Regulatory Flashcards
Accreditation organizations - hospital
TJC
DNV Healthcare
Accreditation Commission for Health Care (ACHC) Acute Care Hospital Accreditation Program
Center for Improvement in Healthcare Quality (CIHQ)
Accreditation organizations - ambulatory
URAC
AAAHC
ACHC (includes Pharmacy Compounding Accreditation Board)
CDC Category 1A recommendations
Seen as best practice. Surveyed by regulatory agencies and accreditation organizations as though they are requirements
Best Practice organizations
Several - can be administrative, clinical, or focused
ACCP
ADA
AHA
Association for Professionals in Infection Control and Epidemiology (APIC)
American Society for Clinical Oncology
ASHP
ASPEN
CDC
NIOSH
Oncology Nursing Society
Parts of Medication Use System
Select
Store
Order
Dispense
Administer
Monitor
Medication Use System - Select
Choosing formulary - should be interprofessional
Includes medication-use policies, ancillary drug information, decision-support tools, and organizational guidelines
Part of CMS - Conditions of Participation
Center for Drug Evaluation and Research (CDER)
Division of FDA that is responsible for regulating drugs to ensure they are safe and effective
Receives NDA, ANDA, IND (investigational new drug), BLA
Emergency Use Authorization
Once Secretary of Health and Human Services declares public health emergency, FDA can authorize unapproved medical products to be used
Center for Biologics Evaluation and Research (CBER)
Similar to CDER - but reviews BLA (Biologic license applications)
Division of FDA
Medication Use System - Order
Determines who can order medications
Impacted by CMS, accreditation organization standards, state regulations, and organizational policy
Includes standing order, protocol
Standing Order
Provider authenticates use of order for another healthcare professional to execute in urgent, emergent situations
Must be evidence-based and nationally-accepted therapy
Protocol
Protocol must be ordered by provider.
Developed in advance of need to support likely or potential circumstance
Ex: provider orders DKA protocol. Already established treatment regimens, titrations, when to d/c, etc.
Must be evidence-based and nationally-accepted therapy
Risk Evaluation and Mitigation Strategies (REMS)
Controlled by FDA
FDA can require REMS if risk»_space;> benefit
Includes Elements to Assure Safe Use (ETASU), which includes the requirements of the drug, like prescribers need special training, pharmacies need to be certified, etc.
Medication Use System - Monitor
Monitor medications and adverse drug events
NCC MERP Index
Categorizes medication errors
A: circumstances or evens that have the capacity to cause error
B: error occurred, did not reach patient
C: error occurred, reached patient, did not cause harm
D: error occurred, reached patient, and required monitoring to ensure no harm
E: error occurred, may have contributed to temporary harm and required intervention
F: error occurred that may have contributed to temporary harm requiring hospitalization
G: error occurred that may have contributed to permanent patient harm
H: error occurred that required intervention necessary to sustain life
I: error occurred that may have contributed to patient death
Adverse Drug Event/Reactions
Med error: ISMP
Med ADR: FDA MedWatch (Also counterfeit)
Vaccine ADE: VAERS
Device ADR: FDA MAUDE
Institute for Healthcare Improvement (IHI)
Global trigger tool to detect adverse drug events
Rapid chart review to detect certain triggers
-Cdiff positive stool
-PTT >100, INR >6
-Glucose <50
-BUN or SCr 2x baseline
-Admin of vitamin K, diphenhydramine, flumazenil, naloxone
Prohibited abbreviations
U, IU, QD, QOD, MS, MSO4, MgSO4
Who decides high alert medications?
ISMP
Includes meds that cause significant patient harm when used in error (insulin, anticoag, opioids, hypoglycemics)
Who defines conflict of interest?
Institute of Medicine (ION) and National Academy of Sciences (NAM)
Set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest
Institutional Review Board (IRB)
Reviews research involving human subjects to ensure it is ethical and complies with regulations
IRB is regulated by Office for Human Research Protections (OHRP) and HHS.
IRB complies with HHS and FDA
Cost minimization
Compares cost of two drugs that have equal efficacy
Cost benefit
Assigns monetary values to both cost and benefit, allowing for direct comparison between two treatment options
Cost effectiveness
Compares cost and outcomes (cure rates, life years gained) of different treatment options
Cost utility
Compares cost and outcomes (QALY) of different treatment options
Retrospective analysis of ADE
Root cause analysis
Prospective analysis of ADE
FMEA
Continuous Quality Improvement Processes
LEAN
Six Sigma
International Safety Organization
WHO
Federal safety organizations
FDA
OSHA
DEA
CDC (NIOSH)
CMS
AHRQ
Quasi-governmental safety organization
USP
Professional safety organizations
ISMP
IHI
ASHP
Safety & Quality System used by TJC
National Patient Safety Goals
Safety & Quality System used by DNV
ISO Quality Standards
Safety & Quality System used by ACHC
National Quality Forum Endorsed Set of Safe Practices
Safety & Quality System used by CIHQ
CMS
Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS)
standardized survey that measures patient experience with inpatient hospital care
32 question survey `
ORYX
Initiative that includes performance measure into TJC accreditation
Healthcare Effectiveness Data and Information Set (HEDIS)
measures a set of standardized healthcare quality measures to assess and compare performance of healthcare organizations and health plans
Part of National Committee for Quality Assurance (NCQA)
Division of Medication Error Prevention and Analysis (DMEPA)
Responsible for monitoring and preventing drug errors
also DMAMES (division of medication assessment and medication error surveillance)
part of FDA
Accountable Care Organization (ACO)
focused on improving quality of care, lowering cost, aligning incentives
part of CMS
Durham Humphrey
Act that set up two types of medications - OTC and Rx
National Committee for Quality Assurance (NCQA)
Committee that has evidence based standards for pharmacies/clinics to follow to improve quality of healthcare and maximize reimbursement
Pro forma
business-type document that lays out anticipated costs and revenue from developing new service/business
Class I recall
most severe
high probability of serious injury or death
Class II recall
risk of serious adverse events but lower risk of serious injury or death
Class III recall
low likelihood of adverse health consequences
National Quality Measure Clearinghouse (NQMC)
has evidence based healthcare measure sets
developed by AHRQ
Federally Qualified Health Centers (FQHC)
community based health centers that provide healthcare to underserved communities
must serve all patients even if unable to pay
accept grants, 340B, enhanced reimbursements by medicare, medicaid
Triple AIM
patient experience
population health outcome
reducing costs of care
capitated healthcare model
receives set amount of money to take care of patients, and the healthcare facility must figure out how to effectively use that money
amount of money is dependent on quality metrics
SBAR
Situation
Background
Assessment
Recommendation
PQRST
Provocative
Quality
Region
Severity
Timing
Questions to ask about pain
