36C26119Q0956-002.docx

PERFORMANCE WORK STATEMENT (PWS)

1. GENERAL:

1.1. SERVICES REQUIRED: The VA Pacific Islands Health Care System (VA PIHCS) requires the following services to be provided to Veterans primarily residing in Lanai, Hawaii, in a private hospital, office, or clinic environment. Site of care is (5V21 459QA).

1.1.1. [X] Primary Care CBOC: offer both medical and mental health care. Primary Care CBOCs are required to provide both primary care and mental health services. Mental Health services will be provided by VA staff on site.

1.2. PLACE OF PERFORMANCE: Straub Lanai Family Health Center, 628 7th Street, Suite B, Lanai City, HI 96763

1.3. AUTHORITY: In accordance with Title 38 United States Code (USC) 8153 to be furnished by the contractor on behalf of VA Pacific Islands Health Care System.

1.4. POLICY AND REGULATIONS: The Contractor is required to meet applicable VHA performance and quality criteria and standards including, but not limited to, access, customer satisfaction, prevention index, chronic disease index and clinical guidelines. Performance and quality standards may change during the contract. New or revised quality/performance criteria or standards will be provided to the Contractor before implementation date and throughout the life of the contract through unilateral or bi-lateral modifications, as applicable. Copies of current VA and VHA publications can be located at http://www.va.gov/vhapublications/ or at http://www.va.gov/vapubs/. Compliance with mandated performance is required as a condition of this contract. Contractor shall comply with all relevant and applicable VA policies and procedures, including those related to quality, patient safety and performance, including, but not limited to, the following:

1.4.1. Title 21 C.F.R 900.12(c), “Mammography Quality Standards” http://www.gpo.gov/fdsys/pkg/CFR-2012-title21-vol8/pdf/CFR-2012-title21-vol8-sec900-12.pdf

1.4.2. Title 21 CFR, “Food and Drugs” Section 1300-end”. https://www.deadiversion.usdoj.gov/21cfr/cfr/index.html

1.4.3. 38 USC. Section 7332, regarding a timely special consent for any medical treatment for drug abuse, alcoholism or alcohol abuse, infection with the human immunodeficiency virus (HIV), or sickle cell anemia, to a Veteran with health insurance. A special consent from the Veteran is needed to allow VA to release bills and medical records associated with the treatment. http://www.gpo.gov/fdsys/granule/USCODE-2011-title38/USCODE-2011-title38-partV-chap73-subchapIII-sec7332/content-detail.html

1.4.4. 42 CFR Part 482, “Conditions of Participation” http://www.gpo.gov/fdsys/pkg/CFR-2010-title42-vol5/pdf/CFR-2010-title42-vol5-part482.pdf

1.4.5. 42 CFR 493.15(b), “Laboratories Performing Waived Tests” https://www.gpo.gov/fdsys/pkg/CFR-2003-title42-vol3/pdf/CFR-2003-title42-vol3-sec493-17.pdf

1.4.6. Clinical Laboratory Improvement Amendments (CLIA): http://cms.hhs.gov/Regulations-and-Guidance/Legislation/CLIA/index.html?redirect=/clia/appendc.asp

1.4.7. VA Directive 1663, “Health Care Resources Contracting – Buying” https://www.va.gov/vapubs/viewPublication.asp?Pub_ID=969&FType=2

1.4.8. VA Directive 6371, “Destruction of Temporary Paper Records” http://www.va.gov/vapubs/viewPublication.asp?Pub_ID=742&FType=2

1.4.9. VHA Record Control Schedule 10-1

http://www1.va.gov/vhapublications/rcs10/rcs10-1.pdf

1.4.10. VHA Directive 6300, “Records Management” https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8113

1.4.11. "Patient Medical Records-VA" 24VA10P2 https://www.oprm.va.gov/privacy/privacy_SOR.aspx

1.4.12. VHA Handbook 1101.11(2), “Coordinated Care for Traveling Veterans” http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=3099

1.4.13. VHA Directive 2007-033, "Telephone Service for Clinical Care," http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1605

1.4.14. VHA Directive 1088, “Communicating Test Results to Providers and Patients” http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=3148

1.4.15. VHA Directive 2009-038 “VHA National Dual Care Policy” http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2058

1.4.16. VHA Directive 1033, “Anticoagulation Therapy Management”http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=3129

1.4.17. VHA Directive 1108.08, “VHA Formulary Management Process” https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3291

