Aqua Dermatology Of Florida Pa

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Aqua Dermatology of Florida PA on November 4, 2025 to December 5, 2025. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Condition was cited: D6108 493.1441 Condition: Technical Supervisor Responsibilities D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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 observation, record review and interview, the laboratory failed to monitor and document temperature and humidity of the room where the immunohistochemical (IHC) slides were stained, failed to record the humidity of the main laboratory, failed to use a certified thermometer to record the refrigerator and freezer temperature, and failed to have a procedure defining criteria for temperature and humidity of the room and temperature refrigerator and freezer from 02/29/2024 to 11/04/2025. Findings: A 1. During a tour of the laboratory on 11/04/2025 at 10:40 PM, the following equipment was seen in the IHC room: two Roche Benchmark Ultra Plus stainers, a Leica ST5020 Multistainer, and a Leica CV5030 Robotic Cover Slipper. 2. Review of the operation manual for the Roche Benchmark Ultra Plus stainers listed 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 5 -- environmental requirements for the room temperature as 68 degree - 90 degrees Fahrenheit (F), 20 to 32 degrees Celsius ( C ) and humidity range of 10% to 90%. 3. Review of the operations manual for the Leica ST5020 listed the operating temperature for the room temperature as 15 to 40 degrees C and relative humidity range of 10% to 80%. 4. Review of the operations manual for the Leica CV5030 Robotic Cover Slipper listed the operational temperature for the cover slipper as 15 to 35 degrees C and relative humidity range of 20% to 80%. 5. Review of the temperature logs revealed there were no temperature logs for the IHC room. 6. During an interview on 11/04/2025 at 12:55 PM, the Laboratory Supervisor stated they were not taking the temperature or humidity of the IHC room. B 1. During a tour of the laboratory on 11/04/2025 at 10:40 PM, the following equipment was seen in the main laboratory: Leica EG1160 Paraffin Embedding Center, Leica RM2125 Rotary Microtome, Boekel Tissue Flotation Bath, Sakura Tissue-Tek SCA Cover Slipper, Leica Peloris II Rapid Tissue Processor, and Leica IP C Automated printing system for tissue cassettes. 2. Review of the operations manual for the Leica EG1160 Paraffin Embedding Center listed the operational temperature as 18 to 35 degrees C. 3. Review of the operations manual for the Leica RM2125 Rotary Microtome listed the operational temperature as 10 to 40 degrees C. 4. Review of the operations manual for the Boekel Tissue Flotation Bath listed the operational temperature as 20 to 30 degrees C and maximum relative humidity range of 80%. 5. Review of the operations manual for the Sakura Tissue-Tek SCA Cover Slipper listed the operational temperature as 10 to 30 degrees C and a relative humidity of 30% to 70%. 6. Review of the operations manual for the Leica Peloris II Rapid Tissue Processor listed the operational temperature as 5 to 35 degrees C and relative humidity as 10% to 80%. 7. Review of the operations manual for the Leica IP C Automated printing system for tissue cassettes listed the operational temperature as 15 to 30 degrees C and relative humidity at 20% to 80%. 8. Review of the Daily Temperature Chart for the main laboratory showed the humidity for the room was not recorded. 9. During an interview on 11/04/2025 at 1:00 PM, the Laboratory Supervisor stated they had not recorded the humidity of the main laboratory. C 1. An observation of the thermometer on 11/04 /2025 at 1:35 PM, revealed the thermometer used to record the refrigerator and freezer temperature did not have a sticker stating the thermometer was certified. 2. Review of the quality control logs showed there was no documentation showing the thermometer was calibrated. 3. During an interview on 11/04/2025 at 1:40 PM, the Laboratory Supervisor stated he did not know if the thermometer was certified and acknowledged it did not have a sticker on it. D 1. Review of the procedure manual showed there was no procedure defining criteria for the temperature and humidity of the rooms, and temperatures of the refrigerator and freezer. 2. During an interview on 11/04/2025 at 4: 20 PM, the Laboratory Supervisor acknowledged he could not find a procedure defining criteria for the temperature and humidity of the rooms, and temperatures of the refrigerator and freezer. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: -- 2 of 5 -- Based on observation, review of procedure manual, and interview, the laboratory failed to properly label the quality control (QC) slides used for Immunohistochemical (IHC) stains from Sysmex from 02/09/2024 to 11/04/2025. Findings included: 1. Review of the test menu for the laboratory showed the laboratory performed the following IHC stains: Actin (Muscle Specific IHC stain), Adipophillin (sebaceous neoplasms IHC stain), Androgen Receptor (tumor cell marker IHC stain), BCL-2 (B- cell lymphoma 2 IHC stain), BCL-6 (lymphoma IHC stain), Ber-EP4 (Epithelial Antigen IHC stain), CD1A (Cluster of Differentiation 1A gastrointestinal epithelium and cytoplasmic hepatocytes IHC stain), CD3 (Cluster of Differentiation 3 T cell Lymphocytic IHC stain), CD4 (Cluster of Differentiation 4 T cell Lymphocytic IHC stain), CD5 (Cluster of Differentiation 5 T cell Lymphocytic IHC stain), CD7 (Cluster of Differentiation 7 T cell Lymphocytic IHC stain), CD8 (Cluster of Differentiation 8 T cell Lymphocytic IHC stain), CD10 (Cluster of Differentiation 10 dendritic cell Cell Surface Enzyme IHC stain), CD20 (Cluster of Differentiation 20 B cell Lymphocytic IHC stain), CD30 (Cluster of Differentiation 30 Transmembrane Cytokine Receptor), CD31 (Cluster of Differentiation 31 platelet endothelial cell adhesion molecule-1 IHC stain), CD34 (Cluster of Differentiation 34 progenitor cells IHC stain), CD45 (Cluster of Differentiation 45 leukocyte IHC stain), CD56 (Cluster of Differentiation 56 neuroedrocrine marker, NK cells IHC stain), CD63 (Cluster of Differentiation 56 melanoma IHC stain), CD68 (Cluster of Differentiation 68 Monocytes and Tissue Macrophages IHC stain), CD117 (Cluster of Differentiation 117, stem cell IHC stain), Chromogranin (Neuroendocrine cell IHC Marker), CK 5/6 (Cytokeratin 5/6 IHC stain), CK7 (Cytokeratin 7 Protein IHC stain), CK-CAM 5.2 (epithelial tumor IHC stain), CK-PAN (Epithelial IHC stain), CK20 (Cytokeratin 20 IHC stain), Desmin (Smooth Muscle Tumor IHC stain), EMA (Epithelial Membrane Antigen IHC stain), ERG (Endothelium; TMPRSS2-ERG IHC stain), Factor XIIIa (Factor XIIIa protein IHC stain), HHV-8 (Herpes Virus Type 8 IHC stain), HMB45 (Anti-Human Melanosome IHC stain), HMW - (high molecular weight IHC stain), HPV (Human Papilloma Virus IHC stain), HSV 1 & 2(Herpes Simplex Virus Type 1 &2 IHC stain), Ki-67 (Nuclear Non-histone Protein IHC stain), Melan-A (Melanocytic Marker IHC stain), MiTF (Microphthalamia Transcription Factor IHC stain), MLH-1 (Mutl Homolog 1 Colorectal Cancer IHC stain), MOC-31 (Epithelial IHC Stain), MPO (Myeloperoxidase IHC stain) MSH2 (Melanocyte Stimulation Hormone 2 Tumor Suppressor Gene IHC stain), MSH6 (Melanocyte Stimulation Hormone 6 Colorectal Cancer and Endometrial Cancer IHC stain), NSE (Neuron Specific Enolase IHC Stain), Neurofilament (neoplastic cells IHC stain), P53 (tumor suppressor protein), P63 (Myoepithelial and Basal cells IHC stain), PMS-2 (Postmeiotic Segregation Increase 2 IHC stain), Podoplanin (lymphatic channel endothelium IHC stain), PRAME (Melanoma IHC stain), S100 (Neural Tissue/Lesion and Melanoma IHC stain), SOX-10 (Melanoma IHC stain), Synaptophysin Neuroendocrine cell IHC Marker), Treponema Pallidum (Syphilis IHC stain), TTlF-1 (Epithelial cells IHC stain), Tyrosinase (Melanocyte IHC stain), Vimentin (Mesenchymal Cells IHC stain), and VZV (Varicella Zoster Virus IHC stain). 2. Observation on 11/04/2025 at 2:50 PM, revealed the IHC QC slides were not labeled. 3. During an interview on 11/04 /2025 at 2:55 PM, the Laboratory Supervisor stated they labeled the boxes that each IHC control slides were in and did not label each individual slide. D5609 HISTOPATHOLOGY CFR(s): 493.1273(e)(f) (e) The laboratory must use acceptable terminology of a recognized system of disease nomenclature in reporting results. (f) The laboratory must document all control procedures performed, as specified in this section. -- 3 of 5 -- This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to document quality control information including the lot numbers, expiration dates, and open dates for all reagents used for the Hematoxylin and Eosin (H&E) stain from 02/09/2024 to 11/04 /2025. Findings included: 1. Review of the policy titled Reagent Log Procedure noted, "A reagent log is kept in order to monitor the incoming, usage, outgoing and expiration dates of all reagents used in the histology laboratory." 