Laboratory Management 1

MODULE 1: LEADERSHIP AND MANAGEMENT Leader vs. Manager

General Role of Clinical Laboratory LEADER MANAGER

- Provides clinicians w/ vital information to: Administrator Implementer
1. Detect diseases or predisposition to diseases. Organizer & developer Maintains control
2. Confirm or reject a diagnosis Risk taker Thinks short term
3. Establish prognosis Inspiration Asks how and when
Thinks long term Watches bottom line
4. Guide patient management
Asks what and why Accepts status quo
5. Monitor efficacy of therapy
Challenges status quo Is a good soldier
Does the right thing Does the thing right
Leadership

- Provides the direction where the organization is going Strategic Planning & Tactical Planning
- Pattern of behaviors used to engage others to complete
• Strategic Planning
tasks in a timely and productive manner
- Deciding on objectives of the organization and the
Leadership styles: need to modify existing objectives
- Allocating resources to aim these objectives
1. Supportive Leader – provides physical and personal - Establishing policies that govern the acquisition, use
resources and disposition of resources
2. Directive Leader – presents rules, orders, instructs
Objectives: Statements that are more specific and
3. Delegating Leader – low support and direction quantifiable steps taken to achieve the organizational goals.
4. Coaching Leader – high support and direction Should be SMART (Specific, Measurable, Attainable, Realistic,
and Time-bound).
Management
Policy: An institutional and laboratory guide reflecting the
philosophy and overall goals and rules.
- Provides the “road” to get there
Procedure: An instructional document that provides
Primary functions: explanations and step-by-step instructions on how to
actually perform a task, test or process.
1. Planning and Prompt Decision Making
2. Organizing Goal: A long-term ambition philosophy of the organization.
3. Leading
4. Controlling • Tactical Planning
- Consists of the detailed, day to day operations
PLANNING AND PROMPT ORGANIZING needed to meet the immediate needs of the
DECISION MAKING laboratory
• Forecasting • Identification and
• Determination of grouping of work Classification of Managers
objectives • Establishing of
• Policy formulation relationships and
• Preparation of programs, hierarchy
policies, procedures, • Integration of work
budgets and rules • Staffing and Scheduling
• Anticipating and
preparing for innovations
LEADING CONTROLLING
• Effective utilization of • Determination of
executive ability performance standards
• Adequate communication • Measurement of
• Good personnel performance
management • Interpretation of 1. First Line
performance - Supervisors, team leaders, chief technologists
• Corrective action for - Completes task of the day
deviations of standards or
goal 2. Middle
- Supervisors, team leaders, chief technologists
Staffing: The setting of long-term goals and objectives for the number and - Completes task of the day
types of personnel needed to meet the labor requirements of the laboratory.
3. Top
Scheduling: It is the matching of people presently working in the laboratory - Laboratory directors, CEO, CFO, CIO
with the current workload requirements. - Concentrates on strategizing and planning
 Laboratory Management 2

Quality Management Quality System Essentials

TRADITIONAL THINKING TQM THINKING QUALITY SYSTEM ESSENTIALS

Acceptable quality Error free quality 1. Organization 7. Information management
Department focused Organization focused 2. Personnel 8. Occurrence management
Quality as expense Quality as means to lower 3. Documents and records 9. Assessments
costs 4. Facilities and safety 10. Process improvement
Defects by workers Defects by system 5. Equipment 11. Customer Service
Management controlled Empowered worker 6. Purchasing and inventory 12. Process Control
workers
Status quo Continuous quality • International Standard for Organization (ISO)
improvement
Manage by intuition Manage by fact - Established guidelines that reflect the highest level of
Intangible quality Quality defined quality
“We vs. They” relationship “Us” relationship - CAP adapted the ISO 15189:2007
End process focus System process
Reactive systems Proactive systems • Clinical and Laboratory Standard Institute (CLSI)
- Created the 12 QSE’s based on ISO standards
Tools used to improve quality:

• Total Quality Management (TQM)

- Systems approach that focuses on teams, processes,
statistics and delivery of services/products that meet
customer expectations

• Continuous Quality Improvement (CQI)

- Part of TQM that continually improves practices and
not just meet established quality standards

• Six Sigma
- Performance improvement program
- Improvement by eliminating process variation
- Based on statistics and quantitative measurement
- Reduces number of defects to zero

1. Define project goal or other deliverable that is critical

to quality.
2. Measure baseline performance and related variables.
3. Analyze data using statistics and graphs to identify and
quantify root cause.
4. Improve performance by developing and
implementing a solution
5. Control factors related to the improvement, verify
impact, validate benefits, and monitor over time.

• Lean Process
- System for reducing waste in production or
manufacturing processes
- Utilizes 5S (Sort, Set in Order, Shine, Standard, and
Sustain) and PDCA (Plan, Do, Check, and Act)
 Laboratory Management 1

MODULE 2: LABORATORY DESIGN AND SERVICE MODELS Walls and Floors

- Must be smooth and continuous surfaces
Considerations When Designing a Laboratory - Materials must be easy to clean, and impermeable and
• Biological hazards resistant to the chemicals and disinfectants
• Radiochemical hazards - Floors must be sufficient load-bearing capacity
• Chemical hazards - Walls ust be solid and properly finished
• Type of work to be performed - Floor drains in the laboratory must include grills or water
• Implementation of risk control measures traps

Risk Assessment and Needs Assessment Windows

- Should normally be sealed
- Must be designed, constructed, operated and maintained - If openable, they must be designed to prevent insects or
to fulfill their intended role and to keep laboratory vermin entering the laboratory, and they should be lockable
personnel, the environment and the wider community safe - Natural ventilation design

Laboratory Floor Space Doors

- Must be lockable and have a vision panel
- Activities can be performed safely, efficiently and - Must be compliant with applicable building regulations
ergonomically - Appropriately labeled
- Movement of personnel, specimens, materials and waste - External doors and windows should be secured against the
can be performed safely entry of pests and wildlife based on the local circumstances
- Sufficient space for personnel to move quickly, or be
assisted, carried or even dragged if illness or injury has Furniture
occurred - Must be cleanable
- Hidden spaces can be accessed for maintenance, cleaning - Must not include any fabric surfaces
and decontamination - No carpets and rugs
- Adequate space and access for any necessary safety - Wood, tile, metal, concrete, or painted bench tops are
equipment acceptable

Corridors and Doors Handwashing Facility

- Must be sufficient width to allow easy delivery, removal, - Must be provided in each room of the laboratory
and replacement of laboratory equipment - Should be located as close as possible to the exit door
- Dedicated to handwashing only
Floor Space for Other Facilities
- Toilets, bathrooms eating and drinking areas, and office Electrical Supplies
facilities - Must be of sufficient capacity and reliability for safe and
effective operation of electrical and electronic devices
Storage (Consumables and Reagents) - Should be placed away from wet processes and in
- Consumables and reagents safely and securely in the long accordance with local electrical safety requirements
and short term
- Provision of long-term storage spaces outside of the Lighting
laboratory - Must be adequate for all activities
- Pest control measures - Needs to be bright enough
- Available long enough to ensure laboratory exit
First Aid
- Space for emergency supplies (Ex: Eye washes, first aid Environmental Controls
materials, and biological or chemical spill kits) where all - Includes cooling and heating systems
must be provided and appropriately located - Should avoid undesirable airflow or turbulence on and
around working surfaces
Specimen
- Refrigerator or freezer space Safety Systems
- Electrical supplies - It is dictated by the needs assessment
- Physical security of specimen - Must comply with government regulations and/or
applicable building regulations
Waste
- Enough floor space must be provided to enable safe and
secure storage of waste before it is decontaminated or
transported for disposal
 Laboratory Management 2

Laboratory Physical Design Considerations

1. Review floor plans and elevations for appropriate usage’

2. Fume hoods and biological safety cabinets must be located

away from high traffic areas and doorways.

3. Consider HVAC requirements to ensure

4. Base cabinets provide 20-30% more storage than

suspended cabinets.

5. Install drop ceiling for noise control in open laboratories

6. Space Requirement:
• 150-200 net ft2
• 27-40 net ft2 per hospital bed

7. Rooms larger than 100 ft2 must have two exits.

8. Corridors used for patients must be 8 ft wide. Those not

used must be 3 ft and 8 inch wide.

9. Eyewash unit must be within 100 ft of work area.

10. Suggested Standard Dimensions:

• Laboratory Counter Width: 2 ft and 6 inches
• Laboratory Counter-Wall Clearance: 4 ft
• Laboratory Counter-Counter Clearance: 7 ft
• Desk Height: 30 inches
• Keyboard Drawer Height: 25-27 inches
• Human Body Standing: 4 square ft
• Human Body Sitting: 6 square ft
• Desk Space: 3 square ft
 Laboratory Management 1

MODULE 3: REGULATION, ACCREDITATION AND LEGISLATION IN

THE PHILIPPINES 1997: OIG Compliance Guidelines
- Help laboratories develop programs that promote high
Laboratory Regulations and their Significance ethical and lawful conduct, especially regarding billing
practices and fraud and abuse.
1983: Prospective Payment System
- Hospitals are paid a fixed amount per DRG, regardless of August 4, 1998 - Laboratory Compliance Program
actual cost. - Requires laboratories that receive payment for services
from any federal agency must have policies addressing the
1984: Deficit Reduction Act medical necessity for tests ordered, ensuring accurate
- Established outpatient laboratory fee schedule to control billing for testing, and promoting a standard of conduct to
costs. be adopted by laboratory employees.
2001: CMS National Coverage Determinations
1988: Clinical Laboratory Improvement Act of 1988 (CLIA ’88) - Used to determine whether certain laboratory tests are
- Established that all laboratories must be certified by the medically necessary and therefore reimbursable.
federal government with mandated quality assurance, - Centers Medicare and Medicaid services
personnel, and proficiency testing standards based on test
complexity. 2003: Hazardous Material Regulations
- CLIA applies to all sites where testing is done (Ex: Physician’s - Deal with shipment of blood and other potentially
offices, clinics) biohazardous products (DOT).

Health Insurance Portability and Accountability Act (HIPAA) 1996

- Provides standards that protect the confidentiality of health

information while allowing interchange of information in
appropriate circumstances.
- Access to protected health information (PHI) is restricted on
a “need-to-know” basis as described in an employee’s job
description/title.

Health Information Technology for Economic and Clinical Health

(HITECH Act) 2009

1989: Physician Self-Referral Ban - Under the American Recovery and Reinvestment Act of
- Prevents physicians from referring Medicare patients to 2009
self-owned laboratories. - This improves privacy and security protections available
under HIPAA, as well as enforcement and penalties for
1989: Ergonomic Safety and Health Program Management noncompliance.
Guidelines - Provides patients access to their PHI within 30 days of the
- Established OSHA guidelines for employee safety. request.

