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WAIVED TESTING PROTOCOL

Protocol Number:CLIN. 43

Goal:Waived tests are performed to assist the provider in determining diagnoses, in screening for disease, and following prescribed therapy to determine effectiveness. Waived tests are performed according to established standards or instructions by competent staff.

Scope:This protocol applies to all medical sites.

Responsibility:Laboratory, nursing/support, provider, WIC staff

Protocol:

  1. Waived testing is performed only by staff with demonstrated competency in the specific waived test, which is being utilized. Competency is demonstrated as defined in the orientation and annual performance appraisal documents.
  2. The Center Manager/Nurse Manager or departmental supervisor is responsible for supervising waived testing at each site where testing occurs.
  3. Each test is performed by following the manufacturers’ instructions.
  4. Test kits and controls are stored per manufacturer specifications.
  5. Reagents are dated upon opening and used until expiration date or according to manufacturer specifications related to storage and expiration.
  6. Universal precautions are followed at all times.
  7. Waived testing instruments are tested per quality control guidelines and according to the preventive maintenance schedule.
  8. Remedial action is taken whenever controls do not fall within expected range or result differs from expected value. Waived test results are not reported unless quality control is acceptable.
  9. Waived test results are documented in the electronic health record (EHR) using the“Labs In-House” form. PT/INR results are documented in the EHR using the “Coumadin Management” form
  10. Each waived test result is assessed by the provider (Exception = Urine Pregnancy tests done at Primary Care sites and at Women’s Care-Bay City on a walk-in basis - the nursing staff performs these tests and results are given to the patient with no provider assessment.)
  11. Waived test results are used in the diagnostic assessment of patients as follows:
  • Hemoglobin/hematocrit - screening and following therapy
  • Urinalysis - screening, diagnosis, and following therapy
  • Glucose - screening and following therapy
  • Strep A - diagnosis
  • Mono - diagnosis
  • Microscopy - diagnosis
  • PT/INR - following therapy
  • Cholesterol - screening
  • HbA1c –screening and following therapy
  • Fecal Occult Blood - screening
  • pH/Nitrozene paper – diagnosis
  • Rapid HIV – screening
  • Pregnancy test - diagnosis and following therapy
  • H. pylori – diagnosis
  • Bacterial vaginosis – diagnosis
  • Trichomonas - diagnosis
  • Urine Drug Screen – screening and following therapy
  1. The table following on pages 3-8 lists the waived test, specimen type, specimen collection methodology, control type, control frequency, test kit/control storage and rationale for control testing.
  2. Confirmatory testing is done for the following waived tests:
  • Rapid HIV – required Western blot testing with preliminary positive test result
  • Cholesterol – recommended fasting lipid for abnormal high result
  • Hemoglobin/Hematocrit – recommended CBC blood draw for abnormal low result (hemoglobin ≤ 6.0, hematocrit ≤ 19.5)
  • PT/INR – Stat PT/INR blood draw required if result higher than 7.5
  1. CLIA (Clinical Laboratory Improvement Act) certification is maintained and posted at each site in the laboratory area.

