Its the monsoon season again and the water seems to be pouring down in Delhi.
The water gives rise to a lot of diseases and the current epidemic to hit Delhi is viral and allergic conjunctivitis.
Without getting into the details,
the best course of preventive as well as treatment course is to use good antibiotic eye drops which are available OTC (Over the counter) such as Festive or Ciplox.
Put them in 2 times a day and be SAFE.
Dr Harkeerat
Saturday, August 21, 2010
Gastric Bypass
Gastric bypass
Gastric bypass surgery makes the stomach smaller and allows food to bypass part of the small intestine. You will feel full more quickly than when your stomach was its original size, which reduces the amount of food you eat and thus the calories consumed. Bypassing part of the intestine also results in fewer calories being absorbed. This leads to weight loss.
The most common gastric bypass surgery is a Roux-en-Y gastric bypass.
In normal digestion, food passes through the stomach and enters the small intestine , where most of the nutrients and calories are absorbed. It then passes into the large intestine (colon), and the remaining waste is eventually excreted.
In a Roux-en-Y gastric bypass, the stomach is made smaller by creating a small pouch at the top of the stomach using surgical staples or a plastic band. The smaller stomach is connected directly to the middle portion of the small intestine (jejunum), bypassing the rest of the stomach and the upper portion of the small intestine (duodenum).
This procedure can be done by making a large incision in the abdomen (an open procedure) or by making a small incision and using small instruments and a camera to guide the surgery (laparoscopic approach).
See a picture of a Roux-en-Y gastric bypass .
What To Expect After Surgery
Most people can return to their normal activities in 3 to 5 weeks.
After surgery, you'll need to make big, permanent changes in how you eat:
* You can eat only a few ounces of food at a time. Your new stomach will only hold a tiny amount of food.
* You must eat very slowly and chew your food to mush. Otherwise, you may vomit often and have pain.
* You won't be able to drink for 30 minutes before you eat, during your meal, and for 30 minutes after you eat. There won't be room in your stomach for both drinks and solid food.
* You probably will need to take vitamins and supplements.
* You may have to avoid foods that contain simple sugars-like candy, juices, ice cream, condiments, and soft drinks. Simple sugars may cause a problem called dumping syndrome. This happens because food moves too quickly through the stomach and intestines. It can cause shaking, sweating, dizziness, rapid heart rate, and often severe diarrhea.
Why It Is Done
Although guidelines vary, surgery is generally considered when your body mass index is 40 or higher or you have a life-threatening or disabling condition related to your weight.
Your doctor may only consider doing gastric bypass surgery if you have not been able to lose weight with other treatments.
The following conditions may also be required or are at least considered:
* You have been obese for at least 5 years.
* You do not have an ongoing problem with alcohol.
* You do not have untreated depression or another major psychiatric disorder.
* You are between 18 and 65 years of age.
All surgeries have risk. And it is important for you and your doctor to discuss your treatment options to decide what is best for you.
How Well It Works
Most people who have gastric bypass surgery quickly begin to lose weight and continue to lose weight for up to 12 months. One study noted that people lost about one-third of their excess weight (the weight above what is considered healthy) in 1 to 4 years. Some of the lost weight may be regained.
The laparoscopic approach showed similar results, with 69% to 82% of excess weight lost over 12 to 54 months.
Risks
Risks common to all surgeries for weight loss include an infection in the incision, a leak from the stomach into the abdominal cavity or where the intestine is connected (resulting in an infection called peritonitis), and a blood clot in the lung (pulmonary embolism). About one-third of all people having surgery for obesity develop gallstones or a nutritional deficiency condition such as anemia or osteoporosis.
Fewer than 10 out of 1000 people die after weight-loss surgery.
After a Roux-en-Y gastric bypass:
* An iron and vitamin B12 deficiency occurs more than 30% of the time. About 50% of those with an iron deficiency develop anemia.
* The connection between the stomach and the intestines narrows (stomal stenosis) 5% to 15% of the time, leading to nausea and vomiting after eating.
* Ulcers develop 5% to 15% of the time.
* The staples may pull loose.
* Hernia may develop.
* The bypassed stomach may enlarge, resulting in hiccups and bloating.
What To Think About
Gastric bypass surgery may increase your chances of living longer. Some studies show that people who have weight-loss surgery have a smaller chance of dying of heart problems, diabetes, or cancer.
In a gastric bypass, the part of the intestine where many minerals and vitamins are most easily absorbed is bypassed. Because of this, you may have a deficiency in iron, calcium, magnesium, or vitamins. This can lead to long-term problems, such as osteoporosis. To prevent vitamin and mineral deficiencies, you may need to work with a dietitian to plan meals, and you may need to take extra vitamin B12 as pills, shots, or nasal spray.
There is also a possibility that you may develop gallstones after gastric bypass. Sometimes the gallbladder is removed as part of the surgery. But if your gallbladder is not removed, then you may need to take medicine to prevent gallstones.
Early studies of the laparoscopic approach to surgery for obesity suggest that it reduces recovery time and postsurgery complications.
Gastric bypass surgery makes the stomach smaller and allows food to bypass part of the small intestine. You will feel full more quickly than when your stomach was its original size, which reduces the amount of food you eat and thus the calories consumed. Bypassing part of the intestine also results in fewer calories being absorbed. This leads to weight loss.
The most common gastric bypass surgery is a Roux-en-Y gastric bypass.
In normal digestion, food passes through the stomach and enters the small intestine , where most of the nutrients and calories are absorbed. It then passes into the large intestine (colon), and the remaining waste is eventually excreted.
In a Roux-en-Y gastric bypass, the stomach is made smaller by creating a small pouch at the top of the stomach using surgical staples or a plastic band. The smaller stomach is connected directly to the middle portion of the small intestine (jejunum), bypassing the rest of the stomach and the upper portion of the small intestine (duodenum).
This procedure can be done by making a large incision in the abdomen (an open procedure) or by making a small incision and using small instruments and a camera to guide the surgery (laparoscopic approach).
See a picture of a Roux-en-Y gastric bypass .
What To Expect After Surgery
Most people can return to their normal activities in 3 to 5 weeks.
After surgery, you'll need to make big, permanent changes in how you eat:
* You can eat only a few ounces of food at a time. Your new stomach will only hold a tiny amount of food.
* You must eat very slowly and chew your food to mush. Otherwise, you may vomit often and have pain.
* You won't be able to drink for 30 minutes before you eat, during your meal, and for 30 minutes after you eat. There won't be room in your stomach for both drinks and solid food.
* You probably will need to take vitamins and supplements.
* You may have to avoid foods that contain simple sugars-like candy, juices, ice cream, condiments, and soft drinks. Simple sugars may cause a problem called dumping syndrome. This happens because food moves too quickly through the stomach and intestines. It can cause shaking, sweating, dizziness, rapid heart rate, and often severe diarrhea.
Why It Is Done
Although guidelines vary, surgery is generally considered when your body mass index is 40 or higher or you have a life-threatening or disabling condition related to your weight.
Your doctor may only consider doing gastric bypass surgery if you have not been able to lose weight with other treatments.
The following conditions may also be required or are at least considered:
* You have been obese for at least 5 years.
* You do not have an ongoing problem with alcohol.
* You do not have untreated depression or another major psychiatric disorder.
* You are between 18 and 65 years of age.
All surgeries have risk. And it is important for you and your doctor to discuss your treatment options to decide what is best for you.
How Well It Works
Most people who have gastric bypass surgery quickly begin to lose weight and continue to lose weight for up to 12 months. One study noted that people lost about one-third of their excess weight (the weight above what is considered healthy) in 1 to 4 years. Some of the lost weight may be regained.
The laparoscopic approach showed similar results, with 69% to 82% of excess weight lost over 12 to 54 months.
Risks
Risks common to all surgeries for weight loss include an infection in the incision, a leak from the stomach into the abdominal cavity or where the intestine is connected (resulting in an infection called peritonitis), and a blood clot in the lung (pulmonary embolism). About one-third of all people having surgery for obesity develop gallstones or a nutritional deficiency condition such as anemia or osteoporosis.
Fewer than 10 out of 1000 people die after weight-loss surgery.
After a Roux-en-Y gastric bypass:
* An iron and vitamin B12 deficiency occurs more than 30% of the time. About 50% of those with an iron deficiency develop anemia.
* The connection between the stomach and the intestines narrows (stomal stenosis) 5% to 15% of the time, leading to nausea and vomiting after eating.
* Ulcers develop 5% to 15% of the time.
* The staples may pull loose.
* Hernia may develop.
* The bypassed stomach may enlarge, resulting in hiccups and bloating.
What To Think About
Gastric bypass surgery may increase your chances of living longer. Some studies show that people who have weight-loss surgery have a smaller chance of dying of heart problems, diabetes, or cancer.
In a gastric bypass, the part of the intestine where many minerals and vitamins are most easily absorbed is bypassed. Because of this, you may have a deficiency in iron, calcium, magnesium, or vitamins. This can lead to long-term problems, such as osteoporosis. To prevent vitamin and mineral deficiencies, you may need to work with a dietitian to plan meals, and you may need to take extra vitamin B12 as pills, shots, or nasal spray.
There is also a possibility that you may develop gallstones after gastric bypass. Sometimes the gallbladder is removed as part of the surgery. But if your gallbladder is not removed, then you may need to take medicine to prevent gallstones.
Early studies of the laparoscopic approach to surgery for obesity suggest that it reduces recovery time and postsurgery complications.
Tuesday, February 9, 2010
Objective Structured Clinical Examination (OSCE) (PLAB PART 2)
Objective Structured Clinical Examination (OSCE) (PLAB PART 2)
PLAB part 2
Centre is now only GMC centre london with a capacity of 13000 exams a year!!
The aim of the OSCE is to test your clinical and communication skills. It is designed so that an examiner can observe you putting these skills into practice.
Overall nature of Exam
When you enter the examination room, you will find a series of booths, known as 'stations'. Each station requires you to undertake a particular task. Some tasks will involve talking to or examining patients, some will involve demonstrating a procedure on an anatomical model. Details of the tasks are explained below under 'Content'.
There will also be two rest stations in the circuit. Sometimes these stations will contain instructions asking you to read or write something about the station you are about to go to or the station you have just left. If there are no instructions, you should remain quietly in the booth until the bell rings signalling the end of that station.
You will be required to perform all tasks. You will be told the number of the station at which you should begin when you enter the examination room. Each task will last five minutes.
Your instructions will be posted outside the station. You should read these instructions carefully to ensure that you follow them exactly. An example might be:
'Mr McKenzie has been referred to you in a rheumatology clinic because he has joint pains. Please take a short history to establish supportive evidence for a differential diagnosis.'
A bell will ring. You may then enter the station. There will be an examiner in each station. However, unlike in the oral examination, you will not be required to have a conversation with the examiner; you should only direct your remarks to him or her if the instructions specifically ask you to do so. You should undertake the task as instructed. A bell will ring after four minutes 30 seconds to warn you that you are nearly out of time. Another bell will ring when the five minutes are up. At this point, you must stop immediately and go and wait outside the next station. If you finish before the end, you must wait inside the station but you should not speak to the examiner or to the patient during this time.
You will wait outside the next station for one minute. During this time you should read the instructions for the task in this station. After one minute a bell will ring. You should then enter the station and undertake the task as instructed.
You should continue in this way until you have completed all the tasks. You will then have finished the OSCE.
Content of the stations
Each station consists of a scenario. An examiner will be present and will observe you at work.
The scenario could be drawn from any medical specialty appropriate to a Senior House Officer (SHO).
Although the tasks you will be instructed to do will involve a number of skills, one skill will predominate.
The skills to be tested are set out below. They will not necessarily be tested in the order given here. Under each skill area you will find some examples. Please note that these are only examples; other topics will be tested.
History taking
Your candidate instructions will set the scene. You will be asked to take a history from an actor pretending to be a patient (a simulated patient). The actor will have been given all the necessary information to be able to answer your questions accurately. You should treat him or her just as you would a real patient.
Examples: abdominal pains, rectal bleeding, amenorrhoea, severe headache, pneumonia
Examination skills
You will be asked to examine a particular part of the body. You may have to examine a simulated or real patient or perform the examination on an anatomical model. Although you should talk to the patient or model as you would to a patient in real life, you should only take a history or give a diagnosis if the instructions require you to do so. You may be asked to explain your actions to the examiner as you go along.
Examples: breast examination, cardiovascular examination, examination of abdomen, hip examination, knee examination
Practical skills/use of equipment
This is to assess some of the practical skills an SHO needs. The stations concerned will normally involve anatomical models rather than patients.
Examples: IV cannulation, cervical smear, suturing, blood pressure
Emergency management
These stations will test whether you know what to do in an emergency situation. You may have to explain what you are doing to the patient or to the examiner. Your instructions will make this clear.
Examples: resuscitation, chest pain, trauma
Communication skills
There will be a communication skills element in most stations. However, in some stations this skill will be the principal skill tested. Areas tested may include interviewing (including appropriate questioning, active listening, explaining clearly, checking understanding) and building rapport (including showing empathy and respect, sensitivity to others' emotions and coping with strong emotions in others).
Examples: instructions for discharge from hospital, explaining treatment, consent for autopsy, ectopic pregnancy explanation
PLAB part 2
Centre is now only GMC centre london with a capacity of 13000 exams a year!!
The aim of the OSCE is to test your clinical and communication skills. It is designed so that an examiner can observe you putting these skills into practice.
Overall nature of Exam
When you enter the examination room, you will find a series of booths, known as 'stations'. Each station requires you to undertake a particular task. Some tasks will involve talking to or examining patients, some will involve demonstrating a procedure on an anatomical model. Details of the tasks are explained below under 'Content'.
There will also be two rest stations in the circuit. Sometimes these stations will contain instructions asking you to read or write something about the station you are about to go to or the station you have just left. If there are no instructions, you should remain quietly in the booth until the bell rings signalling the end of that station.
You will be required to perform all tasks. You will be told the number of the station at which you should begin when you enter the examination room. Each task will last five minutes.
Your instructions will be posted outside the station. You should read these instructions carefully to ensure that you follow them exactly. An example might be:
'Mr McKenzie has been referred to you in a rheumatology clinic because he has joint pains. Please take a short history to establish supportive evidence for a differential diagnosis.'
A bell will ring. You may then enter the station. There will be an examiner in each station. However, unlike in the oral examination, you will not be required to have a conversation with the examiner; you should only direct your remarks to him or her if the instructions specifically ask you to do so. You should undertake the task as instructed. A bell will ring after four minutes 30 seconds to warn you that you are nearly out of time. Another bell will ring when the five minutes are up. At this point, you must stop immediately and go and wait outside the next station. If you finish before the end, you must wait inside the station but you should not speak to the examiner or to the patient during this time.
You will wait outside the next station for one minute. During this time you should read the instructions for the task in this station. After one minute a bell will ring. You should then enter the station and undertake the task as instructed.
You should continue in this way until you have completed all the tasks. You will then have finished the OSCE.
Content of the stations
Each station consists of a scenario. An examiner will be present and will observe you at work.
The scenario could be drawn from any medical specialty appropriate to a Senior House Officer (SHO).
Although the tasks you will be instructed to do will involve a number of skills, one skill will predominate.
The skills to be tested are set out below. They will not necessarily be tested in the order given here. Under each skill area you will find some examples. Please note that these are only examples; other topics will be tested.
History taking
Your candidate instructions will set the scene. You will be asked to take a history from an actor pretending to be a patient (a simulated patient). The actor will have been given all the necessary information to be able to answer your questions accurately. You should treat him or her just as you would a real patient.
Examples: abdominal pains, rectal bleeding, amenorrhoea, severe headache, pneumonia
Examination skills
You will be asked to examine a particular part of the body. You may have to examine a simulated or real patient or perform the examination on an anatomical model. Although you should talk to the patient or model as you would to a patient in real life, you should only take a history or give a diagnosis if the instructions require you to do so. You may be asked to explain your actions to the examiner as you go along.
Examples: breast examination, cardiovascular examination, examination of abdomen, hip examination, knee examination
Practical skills/use of equipment
This is to assess some of the practical skills an SHO needs. The stations concerned will normally involve anatomical models rather than patients.
Examples: IV cannulation, cervical smear, suturing, blood pressure
Emergency management
These stations will test whether you know what to do in an emergency situation. You may have to explain what you are doing to the patient or to the examiner. Your instructions will make this clear.
Examples: resuscitation, chest pain, trauma
Communication skills
There will be a communication skills element in most stations. However, in some stations this skill will be the principal skill tested. Areas tested may include interviewing (including appropriate questioning, active listening, explaining clearly, checking understanding) and building rapport (including showing empathy and respect, sensitivity to others' emotions and coping with strong emotions in others).
Examples: instructions for discharge from hospital, explaining treatment, consent for autopsy, ectopic pregnancy explanation
Professional and Linguistic assessment exam (PLAB)
PLAB test details for overseas doctors
Professional and Linguistic assessment exam (PLAB)
More Details about PLAB part 1 examination
Skills of PLAB part 1 test.
Four groups of skills will be tested in approximately equal proportions:
a. Diagnosis: Given the important facts about a patient (such as age, sex, nature of presenting symptoms, duration of symptoms) you are asked to select the most likely diagnosis from a range of possibilities.
b. Investigations: This may refer to the selection or the interpretation of diagnostic tests. Given the important facts about a patient, you will be asked to select the investigation which is most likely to provide the key to the diagnosis. Alternatively, you may be given the findings of investigations and asked to relate these to a patient's condition or to choose the most appropriate next course of action.
c. Management : Given the important facts about a patient's condition, you will be asked to choose from a range of possibilities the most suitable course of treatment. In the case of medical treatments you will be asked to choose the correct drug therapy and will be expected to know about side effects.
d. Others: These may include:
i. Explanation of disease process: The natural history of disease will be tested with reference to basic physiology and pathology.
ii. Legal/ethical : You are expected to know the major legal and ethical principles set out in the GMC publication Duties of a Doctor.
iii. Practice of evidence based medicine: Questions on diagnosis, investigations and management may draw upon recent evidence published in peer-reviewed journals. In addition, there may be questions on the principles and practice of evidence-based medicine.
iv. Understanding of epidemiology: You may be tested on the principles of epidemiology, and on the prevalence of important diseases in the UK.
v. Health promotion: The prevention of disease through health promotion and knowledge of risk factors.
vi. Awareness of multicultural society: You may be tested on your appreciation of the impact on the practice of medicine of the health beliefs and cultural values of the major cultural groups represented in the UK population.
vii. Application of scientific understanding to medicine
Content of part 1 of PLAB exam (new format since 2004 September)
The content to be tested is, for the most part, defined in terms of patient presentations. Where appropriate, the presentation may be either acute or chronic. Questions in Part 1 will begin with a title which specifies both the skill and the content, for example, The management of varicose veins.
You will be expected to know about conditions that are common or important in the United Kingdom for all of the systems outlined below. Examples of the cases that may be asked about are given under each heading and may appear under more than one heading.
These examples are for illustration and the list is not exhaustive. Other similar conditions might appear in the examination.
a. Accident and emergency medicine (to include trauma and burns)
Examples: Abdominal injuries, abdominal pain, back pain, bites and stings, breathlessness/wheeze, bruising and purpura, burns, chest pain, collapse, coma, convulsions, diabetes, epilepsy, eye problems, fractures, dislocations, head injury, loss of consciousness, non-accidental injury, sprains and strains, testicular pain.
b. Blood (to include coagulation defects)
Examples: Anemia's, bruising and purpura.
c. Cardiovascular system (to include heart and blood vessels and blood pressure)
Examples: Aortic aneurysm, chest pain, deep vein thrombosis (DVT), diagnosis and management of hypertension, heart failure, ischaemic limbs, myocardial infarction, myocardial ischaemic, stroke, varicose veins.
d. Dermatology, allergy, immunology and infectious diseases
Examples: Allergy, fever and rashes, influenza/pneumonia, meningitis, skin cancers.
e. ENT and eyes
Examples: Earache, hearing problems, hoarseness, difficulty in swallowing, glaucoma, ‘red eyes’, sudden visual loss.
f. Female reproductive system (to include obstetrics, gynecology and breast)
Examples: Abortion/sterilization, breast lump, contraception, infertility, menstrual disorders, menopausal symptoms, normal pregnancy, postnatal problems, pregnancy complications, vaginal disorders.
g. Gastrointestinal tract, liver and biliary system, and nutrition
Examples: Abdominal pain, constipation, diarrhea, difficulty in swallowing, digestive disorders, gastrointestinal bleeding, jaundice, rectal bleeding/pain, vomiting, weight problems.
h. Metabolism, endocrinology and diabetes
Examples: Diabetes mellitus, thyroid disorders, weight problems.
i. Nervous system (both medical and surgical)
Examples: Coma, convulsions, dementia, epilepsy, eye problems, headache, loss of consciousness, vertigo.
j. Orthopedics and rheumatology
Examples: Back pain, fractures, dislocations, joint pain/swelling, sprains and strains.
k. Psychiatry (to include substance abuse)
Examples: Alcohol abuse, anxiety, assessing suicidal risk, dementia, depression, drug abuse, overdoses and self harm, panic attacks, postnatal problems.
l. Renal System (to include urinary tract and genitourinary medicine)
Examples: Haematuria, renal and ureteric calculi, renal failure, sexual health, testicular pain, urinary infections.
m. Respiratory system
Examples: Asthma, breathlessness/wheeze, cough, hemoptysis, hoarseness, influenza/pneumonia.
n. Disorders of childhood (to include non-accidental injury and child sexual abuse; fetal medicine; growth and development)
Examples: Abdominal pain, asthma, child development, childhood illnesses, earache, epilepsy, eye problems, fever and rashes, joint pain/swelling, loss of consciousness, meningitis, non-accidental injury, testicular pain, urinary disorders.
o. Disorders of the elderly (to include palliative care)
Examples: Breathlessness, chest pain, constipation, dementia, depression, diabetes, diarrhoea, digestive disorders, headache, hearing problems influenza/pneumonia, jaundice, joint pain/swelling, loss of consciousness, pain relief, terminal care, trauma, urinary disorders, vaginal disorders, varicose veins, vertigo, vomiting.
p. Peri-operative management
Examples: Pain relief, shock,
How to approach the extended matching question examination (part 1 plab-EMQ)
The examination paper will contain 200 questions in the extended matching and SBA (single best answer ) format., divided into a number of themes.
Each theme has a heading which tells you what the questions are about, in terms both of the clinical problem area (e.g. chronic joint pain) and the skill required (e.g. diagnosis).
Within each theme there are several numbered items, usually between four and six. These are the questions the problems you have to solve. There are examples below.
Begin by reading carefully the instruction which precedes the numbered items. The instruction is very similar throughout the paper and typically reads ‘For each scenario below, choose the SINGLE most discriminating investigation from the above list of options. Each option may be used once, more than once or not at all.’
Consider each of the numbered items and decide what you think the answer is. You should then look for that answer in the list of options (each of which is identified by a letter of the alphabet). If you cannot find the answer you have thought of, you should look for the option which, in your opinion, is the best answer to the problem posed.
For each numbered item, you must choose ONE, and only one, of the options. You may feel that there are several possible answers to an item, but you must choose the one most likely from the option list. If you enter more than one answer on the answer sheet you will gain no mark for the question even though you may have given the right answer along with one or more wrong ones.
In each theme there are more options than items, so not all the options will be used as answers. This is why the instruction says that some options may not be used at all.
A given option may provide the answer to more than one item. For example, there might be two items which contain descriptions of patients, and the most likely diagnosis could be the same in both instances. In this case the option would be used more than once.
You will be awarded one mark for each item answered correctly.
