Appendix A

QUALITY ASSURANCE MEASURES

LABORATORY AND BLOOD BANK SERVICES

9
Code Procedure available 24h are:Standard A B Comments
1  Basic
The extent ofHematology
laboratory and blood banks services meet the need of the facility
 Clinical
based on size and Microscopy
the degree of patient care given.
 Basic General Chemistry
2 List of all Laboratory Services are available to all medical staff.
3 10 Basic microbiology
Laboratory Staffing procedures are available.
11  Technical laboratory
 All surgically staff has
removed at least
tissues are12 months
sent laboratory training.
for pathological examination – the
 Technical
reportSupervisor has ainB.Sc.
is documented degree in medical lab or related science field.
the chart.
 Pathologist
 All report(person in charge)
contain gross and actively overseedescription
microscopic the operation
and of the lab.
diagnosis.
 Medical technologist has had formal training and expanded experience that is
12 cytology specific.
Cytological Service
 24 h lab.
Therecoverage is provided
is a written procedureto meet routine and emergency needs of patients.
in place.
 Qualified staff on site available after normal
 All positive and suspicious cytology slides workarehours.
reviewed by a pathologist.
 The on-call
Random technician
samplesarrives withinslides
of negative 30 min.
areofreviewed
being notified.
by a pathologist.
 There is documented training in phlebotomy for phlebotomist.

4 There is a written procedures in the technical areas

BLOOD BANK
 Which AND TRANSFUSION
is well organized and cover allSERVICES
areas.
1  Followed by all
Blood and technologist
blood productsperforming the tests.
are maintained to meet the need of the facility.
 Reviewed annually by the in-charge pathologist.
2 There is a written policies and procedures for all related areas.
5 Program for quality control and quality improvement
3  There is a planned,
A record applied,
is kept for tracingand documented
a unit basic
of blood from program
drawing for final
to its QC & QI.
disposition.
 QC/QI results are shared by all staff and are posted.
4 Screening
 Data retrieval of communicable
sheets diseases,
are available blood types and hematocrit.
for review.
5 Blood types/ Rh, crossmatch , antibody identification are performed according
to the written procedures for blood banking.

6 Mechanism of blood collecting, storage and handling are performed to ensure

that they retain their maximum potency and efficiency.
 7  Temperature regulating equipment that is used that include Rh view boxes,
heating blocks, water baths…etc.
 Testing the temperature of equipment each day of used and is logged each
shift.
 Testing with a thermometer calibrated against a U.S. Bureau of Standards
(NBS) standard thermometer.
 Blood is not warmed above 38oC (100.4 oF), using an approved blood
warming device which is monitored.
 Separate refrigerators are used to store donor samples, patient samples or
blood bank reagents.
 All blood and components are continuously stored in acceptable
temperature (central electronic monitor or 24h chart- manually recorded
every 4 hours).
 The recorded temperature on all systems is checked at least once daily.
 The temperature recorder sensor is stored in a volume of liquid.
 A calibrated reference thermometer is placed in the same container as the
recording temp. sensor (both agree to within 1oC) a second thermometer is
placed as far as possible from the recording thermometer sensor.
 Alarm systems with audible signals to indicate loss of temperature.
 Instructions are posted adjacent to alarm system.
 Alarm system have a separate power in order to allow proper monitoring
during power failures.
 There are procedures to follow in case temperature exceeds the limit, which
is posted on/ near the refrigerator.
 Alarm systems are periodically tested, testing are documented.
 Frozen plasma are stored at –18oC (0.4oF).
 Frozen RBC are stored at –65oC (-85oF).
 Bimetallic thermometer are ideal for freezers.
 In case of using liquid nitrogen for freezing RBC’s, a gas phase temperature
below –120oC (9-184oF) is maintained.
 The alarm system in liquid nitrogen freezers, once installed, is activated
at an unsafe level of contained liquid nitrogen.

QUALITY CONTROL, INFECTION CONTROL AND LABORATORY SAFETY

1 There are developed and written policies and procedures for quality control (including
instrument monitoring, testing and calibration); for infection control and laboratory
safety.

