am that the laboratory did not perform and document an evaluation of unacceptable PT results. Note: This was previously cited. 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 D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Office Manager (OM), the laboratory failed to evaluate results when they received an unacceptable score in Gram Stain tests performed with the the Collage of American Pathologists for first event 2018. The finding include: 1. The laboratory received an "Unacceptable" result Gram Stain on samples D5-05 in 1-2018. 2. There was no documented evidence that the laboratory investigated the failure. 3. The OM confirmed on 10/10/19 at 1:10 pm that the laboratory did not perform and document an evaluation of unacceptable PT results. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --