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TB Policy

This document outlines policies and procedures for tracking tuberculosis (TB) patients who are lost to follow-up or who initially default on treatment at the Aurora Memorial Hospital in Aurora Province, Philippines. It defines lost to follow-up patients as those who interrupt treatment for two or more consecutive months. It describes the steps health staff should take to track lost to follow-up patients and encourage them to resume treatment. It also provides guidance on tracking patients who were diagnosed with active TB but did not initially enroll in treatment, called initial defaulters. Finally, it lists various preventive measures to discourage patients from stopping TB treatment.

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100% found this document useful (1 vote)
1K views33 pages

TB Policy

This document outlines policies and procedures for tracking tuberculosis (TB) patients who are lost to follow-up or who initially default on treatment at the Aurora Memorial Hospital in Aurora Province, Philippines. It defines lost to follow-up patients as those who interrupt treatment for two or more consecutive months. It describes the steps health staff should take to track lost to follow-up patients and encourage them to resume treatment. It also provides guidance on tracking patients who were diagnosed with active TB but did not initially enroll in treatment, called initial defaulters. Finally, it lists various preventive measures to discourage patients from stopping TB treatment.

Uploaded by

yam kuan
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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Republic of the Philippines

PROVINCE OF AURORA
AURORA MEMORIAL HOSPITAL
Brgy. Reserva, Baler, Aurora
Email: auroramemhos@gmail.com
PhilHealth Accredited Health Care Provider

Policies and Procedures for Tracking Lost To Follow-Up TB


Cases and Initial Defaulters and Preventive Measures

According to the National Tuberculosis Control Program (NTP) Manual of Procedures


(MOP) 5th edition, a lost to follow-up (LTFU) TB case is defined as a patient whose treatment
was interrupted for two (2) consecutive months or more. Tracking mechanism for patients
lost to follow-up shall be put in place to ensure that patients who fail to follow-up as
scheduled are immediately traced. Although not clearly emphasized in the NTP MOP, a
patient who was diagnosed as active TB case but did not enroll to TB treatment (so called
“initial defaulter”) must also be tracked and strongly encouraged to undergo treatment to
prevent spread of infection in other people or community.

It is the responsibility of the TB coordinator with the assistance of the health facility
staff (nurse and/or midwife) and Barangay Health Worker (BHW) to ensure adherence of
patients to TB treatment. Below are the steps to pursue for LTFU and initial defaulters. It
also includes various measures to prevent patients from stopping TB treatment.

● Tracking a LTFU TB Case:

a) The treatment partner (e.g. BHW) or must report to the immediate supervisor
(midwife or nurse) any TB patient who did not show up for treatment for 2
consecutive months or more.
b) If LTFU was discovered by the immediate supervisor or TB coordinator, the
treatment partner should be requested to conduct home visit, counsel the
patient and determine the cause of stopping treatment.
c) The TB coordinator should exhaust all possible means to encourage the TB
patient to go back to treatment and help address patient’s concerns.
d) If TB patient refuses further treatment, the health facility physician should
be informed for appropriate actions which includes:

▪ Inform the TB patient the possibilities that would happen if s/he stops

the treatment

▪ Educate the household contacts on infection control


Republic of the Philippines
PROVINCE OF AURORA
AURORA MEMORIAL HOSPITAL
Brgy. Reserva, Baler, Aurora
Email: auroramemhos@gmail.com
PhilHealth Accredited Health Care Provider
▪ Advise the patient that s/he is welcome anytime if the patient decides

to go back to TB treatment.

▪ Making a patient sign a waiver stating full knowledge of the

consequence for not finishing the treatment and emphasizing health


facility’s free from liability is an option.

● Tracking an initial defaulter:

a) The health facility staff and/or BHW visits the residence of the diagnosed
active TB case and counsels the patient to enroll to TB treatment.
b) The TB medical coordinator must provide counseling to the TB patient who
refuses treatment and determine reason/s for not enrolling to TB treatment.
c) Health facility staff should educate the patient and household members on
simple infection control measures. Advise the patient to wear face mask
while not on TB treatment.
d) Health facility staff makes sure to enroll the case on the agreed date.
e) Health facility staff or BHW should monitor the household of a TB case who
refused treatment.
f) Health facility staff or BHW to continue to monitor the TB case until such
time the patient agrees to TB treatment.

● Preventive Measures on Initial Defaulting or LTFU:

a) Practice patient-centered approach of care to all TB patients.


b) All presumptive TB patients who consulted and underwent diagnostic
examination must be followed up.
c) Provide preliminary TB counseling to all diagnosed TB cases before the start
of treatment and reinforce counselling every 2 two months thereafter.
d) Signing of contract with the TB patient until s/he finishes treatment is an
option in drug susceptible TB but not in drug resistant TB cases.
e) TB Patient’s rights and responsibilities must be part of the initial counseling
and included in the contract between the TB patient and the health facility.
f) Health facility should help address TB patients’ concerns on the place of
treatment, follow-ups for working TB cases, and others.
Republic of the Philippines
PROVINCE OF AURORA
AURORA MEMORIAL HOSPITAL
Brgy. Reserva, Baler, Aurora
Email: auroramemhos@gmail.com
PhilHealth Accredited Health Care Provider
g) Ensure all cases diagnosed with active TB are enrolled to TB treatment.
h) Monitor adherence of all cases to TB treatment including adverse drug
reactions, sputum follow-up examinations using a monitoring board or other
approaches, and difficulties encountered by the TB patients (e.g. access to
health facility by working patients or those living in far-flung barangays,
transportation expense, food, schedule of visits for patients who will start
work or will work in other areas).
i) A TB patient undergoing treatment who did not take his/her anti-TB drugs for
2 consecutive days should be considered an alarm. The treatment partner
should visit the TB patient and determine the cause. It should be immediately
reported to the supervising midwife or nurse for assistance.
j) A TB patient who did not take anti-TB drugs for more than 3 days should be
considered in crisis situation and must be reported immediately to the TB
coordinator for appropriate actions.
k) Health facility staff must address TB patient’s concerns and issues as it
arises.
l) Treatment partners must be mentored/monitored by the immediate
supervisors.
m) Maintain and regularly update NTP records including the Presumptive TB
Masterlist.

Approved by:

KRIS MADONNA A. ROXAS RIMANDO M.D


PHO-I/Chief of Hospital
Republic of the Philippines
PROVINCE OF AURORA
AURORA MEMORIAL HOSPITAL
Brgy. Reserva, Baler, Aurora
Email: auroramemhos@gmail.com
PhilHealth Accredited Health Care Provider

POLICIES AND PROCEDURES ON REFERRAL FOR OTHER SERVICES


INCLUDING XPERT AND X-RAY EXAMINATIONS
(source: National TB Control Program Manual of Operations 5th Edition)

Presumptive TB and TB patients consult a wide array of public and private health
facilities and practitioners who are providing TB care services for diagnosis, treatment
and/or counselling. These includes public (health centers, MDR TB treatment or satellite
treatment centers, treatment hubs); other public (government hospitals and laboratories,
jails/prisons, school clinics, military hospital); private health facilities and community
groups (BHWs, Community Health Teams, TB Task Forces, etc.).

