TITLE 7 HEALTH
CHAPTER 5 VACCINES AND IMMUNIZATIONS
PART 5 NEW
MEXICO STATEWIDE IMMUNIZATION REGISTRY
7.5.5.1 ISSUING
AGENCY: Public Health Division, Department of Health.
[7.5.5.1 NMAC - N, 10/30/2018]
7.5.5.2 SCOPE: These regulations govern the use of the New
Mexico statewide immunization registry, a computerized repository of
immunization information maintained by the New Mexico department of health.
[7.5.5.2 NMAC - N, 10/30/2018]
7.5.5.3 STATUTORY
AUTHORITY: The requirements set forth herein are
promulgated by the secretary of the department of health pursuant to the
authority granted under Subsection E of Section 9-7-6 NMSA 1978, Sections
24-5-7 through 24-5-15 NMSA 1978, Subsection R of Section 24-1-3 NMSA 1978, and
Section 24-1-21 NMSA.
[7.5.5.3 NMAC - N, 10/30/2018]
7.5.5.4 DURATION: Permanent.
[7.5.5.4 NMAC - N, 10/30/2018]
7.5.5.5 EFFECTIVE
DATE: October 30, 2018, unless a later date is
cited at the end of a section.
[7.5.5.5 NMAC - N, 10/30/2018]
7.5.5.6 OBJECTIVE: The objective of this rule is to describe
implementation and maintenance, submission, reporting, participation, and
limits on access to the registry portion of the New Mexico immunization
program.
[7.5.5.6 NMAC - N, 10/30/2018]
7.5.5.7 DEFINITIONS:
A. “Authorized user” means a person to
whom the division has provided account credentials authorizing that person to
access to the registry.
B. “CDC” means centers for disease control
and prevention, the federal agency responsible for monitoring and protecting
the United States of America from health, safety, and security threats related
to diseases.
C. “Data elements” means the information
required to be entered into the registry by providers as specified in these
regulations or by official division publication.
D. "Department"
means the department of health.
E. “Division” means
the department of health, public health division.
F. “Government issued
identification” means a legible, current credentialing document issued by a
local, state or federal government entity that includes a photo.
G. “Health information
exchange” means an arrangement that allows the sharing of health care
information about individual patients among different health care institutions
or unaffiliated providers.
H. “Immunization”
means treatment of an individual with either a vaccine licensed by the U.S.
food and drug administration for immunization and distribution in the United
States, or an immune globulin product licensed by the U.S. food and drug administration
and used for the purposes of producing or enhancing an immune response.
I. “NDC” means
National Drug Code.
J. "NMDOH" means
the New Mexico department of health.
K. "NMSIIS" means the New Mexico
statewide immunization information system.
L. “Provider” means
an individual or organization required to submit information to the registry
pursuant to Section 24-5-8 NMSA 1978 including physicians, nurses, pharmacists,
nurse practitioners, physician's assistants and other health care providers
authorized by the division.
M. “Patient” means
any person offered an immunization.
N. “Registry” means
the New Mexico statewide immunization information system (NMSIIS), a
computerized repository of immunization information maintained by the New
Mexico department of health.
O. “Vaccines for
children program" or "VFC” means the program operated by the
division that provides federally funded vaccines to children ages 0-18 years
who are uninsured, on medicaid, or are Alaska
Native/American Indian.
[7.5.5.7 NMAC - N, 10/30/2018]
7.5.5.8 IMPLEMENTATION
AND MAINTENANCE OF THE REGISTRY:
The department is responsible for establishing guidelines as necessary
regarding the implementation and maintenance of the registry.
[7.5.5.8 NMAC - N, 10/30/2018]
7.5.5.9 REPORTING
REQUIREMENTS:
A. Providers shall report all data elements to the
registry for all immunizations they administer to a patient unless the patient
or the patient’s parent or guardian informs the provider that the patient
declines to participate in the registry or does not wish to include a
particular immunization in the registry.
B. Providers shall report all data
elements to the registry within 10 days of administering an immunization. A provider may request an extension of 20
days from the division for large immunization events. Permission for extensions for these events are at the discretion of the division and providers must
obtain pre-approval.
