Texas Surgical Dermatology Pa

Summary Statement of Deficiencies D0000 An announced survey of the laboratory was conducted on 04/18/2024. The laboratory was found in compliance with applicable CLIA regulations (42 CFR Part 493, Requirements for Laboratories). STANDARD LEVEL DEFICIENCIES were cited. 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's observations and staff interview, the laboratory failed to label secondary containers with the content, lot and expiration dates for four of four in- house prepared colored freezing media observed on a shelf in the laboratory. Findings included: 1. Surveyor's observations on 04/18/2025 at 0910 hours in the laboratory revealed 5 bottles (4 with colored solutions and 1 with a clear solution) sitting on a shelf in the laboratory. The containers were labeled 1 through 5 with a marker. The containers were labeled by the manufacturer as follows: Bottle marked number 1 containing a light blue solution: Labeled by Manufacturer as: Subxero Freezing Medium Lot: 85814 Expiration date: 07/21 Bottle marked number 2 containing an orange solution: Labeled by Manufacturer as: Subxero Freezing Medium Lot: 85814 Expiration date: 07/21 Bottle marked number 3 containing a purple solution: Labeled by Manufacturer as: Subxero Freezing Medium Lot: 87145 Expiration date: 09/21 Bottle marked number 4 containing a clear solution: Labeled by Manufacturer as: Subxero Freezing Medium Lot: 45145 Expiration date: 08/2025 Bottle marked number 5 containing a yellow solution: Labeled by Manufacturer as: Polarstat Plus Frozen Embedding Medium Lot: 082330 Expiration date: 2021-06-01 Note: 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 -- Manufacturer prepared Subxero Freezing Medium in its original form was a clear solution. 2. In an interview on 04/18/2024 at 0915 hours in the laboratory, the facility's Histo Tech stated that, except for Solution bottle number 4 which was unadulterated or changed in any form, the other colored solution bottles were reused for an in-house preparation of the current lot of clear Subxero Freezing Medium combined with store bought food coloring. She also stated that these colored solutions of Subxero Freezing Medium on the shelf were recently prepared but was not sure of the exact date. No written policy with formula for the preparation of the mixture was available for review. 3. Further surveyor's observations at the time of the above interview revealed the bottles with the colored solutions did not have labels specifying the bottles' mixture content, date of preparation and date of expiration. 4. In an interview on 04/18/2024 at 0915 hours in the laboratory, the facility's Histo Tech (as indicated on submitted Survey Entrance/Exit Document) confirmed the findings. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on surveyor's observations, review of laboratory's Cryostat maintenance records and staff interview, the laboratory failed to document daily and monthly maintenance for two of two Cryostat instruments in use, the Avantik QS and the Thermo Scientific Microm HM520 Cryostats. Findings included: 1. Surveyor's observations on 04/18/2024 at 0905 hours in the laboratory revealed two Cryostat instruments in use: The Avantik QS Cryostat Serial Number: 59730 The Thermo Scientific Microm HM520 Cryostat Serial Number: 4180 2. In an interview at the time of the observation, the facility's Histo Tech stated that the Avantik Cryostat was the instrument used most of the time and the Thermo Scientific Microm HM520 Cryostat was the backup and used sporadically as needed. 3. Review of laboratory's Cryostat maintenance records for October 2023 to March 2024 revealed the laboratory required the following maintenance of the Cryostats: "Interior is cleaned day of surgery while wearing gloves. Air filter is cleaned as part of the maintenance every month." 4. Further review of the laboratory's Cryostat maintenance records revealed: a. There was only one log sheet where daily Cryostat maintenance was recorded, but it did not specify which of the two instruments underwent maintenance on the day of record/use. b. There was no documentation of when the monthly air filter cleaning took place for either if the instruments. 5. In an interview on 04/18/2024 at 1000 hours in the laboratory, the facility's Histo Tech (as indicated on submitted Survey Entrance /Exit Document) stated that the cryostats' daily maintenance was performed and documented only on the days of use. She could not state which cryostat was in use on the days of record. This confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation 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 the laboratory policy, laboratory records from 2019-2020, and confirmed in interview, the laboratory failed to document twice annual accuracy assessment for 1 of 2 tests (MOHS) in 2019. Findings were: 1. Review of the laboratory policy Quality Assurance Program - Mohs Histopathology revealed "once every 6 months, a quality assurance review of 10 Mohs cases will be performed. Ten past Mohs cases will be randomly selected by the laboratory's histotechnicians... results will be documented in the Quality Assurance section of the laboratory manual." 