Current through Register Vol. 47, No. 17, September 10, 2024
This Rule is promulgated pursuant to sections
12-20-204,
12-275-108(1)(b),
and 12-275-119, C.R.S.
A.
General.
1. Except as provided in subsection (F) of
this Rule, every licensed optometrist shall create and shall maintain records
on their patient(s).
2. Every
optometrist shall retain and maintain a patient record as defined in subsection
(C). of this Rule, on the patient(s) for a period of seven years, commencing on
the termination of optometric services or on the date of last contact with the
patient(s), whichever is later. Records for minor patient(s) shall be kept for
a minimum of seven years after the patient reaches the age of majority (age
eighteen).
3. Every licensed
optometrist shall retain and maintain a prescription drug log as defined in
subsection (D) of this Rule.
B.
Upon Conclusion of an Eye Exam
Where A Valid Prescription Has Been Determined and/or Finalized.
Regardless of whether the patient requests it or not, it is required that the
optometrist immediately provide a(n):
1.
Eyeglass prescription.
2. Contact
lens prescription, as defined in subsection (C)(11) of this Rule, at the
conclusion of a lens fitting.
C.
Patient Record.
Every licensed optometrist shall create and shall maintain, as applicable to
the optometric services rendered, a record for the patient(s) containing the
following information:
1. Name of treating
optometrist;
2. Patient's
identifying data to include name, address, telephone number, gender, date of
birth, and, if applicable, the name of their legal guardian (guardian) or
designated legal representative (representative).
3. Dates of service including, but not
limited to the date of each contact with patient, the date on which services
began, and the date of last contact with patient;
4. When the licensed optometrist prescribes,
dispenses, and/or administers any prescription drug, the following shall be
recorded on the patient's record:
a. Patient
name;
b. Name of authorized
practitioner-dispensing, prescribing, and /or administering drug(s);
c. Diagnosis being treated or services
performed;
d. Date dispensed,
prescribed, and/or administered;
e.
Name and strength of drug dispensed, prescribed, and/or administered;
f. Quantity dispensed, prescribed, and/or
administered;
g. Directions for
use;
h. Number of refills
authorized;
5. When the
licensed optometrist prescribes any prescription drug, the following shall be
recorded on the prescription.
a. All
prescriptions shall bear:
(1) The full name,
date of birth, and address of the patient;
(2) The drug name, strength, dosage form, and
quantity prescribed,
(3) Directions
for use;
(4) Number of refills
authorized, if any;
(5) The date
and signature on the day it was issued; and
(6) Any additional requirements mandated by
the Drug Enforcement Agency.
b. All prescriptions for controlled
substances shall additionally:
(1) Bear the
name, address, Drug Enforcement Administration registration number, and
signature of the licensed optometrist.
A practitioner may sign a prescription in the same manner as
she/he would sign a check or legal document (e.g., J.H. Smith or John H.
Smith). When an oral order is not permitted, prescriptions shall be written
with ink or indelible pencil or typewritten and shall be manually signed by the
practitioner. The prescriptions may be prepared by the office staff or agent
for the signature of the licensed optometrist, but the prescribing optometrist
is responsible in case the prescription does not conform in all essential
respects to the law and regulations. The use of a rubber-stamped, pre-printed,
or pre-signed signature on prescription pads is not acceptable.
6.
Fees;
7. Any release of
information;
8. The records must be
prepared in a manner that allows any subsequent provider or any authorized
regulatory body to yield a comprehensive conclusion as to what
occurred;
9. Name of any test
administered, each date on which the test was administered, and, if applicable,
the name(s) of the person(s) administering the test;
10. Eyeglass prescription (if applicable);
a. An electronic signature on an eyeglass
prescription shall be considered to have the same force and effect as an
original signature.
11.
Contact lens prescription (if applicable);
a.
A valid, written contact lens prescription is an order by an optometrist to
supply contact lens medical devices to a patient. It shall contain all of the
following information;
(1) The patient's full
name;
(2) The date of the
examination/lens fitting;
(3) All
usual and customary specifications, and manufacturer's name and manufacturer's
trade or brand name necessary for an exact replacement contact lens;
(4) The optometrist's signature, name,
license number, address and phone number;
(5) A reasonable limit on refills;
and
(6) An expiration date of one
year from the issue date of the prescription, unless a shorter expiration date
is warranted based on the medical judgment of the prescribing optometrist with
respect to the ocular health of the patient.
b. An electronic signature on a contact lens
prescription shall be considered to have the same force and effect as an
original signature.
12.
Items such as photographs, digital images, corneal topographies, etc.