SBA section
From september 2004, SBA s will make 30 % of the paper. An SBA or single best answer or MCQ (multiple choice answer)or BOF (best of five) is one and the same thing. In such questions you have to choose one single most appropriate answer to the given question. AIPPG forums are well known for carrying the latest papers / SBA;s discussions.
These days some questions are picture questions : common ECGs, X Rays and skin problems are commonly asked in such questions.
Marks are not deducted for incorrect answers nor for failure to answer. The total score on the paper is the number of correct answers given. You should, therefore, attempt all items in part one of PLAB examination.
Professional and Linguistic assessment exam (PLAB)
More Details about PLAB part 1 examination
Skills of PLAB part 1 test.
Four groups of skills will be tested in approximately equal proportions:
a. Diagnosis: Given the important facts about a patient (such as age, sex, nature of presenting symptoms, duration of symptoms) you are asked to select the most likely diagnosis from a range of possibilities.
b. Investigations: This may refer to the selection or the interpretation of diagnostic tests. Given the important facts about a patient, you will be asked to select the investigation which is most likely to provide the key to the diagnosis. Alternatively, you may be given the findings of investigations and asked to relate these to a patient's condition or to choose the most appropriate next course of action.
c. Management : Given the important facts about a patient's condition, you will be asked to choose from a range of possibilities the most suitable course of treatment. In the case of medical treatments you will be asked to choose the correct drug therapy and will be expected to know about side effects.
d. Others: These may include:
i. Explanation of disease process: The natural history of disease will be tested with reference to basic physiology and pathology.
ii. Legal/ethical : You are expected to know the major legal and ethical principles set out in the GMC publication Duties of a Doctor.
iii. Practice of evidence based medicine: Questions on diagnosis, investigations and management may draw upon recent evidence published in peer-reviewed journals. In addition, there may be questions on the principles and practice of evidence-based medicine.
iv. Understanding of epidemiology: You may be tested on the principles of epidemiology, and on the prevalence of important diseases in the UK.
v. Health promotion: The prevention of disease through health promotion and knowledge of risk factors.
vi. Awareness of multicultural society: You may be tested on your appreciation of the impact on the practice of medicine of the health beliefs and cultural values of the major cultural groups represented in the UK population.
vii. Application of scientific understanding to medicine
Content of part 1 of PLAB exam (new format since 2004 September)
The content to be tested is, for the most part, defined in terms of patient presentations. Where appropriate, the presentation may be either acute or chronic. Questions in Part 1 will begin with a title which specifies both the skill and the content, for example, The management of varicose veins.
You will be expected to know about conditions that are common or important in the United Kingdom for all of the systems outlined below. Examples of the cases that may be asked about are given under each heading and may appear under more than one heading.
These examples are for illustration and the list is not exhaustive. Other similar conditions might appear in the examination.
a. Accident and emergency medicine (to include trauma and burns)
Examples: Abdominal injuries, abdominal pain, back pain, bites and stings, breathlessness/wheeze, bruising and purpura, burns, chest pain, collapse, coma, convulsions, diabetes, epilepsy, eye problems, fractures, dislocations, head injury, loss of consciousness, non-accidental injury, sprains and strains, testicular pain.
b. Blood (to include coagulation defects)
Examples: Anemia's, bruising and purpura.
c. Cardiovascular system (to include heart and blood vessels and blood pressure)
Examples: Aortic aneurysm, chest pain, deep vein thrombosis (DVT), diagnosis and management of hypertension, heart failure, ischaemic limbs, myocardial infarction, myocardial ischaemic, stroke, varicose veins.
d. Dermatology, allergy, immunology and infectious diseases
Examples: Allergy, fever and rashes, influenza/pneumonia, meningitis, skin cancers.
e. ENT and eyes
Examples: Earache, hearing problems, hoarseness, difficulty in swallowing, glaucoma, ‘red eyes’, sudden visual loss.
f. Female reproductive system (to include obstetrics, gynecology and breast)
Examples: Abortion/sterilization, breast lump, contraception, infertility, menstrual disorders, menopausal symptoms, normal pregnancy, postnatal problems, pregnancy complications, vaginal disorders.
g. Gastrointestinal tract, liver and biliary system, and nutrition
Examples: Abdominal pain, constipation, diarrhea, difficulty in swallowing, digestive disorders, gastrointestinal bleeding, jaundice, rectal bleeding/pain, vomiting, weight problems.
h. Metabolism, endocrinology and diabetes
Examples: Diabetes mellitus, thyroid disorders, weight problems.
i. Nervous system (both medical and surgical)
Examples: Coma, convulsions, dementia, epilepsy, eye problems, headache, loss of consciousness, vertigo.
j. Orthopedics and rheumatology
Examples: Back pain, fractures, dislocations, joint pain/swelling, sprains and strains.
k. Psychiatry (to include substance abuse)
Examples: Alcohol abuse, anxiety, assessing suicidal risk, dementia, depression, drug abuse, overdoses and self harm, panic attacks, postnatal problems.
l. Renal System (to include urinary tract and genitourinary medicine)
Examples: Haematuria, renal and ureteric calculi, renal failure, sexual health, testicular pain, urinary infections.
m. Respiratory system
Examples: Asthma, breathlessness/wheeze, cough, hemoptysis, hoarseness, influenza/pneumonia.
n. Disorders of childhood (to include non-accidental injury and child sexual abuse; fetal medicine; growth and development)
Examples: Abdominal pain, asthma, child development, childhood illnesses, earache, epilepsy, eye problems, fever and rashes, joint pain/swelling, loss of consciousness, meningitis, non-accidental injury, testicular pain, urinary disorders.
o. Disorders of the elderly (to include palliative care)
Examples: Breathlessness, chest pain, constipation, dementia, depression, diabetes, diarrhoea, digestive disorders, headache, hearing problems influenza/pneumonia, jaundice, joint pain/swelling, loss of consciousness, pain relief, terminal care, trauma, urinary disorders, vaginal disorders, varicose veins, vertigo, vomiting.
p. Peri-operative management
Examples: Pain relief, shock,
How to approach the extended matching question examination (part 1 plab-EMQ)
The examination paper will contain 200 questions in the extended matching and SBA (single best answer ) format., divided into a number of themes.
Each theme has a heading which tells you what the questions are about, in terms both of the clinical problem area (e.g. chronic joint pain) and the skill required (e.g. diagnosis).
Within each theme there are several numbered items, usually between four and six. These are the questions the problems you have to solve. There are examples below.
Begin by reading carefully the instruction which precedes the numbered items. The instruction is very similar throughout the paper and typically reads ‘For each scenario below, choose the SINGLE most discriminating investigation from the above list of options. Each option may be used once, more than once or not at all.’
Consider each of the numbered items and decide what you think the answer is. You should then look for that answer in the list of options (each of which is identified by a letter of the alphabet). If you cannot find the answer you have thought of, you should look for the option which, in your opinion, is the best answer to the problem posed.
For each numbered item, you must choose ONE, and only one, of the options. You may feel that there are several possible answers to an item, but you must choose the one most likely from the option list. If you enter more than one answer on the answer sheet you will gain no mark for the question even though you may have given the right answer along with one or more wrong ones.
In each theme there are more options than items, so not all the options will be used as answers. This is why the instruction says that some options may not be used at all.
A given option may provide the answer to more than one item. For example, there might be two items which contain descriptions of patients, and the most likely diagnosis could be the same in both instances. In this case the option would be used more than once.
You will be awarded one mark for each item answered correctly.
SBA section
From september 2004, SBA s will make 30 % of the paper. An SBA or single best answer or MCQ (multiple choice answer)or BOF (best of five) is one and the same thing. In such questions you have to choose one single most appropriate answer to the given question. AIPPG forums are well known for carrying the latest papers / SBA;s discussions.
These days some questions are picture questions : common ECGs, X Rays and skin problems are commonly asked in such questions.
Marks are not deducted for incorrect answers nor for failure to answer. The total score on the paper is the number of correct answers given. You should, therefore, attempt all items in part one of PLAB examination.
Thursday, January 14, 2010
Rh Disease
Rh Disease
Rh disease (also known as Rh (D) disease, Rhesus disease, RhD Hemolytic Disease of the Newborn, Rhesus D Hemolytic Disease of the Newborn or RhD HDN) is one of the causes of hemolytic disease of the newborn (also known as HDN). The disease ranges from mild to severe. When the disease is mild the fetus may have mild anaemia with reticulocytosis. When the disease is moderate or severe the fetus can have a more marked anaemia and erythroblastosis (erythroblastosis fetalis). When the disease is very severe it can cause morbus haemolyticus neonatorum, hydrops fetalis, or stillbirth.
Serology
During any pregnancy a small amount of the baby's blood can enter the mother's circulation. If the mother is Rh negative and the baby is Rh positive, the mother produces antibodies (including IgG) against the Rhesus D antigen on her baby's red blood cells. During this and subsequent pregnancies the IgG is able to pass through the placenta into the fetus and if the level of it is sufficient, it will cause destruction of Rhesus D positive fetal red blood cells leading to development Rh disease. It may thus be regarded as insufficient immune tolerance in pregnancy. Generally Rhesus disease becomes worse with each additional Rhesus incompatible pregnancy.
The main and most frequent sensitizing event is child birth (about 86% of sensitized cases), but fetal blood may pass into the maternal circulation earlier during the pregnancy (about 14% of sensitized cases). Sensitizing events during pregnancy include miscarriage, therapeutic abortion, amniocentesis, ectopic pregnancy, abdominal trauma and external cephalic version.
The incidence of Rh disease in a population depends on the proportion that are rhesus negative. Many non-caucasian peoples have a very low proportion who are Rhesus negative, so the incidence of Rh disease is very low in these populations. In Caucasian populations about 1 in 10 of all pregnancies are of a Rhesus negative woman with a Rhesus positive baby. It is very rare for the first Rhesus positive baby of a Rhesus negative woman to be affected by Rh disease. The first pregnancy with a Rhesus positive baby is significant for a rhesus negative woman because she can be sensitized to the Rh positive antigen. In Caucasian populations about 13% of Rhesus negative mothers are sensitized by their first pregnancy with a rhesus positive baby. If it were not for modern prevention and treatment, about 5% of the second Rhesus positive infants of Rhesus negative woman, would result in still births or extremely sick babies and many babies who managed to survive would be severely ill. Even higher disease rates would occur in the 3rd and subsequent Rhesus positive infants of rhesus negative woman. By using anti-RhD immunoglobulin (Rho(D) Immune Globulin) the incidence is massively reduced .
Rh disease sensitization is about 10 times more likely to occur if the fetus is ABO compatible with the mother than if the mother and fetus are ABO incompatible.
Prevention
Most Rh disease can be prevented by treating the mother during pregnancy or promptly (within 72 hours) after childbirth. The mother has an intramuscular injection of anti-Rh antibodies (Rho(D) Immune Globulin), sold under the brand name RhoGAM. This is done so that the fetal Rhesus D positive erythrocytes are destroyed before her immune system can discover them. This is passive immunity and the effect of the immunity will wear off after about 4 to 6 weeks (or longer depending on injected dose) as the anti-Rh antibodies gradually decline to zero in the maternal blood.
It is part of modern antenatal care to give all Rhesus D negative pregnant women an anti-RhD IgG immunoglobulin injection at about 28 weeks gestation (with or without a booster at 34 weeks gestation). This reduces the effect of the vast majority of sensitizing events which mostly occur after 28 weeks gestation. Anti-RhD immunoglobulin is also given to non-sensitized Rhesus negative women immediately (within 72 hours - the sooner the better) after potentially sensitizing events that occur earlier in pregnancy.
Blood tests
Maternal blood
* The Kleihauer-Betke test or flow cytometry on a postnatal maternal blood sample can confirm that fetal blood has passed into the maternal circulation and can also be used to estimate the amount of fetal blood that has passed into the maternal circulation.
* The indirect Coombs test is used to screen blood from antenatal women for IgG antibodies that may pass through the placenta and cause hemolytic disease of the newborn.
