Gao : Chapitre 19 (Contrôle qualité et gestion de laboratoire)

Question 1

Qu’est-ce que l’assurance qualité?

Answer 1

• Il s’agit d’un système permettant de réviser les procédures utilisées par des gens qui performent régulièrement un service ou qui produisent un produit afin de s’assurer que des standards de qualité sont maintenus

Question 2

Qu’est-ce que la qualité?

Answer 2

Osti (pu capab côlisse)

• Le Conseil Canadien d’Accréditation des Soins de Santé définit la qualité comme étant
  
  • Un degré d’excellence en contexte de soin de santé. C’est les efforts devant être mis en place par une organisation afin de remplir les besoins de ses patients/clients/résidents et dépasser leurs attentes

Question 3

Pourquoi a-t-on besoin d’un système de contrôle-qualité dans un laboratoire de pathologie?

Why do we need quality assurance in a pathology laboratory?

Answer 3

• Afin de documenter que le laboratoire fonctionne selon des standards acceptables
• Afin d’identifier la source d’une erreur et les zones qui peuvent être améliorées
• Afin de promouvoir des processus permettant de diminuer les erreurs et d’améliorer les soins offerts aux patients

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

Question 4

Qu’est-ce qu’une évaluation de la compétence?

What is proficiency testing?

Answer 4

• Il s’agit d’un processus par lequel des échantillons inconnues sont analysés/processés par un pathologiste/laboratoire puis les résultats obtenus comparés à un standard de référence et aux résultats des autres laboratoires participants

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.

Question 5

Qu’est-ce que le contrôle-qualité?

What is quality control?

Answer 5

Il s’agit d’un système de techniques/activités de routine qui sont effectuées afin de contrôler la qualité de la production d’un produit ou d’un service rendu

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

Review course CAP-ACP: tools/measures included in every test to help detect and correct defects in the system (reactive process/after).

In contrast with with quality assurance that is a proactive, ongoing, comprehensive processs).

Question 6

Nommez 3 exemples de mesures de contrôle-qualité.

List 3 examples of quality control

Answer 6

• Contrôles positifs/négatifs sur une lame d’IHC
• Évaluation quotidienne de la qualité du marquage H&E
• Évaluation quotidienne de la température et du pH des solutions de coloration

On slide positive and negative control in immunohistochemistry.

Daily assessment of H&E stain quality.

Daily checking of the temperature and pH value of a staining solution.

Question 7

Qu’est- ce qu’un “manuel de qualité”?

What is a “quality manual”?

Answer 7

• L’Organisation International pour la Standardisation (ISO) décrit ce document comme étant “un document spécifiant le système de gestion de la qualité d’une organisation”. Il contient toutes les politiques d’un laboratoire.

The International Organization for Standardization (ISO) describes it as “a document specifying the quality management system of an organization.” It contains all of the laboratory’s policies.

Question 8

Qu’est-ce qu’une erreur médicale?

What is a medical error?

Answer 8

• L’échec d’une action a être complétée telle que planifiée OU l’usage d’un plan inappropriée pour accomplir un objectif

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

Question 9

Qu’est-ce qu’une erreur en pathologie?

What is a pathology error?

Answer 9

• L’incapacité à fournir en dedans d’un laps de temps approprié un rapport pathologique qui décrit de façon précise, complète, concise et facilement compréhensible un processus pathologique

Pathology error: the failure to provide a timely pathology report that accurately and thoroughly describes the disease or the findings in a manner that is concise and readily understandable.

Question 10

Qu’est-ce qu’un “near miss”?

What is a near miss?

Answer 10

• Un incident qui n’a pas d’impact par chance ou secondairement à une autre intervention

Near miss: an incident that has no impact due to timely intervention or chance.

Question 11

Qu’est-ce qu’un incident critique?

What is a critical incident?

