Sanjiv K Saini, Md Llc

Summary Statement of Deficiencies 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 record review and interview, the laboratory did not document the open date for reagents used for MOHS surgery to ensure that they were not used past expiration. Findings: 1. The laboratory documented the staining reagents used for tissue from MOHS surgery on the MD Dermatology Reagent Log. The log did not include the date that the stains/reagents were opened for use and therefore it was not possible to determine when the stains/reagents were placed in use. 2. This finding was confirmed during interview on 1/16/25 at 10:00 am with the histotechnologist. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on record review and interview with staff, the laboratory did not ensure that the information recorded on the MOHS surgery patient log agreed with the information 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 -- recorded on the patients MOHS surgery maps. Findings: 1. On 4/17/24 the number of stages for MOHS surgery was recorded as 2 on the patient log for Patient #1, but the MOHS map only showed that 1 stage was obtained during the surgery. 2. On 10/16/24 the date of MOHS surgery was recorded as 10/16/24 on the patient log for Patient #2, but the date of the procedure on the MOHS map was recorded as 11/21/24. 3. This was finding was confirmed with the histotechnician on 1/16/24 at 10:00 am. -- 2 of 2 --

Summary Statement of Deficiencies D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on surveyor observation and interview with the histotechnician, the laboratory did not ensure that an eye wash station was located in the laboratory area where testing occurs. Findings: 1. During a tour of the laboratory at 9:15 AM, it was observed that there was no eye wash station available in the laboratory where laboratory testing is performed. 2. During an interview on 03/30/2023 at 9:15 AM, the histotechnician stated that there was an eyewash station in another room in the office, however laboratory testing is not performed in that room. They confirmed that the eye wash station was not located in the room where laboratory testing is performed. 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 electronic medical record (EMR) review and interview with the histotechnician, the laboratory did not follow the established policies and procedures to ensure positive identification of a 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 -- patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. Findings: 1. The laboratory performs histopathology testing on patient specimens from Mohs surgery. The patients are entered on a patient log, where they are assigned a "Mohs Case Number." The procedure manual states that the case number must include the doctor's initial and the last two digits of the current year followed by the next sequence number for that year. 2. A random review of patient records showed that Patient A was listed as "Case # C22-153" in the patient log. Examination of Patient A's histology slides showed that they were labeled correctly with "C22-153," however a review of the patient final report in the EMR showed that the case number in the "visit note" was documented as "C22-152." 3. During an interview on 03/30/2023 at 11:00 AM, the histotechnician confirmed that written policies and procedures that ensure positive identification of histology specimens from the time of collection or receipt of the specimen through completion of testing and reporting of results were not followed. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation and interview with the histotechnician, the laboratory did not ensure that the in-use histology stain reagents were labeled with the date that they were opened. Findings: 1. During a tour of the laboratory at 10:00 AM, it was observed that the opened and in-use histology stain reagents in the laboratory flammable cabinet were not labeled with the date that they were opened and put in to use. These include Methyl Alcohol, Absolute (lot# 2492-00, expiration date 08/31 /2024); Eosin-Y Alcoholic 0.25% (lot# 15527, expiration date 08/31/2024); 100% Reagent Alcohol (lot# 143775, expiration date 02/29/2024 and lot# 127751, expiration date 08/31/2023); and XS-3 Xylene Substitute (lot# 124488, expiration date 05/31/2023). 2. During an interview on 03/30/2023 at 11:00 AM, the histotechnician confirmed that the histology stain reagents in-use were not labeled with the date that they were opened. -- 2 of 2 --

Summary Statement of Deficiencies 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 procedure manual and proficiency testing (PT) record review and interview with the histotechnician, the laboratory did not ensure that PT was performed at least twice annually for all tests performed in the laboratory. Findings: 1. The procedure, "Quality Assurance Program," "Comparison of Test Results" states, "A review of the test results on each Mohs provider is preformed bi-annually." 2. PT record review from 2019 through 2020 showed that slides from 3 histopathology cases were reviewed in 2019 and that 1 histopathology case was reviewed in 2020; and 3. All of the PT slides were reviewed on 3/31/2021. 3. During an interview on 7/22/2021 at 11: 45 AM, the histotechnician confirmed that the laboratory did not ensure that it verified the accuracy of histopathology testing at least twice 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 --