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Gao Review Book > QA/QC > Flashcards

QA/QC Flashcards

1
Q

Define quality assurance

A

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

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2
Q

Give 3 reasons why we need QA in a pathology laboratory

A
  1. To provide documentation that the laboratory functions to an acceptable standard.
  2. To identify the source of an error or areas that need to be improved.
  3. To promote processes for reducing error and improving patient care.
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3
Q

What is proficiency testing?

A

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.

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4
Q

What is quality control?

A

A system of routine techniques and activities performed to control the quality of the product being produced or
the service being provided.

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5
Q

What is a quality manual?

A

A document specifying
the quality management system of an organization.

It contains all of the laboratory’s policies

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6
Q

What is a near miss?

A

An incident that has no impact due to timely intervention or chance

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7
Q

What is a critical incident?

A

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

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8
Q

What is a medical error?

A

The failure of a planned action to be completed as intended, or the use of an incorrect plan to achieve an aim.

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9
Q

What is a pathology error?

A

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.

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10
Q

What is an adverse event

A

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

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11
Q

CanMEDS framework?

A

Communicator
Collaborator
Medical expert
Leader (Manager)
Health advocate
Scholar
Professional

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12
Q

What is the difference between guidelines and standards

A

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.

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13
Q

What does quality mean in surgical pathology?

A

Quality indicates that a pathology report is:
Timely.
Accurate.
Complete, clearly communicating all necessary information

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14
Q

What QA procedures apply to surgical pathology?

A

Pre-analytical
Analytical
Post-analytical phase

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15
Q

Example of pre-analytical phase

A

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.

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16
Q

Example of analytical phase

A

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.

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17
Q

Examples of post-analytical phase

A

Monitoring turnaround time.
Reviewing report quality, such as use of synoptic reporting and standard terminology.
Reviewing amended reports.
Reviewing record-keeping and storage systems.

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18
Q

List 5 types of peer review.

A

Intraoperative consultation-permanent section correlation.
Cytology-histology correlation.
Intradepartmental consultation.
Interinstitutional consultations.
Audits.

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19
Q

List 5 types of pathology audit.

A

Random review.
Targeted review.
Retrospective review.
Prospective review.
Accountability review.

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20
Q

List 5 quality assurance processes that might reveal diagnostic discrepancies

A

Peer review.
Reviews of previous cases in light of follow-up.
Interdisciplinary conferences or tumor boards.
Clinician requested reviews.
Amended report rate

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21
Q

What is a critical diagnosis in anatomical pathology?

A

Any anatomical pathology result that has the potential to negatively impact patient care if not communicated in
an urgent and timely fashion

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22
Q

List examples of critical diagnoses in anatomical pathology.

A

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.

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23
Q

How should critical diagnoses be reported?

A

Urgent same day timely notification
The notification date, time, and method (e.g., telephone call, email, fax, etc.) should be documented in the
report

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24
Q

What are the College of American Pathologists (CAP) standards for acceptable turnaround times for reporting
intraoperative consultations, surgical pathology specimens, and autopsies?

A

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.

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25
Q

CAP ACP Retention Guidelines for wet tissue

A

4 weeks after final report

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26
Q

CAP ACP Retention Guidelines for paraffin blocks and slides

A

20 years

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27
Q

CAP ACP Retention Guidelines for paper requisition

A

2 years

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28
Q

CAP ACP Retention Guidelines for reports

A

10 years

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29
Q

CAP ACP Retention Guidelines for consultations

A

indefinitely

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30
Q

CAP ACP Retention Guidelines for cyto slides, negative and unsatisfactory

A

5 years

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31
Q

CAP ACP Retention Guidelines for cyto cell blocks

A

20 years

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32
Q

CAP ACP Retention Guidelines for cyto slides, suspicious and positive

A

20 years

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33
Q

CAP ACP Retention Guidelines for FNAB

A

20 years

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34
Q

CAP ACP Retention Guidelines for autopsy wet tissue

A

3 months after final report

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35
Q

CAP ACP Retention Guidelines for autopsy paraffin blocks

A

20 years

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36
Q

CAP ACP Retention Guidelines for autopsy slides

A

10 years

37
Q

CAP ACP Retention Guidelines for hospital autopsy records

A

Indefinitely

38
Q

CAP ACP Retention Guidelines for electron microscopy

A

20 years

39
Q

CAP ACP Retention Guidelines for immunofluorescence slides

A

1 month after case verification in refrigerator

40
Q

CAP ACP Retention Guidelines for immunofluorescence frozen tissue

A

20 years at -70 C

41
Q

CAP ACP Retention Guidelines for electron microscopy

A

Indefinitely

42
Q

What are the QA indicators for intraoperative consultation

A

Turnaround time.
Intraoperative consultation-permanent section discordant rate.

43
Q

List 4 causes of intraoperative consultation-permanent section discordance

A

Technical issue: 10%.
Interpretative error: 40%.
Sampling error: 40%.
Incorrect or incomplete clinical history: 10%.

43
Q

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).

A

Agreement.
Deferral, appropriate.
Deferral, inappropriate, 10% threshold.
Disagreement, minor.
Disagreement, major 3% threshold

44
Q

Categorize the clinical impact of intraoperative consultation-permanent section discordance

A

No clinical significance.
Minor or questionable significance.
Major or potentially major significance

45
Q

List the components of a complete autopsy report

A

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.