2. Review of the laboratory's quality control records revealed there was no documentation of the reagents used in the H&E stain. 4. During an interview on 11/04/2025 at 3:25 PM, the Laboratory Supervisor acknowledge they did not have a reagent log for reagents used for the H&E stain. D6108 LABORATORY TECHNICAL SUPERVISOR CFR(s): 493.1447 The laboratory must have a technical supervisor who meets the qualification requirements of 493.1449 of this subpart and provides technical supervision in accordance with 493.1451 of this subpart. This CONDITION is not met as evidenced by: Based on record review and interview, the Technical Supervisor (Laboratory Director) failed to perform the semi-annual (sixth month) competency evaluation on one (Testing Personnel J) of six (Testing Personnel H, J - N) Testing Personnel's semi- annual competency evaluation on the testing personnel who performed grossing for 2024 and 2025 (See D6127); and the Technical Supervisor (Laboratory Director) failed to perform five (Testing Personnel J - N) of six (Testing Personnel H, J - N) Testing Personnel's competencies on the Testing Personnel who performed grossing for 2024 and 2025. (See D6128) 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: Based on record review and interview, the Technical Supervisor (Laboratory Director) failed to perform the semi-annual (sixth month) competency evaluation on one (Testing Personnel J) of five (Testing Personnel H, J - M) Testing Personnel's semi- annual competency for those that performed grossing for 2024 and 2025. Findings Included: 1. Review of the competency evaluations revealed there were six Testing Personnel who performed grossing. 2. Review of Performance Evaluations revealed the evaluations were performed on 06/01/2024 and on 05/01/2024 for Testing Personnel J. 3. During an interview on 11/04/25 at 2:20 PM, the Laboratory Supervisor acknowledged the competency performed on 06/01/2024 was her initial competency and the sixth month competency evaluation was missing. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES -- 4 of 5 -- CFR(s): 493.1451(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individuals performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on record review and interview, the Technical Supervisor (Laboratory Director) failed to perform four (Testing Personnel H, J - M) of five (Testing Personnel H, J - M) Testing Personnel's competencies that performed grossing for 2024 and 2025. Findings Included: 1. Review of the competency evaluations revealed there were five Testing Personnel who performed grossing. 2. Review of the Performance Evaluations revealed the evaluations were performed on 06/01/2024 for Testing Personnel J, on 04 /01/2024 for Testing Personnel K - M, on 05/01/2025 for Testing Personnel J, and on 04/01/2025 for Testing Personnel K - M. 3. Review of the Performance Evaluation forms, signed and dated by the Laboratory Supervisor, indicated the forms were "Prepared by and Interviewed by" the Laboratory Supervisor. 4. Review of the Histology Equipment and Procedures for Tech Competency form showed the Laboratory Supervisor evaluated the performance, dated, and initialed the competency form for Testing Personnel J - M. 5. Review of the transcripts for the Laboratory Supervisor revealed he had only 19 science credits of which only four credits were in chemistry. Review of the regulation revealed the Laboratory Supervisor did not meet the qualification to be Technical Supervisor 6. During an interview on 11/13/25 at 8: 27 AM, the Laboratory Supervisor acknowledge he performed and filled out the competency evaluations. -- 5 of 5 --

Summary Statement of Deficiencies D0000 Recertification survey was conducted from 1/23/2024 to 2/8/2024. Naples Center for Dermatology & Cosmetic Surgery clinical laboratory was not in compliance with 42 CFR Part 493, requirements for clinical laboratories. The following Condition is not met: D6168 Testing Personnel D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the laboratory failed to have 7 tissue marking dyes and hemoxylin II in use that were not expired for Histology. Findings included: On 1/23/2024 at 3:50 PM, tissues inking station revealed the following for tissue marking dyes: 1. black dye expired 11/1/2022 2. orange dye expired 10/2/2021 3. blue dye expired 11/18/2022. 4. green dye expired 11/18/2022. 5. yellow dye expired 8/2020. 6. red dye expired 12/23/2021. 