Fetal blood (or umbilical cord blood)
* The direct Coombs test is used to confirm that the fetus or neonate has an immune mediated hemolytic anemia.
* Full blood count - the hemoglobin level and platelet count are important
* Bilirubin (total and indirect)
Management
Antenatal
* Ultrasound - to detect and monitor hydrops fetalis
* Quantitative analysis of maternal anti-RhD antibodies - an increasing level is a sign of fetal Rh disease
* Intrauterine blood transfusion
o Intraperitoneal transfusion - blood transfused into fetal abdomen
o Intravascular transfusion - blood transfused into fetal umbilical vein - This is more modern and more effective than intraperitoneal transfusion. A sample of fetal blood can be taken from the umbilical vein prior to the transfusion.
* Early delivery (usually after about 36 wks gestation)
Postnatal
* Phototherapy for neonatal jaundice in mild disease
* Exchange transfusion if the neonate has moderate or severe disease (the blood for transfusion must be less than a week old, Rh negative, ABO compatible with both the fetus and the mother, and be cross matched against the mothers serum)
History of medical advances in Rh disease
The rhesus blood type was first discovered in 1937 by Karl Landsteiner and Alexander S. Wiener.
In 1939 Philip Levine and Rufus E. Stetson published their findings about a family who had a stillborn baby who died of hemolytic disease of the newborn. The mother was aged 25 and it was her second pregnancy and she suffered blood loss at the delivery. Both parents were blood group O and the husband's blood was used to give the mother a blood transfusion, but the mother suffered a severe transfusion reaction. They investigated this transfusion reaction. Since the mother and the father were both blood group O, they concluded that there must be a previously undiscovered blood group antigen that was present on the husband's RBCs but was not present on the mother's RBCs and that the mother had formed antibodies against the new blood group antigen. This suggested for the first time that a mother could make blood group antibodies because of immune sensitization to her fetus's RBCs. They did not name this blood group antigen, but it was subsequently found to be the Rhesus factor.
The first treatment for Rh disease was an exchange transfusion, which was invented by Dr. Alexander S. Wiener. That procedure was further refined by Dr, Harry Wallerstein, a transfusionist. Although the most effective method of treating the problem at the time, it was only partially ameliorative in cases where damage to the neonate had already been done. Children with severe motor damage and/or retardation could result. However, it is estimated that in the two decades it was used approximately 200,000 lives were saved, and the great majority were not brain damaged.
Ronald Finn, in Liverpool, England applied a microscopic technique for detecting fetal cells in the mother's blood. It led him to propose that the disease might be prevented by injecting the at-risk mother with an antibody against fetal red blood cells. He proposed this for the first time to the public on February 18, 1960. A few months later, he proposed at a meeting of the British Genetical Society that the antibody be anti-RhD.
Nearly simultaneously with him, William Pollack, then of Ortho Pharmaceutical Corporation, and researchers John Gorman and Vincent Freda of New York City's Columbia-Presbyterian Medical Center, having come to the same realization, set out to prove it by injecting a group of male prisoners at Sing Sing Correctional Facility with antibody provided by Ortho, obtained by a fractionation technique developed by Dr Pollack (who also provided Dr. Finn with several vials of antibody during a visit by Dr. Finn to Ortho).
Animal studies had previously been conducted by William Pollack, using a rabbit model of Rh. This model, named the rabbit HgA-F system, was a perfect animal model of human Rh, and enabled Dr. Pollack's team to gain experience in preventing hemolytic disease in rabbits by giving specific HgA antibody, as was later done with Rh-negative mothers. One of the needs was a dosing experiment that could be used to determine the level of circulating Rh-positive cells in an Rh-negative pregnant female derived from her Rh-positive fetus. This was first done in the rabbit system, but subsequent human tests at the University of Manitoba conducted under Dr. Pollack's direction confirmed that this result matched the human dosing perfectly. The dose is 20 µG of antibody for 1mL of Rh-positive red cells.
Sir William Liley performed the first successful intrauterine transfusion in 1963.
Dr. Gorman's sister-in-law was the first at risk woman to receive a prophylactic injection on January 31, 1964. Clinical trials set up by Dr. Pollack in 42 clinical centers in the US, Great Britain, Germany, Sweden, Italy, and Australia confirmed their hypothesis, and the vaccine was finally approved in England and the United States in 1968. The FDA approved the drug under the name RhoGAM, with a fixed dose of 300 µG, to be given within three days postpartum. There being no known harm done by delaying the dosage for a week or more after birth, Ortho asked the FDA to grant permission for it to be given without a postpartum time restriction. In addition, Dr. John M. Bowman, one of the researchers at the University of Manitoba, and Dr Freda pushed to allow antepartum use. All of this was subsequently granted. Within a year or so, the antibody had been injected with great success into more than 500,000 women. Time magazine picked it as one of the top ten medical achievements of the 1960s. By 1973, it was estimated that in the US alone, over 50,000 babies' lives had been saved. The use of Rh immune globulin to prevent the disease in babies of Rh negative mothers has become standard practice, and the disease, which used to claim the lives of 10,000 babies each year in the US alone, has been virtually eradicated in the developed world. In 1980 Drs. Pollack, Gorman, Freda, and Finn shared the Albert Lasker Award for their work on Rh disease.
Two of the Canadian researchers from the University of Manitoba, Dr. Bruce Chown and Dr. John M. Bowman, licensed a version of the vaccine, known as WinRho SD, in 1980. The drug is sold in 35 countries by the Manitoba-based research firm Cangene, listed on the Toronto Stock Exchange with worth of about $175 million. Cangene was purchased by the Winnipeg Rh Institute, a facility founded by Chown and Bowman and dedicated to conducting research into blood related diseases. Dr. Chown is honored by the Canadian Medical Hall of Fame for his lifelong work with erythroblastosis fetalis.
Rh disease (also known as Rh (D) disease, Rhesus disease, RhD Hemolytic Disease of the Newborn, Rhesus D Hemolytic Disease of the Newborn or RhD HDN) is one of the causes of hemolytic disease of the newborn (also known as HDN). The disease ranges from mild to severe. When the disease is mild the fetus may have mild anaemia with reticulocytosis. When the disease is moderate or severe the fetus can have a more marked anaemia and erythroblastosis (erythroblastosis fetalis). When the disease is very severe it can cause morbus haemolyticus neonatorum, hydrops fetalis, or stillbirth.
Serology
During any pregnancy a small amount of the baby's blood can enter the mother's circulation. If the mother is Rh negative and the baby is Rh positive, the mother produces antibodies (including IgG) against the Rhesus D antigen on her baby's red blood cells. During this and subsequent pregnancies the IgG is able to pass through the placenta into the fetus and if the level of it is sufficient, it will cause destruction of Rhesus D positive fetal red blood cells leading to development Rh disease. It may thus be regarded as insufficient immune tolerance in pregnancy. Generally Rhesus disease becomes worse with each additional Rhesus incompatible pregnancy.
The main and most frequent sensitizing event is child birth (about 86% of sensitized cases), but fetal blood may pass into the maternal circulation earlier during the pregnancy (about 14% of sensitized cases). Sensitizing events during pregnancy include miscarriage, therapeutic abortion, amniocentesis, ectopic pregnancy, abdominal trauma and external cephalic version.
The incidence of Rh disease in a population depends on the proportion that are rhesus negative. Many non-caucasian peoples have a very low proportion who are Rhesus negative, so the incidence of Rh disease is very low in these populations. In Caucasian populations about 1 in 10 of all pregnancies are of a Rhesus negative woman with a Rhesus positive baby. It is very rare for the first Rhesus positive baby of a Rhesus negative woman to be affected by Rh disease. The first pregnancy with a Rhesus positive baby is significant for a rhesus negative woman because she can be sensitized to the Rh positive antigen. In Caucasian populations about 13% of Rhesus negative mothers are sensitized by their first pregnancy with a rhesus positive baby. If it were not for modern prevention and treatment, about 5% of the second Rhesus positive infants of Rhesus negative woman, would result in still births or extremely sick babies and many babies who managed to survive would be severely ill. Even higher disease rates would occur in the 3rd and subsequent Rhesus positive infants of rhesus negative woman. By using anti-RhD immunoglobulin (Rho(D) Immune Globulin) the incidence is massively reduced .
Rh disease sensitization is about 10 times more likely to occur if the fetus is ABO compatible with the mother than if the mother and fetus are ABO incompatible.
Prevention
Most Rh disease can be prevented by treating the mother during pregnancy or promptly (within 72 hours) after childbirth. The mother has an intramuscular injection of anti-Rh antibodies (Rho(D) Immune Globulin), sold under the brand name RhoGAM. This is done so that the fetal Rhesus D positive erythrocytes are destroyed before her immune system can discover them. This is passive immunity and the effect of the immunity will wear off after about 4 to 6 weeks (or longer depending on injected dose) as the anti-Rh antibodies gradually decline to zero in the maternal blood.
It is part of modern antenatal care to give all Rhesus D negative pregnant women an anti-RhD IgG immunoglobulin injection at about 28 weeks gestation (with or without a booster at 34 weeks gestation). This reduces the effect of the vast majority of sensitizing events which mostly occur after 28 weeks gestation. Anti-RhD immunoglobulin is also given to non-sensitized Rhesus negative women immediately (within 72 hours - the sooner the better) after potentially sensitizing events that occur earlier in pregnancy.
Blood tests
Maternal blood
* The Kleihauer-Betke test or flow cytometry on a postnatal maternal blood sample can confirm that fetal blood has passed into the maternal circulation and can also be used to estimate the amount of fetal blood that has passed into the maternal circulation.
* The indirect Coombs test is used to screen blood from antenatal women for IgG antibodies that may pass through the placenta and cause hemolytic disease of the newborn.
Fetal blood (or umbilical cord blood)
* The direct Coombs test is used to confirm that the fetus or neonate has an immune mediated hemolytic anemia.
* Full blood count - the hemoglobin level and platelet count are important
* Bilirubin (total and indirect)
Management
Antenatal
* Ultrasound - to detect and monitor hydrops fetalis
* Quantitative analysis of maternal anti-RhD antibodies - an increasing level is a sign of fetal Rh disease
* Intrauterine blood transfusion
o Intraperitoneal transfusion - blood transfused into fetal abdomen
o Intravascular transfusion - blood transfused into fetal umbilical vein - This is more modern and more effective than intraperitoneal transfusion. A sample of fetal blood can be taken from the umbilical vein prior to the transfusion.
* Early delivery (usually after about 36 wks gestation)
Postnatal
* Phototherapy for neonatal jaundice in mild disease
* Exchange transfusion if the neonate has moderate or severe disease (the blood for transfusion must be less than a week old, Rh negative, ABO compatible with both the fetus and the mother, and be cross matched against the mothers serum)
History of medical advances in Rh disease
The rhesus blood type was first discovered in 1937 by Karl Landsteiner and Alexander S. Wiener.
In 1939 Philip Levine and Rufus E. Stetson published their findings about a family who had a stillborn baby who died of hemolytic disease of the newborn. The mother was aged 25 and it was her second pregnancy and she suffered blood loss at the delivery. Both parents were blood group O and the husband's blood was used to give the mother a blood transfusion, but the mother suffered a severe transfusion reaction. They investigated this transfusion reaction. Since the mother and the father were both blood group O, they concluded that there must be a previously undiscovered blood group antigen that was present on the husband's RBCs but was not present on the mother's RBCs and that the mother had formed antibodies against the new blood group antigen. This suggested for the first time that a mother could make blood group antibodies because of immune sensitization to her fetus's RBCs. They did not name this blood group antigen, but it was subsequently found to be the Rhesus factor.
The first treatment for Rh disease was an exchange transfusion, which was invented by Dr. Alexander S. Wiener. That procedure was further refined by Dr, Harry Wallerstein, a transfusionist. Although the most effective method of treating the problem at the time, it was only partially ameliorative in cases where damage to the neonate had already been done. Children with severe motor damage and/or retardation could result. However, it is estimated that in the two decades it was used approximately 200,000 lives were saved, and the great majority were not brain damaged.
