:
:
:
Added: Apr 14, 2014 12:08 pm
A. DUTIES AND RESPONSIBILITES
Specific Regulatory Compliance
1. The outsourcer shall have a state pharmacy license available where the compounding center resides.
2. If located outside the state of Tennessee, the outsourcer shall be licensed to ship to Tennessee.
3. If the outsourcer prepares a significant number of non patient-specific preparations (>5% of the outsourcer's volume, the outsourcer shall be registered as a drug manufacturer with the Food and Drug Administration (FDA).
4. If the outsourcer prepares non patient-specific controlled substance preparations, the outsourcer shall be registered as a drug manufacturer with the Drug Enforcement Administration (DEA).
5. All pharmacists working for the outsourcer shall be licensed in the state where they are practicing.
6. If required in the state where the compounding center resides, all pharmacy technicians shall be licensed or registered in the state where they are practicing.
7. The outsourcer meets or exceeds state required pharmacist-to-pharmacy technician ratios for the state in which the compounding center is located.
8. If an FDA-approved product is commercially available (not on backorder), the outsourcer shall never compound the same drug formulation using non-sterile powders or other components.
9. When no commercial source exists to prepare admixtures, the outsourcer shall use USP grade bulk ingredients obtained from a current Good Manufacturing Practice (cGMP) compliant supplier. The outsourcer shall additionally be able to provide a certificate of analysis and potency testing of all bulk ingredients used.
10. The outsourcer shall have the required minimum amount of product liability insurance as outlined by VA TVHS.
11. VA TVHS shall be covered by the outsourcer's product liability insurance in the event of any harm directly related to any product compounded by outsourcer's facility.
12. The outsourcer shall meet American Society of Health System Pharmacists (ASHP), National Institute for Occupational Safety and Health (NIOSH), and USP chapter <797> guidelines for handling hazardous agents.
13. The outsourcer shall be able to provide pedigree information that documents that they do not purchase products outside of traditional drug distribution networks or through secondary wholesalers.
14. If a commercial product component of a preparation is on backorder, the outsourcer shall be able to provide a certificate of analysis, potency testing, and proof that all other requirements are met (e.g., higher level clean room) for High Risk Level Compounding per USP <797>.
15. The outsourcer shall immediately disclose any disciplinary or punitive action by any regulatory agency (e.g., FDA warning letter, state board of pharmacy).
16. The outsourcer shall be able to provide quality control history and quality assurance trend reports upon request.
Quality and Patient Safety Measures
17. The outsourcer shall provide documentation that confirms staff competency (garbing and hand hygiene, aseptic technique and related practices, and cleaning and disinfection procedures) is evaluated prior to compounding of actual drug preparations.
18. The outsourcer shall provide documentation that confirms that the outsourcer tests aseptic techniques by preparing media fill units per USP chapter <797> standards.
19. The outsourcer shall provide documentation that confirms that pharmacists and pharmacy technicians are pre-qualified using media fills before compounding of actual drug preparations.
20. The outsourcer's staff shall be required to undergo re-qualification using media fills at a minimum of an annual basis
21. At any time a positive media fill occurs, the outsourcer shall perform a comprehensive investigation to identify the root cause. The outsourcer shall then institute corrective and preventative action.
22. The outsourcer shall provide customers with substantial evidence that supports extended expiration dating for compounded sterile preparations when BUD limits in USP <797> are exceeded.
23. The outsourcer shall perform studies to determine extended expiration dates, using evidence-based and validated stability testing procedures, for compounded sterile preparations for which no extended expiration evidence exists.
24. The outsourcer shall be able to verify that staff members are complying with gowning, gloving, and glove-tip processes that are consistent with USP chapter <797> standards.
25. The outsourcer shall perform routine surface microbiological and fungal environmental monitoring to minimize contamination on a minimum of a weekly basis.
26. The outsourcer shall perform comprehensive investigations of out-of-limit findings, as recommended by USP chapter <797>, to determine root cause, followed by corrective and preventative actions on a minimum of a weekly basis.
27. The outsourcer shall perform nonviable and viable particle testing in primary engineering controls (e.g., laminar flow workbench, biological safety cabinet) and room air according to USP chapter <797> standards (on a minimum of a weekly basis).
28. The outsourcer shall have a policy in place that requires validation of new or changed facilities, equipment, processes, container types, for sterility, and repeatability.
29. The outsourcer shall be able to provide documentation that confirms that sterile media used are certified by the manufacturer to be sterile and guaranteed to not promote growth.
30. The outsourcer shall provide detailed reports on the incidence of any positive media test results and the follow-up retests after corrective action is completed.
31. In assigning expiration and beyond-use dating, the outsourcer shall follow evidence-based and validated stability testing procedures to evaluate each preparation (drug, diluent and device/container) for :
i. potency at room temperature or refrigerated temperature as applicable.
ii. stability, based on a range of extreme temperatures per USP chapter <797> guidelines, to ensure stability and determine the impact on the preparation (e.g. evaporation, precipitation, degradation, concentration).
iii. chemical characteristics such as pH, particulate matter, color, sterility (container closure integrity testing).
32. The outsourcer shall provide a minimum guaranteed shelf life upon delivery.
33. The outsourcer shall have documented processes and procedures (including shipping validation studies) to ensure that preparations leaving the site retain their integrity and stability through the shipping cycle.
Medication Administration Safety Features
34. The outsourcer shall provide readily accessible information regarding status of latex, bis (2-ethylhexyl) phthalate (DEHP), and preservatives in the preparations they prepare.
35. The outsourcer shall strive to provide quality packaging ad labeling in accordance with cGMP (e.g. drug name differentiation in the form of TALL MAN lettering, visual cues to differentiate drug names and concentrations, auxiliary labeling to indicate contraindicated routes of administration).
