CPA Point-of-Care Guidebook

FAQ:

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. 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:

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:

• The guide developed by Centers for Medicaid and Medicare services:

https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/HowObtainCertificateofWaiver.pdf

• Information on how to fill out the CMS 116 form:

https://outcomes.com/knowledge-base/clia-waiver-application-process 

• The form can be found here:

https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/Downloads/CMS116.pdf

Operations and Workflow: Pharmacist Guide

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.

• Pharmacy technician 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://www.osha.gov/SLTC/etools/hospital/hazards/univprec/univ.html
7. Store the testing equipment according to the manufacturer’s

Please watch a demonstration video provided by BD: https://www.bd.com/en-us/resource-and-education/documentation-landing-page?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://www.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/resource-and-education/documentation-landing-page?video=4562157293001

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. 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

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. 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.

Operations and Workflow: Medication Reference Guide

Influenza:

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

Group A Streptococcal Pharyngitis:

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

Patient Self-Screening Questionnaires

Testing Equipment Guide

Physician Notification Form

Point of Care Encounter Checklist