Dermatology & Skin Surgery Center

Summary Statement of Deficiencies D5006 MYCOLOGY CFR(s): 493.1203 If the laboratory provides services in the subspecialty of Mycology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1263, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: . Based on observation, record review and interviews, the laboratory failed to establish competency assessment policies to assess testing personnel (refer to D5209), failed to have a request for testing (refer to D5301), failed to have the laboratory director approve, sign, and date its Potassium Hydroxide (KOH) testing procedure prior to use (refer to D5407), failed to ensure its Potassium Hydroxide (KOH) solution had not exceeded expiration dates (refer to D5417), and failed to have a test reports (refer to D5801). D5008 PARASITOLOGY CFR(s): 493.1204 If the laboratory provides services in the subspecialty of Parasitology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1264, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: . Based on observation, record review and interviews, the laboratory failed to establish competency assessment policies to assess testing personnel (refer to D5209), failed to have a request for testing (refer to D5301), failed to have the laboratory director 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 -- approve, sign, and date its Scabies preparation testing procedure prior to use (refer to D5407), failed to ensure its Potassium Hydroxide (KOH) solution had not exceeded expiration dates (refer to D5417), and failed to have test reports (refer to D5801). D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: . Based on record review and interview with the office manager, the laboratory failed to establish competency assessment policies to assess testing personnel for one (2024) of two years reviewed. Findings include: 1. A review of the testing personnel competency assessments revealed blank forms with the names of testing personnel #1 and #2 on them and the dates of 12/12/24 and 12/5/24, respectively. Both personnel perform Potassium Hydroxide (KOH) and Scabies preparations. No competency assessments were performed for testing personnel #1 and #2 since 1/14/23. 2. A review of the laboratory's policies and procedures revealed a lack of competency assessment policy established. 3. An interview on 12/18/24 at 2:50 pm with the office manager confirmed a competency assessment policy had not been established. D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: . Based on record review and interview with office personnel #1, the laboratory failed to have a request for testing for two (patients #2 and #5) of six patient test records reviewed. Findings include: 1. A review of the laboratory's testing logs revealed patient #2 received Potassium Hydroxide (KOH) testing on 8/1/23 and patient #5 received Scabies testing on 6/5/23. 2. A review of patient test requests revealed a lack of documentation for patients #2 and #5. 3. An interview on 12/18/24 at 1:50 pm with office personnel #1 confirmed the lack of test requests for patients #2 and #5. ***This is a repeated deficiency from the 7/24/19 recertification survey.*** D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: . Based on record review and interview with the office manager, the laboratory failed to have the laboratory director approve, sign, and date its Potassium Hydroxide (KOH) and Scabies preparation testing procedures prior to use for two (December 2022 to December 2024) of two years reviewed. Findings include: 1. A review of the -- 2 of 5 -- laboratory's procedure manuals revealed a lack of policies and procedures for KOH and Scabies preparation testing. 2. The surveyor requested the policies and procedures on 12/18/24 at 2:44 pm and was provided with a blue folder containing unapproved copies of KOH, Scabies, Tzank, and histopathology procedures. 3. An interview on 12 /18/24 at 2:44 pm with the office manager confirmed the procedures provided were not approved, signed, or dated by the laboratory director and the laboratory had not performed Tzanck smears or histopathology testing. ***This is a repeated deficiency from the 3/15/23 recertification survey.*** 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 and interview with the office manager, the laboratory failed to ensure its Potassium Hydroxide (KOH) solution had not exceeded expiration dates for 14 patients tested since the bottle had expired. Findings include: 1. The surveyor observed a bottle of Potassium Hydroxide (KOH) near the microscope with the expiration date of 9/21/23 and an open date of 11/1/21 written on the bottle on 12/18 /24 at 2:38 pm. 2. An interview on 12/18/24 at 2:44 pm with the office manager confirmed the KOH bottle had exceeded its expiration date. 3. A review of the laboratory's patient testing logs revealed 14 patients received testing since the KOH bottle expired. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: . Based on record review and interview with office personnel #1, the laboratory failed to have a test report for two (patients #2 and #5) of six patient test records reviewed. Findings include: 1. A review of the laboratory's testing logs revealed patient #2 received Potassium Hydroxide (KOH) testing on 8/1/23 and patient #5 received Scabies testing on 6/5/23. 