1.4.18. VHA Directive 1230 “Outpatient Scheduling Processes and Procedures” https://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=3218

1.4.19. VHA Directive 1115, “Military Sexual Trauma (MST) Program” https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=6402

1.4.20. VHA Directive 2010-053, “Patient Record Flags”.

www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2341

1.4.21. VHA Directive 2011-012, “Medication Reconciliation” http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2390

1.4.22. VHA Directive 2011-020, “Automated Safety Incident Surveillance and Tracking System (ASISTS)” http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2407

1.4.23. VHA Directive 1199, “Reporting Cases of Abuse and Neglect”,

1.4.24. http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2782 VHA Directive 2012-026, “Sexual Assaults and Other Defined Public Safety Incidents in VHA” The directive specifically includes contracted sites of care and defines procedures specific to patient disruptive behavior.

https://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2797

1.4.25. VHA Directive 1605.01, “Privacy and Release of Information” www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3233

1.4.26. VA Handbook 0730, “Security and Law Enforcement”

http://www1.va.gov/vapubs/viewPublication.asp?Pub_ID=755&FType=2

1.4.27. VHA Directive 1003.04, "VHA Patient Advocacy," https://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=5970

1.4.28. VHA Handbook 1004.07, “Financial Relationships between Health Care Professionals and Industry” https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3059

1.4.29. VHA Handbook 1006.02, “VHA Site Classifications and Definitions” http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2970

1.4.30. VHA Handbook 1050.01, “VHA National Patient Safety Improvement Handbook” http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2389

1.4.31. VHA Handbook 1100.17, “National Practitioner Data Bank Reports”- http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2135

1.4.32. VHA Handbook 1100.18, “Reporting and Responding to State Licensing Boards” http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1364

1.4.33. VHA Handbook 1108.11, “Clinical Pharmacy Services”

http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3120

1.4.34. Amendment to VHA Handbook 1100.18, “”Reporting and Responding to State Licensing Boards” https://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=5962

1.4.35. VHA Handbook 1100.19, “Credentialing and Privileging” http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2910

1.4.36. VHA Directive 1306, “Querying State Prescription Drug Monitoring Programs (PDMP)” www.va.gov/vhapublications/viewpublication.asp?pub_id=3283

1.4.37. VHA Handbook 1101.10, “Patient Aligned Care Team (PACT)” http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2977

1.4.38. VHA Directive 1105.03, “Mammography Program Procedures and Standards” https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=6423

1.4.39. VHA Directive 1106, “Pathology and Laboratory Medicine Service (P&LMS) Procedures” https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=7477

1.4.40. VHA Handbook 1108.05, “Outpatient Pharmacy Services” http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=3209

1.4.41. VHA Directive 1120.02 Health Promotion and Disease Prevention Core Program Requirements https://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=5965

1.4.42. VHA Handbook 1122, “Podiatric Medical and Surgical Services” https://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=5959

1.4.43. VHA Directive , “1330.01(2) Health Care Services for Women Veterans” https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=5332

1.4.44. VHA Handbook 1160.01, “Uniform Mental Health Services” http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1762

1.4.45. VHA Handbook 1400.01, “Resident Supervision” http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2847

1.4.46. VHA Handbook 5005, Part 2, Appendix G15, “Licensed Pharmacist Qualification Standards”

1.4.47. `````````````` http://www.va.gov/vapubs/viewPublication.asp?Pub_ID=512&FType=2

1.4.48. VHA Handbook 5005, part 2, Appendix G20, “Dietitian Qualification Standard” www.va.gov/vapubs/viewPublication.asp?Pub_ID=764&FType=2

1.4.49. Privacy Act of 1974 (5 U.S.C. 552a) as amended http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm

1.4.50. Title 38 CFR §17.107, “VA Response to Disruptive Behavior of Patients” (2010) www.gpo.gov/.../pdf/CFR-2012-title38-vol1-sec17-107.pdf

1.4.51. Title 38 CFR § 1.203, “Information to be reported to VA Police” (2003) https://www.gpo.gov/fdsys/granule/CFR-2011-title38-vol1/CFR-2011-title38-vol1-sec1-203

1.4.52. “Guidelines for Preventing Workplace Violence for Health Care and Social Service Workers,” Occupational Safety and Health Administration (OSHA) OSHA 3148-01R 2004) https://www.osha.gov/Publications/osha3148.pdf

1.4.53. “Violence: Occupational Hazards in Hospitals, National Institute for Occupational Safety and Health” (NIOSH) NIOSH 2002-101, April 2002. http://www.cdc.gov/niosh/docs/2002-101/default.html

