Suite # 113-114, Level 1, Master Mind IV, Royal Palms, Aarey Colony,
Goregaon East, Mumbai – 400 065. India.
Tel/Fax: 91-22-28794410, 28794411, 28794412
E-Mail: Website:
ON SITE ASSESSMENT REPORT
ISO 15189:2012 - Medical Laboratories–
Requirement for quality and competence
SUPPLEMENTARY CHECKLIST - ANATOMIC PATHOLOGY
Part-I: GENERAL INFORMATION
ACCAB Reference No.: / Date(s) of Assessment:
Assessment Type: / Pre – Assessment / Initial Assessment / Surveillance Visit
Re - Assessment / Extension of Scope / Re-Instatement Visit
Short Notice Visit / On-site Clearance
Assessment Team:
Assessor / Technical Expert(s)::
Persons Interviewed:
Laboratory Details:
Laboratory’s Name:
Address:
Country: / Postcode:
Telephone No. / Fax. No.
Email address: / Web Site:
Principal Contact Name: / Designation:
part - II DETAILED checklist: ANATOMIC PATHOLOGY
Clause
No. / Requirement / (Doc. Ref. / Clause No.) / assessment COMPLIANCE
Y/N/NA / NOTES
1.0 / ANATOMIC PATHOLOGY
1.1 / Quality Control
1.1.1 / Are control specimens tested in the same manner and by the same personnel as patient samples?
1.1.2 / Is quality control data reviewed at least monthly by the laboratory director or designate?
1.1.3 / Is this review documented?
1.1.4 / Are results of controls verified for acceptability before reporting results?
1.1.5 / Are criteria for what is considered to be out of control available to staff?
1.1.6 / Are criteria for referral of “out of control” results to the supervisor and/or senior staff identified?
1.1.7 / Is there documentation of corrective action taken when controls exceed defined tolerance limits?
1.1.8 / Does the documentation include:
1.1.8.1 / What was out of control?
1.1.8.2 / Why the analysis was out of control?
1.1.8.3 / What is Corrective action taken?
1.1.8.4 / Signature/initials of individual responsible
1.1.9 / Are quality control records retained for at least two years?
1.2 / Quality MANAGEMENT
1.2.1 / Does the anatomic pathology laboratory utilize documented cancer checklists ?
1.2.2 / Is the anatomic pathology laboratory enrolled in external proficiency testing for each area of anatomic pathology? If not, please give justification.
1.2.3 / Is there documented peer review, involving either retrospective or prospective review of selected cases, by a second pathologist?
1.3 / Procedure Manual
1.3.1 / Is a current procedure manual available for laboratory staff?
1.3.2 / Is the procedure manual maintained as pe the documented procedure?
1.3.3 / Are the following included for each procedure: (if applicable)
1.3.3.1 / Purpose
1.3.3.2 / Specimens (type, source, amount, storage)
1.3.3.3 / Equipment and Materials required
1.3.3.4 / Preparation and storage of reagents, standards and controls?
1.3.3.5 / Procedure – including Step by step instructions?
1.3.3.6 / Directions for calibration
1.3.3.7 / Derivation of results (ie. mathematical calculations, dilutions)
1.3.3.8 / Quality control
1.3.3.9 / Linearity limits
1.3.3.10 / Precision
1.3.3.11 / Expected results
1.3.3.12 / Clinical Significance
1.3.3.13 / Critical value
1.3.3.14 / Safety
1.3.4 / Is there documentation of annual review of the procedure manual by the laboratory director or designate?
1.3.5 / Is there documentation of annual review of the procedure manual by the laboratory staff?
1.3.6 / Are all changes in methodology signed and dated by whoever made the changes?
1.3.7 / Are all new procedures reviewed by the laboratory director or designate?
1.3.8 / Are discontinued procedures retained for two years after the procedure is taken out of service?
1.3.9 / Is there a current file on manufacturer’s inserts/updates?
