Summary:
Summary Statement of Deficiencies D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the laboratory procedure manual, and staff interview, the laboratory procedure for slide labeling did not include the specimen source/site or Mohs surgical stage. 1. Observation of the laboratory on 05/15 /24 at 8:20 a.m. revealed equipment used for processing and preparing patient tissue removed during Mohs surgical procedures for microscopic examination. 2. The laboratory procedure titled "Mohs Protocol" did not include requirements for slide labeling that included specimen source/site, second patient identifier or Mohs stage. 3. The practice manager confirmed the survey findings during interview on 05/15/24 at 11:30 a.m. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on a review of laboratory procedures and staff interview, the laboratory Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- procedures were not approved, signed or dated by the laboratory director. The findings include: 1. A review of the laboratory procedures titled Quality Assurance Manual, Histology Protocol, Mohs Staining, Mohs Protocol, Quality Assurance Reviews, Equipment Quality Control, and Reagent Handling Protocol revealed the laboratory director had not approved, signed, or dated the procedures. 2. The practice manager confirmed the survey findings during interview on 05/15/24 at 11:30 a.m. 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 observation of the laboratory, review of stain quality assessment logs, and staff interview, the laboratory failed to document the expected staining characteristics for the Hematoxylin and Eosin stain for 12 of 12 days in 2024. The findings include: 1. Observation of the laboratory on 05/15/24 at 8:20 a.m. revealed equipment, stains (Hematoxylin and Eosin (H&E)) and reagents used for processing and preparing patient tissue removed during Mohs surgical procedures for microscopic examination. 2. Review of the laboratory's H&E stain quality assessment log revealed the laboratory did not document the expected staining characteristics for the H&E stain for 12 of 12 days in 2024. 3. The practice manager confirmed the survey findings during interview on 05/15/24 at 11:30 a.m. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on review of the laboratory's Quality Assurance manual, lack of documented review, and staff interview, the laboratory failed to ensure quality assessment reviews were performed monthly by the Laboratory Director as required in the Quality Assurance Manual for four of five months reviewed in 2024. The findings include: 1. A review of the laboratory's Quality Assurance Manual revealed that the Laboratory Director would review charts and logs monthly. 2. Laboratory Director review was not performed timely (monthly) for January, February, March, or April 2024. 3. The practice manager confirmed that the Laboratory Director failed to review laboratory records monthly as required in the Quality Assurance Manual for four of five months reviewed in 2024 during interview on 05/15/24 at 11:30 a.m. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) -- 2 of 3 -- (b) The analytic systems quality assessment must include a review of the effectiveness of