1.4.54. VA Assistant Secretary OSP Memo, Clarification of Policy for Sexual Assault Reporting, June 2011.

http://www.diversity.va.gov/products/files/DAW/v10i05.docx

1.4.55. VHA Directive 1231 Outpatient Clinic Practice Management https://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=3296

1.4.56. VHA Directive 1315 Access to VHA Clinical Programs for Veterans Participating in State-Approved Marijuana Programs https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=5711

1.4.57. VHA Directive 1406, Patient Centered Management Module (PCMM) for Primary Care https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=5430

1.4.58. VHA Directive 1134 Provision of Medical Statements and Completion of Forms by VA Health Care Providers https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=4300

1.4.59. VHA Directive 1192 Seasonal Influenza Prevention Program for VHA Health Care Personnel https://vaww.va.gov/vhapublications/ViewPublication.asp?pub_ID=5472

1.4.60. VHA Handbook 1660.03 Conflict Of Interest For The Aspects Of Contracting For Sharing Of Health-Care Resources (HCR) https://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=3152

1.4.61. VA Directive 6008 Acquisition and Management of VA Information Technology Resources https://www.va.gov/vapubs/viewPublication.asp?Pub_ID=891&FType=2

1.4.62. VA Handbook 6500.6 Contract Security

https://www.va.gov/vapubs/viewPublication.asp?Pub_ID=471&FType=2

1.4.63. VHA Directive 1300.01 National Viral Hepatitis Program https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=6421

1.4.64. VHA Directive 1210 Chiropractic Care https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=6425

1.4.65. VHA Directive 1341 Providing Health Care for Transgender and Intersex Veterans https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=6431

1.4.66. VHA Directive 1177 Cardiopulmonary Resuscitation

https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=7487

1.4.67. VHA Directive 1108.10 Promotion of Drugs and Drug-related Supplies by Pharmaceutical Company Representatives https://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=6435

1.4.68. VHA Directive 1608 Comprehensive Environment of Care (CEOC) Program https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3171

1.4.69. VHA Directive 1003 VHA’s Veteran Customer Service Program https://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=268

1.4.70. VHA Handbook 1003.1 Key Elements of VHA’s Veteran Customer Service Program https://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=422

1.4.71. VHA Handbook 1003.2 Service Recovery in the Veterans Health Administration https://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=433

1.4.72. VHA Handbook 1330.03, Maternity Health Care and Coordination www.va.gov/vhapublications/viewpublication.asp?pub_id=2803

1.4.73. VHA Directive 1330.02 Women Veterans Program Manager https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=7484

1.4.74. VHA Directive 1004.08 Disclosure of Adverse Events to Patients https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8120

1.4.75. VA Handbook 6500 Risk Management Framework for VA Information Systems - Tier 3: VA Information Security Program https://www.va.gov/vapubs/viewPublication.asp?Pub_ID=793&FType=2

1.4.76. VHA Directive 1005(1) Informed Consent for Long-Term Opioid Therapy for Pain https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3005

1.4.77. VHA Handbook 1907.01 Health Information Management and Health Records https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3088

1.4.78. VHA Directive 1198 Intimate Partner Violence Assistance Program https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8192

1.5. DEFINITIONS/ACRONYMS:

1.5.1. ABMS: American Board of Medical Specialties

1.5.2. ACLS: Advanced Cardiac Life Support

1.5.3. ACGME: Accreditation Council for Graduate Medical Education

1.5.4. ACPE: American Council on Pharmaceutical Education

1.5.5. ACO: Administrative Contracting Officer

1.5.6. ADE: adverse drug events

1.5.7. AED: Automatic External Defibrillator

1.5.8. AIS: Automated Information Security

1.5.9. ANA: American Nurses Association

1.5.10. AOA: American Osteopathic Association

1.5.11. ARRT: American Registry of Radiologic Technology

1.5.12. ASC: Ambulatory Surgery Clinic

1.5.13. Assigned: A Veteran is “assigned” to an outpatient clinic via PCMM (i.e. CBOC) where the patient receives their primary care after the patient’s eligibility is determined through registration and enrollment.