Ronald Finn, in Liverpool, England applied a microscopic technique for detecting fetal cells in the mother's blood. It led him to propose that the disease might be prevented by injecting the at-risk mother with an antibody against fetal red blood cells. He proposed this for the first time to the public on February 18, 1960. A few months later, he proposed at a meeting of the British Genetical Society that the antibody be anti-RhD.
Nearly simultaneously with him, William Pollack, then of Ortho Pharmaceutical Corporation, and researchers John Gorman and Vincent Freda of New York City's Columbia-Presbyterian Medical Center, having come to the same realization, set out to prove it by injecting a group of male prisoners at Sing Sing Correctional Facility with antibody provided by Ortho, obtained by a fractionation technique developed by Dr Pollack (who also provided Dr. Finn with several vials of antibody during a visit by Dr. Finn to Ortho).
Animal studies had previously been conducted by William Pollack, using a rabbit model of Rh. This model, named the rabbit HgA-F system, was a perfect animal model of human Rh, and enabled Dr. Pollack's team to gain experience in preventing hemolytic disease in rabbits by giving specific HgA antibody, as was later done with Rh-negative mothers. One of the needs was a dosing experiment that could be used to determine the level of circulating Rh-positive cells in an Rh-negative pregnant female derived from her Rh-positive fetus. This was first done in the rabbit system, but subsequent human tests at the University of Manitoba conducted under Dr. Pollack's direction confirmed that this result matched the human dosing perfectly. The dose is 20 µG of antibody for 1mL of Rh-positive red cells.
Sir William Liley performed the first successful intrauterine transfusion in 1963.
Dr. Gorman's sister-in-law was the first at risk woman to receive a prophylactic injection on January 31, 1964. Clinical trials set up by Dr. Pollack in 42 clinical centers in the US, Great Britain, Germany, Sweden, Italy, and Australia confirmed their hypothesis, and the vaccine was finally approved in England and the United States in 1968. The FDA approved the drug under the name RhoGAM, with a fixed dose of 300 µG, to be given within three days postpartum. There being no known harm done by delaying the dosage for a week or more after birth, Ortho asked the FDA to grant permission for it to be given without a postpartum time restriction. In addition, Dr. John M. Bowman, one of the researchers at the University of Manitoba, and Dr Freda pushed to allow antepartum use. All of this was subsequently granted. Within a year or so, the antibody had been injected with great success into more than 500,000 women. Time magazine picked it as one of the top ten medical achievements of the 1960s. By 1973, it was estimated that in the US alone, over 50,000 babies' lives had been saved. The use of Rh immune globulin to prevent the disease in babies of Rh negative mothers has become standard practice, and the disease, which used to claim the lives of 10,000 babies each year in the US alone, has been virtually eradicated in the developed world. In 1980 Drs. Pollack, Gorman, Freda, and Finn shared the Albert Lasker Award for their work on Rh disease.
Two of the Canadian researchers from the University of Manitoba, Dr. Bruce Chown and Dr. John M. Bowman, licensed a version of the vaccine, known as WinRho SD, in 1980. The drug is sold in 35 countries by the Manitoba-based research firm Cangene, listed on the Toronto Stock Exchange with worth of about $175 million. Cangene was purchased by the Winnipeg Rh Institute, a facility founded by Chown and Bowman and dedicated to conducting research into blood related diseases. Dr. Chown is honored by the Canadian Medical Hall of Fame for his lifelong work with erythroblastosis fetalis.
Friday, November 13, 2009
Health Insurance Portability and Accountability Act (HIPAA)
The Health Insurance Portability and Accountability Act (HIPAA) was enacted by the U.S. Congress in 1996. According to the Centers for Medicare and Medicaid Services (CMS) website, Title I of HIPAA protects health insurance coverage for workers and their families when they change or lose their jobs. Title II of HIPAA, known as the Administrative Simplification (AS) provisions, requires the establishment of national standards for electronic health care transactions and national identifiers for providers, health insurance plans, and employers. This is intended to help people keep their information private, though in practice it is normal for providers and health insurance plans to require the waiver of HIPAA rights as a condition of service.
The Administration Simplification provisions also address the security and privacy of health data. The standards are meant to improve the efficiency and effectiveness of the nation's health care system by encouraging the widespread use of electronic data interchange in the U.S. health care system.
Title I: Health Care Access, Portability, and Renewability
Title I of HIPAA regulates the availability and breadth of group health plans and certain individual health insurance policies. It amended the Employee Retirement Income Security Act, the Public Health Service Act, and the Internal Revenue Code.
Title I also limits restrictions that a group health plan can place on benefits for preexisting conditions. Group health plans may refuse to provide benefits relating to preexisting conditions for a period of 12 months after enrollment in the plan or 18 months in the case of late enrollment. However, individuals may reduce this exclusion period if they had group health plan coverage or health insurance prior to enrolling in the plan. Title I allows individuals to reduce the exclusion period by the amount of time that they had "creditable coverage" prior to enrolling in the plan and after any "significant breaks" in coverage. "Creditable coverage" is defined quite broadly and includes nearly all group and individual health plans, Medicare, and Medicaid. A "significant break" in coverage is defined as any 63 day period without any creditable coverage.
Some health care plans are exempted from Title I requirements, such as long-term health plans and limited-scope plans such as dental or vision plans that are offered separately from the general health plan. However, if such benefits are part of the general health plan, then HIPAA still applies to such benefits. For example, if the new plan offers dental benefits, then it must count creditable continuous coverage under the old health plan towards any of its exclusion periods for dental benefits.
However, an alternate method of calculating creditable continuous coverage is available to the health plan under Title I. That is, 5 categories of health coverage can be considered separately, including dental and vision coverage. Anything not under those 5 categories must use the general calculation (e.g., the beneficiary may be counted with 18 months of general coverage, but only 6 months of dental coverage, because the beneficiary did not have a general health plan that covered dental until 6 months prior to the application date). Unfortunately, since limited-coverage plans are exempt from HIPAA requirements, the odd case exists in which the applicant to a general group health plan cannot obtain certificates of creditable continuous coverage for independent limited-scope plans such as dental to apply towards exclusion periods of the new plan that does include those coverages.
Hidden exclusion periods are not valid under Title I (e.g., "The accident, to be covered, must have occurred while the beneficiary was covered under this exact same health insurance contract"). Such clauses must not be acted upon by the health plan and also must be re-written so that they comply with HIPAA.
To illustrate, suppose someone enrolls in a group health plan on January 1, 2006. This person had previously been insured from January 1, 2004 until February 1, 2005 and from August 1, 2005 until December 31, 2005. To determine how much coverage can be credited against the exclusion period in the new plan, start at the enrollment date and count backwards until you reach a significant break in coverage. So, the five months of coverage between August 1, 2005 and December 31, 2005 clearly counts against the exclusion period. But the period without insurance between February 1, 2005 and August 1, 2005 is greater than 63 days. Thus, this is a significant break in coverage, and any coverage prior to it cannot be deducted from the exclusion period. So, this person could deduct five months from his or her exclusion period, reducing the exclusion period to seven months. Hence, Title I requires that any preexisting condition begin to be covered on August 1, 2006.
Title II: Preventing Health Care Fraud and Abuse; Administrative Simplification; Medical Liability Reform
Title II of HIPAA defines numerous offenses relating to health care and sets civil and criminal penalties for them. It also creates several programs to control fraud and abuse within the health care system. However, the most significant provisions of Title II are its Administrative Simplification rules. Title II requires the Department of Health and Human Services (HHS) to draft rules aimed at increasing the efficiency of the health care system by creating standards for the use and dissemination of health care information.
These rules apply to "covered entities" as defined by HIPAA and the HHS. Covered entities include health plans, health care clearinghouses, such as billing services and community health information systems, and health care providers that transmit health care data in a way that is regulated by HIPAA.
Per the requirements of Title II, the HHS has promulgated five rules regarding Administrative Simplification: the Privacy Rule, the Transactions and Code Sets Rule, the Security Rule, the Unique Identifiers Rule, and the Enforcement Rule.
Privacy Rule
The Privacy Rule took effect on April 14, 2003, with a one-year extension for certain "small plans". The HIPAA Privacy Rule regulates the use and disclosure of certain information held by "covered entities" (generally, health care clearinghouses, employer sponsored health plans, health insurers, and medical service providers that engage in certain transactions.) It establishes regulations for the use and disclosure of Protected Health Information (PHI). PHI is any information held by a covered entity which concerns health status, provision of health care, or payment for health care that can be linked to an individual. This is interpreted rather broadly and includes any part of an individual's medical record or payment history.
Covered entities must disclose PHI to the individual within 30 days upon request. They also must disclose PHI when required to do so by law, such as reporting suspected child abuse to state child welfare agencies.
A covered entity may disclose PHI to facilitate treatment, payment, or health care operations, or if the covered entity has obtained authorization from the individual. However, when a covered entity discloses any PHI, it must make a reasonable effort to disclose only the minimum necessary information required to achieve its purpose.
The Privacy Rule gives individuals the right to request that a covered entity correct any inaccurate PHI. It also requires covered entities to take reasonable steps to ensure the confidentiality of communications with individuals. For example, an individual can ask to be called at his or her work number, instead of home or cell phone number.
The Privacy Rule requires covered entities to notify individuals of uses of their PHI. Covered entities must also keep track of disclosures of PHI and document privacy policies and procedures. They must appoint a Privacy Official and a contact person responsible for receiving complaints and train all members of their workforce in procedures regarding PHI.
An individual who believes that the Privacy Rule is not being upheld can file a complaint with the Department of Health and Human Services Office for Civil Rights (OCR). However, according to the Wall Street Journal, the OCR has a long backlog and ignores most complaints. "Complaints of privacy violations have been piling up at the Department of Health and Human Services. Between April 2003 and Nov. 30, the agency fielded 23,896 complaints related to medical-privacy rules, but it has not yet taken any enforcement actions against hospitals, doctors, insurers or anyone else for rule violations. A spokesman for the agency says it has closed three-quarters of the complaints, typically because it found no violation or after it provided informal guidance to the parties involved."
Transactions and Code Sets Rule
The HIPAA/EDI provision was scheduled to take effect from October 16, 2003 with a one-year extension for certain "small plans". However, due to widespread confusion and difficulty in implementing the rule, CMS granted a one-year extension to all parties. As of October 16, 2004, full implementation was not achieved and CMS began an open-ended "contingency period". Penalties for non-compliance were not levied. However, all parties are expected to make a "good-faith effort" to come into compliance.
CMS announced that the Medicare contingency period ended July 1, 2005. After July 1, most medical providers that file electronically will have to file their electronic claims using the HIPAA standards in order to be paid. There are exceptions for doctors that meet certain criteria.
Key EDI(X12) transactions used for HIPAA compliance are:
EDI Health Care Claim Transaction set (837) is used to submit health care claim billing information, encounter information, or both, except for retail pharmacy claims (see EDI Retail Pharmacy Claim Transaction). It can be sent from providers of health care services to payers, either directly or via intermediary billers and claims clearinghouses. It can also be used to transmit health care claims and billing payment information between payers with different payment responsibilities where coordination of benefits is required or between payers and regulatory agencies to monitor the rendering, billing, and/or payment of health care services within a specific health care/insurance industry segment.
For example, a state mental health agency may mandate all healthcare claims, Providers and health plans who trade professional (medical) health care claims electronically must use the 837 Health Care Claim: Professional standard to send in claims. As there are many different business applications for the Health Care claim, there can be slight derivations to cover off claims involving unique claims such as for Institutions, Professionals, Chiropractors, and Dentists etc.
EDI Retail Pharmacy Claim Transaction (NCPDP Telecommunications Standard version 5.1) is used to submit retail pharmacy claims to payers by health care professionals who dispense medications, either directly or via intermediary billers and claims clearinghouses. It can also be used to transmit claims for retail pharmacy services and billing payment information between payers with different payment responsibilities where coordination of benefits is required or between payers and regulatory agencies to monitor the rendering, billing, and/or payment of retail pharmacy services within the pharmacy health care/insurance industry segment.
