Skin And Cancer Associates Llp

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at SKIN AND CANCER ASSOCIATES LLP on September 10, 2025 to September 15, 2025. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Condition was cited: D6168 493.1487 Condition: Testing Personnel D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observation and staff interview, the laboratory failed to store 100% Reagent Alcohol, 10% Formalin Fixative and Xylenes according to Mercedes Scientific product label, and Ammonium Hydroxide 28% according to the EKI CHEM product label since 01/02/2025. The findings included: 1-During a tour of the laboratory on 09 /10/2025 at 10:45 AM, observed 500ML bottle with about 80% fill of Ammonium Hydroxide 28%, 1/4 gallon 100% Reagent Alcohol, 3/4 gallon 10% Formalin Fixative, and one 2/3 gallon Xylenes under the stainer bench cabinet. 2-Review of product labels for four out of six reagents stored under the stainer bench revealed the following: a) Ammonium Hydroxide 28% #1625-500ML stated "STORAGE /DISPOSAL: Store locked up." b) 100% Reagent Alcohol # MER 1200 - 1 Gallon stated "STORAGE: Store locked up." c) 10% Formalin Fixative # MER 44991GL - 1 Gallon stated "STORAGE: Store locked up." d) Xylenes # MER 1250 - 1 Gallon stated "STORAGE: Store locked up." 3-During interview on 09/10/2025 at approximately 10:55 AM, the TP3 admitted the reagents were not locked up after open, since started working in the laboratory full time. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE 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 -- 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 staff interview, the laboratory failed to verify the accuracy of Histopathology testing at least twice annually for 1 (2024) out of 2 years (2024-2025) reviewed. Findings included: 1. Personnel records reviewed revealed that in the Histopathology section there were three testing personnel TP1 (laboratory director), TP2 (Mohs doctor), and TP3 (histology technician) as per CMS 209 Form. 2. Review of Subpart I, 42 CFR Part 493.901 through 493.959 revealed that there was no approved proficiency testing programs for the interpretation of stained tissues. 3. Review of the laboratory procedure stated in Section 8 Proficiency Testing (PT) "Semi-annually, two cases will be randomly selected by the histotechnologist and will be submitted to a Board-Certified Dermatopathologist/Dermatologist for review." 4. Review of the Quality Assurance (QA) peer review found that peer review for Histopathology was done for TP1 and TP2 on 12/09/2024. 5. During an interview on 09/10/2025 at 1:18 PM, TP3 confirmed there was one QA peer review documented for the year 2024. The Laboratory did not provide documentation for a second PT event in 2024. D6121 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(i) The procedures for evaluation of the competency of the staff must include, but are not limited to-- (b)(8)(i) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing; This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to have the Technical Supervisor (TS) or a designee document direct observation of patient testing during competency evaluation for the one testing personnel (TP2) for year 2024. Findings included: 1-Review of FORM CMS 209 signed by the Laboratory Director on 08/14 /2025, revealed the following: Laboratory Director (LD) was also Clinical Consultant (CC), TS/General Supervisor (GS) and TP1 for Histopathology subspecialty. The laboratory also had TP2 and TP3. 2-Review of personnel records revealed that annual competency for TP2 (Mohs Surgeon) for the Histopathology subspecialty, with patient testing observed by the LD/GS was last performed on 11/12/2023. 3- During an interview on 09/10/2025 at 12:32 PM, TP3 admitted that the competency assessment for the Histopathology subspecialty have not been performed for 2024. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) (b)(9) Evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: -- 2 of 4 -- Based on record review and staff interview, the Technical Supervisor (TS) or a designee failed perform initial and six-month competency evaluations for one out of three testing personnel (TP) in the Histology laboratory during the first year (2025). Findings included: 1-Review of FORM CMS 209 signed by the Laboratory Director on 08/14/2025, revealed the following: Laboratory Director (LD) was also Clinical Consultant (CC), TS/General Supervisor (GS) and TP1 for Histology laboratory. The laboratory also had TP2 and TP3. 2-Review of personnel records revealed that there was no initial and no six month competency evaluation for TP3 (Histology Technician) for patient testing observed by the TS. 3- Email from Office Manager on 09/15/20205 at 2:51 PM confirmed that TP3 was trained on the job and started full- time on 01/02/2025. See tag 6171. 4- During an interview on 09/10/2025 at 12:32 PM, TP3 admitted that the competency assessment for the Histopathology subspecialty had not been performed for 2025. 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 record review and staff interview, the Laboratory failed to verify the education of 1 of 3 Testing Personnel (TP) performing the Histopathology testing. See D6171 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 (b)(2)(i) Have earned a doctoral, master's, or bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or (b)(2)(ii) Be qualified under the requirements of 493.1443(b)(3) or 493.1449(c)(4) or (5); or (b)(3)(i) Have earned an associate degree in a laboratory science or medical laboratory technology from an accredited institution or (b)(3)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes (b)(3)(ii) (A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, includes either (b)(3)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(3)(ii)(A)(2) 24 semester hours of science courses that include (b)(3)(ii)(A)(2)(i) 6 semester hours of chemistry; (b)(3)(ii)(A)(2)(ii) 6 semester hours of biology; and (b)(3)(ii)(A)(2)(iii) 12 semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(3)(ii)(B) Have laboratory training that includes: (b)(3)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES or the CAAHEP (this training may be included in the 60 semester hours listed in paragraph (b)(3)(ii)(A) of this section); or (b)(3)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing; or (b)(4) Successful completion of an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and having held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or -- 3 of 4 -- (b)(5) Notwithstanding any other provision of this section, an individual is considered qualified as a high complexity testing personnel under this section if they were qualified and serving as a high complexity testing personnel in a CLIA-certified laboratory as of December 28, 2024, and have done so continuously since December 28, 2024. (b)(6) For blood gas analysis (b)(6)(i) Be qualified under paragraph (b)(1), (2), (3), (4), or (5) of this section; or (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. (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (f) to perform tissue examinations. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to verify the education of one out of three testing personnel (TP) since 01/02/2025 until 09/15 /2025. Findings included: 1-Review of FORM CMS-209 Laboratory Personnel Report dated and signed by the Laboratory Director on 08/14/2025 listed three TP (TP1, TP2, TP3). 2-Review of employee files revealed that TP3 had a High school diploma from Puerto Rico is Spanish, with no certificate of translation equivalency. Additionally, TP3 had a histology Mohs technician training certificate of completion dated 06/20 /2016. 3- Email from Office Manager on 09/15/20205 at 2:51 PM stated that TP3 did not have a state of Florida (technician) license but was trained on the job and started full time on 01/02/2025. 4-During an interview on 09/10/2025 at 1:11 PM with TP3 stated was not aware of the minimum education requirement for high complexity testing. -- 4 of 4 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted on March 5, 2024. Skin and Cancer Associates LLP Clinical laboratory was not in compliance with 42 CFR 493, requirements for laboratories. 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 electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to document the correct temperature for the cryostat for 25 out 25 months reviewed. Findings included: - Review of "CRYOSTAT TEMPERATURE LOG" records revealed that they stated the following "Normal Ranges are -18 to -28 Degrees C." - Review of "CRYOSTAT TEMPERATURE LOG" for 25 consecutive months from February of 2022 until February of 2024 revealed that all the recorded temperatures were missing the minus (- ) sign for the recorded temperature that were registered in the range of 21 to 25 Celsius Degrees. During an interview on 03/05/2024 at 12:19 PM with Testing Person #A, she confirmed that the "CRYOSTAT TEMPERATURE LOG" records missed the minus sign for temperature recordings. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) 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 -- 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, Quality Control policy review and interview, the laboratory failed to dispose expired reagents since December 2023. Findings included: -Review of content in the reagent storage cabinet during the laboratory tour on 03/05/2024 at 9: 55 AM, revealed that the laboratory had four one-gallon sealed containers of 10% formalin with lot # 2132640 and expiration date 11/30/2023 stored with other lots in use which were within expiration date. -Review of "Quality Control" Policy, revealed that it stated on Section "Reagents" the following: " Reagents that have expired or are no longer suitable for use must be properly disposed." During an interview on 03/05 /2024 at 9:41 AM, Testing Person #A admitted that expired reagents needed to be disposed but have not called to place the order. -- 2 of 2 --

Summary Statement of Deficiencies 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 personnel record review and interview with the laboratory director, the laboratory failed to perform annual competency reviews of testing personnel for 2016 and 2017. Findings include: Review of personnel records for 2016 and 2017 revealed that there was no documentation of competency evaluations for 2 of 3 testing personnel. During an interview on 03/28/18 at 12:00 p.m., the laboratory director confirmed that no annual competency evaluations done for 2 of 3 testing personnel in 2016 and 2017. 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 electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on record review and interview with the histology technician, the laboratory 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 -- failed to document the room temperature and humidity in the room where the cryostat is during 2016, 2017 and 2018 and in histopathology room for 2016 and 2017. Findings include: 1-Review of the cryostat installation requirements revealed that there is a requirement for the maximum temperature of 22 C and humidity no greater than 60%. Review of temperature logs revealed that there were no records of room temperature or humidity in 2016, 2017, and 2018. 2-Review of the quality control records of histopathology room revealed that there were no records of temperatures nor humidity for years 2016 and 2017 3-During an interview on 03/28/18 at 11:00 a. m., the histology technician confirmed that there were no records of room temperature or humidity during 2016, 2017, and 2018 for the cryostat room and for histopathology room there were not records of temperature or humidity for years 2016 and 2017. -- 2 of 2 --