1990: Three-Day Rule Laboratory Related Governmental Agencies

- Payment for any laboratory testing done 3 calendar days
CDC: Centers for Disease Control and Prevention
before admission as an inpatient is not reimbursed because
- Under the U.S Department of Health and Human Services
testing is considered to be part of the hospital stay.
(HHS)
- Provides oversight of public health and safety, including the
1990: Occupational Exposure to Hazardous Chemicals in
laboratory
Laboratories
- Established OSHA guidelines to limit unnecessary exposure
CMS: Centers for Medicare and Medicaid Services
to hazardous chemicals.
- Oversees the largest health care program in the US

1992: Occupational Exposure to Blood-Borne Pathogens

DOT: US Department of Transportation
- Establishes OSHA guidelines to limit unnecessary exposure
- Responsibility of regulating transport of biohazardous
to biological hazards.
materials that include blood and other human products
1996: HIPAA (HIPAA)
EPA: Environmental Protection Agency
- Directs how health care information is managed.
- Sets and enforces standards for disposal of hazardous
- Protects patients from inappropriate dispersion (oral,
laboratory materials, such as formalin, xylene, and other
written, or electronic) of personal information and is the
carcinogens
basis for many of the privacy standards currently in place.
 Laboratory Management 2

Laboratory-Related Non-Governmental Organizations

EEOC: Equal Employment Opportunity Commission
- Oversees and enforces Title VIII dealing with fair
employment practices

FDA: U.S. Food and Drug Administration

- Regulates the manufacture of biologics (such as blood
donor testing and component preparation) and medical
devices (such as laboratory analyzers) and test kits

HHS: Health and Human Services

-Oversees CMS, OIG and FDA
NARA: National Archives and Records Administration
- Provides a number of databases, including access to the
Federal Register, where laboratory and other regulations
are published.

NRC: Nuclear Regulatory Commission

- Ensure the proper use and operation of nonmilitary nuclear
facilities (radioactive materials like radioimmunoassay)

NIDA: National Institute on Drug Abuse

- Regulates standards for performing and maintaining
appropriate quality control for drugs of abuse testing

NIOSH: National Institute of Occupational Safety and Health

- Part of HHS
- Provides research, information, education, and training in
the field of occupational safety and health.

NIH: National Institutes of Health

- Agency of HHS
- World leader in medical research RA 4688: Clinical Laboratory Act of 1966

NIST: National Institute of Standards and Technology - June 18, 1966

- Developed standards for calibration, weights and - Administrive Order 2007-0027
measures, and the International System of Units - Latest IRRR: Administrative Order
- An act regulating the operation and maintenance of clinical
laboratories
OIG: Office of the Inspector General
- Requiring the registration of the same with the Department of
- Part of HHS and is responsible for auditing, inspecting, and
Health, providing penalty for the violation thereof, and for other
identifying fraud and abuse in CMS programs such as purposes
laboratory testing
Authority:
OSHA: Occupational Safety and Health Administration - The DOH, through BHFS in the Health Regulation Cluster, shall
- Develops and enforces workplace standards to protect exercise the regulatory functions under these rules and
regulations:
employees’ safety and health
Purpose:
DOH: US Departments of Health - To protect and promote health of people by ensuring
- Regulate laboratories oversee mandatory proficiency availability of clinical laboratory that are PROPERLY KANAGED
testing and laboratory inspection program with adequate resources, with effective and efficient
performance through compliance with quality standards.

DHS: Department of Homeland Security III. Scope:

- Secure the nation from risk of terrorism ALL except government clinical laboratories, doing microscopy work only
for specific DOH programs such as but not limited to: Malarial Screening,
Acid Fast Bacilli (AFB), STD/STI, Cervical screening (Ex: PAP SMEAR)

IV. Definition of Terms:

• STAT: “immediately”
• BFHS: Bureau of Health Facilities and Services (now: HFSRB)
• CHD: Center for Health Development
 Laboratory Management 3

• Clinical Laboratory: Facility where tests are done on body Equipment/Instruments

specimens to obtain information about the health status of the
patients for the prevention, diagnosis and treatment of - There shall be provisions for sufficient number and types
diseases. of appropriate equipment, instruments, glassware
• CRITICAL VALUES: Panic values; Life threatening
reagents and supplies in order to undertake all the type of
V. Classification of Laboratories activities and laboratory examinations.
• Ownership (Government vs. Private) - Shall comply with safety requirement
• Institutional Character (Institution Based vs Free-Standing)
• Function (Clinical Pathology vs Anatomic Pathology vs Primary Secondary Tertiary
Molecular Pathology) Clinical centrifuge All those in Primary + All those in Category +
• Service Capability (Primary vs Secondary vs Tertiary Hemocytometer Refrigerator Incubator
- Limited Service Capabilities and Special Clinical Microhematocrit Photometer or its Balance,
Laboratories centrifuge equivalent trip/analytical
Microscope wit oil Rotator Hemoglobinometer or
Primary Secondary Tertiary immersion objective its equivalent
Routine Hematology Routine Chemistry Special Chemistry Water bath or its Serofuge or its Differential blood
equivalent equivalent count or its
Qualitative Platelet Quantitative Platelet Special Hematology
equivalent
Count Count (including coagulation
testing PT/PTT) Timer or its Drying oven Biosafety cabinet or
equivalent its equivalent
Routine CM Crossmatching – HB Immunology
Autoclave
Blood Typing – HB Gram Staining - HB Culture and Sensitivity
KOH – HB
+ Primary Service + Primary &
Capabilities Secondary Service Personnel
Capabilities
A. Head of the Laboratory (HOL)
B. Registered Medical Technologist
National Reference Laboratories C. POCT Coordinator – if applicable
D. POCT Operator – if applicable
Tests Instituition E. MCL Personnel – if applicable
Hematology National Kidney and F. Support Staff – Laboratory Technician, Laboratory Aide,
Transplant Institute Encoders, Receptions
Chemistry Lung Center of the Philippines
Microbiology – Dengue, Research Institute for Tropical
License Requirement
Influenza, Tuberculosis and Medicine
other Mycobacteria, Mycology, Where: DOH and BHFS
Enteroviruses, Antimicrobial
resistance and Emerging
When (renewal): Not later than 5 days after the expiration date
Diseases and TTI
HIV San Lazaro Hospital
Histopathology Rizal Medical Center Validity: 1 year
CM; Environmental and East Avenue Medical Center
Occupational Health; Drug Inspection: Annually at any reasonable time (every 2 years or as
Testing/ Toxicology and necessary)
Micronutrient Assay
Changes in Labs: Yes, but notify DOH 10 days before

Physical Facilities Laboratory Floor Space

1. The clinical laboratory shall be well-ventilated, adequately
- There shall be a system of accurate recording to ensure
lighted, clean and safe.
quality results
2. The working space shall be sufficient to accommodate its
activities and allow for smooth and coordinated work flow
3. There shall be an adequate water supply. 1. There shall be an adequate and effective system of recording
4. The working space for all categories of clinical laboratories requests and reports of all specimen submitted and examined.
(both hospital and non-hospital based) shall have at least 2. There shall be provisions for filling, storage and accession of all
following requirements reports.
3. All laboratory records shall be kept on file for at least 1 year.
CATEGORY Space Records of anatomic and forensic pathology shall be kept
in sq. m permanently in the laboratory.
PRIMARY 10
SECONDARY 20
TERTIARY 60
(to include a separate, enclosed and adequately
ventilated room for Microbiology)
 Laboratory Management 1

MODULE 4 (PART 1): OPTIMIZING LABORATORY WORKFLOW

AND PERFORMANCE

Laboratory Wastes

Characteristic of Hazardous Wastes

• Explosivity and Reactivity

- Unstable and routinely experiences violent change
without detonating
- Potential for explosive mixture or violent reaction
when combined with water
- Toxic gases are released when mixed with water
- Reactive wastes – unstable under normal condition • Chemical Wastes
and they can cause explosions, toxic fumes or gases,
vapors when heated, compressed or mixed with - Solvents and reagents used for laboratory
water. preparations, disinfections, sterilant, heavy metals
- Example: Lithium sulfur batteries contained medical devices and batteries.
- Chemical compatibilities should be considered when
• Corrosivity preparing chemical waste for disposal. Incompatible
chemicals should not be stored in the same container.
- A corrosive liquid has a pH of less than or equal to 2 or - Chemicals can be hazardous when stored in a long
greater than or equal to 12.5, or has the ability to period of time
corrode steel. 1. Picric acid has the potential to form peroxide
- Wastes that can corrode storage tank, drums and when stored long period of time and when
barrels. not used; can be shock sensitive and has the
- Example: Corrosive base (battery acid) potential to explode.
2. Sodium azide (type of carcinogen used as
• Toxicity preservative of reagents) when disposed in
the sewer- accumulation of copper and iron
- Harmful or fatal when ingested or absorbed.
3. azides may occur. These metallic salts are
- Example: Containing mercury, lead etc.
explosive esp. when subjected to mechanical
shock.
• Explosivity and Reactivity
- Liquids with a flash point- the lowest temperature at Chemical Wastes in Clinical Laboratory
which fumes above will ignite- of 60 degrees Celsius or • Oxidizers should never be mixed with reducing agents or
140 degrees Fahrenheit. organic materials.
- Solids that spontaneously combust. • Oxidizing acids cannot be stored with combustible materials
- Oxidizers and compressed gasses. • Organic acids should be segregated from inorganic acids.
• Acid-reactive compounds should not be mixed with any
Categories of Laboratory Waste acids.
• Acids should not be mixed with cyanide salts or cyanide
• Infectious Wastes
solutions.
- Wastes contaminated with blood and other bodily • Alkali metals must be kept separate from water.
fluids, cultures and stocks of infectious agents from the
laboratory work or waste from patients with
infections. Waste Management

• Pathological Wastes Disposal Methods

- Human tissues, organs or fluids, body parts and • Incineration
contaminated animal carcasses.
- Most common method of treating waste.
• Radioactive Wastes - Hazardous material is literally burned in ashes at
temperature of 870oC-980o C.
- Products contaminated by radionuclides including
radioactive diagnostic material or radiotherapeutic Recommended Wastes for Incineration
materials. • Clinical specimens such as blood and its containers
• Tissue specimens placed in sealed biohazard bags
• Biomedical Wastes • Non-glass disposal tubes, swabs, and pipette tips placed in
- Any kind of waste containing infectious (potentially sealed double biohazard bags
infectious) materials. • Syringes, needles, and objects with sharp edges marked as
red “sharp” containers.
 Laboratory Management 2

• Pyrolysis - Selected laboratory wastes that can be discarded in

the sink include liquid biological waste that has been
- Involves the thermal decomposition of substance and
materials in the absence of supplied molecular oxygen autoclaved, liquid biological waste diluted with
in the destruction chamber in which said material is bleach/Clorox (final dilution of 1:10), a limited amount
converted into gaseous, liquid or solid form (ash, of radioactive waste that is water soluble, solutions
pyrolysis oil, and synthetic gas). that do not contain any toxic cations or anions, and
- Waste residues may be in form of greasy aggregates or chemical wastes with noncorrosive pH levels
slugs recoverable metals or carbon black. (corrosive pH levels are ≤ 2 and ≥ 12.5).

