Regulatory Flashcards
ORA
office of regulatory affairs, subset of the FDA responsible for inspections every two years
FDA’s five layers or blood safety
- Donor screening 2. Donor Deferral 3. Infectious Disease Testing 4. Quarantine (all units quarantined until ID testing is complete 4. Problems and deficiencies
Five categories that ORA and FDA inspect for:
- Quality assurance 2. Donor eligibility 3. Product testing 4. Quarantine and inventory management 5. Production and processing
FDA form 483
Form served upon inspection to notify manufacturer of objectionable conditions and does not constitute a final determination of whether a violation has occurred.
CBER
centers for biologics, evaluation and research. A subset of the FDA, gets all the reports of blood related fatalities
Categories of FDA enforcement actions
advisory, administrative or judicial
BPD
blood product deviation reporting. (21 CFFR 606.171) all required to report BPD on distributed products. Must not exceed 45 days from date of becoming AWARE of incident.
When is reverse typing of donors not applicable
- confirmation testing of labeled previously typed donor red cells 2. Infants less than 4 months
Reasons for Weak ABO front type
Leukemia or other malignancy, and inheritance of weak ABO subgroup
How long do you have to report a BPD to the FDA
45 days from when the manufacturer became aware of the issue
Recall
Remoal of product that is in violation of the law (Class categories 1, 2 and 3)
Market Withdrawal
minor violation not subject to FDA legal action, manufacturer voluntarily removes product or corrects violation
BSL levels 1-4 what types of precautions/infectious agents
BSL1- no to minimum risk of causing human disease-open bench top (pH water)
BSL2- TS, CBC, moderate risk decrease transmission must have PPE and biohazard warning
BSL3- M. Tuberculosis, directional airflow and HEPA Filter
BSL4- EBOLA, negative pressure, HEPA filtered supply, and exhaust, airlock entry ports changing and decontamination area.
If blood production company creates products AND ships across states lines you need what:
To be registered and Licensed by the FDA, license number needs to be on the outside of the bag
If blood production company only creates products and distributes within state, needs to be…
Registered with the FDA, does not need to be licensed
How to obtain a license for a blood production facility
obtain license by submitting a BLA to the FDA
BLA
biologics license application
Changes made to manufacturing
Must update with FDA any changes in manufacturing from license application
CBER
center for biologics evaluation and research- lead on devices for blood manufacturing, HPCs and RBC collection
CFR Title 21-803
Any serious injury or death related to medical device must be reported to the FDA
CFR portion of regulation for blood components
FDA CFR Title21 Parts 600,601,606,607,610,630,640
CFR process production controls, equiptment, regulations and quality control
21 CFR 211
ORA inspections
every two years
CPGM
compliance program guidance manual for inspection of licensed and unlicensed blood products
CMS and CLIA
CMS requires labs to be registered with CLIA in order to receive reimbursement for/from medicare and medicaid
CLIA requirements for PT
pt= proficiency testing, requires participation of lab in PT program for any nonwaived testing
Tests rating
Rated by complexity lowest level is waived then moderate and then high. Waived tests are typically POC testing such as urine dipsticks etc. simple and easily performed iwth limited tech training
High complexity testing
infectious disease testing and compatibility testing
Blood banks 3 pathways to obtain CLIA registeration
- certificate of compliance approval via state health department inspection 2. certificate of accreditation approval via CMS approved accrediting organization 3. cms exempt: license program for nonwaived labs in NY or WA accepted by CMS.
CMS 6 approved accreditation
- AABB 2.CAP 3.JAICO 4. ASHI- american society for histocompatibilty and immunogenetics 5. American osteopathic association 6. COLA commission office lab association
AABB/CAP inspections
needs to be inspected every two years to maintain accreditation
HCT/P’s
human cells tissue and cellular tissue based products, can be derived from living or dead donors
HCT/P’s from deceased donors
skin, dura mater (tough underlayer of brain and spinal chord) cardiovascular tissues, ocular tissues, musculoskeletal tissues
HCT/P’s from live donors
hematopoietic stem progenitor cellsf rom peripheral cord blood, reproductive cells and tissues and other cellular therapy products (pancreatic islets, mesencymal stem/stromal cells, and fibroblasts)
Four rules HCT/P regulated solely under section 361 of PHS and CFR21,1271 must meet:
- minimally manipulated 2. intended for homologous use only- same function in recipient as in donor 3. not combined with another regulated article 4. does not have systemic effect, not dependent on metabolic activity. If it does not meet criteria listed above must be regulated as drug device or biological product under FD and C act
FACT
foundation for accreditation and cellular therapy
QC portion of quality assurance program (6)
reagent QC, product QC, clerical checks, visual inspections, temp readings, volume or cell counts on finished blood components
Statistical tools in quality management
- process capability measurement 2. control charts
Near Miss event
wrong in tube scenario where patient was not transfused. An error or deviation from standard procedures discovered prior to starting the transfusion which could have led to a reaction in the recipient. WBIT detected before issue or detection of wrong pack of blood being brought to bedside
What are the seven elements of the compliance program
Mandated by the Office of Inspector General (OIG) regulations. 1. Compliance oversight 2. written policies, procedures and standards 3. training and education 4. communication and reporting 5. disciplinary protocols 6. risk assessment
7. auditing and monitoring
What is the role of the officer of the inspector general
- imposes penalties, sanctions, exclusions for misconduct 2. published compliance program guidance in 1997 3. revised and refined in 1998 4. basis for lab’s compliance program 5. mandatory element of compliance program is annual training
Why do labs need to have a compliance program
mandated by patient protection and affordable care act-2009
ABN
advance beneficiary notice- if codes do not pass medical necessity for patients with medicare an ABN is created. , patient has choice of signing the form and taking responsibility for payment or refusing the service.
CPT codes
are assigned to each lab test, the codes are used by insurance companies and medicare administrative contractors to identify the service provided and amount of reimbursement
PHI
protected health information is individually identifiable information transmitted by or maintained in any form.
Breach of PHI
any potential breach of PHI must be documented
How long do you have to add AS to unit after collected
72 hours
What is the concentration of rbc units, what’s in there
30-40 mL CPD and plasma, 100mL of AS and 150-230 mL of blood for 50-60% hct, or 60-70mL of CPDA-1 for 70-80% hct, >80% not acceptable
What’s humate P and alphanate
Both factor 8 concentrates that have vwf and can be used to treat either vwd or hemophilia a