Due to different health needs of the presumptive TB and TB patients and the varying
capacities of the health care providers, patients are being referred to other health facilities
for transfer of service or co-management. Major reasons for the referrals include for
diagnosis, registration and initiation of treatment, continuation of treatment, management
of serious side effects and complications, screening for MDR TB and for screening of TB
among PLHIV.

A systematic process of referral between AURORA MEMORIAL HOSPITAL and other health
facilities and providers should be established to ensure that various diagnostic, treatment
and information needs of presumptive / confirmed TB cases are promptly and appropriately
addressed through an effective two-way referral system between health facilities that will:
 Reduce the delay in the diagnosis and treatment of a TB case;
 Ensure continuity and compliance to treatment;
 Reduce out-of-pocket costs to patients;
 Ensure that the TB patient is registered and notified to NTP.

 Policies
a) All patients consulting the health facility should be screened to determine
presence of risks for TB prior referral for further screening by CXR or
diagnosis by Xpert test.
Republic of the Philippines
PROVINCE OF AURORA
AURORA MEMORIAL HOSPITAL
Brgy. Reserva, Baler, Aurora
Email: auroramemhos@gmail.com
PhilHealth Accredited Health Care Provider
b) All patients consulting the health facility will be offered chest x-ray (if
possible).
c) All presumptive TB cases with negative Direct Sputum Smear Microscopy
(DSSM) result should undergo CXR.
d) All presumptive DSTB (i.e. PLHIV with at least one of the four signs/symptoms
of TB -fever, cough, weight loss, or night sweats; selected vulnerable
population-inmates, children less than 15 years old, elderly 60 years old and
above; new cases who are presumptive extrapulmonary TB; and new cases
who are DSSM negative but CXR positive) and DRTB (i.e. retreatment, new TB
cases who are contacts of confirmed DR-TB, non-converter of Category 1)
cases should be referred to Xpert according to NTP protocol and guidelines
which includes.
e) Patients shall have the right to know the reason/s for referral and to
participate in the choice of facilities where s/he will be referred.
f) The TB coordinator has the responsibility of ensuring prompt and appropriate
response to patient’s health needs by immediate referral for services that
can be provided by other health providers/facilities.
g) A two-way functional referral must be observed by ensuring that a receiving
facility provides feedback to the referring facility
h) The health facility has a shared responsibility with the and receiving facility
to exert all efforts of ensuring that a referred patient is not lost during the
referral process.
i) Must use the standard NTP referral form (Form 7. NTP Referral Form) when
referring to other facilities.
j) Must update the Presumptive TB Masterlist for referring or receiving referrals
from other facilities.
k) Patients who were not referred in accordance to NTP policies and procedures
shall be accommodated and evaluated accordingly.
l) A TB patient diagnosed with other illnesses should be referred (depending on
patient’s choice) to the nearest public or private health facility with
appropriate health services needed by the patient.

 Procedures
 External TB Referral System
1) Explain to the patient why he/she will be referred.
2) Identify the health facility where he will be referred using the
national or local DOTS facility directory or the list of
Republic of the Philippines
PROVINCE OF AURORA
AURORA MEMORIAL HOSPITAL
Brgy. Reserva, Baler, Aurora
Email: auroramemhos@gmail.com
PhilHealth Accredited Health Care Provider
hospitals/diagnostic centers and mutually agree with the patient
where s/he will be referred.
3) Fill-out Form 7. NTP Referral Form, and attach the following,
depending on the purpose of the referral:
 For diagnosis (request for chest x-ray or laboratory
examination)
o For CXR:
- Refer the presumptive TB case or those with
negative DSSM to the nearest facility with free or
affordable quality CXR services.
- Use the health facility referral request form or free
voucher (if available) for CXR.
- If health facility is offering free CXR, all patients
consulting the facility should be offered free CXR.
Use required form for the referral.
- A Memorandum of Agreement (MOA) should be
present between the health facility and the X-ray
facility (e.g. if with PHIC Primary Care Benefit
package, commissioned/contracted by the local
government unit).
- Follow-up results from the patients through the
assistance of the volunteer/BHW or midwife.
o For Xpert examination: (by the nurse coordinator or
MT)
- explains to the patient the importance for Xpert
testing
- prepares and properly labels sputum container
- gives instruction to the patient (at the sputum
collection area) how to properly collect quality
sputum specimen of __ ml.
- check quality and amount of sputum specimen and
keep a cool place
- properly fill out Form 2. NTP Laboratory Request
- sends referral form and specimen to Xpert site by a
courier (e.g. STRIDER, LGU or health facility
vehicle)
Republic of the Philippines
PROVINCE OF AURORA
AURORA MEMORIAL HOSPITAL
Brgy. Reserva, Baler, Aurora
Email: auroramemhos@gmail.com
PhilHealth Accredited Health Care Provider
o For TB Diagnostic Committee (optional or if still
practiced)
- TB medical coordinator conducts thorough physical
examination and obtain medical history of DSSM or
Xpert negative but CXR positive TB patient
- TB coordinator fills out the diagnostic referral form
and attached necessary related documents
- PHN sends/submits patient’s documents to TBDC
and follow up the result within one-two weeks after
the date of submission.
 For initiation/continuation of treatment (Form 5. NTP ID Card
and results of diagnostics)
 For MDR-TB screening: (results of DSSM, CXR, ID card and copy
of previous Form 4. TB Treatment/IPT Card if available)
 For other illness: (Patient is referred to the nearest government
hospital or any health institution preferred by the patient.
4) Discuss the referral process with the patient and emphasize the
importance of giving a feedback to the referring unit.
5) The health facility should inform the receiving facility, as much as
possible with the assistance of the patient or family member.
6) The TB coordinator with the assistance of the patient or family
member to remind the receiving facility to give feedback through the
reply slip of the referral form, telephone call, SMS, email or other
modalities.
7) The TB coordinator should check with ITIS if the patient was
registered in the receiving facility.
8) The TB coordinator should update the records (i.e. Form 1.
Presumptive TB Masterlist or Form 6a. Drug-susceptible TB Register, as
applicable).
9) If the referred patient did not go to the referring facility within five
days, the TB coordinator should exert efforts to retrieve the patient
through the help of barangay health workers, local officials or
community groups. Ensuring successful referral is a shared
responsibility of the referring and receiving health facility.
Republic of the Philippines
PROVINCE OF AURORA
AURORA MEMORIAL HOSPITAL
Brgy. Reserva, Baler, Aurora
Email: auroramemhos@gmail.com
PhilHealth Accredited Health Care Provider
 Referring Presumptive DR-TB (if the health facility staff was not trained on
iDOTS)
1) All presumptive DR-TB (based on NTP guidelines) should be referred
for Xpert examination.
2) All Xpert results with rifampicin-resistance must be immediately
referred to the nearest MDR treatment facility
3) Fill-out Form 7. NTP Referral Form and attach copies of pertinent
supporting documents (i.e. old treatment card/s, DSSM result, CXR
plates and results).
4) Record the details of the referral in Form 1. Presumptive TB
Masterlist.
5) Contact the nearest MDR TB facility for proper coordination (i.e.,
confirm the availability of the service requested and its requirements)
and thereby minimize inconvenience for the patient.
6) The MDR TB facility shall acknowledge the referral through a return
slip, SMS, phone call, facsimile or mail.
7) Record the outcome of the referral in Form 1. Presumptive TB
Masterlist.