Reviewed By:Quality Improvement Committee

Effective Date:November 21, 2000

Revision Date: May 13, 2003; March 17, 2006; June 8, 2009; June 25,2014

May29, 2015; May 18, 2017

Review Date:March 17, 2008; June 8, 2010; June 25, 2014; May 18, 2017

Approval:Douglas Saylor, MD

Chief Medical Officer

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Waived Test / Specimen Type / Collection Methodology / Control Type / Control Frequency / Test Kit/Control Storage / Rationale
Bacterial Vaginosis (BV) using OSOM BV Blue Test / Vaginal swab / Collect a vaginal fluid sample with a swab; contact the swab with the lower one-third of the vaginal wall; put the swab into the BV Test Vessel / Qualitative – positive and negative, both internal and external / Controls done with each new lot. / Store the kit refrigerated (36-46°F), out of direct sunlight. Kit contents are stable until the expiration date. / Test kit validity and test performance assured.
Cholesterol test using AccuTrend / Capillary blood / Fingerstick with lancet device / Quantitative High and Low Levels / Daily or prior to patient testing if not used on daily basis. / Label bottle of controls with date opened. Good for 60 days after opening or the expiration date, whichever comes first. Store at room temperature. / Meter and test strip function and accurate performance of testing
Fecal Occult Blood test cards using Hemoccult or Hemoccult Sensa / Fecal/stool specimen from bowel movement or anal/rectal swab / Using applicator, collect small fecal sample and apply thin smear to box on sample test card / Qualitative / Control area on each test card / Store product at room temperature. Slides and developer remain stable until expiration date on slide and developer bottle. / Assures integrity of test card.
Immunological Fecal Occult Blood Test (iFOB) using Hemosure / Stool specimen from bowel movement (best if no contact with toilet water) / Using applicator, insert into fecal sample 3-6 times, return to Fecal Collection Tube. Add sample to Test Cassette / Qualitative / Control area on each Test Cassette / Store test device at room temperature. Test device is stable until the date printed on the pouch label. / Assures adequate sample volume and validity of test cassette.
Glucose using Assure Prism multi Blood Glucose Monitoring System / Capillary blood / Finger stick using lancet device / Quantitative Level 1 and Level 2 / Daily or prior to use if not used daily. / Test strips – Store in original container at room temperature. Use until expiration date printed on vial. Control solution - Write date first opened on bottle. Discard bottle 3 months after opening or after expiration date, whichever comes first. Store at room temperature. / Daily use
OSOM H. pylori / Capillary blood / Fingerstick with lancet device / Qualitative / Control included with each test kit / Store at room temperature in the original sealed pouch. Stable until the expiration date. / Test kit validity and test performance assured.
DCA Vantage Analyzer for HbA1c / Capillary blood / Fingerstick with lancet device – blood collected in capillary holder / Quantitative Normal and abnormal levels / Daily or prior to patient testing if machine not used on daily basis. / Reagent cartridges – Do not use after the last day of the expiration month. Store reagent cartridges at 36-46°F., Capillary holders at room temperature. Reagent cartridges can be kept at room temperature for 3 months – record on carton the date the carton was placed at room temperature Controls – Unreconstituted store at 36-46°F and can be used until the last day of the expiration month on the bottle. Reconstituted – can stay at room temp for 30 minutes during testing but should be stored in refrigerator. Stable for 3 months when stored refrigerated. / Currently acceptable guidelines and manufacturer recommendations
Hemoglobin using Hemocue (Hb201+ Analyzer) / Capillary blood / Finger/heel stick using lancet device – blood collected onto testing cuvette / Quantitative High/Low value / Daily / May use control up to 60 days if stored at 2-8°C or 30 days stored at room temperature / Daily use and manufacturer recommendation
Infectious Mononucleosis Test using OSOM Mono Test / Capillary whole blood / Fingerstick using lancet device and collect blood in capillary tube / Qualitative / Controls done with each new lot. Control also included on each test kit. / Store test kits at room temperature. Control solutions expire per date on bottle. / Test kits validity assured. Manufacturer recommendations
pH paper, Nitrozene paper / Vaginal secretions / Cotton tipped applicator or Dacron swab is used to collect vaginal specimen. Swab is then wiped on pH paper / Quantitative / Weekly
Pregnancy Test McKesson Medi-Lab Performance hCG Urine Cassette / Urine / Voided urine sample into clean, dry container (plastic or glass) / Qualitative / Controls run with each new box of tests. Control also included on each test kit. / Test pouches - store at room temp. Test cassette is stable through the expiration date printed on the sealed pouch. Controls- store refrigerated 2-8°C (36-46°F) until use or the stated expiration date. Bring to room temp prior to testing. / Test kits validity assured. Manufacturer recommendation
PT/INR using CoaguChek XS PT Test / Capillary blood / Fingerstick using lancet device / Quantitative / Machine has quality control functions integrated into the meter and test strips and automatically run as part of every blood test. / Test strips – store at room temperature until expiration date. / Internal machine control assures proper machine and test strip function.
Rapid HIV testing using Alere Determine HIV-1/2 Ag/Ab Combo / Only fingerstick capillary whole blood / Fingerstick with lancet device then use Capillary pipette (provided in test kit) to collect 50 microliters of whole blood / Qualitative / Once per week when testing is performed. Control also included with each test kit. / Combo Cards - Store the test devices in their original aluminum pouches between 36 and 86°F; store Chase Buffer in its original vial between 36-86°F; do not freeze; do not open the pouch until ready to test; when stored as indicated, kit components are stable until expiration date marked on the cards. Controls - Must be stored in a refrigerator between 36 and 46°F; do not use beyond the expiration date established by the manufacturer; open control vials only when performing a test and recap and store in their original container in the refrigerator between 36-46°F after use. Initial and date all controls and reagents upon receipt into the lab/site; initial and date all controls and reagents when opened and placed into use. / Currently acceptable guidelines and manufacturer recommendations
OSOM Strep A Test Cassette / Throat swab / Collect specimens with a sterile swab (rayon swab supplied with kit) from the tonsils and/or the back of the throat taking care to avoid the teeth, gums, tongue or cheek surfaces. Do not use swabs with cotton tips, wooden shafts or calcium alginate swabs. / Qualitative / Controls run with each new lot. Control also included on each test kit. / Store kit at room temp. Unopened canister stable through expiration date. Once opened, test strips stable for 90 days. / Validates integrity of test canister. Manufacturer recommendation
Trichomonas using OSOM Trichomonas Rapid Test / Vaginal swab / Collect specimen from the vaginal cavity with a sterile rayon swab from the kit (swabs with cotton tips or wooden shafts are not recommended). / Qualitative – positive, both internal and external / Controls done with each new lot. / Store the Test Sticks and reagents tightly capped at room temperature. Do not use after expiration date. Discard unused Test Sticks that have been removed from the canister after 1 hour. / Test kit validity and test performance assured.
Urinalysis using Clinitek Status Analyzer / Urine / Clean catch midstream urine specimen / “The Dipper” Qualitative and Quantitative Normal and Abnormal / Daily / Store at 2-8°C. After initial use control is stable for 3 months or 20 dipstick immersions, whichever occurs first / Daily use
Urinalysis using Multistix or Uristix / Urine / Clean catch midstream urine specimen / “The Dipper” Qualitative and Quantitative Normal and Abnormal / Daily / Store at 2-8°C. After initial use control is stable for 3 months or 20 dipstick immersions, whichever occurs first / Daily use
Rapid Urine Drug Screen using UScreen2 Drugs of Abuse Cup / Urine sample / Urinate directly into test cup. Sample volume should be higher than the minimum urine level. / Qualitative immunoassay test with internal control / Control included with each urine Q-cup / Store at 4-30°C up to the expiration date. Do Not Freeze. Keep away from sunlight, moisture and heat. / Sample cup validity and test performance assured.
Provider performed microscopy/ Wet Prep or Wet Mount / Vaginal swab Urine Amniotic fluid / Vaginal: Using sterile swab, swab the vaginal region and immerse the swab into a vial containing sterile saline. Urine: Place drop of urine onto microscope slide, cover with cover slip and examine under low and high power. Amniotic fluid: Using sterile swab, collect specimen from vaginal region, prepare as above and examine under microscope. / Not applicable / Not applicable / Not applicable