Nea Baptist Clinic-Dermatology

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (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 with laboratory staff, the laboratory had supplies available for use after their expiration date. Findings follow: A) During a tour of the laboratory on 2/12/26 at 1:48 pm, one bottle Avantic Tissue Marking Dye Violet, lot# 176962, expiration date 8/31/2025, 11-9006-12CS was observed in a the laboratory, available for use beyond the expiration date. B) In an interview on 2/12/26 at 1:48 pm the technical consultant confirmed that the item, identified above, had exceeded it's expiration dates and was available for use in the laboratory. D5805 TEST REPORT CFR(s): 493.1291(c) (c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. 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 2 -- . Through a review of Laboratory test reports and interview with staff it was determined the available laboratory test reports failed to include the address of the laboratory where the test was performed. Survey findings include: A) A review of laboratory test reports (one of one) revealed the laboratory results report failed to include the address of the laboratory where testing was performed. B) In an interview at 1:52pm on 2/12/2026 the technical consultant confirmed the available laboratory test report did not include the laboratory address. -- 2 of 2 --

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: Through a review of the laboratory policy and procedure manual and interviews with laboratory staff, it was determined the laboratory's policies could not be followed by laboratory personnel. Survey findings include: A. A review of the laboratory policy and procedure manual revealed six procedures in the manual are titled "Laboratory Procedure". Each procedure has differences from the others. The procedure titled, "Mohs Procedure" is in the manual four times and includes differences in three of the four procedures. B. In an interview, at 9:50 a.m. on 6/15/2022, laboratory employee #2 (as listed on the form CMS-209) confirmed multiple written procedures for the same laboratory activity were included in the policy and procedure manual and further confirmed the differences in the procedures made it impossible for laboratory employees to follow the procedures as written. 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. 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 -- This STANDARD is not met as evidenced by: Through a review of the "Quality Control Staining" log and the "Mohs Log" it was determined the laboratory failed to document stain quality control on two of sixteen days that patient slides were stained and examined in the laboratory. Survey findings include: A. Through a review of the "Mohs Log" it was determined that patient slides were stained and examined on 2/8/22, 2/9/22, 2/10/22, 2/14/22, 2/28/22, 3/7/22, 3/14 /22, 3/21/22, 4/11/22, 4/18/22, 4/25/22, 5/2/22, 5/9/22, 5/23/22, and 6/6/22. B. A review of the "Quality Control Staining" log revealed the laboratory did not document quality control on 2/8/22 or on 5/2/22. On 2/8/22 seven patient cases were documented and on 5/2/22 five patient cases were documented. C. In an interview, at 10:44 on 6/15/2022, laboratory employee #2 (as listed on the form CMS-209) confirmed the laboratory failed to perform stain quality control on two of sixteen days of testing. -- 2 of 2 --