Pediatric Associates, Pa

Summary Statement of Deficiencies D0000 An offsite Proficiency Test (PT) Desk survey was conducted at Pediatric Associates, PA on August 21, 2025. The facility was found to be out of compliance with the Medicare Condition at 42 CFR 493 CLIA Laboratory Requirements. The following is a list of CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016-42 CFR. 493.803 Condition: Successful participation [proficiency testing] D6000 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director 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 proficiency testing desk review of Certification and Survey Provider 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 -- Enhancement Report (CASPER)-0155 report and College of American Pathologist (CAP) 2025 records, the laboratory had not successfully participated in a proficiency testing program approved by (HHS), for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in the specialty Hematology for the analyte Red Blood Cells (RBC), and Hematocrit (HCT). Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) (f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of CASPER 0155D report and graded proficiency reports from CAP 2025 records (Events 1, 2), the laboratory failed to achieve a satisfactory performance (80% or better) for the same analyte in two consecutive testing events in the specialty and subspecialty of Hematology for the analyte RBC and HCT. Findings included: 1. A review of the CAPSER 0155 report revealed the following scores for the laboratory's RBC and HCT: RBC a. FH16-A 2025, Event 1: 60% b. FH16-B 2025, Event 2: 0% HCT c. FH16-A 2025, Event 1: 60% d. FH16-B2025, Event 2: 0% 2. The scores were confirmed by review of the graded CAP results. Scores less than 80% for the analyte indicate failure or unsatisfactory performance. A failure of the analyte for two out of three testing events is scored as unsuccessful. 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 testing desk review of CASPER 0155D report and CAP 2025 records, the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016 D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on proficiency testing desk review of CASPER 0155 report and CAP Proficiency Testing 2025 records, the laboratory director failed to ensure that the overall quality of the laboratory services were provided. The laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2130 -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Recertification Survey was initiated on 02/01/2024 and concluded on 02/01/2024. The facility was found not to be in compliance with the laboratory requirements of 42 CFR Part 493 with deficiencies cited. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on procedure review, personnel file review, and interview, the laboratory failed to ensure 1 (Testing Personnel [TP] #14) of 15 TPs completed and maintained documentation of initial training. Findings included: A review of the undated facility procedure titled, "Employee Training," revealed, "1. Upon hiring, new testing personnel will complete the Training Check Off List." Per the procedure, "3. All testing personnel will undergo evaluation for competency on an annual basis." A review of TP #14's "Employee Competency Evaluation" revealed the last employee competency for TP #14 was conducted on 07/13/2022. A review of TP #14's personnel file, revealed TP #14's last day of full-time employment with the laboratory was on 05/31/2023. Per the personnel file, TP #14 began employment again with the laboratory on 09/08/2023. A review of TP #14's personnel file, revealed no evidence to indicate when initial training was conducted with the TP. During an interview on 02 /01/2024 at 2:15 PM, the Laboratory Manager (LM) acknowledged the laboratory did not conduct initial training with TP #14 when the TP began employment with the laboratory in September of 2023. The LM stated the standard was to conduct an initial training for any TP employee. Per the LM, it was an oversight and acknowledged the laboratory failed to ensure TP #14 completed and maintained documentation of their initial training. 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 --