Getting Started: Obtaining a CLIA Waiver

Frequently Asked Questions

What is a CLIA Waiver?

Prior to initiating Point-of-Care testing in your pharmacy, you must first obtain a CLIA Waiver. Clinical Laboratory Improvement Amendment (CLIA) was passed by Congress in 1988 with the goal of establishing quality standards for laboratory tests performed using samples derived from a human body.

 

Why is a CLIA Waiver important?

The quality standards set forth by CLIA ensure that the waived test results are accurate and reliable, regardless of where it was performed. Under CLIA, a waived test is both simple to use and has a low chance of producing erroneous results.

 

How do I begin the CLIA Waiver application process?

In order to obtain a CLIA Waiver, you must fill out and submit the CMS 116 form to the appropriate state agency. Please note that some states have additional requirements (outlined below).

 

How long does it take to obtain a CLIA Waiver?

Filling out the CMS 116 Form is simple and will not take long. Please watch this short video for instructions on how to complete the form. Mail in the CMS 116 form and allow 10-14 days for a response. Once the form has been processed, a fee remittance coupon will be issued. The fee remittance coupon will indicate your CLIA identification number and the amount due for the certificate. Upon collection of your payment, the state will issue your certificate, which can take several additional weeks.

 

Requirements to apply for a CLIA Waiver:

 Task Expected Time Frame
Step 1

Fill out & mail CMS 116 Form

 

1 day
Step 2

Anticipate response from the State CLIA Department

(a fee remittance coupon will be issued)

 

10-14 days

 

Step 3

Mail in payment and anticipate certificate

 

30-60 days

 

*may vary by state

 

Does the CLIA waiver need to be renewed?

Yes, the CLIA waiver expires after 2 years. An application for renewal must be submitted no later than 9 months prior to the termination date.

 

How much does a CLIA Waiver cost?

The cost of a CLIA waiver is $180 due upon initial certification, as well as with every biennial renewal.

 

For additional information, please visit:

CALIFORNIA:

In addition to the mandatory CLIA Waiver Application, California has other state-specific application requirements. Please find the details below: 

  1. CLIA Waiver Application (Form CMS 116)Information on how to fill out the CMS 116 Form: https://prescribewellnessllc.app.box.com/s/wm473of7frnqgtm4tlcoql7q48j3d2hx\

     

    2. Application for Initial Clinical Laboratory Registration (LAB 155)

    3. Director’s Attestation Form (LAB 183)

    • For the purpose of this form, The Pharmacist in Charge is the Laboratory Director

    The forms can be found here: https://www.cdph.ca.gov/Programs/OSPHLD/LFS/Pages/New-ClinicalLaboratoryRegistration.aspx

    Clients may contact LFSnewfacreg@cdph.ca.gov to inquire about the status of their application.

    Please note: there may be other state-specific requirements

KENTUCKY:

CLIA Waiver Application (Form CMS 116) is a mandatory requirement.

Please note: there may be other state-specific requirements

Operations and Workflow

 Getting Started

  • Upon patient arrival, Pharmacy technician may begin the encounter by verifying patient demographics information available in the patient profile.

Pharmacy technician will provide a Self-Screening Questionnaire to the patient in order to help the Pharmacist determine whether a patient is a candidate for the diagnostic test. Alternatively, the pharmacist may wish to interview the patient in person.

Patient Self Screening Questionnaires

Influenza Chemoprophylaxis (Kentucky only)

Influenza Infection

Group A Streptococcal Pharyngitis

  • Pharmacy technician will utilize PrescribeCare to document all the information gathered in the Self-Screening Questionnaire for review by the pharmacist.
  • Prior to administering the appropriate test, the pharmacist will refer to the patient inclusion and exclusion criteria provided in the protocol to determine whether the patient is a candidate for testing.
  • The Pharmacist will obtain patient’s:
    • Temperature (using an oral thermometer)
    • Respiratory rate (by placing hand on patient’s back and counting breaths for 15 seconds x 4)
    • Pulse (by palpating patient’s radial artery [wrist] with thumb and counting for 15 seconds x 4)
    • Blood pressure
  • Upon ensuring that the patient is eligible to receive the diagnostic test, prepare them for specimen collection (such as escorting them to a private area, explaining what specimen collection will entail, etc.)

Procedure for Obtaining Nasal Specimen for Influenza

  1. Only use swabs provided in the influenza testing kit.
  2. Insert the swab into one nostril. It is best to select the nostril that appears to have more secretions.
  3. While inside the nostril, rotate the swab around fully twice.
  4. Once the swab is removed from the patient’s nostril, the sample is ready to be tested.
  5. Test the sample immediately after removal.
  6. Dispose of any material contaminated with blood or bodily fluids properly and using red biohazard waste bags only. https://wcoww.osha.gov/SLTC/etools/hospital/hazards/univprec/univ.html
  7. Store the testing equipment according to manufacturer’s instructions.