1.5.14. BAA: Business Associate Agreement

1.5.15. BI-RADS: Breast Imaging-Reporting and Data System; a quality assurance tool designed to standardize mammography reporting

1.5.16. BLS: Basic Life Support

1.5.17. BOS: Bureau of Osteopathic Specialists

1.5.18. CAHEA: Committee on Allied Health Education and Accreditation

1.5.19. CAP: College of American Pathologists

1.5.20. CARF: Commission on Accreditation of Rehabilitation Facilities

1.5.21. CBO: VA Central Billing Office.

1.5.22. CDC: Centers for Disease Control and Prevention

1.5.23. CEU: Certified Education Unit

1.5.24. CLIA: Clinical Laboratory Improvement Amendments

1.5.25. CME: Continuing Medical Education

1.5.26. CMS: Center for Medicare and Medicaid Services

1.5.27. CO: Contracting Officer

1.5.28. COPD: chronic obstructive pulmonary disease

1.5.29. COR: Contracting Officer’s Representative

1.5.30. COS: Chief of Staff

1.5.31. CPA: Collaborative Practice Agreement

1.5.32. CPS: Clinical Pharmacy Specialist

1.5.33. CPT: Current Procedural Terminology

1.5.34. CRNP: Certified Registered Nurse Practitioners

1.5.35. CSWE: The Council on Social Work Education the CSWE website is http://www.cswe.org/.

1.5.36. CPARS: Contractor Performance Assessment Reporting System

1.5.37. CPRS: Computerized Patient Recordkeeping System- electronic health record system used by the VA.

1.5.38. CVT: Clinical Video Telehealth

1.5.39. DICOM: Digital Image and Communication in Medicine

1.5.40. DIGMA: Drop in Group Medical Appointment

1.5.41. DRG: Diagnostic Related Group

1.5.42. DSS: Decision Support System

1.5.43. ECC Extended Care Center

1.5.44. Enrollment: The process of establishing eligibility for VA’s “Medical Benefits Package.” Most Veterans are required to “enroll” into the VA Health Care System to be eligible for VA health care and to be assigned to an outpatient clinic like a CBOC, however some can still receive care without enrolling. Applicants are only required to “enroll” once for VA health care unless they are determined ineligible for care at time of application or they have disenrolled.

1.5.45. EPRP: External Peer Review Program

1.5.46. FDA: Food and Drug Administration

1.5.47. FSMB: Federation of State Medical Boards

1.5.48. HCC: Health Care Center A HCC is a VA-owned, VA-leased, contract, or shared clinic operated at least 5 days per week that provides primary care, mental health care, on site specialty services, and performs ambulatory surgery and/or invasive procedures which may require moderate sedation or general anesthesia.

1.5.49. HHS: Department of Health and Human Services

1.5.50. HCFA: HealthCare Financing Administration

1.5.51. HICPAC: Healthcare Infection Control Practices Advisory Committee- a federal advisory committee made up of 14 external infection control experts who provide advice and guidance to the CDC and the Secretary of HHS regarding the practice of health care infection control, strategies for surveillance and prevention and control of health care associated infections in United States health care facilities.

1.5.52. HT: Home Telehealth

1.5.53. ICAVL: Intersocietal Commission for the Accreditation of Vascular Laboratories

1.5.54. INR: International Normalized Ratio

1.5.55. ISO: Information Security Officer

1.5.56. LIP: licensed independent practitioner

1.5.57. MCCR: Medical Care Cost Recovery

1.5.58. Mental Health Services: per VHA Handbook 1160.01 is meant to include services for the evaluation, diagnosis, treatment, and rehabilitation of both substance use disorders and other mental disorders.

General mental health services include:

(a) Diagnostic and treatment planning evaluations for the full range of mental health problems;

(b) Treatment services using evidence-based pharmacotherapy, or primary evidence-based psychotherapy for patients with mental health conditions and substance use disorders;

(c) Patient education;

(d) Family education when it is associated with benefits to the Veterans;

(e) Referrals as needed to inpatient and residential care programs; and

(f) Consultation about special emphasis problems including Post Traumatic Stress Disorder (PTSD) and Military Sexual Trauma (MST).

Specialty mental health services include:

(a) Consultation and treatment services for the full range of mental health conditions;

(b) Evidence-based psychotherapy;

(c) Mental Health Intensive Case Management (MHICM);

(d) Psychosocial Rehabilitation Services, including: PRRCs, family psycho-education, family education, skills training, peer support, and Compensated Work Therapy (CWT) and supported employment;

(e) PTSD teams or specialists;

(f) MST special clinics;

(g) Homeless programs; and

(h) Specialty substance abuse treatment services.

