Chapter 1: General Concepts and Administrative Issues

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Strategic Planning

1. Deciding on the objective of the organization and the need to modify existing objectives 2. Allocating Resources to attain these objectives 3. Establishing policies that governs the acquisition, use, and disposition of these resources

Maintenance log

2 years

accession log

2 years Retention

Reacquisition

2 years retention

muscoskeletal disorders (MSDs)

Affects the muscles, nerves, blood vessels, ligaments and tendons

10 years

Blood Bank Donor/Reciept Records

10 years

Blood Bank Patient Records

5 years

Blood Bank QC records

indefinitely

Blood bank deferred donor records

10 years

Blood bank employee signature/initials

7 days

Blood/Fluid Smears

Top Manager

CEO

Top manager

CFO

Top Manager

CIO

Corrosive

Chemical which corrode substance while in contact

Rop Manager

Chief Executive

First Line

Chief Technologist

2 years

Clinical Pathology test results

CQI

Compares traditional thinking vesus TQM

Top Managers

Concentrates on Strategizing and planning for the next 1 to 5 years

tactical planning

Consits of the detailed, day to day operations needed to meet the immediate need of the laboratory

2009 HITECH Act

Contains incentives vrelated to adoption of health care information technology and the electronic health record set goal of "meaningful use"

20 years

Cytogenetic reports/images

3 years

Cytogenic slides

5 years

Cytology slides

2003 Hazardous Material Regulations

Deals with shipments of blood and other potentially biohazardous products

Six Sigma Steps

Define, Measure, Analyze, Improve, Control

30 inches

Desk Height

3 square feet

Desk Space

Nuclear Regulatory Commission (NRC)

Develops and enforce federal guidelines that ensure the proper use and operation of non military nuclear facilities

1996 Health Insurance Portability and Accountability Act (HIPAA)

Direct how health care information is manage. This law protects patents from inappropriate dispersion of personal information.

Waste Management

Disposal or recycling and monitoring of waste

Middle Manager

Divisions Head

CQI

Element of TQM that strives to continually improve pratices and not just keet established quality standards

1989 Ergonomic Safety and Health Program Management Guidelines

Established OSHA Guidelines for employee safety

1984 Deficit Reduction Act

Established outpatient laboratory fee schedule to control cost

Clincal Laboratory Improvement Act of 1988

Established that all laboratory must be certified by the federal government with mandated quality assurance, .....

10 years

FNA slides

10 years

Flow Cytometry plots/Histograms

Center for Medicare and Medicaid Services (CMS)

Formerly known as the health care financing administration (HCFA)

Planning and Propmt decision Making Leading Organizing Controling

Four Primary Management Functions

human, financial, physical, informational resources

Good Management uses

1997 OIG Compliance Guidelines

Help laboratories develop programs that promote high ethical and lawful conduct

6square feet

Human Body Sitting

4 square feet

Human Body standing

Department of Homeland and security (DHS)

Identifies and Regulates and may inspect high risk chemical facilities and radiation sources

Supporting Delegating Directing Coaching

Key Leadership styles

25 to 27 inches

Keyboard drawer height

7 feet

Laboratory Counter to Counter Clearance

Top Manager

Laboratory Director

4 feet

Laboratory counter to wall clearance

2 feet 6 inches

Laboratory counter width

5s PDCA

Lean Utilizes varities of technique including

Viruses

Living virus needs host

First line manager Middle manager top manager

Manager can be stratofied as:

Oxidizing

Materials that spontaneously evolve oxgen that promote combustion

7 days

Microbiology Stained Slides

Parasite

Multi-celled organism

1992 Occupational Exposure to Blood-Borne Pathogens

OSHA Guidelines to limit exposure to biological hazards

1990 Occupational Exposure to Hazardous Chemicals in Laboratory

OSHA Guidelines to limit unnessary exposure to hazardous chemicals

Middle Manager

Opertions manager

Fungi

Organism that produces toxins

US Department of Health and Human Services

Oversee CMS, OIG and FDA

Equal Employment Opportunity Commission (EEOC)

Oversee and enforces title VII dealing with fair employment practices

Center for Medicare and Medicaid Services (CMS)

Oversees the largest health care program in US

10years

Paraffin Blocks/slides

1990 Three-Day Rule

Payment of any laboratory testing done 3 calendar days before admission

1989 Physician Self-Referal Ban

Prevent physicians from reffering medicare patient to self owned laboratories

Strategic Planning

Process by which high-level decisions are made

Management

Provides the "road" to get there

2 years

Quality Control records

2001 CMS National Coverage Determination

Replaced most local medical review policies used to determine whether certain laboratory tests are medically necessary and therefore reimbursable