***Due to absence of O2 in the material, it does not combust but the chemical • Trash Disposal
compound that make up the material thermally decompose into combustible
gases and charcoal. - Nonhazardous laboratory waste — which include
broken glassware, used filter papers, and rubber and
• Gasification plastic protective clothing—can be discarded in the
trash provided they are not contaminated with
- Converts the solid and liquid waste materials into a gas
hazardous agents. Containers for this kind of
through a chemical reaction.
- Combines those carbon-based materials (known as laboratory waste should be labeled “Nonhazardous.”
feedstocks) with small amounts of air or oxygen (but
Color of Container/Bag Type of Waste
not enough to burn the materials), breaking them
Black Non-infectious Dry Waste
down into molecules, primarily a mixture of carbon
Green Non-infectious Wet Waste (Kitchen,
monoxide and hydrogen.
Dietary etc.)
Yellow Infectious and Pathological Waste
Other Disposal Methods
Yellow w/ Black Band Chemical Waste including w/ heavy
• Microwave Treatment – Exposure to microwaves to raise
metal
the temperature to 1000C or 237F (using moist heat- it
Orange Radioactive Waste
coagulates and denatures enzymes and proteins)
Red Sharps and Pressurized Containers
• Autoclaving – Uses steam sterilization to render waste
harmless.
• Plasma-based Systems - Uses high temperature ionized gas Waste Categories
to convert the waste into a compact substance
• Irradiation - Sterilizing disposables such as syringes catheter ➢ Solid waste, contaminated or uncontaminated organs,
etc. (Ex: ethylene oxide used to sterilize heat sensitive tissues, carcass, and beddings should be placed in big
object). biohazard bags and call the management and handling
• Sterilization – All forms of microorganism rendered inactive. section.
• Sewer system – Materials that can be discarded in the sink ➢ Plastic Petri dish, tissue culture, container with or without
liquid media, contaminated gloves, towels, etc. these
Proper Hazardous Waste Disposal materials can be sterilized or placed in biohazard plastic
bags which are securely taped with sturdy and wet proof
➢ Hazardous wastes are to be placed in a compatible, non- plastic tape.
leaking container, with non-leaking sealable closure. ➢ Liquid wastes like blood urine or microbial cultures are
➢ All waste containers must have yellow chemical waste label autoclave or sterilized and discarded in sanitary drain.
affixed.
➢ Sharps like pipette tip, blades, needle and syringe,
➢ Don’t use chemical symbols, abbreviations or codes for
contaminated or uncontaminated are placed in a light
code waste identification.
plastic sharps container which is securely taped and closed.
➢ Carcinogens and chemotherapeutic agent are kept in
Proper Handling of Hazardous Waste polyethylene bags designed for cytotoxic waste disposal.
The bags are sealed and disposed in burned boxes.
1. Labeling of waste
2. Segregation of waste
3. Storage of waste Common Errors in Waste Handling
4. Always cap waste bottles
5. Accumulation of excessive waste 1. Improper Labeling of Waste
2. Failing to Label a waste bottle
***Hazardous chemicals must never be poured down the drain as a method of
disposal.
3. Improper Storage of Waste
4. Using metal cans for waste
5. Failure to Cap Waste Bottles
Types of Disposals 6. Accumulation of Excessive Waste
7. Improper Segregation of Waste
• Sink Disposal
- Sink disposal of hazardous waste is prohibited.
Safety Guidelines for the Clinical Laboratory
 Laboratory Management 3

Physical Plant Guidelines

General safety rules include the type of building materials

used for facility construction. The building material should be able to
resist storm damage and prevent fire from spreading rapidly.
Fire Prevention Guidelines

Classified flammable liquids also come with some

restriction in terms of allowable amounts within the safety can and
likewise subject to the laboratory’s given floor area.

a. Class A liquids
- Ether, isopentane The skills needed by every personnel for control of fire
- Should be carried by a safety can to no more than 1 accidents taking place are enumerated as follows:
pint
b. Class B liquids 1. Recognition of fires and fire alarms.
- May be allowed to as more than 1 quart 2. Sounding the alarm and making sure help is on the way
- Acetone, ethanol and methanol before taking any other action.
c. Class C flammables 3. Decision-making strategies whether to fight fire or
- Xylene and mineral oil abandon the site. In abandoning a facility that is thrown
- Is allowed to up to more 1 gallon inside safety cans into a fire accident that needs firemen attention, the
capacity to limit fire spreading is the best contribution one
Fire extinguishers are grouped into four classes depending may give to fire-fighting. The best course of action is to
on the nature and source of fire and the type of material needed to establish smoke barriers such as shutting windows and
extinguish it: doors.
4. Acquire the skill in using fire extinguishers and water
1. Class A fires are the most common and are usually started
hydrant hoses.
by ignition of paper or wood materials and other similar to
5. Techniques for when personal garments catch fire.
the type. This fire is extinguished by water.
6. Evacuation drills such as crawling, use of wet blankets to
2. Class B fires consist of flammable liquids such as alcohols,
prevent fire from catching the personnel.
gases and solvents. These are extinguished by dry
7. Familiarization of evacuation plans from the work site.
chemicals or CO2.
3. Class C fires are electrical fires in nature. The extinguishing
Chemical Safety Guidelines
substance is similar to that in Class B.
4. Class D fires involve combustible chemicals or metals (Ex: Safety topics follow which consists of the following
sodium or magnesium need highly specialized information:
extinguishers such as sand or bulk material)
5. Class K – Commercial cooking equipment (Ex: cooking oils, 1. Identification of the hazardous material or compound with
animal fats and vegetable oils). ingredients with their common and technical names.
2. The physical or chemical characteristics of the substance
such as boiling points, vapor pressure and density, solubility
in water, specific gravity, evaporation rate and water
reactivity.
3. Fire and explosive nature of the chemical, flash point,
flammable air concentration levels and fire-fighting and
extinguishing procedures.
4. Reactivity, stability, chemical incompatibility, dangerous
decomposition products and polymerization.
5. Specific health hazard data giving the primary route of
contamination, health complaints and symptoms that may
arise from contact, medical conditions that may be
aggravated, first-aid procedures, and specific health
dangers that may arise from exposure: cancer, cell
mutation, organ damage, and so on.
6. Personal protection equipment, ventilation requirements
Important actions in case of fire and the order in which to and other precautions. Protective equipment may include
perform tasks are remembered as the standard acronym (RACE): respirators, gloves, protective garments or suits, eye
wears, hoods and isolation chambers.
7. Listing on safe handling, storage, spill, leak control and
R-escue any injured individual.
disposal methods.
A-ctivate the fire alarm.
C-ontain (smother) the fire if feasible (Close Fire Doors)
E-xtinguish the fire.
 Laboratory Management 4

Electrical Safety Guidelines

General recommendations to evade electrical mishaps.

1. There should be no extension cords or outlet adapters

2. All equipment, including household items (coffee pots,
microwaves, should be checked for compliance to
electrical safety standards. The engineering department
may be consulted on these prior to purchase of
equipment.
3. Conduct of electrical safety checks on equipment and
move for its inclusion to the laboratory’s preventive
maintenance program for each equipment. The
assessment includes total power needs of the laboratory,
check on equipment proper voltage, grounding, current
leakage and plugs and cord evaluations.
4. Circuit breakers should be conveniently located and
Physical Plant Guidelines labeled
5. Equipment should not be placed near to flammable
Tissues, organs, mucous secretions, saliva, semen, vaginal,
materials
urethral, cavity fluids, exudates, wounds, amniotic fluid and any
6. As prevention is far better than remedy disasters when it
materials acquired from the body.
happens, electrical safety should be made part of the
Urine is considered relatively safe but possibly microbial orientation and educational program of the laboratory
organisms and agents may subsist upon.
Factors in the Safety Management
➢ Laboratories should have an exposure control plan.
➢ Specific guidelines for management of pathogen ➢ Employee’s Role
exposures. ➢ Employer’s Role
➢ Facilities and requisites (Ex: soaps, clean wipes, for hand- ➢ Labels and Signs
washing must be available in the workplace). ➢ Information and Training
➢ Gloves, lab gowns and face masks are routine personal
protective equipment for laboratory personnel
➢ Housekeeping procedures involve disinfection or
sterilization of objects and surfaces that have come in
contact with biological specimens.

Safety Management Program

The components of the program include:

1. Policy and procedures

2. Communications
3. Disaster plan
4. Safety audits and inspections
5. Accident investigations and accident prevention

Accident investigation aims to resolve the following:

1. Who received the accident?

2. When and where it happened?
3. What equipment or supplies were being used?
4. Is modification of the standard procedure would have
averted the accident?
5. Is there need to train personnel in order to be thrown in
the same accident situation?
6. Is there non-compliance to the established safety
protocols?
7. What are the other circumstances that may have
contributed to the accident?
8. Is there need for precautionary warnings?
9. What are the other additional steps or actions that could
be taken to prevent the recurrence of accidents?
 Laboratory Management 1

MODULE 4 (PART 2): OPTIMIZING LABORATORY WORKFLOW Techniques to Collect Workflow and Data
AND PERFORMANCE
➢ Sample and Test Mapping
Understanding Workflow ➢ Tube Analysis
➢ Workstation Analysis

Sample and Test Mapping

Tube Analysis

- Includes the number of containers other than tubes (e.g.,

Laboratory Testing Process
fingerstick collections that may require special processing
or aliquoting) and the number of reruns (i.e., repeats)
needed as the result of instrument flags and/or laboratory
policies (Table 2-2).

➢ Reruns are caused by different factors and can be a source

Laboratory Testing Process of non-productive technologist time and/or turnaround
time delays.
➢ Analyzer A reruns are related to overly tight limits for delta
checks and panic values that flag too many test results for
technologist review and rerun.
➢ Analyzer B reruns are related to instrument flags caused by
a narrow linear range for many methods and a large sample
volume requirement per test.
➢ A nontechnologic solution (i.e., altering laboratory
rerun/review criteria to reduce the number of tubes flagged
for rerun) benefits Analyzer A; however, only a technologic
solution (i.e., a new analyzer) can lower the number of
reruns in Analyzer B.

