§ 111656.3. — 111656.3. (Added by Stats. 2000, Ch. 837, Sec. 35.)

California § 111656.3.

• Jurisdiction: California
• Code HSC: Health and Safety Code - HSC
• Div. 104.: DIVISION 104. ENVIRONMENTAL HEALTH
• Part 5.: PART 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS
• Ch. 6.: CHAPTER 6. Drugs and Devices
• Art. 6.: ARTICLE 6. Licenses

Text

(a)
Each home medical device retail facility shall have written policies and procedures related to home medical device handling and, if authorized by the department pursuant to Section 111656.4, the dispensing of prescription devices. Those written policies and procedures shall be adequate to assure compliance with this article and shall include, but not be limited to:
(1)
Training of staff, patients, and caregivers.
(2)
Cleaning, storage, and maintenance of home medical devices necessary to prevent damage or contamination and to assure their operation in accordance with manufacturer specifications.
(3)
Emergency services. If home medical device malfunction may threaten a patient’s health, access to emergency services 24 hours per day, 365 days per year shall be available for device maintenance or replacement.
(4)
Maintaining all records required by this article and any regulations adopted pursuant to the provisions of this article.
(5)
Storage and security requirements to assure that prescription devices are dispensed in accordance with this article.
(6)
Quality assurance.
(b)
The home medical device retail facility shall make consultation available to the patient or primary caregiver about the proper use of devices and related supplies furnished by the home medical device retail facility. The home medical device retail facility shall notify the patient or primary care giver that this consultation is available.
(c)
Each home medical device retail facility shall ensure all personnel who engage in the taking of orders for, the selling of, or the fitting of prescription devices, if authorized by the department pursuant to Section 111656.4, shall have training and demonstrate initial and continuing competence in the order-taking, fitting, and sale of prescription devices that the home medical device retail facility furnishes pursuant to Section 111656.4.
(d)
Each home medical device retail facility shall prepare and maintain
records of training and demonstrated employee competence required under this article for employees of the home medical device retail facility. The records shall be maintained for three years from and after the last date of employment.
(e)
Each home medical device retail facility shall have an ongoing, documented quality assurance program that includes, but is not limited to, the following:
(1)
Monitoring personnel performance to assure compliance with this article.
(2)
Storage, maintenance, and dispensing of prescription devices to assure that prescription devices are dispensed in accordance with this article.
(f)
The records and documents specified in subdivisions (a) and (e) shall be maintained for three years from the date of making. The
records and documents described in subdivisions (a), (d), and (e), shall be open to inspection at all times during business hours by authorized agents of the department or an inspector from the California State Board of Pharmacy for the purpose of investigating a pharmacist.

Legislative History

Added by Stats. 2000, Ch. 837, Sec. 35. Effective January 1, 2001.