Southwest Skin And Vein Center Pllc

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. D3043 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(7) (a)(7) Slide, block, and tissue retention-- (a)(7)(i) Slides. (a)(7)(i)(A) Retain cytology slide preparations for at least 5 years from the date of examination (see 493.1274(f) for proficiency testing exception). (a)(7)(i)(B) Retain histopathology slides for at least 10 years from the date of examination. (a)(7)(ii) Blocks. Retain pathology specimen blocks for at least 2 years from the date of examination. (a)(7)(iii) Tissue. Preserve remnants of tissue for pathology examination until a diagnosis is made on the specimen. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure, slide review, and interview, the laboratory failed to retain slides from its Mohs cases for at least 10 years for one out of 14 cases reviewed from May 2016 - April 2025. Findings follow. A. Review of the laboratory's policy and procedure titled Quality Assurance, revised 08/22/2023, under Procedure stated "... The specimen is checked to make sure that the first cut contains the entire epidermis layer (sections are taken every 10-12 cuts). The slide will contain 3-4 levels per slide. The number of slides prepared depends on the doctor's preference and the size of the specimen. The slide will be labeled as follows: the accession number (which includes doctor initial, clinic location initial, year, and specimen number) will be written at the top of the slide, the next line will have patient last name, followed by first initial; below the name will be the date on the left of the slide and the layer/stage on the right (EX: I,II, III, IV, V, etc.) If more than one slide is prepared, the first will be labeled "A", the next "B", and so on and so forth. For tissue that has been bisected or quadrisected, the number of the piece as designated by 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 -- the map will also be written on the slide (ex: 1, 2, 3, 4)..." And at 5.9 stated, "Slides are maintained for 10 years." B. Review of slides from case number GA24-824 performed on 07/15/2024 had the following slides: IA, IB, IIA, IIB, IID. It was missing slide IIC. C. Interview with the laboratory director on May 7, 2025 at 1200 hours in the office was unsure whether there was a slide IIC, but also confirmed the laboratory did not record the number of slides per case. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (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 review of laboratory's policies and procedures, reagent log, manufacturer's instructions, observation, Mohs logs, and interview, the laboratory failed to ensure expired reagents and stains were not used in the laboratory. Findings follow. A. Review of the laboratory's policy and procedure titled Quality Assurance, revised 08 /22/2023, under Procedure at 5.2 stated, "... Further tissue is cut and stained, then checked for adequacy for interpretation by the physician; 2) If the stain remains inadequate for interpretation, additional staining solution containers will be emptied and refilled with new, fresh staining solutions. Further tissue is cut and stained, then reviewed for adequacy of interpretation. If necessary, new source containers of staining chemicals are opened and utilized. This process is repeated until the stains are adequate for interpretation by the physician. Make sure that all chemicals are not expired. If it is suspected that a batch of reagents are contaminated or inadequate for staining, contact the manufacturer. All lot numbers and expiration dates are to be recorded in the H&E Linear Stainline Log...." Review of the laboratory's policy and procedure titled Chemical Hygiene/ Chemical Exposure Plan, revised 08/22/2023, at 5.9 stated, "All commercially purchased chemicals/reagents, stock solutions and working solutions must be used within their indicated expiration dates. Discard when stain deteriorates/becomes less than optimal and the stain can not be re-verified as satisfactory by the dermatologist/ surgeon. Once a chemical has deteriorated and it is no longer acceptable for staining, it must be disposed of according to the Safety Data Sheet and local and federal regulations. If the laboratory identifies a problem with the reagent that was used for patient testing (e.g. expired vial, or reagent subjected to unacceptable storage conditions etc.) the laboratory must evaluate the potential impact on patient test results and maintain records of the evaluation and actions taken. 5.10 A record of lot numbers and expiration dates of reagents being used will be logged on the monthly H&E Linear Stainline Log." B. Review of the reagent log documented on the H&E Linear Stainline form revealed Xylene and 95% Reagent may have been used after their expiration dates. The following entries were observed for the chemicals: March 2024/ Eosin/ Lot 159191/ expiration 10/31/2024 March 2024/ Xylene substitute/ Lot 163900/ expiration 01/31/2025 March 2024/ 95% Reagent/ Lot 165427/ expiration 01/31/2025 No subsequent entries made to date, May, 7, 2025. C. During a tour of the laboratory the following reagents/chemicals were observed as opened but were not documented on the H&E Linear Stainline log: Eosin/ Lot 192130/ expiration 02/28/2026/ opened 03/26/2024 Xylene substitute/ lot 217268/ expiration 01/31/2027/ opened 02/25/2025 95% Reagent/ Lot 176393/ expiration 06 /30/2025/ No open date D. No other Xylene substitute entries were made showing Xylene substitute was used beyond the expiration date of 01/31/2025 - 02/25/2025 -- 2 of 3 -- (elapsed time 25 days). Review of the Mohs cases from 02/03/2025 - 02/25/2025 showed cases GA25-110 to GA25- 237 were performed over 8 days of testing. It was unclear whether the 95% Reagent was used beyond its expiration because there was no open date on the bottle in the laboratory. Review of the Mohs cases from 02/03 /2025 - 05/06/2025 (elapsed time 92 days) showed cases GA25-110 to GA25-465 were performed over 23 days of testing. E. Interview with the laboratory director on May 7, 2025 at 1145 hours in the office confirmed the findings. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The laboratory was found NOT to be in compliance with the CLIA regulations found at 42 CFR 493 CLIA requirements. The condition not met was: D6168 - 42 C.F.R. 493.1487 Condition: Laboratories performing high complexity testing; testing personnel. D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on review of the manufacturer's instructions, quality control records, patient testing logs, and interview, the laboratory failed to document the results of the internal controls for the Consult Diagnostics hCG (human chorionic gonadotropin) Urine Test Cassette for 125 patients tested from Sept 2022 - March 2023. Findings follow. A. Review of the McKesson Consult Diagnostics hCG Urine Test Cassette, Rev 00 12 /15, under Quality Control stated, "Internal procedural controls are included in the test. A red line appearing in the control region (C) is the internal procedural control. It confirms sufficient specimen volume and correct procedural technique. A clear background is an internal negative background control. If the test is working properly, the background in the result area should be white to light pink and not interfere with the ability to read the test result..." B. Attempted review of quality control records showed none available for review. Quality control records were requested on March 23, 2023, at 1630 hours but not provided. C. Review of the Urine Pregnancy Test Log showed from 09/14/2021 - 03/21/2023, 125 patients were tested. D. Interview with the Office Manager on March 23, 2023, at 1630 hours confirmed the internal quality control was not documented. 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 -- 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: I. Based on review of the laboratory's policies and procedures, accuracy assessments, patient testing logs, and interview, the laboratory failed to perform twice a year accuracy assessment of Mohs (clear margins) for 1 of 3 events reviewed. Findings follow. A. Review of the laboratory's policy and procedure titled Quality Assurance, revised 09/24/2021, at 5.5 stated, "At least once annually, Mohs surgeons will submit samples of Mohs histopathology slide specimens and maps to either a Mohs surgeon or Dermatopathologist for an in-depth, peer-review-style proficiency testing..." The procedure required annual accuracy assessments versus twice a year accuracy assessment. B. Review of the accuracy assessments from 2021 and 2022 showed 1 event performed in 2022 on 12/20/22. Additional accuracy assessments were requested on March 23 at 1400 hours but not provided. C. Review of the Mohs case log for 2022 showed the laboratory reported 1258 cases, GA22-01 - GA22-1258. D. Interview with the Laboratory Director on March 23 at 1400 hours in the office confirmed one accuracy assessment for Mohs and frozen section biopsies were performed in 2022 because they were told they only had to perform one if they previously had no issues. II. Based on review of the laboratory's policies and procedures, accuracy assessments, patient testing logs, and interview, the laboratory failed to perform twice a year accuracy assessment of frozen section biopsies for the dermatopathology interpretations (diagnosis) for 1 of 3 events reviewed. Findings follow. A. Review of the laboratory's policy and procedure titled Quality Assurance, revised 09/24/2021, at 5.6 stated, "At least once annually, samples of frozen section tissue specimen slides, along with the surgeon's diagnostic interpretations, will be sent to another Mohs Surgeon or Dermatopathologist for peer review..." The procedure required annual accuracy assessments versus twice a year accuracy assessment. B. Review of the accuracy assessments from 2021 and 2022 showed 1 event performed in 2022 on 12/20/22. Additional accuracy assessments were requested on March 23 at 1400 hours but not provided. C. Review of the Frozen Section Biopsies log for 2022 showed the laboratory reported 12 frozen section biopsy cases, FGA22-01 - FGA22- 12. D. Interview with the Laboratory Director on March 23 at 1400 hours in the office confirmed one accuracy assessment for Mohs and frozen section biopsies were performed in 2022 because they were told they only had to perform one if they previously had no issues. D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: Based on review of educational credentials and interview, the laboratory failed to employ testing personnel that met the educational requirements for two of five testing personnel performing high complexity testing in Histopathology. See D6171. -- 2 of 4 -- D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located or have earned a doctoral, master's or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet -- 3 of 4 -- the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: Based on review of educational credentials and interview, the laboratory failed to employ testing personnel that meet the educational requirements for two of five testing personnel performing high complexity testing in Histopathology. Findings follow. A. Review of education credentials for testing personnel # four and five, on the CMS form 209, showed the following: 1. Testing personnel #4 was lacking a diploma or transcript. A diploma was requested on March 23, 2023 at 1415 hours but not provided. 2. Review of the transcript for Testing personnel #5 showed she was lacking 2 hours in chemistry and 3 hours in either a chemistry, biology, or medical laboratory technician (MLT) course. B. Interview with the Laboratory Director on March 23, 2023 at 1340 hours acknowledged testing personnel #4 & 5 performed inking in Mohs testing. Interview with the Laboratory Director on March 29, 2023 at 1605 via phone confirmed the findings for both testing personnel after a review of the findings. -- 4 of 4 --

