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. v. 2022 Page 1
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: ______________________________________ v. 2022 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. v. 2022 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 v. 2022 Page 4
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? v. 2022 Page 5
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: ___________________________________ v. 2022 Page 6
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