2.6 Regulatory requirements Flashcards
What is a SAC?
Name a few categories and what defines them
SAC- severity assessment codes
- Depends on:
1. States differ
2. Consequence serious, major, moderate, minor, minimum AND likelihood of occurrence, almost certain- rare
SAC 1: extreme risk, death or likely permanent harm , immediate action, root cause analysis, reportable incident brief (RIB) to DoH
SAC 2: high risk, temporary harm, permanent lessening of bodily functioning, senior management attention, notification to DoH/
SAC 3: medium risk- increased level of care ie rv evaluation, additional investigation, management responsibility specified- undertake practice improvement project
SAC4: low risk, no harm or near miss, manage by routine procedures
How long should records and diagnostic materials be retained for in the laboratory?
NPAAC 2018
Retention of documents
- personnel: 4 years+ period of employment
- equipment: life of + 4 years
- QC and QA: 3 years
- request , analysis records: 4 years
- original report- 7years for adults, 7years from age of majority for minors
- all specimens unless otherwise stated : 7days from date of receipt or until 2 days after issued report
- serum/plasma infectious serology all sera 4 months
- antenatal sera 12 months
- syphilis 12 months if reactive
- frozen tissue block 1month incl DIF
Define an in vitro diagnostic device (IVD) and an in house IVD
IVD: any material used alone or in combination w other goods for the intended use of in vitro exam of human specimens for diagnostic purposes
E.g. assay kits, instruments, reagents, calibrators, control material, software
In house IVD- is one that is developed or modified within a lab to assist in clinical diagnosis/mx
Outline IVD categories and if any specific regulations are required
depends on intended purpose of device and level of risk to patient/public if incorrect result
Ascending risk class 1 : no public risk or low personal class 2: low public or mod personal ie preg test kit class 3: most lab diagnostic tests * mod (chalmydia, syphilis) public or high personal class 4: transfusion and transplant risk tests; high risk pathogens and load tests, safety of blood/tissue for specific recipient e.g. HIV, high public health risk
Class 4 in house IVD must be
- registered and pre approved by TGA for ARTG
- inform NATA
- full validation
- MSAC/PSTC for billing
Class 1-3 still inform NATA for scope of testing
Outline some of the issues to consider when releasing tissue or specimen to patient
- lab does not own specimen
1. Clear request reason which is reasonable - cultural issues around Maori patients
2. Duty of care to the patient confirm applicant identity - do not release to unauthorised 3rd party
3. May seek legal advice if unusual request
4. minimum retention time does not apply if returned to patient
Define a non -conformity?
Any event that does not conform with the standard or usual procedures of that lab or with its quality management system
e.g. errors, complaints, document changes, safety issues, supplier failures
Why are laboratory audits performed?
- comply with standards ISO/NATA
- ensure all staff are carrying duties appropriately
- detect any risky areas that may not conform to standard
Name and explain the role of main pathology organisations in Australia
- RCPA royal college of pathologists Australia
- main body training/professional development
- college members Australasia, hk, Singapore, Malaysia, Saudi arabia
- not for profit, council/board of directors
- Role: training, exam, CPD, prof practice standards, accreditation w NATa, quality control, advocacy - NATA - national association of testing authorities
- independent private company; technical competence for customers
- council of members /board
- accreditation needed for bill medicare
- educational; publications, training QC programs - NPAAC- national pathology of accreditation advisory council
- division federal dept health ageing, rep from states/terretories/peak prof bodies
- develop/mx standards of practice and guiddelins for accreditation acc ISO 15189 international standards organisation
- educational program
- standards (mandatory nata accreditation) guidelines (consensus recommendations) - TGA- therapeutic goods administration
- reg authority on therapeutic goods
- federal dept health and ageing, TGA 1989 act
- assess and monitor therpauetic goods; reg, analysis, ARTG aust register the goods, accreditation
- executive;
What are the types of medical laboratories and NATA guidelines regarding supervision of these labs?
Designated person- qualif, competence, scope of practice with responsibility for clinical governance, provides oversight and management of staff/and processes
GX- FT supervision of DP, testing delegated to other pathologists (>2 FTE)
GY- under FT supervision of DP in GX laboratory, supervision in 1 or more provided onsite FT pathologists w relevant scope of practice (<2 FTE)
B- integrated with GX or GY- under direction of DP. point of care. DP/quality m visit once per year, delegation of supervision to onsite pathologist. Lab with scientist at least 2 years experience as onsite manager, if no onsite pathologist w scope of practice, need remote access to LIS/quality system, supervising at least 2 days per year
s- specialised- limited range of test for a target population, not a pathologist only relevant to qualification, onsite clinical scientist
m- medical- lab within medical practice limited range of tests only for patients of medical practice
What are requirements for in house IVDs and their exceptions?
Must be validated otherwise not used to provide services
EXCEPT if cannot be validated AND no alternative validated IVD
Only use clinically for new/uncommon, time sensitvie in public health emergency
Lab needs documented plan for validation
what is the difference between certification and accreditation?
Certification - organisation deemed to have appropriate documented procedure and services to meet reg requirements
Accreditation- process by which facility deemed technically competent/evidence perform tasks /sound quality system
What are the management requirements outlined in the ISO 15189?
Requirements for quality management of the lab
Organisation/hierarchy QMS document control/retention of records Referral labs External services/supplies Non conformities/ corrective action, preventative action Continual improvement Internal audits and evaluation Management plans
What are the technical requirements outlined in the ISO 15189?
Personnel Environment/accommodation Equipment, reagent, consumables Pre exam Exam process Post exam process Ensuring quality of exam Reporting of results Release of results LIS
What are equipment records?
Under NATA accreditation requirement
Documented procedure
- selection, purchasing, management of equipment
- acceptance testing
- instructions
- calibr/traceability
- maintenance, repair record log
- adverse incident reporting
- general
- identify, manufactuer, model, serial, contact supplier, date of receiving, location, condition, initialy acceptabiity for use, scheduled maintenance, performance records, damage, modification, repair history
maintenance log - preventative 6-12months
Equipment maintenance at ACT Pathology
- pipette
– NATA accredited pipette assessor/calibration - scale
- temperature
– thermometer
4) Labguard’s calibration of fridge/freezer thermometers- how do they do this? Do they use a second thermometer to measure temperature of i) fluid in fridge ii) air in freezer??
We calibrate our Labguard probes in-house. Labguard calibrate them in compliance with COFRAC, the French counterpart of NATA. If you check on the NATA website, it should be possible to see if NATA have MRA (Mutual Recognition Agreement) with COFRAC.
We use a reference thermometer that has a NATA calibration certificate, to measure the same environment that the working thermometer is monitoring and at the same time. A comparison is made of the measurements of the reference and working devices. The are acceptability thresholds for the performance of working temperature measuring devices.
