Summary:
Summary Statement of Deficiencies 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) and interview with the Office Manager (OM) the laboratory failed to have a complete procedure for Biannual Assesment.(BA) from 7-9-24 to 9-15-26. The finding includes: 1. The the BA procedure failed to have a procedure for third party review if the reviewing physicians assessment disagrees with the diagnosis. 2. The OM confirmed on 9-15-26 at 11:00 am the the laboratory did not have a complete procedure for BA. B) Based on surveyor review of the PM, Requisitions , Final Reports (FR) and interview with the OM the laboratory failed to follow the laboratories procedure "6.8 Turn Around Time" from 4-21-26 to 9-15-26. The findings include: 1. The PM stated "Standard of care: The goal for repotting patient results for routine cases is 5 days. Any lab delays are to be communicated to the laboratory director or pathology administrative staff". "80% of cases prepared in the NJ Certified Dermatology Laboratory should be within the determined Turn Around Time (TAT)". 2. Report dates exceeded five days from the specimen received date on seven out of ten RF reviewed . 3. The OM confirmed on 9-15-26 at 11:00 am the the laboratory did not follow the above mentioned procedure. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test 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 -- procedure: (b)(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)