Answer 11

• Un incident qui altère significativement le plan de traitement ou qui entraîne la mort/des séquelles
• Ce type d’incident doit être rapporté au ministère de la santé

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

Question 12

Qu’est-ce qu’un rapport de non-conformité?

What is a nonconformative report?

Answer 12

• Rapport sur un test qui n’a pas été effectué selon les standards appropriés (erreur du laboratoire)

Nonconformative report: a report on tests that have not been performed to the appropriate standard (i.e., laboratory error).

Question 13

Qu’est-ce qu’un évènement indésirable?

What is an adverse event?

Answer 13

• Définit comme un évènement inattendu lors de la prestation des soins qui entraîne un effet délétère pour le patient et qui est relié aux soins/services reçus par ce patients plutôt qu’aux conditions médicales préexistantes du patient.
• Cela inclus un accident lors du traitement qui entraîne un risque d’effet secondaire non bénin ou une conséquence survenant à un moment ultérieur.

The Health Insurance Reciprocal of Canada defines an adverse event as “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.”

Question 14

Quelles sont les compétences CanMED?

What are the physician competencies defined by the CanMEDS framework?

Answer 14

• Communicateur : qualité des rapports; communication
• Collaborateur : interaction avec les autres pathologistes et les cliniciens
• Expertise médicale : expertise diagnostique
• Leader : gestion du contrôle-qualité; gestion des ressources; évaluation de la charge de travail; évaluation de satisfaction des patients
• Promotion de la santé : contrôle des infections; valeurs critiques; éducation
• Érudition : enseignement; recherche; congrès; éducation médicale continue
• Professionnalisme : être ponctuel; comportement approprié; respecter l’horaire de garde

Question 15

Quelle est la différence entre une ligne directrice et un standard de pratique?

What is the difference between guidelines and standards?

Answer 15

• Ligne directrice : une stratégie recommandée de pratiques de laboratoires. Une certaine variation secondairement aux facteurs spécifiques au patient et au laboratoire est attendue
• Standard de pratique : principes de fonctionnements du laboratoire dont aucune variation n’est attendue

Guidelines: a recommended strategy or range of strategies of laboratory practice. Variation due to patient-specific or laboratory-specific factors is a reasonable expectation.

Standards: accepted principles of laboratory practice in which variation is not expected

Question 16

Comment l’assurance qualité est-elle réalisée?

How is quality assurance achieved?

Answer 16

• En mesurant des indicateurs de performance prédéfinis pour voir si les standards sont respectés et en cherchant à améliorer la performance lorsque les standards ne sont pas respectés
• Processus continuel
• Des rapports devraient être générés au-moins annuellement et présentés/discutés avec le personnel du laboratoire

By 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.

It is done on a continuing basis.

Reports should be generated at least annually and discussed with laboratory personnel

Question 17

Quelles procédures d’assurance-qualité peuvent être utilisées en pathologie chirurgicale?

Answer 17

• Phase pré-analytique :
  
  • Monitor specimen delivery timeliness and specimen condition.
  • Monitor adequacy of clinical history (completeness, relevance).
  • Monitor specimen identification errors and lost specimens.
  • Monitor errors in accession, fixation, grossing, embedding, cutting, and staining
• Phase analytique :
  
  • Prospective:
    
    • Perform intradepartmental consultations.
    • Convene consensus conferences.
  • Retrospective:
    
    • Review frozen section–permanent section correlation.
    • Review cytology–histology correlation.
    • Perform random case reviews.
    • Perform targeted organ system reviews.
    • Convene intradepartmental and interdepartmental conferences.
    • Perform interinstitutional reviews
• Phase post-analytique :
  
  • Monitor turnaround time.
  • Review quality of reports (e.g., use of synoptic reporting, standard terminology).
  • Review addendum reports.
  • Review record-keeping and storage systems.

Question 18

À quoi réfère la qualité en contexte de pathologie chirurgicale?

What does quality mean in surgical pathology?

