Pahrump Dermatology & Skin Cancer

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on October 2, 2024. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on the number and severity of the deficiency cited herein, the Condition: General Laboratory Systems was not met. The laboratory failed to follow established director approved policies and procedures to maintain optimal specimen integrity from collection of the specimen through testing and final reporting of results. (refer to Tag D5203) 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- results. This STANDARD is not met as evidenced by: Based on a review of the director approved policy entitled, "Policy & Procedure Quality Assurance", a review of the director approved policy entitled, "Post Analytical Mohs Audit", a review of the laboratory Post Analytical Mohs audit records between the dates of May 7, 2024 and September 24, 2024, a random audit of Mohs patients tested between the dates of May 9, 2023 and September 10, 2024, and an interview with the office manager, the laboratory failed to ensure that the written policies and procedures were followed to ensure positive identification and optimum integrity of patient specimens was maintained from the time of collection through the completion of testing and reporting of results. Findings include: 1. The director approved policy entitled, "Policy & Procedure Quality Assurance", in the section entitled, "Quality Assurance Procedures During Mohs" stated, "The patient's name is written on the slide, as well as the patients (sic) date of birth, surgery site, surgery date, stage of surgery, and biopsy specimen number." 2. The director approved policy entitled, "Post Analytical Mohs Audit" stated, "The office manager is responsible for verifying the MOHS (sic) map card, MOHS (sic) log, patient electronic record, MOHS (sic) technician log and slides." The policy later stated, "The information that will be checked will be the patient's name, date of birth, diagnosis of lesion treated, site of lesion treated, patient identification number (biopsy accession number & letter), facility name and address and the electronic signature of the board certified dermatologist who performed the procedure. The manager will then print off one patient's finalized chart note, Mohs map card, and take a copy of the patient's slides. This will then be placed behind the Mohs date of service for District Manager auditing purposes. If there are any discrepancies in any of the above named patient information, there will be

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on February 27, 2023. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. 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 a random patient audit of seven patients who had Mohs surgery between the dates of September 14, 2021 and January 3, 2023, a review of the laboratory procedure for the labeling of Mohs slides, and an interview with the Director of Patient Access, the laboratory failed to ensure that positive identification of the patient specimens was maintained from the time of receipt of the specimen through the completion of testing and reporting of results. Findings include: 1. A random audit revealed that the slides for three of seven patients who had Mohs surgery between the dates of September 14, 2021 and January 3, 2023 were not labeled in accordance with the director approved procedure. 2. The slide for Mohs case number GD213016941G, performed on November 9, 2021 did not include the case number on the slide label. 3. The slides for a patient, identified by case number Z22-0283A, that had Mohs surgery on July 5, 2022 did not include the patient date of birth on the slide labels. 4. The slides for a patient, identified by case number Z22-0412A, that had Mohs surgery on October 25, 2022 were not consistently labeled. The month for the patient date of 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 -- birth was not legible on the slide labeled as "I 1,2 A," corresponding to Stage I, 1 and 2-slide A. The case number was not present, and the year for the patient date of birth did not match the patient date of birth on the slide labeled as "II," corresponding to Stage II. 5. The director approved procedure for labeling the slides included an example indicating that the slide label must include the patient Date of Service, Date of Birth, Name, Site of Surgery, Patient ID or Case Number, and the stage of the Mohs surgery. 6. The findings were confirmed during an interview with the Director of Patient Access on February 27, 2023 at approximately 11:00 AM. The laboratory performs approximately 1000 histopathology tests annually. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment 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 a review of the daily Mohs quality assessment review records, a review of the director approved policy entitled, "Post Analytical Mohs Audit," and an interview with the Director of Patient Access, the director failed to ensure that the established quality assessment program detected and corrected errors when they occurred. Findings include: 1. A review of the daily Mohs quality assessment review records revealed that the case number was not included on the patient slides audited on 10 of 39 days of Mohs surgery between the dates of June 22, 2021 and January 31, 2023. 2. The director approved policy entitled, "Post Analytical Mohs Audit" stated, "The office manager will be responsible for verifying the MOHS (sic) map card, MOHS (sic) LOG, patient electronic record, MOHS (sic) technician log and slides. This is to ensure that the information that is input on all of these records is correct and true." 3. The findings were confirmed during an interview with the Director of Patient Access conducted on February 27, 2023 at approximately 11:45 AM. The laboratory performs approximately 1000 histopathology tests annually. -- 2 of 2 --

