PWS Pharmacy Technician Services.docx

Performance Work Statement Pharmacy Technician Services VA Palo Alto Health Care System

1. GENERAL

1.1 SERVICES REQUIRED: VA Palo Alto Health Care System (VAPAHCS) requires contractor services to perform pharmacy technician services for the care of patients. All services will be performed under the direction of a licensed pharmacist at the VAPAHCS Palo Alto, Livermore, or Menlo Park Division. Services include a full range of inpatient and outpatient pharmacy technician duties.

1.2 PLACE OF PERFORMANCE: The Contractor shall perform all work onsite at either of 3 VAPAHCS divisions:

Palo Alto Division 3801 Miranda Avenue Palo Alto, CA 94304 Hours of Operation:

7 days/ week, 24 hours Menlo Park Division 795 Willow Road Menlo Park, CA 94025 Hours of Operation:

M-F, 8am-8pm Livermore Division 4951 Arroyo Road Livermore, CA 94550 Hours of Operation:

M-F, 8am-5:30pm

1.3 PERIOD OF PERFORMANCE: The period of performance (POP) shall be for one (1) year starting on the effective award date of the contract, with 4 option years.

1.3.1 The Contractor shall not perform work beyond the POP unless there is written authorization by the Contracting Officer. Any work performed without prior authorization will be performed by the Contractor at no additional cost to the Government.

2. CONTRACTOR TASKS/RESPONSIBILITIES

2.1 Contractor personnel will be assigned to work in various VAPAHCS Pharmacy Service Inpatient and Outpatient Pharmacy sections of the three Divisions listed above. The Contractor shall provide adequate numbers of pharmacy technicians to cover the patient care needs of each Division; meaning multiple (up to 10) FTE contract pharmacy technician may be needed on the same day at the same location (potentially during the same shift, or during different shifts). The Contractor shall provide pharmacy technician services to cover tours of duty lasting 8 hours each. The following are the potential tours of duty that contractor personnel may be scheduled to work at each of the three locations:

2.1.1 Palo Alto Division: Sunday – Saturday (7 days per week) 7:00am – 3:30pm; 7:30am – 4:00pm; 9:00am – 5:30pm; 12:30pm – 9:00pm; 3:30pm – 12 midnight

2.1.2 Menlo Park Division: Monday – Friday (5 days per week) 8:00am – 4:30pm; 9:30am – 6:00pm; 11:30am – 8:00pm

2.1.3 Livermore Division: Monday – Friday (5 days per week) 8:00am - 4:30pm; 8:30am – 5:00pm Scheduling will be provided to the Contractor minimally 2 weeks or greater in advance.

2.2 Federal Holidays: The Contractor is not expected to work on Federal Holidays. The holidays are: New Year’s Day; Martin Luther King Jr.’s Birthday; President’s Day; Memorial Day; Independence Day; Labor Day; Columbus Day; Veterans Day; Thanksgiving Day; Christmas Day; and any other day officially declared by the President of the United States to be a federal holiday.

2.3 The Contractor shall provide the following services:

2.3.1 Process, fill, and deliver inpatient medication orders and outpatient prescriptions for the assigned section.

2.3.2 Utilize relevant VA computer software applications including the Veterans Health Information Systems and Technology Architecture (VistA) and pharmacy automation in completing daily functions.

2.3.3 Prepare sterile intravenous (IV) medications, including chemotherapy and hazardous agents, and perform required IV room maintenance, quality/environmental control monitoring, and record keeping per United States Pharmacopeia (U.S.P.) 797 and 800 guidelines, departmental policies and procedures.

2.3.4 Maintain adequate medication stock and storage within assigned section, and properly handle outdated, deteriorated, and recalled medications.

2.3.5 Provide excellent customer service to patients, family members, caregivers, visitors and others within the organization.

3. CONTRACTOR QUALIFICATIONS

3.1 BACKGROUND EXPERIENCE

3.1.1 Contractor personnel shall have background experience working in hospital pharmacies for inpatient assignment or retail pharmacies for outpatient assignment. Experience shall include a basic knowledge of: pharmaceutical nomenclature; characteristics, strengths, and dosage forms of pharmaceuticals; pharmaceutical systems of weights and measures; and the variety of procedures and techniques involved in the care, storage, repackaging, bulk compounding, and distribution of pharmaceuticals.

3.1.2 Contractor personnel are required to have certification by the National Pharmacy Technician Certification Board (PTCB), and shall be proficient in spoken and written English.