 Handling TB Patients Previously Managed Outside DOTS facility and


not Referred According to NTP Policies and Procedures
1) Accept the patient
2) Get a detailed clinical history following the same procedures as with
any presumptive TB.
3) Secure copies of supporting documents of TB diagnosis, evidence of
disease activity or history of treatment. Verify each, if necessary and,
with the patient’s consent, contact the attending physician and/or
health care facility. Note them accordingly on the remarks section of
the NTP Form I. Presumptive TB Masterlist.
4) Assess the patient’s willingness and commitment to continue
treatment under a DOTS program.
5) Do DSSM or Xpert examination (refer if not available within the health
facility) depending on the type of presumptive TB case. Repeat DSSM
if not done or done by a non-NTP recognized TB microscopy unit.
Record in Form 3. NTP Laboratory Register as a new presumptive TB.
If with DSSM results from an NTP-recognized diagnostic facility, follow
Republic of the Philippines
PROVINCE OF AURORA
AURORA MEMORIAL HOSPITAL
Brgy. Reserva, Baler, Aurora
Email: auroramemhos@gmail.com
PhilHealth Accredited Health Care Provider
the schedule for follow-up smears according to appropriate treatment
category.
6) The TB physician shall exercise best clinical judgement on deciding
whether to continue, modify, restart or discontinue treatment.
Register if patient will restart or continue treatment.
(Note: Even if the physician decides to continue treatment, patient
should not be registered as “Transfer in.” Assign a registration group
to the patient based on NTP policies.)
7) Provide the necessary treatment based on the evaluation of the
patient and NTP policies.
8) Provide a feedback to the previous attending physician or facility of
the patient.

 Modes of Knowing the Outcome of Referral


1) Receiving the referral reply slip that has been brought back to the
health facility by patient/relative or TB coordinator/health center
staff, or faxed, mailed or e-mailed by the receiving health facility
2) Talking with the receiving health facility through telephone call
3) Following up through SMS or by texting the patient or receiving health
facility
4) Reviewing the IT IS

 Strengthening and Sustaining the TB DOTS Referral System


1) Ensure that the patient understands the reason for the referral and
the importance of going to the receiving facility.
2) Provide an enabler (i.e. in kind such as rice, grocery item, etc. that
can be sourced out from partners or LGUs) to TB patients who had
been diagnosed, had gone to the health center, and had given
feedback.
3) Avail of the PhilHealth outpatient benefit package and share an
amount to the referring TB care providers.
4) Provide motivations and incentives to referring health workers and
facilities through a yearly recognition, recommending them to join an
inter-local area visit or participating in scientific conferences,
providing load or other in-kind incentives.
Republic of the Philippines
PROVINCE OF AURORA
AURORA MEMORIAL HOSPITAL
Brgy. Reserva, Baler, Aurora
Email: auroramemhos@gmail.com
PhilHealth Accredited Health Care Provider
 Hospital Internal Referral System (if the facility for certification is a
hospital)
1) Establish an internal TB referral system through a policy issuance (i.e.
hospital memo).
2) All TB cases identified by the OPD, wards and other units of the
hospitals or sections of the clinics (if with medical arts building) must
be referred to the hospital/ clinic TB team or point person.
3) Referring staff (e.g., attending physician, nurse on duty) fill out an
intra-hospital referral form with the pertinent documents attached
and send it to the hospital TB team or point person.
4) The Hospital TB team or point person evaluates the patient, fills-up
the reply form, and records the patient in the hospital TB Referral
Logbook.
5) Patient may be provided with NTP drugs while at the hospital. Drugs
may come from the health center where the patient resides or from
the hospital TB team.
6) For patients referred outside the hospital, record the referred patient
in Form 8. Hospital TB Referral Logbook or write under remarks in
Form 6a. Drug-susceptible TB Register or Form 1. Presumptive TB
Masterlist. If patient was given treatment at the ward, fill-up Form 5.
NTP ID Card. Upon discharge, refer patient to a DOTS facility and give
at least one or two-week supply of anti-TB drugs.

Approved by:

KRIS MADONNA A. ROXAS RIMANDO M.D


PHO-I/Chief of Hospital
Republic of the Philippines
PROVINCE OF AURORA
AURORA MEMORIAL HOSPITAL
Brgy. Reserva, Baler, Aurora
Email: auroramemhos@gmail.com
PhilHealth Accredited Health Care Provider
POLICY ON HEALTH EDUCATION AND INFORMATION
DISSEMINATION
(source: National TB Control Program Manual of Operations 5th Edition)

Increasing the demand for TB services and the supply of services as the two important
pillars in achieving TB elimination program targets. Communication is one of the essential
tools as it can be used to identify and address challenges in improving interpersonal
communication and counselling (IPC/C) skills of health workers and community health
volunteers so vital information would be communicated well to target clients, and combat
stigma and discrimination among patients, their relatives, people surrounding them, and
even among health workers. (NTP MOP 5th Edition)

Under the Program, the following terminologies were defined as:


 Communication as the process people use to exchange information about TB
 Behavior Change Communication (BCC) is the process of developing tailored
messages and approaches utilizing various channels of communication. Its three
components are IEC, IPC/C, and Community Mobilization.
 Information, Education, and Communication (IEC) is one component of BCC that
attempts to change and/or reinforce a set of behaviors in a targeted segment of
audience on a specific problem in a pre-defined period of time.
 Interpersonal Communication and Counselling (IPC/C) is another component of
BCC which is a face-to-face, verbal and non-verbal exchange of information or
feelings between two or more people. In the TB program, this refers to intense
communication process between the health provider and the patient for the
latter to complete the DOTS treatment.

 Policies
a) The health facility should include communication activities in its local TB plan.
b) The facility health staff shall ensure the provision of accurate, reliable and up to-
date TB information to all clients and patients that will motivate them to seek care
and complete treatment.
c) Communication activities must be customized according to specific needs of the
barangays and communication messages delivered must be consistent with the
messages developed by the National TB Control Program and National Center for
Health Promotion of the DOH.
d) All volunteers or BHWs must be updated on TB Program.
Republic of the Philippines
PROVINCE OF AURORA
AURORA MEMORIAL HOSPITAL
Brgy. Reserva, Baler, Aurora
Email: auroramemhos@gmail.com
PhilHealth Accredited Health Care Provider
e) All volunteers/BHWs must refer presumptive TB identified in the community and
ensure that these patients go to the DOTS facility.
f) IEC materials must be available in the health facility and posters must be well
displayed in visible areas and leaflets should be available for distribution to patients.