Please watch a demonstration video provided by BD:

https://www.bd.com/en-us/company/video-gallery?video=4562157293001

 

Procedure for Obtaining Throat Specimen for Group A Streptococcal Pharyngitis

  1. Only use swabs provided in the GAS Pharyngitis testing kit.
  2. Ask the patient to open their mouth and depress their tongue with a tongue depressor.
  3. Swab the posterior pharynx, tonsils, and other areas where redness and inflammation appear.
  4. Do not touch teeth, cheeks, or tongue while obtaining the sample.
  5. Blood or excess mucus should not appear on the swab. Studies have linked this to false positive test results.
  6. Remove the swab from the mouth and test immediately.
  7. Dispose of any material contaminated with blood or bodily fluids properly and using red biohazard waste bags only. https://wcoww.osha.gov/SLTC/etools/hospital/hazards/univprec/univ.html
  8. Store the testing equipment according to manufacturer’s instructions. 

Please watch a demonstration video provided by BD:

https://www.bd.com/en-us/company/video-gallery?video=4564874294001

Upon a positive diagnostic test result:

  • Review the following information:
    • Past Medical History
    • Current medications
    • Allergies and hypersensitivities

Evaluating this information will help you select an appropriate medication to furnish.

  • Obtain patient’s weight using a pharmacy scale if furnishing a medication dosed by weight.
  • The pharmacist or pharmacy technician will process the selected medication prescription through the pharmacy dispensing system.
  • Upon dispensing the appropriate medication, the Pharmacist will counsel the patient on its use, as well as self-care instructions, the importance of receiving the necessary vaccinations, and when to seek emergency treatment.
  • The Pharmacist will follow up with the patient within 48 hours regarding any medication-related concerns, as well as to assess the need to refer.
  • The Pharmacist will complete recording the details of the encounter in Please be sure to document the manufacturer, lot, and expiration date of the test equipment used to perform the diagnostic test.
  • The Pharmacist will fax the Physician Notification Form to the patient’s PCP or referring Physician’s office to inform them of the test performed and the medication furnished.

Upon a negative diagnostic test result:

  • The Pharmacist will counsel the patient on risks of false-negative test results, any relevant self-care instructions, the importance of receiving the necessary vaccinations, and when to seek treatment.
  • The Pharmacist will complete recording the details of the encounter in Be sure to document the manufacturer, lot, and expiration date of the test equipment used to perform the diagnostic test.
  • The Pharmacist will fax the Physician Notification Form to the patient’s PCP or referring Physician’s office to inform them of the test performed.

Medication Reference Guide

This list includes medications that are included in the CPA. Please refer the Collaborative practice agreement for details on furnishing medications. 

Influenza:

 

Medication

Pharmacologic Category

Administration

Adverse Reactions

Oseltamivir

Neuraminidase Inhibitor

 

May be administered with or without food

 

May open capsules and mix content with sweetened liquid

 

Headache

Vomiting

Nausea

 

Zanamivir

Neuraminidase Inhibitor

 

Administer at the same time every day

 

Use a Diskhaler delivery device. Should not be delivered via nebulizer.

 

Headache

Sore throat

Viral infection

Nasal S/S

Tonsil disease

Cough

 

Baloxavir marboxil

Endonuclease Inhibitor

 

Administer with or without food

Avoid administration with dairy products, calcium-containing agents, polyvalent cation-containing laxatives, antacids, vitamins

 

Diarrhea

Nasopharyngitis

 

* Please reference professional resources for a comprehensive list of administration instructions, adverse reactions, and drug interactions.

 

 

Group A Streptococcal Pharyngitis:

 

Medication

Pharmacologic Category

Administration

Adverse Reactions

Amoxicillin

Penicillin Antibiotic

Administer around-the-clock to promote less variation in peak and trough serum levels

 

Headache

Diarrhea

Nausea

Vomiting

Vulvovaginal infection

 

Penicillin V

Penicillin Antibiotic

Administer around-the-clock to promote less variation in peak and trough serum levels

 

Administer on an empty stomach 1 hour before or 2 hours after meals

Melanoglossia

Nausea

Vomiting

Mild diarrhea

Oral candidiasis

Cephalexin

1st Generation Cephalosporin

Administer around-the-clock to promote less variation in peak and trough serum levels

 

Administer regardless of food intake, unless GI upset occurs

Agitation

Confusion

Dizziness

Fatigue

Hallucinations

Headache

Erythema

Genital pruritus

Skin rash

SJS, TEN

Urticaria

Abdominal pain

Diarrhea

Dyspepsia

Gastritis

Nausea

Vomiting

Colitis

Vaginitis

Candidiasis

Vaginal discharge

Eosinophilia

Neutropenia

Thrombocytopenia

Hemolytic anemia

AST/ALT elevation

Anaphylaxis

Angioedema

Arthralgia

Interstitial nephritis

Cefadroxil

1st Generation Cephalosporin

Administer around-the-clock to promote less variation in peak and trough serum levels

 

Administer regardless of food intake, unless GI upset occurs

Diarrhea

Azithromycin

Macrolide Antibiotic

Administer immediate release tablet without regards to meals

Loose stools

Nausea

Vomiting

Diarrhea

Clindamycin

Lincosamide Antibiotic

Administer without regard to meals

 

