Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at PEDIATRIC ASSOCIATES from 08/25/2025 to 08/29/2025. The laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D6047 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b(8)(i) (b)(8)(i) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing; This STANDARD is not met as evidenced by: Based on record review and staff interview the Technical Consultant (TC) or a designee failed to observe patient testing during competency evaluation for two out of three Testing Personnel (TP) for one out of two years reviewed. Findings included: 1- Review of FORM CMS 209 signed by the Laboratory Director on 08/25/2025, revealed the following: Laboratory Director (LD) was also Clinical Consultant and Technical Consultant for Hematology and Chemistry specialties and there were 3 TP (TP#1, TP#2 and TP#3). 2-Review of personnel records revealed that six-month competency, the component of patient testing was observed by a Lead Supervisor (LS) on 06/10/2025 for TP#2 and on 07/15/2025 for TP#2. LS had no delegation letter to do competence. 3-During an interview on 08/25/2025 at 01:30 PM, the LS confirmed that the TC failed to observe patient testing observation during sis month competency for TP#2 and TP#3. D6050 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iv) (b)(8)(iv) Direct observation of performance of instrument maintenance and function checks; 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 -- This STANDARD is not met as evidenced by: Based on record review and staff interview the Technical Consultant (TC) or a designee failed to observe performance of instrument and function check during competency evaluation for two out of three Testing Personnel (TP) for one out of two years reviewed. Findings included: 1-Review of FORM CMS 209 signed by the Laboratory Director on 08/25/2025, revealed the following: Laboratory Director (LD) was also Clinical Consultant and Technical Consultant for Hematology and Chemistry specialties and 3 TP (TP#1, TP#2 and TP#3). 2-Review of personnel records revealed that six-month competency for TP#2 and TP#3, the component of direct observation of performance of instrument and function check was observed by a Lead Supervisor (LS) on 06/10/2025 for TP#2 and for TP#3 was observed on 07/15/2025. LS had no delegation letter to do competence. 3-During an interview on 08/25/2025 at 01:30 PM, the LS confirmed that the TC failed to observe patient testing observation six month competency for TP#2 and TP#3. -- 2 of 2 --