Policy Title:
DEPARTMENT OF LABORATORY POLICIES
AND OPERATIONS PROCEDURE MANUAL
Prepared By:
DEPARTMENT
MOLECULAR LABORATORY
HAROLD C. RONAN, MD, DPSP
DEPARTMENT HEAD
Approved By:
KHEM G. PEREZ, MD
PRESIDENT / CEO
Page Number
Policy Number
Date of Effectivity
Date Reviewed
35
M-011
October 2020
Date Revised
Date of Next
Review
MANAGEMENT OF BIOLOGICAL SPILLS
This Standard Operating Procedure describes the steps for remediation of spills involving
COVID-19 specimens.
ABBREVIATIONS AND DEFINITIONS
•
BSC – Biosafety cabinet
•
OPIMs – Other potentially infectious materials
•
PPE – Personal protective equipment
SCOPE
This document applies to all individuals who handle COVID-19 specimens at the Metro
Health Specialists Hospital, Molecular Laboratory. This SOP enumerates the basic steps
to properly manage spills in the lab.
4.
Tasks, responsibilities and accountabilities
Task
Authorized
Training of personnel in managing spills involving COVID-19 All users
Responsible
Biosafety Officer
Specimens
Ensures availability of materials for spill cleanup
All users
Supplies and
Equipment Officer
Reporting of spills and submission of incident report
5.
All users
Biosafety Officer
Basic Principles of Spills Management Involving COVID-19 Specimens
● Standard precautions apply, including use and proper donning and doffing of personal
protective equipment (PPE), as applicable
● Spills should be cleared up before the area is cleaned (adding cleaning liquids to spills
increases the size of the spill and should be avoided)
●
Generation of aerosols from spilled material should be avoided
Policy Title:
DEPARTMENT OF LABORATORY POLICIES
AND OPERATIONS PROCEDURE MANUAL
Prepared By:
DEPARTMENT
MOLECULAR LABORATORY
HAROLD C. RONAN, MD, DPSP
DEPARTMENT HEAD
Approved By:
KHEM G. PEREZ, MD
PRESIDENT / CEO
Page Number
Policy Number
Date of Effectivity
Date Reviewed
36
M-011
October 2020
Date Revised
Date of Next
Review
Factors to be considered in the management of spills:
●
Nature (type) of the spill
●
Route of exposure
●
Pathogens most likely to be involved in these different types of spills – for example, stool
samples may contain viruses, bacteria or protozoan pathogens, whereas sputum may
contain Mycobacterium tuberculosis
●
Size of the spill – i.e. spot (few drops), small (<10 cm) or large (=>10cm)
●
Location involved – whether the spill occured in a contained area (such as a BSC), or in a
public or clinical area of a laboratory
●
Whether there is any likelihood of bare skin contact with the soiled (contaminated)
surface
With all spill management protocols, it is essential that the affected area is left clean and
dry. Disposable items in the spill kit should be replaced after each use of the kit.
6. Spill Clean-up
The spill kits are located at the ante room area.
Contents of a Basic Spill Kit
●
Freshly prepared bleach (10%) or some other concentrated disinfectant (i.e. Lysol)
●
70% ethanol
●
Paper towels
●
Biohazard bag(s)
●
Yellow waste bag
●
Leak-proof sharps containers if sharps are involved
●
Tongs for picking up broken glass
●
Standard cleaning materials such as mop, bucket, and pan (similar to ‘pooper scooper’)
●
Disposable rubber gloves
●
SPILL Warning Signage
Policy Title:
DEPARTMENT OF LABORATORY POLICIES
AND OPERATIONS PROCEDURE MANUAL
Prepared By:
DEPARTMENT
MOLECULAR LABORATORY
HAROLD C. RONAN, MD, DPSP
DEPARTMENT HEAD
Approved By:
KHEM G. PEREZ, MD
PRESIDENT / CEO
Page Number
Policy Number
Date of Effectivity
Date Reviewed
37
M-011
October 2020
Date Revised
Date of Next
Review
Personal Protective Equipment
●
Disposable lab coat
●
Shoe covers
●
Fit-tested N95 mask
●
Disposable rubber gloves
Cleaning of Spills Outside a Biosafety Cabinet
1.
Where possible, isolate the spill area. Alert people in the immediate area of the spill.
Place the spill warning signage on the door to warn staff not to enter the room or area.
2.
Move away from the spill.
3.
Following proper doffing procedures, remove contaminated clothing (disposable lab gown,
gloves, shoe covers) and discard in a biohazard bag (double bag). Wash exposed skin with
soap and water.
4.
Put on a clean disposable lab coat, a fresh pair of gloves and mask.
5.
Cover the spill with paper towels from the outside edges of the spill inward.
6.
Flood with 10% bleach from the outside edges of the spill inward.
7.
Allow at least 10-minute contact time.
8.
Gather soaked paper towels using tongs and discard in a separate biohazard bag.
9.
Perform additional room disinfection. Wipe surfaces and mop the floor with 15%
bleach.
10. Seal the biohazard bags and hand over to the assigned personnel for disposal**.
Decontaminate any reusable items with 10% bleach followed by 70% ethanol.
11. Proceed to the designated doffing area and remove PPE. Follow proper doffing
procedure.
Policy Title:
DEPARTMENT OF LABORATORY POLICIES
AND OPERATIONS PROCEDURE MANUAL
Prepared By:
DEPARTMENT
MOLECULAR LABORATORY
HAROLD C. RONAN, MD, DPSP
DEPARTMENT HEAD
Approved By:
KHEM G. PEREZ, MD
PRESIDENT / CEO
Page Number
Policy Number
Date of Effectivity
Date Reviewed
38
M-011
October 2020
Date Revised
Date of Next
Review
12. Wash hands thoroughly with soap and water.
13. Report the incident (refer to SOP on Incident Reporting).
*10% bleach followed by 70% ethanol. Hypochlorites are corrosive to metals and must be
rinsed off after 10 minutes and the area dried.
**Do not autoclave material containing hypochlorite and ethanol, since chlorine gas can be
produced, and ethanol is flammable.
Cleaning of Spills inside a Biological Safety Cabinet
1. LEAVE THE CABINET TURNED ON.
2. If the area is outside the absorbent mat, cover spill with absorbent material from
the estimated edge of the spill to the center.
3. Flood with 10% bleach.
4. After the contaminated area has been cleaned, use 70% ethanol to remove
bleach residue from all surfaces.
5. Dispose all contaminated materials by placing a biohazard bag (double bag).
6. Proceed with doffing.
7. Wash hands and any exposed surfaces thoroughly after the clean-up procedure.
7.
Health and Safety Warnings
All workers handling biohazards must know what to do in an emergency/spill before they
begin work.
Acceptable levels of decontamination, along with methods used to decontaminate, should be
determined before work is begun and should be included in the Standard Operating
Procedures (SOPs) of the laboratory.
Policy Title:
DEPARTMENT OF LABORATORY POLICIES
AND OPERATIONS PROCEDURE MANUAL
Prepared By:
DEPARTMENT
MOLECULAR LABORATORY
8.
HAROLD C. RONAN, MD, DPSP
DEPARTMENT HEAD
Approved By:
KHEM G. PEREZ, MD
PRESIDENT / CEO
Page Number
Policy Number
Date of Effectivity
Date Reviewed
39
M-011
October 2020
Date Revised
Date of Next
Review
Reporting the Incident
Always report blood/body fluid or other biohazardous spills. Use the Incident Reporting
Form. All major spills must be reported immediately to the biosafety officer or laboratory
manager.
REFERENCES
•
Biological Exposure or Spills: Response, Decontamination & Clean-up
•
(https://wp.stolaf.edu/chemical-hygiene/biological-spills-decontamination-cleanup/). Accessed on 1 Jan 2019.
•
Emergency Response Guide for Laboratories. Carnegie Mellon University Qatar
(https://www.cmu.edu/ehs/Laboratory-Safety/chemicalsafety/documents/Appendix%20C%20New%20Lab%20ER%20Guide%20for%20CM
U -Q%20.pdf). Accessed on 1 Jan 2019.
