Cal. HSC § 125286.25 — California Code / Code hsc / Division 106 / Part 5 / Chapter 2 / Article 5 / Section 125286.25
Section 125286.25
Status: in_force

Each provider of blood clotting products for home use shall meet all of the following requirements:

(a) Have sufficient knowledge and understanding of bleeding disorders to accurately follow the instructions of the prescribing physician and ensure high-quality service for the patient and the medical and psychosocial management thereof, including, but not limited to, home therapy.

(b) Have access to a provider with sufficient clinical experience providing services to persons with bleeding disorders that enables the provider to know when patients have an appropriate supply of clotting factor on hand and about proper storage and refrigeration of clotting factors.

(c) Maintain 24-hour on-call service seven days a week for every day of the year, adequately screen telephone calls for emergencies, acknowledge all telephone calls within one hour or less, and have access to knowledgeable pharmacy staffing on call 24 hours a day, to initiate emergency requests for clotting factors.

(d) Have the ability to obtain all brands of blood clotting products approved by the federal Food and Drug Administration in multiple assay ranges (low, medium, and high, as applicable) and vial sizes, including products manufactured from human plasma and those manufactured with recombinant biotechnology techniques, provided manufacturer supply exists and payer authorization is obtained.

(e) Supply all necessary ancillary infusion equipment and supplies with each prescription, as needed.

(f) Store and ship, or otherwise deliver, all blood clotting products in conformity with all state and federally mandated standards, including, but not limited to, the standards set forth in the product’s approved package insert (PI).

(g) Upon receiving approved authorization for a nonemergency prescription, provided manufacturer supply exists, ship the prescribed blood clotting products and ancillary infusion equipment and supplies to the patient within two business days or less for established and new patients.

(h) Upon receiving approved authorization to dispense a prescription for an emergency situation, provided manufacturer supply exists, deliver prescribed blood products, ancillary infusion equipment and supplies, and medications to the patient within 12 hours for patients living within 100 miles of a major metropolitan airport, and within one day for patients living more than 100 miles from a major metropolitan airport.

(i) Provide patients who have ordered their products with a designated contact telephone number for reporting problems with a delivery and respond to these calls within a reasonable time period.

(j) Provide patients with notification of Class 1 and Class 2 recalls and withdrawals of blood clotting products and ancillary infusion equipment within 24 hours of the provider of blood clotting products for home use receiving notification and participate in the National Patient Notification System for blood clotting product recalls.

(k) Provide language interpretive services over the telephone or in person, as needed by the patient.

(l) Have a detailed plan for meeting the requirements of this article in the event of a natural or manmade disaster or other disruption of normal business operations.

(m) Provide appropriate and necessary recordkeeping and documentation as required by state and federal law and retain copies of the patient’s prescriptions.

(n) Comply with the privacy and confidentiality requirements of the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA).