Cosmetic Skin Surgery Center

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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 Temperature Log (TL), Procedure Manual (PM) and interview with the Office Manager (OM), the laboratory failed to record the Cryostat temperature, room temperature and humidity where Histopathology tests are performed from 12/6/24 to 7/22/25. The finding includes. 1. The PM stated, " Laboratory instruments that require daily temperatures or special start up operations will be documented as monitored." 2. The laboratory failed to record the temperature of the Cryostat, room temperature and humidity on 12/6/24. 3. The laboratory resulted 4 patients tests on that day. 4. The OM confirmed on 7/22/25 at 1:35 pm, the laboratory failed to record the Cryostat temperature, room temperature and humidity on each day of patient testing. 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 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 -- each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. This STANDARD is not met as evidenced by: Based on surveyor review of the Quality Control (QC) records, Procedure Manual (PM), and interview with the Office Manager (OM), the laboratory failed to record the reaction of the control slide for Hematoxylin-Eosin (HE) stain on each day of patient testing from 12/6/24 to 7/22/25. The finding includes: 1. The laboratory failed to document HE QC slide reactions for Histopathology tests on 12/6/24. 2. The laboratory resulted 4 patient results on that day. 3. The OM confirmed on 7/22/25 at 1: 45 pm. the HE QC slide reaction was not recorded on each day of patient testing. Note: This deficiency was previously cited on the survey performed on 4/30/24. -- 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 testing twice annually from 7/30/19 to the date of the survey. The findings include: 1. There was no documented evidence that BA was performed in 2021, 2022 and 2023. 2. The OM confirmed on 4/30/24 at 12:30 pm that the laboratory did not perform BA as mentioned 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 Temperature Log (TL) and interview with the Office Manager (OM), the laboratory failed to record Room temperature and humidity and cryostat temperature where Histopathology tests are performed on the date of 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 -- survey. The finding includes. 1. The TL did not have room temperature and humidity listed on the form. 2. The TL recorded Cryostat temperature twice in the calendar year 2023 2. The OM confirmed on 4/30/24 at 1:35 pm that the laboratory failed to record Room temperature and humidity and cryostat temperature 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 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) records and interview with the Office Manager (OM), the laboratory failed to document Hematoxylin and Eosin (H&E) control slide reactions for Histopathology testing for all dates testing was performed in the calendar year 2023. The findings include: 1. The laboratory did not document H&E stain QC reactions on the dates listed below. a. 2/24/23 b. 3/17/23 c. 4/21/23 d. 5 /19/263 e. 6/9/23 f. 7/28/23 g. 12/8/23 2. The laboratory read and reported approximately 34 patient. 3. The OM confirmed on 4/30/24 at 1:30 pm that the laboratory did not document H&E QC stain reactions. -- 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 testing twice annually from 7/30/19 to the date of the survey. The findings include: 1. There was no documented evidence that BA was performed in 2021, 2022 and 2023. 2. The OM confirmed on 10/25/23 at 12:30 pm that the laboratory did not perform BA as mentioned 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 Temperature Log (TL) and interview with the Office Manager (OM), the laboratory failed to record Room temperature and humidity and cryostat temperature where Histopathology tests are performed on the date of 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 -- survey. The finding includes. 1. The TL did not have room temperature and humidity listed on the form. 2. The TL recorded Cryostat temperature twice in the calendar year 2023 2. The OM confirmed on 10/25/23 at 1:35 pm that the laboratory failed to record Room temperature and humidity and cryostat temperature 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 surveyor observation of the Staining Station and interview with the Office Manager (OM) the laboratory failed to label the identity of all staining jars used for Histopathology testing from 10/04/19 to the date of the survey. The OM confirmed on 10/25/23 at 12:35 pm that all staining jars were not labeled. 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 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) records and interview with the Office Manager (OM), the laboratory failed to document Hematoxylin and Eosin (H&E) control slide reactions for Histopathology testing on the date of survey. The findings include: 1. The laboratory did not document H&E stain QC reactions. 2. The laboratory read and reported approximately 60 patients annually,. 3. The OM confirmed on 10/25/23 at 1:30 pm that the laboratory did not document H&E QC stain reactions. -- 2 of 2 --

Summary Statement of Deficiencies D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) 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 establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on surveyor review of the laboratory records, procedure manual and interview with the Testing Personnel (TP), the laboratory failed to establish a maintenance protocol for the Microscope when protocols were not provided by the manufacturer from 10/27/17 to the date of the survey. The TP confirmed on 10/4/19 at 10:30 am that the laboratory did not establish a maintenance protocol. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. 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 -- This STANDARD is not met as evidenced by: Based on surveyor review of the Final Report (FR) and interview with the Testing Personnel (TP), the laboratory failed to have the address of the laboratory where the Histopathology tests were performed from 10/27/17 to the date of survey. The TP confirmed on 10/4/19 at 11:30 am the address of the laboratory was not on the FR. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM) and interview with the Testing Personnel (TP), the Laboratory Director (LD) failed to establish a Competency Assessment (CA) procedure with all the required elements for Testing Personnel from 10/27/17 to the date of survey. The TP confirmed on 10/4/19 at 9:30 am that a CA procedure was not established. -- 2 of 2 --