Newton Wellesley Dermatology Associates Pc

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Newton Wellesley Dermatology Assoc laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: . Based on record review and interview on 4/9/2021, the laboratory failed to verify at least twice annually procedures it performs that are not included in subpart I of this part as evidenced by the following: The surveyor reviewed the laboratory's quality assurance records for twice annual peer slide review of Mohs histopathology cases, Potassium Hydroxide (KOH) preparations, and wet mounts for scabies for calendar years 2019 and 2020 on 4/9/2021. The review revealed that laboratory did not verify accuracy twice annually for Mohs histopathlogy slides or wet mounts for scabies in 2019 and verified accuracy of KOH preparations once in July 2019. The laboratory director interviewed on 4/9/2021 at 4:15 PM stated that Mohs twice annual peer slide review was performed but not documented for calendar year 2019. The laboratory director confirmed that twice annual accuracy checks for scabies wet mounts were not performed in calender year in 2019 and that KOH preparation accuracy checks were performed once in calendar year 2019. The laboratory performs 600 Mohs cases and 150 KOH/wet mounts annually. . Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D0000 An initial CLIA certification survey was conducted for the Newton Wellesley Dermatology Associates, PC laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on policy review and interview, the laboratory failed to establish a maintenance protocol for the laboratory microscope as evidenced by the following: Procedure review on 11/29/18 revealed no written policies regarding microscope maintenance. There was no documentation that maintenance of the microscope had been performed on a regular basis. The laboratory director confirmed in an interview on 11/29/18 at 1: 55 PM that a maintenance schedule had not been set up for the microscope. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --