QA/QC Flashcards
Define quality assurance
A system for reviewing procedures used by those who regularly perform a service or produce a product with the
goal of ensuring that standards have been met
Give 3 reasons why we need QA in a pathology laboratory
- To provide documentation that the laboratory functions to an acceptable standard.
- To identify the source of an error or areas that need to be improved.
- To promote processes for reducing error and improving patient care.
What is proficiency testing?
A process for evaluating unknown specimens, carried out by pathologists or laboratories, in which the results are retained and evaluated against a reference standard and compared with the results from other participating
laboratories.
What is quality control?
A system of routine techniques and activities performed to control the quality of the product being produced or
the service being provided.
What is a quality manual?
A document specifying
the quality management system of an organization.
It contains all of the laboratory’s policies
What is a near miss?
An incident that has no impact due to timely intervention or chance
What is a critical incident?
An incident that significantly alters treatment or results in death or disability. This type of incident must be
reported to the Provincial Minister of Health
What is a medical error?
The failure of a planned action to be completed as intended, or the use of an incorrect plan to achieve an aim.
What is a pathology error?
The failure of a diagnostic or surgical procedure to be followed by a timely, accurate, and complete pathology
report that describes the disease and the findings in a manner that is concise and readily understandable.
What is an adverse event
An unexpected event in health-care delivery that results in harm to a patient and that is related to the care and/or services provided to the patient rather than to the patient’s underlying medical condition. This includes an incident, in the course of health-care treatment, that results in a recognized risk of a nontrivial adverse outcome or consequence at some future time
CanMEDS framework?
Communicator
Collaborator
Medical expert
Leader (Manager)
Health advocate
Scholar
Professional
What is the difference between guidelines and standards
Guidelines are a recommended strategy or range of strategies of laboratory practice. Variation due to patient specific or laboratory-specific factors is a reasonable expectation.
Standards are accepted principles of laboratory practice in which variation is not expected.
What does quality mean in surgical pathology?
Quality indicates that a pathology report is:
Timely.
Accurate.
Complete, clearly communicating all necessary information
What QA procedures apply to surgical pathology?
Pre-analytical
Analytical
Post-analytical phase
Example of pre-analytical phase
Specimen delivery timeliness and specimen condition.
Adequacy of clinical history, including completeness and relevance.
Specimen identification errors.
Lost specimens.
Errors in accessioning, fixation, grossing, embedding, cutting and staining.
Example of analytical phase
Prospective procedures
Intradepartmental consultations.
Consensus conferences.
Retrospective procedures*
Intraoperative consultation-permanent section correlation.
Cytology-histology correlation.
Targeted case reviews (random not recommended).
Intra- and interdepartmental case conferences.
Interinstitutional consultations.
Examples of post-analytical phase
Monitoring turnaround time.
Reviewing report quality, such as use of synoptic reporting and standard terminology.
Reviewing amended reports.
Reviewing record-keeping and storage systems.
List 5 types of peer review.
Intraoperative consultation-permanent section correlation.
Cytology-histology correlation.
Intradepartmental consultation.
Interinstitutional consultations.
Audits.
List 5 types of pathology audit.
Random review.
Targeted review.
Retrospective review.
Prospective review.
Accountability review.
List 5 quality assurance processes that might reveal diagnostic discrepancies
Peer review.
Reviews of previous cases in light of follow-up.
Interdisciplinary conferences or tumor boards.
Clinician requested reviews.
Amended report rate
What is a critical diagnosis in anatomical pathology?
Any anatomical pathology result that has the potential to negatively impact patient care if not communicated in
an urgent and timely fashion
List examples of critical diagnoses in anatomical pathology.
Crescents in > 50% of glomeruli in a kidney biopsy specimen.
Transplant rejection.
Leukocytoclastic vasculitis.
Fat in a colonic endoscopic polypectomy specimen.
Uterine contents without villi or trophoblasts.
Fat in an endometrial curettage specimen.
Mesothelial cells in an endocardial biopsy specimen.
Malignancy in superior vena cava syndrome.
Neoplasms causing paralysis.
Unexpected or discrepant findings:
- Unexpected malignancy.
- Significant disagreement between intraoperative consultation and final diagnoses.
- Significant disagreement between immediate interpretation and final diagnosis by fine needle aspiration
biopsy (FNAB).
- Significant disagreement and/or change between diagnoses of primary pathologist and external
pathologist consulted.
Infections:
- Any invasive organism in specimens from immunocompromised patients.
- Acid-fast bacilli in immunocompromised and immunocompetent patients.
- Bacteria in heart valve or bone marrow.
- Herpes simplex viral changes in gynecologic samples of near-term pregnant patients.
- Bacteria or fungi in cerebrospinal or orbital fluid cytology.
- Pneumocystis organisms, fungi, or viral cytopathic changes in bronchoalveolar lavage, bronchial washing,
brushing cytology specimens, or FNAB specimens.
How should critical diagnoses be reported?
Urgent same day timely notification
The notification date, time, and method (e.g., telephone call, email, fax, etc.) should be documented in the
report
What are the College of American Pathologists (CAP) standards for acceptable turnaround times for reporting
intraoperative consultations, surgical pathology specimens, and autopsies?
Intraoperative consultations: 90% of cases reported within 20 minutes per block.
Surgical pathology specimens: 80% of routine cases reported within 2 working days.
Autopsy, preliminary report: 3 working days.
Autopsy, final report: 30 working days for routine cases, 3 months for complex cases.
CAP ACP Retention Guidelines for wet tissue
4 weeks after final report
CAP ACP Retention Guidelines for paraffin blocks and slides
20 years
CAP ACP Retention Guidelines for paper requisition
2 years
CAP ACP Retention Guidelines for reports
10 years
CAP ACP Retention Guidelines for consultations
indefinitely
CAP ACP Retention Guidelines for cyto slides, negative and unsatisfactory
5 years
CAP ACP Retention Guidelines for cyto cell blocks
20 years
CAP ACP Retention Guidelines for cyto slides, suspicious and positive
20 years
CAP ACP Retention Guidelines for FNAB
20 years
CAP ACP Retention Guidelines for autopsy wet tissue
3 months after final report
CAP ACP Retention Guidelines for autopsy paraffin blocks
20 years
CAP ACP Retention Guidelines for autopsy slides
10 years
CAP ACP Retention Guidelines for hospital autopsy records
Indefinitely
CAP ACP Retention Guidelines for electron microscopy
20 years
CAP ACP Retention Guidelines for immunofluorescence slides
1 month after case verification in refrigerator
CAP ACP Retention Guidelines for immunofluorescence frozen tissue
20 years at -70 C
CAP ACP Retention Guidelines for electron microscopy
Indefinitely
What are the QA indicators for intraoperative consultation
Turnaround time.
Intraoperative consultation-permanent section discordant rate.
List 4 causes of intraoperative consultation-permanent section discordance
Technical issue: 10%.
Interpretative error: 40%.
Sampling error: 40%.
Incorrect or incomplete clinical history: 10%.
Categorize intraoperative consultation-permanent section correlation results, and the thresholds for acceptable
deferral and discordance rates, as recommended by the Association of Directors of Anatomic and Surgical
Pathology (ADASP).
Agreement.
Deferral, appropriate.
Deferral, inappropriate, 10% threshold.
Disagreement, minor.
Disagreement, major 3% threshold
Categorize the clinical impact of intraoperative consultation-permanent section discordance
No clinical significance.
Minor or questionable significance.
Major or potentially major significance
List the components of a complete autopsy report
Consent.
Clinical information and any questions to be answered by the autopsy (from the clinician)
Gross findings.
Microscopic findings.
Primary diagnosis and comments.
Cause of death.
What are the standard staining techniques used for cytopathologic specimens
For gynecologic specimens: Papanicolaou staining.
For fixed nongynecologic specimens: Papanicolaou staining.
For air-dried nongynecologic specimens: Romanowsky-type staining.
For cell-block preparations: hematoxylin-based stains
List the rescreening methods for gynecologic cytology specimens
Prospective rescreening: targeted, random, rapid, or prescreening.
Retrospective rescreening
Why are rescreening procedures carried out?
