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QA Flashcards

1
Q

Define Quality

A

Degree of excellents; in the context of health care, it is the extent to which an organization meets client/patient/resident needs and exceeds their expectations

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2
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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3
Q

Why do we need QA in a pathology lab

A
  • to provide documentation that the lab 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
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4
Q

What is proficiency testing

A

A process for evaluating unknown specimens, carried out by pathologists or labs, in which the results are retained and evaluated against a reference standard and compared with the results from other participating labs

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5
Q

What is quality control

A

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

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6
Q

List 3 examples of quality control

A

On slide pos and neg controls in IHC
Daily assessment of H&E stain quality
Daily checking of the temp and pH value of staining solution

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7
Q

What is a quality manual

A

ISO:
A document specifying the quality management system of an organization
Contqains all the lab’s policies

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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 that disease and the findings in a manner that is concise and readily understandable

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10
Q

What is a near miss

A

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

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11
Q

What is a critical incident

A

An incident that significantly alters treatment or results in death/disability. This type of incident must be reported to the provincial minister of health

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12
Q

What is a nonconformity report

A

A report on tests that hav enot been performed to the appropriate standard (ie lab error)

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13
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 the patient’s underlying medical condition. This include an incident, in the course of health care treatent, that results in a recognized risk of a nontrivial adverse outcome or consequence at some future time

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14
Q

Examples of activities in pathology of the physician competencies (CanMEDS framework)

A

Communicator: quality reports, critical values, rounds
Collaborator: interaction with pathology peers and clinicians
Medical expert: diagnostic expertise
Leader/Manager: quality management, resource management, workload assessment, client satisfaction
Health advocate: infection conto, critical values, education
Scholar: teaching, research, conferences, CME
Professional: respecting the call schedule, punctuality, appropriate behaviour

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15
Q

Difference between guidelines and standards

A

Guideliens are a recommended strategy or range of strategies of lab practice. Variation due to patient-specific or lab-specific factors is a reasonable expectation
Standards are accepted principles or lab practice in which variation is not expected

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16
Q

How is QA achieved

A

Measuring a set of performance indicators to determine whether performance conforms to accepted standards, and by seeking to improve performance when accepted standards are not met
Done on a continuing basis
Reports should be generated at least annually and discussed with lab personnel

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17
Q

What does quality mean in surgical pathology

A

A report is timely, accurate, complete, clear

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18
Q

QA procedures in surgical pathology

A

Preanalytical
* 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, staining

Analytical:
* Intradepartmental consultations, consensus conferences
* Intraoperative consultation-permanent section correlation
* Cytology-histology correlation
* Targeted case reviews
* Intra- and interdepartmental case conferences
* Interinstitutional consultations

Postanalytical:
* 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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19
Q

List 5 types of peer reiew

A

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

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20
Q

List 5 types of pathology audit

A

Randon review
Target review
Retrospective review
Prospective review
Accountability review

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21
Q

List 5 QA 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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22
Q

What is a critical diagnosis in AP

A

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

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23
Q

Examples of critical diagnoses in AP

A
  • Crescents in >50% of glomeruli in kidney biopsy
  • Transplant rejetion
  • Leukocytoclastic vasculitis
  • Fat in a colonic endoscopic polypectomy specimen
  • Uterine contents without villi or trophoblasts
  • Mesothelial cells in an endocardial biopsy specimen
  • malignancy in superior vena cava syndrome
  • Neoplasms causing paralysis
  • Unexpected or discrepant findings
  • Infections - any invasive organism in immunocompromised host, AFB in any patient, bacteria in heart valve or bone marrow, HSV in gynepath samples of pregnant patient, PJP
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24
Q

How should critical diagnoses be reported

A

Urgent (same day) verbal notification of the submitting clinician is required in cases of unexpected malignancy or identification of organisms in an immunocompromised patient
Timely notification should otherwise be initiated based on the findings and professional judgement
The notification date, time, method should be documented in report

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25
Q

List components of a complete surgical pathology report

A

Patient ID: name, DOB, health card number, hospital number
Physician ID
Dates when specimen was collected, recieved, processed, reported
Diagnosis
Gross description: labeling, container in which recieved, medium in which recieved, whether opened, orientation, dimensions, weight, sampling, block description
Microscopic description
If relevant: special stains, IHC, biomarkers, molecular, IF, EM, Adequacy, references, additiona comments, additional comments, intaoperative consultation diagnosis, cancer synoptic report, communication with physician, details if corrected/amended, addendum
Diagnosti SNOMED coding
Optional quality-type coding

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26
Q

CAP standards for acceptable turnaround times for reporting intraoperative consultations, surgial pathology specimens, and autopsies

A

Intraop consultation: 90% of cases reported within 20 min per block
Surgpath specimen: 80% of routine cases reported within 2 working days
Autopsy: prelim 3 working days, final 30d for routine, 3 months for complex

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27
Q

Retention of pathology materials and records

A

Most wet tissues 4 weeks after final report
Most slides/blocks 20y

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28
Q

QA indicators for intraoperative consultation

A

Turnaround time
Intraoperative consultation-permanent section discordant rate

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29
Q

4 casuse of intraoperative consultation-permanent section discordance

A

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

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30
Q

Categorize intraop consultation-permanent section correlation results and give thresholds for acceptable deferral and discordance rates

A

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

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31
Q

Categorize clinical impact of intraoperative consultation-permanent section discordance

A

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

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32
Q

QA elements in autopsy pathology

A
  • Preautopsy process timely and complete
  • Permissions appropriate and paperwork complete
  • CLinical questions and medicolegal issues addressed
  • Clionicopathological correlation provided in report
  • Safety regulations adhered to during autopsy
  • Consultation sought for subspec expertise
  • Findings documented via photographs
  • Tissue blocking and slide prep timely and of good quality
  • Ancillary studies used appropriately
  • Prelim and final reports acceptable TAT
  • Cases reviewed at M&M rounds
  • Peer review process followed
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33
Q

Components of complete autopsy report

A
  • Consent
  • Clinical information and questions to be answered by the autopsy
  • Gross findings
  • Microscopic findings
  • Primary diagnosis and comments
  • Cause of death
34
Q

Elements in cytology QA manual

A

Lab personnel
Physical facilities and equipment
Requisition forms, specimen collection, and acessioning
Preparation and staining techniques
Cytotechnologist responsibilities
Screening practices
Diagnostic practice
Reporting
Records
Gynecologic cytology utilization registry
QA practices
Performance evaluation
Continuing education practices

35
Q

Standard staining techniques used for cytopath specimens

A

Gyne: papanicolaou
Fixed nongyne: papanicolaou
Air dried nongyne: Romanowsky-type staining, Giemsa-Wright
Cell-block prep: H&E

36
Q

How should stain quality be monitored in the lab

A

Should be monitored daily with appropriate correction of suboptimal results
Should be filtered or replaced regularly to maintain potency and freedom from contamination

37
Q

What qualifiactions does a director of cytopathology require

A

Must be a legally qualified physician with qualifications in AP and cytopathology. Recommended that the director have extra training and/or experience in cytopathology and lab management to oversee the quality of the lab

38
Q

QA responsbilities of director of cytopathology

A

Update lab manuals (at least annually)
Generate lab QA reports (at least annually)
Conduct regular meetings (at least quarterly) with all lab personnel to discuss lab performance and measures for quality improvement as necessary
Facilitate lab-based CME for all lab personnel
Identify deficiencies in knowledge, attitude, and skill of lab personnel
Faciliate remedial training for lab personnel asd needed

39
Q

How should cytology specimens be screened

A

All nongyne and gyne specimens must be screened by cytotechnologist
Hierarchical screening by senior cytotechnologist or second mandatory screening by another cytotechnologist may be carried out in some labs
Automated screening by approved commercial devices may be used in some labs following protocols recommended by the manufactuer and regulatory bodies

40
Q

Responsibilities and expectations of associate cytopathologists in a department

A

They should
* have malpratice insurance
* consult as needed with cytotechnologists, lab and clinical colleagues
* keep up to date by reviewing current literature and participating in CME
* maintain diagnostic competence in areas they report specimens
* Obtain pertinent clinical information
* Report all cytolog cases referred to them by cytotechnologists
* Provide appropriate feedback on case material to cytotechnologists

41
Q

List rescreening methods for gyne cytology specimens. Why are rescreening procedures carried out

A

Methods include: prospective screening (random, targetted, rapid, or prescreening), retrospective screening
Cytotechnologist with established competence carried out all manual rescreening
Aim of rescreening procedures is to identify false negative results

42
Q

Target rate for prospective rescreening for gyne cytology specimens

A

Total of 10% of all negative gyne cytology specimen should be prospectively rescreened. These slides will be selected through a combination of random and targetted rescreening

43
Q

What is a prospective targetted rescreen

A

Involves rescreening a slide if a patient belongs to a high risk group
* CLinical history of vaginal bleeding or spotting
* History of cervical/vaginal/vulvar carcinoma
* previous cytology reported as at least atypical squam/glandular cells within 2 y
* Abnormal cervix on speculum exam

44
Q

What is a prospective randon rescreen

A

This involves rescreening 10% of randonly selected negative gyne cyto slide
Questionable value in detecting false negatives

