Summary:
Summary Statement of Deficiencies D2003 ENROLLMENT CFR(s): 493.801(a)(2)(ii) (2)(ii) For those tests performed by the laboratory that are not included in subpart I of this part, a laboratory must establish and maintain the accuracy of its testing procedures, in accordance with 493.1236(c)(1). This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to follow their established 'Proficiency Testing' (PT) policies and procedures by not submitting two micrographic surgery (MOHS) cases semiannually for PT without including any differential diagnosis in the subspecialty of histopathology. Findings include: 1. Record review on 07/07/2026 of the laboratory's 2025 'Semi Annually - Quality Assurance - Quality Control Proficiency Testing' forms revealed the following: a. One of one MOHS case was sent out for external consultation on 05/11/2025. i. Differential diagnosis included: 'Squamous Cell Carcinoma'. b. One of one MOHS case was sent out for external consultation on 11/06/2025. i. Differential diagnosis included: 'Basal Cell Carcinoma'. c. Lack of documentation of two MOHS cases sent out for external consultation semiannually as indicated in the laboratory's policies and procedures 2. Record review on 07/07/2026 of the laboratory's 'Proficiency Testing' policies and procedures revealed the following: a. 'Semi-annually, the tech or Risk Manager will send two cases containing the original slides, label it with only the surgical case number, and send it out for microscopic examination by a board- certified Dermatopathologist'. b. 'No differential diagnosis will be offered with the specimen'. 3. Staff interview on 07/07/2026 at 11:45 AM with the laboratory histotechnician confirmed the above findings. 4. The laboratory performs 150 MOHS cases annually in the subspecialty of histopathology. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to establish competency assessment policies and procedures to assess competency for the regulatory responsibilities of the clinical consultant (CC). Findings include: 1. Record review on 07/07/2026 of the laboratory's 'Centers for Medicare & Medicaid Services (CMS) 209 form - Laboratory Personnel Report' revealed one of one CC is listed. 2. Record review on 07/07/2026 of the staff training and competency files for 2024 and 2025 revealed lack of competency assessment policies and documented competency assessment records for the regulatory position of CC. 3. Staff interview on 07/07/2026 at 09:40 AM with the laboratory histotechnician confirmed the above findings. 4. The laboratory performs 150 micrographic surgery cases annually in the subspecialty of histopathology. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to ensure that the acceptable humidity ranges listed on the laboratory's humidity log are consistent with manufacturer's instructions in the subspecialty of histopathology. Findings include: 1. Record review on 07/07/2026 of 'The Avantik QS12 and QS12UV Cryostat' manufacturer's manual revealed an acceptable relative humidity of 'Max. 60% Relative Humidity'. 2. Record review on 07/07/2026 of the laboratory's 'Room Temp /Humidity' log revealed the following: a. Laboratory's acceptable humidity range: 60% to 75%. b. 40 of the 40 working days in 2025 and 21 of 21 working days in 2026, recorded humidity was within the laboratory's acceptable operating range (60%-75%), but outside the humidity range specified by the manufacturer listed in line item 1 above. 3. Staff interview on 07/07/2026 at 11:15 AM with the laboratory histotechnician (HT) confirmed the above findings. The HT further commented that he /she was unaware of the manufacturer requirement of 'Max. 60% Relative Humidity'. 4. The laboratory performs 150 micrographic surgery cases annually in the subspecialty of histopathology. D5779