•
Blue Book: managing spills of blood and body fluids/substances
•
(https://www2.health.vic.gov.au/public-health/infectious-diseases/infectioncontrol-guidelines/manage-blood-body-fluid-spills). Accessed on 1 Jan 2019.
•
BSL-2 Biological Spill Response (https://research.uga.edu/docs/units/biosafety/UGABSL-2-Biological-Spill-Response-2014.pdf). Accessed on 1 Jan 2019.
•
Biological Spills in Laboratories. Manager OHS
•
(https://www.deakin.edu.au/__data/assets/pdf_file/0005/228704/spills-in-labs.pdf). Accessed
on 1 Jan 2019.
Policy Title:
DEPARTMENT OF LABORATORY POLICIES
AND OPERATIONS PROCEDURE MANUAL
Prepared By:
DEPARTMENT
MOLECULAR LABORATORY
HAROLD C. RONAN, MD, DPSP
DEPARTMENT HEAD
Approved By:
KHEM G. PEREZ, MD
PRESIDENT / CEO
Page Number
Policy Number
Date of Effectivity
Date Reviewed
40
M-011
October 2020
Date Revised
Date of Next
Review
INCIDENT REPORTING OF INCIDENTS/ACCIDENTS IN THE LABORATORY
1. Purpose
The purpose of this SOP is to establish procedures for reporting, investigation, corrective action
processes and data tracking associated with incidents and accidents at MHSHI-Molecular laboratory.
A. Input: Referenced and cross-referenced documents.
B. Output: Effective reporting, investigation and corrective action processes to reduce
recurrences of incidents and accidents at BMC-Molecular laboratory.
2. Abbreviations and Definitions
•
Accident - Unintended event giving rise to harm
•
Incident - Event with a potential for causing harm.
•
Harm - Adverse effect on the health of people, animals or plants, on the environment or on
property.
Incident and accident investigations may require visiting specific rooms or locations of the laboratories
of MHSHI-Molecular laboratory and therefore will include examination of laboratory environments and
other environments in the Field. Follow all required SOPs for laboratory safety and field activity safety
when conducting investigations.
3. Scope
This document applies to all individuals who will perform any procedure on the processing of samples
from COVID-19 PUIs within the MHSHI-Molecular laboratory. This SOP enumerates the specific steps
to properly report incidents.
Policy Title:
DEPARTMENT OF LABORATORY POLICIES
AND OPERATIONS PROCEDURE MANUAL
Prepared By:
DEPARTMENT
MOLECULAR LABORATORY
HAROLD C. RONAN, MD, DPSP
DEPARTMENT HEAD
Approved By:
KHEM G. PEREZ, MD
PRESIDENT / CEO
Page Number
Policy Number
Date of Effectivity
Date Reviewed
41
M-011
October 2020
Date Revised
Date of Next
Review
4. Tasks and responsibilities Institute
Department Head
1.
Ensure staffs attend training on incident and accident reporting.
2.
Ensure staff report incidents and accidents as required by this SOP
3.
Evaluate the report submitted by the Biosafety Officer and make the
necessary recommendations.
Biosafety Officer
1. Receive incident reports
2. Conduct investigations of incidents to identify root causes
3. Present the results of incident and accident investigations to the Director of the institute
4. Track corrective actions to completions and report progress.
5. Analyze the filed records every six months and generate a report. This shall be done
together with the two Incident Report Officers.
6. To identify trends in incidents and accidents and report trends to the whole institute to
support the modification of existing related practices and procedures.
All personnel working for the COVID-19 Testing are responsible for:
1.
Reporting all incidents, accidents and dangerous conditions to supervisor and Biosafety
Officer as soon as possible.
2.
Completing and submitting the Incident and Accident Reporting Form to the Biosafety
Officer.
3.
Cooperating and participating in the investigation process.
4.
Attending any training related to incidents and accident management.
Policy Title:
DEPARTMENT OF LABORATORY POLICIES
AND OPERATIONS PROCEDURE MANUAL
Prepared By:
DEPARTMENT
MOLECULAR LABORATORY
HAROLD C. RONAN, MD, DPSP
DEPARTMENT HEAD
Approved By:
KHEM G. PEREZ, MD
PRESIDENT / CEO
Page Number
Policy Number
Date of Effectivity
Date Reviewed
42
M-011
October 2020
Date Revised
Date of Next
Review
5. Preparation
Materials
1. Standard Operating Procedure
2. Incident and Accident Reporting Form
3. Supervisor Accident Investigation Form
4. Incident Investigation Report
5. Incident Response Log
Equipment
None
6. Procedure
A. Incident and Accident Reporting
1. All staff will report all incidents, accidents and hazardous conditions to Head of the Molecular
Laboratory and Biosafety Officer as soon as possible.
2. All staff involved in incidents and accidents or identifying a hazardous condition will complete the
Incident and Accident Reporting Form (Attachment A) and submit it to Manager/Supervisor and the
Biosafety Officer.
3. Managers/Supervisors of staff involved in incidents and accidents will complete the
Manager/Supervisor Accident Investigation Form (Attachment B).
4. Submit all completed, dated and signed forms to the Biosafety Officer.
Policy Title:
DEPARTMENT OF LABORATORY POLICIES
AND OPERATIONS PROCEDURE MANUAL
Prepared By:
DEPARTMENT
MOLECULAR LABORATORY
HAROLD C. RONAN, MD, DPSP
DEPARTMENT HEAD
Approved By:
KHEM G. PEREZ, MD
PRESIDENT / CEO
Page Number
Policy Number
Date of Effectivity
Date Reviewed
43
M-011
October 2020
Date Revised
Date of Next
Review
B. Incident and Accident Investigation
1. Biosafety Officer will review both the Incident and Accident Reporting Form(s) and Supervisor
Accident Investigation Form (Attachments A and B, respectively).
2. Biosafety Officer will enter all data required in the Incident Response Log (Attachment D).
3. Biosafety Officer will follow up on all incidents, accidents and conduct investigations using
Attachment C to identify remedial actions to reduce the likelihood of incident recurrences.
4. Biosafety Officer will work with the manager/supervisor involved to agree remedial corrective
actions and a timely completion date for the corrective actions.
5. Biosafety Officer will summarize and present all incident and accident data at MHSHI-Molecular
laboratory meetings.
a. BIOSAFETY OFFICER will review anonymized incident and accident reports and investigations,
remedial actions, and action progress at each meeting until issue is closed out.
b. BIOSAFETY OFFICER will, with the Head of the Laboratory, amend any affected SOPs, plans, and
the Biosafety manual, as necessary with the aim of preventing, or reducing the likelihood of similar
incidents/accidents in the future.
c. The BIOSAFETY OFFICER will identify additional training in targeted areas and approve the
development of necessary trainings.
6. The whole personnel of BMC Molecular laboratory will implement all necessary corrective actions.
C. Incident and Accident Records
1. Incident Report Officers will collect all reports and list in the Incident Report Log (Attachment D).
2. Incident Report Officers will maintain a yearly summary collection of incidents and accidents.
3. Hard copies of reports will be kept for at least 3 years or as required under Philippines law.
Electronic version may be kept longer.