Optimizing Laboratory Workflow and Performance By Mark S, Lifshiz; page 11

 Laboratory Management 2

Workflow Analysis - Maximum number of samples that can be processed per

hour
- Number of samples that can be loaded at a single time
- Number of reagent containers and assays that can be stored
on board.
- Instrument throughput (cost/tests/hour)
- Statistical reports that can be extracted from the
instrument and the LIS.

Test Menu

- Examination Test
- Send out test – to send specimen sample to a reference
laboratory where it is performed more frequently

Processing Mode and Load Balancing

1. Batch Sample
2. Random Access
Workflow Modeling 3. Continuous Sample Processing

Batch Sample
Stat Sample
Mixed Sample

Test Ordering Patterns / Interviews

- Orders for “add-on” tests -or added electronically,

processing special requests, and troubleshooting incorrect
orders, unacceptable samples, or misaligned bar code
labels.
- Computer-generated orders may still be associated with
considerable manual laboratory labor that may be
identified only through interviews.
- Stat systems to collect, identify, and process these samples,
as well as report results, during the busiest time of the day
sometimes, dedicated (stat instrument) or new technology
(point-of-care device) is used for this purpose.
- However, one can ensure that results are available in the
chart during early-morning clinical rounds by simply
collecting laboratory samples from patients on the evening
Goal of Workstation Analysis before discharge (Sorita et al, 2014).

➢ Instrument Audit Task Mapping

➢ Test Menu
➢ Processing Mode and Load Balancing - Workflow maps are also referred to as flowcharts, flow
➢ Interviews maps, flow diagrams, flow sheets, and process maps
➢ Task Mapping - No workflow study is complete without mapping the tasks
or processes involved in performing a test (Middleton &
Tube Analysis Mountain, 1996).

- Equipment is the key of any workstation.

 Laboratory Management 3

Pneumatic Tube System

- Transport of Specimens.
- Engineering department of the hospital maintains the
system on a daily basis.
- Enough specimen carriers must be available to supply all
areas of the hospital in need of specimen transport to the
laboratory.
- Moving samples within a building or to another building a
short distance may be accomplished by a pneumatic tube
system.

Understanding Technology

➢ Testing equipment (Ex: Analyzers)

➢ Pre-analytic Processors
➢ Information Technology

The Role of Technology: Principles and Pitfalls

➢ Is technology needed?
➢ Technology is a means to an end, not an end.
➢ Overbuying – the cardinal sin.
➢ Do you understand what you are buying?

Optimizing Performance

To successfully consolidate tests from multiple facilities, a

central site must control new costs (by minimizing additional staff or
equipment to perform the tests) and provide better or comparable
quality and service to what had been provided (Carter et al., 2001).

➢ Consolidation
➢ Integration
➢ Standardization
➢ Six Sigma and Lean
➢ Managing Utilization
 MTY1205: LABORATORY MANAGEMENT
MODULE 7: ANALYSIS
NAME OF LECTURER: Jeffrey Castillo
DATE: October 22, 2021

TABLE OF CONTENTS o Also known as exciter lamp

o Types of light source:
I. ANALYSIS: PRINCIPLES OF 1 § Continuum:
INSTRUMENTATION - Emits radiation that changes in intensity
II. GENERAL ANALYTIC METHODS 5 very slowly as a function of wavelenght
III. ANALYSIS: CLINICAL LABORATORY 7 § Line
AUTOMATION - Emits a limited number of discrete lines
or bands of radiation
REFERENCES ………………………………………………………. 10 - Limited range of wavelenghts

ANALYSIS: PRINCIPLES OF INSTRUMENTATION

SPECTROPHOTOMETRY
• Absorption spectroscopy:
o Provides scientists with a means to use both
qualitative and quantitative methods of
measuring analytes in body fluids.
o Developed by Lambert and Beer
• Diverse spectrophotometric methods use
electromagnetic radiation (EMR)
o Light and radiant heat
o Gamma rays • Wavelenght selector/filter
o X-rays o Isolates a portion of the spectrum emitted by
o Microwaves the source and focuses it on the sample
o Radiofrequency radiation o Filters:
o Ultraviolet radiation § Presample filters:
• Beer’s Law: - Limit the wavelengths of light that enter
o Fundamental principles of absorption the sample
spectroscopy. § Postsample filters:
o A = 2 – log%T - Allows multiwavelength light to pass
§ Absorbance and transmittance are inversely through the sample and then to break
related up this light into it’s component
§ Directly proportional to the amount of light wavelenghts
absorbed o Monochromator
§ Indirectly proportional to the logarithm of § Used to select the appropriate wavelength
transmitted light § Types:
o Calculation of absorbance from percentage - Prism
transmittance data. - Grating monochromators
o If all light passes through the solution without - Holographic gratings
any absorption, then the absorbance is zero, and • Sample container/Cuvet
absorption is infinite. o Used to hold samples
o Law states that the fraction of the light o Must be made of material that is transparent to
absorbed by each layer of the solution is the radiaton in the spectral region of interest
same. o Many double-beam spectrophotometers are
designed with two cuvet holders; One for the
COMPONENTS OF A SPECTROPHOTOMETER sample and other for the solvent
• Light source § If two cuvets are used, they should be
o Provides the energy that the sample will modify optically matched for more accurate results.
or attenuate by absorption. • Radiation detector/photodetector
o Provides polychromatic light. (i.e., all visible o The light that passes through the cuvet and
wavelengths are present.) sample strikes the cathode of the photodetector
and generates an electrical signal.

MARTINEZ, C. 1
 o Converts transmitted radiant energy into an
equivalent amount of electrical energy
o Types:
§ Photomultiplier tubes (PMTs)
- Most common type
- Highly sensitive to UV and visible
radiation
- Used when radiant power is very low,
which is a characteristic of very-low-
analyte concentrations
- Fast response time
- Intense light causes irreversible damage
to the photoelectric surface
QUALITY ASSURANCE IN SPECTROPHOTOMETRY
§ Photovoltaic/ Barrirer layer cell
• Several photometric parameters must be monitored
- Used for detecting and measuring
periodically by users.
radiation in the visible region
• Monitoringthse paramters is recommended by most
- Detects photon-induced current
regulatory agencies and accrediting organizations
- Rugged and cheap
• Parameters routinely monitored includes:
- Require no external source of electrical
o Accuracy
energy
§ The closeness of a measurement to its true
- Low sensitivity and fatigue
value
§ Vacuum Phototubes
§ Wavelenght accuracy implies that a
- Has a semicylindrical cathode and a wire
photometer is measuring at a the
anode sealed inside an evacuated
wavelenght that it is set to.
transparent envelope
§ Photometric accuracy can be assessed easily
- The concave surface of the electrode
using special glass-type optical filters
supports a layer of photoemissive
o Absorbance check
material that tends to emit electrons
§ Performed using glass filters or solutions
when it is irradiated
that hae known absorbance values for a
§ Silicon Diode Transducers
specific wavelength.
- Contain positively (P) and negatively (N)
§ Operator measures the absorbance of each
charged semiconductive materiasl
solution at a specified wavelength and
adjoining one another embedded on a
compares the results with the stated values.
silicon chip
o Linearity
- More sensitive than vacuum
§ The ability of a photometric system to yield
phototubes, but less sensitive than the
a linear relationship between the radiant
PMTs
power incident upon its detector and the
§ Multichannel Photon Transducers
concentration
- Consists of an array of small
§ Can be determined using optical filters or
photoelectricsensitive elements
solutions that have known absorbance
arragned linearly or in a two-
values for a given wavelength
dimensional pattern on a single
§ Should be evaluated for both slope and
semiconductor chip
intercept
• Signal processor
o Stray light
o Electrical signal is processed electronically
§ Any light that impinges upon the detector
o The processing of an electrical signal received
that does not originate from a
from a transducer is accomplished by a device
polychromatic light source
that amplifies, rectifies AC to DC (or the
§ Can have a significant impact on any
reverse), alters the phase of the signal, and
measurement made.
filters it to remove unwanted components.
§ Stray light effect can be evaluated by using
• Readout device
special cutoff filters
o The processed signal is electronically coupled to
the display unit
§ Light emitting diode (LED)
§ X-Y Strip chart recorder
§ Meter

MARTINEZ, C. 2
TYPES OF PHOTOMETRIC INSTRUMENTS COMPONENTS OF REFLECTOMETERS
• Spectroscope • Tungsten-quartz halide lamp
o Optical instrument o Serves as a source of polychromatic radiation
o Used for visual • Monochromator
identification of atomic o Used to isolate the wavelength of interest
emission lines o Stationary filter or filter wheel for multiple
o Has a monochromator, analytes
usually a prism or • Slit
diffraction grating o Monochromatic light passes through a slit and is
§ Exit slit is replaced directed onto the surface of a urine dipstick pad
by an eyepiece that or dry slide, depending on the instrumentation
can be moved used.
along the focal plane • Photodetector
• Colorimeter o Solid-state photodiodes are typically used to
o Uses the human eye detect reflected radiant energy.
as the detector o Special optical devices
o User compares the § Can be used to direct radiant energy onto
observed color of the the detector
unknown sample § Eg: Fiber optics or ellipsoidal mirrors
against a standard or • Read out device
a series of colored o A computer or microprocessor is used to
standards of known convert nonlinear reflectance signals into direct
concentrations readout concentration units.
• Spectrometer
o An instrument that
provides information
about the intensity of
radiation as a function
of wavelength or
frequency

REFLECTOMETRY
• Clinical applications:
o Urine dipstick
o Dry slide chemical
• Reflectometer:
o Instrument used for the application of
reflectometry
o A filter photometer that measures the quantity
of light reflected by a liquid sample that has
been dispensed onto a grainy or fibrous solid FLUOROMETRY
support • Molecular Luminescence Spectroscopy
• Types of Reflectance • Based on an energy exchange process that occurs
o Specular: when certain compounds absorb electromagnetic
§ Occurs on a polished surface radiation, become excited, and return to an energy
§ Angle of incidence of the radiant energy is level lower than or equal to their original level.
equal to the angle of reflection • Widely used because of it’s high sensitivity
o Diffuse o Signal-to-noise ratio is very high because light is
§ Occurs on nonpolished surfaces measured against a nearly dark background
§ Ex: Grainy or fibrous surface • Fluorescence
§ Reflected radiant energy tends to go in o Light emission from a singlet excited state
many directions • Phosphorescence
§ Occurs within layers and depends on the o Light emission from an exicted triplet state
properties and characteristics of the layers

MARTINEZ, C. 3
COMPONENTS OF FLUOROMETERS o Light emitting diode
• Light source o Laser
o Exciter lamp is a high-intensity light source such § Produce stable, nearly ideal monochromatic
as a mercury vapor lamp or a xenon arc lamp light of marrow bandwidth and emit energy
• Excitation (primary) monochromator that is coherent, parallel and polarized.
o Primary filter § Laser beam can be maintained as a very slim
• Cuvet cylinder only a few micrometers in cross
• Emission (secondary) monochromator section
o Secondary filter § Disadvantages:
• Photodetector - Cost
§ Emitted light is detected at a right angle to - Safety
the incident light - Cooling requirements
- Limited availability of wavelenghts
• Collimator
• Monochromator
• Cuvet
• Stray light strap
• Photodetector