2 Quality Control
 QC systems, measures are designed to assure the medical reliability of laboratory
data.
 Verified identification of any specimen for each patient.
 Minimizing sample mix-ups, mislabeling by unique identification of each specimen.
 As routine procedure on all shifts, active review of results of controls, instruments
maintenance and functions is evidenced.
 Results are reviewed by a supervisory personnel as a double check.
 Tolerance limits are identified and quality control data are evaluated daily.
 There is evidence of collective actions taken when controls exceeded defined
tolerance limits.
 Standard deviation and coefficient of variation is calculated on monthly basis.
 All used reagents are within their indicated expiration date.
 Pipetors and dilutors are check for accuracy and reproducibility at regular intervals.
 Instruments are properly calibrated.
 There is documented preventive maintenance, periodic inspection, performance
testing against established criteria and tolerance limits, for all instruments and
equipments.

3 Hematology
 Preserved or stabilized whole blood preparations are used for control material.
 Moving averages of red cell indices from patient specimen are used as an additional
control procedure , in case of automatic analyzers.
 Analysis of at least two retained patient specimen per shift is used as an additional
control procedure.
 The quality of peripheral blood smears is satisfactory (properly stained, free of
precipitate, good cell distribution).
 4 Chemistry
Control specimen at more than one level –normal/abnormal – are used for all tests at
least daily if patient specimens are run.

5 Microbiology
 All media must be checked for sterility and the ability to support the growth of
expected organisms.
 Sufficient reference organisms are maintained for adequate verification of media and
tests.
 Positive and negative controls are run for Gram stain, coagulase, oxidase, antisera,
and others depending on the level of service offered
 Anti-microbial testing is properly controlled.

INFECTION CONTROL AND SAFETY

1 There are developed policies and procedures for infection control and safety in lab.
Special precautions are taken to eliminate or control physical, chemical
and biological hazards in lab.
2 General Safety
 There is a laboratory safety officer in charge.
 A laboratory safety manual is developed including safety policies and procedures,
are periodically reviewed, and available to all related employees.
 Ongoing program to review operations and equipment. Work sites are inspected
annually.
 The fire-fighting equipment, emergency showers and eye-wash stations are properly
installed and functioning.
 Flammable/combustible elements are properly contained and within permitted
volumes.
 All laboratory staff follow the universal precautions.
 All employees are trained in emergency procedures and understand properly the
hazards associated with their work.
 Identification of any hazards associated with new chemicals, equipment or
procedures.
 Laboratory is complying with the established safety policies and procedures.

3 There is an incident reporting system for investigating and evaluating all potential
hazards and accidents including blood/fluid exposures, for treatment and
follow up of affected individuals; and for documenting the review of
reports and action taken.

4  Instruction on safe work practices are documented and is included within the new
employee orientation program and continuing education.
 Employee received information on the potential toxic effect of substances to which
they are expose to prior to working.

5 Smoking, eating, drinking are absolutely prohibited in all technical area, these
instructions are in written.

6 Personnel protective clothing and equipment is used in all technical area, changed at
appropriate interval, not worn outside the technical areas.
 7 Universal precautions is implemented to protect the laboratory personnel from
exposure to pathogens (parentheral/ mm / non-intact skin/ blood borne).

8 No mouth pipetting - pipetting aids are available for every task.

9  Good housekeeping practices are implemented.

 There are procedures for daily cleaning and disinfecting of work surfaces and
equipment.
 No obstruction of exit fire extinguishers, fire alarm boxes,…etc.

10 Locking of the laboratory if not in use.

11 Broken glass are kept in special container.

12 Storage mechanism to ensure the stability and non splitting of materials.

SAFETY SIGNS AND LABELS AND IDENTIFICATION OF HAZARDS

1 All doors leading to laboratory is marked to indicate fire hazards.

2 Warning signs are posted to identify areas/ equipment where unusual hazards exist;
 Refrigerator used for storage of flammable materials.
 Refrigerators labeled as explosion proof /non explosion proof.
 Radiation sign.

3 No Smoking sign is posted.

 4 Danger sign - places where special precaution is required. Danger sign is red, black
and white.

5 Caution sign – area of potential hazards warning against unsafe practices. Yellow and
black.

6 Safety instruction sign are green and white.

7  There are precautionary labels on containers of all hazardous materials

(flammable / toxic / corrosives / carcinogens) and hazardous waste container.
 Information on labels must include the chemical name, appropriate hazard
warning, name and address of the chemical manufacturer.
 The effect of the chemical and organ involved is specified.
 If chemicals are transferred into a secondary container, it must be labeled as well.

8 Emergency telephone directory are posted (number, name of supervisors, and

laboratory staff.