Answer 18

Quality indicates that a pathology report is:

• Timely
• Accurate
• Complete (clearly communicates all necessary information)

Question 19

List 4 examples of quality assurance in surgical pathology.

Answer 19

• Frozen section–permanent section correlation.
• Cytology–histology correlation.
• Turnaround time.
• Percentage of amended reports.

Question 20

List 5 types of pathology audit

Answer 20

• Random review
• Targeted organ system review
• Retrospective review
• Prospective review
• Accountability review

Question 21

List 5 types of peer review.

Answer 21

• Frozen section–permanent correlation.
• Cytology–histology correlation.
• Intradepartmental consultation.
• External consultation.
• Institute audits.

Question 22

List 5 quality assurance processes that might reveal diagnostic discrepancies.

Answer 22

• Frozen section–permanent section correlation
• Cytology–surgical correlation
• Case review correlation rate
  
  • Interdisciplinary conferences/tumor boards
  • Clinician requested reviews
  • Reviews of previous cases in light of follow-up
  • External consultations
• Amended report rate
• Audits

Question 23

What is critical value in anatomical pathology?

Answer 23

Critical value: any anatomical pathology result that has the potential to negatively impact patient care if not communicated in an urgent and timely fashion.

Question 24

List examples of critical value in anatomical pathology.

Answer 24

• Crescents in > 50% of glomeruli in a kidney biopsy specimen
• Leukocytoclastic vasculitis
• Uterine contents without villi or trophoblasts
• Fat in an endometrial curettage specimen
• Mesothelial cells in an endocardial biopsy specimen
• Fat in a colonic endoscopic polypectomy specimen
• Transplant rejection
• Malignancy in superior vena cava syndrome
• Neoplasms causing paralysis
• Unexpected or discrepant findings :
  
  • Significant disagreement between frozen section and final diagnoses
  • Significant disagreement between immediate interpretation and final diagnosis by fine-needle aspiration biopsy (FNAB)
  • Unexpected malignancy.
• Significant disagreement and/or change between diagnoses of primary pathologist and external pathologist consulted
• Infections :
  
  • Bacteria or fungi in cerebrospinal fluid cytology in immunocompromised or immunocompetent patients
  • Pneumocystis organisms, fungi, or viral cytopathic changes in bronchoalveolar lavage, bronchial washing, or brushing cytology specimens in immunocompromised or immunocompetent patients
  • Acid-fast bacilli in immunocompromised or immunocompetent patients
  • Fungi in FNA specimens of immunocompromised patients.
  • Bacteria in heart valve or bone marrow.
  • Herpes in Papanicolaou smears of near term pregnant patients
  • Any invasive organism in surgical pathology specimens of immunocompromised patients

Question 25

List the components of a complete surgical pathology report.

Answer 25

• Patient identification: name, hospital number, date of birth
• Physician identification
• Dates: date of procedure, date received, date processed, date reported
• Gross description: labeling, fresh/saline/formalin, description (containers, sampling in toto/representative, orientation, fragments, open/unopened)
• Any special stain and immunohistochemistry
• Diagnosis or any communication made to physician
• Cancer synoptics
• Coding: SNOMED (diagnostic coding), quality type coding (optional).

Question 26

What are the College of American Pathologists (CAP) standards of acceptable turnaround time for reporting frozen sections, surgicals, and autopsies?

Answer 26

• Frozen sections: 90% report at 20 minutes per block.
• Surgical pathology: 80% of routine cases report within 2 working days. (Different benchmarks outside of the United States have acceptable turnaround times in the range of 2–7 days.)
• Autopsy preliminary: 3 working days. Final report: 30 working days for routine cases, 3 months for complex cases.

Question 27

Discuss the Canadian guidelines on retention of blocks, slides, and laboratory records

Answer 27

Question 28

What are the quality assurance indicators in frozen sections?

Answer 28

• Turnaround time
• Frozen section–permanent section discordant rate.

