[TRANS] AUBF: SAFETY AND QUALITY ASSESSMENT

• Primary objective of biologic safety: preventing the

completion of the chain of infection
SAFETY • Concern over exposure to blood-borne pathogens (e.g.,
• Safety procedure manuals HBV, HCV, HIV) resulted in the drafting guidelines and
o Must be readily available regulations by the CDC and OSHA
o Safety policies mandated by CDC and OSHA • Universal Precautions (UP)
o Updated and reviewed annually by lab director o In 1987 by CDC
o CLSI: provides guidelines for writing the policies and o Consider all patients to be carriers of blood-borne
procedures pathogens
o Focuses on specimens with visible blood (excluded:
urine and other body fluids not visibly contaminated
by blood)
• Body Substance Isolation (BSI)
o Modified UP
o Consider ALL body fluids and moist body
substances to be potentially infectious
o Disadv: No recommendation of handwashing after
every removal of gloves (done only if contamination
is visible)
• Standard Precautions
o In 1996 by CDC and HICPAC
o Combined features of UP and BSI
1. Hand hygiene
a. Handwashing
b. Use of alcohol-based antiseptic cleansers
2. Gloves
3. Mouth, nose, and eye protection
BIOLOGICAL HAZARDS a. N95 must be used when a patient is
suspected to the exposed to mycobacterium
• Chain of infection 4. Gown
• In clin lab, the most direct contact with a source of infection 5. Patient care equipment
is through contact with patient specimen 6. Environmental control
7. Linen
8. Occupational health and blood-borne pathogens
a. Never recap used needles
b. Use self-sheathing needles or a mechanical
device to conceal the needle
c. Use mouthpieces, resuscitation bags or other
ventilation devices as an alternative mouth-
to-mouth resuscitation method
9. Patient placement
a. Place contagious patients in a private room
10. Respiratory hygiene/ cough etiquette
• Occupational Exposure to Blood-Borne Pathogens
Standard
o Set by OSHA
o Any accidental exposure to BBPs must be
immediately reported to the supervisor
o Evaluation of the incident must be immediate to
ensure appropriate postexposure prophylaxis (PEP)
o Engineering Controls
1. Sharp disposal containers and needles with
safety devices
2. Discard needles with safety device activated and
the holder attached

JEAN BELCIÑA 1
 TRANS: Safety and Quality Assessment

3. Label all biohazardous materials and containers BIOLOGICAL WASTE DISPOSAL

o Work Practice Controls
4. Standard precautions practiced by all • All biologic waste, except urine, must be placed in
employees; annual training documentation appropriate containers labeled with biohazard symbol
5. No eating, drinking, smoking, and applying • The waste is decontaminated following institutional policy:
cosmetics in work area incineration, autoclaving, or pickup by a certified hazardous
6. Daily work surface disinfection protocol waste company
o Personal Protective Equipment • Urine
7. Lab coats, gowns, face shields, and gloves to o May be discarded in lab sink under a Plexiglass
employees and laundry facilities countertop shield then flushed with water
o Medical o Disinfect sink with 1:5 or 1:10 dilution of NaOCl daily
8. Free HBV vaccine ▪ Dilutions are effective for 1 month in plastic
9. Medical follow-ups to employees accidentally bottle and if protected from light
exposed to BBPs o Empty urine containers can be discarded as
o Documentation nonbiologically hazardous waste
10. Documentation of annual training of employees
SHARP HAZARDS
in safety standards
11. Documentation of evaluations and • All sharp objects must be disposed in puncture-resistant,
implementation of safer needle devices leak-proof container with a biohazard symbol
12. Maintain a list of employees involved in selection
and evaluation of new devices CHEMICAL HAZARDS
13. Maintain sharp injury logs (include: type, brand
of device, location and incident description) and • Every chemical in the workplace should be presumed
confidential employee follow-up hazardous

