Summary:
Summary Statement of Deficiencies D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (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. This STANDARD is not met as evidenced by: Based on lack of Quality Control (QC) documentation for review, review of patient test reports and interview with the testing personnel (TP-3) on November 6, 2025 at 11:15 AM, the laboratory failed to document the acceptability of Gram Stain and Periodic Acid-Schiff (PAS) staining materials, for intended reactivity and to ensure predictable staining characteristics on 2 out of 2 testing dates reviewed during the survey Findings include: 1. The laboratory performs the microscopic examination and diagnostic interpretation of dermatopathology specimens under the subspecialty of Histopathology with a reported annual test volume of 75,063. The laboratory has the capability of performing approximately 8 different special stains, if ordered by the individual who renders the diagnosis. 2. The laboratory failed to document the acceptability of the Gram stain performed on 1 testing date (9/09/25, case# E25-19634 ) reviewed during the survey. 3. The laboratory failed to document the acceptability of the PAS stain performed on 1 testing date (7/10/24, case# E24-16255) reviewed during the survey 4. TP-3 interviewed on 11/06/25 at 11:15 AM stated the laboratory performs a control slide with each batch of slides that are stained with special stains (including Gram Stain and PAS), and the control slide was assessed for acceptable staining characteristics but the results were not documented. TP-3 confirmed the laboratory failed to document the acceptability of all special stains performed by the laboratory from May 2024 through the date of the survey, 11/06/25. D5475 CONTROL PROCEDURES CFR(s): 493.1256(e)(3)(g) 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 -- (e)(3) Check fluorescent and immunohistochemical stains for positive and negative reactivity each time of use. This STANDARD is not met as evidenced by: Based on lack of positive and negative Quality Control (QC) documentation for Immunohistochemical (IHC) stains from 5/08/2024 through the date of the survey on 11/06/2025 and interview with the testing personnel (TP-3) on 11/06/25 at 11:45 AM, the laboratory failed to check IHC stains for positive and negative reactivity each time of use. Findings include: 1. The laboratory performs the microscopic examination and diagnostic interpretation of dermatopathology specimens in the subspecialty of Histopathology, with a reported annual test volume of 75,063. The laboratory has the capability of performing approximately 35 IHC stains, if ordered by the individual who renders the diagnosis. 2. The laboratory failed to document the positive and negative reactivity of each IHC stain performed, each time of use, between 5/08/24 through and 11/06/25. 3. The number of patient specimens tested with IHC stains during the timeframe indicated above could not be determined at the time of the survey. 4. TP-3 interviewed on 11/06/25 at 11:45 AM stated the laboratory assesses the positive and negative reactivity of each IHC stain performed, each time of use, but failed to document the results of that assessment during the timeframe indicated above. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) (b)(9) Evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of semi-annual competency evaluations from 2025 for two testing personnel and interview with the testing personnel (TP-3) on 11/06/25 at 10:37 AM, the technical supervisor failed to evaluate and document the performance of one out of two testing personnel responsible for high complexity testing at least semiannually during the first year the individuals tested patient specimens. Findings include: 1. The technical supervisor failed to perform and document a semiannual competency evaluation for one out of two testing personnel (TP-5) who was hired in July 2024 and performs the gross examination of dermatopathology specimens. 2. TP-3 interviewed on 11/06/25 at 10:37 AM confirmed that the technical supervisor failed to perform and document a semi-annual competency evaluation for TP-5 during 2025 as indicated above. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individuals performance must be reevaluated to include the use of the new test methodology or instrumentation. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on lack of documentation of annual competency evaluations from 2024 and interview with the Testing Personnel (TP-3) on November 6, 2025 at 10:37 AM, the technical supervisor failed to evaluate and document the performance of 2 out of 2 individuals responsible for high complexity testing at least annually after the first year the individual tested patient specimens. Findings include: 1. No evidence of an annual competency evaluation was presented for review from 2024 for two out of two testing personnel (TP-3 and TP-4) who perform the gross examination on patients' specimens. 2. TP-3 interviewed on 11/06/25 at 10:37 AM confirmed the technical supervisor failed to perform and document an annual competency evaluation during 2024 for the two testing personnel indicated above. -- 3 of 3 --