Management / Development Flashcards

Question

What should be contained within an audit record?

Answer 1

``` Name of staff member performing the audit Date performed Reference number The scope of the audit Any non-conformaties Any CAPAs Date and signature on completion ```

Answer 2

Clinical audits - they form part of clinical governance, they are required to provide evidence of current practice against national guidelines and monitor patient outcomes. They can be prospective or retrospective. e.g. referral patterns or TATs Vertical audits - allow audit of an entire workflow/process. Used in labs to follow one sample from receipt to report - record everything (temperature of fridges, lot numbers, staff training records etc.) Horizontal audits - examine one part of the process in detail. Can be used to determine if all batch records are held in the right place. Examination audits - Witness to see if a SOP is being correctly followed, or staff members are appropriately trained.

Answer 3

1. Clinical audit 2. Horizontal Audit 3. Vertical Audit 4. Examination audit

Answer 4

``` To demonstrate quality of service Identify areas for change Continued improvement Assist in implementation of guidelines and services Monitor consistency of performance Measure performance against benchmark ```

Answer 5

``` Set standards Measure current practice Compare practice vs standards Reflect, plan, implement change Re-audit ```

Answer 6

A systematic, documented and independent process to obtain evidence and objectively evaluate the extent to which a set of criteria are fulfilled.

Answer 7

Various definitions: The grouping of patients based on risk of disease or response to therapy by using diagnostic tests or techniques. The tailoring of medical treatment to the individual characteristics of each patient [through assigning patients to certain subpopulations]. [Within genetics}: The use of genetic or other biomarker information to improve the safety, effectiveness and health outcomes of patients via more efficiently targeted risk stratification, prevention and tailored medication and treatment management approaches. An emerging approach for disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person.

Answer 8

Better/more accurate diagnosis (molecular sub typing of disease) e.g. in CNS tumours Optimal treatment selection e.g. response to TKIs / immunotherapy Improved/more accurate prognostication e.g. high/low risk profiles in acute leukaemias Avoidance of drug toxicities (e.g. DPYD/TPMT testing) More cost effective healthcare (improved response rates by not giving patients expensive drugs that are unlikely to work)

Answer 9

Precision medicine involves the 'Four Ps': 1. Prediction and prevention of disease 2. Precise diagnosis 3. Personalised interventions 4. Participatory role for patients

Answer 10

Selection of the best approach to manage a specific patient, based on available biological information about the patient as well as a patient’s personal preferences, environmental factors, social factors and other factors that may affect the treatment choice.

Answer 11

A disease treatment or prevention that takes into account some individual variability. An example may be the decision to proceed with allogeneic stem cell transplant in the context of AML patients in complete morphological remission: clinicians have to consider not just the prognostic risk associated with the genetic profile of the AML clone, but also patient’s age, co-morbidities, MRD, personal preferences.

Answer 12

* Higher volumes of testing mean lower costs per test * Expertise is concentrated, resulting in higher-quality testing * All molecular tests are available to all patients in each region in a single location, simplifying logistics

Answer 13

• Turnaround times deteriorate severely, both from transporting tissue/reports and in cases being queued for testing in large laboratories.