7. black dye expired 7/31 /2022 On 1/23/2024 at 3:59 PM, the Hematoxylin II cartridge rack in the refrigerator was noted with an expiration date of 1/17/2024. Review of Expired reagent Policy signed by laboratory director read, "in order to comply with Cap regulation ANP 21366, our laboratory will not and does not use expired reagents of any kind." Review of Dermatology Report revealed the following: a. patient #1 was tested on 12/13/2023 for Periodic Acid Shiff (PAS). b. patient #2 was tested on 10/13/2022 for Acid Fast 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 -- Bacillus (AFB), Gram stain, and PAS. c. patient #3 was tested on 1/18/2024 for PAS, AFB and Gram stain. On 1/23/24 at 4:41 PM, the Testing Personnel confirmed 7 tissue marking dyes and hemoxylin II were expired. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on record review, and interview, the Technical Supervisor failed to perform 2 out of 11 Testing Personnels' annual competencies for 2022 and 2023, (Testing Personnel E and F). Findings Included: Laboratory Personnel Report revealed the following: Employee E was Testing Personnel E. Employee F was Testing Personnel F. Review of 11 Competency Assessments revealed no documentation of annual competency assessments performed for 2 Testing Personnel, E and F in 2022 and 2023. Review of Quality Assurance read, " New testing personnel will receive initial competency before testing is performed, they will receive another competency assessment 6 months after, in order to get everyone on the same page on competency schedule an additional competency will be performed in June or December, whichever date falls first so all competency assessments will eventually be done in June or December." On 1/23/24 at 4:41 PM, Testing Personnel and Lab Office Manager confirmed annual competency assessments were not performed for Testing Personnel E and F in 2022 and 2023. 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 interview, the laboratory failed to have a qualified testing personnel performing high complexity grossing in Histopathology. (Refer to 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 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 -- 2 of 4 -- 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 the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: Based on record review, and interview, the laboratory failed to have a qualified testing personnel performing high complexity grossing in Histopathology. Findings included: Review of Laboratory Personnel Report revealed Employee J was Testing Personnel J. Review of Performance Review revealed Testing Personnel J had completed grossing performance review on 4/1/22 and 4/3/2023 with the Laboratory Director's signatures. Review of College Transcripts revealed Testing Personnel J had Associate in Arts degree with one chemistry course for 3 units. Testing Personnel J was not -- 3 of 4 -- qualified to perform high complexity grossing due to not having 6 semester hours of chemistry. On 1/23/2024 at 4:42 PM, Clinical lab Operations Manager and Lab Office Supervisor confirmed Testing Personnel J was unqualified to perform high complexity grossing for histopathology. -- 4 of 4 --

Summary Statement of Deficiencies D0000 An announced recertification survey was conducted on 9/8/21 at Waters Edge Dermatology LLC, a clinical laboratory in Palm Beach Gardens, Florida. Waters Edge Dermatology LLC is not in compliance with Code of Federal Regulations (CFR) 42, Part 493, Laboratory Requirements. The following is a description of the standard level deficiencies: D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on Wisconsin State Laboratory of Hygiene (WSLH) proficiency record review and interview with the General Supervisor, the laboratory failed to have documentation of signed attestations for the mycology subspecialty for dermatophyte testing medium (DTM) proficiency testing for two out of two years reviewed (2019- 2021). The findings included: Review of WSLH DTM proficiency testing records for two out of two years (2019 - 2021) revealed the laboratory had 4 proficiency testing events (3rd Event 2019, 3rd Event 2020, and 1st and 2nd Event 2021) that the attestation statements were not signed and were missing 2 proficiency testing events 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 -- (1st and 2nd Event 2021) attestation statements. Interview on 9/08/21 at 12:05 p.m., the General Supervisor stated he did not know that the Laboratory Director and Testing Personnel had to sign the WLSH DTM proficiency testing attestation statements. -- 2 of 2 --