Metropolitan Fine Needle Aspiration Service

Summary Statement of Deficiencies D0000 A recertification survey was conducted on 7/29/2026 and standard level deficiencies were cited. 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: Based on review of the laboratory's procedure, 2025 case statistics, 2025 negative reports, and in an interview with the laboratory director, the laboratory failed to follow their own written procedure for ensuring 10% of negative cases (fine needle aspiration/non-gyn) were reviewed and accounted for 32 of 32 patients in 2025. Findings included: 1. Review of the laboratory's procedure "Random review of slides & reports" stated, "negatives: 10% done at Georgetown Univ. Hosp.; kept in this folder ..." 2. Review of the "2025 - Statistics: " ...neg rate: 323/371: 87%; 10%: 32 cases." Patient specimens were fine needle aspirations (FNA). 3. Review of 2025 negative cases that were sent to Georgetown University Hospital included 27 case reports versus the 32 negative cases for 2025. 4. During an interview on 7/29/2026 at 2:51 pm, the laboratory director stated she would find out what happened to the rest of the cases. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e)(2) Each day of use (unless otherwise specified in this subpart), test staining 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 -- materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedure, workload records, and in an interview with the laboratory director, the laboratory failed to define intended reactivity to ensure the predictable staining characteristics for one of two stains (Hematoxylin & Eosin [H&E]). Findings included: 1. Review of the laboratory's procedure stated, "FLUIDS AND ANCILLARY STUDIES: ...Thin preps (non-gyn] and potential cell blocks are made by CBL ...Any discrepancy is noted in the qc/qa quarterly review sheet ..." The laboratory sent patient fine needle aspiration fluid specimens to a reference laboratory for a thin prep slide and an H&E stained slide. The procedure did not include defined intended reactivity to ensure the predictable staining characteristics of H&E. 2. Review of documented workload and H&E stain quality from 1/2026, 4/2026, 5/2026, 6/2026 included a random sampling of cases that had a checkmark for the stain quality: 1/13/26: 26-N-001 through 26-N-004 4/15/26: 26-N- 070 through 26-N-074 5/4/26: 26-N-088 through 26-N-091 7/21/26: 26-N-180 through 26-N-184 The laboratory's procedure did not define intended reactivity to ensure the predictable staining characteristics of H&E stain quality. 3. During an interview on 7/29/2026 at 2:50 pm, the laboratory director confirmed the written procedure did not include defined intended reactivity to ensure the predictable staining characteristics of H&E stain quality. D5645 CYTOLOGY CFR(s): 493.1274(d)(3) (d)(3) The laboratory must maintain records of the total number of slides examined by each individual during each 24-hour period and the number of hours spent examining slides in the 24-hour period irrespective of the site or laboratory. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedure, review of the log book, and in an interview with the laboratory director, the laboratory failed to document the number of slides reviewed for 7 of 24 days. Findings included: 1. Review of the laboratory's procedure for Workload Limits stated, "She keeps a log book next to the microscope wherein the following information is noted on the days cases are signed out: date, case number with number of slides, total number of slides looked at on that day, total number of hours spent signing out ..." and "The workload of the pathologist is not to exceed 100 slides per day. Smears are counted as on [sic] slide, a thin prep as and cell blocks are exempt ...The limit is as follows: 12 slides/hour or 100 slides in an 8 hour period." 2. Review of the log book from 1/2026, 4/2026, 5/2026, and 6/2026 included the following days the "totaled slides" column was not documented: 1/13/26, 1/14/26, 1/15/26, 1/20/26 1/21/26, 2/6/26, and 6/5/26. Slides included FNA specimen slides stained with Diff Quick, H&E, and a thin prep slide was made. 3. During an interview on 7/29/2026 at 2:50 pm, the laboratory director confirmed there were days the total number of slides was not documented. -- 2 of 2 --

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation and interview, the laboratory did not ensure reagents were not used past expiration. This finding was corrected by the laboratory director at the time of survey. Findings: 1. The laboratory performs a differential stain for adequacy, but did not document the manufacturer name, lot number and expiration dates of the stains /reagents used; 2. This was confirmed during interview with the laboratory director at approximately 12:00 hours on the day of survey. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview with the laboratory director, the laboratory did not specify which stain quality control results were reported for. This was corrected by the laboratory director at the time of survey. Findings: 1. The laboratory performed 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 -- microscopic analysis of slides stained by hematoxylin & eosin, PAP stain and Wriights stain, but the result of the quality control review was a single check mark and that check mark did not correspond to a specific stain, during interview at approximately 12:00 hours, the laboratory director stated that the check mark would apply to all stains reviewed that day. -- 2 of 2 --

Summary Statement of Deficiencies No Tags No deficiency details available. 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 --