The aim of rescreening procedures is to identify false negative results
What is the target rate of prospective rescreening for gynecologic cytology specimens?
A total of 10% of all negative gynecologic cytology specimens should be prospectively rescreened. These slides
will be selected through a combination of random and targeted rescreening methods.
What is a prospective targeted rescreen?
Rescreening a slide if the patient belongs to a high risk group
High risk group in a prospective targeted rescreen?
Clinical history of vaginal bleeding or spotting.
History of cervical/vaginal/vulvar carcinoma.
Previous cytology reported as ≥ atypical squamous or glandular cells within the last 2 years.
Abnormal cervix on speculum examination.
History of DES exposure.
What is a prospective random rescreen?
This involves rescreening 10% of randomly selected negative gynecologic cytology slides.
It is of questionable value in detecting false negatives
What is a prospective rapid rescreen?
This involves rescreening all negative gynecologic cytology slides for a specified time period (< 1 minute) after
a routine screen. The use of this method precludes the 10% random rescreen.
There is increased detection of false negatives with this technique.
What are 4 potential applications of high risk human papillomavirus (hrHPV) testing in gynecologic cytology
Primary HPV screening.
An up-front cotesting approach in which both a hrHPV test and cervical cytology specimen are obtained at the
time of patient screening.
Triage of an abnormal cytology result using a hrHPV test
HPV genotyping
What is the hrHPV positivity rate in gynecologic cases with a cytologic diagnosis of atypical squamous cells of
undetermined significance (ASC-US)?
High risk HPV: 40-50% of cases
What is the underlying risk of HSIL in ASC-US cases?
10-20% have underlying HSIL
Recommended target rate for ASC-SIL ratio
Should not exceed 3:1
Recommended target rate for ASC-H
<10% of all ASC interpretations
How many of ASC-H should have underlying HSIL
30-40%
Recommended target rate for AGC
<1%
What are performance indicators in a cytology lab
Done annually
Productivity rates for each cytotechnologist and cytopathologist.
Individual performance indicators (delivered confidentially).
Overall laboratory performance, which should be shared with all personnel.
Specimen adequacy, which may be communicated to individual health-care providers.
List at least 5 gynecologic cytology performance indicators
The total number and rates of unsatisfactory specimens for the laboratory, each cytotechnologist,
cytopathologist, and health-care provider.
The total number and rates of each major diagnostic category for the laboratory, each cytotechnologist, and
each pathologist.
The false negative/positive rate on 10% rescreening.
The hrHPV positivity rate in ASC cases, if available.
The ASC:SIL ratio for the laboratory overall and for each cytopathologist. The ASC includes ASC-US and ASC-H,
while the SIL includes LSIL and HSIL diagnostic categories.
The cytohistological correlation rates for HSIL, ASC-H, AIS, and malignancy.
The false negative/positive rate in cytology–histology correlation.
Screening misses of ASC-H or AGC or other abnormality that changes management.
The laboratory turnaround time (from receiving specimen to finalized report).
List at least 5 non-gynecologic cytology performance indicators.
The total number of cases categorized by anatomic site and specimen type.
The total number and rates of unsatisfactory cases for the laboratory, and each cytotechnologist and
cytopathologist.
The major diagnostic category rates (e.g., unsatisfactory, negative, atypical, suspicious, malignant) for the
laboratory overall and for major nongynecological specimen types.
Correlation of results of FNAB specimens with their corresponding surgical material — at a minimum, the
malignant diagnoses should be correlated.
Major and minor discrepancy rates between cytotechnologist and cytopathologist diagnoses.
The laboratory turnaround time (from receiving specimen to finalized report).
List 3 postanalytical performance indicators that can be monitored by the cytopathology laboratory
The number of corrected and supplemental cytology reports issued by the laboratory and/or by individual
cytopathologists.
The number of internal and external cytology consultations.
The number of external review requests, the reasons for external consultation, and any diagnostic
discrepancies
What performance indicator should be carried out in specimens obtained via rapid on-site evaluation (ROSE)?
A comparison of the initial specimen adequacy assessment/preliminary diagnosis versus the final diagnosis
What are 3 aspirator outcome performance indicators?