 Procedures
a) Communicating with TB Patients (by the TB coordinator or midwife and BHW)
 Provide health education sessions for both patient and his/her family.
Emphasize the following key points:
 Importance of regular drug intake
 Effect of irregular drug intake
 Side-effects of taking anti-TB drugs
 Necessity of DSSM follow-up
 Importance of treatment compliance
 Importance of family and treatment partner support
 Rights and responsibilities of a TB patient
 Conduct regular consultation meetings with patient and treatment partner.
 Continuously disseminate key TB communication messages. Localized key
messages should be in-line and consistent with the NTP Communication Plan
developed by the NTP and NCHP of the DOH. The key messages are:
 Maling kaalaman ang magpapalala sa TB.
 Anim na buwang gamutan para gumaling. Kaya mo ‘yan! Kapag tumigil
bago makumpleto ang anim na buwan ay maaaring humaba ang buwan
ng gamutan hanggang dalawang taon.
 Huwag bibitiw sa DOTS para mapuksa ang TB sa katawan. Bawat araw
na kumpleto ang pag-inom sa gamot, paganda nang paganda ang
pakiramdam mo. Kapag bumitiw, ang anim na buwan ay maaaring
maging dalawang taong gamutan.
 Pagkatapos ng dalawang linggong gamutan, hindi na nakahahawa ang
TB. Pero dapat tapusin ang anim na buwang gamutan para todo-
todong gumaling.
 Ekspertong kaalaman. Dekalidad na serbisyo. May nagmamalasakit
pang treatment partner na sinisigurong nasusunod ang tamang
paggamot.
 Sa TB-DOTS, ang mga mahal sa buhay ay natututukan sa tamang
paggamot.
Republic of the Philippines
PROVINCE OF AURORA
AURORA MEMORIAL HOSPITAL
Brgy. Reserva, Baler, Aurora
Email: auroramemhos@gmail.com
PhilHealth Accredited Health Care Provider
 Kung may kakilala kang may TB, dapat silang kumbinsihin na mag-
DOTS – ang nag-iisang paraan para gumaling siya nang husto.
Naprotektahan mo pa ang sarili mo.

b) Advocating for Greater Public Support and De-stigmatization of TB (by the TB


coordinator with the assistance of the midwife and BHWs)
 Hold assemblies in the barangay, schools, companies and other institutions
 Celebrate World TB Day in March and Lung Month in August of every for
increased awareness.
 Key advocacy messages should include:
 TB elimination is a national priority.
 TB is a public health problem. It is the 6th leading cause of illness in
the Philippines.
 TB is everyone’s concern.
 TB affects the most economically productive age group, resulting in
enormous economic losses.
 DOTS is the most cost-effective strategy to control TB.

Approved by:

KRIS MADONNA A. ROXAS RIMANDO M.D


PHO-I/Chief of Hospital
Republic of the Philippines
PROVINCE OF AURORA
AURORA MEMORIAL HOSPITAL
Brgy. Reserva, Baler, Aurora
Email: auroramemhos@gmail.com
PhilHealth Accredited Health Care Provider
CRITERIA AND PROCEDURE FOR THE SELECTION OF AND
ASSIGNMENT OF TB DOTS PARTNERS
(source: National TB Control Program Manual of Operations 5th Edition)

Directly Observed Treatment (DOT) is a strategy developed to ensure treatment


compliance by providing constant and motivational supervision to TB patients. DOT works by
having a responsible person, referred to as treatment partner, who watches the TB patient
take medicine daily during the whole course of treatment. DOT can be done in any
accessible and convenient place for the patient (e.g., DOTS facility, treatment partner’s
house, patient’s place of work, or patient’s house) as long as the treatment partner can
effectively ensure the patient’s intake of the prescribed drugs and monitor his/her reactions
to the drugs.

Criteria for the selection of and assignment of TB Treatment Partners:


 A treatment partner should be a healthy and active member of the community (e.g.
DOTS facility midwife or nurse, a trained community member such as the BHW, local
government official, a former TB patient).
 Trained family members may be assigned to administer oral medications during
weekends and holidays; or as the sole treatment partner in special/exceptional
cases, such as:
 Poor access to a DOTS facility due to geographical barriers (including
temporarily displaced populations)
 Debilitated and/or bed-ridden patients
 DOT schedule conflicts with the patient’s work/school schedule and unable to
access other DOTS facilities
 Cultural beliefs that limit the choice of a treatment partner (e.g., indigenous
peoples)
 Treatment of children
 Post-disaster scenarios
 Should be well-oriented on the basic policy and procedure regarding TB DOTS
 Should be residing in a place accessible to the patient
 Should be reliable and committed person
PROCEDURE:
Republic of the Philippines
PROVINCE OF AURORA
AURORA MEMORIAL HOSPITAL
Brgy. Reserva, Baler, Aurora
Email: auroramemhos@gmail.com
PhilHealth Accredited Health Care Provider
 Once the patient is diagnosed with active TB disease, the TB coordinator counsels
the patient for enrolment to the TB Program. During the counseling session, the TB
coordinator assist the patient identify its appropriate treatment partner.
 If the treatment partner and a family member are not present during the initial
counseling, another session may be done to ensure both the family member and the
treatment partner .
 The TB coordinator decides who wi the health staff will immediately look for a
treatment partner for the said patient. Based on the patient’s address.

Review the list of prospective DOT partner per barangay who lives near the patient.
(Usually these are the BHWs)

Inform the responsible health worker/prospective DOT partner and the TB patient to
meet at the health center for the initiation of treatment and for other instruction related to
patient’s treatment and follow up.

In such cases where a family member is the treatment partner, drug supply is to be
distributed on a weekly basis or as agreed by the health worker and the family member.

Approved by:

KRIS MADONNA A. ROXAS RIMANDO M.D


PHO-I/Chief of Hospital
Republic of the Philippines
PROVINCE OF AURORA
AURORA MEMORIAL HOSPITAL
Brgy. Reserva, Baler, Aurora
Email: auroramemhos@gmail.com
PhilHealth Accredited Health Care Provider
POLICIES AND PROCEDURES ON
MANAGING ANTI-TB DRUGS AND DIAGNOSTIC SUPPLIES
(source: NTP Manual of Operations 5th Edition)
One of the key elements of the National TB Control Program (NTP) are the availability of
quality anti-TB drugs, laboratory and other medical supplies. The adequate and
uninterrupted supply of diagnostic supplies and drugs is necessary for the sustained
provision of quality TB diagnostic and treatment services in all service delivery facilities. It
promotes better patient care, improves the public health services’ credibility, and increases
the patients’ trust and participation in the program. This can translate to better treatment
success and reduced TB deaths, and contribute to better overall health in the family and
community. TB drugs represent a major out-of-pocket expense for a patient and the family.
The high cost of anti-TB drugs for the poor is a major barrier that limits access to treatment
and cure.

Policies:
a) The overall management of all TB drug supplies and diagnostic supplies shall be the
responsibility of the DOTS Center.
b) The Rural Health Unit shall ensure that NTP policies and guidelines for NTP supplies
management are implemented properly at their level. They shall also actively
participate in the monitoring and evaluation of the implementation of these policies
and guidelines.
c) Quantification and ordering shall be based on utilization rate, projected increase of
cases due to strengthened case finding and provision of buffer stocks.
d) Procurement of TB drugs and diagnostic supplies at the local government level shall
follow the “Government Procurement Reform Act” or RA 9184 and the DOH policies,
guidelines, and standards for the procurement of TB drugs and laboratory supplies.
e) Local procurement of anti-TB drugs for the use of the program is in accordance to
international guidelines (e.g., WHO), are indicated in the national standard
guidelines (i.e., NTP-MOP), registered with the Philippines FDA and included in the
national formulary. Standardized fixed dose combination (FDC) of anti-TB drugs shall
be used under the NTP whenever appropriate.
f) Medicines and supplies shall be stored under appropriate conditions and accounted
for through proper recording and reporting.
g) The RHU ensure that drugs and diagnostic supplies are promptly distributed to the
district or barangay if needed.
Republic of the Philippines
PROVINCE OF AURORA
AURORA MEMORIAL HOSPITAL
Brgy. Reserva, Baler, Aurora
Email: auroramemhos@gmail.com
PhilHealth Accredited Health Care Provider
h) The use of medicines shall be guided by the presence of appropriate indications for
treatment based on the NTP standards for diagnosis of TB, and the absence of
contraindications to their use.
i) Disposal of expired and damaged drugs and diagnostic supplies shall follow the
government rules and regulations.
j) The RHU shall be responsible for the reproduction of all official NTP forms to ensure
availability and adequacy in all RHUs/DOTS facilities including jails and prisons.
k) The RHU shall advocate/request the LGU set aside funds for the emergency
procurement of sufficient quantities of TB drugs and diagnostic supplies in times of
impending shortage to ensure continuous availability of NTP commodities at their
service delivery points.

