#06-5558 Accrd Manual V7 - COLA

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HISTOPATHOLOGY>IntroductionThe following standards and criteria for histopathology laboratories are unique to the discipline of histopathology(including dermatopathology, oral and ophthalmic pathology), and represent additional requirements forCOLA accreditation.These criteria are divided into eight sections, each addressing a particular aspect of laboratory operation. Eachsection has:• Policy statements, which are preceded by a capital letter E(Essential) or R(Required),• Criteria interpreting those policies (numbered),• Notations (in italics) that explain the requirement in more detail.OrganizationThe laboratory (or the organization with which it is associated) must be a legal entity, and must be in compliancewith all applicable state and federal laboratory regulations.810. EIs the histopathology laboratory, or the laboratory with which it is associated, a legal entity, and in compliancewith local, regional, and national licensing requirements?The Laboratory may use any of the following items to establish its status: a federal tax identification number,state licensure and / or certification, and federal accreditation or certification / accreditation by a nationalorganization.811. EDoes the histopathology laboratory meet the general laboratory organization requirements for COLA accreditation?The histopathology laboratory must meet the Laboratory Organization Requirements as outlined in questions810, 833, 836, 844, 847, 871, 880, and 887.PersonnelThe laboratory shall establish and implement a personnel management plan that includes personnel policiesand a job description containing the qualifications, responsibilities and authorities for each position.Does the plan include policies to ensure that:812. EThere are job descriptions for each position in Histology including the Director?813. EThe laboratory is directed by an individual with the appropriate professional education, experience and skillsnecessary for the services rendered and who meets all applicable local, regional, and national requirements?814. ESupervisory personnel have the training and experience necessary to examine and diagnose microscopic sectionsfrom tissue specimens and for the services rendered and meets the applicable local, regional, and nationalrequirements?815. EHistotechnicians and Histotechnologists have the necessary training and experience for the services they renderand meet all applicable local, regional, and national requirements?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .FOR MORE INFORMATION CONTACT COLA PHONE 800.981.9883 | FAX 410.381.8611 | ON-LINE www.cola.org95
HISTOPATHOLOGY816. EResponsibilities of all personnel are defined and meet all applicable local, regional, and national requirements?Specific written policies must be present to address job descriptions, laboratory director qualifications andexperience, supervisory personnel training and experience, histotechnician & histotechnologist training andexperience and personnel responsibilities. These policies must be in compliance with COLA accreditation criteriaand state and federal regulations.Does the job description for each position contain:817. ETraining and experience qualifications required by the position?818. EResponsibilities of the position?Refer to the COLA Personnel Requirements Table to identify the minimum qualifications for each position.Laboratories subject to CLIA regulations must meet specific requirements for education, experience andresponsibilities for the director of histopathology services, technical supervisor of histopathology services,general supervisor of histopathology services, and testing personnel, which can be found at 42 CFR 493,Subpart M, and have state licensure, if required.Documentation can be in the form of high school, college, and medical school diplomas indicating the highestlevel of education received; certificates of histopathology training or Pathology residency completion;certification in Anatomic and Clinical Pathology or in Anatomic Pathology by the American Board ofPathology or the American Osteopathic Board of Pathology; AND resumes / applications indicating the yearsof experience, AND current state licensure, if appropriate, that qualifies them for the position(s) they hold inthe histopathology laboratory.819. EIs there sufficient staff to perform the volume of work with the proper training to examine the variety of materialprocessed by the laboratory?The histopathology laboratory must employ sufficient number of staff persons with appropriately wide experienceto process, in a timely manner, the variety and volume of material received by the laboratory. Theremust be enough qualified supervisory personnel to examine and review the processed material and reportresults in a timely manner.Personnel shall be evaluated on their competency to carry out their assigned responsibilities.820. EDoes the personnel evaluation cover all aspects of each individual’s responsibilities?Histotechnicians & histotechnologists must have written evaluations which address all aspects of theirresponsibilities including competency, technical proficiency and performance and adherence to laboratoryquality control and quality assurance policies and procedures.821. EAre the evaluations documented and retained?The documented reviews should consist of a personnel evaluation form or a written statement from the person’ssupervisor that their performance was reviewed. Documentation should include the name of the personperforming the review, the date and the outcome of the review. All lab personnel evaluations should bemaintained for a minimum of two years.96. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .FOR MORE INFORMATION CONTACT COLA PHONE 800.981.9883 | FAX 410.381.8611 | ON-LINE www.cola.org
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#06-5558 Accrd Manual V7 - COLA

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