1.5.59. MQSA: Mammography Quality Standards Act

1.5.60. MSN: Master of Science in Nursing

1.5.61. NCCPA: National Commission on Certification of Physician Assistants

1.5.62. NLN: National League for Nursing

1.5.63. NSQIP/CICSP: National Surgical Quality Improvement Program/Continuing Improvement in Cardiac Surgical Program

1.5.64. OTC: Over the Counter

1.5.65. PA: Physician Assistant

1.5.66. PACS: Picture Archiving and Communications System

1.5.67. PACT: Patient Aligned Care Team Background & Introduction: VA has implemented a PCMH model at all VA Primary Care sites which is referred to as PACT. This initiative supports VHA’s Universal Health Care Services Plan to redesign VHA healthcare delivery through increasing access, coordination, communication, and continuity of care. PACT provides accessible, coordinated, comprehensive, patient-centered care, in team based environment including the active involvement of other clinical and non-clinical staff. PACT allows patients to have a more active role in their health care and is associated with increased quality improvement, patient satisfaction, and a decrease in hospital costs due to fewer hospital visits and readmissions.

1.5.68. Parent Facility: VAMC responsible for performance monitoring and payment for contracted Outpatient Site of Care services.

1.5.69. PCMH: Patient-Centered Medical Home

1.5.70. PCMM: Primary Care Management Module- a software program used to track Primary Care Clinic Veteran rosters.

1.5.71. PCP: Primary Care Provider

1.5.72. Phar.D.: Doctor of Pharmacy

1.5.73. POC: Point of Care Testing

1.5.74. PRIMARY CARE VISIT: an episode of care furnished in a clinic that provides integrated, accessible health care services by clinicians who are accountable for addressing a large majority of personal health care needs, developing a sustained partnership with patients, and practicing in the context of family and community. Primary care includes, but is not limited to, diagnosis and management of acute and chronic biopsychosocial conditions, health promotion, disease prevention, overall care management, and patient and caregiver education. The VHA site classification defines primary care as those encounters that occur within the primary care class of encounters.

1.5.75. PCMHI:Primary Care-Mental Health Integration

1.5.76. PWS: Performance Work Statement

1.5.77. QAPI: Quality Assessment and Performance Improvement

1.5.78. QASP: Quality Assurance Surveillance Plan

1.5.79. RME: reusable medical equipment

1.5.80. SOP (Clinical): Scope of Practice

1.5.81. SELF- REFERRAL: Referring patients to Contractor’s facility for follow-up care. Self-referral for outpatient services at the Contractor’s facility is prohibited.

1.5.82. SFT: Store and Forward Telehealth

1.5.83. SMA: Shared Medical Appointments

1.5.84. SPD: Sterile Processing Division

1.5.85. SPE: Senior Procurement Executive

1.5.86. SPECIALTY CARE VISIT: A specialty care outpatient visit is an episode of care furnished in a clinic that does not provide primary care, and is only provided through a referral.” These services are generally divided into two sub-categories: medicine specialties and surgery specialties. The VHA site classification defines specialty care as those encounters that occur within the geriatric medicine; allergy; cardiology; dermatology; emergency; employee health; endocrinology; gastroenterology; general medicine; hematology or oncology; infectious disease; nephrology; neurology; outreach; pulmonary or respiratory disease; rheumatology; amputation follow-up; amputation; anesthesia; cardio-thoracic; ear, nose, and throat (ENT); eye; general surgery; gynecology (GYN); neurosurgery; orthopedics; plastic surgery; urology; or vascular clinic stops.

1.5.87. SUPPORT STAFF: staff present in the clinic area assisting providers in the actual delivery of care to patients. It consists of RNs, LPNs, Medical Assistants, Health Technicians, and Medical Clerks in the clinic.

1.5.88. TJC: The Joint Commission

1.5.89. TIU: Text Integration Utility

1.5.90. TCT: Telehealth Clinical Technicians

1.5.91. VA: Veterans Affairs

1.5.92. VAMC: Veterans Affairs Medical Center

1.5.93. VetPro: a federal web-based credentialing program for healthcare providers.

1.5.94. VHA: Veterans Health Administration

1.5.95. VISTA: Veterans Health Information Systems and Technology Architecture

2. STAFFING AND QUALIFICATIONS

2.1. STAFFING REQUIREMENTS: Total Estimated Patients enrolled/assigned to site: 24. Staffing for Lanai Clinic is provided by travelling provider(s). Contractor provides an administrative clerk/receptionist and medical assistant.

