Clinical Service: Formation of a New or Enhancement of Inpatient or Outpatient Service QUALITY/SAFETY/RISK POLICY: NUMBER:

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1 QUALITY/SAFETY/RISK POLICY CREATED: REVIEWED: REVISED: Clinical Service: Formation of a New or Enhancement of Inpatient or Outpatient Service NUMBER: SCOPE: APPROVED BY: Chief Clinical Officer, HSD FORMUALTED BY: Finance, Risk Management, Clinical Services, Medical Staff Office, Compliance, IP&C, Legal and OCI. Appendix A Checklist Appendix B Request of Clinical Privileges Appendix C Request for Additional Privileges I II PURPOSE: 1.1 Definition: A clinical service is defined as a service that is billable, maybe regulated, or requires privileging for providers. To provide a standardized systematic approach for the implementation of a new clinical service through the notification, involvement, and coordination departments that facilitate quality and safety, technical proficiency, clinical care, patient experience, and financial impact. POLICY: 2.1 Request and application to initiate a new clinical service must be made to the Department/Clinic Director and Director of Clinic Operations as appropriate Final hospital approval is by the appropriate Vice President(s) Final clinic approval is by the Executive Team or Board of Governors when appropriate Final approval is by network hospital Executive Management. 2.2 After obtaining preliminary director and VP approval, departments/clinics proposing a new clinical service must complete all application steps defined in the attached checklist and submit to the New Services Committee. (SEE Appendix A). 2.3 The Professional Practice Committee must review. 2.4 After all of the steps have been completed the service/implementation will be approved by the clinic Board of Governors. 2.5 The initiation of service begins after final approval has been completed. 2.6 All new clinical services are to be evaluated after implementation according to the plan agreed upon with the Vice President. The plan for evaluation must be submitted with the application. III PROCEDURE:

2 Clinical Service: Formation of a New Page 2 of Individuals desiring to initiate a new clinical service must meet with their superior to discuss the operational issues which must be considered in instituting a new service. 3.2 The director will make initial contact with one of the departments listed on the attached checklist to get on the New Services Meeting agenda. 3.3 The director desiring to initiate a new clinical service is required to make application to their Vice President by compiling and submitting the following information: Definition of needs, Description of service (educational, diagnostic, therapeutic), Target patient population and volumes, Expected charges, Payer mix and expected reimbursement, Anticipated risks and opportunities, Timelines, Plan for outcome based evaluation after implementation, Business Performa (sample needed). 3.4 Final approval to initiate a new clinical service is granted by Final approval is by the appropriate hospital Vice President(s) Final approval is by the clinic Executive Team or Board of Governors when appropriate Final approval is by hospital network Executive Management 3.5 After VP final approval has been granted, the individual(s) must schedule an appointment with the Chargemaster Committee for review before the service is initiated. CHIEF CLINICAL OFFICER, HSD

3 Clinical Service: Formation of a New Page 3 of 9 APPENDIX A NEW OUTPATIENT CLINIC/SERVICE CHECKLIST After obtaining preliminary director and VP approval, prepare for the initiation of a new outpatient clinic or service by collecting the following information. Resources are listed to the right. Please prepare the answers to all questions. When all answers have been determined, schedule to be placed on New Service Committee Agenda by contacting Risk Management. After presentation and approval by the New Service Committee, obtain final VP approval, then schedule a visit with the Charge Master Committee by calling the Finance Department. Business Plan Questions Resources/Contacts Completed 1. Do you have preliminary approval from your Director and Vice President to initiate this service? Please obtain preliminary approval before continuing with this process. Department Director, Vice President 2. What is the purpose/intent of the service? Clearly and specifically identify what the services will be. What volume of patients do you anticipate initially and within one year? 3. What statistics will you want to track regarding this service such as cost, quality, outcomes, volumes, satisfaction etc. Those individuals involved in planning the service. Decision Support Finance Questions: Resources/Contacts Completed 4. Will this service be provided under an existing cost center or will a new cost center be developed? Will the expenses related to providing these services (Labor & Supply) be in the same cost center as the charges are generated? Department Director, Director of Finance 5. What will you be charging the patient for? Will there be cycle billing of recurring outpatient accounts or billing on discharge only? Are these charges billable under Medicare or Medicaid guidelines? Are other hospitals that provide and bill for this service succeeded in getting reimbursement for this service? If yes, please contact applicable sites and ask how the billing has been done (CPT codes, what services reimbursed, how, etc.) Insurance Supervisor and Director of Reimbursement 6. Are there any NCDs or LCDs regarding this service? HIM Coding Specialist/Compliance 7. Are there APCs regarding this service? APC/Utilization 8. A form must be completed for each charge code you will need to create. For each code, identify: a. Expense of the service-labor, supply etc. b. Appropriate CPT code for the charge c. Proposed charge amount 9. How will charges be entered (order entry or charge posting)? Who will be responsible to enter charges? Is training needed on order entry or charge posting? Charge Committee Installation & Support Manager