3.2 MEDICAL RECORDS

3.2.1 Authorities: Contractors providing healthcare services to VA patients shall be considered as part of the Department Healthcare Activity and shall comply with the United States Code (U.S.C.) 551a (Privacy Act), 38 U.S.C. 5701 (Confidentiality of Claimants Records), 5 U.S.C. 552 (Freedom of Information Act FOIA)), 38 U.S.C. 5705 (Confidentiality of Medical Quality Assurance Records) 38 U.S.C. 7332 (Confidentiality of Certain Medical Records), Title 5 U.S.C. § 522a (Records Maintained on Individuals) as well as 45 Code of Federal Regulations (C.F.R.) Parts 160, 162, and 164 (Health Insurance Portability and Accountability Act (HIPAA)). This contract and its requirements meet the exception in 45 C.F.R. 164.502(e), and does not require a BAA in order for Covered Entity to disclose Protected Health Information to: a health care provider for treatment. Based on this exception, a BAA is not required for this contract. Treatment and administrative patient records generated by this contract or provided to the Contractor by the VA are covered by the VA system of records entitled ‘Patient Medical Records-VA’ (24VA19). Contractor generated VA patient records are the property of the VA and shall not be accessed, released, transferred, or destroyed except in accordance with applicable laws and regulations. Contractors shall ensure that all records pertaining to medical care and services are available for immediate transmission when requested by the VA. Records identified for review, audit, or evaluation by VA representatives and authorized federal and state officials, shall be accessed on-site during normal business hours or mailed by the Contractor at the Contractor’s expense. Contractors shall deliver all final patient records, correspondence, and notes to the VA within twenty-one (21) calendar days after the contract expiration date.

3.2.2 Disclosure: The Contractor may have access to patient medical records; however, the Contractor must obtain permission from the VA before disclosing any patient information. Subject to applicable federal confidentiality or privacy laws, the Contractor, or their designated representatives, and designated representatives of federal regulatory agencies having jurisdiction over the Contractor, may have access to VA‘s records, at VA’s place of business on request during normal business hours, to inspect and review and make copies of such records. The VA will provide the Contractor with a copy of VHA Handbook 1907.1, Health Information management and Health Records and VHA Handbook 1605.1, Privacy and Release of Information. The penalties and liabilities for the unauthorized disclosure of VA patient information mandated by the statutes and regulations mentioned above, apply to the Contractor, Contractors and/or Sub-Contractors.

3.2.3 Release of Information: The VA shall maintain control of releasing any patient medical information and will follow policies and standards as defined, but not limited to Privacy Act requirements. In the case of the VA authorizing the Contractor and Contractors to release patient information, the Contractor and Contractors in compliance with VA regulations, and at his/her own expense, shall use VA Form 3288, Request for and Consent to Release of Information from Individual’s Records, to process “Release of Information Requests.” In addition, the Contractor and Contractors shall be responsible for locating and forwarding records not kept at their facility. The VA’s Release of Information Section shall provide the Contractor and Contractors with assistance in completing forms. Additionally, the Contractor shall use VA Form 10-5345, Request for and Authorization to Release Medical Records or Health Information, when releasing records protected by 38 U.S.C. 7332. Treatment and release records shall include the patient’s consent form. Completed Release of Information requests will be forwarded to the VA Privacy Officer at the following address:

3.3 ACCURATE MEDICATION ORDERS/PRESCRIPTIONS – The Contractor shall meet the following responsibilities:

3.3.1 All medication orders/prescriptions are processed and filled accurately in accordance with all laws, rules, regulations, and policies. Workload is prioritized so that orders/prescriptions are delivered in a timely manner. Any potential order/prescription problems are brought to the attention of the pharmacist for review. Products prepared for mailing are wrapped and packaged properly and all necessary forms are completed.

3.3.2 Medications deemed unnecessary or unusable by nursing staff and placed in “Return to Pharmacy” bins are retrieved and returned to Pharmacy Service in a timely manner and assessed for appropriateness to reuse or dispose per pharmacy policy. Patient medications brought into the hospital upon admission are surrendered to the pharmacy and processed according to policy.

3.3.3 Prior to releasing medications, prescriptions, or supplies for window pick up, the correct identity of the patient or patient’s representative is verified by using at least two patient identifiers.

3.3.4 Pharmacy equipment is routinely cleaned and properly maintained and calibrated if required according to policies and procedures and/or manufacturer recommendations.

3.4 STERILE INTRAVENOUS MEDICATIONS – The Contractor shall meet the following responsibilities:

3.4.1 Complex technical functions involved in compounding all IV admixtures are performed accurately and thoroughly in accordance with U.S.P. 797 and 800 guidelines and IV policies and procedures. All pharmacy IV admixture products, compounded or commercially available stock items, are not released from pharmacy custody unless and until they are verified and initialed by a pharmacist. Strict measures and documentation for the compounding and delivery of controlled substance IV admixtures/syringes are adhered to per departmental policies and procedures. Any unused, returned IV products are recycled for reuse if appropriate. The technician will perform required IV room maintenance, quality/environmental control monitoring, and record keeping per United States Pharmacopeia (USP) 797 and 800 guidelines departmental policies and procedures.