MARY C STAFFING – CLERICAL ASSOCIATE [X] Mandatory for all sites

2.2. ADMINISTRATIVE CLERK/RECEPTIONIST AND MEDICAL ASSISTANT. Qualifications: Required education and experience demonstrating skills and abilities to perform duties ensuring smooth site operations. Position Responsibilities: Administrative clerk/receptionist is responsible for answering telephone calls from Veterans, scheduling and cancelling patients. Medical assistant is responsible for checking in/checking out patients, taking vital signs, and providing assistance with procedures and paperwork for VA provider(s). Must have knowledge of medical terminology and patient confidentiality and demonstrate skills in interpersonal communication. Shall assist travelling health care provider(s) in performing patient care services.

2.3. TRAINING (ACLS/BLS): Applicable Contractor staff shall complete BLS training and keep BLS certificatons current throughout the life of the contract.

2.4. ACCESS TO PATIENT INFORMATION: In performance of official duties, Contractor’s staff shall have access to patient information, which must be protected under the provisions of the Privacy Act of 1974 (5 U.S.C. 552a), and other applicable laws, Federal Regulations, Veterans Affairs statutes and policies. Contractor’s staff 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 patient information as set out in a computer access agreement which applicable contract staff signs.

2.5. RULES OF BEHAVIOR FOR AUTOMATED INFORMATION SYSTEMS: Applicable Contractor staff having access to VA Information Systems are required to read and sign a Rules of Behavior statement which outlines rules of behavior related to VA Automated Information Systems. The COR will provide, through the facility ISO, the Rules of Behavior to the Contractor for the respective facility. A copy of the Rules of Behavior may also be found in the attachments section of this solicitation.

2.6. STANDARD INFECTION CONTROL MEASURES (PPD, IMMUNIZATIONS, ETC): Contractor shall provide statement that all required infection control testing and immunizations for their personnel are current and that the contractor is compliant with OSHA regulations concerning occupational exposure to blood borne pathogens. Clinic staff shall receive annual influenza vaccination. The Contractor shall also notify the VA of any significant communicable disease exposures and the VA will also notify the Contractor of the same, as appropriate. Contractor shall adhere to current CDC/HICPAC Guideline for Infection Control in Health Care Personnel (as published in American Journal for Infection Control- AJIC 1998; 26:289-354 http://www.cdc.gov/hicpac/pdf/InfectControl98.pdf) for infection control in their personnel..

2.7. NATIONAL PROVIDER IDENTIFICATION (NPI): All Contractors who provide billable healthcare services to VA; VHA, shall obtain a NPI as required by the Health Insurance Portability and Accountability Act (HIPAA) National Provider Identifier Final Rule, administered by the CMS. This rule establishes assignment of a 10-digit numeric identifier for Contractor staff, intended to replace the many identifiers currently assigned by various health plans. Contractor staff needs only one NPI, valid for all employers and health plans. Contractor staff must also designate their Specialties/Subspecialties by means of Taxonomy Codes on the NPI application. The NPI may be obtained via a secure website at: https://nppes.cms.hhs.gov/NPPES

2.8. CONFLICT OF INTEREST: The Contractor is responsible for identifying and communicating to the CO and COR conflicts of interest at the time of proposal and during the entirety of contract performance. At the time of proposal, the Contractor shall provide a statement which describes, in a concise manner, all relevant facts concerning any past, present, or currently planned interest (financial, contractual, organizational, or otherwise) or actual or potential organizational conflicts of interest relating to the services to be provided. The Contractor shall also provide statements containing the same information for any identified consultants or sub-Contractors who shall provide services. The Contractor must also provide relevant facts that show how its organizational and/or management system or other actions would avoid or mitigate any actual or potential organizational conflicts of interest in accordance with VHA Handbook 1660.03. See attachment in Section D.

2.9. CITIZENSHIP RELATED REQUIREMENTS:

2.9.1. The Contractor certifies that the Contractor shall comply with all legal provisions contained in the Immigration and Nationality Act of 1952, As Amended; its related laws and regulations that are enforced by Homeland Security, Immigration and Customs Enforcement and the U.S Department of Labor as these may relate to non-immigrant foreign nationals working under contract or subcontract for the Contractor while providing services to Department of Veterans Affairs.

Workers’ compensation Professional liability insurance Health examinations Income tax withholding, and Social security payments

2.13. TORT: The Federal Tort Claims Act does not cover Contract staff. When a contract staff member has been identified as a provider in a tort claim, the Contractor’s staff member shall notify the Contractor’s legal counsel and/or insurance carrier. Any settlement or judgment arising from a Contractor’s provider’s action or non-action is the responsibility of The Contractor and/or insurance carrier.

