Wednesday, August 12, 2009

Guidelines for diagnostic laboratories: Swine Flu Testing

Guidelines for diagnostic laboratories pertaining to requirements of infrastructure for testing of specimens for Pandemic Influenza A (H1N1) virus infection (based on CDC/WHO guidelines1)

General Bio-safety measures: Gloves (latex), shoe cover, head cover, goggles, triple layered mask, mask with N-95 specification, front closed full length apron, puncture resistant autoclavable yellow coloured bio-safety bag with bio-safety symbols, hypochlorite solution. (As per bio-safety manual attached as Document 2).

Civil Infrastructure: Separate dedicated areas for sample handling and PCR testing as per recommended guidelines (Document 3).

Sample collection kit: Throat/Nasal swab with synthetic up (polyester or Dacron) and aluminium or plastic shaft sample collection vials or tubes (leak proof and autoclavable) containing 1-3 ml. virus transport media (with protein stabilizer and antibiotics) as primary container.

Sample storage: Refrigerator (4-80 C) for storage up to 48 hrs. Deep freeze (-700C) for longer storage.

Back up sample for future testing etc. should be kept at -700 C.


Sample Transport: Absorbent cotton, tissue paper or waste newspaper for wrapping primary container. Secondary container to hold the primary container i.e. bigger tube or sealed plastic bag. Insulated ice box with ice pack, sample proforma fastened on to the secondary container.

Sample handling and testing:

Handling: In BSL-3 Bio-safety or BSL-2+ facility with BSL-3 precautions.

Testing: Real time RT-PCR test, by Real Time PCR machine using validated reagents accessories and protocol as per CDC/WHO guidelines/testing protocols3 and subsequent amendments published from time to time.

Reporting of Results: Standardized uniform reporting proforma. PC with internet facilities, fax machine.

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1. http://www.cdc.gov/swineflu/specimen collection.htm
2. http://www.who.int/csr/resources/publications/biosafety/ WHO¬¬¬_CDS_ CSR_LYO_2004_ 11/en/
3 .http://ww.who.int/csr/resources/publications/swineflu/realtimeptpcr/en/index.html dated 28th April 2009 and 30th April,2009

Tuesday, August 11, 2009

Press release from Jan Arogya Abhiyan on Swine Flu

Lack of clear-cut swine flu guidelines, to citizens and private doctors, by Municipal Corporation and health officials resulted in unnecessarily long queues in Naidu Hospital. Moreover a lot of confusion continues amongst lay people and doctors about specific steps to be taken.

There are two criteria for throat swab collection and its testing at National Institute of Virology (NIV) and those are: only those patients with cough, cold, fever who had been a) to foreign countries in last eight days or b) in contact with swine flu patients. However this was not made sufficiently clear through newspaper, radio and TV by Municipal Authorities leading to overcrowding at Naidu Hospital.

Even persons not fitting in above two criteria are also getting swine flu infection. Hence there is need to change these criteria and new ones should be properly publicized through media. Even today, there is no clear guideline for private practitioners and doctors. On the contrary on 6th August, government issued a threat of registration cancellation to doctors, through newspaper if they did not take proper care of patients, without making it clear what does it mean to take proper care!

Municipal Corporation printed more than one lakh information pamphlets. But it contains some incomplete and faulty instructions. E.g. ‘wash hands continuously’, ‘avoid congested places’. What does it mean to citizens? Some instructions have been taken from ‘Centre for Disease Control’,USA website. However CDC website says keep 6 feet distance from swine flu patient, PMC pamphlet says only 3 feet! Despite conveying these corrections to concerned health officials, there is no response from them.

No clear publicized information is provided to public and doctors on why only Naidu Hospital is collecting samples and only NIV is testing them, why only Naidu Hospital is providing required medicines.

Directorate of Maharashtra Health services has issued impracticable and vague instructions to doctors in today’s Indian Express.

Jan Arogya Abhiyan demands an immediate end to this indifference by Municipal and Health authorities. There is need to issue proper, scientific instructions for public and doctors through all newspapers and display them frequently on all television, radio channels.

Who one should visit doctors and when? When to directly approach Naidu Hospital and other 15 screening centres? What kind of congested places should be avoided? Who is at greater risk of infection? Who should use mask? What is exact meaning of ‘contact with swine flu patient’? Does it mean spending whole day with such patient or just brief time? Is it necessary to sterilize entire class or office if there is any swine flu patient? People should get proper scientific and specific answers to all such questions.

Private medical practitioners and civil society experts should be consulted while preparing guidelines for public and doctors.

