Somerset Pediatric Group Llc

CLIA Laboratory Citation Details

1
Total Citation
1
Total Deficiency
1
Unique D-Tag
CMS Certification Number 31D2058330
Address 2 World'S Fair Drive, Suite 302, Somerset, NJ, 08873
City Somerset
State NJ
Zip Code08873
Phone908 725-5530
Lab DirectorGERARD FRITZ

Citation History (1 survey)

Survey - December 27, 2023

Survey Type: Standard

Survey Event ID: LNZJ11

Deficiency Tags: D2021

Summary:

Summary Statement of Deficiencies D2021 BACTERIOLOGY CFR(s): 493.823(b) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with Technical Consultant (TC), the laboratory failed to participate in PT for Throat Culture from the College of American Pathologists (CAP) for the 3rd event of 2022 for Bacteriology. The findings include: 1. The TC contacted CAP regarding they received a damaged shipment for event D1-C-2022. CAP stated in an email to the TC " To avoid a penalty on the evaluation, please leave the area blank and fill in the bubble for Exception Code 33 (Specimen Unsatisfactory) and perform an alternate assessment." 2. There was no documented evidence an alternate assessment was performed for Throat Culture for the 3rd Bacteriology event of 2023. 3. The TC confirmed on 12/27/23 at 1:30 pm am that the laboratory failed to participate in Throat Culture PT for the 3rd Bacteriology event of 2022. 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 --

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