Question 29

List 4 causes of frozen section–permanent section discordance.

Answer 29

• Technical problem: 10%
• Interpretative error: 40%
• Sampling (tissue sampling or block sampling) error: 40%
• Inadequate (incorrect/incomplete) clinical history: 10%.

Question 30

What is the acceptable rate of major discordance between frozen section and permanent section diagnosis?

Answer 30

The acceptable rate is 3%.

Question 31

Categorize frozen section–permanent section correlation and describe the recommended correlation threshold according to the Association of Directors of Anatomic and Surgical Pathology (ADASP).

Answer 31

• Agreement
• Deferral — appropriate
• Deferral — inappropriate (ADASP recommends 10% threshold)
• Disagreement — minor
• Disagreement — major (ADASP recommends 3% threshold)
• Denominator must be consistent (blocks vs. cases).

Question 32

Categorize frozen section–permanent section discordance based on medical consequences.

Answer 32

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

Question 33

What do you need to check to conduct quality assurance in autopsy?

Answer 33

• Preautopsy process timely and complete?
• Permissions appropriate and paperwork complete?
• Clinical questions/medical-legal issues addressed?
• Clinicopathological correlation provided in report?
• Cases reviewed at morbidity and mortality rounds?
• Safety regulations adhered to during autopsy?
• Preliminary and final reports within accepted timeframe?
• Consultation sought, when required, for subspecialty expertise?
• Documentation of findings via digital photographs?
• Timely tissue blocking and slide preparation and quality?
• Ancillary studies used appropriately?
• Peer review process followed?

Question 34

List the components of a complete autopsy report.

Answer 34

• Consent
• Clinical information and any question/problem (this should be the clinician’s responsibility)
• Gross/histology findings (optional, but it is necessary to report that microscopy was done)
• Primary diagnosis, comments
• Cause of death.

Question 35

What are elements in a cytology quality assurance manual?

Answer 35

• Personnel
• Physical facility
• Equipment
• Specimen collection, requisitioning, and accessioning
• Preparation and staining techniques
• Pathologist responsibilities
• Cytotechnologist responsibilities
• Screening practices
• Diagnostic practices
• Reporting
• Records
• Gynecologic cytology utilization registry
• Quality assurance
• Performance evaluation
• Proficiency testing
• Continuing education.

Question 36

What are standard staining techniques on cytopathologic specimens?

Answer 36

• For gynecological specimens: Papanicolaou staining
• For fixed nongynecological specimens: Papanicolaou staining
• For air-dried gynecological specimens: Romanowsky-type staining.

Question 37

Who can be the director of cytopathology?

Answer 37

A physician specialist with qualifications in anatomical pathology and cytopathology.

Question 38

What responsibilities for quality assurance does a director of cytopathology have?

Answer 38

• Quality assurance reports (at least annual).
• Updated laboratory manuals (at least annual).
• Regular meetings about laboratory performance with all laboratory personnel (at least every quarter)
• Continuing education for all laboratory personnel
• Identification of deficiencies in knowledge, attitude, and skills of laboratory personnel
• Remedial training for laboratory personnel.

Question 39

How should cytology specimens be screened?

Answer 39

• Screening by a cytotechnologist: required for all nongynecological (including FNABs) and all gynecological specimens
• Hierarchal screening by a senior cytotechnologist or second mandatory screening by another cytotechnologist: routine in some labs for some gynecological and nongynecological specimens
• Automated screening by approved commercial devices: used in some labs following protocols recommended by the manufacturer and regulatory bodies.

Question 40

What are the responsibilities of, or expectations for, cytopathologists?

Answer 40

They should :

• Have malpractice insurance
• Consult, as needed, with cytotechnologists, laboratory and clinical colleagues, and other allied health providers
• Keep up to date via continuing education and reviewing current literature
• Maintain diagnostic competence: report a sufficient variety of gynecological and nongynecological material each year.
• Obtain pertinent clinical information
• Report all cytology referred to them by cytotechnologists
• Give appropriate feedback on case material to cytotechnologists

Question 41

What is the recommended reporting terminology?

