Summary:
Summary Statement of Deficiencies D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on surveyor observation of the laboratory's New Jersey Clinical Laboratory License and an in office review of the laboratory's requirements for a NJCLL under New Jersey Statutes Annotated: N.J.S.A. 45:9-42.26. License; necessity; categories, the laboratory performed unauthorized patient testing under the subspecialty General Immunology from 1/1/25 to 7/9/25. The findings include: 1. Surveyor observation of the laboratory's NJCLL revealed the laboratory was only authorized to perform the below indicated specialties from 1/1/25 to 12/31/25: a) Chemistry b) Endocrinology c) Hematology d) Urinalysis 2. The laboratory performed approximately 2,500 unauthorized patient tests under the General Immunology subspecialty. 3. A surveyor from the NJCLL program confirmed on 7/11/25 at 1:00 pm, he laboratory was not authorized to perform testing under the General Immunology subspecialty. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- Based on surveyor review of the Proficiency Testing (PT) records and interview with the Techincal Consultant (TC) laboratory failed to verify the accuracy of Folate test results obtained from the American Proficiency Institute (API) for the Chemistry-Core 2nd event 2025. The findings include: 1. The laboratory received a score of 100% but received a code "9" for Folate samples IA-07 and AI-09. 2. API reported the range for Folate sample IA-07 as 3.7-7.1 ng/mL. 3. The laboratory reported Sample IA-07 as out of range for Folate with 7.4 ng/mL. 4. The TC confirmed on 7/9/25 at 10:20 am accuracy of the PT results were not verified. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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: A) Based on surveyor review of the Procedure Manual (PM), Unassayed Quality Control Verification Sheet (UQCVS) and interview with the Technical Consultant (TC), the laboratory failed to have a complete procedure for "Establish or verify the criteria for acceptability of all control materials" from 7/5/22 to 7/9/25. The findings include: 1. The PM stated, "the laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory." 2. The above procedure doe not state how the Quality Control (QC) material will be "verified." 3. The PM stated, "Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control material previously determined statistical parameters." 4. The above procedure does not state how new unassayed QC lots will be verified before being put into use for patients testing. 5. The TC confirmed on 7/9/25 at 11:30 am that the laboratory did not have the above mentioned procedures. B) Based on surveyor review of the Procedure Manual (PM), lack of Levy Jennings Graphs (LJG) and interview with the Technical Consultant (TC), the laboratory failed to follow their procedure for "Quality Control" from 7/5/22 to 7/9/25. The findings include: 1. The PM stated "The supervisor is to monitor on a monthly basis adherence to QC frequency, monitor any failed runs and