are you ready for a site visit? presented by: beth meadows, rn wendy holmes, rn

Are you ready for a Site Visit?

Presented by:Presented by:

Beth Meadows, RNBeth Meadows, RN

Wendy Holmes, RNWendy Holmes, RN

NCIP 2011 State Immunization NCIP 2011 State Immunization ConferenceConference 22

Background on the North Carolina Immunization Program (NCIP) ???

The North Carolina Immunization Program (NCIP) works in conjunction with the federal vaccine supply program, called the Vaccines for Children (VFC) program, to provide vaccines to health care providers across the state who administer childhood immunizations

The NCIP and Vaccines for Children (VFC) Program provides vaccines to children whose parents or guardians may not be able to afford them


Background Cont…

NCIP helps to ensure that all children have a better chance of getting their recommended vaccinations on schedule


Which Vaccines are Available?

ACIP Recommended CDC approved


Who is enrolled in the program?

Health Departments

Federally Qualified Health Clinics/Rural Health Centers

Private Physician Offices

School-based Health Clinics

Hospitals

Youth Detention Centers


What is a Site Visit?

~ Formal quality assurance visit to enrolled providers.


Site Visit Objectives:

Evaluate provider compliance with the NCIP and Vaccines for Children Program in both private and public healthcare settings

Evaluate compliance with NC specific Immunization Laws and rules


Provider Agreement

READ and HEED!!!!!


Site Visit Objectives:

Evaluate provider compliance with the NCIP and Vaccines for Children Program in both private and public healthcare settings

Evaluate compliance with NC specific Immunization Laws and rules


Provider Enrollment Who Should Sign the Provider Enrollment

Form? Who Should Sign the VFC Provider Enrollment Form? Section 1928 (c) (1) (A) of the Social Security Act (42 U.S.C. 1396s (c) (1)

(A) states that the following providers qualify to be VFC program-registered providers: those healthcare providers "licensed or otherwise authorized for administration of pediatric vaccines under the law of the State in which the administration occurs" (subject to section 333 (e) of the Public Health Service Act, which authorizes members of the Commissioned Corps to practice).

The VFC statute follows state law in qualifying practitioners as VFC providers. The term “authorized for administration of pediatric vaccines” is intended to mean authorized to “prescribe” vaccines. Therefore, only providers authorized to prescribe vaccines under state law should be the official VFC program-registered providers. However, other providers authorized to administer vaccines can operate under the supervision of a prescribing VFC provider and should be listed on the Provider Enrollment Form.


NC Prescribing Authority SECTION .1000 - PRESCRIBING 21 NCAC 32B .1001 AUTHORITY TO

PRESCRIBE

(a) A license to practice medicine issued under this Subchapter allows the physician to prescribe medications, including controlled substances, so long as the physician complies with all state and federal laws and regulations governing the writing and issuance of prescriptions.

(b) A physician must possess a valid United States Drug Enforcement Administration ("DEA") registration in order for the physician to supervise any other health professional (physician assistant, nurse practitioner, clinical pharmacist practitioner) with prescriptive authority for controlled substances. The DEA registration of the supervising physician must include the same schedule(s) of controlled substances as the supervised health professional's DEA registration.

History Note: Authority G.S. 90-2(a);

Eff. June 1, 2007.


Provider AgreementsType of Agreements Local Health Department Agreement Private Provider Agreement NCIR Provider Agreement Non-NCIR Provider Agreement


Coverage Criteria


Provider Level Compliance Site Visits

How we pick provider sites to visit?


Items needed for the site visit

Include: Un-interrupted meeting time with the

vaccine contact staff

Past three months of vaccine temperature logs

Access to vaccine storage units, temporary and permanent storage

Access to the circuit breaker


Items Needed, Cont.

Vaccine Information Statements (VISs)

Borrowing and Replacement Forms

Disaster Recovery Plan


Items Needed, Cont.

Vaccine Information Statements (VISs)


Items Needed, Cont.

Borrowing and Replacement Forms


Items Needed, Cont.

Disaster Recovery Plan


Who Conducts the Visit?

