Ali Hendi, Md, Pc

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 review of stain records for stain changes and topping off histology stains for 2022, the records did not differentiate between topping off and changes for the histopathology H& E stain. This was confirmed during interview with the histotechnician the afternoon of the survey. 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 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 reagent log review and interview with the histotech, the laboratory did not ensure that all histopathology reagents were documented on the reagent log and labeled upon opening. Findings: 1. A review of reagent logs from 06/11/2018 to 08/29 /2020 showed that a bottle of "Eosin Y Stain 1%," lot # 1801907, expiration date 01/26 /2020 was opened on 10/15/2019. There were no other bottles of Eosin stain documented after that date. 2. During a telephone interview on 12/11/2020 at 1:35 PM, the histotech stated that a new bottle of Eosin stain had been opened and was currently in-use and that the in-use bottle was not labeled with the date of opening. They confirmed that the new bottle of Eosin stain had not been documented on the laboratory's reagent log. 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 record review and interview with lab staff, the histology lab did not record the temperature reading of the thermometer in the cryostat. Findings: 1. The lab uses a cryostat to process tissue samples. The temperature of the cryostat is important to its function and the laboratory observes and records the temperature of the cryostat each day of use. The temperature readings may assist the lab in identifying trends in temperature requiring attention; and 2. From January thru April of 2018 lab staff recorded a checkmark to indicate that the temperature of the cryostat was observed and that it was within an allowable range, and did not document the temperature that was observed. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The 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 -- laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: A. Based on observation and interview with lab staff, the lab did not have quality control policies to document the staining characteristics for the hematoxylin and eosin (H&E) stain each day of use to show that the stain reacted in an accurate and reliable manner. The lab did not have records showing that it observed the first slide stained on each day of testing and that the stain characteristics were acceptable. B. Based on review of the written procedure for the Mart-1 stain and interview with lab staff, the written lab procedure to test a known positive and negative tissue sample each day the Mart -1 stain is used was not the control procedure the lab used. Findings 1. The labs written procedure for immunohistochemistry stains states that a positive and negative control slide are to be tested to confirm the reactivity of the Mart-1 stain; and 2. The MOHS surgeon states that the Mart-1 stain will stain the patient tissue in a manner that can be evaluated and interpreted as a control. The control procedures for the Mart- 1 stain the lab used were not described in the written procedure. -- 2 of 2 --