13. Information on each referral made to and
each consultation with another optometrist or other health care provider. This
information shall include the date of referral or consultation, the name of the
person to whom the patient was referred, the name of the person with whom
consultation was sought; the outcome (if known) of the referral, and the
outcome (if known) of the consultation;
14. Records of exams, notes, correspondence,
audio or visual recordings, electronic data storage, and other documents
considered professional information for use in optometry;
15. If applicable, any original patient
records from a previous optometrist(s); and
16. A final closing statement (if services
have been discontinued), if applicable.
If changes, corrections, deletions, or other modifications
are made to any portion of a patient record, the person must note in the record
date, nature, reason, correction, deletion, or other modification, and her/his
name.
D.
Prescription Drug Log. Every licensed optometrist
shall keep a complete and accurate inventory of all stocks of controlled
substances on hand in her/his office as may be required by these Rules or any
other state or federal law or rule pertaining to such drugs. Such records shall
be maintained on a current basis and shall be complete and accurate for all
drugs which the licensed optometrist receives, dispenses, distributes,
prescribes or otherwise disposes of in any other manner.
1. Records and inventories of controlled
substances shall be deemed to be "complete" only if each individual record and
inventory contains all required information regarding each specific
transaction, and if the set of records and inventories contains all information
and documents required to be kept by state and federal laws and
rules.
2. A record or inventory
shall be deemed to be "accurate" only if it is a complete, true and factual
statement regarding or reflecting each specific transaction. A set of records
or inventories shall be deemed to be "accurate" only if they are complete, and,
when considered as a whole, they demonstrate that the controlled substances
and/or the records and inventories pertaining there to have been handled in
compliance with all applicable laws or rules and that all such controlled
substances are properly accounted for.
3. For the purposes of these Rules, records
and inventories shall be "readily retrievable" if they meet the following
requirements:
a. The following records shall
be maintained on the premises at all times and shall be made available for
inspection by the Board immediately upon request.
(1) All DEA-222 forms executed during the two
years preceding the request;
(2)
All inventories of controlled substances required to be taken during the two
years preceding the request;
(3)
All records of dispensing, receipt (invoices for drugs received and drugs
credited), distribution, loss, surrender, or disposal in any other manner of
prescription drugs and controlled substances during the two years preceding the
request;
b. The following
records shall be made available within forty-eight hours or two business days,
whichever is longer, on request by the Board:
(1) All unexecuted DEA-222 forms.
c. In the case of a request by the
Board for specific records:
(1) Records shall
be maintained in such a manner as to permit the Board to retrieve specific
records immediately.
(2) If the
Board determines the records are not maintained in the manner specified in (1)
above, the Board may give the licensed optometrist or their staff a list of the
items to be retrieved. The requested records shall be made available to the
Board within forty-eight hours of the request.
4. Inventories of controlled substances. Any
inventory of controlled substances shall comply with the following:
a. Each inventory shall contain a complete
and accurate record of all controlled substances on hand on the date the
inventory is taken. The inventory shall be maintained in written, typewritten
or printed form on the premises. The inventory for schedule II drugs shall be
separated from the inventory of schedule III, IV, and V drugs. Controlled
substances shall be deemed to be "on hand" if they are in the possession of or
under the control of the optometrist. However, the inventory shall exclude any
drug that has been dispensed pursuant to a lawful order but which has not yet
been delivered or picked up.
b. The
licensed optometrist shall maintain a record of any controlled substance(s)
lost, destroyed, or stolen, and the record shall include the schedule, name,
strength and quantity of such controlled substance(s) and the date of such
loss, destruction or theft. In addition, the licensed optometrist must report
such loss or theft to the Drug Enforcement Administration District Office
within one business day of discovery of such loss or theft.
c. The inventory shall be taken either as of
opening of business or as of the close of business on the inventory date and
this shall be recorded on the inventory.
d. After the initial inventory is taken, the
licensed optometrist shall take a new inventory of all stocks of controlled
substances on hand at least quarterly (every three months).
e. On the effective date of a law or rule on
which a previously non-scheduled drug is added to any schedule of controlled
substances, every optometry office or optometrist that possesses that drug
shall take an inventory of all stocks of the drug on hand. Thereafter, that
drug shall be included in each inventory made by the optometry office or
optometrist.
f. The following
information shall be recorded on the inventory:
(1) The name of the drug;
(2) Each finished form of the drug (strength
and dosage form);
(3) The number of
units or volume of each finished form; and
(4) All outdated controlled
substances.
g. In
determining the number of units of each finished form of a controlled substance
in a commercial container which has been opened, the licensed optometrist shall
do as follows:
(1) If the drug is a schedule
II drug, an exact count of the contents shall be made.
(2) If the substance is listed in schedule
III, IV, or V, an estimated count of the measure of the contents may be made,
unless the container holds more than 1000 tablets or capsules, in which case an
exact count of the contents must be made.