Policy Title:
DEPARTMENT OF LABORATORY POLICIES
AND OPERATIONS PROCEDURE MANUAL
Prepared By:
DEPARTMENT
MOLECULAR LABORATORY
HAROLD C. RONAN, MD, DPSP
DEPARTMENT HEAD
Approved By:
KHEM G. PEREZ, MD
PRESIDENT / CEO
Page Number
Policy Number
Date of Effectivity
Date Reviewed
44
M-011
October 2020
Date Revised
Date of Next
Review
7. References
•
Centers for Disease Control and Prevention (CDC)/National Institutes of Health (NIH),
Biosafety in Microbiological and Biomedical Laboratories (BMBL), 5th Edition,
http://www.cdc.gov/biosafety/publications/bmbl5/index.htm
•
Comité Européen de Normalisation (European Standards Organization) (CEN) Workshop
Agreement (CWA) 15793:2011, Laboratory biorisk management,
ftp://ftp.cenorm.be/CEN/Sectors/TCandWorkshops/Workshops/CWA15793_September2 011.pdf
•
CWA 16393:2012, Laboratory biorisk management - Guidelines for the implementation of CWA
15793:2008, ftp://ftp.cen.eu/CEN/Sectors/List/ICT/Workshops/CWA%2016393.pdf
•
WHO, Laboratory Biosafety Manual, 3rd Edition.
http://www.who.int/csr/resources/publications/biosafety/WHO_CDS_CSR_LYO_2004_11 /en/
•
OSHA Employee’s Report of Injury Form https://www.osha.gov/sites/default/files/201812/fy11_sh-22224-11_3_Accident_Investigation_Form.pdf
8. Attachments
•
Example Incident and Accident Reporting Form (Appendix A)
•
Example Supervisor Accident Investigation Form (Appendix B)
•
Example BMO Incident Investigation Report (Appendix C)
•
Example Incident Response Log (Appendix D)
Policy Title:
DEPARTMENT OF LABORATORY POLICIES
AND OPERATIONS PROCEDURE MANUAL
Prepared By:
DEPARTMENT
MOLECULAR LABORATORY
HAROLD C. RONAN, MD, DPSP
DEPARTMENT HEAD
Approved By:
KHEM G. PEREZ, MD
PRESIDENT / CEO
Page Number
Policy Number
Date of Effectivity
Date Reviewed
Date Revised
Date of Next
Review
Appendix A
Incident and Accident Reporting Form
Instructions: Staff shall use this form to report all work-related accidents (injuries,
illnesses), or incidents (“near miss” events which could have caused an injury or
illness) – no matter how minor. This helps to identify and correct hazards before they
cause serious injuries. This form shall be completed by staff as soon as possible and
given to a manager/supervisor for further action.
Incident and Accident Reporting Form
Official use only
Date received:
I am reporting a work related:
Reference #:
❑
Injury
❑
Illness
❑
Near miss
Your Name:
Job title:
Supervisor:
Have you told your supervisor about this injury/near miss?
Date of injury/near miss:
Names of witnesses (if any):
Where, exactly, did it happen?
❑
Yes
❑
No
Time of injury/near miss:
45
M-011
October 2020
Policy Title:
DEPARTMENT OF LABORATORY POLICIES
AND OPERATIONS PROCEDURE MANUAL
Prepared By:
DEPARTMENT
MOLECULAR LABORATORY
HAROLD C. RONAN, MD, DPSP
DEPARTMENT HEAD
Approved By:
KHEM G. PEREZ, MD
PRESIDENT / CEO
Page Number
Policy Number
Date of Effectivity
Date Reviewed
46
M-011
October 2020
Date Revised
Date of Next
Review
What were you doing at the time?
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
Describe step by step what led up to the injury/near miss. (continue on the back or
page if necessary):
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
What could have been done to prevent this injury/near miss?
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
What parts of your body/other person’s body were injured? If a near miss, how could
you/other person have been hurt?
❑
Did you see a doctor about this injury/illness?
Yes
If yes, whom did you see?
Doctor’s phone number:
Date:
Time:
❑
Has this part of your body been injured before?
If yes, when?
Supervisor:
Your signature:
Date:
Yes
❑
❑
No
No
Policy Title:
DEPARTMENT OF LABORATORY POLICIES
AND OPERATIONS PROCEDURE MANUAL
Prepared By:
DEPARTMENT
MOLECULAR LABORATORY
HAROLD C. RONAN, MD, DPSP
DEPARTMENT HEAD
Approved By:
KHEM G. PEREZ, MD
PRESIDENT / CEO
Page Number
Policy Number
Date of Effectivity
Date Reviewed
47
M-011
October 2020
Date Revised
Date of Next
Review
WASTE MANAGEMENT PROCEDURE FOR SARS-COV TESTING
1. PURPOSE
This Standard Operating Procedure (SOP) describes the procedure to be followed in
disposing the waste generated by MHSHI- Molecular laboratory during the COVID-19
testing operations to minimize the risks associated with the disposal.
2. ABBREVIATIONS AND DEFINITIONS
•
Biological waste – Biological materials of animals, human, plant or animal origin
•
Biohazardous waste – Infectious materials such as specimen-contaminated plasticware
and containers
•
Decontamination – Any procedure that eliminates or reduces biological agents and
toxins to a safe level with respect to the transmission of infection or other adverse effects
3. Scope
This procedure applies to all laboratory personnel of the MHSHI-Molecular who generate
waste during the COVID-19 testing operations.
4. Tasks, responsibilities and accountabilities
Task
Disposes waste in designated
Authorized
Responsible
All users
Biosafety Officer
All users
Biosafety Officer
All users
Biosafety Officer
containers
Collects waste generated for
decontamination
Ensures proper decontamination
procedure is done
Policy Title:
DEPARTMENT OF LABORATORY POLICIES
AND OPERATIONS PROCEDURE MANUAL
Prepared By:
DEPARTMENT
MOLECULAR LABORATORY
HAROLD C. RONAN, MD, DPSP
DEPARTMENT HEAD
Approved By:
KHEM G. PEREZ, MD
PRESIDENT / CEO
Page Number
Policy Number
Date of Effectivity
Date Reviewed
48
M-011
October 2020
Date Revised
Date of Next
Review
5. Summary
MHSHI MOLECULAR LABORATORY generates different types of waste during the COVID-19
testing operations. Such includes leftover biological materials, contaminated plasticware, and
paper towels, and may vary depending on the workflow step. Waste management is a
process wherein waste is segregated, treated as needed and disposed. Proper identification,
segregation, and disposal of wastes are necessary to prevent dispersal of biological agents.
The principle of “cradle to the grave” must be practiced in order to ensure that all waste is
safe for disposal once it gets out of the MHSHI-Molecular laboratory facility.
6. Considerations
•
All potential waste streams that will be generated from each procedure shall be assessed
and an appropriate process shall be placed prior to the procedure from being done.
•
Ensure that containers are properly labeled and are suitable for every type of waste.
•
Ensure the container is not leaking.
•
Untrained staff shall not be allowed to handle hazardous waste and must not be given
responsibility for them. Personal Protective Equipment (PPE) shall be used when handling
waste based on risk assessment.
•
A record book of the type of waste and estimated quantity must be filled out prior to
autoclaving.
7. Personal Protective Equipment
Users must wear the appropriate PPE depending on the items they are handling and the
procedures they are doing. The minimum PPE includes:
•
Laboratory coat / disposable laboratory gown
•
Nitrile gloves
•
Properly enclosed footwear
Policy Title:
DEPARTMENT OF LABORATORY POLICIES
AND OPERATIONS PROCEDURE MANUAL
Prepared By:
DEPARTMENT
MOLECULAR LABORATORY
HAROLD C. RONAN, MD, DPSP
DEPARTMENT HEAD
Approved By:
KHEM G. PEREZ, MD
PRESIDENT / CEO
Page Number
Policy Number
Date of Effectivity
Date Reviewed
Date Revised
Date of Next
Review
8. Procedure
Waste Collection and Material Preparation
•
Segregate all laboratory generated waste following Table 1.