36. The outsourcer shall offer tamper-evident options which may include overwrap, shrink wrap, tamper-evident foil, and/or tamper-evident caps.
Service
37. The outsourcer shall be able to compound products in the containers types (e.g., syringes, minibags, pump-specific cassettes) to meet the needs of VA TVHS.
38. The outsourcer shall have business continuity plans in place in the event of a natural or man-made disaster or public health emergency.
39. The outsourcer shall be able to compound medications for intrathecal administration.
40. The outsourcer shall be able to compound controlled substances.
41. The outsourcer shall be able to provide guaranteed timeframes for compounded sterile preparations.
42. The outsourcer shall be able to provide next day delivery, trackable by signature-receipt.
43. The outsourcer's current production capacity shall be able to meet the requirements of VA TVHS.
44. The outsourcer shall have a mechanism to respond to customer service issues or questions 24 hours a day, 7 days a week.
45. The outsourcer shall have clinical expertise as documented/verified by PCAB accreditation in the area of products provided.
B. Compunds includes but not limited to the following:
" Coal Tar 10%/ Aquaphor -40g
" Tacrolimus 0.03% opth oint -4gm
" Acetylcysteine 10% opth drops -30ml
" Vancomycin 14 mg/ml BAK eye drops -5ml
" Glycopyrrolate 2% cream -60g
" Salicylic acid 5%/Urea 10%/ petrolatum oint-120g
" Nifedipine 0.2% ointment -60g
C. PROCEDURES:
1. Service Hours:
i. Compounding services shall be available for a minimum of 5 days (40 hours) per week.
2. Ordering of Compounding Products:
i. All orders for compounded products will be initiated pursuant to a valid prescription from a VA TVHS provider for a product that is NOT commercially available and/or cannot be currently obtained from a commercial source.
ii. Compounding prescription orders will be transmitted to the contractor via facsimile from the VA TVHS pharmacy service, except for controlled substances where a signed hard copy is required.
3. Order Processing/Preparation:
i. All products will be labeled with the following information:
a. Drug name(s), strength(s), and amount(s)
b. Beyond use date (and time if applicable)
c. Manufacturer's lot numbers for all ingredients
d. Patient's name
e. Patient's location (if currently inpatient) or address
f. Directions for use and any applicable cautionary statements, either on the
label or attached as an accessory label
4. Order Delivery:
i. The compounded product(s) shall be delivered to VA TVHS prior to the designated due date.
ii. For all orders considered "URGENT," the contractor shall make all reasonable efforts to prepare and deliver the preparation as quickly as possible
D. TERM OF THE TASK ORDER:
This task order is effective from the date of award and the terms of this contract shall be reviewed and amended, as necessary, at a minimum of an annual basis. This contract is subject to the necessity of compounding services pursuant to a valid patient-specific prescription for which there are no commercially available alternatives.
E. REGULATIONS/STANDARDS:
The contractor must perform the required work in accordance with all applicable USP <797>, American Society of Health-System Pharmacists, National Institute for Occupational Safety and Health (NIOSH),and Joint Commission standards.
F. HHS/OIG:
To ensure that the individuals providing services under the task order have not engaged in fraud or abuse regarding Sections 1128 and 1128A of the Social Security Act regarding federal health care programs, the contractor is required to check the Health and Human Services - Office of Inspector General (HHS/OIG), List of Excluded Individuals/Entities on the OIG Website (www.hhs.gov/oig) for each person providing services under this task order. Further the Contractor is required to certify in its proposal that all persons listed in the contractor's proposal have been compared against the OIG list and are NOT listed. During the performance of this task order the Contractor is prohibited from using any individual or business listed on the List of Excluded Individuals/Entities.
G. HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT OF 1996 (HIPAA)
Contractor must adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the National Standards to Protect the Privacy and Security of Protected Health Information (PHI). As required by HIPAA, the Department of Health and Human Services (HHS) has promulgated rules governing the security and use and disclosure of protected health information by covered entities, including the Department of Veterans Affairs (VA). In accordance with HIPAA, the Contractor may be required to enter into a Business Associate Agreement (BAA) with VA. VA has recognized Locum Providers as entities that do not require a BAA with their contractors as long as they are conducting health care on VA's behalf - Pharmacist qualifies as a medical service - therefore, no BAA is required.
H. CONFIDENTIALITY OF PATIENT RECORDS
The Contractor, as a VA provider, will assist in the provision of health care to patients seeking such care from or through VA. As such, the Contractor is considered as being part of the Department health care activity. Contractor is considered to be a VA provider for purposes of the Privacy Act, Title 5 U.S.C. 552a. Further, for the purpose of VA records access and patient confidentiality, Contractor is considered to be a VA contractor for the following provisions: Title 38 U.S.C. 5701, 5705, and 7362. Therefore, Contractor may have access, as would other appropriate components of VA, to patient medical record information including patient treatment information pertaining to drug and alcohol abuse, HIV, and sickle cell anemia, to the extent necessary to perform its contractual responsibilities. However, like other components of the Department, and not withstanding any other provisions of the task order, the Contractor is restricted from making disclosures of VA records, or information contained in such records, to which it may have access, except to the extent that explicit disclosure authority from VA has been received. The Contractor is subject to the same penalties and liabilities for unauthorized disclosures of such records as VA.
I. RECORD KEEPING
The Pharmacy office shall have a recordkeeping system of monthly prescriptions compounded by the contractor. The Pharmacy office will be responsible for verifying all work performed by the contractor. The monthly listing of prescriptions compounded will be submitted by the COR's to the Chief, Pharmacy Service's office. Additionally, the responsible Pharmacy Supervisor will monitor through observation that the contractor is performing the duties as described in the contract.
continue to read here
No comments:
Post a Comment