Integrated Dermatology Of I Street

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on review laboratory logs, interview with the testing person (TP), and the medical assistant (MA) at 1:00 PM, The lab did not perform maintenance procedures on all lab equipment to ensure accurate and reliable patient testing. Findings: 1. The lab performs MOHS surgery. The lab prepares slides with patient tissue collected during the surgery procedures for review by the pathologist. 2. The autoclave is used to sterilizes tools used during surgery procedures. 3. The lab did not perform spore checks on the autoclave to ensure contamination was not present. 4. The MA stated that she was unaware that spore checks needed to be performed on the autoclave. 5. The TP confirmed that spore checks were not performed on the autoclave to ensure contamination was not present. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on review of the written procedure manual, review of Histopathology reagents, 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 -- and interview with the testing person at 11:30 AM, the lab failed to ensure that reagents were not used beyond the expiration date. Findings: 1. The lab performs MOHS surgery. The lab prepares slides with patient tissue collected during surgery procedures for review by the pathologist. 2. The Eosin stain used for slide preparation had expired in December 2021. The bottle was opened in the year 2022 and used for testing. 3 The testing person (TP) did not realize the stain had expired. The TP stated that the stain was ordered from a different vendor and the expiration date was shorter. He was unsure of the exact date the stain was opened. 4. The written procedure manual QA procedure states that reagents must not be used when expired. 5. The TP confirmed that the Histopathology Eosin stain used for patent testing expired in December 2021. -- 2 of 2 --

Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on record review and interview, the records for the laboratory proficiency checks for MOHS surgery microscopic analysis were not reviewed in a reliable manner and did not ensure that the proficiency checks were performed. Findings: 1. The laboratory submits MOHS cases for peer review biannually for proficiency checks; 2. The peer review records for cases submitted June 2018 did not have documentation showing the result of the peer review and were not signed by the reviewer; 3. The peer review records for cases submitted January 2019 did not have documentation showing the printed name of the reviewer and the surveyor was unable to determine the name of the reviewer from the reviewers signature. 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 D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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: (1) Water quality. (2) Temperature. (3) Humidity. (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 the review of the laboratory's policies and procedures and the manufacturer's instructions, and interview with the Mohs Technician on February 26, 2017 at approximately 3:30 PM, the laboratory failed to develop environmental monitoring mechanism to ensure that the two (2) equipment used with Mohs procedure were stored and operated in accordance with the manufacturer's specifications (cryostat and microscope). The findings included: 1. Review of the Leica's (manufacturer of the cryostat) instructions for storage and operation of the cryostat revealed that the cryostat must be operated consistently, between 18-35 degrees centigrade (C). The storage of the cryostat must be between 5-50C. It should be noted that the cryostat is operated and stored in different rooms. Review of the laboratory's procedure manual did not reveal instructions to monitor the room temperature where the cryostat is stored or operated. 2. Review of the Leica's (manufacturer cryostat) instructions for storage and operation revealed that the maximum non-condensing relative humidity to be 60%. Review of the laboratory's procedure manual did not reveal instructions to monitor the relative humidity where the cryostat is stored or operated. 3. Review of the Leica's (manufacturer of the microscope) instructions revealed that the operating temperature to be between 10-40C and the storage temperature to be between -20-52 C. It should be further noted that the microscope is operated and stored in different 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 -- rooms. Review of the laboratory's procedure manual did not reveal instructions to monitor the room temperature where the microscope is stored or operated. 4. Interview with staff confirmed the lack of monitoring mechanism for the room temperature and the relative humidity where the cryostat and the microscope are stored and operated. -- 2 of 2 --