45
Q

What is a prospective rapid rescreen

A

Involves rescreening all neg gyne cyto slides for a specific time period (<1min) after a routine screen. Precudes the 10% random rescreen
Increased detection of false negs with this technique

46
Q

What is a prospective rapid prescreen

A

Involves reviewing all gyne cyto slides for abnormal cells (<2min) prior to the full routine screen (at least 6 min). Precludes 10% prescreen
Increased detection of false negs

47
Q

What is involved in retrospective rescreening of gyne cyto specimens

A

If current sample shows high grade abnormality, screening technologist pulls and rescreens the patient’s neg gyne cyto slides from the previous 5y. All slides referred to pathologist for review
Corrected report issued only when findings on rescreening change the patient’s current management
Findings used for educational feedback

48
Q

Indications for cytology-histology correlation

A

Nongyne cyto: malignant cases should be correlated when tissue available. Correlation with concurrent surgical pathology also recommended
Gyne cyto: comparison with concurrent colpo sampled should be carried out. Diagnoses of high grade lesions should be compared to follow up biopsies

49
Q

Purpose of follow up program in cytology

A

Involves correlating cytological dx with biopsy, resection, autopsy dx
* Help resolve apparent cyto-histo discrepany
* Streamline and standardize lab diagnostic criteria
* Provide valuable CME material for lab staff and trainees

50
Q

4 potential applications of high risk HPV testing in gyne cytology

A
  1. Primary HPV screening
  2. Up-front cotesting approach in which both HPV test and cervical cyto specimen are obtained at time of screening
  3. Triage of abnormal cyto result using HPV testing
  4. HPV genotyping - allowed for selective reporting for those with increased risk
51
Q

High risk HPV positivity rate in ASC-US

A

40-50%

52
Q

Underlying risk of HSIL in ASC-US

A

10-20% have underlying HSIL

53
Q

Recommended ASC:SIL ratio and rates for ASC-H and AGC

A

ASC:SIL shoud not exceed 3:1
ASC-H should represent <10% of all ASCs
AGC should represent <1% of cases

54
Q

How should performance indicators be documnted in cyto lab

A

Should be documented annually and include:
* Productivity rates for cytotechs and cytopaths
* Individual performance indicators
* overall lab performance
* Specimen adequacy

55
Q

List gyne cyto performance indicators

A
  • Total number and rates of unsat specimens of the lab, each cytotech, cytopath
  • Total number and rates od each major diagnostic ategory for lab, cytotech, cytopath
  • False neg/pos rates on 10% rescreening
  • High risk HPV rate in AS cases
  • ASC:SIL ratio for lab and cytopath
  • Cytohistological correlation rates for each diagnostic category
  • False neg/pos rates on cyto-histo correlation
  • Screening misses of ASC-H or AGC or other abnormality that changes management
  • Lab TAT
56
Q

Nongyne cyto performance indicators

A
  • Total number of cases categorized by anatomic site and specimen type
  • Total number and rates of unsat cases for lab, cytotech, cytopath
  • Rates for major diagnostic categories
  • Correlation of FNAB with surgical material
  • Major and minor discrepancy rates between cytotech and cytopath
  • Lab TAT
57
Q

3 postanalytical prformance indicators that can be monitored by cytopath lab

A
  1. Number of corrected and supplemental cyto reports issues by lab and/or individual pathologists
  2. Number of internal and external cyto consultations
  3. Number of external review requests, reasons for external consultation, diagnostic discrepancies
58
Q

Performance indicators that should be carried out in specimens obtained via ROSE

A

A comparison of the initial specimen adequacy assessment/prelim dx vs final

59
Q

3 aspirator outcome performance indicators

A

FNAB unsat rates
FNAB complication rates/outcomes
FNAB service satisfaction

60
Q

4 continuing education practices in cytopath

A
  1. Keeping up to date through review of current cytology journals
  2. Consulting appropriate, current cytology textbooks
  3. Attending scientific meetings, review courses, or specialty conferences
  4. Attending lectures or symposia
61
Q

Workload limit for Canadian cytotechs

A

If exclusively screening without othr duties, maximum 60-80 slies in 8h work day
Labs with automated screening technologies such as field of view, number of slides should be adjusted as they are considered half a slide. Slides that require both field of view and full manual review are 1.5x

62
Q

Under what conditions is a cyto case referred from cytotech to a cytopath

A

Gyne:
* all cases of NILM with reparative changes
* All cases of ASC/AGC

All nongyne cyto

63
Q

Sources for external proficiency testing in cytopathology

A
  • CAP
  • ASCP
  • Lab services of ontario
64
Q

3 scenarios in which obstaining a prospective second opinion may be prudent in cyto