C. The following
are the minimum data elements that must be reported to the registry:
(1) Vaccination information, including:
(a) name of vaccine;
(b) manufacturer of vaccine;
(c) lot/serial
number of vaccine;
(d) funding source of vaccine;
(e) expiration date of vaccine;
(f) NDC
number of vaccine;
(g) date of administration of vaccine;
(h) dosage administered to patient;
(i) body site
and route of administration.
(2) Patient
demographic information, including:
(a) last name;
(b) first name;
(c) middle name, if applicable;
(d) sex;
(e) date of birth;
(f) insurance status;
(g) insurance information;
(h) mailing address;
(i) physical
address;
(j) contact information.
D. Providers will be notified through
an official memo by the division of any additional required data elements for
reporting not already included herein.
Any included data elements published through an official memo to
providers are incorporated herein by reference as required data elements.
[7.5.5.9 NMAC - N, 10/30/2018]
7.5.5.10 SUBMISSION
OF REPORTS OF IMMUNIZATION TO THE REGISTRY:
A. All data elements
shall be reported to the registry in a manner and format approved by the
division.
B. Direct
reporting:
(1) Authorized
users may directly review and submit data elements electronically through the
registry website interface using individual account credentials assigned by the
division.
(2) Each
user may only use their individual account credentials assigned to the
authorized user.
(3) Authorized
user account credentials may not be shared.
C. Data exchange
reporting:
(1) Providers
with electronic systems that are compatible with the division's data exchange
program may request to receive approval to utilize the compatible system for
reporting the required data elements.
(2) Providers
using data exchange reporting must utilize the file format approved by the
division and are responsible for all associated costs.
(3) Providers
using data exchange reporting must update their systems to maintain
compatibility with the divisions data exchange program as necessary to maintain
the integrity of the data transfers.
D. A health
information exchange may exchange information with the registry on behalf of a
provider. When a health information
exchange operates in this manner, the exchange is subject to the same rules as
the provider.
E. To decrease duplication
of patient records and duplicate vaccines, the division may utilize other
information sources to populate the registry and perform data quality
activities, such as birth certificates, adoption decrees, paper shot records,
or medicaid enrollment information.
[7.5.5.10 NMAC - N, 10/30/2018]
7.5.5.11 PROCEDURES TO DECLINE
PARTICIPATION
(1) The
provider shall document the patient's opt-out decision using a form provided by
the division, or the provider's own form provided the same information as the
division's form is included.
(2) The
provider will store all opt-out documentation in an accessible, orderly system
so that in the event of a public health emergency, the department can review
the opt-out data to inform emergency responses.
B. Patients
must complete the opt-out process with each healthcare provider that offers
immunization services to the patient, each time immunization services are
provided. If the patient declines
participation for certain immunizations only, the patient must complete the
opt-out process for each immunization for which the patient opts out.
[7.5.5.11 NMAC - N, 10/30/2018]
7.5.5.12 PROCEDURES
FOR REVIEWING AND CORRECTING PATIENT RECORDS:
A. At
the time an immunization is offered, the provider shall notify the patient of
the procedures to review and correct information contained in the registry.
B. A patient, or a minor patient's
parent or guardian, who wishes to review the patient’s registry immunization
record may request a copy from the patient’s provider or from a
department public health office, or through a department-approved online
portal.
C. If a patient
requests to correct any information in the registry, the patient shall submit a
written request to the division, the NMDOH Helpdesk, to a department public
health office, or to the patient's provider.
The request shall identify the patient and the information to be
corrected.
D. All requests for
corrections must be accompanied by a copy of patient identification. If a patient is a minor, the request must be
accompanied by a certified copy of the patient's birth certificate and a copy
of identification for the submitter or the parent/guardian of the requesting
patient. If the requester is a
non-parent legal guardian, the guardian must also submit a copy of the
guardian’s legal appointment of guardianship.
E. If a patient
requests to change the registry’s record of the patient’s date of birth, the
patient must present a birth certificate or other legal documentation to verify
the patient’s correct date of birth. All
such requests must be submitted to division staff via the NMDOH Helpdesk. Information on how to contact the NMDOH
Helpdesk can be found on the NMSIIS webpage
https://nmsiis.health.state.nm.us/webiznet_nm/Login.aspx.
F. If the
department bureau of vital records and health statistics provided the date of
birth for a patient, the patient’s date of birth may not be changed except
through notification by vital records or a court order.