Procedures:
a) Calculation of Anti-TB Drugs and Diagnostic Supplies (by the TB coordinator)
1. Estimate the number of patients expected to be tested and treated for the
order period.
 The number of patients treated in the previous quarter can be used to
guide in estimating the number or the number of patients treated in the
same quarter last year.
 Consider special activities (intensified case finding, health promotion
activities, etc.) that may result into more patients diagnosed and
requiring treatment.
2. Calculate buffer stock quantity equivalent to one quarter.
 For DSSM laboratory supplies, calculation of annual needs may be done
using the guide matrices found in the NTP MOP 5th edition.
 The buffer stock should be maintained at 25% of the total number of
patient of the current year.
 In the event of <25% buffer stock, the TB Nurse coordinator should
request from the Provincial Health Office for replenishment. If in case
there is no available medicines from PHO, the DOTS Physician should
request for emergency purchase from the local government unit to fill-
up the deficiencies of buffer stock.
3. Fill-up Order Request Form and submit to the Provincial Health Office NTP

b) Receiving Supplies of Medicines and Diagnostic Supplies (by the TB coordinator


and/or Supply Officer or Store Keeper)
Republic of the Philippines
PROVINCE OF AURORA
AURORA MEMORIAL HOSPITAL
Brgy. Reserva, Baler, Aurora
Email: auroramemhos@gmail.com
PhilHealth Accredited Health Care Provider
1. Obtain the supply receipt forms accompanying the delivery.
2. Check for the following: quantities for each item listed, check medicine
labels for name, strength, and dosage form, inspect for damages, and note
the expiry dates.
3. Record discrepancies noted and send feedback to the PHO NTP.
4. Record the quantity of good items and quantity that are missing or damaged
on the receipt form.
5. Sign the receipt form. If possible, have a fellow health worker verify and sign
too for the quantities received.
6. Keep a copy of, and file the delivery receipt form, for documentations.

c) Storage of Drugs and Diagnostic Supplies (by the TB coordinator, Supply Officer or
Store Keeper)
1. Maintain clean storeroom with regular cleaning, prohibit food consumption
where stocks are kept, remove spoiled products and clean affected areas
immediately.
2. Perform regular inspections to check for signs of theft, pest, water damage,
or deterioration due to high humidity.
3. Organize TB kits so labels can be easily read (product name, expiry date).
4. Promote air circulation in the storage room – high ceilings with vents; if
feasible, install air conditioner, an exhaust fan, or a window or air vents.
Allow more space between shelves. Leave adequate space (about 10-15 cm)
between the walls and the shelves or stack of medicines for better
circulation. Monitor and record daily the temperature in the storage area.
5. Keep medicine containers closed to avoid exposure to humid air. Light
sensitive products must be kept in their original packaging and stored in
closed cupboard or in a shady corner.
6. Store medicines and supplies under recommended storage temperatures (i.e.,
PPD and BCG at 2-8C; Xpert MTB/RIF cartridge below 280C)
7. Store medicines only on shelves or pallets, never on the floor. Do not store
medicines near the ceiling where temperatures are higher. Do not stack
containers too high to avoid crushing the lower ones.
8. Practice “First Expiring, First Out” (FEFO) to avoid expired medicines and
wastage.
9. Remove all expired or damaged items from the usable stocks and place in a
clearly marked area for such items. Expired anti-TB drugs shall be reported to
Republic of the Philippines
PROVINCE OF AURORA
AURORA MEMORIAL HOSPITAL
Brgy. Reserva, Baler, Aurora
Email: auroramemhos@gmail.com
PhilHealth Accredited Health Care Provider
the MHO/PHN and shall be disposed properly. Maintain records of expired or
damaged medicines.
10. Return excess medicines to the PHO NTP for redistribution and record all
items that were returned.
11. Access to the storage area must be restricted and those authorized to handle
supplies shall be accountable for their actions. Fit doors with security locks
and install bars on storeroom windows.
12. Maintain inventory records for accountability.

d) Maintaining Records for TB Drugs and Diagnostic Supplies (by the TB coordinator,
Supply Officer or Store Keeper)
1. The RHU shall maintain proper records for drugs and supplies to facilitate
monitoring of available stocks and consumption.
2. Maintain and update drugs and diagnostic supplies stock records – to track
supplies ordered, delivered, consumed, or loaned to another treatment
facility; expiry dates; and as a reference for next order of anti-TB drugs.
3. Perform physical inventory or counting of stock items regularly to monitor
stock levels. The physical counts should be compared to quantities written on
the stock records or stock cards.

e) Rational Use of Anti-TB Drugs and Diagnostic Supplies (by the TB coordinator)
1. Prepare and administer appropriate treatment to patient in the RHU.
Treatment must be based on the NTP’s guidelines for treatment regimen and
administration and should be recorded on patients’ treatment cards and on
the TB register.
2. Each patient enrolled in TB Program shall be allotted with a complete supply
of TB drugs for the whole duration of TB treatment

Approved by:

KRIS MADONNA A. ROXAS RIMANDO M.D


PHO-I/Chief of Hospital
Republic of the Philippines
PROVINCE OF AURORA
AURORA MEMORIAL HOSPITAL
Brgy. Reserva, Baler, Aurora
Email: auroramemhos@gmail.com
PhilHealth Accredited Health Care Provider