Answer 41

• The Bethesda System (TBS) should be used as the primary diagnosis for gynecological cytology.
• For nongynecological cytology, use clear interpretive terminology and published classification systems.

Question 42

Describe the methods of rescreening practiced in gynecological pathology.

Answer 42

• Methods include :
  
  • Prospective: targeted, random, rapid, or prescreening. - Retrospective
  • A cytotechnologist carries out all manual rescreening and documents all details.

Question 43

. What should be the rate of prospective rescreening?

Answer 43

A total of 10% of negative gynecological cytology

Question 44

What is a targeted rescreen?

Answer 44

• Targeted rescreen: a strategy to rescreen slides of patients in high risk groups
• High risk patients include those with :
  
  • 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.

Question 45

What is random rescreening?

Answer 45

• Random rescreening: rescreening a randomly selected proportion of negative gynecological cytology
• It is of questionable value in detecting false negatives.

Question 46

What is rapid rescreening?

Answer 46

• Rapid rescreening: a review of all negative gynecological cytology for a specified time period (< 1 minute) after a routine screen. The use of this method precludes the 10% rescreen
• There is increased detection of false negatives with this technique.

Question 47

What is rapid prescreening?

Answer 47

• Rapid prescreening:
  
  • A review of all gynecological cytology for abnormal cells (< 2 minutes), prior to the full routine screen (≥ 6 minutes)
  • There is increased detection of false negatives with this technique

Question 48

How do you conduct retrospective rescreening?

Answer 48

• Retrospective rescreening:
  
  • Acytotechnologist rescreens, and then refers to a pathologist, all negative gynecological cytology of the previous 3 years in a woman with current cytology showing ≥ high grade squamous intraepithelial lesion (HSIL) or adenocarcinoma in situ (AIS)
  • A corrected report is issued only when findings on rescreening change the current management of the case
  • The findings are used for educational feedback.

Question 49

What are the indications of cytology–histology correlation?

Answer 49

• Nongynecological: all positive cases
• Gynecological: all diagnoses of invasive carcinoma, HSIL, and AIS

Question 50

What is the purpose of a follow-up program?

Answer 50

• A follow-up program involves correlating cytological diagnoses with biopsy, resection, or autopsy diagnoses.
• It can help resolve apparent biopsy discrepancies
• It can streamline and standardize laboratory diagnostic criteria.

Question 51

How can the atypical squamous cells of undetermined significance (ASCUS) rate be verified?

Answer 51

• ASCUS should be positive for human papillomavirus (HPV) at a rate of 44%.
• A rate that is 2 standard deviations away from 44% should lead to reinterpretation of ASCUS diagnosis and HPV prevalence in population

Question 52

How should the ASCUS patient be managed?

Answer 52

• ASCUS if HPV positive: go to colposcopy
• ASCUS if HPV negative: routine follow-up.

Question 53

What is the atypical squamous cell-high grade (ASC-H) rate and the atypical glandular cell (AGC) rate?

Answer 53

• ASC-H:
  
  • This represents 5–10% of overall ASC cases (0.5–1.0% overall depending on population)
  • Of these, 30–40% will have underlying HSIL.
• AGC:
  
  • This represents < 1% (0.11–2.10%) of cases.
  • Of these, 41% show significant lesions on follow-up.

Question 54

How should performance indicators be documented?

Answer 54

• Performance indicators should be documented at least annually, and include:
  
  • Productivity rates for each cytotechnologist and pathologist
  • Individual performance indicators (delivered confidentially)
  • Specimen adequacy, which may be communicated to individual health care providers
  • Overall laboratory performance, which should be shared with all personnel
  • Note that no national standard exists: laboratories should aim for equivalency with comparable laboratories and published data.