2. A review of patient test reports revealed a lack of documentation for patients #2 and #5. 3. An interview on 12/18/24 at 1:50 pm with office personnel #1 confirmed the lack of test reports for patients #2 and #5. ***This is a repeated deficiency from the 7/24/19 recertification survey.*** D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 -- 3 of 5 -- The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: . Based on observation, record review, and interviews, the laboratory director failed to ensure its Potassium Hydroxide (KOH) solution had not exceeded expiration dates (refer to D6004), failed to establish competency assessment policies to assess testing personnel competency (refer to D6014), failed to ensure quality assessment programs were maintained to monitor its Potassium Hydroxide (KOH) and Scabies preparation testing (refer to D6021), and failed to approve, sign, and date its Potassium Hydroxide (KOH) and Scabies preparation testing procedures prior to use (refer to D6031). D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: . Based on observation and interview with the office manager, the laboratory director failed to ensure its Potassium Hydroxide (KOH) solution had not exceeded expiration dates. Refer to D5417. D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(iii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(3) Ensure that-- (e)(3)(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: . Based on record review and interview with the office manager, the laboratory director failed to establish competency assessment policies to assess testing personnel competency. Refer to D5209. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) -- 4 of 5 -- The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: . Based on record review and interview with the office manager, the laboratory director failed to ensure quality assessment programs were maintained to monitor its Potassium Hydroxide (KOH) and Scabies preparation testing for two (December 2022 to December 2024) of two years reviewed. Findings include: 1. A review of the laboratory's "Quality Assurance" policy revealed a section stating, "Every six months log books are to be checked for accuracy. Ten or so charts will be chosen at random from the KOH, DTM, Tzank, scabies, and Mohs carts. These charts are to be checked by making sure all information in the log is in the chart. All results are to be logged on Quality Assessment chart review sheets located in the QA binder located in the lab. Every year manuals for equipment and procedure protocols will be reviewed. All manuals, logs, and tests will be reviewed, signed, and dated by (laboratory director) as designated in every protocol." 2. A review of the laboratory's quality assessment documentation revealed the most recent completed form was for the review period of July 2022 to December 2022. 3. An interview on 12/18/24 at 2:44 pm with the office manager confirmed quality assessment documentation was not present. D6031 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(13) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(13) 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 the office manager, the laboratory director failed to approve, sign, and date its Potassium Hydroxide (KOH) and Scabies preparation testing procedures prior to use. Refer to D5407. -- 5 of 5 --

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: . Based on record review and interview with the Office Manager, the laboratory failed to verify the accuracy of its histopathology testing at least twice annually for 2 (2021 and 2022) of 2 years reviewed. Findings include: 1. A review of the laboratory's verification of accuracy records revealed histopathology cases had been sent to an outside laboratory for verification on 6/18/21 and 12/20/22. There was a lack of documentation of second verification of accuracy events for 2021 and 2022. 2. A review of the laboratory's "Protocol for Peer Review" policy revealed a section stating, "There are to be four cases sent for the year. Two cases are to be sent from the first 6 months of the year, and two cases from the second six months of the year." 3. An interview on 3/15/23 at 11:25 am with the Office Manager confirmed the laboratory had not performed verification of accuracy for histopathology testing at least twice annually in 2021 and 2022. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: . Based on record review and interview with the Office Manager, the laboratory failed to have the procedures for Mohs Micrographic Surgery testing, Potassium Hydroxide 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 -- (KOH), and Scabies testing approved, signed, and dated by the Laboratory Director before use for 19 (August 2021 to March 2023) of 19 months reviewed. Findings include: 1. A review of the laboratory's policies and procedures revealed the Mohs Micrographic Surgery Testing procedures had been signed and approved by Testing Personnel #2, not the Laboratory Director. 