Waste Type
Non-Hazardous
Paper
Examples
Waste Container
Scratch paper
Standard waste bin
labeled paper
Plasticware
Wrapper of
consumables, tips
generated from
reagent preparation
and template
addition areas, PCR
plates
YELLOW waste
bags
(double bag)
Disposable PPE from
samples receiving,
reagent preparation,
template addition,
and PCR areas
Hazardous
Hazardous
biological waste
from extraction
procedure
(non-sharp)
Absorbent pads,
other plasticware
contaminated with
patient sample
PPE from inspection
and extraction area
RED biohazard bag
(Double bag)
49
M-011
October 2020
Policy Title:
DEPARTMENT OF LABORATORY POLICIES
AND OPERATIONS PROCEDURE MANUAL
Prepared By:
DEPARTMENT
MOLECULAR LABORATORY
HAROLD C. RONAN, MD, DPSP
DEPARTMENT HEAD
Approved By:
KHEM G. PEREZ, MD
PRESIDENT / CEO
Page Number
Policy Number
Date of Effectivity
Date Reviewed
50
M-011
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Date Revised
Date of Next
Review
1. Waste shall not be mixed.
2. If waste is a non-hazardous waste, it shall be placed in the container prescribed in
Table 1. If waste is biohazardous then decontamination using the autoclave shall be
done following collection.
3. Ensure that each waste container is properly sealed. Check for leaks, breaks, or
items poking out of bags.
4. Do not overfill the waste container. Fill only up to ½ of the bag’s volume.
5. For hazardous wastes, perform decontamination treatment using vacuum-assisted
autoclave or use chemical disinfectant such as 10% bleach and 70% ethanol
alcohol .
Policy Title:
DEPARTMENT OF LABORATORY POLICIES
AND OPERATIONS PROCEDURE MANUAL
Prepared By:
DEPARTMENT
MOLECULAR LABORATORY
HAROLD C. RONAN, MD, DPSP
DEPARTMENT HEAD
Approved By:
KHEM G. PEREZ, MD
PRESIDENT / CEO
Page Number
Policy Number
Date of Effectivity
Date Reviewed
51
M-011
October 2020
Date Revised
Date of Next
Review
OPERATION OF AUTOCLAVE
1.
PURPOSE
This Standard Operating Procedure (SOP) describes the steps to be followed operating
the Biobase Autoclave 50L.
2.
ABBREVIATIONS AND DEFINITIONS
●
BSC – Biosafety Cabinet
●
BSL2 – Biosafety Level 2 Laboratory
●
PPE – Personal Protective Equipment
3.
SCOPE
This document applies to all laboratory staff and personnel who will perform testing of
COVID-19 specimens at the BMC Molecular laboratory.
4.
Tasks, Responsibilities and Accountabilities
Task
Authorized
Responsible
Training on the proper use of PPE
All Users
Biosafety Officer
Training on biosafety
All Users
Biosafety Officer
PPE Maintenance and Monitoring
All Users
Supplies and Equipment
Officer
Proper Equipment Operation
All users
Supplies and Equipment
Officer
Equipment Maintenance
All users
Supplies and Equipment
Officer
Policy Title:
DEPARTMENT OF LABORATORY POLICIES
AND OPERATIONS PROCEDURE MANUAL
Prepared By:
DEPARTMENT
MOLECULAR LABORATORY
5.
HAROLD C. RONAN, MD, DPSP
DEPARTMENT HEAD
Approved By:
KHEM G. PEREZ, MD
PRESIDENT / CEO
Page Number
Policy Number
Date of Effectivity
Date Reviewed
52
M-011
October 2020
Date Revised
Date of Next
Review
Description
This SOP describes the steps to be followed when preparing laboratory wastes/materials
for sterilization and operating the Biobase Autoclave.
6.







To ensure the health and safety of personnel using the autoclave, it is important for
each department to maintain autoclaves and to train personnel in their proper use.
The name of the person responsible for the autoclave shall be posted near the
autoclave. This SOP should be posted on the outside to the autoclave.
It is the supervisor's responsibility to ensure employees are trained before operating
any autoclave unit.
Procedural and instructional documents provided by the manufacturer must be
followed.
Personal protective clothing and equipment must be worn when loading and
unloading the autoclave.
Autoclaves must be inspected at least annually. Inspection services may be
managed by your manufacturer’s preventative maintenance contract. A basic visual
inspection should be performed monthly by the person responsible for the autoclave.
The inspection, service and repair records should be available upon request.
Spore strips may be used to validate autoclave effectiveness.
7.





Safety Measures
Personnel Protective Equipments
Equipment to protect against scalds and burns include:
Heat-insulating gloves that provide complete coverage of hands and forearm
Lab coat
Eye protection
Closed-toe footwear
8.
Operator Instructions
Material Preparation


Ensure that the material is safe for autoclaving:
Samples containing solvents or substances that may emit toxic fumes should not be
autoclaved.
Policy Title:
DEPARTMENT OF LABORATORY POLICIES
AND OPERATIONS PROCEDURE MANUAL
Prepared By:
DEPARTMENT
MOLECULAR LABORATORY


HAROLD C. RONAN, MD, DPSP
DEPARTMENT HEAD
Approved By:
KHEM G. PEREZ, MD
PRESIDENT / CEO
Page Number
Policy Number
Date of Effectivity
Date Reviewed
53
M-011
October 2020
Date Revised
Date of Next
Review
Do not autoclave bleach!
Glassware must be inspected for cracks prior to autoclaving.
Prepare and package material suitably:







Loose dry materials must be wrapped or bagged in steam-penetrating paper or
loosely covered with aluminum foil. Wrapping too tightly will impede steam
penetration, decreasing effectiveness of the process.
Loosen all lids to prevent pressure buildup. All containers must be covered by a
loosened lid or steam penetratingstopper.
Containers of liquid must not exceed two-thirds (2/3) full, with lids loosened.
Glassware must be heat-resistant borosilicate.
Plastics must be heat-resistant, i.e., polycarbonate (PC), PTFE (“Teflon”) and most
polypropylene (PP) items.
Discarded sharps must be in a designated ‘Sharps’ container.
All items must be tagged with autoclave tape.
Place items in secondary containers to secure and contain spills:




Items should be placed in a stainless steel pan or other autoclavable container for
their stability and ease of handling.
Place containers of liquid, bags of agar plates, or other materials that may boil over
or leak, into a secondary pan in the autoclave.
The pan must be large enough to contain a total spill of the contents.
Bags must not be tightly sealed as steam cannot penetrate.
Biohazardous waste must be processed accordingly an based on proper guidelines.
9.








Loading the Autoclave
Wear lab coat, eye protection, heat-insulating gloves, and closed-toe shoes.
Place material in autoclave. Do not mix incompatible materials.
Do not overload; leave sufficient room for steam circulation. If necessary, place the
container on its side to maximize steam penetration and avoid entrapment of air.
Close and latch door firmly. Close and lock door.
Choose appropriate cycle (e.g., gravity, liquid, or dry cycle) for the material. Consult
the autoclave manual for assistance in choosing a cycle. The manuals for operation
of the autoclave should be located near the autoclave.
Set appropriate time and temperature if you are using a customized cycle.
Start your cycle and fill out the autoclave user log with your contact information. A
completed cycle usually takes between 1-1.5 hours, depending on type of cycle.
Do not attempt to open the door while autoclave is operating.
Policy Title:
DEPARTMENT OF LABORATORY POLICIES
AND OPERATIONS PROCEDURE MANUAL
Prepared By:
DEPARTMENT
MOLECULAR LABORATORY








Date of Next
Review
Unloading the Autoclave
Autoclave Use Logs
Entries must be placed in the log book each time the autoclave is used. These
records are used for maintenance/service schedules and reporting of incidents,
accidents and/or faults.
Entries should include: operator's name, phone number, date, time and duration.
The log book must be kept adjacent to the autoclave.
An Autoclave Use Log example is provided in this document.
12.




Date Revised
Wear heat-insulating gloves, eye protection, lab coat, and closed-toe shoes.
Ensure that the cycle has completed and both temperature and pressure have
returned to a safe range. Wearing Personal Protective Equipment (PPE), stand back
from the door as a precaution and carefully open door no more than 1 inch. This will
release residual steam and allow pressure within liquids and containers to normalize.
