Easton Dermatology Associates Llc

Summary Statement of Deficiencies D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on procedure manual, laboratory patient log, and patient histopathology slide review, surveyor observation, and interview with the histotechnician (HT), the laboratory did not follow the established policies and procedures to ensure positive identification of histology specimens from the time of collection through completion and reporting of patient results. Findings: 1. The procedure manual shows an example of how to label the histopathology slides for Mohs surgery. The HT is required to include the last two digits of the current year followed by the next sequence number for that year, along with the patient's name, date of testing, specimen source (location), and stage number. All patients for Mohs surgery are documented on the "Mohs Accession Log" (patient log). 2. A random review of patient records showed that Patient A was documented as case # "C25-185" in the patient log. Examination of Patient A's histopathology slides showed that there were three slides labeled with the correct name, however one of three slides was labeled with the incorrect case number "C25-184." 3. Patient log record review showed that case # "C25-184" belonged to Patient B. An examination of Patient B ' s slides showed that all three slides were labeled with the correct name, however two of three slides were labeled with the incorrect case number "C25-185" (Patient A ' s case number). 4. During an interview on 07/28/2025 at 12:40 PM, the HT confirmed that histopathology specimens were not correctly identified from the time of collection through completion and reporting of patient results. 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 -- D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) (e)(4)(iii) All proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratorys performance and to identify any problems that require

Summary Statement of Deficiencies D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: A. Based on record review and interview, the laboratory director did not ensure that review of laboratory worksheets identified problems such as incomplete entries. Findings: 1. The laboratory did not have a written policy that stated how to conduct reviews of the cryostat preventive maintenance worksheet to ensure that the maintenance performed by the laboratory is documented; 2. The cryostat preventive maintenance worksheet is a document that is completed each day of testing (MOHS surgery) and the daily tasks on the worksheet ensure that the cryostat is performing as expected for the processing of patient tissue for histology testing. The worksheet is designed so that three months of maintenance are recorded on one sheet and in the bottom right corner of the worksheet is a space to document review of the completed record; 3. The written procedure did not identify the person responsible for the review and did not identify how to conduct the review to identify problems; 4. From January 2019 to May 2019, one out of twentytwo days reviewed, the cryostat preventive maintenance was not documented for MOHS surgery conducted 5/24/19; 5. From January 2018 to June of 2018, three out of forty days reviewed , the cryostat preventive maintenance was not documented for MOHS surgery conducted February 23, 2018; March 30, 2018 and June 29, 2018; 6. On the December 2017 cryostat preventive maintenance worksheet, maintenance was not documented for surgery performed December 15, 2017; 7. On the November 2017 cryostat preventive 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 -- maintenance worksheet, the maintenance was not documented for surgery performed November 3, 10 and 17, 2017; 8. On the October 2017 cryostat preventive maintenance worksheet, the maintenance was not documented for surgery performed October 13, 20 and 27, 2017; and 9. On the September 2017 cryostat preventive maintenance worksheet, the maintenance was not documented for surgery performed September 8, 15 and 29, 2017. B. Based on record review and interview, the laboratory (lab) director did not ensure that October, November, December 2017 slide quality control results were available for review at the time of survey. Findings: 1. The worksheet for the stain quality control was not in the labs records; and 2. this was confirmed with the histology technician during interview on the day of survey. -- 2 of 2 --