Us Dermatology Partners

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representatives at the exit conference. The facility was found to be in compliance with applicable Conditions in the CLIA program, and recertification is recommended. 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 review of accuracy assessments, case logs, and interview, the laboratory failed to verify the accuracy of dermatopathology interpretations of its frozen section biopsies at least twice annually for 2 of 2 years reviewed in 2021, and 2022. Findings follow. A. Accuracy assessments for dermatopathology interpretations of frozen section biopsies (verticals) were requested on February 28, 2023, at 1645 hours but not provided. B. Review of the Frozen Section Biopsy Log showed from 01/12/2021 - 12/05/2022 there were 67 and 63 cases reported respectively in 2021 and 2022. C. Interview with the Laboratory Director on February 28, 2023, at 1645 hours in his office confirmed accuracy assessments for verticals/frozen section biopsies were not performed. 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. 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 observation and interview, the laboratory failed to label solutions used in the Mohs laboratory, lacking the identity of the solution, lot number, pour over date, and expiration, as applicable. Findings follow. A. Surveyor observed on February 28, 2023, at 1435 hours in the laboratory two unlabeled bottles sitting on the cryostat. B. Interview with the histotechnologist on February 28, 2023, at 1435 hours in the laboratory acknowledged one of the bottles was microtone oil that the label fell off, and the other unlabeled bottle was alcohol used to clean the cryostat. 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 observation, manufacturer's instructions, interview, and pre-survey paperwork the laboratory failed to ensure reagents had not exceeded their expiration date for Xylene used in the Hematoxylin and Eosin (H&E) stain used for Mohs and frozen section biopsies for 365 of 365 days of testing. Findings follow. A. During a tour of the laboratory on February 28, 2023, at 1430 hours, the surveyor observed Xylene used to stain H&E slides in Mohs and frozen section biopsies (verticals) was expired: Opened gallon, Lot 094579, expiration 02/28/2022, expired for 365 days. Unopened gallon, Lot 112231, expiration 12/31/2022. B. Interview with the histotechnologist on February 28, 2023, at 1430 hours in the Mohs lab confirmed there was no other Xylene in the lab available for staining. C. Review of the CMS form 116 from the presurvey paperwork showed an annual testing volume of 1249 Mohs and frozen section biopsies. -- 2 of 2 --

Summary Statement of Deficiencies D0000 Laboratory representatives were present at the entrance conference. The survey process was discussed. An opportunity for questions and comments was given. The exit conference was held with the laboratory representatives. The laboratory was found to be in substantial compliance for the specialties/subspecialties for which it was surveyed. The standard level deficiencies cited were discussed. The process for submitting the corrections was explained. CMS form 2567 will be emailed from the Texas Health and Human Services Commission, Health Facility Compliance Arlington Group. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D0000 The Histotechnician, Regional Clinical Manager, and Office Manager were at the entrance conference conducted 11/18/2019. The survey process was discussed. An opportunity for questions and comments was given. Exit conference was held with the Laboratory Director, Histotechnicians, Regional Clinical Manager, and Office Manager on 11/18/2019. The laboratory was found to be in substantial compliance for the specialties/subspecialties for which it was surveyed. The standard level deficiencies cited were discussed. The process for submitting the corrections was explained. CMS form 2567 will be emailed from the Texas State Health and Human Services Commission, Health Facility Compliance Arlington Group. 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 review of manufacturer's instructions, cryostat maintenance logs, and staff interview, the laboratory failed to properly monitor and document cryostat temperatures used to process patient histology specimens for 151 of 167 days in 2018 and 155 of 157 days in 2019. Findings: 1. Review of the cryostat operator's manual revealed "Chamber Temperature Max -35C". 