Att 10 - Report of Findings

Attachment 10

Report of Findings

Attachment 10 - Reports of Findings

The contractor’s advance arrangements team will contact county health officials and other community groups at each survey location to obtain lists of health clinics and/or doctors that are both acceptable and accessible to survey participants who do not have a source of health care.

There will be three circumstances in which communication between NCHS and a sample person and possibly source of health care will be made, based on the importance of the survey findings. This discussion describes three levels of referrals.

LEVEL I

A Level I referral is made in situations in which a medical emergency is discovered by a member of the NHANES exam team and verified by the staff physician, who further determines that the medical findings require immediate attention by a health care provider.

An emergency medical kit will be kept in each MEC so that emergency aid can be provided when necessary to stabilize the individual’s health status. The preferred manner of handling medical emergencies that occur at the examination center will be to contact local rescue squads, ambulance services and hospital emergency rooms. Contact information for all of these groups is kept at the NHANES examination centers. Level I contacts with a health care provider on behalf of a sample person occur infrequently.

An in-house NCHS response team is available to answer calls from NHANES participants regarding the results from the Report of Finding System. The response team effort works both as a triage mechanism and a surveillance system. A receipt and control record is kept on all sample person inquiries. Also available at no cost to sample persons, is a toll-free telephone number which can be accessed during normal business hours. The response team members consist of a physician, a nurse with a Master’s degree, and other staff who have been trained to answer specific questions. Attachment 10-1 is used for MEC exams in which a participant refuses further medical attention.

LEVEL II

Level II contacts occur frequently. An example of a Level II contact is when the examination center staff determines that there are major medical findings that can be expected to cause adverse effects within two or three weeks. When such a condition is identified based upon the information collected during the survey, the NHANES physician will do the following: explain the health concern to the participant, provide the participant with a written report of the findings, and encourage the respondent to see their personal medical provider within the next two weeks. If the survey participant does not have a health care provider or usual source of health care, the NHANES physician will assist the participant by reviewing the list of health care providers that are listed on the referral list for their community. The same procedure will be used for referrals that are needed for oral health care.

A second type of Level II contact occurs when abnormal findings are reported by a contract laboratory or consultant reviewing the examination data for a particular component off-site. The consultant or laboratory will contact NCHS staff immediately. The survey participant will be notified by mail (see Level II letter - Attachment 10-2). The letter will describe the findings and will encourage the survey participants to see medical care from their personal health care provider. This type of Level II contact with a sample person can occur as early as several days after the exam, but usually within two to three weeks of it. Attachment 10-3 shows another example of a Level II report.

LEVEL III

Level III refers to the routine Report of Findings that are sent to all examinees whether or not any extremely abnormal findings were present. The Report does not include the results of every test and exam that was performed but it will include a complete summary of findings that are of clinical interest (see Level III Routine Report of Findings - Attachment 10-4). The Report will also remind the participant to consult their personal health care provider when the results include abnormal findings. The report includes height and weight results, and, depending on the age of the participant, blood pressure and the results from special studies and laboratory tests. The report packet will also contain the medical referral listing for the specific community and a list of health information resources (Attachment 10-5). See Attachments 8 and 10-6 for the laboratory and examination results which will be given to survey participants.

For examinees under 18 years of age, the reports of findings will be given to their parents or guardians, except for the results of testing for sexually transmitted diseases.

10-1. NHANES MEC RELEASE FORM

Date ________________________

This is to certify that, against the advice of the medical doctor, I:

 am leaving the Mobile Exam Center.

 am removing ____________________________ from the Mobile (Name of Sample Person)

Exam Center.

 choose no further medical referral or follow-up.

By so doing, I assume all responsibility for my act.

_________________________ Signed

_________________________

Relationship

____________________________

Witness

SP ID _ _ _ _ _ _

OMB #0920-NEW

Attachment 10-2 – Early Reporting Letter – General laboratory

NHANES Early Reporting Letter Example

Sample person name

Address

Telephone number

Sample Number:

Dear,

Recently, you participated in a voluntary health examination at special mobile facilities operated by the National Center for Health Statistics, part of the Centers for Disease Control and Prevention. We reviewed your test results from your examination on <insert date>, and found that some values were abnormal and require your immediate attention.

We cannot be sure whether or not these test results represent illness. Only your doctor can determine that. We strongly recommend that you talk to your doctor and give him or her your test results on the enclosed sheet. He or she can evaluate your findings and help you understand what they mean for your health. The NHANES program will not pay for further tests or treatment you may require.

