Attachment 6
Case Report Form
OMB NO. 0920-0641
Exp. Date 12/30/2006
Case Report Form
2. Condition (must have been screened for in state of birth at the time of birth)
(Check one)
____Classical phenylketonuria
____Primary congenital hypothyroidism
____Galactosemia (any type if law is not restrictive)
____Maple syrup urine disease
____Homocystinuria
____Biotinidase deficiency
____Classical congenital adrenal hyperplasia (saltwasting or simple virilizing)
____Sickle cell disease
3. Child’s birth month/year_____________
4. Reason(s) for missed or delayed diagnosis (choose all that apply):
____No specimen collected
____Specimen mislabeled
____Transfer to another hospital, no specimen collected
____Delayed first specimen because of home delivery
____Delayed first specimen because infant was in NICU
____No satisfactory specimen collected (initial specimen invalid and repeat not obtained)
____First specimen was unsatisfactory, repeat obtained after delay
____Other (explain)
Public reporting burden of this collection of information is estimated to average 10 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to CDC/ATSDR Reports Clearance Officer; 1600 Clifton Road NE, MS-D73, Atlanta, Georgia 30333; ATTN: PRA (0920-0641).
____Specimen not shipped in a timely manner
____Specimen delayed in transport, by how long?______(days)
____Specimen lost in transport
____Other (explain)
Additional details if available:
____Delay in running analysis
____Measurement error, Chemistry
____Measurement error, Instrument
____Misinterpretation of result
____Improper cutoff used
____Mishandling of specimen
____Wrong specimen assayed
____Abnormal value not recorded
____Misread identification number
____Clerical error
____Lack of notification of physician or follow-up coordinator
____Other (explain)
Additional details if available:
____No follow-up
____Second specimen requested but not received
____Follow-up coordinator unable to locate physician of record
____Follow-up coordinator unable to locate family of patient
____Follow-up coordinator delayed contacting physician or family of patient
____Other (explain)
Additional details if available:
____Physician of record fails to notify patient or other physician of screening result
____Physician does not ensure that patient is retested in timely manner
____Physician does not order diagnostic tests
____Diagnostic results not communicated by laboratory to physician
____Diagnostic results not communicated by physician to patient
____After diagnosis, provider does not prescribe treatment
____Parent refuses retesting or treatment
____Other (explain)
Additional details if available:
____Sample collected too early
____Late onset variant not detectable in first few days
____Form of disorder not detectable through assay used by screening laboratory
____Other (explain)
Additional details if available:
Please explain:
Additional details if available:
Health outcome
____Death
____Mental retardation
____Developmental delay
____Other neurological symptoms (explain)
____Other (explain)
Additional details if available:
Legal outcome
Litigation
____Yes ____No
Additional details if available:
6. Analysis
What steps could be taken to prevent this situation from recurring?
Please explain:
Has the state changed the newborn screening regulations, policies or protocols as a result of this case? _____Yes ____No
If yes, specify the changes:
7. Comments:
| File Type | application/msword |
| File Title | OMB NO |
| Author | zfa4 |
| Last Modified By | zfa4 |
| File Modified | 2006-12-08 |
| File Created | 2006-12-08 |