TURBIDIMETRY
• Measures a reduction in light transmission due to
OTHER INSTRUMENTS particle formation
• Time-resolved fluorescence assays • Detects a small decrease in a large signal
o Minimize problems in other flurescent assays • Applications:
such as overlapping excitation or emission o Antimicrobial sensitivity
spectra of compounds present in the sample § Detect bacterial growth in broth cultures
with the fluorophore o Coagulation studies
o Similar to a typical fluorometer § Detect clot formation in the sample cuvets
o Uses a time-gated measure on only a portion of
the total emission spectra o Concentration of biologic fluids
• Chemiluminescence § Urine, CSF
o More sensitive than fluorescence
o Light signal is measured against a completely REFRACTOMETRY
dark background • Based on light refraction
o No excitation light is required • Indirect measurement of total solute concentration
• Dependent on wavelength of light, temperature,
NEPHELOMETRY nature of liquid medium and concentration of the
• Detects light that is scattered at various angles solute in the dissolved medium
• Scattered light yields a small signal that must be • Refractivity
amplified o Ability of a substance to bend light
o Measured as a difference between the angle of
COMPONENTS OF NEPHELOMETER incidence and the angle of refraction
• Light source • Applications
o Mercury-arc lamp o Measure protein concentration
o Tungsten-filament lamp o Specific gravity of urine

MARTINEZ, C. 4
 o Column effect of high performance liquid CONDUCTANCE
chromatography analysis • Electrolytic conductivity is a measure of the ability of
the solution to carry an electrical current
OSMOMETRY • Applications include:
• Based on measuring changes in the colligative o Monitoring water purity
properties of solutions that occur owing to o Blood analyte measurement
variations in particle concentration o Component detectors in HPLC, GC, cell counters,
• Osmometry is the measurement of the osmolality of and capillary electrophoresis
aqueous solution such as serum, plasma, or urine.
• As osmotically active particles are added to a IMPEDANCE
solution, osmolality increases • Measurement is based on the change in electrical
o As osmolality increases resistance across an aperture when a particle in
§ Osmotic pressure increases conductive liquid passes through this aperture
§ Boiling point is elevated
§ Freezing point is depressed ELECTROPHORESIS
§ Vapor pressure is depressed • The separation of charged compounds based on
o These are called colligative properties of the their electrical charge
solution because they can be related to one • When a voltage is applied to a salt solution (sodium
another and to the osmolality chloride), an electrical current is produced by the
• Freezing point depression osmometry is the most flow of ions
commonly used method for measuring changes in o Cations -Cathod
colligative properties of a solution o Anions- Anode
o Addition of solute molecules lowers the
temperature at which a solution freezes ISOELECTRIC FOCUSING
• Separating molecules migrate through a pH gradient
FLOW CYTOMETRY • pH gradient: created by adding acid to the anodic
• Measures multiple properties of cells suspended in a area and adding base to the cathodic area
moving fluid medium. • Useful in measuring serum ACP isoenzymes, CK
• As each particle passes single file through a laser isoenzymes ALP and detection of oligoclonal bands
light source, it produces a characteristic light pattern in CSP
that is measured by multiple detectors for scattered
light and fluorescent light CHROMATOGRAPHY
• Particle • Separation method based on different interactions
o Any object flowing through the instrument of the specimen compounds with the mobile phase
• Event and with the stationary phase as the compounds
o Anything that is interpreted by the instrument travel through a support medium
to be a single particle
• Application MASS SPECTROMETRY
o Count and sort cell, viral particles, DNA • Based on fragmentation and ionization of molecules
fragments, Bacteria and latex beads using a suitable source of energy
o It is a core component of hematology cell
counters and the technology used to
differentitate WBCs GENERAL ANALYTIC METHODS
CHEMICALS
• Proper selection of chemicals is important so the
ELECTROCHEMISTRY desired results may be attained
• Involves measurement of the current or voltage • Exist in varying degrees of purity
generated by the activity of specific ions. • Must meet the specifications of American Chemical
• Analytic techniques includes: Society (ACS)
o Potentiometry • Proper chemical selection and reagent preparation
o Coulometry guideline is provided by CAP and CLSI
o Voltammetry • Classifications:
o Amperometry o Analytic or reagent grade
o Ultrapure chemicals
o Pharmaceutical chemicals

MARTINEZ, C. 5
 WATER LABORATORY PLASTICWARE
• Water must be of the highest purity, whereas the • Types:
water required for rinsing glassware may be of a o Polypropylene
lesser purity § Flexible or rigid
• CLSI and CAP have defined three grades of water § Chemically resistant
purity § Can be autoclaved
• Criteria for each type are outlined in the CLSI o Polyethylene
guidelines § May bind or absorb protein, dyes, stains,
• Types of water purity and picric acid
o Type 1 o Teflon
o Type 2 § Chemically inert
o Type 3 § Resistant to a wide range of chemical
• Feed water: classes. Including acids, bases, alcohol, and
o Laboratory’s tap water hydrocarbons
o Contain unique contaminants or may have high o Polycarbonate
mineral content (hardness) § Not suitable for use with strong acids, bases,
• Many laboratories produce or purify their own and oxidizing agents
water § May be autoclaved but with limitations
• Purification includes: o Polystyrene
o Distillation: § Rigid, clear
§ Liquid is vaporized and condensed § Should not be autoclaved
o Reverse Osmosis
§ Water is forced through a semipermeable VOLUMETRIC LABORATORYWARE
membrane that acts as molecular filter PIPETS
§ • Used for reconstituting controls and calibrators,
o Deionization preparing serum or plasma dilutions, and aliquoting
§ Passing water through insoluble resin specimens
polymers that contain anion- or cation • Types of manual pipets:
exchange resins o Transfer (volumetric)
o Measuring
BALANCES • Subclassifications
• Measurement of mass o TC
• Types: o To deliver (TD)
o Unequal arm substitution balances o To deliver (TD)/blow-out
o Magnetic force restoration balances
o Top loading balances VOLUMETRIC FLASKS
o Electronic balances • Represent a special type of glassware in the
laboratory
LABORATORY GLASSWARE • Often used to prepare standards for quantitative
• Borosilicate glass procedures
o Most common type of glassware encountered in
volume measurements THERMOMETRY
• Types of glassware THERMOMETERS
o Thermal resistant glass • Types of liquid in glass thermometers
o Alumina-silicate glass o Total immersion
o Acid and alkali resistant glass § Requires that the bulb and entire column of
o Low actinic glass liquid be immersed into the medium
o Flint glass measured
• Glass should not be heated above its strain point § Used to monitor freezers and refrigerators
o Rapid cooling strains and cracks glass easily o Partial immersion
when it is heated again § Must have the bulb and stem immersed to
• Corex the immersion line or defined depth on the
o A special alumina-silicate glass thermometer
o Strenghtened chemically rather than thermally § Often used for water baths and heating
o Six times stronger than borosilicate glass blocks
o Resists clouding and scratching better

MARTINEZ, C. 6
 § Move sample between analyzers and into
and out of processing stations
• Improvements leads to:
o Reduced error rates
o Creation of quality laboratory results
o Improved patient care

ANALYSIS: CLINICAL LABORATORY AUTOMATION

• Automation
o The process by which an instrument
automatically performs tasks
• Laboratory automation
o A broader process wherein multiple devices,
often linked together are capable of automating
preanalytic, analytic and postanalytic stages of
testing • Technicon autoanalyzer
o Single channel analyzer
EVOLUTION OF AUTOMATION § One sample, one test
• 1950s o Continuous flow analysis
o Laboratory testing was a completely manual o Disadvantages:
process § Measurement of every analyte configured
o Technicon autoanalyzer: on the system for every sample
§ Examples, etc • Discrete testing
§ Eliminates manual intervention o Measure only the tests requested on sample
§ Significantly improves the reproducibility, o Types:
accuracy, flexibility, and TAT § Centrifugal analyzer
§ Lowers costs - Discrete
§ Eliminates errors due to - Batch type
- Analyst fatigue - Low throughput (disadv.)
- Erroneous sample ID § Modular analyzer
§ Enchance patient safety through robust - Multiple analytes on multiple sample
sample identification and test reporting - Random access testing:
technologies - Allows users to add on additional units
o First automated analyzers were based on (ISE, immunoassay modules)
continuous flow technology - Modular + Random acess
• 1970 - Specimen throughput (100/hr)
o Start of high level of computerization - Test throughput (1000/hr)
o Increased use of computer
§ Decreases errors PREANALYTIC STAGE
• 1990 • Focuses on sample or specimen collection and
o Total laboratory automation (TLA) processing
o Production of intralaboratory transportation • Specimen collection
system o Within the facility:
§ Conveyors or trucks § Blood drawers “runners”

MARTINEZ, C. 7
 § Specimen is transported to the laboratory o Used for specimens that needs to send out
by phlebotomists or other staff • Recapping/storage/retrieval
o Outside the facility: o Specimens stored in freezers or refrigerators
§ Courier service is used if specimens were o Must be organized for easy retrival when
obtained outside the facility needed

GOALS OF AUTOMATED SAMPLE PROCESSING

• Minimize non-value added steps in the laboratory
process
o Sorting tubes
• To increase available time for value-added steps
o Tasks to make quality test results
• Modular system:
o Designed to automate the entire process
INTRODUCTION OF AUTOMATED SPECIMEN
TRANSPORTATION
ANALYTIC STAGE
• Pneumatic tube system
o Point to point delivery of specimens
o Earliest automated transport system to be
introduced
o Desired to prevent hemolysis
§ Avoids significant elevation of gravitational
forces during acceleration and deceleration
• Electrical track vehicles
o Can transport a large amount of samples
o Requires a station for loading and unloading
SAMPLE INTRODUCTION
specimens
• Involves several different physical mechanism
• Conveyors/ Track systems
o Peristaltic pumps
o For very large number of samples
§ Roller pumps
o Designed to transport specimen horizontally
§ Used in ISE
(upward) or vertically
o Positive liquid displacement pipets
o Horizontally
§ Dispense aspirated sample into reaction
§ Across the floor
container
o Vertically
§ Flush out samples together with diluent
§ To a different floor
• Clotted sample
o Ability to detect presence of liquid
SAMPLE PROCESSING TASK
o Equipped with clot detector
• Labeling • Carry over
o Manual ID requires a lot of time o Contamination of one sample by the previous
o Large source of laboratory error
sample
• Sorting o Creates spurious results
o Separating of samples by stopper color, size, test o Reusable pipette probes are subject to carry
ordered over
• Centrifugation: o Reduce carry over:
o Loading of tube to centrifuge § Aspirate wash solution
o After centrifugation, specimens requires re- § Back flushprobe with wash solution
sorting • Use of disposable plastic pipet tips
• NOTE o Pros:
o BARCODES IMPROVES PROCESSING TIME AND
§ Elimination of carry over
REDUCES PREANALYTIC ERROR o Cons:
• Decapping § Coasting
o Happens after centrifugation prior to aliquoting
§ Plastic consumption
o Posed health hazards to technologist via
§ Cannot detect clot or volume of sample
§ Aerosol leading to delay on testing
§ Direct contact
• Aliquoting
o Splitting of samples