FIRE PREVENTION AND CONTROL

1 There is a fire alarm station near / in the laboratory.

2 Fire alarm system is audible in all laboratory sections.

3 All laboratory rooms have a direct access to the hall or second exit.
 4 All exit are kept free from obstruction.

5 There are fully charged, operable fire extinguisher, which is kept near by areas with
potential fire hazards.

6 Smoking is not permitted.

7 Flammable liquid storage cabinets are labeled.

8 There is a written fire plan which is implemented and employees are trained on the
proper use of fire extinguishers and fire fighting equipment.

ELECTRICAL SAFETY
1  Annual electrical checks are conducted and documented.
 Grounding checks are conducted on all electrical outlets.

2  Electrical equipment is grounded or is double insulated.

 Flexible cables, electrical outlets and plugs are free from damage.
 Ground fault circuit interpreters are installed in wet locations.

COMPRESSED GASES
1 All cylinders are marked as to its content.

2 There are valve protection kept on all cylinders unless it is in use.

 3 All cylinders (full not in use / full in use / empty cylinders) are placed secure in upright
position against the wall, rack or stand to prevent them form being knocked over.

4 Empty cylinders are marked EMPTY.

5 Only one standby cylinder is stored in the laboratory.

6 Flammable gas cylinders are stored separate room / enclosure for this exclusive
purpose.

7 Flammable gases are not stored with oxidizing gases.

CHEMICAL HAZARDS
1  There is a written chemical hygiene plan that defines the safety procedures to be
followed for all hazardous chemicals used in the laboratory.

 The plan defines the storage requirements, handling procedures, requirements for
personal protective equipment, location of material safety data sheets and
medical procedures following accidental contact or over exposure.

 The plan is reviewed annually and is part of new employee orientation and the
continuing education program.

CARCINOGENS
1 All cancer causing chemicals in the laboratory is identified.
 2 There are written, implemented procedures to minimize the hazards of these
chemicals.

3 Employees know about these hazards and are educated and follow the procedures.

4 There are protective clothing and equipment.

MICROBIOLOGICAL HAZARDS
1  Universal blood and fluid precautions (Universal precaution) have been
implemented throughout the laboratory.
 Used all times during handling all specimen, when performing phlebotomies, and
when in the technical areas.

2 Exposure to HBV
 Employees are vaccinated.
 Pre-screening prior to vaccination to determine their susceptibility.
 There is a post-exposure follow-up program for employees who are acutely
exposed to HBV through pricking needles / blood or fluid exposure.

3 Porters are provided by trays – no specimen is carried in hands or pockets.

4 All specimen of blood and body fluid are transported in leak-proof containers.

5 Blood specimens are collected in vacuum type collection tubes.

6 The microbiology laboratory is fitted with biological safety cabinets to protect workers
and the environment from exposure to pathogens.
VENTILATION
1  Laboratory ventilation is maintained at a negative pressure.
 100% fresh air – no air is re-circulated.

WASTE DISPOSAL
1 Developed written procedures are in place and implemented for the identification,
handling, transportation and disposal of all hazardous waste in the laboratory.

2 All sharps waste (needles, syringes, blades, lancets) are discarded in a puncture
proof rigid labeled container. Discarded container are removed when 2/3 full, must be
securely closed and discarded in safe and sanitary manner.

3 Contaminated pipettes and glassware are placed in protective containers before

being discarded.

4  Biological indicators (spore tests) are used to monitor autoclaves where laboratory
waste are sterilized.
 Sterilization times and temperatures follow guidelines listed under solid waste
disposal.
6 Referral Laboratory Services
 Availability of referral lab services which is not done by the laboratory.
 There are procedures that ensure timely transportation and timely reporting of results
 The referred lab. Is recognized as a quality, fulfill criteria required.

7 STAT blood tests

 List of STAT blood tests are available.
 The list include but not limited to:
- Chemistry
- Arterial blood gases
- Amylase
- Bilirubin neonates
- BUN / Creatinine
- Electrolyte (Na , K , Ca , CO2)
- Glucose
- Coagulation
- Protime
- PTT
- Urine
- Dipstick
- Drug levels
- Digoxin
- Salicylate
- Theophiline
- Hematology
- Hemogram
- Platelet
- Blood bank
- Crossmatch
- Direct Coombs
- Type and Screen
 STAT results are reported in a timely manner.

8 Lab Results
 are available in the patients’ chart in a timely manner.
 There is a reference (Normal Range) specific for age and sex within the laboratory report.
 The panic values are documented to include time, date and individual contact in
accordance with the mechanism in place.