1.3.10 / Are there adequate and up to date reference text books available to laboratory staff?
1.4 / Reagents
1.4.1 / Are all reagents used within their expiry date?
1.4.2 / Are all reagents used according to manufacturer’s instructions?
1.4.3 / Are all reagents labelled with:
1.4.3.1 / Date of receipt
1.4.3.2 / Date prepared or opened
1.4.3.3 / Expiry date
1.4.3.4 / Content and concentration
1.4.4 / Are all reagents stored according to manufacturer’s instructions?
1.4.5 / If there are multiple components of a reagent kit, does the laboratory use components of reagent kits only within the same kit lot, unless otherwise specified by the manufacturer?
1.4.6 / Prior to use, are new reagent lots checked against old reagent lot?
1.5 / INSTRUMENTS AND EQUIPMENT
1.5.1 / Is there a procedure for maintenance of all instruments and equipment?
1.5.2 / Are the maintenance records reviewed by a supervisor?
1.5.3 / Is this review documented?
1.5.4 / Is there a procedure for maintenance of all instruments and equipment?
1.5.5 / Are there instructions for troubleshooting?
1.5.6 / Are service records maintained for the life of the instrument, plus two years?
1.5.7 / Is there emergency power for instruments and equipment? (where applicable)
1.5.8 / Are instruments equipped with surge protection? (where applicable)
1.5.9 / Are pipettors and dilutors (fixed volume or adjustable) checked at least annually for accuracy and reproducibility, and results recorded?
1.5.10 / Is the temperature of temperature dependent equipment documented daily:
1.5.10.1 / Room temperature
1.5.10.2 / Freezer
1.5.10.3 / Refrigerator
1.5.10.4 / Water baths
1.5.10.5 / Paraffin dispenser
1.5.10.6 / Ovens
1.5.10.7 / Embedding centres
1.5.10.8 / Floatation baths
1.5.11 / Is there evidence of active review of results of temperature?
1.5.12 / Are these reviews documented?
1.5.13 / Is there a procedure available if acceptable temperature ranges are exceeded?
1.5.14 / Are tissue processor solutions changed as needed?
1.5.15 / Is the paraffin bath dispenser clean and well-maintained?
1.5.16 / Is the temperature of the paraffin dispenser adjusted properly for the type of paraffin used?
1.5.17 / Are flotation baths clean and well-maintained?
1.5.18 / Is there a procedure for preventing cross-contamination of paraffin sections in the bath?
1.5.19 / Are microtome blades stored and disposed of safely?
1.5.20 / Is there adequate venting of the fumes from the tissue processors, strainers and cover slippers?
1.5.21 / Are microwave devices used in accordance with manufacturer’s instructions?
1.5.22 / Are microwave devices monitored annually for reproducibility?
1.5.23 / Are containers used in microwave devices vented?
1.5.24 / Are microwave devices properly vented?
1.5.25 / Are microwaves checked annually for leakage?
2.0 / SURGICAL PATHOLOGY
2.1 / QUALITY MANAGEMENT
2.1.1 / Does the laboratory have a policy for including intra- departmental consultations in the patient’s final report?
2.1.2 / When significant disparity exists between initial intra-operative consultation and final pathology diagnosis, is this reconciled and documented?
2.1.3 / Is previous cytologic and histological material from the patient reviewed with current material being examined?
2.1.4 / Is there a policy regarding what types of surgical specimens (if any) may be exempt from microscopic examination?
2.1.5 / Is there a policy that lists types of specimens that the facility may choose to exclude from routine submission to the pathology department for examination?
2.1.6 / Are extra-departmental consultations documented, and records of these consultations maintained in the pathology department?
2.1.7 / When extra-departmental cases are submitted to the laboratory for consultation, are they accessioned according to the standard practices of the laboratory and is a documented report prepared, with a copy sent to the originating pathologist?
2.1.8 / Is there a policy defining the handling of original slides/blocks for consultation?