3.4.2 All hazardous drugs are stored, maintained, compounded, and disposed appropriately in accordance with departmental policies, procedure, and State and Federal laws and regulations. Any waste, spills, and/or exposures are handled in accordance with health care system policies and procedures.

3.4.3 In accordance with departmental policies and procedures: Mandatory records, documents, and quality control logs are maintained; all required maintenance, cleaning activities, and environmental control monitoring are performed thoroughly and consistently, and documentation of completion is logged concurrently.

3.5 ADEQUATE MEDICATION STOCK AND STORAGE – The Contractor shall meet the following responsibilities:

3.5.1 Adequate stock of pharmaceuticals and supplies for the pharmacy area of responsibility is maintained by communicating with the procurement personnel items that are low or out of stock. During the filling and processing, out of stock orders are communicated to the pharmacist at the time of discovery so that the pharmacist can follow up with the ordering provider appropriately.

3.5.2 All incoming stock is received and stored per departmental policies and procedures. Stock is rotated as necessary to utilize the shortest expiration date items first. Refrigerators/freezers are monitored and any problems resolved to ensure no drug is wasted due to improper storage. Monthly assigned ward inspections are thoroughly and consistently performed within timeframes.

3.5.3 Outdated, deteriorated, and damaged medications are disposed of in the appropriate pharmaceutical waste container and/or placed inside the reverse distributor returned bin for credit processing according to policy and procedures. As assigned, recalled drugs are properly returned to Pharmacy Service, isolated, and secured to prevent dispensing.

3.6 EXCELLENT CUSTOMER SERVICE – The Contractor shall meet the following responsibilities:

3.6.1 Communicates with customers in a courteous, tactful, and helpful manner. Identifies the customer’s situation properly, and performs the tasks required to resolve the customer’s questions/issues accurately and in a timely manner. Conducts necessary follow-up to ensure a satisfactory resolution. If needed, verbal and/or written information is provided in a timely manner that is thorough and correct, using clear and precise communication methods to ensure customers understand. Questions/issues are referred in a timely manner to appropriate staff able to assist with the situation.

3.7 GENERAL PERFORMANCE

3.7.1 The Contractor shall comply with policies and procedures, State and Federal laws and regulations (e.g., Occupational Safety and Health Administration (OSHA), National Institute for Occupational Safety and Health (NIOSH), U.S.P., Environmental Protection Agency (EPA)), The Joint Commission standards, and other program review criteria that govern service, and ensures that requirements are in place, documented, and functioning properly as evidenced by both internal and external reviews. The Contractor shall demonstrate participation and knowledge of the facility’s Compliance and Business Integrity Program to prevent violations of the law as well as maintaining high ethical standards.

3.7.2 Medication variances (i.e., actual event as well as close calls) and adverse drug reactions are documented and reported per policy by completing the appropriate documentation tool in a timely and accurate manner.

3.7.3 Proficiency in the operations of the relevant VA computer packages and pharmacy automation is consistently demonstrated.

3.7.4 Work area is consistently maintained in a clean, organized, and secure manner. Shared work areas are adequately stocked with supplies to ensure subsequent staff has appropriate tools to perform work.

3.7.5 Provide timely and quality service to Veterans. Work is prioritized and completed in a timely manner within established timeframes and deadlines.

3.8 MANDATORY TRAINING AND ADP SECURITY – Contractor personnel shall meet all VA Contractor educational requirements.

3.8.1 In performance of official duties, Contractor personnel have regular access to printed and electronic files containing sensitive data, which must be protected under the provisions of the Privacy Act of 1974 (5 U.S.C. 552a), and other applicable laws, federal regulations, VA statutes, policies and regulations. Contractor personnel are responsible for: (1) protecting that data from unauthorized release or from loss, alteration, or unauthorized deletion; and (2) following all applicable regulations and instructions regarding access to computerized files, release of access codes, etc., as set out in a computer access agreement which Contract personnel sign.

3.9 PERFORMANCE STANDARDS, QUALITY ASSURANCE, AND QUALITY IMPROVEMENT

3.9.1 The Government reserves the right to refuse acceptance of Contractors at any time after performance begins, if personal or professional conduct jeopardizes patient care or interferes with the regular and ordinary operation of the facility. Breaches of conduct include intoxication or debilitation resulting from drug use, theft, patient abuse, dereliction or negligence in performing directed tasks, or other conduct resulting in formal complaints by patient or other staff members to designated Government representatives. Standards for conduct shall mirror those prescribed by current federal personnel regulations. The Contracting Officer (CO) and Contracting Officer’s Representative (COR) shall deal with issues raised concerning Contractor’s conduct. The final arbiter on questions of acceptability is the CO.

