Pediatric Health Of Weston Pa

Summary Statement of Deficiencies D0000 A recertification survey conducted on 04/23/2021 found that the PEDIATRIC HEALTH OF WESTON PA clinical laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. 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 XP-300 Sysmex maintenance records review and interview, the laboratory failed to document all required maintenance performed from 08/2019 to 04/2021. Findings include: Based on user manual for XP-300 Sysmex analyzer the laboratory had to perform daily, weekly, monthly and semiannual maintenance actions. Review of the ell XP-300 Sysmex Maintenance log for 2019 (August to December), 2020 and 2021 (January to April) revealed that the laboratory failed to have documentation of all the required maintenance performed during period of reference. During an interview on 04/23/2021 at 10:00 am, the laboratory director confirmed that there was no documentation of all required maintenance for the period of reference. 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 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 record review and interview with laboratory director (LD), the laboratory failed to document the annual competency assessment on 1 out of 1 testing personnel for 2 out of 2 years reviewed. Findings include: Review of employee documentation showed that the laboratory failed to have documentation of annual competency assessment on 2017 and 2018 for TP. During an interview on 03/20/2019 at 11:30 AM, with the LD, he confirmed that there was no competency assessment documented for the period of reference for TP. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of