Allow the autoclaved load to stand for 10 minutes in the chamber. This will allow
steam to clear and trapped air to escape from hot liquids, reducing risk to operator.
Do not agitate containers of super-heated liquids or remove caps before unloading.
Wearing heat-insulated gloves remove items from the autoclave and place them in
an area which clearly indicates the items are ‘hot’ until the items cool to room
temperature.
Shut autoclave door
11.

54
M-011
October 2020
If problems with your autoclave are perceived, abort cycle and report it to your PI
immediately
10.


HAROLD C. RONAN, MD, DPSP
DEPARTMENT HEAD
Approved By:
KHEM G. PEREZ, MD
PRESIDENT / CEO
Page Number
Policy Number
Date of Effectivity
Date Reviewed
Maintenance and Repair
No person shall operate the autoclave unless the autoclave is in good condition.
Only qualified professionals are permitted to make repairs.
Report possible malfunctions to .
Repairs are performed by your service contract or any other contractor you choose to
hire.
Policy Title:
DEPARTMENT OF LABORATORY POLICIES
AND OPERATIONS PROCEDURE MANUAL
Prepared By:
DEPARTMENT
MOLECULAR LABORATORY
13.
HAROLD C. RONAN, MD, DPSP
DEPARTMENT HEAD
Approved By:
KHEM G. PEREZ, MD
PRESIDENT / CEO
Page Number
Policy Number
Date of Effectivity
Date Reviewed
55
M-011
October 2020
Date Revised
Date of Next
Review
Contingency Plans
Equipment Malfunction
















If the autoclave does not operate exactly as expected, do not attempt to fix the
problem. A notice shall be placed on the autoclave indicating that it is not to be used
until the problem is diagnosed and corrected.
Record the problem in the autoclave log book.
Inform your supervisor to report the problem.
Only qualified professionals are permitted to make repairs.
14.
Incident Response
All incidents, including a spill or release of biohazardous materials and recombinant or
synthetic nucleic acid molecules, must be reported to your supervisor and Biosafety &
Biosecurity.
If any injury occurs seek first aid or, if necessary, seek medical assistance .
If clothing is soaked in hot water/steam, remove clothing and place the injury in cool
water.
Place a notice on the autoclave indicating that it is not to be used until the cause of the
incident is determined, procedures enacted to prevent future incidents, and the
autoclave is deemed safe for operation.
15.
Spill- Clean Up
Spills may occur from a boil-over or breakage of containers.
No operation of the autoclave is allowed until the spill is cleaned up.
The operator is responsible for clean-up of spills. Contain the spilled material using
paper towels. Use your laboratory’s spill kit if necessary. Wait until the autoclave and
materials have cooled to room temperature before attempting clean-up.
Review the Safety Data Sheet if appropriate, to determine appropriate PPE, spill
cleanup and disposal protocols that are necessary.
Dispose of the waste following the protocol appropriate for the material (e.g., red
biohazard bag). If materials have been intermingled, follow the clean-up and disposal
protocol for the most hazardous component of the mixture.
Cracked glassware must be disposed of properly.
Record the spill and clean-up procedure in the autoclave log book.
16.
o
Checking the sterilization performance
The performance of the autoclave cycle shall be validated using a biological
indicator. Running different types of materials with varying amount must be
validated to ensure enough temperature and holding time is applied
Policy Title:
DEPARTMENT OF LABORATORY POLICIES
AND OPERATIONS PROCEDURE MANUAL
Prepared By:
DEPARTMENT
MOLECULAR LABORATORY
o
17.
HAROLD C. RONAN, MD, DPSP
DEPARTMENT HEAD
Approved By:
KHEM G. PEREZ, MD
PRESIDENT / CEO
Page Number
Policy Number
Date of Effectivity
Date Reviewed
56
M-011
October 2020
Date Revised
Date of Next
Review
When autoclaving laboratory materials such as tips, microcentrifuge tubes,
etc., the use of an autoclave tape ensures that the materials have undergone
heating process (not sterilization)
Reference
BIiobase Operating Manual
Policy Title:
DEPARTMENT OF LABORATORY POLICIES
AND OPERATIONS PROCEDURE MANUAL
Prepared By:
DEPARTMENT
MOLECULAR LABORATORY
HAROLD C. RONAN, MD, DPSP
DEPARTMENT HEAD
Approved By:
KHEM G. PEREZ, MD
PRESIDENT / CEO
Page Number
Policy Number
Date of Effectivity
Date Reviewed
57
M-011
October 2020
Date Revised
Date of Next
Review
CENTRIFUGE OPERATION
1.
PURPOSE
This Standard Operating Procedure (SOP) describes the steps to be followed when using
the centrifuges of MHSHI Molecular laboratory.
2.
ABBREVIATIONS, DEFINITIONS, AND PARTS OF THE CENTRIFUGE
●
RPM (revolutions per minute): A measure of how fast the centrifuge is going regardless
of the rotor size. It is not a measure of the force applied to the contents.
●
Centrifugal force: The force generated when an object rotates around a single point.
●
RCF (relative centrifugal force): The force exerted on the contents of the rotor resulting
from the revolution speed. This determines how the contents of an aqueous solution will
separate.
2
3.
SCOPE
This document applies to all individuals who use any of the centrifuges within the BMC
Molecular laboratory. This SOP is meant to enumerate the steps necessary to properly
operate and maintain the centrifuges. It is not intended to enumerate model-specific
procedures or answer project/ sample-specific questions.
Policy Title:
DEPARTMENT OF LABORATORY POLICIES
AND OPERATIONS PROCEDURE MANUAL
Prepared By:
DEPARTMENT
MOLECULAR LABORATORY
4.
HAROLD C. RONAN, MD, DPSP
DEPARTMENT HEAD
Approved By:
KHEM G. PEREZ, MD
PRESIDENT / CEO
Page Number
Policy Number
Date of Effectivity
Date Reviewed
58
M-011
October 2020
Date Revised
Date of Next
Review
Tasks and Responsibilities
TASK
RESPONSIBLE
MONITOR
Training on Proper Use
MHSHI Molecular personnel
Biosafety Officer
Daily Maintenance
All Users
Equipment Officer*
Monthly Preventive Maintenance
Assigned MHSHI Molecular
personnel
Equipment Officer
Equipment Repair and Calibration
Supplier/ Service personnel
Equipment Officer
5.
Description of the Equipment
The centrifuge uses centrifugal force, for separating solids suspended in a liquid by
sedimentation, or liquids of diverse density. The rotational movement allows forces much
greater than gravity to be generated in controlled periods of time. In the laboratory, centrifuges
are generally used in processes such as separation of solid components from biological liquids
through sedimentation, most commonly of blood components: red blood cells, white blood
cells, platelets, among others. There are several kinds of centrifuges. The most widely used
in public health, surveillance and diagnostic laboratories are the table-top and ultracentrifuges
which both have varying speeds depending on their rotor set-up.
Policy Title:
DEPARTMENT OF LABORATORY POLICIES
AND OPERATIONS PROCEDURE MANUAL
Prepared By:
HAROLD C. RONAN, MD, DPSP
DEPARTMENT HEAD
Approved By:
KHEM G. PEREZ, MD
PRESIDENT / CEO
DEPARTMENT
MOLECULAR LABORATORY
6.
Page Number
Policy Number
Date of Effectivity
Date Reviewed
59
M-011
October 2020
Date Revised
Date of Next
Review
Centrifuge Models covered by the SOP
BRAND
MODEL
DESCRIPTION
Microfuge 20R
RCF/RPM RANGE
Sample Volume: up to 72 mL (rotor-
up to 15,000 rpm or
based)
more than 20,000 x g
Temperature: -10°C to 40°C
Biobase
Centrifuge
5804R
Sample Volume: up to 250 mL (rotor-
up to 14,000 rpm or
based)
20,913 x g
Temperature: -9°C to 40°C
Running Time: 1 sec to 99 min
7.