EDI Health Care Claim Payment/Advice Transaction Set (835) can be used to make a payment, send an Explanation of Benefits (EOB) remittance advice, or make a payment and send an EOB remittance advice only from a health insurer to a health care provider either directly or via a financial institution.
EDI Benefit Enrollment and Maintenance Set (834) can be used by employers, unions, government agencies, associations or insurance agencies to enroll members to a payer. The payer is a healthcare organization that pays claims, administers insurance or benefit or product. Examples of payers include an insurance company, health care professional (HMO), preferred provider organization (PPO), government agency (Medicaid, Medicare etc.) or any organization that may be contracted by one of these former groups.
EDI Payroll Deducted and other group Premium Payment for Insurance Products (820) is a transaction set which can be used to make a premium payment for insurance products. It can be used to order a financial institution to make a payment to a payee.
EDI Health Care Eligibility/Benefit Inquiry (270) is used to inquire about the health care benefits and eligibility associated with a subscriber or dependent.
EDI Health Care Eligibility/Benefit Response (271) is used to respond to a request inquire about the health care benefits and eligibility associated with a subscriber or dependent.
EDI Health Care Claim Status Request (276) This transaction set can be used by a provider, recipient of health care products or services or their authorized agent to request the status of a health care claim.
EDI Health Care Claim Status Notification (277) This transaction set can be used by a health care payer or authorized agent to notify a provider, recipient or authorized agent regarding the status of a health care claim or encounter, or to request additional information from the provider regarding a health care claim or encounter. This transaction set is not intended to replace the Health Care Claim Payment/Advice Transaction Set (835) and therefore, is not used for account payment posting. The notification is at a summary or service line detail level. The notification may be solicited or unsolicited.
EDI Health Care Service Review Information (278) This transaction set can be used to transmit health care service information, such as subscriber, patient, demographic, diagnosis or treatment data for the purpose of request for review, certification, notification or reporting the outcome of a health care services review.
EDI Functional Acknowledgement Transaction Set (997) this transaction set can be used to define the control structures for a set of acknowledgments to indicate the results of the syntactical analysis of the electronically encoded documents. Although it is not specifically named in the HIPAA Legislation or Final Rule, it is necessary for X12 transaction set processing . The encoded documents are the transaction sets, which are grouped in functional groups, used in defining transactions for business data interchange. This standard does not cover the semantic meaning of the information encoded in the transaction sets.
Security Rule
The Final Rule on Security Standards was issued on February 20, 2003. It took effect on April 21, 2003 with a compliance date of April 21, 2005 for most covered entities and April 21, 2006 for "small plans". The Security Rule complements the Privacy Rule. While the Privacy Rule pertains to all Protected Health Information (PHI) including paper and electronic, the Security Rule deals specifically with Electronic Protected Health Information (EPHI). It lays out three types of security safeguards required for compliance: administrative, physical, and technical. For each of these types, the Rule identifies various security standards, and for each standard, it names both required and addressable implementation specifications. Required specifications must be adopted and administered as dictated by the Rule. Addressable specifications are more flexible. Individual covered entities can evaluate their own situation and determine the best way to implement addressable specifications. The standards and specifications are as follows:
* Administrative Safeguards – policies and procedures designed to clearly show how the entity will comply with the act
o Covered entities (entities that must comply with HIPAA requirements) must adopt a written set of privacy procedures and designate a privacy officer to be responsible for developing and implementing all required policies and procedures.
o The policies and procedures must reference management oversight and organizational buy-in to compliance with the documented security controls.
o Procedures should clearly identify employees or classes of employees who will have access to electronic protected health information (EPHI). Access to EPHI must be restricted to only those employees who have a need for it to complete their job function.
o The procedures must address access authorization, establishment, modification, and termination.
o Entities must show that an appropriate ongoing training program regarding the handling of PHI is provided to employees performing health plan administrative functions.
o Covered entities that out-source some of their business processes to a third party must ensure that their vendors also have a framework in place to comply with HIPAA requirements. Companies typically gain this assurance through clauses in the contracts stating that the vendor will meet the same data protection requirements that apply to the covered entity. Care must be taken to determine if the vendor further out-sources any data handling functions to other vendors and monitor whether appropriate contracts and controls are in place.
o A contingency plan should be in place for responding to emergencies. Covered entities are responsible for backing up their data and having disaster recovery procedures in place. The plan should document data priority and failure analysis, testing activities, and change control procedures.
o Internal audits play a key role in HIPAA compliance by reviewing operations with the goal of identifying potential security violations. Policies and procedures should specifically document the scope, frequency, and procedures of audits. Audits should be both routine and event-based.
o Procedures should document instructions for addressing and responding to security breaches that are identified either during the audit or the normal course of operations.
* Physical Safeguards – controlling physical access to protect against inappropriate access to protected data
o Controls must govern the introduction and removal of hardware and software from the network. (When equipment is retired it must be disposed of properly to ensure that PHI is not compromised.)
o Access to equipment containing health information should be carefully controlled and monitored.
o Access to hardware and software must be limited to properly authorized individuals.
o Required access controls consist of facility security plans, maintenance records, and visitor sign-in and escorts.
o Policies are required to address proper workstation use. Workstations should be removed from high traffic areas and monitor screens should not be in direct view of the public.
o If the covered entities utilize contractors or agents, they too must be fully trained on their physical access responsibilities.
* Technical Safeguards – controlling access to computer systems and enabling covered entities to protect communications containing PHI transmitted electronically over open networks from being intercepted by anyone other than the intended recipient.
o Information systems housing PHI must be protected from intrusion. When information flows over open networks, some form of encryption must be utilized. If closed systems/networks are utilized, existing access controls are considered sufficient and encryption is optional.
o Each covered entity is responsible for ensuring that the data within its systems has not been changed or erased in an unauthorized manner.
o Data corroboration, including the use of check sum, double-keying, message authentication, and digital signature may be used to ensure data integrity.
o Covered entities must also authenticate entities it communicates with. Authentication consists of corroborating that an entity is who it claims to be. Examples of corroboration include: password systems, two or three-way handshakes, telephone callback, and token systems.
o Covered entities must make documentation of their HIPAA practices available to the government to determine compliance.
o In addition to policies and procedures and access records, information technology documentation should also include a written record of all configuration settings on the components of the network because these components are complex, configurable, and always changing.
o Documented risk analysis and risk management programs are required. Covered entities must carefully consider the risks of their operations as they implement systems to comply with the act. (The requirement of risk analysis and risk management implies that the act’s security requirements are a minimum standard and places responsibility on covered entities to take all reasonable precautions necessary to prevent PHI from being used for non-health purposes.)
Unique Identifiers Rule (National Provider Identifier)
HIPAA covered entities such as providers completing electronic transactions, healthcare clearinghouses, and large health plans, must use only the National Provider Identifier (NPI) to identify covered healthcare providers in standard transactions by May 23, 2007. Small health plans must use only the NPI by May 23, 2008.
Effective from May 2006 (May 2007 for small health plans), all covered entities using electronic communications (e.g., physicians, hospitals, health insurance companies, and so forth) must use a single new NPI. The NPI replaces all other identifiers used by health plans, Medicare (i.e., the UPIN), Medicaid, and other government programs. However, the NPI does not replace a provider's DEA number, state license number, or tax identification number. The NPI is 10 digits (may be alphanumeric), with the last digit being a checksum. The NPI cannot contain any embedded intelligence; in other words, the NPI is simply a number that does not itself have any additional meaning. The NPI is unique and national, never re-used, and except for institutions, a provider usually can have only one. An institution may obtain multiple NPIs for different "subparts" such as a free-standing cancer center or rehab facility.
Enforcement Rule
On February 16, 2006, HHS issued the Final Rule regarding HIPAA enforcement. It became effective on March 16, 2006. The Enforcement Rule sets civil money penalties for violating HIPAA rules and establishes procedures for investigations and hearings for HIPAA violations; however, its deterrent effects seem to be negligible with few prosecutions for violations.
HITECH Act security-breach notification requirements
The Health Information Technology for Economic and Clinical Health Act (HITECH Act), enacted as part of the American Recovery and Reinvestment Act of 2009, imposes notification requirements on covered entities, business associates, vendors of personal health records (PHR) and related entities in the event of certain security breaches relating to protected health information (PHI). The U.S. Department of Health and Human Services (HHS) issued guidance on the subject; HHS and the Federal Trade Commission (FTC) are working to harmonize their respective regulations and are seeking public comment with a view to issuing interim final regulations by August 17, 2009, the deadline imposed by the HITECH Act.
Effects on research and clinical care
The enactment of the Privacy and Security Rules has caused major changes in the way physicians and medical centers operate. The complex legalities and potentially stiff penalties associated with HIPAA, as well as the increase in paperwork and the cost of its implementation, were causes for concern among physicians and medical centers. An August 2006 article in the journal Annals of Internal Medicine detailed some such concerns over the implementation and effects of HIPAA.
Effects on research
HIPAA restrictions on researchers have affected their ability to perform retrospective, chart-based research as well as their ability to prospectively evaluate patients by contacting them for follow-up. A study from the University of Michigan demonstrated that implementation of the HIPAA Privacy rule resulted in a drop from 96% to 34% in the proportion of follow-up surveys completed by study patients being followed after a heart attack. Another study, detailing the effects of HIPAA on recruitment for a study on cancer prevention, demonstrated that HIPAA-mandated changes led to a 73% decrease in patient accrual, a tripling of time spent recruiting patients, and a tripling of mean recruitment costs.In addition, informed consent forms for research studies now are required to include extensive detail on how the participant's protected health information will be kept private. While such information is important, the addition of a lengthy, legalistic section on privacy may make these already complex documents even less user-friendly for patients who are asked to read and sign them.
These data suggest that the HIPAA privacy rule, as currently implemented, may be having negative impacts on the cost and quality of medical research. Dr. Kim Eagle, professor of internal medicine at the University of Michigan, was quoted in the Annals article as saying, "Privacy is important, but research is also important for improving care. We hope that we will figure this out and do it right."
Effects on clinical care
The complexity of HIPAA, combined with potentially stiff penalties for violators, can lead physicians and medical centers to withhold information from those who may have a right to it. A review of the implementation of the HIPAA Privacy Rule by the U.S. Government Accountability Office found that health care providers were "uncertain about their [legal] privacy responsibilities and often responded with an overly guarded approach to disclosing information...than necessary to ensure compliance with the Privacy rule". Reports of this uncertainty continue. Costs of implementation
In the period immediately prior to the enactment of the HIPAA Privacy and Security Acts, medical centers and medical practices were charged with getting "into compliance". With an early emphasis on the potentially severe penalties associated with violation, many practices and centers turned to private, for-profit "HIPAA consultants" who were intimately familiar with the details of the legislation and offered their services to ensure that physicians and medical centers were fully "in compliance". In addition to the costs of developing and revamping systems and practices, the increase in paperwork and staff time necessary to meet the legal requirements of HIPAA may impact the finances of medical centers and practices at a time when insurance company and Medicare reimbursement is also declining.
HIPAA and drug and alcohol rehabilitation organizations
Special considerations for confidentiality are needed for health care organizations that offer federally-funded drug or alcohol rehabilitation services.
Predating HIPAA by over a quarter century are the Comprehensive Alcohol Abuse and Alcoholism Prevention, Treatment and Rehabilitation Act of 1970 and language amended by the Drug Abuse Office and Treatment Act of 1972.
The Administration Simplification provisions also address the security and privacy of health data. The standards are meant to improve the efficiency and effectiveness of the nation's health care system by encouraging the widespread use of electronic data interchange in the U.S. health care system.
Title I: Health Care Access, Portability, and Renewability
Title I of HIPAA regulates the availability and breadth of group health plans and certain individual health insurance policies. It amended the Employee Retirement Income Security Act, the Public Health Service Act, and the Internal Revenue Code.