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Based on review of the testing logs, patient charts, and interview, the laboratory failed to ensure the test result was recorded into the patient's chart for 1 of 13 test reports reviewed. Findings follow. 1. Review of the Mycology and Parasitology Test Log showed: a. Patient tested on 12/11/2020 tested negative by KOH (Potassium Hydroxide) prep for fungal elements. 2. Review of the patient chart for MRN 89295 on 12/11/2020 showed the KOH test was not reported. 3. Interview with the Laboratory Director on August 3, 2021 at 1540 hours in the laboratory confirmed the KOH test was performed but not recorded in the patient's chart. KEY: MRN = Medical Record Number 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 --

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: Review of policies and procedures, laboratory records and interview facility personnel found that the laboratory failed to verify the accuracy of results for DTM, scabies and potassium hydroxide (KOH) direct amount examinations at least twice each year in 2018. The findings included: 1. Review of the policies and procedures found: DTM - "at least twice annually, the laboratory director and testing personnel will complete the proficiency testing form and will demonstrate proficiency regarding the accuracy of interpretation for the presence or absence of growth of yeast for dermatophytes." Scabies Prep : "at least twice annually, the laboratory director and testing personnel will complete the proficiency testing form and will review scabies prep test specimens that each of the other has interpreted, to see if there is any discrepancy in interpretation." potassium hydroxide (KOH) direct amount examinations:"at least twice annually, the laboratory director and testing personnel will complete the proficiency testing form and will review scabies prep test specimens that each of the other has interpreted, to see if there is any discrepancy in interpretation." 2. Review of laboratory records for the verification of accuracy of results found that the laboratory verify the accuracy of DTM, KOH and scabies exam one of two expected times in 2018. Scabies exam were concluded on March 2, 2018 KOH exams were completed on March 16, 2018 and DTM was completed on March 6, 2018. 3. Interview of testing person three listed on the CMS report 209 laboratory personnel report conducted on March 21, 2019 at 9:31 AM confirmed that no other results were available to ensure that the laboratory had verify the accuracy of results a second time in 2018. 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 -- D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Observations, review of reagent labels and interview of facility personnel found that the laboratory failed to store the reagents and solutions used for Hematoxylin and Eosin (H and E) staining of tissue specimens as specified by the manufacturer for three of four reagents. The findings included: 1. Observations made during the tour the facility found that the laboratory stored all reagents and solutions used for H and E staining in the cabinet below the sink in the laboratory. 2. Review of the manufacturer's labels found: Stat-Lab EOSIN -Y ALCOHOLIC 0.25% lot 069671 expiration 2020-10-01 - "storage store in a dry, cool and well ventilated place. Keep container closed when not in use. Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. Keep in fireproof place." Fisher brand HistoPrep 95% Reagent Alcohol Lot 456246 Expiration 06/2022 - "Storage: store locked up. Store in a well ventilated place. Keep container tightly closed." Stat-Lab XS-3 Xylene Substitute - "storage store in a dry, cool, locked to place. Keep/store away from direct sunlight, extremely high or low temperatures and incompatible materials. Store in a well ventilated place. Keep container tightly closed in a fireproof place." 3. Interview of testing person three on the CMS report 209 laboratory personnel report conducted on March 21, 2019 at 9:43 AM confirmed that the laboratory did not have a fireproof cabinet to store reagents and solutions used for H&E staining of tissue specimens. D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Review the CMS 209 laboratory personnel report, laboratory records and interview of facility personnel found that the laboratory director failed to specify in writing the responsibilities and duties for each testing person performing moderate and high complexity testing procedures. The findings included: 1. Review of this CMS 209 laboratory personnel report found that the laboratory designated to testing personnel performing high complexity testing and one testing person performing moderate complexity testing. 2. Review of laboratory records found no written delegation of responsibilities and duties for three of three testing personnel. 3. Interview of testing person three conducted on March 21, 2019 at 10:21 AM confirmed that written delegation of duties were not available for three of three testing personnel. -- 2 of 2 --