The examination was not intended to be a complete physical examination nor a substitute for a visit to a doctor. Our survey physicians are not authorized to administer treatment or engage in any follow-up with examinees.

You will receive a full report of your examination findings in the future, but we thought you should know about these results right away.

If you have any questions, you may call me at our toll-free number,

1-800-452-6115, between 8:30 AM and 6 PM Eastern Time, Monday through Friday.

Sincerely yours,

Kathryn S. Porter, M.D., M.S.

Medical Officer

Enclosure

Laboratory

Test Result Units Flag Reference Range

Abnormal value(s)

Glucose 156 mg/dL high 60-109

Other values

Glycohemoglobin 6.8 % 0 -6.9

AL T 22 U/L 0 -31

AST 26 U/L 0 -31

Alkaline Phosphatase 41 U/L 39-117

Albumin 4.1 g/dL 3.2 -5.2

Bicarbonate 24 mmol/L 22-29

BUN 8.0 mg/dL 6.0 -19.0

Calcium 9.4 mg/dL 8.4 -10.2

Cholesterol 198 mg/dL 0 -199

Triglycerides 146 mg/dL 0 -149

HDL ^^^ mg/dL >= 40.0

LDL ^^^ mg/dL 0 -129

Serum Creatinine 0.8 mg/dL 0.4 -1.2

GGT 20 U/L 7-33

LDH 100 U/L 94.0 -250.0

Phosphorus 4.2 mg/dL 2.6 -4.5

Sodium 137 mmol/L 133.0 -145.0

Potassium 3.6 mmol/L 3.3 -5.1

Chloride 103 mmol/L 96.0 -108.0

Total Protein 6.8 g/dL 5.9 -8.4

Uric Acid 4.0 mg/dL 2.4 -5.7

Bilirubin 0.9 mg/dL 0 -1.0

Serum Folate ^^^ ng/mL 1.7 -20.6

RBC Folate ^^^ ng/mL RBC 70-424

Iron ^^^ ug/dL 22.0 -163.0

Serum Ferritin ^^^ ng/ML 15-570

Blood Lead ^^^ ug/dL 0 -20.0

Cadmium 0.4 μg/L 0.3 - 1.2

Total Blood Mercury 0.6 μg/L < 10.0

*** Test not done on this age group

^^^ Result still pending

--- Test not done

<< Lower than the limit of detection Number of hours fasted prior to blood draw: 6 hours

Attachment 10-4 – Early Reporting Letter – Hepatitis C

Sample person name

Address

Sample Number:

Date

Dear <insert name>,

Recently, you participated in a voluntary health examination at special mobile facilities operated by the National Center for Health Statistics, part of the Centers for Disease Control and Prevention. As part of this examination your blood was tested for hepatitis C virus. Your blood sample collected on <insert exam date>, indicates you were infected with the hepatitis C virus even though you may never have felt sick.

If no one has told you before that you have the virus, we strongly recommend you take this letter to your doctor as soon as you can. You will want to talk with your doctor about possible treatment for hepatitis C and how to prevent spreading the disease to other people. Your doctor may want to do more tests to find out if the virus has done any damage to your liver.

Almost four million Americans are infected with hepatitis C virus. Most persons who are infected carry the virus for the rest of their lives. The infection can lead to liver damage, although many people with the virus never feel sick. We have enclosed a fact sheet with information on hepatitis C. You may obtain other information on hepatitis C by calling toll free:

American Liver Foundation 1-800-223-0179

Hepatitis Foundation International 1-800-891-0707

Centers for Disease Control and Prevention 1-888-4HEPCDC

or the CDC web site: http://www.cdc.gov/hepatitis

We want to give you this important information and urge you to see your doctor. The NHANES program will not pay for any follow-up tests or care you may require, but we will be available to talk with you or your physician about this letter and to answer any questions you may have. You can reach me on our toll-free number 1-800-452-6115 between 9 AM and 6 PM Eastern Time, Monday through Friday.

Sincerely yours,

Kathryn S. Porter, M.D., M.S.

Medical Officer

Enclosure

This information will help you to better understand what hepatitis C is, how you may have gotten hepatitis C, and what you can do to prevent passing hepatitis C virus to others.

If you have

HEPATITIS C

ALMOST 4 MILLION AMERICANS ARE INFECTED WITH HEPATITIS C VIRUS

What is hepatitis C?

Hepatitis C is a liver disease caused by the hepatitis C virus (HCV), which is found in the blood of persons who have this disease. The infection is spread by contact with the blood of an infected person.