FNAB unsatisfactory rates.
FNAB complication rates/outcomes.
FNAB service satisfaction (e.g., clinician feedback survey).
What is the workload limit for cytotechnologists in the United States and Canada?
If cytotechnologists are exclusively screening without other duties, the maximum is 60–80 slides in an
average 8-hour working day
When is a cytology case referred from a cytotechnologist to a cytopathologist?
Gyne
All cases of NILM with reparative changes.
All cases of ASC or AGC, for reporting
All nongynecologic cytology must be signed out by a cytopathologist.
List at least 3 sources of external proficiency testing.
College of American Pathologists (CAP) (PAP, nongynecologic).
American Society of Clinical Pathologists (ASCP) (CheckPath program).
Laboratory Services of Ontario
List 3 scenarios in which obtaining a prospective second opinion may be prudent in cytopathology
A sample obtained from an unusual anatomic location.
Cytologic diagnoses that may result in “high stakes” treatment decisions (e.g., positive ureteric brushings with
subsequent nephroureterectomy).
A major discordance between a cytotechnologist and cytopathologist diagnostic interpretation
List 4 important types of quality management documents
Policy: statement of intent, what is to be done, and why.
Process: the interrelated steps involved in an activity, which often involves a number of individuals and which
may be illustrated with a flow chart.
Standard operating procedures: specific details of how an individual performs an activity.
Forms: documentation of what was done.
What information is required on a requisition form?
Patient name.
Date of birth.
Provincial health card number.
Hospital identification number.
Address.
Name of requesting health-care provider.
Anatomic site and laterality of specimen.
Appropriate clinical history.
Date and time of specimen collection.
What information is required on a specimen-container label?
Patient name.
Date of birth.
Identifying number.
Anatomic site and laterality of the specimen
What advantages does computerization have in laboratories?
Computerization facilitates:
- Accessioning.
- Reporting.
- Archiving records.
- Accessing data for QA practices
If you were employed in a small hospital and wished to establish an IHC service with limited resources, which 4
stains would you initially choose?
Pancytokeratin to identify carcinoma.
CD45 to identify lymphoma.
S100 to identify melanoma.
A neuroendocrine marker such as synaptophysin, CD56 or chromogranin.
What are the processes involved in handling an adverse event?
Incident review and root cause analysis.
Performance review and performance management.
Disclosure.
Identifying and managing medicolegal consequences.
Managing media relations.
What is root cause analysis?
Root cause analysis is a method of problem solving that identifies root causes. Removing a root cause from a
problem-fault sequence prevents the recurrence of a problem.
How is root cause analysis done?
A variety of techniques can be used to uncover root causes, such as:
1. Cause mapping
2. Change analysis
3. Using the Ishikawa fishbone diagram
4. The “5 whys.”
What should be done when for a period appropriate expertise is not available?
Cases should be referred out
What must the informatics systems in a laboratory support?
- Pathology case management
- Synoptic reporting
- QA activities
- Workload capture
Elements of interpretive pathology testing cycle
- Preinterpretive phase
- Interpretive phase
- Postinterpretive phase
What are the requirements for case review?
Timeliness.
Incorporation into normal laboratory work flow.
Professionalism.
Independent analysis.
Formal documentation.
Targeted review of difficult, or significant and unexpected diagnoses.
Protection from civil legal action.
Which factors are relevant to the timeliness of the report?
Clinical urgency.
Specimen type.
Whether additional investigations and consultations are required.
Definition of addended report
Adds information to a previously completed pathology report
Does not change the diagnosis or any data elements related to the diagnosis.
Definition of amended or corrected report
Changes information in the finalized report.
Can be related to diagnosis vs other information (specimen site, patient identification)
List some reasons for addended and amended reports.
Retrospective reviews.
Acquisition of new information related to ancillary testing.
Receipt of additional clinical information
What are Class II IHC tests and how should the results of these be monitored?
Prognostic and/or predictive tests that trigger specific treatment decisions independent of
morphologic findings and classification
What is a nonconformative report?
Nonconformative report: a report on tests that have not been performed to the appropriate standard