PERSONAL PROTECTIVE EQUIPMENT CHEMICAL SPILLS AND EXPOSURE

• Includes gloves, fluid-resistant gowns, eye and face • Best first aid: flush the contacted skin area with large
shields, and Plexiglass countertop shields amounts of water for at lest 15 mins, then seek med
• Wearing gloves is not a substitute for hand hygiene attention
• Gloves: Latex allergy • Remove contaminated clothing ASAP
o Symptoms • Do not attempt to neutralize chemicals that come in contact
▪ Irritant contact dermatitis (patches of dry, with the skin
itchy irritation on the hands) • Chemical spill kits
▪ Delayed hypersensitivity reactions o Should be available for cleaning up spills
(resembles poison ivy that appear 24-48 hrs o Include protective apparel, nonreactive absorbent
after expo) material, and bags for disposing contaminated
▪ Immediate hypersensitivity reactions (facial materials
flushing and breathing difficulties)
o Action required CHEMICAL HANDLING
▪ Avoid powdered gloves • Never mix chemicals together unless specific instructions
▪ Sanitize hands after gloves removal are followed, and must be added in the order specified
▪ Use nitrile or vinyl gloves instead of latex
• ALWAYS ADD ACID TO WATER
▪ Symptoms of latex allergy should be reported
• Wear goggles and prepare reagents under a fume hood
to a supervisor
• Fluid-resistant lab coats with wrist cuffs CHEMICAL HYGIENE PLAN (CHP)
o Should always be completely buttoned
o Gloves should be pulled over cuffs • By OSHA
o Disposable coats: placed in biohazardous waste • Required to all facilities that use hazardous chemicals;
o Nondisposable coats: placed in designated laundry must appoint a chemical hygiene officer for implementation
receptacles and documentation of compliance
• Purpose is to detail the ff:
HAND HYGIENE 1. Appropriate work practices
2. SOP
• Alcohol-based cleansers
3. PPE
o Can be used when hands are not visibly
4. Engineering controls (e.g., fume hoods and
contaminated
flammables safety cabinet
o Not recommended after contact with spore-forming
5. Employee training requirements
bacteria (e.g., Clostridium difficile and Bacillus sp)
6. Medical consultation guidelines
• Hand washing
o Developed by CDC CHEMICAL LABELING

• Hazardous chemicals should be labeled with a description

of their particular hazard

JEAN BELCIÑA 2
 TRANS: Safety and Quality Assessment

• NFPA 704: Standard System for the Identification of the o Use non-conducting object when trying to unplug or
Fire Hazards of Materials move the equipment
o By the National Fire Protection Association (NFPA) Give immediate medical assistance to the victim
o Used to inform firefighters of the hazards they may following discontinuation of the electricity
encounter with fires in a particular area
o Placed on doors, cabinets and containers FIRE/EXPLOSIVE HAZARD

• JC requires all health-care institutions to post evacuation

routes and detailed plans to follow in the event of fire
• RACE
o Rescue
o Alarm
o Contain
o Extinguish/Evacuate
• Store flammable chemicals in safety cabinets and
explosion-proof refrigerators
• Cylinders of compressed gas should be located away from
heat and securely fastened to a stationary device to
prevent accidental capsizing

• Extinguishers
o Multipurpose ABC fire extinguishers are the most
common
MATERIAL SAFETY DATA SHEETS (MSDSs) o PASS
1. Pull pin
• By OSHA Federal Hazard Communication Standard
2. Aim at the base of the fire
• Gives employees the right to know about all chemical 3. Squeeze handles
hazard present in their workplace 4. Sweep nozzle side to side
• Info contained in an MSDS includes the ff:
1. Physical and chemical characteristics PHYSICAL HAZARDS
2. Fire and explosion potential
3. Reactivity potential • General Precautions
4. Health hazards and emergency first aid procedures o Avoid running in hallways
5. Primary routes of entry o Watch for wet floors
6. Exposure limits and carcinogenic potential o Bend the knees when lifting heavy objects
o Keep long hair pulled back
RADIOACTIVE HAZARDS o Avoid dangling jewelry
o Maintain a clean, organized work area
• Radioactivity may be encountered in the clin lab when • Use closed-toe shoes
procedures using radioisotopes are performed
• Effects of radiation are cumulative related to the amount of QUALITY ASSESSMENT
exposure
• Amount of radiation exposure is related to combination of • Quality Assessment (QA)
time, distance, and shielding o Continual monitoring of the entire test process from
• Symbol must be displayed on the doors of all areas where test ordering and specimen collection through
reporting and interpreting results with the purpose of
radioactive material is present
guaranteeing quality patient care
ELECTRICAL HAZARD • Quality system
o refers to all of the laboratory’s policies, processes,
• Designated hospital personnel should monitor electrical procedures, and resources needed to achieve
equipment closely quality testing
• All electrical equipment must be grounded with three- • QA program encompasses:
o Quality control (QC)
pronged plugs
o Pre-examination variables
• Accident involving electric shock o Examination variables
o Remove electric source immediately (never touch o Post-examination variables
the person receiving the electric shock)

JEAN BELCIÑA 3
 TRANS: Safety and Quality Assessment

• QA program includes the ff: • Criteria for specimen rejection for both physical
o Procedure manuals characteristics and labeling errors must be present
o Internal, external, and electronic QC
o Calibration/ calibration verification, standardization
o Proficiency testing (PT): known as external quality
assessment (EQA)
o Record keeping
o Equipment maintenance
o Safety programs
o Training
o Education and competency assessment of
personnel
o Scheduled and documented review process
• Having written remedial actions mandating the steps to
take when any part of the system fails is essential to a QA
program
• Written criteria for rejecting specimens must be
• Documentation of QA procedures
documented and available to the health-care provider and
o Required by all lab accreditation agencies (e.g., JC,
nursing staff
CAP, AABB, AOA, ASHI, COLA)
o Also required in Medicare reimbursement
o Guidelines are provided by CAP and CLSI EXAMINATION VARIABLES