How serious is hepatitis C?

Hepatitis C is serious for some persons, but not for others. Most persons who get hepatitis C carry the virus for the rest of their lives. Most of these persons have some liver damage but many do not feel sick from the disease. Some persons with liver damage due to hepatitis C may develop cirrhosis (scarring) of the liver and liver failure which may take many years to develop. Others have no long term effects.

What can I do now that my hepatitis C test is positive?

Contact your doctor. Additional tests may be needed to check your diagnosis and to see if you have liver damage.

What if I don't feel sick?

Many persons with long-term hepatitis C have no symptoms and feel well, but should still see their doctor. For some persons, the most common symptom is extreme tiredness.

How could I have gotten hepatitis C?

HCV is spread primarily by exposure to human blood. You may have gotten hepatitis C if:

 you received a blood transfusion or solid organ transplant (e.g., kidney, liver, heart) before 1992

 you received clotting factor concentrates before 1987

 you ever injected street drugs, even once

 you were ever on long-term kidney dialysis

 you were ever a health care worker and had frequent contact with blood in the work place, especially accidental needlesticks

 you ever had sex with a person infected with HCV

 you have had multiple sex partners

 your mother had hepatitis C at the time she gave birth to you

 you lived with someone who was infected with HCV and shared items such as razors or toothbrushes that had blood on them

How can I prevent spreading HCV to others?

 Do not donate your blood, body organs, other tissue, or sperm

 Do not share toothbrushes, razors, or other personal care articles that might have your blood on them

 Cover cuts or open sores in your skin

 If you shoot drugs, stop and get into a treatment program. If you can't stop, use a clean needle and works every time and don't share them

 If you have one steady sex partner, there is a very low chance of giving hepatitis C to that partner through sexual activity, and you do not need to change your sexual practices. If you want to lower the small chance of spreading HCV to your partner, you may want to use latex condoms. Ask your doctor about having your sex partner tested

 If you have sex with multiple partners, lower your number of partners, inform them that you have hepatitis C, and always use barrier precautions, such as latex condoms

What if I am pregnant?

Five out of every 100 infants born to HCV infected women become infected. This occurs at the time of birth, and there is no treatment that can prevent this from happening. However, infants infected with HCV at the time of birth seem to do very well in the first few years of life. More studies are needed to find out if these infants will be affected by the infection as they grow older. Breast feeding does not spread HCV.

Hepatitis C is not spread by:

· sneezing

· hugging

· coughing

· sharing eating utensils or drinking glasses

· food or water

· casual contact

There is no vaccine available to prevent hepatitis C.

A person who has hepatitis C can still get other types of viral hepatitis, such as hepatitis A or hepatitis B.

Is there a treatment for hepatitis C?

People with liver damage from hepatitis C should get vaccinated against hepatitis A and hepatitis B. See your doctor.

A drug called interferon is licensed for the treatment of persons with long-term hepatitis C. About 2 out of every 10 patients who are treated get rid of the virus. You should check with your doctor to see if treatment would help you.

How can I take care of my liver?

· See your doctor regularly

· Do not drink alcohol

 Tell your doctor about all medicines that you are taking, even over the counter and herbal medicines

 Your doctor may want to do additional tests to determine the progress of your disease. The government agency responsible for the NHANES survey cannot provide any additional testing for you

For information on viral hepatitis:

call the Hepatitis Hotline at

1-888-4HEPCDC

1-888-443-7232

or access the Internet at

http:/www.cdc.gov/ncidod/diseases/hepatitis/hepatitis.htm

or write

Hepatitis Branch, Mailstop G37

Division of Viral and Rickettsial Diseases

National Center for Infectious Diseases

Centers for Disease Control and Prevention

Atlanta, GA 30333

Attachment 10-5 – Final Report of Findings

Date of Examination: July 1, 2005

Participant Name: John Doe

P

These measurements were obtained as part of a survey and do not represent a medical diagnosis. Interpretation of these measurements must be made by a physician.

articipant Age:

Participant Gender: Male

SP ID: 123456

Body Measurements

Height: 5’8”

Weight: 174 lbs.

For a person of your height, your weight is above the range of a healthy weight, and you may be overweight

Blood Pressure & Heart Rate

Your Measurements Normal

Systolic Blood Pressure: 142 mm Hg < 120

Diastolic Blood Pressure: 88 mm Hg < 80

Resting Pulse Rate: 64 bpm

Your blood pressure today is high, based on the Seventh Report of the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. NIH Publication, 2003

Oral Health

The dental examination you received today is not, and is not intended to be, a substitute for the examination usually given to persons seeking care from their own dentists. Neither a dental history nor x-rays are taken, and therefore the findings are solely the result of what can be seen at the time of the examination.