MARTINEZ, C. 8
REAGENTS o Uses elongated cuvet path length and
• Automated analyzers: fluorocarbon oil incubation bath
o Handling, preparation, storage
o Proportioning DETECTION
o Dispensing • Adsorption spectroscopy
• Stored in environmentally controlled compartments, o Reflectance photometry
and inventory is monitored in real time. § Dry slide and chemistry
• Types of reagents: o Fluorescent compounds
o Lyophilized: § Drugs
§ Needs reconstitution § Hormones
o Ready to use: § Vitamins
§ Wet or dry o Ion-selective electrodes
• Reagent inventory within the analyzer § Electrolytes
o What are the reagents onboard
o Quantity of each reagent POST ANALYTIC STAGE
o Reagent onboard stability DATA PROCESSING AND REAL-TIME MONITORING
• Reagent identification and inventory is • The instrument computer controls signal processing,
accomplished using barcode labels data handling and process contrl.
• Category of automated analyzer based on reagent • Signal processing converts an analog signal from the
system detector to a digital signal that is usable by all
o Open reagent system: communication devices
§ System in which reagents other than the o ANALOG SIGNAL IS CONVERTED TO DIGITAL
manufacturer’s reagent can be used SIGNAL
o Closed reagent system: • Data processing by computer includes:
§ System wherein the operator can use only o Data acquisition
the manufacturer’s reagent o Calculations
• Proportioning o Monitoring
o Volumetric overflow devices o Displaying data
§ Proportion reagent and samples into a test • Computers can display
tube or other type of container o Patient result
o Continuous flow technique o QC data
§ Sample and reagent are proportional by o Maintenance and instrumentation operation
their relative flow rates checks
o Monitor patient result against reference value
MIXING OF SAMPLE AND REAGENT or established QC protocols
• Mixing methods: • Automated system designs avaliable
o Magnetic stirring o Total laboratory automation (TLA)
o Rotating paddles o Modular integrated systems
o Forceful dispensing
o Ultrasonic energy TOTAL LABORATORY AUTOMATION (TLA)
o Vigorous lateral displacement • Combination of several instruments that are coupled
• Dry slide analyzers: to a specimen management and transportation
o Do not require sample and reagent mixing system to automate large percentage of laboratory
because sample only needs to flow through the work.
reagent layers to accomplish this task. • Process control software (middleware) coordinates
INCUBATION the activities of the various automation modules
• Incubator • Middleware:
o Must provide a constant and accurate o Central hub that can consolidate most of the
temperature for the reaction user interaction emanating from all the devices
o Achieved by using circulating air or water baths and present it to the technologist on a single
or heated metal blocks display
o Electronic thermocouples and thermistors • Designed for hospital based laboratories
monitor and maintain required temperatures • Advantage:
• Warming process must be constant and accurate o Reduce labeling errors
• Siemens healthcare diagnostics (advia chemistry o Shorter TAT
systems) o Decrease overall errors

MARTINEZ, C. 9
• Disadvantages:
o High financial investment
o Needs large floor space

Modular Integrated System

• Good for smaller systems
• Requires less initial capital investment and planning

CONFIGURATION OF AUTOMATED MODULES

• Workstation consolidation
o Basic unit of automation
o Samples are manually loaded and unloaded
o Unique environment within laboratory facility
dedicated to one type of testing
o Ex:
§ Hematology
§ Clinical chemistry
• Workcells
o Integrated groups of analyzers that can function
as a single unit REFERENCES
o Can be monitored by a single technologist
• Henry’s clinical diagnosis and management by
o Preanalytic and postanalytic specimen
laboratory methods 22nd ed.
processing capabilities
o Ex:
Goodluck MT Tams! Road to RMT on 2024. Kaya natin
§ Versacell ‘to.
• Fully integrated system
“Whatever you do, do it for the glory of God.” -I Cor. 10:31
o Design is to integrate several modules into one
continuous system that will allow the user to
assay:
§ Examples, etc
§ photometric chemistry
§ immunoassay chemistries, both
homogeneous and heterogeneous
§ Electrochemistries

MARTINEZ, C. 10
 Laboratory Management 1

MODULE 6: POST-ANALYSIS • Verifying laboratory results

• Feeding them into the laboratory information system
Introduction • Communicating them to the clinicians in a number of ways
▪ Producing a report and making any necessary
Post Analytical Quality oral communications regarding “alert” or “panic”
- This is the ultimate check on the consistency of pre- values.
analytical and analytical quality and can be considered as • Report generation without any transcription errors
the overall quality. • Double checking of printed report and counter signed by a
- It ties together: pathologist or senior laboratory scientist
• The analytical quality achieved • Report dispatch to right person
• The context of the patient. • Storage of reported material
• The perceived abilities of the physician to • Disposal of specimen
interpret and utilize the laboratory information. • Monitor of turnaround time.

Similar to the pre-analytical step, the post-analytical phase can be

subdivided into:
• One-phase performed within the laboratory
• Post-post analytical phase
▪ Clinicians receive, interpret, and react to
laboratory results.

Factors Influencing Quality

Post-Analytical Errors

Post-analytical causes of errors accounting for 18.4% – 47% of total

laboratory errors.

• Transcription errors
• Wrong validation
Total Testing Process
• Excessive delay in reporting values
• Incorrect reference values
• Physician not notified of a panic or critical value
• Incorrect interpretation of lab results by physician
• Incorrect data entry

Validation

Manual Test Validation

- This is a time-consuming process with large inter-

individual variation.
- It slows down the response of the laboratory, thus causing
delay in the diagnostic and therapeutic process.

Post-Analytical Activities

Automated Validation System

Post Analytical Procedures
• High sensitivity
The post-analytical procedures performed within the laboratory • High specificity
include:
 Laboratory Management 2

Review and evaluate the following: - A laboratory result that may represent a life-threatening
situation that may not otherwise be readily detectable.
• Effectiveness of the corrective actions - Must be reported immediately to a health care provider
• Procedures and policies to prevent recurrences who can provide necessary medical interventions.
• Accuracy and completeness of results and reports - The laboratory then has to document the event, including
• Disposition of unacceptable specimens the name and title of the caregiver who is notified, the
• Turnaround times time and date of notification, and the read-back by the
• Referral specimens and their reports care provider.
• Corrected reports
• Procedures for notification of test results with statistics Reference Ranges
• Assurance of confidentiality of patients’ information - Reference intervals are usually defined as the range of
values into which 95% of nondiseased (“normal”)
Assessment of Analytic Correctness of Results individuals will fall
▪ 2.5% of nondiseased individuals will have
Alarms and Flags laboratory results “below” the reference range.
▪ 2.5% of nondiseased individuals will have
- Automated analyzers can flag specimens that require laboratory results “above” the reference range
additional or repeat testing before results are released by (CLSI, 2008).
specialized middleware or by the laboratory information
system. Factors that Influence Reference Ranges
- Flags can indicate a problem with the specimen (Ex: • Different laboratory methods often yield significantly
Presence of an interfering substance) or an issue with the different results and therefore require different
result (Ex: A numeric value outside the analytic range of reference ranges.
the method, or the need for confirmation by an additional • Differences in age, genetic background, or exposure to
assay). environmental factors, different populations may need
different reference ranges for certain laboratory
Flags for Problem Specimens analytes.
• Many other factors can affect reference ranges,
- Many automated instruments can measure the amount of
including sample collection container (Ex: Glass vs.
sample present in a collection tube and flag samples that
plastic tubes), sample transport (Ex: By messenger or
contain amounts that are inadequate for a reliable
analysis. pneumatic tube), the time between specimen
collection and analysis, and sample storage before
- Another frequent cause of inadequate samples is the
analysis.
presence of high concentrations of interfering substances
in the specimen:
▪ Lipids (lipemia), Hemoglobin (Hb) (hemolysis), Determination of Reference Ranges
Paraproteins (gammopathies), or Bilirubin • Because many factors can affect reference ranges,
(icterus). laboratories are strongly encouraged to perform their
▪ The mechanism for this interference is own studies to establish reference ranges for all
dependent on the substance and the analytic analytes they report, usually by testing at least 120
method. samples from non- diseased individuals in each
- Automated analyzers are also able to detect troublesome “partition” (Ex: Gender, age group).
levels of interfering substances, even when they are not • If this is not possible, the laboratory can verify a
apparent to the laboratorian at the macroscopic level. reference interval that it has previously established for
- Automated systems can measure the concentrations of a different method by transference (Ex: Demonstrating
bilirubin, lipid, and hemoglobin in samples and can report that the new method yields identical results to the
the degree of interference as an index. previous method).
• The laboratory can verify another laboratory’s or the
Delta Checks manufacturer’s reference interval if the analyte was not
previously tested for in the laboratory.
- Defined as comparing a current laboratory result with
results obtained on a previous specimen from the same
Variability of Laboratory Results
patient.
- Detect preanalytical (Ex: Mislabeling of specimens) and Variability of laboratory results is still part of the assessment of
analytic issues (Ex: Aspiration of insufficient sample clinical significance results. It has three types:
volume by the instrument sample probe).
1. Random Variability
- Sum of analytic and intraindividual variability.
Assessment of Clinical Significance of Results
2. Analytic Variability
Critical Values (Panic Values)
- Result of assay imprecision.
 Laboratory Management 3

- It is usually determined during validation studies Predictive Value of a Positive Test or Positive Predictive Value
for a new method by running the same sample • The probability that a positive test indicates disease.
multiple times and is expressed quantitatively as • Proportion of persons with a positive test who truly
the coefficient of variation (CV). have the disease.