3. HOURS OF OPERATION: The following outlines the required hours of operation:

3.1. BUSINESS HOURS:

3.2. WEEKDAY HOURS: Monday through Friday, 8am-4:30pm.

3.3. WEEKEND HOURS: None

3.4. FEDERAL HOLIDAYS: The following holidays are observed by the Department of Veterans Affairs:

New Year’s Day Washington’s Birthday Martin Luther King’s Birthday Memorial Day Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Christmas Any day specifically declared by the President of the United States to be a national holiday.

4. CONTRACTOR RESPONSIBILITIES:

4.1. GENERAL: Contractor shall provide the following space, personnel, and services:

4.1.1. Clinic space:

One office for Primary Care/Mental Health Provider(s) One to two clinical exam/treatment rooms as needed for one day per month.

4.1.2. Clinic personnel:

One administrative clerk/receptionist to answer telephone calls from Veterans and to schedule/cancel patient appointments. The administrative clerk/receptionist does not provide administrative support.

One medical assistant (MA) to check in and check out patients and to do vital signs. The MA shall assist VA provider(s) and provide assistance with procedures and paperwork as needed.

4.1.3. Clinic services:

No telehealth services available.

Provision for office supplies and clinical supplies as needed to operate the clinic

4.2. PRIMARY CARE TASKS SUMMARY: Contractor staff will assist VA staff with providing all services in accordance with Handbook 1101.10.

4.2.1. ENHANCE ACCESS TO CARE: VA strives for superb access to care in venues like face-to- face and virtual access to care. VA staff is expected to enhance access to care by offering care in the modalities listed below. Contractor collaborates with VA to facilitate processes (phone connectivity, physical environment, etc).

4.2.1.1. Virtual Access- the Contractor shall provide the following virtual access:

4.2.1.1.1. Telephones: Phones should be answered by a “live” person with a focus on achieving first call resolution. First call resolution is taking care of the Veteran’s issue/request during that call. This approach requires thoughtful planning and strategy (Contract employee).

4.3. DIRECT PATIENT CARE:

4.3.1. PRIMARY CARE SERVICES SCOPE OF CARE: Contractor shall provide one administrative clerk/receptionist and one medical assistant to support VA travelling provider(s).

4.3.2. EMERGENCY RESPONSE REQUIREMENTS:

4.3.2.1. The Contractor shall have a local policy or standard operating procedure defining how emergencies are handled.

4.3.2.2. The Contractor shall maintain appropriate emergency response capability.

4.4. TELEPHONE ACCESS TO CLINICAL CARE: Contractor shall provide phone access during clinic business hours. After hours, Veterans will utilize the VA PIHCS Call Center at 1-800-214-1306.

4.4.1. After Hours Telephone Care: After hours, Veterans will utilize the VAPIHCS Call Center at 1-800-214-1306.

4.4.2. Business Hours Telephone Care: Contractor’s shall 1) answer all incoming calls with a “live person” (vs. voice mail) and 2) resolve the patient’s reason for calling while on the phone with the Veteran (known as First Call Resolution)

4.5. MEDICAL RECORDS/COMPUTERIZED RECORD SYSTEMS/DISCLOSURE/RECORD RETENTION

4.5.1. MEDICAL RECORDS REQUIREMENTS: Authorities: Contractor providing treatment and healthcare services to VHA patients shall comply with the U.S.C.552 (Privacy Act), 38 U.S.C. 5701 (Confidentiality nature of claims), 5 U.S.C. 552 (FOIA), U.S.C. 5705 (Confidentiality of medical quality assurance records) 38 U.S.C. 7332 (Confidentiality of certain medical records) and 45 C.F.R. Parts 160, 162, and 164 (Health Insurance Portability and Accountability Act’s Privacy Rule).

4.5.2. The resultant contract and its requirements meet exception in 45 CFR 164.502(e), and do not require a Business Associate Agreement (BAA) for a covered entity such as VHA to disclose protected health information to another health care provider for treastment. 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 VHA system of records entitled ‘Patient Medical Records-VA’ 24VA10P2 at https://www.oprm.va.gov/privacy/privacy_SOR.aspx. Contractor generated VHA patient records are the property of VHA and shall not be accessed, released, transferred, or destroyed except in accordance with applicable laws and regulations

4.5.3. Neither the VA nor the Contractor has the legal authority to require that a patient provide his/her Social Security Number to the VHA as a condition for receiving medical care under Title 38, United States Code. If the patient does not provide a Social Security Number, the VA will assign a unique identification

4.5.4.. Access to VA Records: Subject to applicable federal confidentiality laws, the Contractor or its designated representatives may have access to VHA records during normal business hours where necessary to perform the duties under this resultant contract.

