Summary:
Summary Statement of Deficiencies D0000 An announced CLIA initial survey was conducted at MARK LAMET MD PA from 01 /30/2026 to 02/11/2026. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiency cited as follows: D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to document the acceptability of the negative control for Immunohistochemical (IHC) stains: Cluster of Differentiation 3 T cell Lymphocytic (CD3) IHC and Helicobacter pylori IHC (H. pylori) from 08/26/2025 to 12/09/2025. Findings included: 1-Review of the form CMS-116, revealed that the laboratory performed the Professional Component for the interpretation of the Hematoxylin and Eosin stain, Alcian Blue and Periodic Acid- Schiff (AB/PAS) stain and the IHC stains CD3 and H. pylori. 2- Review of quality control slide review log revealed no reference to negative controls for IHC CD3 and H. pylori. 3-Review of 3 patient reports and slides with collection dates 09/16/2025, 10 /17/2025 and 12/01/2025, revealed that the patients had AB/PAS stain, H&E, and IHC CD3 and H. pylori stain. Review of patient slides revealed that there was no negative control for the IHC CD3 and H. pylori. Review of the report stated "CONTROLS ARE ADEQUATE" no reference to the negative control acceptability found. 4- During an interview on 01/30/2026 at 11:30 AM with the consultant, she confirmed that the laboratory failed to document the aceptability of the negative control for the IHC CD3 and H. pylori from 08/26/2025 to 12/08/2025. 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 -- D6121 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(i) The procedures for evaluation of the competency of the staff must include, but are not limited to-- (b)(8)(i) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing; This STANDARD is not met as evidenced by: Based on record review and staff interview, the Technical Supervisor (TS) or a designee failed to do direct observation of patient testing during competency evaluation for testing personnel (TP) 1 in 2025. Findings included: 1-Review of FORM CMS 209 signed by the Laboratory Director on 01/29/2026, revealed the following: Laboratory Director (LD) was also Clinical Consultant, Technical Supervisor (TS) for Histology, Testing personnel (TP) #1 and TP#2 that was also the General Supervisor (GS). TP#1 was testing from 08/26/2025 to 12/09/2025. 2-Review of personnel records revealed that initial competency for TP#1 for interpretation of Histopathology slides had a date of 09/15/2025 and was signed by TP#1 as designee. The laboratory could not provide the designee letter for TP#1 to do Competency evaluations. 3-During an interview on 01/30/2026 at 12:00 PM, the owner explained that they did a team meeting for the competency evaluation but could not provide any documentation and confirmed that the TP#1 had no delegation for observation of patient testing to do Initial competency on 09/15/2025. -- 2 of 2 --