Summary:
Summary Statement of Deficiencies D0000 An announced CLIA exempt-state validation survey was conducted at Northwell Health Laboratories - Little Neck Pkwy on June 13, 2023, by a CMS New York CLIA Branch Location federal surveyor. The laboratory was surveyed under 42 CFR part 493 CLIA regulations. The laboratory was found to be in compliance with condition- level CLIA requirements. The following standard-level deficiency was found during CLIA exempt-state validation survey performed on June 13, 2023. D5523 PARASITOLOGY CFR(s): 493.1264(a)(d) The laboratory must have available a reference collection of slides or photographs and, if available, gross specimens for identification of parasites and use these references in the laboratory for appropriate comparison with diagnostic specimens. (d) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of the parasitology laboratory records, the pinworm identification (ID) procedure and interview with technical supervisor (TS) number 3 and 4, the laboratory failed to document quality control (QC) for microscopic pinworm identification examinations performed from June 2021 to June 2023. Finding Include: 1. On the day of survey, June 13, 2023, the laboratory could not provide documentation of QC performed for microscopic pinworm identification performed from June 2021 to June 2023. 2. Review of the microscopic pinworm identification procedure revealed, the procedure manual did not include QC for microscopic pinworm ID examinations. 3. From June 2021 to June 2023, the laboratory performed 351 microscopic pinworm identification examinations. 4. TS#3 and #4 confirmed the findings above on June 13, 2023 around 2:45 PM. 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 --