520
Detailed Needs and Requirements: Clinical Studies Unit
2. Organization
In order to conduct these studies with the requisite degree of precision,
it is necessary to keep the patients in a separate unit where control
over significant variables can be maintained and where supervision is
available to insure that patient activities will not invalidate test results.
The study programs carried on in the metabolic unit may require that
the patients significantly alter their usual patterns of activity. They may
eat or drink only what is given to them; they have to collect all waste
products, i.e., feces and urine, rather than disposing of them by
flushing the toilet and they have to be available at specific times for
various tests, measurements, and collection of samples. Since these
requirements may conflict with long established habits, the patients
may have to be thoroughly instructed in these requirements, and
wherever possible, safeguards should be instituted to insure
appropriate action.
The quantity and content of all patient meals may have to be carefully
controlled, measured, and recorded. To assure this, these meals are
prepared on the unit by specially trained deictic personnel.
Many of the sample analysis and measurement procedures are
essentially routine and may be done in a central clinical laboratory;
however, some test may be done in a laboratory on the unit.
Various levels of psychological monitoring may be required for any
patient in the unit.
527.1.4
Primary Users
1. Patients
The majority of patients in the clinical studies units are ambulant and
mostly capable of caring for themselves. They can feed themselves,
use toilet facilities, and take care of their general hygiene and toilets
requirements, without nursing assistance. They are capable of utilizing
out-of-bed entertainment and recreation facilities, e.g., lounge, and
card playing facilities, etc. They are also capable of taking their meals
out of bed. If there is no conflict with the test being conducted, these
patients may be encouraged to utilize their ambulant or self-care
abilities as much as possible.
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