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Setting up an immunization clinic-the minimum requirements

(Dr. Gaurav Gupta)

Introduction

Immunization is one of the most cost-effective ways to decrease the disease burden
of the vaccine preventable disease (1). There is a high demand of vaccines
providers in India. You can start an immunization clinic as a part of regular pediatric
OPD or even have a separate immunization clinic, working at specific times/ days.
This chapter summarizes the basics necessities to set up an immunization clinic
under the following headings.

1. Plan workflow and workspace


2. Training of staff for immunization
3. Purchase of vaccine storage equipment
4. Purchase vaccine administration supplies
5. Purchase emergency response supplies
6. Organize other vaccination paperwork and reference materials
7. Order vaccines and stock maintenance
8. Payment methods
9. AEFI reporting
10. Medical Waste Disposal

Conclusion

1. Plan workspace

Designated vaccination space will be needed to vaccinate and to draw and prepare
the vaccine. Along with there should be an adequate waiting area. It should have
proper ventilation, good lightening, drinking water facility, restroom, toys for
distracting children, preferably with lights and sound, magazine and newspaper for
the caregivers and a seating area are recommended (2). Space for the proper
disposal of the sharp needles will be needed near the place of vaccination.
Vaccination area should also have space for placing refrigerator, cupboard for
storing the needles, alcohol wipes, and other essentials like emergency medicines.
An area that can be considered private should be available if clothing needs to be
removed to access immunization site, especially for adolescents. Space for storing
vaccination record will be needed if physical records are kept. A computer could be
used successfully for this purpose, as it helps in decreasing the space requirement
and time needed to store and retrieve the records. Finally, using computerized
records vaccination reminders can be sent easily to patients via calls/ SMS/ emails/
whatsapp messages, to ensure better compliance with appropriate vaccination
schedule. IAP has partnered with Immunize India to setup a free SMS service for this
purpose as well. The reminder service will be available free of cost for parents
across the country and they can opt for the service by sending a text message to the
national code 566778 from any mobile network in India. The parents will receive
immediate confirmation through a text message and will be reminded for 12 years,
the prescribed immunization schedule for their child. A total of three reminders would
be sent, at two-day intervals, for each vaccination due (3).

2. Training of staff for immunization

For your clinic, you should have sufficient staff to handle the personnel registration,
payment collection, vaccination assistant, vaccination administration, and for
handling emergency situations, including security. Staff should be polite and
conversant with the local language. You should orient your staff regarding the basic
training in overall need, purpose, and flow of vaccination clinic. Each staff should
understand their responsibilities clearly. Cross-train staff members, it would help in
handling the situation of absenteeism of any staff, and meeting the fluctuating
demands of your clinic. Take care of the staff by providing adequate rest breaks and
snacks in a designated area (4). Counsel the staff regarding the importance of cold
chain, so that they do not open the refrigerator unnecessarily and for long durations.

3. Purchase of vaccine storage equipments

Inadequate storage of immunological can leads to loss of potency, therefore it is


important to maintain the cold storage chain. This is the collective responsibility of all
the staff. Package inserts in the vaccine have the instruction for storage,
reconstitution, and administration. Proper care should be taken to inspect the quality
of vaccine at the time of delivery, storage, and administration.

Vaccines need to be stored at refrigerator should be stored at (2°C–8°C). Freezing


temperature could lead to the loss in potency vaccines contain aluminum as an
adjuvant. Exposure to a higher temperature for live, attenuated virus vaccines (that
needs to be stored at freezing temperature) could lead to the loss of potency.

A dedicated refrigerator cum freezer will be needed to store the vaccine. This
refrigerator should be used only for storing the biological and pharmaceuticals. Care
should be taken to avoid the frequent opening, to avoid the temperature to go out of
the desired range. While purchasing the refrigerator care should be taken to
purchase the unit with a double door. Single door refrigerators are generally not able
to maintain the temperature. A good quality thermometer will be needed to keep
track on the temperature in refrigerator and freezer. A dial thermometer is
recommended and the temperature should be taken at least twice a day. Continuous
monitoring thermometers with alarms are preferred. For more details refer to the
chapter on “Cold Chain and Storage of Vaccines” in this guidebook.

Ice Lined Refrigerator (ILR)

ILR operates on electricity, it has specifically microprocessor for controlling


temperature designed evaporator and condenser to provide maximum refrigeration.
It can maintain the temperature up to 16 hours without power (5). They are ideal for
vaccine storage, but are more expensive than domestic refrigerators, costing Rs
75,000 (seventy five thousand) or more.
Figure 1: Recommendation for storing vaccines in ILR

4. Purchase vaccine administration supplies

Vaccine administration supplies should compose of sufficient stock of syringes,


needles, and sharp disposal containers. You should maintain a stock register of
administration supply to place the order on time. Other than this you should
purchase medical waste disposal services for the safe disposal of used needles and
syringes.

5. Purchase emergency response supplies

Administration of vaccine could lead to an anaphylactic reaction in extremely rare


cases. To handle such situation you should have sufficient facilitates along with
training. An anaphylaxis pack, containing two adrenaline (epinephrine) 1:1000
ampoules, four 23G needles and four 1ml syringes, and Cardiopulmonary
Resuscitation (CPR) mask suitable for children and adults (6). This should be
checked regularly to confirm that the contents expiry.

Hydrocortisone and chlorpheniramine are not the first line drugs; however, these
drugs could be used in the further management of anaphylaxis by trained staff.
Hydrocortisone should only be given after a severe anaphylactic attack to prevent
any late symptoms (7).

If further skills and equipment are available, patients ECG and pulse oximetry should
be done. Blood pressure should be measured regularly (7). It is preferable to have
oxygen supplies in the premises as well for managing severe anaphylactic reactions.
For standalone outpatient (OPD) clinics, a tie up with a nearby hospital is essential
for possible transport of a sick child that requires admission.

6. Organize other vaccination paperwork and reference materials

Reference material includes the vaccination screening questionnaire, vaccine


information leaflets for patients, proof of vaccination in the form of immunization
record card, logs for refrigerator temperature, adverse event following immunization
(AEFI), and others. The latest IAP schedule should be available, and displayed
prominently in the clinic for the parent’s benefit.

7. Order vaccines and stock maintenance

You should have someone who will be responsible for ordering vaccine, maintaining
vaccine stock register, and storing the vaccine after the receipt from the vendor.
Vaccines have known shelf lives, are expensive, and fragile, therefore they need to
be ordered in last after your clinic is setup. Always order vaccines from an
authorized distributor of the company, as this will ensure proper documentation in
case of any rare side-effects from any vaccine. Vaccines can be ordered as per the
need of the clinic, either daily or weekly. Vaccines should be stored in the fridge
immediately after delivery without breaking the cold chain. Delivery should be
checked for any leakage or breakage. A stock register should be maintained to keep
a track of the expiring vaccine. A policy of FIFO (First In, First Out) should be
followed so that the vaccines with shorter expiry are consumed first. A proper
inventory will ensure adequate stock of all vaccine all the time in the clinic.

A sufficient stock of vaccines in form of combination and monovalent vaccines


needed to vaccinate the children and adults against all vaccine preventable diseases
should be maintained (8, 9). Only the products in demand need to be stored, it helps
in eliminating the chances of error due to confusion; reducing the wastage of
vaccines in less demand; reducing the need of cold storage space; and reduce the
cost of administrative accounting, purchasing, and handling (10).
8. Payment methods

You should try to accept all possible methods of payment including cash, credit card,
debit card, and e-payments via net banking or e-wallets. Insurance providers help in
cashless immunization if you have tied up with the insurance providers that will be an
additional advantage for the customers who are insured.

9. AEFI reporting

An adverse event following immunization (AEFI) defined as “any untoward medical


occurrence which follows immunization and which does not necessarily have a
causal relationship with the usage of the vaccine”(11). Serious AEFIs (including
death, disability, cluster, and hospitalization) should be reported immediately.
Pediatricians involved in private practice in rural areas should reports the serious
AEFIs immediately to the medical officer of the nearest primary health center. In
urban areas, you could report the serious AEFI to the District Immunization Officer
(DIO) (12). ‘First Information Report’ (FIR) form should be used by a private
practitioner for reporting of the serious AEFI to the medical officers.

Vaccine-like any other biological and pharmaceutical know to have certain


associated side effects. Vaccine providers expected to know about the vaccine
contraindications, side effects along with the benefits of vaccines. He should inform
the receiver about these side effects along with the benefits. Caregivers should be
informed to report any adverse event after vaccination to the doctor. For more
information on AEFI, refer to the chapter on Adverse Effect following Immunization,
elsewhere in this guidebook.

