AP checklist Flashcards
ANP.08216, Formaldehyde/Xylene Safety
“Formaldehyde and xylene vapor concentrations are maintained below the following maxima, expressed as parts per million, in all areas of the Anatomic Pathology Department where formaldehyde or xylene are used., NOTE: Formaldehyde and xylene vapor concentrations must be monitored in all areas where these reagents are used: e.g. surgical pathology gross dissection room, frozen section area, histology laboratory, autopsy room, etc. Xylene vapor concentration monitoring in histology laboratories should include manual and automated coverslipping areas, as these locations are often not ventilated. Initial monitoring involves identifying all employees who may be exposed at or above the action level or at or above the STEL and accurately determining the exposure of each employee identified. Further formaldehyde monitoring is mandated at least every 6 months if results of the initial monitoring equal or exceed 0.5 ppm (8 hr time-weighted exposure, the “action level”) or at least once per year if the results exceed the short term exposure limit (STEL) 2.0 ppm. The laboratory may discontinue periodic formaldehyde monitoring if results from 2 consecutive sampling periods taken at least 7 days apart show that employee exposure is below the action level and the short-term exposure limit, and 1) no change has occurred in production, equipment, process or personnel or control measures that may result in new or additional exposure to formaldehyde, and 2) there have been no reports of conditions that may be associated with formaldehyde exposure.
Formaldehyde monitoring must be repeated any time there is a change in production, equipment, process, personnel, or control measures which may result in new or additional exposure to formaldehyde for any employee involved in the activity. If any personnel report signs or symptoms of respiratory or dermal conditions associated with formaldehyde exposure, the laboratory must promptly monitor the affected person’s exposure.
Xylene must be monitored initially, but there is no requirement for periodic monitoring of xylene. Repeat monitoring should be considered when there is a change in production, equipment, process, personnel, or control measures likely to increase exposure levels., “
ANP.10016, Surgical Pathology Exclusion
“There is a policy that lists specimens that an institution may choose to exclude from routine submission to the pathology department for examination. , NOTE: This policy should be made in conjunction with the hospital administration and appropriate medical staff departments. The laboratory director should have participated in or been consulted by the medical staff in deciding which surgical specimens are to be sent to the pathology department for examination.
This checklist item is not applicable if 1) all specimens are submitted to pathology, or 2) the laboratory is not part of an institution that provides surgical services., “
ANP.10032, Surgical Pathology Microscopic Exemptions
There is a policy regarding what types of surgical specimens (if any) may be exempt from microscopic examination., NOTE: Irrespective of any exemptions, microscopic examination should be performed whenever there is a request by the attending physician, or at the discretion of the pathologist when indicated by the clinical history or gross findings. If there is such a policy, it should be approved by the medical staff or appropriate committee. Typical exempt specimens include foreskins in children, prosthetic cardiac valves without attached tissue, torn meniscus, varicose veins, tonsils in children below a certain age, etc.,
ANP.10050, Previous/Current Material Review
Whenever appropriate, pertinent previous cytologic and/or histologic material from the patient is reviewed with current material being examined., NOTE: Because sequential analysis of cytologic and histologic specimens may be critical in patient management and follow-up, efforts must be made to routinely review pertinent previous material. Documentation of the retrospective review should be included in the current patient report.,
ANP.10100, Intra-operative/Final Diagnosis Disparity
When significant disparity exists between initial intra-operative consultation (e.g. frozen section, intra-operative cytology, gross evaluation) and final pathology diagnosis, it is reconciled and documented in the surgical pathology report and in the departmental quality management file., ,
ANP.10150, Intra and Extra-Departmental Consultations
“The laboratory has a policy for handling intra- and extra-departmental consultations in the patient’s final report., NOTE: Intra-departmental consultations may be included in the patient’s final report, or filed separately. The pathologist in charge of the surgical pathology case must decide whether the results of intra-departmental consultations provide relevant information for inclusion in some manner in the patient’s report.
Documentation of extra-departmental consultations must be readily accessible within the pathology department. The method used to satisfy this requirement is at the discretion of the laboratory director, and can be expected to vary according to the organization of the department. These consultations can be maintained with the official surgical pathology reports or kept separately, so long as they can be readily linked., “
ANP.10250, Extra-Departmental Consultation
When extra-departmental cases are submitted to the laboratory for consultation, they are accessioned according to the standard practices of the laboratory, and a documented report is prepared, with a copy sent to the originating laboratory., NOTE: In most cases, original materials including slides and blocks should be promptly returned to the original institution. However, in some situations (for example, when the patient is receiving ongoing care at the referral institution pending tumor resection, etc.) it may be appropriate for the referral laboratory to retain slides/blocks for a period of time. In such situations, a letter should be sent to the originating laboratory along with the consultation report, requesting permission to retain the slides/blocks and accepting transfer of stewardship of the patient materials from the original laboratory to the referral institution.,
ANP.10255, Professional Competency
The laboratory director ensures the professional competency of pathologists who provide interpretive services to the anatomic pathology laboratory., NOTE: The mechanism for competency assessment must be pertinent to the type of interpretive services provided. There must be a written policy for assessing professional competency, criteria for the assessment, and records of the assessment must demonstrate review by the laboratory director.,
ANP.10260, Slide/Block Handling
There is a policy defining the handling of original slides/blocks for consultation and legal proceedings., NOTE: This must include appropriate handling and documentation of the use, circulation, referral, transfer, and receipt of original slides and blocks. The laboratory must have a record of the location of original slides and blocks that have been referred for consultation or legal proceedings.,
ANP.10270, Off-Site Autopsies
As applicable, there is a policy for performance of autopsies off-site., NOTE: If feasible, the autopsy room should be located within the institution. Requirements in the Autopsy Pathology section that relate to the physical facility, dissection and handling of organs and tissues apply only to those cases that are performed at the site under CAP accreditation. The pathologist should encourage off-site locations where autopsies are performed (e.g. Funeral homes) to provide facilities that meet the standards expected for accredited autopsy rooms.,
ANP.11250, Adequate Storage
Refrigerated storage is available for large or unfixed specimens., ,
ANP.11275, Radioactive Material Handling
“There are specific policies and procedures for the safe handling of tissues that may contain radioactive material (e.g. sentinel lymph nodes, breast biopsies, prostate ““seeds,”” etc.)., NOTE: These procedures should be developed in conjunction with the institutional radiation safety officer, and must comply with any state regulations for the safe handling of tissues containing radionuclides. The policy should distinguish between low radioactivity specimens such as sentinel lymphadenectomy and implant devices with higher radiation levels.