Regional Immunization Nurses

Regional Program Consultants


Site Visit Process

Scheduling Letter/Questionnaire


NCIR Review


NCIR ReviewVaccine Transaction Summary By Provider


NCIR Review Vaccine Accountability Report


NCIR ReviewVaccine Usage Report


NCIR ReviewWasted/Expired Vaccine Report


Non-NCIR User Vaccine Administered Log Borrowing Reports Wasted/Expired Forms


Day of the Visit- Assessment

VIS’s/temps, etc.

Storage units

Circuit Breaker


Day of the Visit- Assessment

VIS statements for all vaccines administered

Past three months temperature logs for the refrigerator and freezer

Access to all vaccine storage units, including those used for temporary storage

Clear assess to circuit breaker


Day of the Visit, Feedback All findings will be reviewed with the vaccine

contact

Areas that need improvement will be discussed

Education will be provided to improve vaccine services

Follow up recommendations/requirements will be reviewed


Provider Improvement Plan

Summary of out of compliance items will be provided

Providers have thirty days to submit a corrective action plan to the NCIP


Remember:

We are EDUCATORS not AUDITORS


Common Site Visit Questions


Do I have to complete the site visit?

Yes!!!!!!Yes!!!!!!

Item #(17)Provider Agreement: Allow periodic VFC Site Visits or inspection of vaccine supplies and records as requested by the Immunization Branch


How often are visits done?

Every other year (or more often as needed).


How Long Do the Visits Take?

Approximately 1-3+ hours


What are you looking for in

my Fridge/Freezer?

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Vaccine Storage Equipment

Problems with Household Combination

•For food/ beverage storage•Temperature fluctuations•Inadequate usable space

This is an improper way to store vaccine. There are many reasons why this is unacceptable but the main reason is improper/poor air circulation.

This provider will be required to purchase additional refrigerator space to allow air circulation.

This is an improper way to store vaccine. There are many reasons why this is unacceptable but the main reason is improper/poor air circulation.

This provider will be required to purchase additional refrigerator space to allow air circulation.


Vaccine Storage Equipment Phase out interior freezer by 12/31/2009 (requirement)

•Any size unit with interior freezer•Day storage only

• Temperatures 2 X daily

Phase out units with interior freezers, regardless of size. This is effective December 31, 2009 (requirement)

Phase out units with interior freezers, regardless of size. This is effective December 31, 2009 (requirement)


Vaccine Storage Practices

Diluents

Diluents

Water Bottles

Water Bottles


Vaccine Ordering and Inventory Management

Label shelves/trays

Mark multi-dose vials• Date open• Doses used


Site Visit Requirements

Appropriate Refrigerator/Freezer – Distinguish private/state

– Biological specimens

– Jugs of water – refrigerator

– Ice packs - freezer

– Certified calibrated thermometer (middle with vaccine)


Site Visit Requirements Appropriate Refrigerator/Freezer Appropriate Refrigerator/Freezer

– No foodNo food– Vaccine not in doorVaccine not in door– Proper air circulationProper air circulation– MMR in the freezer MMR in the freezer – Properly rotate vaccineProperly rotate vaccine– Do not pre-drawDo not pre-draw– ““DO NOT DISCONNECT” signs on the DO NOT DISCONNECT” signs on the

outlet and circuit breakeroutlet and circuit breaker


Site Visit Requirements

Temperatures log

– Checked and documented in a.m. & p.m.

– Temperatures maintained

– Written documentation of action taken


Why do you need to see our Vaccine Information

Statements? Ensure you are using the appropriate VIS

for each dose of vaccine you administer

Ensure you provide a current VIS for each dose of vaccine given

Review our providers responsibilities regarding the use of VIS’s


VIS FACT According to CDC, every time one of

these vaccines is given — regardless of what combination vaccine it is given in — regardless of whether it is given by a public health clinic or a private provider — regardless of how the vaccine was purchased — and regardless of the age of the recipient — the appropriate VIS must be given out prior to the vaccination.


VIS FACT Use of the VIS is mandatory!