POLICIES AND PROCEDURES ON ENSURING CONFIDENTIALITY

In TB control, the relationship between the patient and the health care provider (HCP) is
extremely important. Confidentiality is the protection of all patient information, including
patient records and information discussed or identified during patient-HCP encounters.
While data security is the protection of public health data and information systems to
prevent unauthorized release of identifying information and accidental loss of data or
damage to the systems. HCP should be aware of the importance of confidentiality problems
involving client-HCP meets, and in the collection, management, and sharing of TB patient
data and information. Disclosure of client’s information to unauthorized persons without the
client’s permission, the client may be stigmatized or experience rejection from family and
friends, lose a job, and others. HCP may lose the trust of the client.
Protection of a patient’s private information is critical in TB control. However, there are
times that the health facility must also consider the interests of the public since it has a
responsibility to protect the health of the public. This is embodied under Republic Act No.
10173 or Data Privacy Act of 2012 which aims to protect the right to information privacy
while ensuring free flow of information. Further, R.A. 10173 does not prohibit the DOH from
collecting and processing personal data for purposes necessary to its mandate, with the
concomitant responsibility of complying with the requirements of the DPA, its Implementing
Rules and Regulations, and other issuances of the National Privacy Commission.
Security measures should be in place specifically measures to detect, document, and
counter threats to data confidentiality or the integrity of data systems. HCP should protect
the patient’s rights and their confidentiality and help the TB program fulfill its
responsibilities to the public.
Policies:
l) It is the responsibility of the Rural Health Unit (RHU) to protect patient information.
m) RHU staff should be familiar with the confidentiality laws in their jurisdiction.
n) Confidentiality must be preserved in:
 Ensuring adequate patient care
 Performing contact investigations
 Collecting and analyzing data
 Conducting program evaluation
 Referring patients to other health facility
o) Treatment partner (e.g. BHW) should be informed and should practice
confidentiality of patient’s identity and disease status and treatment.
Republic of the Philippines
PROVINCE OF AURORA
AURORA MEMORIAL HOSPITAL
Brgy. Reserva, Baler, Aurora
Email: auroramemhos@gmail.com
PhilHealth Accredited Health Care Provider
p) No data or information shall be given to the public or to anyone without the consent
of the patient concerned, except for program monitoring and evaluation and for
legal purposes.
q) Patient information/data can be given to a second party only with a written
authorization from the patient concerned.
r) Any allied or health personnel of the Rural Health Unit who divulge any information
regarding patient’s identity without permission shall be acted upon accordingly.
Procedures:
f) On ensuring adequate patient care: (by the TB coordinator)
a. confidentiality must be included during initial counseling of the TB case upon
enrolment to TB program
b. patient should be informed that sometimes despite best efforts, their TB
status may be inadvertently disclosed to others (e.g. a friend, family
member, or co-worker of the patient may share information about the
patient to others)
c. should discuss with the patient the possibility and be prepared to address the
situation if privacy is not maintained
d. advise TB patient to inform only persons they trust about their TB diagnosis
e. All TB data and information of the patient shall be placed in filling cabinet
with secured lock
f. Only authorized DOTS facility personnel can have access to ITIS and NTP
records.
g. TB kits (boxes/containers) of TB patients shall be coded properly (e.g. TB
case no. should be placed instead the name of the patient in the kit or box).
g) On performing contact investigation: (by the TB coordinator or representative)
a. ensure that interviews with the patient take place in private
b. emphasize confidentiality, but inform the patient that relevant information
may need to be shared with other RHU health staff who have a need to know
c. if the TB case spent time in a congregate setting (e.g., a school, jail, shelter)
while infectious, the TB case patient should be informed that appropriate
personnel of the said-facility where the TB case spent his/her time may need
to be notified so that the facility can assist in accurately and efficiently
identifying contacts who need to be evaluated
d. if patient’s identity is revealed to facility personnel interviewed, the TB
coordinator should inform and advise facility personnel to observe
confidentiality
e. should take extra care not to inadvertently reveal clues about the TB case
identity while meeting with the contacts
Republic of the Philippines
PROVINCE OF AURORA
AURORA MEMORIAL HOSPITAL
Brgy. Reserva, Baler, Aurora
Email: auroramemhos@gmail.com
PhilHealth Accredited Health Care Provider
f. confidentiality should not be violated even if contacts refuse to be evaluated
g. some approaches to use in order to protect the confidentiality of the patient
when meeting with contacts are:
i. use gender-neutral language (use someone instead of a woman or
man)
ii. do not mention the TB case health care worker, place and dates of
diagnosis, or hospitalization history
iii. do not mention the environment in which the exposure occurred
iv. do not confirm the name of the patient if the contact correctly
guesses his or her identity
h) On collecting and analyzing data: (by the TB coordinator)
a. Update IT IS on a regular basis
b. disclosure of TB patient information to a designated another public health
facility or authority is allowed without written authorization from the patient
because TB is considered a significant threat to public health and included in
Data Privacy Act of 2012.
i) On conducting program evaluation: (by TB coordinator)
a. serve as a basis for policy, program development and assess program
performance
b. should not include patient-identifiable information, such as names,
addresses, or detailed demographic information that could be used to identify
the patient
j) On referring patients to other health facility: (by the TB coordinator)
a. properly fills out the NTP referral form and give to patient or family member
b. should inform the receiving facility to ensure patient continues the treatment
c. transfer confidential information via secure electronic methods (e.g. sent
directly to a specific person and if possible, with added security such as
signature confirmation, restricted delivery, or certified mail), personal
communication, or hard-copy mail delivery whenever possible.
d. Do not send by fax if the receiving fax machine is not in a secured area

Approved by:

KRIS MADONNA A. ROXAS RIMANDO M.D


PHO-I/Chief of Hospital
Republic of the Philippines
PROVINCE OF AURORA
AURORA MEMORIAL HOSPITAL
Brgy. Reserva, Baler, Aurora
Email: auroramemhos@gmail.com
PhilHealth Accredited Health Care Provider

POLICIES AND PROCEDURES ON IDENTIFYING AND WORKING


WITH EXTERNAL PROVIDERS OR GROUPS

Collaboration between the public and private health sector is recognized as one of the
critical elements in eliminating tuberculosis. The private health sector provided a
considerable proportion of services for communicable diseases, including tuberculosis. The
private providers have been shown to be often the first and only point of contact of many
patients with tuberculosis, thus, their role is particularly important since detection and cure
remain the major interventions for reducing disease transmission.

In addition, advocacy with public leaders or decision-makers and mobilizing communities


are equally important in eliminating TB. Advocacy aims to secure needed financial resources
and change policies, guidelines or procedures by influencing stakeholders such as
politicians, decision-makers and journalists. While social mobilization aims to change norms,
improve services, expand community support and solve social problems, often by bringing
groups together to act at a community level.

Collaboration, advocacy and social mobilization are a means to an end, not an end in
themselves. But, they address key barriers to accessing TB care and completing treatment,
and thus support the achievement of reaching the NTP goals.

Policies and Procedures:

a) The RHU TB facility should formulate strategies to build partnerships with private
physicians within the area to synchronize diagnosis and treatment of TB cases.

b) The RHU should have a masterlist of all external TB providers in the locality and
partners supporting the local TB Program.

c) The RHU DOTS facility should coordinate or collaborate with external TB providers to
ensure all TB providers follow the NTP guidelines and protocols for managing TB.

d) Establish partnerships with existing community-based organizations (e.g. local non-


government organizations), private institution and other sectors to set up a private-
public mixed mechanism for NTP implementation.
Republic of the Philippines
PROVINCE OF AURORA
AURORA MEMORIAL HOSPITAL
Brgy. Reserva, Baler, Aurora
Email: auroramemhos@gmail.com
PhilHealth Accredited Health Care Provider
e) Organize or create or strengthen Municipal TB Task Force and provide assistance

f) Network with local industries/establishments within the catchment area regarding


proper referral of Presumptive TB must be advocated.

g) There must be coordination with DECS regarding health education dissemination to


school children (Elementary and High School) as well as to teachers to increase their
awareness on Tuberculosis prevention and control.