The examining dental hygienist recommends that you: Should see a dentist within the next 2 weeks

The examining dental hygienist observed the following conditions: Decayed Teeth

Soft Tissue Problems

Laboratory

Complete Blood Count Result Units Flag Reference Range

White Blood Count 7.4 (x10⁹/L) 3.9 - 12.1

Lymphocytes 23.5 (%) 17.8 - 52.8

Monocytes 7.2 (%) 0 - 12

Neutrophils 67.4 (%) 39.7 - 77.8

Eosinophils 1.9 (%) 0 - 8

Basophils 0.1 (%) 0 - 2

Red Blood Count 3.8 (x10¹²/L) 3.7 - 5.2

Hemoglobin 10.0 (g/dl) Low 10.4 - 15.2

Hematocrit 35.0 (%) 32 - 45

MCV 78.9 (fL) 73.4 - 98.3

MCH 28.9 (pg) 23.2 - 33.3

MCHC 32.2 (g/dL) 31.4 - 35.1

RDW 12.0 (%) 11.8 - 16.6

Platelet Count 217.0 (x10⁹/L) 172 – 453

Body scan and bone density

The bone density measurement can help spot persons who may be at greater risk for fracture because they have weaker bones. In general, a lower bone density means that the bone is weaker. Yet, not all men or women with low bone density will have fractures.

The results from your hip (left) scan show:

Hip bone density 1.32 g/cm²

Z-score 1.6

Compared with men your age, your hip bone density is normal.

The results from your spine (lumbar) scan show:

Spine bone density 1.21 g/cm²

Z-score 1.2

Compared with men your age, your spine bone density is normal

Laboratory

Laboratory Test Result Units Flag Reference Range

Glucose 96 mg/dL 60 - 109

Glycohemoglobin 5.3 % < 7.0

2-hour Glucose Tolerance Test 172 mg/dL 60 - 139

AL T 22 U/L < 40

AST 26 U/L < 31

Alkaline Phosphatase 41 U/L 39 - 117

Albumin 4.1 g/dL 3.2 - 5.2

Bicarbonate 24 mmol/L 22 - 29

BUN 8 mg/dL 6 - 19

Calcium 9.4 mg/dL 8.4 - 10.2

Cholesterol 246 mg/dL high < 200

Triglycerides 129 mg/dL < 150

HDL 107 mg/dL > 39

LDL 83 mg/dL < 130

Serum Creatinine 0.8 mg/dL 0.4 - 1.2

GGT 20 U/L 11 - 51

LDH 100 U/L 94 - 250

Phosphorus 4.2 mg/dL 2.6 - 4.5

Sodium 137 mmol/L 133 -145

Potassium 3.6 mmol/L 3.3 -5.1

Chloride 103 mmol/L 96 - 108

Total Protein 6.8 g/dL 5.9 - 8.4

Uric Acid 4.0 mg/dL 3.4 – 7.0

Bilirubin 0.9 mg/dL 0 -1.0

Serum Folate 9 ng/mL 2 - 21

RBC Folate 245 ng/mL RBC 70 - 424

Iron 157 μg/dL 22 - 163

Vitamin B12 509 μg/dL 204 - 1261

Blood Lead 1.7 μg/dL 0 - 20

Cadmium 0.4 μg/L 0.3 - 1.2

Total Blood Mercury 0.6 μg/L < 10.0

Thyroid Stimulating Hormone 4.10 μIU/mL 0.34 - 5.60

Free T4 1.30 ng/dL 0.58 – 1.64

Free T3 2.64 pg/ml 2.50 – 3.90

Results that are flagged “high” or “low” may indicate a health problem. You may wish to share these results with your doctor.

^^^ Results still pending

--- Test not done

<<< Lower than the limit of detection Number of hours fasted prior to blood draw: 12 hours

Laboratory

Result Flag Reference Range

Urine

Sample collected on <insert date>

Albumin Creatinine Ratio 330 High < 30

(ug albumin/g creatinine)

Attachment 10-6. Federal Resource List to be Included with all Reports of Findings

HEALTH INFORMATION RESOURCE LIST

Information on a variety of health topics is available from

the following Federal agencies.

