It is the policy of Hillcrest Educational Centers, Inc. (HEC) that all medical care providers will implement the procedures described in this policy relative to waived testing.

Purpose: To provide a framework for waived tests by establishing minimum requirements for quality control, responsibility of the testing personnel and required reporting for waived tests including Clinical Laboratory Improvement Amendments of 1988 (CLIA 88), Department of Public Health and JCAHO standards.

Applicability: All personnel in the residential sites nursing departments performing waived testing. The current Nursing Director under the direction of the Medical Director will serve as the laboratory director and oversee all pertinent policies and procedures.

Definitions:

CLIA: Clinical Laboratory Amendments of 1988. When an individual performs a test or interprets the results of a test, it is an activity regulated by CLIA.

Waived testing: A wide variety of simple laboratory examinations and procedures that are cleared by the FDA for home use. These tests employ methodologies that are simple and accurate and pose no reasonable risk of harm to the patient. These tests may include but are not limited to urine multistix, urine drug screen, rapid strep test, urine pregnancy test, blood glucose test.

Certification:

CLIA application for certificate of waiver will be obtained from the Massachusetts Department of Health and Human Services and maintained every 2 years.

Standards:

Personnel performing and supervising the waived testing will be identified and adequately trained by the Laboratory Director

Satisfactory staff competencies will be established and performed annually

Written records of competence will be maintained on each campus. (See attached record)

Specific testing processes from the manufacturer will be current and readily available in the “Waived Testing Manual.”

Quality-control checks will be conducted on each kit as recommended by the manufacturer. One person at each campus will be assigned to complete the checks and maintain a written record in the “Waived Testing Manual.” (See attached)

Test records will be kept in the “Waived Testing Manual” as well as the client record. (See attached flow sheet).

All urine tests will be sent to the contract laboratory for confirmatory testing.

Quality Control Testing Flowsheet

Record of CLIA Medical Testing

CLIA waived kits available through Moore Medical

82790- Moore brand HCG cassette- Alere North America, Inc/Form (manufacturer) 877-441-7440

82808 -6 Panel drug test icassette- Instant technologies (manufacturer) 800-340-4029

82792- Moore brand Strep A dipstick- Alere North America Inc/Form (manufacturer) 877-441-7440

32403- Multistix 10SG- Siemans Healthcare Diag/Bayer (manufacturer)
800-255-3232

Controls

82794 HCG Controls
92518 Drug Screen Controls- ICassette
55607 Multistix Controls

SAMPLE GLUCOSE TESTING BY FINGER STICK PROCEDURE
I. Purpose
To determine blood sugar level. Testing blood sugar is an integral part of
diabetes management. Testing helps monitor diabetes and make adjustments in
diet and exercise regimen as needed. The goal is to keep blood sugar level as
close to normal as possible. In doing so, long term health problems caused by
abnormal blood sugar levels may be delayed or prevented.
II. Specimen
One large drop of whole blood collected by finger stick at the time of testing.
Glucose tests are to be performed as indicated by physician or nurse.
III. Materials
One Touch Basic Meter
Test Strips
Lancets
Penlet II
Alcohol Prep Pads
Gloves
Sharps Container
IV. Procedure
1. Wash hands and put on gloves.
2. Ask consumer to wash hands with soap and warm water and dry thoroughly
to clean area for prick.
3. Press the On/ Off Button on Meter.
4. Press C Button until the code number matches the code number on the Test
Strip package. The Meter will remember this code until it is changed for a
new package of Test Strips.
5. Insert test strip
6. Remove Penlet II Cap and insert Lancet by pushing it into the Lancet holder.
Twist off the protective disk and replace Penlet II Cap.
7. Cock the Penlet II by pulling out the dark gray sliding barrel on the end of the
device.
8. Place Penlet II against the side of finger and press the dark gray Release
Button on its side. Be sure to rotate which finger you use to avoid soreness
or callouses.
9. Squeeze the finger gently to get a large, hanging drop of blood.
10. Apply drop of blood to test spot by only touching the drop to the test spot.
Allow 45 seconds for results.
11. Use caution when removing the Lancet and Penlet II Cap. Remove cap and
grasp the dark gray T-Shaped prongs. Point the Lancet down and away from
you into the sharps container. Pull back on the dark gray sliding barrel until
the Lancet drops out into the sharps container.
12. Remove Test Strip and discard after obtaining and documenting results.
13. Remove gloves and wash hands.
V. Interpretation
1. Follow physician/ nurse orders regarding interpretation of test results.
Client’s home staff must communicate to habilitation staff any changes in
physician/ nurse orders regarding glucose levels as changes occur. Current
physician orders must be on site. Test results and any interventions must be
documented and communicated to home staff when client returns home.
VI. Quality Control
1. Check the One Touch II meter using Normal Glucose Control Solution-Blue
Formula, which is available from drug stores or Authorized Life-Scan
Distributor. To do a Control solution test, follow the same procedure you
would if you were testing a blood sample. The Control Solution results will
appear on the meter display. The acceptable level for the One Touch Normal
Control Solution- Blue Formula is marked on the test strip vial or the foil
wrapper. In addition, a Check Strip is included with the meter. Follow
manufacturer’s instruction for use of the Check Strip.
2. Use the Glucose Control Solution at least once a week, when using a new
package of Test Strips, or whenever the meter is suspected to not be working
properly. Use Check Strip at least once a week, after cleaning the meter,
whenever results seem to be inaccurate or inconsistent, or whenever the
meter’s “NOT OK REDO” message appears on the meter.
3. Document quality control results in maintenance log.