Title I also limits restrictions that a group health plan can place on benefits for preexisting conditions. Group health plans may refuse to provide benefits relating to preexisting conditions for a period of 12 months after enrollment in the plan or 18 months in the case of late enrollment. However, individuals may reduce this exclusion period if they had group health plan coverage or health insurance prior to enrolling in the plan. Title I allows individuals to reduce the exclusion period by the amount of time that they had "creditable coverage" prior to enrolling in the plan and after any "significant breaks" in coverage. "Creditable coverage" is defined quite broadly and includes nearly all group and individual health plans, Medicare, and Medicaid. A "significant break" in coverage is defined as any 63 day period without any creditable coverage.
Some health care plans are exempted from Title I requirements, such as long-term health plans and limited-scope plans such as dental or vision plans that are offered separately from the general health plan. However, if such benefits are part of the general health plan, then HIPAA still applies to such benefits. For example, if the new plan offers dental benefits, then it must count creditable continuous coverage under the old health plan towards any of its exclusion periods for dental benefits.
However, an alternate method of calculating creditable continuous coverage is available to the health plan under Title I. That is, 5 categories of health coverage can be considered separately, including dental and vision coverage. Anything not under those 5 categories must use the general calculation (e.g., the beneficiary may be counted with 18 months of general coverage, but only 6 months of dental coverage, because the beneficiary did not have a general health plan that covered dental until 6 months prior to the application date). Unfortunately, since limited-coverage plans are exempt from HIPAA requirements, the odd case exists in which the applicant to a general group health plan cannot obtain certificates of creditable continuous coverage for independent limited-scope plans such as dental to apply towards exclusion periods of the new plan that does include those coverages.
Hidden exclusion periods are not valid under Title I (e.g., "The accident, to be covered, must have occurred while the beneficiary was covered under this exact same health insurance contract"). Such clauses must not be acted upon by the health plan and also must be re-written so that they comply with HIPAA.
To illustrate, suppose someone enrolls in a group health plan on January 1, 2006. This person had previously been insured from January 1, 2004 until February 1, 2005 and from August 1, 2005 until December 31, 2005. To determine how much coverage can be credited against the exclusion period in the new plan, start at the enrollment date and count backwards until you reach a significant break in coverage. So, the five months of coverage between August 1, 2005 and December 31, 2005 clearly counts against the exclusion period. But the period without insurance between February 1, 2005 and August 1, 2005 is greater than 63 days. Thus, this is a significant break in coverage, and any coverage prior to it cannot be deducted from the exclusion period. So, this person could deduct five months from his or her exclusion period, reducing the exclusion period to seven months. Hence, Title I requires that any preexisting condition begin to be covered on August 1, 2006.
Title II: Preventing Health Care Fraud and Abuse; Administrative Simplification; Medical Liability Reform
Title II of HIPAA defines numerous offenses relating to health care and sets civil and criminal penalties for them. It also creates several programs to control fraud and abuse within the health care system. However, the most significant provisions of Title II are its Administrative Simplification rules. Title II requires the Department of Health and Human Services (HHS) to draft rules aimed at increasing the efficiency of the health care system by creating standards for the use and dissemination of health care information.
These rules apply to "covered entities" as defined by HIPAA and the HHS. Covered entities include health plans, health care clearinghouses, such as billing services and community health information systems, and health care providers that transmit health care data in a way that is regulated by HIPAA.
Per the requirements of Title II, the HHS has promulgated five rules regarding Administrative Simplification: the Privacy Rule, the Transactions and Code Sets Rule, the Security Rule, the Unique Identifiers Rule, and the Enforcement Rule.
Privacy Rule
The Privacy Rule took effect on April 14, 2003, with a one-year extension for certain "small plans". The HIPAA Privacy Rule regulates the use and disclosure of certain information held by "covered entities" (generally, health care clearinghouses, employer sponsored health plans, health insurers, and medical service providers that engage in certain transactions.) It establishes regulations for the use and disclosure of Protected Health Information (PHI). PHI is any information held by a covered entity which concerns health status, provision of health care, or payment for health care that can be linked to an individual. This is interpreted rather broadly and includes any part of an individual's medical record or payment history.
Covered entities must disclose PHI to the individual within 30 days upon request. They also must disclose PHI when required to do so by law, such as reporting suspected child abuse to state child welfare agencies.
A covered entity may disclose PHI to facilitate treatment, payment, or health care operations, or if the covered entity has obtained authorization from the individual. However, when a covered entity discloses any PHI, it must make a reasonable effort to disclose only the minimum necessary information required to achieve its purpose.
The Privacy Rule gives individuals the right to request that a covered entity correct any inaccurate PHI. It also requires covered entities to take reasonable steps to ensure the confidentiality of communications with individuals. For example, an individual can ask to be called at his or her work number, instead of home or cell phone number.
The Privacy Rule requires covered entities to notify individuals of uses of their PHI. Covered entities must also keep track of disclosures of PHI and document privacy policies and procedures. They must appoint a Privacy Official and a contact person responsible for receiving complaints and train all members of their workforce in procedures regarding PHI.
An individual who believes that the Privacy Rule is not being upheld can file a complaint with the Department of Health and Human Services Office for Civil Rights (OCR). However, according to the Wall Street Journal, the OCR has a long backlog and ignores most complaints. "Complaints of privacy violations have been piling up at the Department of Health and Human Services. Between April 2003 and Nov. 30, the agency fielded 23,896 complaints related to medical-privacy rules, but it has not yet taken any enforcement actions against hospitals, doctors, insurers or anyone else for rule violations. A spokesman for the agency says it has closed three-quarters of the complaints, typically because it found no violation or after it provided informal guidance to the parties involved."
Transactions and Code Sets Rule
The HIPAA/EDI provision was scheduled to take effect from October 16, 2003 with a one-year extension for certain "small plans". However, due to widespread confusion and difficulty in implementing the rule, CMS granted a one-year extension to all parties. As of October 16, 2004, full implementation was not achieved and CMS began an open-ended "contingency period". Penalties for non-compliance were not levied. However, all parties are expected to make a "good-faith effort" to come into compliance.
CMS announced that the Medicare contingency period ended July 1, 2005. After July 1, most medical providers that file electronically will have to file their electronic claims using the HIPAA standards in order to be paid. There are exceptions for doctors that meet certain criteria.
Key EDI(X12) transactions used for HIPAA compliance are:
EDI Health Care Claim Transaction set (837) is used to submit health care claim billing information, encounter information, or both, except for retail pharmacy claims (see EDI Retail Pharmacy Claim Transaction). It can be sent from providers of health care services to payers, either directly or via intermediary billers and claims clearinghouses. It can also be used to transmit health care claims and billing payment information between payers with different payment responsibilities where coordination of benefits is required or between payers and regulatory agencies to monitor the rendering, billing, and/or payment of health care services within a specific health care/insurance industry segment.
For example, a state mental health agency may mandate all healthcare claims, Providers and health plans who trade professional (medical) health care claims electronically must use the 837 Health Care Claim: Professional standard to send in claims. As there are many different business applications for the Health Care claim, there can be slight derivations to cover off claims involving unique claims such as for Institutions, Professionals, Chiropractors, and Dentists etc.
EDI Retail Pharmacy Claim Transaction (NCPDP Telecommunications Standard version 5.1) is used to submit retail pharmacy claims to payers by health care professionals who dispense medications, either directly or via intermediary billers and claims clearinghouses. It can also be used to transmit claims for retail pharmacy services and billing payment information between payers with different payment responsibilities where coordination of benefits is required or between payers and regulatory agencies to monitor the rendering, billing, and/or payment of retail pharmacy services within the pharmacy health care/insurance industry segment.
EDI Health Care Claim Payment/Advice Transaction Set (835) can be used to make a payment, send an Explanation of Benefits (EOB) remittance advice, or make a payment and send an EOB remittance advice only from a health insurer to a health care provider either directly or via a financial institution.
EDI Benefit Enrollment and Maintenance Set (834) can be used by employers, unions, government agencies, associations or insurance agencies to enroll members to a payer. The payer is a healthcare organization that pays claims, administers insurance or benefit or product. Examples of payers include an insurance company, health care professional (HMO), preferred provider organization (PPO), government agency (Medicaid, Medicare etc.) or any organization that may be contracted by one of these former groups.
EDI Payroll Deducted and other group Premium Payment for Insurance Products (820) is a transaction set which can be used to make a premium payment for insurance products. It can be used to order a financial institution to make a payment to a payee.
EDI Health Care Eligibility/Benefit Inquiry (270) is used to inquire about the health care benefits and eligibility associated with a subscriber or dependent.
EDI Health Care Eligibility/Benefit Response (271) is used to respond to a request inquire about the health care benefits and eligibility associated with a subscriber or dependent.
EDI Health Care Claim Status Request (276) This transaction set can be used by a provider, recipient of health care products or services or their authorized agent to request the status of a health care claim.
EDI Health Care Claim Status Notification (277) This transaction set can be used by a health care payer or authorized agent to notify a provider, recipient or authorized agent regarding the status of a health care claim or encounter, or to request additional information from the provider regarding a health care claim or encounter. This transaction set is not intended to replace the Health Care Claim Payment/Advice Transaction Set (835) and therefore, is not used for account payment posting. The notification is at a summary or service line detail level. The notification may be solicited or unsolicited.
EDI Health Care Service Review Information (278) This transaction set can be used to transmit health care service information, such as subscriber, patient, demographic, diagnosis or treatment data for the purpose of request for review, certification, notification or reporting the outcome of a health care services review.
EDI Functional Acknowledgement Transaction Set (997) this transaction set can be used to define the control structures for a set of acknowledgments to indicate the results of the syntactical analysis of the electronically encoded documents. Although it is not specifically named in the HIPAA Legislation or Final Rule, it is necessary for X12 transaction set processing . The encoded documents are the transaction sets, which are grouped in functional groups, used in defining transactions for business data interchange. This standard does not cover the semantic meaning of the information encoded in the transaction sets.
Security Rule
The Final Rule on Security Standards was issued on February 20, 2003. It took effect on April 21, 2003 with a compliance date of April 21, 2005 for most covered entities and April 21, 2006 for "small plans". The Security Rule complements the Privacy Rule. While the Privacy Rule pertains to all Protected Health Information (PHI) including paper and electronic, the Security Rule deals specifically with Electronic Protected Health Information (EPHI). It lays out three types of security safeguards required for compliance: administrative, physical, and technical. For each of these types, the Rule identifies various security standards, and for each standard, it names both required and addressable implementation specifications. Required specifications must be adopted and administered as dictated by the Rule. Addressable specifications are more flexible. Individual covered entities can evaluate their own situation and determine the best way to implement addressable specifications. The standards and specifications are as follows:
* Administrative Safeguards – policies and procedures designed to clearly show how the entity will comply with the act
o Covered entities (entities that must comply with HIPAA requirements) must adopt a written set of privacy procedures and designate a privacy officer to be responsible for developing and implementing all required policies and procedures.
o The policies and procedures must reference management oversight and organizational buy-in to compliance with the documented security controls.
o Procedures should clearly identify employees or classes of employees who will have access to electronic protected health information (EPHI). Access to EPHI must be restricted to only those employees who have a need for it to complete their job function.
o The procedures must address access authorization, establishment, modification, and termination.
o Entities must show that an appropriate ongoing training program regarding the handling of PHI is provided to employees performing health plan administrative functions.
o Covered entities that out-source some of their business processes to a third party must ensure that their vendors also have a framework in place to comply with HIPAA requirements. Companies typically gain this assurance through clauses in the contracts stating that the vendor will meet the same data protection requirements that apply to the covered entity. Care must be taken to determine if the vendor further out-sources any data handling functions to other vendors and monitor whether appropriate contracts and controls are in place.
o A contingency plan should be in place for responding to emergencies. Covered entities are responsible for backing up their data and having disaster recovery procedures in place. The plan should document data priority and failure analysis, testing activities, and change control procedures.
o Internal audits play a key role in HIPAA compliance by reviewing operations with the goal of identifying potential security violations. Policies and procedures should specifically document the scope, frequency, and procedures of audits. Audits should be both routine and event-based.
o Procedures should document instructions for addressing and responding to security breaches that are identified either during the audit or the normal course of operations.