G. Only division
staff are permitted to change a patient's name or date
of birth on a patient record.
(1) Appropriate
documentation as required by this section must be presented to division staff
to have the patient's name changed, or spelling corrected or changed.
(2) If
a court order for adoption requires a name change, the request for change must
be submitted to division staff via the NMDOH helpdesk and must include copies
of the patient's legal documentation supporting the request.
H. If a patient
requests to change any other information in the registry, supporting materials
such as medical records, should be attached to the patient's written request.
I. The division
may make a change if the change is supported by appropriate documentation.
J. If the patient
cannot be uniquely identified in the registry, or if the request is
insufficiently supported, the division will contact the patient to obtain
additional information.
K. Upon making a
determination, the division will notify the requestor of that decision. If the request is denied, the division will
notify the patient of the reason(s) for denial.
If the request is approved, the division will record the change in the
registry.
[7.5.5.12 NMAC - N, 10/30/2018]
7.5.5.13 PROCEDURES TO WITHDRAW CONSENT
AND REMOVE INFORMATION FROM REGISTRY:
A. To remove
a record from NMSIIS, a patient must submit by mail or hand delivery to the
department a completed decision to remove NMSIIS record form. The decision to remove form can be obtained
from a provider or printed from the department website at
https://nmhealth.org/about/phd/idb/imp/siis/.
B. The
patient's request
to remove information must be accompanied by a copy of patient
identification. If the patient is a
minor, the request must be accompanied by a copy of the patient's birth
certificate and a copy of identification for the submitter or parent/guardian
of the patient. If the requester is a
guardian, a copy of the legal appointment of guardianship will be required.
C. Upon
receipt of the request, or upon receipt of any requested additional
information, the division shall delete the patient's record from the
registry. The division shall notify the
patient when the record is deleted.
[7.5.5.12 NMAC - N, 10/30/2018]
7.5.5.14 LIMITS ON ACCESS TO THE
REGISTRY:
A. Access to
the information in the registry shall be limited to primary care physicians,
nurses, pharmacists, managed care organizations, school nurses, and other
appropriate health care providers including nurse practitioners and physician
assistants, or public health entities as designated by the secretary of
health. A managed care organization may
only access information for its enrollees.
B. Requests
for access to the registry shall be made by a provider in writing to the
division and access shall be determined by the division.
C. No
person or automated system may access or attempt to access the registry without
approval from the division.
D. At
the division's discretion, access may be modified.
E. A
patient, or a patient's parent or guardian if the patient is under the age of
18, may access the patient’s records.
[7.5.5.13 NMAC - N, 10/30/2018]
7.5.5.15 COMPLAINT INVESTIGATIONS:
A. If the
division receives a complaint or otherwise learns of noncompliance of a
provider relating to these rules, an investigation will be initiated.
B. Upon
completion of the investigation, the division will issue an investigative
report substantiating or not substantiating the alleged noncompliance.
[7.5.5.14 NMAC - N, 10/30/2018]
7.5.5.16 SANCTIONS
AND NONCOMPLIANCE:
A. A provider
is in noncompliance if they fail to follow any of these regulations.
B. If noncompliance
is substantiated, the department will issue the provider a written report of
deficiencies which shall include a plan of correction.
(1) The provider must correct any
deficiencies identified in the department’s plan of correction within a fixed
period of time.
(2) The
period of time for a provider to correct deficiencies will be reasonably
determined by the division and be based on the circumstances of the
noncompliance. The time period will be
specified in the plan of correction.
C. Upon expiration
of the correction date as stated in the plan of correction, pursuant to Section
24-1-21 NMSA the division may impose a separate civil monetary penalty of one
hundred dollars ($100) for each repeated instance of noncompliance, including,
but not limited to each invalid or improper entry. The division shall issue a written report
detailing the repeated non-compliance and the civil monetary penalty. The civil monetary penalty shall not exceed
five thousand dollars ($5,000) per report.
[7.5.5.15 NMAC - N, 10/30/2018]
7.5.5.17 ADMINISTRATIVE REVIEW:
A. If a
provider wishes to appeal the issuance of a civil monetary penalty, the
provider must submit a written request for an administrative review within 10
working days from the date of issuance of the civil monetary penalty.