Question 55

List 5 gynecological cytopathology performance indicators.

Answer 55

• The total number and rates of unsatisfactory specimens
• The false negative/positive rate on 10% rescreening
• HPV positive rate in ASC
• Percentage of ASC and AGC, and the atypical squamous cell/squamous intraepithelial lesion (ASC/SIL) ratio
• Cytohistological correlation rates for HSIL, ASC-H, AIS, and malignancy
• False negative/positive rate in cytology–histology correlation
• Screening misses of ASC-H or AGC or other abnormality that changes management
• Turnaround time (from receiving specimen to finalized report).

Question 56

List at least 5 nongynecological cytology performance indicators.

Answer 56

• The total number of cases categorized by anatomic site and type of specimen
• The total number and rates of unsatisfactory cases
• The rates of major diagnostic categories (e.g., unsatisfactory, negative, atypical, suspicious, malignant) for the laboratory overall and for major groups of nongynecological cytology
• Correlation of results of FNAs with their corresponding surgical material — at a minimum, the malignant diagnoses should be correlated
• Sensitivity and specificity rates. • Discrepancy (minor and major) between cytotechnologist and pathologist diagnoses
• Turnaround time.

Question 57

List at least 3 performance indicators for gynecological and/or nongynecological cytopathology.

Answer 57

• Workload: the number of gynecological, nongynecological, and total cytology cases and slides
• The number and reasons for corrected and supplemental cytology reports
• The number of internal and external cytology consultations
• The number of external review requests, the reasons for external consultation, and discrepancies

Question 58

What is the FNAB performance indicator?

Answer 58

A comparison of adequacy assessment/preliminary diagnosis to the final diagnosis.

Question 59

What are 3 aspirator outcome performance indicators?

Answer 59

• FNAB unsatisfactory rates
• FNAB complication outcomes
• Service satisfaction.

Question 60

List 4 continuing education practices in cytopathology.

Answer 60

• Reading 1 or more cytology journals
• Consulting appropriate, current cytology textbooks
• Attending scientific meetings, review courses, or specialty conferences
• Attending lectures or symposia

Question 61

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

Answer 61

• US workload limit: primary screen maximum 100 slides/24 hours; at least 8 hours screen time needed (i.e., 12.5/hour). Secondary review is not regulated
  
  • Automatic system assist in screening (thinprep, focalpoint): each machine-screened slide counts as 0.5 slides of daily 100 limit in the US.
• Canadian workload limit: 60–80 slides cumulative in an average 8-hour working day.

Question 62

Under what conditions is a cytology case referred to a pathologist?

Answer 62

• Gynecologic cytology screened as “negative for SIL or malignancy” (excluding reparative changes) may be finalized by a cytotechnologist.
• All other gynecological cytology (i.e., > ASC or AGC) must be referred to a pathologist for reporting
• All nongynecological cytology must be signed out by a pathologist
• The pathology report must document the names of the cytotechnologist and the pathologist.

Question 63

Discuss Canada guidelines regarding the retaining of blocks, slides, and paper records.

Answer 63

Question 64

List at least 3 sources of external proficiency testing.

Answer 64

• College of American Pathologists (CAP) (PAP, nongynecological)
• American Society of Clinical Pathologists (CheckPath program)
• Quality Management Program (Laboratory Services of Ontario), which is now compulsory for cytopathology laboratories throughout Quebec
• Laboratory Services of Ontario (CheckPath program of ASCP, PAP program of CAP)

Question 65

List at least 3 quality assurance procedures in gynecological cytology.

Answer 65

• Prospective rescreening of negative gynecological cytology: 10%.
• Random. - Targeted. • Rapid prescreening/rescreening
• Retrospective screening of all newly diagnosed HSIL/AIS
• Cytology–histology correlation.

Question 66

List at least 3 quality assurance procedures in nongynecological cytology.