46
Q

What are the standard staining techniques used for cytopathologic specimens

A

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

47
Q

List the rescreening methods for gynecologic cytology specimens

A

Prospective rescreening: targeted, random, rapid, or prescreening.
Retrospective rescreening

48
Q

Why are rescreening procedures carried out?

A

The aim of rescreening procedures is to identify false negative results

49
Q

What is the target rate of prospective rescreening for gynecologic cytology specimens?

A

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.

50
Q

What is a prospective targeted rescreen?

A

Rescreening a slide if the patient belongs to a high risk group

51
Q

High risk group in a prospective targeted rescreen?

A

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.

52
Q

What is a prospective random rescreen?

A

This involves rescreening 10% of randomly selected negative gynecologic cytology slides.
It is of questionable value in detecting false negatives

53
Q

What is a prospective rapid rescreen?

A

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.

54
Q

What are 4 potential applications of high risk human papillomavirus (hrHPV) testing in gynecologic cytology

A

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

55
Q

What is the hrHPV positivity rate in gynecologic cases with a cytologic diagnosis of atypical squamous cells of
undetermined significance (ASC-US)?

A

High risk HPV: 40-50% of cases

56
Q

What is the underlying risk of HSIL in ASC-US cases?

A

10-20% have underlying HSIL

57
Q

Recommended target rate for ASC-SIL ratio

A

Should not exceed 3:1

58
Q

Recommended target rate for ASC-H

A

<10% of all ASC interpretations

59
Q

How many of ASC-H should have underlying HSIL

A

30-40%

60
Q

Recommended target rate for AGC

A

<1%

61
Q

What are performance indicators in a cytology lab

A

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.

62
Q

List at least 5 gynecologic cytology performance indicators

A

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).

63
Q

List at least 5 non-gynecologic cytology performance indicators.

A

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).

64
Q

List 3 postanalytical performance indicators that can be monitored by the cytopathology laboratory

A

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

65
Q

What performance indicator should be carried out in specimens obtained via rapid on-site evaluation (ROSE)?

A

A comparison of the initial specimen adequacy assessment/preliminary diagnosis versus the final diagnosis

66
Q

What are 3 aspirator outcome performance indicators?

A

FNAB unsatisfactory rates.
FNAB complication rates/outcomes.
FNAB service satisfaction (e.g., clinician feedback survey).

67
Q

What is the workload limit for cytotechnologists in the United States and Canada?

A

If cytotechnologists are exclusively screening without other duties, the maximum is 60–80 slides in an
average 8-hour working day

68
Q

When is a cytology case referred from a cytotechnologist to a cytopathologist?

A

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.

69
Q

List at least 3 sources of external proficiency testing.

A

College of American Pathologists (CAP) (PAP, nongynecologic).
American Society of Clinical Pathologists (ASCP) (CheckPath program).
Laboratory Services of Ontario

70
Q

List 3 scenarios in which obtaining a prospective second opinion may be prudent in cytopathology

A

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

71
Q

List 4 important types of quality management documents

A

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.

72
Q

What information is required on a requisition form?

A

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.

73
Q

What information is required on a specimen-container label?

A

Patient name.
Date of birth.
Identifying number.
Anatomic site and laterality of the specimen

74
Q

What advantages does computerization have in laboratories?

A

Computerization facilitates:
- Accessioning.
- Reporting.
- Archiving records.
- Accessing data for QA practices

75
Q

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?

A

Pancytokeratin to identify carcinoma.
CD45 to identify lymphoma.
S100 to identify melanoma.
A neuroendocrine marker such as synaptophysin, CD56 or chromogranin.

76
Q

What are the processes involved in handling an adverse event?

A

Incident review and root cause analysis.
Performance review and performance management.
Disclosure.
Identifying and managing medicolegal consequences.
Managing media relations.

77
Q

What is root cause analysis?

A

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.

78
Q

How is root cause analysis done?

A

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.”

79
Q

What should be done when for a period appropriate expertise is not available?

A

Cases should be referred out

80
Q

What must the informatics systems in a laboratory support?

A
  1. Pathology case management
  2. Synoptic reporting
  3. QA activities
  4. Workload capture
81
Q

Elements of interpretive pathology testing cycle

A
  1. Preinterpretive phase
  2. Interpretive phase
  3. Postinterpretive phase
82
Q

What are the requirements for case review?

A

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.

83
Q

Which factors are relevant to the timeliness of the report?

A

Clinical urgency.
Specimen type.
Whether additional investigations and consultations are required.

84
Q

Definition of addended report

A

Adds information to a previously completed pathology report
Does not change the diagnosis or any data elements related to the diagnosis.

85
Q

Definition of amended or corrected report

A

Changes information in the finalized report.
Can be related to diagnosis vs other information (specimen site, patient identification)

86
Q

List some reasons for addended and amended reports.

A

Retrospective reviews.
Acquisition of new information related to ancillary testing.
Receipt of additional clinical information

87
Q

What are Class II IHC tests and how should the results of these be monitored?

A

Prognostic and/or predictive tests that trigger specific treatment decisions independent of
morphologic findings and classification

88
Q

What is a nonconformative report?

A

Nonconformative report: a report on tests that have not been performed to the appropriate standard

Gao Review Book (2 decks)

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