Personal Protective Equipment for Using, Cleaning, and Maintaining the
Equipment
Users must wear the appropriate PPE for the organisms they are handling. The minimum
PPE includes the:
●
Laboratory coat
●
Nitrile gloves
●
Properly enclosed footwear
●
Tied-back hair
Policy Title:
DEPARTMENT OF LABORATORY POLICIES
AND OPERATIONS PROCEDURE MANUAL
Prepared By:
DEPARTMENT
MOLECULAR LABORATORY
8.
HAROLD C. RONAN, MD, DPSP
DEPARTMENT HEAD
Approved By:
KHEM G. PEREZ, MD
PRESIDENT / CEO
Page Number
Policy Number
Date of Effectivity
Date Reviewed
60
M-011
October 2020
Date Revised
Date of Next
Review
Health and Safety Warnings
All the information discussed in this section is relevant to all high-speed centrifuge models.
●
The centrifuge should be certified by a qualified technician before initial use.
●
Instrument must not be placed near areas containing flammable reagents or combustible
fluids, or where vibration will cause items to fall off nearby shelves.
●
Always make sure that the centrifuge users know the risks associated with the procedure
(Refer to the Risk Assessment) and have been trained beforehand on the proper use of
the equipment.
●
Personnel should use proper PPE when using the centrifuges. Remember that the
centrifuges in the laboratory are used for processing/testing potentially contaminated or
clinical samples. Review the standard precautions outlined in the Biorisk Management
Plan.
●
Keep in mind that ergonomics and safety is important when loading and unloading
materials in the centrifuge. Always balance the centrifuge tubes and load in opposing
positions of the rotor to prevent equipment failure and explosions.
●
Do not exceed the speed range of each centrifuge and ensure that the rotors are tightly
screwed prior to every use.
●
Always wait until the centrifuge reaches the target speed before walking away. If anything
is going to go wrong (e.g. an imbalance), it will usually occur during the initial period. Take
immediate action when an error occurs.
●
Always use tubes appropriate for the sample type (eg. phenol and chloroform rapidly
destroy polycarbonate tubes and must be processed in polypropylene tubes).
●
Do not operate the centrifuge with the following materials and/or dangerous
substances: Explosive materials
High Acid or alkaline
materials Flammable
materials Corrosive
materials
●
Keep the electronic components of the equipment from getting wet with water or other
liquids.
Policy Title:
DEPARTMENT OF LABORATORY POLICIES
AND OPERATIONS PROCEDURE MANUAL
Prepared By:
DEPARTMENT
MOLECULAR LABORATORY
●
HAROLD C. RONAN, MD, DPSP
DEPARTMENT HEAD
Approved By:
KHEM G. PEREZ, MD
PRESIDENT / CEO
Page Number
Policy Number
Date of Effectivity
Date Reviewed
61
M-011
October 2020
Date Revised
Date of Next
Review
In the event where the safe operation of the centrifuge cannot be guaranteed, the
instrument must be switched off, labeled, and locked until a qualified personnel can
repair it.
9.
Operation
Preparation
●
Thoroughly understand the procedure and equipment requirement before beginning
work.
●
Make sure that the laboratory centrifuges are appropriate for the centrifuge speed/s
indicated in the experiment protocol. Check the centrifuge manuals for the proper
installation of rotors.
●
Ensure that the centrifuge is working properly and is not damaged.
●
Know the location of spill kits, eyewashes, safety showers, first aid kits before
starting work.
Rotors
●
Only use rotors that are designed for the centrifuge model that you plan to use.
●
Inspect the rotor for signs of corrosion or cracks before using. Do not use rotors that
are not in good condition.
●
Make sure that the rotor is symmetrically balanced before starting the centrifuge.
●
Never exceed the recommended speed of the rotor.
●
Never operate the centrifuge without properly securing the rotor lid and the
centrifuge chamber door. Make sure that the interlock systems of the lid and door
are functional. If the rotor lid and centrifuge chamber door cannot be locked, that
particular centrifuge should be switched off and reported to the equipment officer. It
can only be used once it has undergone maintenance procedures.
Sample properties and handling
●
●
●
Always use sample tubes or bottles that are appropriate or designed for the rotor to
be used.
In general, samples should be capped to avoid spills or the generation of aerosols.
Make sure that each pair of tubes is balanced by visual inspection or, if possible, by
weighing. When necessary, prepare balance tubes.
Policy Title:
DEPARTMENT OF LABORATORY POLICIES
AND OPERATIONS PROCEDURE MANUAL
Prepared By:
DEPARTMENT
MOLECULAR LABORATORY
●
HAROLD C. RONAN, MD, DPSP
DEPARTMENT HEAD
Approved By:
KHEM G. PEREZ, MD
PRESIDENT / CEO
Page Number
Policy Number
Date of Effectivity
Date Reviewed
62
M-011
October 2020
Date Revised
Date of Next
Review
After each run, properly dispose of all waste solutions, tubes, and disposable
materials (eg. tips used for blood separation) in the bleach bottle.
Safe use of the centrifuge
10.
●
Double-check the centrifuge settings. Please refer to the centrifuge manuals on
how to adjust settings of the centrifuges. Make sure that the SPEED, TIME, and
TEMPERATURE are correct.
●
Place the cap and close the centrifuge lid gently when ready to begin and press
the Start or Run button.
●
Do not lean on the centrifuge or place anything on it while it is running.
●
Wait until the centrifuge has reached full speed before leaving the centrifuge.
●
In the case that the run has to be stopped, press the STOP button and wait
until the centrifuge has completely decelerated before opening it.
●
In case of error, check the error code displayed on the screen and the load the
balances.
●
In case of power failure, wait for at least one hour before opening the centrifuge
to recover the samples. Check the centrifuge manuals for instructions for
recovery.
●
If the risk assessment indicates the need to do so, allow the centrifuge to stand at
least 1 minute in order for the aerosols to settle after completing the run. Open the
chamber door and remove the samples (or the rotor for Beckman Coulter Optima
ultracentrifuge).
●
After the run, leave the chamber door open and switch off the machine.
Decontaminate the centrifuge AFTER EACH RUN using an appropriate
disinfectant, which is usually 70% ethanol.
Preventive Maintenance
Monthly
1. Disassemble the attached rotor using a Hex wrench.
2. Verify that the centrifuge’s external components are free of dust and stains.
3. Soak the rotor and wipe the rotor compartment with 10% bleach for 30 minutes.
4. Wash the rotor and wipe the rotor compartment with distilled water to rinse of bleach.
5. Spray and wipe with 70% ethanol to prevent corrosion from bleach.
Policy Title:
DEPARTMENT OF LABORATORY POLICIES
AND OPERATIONS PROCEDURE MANUAL
Prepared By:
DEPARTMENT
MOLECULAR LABORATORY
HAROLD C. RONAN, MD, DPSP
DEPARTMENT HEAD
Approved By:
KHEM G. PEREZ, MD
PRESIDENT / CEO
Page Number
Policy Number
Date of Effectivity
Date Reviewed
63
M-011
October 2020
Date Revised
Date of Next
Review
6. Verify the locking /safety mechanism of the centrifuge cap.
7. Lubricate elements such as for O-rings as the manufacturer recommends (check if the
centrifuge has O-rings).
8. Verify the state of gaskets and clean with bleach and alcohol when necessary.
9. Document maintenance in the “Equipment Log”.
10. If in doubt, consult the user manuals of the centrifuge models or contact the qualified
service personnel.
Emergency Procedure
In case an incident or accident occurs while using the centrifuges:
1. Turn off the centrifuge and disconnect it from the power source.
2. Notify the biosafety officer and the other members of the laboratory.
3. If breakage or spillage occurs, IMMEDIATELY perform risk assessment and the
appropriate decontamination procedure. In general, the rotors and centrifuge chamber
should be cleaned with 70% ethanol to prevent deterioration of rubber sealing.
4. Refer to PSDS (section on Biohazard Spills or Chemical Wastes) to know the
appropriate way of disposing of the wastes.