Answer 66

• Cytology–histology correlation
• Turnaround time
• Retrospective review
• Site specific review

Question 67

List at least 5 examples of critical diagnoses in cytology.

Answer 67

• Bacteria or fungi in cerebrospinal fluid cytology in all patients
• Herpes infection in Papanicolaou smear of near term pregnant woman
• Pneumocystic, fungal, or viral cytopathic changes in bronchoalveolar lavage, bronchial washing, and brushing cytology specimens in all patients
• Candida on placental membrane
• Acid-fast stain that is positive in any patient
• Any invasive organism in any specimen from an immunocompromised patient
• Fungi in FNAB specimen of an immunocompromised patient
• Unexpected cancer diagnosis
• Discordance between preliminary and final diagnosis.

Question 68

How would you develop a quality assurance program in anatomical pathology?

Answer 68

• Establish a quality assurance committee that includes a medical leader, technical managers, and quality assurance coordinators
• Develop a quality assurance plan based on CAP standards and anatomical pathology workflow:
  
  • Preanalytical: from the point when a specimen is removed from the patient (through delivery to the laboratory and processing in the laboratory) to when the slide is ready for the pathologist
  • Analytical: from the point when the pathologist receives the slide to when the pathologist verifies the report
  • Postanalytical: from the point when the report is verified to when the clinician acts on it
• Draw up a quality manual (a document that specifies the quality management system of the laboratory)
• Convene regular committee meetings to review, monitor, and evaluate various aspects of the laboratory service to ensure that standards of quality are being met
• Identify quality improvement opportunities and manage unexpected events.

Question 69

List 4 important quality management documents.

Answer 69

• Policy: statement of intent, what is to be done and why, the goal
• Process: the interrelated steps involved in an activity; often involves a number of individuals and 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

Question 70

What are universal precautions in laboratories?

Answer 70

Universal precautions apply to semen, human tissue, cerebrospinal fluid, and synovial fluid, and to pleural, peritoneal, pericardial, and amniotic fluids.

• Workers should routinely use appropriate barriers (gloves, aprons, masks, protective eyewear, or face shields) to prevent skin and mucous membrane exposure when they expect to come into contact with blood or other body fluids
• Workers should wear gloves when processing blood and body fluid specimens, such as when removing tops from vacuum tubes
• Workers should wash their hands and other skin surfaces immediately and thoroughly if contaminated with blood or other body fluids
• Workers should change their gloves and wash their hands upon completion of specimen processing.
• Workers should take precautions to prevent injuries caused by needles, scalpels, and other sharp instruments or devices during procedures. After sharp instruments are used, they should be placed in puncture resistant containers for disposal. The puncture resistant containers should be located as close as practical to the area where they are used
• All specimens of blood and body fluids should be placed in a well-constructed container with a secure lid to prevent leakage during transport
• Workers should use biological safety cabinets for procedures that have a high potential to generate droplets, such as blending, sonicating, and vigorous mixing
• Workers should not use their mouths for pipette procedures
• Workers should decontaminate after spills and should decontaminate equipment after use
• Workers should wash their hands after completing a laboratory task and should remove protective clothing before leaving the laboratory

Question 71

What is quality improvement and what steps does it include?

Answer 71

• Quality improvement is a series of (sometimes repeated) processes that include the following steps:
  
  • Identify a process that needs to be improved; establish realistic goals or respond to deficiencies
  • Measure the current level of performance for that process
  • Determine the target or desirable level of performance
  • Design and implement an intervention to achieve the desired level of performance
  • Monitor performance
  • Assess/document the improvement

Question 72

If you were employed in a small hospital and wished to establish an immunohistochemistry service with limited resources (4–5 stains), what stains would you choose?

Answer 72

• Pan cytokeratin (carcinoma)
• CD45 (lymphoma)
• S100 (melanoma)
• Neuroendocrine marker (synaptophysin, CD56, chromogranin).

Question 73

What advantages does computerization have in laboratories?