2.1.9 / When slides/blocks are sent to another facility for consultation, is this documented?
2.2 / Specimen Examination
2.2.1 / Are there specific policies and procedures for the safe handling of tissues that may contain radioactive material?
2.2.2 / Are primary specimen containers labelled with at least two identifiers?
2.2.3 / Are there procedures for handling sub-optimal specimens?
2.2.4 / Are gross specimens retained for at least 8 weeks after the final reports are signed and results reported?
2.2.5 / Are all macroscopic tissue gross examinations performed by a pathologist or under the supervision of a qualified pathologist?
2.2.6 / Are there defined procedures if gross examinations are performed by laboratory personnel other than a pathologist?
2.2.7 / Does a qualified pathologist do periodic evaluation of the non-pathologist gross examinations?
2.2.8 / Are surgical tissue diagnoses made by a pathologist?
2.2.9 / Are there instructions available for the proper dissection, description and histological sampling of various specimen types?
2.2.10 / Are slides of sufficient quality for diagnosis?
2.2.11 / Is there documented evidence of daily review of the technical quality of histological preparations by the pathologist?
2.3 / INTRA-OPERATIVE CONSULTATION
(RAPID DIAGNOSIS)
2.3.1 / Are frozen sections, touch and scrape preparations adequate for intra-operative diagnosis?
2.3.2 / Are the results of intra-operative surgical consultations signed by the pathologist who made the diagnosis?
2.3.3 / If verbal reports are given, does the pathologist speak directly to the surgeon?
2.3.4 / Are the patient’s identification checked and confirmed before delivery of any verbal report?
2.3.5 / Are all intra-operative consultation reports made a part of the final surgical pathology report?
2.3.6 / Is all frozen section, touch and scrape preparation slides permanently stained, mounted, properly labelled and retained with the rest of the slides from the case?
2.3.7 / Is the residual frozen tissue routinely processed into paraffin, and a histological section prepared and examined for comparison with the frozen section interpretation?
2.3.8 / Is there a documented procedure for the routine decontamination of the cryostat at defined intervals, and decontamination records are evident?
2.4 / REPORTS
2.4.1 / Is there a policy regarding the communication and documentation of significant surgical pathology findings?
2.4.2 / Do surgical pathology reports include gross descriptions that contain type, number, dimensions and/or weight of the specimens, measurements and extent of gross lesions and other information essential to the diagnosis?
2.4.3 / Do gross descriptions include a summary noting block and slide designations for special sections?
2.4.4 / Do gross descriptions and microscopic findings support the pathologic diagnosis?
2.4.5 / Are all data elements required in applicable Cancer Protocols included in the surgical pathology report?
2.4.6 / Are data elements required by applicable Cancer Protocols reported using a synoptic format?
2.4.7 / Are specialized testing studies utilized to support the morphologic diagnosis? (ex. electron microscopy, immunohistochemistry, nucleic acid probes)
2.4.8 / Are routine surgical reports completed within two working days?
3.0 / HISTOLOGY LABORATORY
3.1 / Is the identity of every specimen maintained through each step of processing and slide preparation?
3.2 / Does the histology laboratory maintain a record of the number of blocks, slides and stains prepared?
3.3 / Are formaldehyde and xylene vapour concentrations maintained below the following maxima, expressed as parts per million, in all areas of the Anatomic Pathology department where formaldehyde or xylene are used?
3.4 / Is each open automated tissue processor operated at least 5 feet from the storage of combustible materials and from the paraffin dispenser?
3.5 / Are infectious tissues and other contaminated materials disposed of with minimum danger to all personnel?
3.6 / Are there documented procedures for the special handling of tissues in the laboratory from cases in which Creutzfeldt-Jakob disease is suspected?
3.7 / Are there procedures for safe disposal of used glass slides and paraffin blocks?
3.8 / Are safety policies and procedures for contaminated cases/specimens, hazardous chemical available to laboratory personnel?
