Delaware Pediatrics Pa

Summary Statement of Deficiencies D0000 D0000 A Recertification Survey was conducted on August 1, 2025 at approximately 9: 00AM. The laboratory was surveyed according to 42 CFR Part 493 Clinical Laboratory Improvement Amendments (CLIA) requirements. Deficiencies were identified as follows: D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on facility document review and interview, the laboratory failed to document the review and evaluation of results of proficiency testing (PT) for Strep Group A Identification. This was noted for 7 out of 7 (WSLH 2025 Bacti Viral 1, WSLH 2024 Bacti Viral 1, WSLH 2024 Bacti Viral 2, WSLH 2024 Bacti Viral 3, WSLH 2023 Bacti Viral 1, WSLH 2023 Bacti Viral 2, WSLH 2023, Bacti Viral 3) events reviewed. Findings included: Review of PT testing results from Wisconsin State Laboratory Hygiene (WSLH) PT Program revealed the Lab Director (LD) or designee had not signed as having reviewed the results for the following events: WSLH 2025 Bacti Viral 1, WSLH 2024 Bacti Viral 1, WSLH 2024 Bacti Viral 2, WSLH 2024 Bacti Viral 3, WSLH 2023 Bacti Viral 1, WSLH 2023 Bacti Viral 2, WSLH 2023, Bacti Viral 3. During an interview on 08/01/2025 at 10:40 AM, Head Nurse (HN) #4 was asked for documentation of the LD's review of the PT results and could not provide any documentation. 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 D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a review of the CASPER Report 155 report and graded results from the proficiency testing organization American Academy of Family Physician's (AAFP), the laboratory failed to successfully participate in proficiency testing for the Throat Culture (Bacteriology). Refer to D2028. D2028 BACTERIOLOGY CFR(s): 493.823(e) Failure to achieve an overall testing event score of satisfactory performance for two 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 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of the CASPER 155 report and graded results from the proficiency testing organization American Academy of Family Physician's (AAFP), the laboratory failed to successfully participate in a proficiency testing for the Throat Culture (Bacteriology) listed below. It is the laboratory's 2nd subsequent failure to achieve satisfactory performance for Throat Culture (Bacteriology) in two consecutive or two out of three consecutive proficiency testing (PT) events. The laboratory had unsatisfactory scores for the 1st and 2nd events of 2021. Findings include: Analyte /Year/Event/Score % Throat Culture (Bacteriology)/2021/1st/60 Throat Culture (Bacteriology)/2021/2nd/40 -- 2 of 2 --