URINALYSIS PROCEDURE MANUAL • Processes that directly affect the testing of specimens

• Procedure manual must be available in the working area Reagents

and must comply with the CLSI guidelines
• Evaluating procedures and adopting new methodologies is • The manual should state the ff:
an ongoing process in the clin lab o Name and chemical formula of reagent
o When changes are made: procedure should be o Instructions for preparation
reviewed, referenced, signed by the lab director or
section supervisor, and notify personnel

PREEXAMINATION VARIABLES

• Occur before actual testing of the specimen and includes:

o Test requests
o Patient preparation
o Timing
o Specimen collection
o Handling and storage
• Turnaround Time (TAT)
o Amount of time required from the point at which a o Company sourced of prepared material
test is ordered until the results are reported o Storage requirements
o Improves when there is great commu between o Procedure for reagent QC
departments combined with adequate training o Type of water used in reagent preparation
• Any safety or health precautions associated with reagents
Specimen Collection and Handling should be written in bold
• Reagent strip must never be refrigerated, and mist be
recapped immediately
• Stated at the beginning of each procedure in the manual
• Requisition forms and computerized entry forms should
designate the type of urine specimen to be collected and Instrumentation and Equipment
the date and time of collection
• The form should include space for recording the ff: • Instructions regarding the operation, performance and
1. Date and time of specimen collection frequency of calibration, limitations, and procedures to
2. Whether specimen was refrigerated follow when limitations or linearity are exceeded must be
3. Time the specimen was received in lab and time the clearly stated in the procedure manual
test was performed • Instructions detailing the appropriate recording procedures
4. Tests requested must be included
5. Are for specific instructions • Frequent instruments found in urinalysis lab:
6. Patient ID o Refractometers
• Patient preparation, type and vol of specimen required, and o Osmometers
the need for sterile or opaque containers must be included o Automated strip readers
with the specific procedure o Automated microscopy instruments
• All urine specimens must be examined within 2 hrs unless • All control values must be recorded
preserved • Frequent equipment found in urinalysis lab:
• Instructions of general nature that are given to patients are o Refrigerators – temp recorded daily
also included in the manual

JEAN BELCIÑA 4
 TRANS: Safety and Quality Assessment

o Centrifuges – calibrated every 3 months; disinfected • Processes that affect the reporting of results and correct
weekly interpretation of data
o Microscopes – must be clean at all times;
professionally cleaned annually Reporting Results
o Water baths – temp recorded daily
• Standardized reporting formats and, when applicable,
Testing Procedure
reference ranges should be included with each procedure
covered in the procedure manual
• Detailed, concise testing instructions are written in a step- • Forms for reporting results should provide adequate space
by-step manner (beginning with specimen prep) for writing and should present the information in a logical
• Reference sources should be listed sequence
• The laboratory director must sign and date new procedures • Errors may be discovered in the laboratory through a QA
and all modifications of procedures before they are used procedure known as the delta check that compares a
patient’s test results with the previous results
Quality Control • The patient’s record should be corrected as soon as the
error is detected but the original report must not be erased
• Refers to the materials, procedures, and techniques that • The JC Patient Safety Goals require that when verbally
monitor the accuracy, precision, and reliability of a lab test reporting test results the information must be repeated by
the person receiving the information and documented by
• Performed at scheduled time (beginning of each shift or
the person giving the report
before testing patient sample)
• Must always be performed if reagents are changed, when
instrument malfunction occurs, and when test results are
questioned by a health-care provider
• Control result must be recorded in a log

A. External QC
o Used to verify the accuracy and precision of a test
and are exposed to the same conditions as the
patient samples
o Documentation of QC includes dating and initialing
the material when it is first opened and recording the
manufacturer’s lot number and the expiration date
each time a control is run and the test result is
obtained
o External controls are tested and interpreted in the
laboratory by the same person performing the
patient testing.
B. Internal QC
o Internal/Procedural controls
o Monitor the sufficient addition of a patient specimen
or reagent, the instruments/reagents interaction,
and, for lateral flow test methods, whether the
sample migrated through the test strip properly
C. Electronic QC
o Uses a mechanical or electrical device in place of a
liquid QC specimen inserted into a POC instrument
o Verifies the functional ability of a testing device, but
it does not verify the integrity of the testing supplies
D. Proficiency Testing (External QA)
o Testing of unknown samples received from an Interpreting Results
outside agency, and provides unbiased validation of
the quality of patient test results • The specificity and the sensitivity for each test should be
o The Clinical Laboratory Improvement Amendments included in the procedure manual for correct interpretation
(CLIA) mandates comparison testing for laboratory of results
accreditation

Personnel and Facilities

• Personnel assessment includes education and training,

continuing education, competency assessment, and
performance appraisals
• An adequate, uncluttered, safe working area is also
essential for both quality work and personnel morale

POSTEXAMINATION VARIABLES

JEAN BELCIÑA 5