COMMUNITY HEALTH CLINIC (CHC) SELF-INSPECTION FORM - Oregon.gov

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2022
                                          COMMUNITY HEALTH CLINIC (CHC)
                                             SELF-INSPECTION FORM

ATTENTION: MEDICAL DIRECTOR or CLINIC REPRESENTATIVE

An Oregon public healthcare facility that utilizes a Registered Nurse to dispense medications for the purpose of birth
control, caries prevention, the treatment of amenorrhea, the treatment of a communicable disease, hormone deficiencies,
urinary tract infections or sexually transmitted diseases requires registration with the Oregon Board of Pharmacy as a
Community Health Clinic (CHC). Oregon Administrative Rule 855-043-0710 states that a Community Health Clinic Drug
Outlet must employ a Medical Director who is an Oregon practitioner with prescriptive and dispensing authority. The CHC
must designate a representative employee who will be the contact person for the Oregon Board of Pharmacy and must be
onsite the majority of the CHC’s normal operating hours.

The medical director or designated representative of the registered CHC shall conduct and document an annual review of
the outlet by completing this Self-Inspection Form by February 1, 2022. This form is designed to provide the facility with a
clear understanding of compliance expectations and to provide an opportunity to identify and correct areas of non-
compliance with Oregon Board of Pharmacy rules. The inspection form serves as a necessary document used by Board
Compliance Officers during an inspection to evaluate an outlet’s level of compliance, specifically focused on the
acquisition, storage, security, labeling, and recordkeeping of drugs intended for dispensing. Please review your completed
self-inspection form with staff and file it in a manner that is immediately retrievable at the time of inspection.

Do not assume that you are in compliance. Please review Board regulations and take the time to personally verify that
compliance exists. Email all Compliance related questions to: pharmacy.compliance@bop.oregon.gov. (Note: The Board
does not provide individualized legal advice on how the law applies to practice in the field. You may also want to contact a
qualified attorney.)

By answering the questions and referencing the appropriate laws and rules provided, you can determine whether the CHC
is compliant with many of the rules and regulations. If you have corrected any discrepancies, please write corrected and
the date of correction by the appropriate question.

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2022
                                             COMMUNITY HEALTH CLINIC
                                              SELF-INSPECTION FORM

Date:
                                                                       Date:
Outlet Registration #:
                                                                       In Person or Virtual Inspection (circle)
Controlled Substance License #:__________________________

Clinic Name:                                                           Compliance Officer: ________________

Medical Director Name and License #: _____________________             RPh or clinic representative present for
Hours:                                                                 Inspection: _________________________
Telephone:                                                             Result: ____________________________
Address:                                                               Comments: _________________________
City, Zip:

DPDO Registration #: __________________________________

INSTRUCTIONS
The clinic’s Medical Director or designated employee representative shall evaluate the outlet’s compliance with Board of
Pharmacy rules. Please complete this form by February 1, 2022. This form must be kept on file at the outlet and available
for Board inspection (OAR 855-043-0710(2)(a)).

 Yes     No    N/A                                                                                Rule Reference
  □ □ □              1   Does the outlet employ a Medical Director who is an Oregon
                         practitioner with prescriptive and dispensing authority?
                                                                                              OAR 855-043-0710(1)
                                                                                              OAR 855-043-0715

                         Name:

                         Email address: __________________________________

                         *The Medical Director shall establish and enforce policies and
                         procedures, drug dispensing formularies and protocols for the
                         dispensing of drugs by authorized persons in the CHC*

  □ □ □              2   Does the outlet employ a designated representative who works
                                                                                              OAR 855-043-0710(2)
                         onsite the majority of the CHC’s normal operating hours and who
                         is the contact person for the Oregon Board of Pharmacy?
                         (Note: this may be the Medical Director)

                         Name: ____________________________________________

                         Email address: ______________________________________

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                                                                                                                   Page 2
Yes   No   N/A                                                                                 Rule Reference
□ □ □            3   Does the clinic (CHC) utilize a Registered Nurse (RN) to
                                                                                           OAR 855-043-0700(1)
                                                                                           ORS 689.605(6)
                     dispense medications?

                     Note: An RN who is an employee of a Board of Pharmacy
                     registered CHC may, pursuant to the order of a person
                     authorized to prescribe a drug or device, dispense a drug or
                     device to a client for purposes of caries prevention, birth control
                     or prevention or treatment of a communicable disease.

□ □ □            4
                     Is any dispensing being done by a person other than a
                     practitioner who has been given dispensing privileges by their
                                                                                           OAR 855-043-0700

                     own licensing board (such as the Oregon Medical Board or
                     Oregon State Board of Nursing), or by an RN employed by the
                     clinic who is authorized to dispense?

                     Please provide the name(s), license number, licensing Board,
                     and identify under what authority that person is permitted to
                     dispense:

□ □ □            5
                     Does the outlet have policies and procedures for drug
                     management, including security, acquisition, storage, dispensing
                                                                                           OAR 855-043-0715(1) and
                                                                                           (2)
                     and drug delivery, disposal, record keeping, and RN training
                     (related to drug dispensing)?

                     Where are the policies and procedures located?

□ □ □            6   Were the outlet’s written policies and procedures developed in
                     collaboration between the Medical Director and the designated
                                                                                           OAR 855-043-0710(2)(b)

                     representative?

                     How does the outlet ensure a RN’s continued competence in the         OAR 855-043-0715(2)
                 7
                     dispensing of drugs?

                     Where are the training documents located?

