Contract Management and Vendor Oversight: Regulations and Management Oversight

1. Contract Management and Vendor Oversight:Regulations and Management Oversight Marianne Klaas, RN, MN, CHSP Swedish Medical Center Administrative Director Accreditation, Safety, Injury Management, and Clinical Patient Relations

2. Acknowledgement • VHA Program 5/29/12 • Sentara- Norfolk, Virginia • St. Lukes’s – Boise, Idaho

3. Center for Medicare and Medicaid Services (CMS) • 482.12(e) Standard: Contracted Services • The governing body must be responsible for services furnished in the hospital whether or not they are furnished under contracts. • The governing body must ensure that a contractor of services (including one for shared services and joint ventures) furnishes services that permit the hospital to comply with all applicable conditions of participation and standards for the contracted services.

4. CMS • The governing body has the responsibility for assuring that hospital services are provided in compliance with the Medicare Conditions of participation and according to acceptable standards of practice, irrespective of whether the services are provided directly by hospital employees or indirectly by contract. • The governing body must take actions through the hospital’s QAPI program to: assess the services furnished directly by hospital staff and those services provided under contract, identify quality and performance problems, implement appropriate corrective or improvement activities, and to ensure the monitoring and sustainability of those corrective or improvement activities. (See 482.21 QAPI.)

5. The Joint Commission • LD.04.03.09: Care, treatment, and services provided through contractual agreement are provided safely and effectively.

6. Contracted Services • The same level of care should be delivered • Governing Body / Leaders provide oversight • The contractual agreements are those for hospital’s patients. • Contracts for consultation or referrals are not subject to the requirements in Standard LD.04.03.09. • The expectations for the performance of contracted services should reflect basic principles of risk reduction, safety, staff competence, and performance improvement.

7. Methods for Oversight • Leaders are expected to select the best methods for their hospital to oversee the quality and safety of services provided through contractual agreement. • Reviews • Direct observations • Audits • Incident reports • Periodic performance reports • Collection of efficacy data • Performance indicators • Staff input • Patient satisfaction surveys • Risk management

8. CMS- TJC Crosswalk • CMS 482.12 (e)(1) The governing body must ensure that the services performed under a contract are provided in a safe and effective manner. • (e)(2) The hospital must maintain a list of all contracted services, including the scope and nature of the services provided. • TJC LD.04.03.09 EP4 Leaders monitor contracted services by establishing expectations for the performance of the contracted services. Note 3: The leaders who monitor…are the governing body • EP2 The hospital describes, in writing, the nature and scope of services provided through contractual agreements • EP3 Designated leaders approve contractual agreements

9. Clinical vs. Non-Clinical • CMS 482.12 (e)(1) The governing body must ensure that the services performed under a contract are provided in a safe and effective manner. • (e)(2) The hospital must maintain a list of all contracted services, including the scope and nature of the services provided. • An inventory of contract services that affect the quality and safety of patient care (clinical and non-clinical) should be developed and maintained. • Using hospital defined “Inclusion and Exclusion” criteria to identify relevant contracts and include on the hospital's inventory ONLY those contract services that meet the Inclusion criteria.

10. Inclusion vs. Exclusion Criteria • Inclusion Criteria: Those contract services that contribute to the quality and safety of care, treatment and services including contract services with staff associated. Examples: • Clinical Care • Medication Management • Physician Services (patient care) • Purchased Labor (patient care) • Affiliation Agreements (patient care) • Translation Services (Deaf • Talk/Interpretation Services) • Entire Department Contracted • Exclusion Criteria: Those contract services that do not contribute to the quality and safety of care, treatment and services. Examples: • Cable TV • Vending/ATMs • Lawn Services and Maintenance of Plants/Flowers • Lease agreements

11. TJC- LD 04.03.09

12. LD.04.03.09 EP1- 4Contracted Services • 1-Clinical leaders and medical staff advise on the sources of clinical services to be provided through contractual agreement. • 2 - The hospital describes the nature and scope of services provided through contractual agreements. • 3 - Designated leaders approve contractual agreements. • 4 - Leaders monitor contracted services by establishing expectations for the performance of the contracted services. • Note 1: In most cases, each licensed independent practitioner providing services through a contractual agreement must be credentialed and privileged by the hospital using their services following the process described in the “Medical Staff” (MS) chapter. • Note 3: The leaders who monitor the contracted services are the governing body.