Sunday, August 9, 2009

Swine Flu update: Revised Guidelines from Health Minstry

Revised Guidelines for testing of persons with flu like symptoms reporting at hospitals notified for influenza H1N1

So far, the present guidelines stipulate that a person suspected of influenza A H1N1 need to be referred to an identified govt. health facility. He/she needs to be kept in an isolation facility in that hospital and if found positive, is treated accordingly.
In order to make the testing facility for H1N1 more accessible at large and due to the onset of the Influenza season in the country, it has been decided to revise the existing guidelines.
Under the new guidelines, any person with flu like symptoms such as fever, cough, sore throat, cold, running nose etc. should go to a designated Government facility for giving his/her sample for testing for the H1N1 virus. After clinical assessment, the designated medical officer would decide on the need for testing. Except for cases that are severe, the patient would be allowed to go home (This was not allowed under the existing guidelines).
The sample of the suspect case would be collected and sent to the notified laboratory for testing. If tested as positive for H1N1 and in case the symptoms are mild, the patient would be informed and given the option of admission into the hospital or isolation and treatment at his own home.
In case the patient opts for home isolation and treatment, he/she would be provided with detailed guidelines / safety measures to be strictly adhered to by the entire household of the patient. He/ she would have to provide full contact details of his entire household. The house hold and social contacts would be provided with the preventive treatment.
Notwithstanding the above guidelines, the decision of the doctor of the notified hospital about admitting the patient would be final.

In case the test is negative, the patient will accordingly be informed.
These guidelines have been issued by the Government in public interest and shall be reviewed from time to time depending on the spread of the pandemic and its severity in the country. These guidelines would however not apply to passengers who are identified through screening at the points of entry. The existing policy of isolating passengers with flu like symptoms would continue.

Swine Flu Scenario in Pune

The number of death victims associated to Swine Flu has touched 6(it was 5 when I started typing this) and the scare is quite palpable amongst the citizens of Pune. I have been carefully observing the developments in the last couple of days and wanted to register some of my thoughts on this issue.

First and foremost of the concerns is that it has been more than a week and the government is yet to come with the defined protocol to follow while dealing with Swine Flu. It is understandable in a situation like this, the government cannot work with some pre-set guidelines and needs to condition their strategy and evolve different protocols as the situation demands.

Just the day after the first victim had died, the government attributed it to not approaching the designated health care facilities in time and losing valuable time by consulting the private medical practitioners. In-fact, one of the health department official(I think it is the health minister of Maharashtra) went as far as telling that licensing of the private doctors will be cancelled if they treat someone showing swine flu symptoms.

Just a day or two after that, government is suggesting that private doctors needs to treat them and should not send them away. The ambiguity and dilemma in defining the strategy to deal with how situation evolve is understandable. But should not they deal with some forethought. I mean if within a couple of days, one imagines a scenario of engaging private medical professional in handling the crisis, what is the need to take such an aggressive posture.

And the information also seems going back and forth on all the issues associated, like administering Tamiflu to suspected individuals and everything. The teacher who lost his life in pune was asked to go back and told that he is not a possible suspect by the same government doctors when he has approached them. Such cases are in the rise, so the diagnosing doctors decision whether to send the sample for testing or not is still very ambiguous.

Even for simple things like procuring the masks to protect against the virus, the special protection masks, which are not so easily available at-least needs to be made available to the high risk people such as the pregnant women or other ailing people who are more risk prone and are under medical care and more susceptible to medical infection.

Also with the number of death counts increasing, it is a issue of serious concern, whether the government has any strategy on how intensive and critical care departments will cope with high patient numbers.

It is not just enough to request people not to panic, without making adequate actions that would make them feel confident of the situation.

As regards to spreading the awareness and establishing the proper information to communicate, the fundamental issue as stated in the earlier paras are to establish and define, clearly what needs to be communicated.

One of the doctors on TV, suggested that information spread through radio does not seem to be happening at all, I think all media tools like SMS, FM radio channels all need to be channelized for the information spread. Fortunately it is reported that the spread of the Flu is not large in rural areas, in the event of such a spread, the information spread through Radio needs to be effectively used.

I will keep posting on whatever that in the course of time thoughts I have on this issue that needs to be shared with.

Tuesday, June 9, 2009

Dame Cicely Saunders, founder of the modern hospice movement

“When you arrive in the world you are guided in, looked after and physically held by an expert, a midwife. This is a person who is a specially trained multi-tasker who can ensure that a new life begins in the safest, most positive way possible,” she says. “But there is no equivalent person to gently lead you out of the world, to hold you when you are departing and to make you feel safe when you cross over from life into death.”

Link to write-up in The Hindu on hospice care