Trieu Dermatology, Llc

Summary Statement of Deficiencies D0000 A Recertification survey was performed at Trieu Dermatology, LLC, CLIA ID 19D2120244, on January 16, 2025. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, 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 patient logs, patient slides, patient case reports, and interview with personnel, the laboratory failed to establish written procedures to ensure positive identification of patient specimens from receipt through reporting of results for two (2) of nine (9) patients reviewed. Findings: 1. Review of the laboratory's "Monthly Quality Assurance Overview Policy" revealed "On a monthly basis all the slides, logs, and forms will be evaluated by the laboratory director and updated in the Monthly Quality Assurance Overview to ensure that all procedures and protocols are up to date and correct." 2. Review of random selection of patient logs, patient case reports with accompanying slides revealed the written case numbers on the slides and Mohs log book did not match the written case numbers on the patient case reports for the following two (2) of nine (9) patients reviewed: Patient 1: Mohs log book and slide- Case # DT24-730; Patient case report- Case # DT24-731 Patient 2: Mohs log book and slide- Case # DT24-731; Patient case report- Case # DT24-730 3. Review of the laboratory's "Monthly Quality Assurance Overview" logs for 2024 and the laboratory's records revealed the laboratory did not have documentation of

Summary Statement of Deficiencies D0000 A Recertification survey was performed on March 23, 2023 at Trieu Dermatology, LLC, CLIA ID # 19D2120244. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure manual and interview with personnel, the laboratory failed to establish a complete policy and procedure for record retention. Findings: 1. Review of the laboratory's procedure manual revealed a retention policy; however, the laboratory did not address retention of patient reports and quality control records. 2. In interview on March 23, 2023 at 10:10 AM, the Histotech confirmed the policy and procedure manual did not include record retention requirements for patient reports and quality control. 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 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 -- electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and maintenance logs and interview with personnel, the laboratory failed to define and document the acceptable temperature for operation of the cryostat and document temperature readings for the cryostat. Findings: 1. Review of the laboratory's policy "Frozen Section Workroom Set-up" revealed the following instructions: Cryostat 1. Check temperature and note it in cryostat log book, if out of range. 2. Confirm that the mechanics are working properly. 2. Review of the laboratory's "Cryostat Maintenance Record" for 2023 revealed the laboratory documented "Thermometer Check" performance with a check mark; however, the cryostat thermometer reading is not documented. 3. In interview on March 23, 2023 at 10:43 AM, the Histotech stated the temperature for the cryostat is checked but not documented, and it is always at -20. 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 by surveyors, review of the laboratory's policies, and interview with personnel, the laboratory failed to ensure supplies did not exceed expiration dates. Findings: 1. Observation by surveyors during the laboratory tour on March 23, 2023 at 09:48 AM revealed the following expired item: -0.5 Toluidine Blue O Alcoholic Solution, Lot 122154, Expiration Date: 5-31-22, Quantity: one (1) bottle 2. Review of the laboratory's policy "Frozen Section Workroom Set-up" section "Supplies" revealed "Make sure adequate supplies (slides, slide marking pens, permanent marking pens, tissue marking dyes, brushes, and solutions) are available and in place. Supplies will be checked on a monthly basis to ensure expired supplies are disposed of properly." 3. In interview on March 23, 2023 at 09:54 AM, the Histotech stated it was the only bottle they had and confirmed the identified bottle was expired. D6087 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(iii) The laboratory director must ensure that laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with personnel, the Laboratory Director failed to ensure laboratory personnel performed test methods as required. Findings: 1. The laboratory failed to define and document the acceptable temperature for operation of the cryostat and document temperature readings for the cryostat. Refer to D5413. 2. The laboratory failed to ensure supplies did not exceed expiration dates. Refer to D5417. -- 2 of 3 -- D6106 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(14) The laboratory director must ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel, the Laboratory Director failed to ensure that an approved procedure manual was available to all personnel responsible for any aspect of the testing process. Refer to D5401. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Certification Survey was performed on February 7, 2019 at Trieu Dermatology, LLC, CLIA ID # 19D2120244. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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, record review, and interview with personnel, the laboratory failed to ensure marking dyes have not exceeded their expiration dates. Findings: 1. Observation by surveyor during laboratory tour on February 7, 2019 revealed the following expired items: a) Mark IT Tissue Marking Dye, Green, Lot # 393019, Expiration Date: 11/2018, Quantity: one (1) bottle b) Mark IT Tissue Marking Dye, Orange, Lot # 393015, Expiration Date: 11/2018, Quantity: one (1) bottle c) Mark IT Tissue Marking Dye, Red, Lot # 389377, Expiration Date: 10/2018, Quantity: one (1) bottle d) Mark IT Tissue Marking Dye, Black, Lot # 394875, Expiration Date: 11 /2018, Quantity: one (1) bottle e) Mark IT Tissue Marking Dye, Blue, Lot # 389376, Expiration Date: 10/2018, Quantity: one (1) bottle 2. Review of the laboratory's "Expiration of Supplies/Chemicals" policy revealed the following: "Histotech will review supply stock periodically and dispose of expired items in accordance with established procedures." 3. In interview on February 7, 2019 at 1:15 pm, Personnel 1 stated the laboratory maintains a reagent log with expiration dates. 4. Review of the laboratory's "Reagent Receipt Log" revealed the laboratory did not include the identified items on the log. 5. In further interview on February 7, 2019, Personnel 1 stated she was unaware the identified marking dyes had an expiration date. 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 -- D5609 HISTOPATHOLOGY CFR(s): 493.1273(e)(f) (e) The laboratory must use acceptable terminology of a recognized system of disease nomenclature in reporting results. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to ensure testing personnel documented the stain quality for Histopathology testing. Findings: 1. Review of the laboratory's CMS 209 form (Laboratory Personnel Report) revealed Personnel 1 serves as the testing personnel 2. Review of random selection of patients and quality control records revealed the laboratory did not have documented QC assessment performed by the testing personnel identified on the laboratory's CMS 209 form (Laboratory Personnel Report) for the following dates: August 31, 2017 December 12, 2017 February 7, 2018 June 11, 2018 September 5, 2018 October 10, 2018 November 27, 2018 January 15, 2019 February 6, 2019 3. In interview on February 7, 2019 at 2:00 pm, Personnel 1 stated the histotech makes a quality control slide, which she examines for stain quality. Personnel 1 stated she is not always the person documenting the acceptability, sometimes it is the histotech who performed the staining. D5781