2. Review of the laboratory's Cryostat Maintenance log revealed a defined cryostat temperature range of "-25 to -35". Note the range was not defined in Celcius or Fahrenheit. Review of the logs from 01/2018 through 12/2018 and 01/2019 through 11/2019 revealed the documented temperatures Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- were not within the defined range. The following are a sampling of those dates and temperature: 04/02/2018 "34" 04/03/2018 "33" 04/04/2018 "32" 04/10/2018 "33" 12 /11/2018 "34" 12/12/2018 "34" 12/17/2018 "35" 12/18/2018 "34" 12/19/2018 "34" 10 /28/2019 "34" 10/29/2019 "34" 10/30/2019 "34" 11/04/2019 "33" 11/05/2019 "34" 11 /06/2019 "35" 11/08/2019 "34" 11/11/2019 "33" 11/12/2019 "34" 11/13/2019 "35" The laboratory failed to properly monitor and document cryostat temperatures. 3. During an interview on 11/18/2019 at 10:12 am the histotechnician stated that the documented temperatures should be "negative" and the histotechnicians do not write the negative sign in front of the number for the temperature because they know it is negative. This confirmed the above findings. 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 laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: I. Based on review of the laboratory's procedure manual, Quality Control (QC) logs and confirmed in interview, the laboratory failed to define for each day of use, test staining materials for intended reactivity to ensure the predictable staining characteristics for the Hematoxylin and Eosin (H&E) QC for 12 of 12 days in 2018 (random review 12/2018) and 25 of 25 days in 2019 (random review 08/2019, 10 /2019). Findings: 1. Review of laboratory policy Hematoxylin and Eosin Stain revealed: "Quality Control: Frozen sections have an internal control. There is a QC sheet that will be filled out daily (see last sheet in procedure. [sic] ... RESUTLS Nuclei Blue Erythrocytes and eosinophillic granules Bright pink to red Cytoplasm and other tissue elements Various shades of pink" 2. A random review of the "Slide Quality & Maintenance" log in 2018 and 2019 revealed the following: The log had a column for "Stain Quality" and each day QC was documented with a checkmark in the column and the initials the laboratory director in another column. The log did not specify the meaning of the checkmark. The bottom of the log stated "H&E stain and section quality should be completed daily by the physician." The following dates were observed to be documented with a checkmark: December 2018: 3, 4, 5, 7, 10, 11, 12, 18, 19, 20, 26, 27 August 2019: 5, 6, 7, 12, 13, 14, 16, 19, 20, 21, 26, 27 October 2019: 1, 2, 7, 8, 14, 15, 16, 21, 22, 23, 25, 28, 29, 30 The laboratory failed to document the staining characteristics for the H&E stain. 3. During an interview on 11 /18/2019 at 12:10 pm, the histotechnician confirmed the above findings. II. Based on review of laboratory policy, Quality Control (QC) logs and confirmed in interview, the laboratory failed to document for each day of use, test staining materials for intended reactivity to ensure the predictable staining characteristics for the Hematoxylin and Eosin (H&E) QC for 1 of 12 days in 2018 (12/2018) and 4 of 29 days in 2019 (08/2019, 10/2019). 1. Review of laboratory policy Hematoxylin and Eosin Stain revealed: "Quality Control: Frozen sections have an internal control. There is a QC sheet that will be filled out daily (see last sheet in procedure. [sic] ... RESUTLS Nuclei Blue Erythrocytes and eosinophillic granules Bright pink to red Cytoplasm and other tissue elements Various shades of pink" 2. Review of the "Slide Quality & Maintenance" log in 2018 and 2019 revealed the following: The log had a column for "Stain Quality" and each day QC was documented with a checkmark in -- 2 of 3 -- the column and the initials the laboratory director in another column. The log did not specify the meaning of the checkmark. The bottom of the log stated "H&E stain and section quality should be completed daily by the physician." The laboratory failed to document intended reactivity of the H&E stain on the following dates patients were tested in 2018 and 2019: 12/17/2018 Patient IDs: M18-1047, M18-1048, M18-1049, M18-1050, M18-1051, M18-1052 08/28/2019 Patient IDs: M19-763, M19-764, M19- 765, M19-766, M19-767, M19-168 08/30/2019 Patient IDs: M19-769, M19-770, M19. 770, M19-771, M19-772, M19-773, M19-774 10/09/2019 Patient IDs: M19-894, M19- 895, M19-896, M19-897, M19-898 10/11/2019 Patient IDs: M19-899, M19-900, M19- 901, M19-902, M19-903 The laboratory failed to document the staining characteristics for the H&E stain for each day of use. 3. During an interview on 11/18 /2019 at 12:10 pm, the histotechnician confirmed the above findings. -- 3 of 3 --