□ □ □            8
                     Does the outlet store all drugs intended for dispensing in a
                     locked cabinet or designated storage area that is sufficiently
                                                                                           OAR 855-043-0720(1) and
                                                                                           (2)
                     secure to deny access to unauthorized persons?

                     How does the outlet maintain security?

                     Note: The drug storage cabinet or area must remain locked and
                     secure when not in use, and only a physician, clinical nurse
                     specialist, nurse practitioner, or RN shall have access to the key.

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                                                                                                         Page 3
Yes   No   N/A                                                                                 Rule Reference
□ □ □            9
                      Does the outlet only acquire drugs from a supplier registered with
                      the Oregon Board of Pharmacy?
                                                                                           OAR 855-043-0725

                      Name of supplier(s) and registration #(s):

                      Where are the invoices located?

                      Note: Verify a supplier’s Board of Pharmacy registration at
                      https://orbop.mylicense.com/verification/

□ □ □            10 Are all drugs, including drug samples, stored in accordance with
                    the manufacturer’s labeling?
                                                                                           OAR 855-043-0730

                      Note: This includes maintaining proper temperature and having
                      documentation to show that temperature is being tracked

□ □ □            11 Prior to dispensing a medication, does the RN obtain a
                    prescription from the practitioner?
                                                                                           OAR 855-043-0740

□ □ □            12 Are drugs dispensed in compliance with the current provisions of
                                                                                           OAR 855-043-0740(6)
                    the Poison Prevention Packaging Act in 16 CFR 1700, 16 CFR
                    1701, and 16 CFR 1702?

□ □ □            13 Are all drugs packaged by the practitioner, RN, a pharmacy, or a
                                                                                           OAR 855-043-0740(7)
                    manufacturer registered with the Board?

□ □ □            14
                      Are all repackaged drugs labeled with the required information?
                          • Brand name, or generic name and the manufacturer;
                                                                                           OAR 855-041-1135(1)(a-d)

                          • Strength;
                          • Lot number;
                          • Manufacturer’s expiration date, or an earlier date if
                               preferable

□ □ □            15 Does the practitioner or RN provide the patient with appropriate
                                                                                           OAR 855-043-0740(5)
                    drug information for medications at the time of dispensing?

□ □ □            16 Is staff aware that a CHC may not accept the return of drugs
                                                                                           OAR 855-043-0740(8)
                    from a previously dispensed prescription, may not re-dispense a
                    prescription that was already released to a patient, and must
                    maintain a list of sites in Oregon where drugs may be disposed?

                      Where is the outlet’s pharmaceutical reference(s) kept?              OAR 855-043-0740(9)
                 17

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Yes   No   N/A                                                                                    Rule Reference
□ □ □            18 Are all prescriptions labeled with all of the required information?
                        • Unique identifier (easily retrievable “prescription number”
                                                                                              OAR 855-043-0735(1)(a-k)

                             for tracking purposes);
                        • Name of patient;
                        • Name of prescriber;
                        • Name, address and phone number of CHC;
                        • Date of dispensing;
                        • Name of drug, including strength – when a generic name
                             is used the label must also contain the identifier of the
                             manufacturer or distributor;
                        • Quantity dispensed;
                        • Directions for use;
                        • Initials of the practitioner with dispensing privileges, or
                             the RN;
                        • Cautionary statement, if any, as required by law;
                        • Manufacturer’s expiration date, or an earlier date if
                             preferable, after which the patient should not use the
                             drug (e.g. The expiration date on NuvaRing® should not
                             exceed 4 months from the date of dispensing)

 □ □ □           19
                      Are directions for use on prescription labels available in all of the
                      14 languages required, if requested by the patient or patient’s         ORS 689.564
                      agent?                                                                  OAR 855-043-0736

                      If not, what is the anticipated date of compliance?

□ □ □            20
                      Are all recalled, outdated/expired, damaged, deteriorated,
                      suspect, illegitimate, misbranded or adulterated drugs properly
                                                                                              OAR 855-043-0745

                      quarantined and physically separated from other drugs until
                      destroyed or returned to the supplier?

                      Where does the outlet keep drugs quarantined, awaiting
                      destruction or disposal?

                      Are all of the following requirements met for each dispensed            855-043-0740(10)
                 21
                      prescription that is delivered or mailed to a patient?
                          • Maintain Proper drug storage conditions
                          • Provide offer in writing, for direct counseling, how to
                               contact the practitioner, and information about the drug,
                               including, but not limited to:
                                    o Drug name, class and indications
                                    o Proper use and storage
                                    o Common side effects
                                    o Precautions and contraindications
                                    o Significant drug interactions

□ □ □            22
                      Is the dispensing record separate from the patients’ charts, and
                      maintained for at least three years?
                                                                                              OAR 855-043-0750(1)

                      Where are the records kept?

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Yes   No     N/A                                                                            Rule Reference
 □ □ □              23 Does the dispensing record contain all of the required
                       information?
                                                                                         OAR 855-043-0750(1)(a-f)

                            • Name of patient;
                            • Unique identifier (“prescription number”)
                            • Dose, dosage form, quantity dispensed and either brand
                               name of drug, or generic name and name of
                               manufacturer or distributor;
                            • Directions for use;
                            • Date of dispensing;
                            • Initials of person dispensing the prescription.

 □ □ □              24
                         Are all records of receipt and disposal of drugs kept for a
                         minimum of three years?
                                                                                         OAR 855-043-0750(2)

                         Where are the records kept?

Print name:                                                        Title:

Signature:                                                          Date: ___________________________________

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