(3) All controlled substance inventories
shall be retained at the office, by the licensed optometrist, for at least two
years from the date of such inventory.
h. At minimum, dispensing records, maintained
separate of the individual patient record, must include the following
information for every transaction:
(1)
Patient name;
(2)
Prescriber;
(3) Date
dispensed/administered;
(4) Name
and strength of drug dispensed/administered;
(5) Quantity
dispensed/administered;
(6) Whether
the transaction is a new or refill transaction;
(7) If refill transaction, the date of the
initial order;
(8) Number of
refills authorized;
(9) Number of
refills dispensed to date;
(10)
Identification of individual responsible for
dispensing/administering;
(11) If a
controlled substance, the Drug Enforcement Administration registration number
of the prescriber/dispenser;
E.
Record Storage.
Every optometrist shall keep and store patient records in a secure place and in
a manner that both assures that only authorized persons have access to the
records and protects the confidentiality of the records and of the information
contained in the records.
F.
Transfer of Records. Whenever a Licensee deems it
necessary to transfer her/his records to another licensee or other health care
provider, the Licensee making the transfer shall obtain the client's consent to
transfer (when possible).
G.
Release of Records.
1. Every patient's record in the custody of a
licensed optometrist shall be available to a patient, their guardian, or
representative at reasonable times and upon reasonable notice.
2. Duplication of the record may not be
withheld for past due fees relating to treatment; for patient's failure to
follow treatment instructions, or the patient's failure to return for
subsequent care, etc.
3.
Duplication of Record Request
a. The
optometrist may charge a reasonable fee for copying of records and may require
payment in advance, prior to beginning the duplication process. Actual postage
costs may also be charged.
b. It is
customary when a patient is transferring care for optometrists to provide
copies of records to another optometrist's or physician's office free of
charge.
c. The optometrist shall
make the duplicated record available within a reasonable time from the date of
the signed request, and, if required, pre-payment of duplication cost,
whichever is later, normally not to exceed fifteen days, excluding weekends and
holidays.
d. If the patient,
guardian or representative so approves, the custodian may supply a written
interpretation by the attending provider or representative of patient records,
such as photographs, digital images, corneal topographies, or non-written
records which cannot be reproduced without special equipment. If the requestor
prefers to obtain a copy of such patient records, the patient must pay the
actual cost of such reproduction.
e. The optometrist may request the patient,
guardian or representative identify which parts of the record they would like
to have duplicated.
f. Nothing
prevents the patient, guardian or representative from requesting certain parts
of their record.
4.
Eyeglass or Contact Lens Prescription Requests.
a. A patient, guardian or representative may
obtain a copy of her/his prescription after submitting a signed and dated
request to the custodian of the patient record.
5. Nothing in this Rule shall be construed to
waive the responsibility of a custodian of records to maintain confidentiality
of those records under the care of the custodian.
H.
Disposition of
Records. At the time a licensed optometrist discontinues her/his
practice, or if the licensed optometrist is not available to handle her/his own
records, the licensed optometrist and/or his/her estate shall designate an
appropriate person to handle the disposition of records. A plan for the
disposition of records shall be in place for all licensed optometrists who are
in the following circumstances:
1. Disability,
illness, retirement, or death of the licensed optometrist;
2. Termination of the licensed optometrist's
practice;
3. Sale or transfer of
practice.
In any event the optometrist or designee shall make a
reasonable effort to notify the patient(s) of the transfer and provide
instructions to submit a written authorization/release if they wish their
records to be transferred to another optometrist or physician. Records should
be retained after discontinuation of practice using the guidelines as defined
in subsection (A) of this Rule.
I.
Record
Destruction. Every licensed optometrist shall dispose of a
patient(s) records in a manner or by a process that destroys or obliterates all
patient identifying data. However, records cannot be destroyed until after a
period of seven years commencing on the termination of optometric services or
on the date of last contact with the patient(s), whichever is later and records
for minor patient(s) shall be kept for a minimum of seven years after the
patient reaches the age of majority (age eighteen) or as otherwise provided in
these Rules or any other applicable statutes.
1. In the case of litigation, Board
investigation or other investigation, all relevant records must be retained
until resolution of the matter.
2.
Records may not be withheld for past due fees relating to treatment.
J.
Record Keeping in
Agency/Institutional Settings. A licensed optometrist need not
create and maintain separate patient records if the licensed optometrist
practices in an agency or institutional setting and:
1. The licensed optometrist sees the patient
in the usual course of that practice; and
2. The licensed optometrist keeps client
records as required by the agency or institution; and
3 The agency or institution maintains the
client records.
