Southwest Skin Specialists, Llc Dba

Summary Statement of Deficiencies 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 direct observation of histopathology stain reagents and interview with the facility personnel, the laboratory used reagents for the CK-5 Stain past the expiration date. Findings include: 1. The laboratory performs the CK-5 Stain on patient slides in conjunction with dermatopathology testing, with an approximate annual test volume of 9 tests. 2. During the survey conducted on May 31, 2023, direct inspection of the 'IHC Blocker' reagent in use at the time of the survey, lot# 00001524, expiration date 3 /20/2022, revealed the reagent was used for patient testing past the expiration date. 3. During the survey conducted on May 31, 2023, direct inspection of the 'CK5 pHRP' reagent in use at the time of the survey, lot# 00001523, expiration date 4/15/2022, revealed the reagent was used for patient testing past the expiration date. 4. The exact number of patient specimens tested with the expired reagents could not be determined at the time of the survey. 5. The facility personnel interviewed on May 31, 2023 at 2: 08pm confirmed the expired reagents indicated above were in use on the day of the survey. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a 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 -- maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on review of microscope maintenance records and interview with the facility personnel, the laboratory failed to perform and document the annual preventative maintenance of the microscope used for patient testing under the subspecialty of Histopathology. Findings include: 1. During the survey conducted on May 31, 2023, no documentation was presented for review from 2022 to indicate the laboratory performed and documented annual preventative maintenance on the microscope used for reading patient slides. 2. The facility personnel interviewed on May 31, 2023 at 1: 55pm confirmed there was no documentation of annual preventative maintenance from 2022 for the microscope used by the laboratory to read patient slides under the subspecialty of Histopathology. 3. The laboratory's reported annual test volume under the subspecialty of Histopathology is 2,424. 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: Based on lack of Quality Control (QC) documentation and interview with the facility personnel, the laboratory failed to document the acceptability of CK-5 staining materials each day of use for intended reactivity to ensure predictable staining characteristics. Findings include: 1. The laboratory performs the microscopic interpretation of tissue specimens in the sub-specialty of Histopathology, with a reported annual test volume of 2,424. The laboratory performs the CK-5 Stain on certain tissues, if warranted and ordered by the physician who issues the diagnosis. 2. No documentation of the CK-5 stain acceptability was presented for review for testing that occurred during 2021, 2022 and 2023 through the date of the survey conducted on May 31, 2023. 3. The laboratory's reported annual test volume for the CK-5 Stain is 9. 4. The facility personnel interviewed on May 31, 2023 at 1:40pm confirmed the laboratory failed to document the acceptability of the CK-5 Stain, for intended reactivity to ensure predictable staining characteristics, during the timeframe indicated above. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's quality assessment (QA) records and interview with the facility personnel, the laboratory's QA processes failed to identify and correct errors found in the analytic systems specified in 493.1251 through 493.1283. Findings include: 1. The laboratory processes and interprets dermatopathology slides from patient specimens for Mohs testing, Frozen Biopsy testing and, if warranted, CK-5 Stain testing. The laboratory's approximate annual test volume is 2,424. 2. The laboratory performs and documents a monthly Quality Assessment (QA) checklist. 3. The laboratory's monthly QA checklists reviewed during the survey from 2021 through April 2023 failed to monitor, identify and correct problems found in the analytic systems. (See D5417, D5433, and D5473 for specific findings) 4. The facility personnel interviewed on May 31, 2023 at 2:15pm confirmed the laboratory's QA processes at the time of the survey failed to identify and correct errors found in the analytic systems. D5803 TEST REPORT CFR(s): 493.1291(b) Test report information maintained as part of the patient's chart or medical record must be readily available to the laboratory and to CMS or a CMS agent upon request. This STANDARD is not met as evidenced by: Based on lack of test reports for review and interview with the facility personnel, the laboratory failed to provide the test report for one out of two patient records reviewed during the survey. Findings include: 1. The laboratory performs testing in the subspecialty of Histopathology, with an approximate annual test volume of 2,424. The laboratory performs the CK-5 IHC Stain on specimens, if ordered. The laboratory utilizes an electronic medical record (EMR) system to maintain final test reports for patients. 2. No CK-5 IHC Stain test report was presented for review for one out of two patient test records (D.D. from 6-07-22) reviewed during the survey conducted on May 31, 2023. 3. The facility personnel interviewed on May 31, 2023 at 1:40pm confirmed the laboratory failed to enter the patient's test report into the EMR as indicated above. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on lack of CK-5 Stain Acceptability records for review for testing that occurred during 2021 through May 31, 2023, the laboratory director failed to ensure that quality control programs are maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. See D5473 and D5791 for findings. -- 3 of 3 --