3.9.2 The CO shall resolve complaints concerning the Contractor and/or Contractors’ relations with the Government employees or patients. The CO is final authority on validating complaints. In the event that the Contractor is involved and named in a validated patient complaint, the Government reserves the right to refuse acceptance of the services of such personnel. This does not preclude refusal in the event of incidents involving physical or verbal abuse.

3.9.3 Quality Improvement: Contractors shall participate in Quality Improvement and Performance Improvement activities with staff as required by The Joint Commission (or equivalent), and directed by the Chief of Service, Chief of Staff, or designee. The Government may evaluate the quality of professional and administrative services provided, but retains no control over the medical, professional aspects of services rendered (e.g., professional judgments, diagnosis for specific medical treatment), in accordance with Federal Acquisition Regulation (FAR) 37.401(b). Contract personnel shall be subject to Quality Management measures, such as patient satisfaction surveys, timely completion of medical records, and Peer Reviews.

3.9.4 In order to adequately document services provided under this contract, a record keeping system of Contractor work hours shall be established and implemented by the COR. The COR is responsible for verifying the number of actual hours worked by each contract person through medical records and/or other appropriate methods and certifying payment of each hour worked. Documentation of actual work hours must be sufficient to ensure proper payment and allow audit verification that services were provided. The COR shall monitor the response of contract personnel to all VA calls/pages and requests for callback.

3.10 QUALITY ASSURANCE SURVEILLANCE PLAN (QASP) – See attached

3.11 REQUIRED REGISTRATION WITH CONTRACTOR PERFORMANCE ASSESSMENT REPORTING SYSTEM (CPARS)

3.11.1 As prescribed in FAR Part 42.15, the VA evaluates Contractor past performance on all contracts that exceed $150,000, and shares those evaluations with other Federal Government contract specialists and procurement officials. The FAR requires that the Contractor be provided an opportunity to comment on past performance evaluations prior to each report closing. To fulfill this requirement VA uses an online database, Contractor Performance Assessment Reporting System (CPARS), which is maintained by the Naval Seal Logistics Center in Portsmouth, New Hampshire. CPARS has connectivity with the Past Performance Information Retrieval System (PPIRS) database, which is available to all Federal agencies. PPIRS is the system used to collect and retrieve performance assessment reports used in source selection determinations and completed CPARS report cards transferred to PPIRS. CPARS also includes access to the federal awardee performance and integrity information system (FAPIIS). FAPIIS is a web-enabled application accessed via CPARS for Contractor responsibility determination information.

3.11.2 Each Contractor whose contract award is estimated to exceed $150,000 is required to register with CPARS database at the following web address: www.cpars.csd.disa.mil. Help in registering can be obtained by contacting Customer Support Desk @ DSN: 684-1690 or COMM: 207-438-1690. Registration should occur no later than thirty days after contract award, and must be kept current should there be any change to the Contractor’s registered representative.

3.11.3 For contracts with a period of one year or less, the Contracting Officer will perform a single evaluation when the contract is complete. For contracts exceeding one year, the Contracting Officer will evaluate the Contractor’s performance annually. Interim reports will be filed each year until the last year of the contract, when the final report will be completed. The report shall be assigned in CPARS to the Contractor’s designated representative for comment. The Contractor representative will have thirty days to submit any comments and reassign the report to the VA Contracting Officer.

3.11.4 Failure to have a current registration with the CPARS database, or to reassign the report to the CO within those thirty days, will result in the Government’s evaluation being placed on file in the database with a statement that the Contractor failed to respond.

4. OTHER ADMINSTRATIVE RESPONSIBILITIES

4.1 INVOICES: Invoices will be paid in arrears monthly. Invoices must include at minimum, the following information: date of invoice; vendor name; contract number, purchase order number, services provided, and the period of service. Under no circumstances shall the Contractor commence with any additional services without the written approval of the Contracting Officer. Any additional services performed without this approval will be at the Contractor’s expense.

4.2 The Contractor shall be paid for actual services provided by Contractor personnel. The Contractor will not be paid for “availability” or “on-call” services unless otherwise provided herein.

4.3 The Contracting Officer is the only person authorized to approve changes or modify any of the requirements of this contract. Only the Contracting Officer is authorized to make commitments or issue changes that shall affect price, quantity or quality of performance of this contract.