Southwest Dermatology And Vein

Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, and recertification is recommended. Standard level deficiencies were cited. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure, testing logs, patient reports, slides, Mohs maps, and interview, the laboratory failed to ensure positive identification and optimum integrity of patient specimens from the time of collection and receipt of the specimen through completion of testing and reporting of results for one of nine cases reviewed. Finding follow. A. Review of the laboratory's policy and procedure titled Quality Assurance, approved 09/06/2023, under Procedure at 5.2 stated, "Mohs: The specimen arrives in the lab with the properly labeled petri dish (patient name, layer, location), and a Mohs map with the same matching information. Any quality assurance/ quality control issues/ discrepancies will be addressed at this time and documented on the Discrepancy Log. The time the specimen was received is written on the map and the histotechnicians will initial it. After all information has been verified as correct, the specimen is logged in the Mohs Accession Log and assigned as accession number. Logging in the patient includes date, patient name, DOB, MRN, Referral, DX, and location." B. Review of the Mohs log against the patient report showed two different last names for case GM25-043 performed 05/05 /2025. In addition, the Mohs log did not have a DOB or MRN recorded. C. Review of the Mohs slides for case GM25-043 showed the same name as printed on the Mohs 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 -- log (incorrect name). D. Review of the Mohs map for case GM25-043 showed the name could have been interpreted as the name entered on the Mohs log and slides. E. Interview with the Laboratory Director on June 4, 2025 at 1110 hours in the office confirmed the findings. KEY:DOB = Date of birth MRN = Medical Record Number D5805 TEST REPORT CFR(s): 493.1291(c) (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. This STANDARD is not met as evidenced by: Based on review of Mohs maps and interview, the laboratory failed to include the correct address of the facility where the Mohs testing was performed for three of nine Mohs maps reviewed. Findings follow. A. Review of nine Mohs maps showed three had the following address for the Mohs testing performed- 4419 Frontier Trail Suite 110, Austin, TX 78745, as listed by date of service and case number: 1. 08/07/2023 GM23-051 2. 02/05/2024 GM24-009 3. 11/04/2024 GM24-082. B. Interview with the Laboratory Director on June 4, 2025 at 1110 hours in the office confirmed the Mohs maps had the address of their other location and spent most of his time at the other location. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, and recertification is recommended. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure, slides, and interview, the laboratory failed to label the slides with the patient's name on one of ten cases reviewed in dermatopathology. Findings follow. A. Review of the laboratory's policy and procedure titled Quality Assurance, approved 01/05/2022, under 5.3 Frozen Sections stated, "The assigned frozen accession number, patient name, date of procedure and tech initials will be labeled on the slide." B. Review of a combination of ten Mohs and Frozen section biopsy cases showed the Frozen Section biopsy case GMF23-002 did not have the patient's name on the slide. C. Interview with the Laboratory Director on June 14, 2023 at 1045 confirmed the findings and added GMF23-001 from the same patient was also not labeled with the name. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper 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 -- 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: I. Based on review of manufacturer's instructions, laboratory's policy and procedure, temperature logs, testing logs, pre-survey paperwork, and interview, the laboratory failed to ensure the temperature was within the operating specifications for the Avantik QS12 cryostat used in Mohs testing for 12 of 12 months reviewed over 16 days of testing. Findings follow. A. Review of the Avantik QS12 Instruction Manual, 5259000 rev 1, on chapter 2. Introduction under Technical Specifications stated, "Temperature (Recommended Operation) 15 to 30 degrees Celsius (59 to 86 degrees Fahrenheit) Note Performance may deteriorate when operated outside of this range". B. Review of the laboratory's policy and procedure titled Equipment Management, approved 01/05/2022, at 5.0 Procedure stated, "The temperature and humidity is checked and recorded each day for all temperature dependent equipment and environments using a thermometer." C. Temperature logs were requested on June 14, 2023 at 1015 hours but not provided. D. Review of the Mohs Accession Logs from 06 /08/22 - 06/05/23 showed Mohs testing was performed on the following dates: 06/05 /23, 05/11/23, 04/03/23, 03/06/23, 02/06/23, 01/09/23, 12/05/22, 11/07/22, 10/12/22, 09/14/22, 08/31/22, 08/17/22, 08/03/22, 07/20/22, 07/06/22, and 06/08/22. E. Interview with the Laboratory Director on June 14, 2023 at 1015 hours confirmed the laboratory did not monitor room temperature. F. Review of the CMS form 116 showed approximately 171 stages were performed annually. II. Based on review of manufacturer's instructions, laboratory's policy and procedure, humidity logs, testing logs, pre-survey paperwork, and interview, the laboratory failed to ensure the humidity was within the operating specifications for the Avantik QS12 cryostat used in Mohs testing for 12 of 12 months reviewed over 16 days of testing. Findings follow. A. Review of the Avantik QS12 Instruction Manual, 5259000 rev 1, on chapter 2. Introduction under Technical Specifications stated, "Relative Humidity [RH] maximum 60% RH up to 35 degrees Celsius". B. Review of the laboratory's policy and procedure titled Equipment Management, approved 01/05/2022, at 5.0 Procedure stated, "The temperature and humidity is checked and recorded each day for all temperature dependent equipment and environments using a thermometer." C. Humidity logs were requested on June 14, 2023 at 1015 hours but not provided. D. Review of the Mohs Accession Logs from 06/08/22 - 06/05/23 showed Mohs testing was performed on the following dates: 06/05/23, 05/11/23, 04/03/23, 03/06/23, 02/06 /23, 01/09/23, 12/05/22, 11/07/22, 10/12/22, 09/14/22, 08/31/22, 08/17/22, 08/03/22, 07/20/22, 07/06/22, and 06/08/22. E. Interview with the Laboratory Director on June 14, 2023 at 1015 hours confirmed the laboratory did not monitor humidity. F. Review of the CMS form 116 showed approximately 171 stages were performed annually. 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. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on observation, review of manufacturer's instructions, pre-survey paperwork, and interview, the laboratory failed to ensure reagents were not used beyond their expiration for seven of seven tissue marking dyes, two of two submount mounting media, 16 of 16 bottles of frozen embedding medium, and four of four bottles of frozen section compound currently in use by the laboratory used in Mohs testing. Findings follow. A. Expired Supplies: 1. Surveyor observed on June 14, 2023 at 1020 hours in the laboratory seven of seven Stat Lab Tissue Marking Dyes available and in use by the laboratory were expired as listed by color, Lot number, and expiration date: a. Red 104899 08/31/22 b. Blue 105571 09/30/22 c. Orange 104908 08/31/22 d. Green 104169 08/31/22 e. Yellow 105567 09/30/22 f. Violet 102900 07/31/22 g. Black 103254 07/31/22 2. Surveyor observed on June 14, 2023 at 1025 hours in the laboratory two of two bottles of Submount Mounting Media, Lot 1145, expiration 05 /25/22 available and in use by the laboratory. 3. Surveyor observed on June 14, 2023 at 1030 hours in the laboratory 16 of 16 bottles of Stat Lab Polarstat Plus Frozen Embedding Medium, Lot 118027, expiration 03/31/2023 available and in use by the laboratory. 4. Surveyor observed on June 14, 2023 at 1030 hours in the laboratory four of four bottles of Ultra Freeze Frozen Section Compound, Lot 20324, expiration 11/22 available and in use by the laboratory. B. Interview with the Laboratory Director on June 14, 2023 at 1015 and 1035 hours confirmed the findings. C. Review of the CMS form 116 showed approximately 171 stages were performed annually. -- 3 of 3 --