Optum Medical Care Of Nj Pc

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM), and interview with the Office Manger (OM), the laboratory failed to to change their procedure for "Peer Review" for Histopathology testing from November 2022 to the date of survey. The findings include: 1) The OM stated that the Pathnostics laboratory performing the Techincal Component (TC) for histropathology testing was changed to Optrum in November 2022. 2) The PM stated that "peer review will be sent to" Pathnositics laboratory Director (LD) for review but the Laboratory is no longer using Pathnositcs. 3) The OM stated that the OM "needs to be updated to reflect the current procedure". 4) The OM confirmed on 3/22/23 at 11:30 am that the PM did not match the laboratories current procedure. 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 D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor review of the Quality Control (QC) records, Procedure Manual and interview with the Office Manager (OM), the laboratory failed to retain the QC Slides for Hematoxylin and Eosin stain from 4/20/16 to the date of survey. The OM confirmed on 5/22/18 at 10:00 am that the QC slides were not retained. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on surveyor review of the Biannual Assessment (BA) records, Procedure Manual (PM) and interview with the Office Manager (OM), the laboratory failed to verify the accuracy of Histopatholgy testing twice annually from 4/20/16 to the date of the survey. The finding includes; 1) The BA was performed once in 2017 and 2016. 2) The OM confirmed on 5/22/18 at 10:00 am the laboratory did not verify the accuracy of Histopatholgy testing twice annually. 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 --