National Institute on Aging Office of Disease

Federal Building, Room 6C12, National HEALTH INFORMATION

9000 Rockville Pike, Center, P.O. Box 1133,

Bethesda, MD 20892,(301)496-1752 Washington, DC 20013-1133

(800)336-4797 (Metropolitan

Publishes brochures and a ser- Washington, DC (301)565-4167)

ies of fact sheets called Age

Pages, covering a wide variety Provides assistance in locat-

of topics related to aging. ing health information

resources, and distributes

National AIDS Information publications on health

Clearinghouse promotion and disease

P.O. Box 6003, Rockville, MD prevention.

20850 (800)458-5231

National Heart, Lung, and Blood

Provides information and pub- Institute Education Programs

lications on AIDS and supports Information Center, 4733

a national hotline and resource Bethesda Avenue, Suite 530,

center. Bethesda, MD 20814, (301)951-

3260

National Clearinghouse for ALCOHOL

and Drug Information, P.O. Box Provides information and

2345, Rockville, MD 20852, materials on smoking, choles-

(301)468-2600 terol, high blood pressure,

heart disease, stroke, exer-

Distributes a variety of publica- cise, and other topics related

tions on alcohol and drug abuse. to heart and lung health.

CANCER Information Service, National Center for Education

National Cancer Institute, in MATERNAL and Child Health,

Building 31, Room 10A24, 38th and R Streets NW, Wash-

9000 Rockville Pike, MD 20892, ington, DC 20056 (202)625-

(800)4-CANCER 8400

Provides information about cancer Provides information on pregnancy

diagnosis and treatment to and childbirth,

patients and families. Spanish- child and adolescent health, nutri-

speaking staff members are tion, high risk infants,

available in California, Florida, chronic illness and

Georgia, Illinois, northern disability, genetics, and

New Jersey, New York, and women’s health. Resource

Texas. Center distributes materials

on organizations and programs.

National DIABETES Information National Institute of MENTAL

Clearinghouse, Box NDIC, HEALTH, 5600 Fishers Lane,

Bethesda, MD 20892 (301)468- Room ISC-05, Rockville, MD

2162 20857, (301)443-4513

Collects and disseminates Answers general inquiries

information to consumers and about mental health and

health professionals on diabetes distributes a variety of

and its complications. publications in English and

Spanish at no charge.

FOOD and Drug Administration,

Office of Consumer Affairs, 5600 Office on SMOKING and Health,

Fishers Lane (HFE-88) Department of Health and Human

Rockville, MD 20857 Services, Park Bldg, Room 1-16,

(301)443-3170 Rockville, MD 20857, (301)443-

1690

Responds to inquiries about foods,

cosmetics, medical devices, drugs, Distributes consumer

health fraud, Reye’s syndrome, publications on smoking and

and radiological health and health, including smoking

serves as a clearinghouse for and teenagers, smoking and

related consumer publications. pregnancy, and smoking

cessation.

This resource list is a service of the National Center

for Health Statistics(NCHS) and the Office of Disease

Prevention and Health Promotion(ODPHP).

Attachment 10-7. List of Exam Measurements Noting Which Results Will Be Given to Respondent

Health Measurements:

*Blood Pressure

*Bone Density Measurement (low dosage x-ray of spine)

*Oral Health Exam

*Height, Weight, and Other Body Measures

Laboratory Tests on Urine:

*Kidney Tests

*Pregnancy Test

*Sexually Transmitted Diseases (STDs)

*Exposure to environmental chemicals

* Hormone tests

Laboratory Tests on Blood:

*Human Immunodeficiency Virus (HIV) antibody

*Anemia

*Cholesterol

*Glucose Measures

*Herpes Simplex Virus Type 2

**Infectious Diseases

Kidney Tests

**Environmental chemicals

*Liver Tests

*Nutritional Status

* Markers of immunization status

*Celiac Disease

* Bone Status Test

Laboratory Tests on Swabs:

*Human Papillomavirus (HPV)

Private Health Interviews:

Health Habits

Mental Health

Nutrition

Physical Activity

Reproductive Health

Sexual Experience

*You will receive results

**You will receive results only if abnormal

Attachment 10-8. Referral for participants who may have suicidal thoughts

Information volunteered or reported during the Depression Questionnaire can prompt a referral to the Mobile Examination Center (MEC) physician. MEC interviewers send a mental health observation to the physician if the participant’s response to question 05DPQ.090 is 1, 2 or 3 – or if the participant becomes visibly upset while answering the question about suicide. The system will alert the physician and coordinator that the examinee needs to be seen by the physician prior to leaving the exam center. The physician is responsible for assessing the mental health concern and facilitating referral as needed.

A-4