13. LD.04.03.09 EP 5-7Contracted Services • 5 – Leaders monitor contracted services by communicating the expectations in writing to the provider of the contracted services. • Note: A written description of the expectations can be provided either as part of the written agreement or an addendum. • 6 - Leaders monitor contracted services by evaluating these services in relation to the hospital's expectations. • 7 - Leaders take steps to improve contracted services that do not meet expectations. • Examples of improvement efforts to consider include the following: • Increase monitoring of the contracted services. • Provide consultation or training to the contractor. • Renegotiate the contract terms. • Apply defined penalties. • Terminate the contract.

14. LD.04.03.09 EP 8-10Contracted Services • 8 – When contractual agreements are renegotiated or terminated, the hospital maintains the continuity of patient care. • 10 - Reference and contract laboratory services meet the federal regulations for clinical laboratories and maintain evidence of the same. * • *: For law and regulation guidance on the Clinical Laboratory Improvement Amendments of 1988, refer to 42 CFR 493.

15. LD.04.03.09 EP 23Contracted Services (Telemedicine) • 23 - For hospitals that use Joint Commission accreditation for deemed status purposes: The originating site has a written agreement with the distant site that specifies the following: • The distant site is a contractor of services to the hospital. • The distant site furnishes services in a manner that permits the originating site to be in compliance with the Medicare Conditions of Participation (Appendix A) • The originating site makes certain through the written agreement that all distant site telemedicine providers’ credentialing and privileging processes meet, at a minimum, the Medicare Conditions of Participation at 42 CFR 482.12(a)(1) through (a)(9) and 482.22(a)(1) through (a)(4). (See also MS.13.01.01, EP 1) • If the originating site chooses to use the credentialing and privileging decision of the distant-site telemedicine provider, then the following requirements apply: • The governing body of the distant site is responsible for having a process that is consistent with the credentialing and privileging requirements in the “Medical Staff” (MS) chapter (Standards MS.06.01.01 through MS.06.01.13). • The governing body of the originating site grants privileges to a distant site licensed independent practitioner based on the originating site’s medical staff recommendations, which rely on information provided by the distant site.

16. Det Norske Veritas (DNV)

17. DNV

18. DNV

19. DNV

20. So Easy? So Far From It!

21. Oversight Issue #1 • Contracted Services’ own accreditation and certification • Validate currency • “Meets all applicable standards”

22. Oversight Issue #2 • Direct Observation • After hours • Weekends

23. Oversight Issue #3 • Documentation Audits: • Vendor may use different forms • Vendor may lack details/specific for tracking and tracing • Vendor may not have access to electronic medical record • Vendor forms may be scanned into the record • Not documented, not done

25. Oversight Issue #4 • Incident Reporting Structure • If asked to produce any incident reports based on contractor/vendor, could you? • Role of risk management • How can staff/medical staff report issues for tracking and trending? (ends up via QAPI)

26. Oversight Issue #5 • Timely reviewing of periodic reports submitted by the individual or organization providing the services

27. Oversight Issue #6 • Trust but verify that the organization is collecting data that addresses the service efficacy.

28. Oversight Issue #7

29. Oversight Issue #8 • Human Resources: Monitoring contracted services can be challenging because people doing the work are not direct employees of the organization. • COMPETENCY! • “Trust but verify”

30. Oversight Issue #9 Sub-contracting: • No contractor should be sub-contracting their work without your express consent and knowledge. • Sub-contractors must meet same performance metrics. • Audit for any variances e.g., a different dialysis machine suddenly shows up (substituted) from a sub-contracted vendor.

31. Oversight Issue #10 • Review patient satisfaction surveys

32. Bottom Line • Highly regulated • Specifics for being compliant • Daunting scope • Quality and patient care at stake • Financial gains possible (reducing contracts; patient satisfaction)

33. Thank you!