A
  1. A sample obtained from an unusual anatomic location
  2. Cyto diagnoses that may results in high stakes treatment deisions
  3. Major discordance between cytotech and cytopath interpretation
65
Q

How to develop QA program in AP

A
  1. Establish QA committee (medical leader, technical manage, QA coordinator)
  2. Develop QA plan based on CAP standard and AP workflow
  3. Create quality manual
  4. Covene regular committee metings to review, monitor, evaluate lab service to ensure quality standards are being met
  5. Identify qualiy improvement opportunities and manage unxpected events
66
Q

Steps in quality improvement initiative

A
  1. Identify a procss that needs to be improved by establishing realistic goals or responding to deficiencies
  2. Measure current level of performance for that process
  3. Determine target or desirable level of performance
  4. Design and implement an intervention to achieve the desired level of performance
  5. Monitor performance
  6. Assess and document improvement
67
Q

4 important types of quality management documents

A
  1. Policy - statement of intent, what is to be done, why
  2. Process - interrelated steps involved in an activity
  3. Standard operating procedure - specific details of how an individual performs the activity
  4. Forms - documentation of what was done
68
Q

What are universal precautions in laboratories

A
  • Apply to handling of human tissue
  • All specimens should be placed in a well constructed container with secure closure to prevent leakage during transport
  • Workers should use appropriate barriers to prevent skin and mucous membrane exposure when in contact with specimens
  • Workers should use biological safety cabinets for procedures that have a high potential to generate droplets
  • Workers should not use mouth pipetting
  • Workers should wash their hands and othr skin surfaes immediately and thoroughly if contaminated AND after completing a lab task
  • Workers should decontaminate equipment after use
  • Workers should take precautions with sharps
69
Q

Info required on a requisition form

A

Patient name
DOB
Provincial health card number
Hospital identification number
Address
Name of requesting health care provider
Anatomic site and laterality
Appropriate clinical history
Date and time of specimen collection

70
Q

Required info on specimen-container label

A

Patient name
DOB
Identifying number
Anatomic site and laterality

71
Q

Standard practices in specimen accessioning

A
  • Specimens should only be accessioned if ordered by an appropriate health care provider
  • A clear rejection policy should be developed and communicated to all lab users
  • Specimens should be accessioned with a unique number
  • Time and date of specimen receipt should be recorded
  • Accessing number should be recorded on each specimen and slide
72
Q

How should slides be labeled

A

2 unique identifiers - accession number and name

73
Q
A
74
Q

Advantages of computerization in labs

A

Accessioning
Reporting
Archiving records
Accessing data for QA

75
Q

Processes involved in handling adverse event

A
  • Incident review and root cause analysis
  • Performance review and performace management
  • Disclosure
  • Identifying and managing medicolegal concerns
  • Managing media relations
76
Q

Define root cause analysis

A
  • Method of problem solving that identified root causes
  • The root cause is the factor that removal of which prevents a recurrence
77
Q

Purpose of root cause analysis

A

To idehntify the causes, factors or sources of variation that led to a specific event, result, or defect in a product or process

78
Q

How is root cause analysis done

A

Variety of techniques - cause mapping, change analysis, Ishikawa fishbone diagram, 5 whys
Process poses 3 questions:
1. what was the problem
2. What were the causes of the problem
3. What actions should be taken to prevent the problem from recurring

79
Q

What should you do if you notice that one of your colleagues has made a diagnostic erre that could impact the care of the patient

A
  1. Discuss case with colleague
  2. If they agree - they should inform clinician and issue amended report
  3. If disagree - third opinion should be sought
  4. Notify clinician so not irreversible clinican management takes plae before diagreement is resolved
  5. If colleague refuses to seek third opinion, notify lab medical director
80
Q

A surgeon approaches you because they strongly disagree with a diagnosis your colleague has made. What do you do?

A

Obtain clinical information as to the nature of the disagreement and surgeon’s reasons for not approaching your colleague directly
Review case
Discuss situation with colleague
If there is new information, collaborate with colleague to issue an addendum or corrected/amended report

81
Q

If a surgeon asks you to review all the cases your colleague signs out, what do you do?

A

Clarify reason for request
Contact lab medical director to manage the issue

82
Q

What are the foundational elements for interpretive pathology QA

A
  • Appropriate governance, and oversight at jurisdictional and instutitional level, linkaget to existing QA programs
  • Accreditation
  • A human resource plan, workload measurement and sufficent staffing
  • Appropriate training, licensure, credentialing and continuing professional development
  • Privacy, confidentiality, disclosure and duty to report
  • Informatics and qualityt documentation systems
  • Appropriate pathologist workspace and related tools

RC (20 decks)

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