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Summary Statement of Deficiencies D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: No deficiency details available. D6035 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 (a) The technical consultant must be qualified and must possess a current license issued by the State in which the laboratory is located, if such licensing is required. (b) The technical consultant must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (b)(2)(i) 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; and (b)(2)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine are qualified to serve as the technical consultant in hematology); or (b)(3)(i) Hold an earned doctoral or master's degree in a chemical, physical, biological or clinical laboratory science or medical 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 -- technology from an accredited institution; and (b)(3)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. Note: The technical consultant requirements for "laboratory training or experience, or both" in each specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service, excluding waived tests. For example, an individual who has a bachelor's degree in biology and additionally has documentation of 2 years of work experience performing tests of moderate complexity in all specialties and subspecialties of service, would be qualified as a technical consultant in a laboratory performing moderate complexity testing in all specialties and subspecialties of service. This STANDARD is not met as evidenced by: No deficiency details available. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Tidewater Skin Care and Pathology, PC on February 28, 2018 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), laboratory Quality Assessment (QA) manual, competency assessment records, and an interview, the laboratory failed to follow its policy for competency assessment of five (5) of five (5) testing personnel (TP) in 2016 and 2017. Findings include: 1. Review of the CMS 209: Laboratory Personnel revealed five (5) clincial consultants that are also testing personnel. 2. Review of the QA manual revealed the following statement: "The competency of Testing Personnel and all staff members will be evaluated and documented every six (6) months by the Laboratory Director or an appropriate, designated staff member (e.g. Technical Consultant or Technical Supervisor) to ensure that all laboratory staff maintain their competency in testing and laboratory management functions." 3. Review of competency assessment records for Potassium Hydroxide (KOH) microscopic examinations revealed the following KOH competnecy assessments: Testing Personnel A: assessed 12/13/17, no second competency assessment in 2017, Testing Personnel B: assessed 6/10/16, no second competency assessment in 2016, 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 3 -- Personnel C: assessed 6/21/16 , no second competency assessment in 2016, Testing Personnel D: assessed 6/18/16 , no second competency assessment in 2016, Testing Personnel E: assessed 6/18/16 , no second competency assessment in 2016. 4. An interview with the office CLIA coordinator at approximately 4:00 PM confirmed that the laboratory failed to assess competency every 6 months per their policy for four (4) of five (5) TP in 2016 and one (1) of five (5) TP in 2017. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on a tour of the laboratory, review of the procedure manual, maintenance logs, and an interview, the laboratory failed to establish a maintenance protocol for the calibration of one (1) thermometer used in the laboratory in calendar years 2016 and 2017. Findings include: 1. During a tour of the laboratory, the inspectors noted an Acurite non-certified thermometer utilized to monitor room temperature in the histology laboratory. 2. Review of the laboratory's procedure manual revealed no policy for the periodic calibration of laboratory thermometers. 3. Review of maintenance logs revealed no documentation of thermometer calibrations in 2016 and 2017. The inspectors requested documentation for thermometer calibrations. No documentation was available for review. 4. An interview with the office CLIA coordinator at approximately 4:00 PM confirmed that the laboratory failed to establish a maintenance policy to ensure calibration of non-certified thermometers in the laboratory. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), laboratory personnel files, and interview, the laboratory director failed to ensure maintenance of personnel education documentation for one (1) of six (6) testing personnel (TP). See D6065. D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the -- 2 of 3 -- 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; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), laboratory personnel files, and interview, the laboratory director failed to ensure maintenance of personnel education documentation for one (1) of six (6) testing personnel (TP). Findings include: 1. Review of the CMS 209 Laboratory Personnel Report revealed six (6) testing personnel. 2. Review of the laboratory personnel files revealed no documentation of education or training for Testing Personnel F. (See Personnel Code Sheet.) The inspector requested to review the documentation. It was not available for review. 3. An interview with the office CLIA coordinator at approximately 4:00 PM confirmed that the laboratory director failed to maintain documentation of personnel qualifications for the one (1) testing personnel listed above. 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, accurately and proficiently. This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), laboratory personnel files, and interview, the technical supervisor failed to ensure maintenance of competency assessment documentation for one (1) of six (6) testing personnel (TP) in 2016 and 2017. Findings include: 1. Review of the CMS 209 Laboratory Personnel Report revealed six (6) testing personnel. 2. Review of the laboratory personnel files revealed no documentation of competency assessment in calendar years 2016 and 2017 for Testing Personnel F. (See Personnel Code Sheet.) The inspector requested to review the competency documentation. No documentation was available for review. 3. An interview with the office CLIA coordinator at approximately 4:00 PM confirmed that the technical supervisor failed to maintain documentation of competency assessment for the one (1) testing personnel listed above in 2016 and 2017. -- 3 of 3 --