10. Waste disposal

Waste disposal including used syringes, needles, damaged vials, and other
biological waste at the immunization site should be disposed of according to
recommended guideline (13). In India, Central Pollution Control Board (CPCB)
guideline for biomedical waste disposal should be followed for the disposal of
immunization waste. Improper disposal could harm the injection recipient, health
care providers, and the community. It could lead to spread of life-threatening
infections like HIV/AIDS, Hepatitis B and C, and others (14).
Needle caps and wrappers should be disposed of in the black color bag. This bag
could be disposed of as municipal waste. Syringes plastic part and unbroken empty
vials should be disposed of in the red color bag. Content needs to be disinfected
before sending for recycling. Broken vials, ampules, and AD syringes should be
disposed of in safety pits post disinfection treatment (15).

Nowadays, specialized medical waste disposal agencies provide you with the bags,
chemicals, and recording sheets needed to dispose of the vaccination related
consummables. Ensure that your staff takes all precautions and follows instructions
as specified by the waste disposal company.

Figure 2: Disposal of immunization waste

Conclusion: Congratulations! If you have read so far, and follow these


recommendations, you are doing great! If more settings like yours did this
preparation and planning, we would see many fewer missed vaccinations, and
higher coverage rates for vaccinations. We would eventually see less preventable
disease and death. It really does happen one clinic at a time and one vaccination at
a time. (2)

Acknowledgement: Rajiv Ahlawat, NIPER for helping prepare the manuscript.


References

1. WHO, UNICEF, World Bank. State of World Vaccines and Immunizaion. 3rd
Ed, Geneva: World Health Organization; 2009.

2. Step 2: Setting Up for Vaccination Services. Adults Only Vaccination: A Step-


by-Step Guide. Immunization Action Coalition. [cited 2016 Dec 26]; Available from:
http://www.immunize.org/guide/aov03_setup.pdf.

3. Immunize India. The Indian Academy of Pediatrics. [cited 2016 Dec 30];
Available from: http://www.immunizeindia.org/.

4. CDC. Guidelines for Large-Scale Influenza Vaccination Clinic Planning.


Centers for Disease Control and Prevention. [cited 2016 Dec 27]; Available from:
https://www.cdc.gov/flu/professionals/vaccination/vax_clinic.htm.

5. WHO. Category E003 Refrigerators and freezers for storing vaccines and
freezing waterpacks. World Health Organization [cited 2016 Dec 28]; Available from:
http://apps.who.int/immunization_standards/vaccine_quality/pqs_catalogue/category
page.aspx?id_cat=17.

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immunisation. Green Book Chapter 8 v4_0. 2012 [cited 2016 Dec 27]; Available
from:
https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/14786
8/Green-Book-Chapter-8-v4_0.pdf.

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providers. Resuscitation Council (UK). [cited 2016 Dec 27]; Available from:
https://www.resus.org.uk/anaphylaxis/emergency-treatment-of-anaphylactic-
reactions/.

8. CDC. Recommended immunization schedules for persons aged 0 through 18


years---United States, 2011. MMWR 2011;60(5).

9. CDC. Recommended adult immunization schedule---United States, 2011.


MMWR 2011;60(4).
10. General recommendations on immunization --- recommendations of the
Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep.
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11. Adverse events following immunization (AEFI). World Health Organization.


Vaccine safety basics. e-learning course. [cited 2016 Dec 26]; Available from:
http://vaccine-safety-training.org/classification-of-aefis.html.

12. Chitkara AJ, Thacker N, Vashishtha VM, Bansal CP, Gupta SG. Adverse
event following immunization (AEFI) surveillance in India, position paper of Indian
Academy of Pediatrics,2013. Indian Pediatr. 2013;50(8):739-41.

13. Immunization hanbook for health workers. Ministry of health and family
welfare. Governemnt of India. 2011 [cited 2016 Dec 27]; Available from:
http://www.pbhealth.gov.in/Immunization/Immunization_Handbook.pdf.

14. Universal Immunization Program. Immunization division at MoHFW. [cited


2016 Dec 26]; Available from:
http://www.mohfw.nic.in/WriteReadData/l892s/5628564789562315.pdf.

15. Immunization Handbook for Medical Officers. Department of Health and


Family Welfare, Government of India. 2008 [cited 2016 Dec 26]; Available from:
http://www.nihfw.org/pdf/NCHRC-Publications/ImmuniHandbook.pdf.

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