20b. Letter Report of Critical Values

Attachment 20b. Letter Report of Critical Values

Multi-site Study

Letter Report of Critical Values

Flesch-Kincaid Readability Score – 6.9

[ON INSTITUTION NAME LETTERHEAD]

[DATE]

[NAME OF ADULT/PARENT OF CHILD PARTICIPANT]

[ADDRESS]

[CITY, STATE ZIP CODE]

Subject: Report of Critical Values – Multi-site Study (CDC Protocol No. xxxx)

Dear [NAME OF ADULT/PARENT OF CHILD PARTICIPANT]:

Thank you for taking part in the Multi-site Study conducted by [institution name] and Agency for Toxic Substances and Disease Registry (ATSDR).

We called you on [mm/dd/yyyy] to inform you that (one/some) of (your/your child’s) test (result was/results were) reported to be outside of the normal range provided by the laboratory. We called as soon as we received the lab report, because critical test results fall greatly outside the normal range. They may indicate a very serious medical situation that needs immediate attention. We are sending this letter for your records.

Your specimens were collected on [mm/dd/yyyy]. Even though it has been some months since we collected them, we provide our call and this letter to encourage you to talk to [your/your child’s] doctor about these results. Since some time has passed, it is possible that (you have/your child has) already seen the doctor.

TEST	DATE PERFORMED	LABORATORY RESULT	CRITICAL VALUE
Glucose, fasting	mm/dd/yyyy	|__|__|__| mg/dL	<40 or >400 mg/dL
Triglyceride	mm/dd/yyyy	|__|__|__|__| mg/dL	>1,000 mg/dL
Serum albumin	mm/dd/yyyy	|__|__|.|__| g/dL	<1.5 g/dL or >7.9 g/dL
Total bilirubin	mm/dd/yyyy	|__|__|.|__| mg/dL	>12.9 mg/dL

What do these values mean?

Glucose <40 mg/dL	(Your/Your child’s]) diabetes was poorly controlled. (Your/his/Her) medications might need to be adjusted.
Glucose >400 mg/dL	(Your/Your child’s]) diabetes was poorly controlled. (Your/His/Her) medications might need to be adjusted.
Triglyceride >1,000 mg/dL	(You have/Your child has] a problem with lipid metabolism. This shows a very high risk of heart disease.
Serum albumin <1.5 g/dL	(You/Your child) may have a nutrition, liver, or kidney problem.
Serum albumin >7.9 g/dL	(You/Your child) may be severely or chronically dehydrated.
Total bilirubin >12.9 mg/dL	[You/Your child] may have a liver problem or a bile duct problem.

If you or your doctor has a question about these test results, please call us at [insert telephone number].

Thank you for [your/your child’s] participation in the study.

Sincerely,

Study Investigators

Multi-site Study