3.9 / Do the safety policies and procedures provide instructions for:
3.9.1 / Daily cleaning
3.9.2 / Proper handling of highly infectious cases
3.9.3 / Disposal of tissues
3.9.4 / tables, re-useable instruments and aprons disinfected after use
4.0 / SPECIAL STAINS
4.1 / On each day of use do the following special stains demonstrate the tissue components or organisms for which they were designed:
4.1.1 / Iron
4.1.2 / Bacteria
4.1.3 / Elastic tissues
4.1.4 / Fungi
4.1.5 / Mucin
4.1.6 / Connective tissue
4.1.7 / Myelin
4.1.8 / Nerve fibres
4.1.9 / Glycogen
4.1.10 / Reticulin fibres
4.1.11 / Amyloid
5.0 / IMMUNOLOGIC AND MOLECULAR METHODS
5.1 / Immunofluorescence Microscopy
5.1.1 / Are appropriate positive and negative controls performed?
5.2 / Immunohistochemistry
5.2.1 / Is the pH of the buffers used in immunohistochemistry routinely monitored?
5.2.2 / Are positive tissue controls used for each antibody?
5.2.3 / Are appropriate negative controls used?
5.2.4 / Are tissue controls fixed and processed in the same manner as the patient specimen?
5.2.5 / If tissue controls and patient specimens are not fixed and processed in the same manner, has parallel testing been performed and documented?
5.2.6 / If the laboratory uses an avidin-biotin complex (ABC) detection system, is there a policy that addresses non-specific false-positive staining from endogenous biotin?
5.2.7 / Has the laboratory validated new antibodies prior to use in patient diagnosis?
5.2.8 / Are new lots of antibody and detection system reagents tested in parallel with old lots?
5.2.9 / Are the immunohistochemical stains produced of acceptable technical quality?
5.3 / Fluorescence and Non-Fluorescence in-SITU Hybridization (FISH, ISH)
5.3.1 / Is there documentation of validation of commercially available ISH and FISH probes used?
5.3.2 / Is there documentation of validation of probes that are developed in-house?
5.3.3 / Are there documented procedures for scoring results, including the number of cells scored?
5.3.4 / Are quantitative and semi-quantitative analyses scored according to these procedures?
5.3.5 / Are control loci (internal or external) used with and documented for each FISH analysis?
5.3.6 / Are photographic or digitized images retained for documentation of all FISH assays?
5.3.7 / Is the morphologic interpretation and correlation of results performed by a qualified pathologist as appropriate for in-situ hybridization studies?
5.3.8 / Are interpretations of in situ hybridization results provided in the report?
5.4 / Predictive Markers
5.4.1 / For immunohistochemical and FISH/ISH tests that provide independent predictive information, does the patient report include information on:
5.4.1.1 / specimen processing
5.4.1.2 / antibody clone/probe
5.4.1.3 / scoring method used
5.4.2 / For immunohistochemical and FISH/ISH tests that provide independent predictive information, does the laboratory (at least annually) compare its patient results with published benchmarks, and evaluate inter-observer variability among the pathologists in the laboratory?
5.4.3 / Does the laboratory have documented appropriate validation for HER2 testing?
5.4.4 / If the laboratory assesses HER2 protein over-expression by immunohistochemistry, HER2 gene amplification by in-situ hybridization, or estrogen/progesterone receptor expression by immunohistochemistry, is there a documented procedure to ensure appropriate specimen fixation time?
5.4.5 / If the laboratory interprets HER2 protein over-expression by immunohistochemistry (IHC), are results reported using the ASCO/CAP scoring criteria?
5.4.6 / If the laboratory interprets HER2 gene amplification by in-situ hybridization (e.g. FISH, CISH, SISH) are results reported using the ASCO/CAP scoring criteria?
5.4.7 / Are immunohistochemical estrogen receptor and/or progesterone receptor test results reported using the ASCO/CAP scoring criteria?
