Pinnacle Dermatology

Summary Statement of Deficiencies D3001 FACILITIES CFR(s): 493.1101(a)(1) The laboratory must be constructed, arranged, and maintained to ensure the space, ventilation, and utilities necessary for conducting all phases of the testing process. This STANDARD is not met as evidenced by: Based on observations; review of laboratory's procedures and records; and interview with the Histology Technician (HT) and Laboratory Director (LD), the laboratory was not constructed, arranged, and maintained to ensure the space, ventilation, and utilities necessary for conducting all phases of the testing process. Findings: 1. At 9:30 AM on October 8, 2019 the surveyor was escorted to the laboratory, where she observed that the following equipment was in use: a. Microtome b. Stainer c. Slide Storage File Cabinet d. Microscope 2. There was a location above the stainer where an air Filter should be installed but was not installed. 3. The HT told the surveyor that the air filter was not installed, because, "there was not enough space to install it". 4. There were no procedures that described maintenance of the air filter. 5. There was no documentation to show that an air filter was maintained. 6. Observation of the laboratory's equipment revealed that testing personnel used the top of the microtome to place equipment such as slides, slide covers, pens, and permanent markers; and the stainer was propped up on square, plastic, boxes of some sort. 7. At 10:00 AM on October 8, 2019, the LD confirmed the surveyor's findings. D5201 CONFIDENTIALITY OF PATIENT INFORMATION CFR(s): 493.1231 The laboratory must ensure confidentiality of patient information throughout all phases of the total testing process that are under the laboratory's control. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- This STANDARD is not met as evidenced by: Based on review of patients' test records; observations; and interview with the Hitstotechnician (HT) and laboratory director (LD), the laboratory failed to ensure confidentiality of patient information throughout all phases of the testing process. Findings: 1. Review of patients test records revealed that patients Mohs maps that contain patients information and test results, were stored in a binder at the reception desk. 2. The Histotechnician told the surveyor that office staff scans patients' Mohs maps into the Electronic Medical Record. After scanning, the Mohs maps are put into a binder and left on the counter of the reception desk. 3. The surveyor observed that there was no lock on the door where patients' Mohs maps are stored. 4. At 11:00 AM on October 8, 2019, the LD confirmed the surveyor's findings. 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 review of Laboratory Personnel Report (FORM CMS 209); procedures manuals; personnel records; and interview with the laboratory director (LD), the laboratory failed to establish and follow written policies and procedures to assess employee competency. Findings: 1. The laboratory listed a total of 3 persons (P1, P2, and P3)) as laboratory personnel who fulfil the following positions in the laboratory: a. P1 = Laboratory Director b. P2 = Clinical Consultant, Technical Supervisor, General Supervisor, and High Complexity Testing Personnel. c. P3 = High Complexity Testing Personnel (processing). 2. Review of laboratory procedures manuals revealed that there were no procedures to show that the laboratory established and followed policies to monitor each individual's competency. 3. Review of personnel records revealed that there was no documentation to show the performance of competency assessments since the last survey in February 2018 for 3 of 3 laboratory personnel. 4. At 11: 00 AM on October 8, 2019, the LD confirmed the surveyor's findings. D5313 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(b) The laboratory must document the date and time it receives a specimen. This STANDARD is not met as evidenced by: Based on review of procedures manuals and laboratory records and interview with the laboratory director, the laboratory failed to document the date and time it receives a specimen. Findings: 1. The laboratory procedures manual instructs testing personnel to document the date of specimen receipt; patient information, Mohs Case number, specimen cite location, diagnosis, and Tech initials into a patient testing log. 2. Review of laboratory records revealed that testing personnel used a scheduling page as its documentation for specimen receipt. The scheduling page was also used to note when a patients did not show up for their scheduled appointments. 3. The surveyor asked the HT how patients' specimens were received into the laboratory. 4. The HT told the surveyor that she got a copy of the patients' schedule. She would then -- 2 of 6 -- document when she recieved a specimen on a copy of the patients' schedule. Later, at the end of the day, she typed the specimen receipt page. 5. The surveyor observed that the HT mistakenly documented that a specific case number was given to a patient, but later scratched it out with the words, "accession number not used." 6. The surveyor pointed out that the specimen receipt log should be completed when a specimen is received into the lab, not later. She also told the laboratory director that retyping or completing documentation later, leads to clerical errors. 7. At 11:30 AM, the LD confirmed the surveyor's findings. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of patients test reports and interview with the laboratory director, the test report did not indicate the following: *The name and address of the laboratory location where the test was performed. Findings: 1. The surveyor selected 5 patients' test reports for review. The name and address of the laboratory location where the test was performed was not indicated on 5 of 5 patients' test reports reviewed. 2. During survey date 02/06/18, the laboratory director confirmed the surveyor's findings. D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. 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 -- This STANDARD is not met as evidenced by: Based on review and interview, the laboratory director failed to ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably. Findings: 1. Review of Laboratory Personnel Report (FORM CMS 209), signed by the laboratory director, and dated 02/06/2018, revealed that there were 3 persons listed as high complexity testing personnel who perform histopathology procedures and 3 persons listed as moderate complexity testing who perform Potassium Hydroxide (KOH) wet mount procedures. 2. Review of personnel records revealed that there was no documentation to show the highest level of education (degree, diploma, or transcript) for 1 of 3 persons performing high complexity, and 3 of 3 persons performing moderate complexity testing. 3. During survey date 02/06/18, the laboratory director confirmed the surveyor's findings. D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review policies and procedures and laboratory records and interview, the laboratory director failed to specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of all testing, that identifies which examinations and procedures each individual is authorized to perform. Findings: 1. Review of the laboratory's policies and procedures revealed that the laboratory performed histopathology and potassium hydroxide (KOH) procedures. There was no documentation to show that the laboratory director specified in writing which individuals fulfilled the duties and responsibilities of the following positions: a. Laboratory Director b. Clinical Consultant c. Technical Supervisor d. General Supervisor e. High Complexity Testing Personnel (Histopathology) f. Moderate Complexity Testing Personnel (KOH) 2. Review of 6 laboratory personnel listed on Laboratory Personnel Report (FORM CMS 209) revealed that there was no documentation to show that the laboratory director assigned their duties and responsibilities, as well as which tests each individual is authorized to perform for 6 of 6 laboratory personnel. 3. During survey date 02/06/18, the laboratory director confirmed the surveyor's findings. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, -- 2 of 3 -- accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of personnel records and interview, the technical supervisor failed to be responsible for training and evaluating testing personnel. Findings: 1. Review of personnel records of persons listed as testing personnel on the Laboratory Personnel Report (FORM CMS 209) revealed that there was no documentation to show that testing personnel were trained and there competency assessed for 5 of 6 testing personnel who perform histopathology and potassium hydroxide (KOH) procedures. 2. During survey date 02/06/18, the laboratory director confirmed the surveyor's findings. -- 3 of 3 --