Approved by:

KRIS MADONNA A. ROXAS RIMANDO M.D


PHO-I/Chief of Hospital
Republic of the Philippines
PROVINCE OF AURORA
AURORA MEMORIAL HOSPITAL
Brgy. Reserva, Baler, Aurora
Email: auroramemhos@gmail.com
PhilHealth Accredited Health Care Provider
POLICIES AND PROCEDURES ON QUALITY ASSURANCE FOR
DIRECT SPUTUM SMEAR MICROSCOPY (DSSM)
(source: Administrative Order No. 2007-0019 entitled “Guidelines for the Implementation of the
Quality Assurance System on Direct Sputum Smear Microscopy)

A. Two sputum specimens should be collected (using spot-spot or early morning-spot


method) for DSSM.

B. All Presumptive TB patients should be instructed by the BHW, midwife or nurse on


how to properly collect quality sputum specimen.

C. Sputum specimen should be collected in specified sputum cups that are properly
labelled and sealed.

D. If possible, the sputum specimens collected should be immediately smeared, fixed


and stained and recorded within the day they are collected.

E. Microscopy results should be released within one week after collection.

F. Only trained microscopists under the National TB Reference Laboratory of the


Research Institute for Tropical Medicine are allowed to perform the Direct Sputum
Smear Microscopy (DSSM).

G. All slides should be subjected to validation by the External Quality Assurance System
of the Provincial Health Office.
 The RHU MT should prepare all the slides made in the quarter prior to the visit of
the NTP Coordinator for the collection of sample slides.

H. All patients referred for enrollment to NTP DOTS with sputum examinations from
non-certified microscopy centers will have to undergo repeat sputum microscopy by
our trained microscopist.

I. The RHU TML serves as the peripheral laboratory and should have at least one
binocular brightfield microscope, and at least one NTP trained microscopist covering
Republic of the Philippines
PROVINCE OF AURORA
AURORA MEMORIAL HOSPITAL
Brgy. Reserva, Baler, Aurora
Email: auroramemhos@gmail.com
PhilHealth Accredited Health Care Provider
a population of about 100,000-150,000, provided that the daily workload is adequate
to maintain the staff’s proficiency.

J. Perform sputum smear microscopy for diagnosis, and for follow-up of TB patients on
therapy using the brightfield/fluorescence microscopy

K. Organize and supervise the RSS including ensuring the availability of supplies (if
present)

L. Assess smeared slides submitted by RSS and provide feedback of quality check

M. Store sputum slides for EQA

N. File EQA results and feedback sheets from the QAC

O. The RHU TML MT shall update and submit quarterly reports through the Integrated
Tuberculosis Information System (ITIS) Laboratory Module.

P. RHU TML MT responds to the feedback of EQA results from the PHO QA Center,
report to the TB medical coordinator, and take corrective actions as needed.

Approved by:

KRIS MADONNA A. ROXAS RIMANDO M.D


PHO-I/Chief of Hospital
Republic of the Philippines
PROVINCE OF AURORA
AURORA MEMORIAL HOSPITAL
Brgy. Reserva, Baler, Aurora
Email: auroramemhos@gmail.com
PhilHealth Accredited Health Care Provider
ESSENTIAL BIOSAFETY MEASURES TO MINIMIZE RISKS IN THE
RHU TB MICROSCOPY LABORATORY
sources:
 DOH Guidelines on Infection Control for TB and Other Airborne Infectious Diseases in
Healthcare Facilities, Congregate Settings and Households
 WHO TB Laboratory Biosafety Manual 2012

Laboratory biosafety is the process of applying a combination of administrative


controls, containment principles, practices and procedures, safety equipment, emergency
preparedness, and facilities to enable laboratory staff to work safely with potentially
infectious microorganisms; biosafety also aims at preventing unintentional exposure to
pathogens or their accidental release. This manual describes the minimum biosafety
measures that should be implemented at the different levels of tuberculosis (TB) testing
laboratories to reduce the risk of a laboratory-acquired infection. (WHO)

A. Codes of practice
i. laboratory access
 a warning symbol and sign must be displayed on the laboratory door
 only authorized persons should be allowed to enter the laboratory’s working
areas
 children should not be authorized or allowed to enter the laboratory’s
working areas
 A trained MT is responsible to ensure safety and a simple operations manual
and a set of standard operating procedures developed.
 Systems for heating, ventilation, air and containment (directional airflow) are
always functioning properly.

ii. Personal protective equipment


 Protective laboratory clothing must be worn at all times while staff are
working in the laboratory and must not be worn outside the laboratory area.
 Laboratory clothing must be stored separately from personal clothing.
 Gloves must be worn for all procedures that involve direct contact, or may
involve accidental contact, with sputum, blood, body fluids and other
potentially infectious materials. After use, gloves should be removed
aseptically and hands washed.
Republic of the Philippines
PROVINCE OF AURORA
AURORA MEMORIAL HOSPITAL
Brgy. Reserva, Baler, Aurora
Email: auroramemhos@gmail.com
PhilHealth Accredited Health Care Provider
 Lab staff must wash their hands (with soap and water) after any overt
contamination, after completing work during which infectious materials were
handled, and always before they leave the laboratory’s working areas.
 Eating, drinking, smoking, applying cosmetics and handling contact lenses are
prohibited in the laboratory.
 Storing food or drink anywhere in the laboratory’s working areas is
prohibited.
 If possible, an open-toed footwear must not be worn in the laboratory and
mobile telephones should not be used inside the laboratory

iii. Procedures
 All procedures must be performed in such a way as to minimize or prevent
the formation of aerosols and droplets includes:
o When preparing smears, wooden sticks or disposable loops are
preferable rather than reusable loops, which need to be heat
sterilized.
o When preparing a smear using a stick or loop, move it slowly and
smoothly to avoid creating an aerosol.
o Do not move or heat-fi x smears until they have been completely air-
dried
 Mouth pipetting must be strictly prohibited.
 No materials should be placed in the mouth. All labels used in the laboratory
must be self-adhesive.
 The use of needles and syringes should be limited, and they should never be
used as a substitute for pipetting.
 Written documentation that may be removed from the laboratory must be
protected from contamination.
 Standard operating procedure for handling accidents and spills must be
developed and be available in the laboratory.
 Packing and transportation of samples must follow triple packaging technique

iv. Work area


 The laboratory should be divided into “functionally clean” and “potentially
contaminated” areas, with the clean areas reserved for administrative and
preparatory work.
Republic of the Philippines
PROVINCE OF AURORA
AURORA MEMORIAL HOSPITAL
Brgy. Reserva, Baler, Aurora
Email: auroramemhos@gmail.com
PhilHealth Accredited Health Care Provider
 The laboratory should be kept neat, clean and free of materials and
equipment not used for performing routine work.
 A cleaning schedule will be distributed among the laboratory staff to ensure
the cleanliness of all work stations
 Equipment and materials that are not being used or that do not work should
be removed from work areas.
 Laboratory instruments, disinfection and sterilization must be done by the
trained personnel or utility or Lab Aide.
 Strict Hand washing protocol is imposed before and after handling each
patient.
 Work surfaces must be decontaminated (by chlorine or Lysol) after any spill
of potentially infectious material and at the end of each work session.
 Laboratory room and equipment should be properly cleaned and disinfected
before and after use each day.

