Grace U Chung, Md Pc

Summary Statement of Deficiencies 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 surveyor review of the Procedure Manual (PM) and interview with the Office Manager (OM), the laboratory failed to provide a written procedure for calibrating or replacing the thermohygrometer used for room temperature and humidity in the laboratory when the calibration expires from 9/26/23 to 11/19/24. The findings include: 1. The laboratory could not provide a written procedure for the calibration or purchasing of a replacement for the thermohygrometer used for room temperature in the laboratory when it expires. 2. The OM confirmed on 11/19/24 at 1: 15 pm that they could not provide a written procedure for performing calibration or purchasing a new thermohygrometer when the calibration expires. D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each 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 -- special stain must be documented. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on the lack of Quality Control (QC) slides found during a random review of 10 patients from 1/5/24 to 10/11/24 and interview with the Office Manager (OM), the laboratory failed to provide QC slides for each day of Histopathology slide reading from 9/26/23 to 11/19/24. The finding includes: 1. The laboratory failed to provide QC slides for 7 out of 10 patient records and slides reviewed, the laboratory could not provide the QC slide for the following patients: a. M24-02 from 1/5/24 b. M24-132 from 5/10/24 c. M24-207 from 7/26/24 d. M24-217 from 8/2/24 e. M24-263 from 8/30 /24 f. M24-269 from 9/13/24 g. M24-292 from 10/11/24 2. The laboratory read approximately 1,500 patients annually. 3. The OM confirmed on 11/19/24 at 1:45 pm that the QC slides could not be provided for the aforementioned patients. -- 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 surveyor review of Biannual Assessment (BA) records and interview with Office Manager (OM), the laboratory failed to verify the accuracy and reliability of Mohs and Histopathology testing twice annually from 12/4/19 to the date of the survey. The findings include: 1. The BA for Mohs was not performed twice annually in 2021, 2022 and 2023. 2. The BA for Histopathology was not performed twice annually in 2021 and 2023. 3. The OM confirmed on 9/26/23 at 10:30 am that the laboratory did not perform BA twice annually for Mohs and Histopathology testing as stated above. 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 surveyor review of the Lecia DME Microscope, Leica CM1510S Cryostat 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 Avantik QS12 Cryostat Instruction Manuals (IM's) and "Equipment Quality Control Form 18: Room and Temperature Log Sheet" and interview with the Office Manager (OM), the laboratory failed to document the room temperature and humidity per the IM's requirements in the laboratory from 12/4/19 to the date of the survey. The findings include: 1. The surveyor observed requirements for room temperature, 50- 71F and humidity, 20-60%, per the IM's. 2. Room temperature, humidity and Cryostat temperature acceptable ranges were not provided. 3. Room humidity was not documented. 4. The OM confirmed on 9/26/23 at 11:00 am that acceptable ranges were not provided and humidity was not documented on the "Equipment Quality Control Form 18: Room and Temperature Log Sheet". 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 surveyor review of the Procedure Manual (PM) and thermometers and interview with the Office Manager (OM), the laboratory failed to provide a written procedure for and documentation of calibration for the thermometer used in the laboratory. The findings include: 1. The laboratory could not provide a written procedure for the calibration or purchasing of a replacement of the thermometer used for room temperature in the laboratory from 12/4/19 to the date of the survey. 2. The laboratory could not provide documentation of calibration for the thermometer used in the laboratory. 3. The OM confirmed on 9/26/23 at 11:15 am that they could not provide a written procedure for performing calibration or purchasing a new thermometer nor provide documention of calibration. -- 2 of 2 --

Summary Statement of Deficiencies D5028 HISTOPATHOLOGY CFR(s): 493.1219 If the laboratory provides services in the subspecialty of Histopathology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1273, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on surveyor review of Quality Control records (QC), observation of reagents and interview with the Office Manager (OM), the laboratory failed to ensure that quality systems for the analytic phase of Histopathology testing were monitored from 12/12/18 to the date of survey. 1. The laboratory did not define an acceptable temperature range for the Leica Cryostat. Cross Refer to D5413. 2. The laboratory did not ensure Reagents were labled with preparation and expiration dates. Cross Refer to D5415 3. The laboratory did not ensure Reagents were not used past their expiration dates. Cross Refer to D5417 4. The laboratory did not document all control procedures performed. Cross Refer D5601 5. The laboratory did not maintain an information or record system. Cross Refer D5787(b) D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on the lack of Competency Assessment (CA) records and interview with the Office Manager (OM), the laboratory failed to perform a CA on four out of four Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- testing personnel for the calendar year 2018 to the date of survey. The OM confirmed on 12/4/19 at 9:40 am that the CA was not performed as stated above. This was previously cited. The

Summary Statement of Deficiencies No Tags No deficiency details available. 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 --