4.6. PATIENT RIGHTS, SAFETY, COMPLAINTS, GRIEVANCE SYSTEM PROCESSES

4.6.3. THE GOVERNMENT RESERVES THE RIGHT TO REFUSE ACCEPTANCE of Contractor, 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 CO and COR shall deal with issues raised concerning contract personnel’s conduct. The final arbiter on questions of cceptability is the CO.

4.7. SPACE REQUIREMENTS.

4.7.1. Contractor shall provide a floor plan of their proposed space:

one office for Primary Care/Mental Health provider(s) one to two clinical exam/treatment rooms as needed for one day per month

4.7.2. The Contractor's facility must be in compliance with National Fire Protection Association (NFPA) Life/Safety requirements and the Americans with Disabilities Act.. Parking should be adequate to accommodate Veteran patients and shall include handicapped parking spaces.

4.8.1. The Contractor shall be responsible for:

4.8.2. The VA will be responsible for:

4.8.2.1. providing laptop/I-pad to travelling provider(s) and network connection and access to VISTA/CPRS system.

4.9. PERFORMANCE STANDARDS, QUALITY ASSURANCE AND QUALITY IMPROVEMENT: Services and documentation of care provided under the resultant contract shall be subject to quality management and safety standards as established by VA, consistent with the standards published by TJC or equivalent.

4.9.1.The Contractor shall permit on-site visits by VA personnel to assess contracted services are in compliance with contract requirements.

4.9.2. The Contractor shall meet all Federal, State, and Local fire and Life Safety Codes.

4.9.3. The Contractor shall be responsible for meeting national quality standards.

4.10 . PERFORMANCE STANDARDS AND SURVEILLANCE- To be paid the full capitated rate on the schedule, the Contractor must collaborate with VA staff to provide services as required in the entire contract and to meet or exceed the acceptable quality level outlined in this section/sub-sections. If any portion of the requirement is not met and/or the acceptable quality level in any of the elements in this section/subsection are not maintained, the Contractor will be notified by the Contracting Officer for response outlining the Contractor’s proposed remedy. The Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming services per FAR 52.212-4.

4.11. REQUIRED REGISTRATION WITH CONTRACTOR PERFORMANCE ASSESSMENT REPORTING SYSTEM (CPARS)

4.11.1. As prescribed in Federal Acquisition Regulation (FAR) Part 42.15, the Department of Veterans Affairs (VA) evaluates Contractor past performance on all contracts that exceed the Simplified Acquisition Threshold 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, 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.

4.11.2. Each Contractor whose contract award is estimated to exceed the simplified acquisition threshold (SAT) 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.

4.11.3. 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, theCcontracting 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 re-assign the report to the VA Contracting Officer.

4.11.4. Failure to have a current registration with the CPARS database, or to re-assign the report to the VA contracting officer 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.

5. GOVERNMENT RESPONSIBILITIES:

5.1. Oversight of Service/Performance Monitoring:

5.1.1. CO Responsibilities: The CO is the only person authorized to approve changes or modify any of the requirements of this contract. The Contractor shall communicate with the CO on all matters pertaining to contract administration. Only the CO is authorized to make commitments or issue any modification to include (but not limited to) terms affecting price, quantity or quality of performance of this contract. The CO shall resolve complaints concerning Contractor’s provider relations with the Government employees or patients. The CO is final authority on validating complaints. In the event the Contractor effects any such change at the direction of any person other than the CO without authority, no adjustment shall be made in the contract price to cover an increase in costs incurred as a result thereof. If contracted services do not meet quality and/or safety expectations, the best remedy will be implemented, to include but not limited to a targeted and time limited performance improvement plan; increased monitoring of the contracted services; consultation or training for the contract staff to be provided by the VA; replacement of the contract staff and/or renegotiation of the contract terms or termination of the contract.

5.1.2. The COR: The COR shall be the VA official responsible for verifying contract compliance. After contract award, any incidents of Contractor or Contractor’s provider noncompliance as evidenced by the monitoring procedures shall be…