5. Incidents and injuries must be reported to the Biosafety Officer within 24 hours.
11.
Annual Electrical and System Inspection/ Certification/ Validation (should be
done by supplier)
1. Verify that electronic cards are clean and well connected.
2. Test operation controls needed for the selection of the different parameters of the
centrifuge: speed, time, temperature, alarms selectors, and analog or digital instruments.
3. Document maintenance in the “Equipment Log”.
4. If in doubt, consult the user manuals of the centrifuge models or contact the qualified
service personnel.
Policy Title:
DEPARTMENT OF LABORATORY POLICIES
AND OPERATIONS PROCEDURE MANUAL
Prepared By:
DEPARTMENT
MOLECULAR LABORATORY
12.
HAROLD C. RONAN, MD, DPSP
DEPARTMENT HEAD
Approved By:
KHEM G. PEREZ, MD
PRESIDENT / CEO
Page Number
Policy Number
Date of Effectivity
Date Reviewed
64
M-011
October 2020
Date Revised
Date of Next
Review
Troubleshooting
a. Refer to the User Manual of Biobase.
13.
References
a. Maintenance Manual for Laboratory Equipment, 2nd ed., World Health Organization
(WHO) and Pan American Health Organization (PAHO), World Health Organization,
2008, Geneva, 45-52.
b. User Manual of Biobase
14.
Attachments
a. User manual of the centrifuge models covered by this SOP
b. Centrifuge Preventive Maintenance Form
c. Equipment Log Book
Policy Title:
DEPARTMENT OF LABORATORY POLICIES
AND OPERATIONS PROCEDURE MANUAL
Prepared By:
DEPARTMENT
MOLECULAR LABORATORY
HAROLD C. RONAN, MD, DPSP
DEPARTMENT HEAD
Approved By:
KHEM G. PEREZ, MD
PRESIDENT / CEO
Page Number
Policy Number
Date of Effectivity
Date Reviewed
65
M-011
October 2020
Date Revised
Date of Next
Review
PREPARATION OF DISINFECTANTS
1.
PURPOSE
This Standard Operating Procedure (SOP) describes the steps for preparing ethyl alcohol and
bleach solutions for disinfection.
2.
•
3.
ABBREVIATIONS AND DEFINITIONS
MSDS – Material Safety Data Sheet
SCOPE
This document applies to all individuals who handle COVID-19 specimens at the BMC Molecular
laboratory. This SOP enumerates the basic steps to properly prepare disinfectant solutions in the
lab.
4.
Tasks, responsibilities and accountabilities
Task
Authorized
Responsible
Training of personnel in preparing disinfectants
All users
Biosafety Officer
Ensures availability of materials for disinfectant
All users
Supplies and Equipment
preparation
5.
Officer
Basic Principles of Disinfectant Preparation
● The two commonly used disinfectants are ethyl alcohol and hypochlorite solutions.
● Ethyl alcohol is a potent virucidal agent that inactivates lipophilic viruses and many hydrophilic
viruses. Seventy percent is its most effective concentration for disinfection of general surfaces.
● Hypochlorite solutions in low concentrations have biocidal effect. As advised the US-CDC, the
minimum concentration needed for disinfection of general surfaces is 0.5% with 10-minute wet
contact time. To decrease this contact time, the prescribed concentration of the bleach solution
is increased to 1%.
● According to Zonrox® Philippines, the hypochlorite concentration, the active ingredient, in Original
Zonrox® Bleach is 4% to 6%. This must be noted for the preparation of bleach solution.
● To assure that the prepared bleach solution is at least 1% concentration, the stock solution of
bleach/Zonrox® is assumed to have 4% hypochlorite concentration.
Policy Title:
DEPARTMENT OF LABORATORY POLICIES
AND OPERATIONS PROCEDURE MANUAL
Prepared By:
DEPARTMENT
MOLECULAR LABORATORY
HAROLD C. RONAN, MD, DPSP
DEPARTMENT HEAD
Approved By:
KHEM G. PEREZ, MD
PRESIDENT / CEO
Page Number
Policy Number
Date of Effectivity
Date Reviewed
66
M-011
October 2020
Date Revised
Date of Next
Review
● Lysol® Concentrate Disinfectant’s active ingredient is o-benzyl-p-chlorophenol. High
concentrations of o-benzyl-p-chlorophenol, and other phenolic disinfectants, serve as a general
protoplasmic inhibitor. It’s mechanism involves the infiltration of the cell wall and aggregation of
proteins. Phenolics have been shown to exhibit bactericidal, fungicidal, tuberculocidal, and
virucidal properties.
● Low concentrations deactivate important enzyme pathways and leak cell contents from the cell
walls of bacteria, effectively killing them. A 2.7% dilution of o-benzyl-p-chlorophenol inactivated
HIV.
6. Preparation
•
Preparation of 70% Ethyl Alcohol Solution using 95% Technical Grade Ethyl Alcohol
1. Retrieve the gallon-bottles for ethanol for disinfection from Person 1.
2. Use the following glassware that are labeled “For Ethanol Preparation Only”:
a. 1000-mL volumetric flask
b. 1000-mL graduated cylinder
c. funnel
3. To make one liter of 70% ethyl alcohol solution, measure 734 mL of technical grade ethanol using
the graduated cylinder and transfer to the volumetric flask using a funnel to avoid spills.
4. Fill to mark the 1000-mL volumetric flask with distilled water.
5. Cover the opening of the volumetric flask with Parafilm® then mix properly by inverting
6. Transfer the resulting ethyl alcohol solution to the gallon-bottle.
7. Repeat steps 3 to 6 as needed.
8. Log the details needed at the Ethanol Preparation Logbook.
•
Preparation of 1% Bleach/Hypochlorite Solution using Original Zonrox® Bleach
1. Retrieve the gallon-bottles for bleach both for disinfection and for dunk tank from Person 1.
2. Use the following glassware that are labeled “For Bleach Preparation Only”:
a. 1000-mL volumetric flask
b. 100-mL graduated cylinder
c. funnel
3. To make one liter of ~1% hypochlorite bleach solution, measure 250 mL of Zonrox® Bleach using
the graduated cylinder and transfer to the volumetric flask using a funnel to avoid spills.
4. Fill to mark the volumetric flask with distilled water.
5. Cover the opening of the volumetric flask with Parafilm® then mix properly by inverting.
6. Transfer the resulting bleach solution to the gallon-bottle.
7. Repeat steps 3 to 6 as needed.
8. Log the details needed at the Bleach Preparation Logbook.
• Preparation of 3% Lysol® Solution from Lysol® Concentrate Disinfectant
Policy Title:
DEPARTMENT OF LABORATORY POLICIES
AND OPERATIONS PROCEDURE MANUAL
Prepared By:
DEPARTMENT
MOLECULAR LABORATORY
HAROLD C. RONAN, MD, DPSP
DEPARTMENT HEAD
Approved By:
KHEM G. PEREZ, MD
PRESIDENT / CEO
Page Number
Policy Number
Date of Effectivity
Date Reviewed
67
M-011
October 2020
Date Revised
Date of Next
Review
1. Retrieve gallon-bottles for Lysol® solution for disinfection from Person 1.
2.
a.
b.
c.
Use the following glassware labeled “For Lysol® Solution Preparation Only”:
1000-mL volumetric flask
100-mL graduated cylinder
funnel
3. To make one liter of ~3% Lysol® solution, measure 50 mL of Lysol® concentrate using the 100mL graduated cylinder and transfer to the volumetric flask using a funnel to avoid spills.
4. Fill to mark the volumetric flask with distilled water.
5. Cover the opening of the volumetric flask with Parafilm® then mix properly by invert
6. Transfer the resulting Lysol® solution to the gallon-bottle.
7. Repeat steps 3 to 6 as needed.
8. Log the details needed at the Lysol® Disinfectant Logbook.
7.
