LICENSING Flashcards
Government rules and regulations include the following: (LOR)
- Labor relations
- OSHA (Occupational Safety and Health Administration)
- Rules affecting the general conduct of business
OSHA meaning
Occupational Safety and Health Administration
2 Federal Regulation of Medical Laboratories
- Licensure of Laboratories
- Licensure of Personnel
Permission to engage in business activity
Licensure of Laboratories
Permission to practice an occupation/profession
Licensure of Personnel
Medicare Legislation an amendment to the social security act
1965
First edition of CLIA became law
1967
CLIA meaning
Clinical Laboratories Improvement Amendment
CLIA was revised
1988
classifies and regulates laboratories based on the complexity if procedures being performed rather than on location
CLIA’88
Highlights of CLIA’88 (CSRB)
- Classifies laboratories based on the complexity of procedures being performed
- Set personnel qualifications for six groups
- Rules apply to all testing sites
- Baccalaurate laboratories can perform at four levels
Classifies laboratories based on the complexity (LMHP)
- Low complexity testing
- Moderate complexity testing
- High complexity
- Provider performed microscopy procedure
Set personnel qualifications for six groups (DTTCGT)
Diretor
Technical consultant
Technical supervisor
Clinical consultant
General supervisor
Testing personnel
Baccalaurate laboratories can perform at four levels
Director
Technical consultan
General/Technical supervisor
Testing personnel
Waived tests, considered to have low-complexity testing methodology
Category l
Moderate complexity testing methodology
Category ll
High complexity testing methodology
Category lll
Provider Perfomed Microscopy Procedure (PPMP)
Category lV
Uses 7 criteria to differentiate tests that maybe performed by moderate/high complexity laboratories
Department of Health and Human Resources
The 7 criteria of DHHR (LTCOCED)
- Level of knowledge needed
- Training and experience required
- Complexity of the preparation or reagents and material
- Operational steps required in the procedures
- Characteristics and availability of calibration, quality control and proficiency testing material
- Extent of troubleshooting and maintenance required
- Degree of interpretation and judgement necessary in the testing process
2 Qualifiers of Moderate-Complexity category
- Automated procedures that do not require operator intervention
- Manual procedures with limited steps and limited samplw
5 practice standards for moderate and high complexity laboratories requirements (CQPIP)
- Certification of waiver or registration
- Quality control and quality assurance
- Patient test management
- Inspection
- Personnel qualification
Laboratories are initially require to obtain a certificate from the health care financing administration
Ceritificate of waiver or registration
Standards are similar to those established by the practice parameters of professional laboratorian
Quality control and quality assurance
Protects the integrity of specimen and the reporting of accurate results
Patience test management
Patient test management provides regulations regarding the following aspects of practice (PSHI)
Processing and receiving service requisition
Requires both records and facilities of certified laboratories be available unannounced inspection to check for compliance with its rule
Inspection
Laboratory Inspection and Accreditation Programs (JCAC)
- JCAHO
- CAP
- AABB
- COLA
JCAHO
Joint Commission on the Accreditation and Healthcare Organizations
CAP
College of American Pathologists
AABB
American Associate of Blood Bank
COLA
Commission on Office Laboratory Accreditation
Professional Certification of Laboratory Personnel (AANP)
- AMT
- ASCP
- NCAASCLS
- PRC
AMT
American Medical Technologist
ASCP
American Society for Clinical Pathologist
NCAASCLS
National Certifying Agency of the American Society of Clinical Laboratory Science
PRC
Professional Regulation Commision
Any person, firm or corporation operating a clinical lab shall secure a license annually at the office of ?
the Secretary of Health or Department of Health (DOH)
Revised rules and regulations governing the registration, operation and maintenance of clinical lab in the PH
Administrative Order No. 201 Series 1973
a fee of ___ is to be paid to the Bureau of Research Lab for every license issued
100 pesos
how much is the renewal fee
50 pesos
renewal fee must be paid within
last 2 months of each year
grace period of renewal of license
2 monts
fine per month
10 pesos
___ laboratories are exempted from these fees
government laboratories
if a clinical lab manager will transfer his registered lab to another place, they should inform in writing the BRL within ___ after transfer
15 days
Required Personnel (HAPMLL)
- Head of Laboratory Pathologist
- Associate Pathologist
- Pathology Assistant
- Medical Technologist
- Medical Technicians
- Laboratory Aids