3. Intraindividual Variability Take note!!!

- Due to biologic changes that cause analyte levels ➢ The predictive value of a positive test is highly
to fluctuate over time. dependent on the prevalence of the disease being
tested.
- Well-known examples of this phenomenon
➢ The higher the prevalence, or pretest probability, the
include diurnal variations in cortisol levels,
higher the posttest probability, or predictive value of a
estrogen levels that vary with the menstrual positive test.
cycle, and seasonal variations of vitamin D.
- Many other analytes show some biologic Predictive Value of a Negative Test or Negatiive Predictive Value
variability, including changes related to exercise • The probability that a negative test indicates absence of
or food intake. disease.
• Proportion of persons with a negative test who are
truly without disease.
General Interpretation of Laboratory Results

Bayes Theorem | Predictive Value Theory

• Sensitivity - ability of a test to detect disease and is

expressed as the proportion of persons “with disease” in
whom the test is “positive”.
• Specificity - ability to detect the absence of disease and is
expressed as the proportion of persons “without disease”
in whom the test is “negative”.
 Laboratory Management 4

Reporting of Results

- Release of reports only to authorized person.

- Timely release of provisional and final report.
- Any value which exceeds the normal limit must be clearly
published, understood and conveyed verbally,
electronically or printed form when, where, what and to
whom was reported document it.

Result Format
• Name and address of laboratory
• Name of patient with gender
• Laboratory ID number
• Date and time of receipt of sample
• Type of sample
• Name of test requested with a brief clinical background
• Results with the units
• The normal or reference range of the test
 Laboratory Management 1

MODULE 7: QUALITY CONTROL & QUALITY ASSURANCE Systematic Bias

Introduction • Difference between the observed mean and the expected

value for a QC material.
Quality Control • Brought about by changes in calibration.

• A process to periodically examine a measurement Accuracy

procedure to verify that it is performing according to pre-
established specifications. • The combination of systematic bias and imprecision that
occurred for that specific measurement.

Trueness
Analytic Bias Imprecision
• Refer to an average systematic bias that may be present in
a given method.

Why do we need to measure QC samples?

➢ To statistically evaluate the measurement process to verify that the
method continues to perform within the specifications consistent
with acceptable systematic bias and imprecision.
➢ To identify that a change in performance occurred that needs to be
corrected.

Calibration Considerations in QC

Calibration and Verification of Calibration

• Method calibration is most often performed by the

laboratory using calibrator materials provided by the
Impercision method or instrument manufacturer.
• (Ex: Point-of-care devices) - methods are calibrated during
• Dispersion of results for repeated measurements of the manufacturing process, and the laboratory performs a
aliquots of the same QC material. verification of that calibration.
• Recalibrate methods on a time schedule that is established
Standard Deviation
based on experience.
• Measure of expected imprecision in a measurement • In vitro device (IVD) manufacturers frequently specify
procedure when it is performing correctly. calibration intervals.
o Interval of ± 1SD – 68% of measured values
o Interval of ± 2SD – 95% of measured values

✓ Correct calibration of a method eliminates systematic biases.

 Laboratory Management 2

Calibration Traceability to a Reference System and Commutability Implementing QC Procedures

Considerations
Implementing QC Procedures
• Calibration of routine methods should be traceable to a • Selection of QC Materials
higher-order reference measurement procedure or • Frequency to Assay Quality Control Samples
• Establishing Quality Control Target Value and Standard
international reference material (ISO, 2003; Vesper & Deviation That Represent a Stable Measurement Operating
Thienpont, 2009; Miller et al., 2014). Condition
• Performance of a Measurement Procedure for Its Intended
Medical Use
Overview of QC Procedures • Establishing Rules to Evaluate Quality Control Results
• Corrective Action When a Quality Control Result Indicates a
Measurement Problem
• Reviewing Quality Control Data

Selection of QC Materials

• Two different concentrations are necessary for adequate

statistical QC.
• Analyte concentrations that monitor the analytic
measurement range of the method, should be selected for
Quantitative Methods.

Frequency to Assay Quality Control Samples

• Analytic stability of the measurement procedure.

• Risk of harm to a patient from clinical action being taken
before a significant error is detected.
• Number of patient results produced in a period of time
when an error condition existed but was not yet detected.
• Events such as recalibration or maintenance that may alter
the current performance condition of the measurement
system.
Statistical QC • Training and competency of the test operator, particularly
• Evaluates a measurement procedure by periodically for manual or semi-automated methods.
assaying a QC sample for which the expected result is • Risk of failure of the measuring device.
known in advance. Establishing Quality Control Target Value and Standard Deviation
• Part of the process management component of the quality That Represent a Stable Measurement Operating Condition
system that integrates good laboratory practices to ensure
correct patient results. • A minimum of 20 observations is recommended for the
initial SD estimate.
Levey-Jennings/Shewhart Plot
• Determine the SD for stable measurement performance
• Most common presentation for evaluating QC results. from the cumulative SD over a 6- to 12-month period for a
• The number of results expected within the SD intervals is as single lot of QC material.
follows:
o ± 1SD = 68.3% of observations
o ± 2SD = 95.4% of observations
o ± 3SD = 99.7% of observations
 Laboratory Management 3

***CUSUM and EWMA – preferred to monitor for bias trends.

Establishing Rules to Evaluate Quality Control Results

Performance of a Measurement Procedure for Its Intended Medical

Use

• Sigma Metric
o Commonly used to assess how well a method
performs relative to the medical requirement.
o Compares the variability in a measurement
process (in SD) vs. the acceptable variability
because it will not cause an error diagnosis or
treatment of a patient.

Establishing Rules to Evaluate Quality Control Results

• Westgard Rules
o Conventional way to express QC interpretive The glucose method stability and performance over the 10 months were
rules is by using an abbreviation nomenclature considered acceptable for clinical use.
popularized among clinical laboratories.
 Laboratory Management 4

Corrective Action When a Quality Control Result Indicates a Measurement regression analysis (Cornbleet & Gochman, 1979;
Problem Linnet, 1993).

• A QC alert occurs when a QC result fails an evaluation rule, which

indicates that an analytic problem may exist.
o There is a high probability that the assay is producing
results unreliable for patient care.

Review Quality Control Data

• Immediate impact of QC data is to determine if patient results can

be reported and used for clinical decision making.
• Review Schedules of QC Data:
Time Responsible Purpose
Person
Weekly Senior Ensure that correct follow-up of any QC
Technologist alerts was conducted.
/ Patient samples that may have had
Supervisors erroneous results were repeated.
Ensure that process was properly
documented in QC records.
Monthly Laboratory Address/Include any issues identified by the
Director weekly review process.
Examination of the Levey-Jennings chart* or
other tool to identify trends or changes in
assay performance that may need to be
addressed.
Review consistency of reagent lot changes,
calibrator lot changes and any patient data–
based QC procedures.

• Major Functions of the QC Review Process:

o Verifies that test procedures are stable and meet
performance specifications.
o Identifies test procedures that may need intervention to
address trends in performance deterioration.

Reagents and Calibrator Lot Changes

• Changing reagent lots can have an unexpected impact on QC

results.
• Use of clinical patient samples to verify the consistency of results
between old and new lots of reagents is necessary.
o CLSI document EP26 (CLSI, 2013) recommends 3 or
more samples.
o Alternate: 10 or more patient samples that span the
analytic measurement range and use Deming
 Laboratory Management 5

Using Patient Data in QC Procedures

• Results from patient samples support QC processes in a laboratory

by verification of:
o Consistency of patient results when changing lots of
reagent or calibrators for a method.
o Identified inconsistent results using a delta check with a
previous result for a patient.
o Consistency of patient results when an analyte is
measured using more than one instrument or method
in a health care system.
o Method performance using results from patient
samples in a statistical QC scheme.

Delta Check with a Previous Result for a Patient

• Comparing a patient’s current test result to a previous result for

the same analyte.
• Most useful to detect mislabeled samples and samples altered by
dilution with IV fluid during collection from a patient.
Proficiency Testing/External Quality Assessment

• A program to evaluate method performance by comparison of

results versus those of other laboratories for the same set of
samples.
➢ Each laboratory assays the PT samples as if they were
patient samples and reports the results for the PT
samples to the PT provider for evaluation.
➢ The PT provider assigns a target value to the PT samples
and determines if the results for an individual
laboratory are in close enough agreement with the
Verify Consistency of Results between More than One Instrument or target value.
Method ➢ PT allows a laboratory to verify that its results are
consistent with those of other laboratories and to verify
• Round robin
that it is using a method in conformance with the
o Clinical patient sample aliquots are assayed using each
manufacturer’s specifications.
of two or more methods (or analyzers) to evaluate,
and if necessary, adjust the calibration as needed, to
achieve agreement in results for patient samples. Common Causes for PT Failure

Using Patient Data for Statistical Quality Control

• Patient results can be used to monitor method performance

• Not widely adopted because of lack of consensus guidelines for use
and lack of computer support from instrument and LIS suppliers.
• Average of Normals (AON) /Moving average
o Automated approaches to determine the mean (or
median) for groups of sequential patient results.
 Laboratory Management 6

Quality Management

• Refers to the overall process used to ensure that laboratory results

meet the requirements for health care services to patients.
CLINICAL LABORATORY INFORMATICS
*Primary memory has limited storage
BASIC INFORMATION CONCEPTS AND *Data is not permanently stored, hence the reason why
TECHNOLOGY we need a secondary memory
• Hardware and software
• Networks and security • Secondary Memory
• Databases o Auxiliary memory
o External memory
COMPUTER o Back up
• An electronic device for storing and processing o Storage devices
data, according to instructions given to it in a § Hard drive
variable program • Can store large amount
• User gives instruction to the computer of data
• If there is no given instructions, it will not work • Form of external
memory
2 MAIN PARTS OF THE COMPUTER • Can be inside or outside
computer
HARDWARE § Drive arrays
• Physical parts of a computer • Commonly used in
o Central processing unit (CPU) laboratory
o Monitor • Redundant Array of
o Mouse Independent/inexpensiv
o Keyboard e Disks (RAID)
• Collection of hard disk/
CPU hard drive
• Circuitry that serves as main information • For better storage
processor capacity
• Piece of hardware that enables your computer to • It hastens the
interact with all application and programs processing of computer
installed • Ex: In a CPU there is a
• It interprets the programs instructions and collated three hard
creates OUTPUT that you interface with when drives
using a computer § Compact disk
• Driven by clock pulses • Portable and cheaper
o The speed is measured in gigahertz • Limited capacity
o 1 GHz = 1 Billion clock pulses per second § Digital Versatile disk
• 6x storage capacity than
MEMORY CD
• Physical chips on a motherboard that holds • DVD
programs and data • It can be single or
• The brain of the computer double sided
• The storage is still small
2 TYPES OF MEMORY compared to others
• Primary memory § Flash drive
o RAM (Random Access Memory) • Similar to hard disk but
§ Retaining memory as long as portable and cheaper
connected to power source • USB
(read/write memory) § Floppy disk
§ Volatile memory • One widely used
o ROM (Read Only Memory) • Small in size and storage
§ Can store data permanently capacity
 • Obsolete • Common type of networking standard
SOFTWARE • Local area network (LAN)
• Instructions that tell computer what to do o Very common wherein we connect the
• Comprises of the entire set of programs, computer into an internet network
procedures, and routines associated to computer o Adapter is used to connect the internet
operation from router to the computer
o Covers small geographic area
OPERATING SYSTEM • Wide area network (WAN)
• Operating system of a device, whether a o Covers a broader area
computer or an analyzer, refers to a set of • Bandwidth
programs responsible for the management and o Refers to rate of data transmission
coordination of activities and the sharing of o The internet bandwidth should be high
resources since the computer/internet will lag if it is
low
FILES
• Collection of data identified by specific name and Internet
grouped according to its purpose • Publicly accessible
• 2 types • Internet protocol (IP)
o Applications o Data are accessed using the IP
§ Executable files • World wide web (www)
§ Applications in phone o Hypertext data system
o Data files o Uses internet as its transportation
§ Images, documents • Hypertext Markup Language (HTML)
§ Can put in a folder o Specifies the webpage when it is
• Folder interpreted in a web browser
o Collection of files
Intranet
NETWORKS AND SECURITY • Private network that uses the same protocols with
the internet
NETWORK • The information is shared within specific
• Interconnected group of computers that shares organization only
information and resources
• In a clinical laboratory, it is very important since SECURITY
it pertains to the ability of a computer to obtain • Data security is very important particularly in
orders (e.g., test orders from physicians) health care institutions since the patient’s privacy
• Needed to send the test results is a major concern
• Needed especially if the hospital or clinic is fully- • Encryption
automated o To secure the privacy of data in a
• Fully automation – paperless institution healthcare facility or institution
• Can aid on sending results from a hospital to o Conversion of data via algorithm that
another (e.g., ung ginawa ni mayor vico sa pasig) rearranges the details that cannot be
• Client rearranged without encryption
o Thin • Virtual Private Network (VPN)
o Thick or fat o Gives privacy
• Server o Prevents the hackers to hack the
• Maintenance and terminal – traditional client information data
server relationship o Now widely use especially on healthcare
o Terminal emulators institutions