Capsule should be taken with a full glass of water to avoid esophageal irritation

Hypotension

Thrombophlebitis

Metallic taste

Skin rash

Pruritus

SJS, TEN

Urticaria

Abdominal pain

Diarrhea

Nausea

Vomiting

Esophagitis

Colitis

Vaginitis

Proteinuria

Jaundice

Abnormal LFTs

Anaphylaxis

Angioedema

DRESS Syndrome

 

Clarithromycin

Macrolide Antibiotic

Administer immediate release tablet without regards to meals

Headache

Insomnia

Skin rash

Dysgeusia

Vomiting

Diarrhea

Nausea

Abdominal pain

Dyspepsia

Prolonged prothrombin time

Abnormal LFTs

Anaphylactoid reaction

Candidiasis

* Please reference professional resources for a comprehensive list of administration instructions, adverse reactions, and drug interactions.

 

 

Testing Equipment

  • All tests are CLIA waived to be utilized at the Point-of-Care
  • All Influenza tests differentiate between Influenza A and B
  • All Strep tests require a throat swab sample, all Influenza tests require a nasal or nasopharyngeal sample
  • Note: the following list is not inclusive – other tests may be available on the market that are not discussed in this guide.
  • The testing devices included are not selected based on brand or PrescribeWellness affiliation with any brand. The devices were selected based on factors such as affordability, sensitivity and specificity results, relative simplicity of use, and FDA-clearance status (Influenza Diagnostic Tests only)

BD Veritor System

Sensitivity:

  • Group A Strep: 96.6%
  • Influenza A: 83.6% PPA
  • Influenza B: 81.3% PP

Specificity:

  • Group A Strep: 95.5%
  • Influenza A: 97.5%
  • Influenza B: 98.2%

Time to result:

  • Influenza: 10 minutes
  • Group A Strep: 5 minutes

Shelf life: 683 days (analyzer)

Directions for use:

  • Requires a BD Veritor Analyzer
  • Please refer to the website

Sofia Influenza A+B FIA; Strep A+ FIA [Quidel]

    Sensitivity:

    • Group A Strep: 93.7%
    • Influenza
      • Nasal A: 90%
      • Nasal B: 89%
      • Nasopharyngeal A: 97%
      • Nasopharyngeal B: 90%

    Specificity:

    • Group A Strep: 94.4%
    • Influenza
      • Nasal A: 95%
      • Nasal B: 96%
      • Nasopharyngeal A: 95%
      • Nasopharyngeal B: 97%

    Time to results:

    • Influenza: 15 minutes
    • Group A Strep: 5 minutes

    Shelf Life:

    • Analyzer does not have an expiration date
    • 24 months for test kits

    Directions for use:

    • Requires a Sofia or Sofia 2 Analyzer
    • Please refer to this website for Influenza test
    • Please refer to this website for Group A Strep test

    OSOM Ultra (Sekisui)

    Sensitivity:

    • Strep: 92.6%
    • Influenza:
      • Nasal A: 91.7%
      • Nasal B: 82.4%
      • Nasopharyngeal A: 89.6%
      • Nasopharyngeal B: 86.8%

    Specificity:

    • Strep: 92.8%
    • Influenza:
      • Nasal A: 75.2%
      • Nasal B: 88.3%
      • Nasopharyngeal A: 77%
      • Nasopharyngeal B: 92.9%

    Time to result:

    • Strep A: 5 minutes
    • Influenza: 15 minutes
    • Shelf life:
      • 24 months
    • Directions for use:
      • Does not require analyzer. Visual test result interpretation.
      • Please refer to this website for Influenza test
      • Please refer to this website for Group A Strep test

    Consult (McKesson)

    Sensitivity:

    • Strep: 97%
    • Flu A: 91.4%, 90.8%, 92.2%, 90.2%
    • Flu B: 87.6%, 85.5%, 90%, 81.8%

    * Nasopharyngeal & nasal swabs combined

    Specificity:

    • Strep: 95%
    • Flu A: 95.7%, 75.9%, 94.2%, 99%
    • Flu B: 95.9%, 90.1%, 94.3%, 98.9%

    * Nasopharyngeal & nasal swabs combined

    Time to result:

    • Influenza: 15 minutes
    • Strep: 5 minutes

    Shelf life:

    • 24 months

    Directions for use:

    • Does not require analyzer. Visual test result interpretation.
    • Please refer to this website for Influenza test
    • Please refer to this website for Group A Strep test

    QuickVue (Quidel)

     

     

    Sensitivity:

    • Strep A: 92%
    • Influenza A PPA: 81.5%
    • Influenza B PPA: 80.9%

    Specificity:

    • Strep A: 98%
    • Influenza A NPA: 97.8%
    • Influenza B NPA: 99.1%

    Cost:

    • Influenza test kit #25: $355
    • Strep test kit #25: $140

    Time to result:

    • Strep A: 5 minutes
    • Influenza A & B: 10 minutes

    Shelf life:

    • 24 months

    Directions for use:

    • Does not require analyzer. Visual test result interpretation.
    • Please refer to this website for Influenza test
    • Please refer to this website for Group A Strep test