* Physical Safeguards – controlling physical access to protect against inappropriate access to protected data
o Controls must govern the introduction and removal of hardware and software from the network. (When equipment is retired it must be disposed of properly to ensure that PHI is not compromised.)
o Access to equipment containing health information should be carefully controlled and monitored.
o Access to hardware and software must be limited to properly authorized individuals.
o Required access controls consist of facility security plans, maintenance records, and visitor sign-in and escorts.
o Policies are required to address proper workstation use. Workstations should be removed from high traffic areas and monitor screens should not be in direct view of the public.
o If the covered entities utilize contractors or agents, they too must be fully trained on their physical access responsibilities.
* Technical Safeguards – controlling access to computer systems and enabling covered entities to protect communications containing PHI transmitted electronically over open networks from being intercepted by anyone other than the intended recipient.
o Information systems housing PHI must be protected from intrusion. When information flows over open networks, some form of encryption must be utilized. If closed systems/networks are utilized, existing access controls are considered sufficient and encryption is optional.
o Each covered entity is responsible for ensuring that the data within its systems has not been changed or erased in an unauthorized manner.
o Data corroboration, including the use of check sum, double-keying, message authentication, and digital signature may be used to ensure data integrity.
o Covered entities must also authenticate entities it communicates with. Authentication consists of corroborating that an entity is who it claims to be. Examples of corroboration include: password systems, two or three-way handshakes, telephone callback, and token systems.
o Covered entities must make documentation of their HIPAA practices available to the government to determine compliance.
o In addition to policies and procedures and access records, information technology documentation should also include a written record of all configuration settings on the components of the network because these components are complex, configurable, and always changing.
o Documented risk analysis and risk management programs are required. Covered entities must carefully consider the risks of their operations as they implement systems to comply with the act. (The requirement of risk analysis and risk management implies that the act’s security requirements are a minimum standard and places responsibility on covered entities to take all reasonable precautions necessary to prevent PHI from being used for non-health purposes.)
Unique Identifiers Rule (National Provider Identifier)
HIPAA covered entities such as providers completing electronic transactions, healthcare clearinghouses, and large health plans, must use only the National Provider Identifier (NPI) to identify covered healthcare providers in standard transactions by May 23, 2007. Small health plans must use only the NPI by May 23, 2008.
Effective from May 2006 (May 2007 for small health plans), all covered entities using electronic communications (e.g., physicians, hospitals, health insurance companies, and so forth) must use a single new NPI. The NPI replaces all other identifiers used by health plans, Medicare (i.e., the UPIN), Medicaid, and other government programs. However, the NPI does not replace a provider's DEA number, state license number, or tax identification number. The NPI is 10 digits (may be alphanumeric), with the last digit being a checksum. The NPI cannot contain any embedded intelligence; in other words, the NPI is simply a number that does not itself have any additional meaning. The NPI is unique and national, never re-used, and except for institutions, a provider usually can have only one. An institution may obtain multiple NPIs for different "subparts" such as a free-standing cancer center or rehab facility.
Enforcement Rule
On February 16, 2006, HHS issued the Final Rule regarding HIPAA enforcement. It became effective on March 16, 2006. The Enforcement Rule sets civil money penalties for violating HIPAA rules and establishes procedures for investigations and hearings for HIPAA violations; however, its deterrent effects seem to be negligible with few prosecutions for violations.
HITECH Act security-breach notification requirements
The Health Information Technology for Economic and Clinical Health Act (HITECH Act), enacted as part of the American Recovery and Reinvestment Act of 2009, imposes notification requirements on covered entities, business associates, vendors of personal health records (PHR) and related entities in the event of certain security breaches relating to protected health information (PHI). The U.S. Department of Health and Human Services (HHS) issued guidance on the subject; HHS and the Federal Trade Commission (FTC) are working to harmonize their respective regulations and are seeking public comment with a view to issuing interim final regulations by August 17, 2009, the deadline imposed by the HITECH Act.
Effects on research and clinical care
The enactment of the Privacy and Security Rules has caused major changes in the way physicians and medical centers operate. The complex legalities and potentially stiff penalties associated with HIPAA, as well as the increase in paperwork and the cost of its implementation, were causes for concern among physicians and medical centers. An August 2006 article in the journal Annals of Internal Medicine detailed some such concerns over the implementation and effects of HIPAA.
Effects on research
HIPAA restrictions on researchers have affected their ability to perform retrospective, chart-based research as well as their ability to prospectively evaluate patients by contacting them for follow-up. A study from the University of Michigan demonstrated that implementation of the HIPAA Privacy rule resulted in a drop from 96% to 34% in the proportion of follow-up surveys completed by study patients being followed after a heart attack. Another study, detailing the effects of HIPAA on recruitment for a study on cancer prevention, demonstrated that HIPAA-mandated changes led to a 73% decrease in patient accrual, a tripling of time spent recruiting patients, and a tripling of mean recruitment costs.In addition, informed consent forms for research studies now are required to include extensive detail on how the participant's protected health information will be kept private. While such information is important, the addition of a lengthy, legalistic section on privacy may make these already complex documents even less user-friendly for patients who are asked to read and sign them.
These data suggest that the HIPAA privacy rule, as currently implemented, may be having negative impacts on the cost and quality of medical research. Dr. Kim Eagle, professor of internal medicine at the University of Michigan, was quoted in the Annals article as saying, "Privacy is important, but research is also important for improving care. We hope that we will figure this out and do it right."
Effects on clinical care
The complexity of HIPAA, combined with potentially stiff penalties for violators, can lead physicians and medical centers to withhold information from those who may have a right to it. A review of the implementation of the HIPAA Privacy Rule by the U.S. Government Accountability Office found that health care providers were "uncertain about their [legal] privacy responsibilities and often responded with an overly guarded approach to disclosing information...than necessary to ensure compliance with the Privacy rule". Reports of this uncertainty continue. Costs of implementation
In the period immediately prior to the enactment of the HIPAA Privacy and Security Acts, medical centers and medical practices were charged with getting "into compliance". With an early emphasis on the potentially severe penalties associated with violation, many practices and centers turned to private, for-profit "HIPAA consultants" who were intimately familiar with the details of the legislation and offered their services to ensure that physicians and medical centers were fully "in compliance". In addition to the costs of developing and revamping systems and practices, the increase in paperwork and staff time necessary to meet the legal requirements of HIPAA may impact the finances of medical centers and practices at a time when insurance company and Medicare reimbursement is also declining.
HIPAA and drug and alcohol rehabilitation organizations
Special considerations for confidentiality are needed for health care organizations that offer federally-funded drug or alcohol rehabilitation services.
Predating HIPAA by over a quarter century are the Comprehensive Alcohol Abuse and Alcoholism Prevention, Treatment and Rehabilitation Act of 1970 and language amended by the Drug Abuse Office and Treatment Act of 1972.
Medical Transcription and India: The Current Scenario and the Future
Medical transcription is an interesting, challenging and paying career and one of the fastest growing fields in healthcare. Medical records dictated by doctors (or their secretaries/nurses) into a tape or onto a digital voice processing system are accurately and swiftly transcribed i.e. converted into a word document, by the MT or MLS (medical language specialist). These records could be clinic notes, office notes, operative or consultation notes, discharge summaries, etc. The document is proofread to at least 98% accuracy before being “uploaded” back to the doctor’s office or clinic.
In the US, the entire healthcare industry is based on insurance. Therefore, detailed medical records are needed for processing insurance claims. As a result, MTs are in high demand there, and the cost of getting the job done is also very high. India is a very good locale for outsourcing this work due to a number of factors. We have a huge mass of English-speaking and computer-literate people in this country. Moreover, the difference in time zones between the US and India, makes it quite easy to return documents within the usual stipulated time frame of 24 hours.
A transcription service could range from a small home-based business to sophisticated, high-tech corporations, which employ large numbers of transcriptionists, proofers, quality analysts etc. Athough the clientele is mostly in the US, British and even Australian doctors are beginning to consider India as a possible source of getting this work done – done quickly and well, at a fraction of the cost incurred in their own countries!!
India witnessed an “MT boom” a few years ago, with innumerable training institutes mushrooming all over the place. Lack of proper training and understanding of this new concept led to an almost total closure of these institutes. Those that have remained in the field are today flourishing business enterprises, offering this new job opportunity to thousands.
To be a good MT one needs good listening and language skills and knowledge of medical terms (also called Language of Medicine or LOM). Fluency in English with understanding of the American way of speech and accent is a must. A thorough knowledge of the AAMT (American Association for Medical Transcription) rules is also needed. A full-fledged training course would impart all this. Throughout his/her career an MT needs to keep up with changes in medical terminology, medical procedures etc. and have the ability to detect medical inconsistencies in dictation and fix poor grammar and syntax. One also needs patience, as the work tends to get monotonous and repetitive. Regular continuing education programs, which are comprehensive, are therefore essential to be successful in this field.
In the metros and major cities of India, many big business names have ventured into this field and are flourishing. Most of these companies have in-house training programs so that the trainees are assured of a job at the end of their course. As a rule, a fresh MT starts with a salary of Rs. 5000 per month. Incentives are based on the amount of work done (called “line-count”) and the accuracy maintained. A really conscientious and skilled MT would earn a pretty decent salary. As the work can be done at home, it provides a wonderful opportunity for young, educated mothers who would otherwise have to put their careers on hold while their children grow up. Retired persons, the disabled, or those who simply do not wish to venture out of their homes for earning could all thrive in this career.
In short, the future looks bright for those in the field of Medical Transcription.
In the US, the entire healthcare industry is based on insurance. Therefore, detailed medical records are needed for processing insurance claims. As a result, MTs are in high demand there, and the cost of getting the job done is also very high. India is a very good locale for outsourcing this work due to a number of factors. We have a huge mass of English-speaking and computer-literate people in this country. Moreover, the difference in time zones between the US and India, makes it quite easy to return documents within the usual stipulated time frame of 24 hours.
A transcription service could range from a small home-based business to sophisticated, high-tech corporations, which employ large numbers of transcriptionists, proofers, quality analysts etc. Athough the clientele is mostly in the US, British and even Australian doctors are beginning to consider India as a possible source of getting this work done – done quickly and well, at a fraction of the cost incurred in their own countries!!
India witnessed an “MT boom” a few years ago, with innumerable training institutes mushrooming all over the place. Lack of proper training and understanding of this new concept led to an almost total closure of these institutes. Those that have remained in the field are today flourishing business enterprises, offering this new job opportunity to thousands.
To be a good MT one needs good listening and language skills and knowledge of medical terms (also called Language of Medicine or LOM). Fluency in English with understanding of the American way of speech and accent is a must. A thorough knowledge of the AAMT (American Association for Medical Transcription) rules is also needed. A full-fledged training course would impart all this. Throughout his/her career an MT needs to keep up with changes in medical terminology, medical procedures etc. and have the ability to detect medical inconsistencies in dictation and fix poor grammar and syntax. One also needs patience, as the work tends to get monotonous and repetitive. Regular continuing education programs, which are comprehensive, are therefore essential to be successful in this field.
In the metros and major cities of India, many big business names have ventured into this field and are flourishing. Most of these companies have in-house training programs so that the trainees are assured of a job at the end of their course. As a rule, a fresh MT starts with a salary of Rs. 5000 per month. Incentives are based on the amount of work done (called “line-count”) and the accuracy maintained. A really conscientious and skilled MT would earn a pretty decent salary. As the work can be done at home, it provides a wonderful opportunity for young, educated mothers who would otherwise have to put their careers on hold while their children grow up. Retired persons, the disabled, or those who simply do not wish to venture out of their homes for earning could all thrive in this career.
In short, the future looks bright for those in the field of Medical Transcription.
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