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SAMPLE KETONE TESTING BY URINE DIP PROCEDURE
I. Purpose
To determine whether ketones are being spilled into urine. An individual with
diabetes is likely to spill ketones into urine as a result of burning too much fat.
Burning too much fat and producing too many ketones may be a sign that an
individual’s diabetes is out of control. When this occurs, a complication called
ketoacidosis develops which may lead to serious medical complications such as
coma.
II. Specimen
Fresh urine sample voided within 10 minutes. If there is a greater than 10 min
delay in testing specimen, obtain a second specimen.
III. Materials
Clean and dry paper cup
Ketostix Reagent Strip
Gloves
IV. Procedure
1. Put on gloves and hand client clean and dry paper cup. Have client collect
urine sample in bathroom. Have client leave specimen in bathroom.
2. Remove strip from bottle replace cap immediately and tightly. Do not touch
test area of strip. Check expiration date printed on the bottle label. If date
has passed, discard and retest with strips from a new bottle. If the bottle has
been opened, check the date recorded from when it was first opened.
3. Dip the end of the strip into fresh urine sample and remove it immediately
drawing the edge of strip against rim of the urine container to remove excess
urine.
4. Begin timing and at exactly 15 seconds, match the reagent area to the ketone
color chart. Ignore color changes that occur after 15 seconds.
5. Document results and discard test strip.
V. Interpretation
1. Follow physician/ nurse orders regarding interpretation of test results.
Client’s home staff must communicate to habilitation staff any changes in
physician/ nurse orders regarding changes occur. Current physician orders
must be on site. Test results and any interventions must be documented and
communicated to home staff when client returns home.
VI. Quality Control
1. Always check the expiration date on the bottle. A new bottle can be used for
6 month after being opened. Always write the date you open a bottle on the
label. Do not use product (opened or unopened) after expiration date.

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FASTECT II DRUG SCREEN DIPSTICK TEST
I. Purpose
The Fastect II Drug Screen Dipstick Test is an in vitro screen test for the rapid
detection of multiple drugs and drug metabolites in human urine at or above the
determined cutoff concentrations. This test provides only a preliminary screening
test result.
II. Specimen
Only freshly voided, untreated urine obtained in a clean collection cup should be
used. Urine samples should be collected so that testing may be performed as
soon as possible, preferably during the same day.
III. Materials
Dipstick Test Device
Clean collection cup
Disposable towel upon which test device laid
Gloves
IV. Procedure (per Manufacturer’s manual)
1. Test device and donor sample (urine specimen) should be at room
temperature. Do not open sealed pouch until ready to perform the assay.
2. Remove the test device from the sealed pouch.
3. Push the sleeve on the test device all the way up.
4. Dip the sample pad of the test device into the urine sample for at least 10
seconds. Dip up to, but not beyond, the tips of the arrows.
5. Slide the sleeve down to the read indicator mark and lay the device on a level
surface.
6. Once the control band (C) appears (in 5 minutes or less) results are ready to
interpret. (Results are stable and may be interpreted up to 1 hour after the
control band forms.)
7. Record results and properly dispose of urine sample and test device.
8. Precaution: The urine sample and all materials coming in contact with the
urine sample should be handled and disposed of as if potentially infectious.
Established universal precautions must be followed.
V. Interpretation
For interpretations of results, manufacturer’s procedures must be followed:
1. Negative Results: The presence of a colored band at the control region (C)
and a colored band at a specific test region (T) regardless of the intensity
indicate that the result is negative for that particular test.
2. Positive Results: The presence of a colored band at the control region (C)
and the absence of a colored band at the test region (T) indicate a positive
result for that particular test.
3. Invalid Results: No band appears at the control region (C). The test is
inconclusive even if there is a band at the test region (T). If the test device
does not produce a band at the control region, check testing procedure,
sample, and/or control materials, and repeat the test using a new device.
VI. Quality Control (per Manufacturer’s manual)
1. The Fastech II test device has built-in internal procedural controls (See
Invalid Results above).
2. The assay is designed for use with human urine only.
3. Positive results only indicate the presence of drug/metabolites and do not
indicate or measure intoxication.
4. There is a possibility that technical or procedural errors as well as other
substances in certain foods and medication may interfere with test and cause
false results.
5. If a drug/metabolite is found present in the urine specimen, the assay does
not indicate frequency of drug use or distinguish between drugs of abuse and
certain food and/or medication.
6. If it is suspected that the sample may have been tampered with, the test
should be repeated, and a new specimen should be collected.