Before a healthcare provider vaccinates a child or an adult with a dose of any vaccine containing diphtheria, tetanus, Pertussis, measles, mumps, rubella, polio, hepatitis A, hepatitis B, Haemophilus influenzae type b (Hib), influenza, pneumococcal conjugate, meningococcal, rotavirus, human papillomavirus (HPV), or varicella (chickenpox) vaccine, the provider is required by the National Childhood Vaccine Injury Act (NCVIA) to provide a copy of the VIS to either the adult recipient or to the child’s parent/legal representative.


What else are you looking for? Vaccine Administration Practices

– Administration fee(s) to non-Medicaid VFC eligible patients

– Patient is unable to pay administration fee

– Office fee for an immunization only visit

– Prerequisite (i.e. physical exam) prior to an immunization only visit


Site Visit Requirements– Vaccine Schedule

Vaccine Schedule for children age 0 through 6 years:

Dose 1 Dose 2 Dose 3 Dose 4 Booster

Hep B schedule XXX XXX

DTaP schedule

Hib schedulea. 3 dose Hib (i.e. Pedvax®)b. 4 dose Hib (i.e. ActHIB®, Pentacel®)

IPV schedule Booster XXX

MMR schedule XXX XXX XXX

Varicella schedule XXX XXX XXX

Hep A schedule XXX XXX XXX

Rotavirus schedule XXX XXX


Site Visit Requirements– Vaccine Schedule

Vaccine Schedule for children aged 7 through 18 years:

Dose 1 Dose 2 Dose 3

Adolescent schedule for MCV4 XXX

Adolescent schedule for Tdap XXX XXX

Adolescent schedule for HPV


Site Visit Requirements Chart Review

– Documentation of VFC eligibility screening

– Provide all vaccines needed at every encounter

– Follow the recommended vaccine

schedule/immunization rules/laws

– Document the relevant VIS publication date

– Documentation of the vaccine manufacture, lot

number, site and route of administration

– Contraindications or precautions

Copy/update lifetime immunization card/immunization record


Site Visit Requirements Vaccine Inventory

– Physical inventory 1X month

– Reconcile inventory weekly

– Record vaccine at time of administration and by no

later than the COB daily

– Orders are appropriate based on enrollment data

– Rotate vaccines according to shortest expiration date

– Vaccines are clearly labeled


Site Visit Requirements Chart Review (medical record)

– Name of vaccine given– Date vaccine was given– Date VIS was given – Name of vaccine manufacturer– Lot Number– Name and title of person who gave the vaccine– Address of clinic where vaccine was given – Publication date of VIS– Site noted in the patient’s medical record – Route noted in the patient’s medical record


Site Visit RequirementsOther items

Proper needle length for intramuscular injection

VAERS forms/report adverse reactions


Items Most Often Out of Compliance at a Site Visit Incorrect administration fee charged to

non-Medicaid VFC eligible patients

Current Coverage Criteria not followed– Misuse of state-supplied vaccine

Inappropriately use –Insured/Health Choice–MMR, Td, Tdap for Adults–Use DTaP instead of Tdap for Adults


Items Most Often Out of Compliance at a Site Visit

Does not provide and or stock required and or recommend vaccines for VFC children (Medicaid, No Insurance, American Indian/Alaskan Native, Underinsured)


Items Most Often Out of Compliance at a Site Visit

Does not follow required and or recommended schedule

Does not follow immunization rules/laws

Improper needle length for intramuscular injection


Items Most Often Out of Compliance at a Site Visit Vaccine Information Statements (VIS)

– VIS not up to date– Publication date of VIS not recorded

Medical Record– Does not consistently record the date VIS

was given– Did not document signature and title of

person who gave the vaccine– Did not document publication date of VIS– Did not document route


Items Most Often Out of Compliance at a Site Visit Vaccine Storage

Written procedures for vaccine storage are not in place

Temperatures out of range– No action taken– No written documentation of action taken– Did not call the Immunization Branch for

guidance

A “Do Not Disconnect” sticker was not on the circuit breaker


Always Remember:

Follow your provider agreement and the law!

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Questions????

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are you ready for a site visit? presented by: beth meadows, rn wendy holmes, rn

Documents

state law

vfc providers

children program

children vfc program

nc specific immunization

rules ncip

schedule ncip

provider compliance