Answer 73

• Computerization facilitates:
  
  • Accessioning
  • Reporting
  • Archiving records
  • Quality assurance practices such as pulling data.

Question 74

What information is required on a requisition form?

Answer 74

• Patient name
• Provincial health number
• Address and/or hospital identification number
• Date of birth (including day, month, and year)
• Name of referring health care provider
• Anatomic site and laterality of the specimen
• Appropriate medical history
• Date of specimen collection.

Question 75

What should a specimen container be labeled with?

Answer 75

• Patient name and/or date of birth
• Identifying number
• Anatomic site
• Laterality of the specimen

Question 76

How should slides be labeled?

Answer 76

• Each slide should have 2 unique identifiers
• One identifier should include the patient’s last name and initials.

Question 77

What are some standard practices in specimen accessioning?

Answer 77

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

Question 78

What are the processes involved in handling an adverse event?

Answer 78

• incident review and root cause analysis
• Performance review and performance management
• Disclosure
• Medical-legal
• Media relations.

Question 79

What is root cause analysis?

Answer 79

• Root cause analysis: a method of problem solving based on identifying root causes. A root cause is a cause that, once removed from the problem–fault sequence, prevents a recurrence of the problem
• It is important to know that:
  
  • Quality assurance data collection alone does not result in a change in education or process. It helps locate the problem but usually does not elucidate why the problem exists
  • Monitoring of and response to events should take place as close as possible to the time of sign-out to minimize the impact of an error.

Question 80

What is the purpose of root cause analysis and how is it done?

Answer 80

• Purpose: to identify the causes, factors, or sources of variation that led to a specific event, result, or defect in a product or process
• How it is done: a variety of techniques can be used to uncover root causes, including cause mapping, change analysis, the Ishikawa fishbone diagram, and the “5 whys.” -
• At its most basic, the process poses 3 questions:
  
  • What was the problem?
  • What were the causes of the problem?
  • What actions should be taken to prevent the problem from recurring?

Question 81

A surgeon approaches you because he or she strongly disagrees with a diagnosis your colleague has made. What do you do?

Answer 81

• Obtain clinical information from the surgeon as to the nature of the disagreement and the surgeon’s reasons for not approaching your colleague directly
• Review the case and pull slides/blocks. Contact your colleague, determine why your colleague made the diagnosis, and explain the situation
• If there is any new diagnostic information (e.g., a corrected or revised diagnosis), collaborate with your colleague to issue an addendum

Question 82

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

Answer 82

• Clarify the reason for the surgeon’s concern and the reason for the request
• Contact your superior/laboratory director for guidance
• Know your limits in terms of your involvement in the situation.

Question 83

A review reveals that your colleague makes many errors. What do you do?

Answer 83

• Contact your laboratory director
• The laboratory director should consider temporarily suspending the pathologist from signing out the specific types of case on which the pathologist tends to make errors and should arrange for remedial training so the pathologist can reestablish his/her competency.

Question 84

What do you do if your colleague refuses to undergo remedial training?

Answer 84

• In a confidential manner, seek advice from superiors and more experienced colleagues about how to proceed
• Remember that patient care is the number one priority, and any potential harm to patients must not be ignored
• Document everything, as you are now legally involved in the situation
• Seek advice from your laboratory director
• Seek advice from your provincial college

Question 85

What should you do if you are subject to an accountability review?

Answer 85

• Contact the Canadian Medical Protective Association (CMPA)

Question 86

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

Answer 86

• Go to the colleague and discuss the case with him/her
• If the colleague agrees with the change in diagnosis, he/she should inform the clinician and issue an addendum report
• If the colleague disagrees with the change in diagnosis, suggest that a third opinion be sought, either internally or externally
• If an external opinion is deemed necessary, notify the clinician so that no irreversible clinical management takes place before the external expert reports back
• If the colleague refuses to correct the diagnosis and refuses to seek a third opinion, the service chief must be notified