2. Review of the laboratory records from 2019-2020 revealed no documentation of the twice annual accuracy assessment for Mohs in 2019. 3. Random review of patient records from January to December 2019 revealed the laboratory performed 21 Mohs patient testing. 4/1/19 - Mohs Case #110, 111, 112 4/4/19 - Mohs Case #117, 118, 119, 120, 121 10/14/19 - Mohs Case #388, 389, 390, 391, 392, 393 10 /17/19 - Mohs Case # 394, 395, 396 10/21/19 - Mohs Case # 397, 398, 399, 400 4. An interview with the histotechnician on 11/13/20 at 1420 hours in the laboratory confirmed the above findings. 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 -- 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 observations, review of laboratory records, and confirmed in interview, the laboratory failed to ensure expired reagent for 1 of 2 testing (KOH - potassium hydroxide) were not used for patient testing. Findings were: 1. Surveyor observation on 11/13/20 at 1310 hours revealed the following expired reagents in the laboratory cabinet: KOH lot 1721311, exp 8/1/18 2. Review of the laboratory patient test log sheet from 2019-2020 revealed documentation that the laboratory performed 4 KOH patient testing using the above expired reagents. Refer to patient alias list. 3. An interview with the histotechnician on 11/13/20 at 1420 hours in the laboratory confirmed the above findings. She confirmed that that was the only KOH bottle in the laboratory and agreed it should be discarded. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on review of the manufacturer's instructions, laboratory maintenance records from 2019-2020, patient test records, and confirmed in interview, the laboratory failed to document required maintenance for the Thermo Scientific Microtome Cryostat for 2019 and 2020. Findings were: 1. Review of the Thermo Scientific Microtome Cryostat instruction manual under Maintenance and care of the cryostat revealed "cleaning, care and decontamination of the cryostat depends on how frequently the instrument is used. However, it is recommended to shut the instrument off every 6-8 weeks." 2. Review of the laboratory records Cryostat Temperature from 2019-2020 revealed the following maintenance: - defrost of machine is done day of surgery - interior is clean day of surgery while wearing gloves -air filter is cleaned as part of the maintenance every month 3. Review of the laboratory records from 2019-2020 revealed no documentation of the above maintenance for the Thermo Scientific Microtome Cryostat for 2 of 2 years. 4. An interview with the histotechnician on 11/13 /20 at 1405 hours in the laboratory confirmed the above findings. She was unaware of the maintenance for the cryostat. She also stated that she does clean the cryostat each day of patient testing but she did not document it. 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 -- 2 of 4 -- 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 review of quality control records from 2019 -2020, patient test records, and confirmed in interview, the laboratory failed to document the slide quality of the Hemotoxin and Eosin (H & E) differential stain for 3 of 20 days of patient testing reviewed. Findings were: 1. A review of the quality control log for the H & E stain from January 2019 to October 2020 reveal no documentation of the slide quality for the H & E stain for 3 of 20 days reviewed. 10/14/19 10/17/19 10/21/19 2. Random review of patient test records for the above dates revealed the laboratory performed Mohs testing. 10/14/19 - Mohs Case #388, 389, 390, 391, 392, 393 10/17/19 - Mohs Case # 394, 395, 396 10/21/19 - Mohs Case # 397, 398, 399, 400 3. An interview of the histotechnician on 11/13/20 at 1430 hours in the laboratory confirmed the above findings. D5781

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 laboratory records from 2017 through 2018 and staff interview, it was revealed the laboratory failed to have documentation of performing twice annual accuracy assessment for MOHS testing. Findings included: 1. A review of the laboratory's records from 2017 through 2018 found the laboratory had no documentation for performing twice annual accuracy assessment of MOHS testing available for review. 3. Interview of the laboratory director conducted on October 23,2018 at 1:49 PM confirmed that there was no documentation available for review of semi-annual accuracy assessment of MOHS testing. He stated that he had participated in the 2017 MOHS College Peer review in 2017 but did not have that available for review, and did not send out slides for peer review. 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 --