LABMAN
For MediCare patients who establish based on Diagnosis Related Groups (DRG). •
1983- PROSPECTIVE PAYMENT SYSTEM
Established out-patient laboratory fee to schedule control cost.
1984- DEFICIT REDUCTION ACT ( DEFRA)
All laboratories must be certified by the federal government with mandated quality assurance, personnel, and proficiency testing standards
1988- CLIA - CLINICAL LABORATORY IMPROVEMENT ACT
Law that protects patients from inappropriate dispersion of personal information. - Access to protected health information (PH
1996- HIPAA , HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT
Replace most local medical review policies which are used to determine whether laboratory tests are medically necessary and reimbursable.
2001- CMS NATIONAL COVERAGE DETERMINATION
Deals with shipment of blood and other potentially biohazardous products.
2003- HAZARDOUS MATERIAL REGULATIONS
The largest organization for laboratory professionals and offers certification for various specialties
AMERICAN SOCIETY FOR CLINICAL PATHOLOGY
Substance or competent being analyzed or measured
ANALYTE
Proficiency Testing/ External Quality Assurance, Reliability.
ASSESSMENT
Usually used for equipment -To ensure accurate and reliable measurements
CALIBRATION AND MAINTENANCE
Solution of known concentration Must have the same matrix as sample Can be run in single or multiple parameters Has to be purchased separately Expensive
CALIBRATORS
Largest healthcare medical programs in the US.
CENTERS FOR MEDICARE AND MEDICAID SERVICES
Develops standardized criteria regarding laboratory practices.
CLSI- CLINICAL AND LABORATORY STANDARD INSTITUTE
Offers the largest proficiency program in the US
COLLEGE OF AMERICAN PATHOLOGIST
Non-profit organization that provide assistance to physician office laboratory
COMMISSION ON OFFICE LABORATORY ACCREDITATION
Is the adherence of the establish standards, protocols, and regulations relevant to laboratory activities
COMPLIANCE
PDCA, Six Sigma, Lean
CONTINUOUS IMPROVEMENT
Substance having similar composition as sample used to monitor the status of analysis Matrix is same with the sample Test if the analyzer after calibration is giving satisfactory results or not They have value in range (low, medium, high) Can be obtained from the reagent or instrument supplier or third party control
CONTROL
Identifies, regulate, and may inspect high risk chemical facilities and radiation sources that may be risk of terrorism
DEPARTMENT OF HOMELAND SECURITY
Hospitals are paid a fixed amount
DIAGNOSIS RELATED GROUP
Enforces standards for disposal of hazardous lab materials.
ENVIRONMENTAL PROTECTION AGENCY
- It deals with fair employment practices.
EQUAL EMPLOYMENT OPPORTUNITY COMMISSION
Laboratory Design, Floor Plan, Measurements Involved
FACILITIES AND SAFETY
- Regulates and manufactures of biologics and medical device and test kits.
FOOD AND DRUG ADMINISTRATION
Laboratory Information Management System (LIMS) katumbas nya ang Electronic Health Record (EHR)
INFORMATION MANAGEMENT
)Most common presentation for evaluating QC results Allow a quick visual assessment of method performance, including trend detection The mean value represents the target (or expected) value for the result, and the SD lines represent the expected imprecision for the method
LEVEY-JENNINGS CHART
Background component of sample other than the test to perform
MATRIX
- Provides database and access to the federal register. •
NARA- NATIONAL ARCHIVES AND RECORDS ADMINISTRATION
Provides research, information, education, and training in the field of occupational safety and health. -Allows recommendations, not enforcing.
NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH
Under ng Commerce Department - Contributed to the development of many healthcare products.
NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY
Laboratory that is under government that had been designated by the DOH to provide special function and services for specific disease.
NATIONAL REFERENCE LAB
The negative impact must be corrected to positive impact. dapat lahat icorrect
NON CONFORMING EVENT MANAGEMENT
Responsible for auditing, inspecting, and identifying fraud and abuse in CMS programs.
OIG
Laboratory must support an optimal path of workflow by allowing processes that yield efficient sample handling while minimizing error
PATH OF WORKFLOW
Quality Assurance And Quality Control
PROCESS MANAGEMENT
Quality Assurance measure designed to ensure that laboratories procedure accurate and reliable results
PROFICIENCY TESTING
Reagents And Calibrators
PURCHASING AND INVENTORY
A ensures that everything is executed in the right way, and that is why it falls under verification activit y
QA
In order to meet the customer requirements, THIS defines standards and methodologies
QAULITY ASSURANCE
aims to identify and fix defect s
QC
ensures that whatever we have done is as per the requirement, and that is why it falls under validation activity
QC
Refers to the degree to which a set of inherent characteristics of a product, service or, process fulfills requirements and meets established standards
QUALITY
aims to prevent the defecT
QUALITY ASSURANCE
A process to periodically examine a measurement procedure to verify that it is performing according to pre established specifications
QUALITY CONTROL
confirms that the standards are followed while working on the produc t
QUALITY CONTROL
Refers to the overall process used to ensure that laboratory results meet the requirements for health care services to patients - Used by ISO and CLSI
QUALITY MANAGEMENT SYSTEM
Essential in laboratory analyses, helping to identify, quantify, or modify the properties of substances
REAGENTS
Defined as the ability of a laboratory to consistently produce accurate and precise results.
RELIABILITY
Solution of known concentration Matrix may or may not be same as sample Provided with kit Cost effective
STANDARDS
The capability to link measurement results to be able to ensure validity
TRACEABILITY