Health and Safety Warnings
All workers must know how to prepare disinfectant solutions. Refer to the attached MSDS of ethyl
alcohol and bleach/hypochlorite for the health and safety warnings.
8. References
•
Centers for Disease Control and Prevention (2019). Rationale and considerations for chlorine use
in infection control for non- U.S. general healthcare settings. Retrieved from
https://www.cdc.gov/vhf/ebola/clinicians/non-us-healthcare-settings/chlorine-use.html
•
Centers for Disease Control and Prevention (2008). Chemical disinfectants: guideline for
disinfection and sterilization in healthcare facilities. Retrieved from
https://www.cdc.gov/infectioncontrol/guidelines/disinfection/disinfection-methods/chemical.html
•
Val Tech Diagnostics (2013). Bleach Material Safety Data Sheet. Zelienople, PA. Retrieved 02
April 2020 from http://www.labchem.com/tools/msds/msds/VT150.pdf
•
Val Tech Diagnostics (2014). Ethyl alcohol, 95% v/v Material Safety Data Sheet. Zelienople, PA.
Retrieved 02 April 2020 from http://www.labchem.com/tools/msds/msds/VT230.pdf
Policy Title:
DEPARTMENT OF LABORATORY POLICIES
AND OPERATIONS PROCEDURE MANUAL
Prepared By:
DEPARTMENT
MOLECULAR LABORATORY
HAROLD C. RONAN, MD, DPSP
DEPARTMENT HEAD
Approved By:
KHEM G. PEREZ, MD
PRESIDENT / CEO
Page Number
Policy Number
Date of Effectivity
Date Reviewed
68
M-011
October 2020
Date Revised
Date of Next
Review
INVENTORY OF SUPPLIES
1. PURPOSE
This Standard Operating Procedure (SOP) describes the steps to be followed when getting and receiving
supplies.
2. ABBREVIATIONS AND DEFINITIONS
•
Personal Protective Equipment (PPE) - equipment worn to minimize exposure to hazards that
cause serious workplace injuries and illnesses.
3. SCOPE
This document applies to all individuals who gets and receives supplies within the MHSHI Molecular
laboratory. This SOP enumerates the basic steps to properly monitor the supplies during daily use.
4. Tasks and responsibilities
Task
Authorized
Responsible
Receives the supplies
All Users
Supply Manager
Monitors the supplies
All Users
Supply Manager
5. Supplies covered by this SOP
A. Consumables
Items
2-inches cryoboxes
Biohazard bags
Biohazard bags
Biohazard bags
Black bags
Microcentriguge tubes
Paper Towels
Pipette tips
Pipette tips
Pipette tips
qPCR plate
qPCR strips
Yellow bags
Yellow bags
B. Personal Protective Equipment
Description
80-placer cardboard and plastic cryoboxes
Large size (25x35)
Medium size (19x23)
Small size (8x12)
Large size (25x35)
1.5ml, pack of 500s
Interfold
Filtered, 20-200uL non-sterile,clear, pack of 1000s
Filtered, 100-1000uL non-sterile,clear, pack of 1000s
Filtered, 0.1-10uL non-sterile,clear, pack of 1000s
96-wells, low profile
8-strips, low profile
Large size (25x35)
Small size (8x12)
Policy Title:
DEPARTMENT OF LABORATORY POLICIES
AND OPERATIONS PROCEDURE MANUAL
Prepared By:
DEPARTMENT
MOLECULAR LABORATORY
HAROLD C. RONAN, MD, DPSP
DEPARTMENT HEAD
Approved By:
KHEM G. PEREZ, MD
PRESIDENT / CEO
Items
Surgical Mask
N95
Googles
Face shield
Hair cover
Lab gown
Shoe Cover
Gloves
Page Number
Policy Number
Date of Effectivity
Date Reviewed
69
M-011
October 2020
Date Revised
Date of Next
Review
Variants
3M 8210, KN95
Small, Medium, Large
C. Disinfecting Materials
•
Absorbent pads
•
Bleach
•
Ethyl alcohol
•
Isopropyl alcohol
•
Tissue
•
Disinfectant Wipes
•
Hand soap
•
Dishwashing liquid
•
Lysol®
6. Basic Operation
A. RECEIVING OF PERSONAL PROTECTIVE EQUIPMENT (PPE)
1. The PPE is supplied by the Procurement Department of MHSHI
2. Once the supplies are received, the supply manager must immediately encode the number of
items to the Bizbox intended for the inventory.
3. The received supplies must be stored directly in the supply room, in their respective cabinets
and/or boxes.
4. The following PPE must be counted per box:
Policy Title:
DEPARTMENT OF LABORATORY POLICIES
AND OPERATIONS PROCEDURE MANUAL
Prepared By:
DEPARTMENT
MOLECULAR LABORATORY
HAROLD C. RONAN, MD, DPSP
DEPARTMENT HEAD
Approved By:
KHEM G. PEREZ, MD
PRESIDENT / CEO
Page Number
Policy Number
Date of Effectivity
Date Reviewed
70
M-011
October 2020
Date Revised
Date of Next
Review
4.1.N95 Masks
4.2.Surgical Masks
4.3.Gloves
5. The following PPE must be counted per packs:
5.1.Shoe Cover
5.2.Hairnet
6. The following PPE must be counted per piece:
6.1.Face Shield
6.2.Disposable Laboratory Gowns
B. RECEIVING OF DISINFECTING SUPPLIES
1. Once the supplies are received, the procurement officer must immediately encode the
number of items to the excel file intended for the inventory.
2. The received supplies must be stored directly in the supply room, in their respective cabinets
and/or boxes.
3. All materials are counted by piece.
C. RECEIVING OF CONSUMABLES
1. Once the supplies are received, the procurement officer must immediately encode the
number of items to the excel file intended for the inventory.
2. The received supplies must be stored directly in the supply room, in their respective cabinets
and/or boxes.
3. The following consumables must be counted per box:
3.1. All Sizes of Filtered Tips
3.2.Microcentrifuge Tubes
Policy Title:
DEPARTMENT OF LABORATORY POLICIES
AND OPERATIONS PROCEDURE MANUAL
Prepared By:
DEPARTMENT
MOLECULAR LABORATORY
HAROLD C. RONAN, MD, DPSP
DEPARTMENT HEAD
Approved By:
KHEM G. PEREZ, MD
PRESIDENT / CEO
Page Number
Policy Number
Date of Effectivity
Date Reviewed
71
M-011
October 2020
Date Revised
Date of Next
Review
3.3.qPCR Plates
3.4.Kimwipes
4. THE following consumables must be counted per piece:
4.1. All Sizes of Biohazard Bags
4.2 Yellow Bags
4.3.Black Bags
4.4 Cryoboxes
4.5. Transfer pipettes
D. Monitoring of Supplies
1. The laboratory personnel must tell the procurement officer all the items they need for the
day.
2. The procurement officer must encode all the items that were consumed within the day.
3. Every week, the procurement officer must tally all the consumed items so that he/she will
have an idea what are the items that were running low for request.
Policy Title:
DEPARTMENT OF LABORATORY POLICIES
AND OPERATIONS PROCEDURE MANUAL
Prepared By:
DEPARTMENT
MOLECULAR LABORATORY
HAROLD C. RONAN, MD, DPSP
DEPARTMENT HEAD
Approved By:
KHEM G. PEREZ, MD
PRESIDENT / CEO
Page Number
Policy Number
Date of Effectivity
Date Reviewed
Date Revised
Date of Next
Review
72
M-011
October 2020
Policy Title:
DEPARTMENT OF LABORATORY POLICIES
AND OPERATIONS PROCEDURE MANUAL
Prepared By:
DEPARTMENT
MOLECULAR LABORATORY
HAROLD C. RONAN, MD, DPSP
DEPARTMENT HEAD
Approved By:
KHEM G. PEREZ, MD
PRESIDENT / CEO
Page Number
Policy Number
Date of Effectivity
Date Reviewed
Date Revised
Date of Next
Review
73
M-011
October 2020