10 years

Reports

Office of the Inspector General (OIG)

Responsible for audits, investigations, inspections, and identifying fraud and abuse in CMS

2 years

Retired Laboratory Procedures

Social Technologic Economic Environmental Political

STEEP

48 hours

Serum/CSF/Body Fluids

Bateria

Single Celled living organism

TQM thniking

Stives to contually look for waysto reduce errors

Middle Manager

Stradle both areas to some degree

Flammable

Substance which may be ignited by source of ignition

Explosive

Substances may explode due to a source of ignition

Radioactive

Substances that generate radiation

Biological Hazards

Substances that pose a threat to The health of the living organisms primary that of humans.

Appropriate data collection Observing Current Projected conditions

Successful Strategic Planning requires

First line

Supervisors

10 years

Surgical Pathology slides

First Line

Team Leaders

LEAN Six Sigma

Two other tools often used to improve quality throuhout the health care industry

Physical Chemical Biological Ergonomic Psychological

Types of Hazards

24 Hours

Urine

Strategic planning

Usually based on long term projections and a global view

2 weeks

Wet tissue

Plan Do Check Act

What does PDCA stand for?

National Institute of Standards and Technology (NIST)

a branch of the Commerce Department and has contributed to the development of many health care products.

Leadership

a pattern of behavior used to engage others to complete task in a timely manner

Six Sigma

a structured process based upon statistics and quantitative measurement which process defects or error are analyzed

labor

accounts for 50 to 70 percent of laboratory's cost

National Institute of Health (NIH)

agency of HHS and is a world leader in medical research

Chemical hazards

any

Defect

anything that does not meet customer requirement

Regionalization

consolidation process on a grand scale

Lean

developed from the priciples used by the Toyota Corporation

Occupational Safety and Health Administration (OSHA)

enforces workplace standards to protect employee s' safety and health

Biological Hazard

exposure to bacteria, viruses, parasites or other biological entities.

1983 Prospective Payment System

for Medicare established payment based on diagnosis related groups

Clinical and Laboratory Standards Institute (CLSI)

formely NCCLS develops standardized criteria regarding laboratory practices

U.S. Department of Transportation

has the responsibility of regulating biohazardous materials that includes blood ajd other human products

U.S. Food and Drug Administration (FDA)

is a part of HHS and regulates the manufacture of biologics and medical devices and test kits

The Joint Commision (TJC)

is an independent not for profit entity that accredits nearly 17000 health care oraganizations and programs in US

American Society for Clinical Pathogens (ASCP)

largest organization for laboratory proffesionals amd offers certifications for various Specialties

Wrong Decisions

may burden a laboratory with unnessary cost.

First Line

more concentrated on completion of day's work

Commission on Office Laboratory Accreditation (COLA)

organize to provide assistance to physicians

National Institute of Occupational Safety and Health (NIOSH)

part of HHS and provides research, information, education and training in the field of Occupational safety and health

American Association of Blood Banks (AABB)

peer of professional group that offers blood bank accreditation program.

Six Sigma

performance improvement program, the goal of which is to improve by eliminating process variation

Directing leader

presents rules, orders or other defined instructionsto that individual

National Archives and Records Administration (NARA)

provides a number of database, including access to federal register

Leadership

provides direction to where one is going

Coaching Leader

provides high support and direction

Delegating Leader

provides low suppprt and direction

Center for Disease Control and Prevention (CDC)

provides oversight of public health and safety, including laboratory

National Institute on Drug Abuse (NIDA)

regulates standards fro performing and maintaining appropriate quality control for drugs of abuse testing

Ergonomic Hazards

science of fitting the job to the workers

Environmental Protection Agency (EPA)

sets and enfores standards for disposal of hazardous laboratory materials

Total Quality Management (TQM) and Continuous Quality Improvement (CQI)

standard approches to quality leadership and management for over 30 years

TQM

system approach that focuses on teams, processes, statistics and delivery of sevices and etc. that meet or exceed customer expectations

Lean

system for reducing waste in production or manufacturing processes.

Safety

the condition of being protected from or unlikely to cause danger, risk, or injury.

Good Management

useds the most efficient and effective manner, the human financial physical and information resources available to an organization

State Department of Health

vary in extent to which they regulates laboratories. Oversee mandatory proficiency testing and laboratory inspection program

Sort Set in order Shine Standardize Sustain

what does 5s stand for?


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