2. A review of the laboratory's policies and procedures revealed a lack of established procedure for the performance of KOH and Scabies testing. 3. The surveyor requested the KOH and Scabies preparation procedures on 3/15/23 at 11:00 am. The Office Manager provided a copy of a procedure that had been in use by Testing Personnel #3 and #4 but was not part of the procedure manual. The procedures provided had not indicated the Laboratory Director had approved the test procedures. 4. An interview on 3/15/23 at 11:05 am with the Office Manager confirmed the Laboratory Director had not approved, signed, and dated the Mohs Micrographic Surgery testing, KOH preparation testing, or Scabies preparation testing procedures. 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 record review and interview with the Office Manager, the Laboratory Director failed to ensure the laboratory's quality assessment program was maintained according to its established policy for 21 (last performed on 6/28/21) of 21 months reviewed. Findings include: 1. A review of the laboratory's "Quality Assurance" policy revealed a section stating, "Every six months log books are to be checked for accuracy. Ten or so charts will be chosen at random from the KOH, DTM, Tzank, scabies, and Mohs charts. These charts are to be checked by making sure all information in the log is the in the chart. All results are to be logged on Quality Assessment chart review sheets located in the QA binder located in the lab." 2. A review of the laboratory's "Quality Assessment Chart Reviews" revealed the most recent review was performed on 6/28/21 and only covered patients receiving Potassium Hydroxide (KOH) and Scabies preparation testing. 3. An interview on 3/15 /23 at 11:25 am with the Office Manager confirmed the laboratory did not have documentation of quality assessments performed since 6/28/21. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The Dermatology & Skin Surgery Center, PLC laboratory was found to be in substantial compliance with CLIA regulations (42 CFR Part 93, effective April 24, 2003). No deficiencies were cited. D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: . Based on record review, lack of documentation, and interview with the Office Administrator, the laboratory failed to report SARS-CoV-2 test results every day of patient testing for 32 of 34 tests performed by the laboratory. Findings include: 1. A tour of the facility on 8/31/21 at 9:01 am revealed the laboratory is performing SARS- CoV-2 testing using the BD Veritor Plus test system. 2. An interview with the Office Administrator on 8/31/21 at 9:32 am revealed the laboratory does not send results of its antigen testing to the health department. 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 D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: . Based on patient chart review and interview with Testing Personnel #4 (TP4), the laboratory failed to have a electronic request for patient testing from an authorized person for the potassium hydroxide (KOH) testing for 1 (patients #2) of 29 patient charts audited. Findings include: 1. A patient chart review conducted on 29 patient charts revealed for 1 (#2) the laboratory did not have an electronic request for the KOH testing performed on 12/21/2017. 2. An interview on July 24, 2019 at approximately 11:45 am with TP4 confirmed no electronic request for patient testing from a authorized person was present in the patient's electronic medical record. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: . Based on record review and interview with Testing Personnel #4 (TP4), the laboratory failed to maintain a record system that included the identity of the testing 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 -- personnel performing the Mohs Micrographic surgery for 1 (#17) of 29 patient charts audited. Findings include: 1. Record review for 29 patient charts audited revealed the laboratory did not have a record system in place that included the identity of the testing personnel who performed the Mohs surgery on the final patient Mohs Map. 2. During the interview on July 24, 2019 at approximately 11:45 am, TP4 confirmed the identity of the testing personnel was not available on the patient's final Mohs Map report. ***Repeat Deficiency from 2/6/2017 survey*** D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: . Based on record review and interview with Testing Personnel #4 (TP4), the laboratory failed to ensure test results are accurately and reliably sent from the point of data entry to the final report destination for 1 (#2) of 29 patient charts audited. Findings include: 1. A record review exposed a lack of documentation for 1 (#2) of 29 patient charts audited to verify manual entry of results were being accurately and reliably conveyed to the final report destination. 2. An interview on July 24, 2019 at approximately 11:45 am with TP4 confirmed the laboratories routine checks to verify manual entry of results to the final report destination were not dependable. -- 2 of 2 --