6.0 / AUTOPSY PATHOLOGY
6.1 / QUALITY MANAGEMENT
6.1.1 / Are intra and extra-departmental consultations documented and the reports kept with the patient’s autopsy report?
6.1.2 / Are the findings of the post-mortem examination used for correlative clinicopathological teaching purposes?
6.1.3 / Are findings from autopsies incorporated into the institutional quality management program?
6.2 / AUTOPSY PERFORMANCE AND DOCUMENTATION
6.2.1 / Is appropriate consent verified prior to the autopsy?
6.2.2 / Are clinical records reviewed prior to conducting the autopsy?
6.2.3 / Are autopsies performed or directly supervised by a qualified pathologist?
6.2.4 / Is a preliminary report of the gross pathology finding issued within 72 hours?
6.2.5 / Is the final autopsy report produced within:
6.2.5.1 / -30 days – routine cases
6.2.5.2 / -90 days – complicated cases
6.5.6 / Gross Descriptions:
6.2.6.1 / clear and concise
6.2.6.2 / pertinent findings described
6.2.7 / Do the descriptions support the diagnosis?
6.2.8 / Are microscopic descriptions in the report clear and concise?
6.2.9 / Do microscopic descriptions support the diagnosis?
6.2.10 / Does the report include a summary noting block and slide descriptions to allow identification of the source of specific microscopic sections?
6.2.11 / Does the final autopsy report contain sufficient information so that a physician may ascertain the patient’s major disease processes and probable cause of death?
6.2.12 / Are autopsy records organized and available for review?
6.2.13 / Are data from the final report entered into a database that allows for prompt retrieval of cases according to diagnosis?
7.0 / ELECTRON MICROSCOPY
7.1 / QUALITY MANAGEMENT
7.1.1 / Do requisitions include sources of tissue and appropriate clinical data?
7.1.2 / Are electron microscopy fixatives easily accessible to collection areas?
7.1.3 / Is the identity of every specimen maintained through each step in processing?
7.1.4 / Are blocks identified adequately?
7.1.5 / Are sections of embedded tissue reviewed by the pathologist or designate to ensure that appropriate areas are selected for electron microscopic examination?
7.1.6 / Are one micron sections reviewed by the pathologist or designate to ensure that appropriate areas have been selected?
7.1.7 / Are slides of face (semi-thin) and one micron sections labelled adequately?
7.1.8 / Are the electron micrographs identified adequately?
7.1.9 / Does the report include correlation with light microscope, immunohistochemical and immunofluorescent studies?
7.1.10 / Are reports signed by a pathologist?
7.1.11 / Are safety policies and procedures established for electron microscopy sample preparations?
7.1.12 / Is there a procedure for the safe handling and disposal of osmium tetroxide, epoxy resins and other hazardous chemicals?
7.1.13 / Is the electron microscope checked for x-ray leakage at the time of installation and after major repair?
Bibliography:
FAIR USE ACT 1976 NOTICE: Thisdocumentmay contain copyrighted material the use of which has not always been specifically authorized by the copyright owner. such material is made available to advance understanding of political, human rights, economic, scientific, moral, ethical, and social justice issues. this constitutes a 'fair use' of any such copyrighted material as provided for in section 107 of the 1976 us fair use copyright act. in accordance with title 17 U.S.C. section 107, this material is distributed without profit, to those who have expressed a prior general interest in receiving similar information for research and educational purposes. In the event that any content of this checklist causes harm/unlawful use/loss/unhappiness to anyone, the same should be brought to the notice of Accreditation Commission For Conformity Assessment Bodies Private Limited, Mumbai India
- College of Physicians & Surgeons of Saskatchewan
- College of Physicians & Surgeons of Alberta
- Various other internet sources.
CRA-F-05-15189-S-01-AP / RD-00-01/07/2014 / Page 1 of 14
This report shall not be reproduced in part without the permission of ACCAB