The pathology department may wish to monitor these specimens for radioactivity, with safe storage of specimens until sufficient decaying has occurred, before proceeding with processing in the histology laboratory. , “
ANP.11475, Sub-Optimal Specimens
There are documented procedures for handling sub-optimal specimens (e.g. specimens that are unlabeled, not labeled with two patient identifiers on the container, unaccompanied by adequate requisition information, left unfixed or unrefrigerated for an extended period, received in a container/bag with a contaminated outside surface)., ,
ANP.11500, Specimen Identity
The identity of every specimen is maintained at all times during the processing and examination steps., ,
ANP.11525, Tissue/Cytology Assessment Record
If a statement of adequacy, preliminary diagnosis, or recommendations for additional studies is provided at the time of tissue and cytology sample collection, documentation of that statement is maintained., NOTE: Documentation might include a note in the medical record or in the final report.,
ANP.11550, Specimen Retention
Gross specimens are retained until at least 2 weeks after the final reports are signed and results reported to the referring physician., ,
ANP.11600, Gross Examination - Pathologist
All macroscopic tissue gross examinations are performed by a pathologist or pathology resident, or under the supervision of a qualified pathologist., NOTE: Specific requirements for supervision of non-pathologists who assist in grossing specimens, are given below.,
ANP.11605, Gross Examination - Non-Pathologist
When individuals other than a pathologist or pathology resident assist in gross examinations, the extent of their activities and the nature of supervision (direct vs. indirect) is defined in a documented protocol., NOTE: This protocol must list the specific types of specimens for which non-pathologists are permitted to assist in the gross examination. The nature of the supervision must be established individually, for each non-pathologist. The laboratory director is responsible for this protocol. For Mohs surgery a dermatologist is also qualified to perform the gross examination and to supervise non-pathologists.,
ANP.11610, Gross Examination Qualifications
“If individuals other than a pathologist or pathology resident assist in gross examinations, such individuals qualify as high complexity testing personnel under CLIA regulations., NOTE: The laboratory director may delegate the dissection of specimens to non-pathologist individuals; these individuals must be qualified as high complexity testing personnel under CLIA regulations. The minimum training/experience required of such personnel is:
- An earned associate degree in a laboratory science or medical laboratory technology, obtained from an accredited institution, OR
- Education/training equivalent to the above that includes at least 60 semester hours or equivalent from an accredited institution. This education must include 24 semester hours of medical laboratory technology courses, OR 24 semester hours of science courses that includes 6 semester hours of chemistry, 6 semester hours of biology, and 12 semester hours of chemistry, biology or medical laboratory technology in any combination. In addition, the individual must have laboratory training including either completion of a clinical laboratory training program approved or accredited by the ABHES, NAACLA, or other organization approved by HHS (note that this training may be included in the 60 semester hours listed above), OR at least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing.
It is the responsibility of the laboratory director to determine whether an individual’s education, training and experience satisfies the requirements of this checklist requirement.
This checklist requirement applies only to laboratories subject to US regulations., “
ANP.11640, Competency Assessment of Non-Pathologists
“The competency of non-pathologist(s) who assist in the performance of gross tissue examinations is assessed by the pathologist at least annually., NOTE: Please refer to GEN.55500, Competency Assessment, in the Laboratory General checklist for a list of criteria and frequency for competency assessment. Not all six elements may apply in all cases.
For Mohs surgery a dermatologist is also qualified to perform the gross examination and evaluate non-pathologists., “
ANP.11650, Mohs Diagnosis
Mohs surgically excised tissue diagnoses are made by a dermatologist, dermatopathologist, or pathologist., NOTE: The diagnosis includes whether or not tumor is present, assessment of the margins, etc.,
ANP.11660, Pathologist Diagnosis
All surgical tissue diagnoses are made by a pathologist., ,
ANP.11670, Specimen - Gross Examination
Documented instructions or guidelines are readily available in the laboratory for the proper dissection, description, and histologic sampling of various specimen types (e.g. mastectomy, colectomy, hysterectomy, renal biopsy, etc.)., NOTE: The guidelines should address large or complicated specimen types and smaller specimens requiring special handling, such as muscle biopsies, renal biopsies, and rectal suction biopsies for Hirschsprung’s disease. Guidelines serve an important educational function in departments with postgraduate (residency) programs. However, they also are useful in providing consistency in the handling of similar specimen types in departments without such training programs.,
ANP.11713, Histologic Prep Quality
“There is documented evidence of daily review of the technical quality of histologic preparations by the pathologist or designee., NOTE: If specimens are referred to an outside laboratory for histologic processing, there must be a procedure for providing feedback on slide quality to the outside laboratory.
This checklist requirement is intended to apply to routine histology slides. Specific quality control requirements for special stains, immunohistochemistry, and other special studies are found elsewhere in this checklist., “