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on June 14, 2021. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. 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 a random patient audit between the dates of November 29, 2019 and March 30, 2021, a review of the director approved policy and procedure entitled "Post Analytical Mohs Audit" and the policy and procedure entitled "Policy & Procedure Quality Assurance," subtitled, "Quality Assurance Procedures During Mohs," and an interview with the Laboratory Regional Manager, the laboratory failed to ensure that positive patient specimen identification was maintained throughout the testing process for four of ten patients reviewed. Findings include: 1. A random patient audit between the dates of November 29, 2019 and March 30, 2021 revealed that for the March 18, 2019 Mohs case number DAC18-12590A records reviewed, the surgical site for the Mohs surgery performed was not included on the label of one of one patient slides. The site was identified on the Mohs surgery log, Mohs Map, and the patient report as the left anterior medial lower leg. The director approved policy entitled Policy & Procedure Quality Assurance," subtitled, "Quality Assurance Procedures During Mohs," stated, "The patient's name is written on the slide, as well as the patient's 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 4 -- of birth, surgery site, surgery date, site of surgery, and biopsy specimen number." The Laboratory Regional Manager confirmed the finding during an interview conducted on June 14, 2021 at approximately 10:45 AM. 2. A random patient audit between the dates of November 29, 2019 and March 30, 2021 revealed that on September 17, 2019 for Mohs case number DAC19-19043A records reviewed, the surgical site for the Mohs surgery identified on the Mohs log did not match the site identified on the patient report and on the label of one of one patient slides. The Mohs surgical site was identified on the Mohs log as the right parietal scalp. The Mohs map, the slide label, and the patient report identified the surgical site as the left posterior ear. The director approved policy entitled, ""Post Analytical Mohs Audit" stated, "The Office Manager will be responsible for verifying the Mohs map card, Mohs Log, patient electronic record, Mohs technician log and slides. This is to ensure that the information that is input on all these records is correct and true." The Laboratory Regional Manager confirmed the finding during an interview conducted on June 14, 2021 at approximately 10:45 AM. 3. A random patient audit between the dates of November 29, 2019 and March 30, 2021 revealed that for the November 19, 2019 Mohs case number DAC19-27153B records reviewed, the number of slides listed on the Mohs log did not match the number of slides made and read by the dermatologist. The Mohs log indicated that there were two slides associated with the Mohs case. The Mohs operative note, and the Mohs map revealed that the patient's Mohs procedure consisted of three stages, and that three slides were made and read by the dermatologist. Three slides associated with the Mohs case were observed and reviewed during the patient audit. The director approved policy entitled, "Post Analytical Mohs Audit" stated, "The Office Manager will be responsible for verifying the Mohs map card, Mohs Log, patient electronic record, Mohs technician log and slides. This is to ensure that the information that is input on all these records is correct and true." The Laboratory Regional Manager confirmed the finding during an interview conducted on June 14, 2021 at approximately 10:45 AM. 4. A random patient audit between the dates of November 29, 2019 and March 30, 2021 revealed that for the February 4, 2020 Mohs case number DAC19-31174A records reviewed, the Mohs case number on one of one patient slides did not match the case number identified on the Mohs log, the Mohs map, and the Mohs operative note. The case number written on the slide was identified as DAC19-3117A. The case number entered into the Mohs log, written on the Mohs map, and entered into the patient chart operative note was identified as DAC19-31174A. The director approved policy entitled, ""Post Analytical Mohs Audit" stated, "The Office Manager will be responsible for verifying the Mohs map card, Mohs Log, patient electronic record, Mohs technician log and slides. This is to ensure that the information that is input on all these records is correct and true." The Laboratory Regional Manager confirmed the finding during an interview conducted on June 14, 2021 at approximately 10:45 AM. The laboratory performs approximately 360 histopathology tests annually. 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 a review of laboratory records of documentation of twice per year verification of accuracy, a review of the director approved policy entitled, "Proficiency Testing," and an interview with the Laboratory Regional Manager, the -- 2 of 4 -- laboratory failed to ensure that the twice per year verification of accuracy was performed for one of two dermatologists performing Mohs testing for the years of 2019 and 2020. Findings include: 1. There was no documentation of the twice per year verification of accuracy during 2019, and 2020 for one of two dermatologists performing Mohs procedures in the laboratory. 2. The director approved policy entitled "Proficiency Testing" stated, "Twice a year, an assigned medical assistant is to go through the patient surgery lists and randomly choose one patient to have the Mohs surgery slide(s) sent out to be reviewed by another Board Certified Dermatologist in our company to check the performing Doctor's accuracy." 3. The Laboratory Regional Manager confirmed the finding during an interview conducted on June 14, 2021 at approximately 10:45 AM. The laboratory performs approximately 360 histopathology tests annually. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment 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 a review of the laboratory quality assessment records, a review of the director approved policy entitled "Post Analytical Mohs audit," and an interview with the Laboratory Regional Manager, the director failed to ensure that the established quality assessment program was maintained to identify failures in quality when they occur. Findings include: 1. The laboratory failed to document