B. An
administrative review will be conducted by an assigned division bureau chief or
designee within 30 days of the request for review. Additional time to conduct the administrative
review may be granted if requested by the provider and good cause is shown.
(1) The
provider may request a paper administrative review, limited to records and a
written appeal, or may appear in person or through an advocate of the
provider’s choice and present evidence to refute the results of the
investigation and the reason for the issuance of the civil monetary penalty
during an administrative review.
(2) The
assigned bureau chief or designee will complete their review and either
overturn, modify, or uphold the civil monetary penalty in a written decision
within 10 days of the completion of the administrative review.
[7.5.5.16 NMAC - N, 10/30/2018]
7.5.5.18 ADMINISTRATIVE HEARING:
A. If the
provider wishes to appeal the result of the administrative review, the provider
must submit a written request to the division within 10 working days from the
date of issuance of the assigned bureau chief or designee's written decision.
B. Hearing
process:
(1) Hearing
will be conducted by a hearing officer appointed by the secretary.
(2) Hearings
shall be conducted in Santa Fe, New Mexico, unless the appellant can show
significant hardship sufficient to require the case be held in a different
location.
(3) Due
to federal and state laws regarding the confidentiality of protected health
information, all hearings held pursuant to this section shall be closed to the
public.
(4) The
hearing shall be recorded on audio recording equipment. The hearing officer shall maintain the
recording. No other recordings may be made except with the permission of the
hearing officer.
(5) Any
hearing provided for in this rule may be held telephonically, with the consent
of the parties.
(6) A
request for a telephonic hearing must be made no later than 10 business days
prior to the date of the hearing; notice of the telephonic hearing shall be
given to all parties and shall include all necessary telephone numbers;
(6) The
department shall schedule and hold the hearing no later than 60 calendar days
from the date the department receives the appellant's request for hearing. The hearing officer may extend the 60-day
time period for good cause shown, or the parties may extend that period by
mutual agreement.
(7) The
department shall issue notice of the hearing at least fifteen days prior to the
scheduled date of the hearing. The
notice shall include a statement of the time, place, and nature of the hearing.
(9) An
appellant's failure to appear at the hearing at the date and time noticed shall
constitute a default unless good cause for the failure to appear is shown.
(10) All
parties shall be given the opportunity to respond and present evidence and
argument on relevant issues.
(11) A
party may be represented by a person licensed to practice law in New Mexico or
a non-lawyer representative or may represent himself or herself.
(12) The
hearing officer shall create a record of the proceedings which shall include
the following:
(a) all pleadings, motions, and rulings;
(b) evidence
and briefs received or considered;
(c) a statement of any matters officially noticed;
(d) offers of proof, objections, and
rulings thereon;
(e) proposed findings and conclusions; and
(f) any action recommended by the hearing officer.
(13) Unless
the hearing officer determines a different procedure is appropriate, the
hearing officer shall conduct the hearing as follows:
(a) opening statements by the appellant and the department;
(b) upon conclusion of the opening statements, the department
shall present its case;
(c) upon conclusion of the departments case, the appellant may
present his or her case;
(d) upon conclusion of either party's case, the opposing party
may present rebuttal evidence; and
(e) after presentation of the evidence by the parties, the
parties may present closing arguments.
(14) The
rules of evidence as applied in courts do not apply in the proceedings; any
relevant evidence shall be admitted; irrelevant, immaterial, or unduly
repetitious evidence may be excluded.
(15) The department
shall be required to prove its case by a preponderance of the evidence.
(16) The
parties may submit briefs including findings of fact and conclusions of law for
consideration by the hearing officer.
All briefs must be submitted 15 days after the conclusion of the
hearing.
(17) No
later than 30 calendar days after the last submission by a party, the hearing
officer shall prepare and submit to the secretary a written recommendation of
action to be taken by the secretary; the recommendation shall propose
sustaining, reversing, or modifying the proposed action of the department.
(18) The
secretary shall issue a final written decision accepting or rejecting the
hearing officer's recommendation in whole or in part no later than 30 calendar
days after receipt of the hearing examiner's recommendation; the final decision
shall identify final action taken.
Service of the secretary's final decision shall be made upon the
appellant by registered or certified mail.
[7.5.5.18 NMAC - N, 10/30/2018]
History of 7.5.5 NMAC: [RESERVED]