B. Equipment
i. The microscope should provide regular maintenance, cleaning,
decontamination on other safety

C. laboratory design and facilities


i. ensures there is a separate laboratory’s work area from the public, ensuring
proper waste disposal, and providing hand washing facilities
ii. The laboratory should have adequate ventilation and directional airflow and
ample are space for the safe conduct of laboratory work, and for cleaning and
maintenance.
iii. There should be a reliable and adequate electricity supply
iv. Sputum Collection Area
 should be located outside the laboratory (where aerosols containing TB
bacilli are diluted and sterilized by direct sunlight) and away from the
public.
 Patient should be properly instructed on expectoration which should be
done in an open air with patient facing away from the wind and no one
should be standing in front of him
 Expectorating sputum onto the container should be done carefully to
avoid contamination of the exterior of the container. If contaminated,
Republic of the Philippines
PROVINCE OF AURORA
AURORA MEMORIAL HOSPITAL
Brgy. Reserva, Baler, Aurora
Email: auroramemhos@gmail.com
PhilHealth Accredited Health Care Provider
carefully wipe it off with a piece of paper and dispose the paper with
sputum as infectious waste, then wash hands with soap.]
 Sputum container should be tightly closed to prevent leakage during
transport.

v. Smearing area
 should be done in an open/ well ventilated, well lighted area/room
 no other personnel except the microscopist is allowed inside the
laboratory during smearing /microscopy periods (at all times)
 Formation of aerosols must be avoided as strictly as possible (opening of
the sputum container cap, picking up sputum from the container, sputum
smearing on glass slides and flaming of the wire loop are especially
dangerous).

D. Health surveillance
i. Laboratory staff should have an annual medical examination including CXR.

E. training
i. a well-informed, competent and safety-conscious staff are essential for
preventing laboratory-acquired infections, incidents and accidents
ii. all staff should have safety training; this should include reviewing the code of
practice and the practices and procedures incorporated into the safety manual.
iii. The MT should ensure that staff are oriented/informed for ex. information on
safe practices to be followed to avoid or minimize risks of inhalation, ingestion
and inoculation, information on how to properly decontaminate and dispose of
infectious material
F. Waste handling
i. all infectious materials should be decontaminated using chlorine (diluted to 1:50
or 1:10 in water to obtain final concentrations of 1 g/l or 5 g/l) and prepared to
be buried or autoclaved (if available)
ii. Bleach, either in stock or in solution, must be stored in a well ventilated, dark
area. In good storage conditions, the 50g/l solution may last as long as 3 months;
diluted solutions should be prepared daily.
iii. Use of Discard bags should be used to segregate waste.
iv. 70% alcohols (ethanol or isopropyl) are used on laboratory benches and BSCs for
routine decontamination.
Republic of the Philippines
PROVINCE OF AURORA
AURORA MEMORIAL HOSPITAL
Brgy. Reserva, Baler, Aurora
Email: auroramemhos@gmail.com
PhilHealth Accredited Health Care Provider
v. When hands become contaminated, a rinse with 70% ethanol or isopropyl alcohol
followed by thorough washing with soap and water is effective.

G. Disposal procedures for contaminated materials


i. person in charge of disposal should wear gloves and mask
ii. identify and separate infectious materials and their containers for proper
disposal
iii. Broken slides and used slides must be disposed of in a sharps container.
Containers for sharps disposal must be puncture-proof, have a fitted lid, and
must not be filled to capacity. When they are three quarters full, they should be
placed in containers for infectious waste for proper disposal
iv. Containers for sharps disposal must not be discarded in a landfill unless they have
been incinerated or autoclaved.
v. Used slides must not be reused.
vi. Plastic sputum containers, cartridges used for molecular analysis (e.g. Xpert
MTB/RIF cartridges), and wooden applicator sticks should be removed from the
laboratory in sealed disposal bags and incinerated.
vii. All disposal materials should be buried in the pit provided after sterilization
(preferably once a week).
viii. Cups and slides should be decontaminated with Lysol prior to disposal.
ix. Dispose used cup and slides in a separate receptacle, filled with Lysol and with
cover (receptacle should be properly labeled).

Approved by:

KRIS MADONNA A. ROXAS RIMANDO M.D


PHO-I/Chief of Hospital
Republic of the Philippines
PROVINCE OF AURORA
AURORA MEMORIAL HOSPITAL
Brgy. Reserva, Baler, Aurora
Email: auroramemhos@gmail.com
PhilHealth Accredited Health Care Provider

Policies and Procedures in Assuring the Quality of Xpert MTB


/Rif Assay Results

Quality Assurance is a way of preventing mistakes and avoiding problems in the


delivery of service. A Rapid TB Diagnostic Laboratory (RTDL) must ensure accuracy,
reliability and reproducibility of TB diagnostic services. In order for RTDLs to ensure
quality of Xpert MTB/Rif Assay results the following should be implemented.

1. An Xpert operator must have a training on Xpert MTB/Rif Assay for Implementers

2. In the absence of training, mentoring by regional, provincial or RTDL trainer must


be given to the GX operator.

3. Proper specimen collection must be followed accordingly to produce a quality


specimen

4. At least 1 ml in volume of sputum specimen must be collected either spot collection


or early morning collection

5. Sputum specimen should be collected in specified sputum cups that are properly
labelled and sealed.

6. Processing of specimens must follow the standard procedures set by the National
TB Reference Laboratory (NTRL)

7. Process all specimens as soon as possible

8. Release result within the day if possible or follow the standard turnaround time of
1-2 days.

9. Storage of samples and inoculated cartridges must be followed accordingly.


Storage of specimen:

 Refrigerate at 2–8°C, for 10 days maximum (e.g. TBMS)


 If necessary, at room temperature (up to 35°C) for up to 3 days, and then
refrigerated at 2–8°C, for a combined maximum of 10 days

Storage of specimen in presence of sample reagent:

 Process within 12 hours, kept at 2-8°C degrees. If refrigeration is not possible,


process within 5 hours
Republic of the Philippines
PROVINCE OF AURORA
AURORA MEMORIAL HOSPITAL
Brgy. Reserva, Baler, Aurora
Email: auroramemhos@gmail.com
PhilHealth Accredited Health Care Provider
Storage of inoculated cartridge (eg, in case of power failure):

 Run test within 4 hours from the addition of the sample


 If more than 4 hours has elapsed, inoculate a new cartridge

10. Do not use cartridge if:

 The expiration date has passed


 It appears wet
 Its lid seal appears broken or (accidentally) opened
 It has been dropped or shaken after you added the treated sample
 The reaction tube on the back side appears to be damaged
 It has already been processed: each cartridge is for single-use only, and can not
be reused once scanned
 Its package (pouch of 10 cartridges) has been open for more than 6 weeks

11. Calibration of the Gene Xpert modules must be done annually or after 2000
runs/tests per module. Calibration date must be calculated from the initial
installation date, or based from the Installation Qualification Report (IQR) sent to
Cepheid. If calibration fails, the modules must be exchanged or swapped for new or
refurbished modules from Cepheid. The old modules must be sent back to Cepheid.
Calibration may be done by the GX operator or may be guided/assisted by
engineers from Macare Medicals, Inc

7Approved by:

KRIS MADONNA A. ROXAS RIMANDO M.D


PHO-I/Chief of Hospital

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