Summary Statement of Deficiencies 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 Mohs log, review of patient slides, review of the electronic test report and interview with the facility personnel, the laboratory failed to follow established procedures to ensure positive identification of patient's dermatopathology specimens. Findings include: 1. The laboratory performs Mohs testing under the sub-specialty of histopathology, with an approximate annual test volume of 3,600. It is the practice of the laboratory to assign a unique case number to each patient's Mohs specimen. The case number is included on the Mohs log, the patient slide(s) and the patient's electronic test report. 2. Review of the electronic test report for patient W.O. from 8/25/20 indicated the Mohs case number as "CMS20- 1105". The Mohs log and Mohs slides for this patient indicated the Mohs case number as "CMS20-1108". 3. The facility personnel confirmed that the electronic test report indicated above contained the incorrect specimen ID (case #). D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the 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 -- laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on lack of established control procedure documentation for review and interview with the facility personnel, the laboratory failed to establish control procedures for the histopathology stain, CK-5. Findings include: 1. The laboratory performs testing in the sub-specialty of Histopathology, with an approximate annual test volume of 3,600. 2. The laboratory performs the CK-5 stain (IHCDirect Cytokeratin 5) on certain specimens, as determined by the diagnosing physician. 3. No evidence was presented for review during the survey conducted on 10/21/20 to indicate the laboratory established a control procedure for the CK-5 stain, including the number, type and frequency of testing control materials. The laboratory began using the stain in July 2020. 4. The manufacturer's instructions for the CK-5 stain states, "Positive and negative controls should be run simultaneously with patient specimens." 5. The facility personnel confirmed that the laboratory did not have documentation of an approved QC procedure for the CK-5 stain. 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: Based on lack of Quality Control (QC) documentation and interview with the facility personnel, the laboratory failed to document the acceptability of staining materials used for testing performed in the sub-specialty of histopathology. Findings include: 1. The laboratory performs testing in the sub-specialty of Histopathology, with an approximate annual test volume of 3,600. 2. The laboratory performs the CK-5 stain (IHCDirect Cytokeratin 5) on certain specimens, as determined by the diagnosing physician. 3. No documentation of the CK-5 stain acceptability was presented for review for patient testing that occurred on 07/16/20 and 09/10/20. Approximately 2 patients were tested on those dates. 4. The manufacturer's instructions for the CK-5 stain states, "Positive and negative controls should be run simultaneously with patient specimens." 5. The facility personnel confirmed that the laboratory failed to document the stain acceptability on the testing dates indicated above. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on review of quarterly Quality Assessment (QA) documentation, review of electronic test records and interview with the facility personnel, the laboratory failed to establish written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified with electronic test reports. Findings include: 1. The laboratory performs Mohs testing in the sub-specialty of Histopathology, with an approximate annual test volume of 3,600. The laboratory utilizes an electronic medical record (EMR) system to document the test procedure and test results. 2. The laboratory's QA process at the time of the survey conducted on 10/21/20 consisted of a quarterly review of records including the patient consent form, Mohs map and Mohs slides. Approximately 2 patient records from each month were reviewed on a quarterly basis. 3. No documentation was provided for review during the survey to indicate the laboratory established policies and procedures to monitor, assess and, when indicated, correct problems identified with the Mohs test results entered into the EMR. 4. The laboratory failed to correctly identify the Mohs case number in the EMR for one out of four patient records reviewed during the survey. See D5203 for findings. 5. The facility personnel confirmed that the laboratory's established QA procedures failed to monitor, assess and correct problems identified with the test report information entered into the EMR. -- 3 of 3 --

Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of quality assessment (QA) policies and interview with the facility personnel, the laboratory failed to perform and document monthly quality assessment activities. Findings include: 1. The laboratory performs testing under the sub-specialty of Histopathology, with an approximate annual test volume of 3,408. 2. The laboratory's established policy titled, "Internal Quality Control/Proficiency Testing" states, "Two cases are chosen randomly by one of the Mohs technicians monthly. All slides prepared for the cases as well as the coinciding Mohs map interpreting the histology will be available for review. Findings are noted on tables represented below and records are kept in the laboratory QA manual....The interpretation of the slides is evaluated in order to verify that: Maps are labeled with the case number, date, patient name, site of tumor and tumor type...(also) tumor is marked correctly on the map." 3. No documentation was presented for review to indicate the laboratory performed and documented the monthly QA review as indicated above from June 2016 through the date of the survey conducted on May 9, 2018. 4. The facility personnel confirmed that the laboratory did not have documentation of the monthly QA review stated above. 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 --