Ethernet *We give off information whenever we connect to a public

• Cord or adapter wifi
 § Most commonly used in the
laboratory who uses automated
data

LABORATORY INFORMATION SYSTEMS

• Hardware, software, and connectivity that are
designed to perform the data management
function
DATABASES • A communication tool for the laboratory
• Building blocks of information system • Limited to the laboratory and physician but not to
• Structured collection of records comprising of the administration of the hospital
data fields • Stand-alone insolated system that generates
• Database Management System (DBMS) result from manual reporting by a laboratory
o Flat file personnel or for viewing by the clinicians
§ Single two-dimensional array of • Main goal is to make communication between the
data elements similar to an laboratory and the physician much easier
electronic spreadsheet o By requesting through computers
§ There might be redundancy of • LIS exchanges information will all the system
data as well as confusions • Today, it is frequently part of the healthcare
o Relational system networks with communication with the
§ Data are organized in a table patient registration and billing system as well as
(grouped) the electronic medical record (EMR)
§ In a table, it is composed unique • Before connecting it to other networks, it should
sets of data for the fields be connected to the hospital information system
§ Table are related to a single field (from billing, admission etc.)
between the common fields o Through that it will exchange information
§ Data are related to previous with the other networks
tables
§ One data are transferred per Legal requirements
table • In the US, FDA, CAP, Joint Commission, AABB,
§ Simplifying the collection of data and CMS gives the requirements
§ The redundancy of data is • Unique specimen and patient identification must
eliminated have at least 2 identifiers (Joint Commission)
 o Date of patient’s birth, whole name, date
of specimen collection, date and time of
receiving the specimen in the lab,
personnel who conducted the test
• CAP general checklist requires periodic
verification of data sent from LIS to another
computer system to secure the QA of LIS
• The Health Insurance Portability and
Accountability Act of 1996 (HIPAA) requires all
health plans to accept electronically field claims
in a standard format, there must existing security
measure to protect the health information
• VPN is required to be installed
• Communication standards
• The flow of information in LIS is generally
uniformed across different laboratories, however,
there are still variations and it will vary depending
on the rules and regulation of the institutions
* Not necessary na i-equip ng isang healthcare
institution ung lahat ng nasa table
* ADT – Nurses
* CIS – Doctors or Nurses
* EMR – Physicians
* Ex (EDW): relationship of having high WBC Count
in development of a certain disease such as leukemia
* EDW – certain period of time and people
* Billing – Billing department of the hospital

BIOINFORMATICS
• How information is stored in biological
systems
• Focused on DNA, RNA, and protein
sequences
• Field of science where they are merged into
one
• Acquiring, managing, analyzing, and
understanding data
• The stored data are used to create testing
tools which can be used on emerging new
diseases or virus
*Barcoding of samples is very critical since during the • Aids on providing an improved quality of
extraction, some of the samples are labeled manually health care
(preanalysis) • EX: Pandemic and the Philippine genome
*Counter check the name/labels before putting the where they collect and define different DNA,
barcode to avoid erroneous result RNA, and protein sequences of the virus and
*Very vital if the laboratory uses automated analyzers store it in a computer system
since baka iba ung barcode na madetect if hindi naayos
ung pagkakapatong ng barcode (if namali lang naman sa THE FUTURE OF INFORMATICS
paglagay ng barcode) • Microfluidic instrumentation
*Manual result entry is also prone to error (kapag hindi o Applied to common laboratory
automated ung interface) techniques that essentially provides a lab
 on a chip solution that allows a patient
centric approach to the testing and may
eventually perform levels comparable to
centralized analyzers
o EX: pandemic – POCT against COVID-19
from PCR-testing to innovations such as
saliva testing
• Translational bioinformatics
LABORATORY DOCUMENTATION • Serves as a quick reference for testing
personnel
DOCUMENTATION • Provides uniformity in testing over time, and
• used to describe any policy, procedure, from one person to the next
manual, log, file, report, record, etc. kept by
the laboratory. INSTRUMENT FILES
• allows you to easily review and track your
laboratory’s activities. Each instrument should have a file that contains
• provide an audit trail for laboratory inspectors the following information:
and surveyors to see that requirements have • Instrument name
been met. • Model number and serial number
• Be useful when a problem arises • Purchase date
• Documents not only tell your • Manufacturer and/or supplier contact
staff what activities to perform, information
but also how and when to • Technical service contact information
perform them • Repair service contact information
• Records provide evidence that • Warranty information
the activities were performed. • Preventive maintenance and repair services
They detail when the activities performed by company representatives
were done, who performed • Verification of performance specifications, if
them and what happened applicable
when they were done.
EQUIPMENT MAINTENANCE
PERSONNEL FILES • is essential for optimal instrument performance
• detailed documentation about the • include a place to document instrument
qualifications of each employee function checks, preventive maintenance, and
any other required monitoring.
Examples of required documentation:
• Copies of transcripts MAINTENANCE LOG
• Diplomas
• Letters from former employers can be a chart that includes:
• Current licenses • the frequency to perform the maintenance
• Continuing education activity
• Hepatitis B vaccination status • dates of activity performance
• Annual safety training • initials of the staff who performed the
• Job descriptions/ Job specifications activity
• Records of any exposure incidents
CALIBRATION AND CALIBRATION
PROCEDURE MANUAL VERIFICATION
• A procedure for performing every test on your • Calibration is the process of testing standards
laboratory’s test menu or calibrators of known value and adjusting the
• Instructions for patient identification, instrument readout to establish a correlation
specimen collection and handling, between the instrument’s measurement of the
documentation, and test reporting analyte being tested and its actual
• Laboratory policies concentration.
• Calibration Verification confirms that the
AN UP-TO-DATE PROCEDURE MANUAL: calibration setting continues to allow test
• Acts as a training guide for new personnel results to be accurate throughout the
reportable range of the test system.
THE MANUFACTURER TEST REQUISITIONS
• Who determine the number, type and • Either written or electronic form
concentration of calibrators to be used? • Verbal orders are allowable, but must be
followed by a written request within minutes.
CALIBRATION VERIFICATION • Upon receipt of a specimen, the laboratory
• new lot number of reagents must record the following on the requisition:
• complete change of reagents o The patient’s unique identification,
• instrument service of critical parts e.g., name, SSN, lab#, accession#, or
• may be used to troubleshoot unacceptable client# (two
Quality Control or Proficiency Testing results o forms of identification are usually
required)
QUALITY CONTROL (QC) o Date and time of specimen / requisition
• process of testing materials (controls) that receipt
have a known concentration of the substance o Condition of the specimen (acceptable
being measured, prior to or concurrently with or unacceptable)
patient testing o Date of testing
o Test results
GOAL OF QC
• obtain results that are within the expected TEST RECORDS
target range of the control material giving • A worksheet and/or log must be kept at each
confidence that the test system is accurately testing station documenting dates and results
measuring the analyte of all patient and quality control specimens
analyzed
TEMPERATURE AND HUMIDITY LOGS
• Laboratory room temperature must be checked TEST REPORTS
and recorded daily, prior to testing QC or The final report must include:
patient specimens. • Patient’s unique identification
• Also monitor any temperature-dependent • The tests performed
equipment (such as water baths, heat blocks, • The result release date
refrigerators, freezers, etc.) • Reference or normal ranges.
• Humidity must also be monitored and recorded • The name and address of the lab where testing
daily was performed
• The collection date
TEST TRACKING SYSTEM • Test results (w/ units of measurement and/or
• Laboratory’s method for monitoring and interpretation)
keeping track of a given test and its
components PROFICIENCY TESTING (PT)
• Example: • A copy of the PT enrollment order form
o Test request • The instructions that come with the samples
o Specimen Collection and Transport • All worksheets and instrument printouts of
o Analysis Report testing
o Patient Result • A copy of the final completed result form that
• should track the test from the time it is ordered you send to the PT provider, including the
→ specimen collection → analysis in the lab → signed attestation statement
the result is reported to the physician • The reviewed PT score report, including the
• 2 most common errors: summary page
o MISIDENTIFICATION • Documentation of investigations and corrective
o MISLABELING actions for any PT failures
QUALITY ASSESSMENT (QA)
• Quality Assessment (QA) is a planned, ongoing
review process that observes the performance
and evaluates the quality of all laboratory-
related activities
• Evaluate
o Evaluate your current policies and
procedures
• Identify
o Identify activities that have the
potential for problems that can impact
the quality of your test results
• Detect and keep
o Detect and keep track of errors over
time
• Find
o Find the root cause of errors and
formulate solutions
• Make
o Make corrections and improvements

Documentation Storage and Retention

To determine the type of storage and retention

consider the following:
• Who can access the information?
• How often does the document needed
• to be revisit or reviewed?
• How long does the document serves its
• purpose to be stored?

Most documents and records generated in the office

laboratory must be available for two years; however,
some must be stored for a longer time period.