4 Clinical Service: Formation of a New Page 4 of Have you scheduled a meeting with the Chargemaster Committee? Charge master committee HIM/ONE Chart Plan Resources/Contacts Completed 11. What are your medical record requirements? a. Does the patient need to be registered? b. Will you need a chart on the patient? c. Where will the chart be maintained? Health Information Management or EHR/Revenue Cycle, Clinical Informatics d. How will you identify and document medical necessity? e. How will you document care? f. What are the documentation requirements? g. Who will be the attending provider (Attending or Medical Director)? h. Do you need provider orders for the services provided? i. Does the provider need to sign off the orders? j. What other chart requirements are these of the provider? 12. What templates/flowcharts are necessary to accurately Clinical Informatics document the procedure? 13. What EMR training is necessary of each Clinical Informatics job title/function 14. Do you have the Information Service Equipment you need Clinical Informatics, to facilitate this service? Information Technology Patient Access Plan Resources/Contacts Completed 15. How will patients be scheduled and how will preregistration Patient Appointment occur? What information needs to be given to Center the individual scheduling the service and to the patient at pre-registration? 16. Will the patient be a one-time outpatient or recurring outpatient? What clinic code and medical service code will be used? Patient Access Communications/Marketing Plan Resources/Contacts Completed 17. Will you need publicity or marketing to introduce this service? Will you need to market internally to other employees and departments? To providers locally? To others in the System, to the public? Marketing 18. What will the communication/phone service needs be? Information Technology Quality/Safety/Risk/Accreditation Resources/Contacts Completed 19. Will Joint Commission need to be notified of the new service? Center for Strategic Improvement 20. Are supporting policies and procedures in place? Policy Coordinator 21. What is the education information for the patient on risks/benefits of the service? Risk Management, Center for Learning 22. Is the service covered under the current medical Risk Management

5 Clinical Service: Formation of a New Page 5 of 9 malpractice premium? 23. Is Universal Protocol indicated? Center for Strategic Improvement Facility Plan Resources/Contacts Completed 24. Where will the service be performed? clinic/hospital Facilities 25. Are there requirements for the service related to safety Facilities planning? i.e.: lead rooms 26. What is the emergency preparedness/equipment needed Facilities, Safety for the service? Officer Medication Plan Resources/Contacts Completed 27. What medications, if any will be used? Pharmacy 28. Who will be administering them? 29. Is conscious sedation planned on being used? Pharmacy 30. Do you have sufficient staff? 31. Do you have sufficient equipment/room to monitor patient? 32. How will the medications be stored? Pharmacy Staff/Provider Plan Resources/Contacts Completed 33. Contact Medical Staff Office to determine if a new guideline needs to be developed. Does the staff providing the service need to be credentialed? If so, what are the requirements? Medical Staff Office Appendix B and C 34. Will current employees of the new clinic/service be affected? If so contact Human Resources. Human Resources; Center for Learning 35. What level of staffing is needed? 36. Is it within their scope of practice? 37. How will staff training and validations of competencies be completed? Supply and IP&C Plan Resources/Contacts Completed 38. What will the supply needs be and the process for receiving them. 39. Where will they be stored? 40. What types of equipment is needed? 41. Are the supplies single use? If so do they qualify for the third party reprocessing program? 42. How will they be cleaned/sterilized or reprocessed? Supply Chain Management Infection Prevention and Control

6 Clinical Service: Formation of a New Page 6 of 9 APPENDIX B CREDENTIALING GUIDELINESFOR REQUEST OF CLINICAL PRIVILEGES REQUESTING CLINICAL PRIVILEGES Appointment or reappointment does not confer any clinical privileges or right to practice at the Hospital. Providers granted Temporary Clinical Privileges or appointees to the Medical Staff are entitled to exercise only those clinical privileges formally approved by the Board of Directors in accordance to the process described in the Medical Staff Policy on Appointment, Reappointment and Clinical Privileges. Eligibility criteria for clinical privileges are defined within Core Privilege Guidelines and Specialty Request Privilege Guidelines. If criteria for a specific privilege are not currently defined, it shall be the determination of the Credentials Committee if written guidelines are required considering factors to include: level of clinical and technical skill required; risk of complication; experience with the procedure; and industry standards. Applicants for appointment or reappointment must complete a Privilege Request Form indicating the requested Core Privilege Definition(s), all special Request Privileges, and any other privilege that may or may not be included in the core definition. During the term of appointment, an appointee may request increased or additional privileges via written request to the Credentials Committee. Requests for privileges must be accompanied by supporting documentation and information sufficient to establish eligibility as specified in the applicable criteria. The applicant has the burden of establishing qualification and current competence for all clinical privileges requested. PROCESSING REQUESTS FOR PRIVILEGES Applicants must satisfy applicable eligibility requirements before a privilege request will be processed. If an applicant fails to provide evidence of appropriate education, training, and experience, the applicant is deemed ineligible to apply for the privilege requested. If the individual is eligible and the application is complete, it shall be processed in accordance with the Medical Staff Policy on Appointment, Reappointment and Clinical Privileges. An applicant may seek additional training and experience at outside facilities in order to become eligible for specific privileges. The Credentials Committee shall determine whether the outside training and experience are appropriate and adequate to meet the eligibility requirements for the procedure. CLINICAL PRIVILEGES FOR NEW PROCEDURES Requests for clinical privileges to perform a significant procedure or service not currently being performed at the Hospital or a significant new technique to perform an existing procedure will not be processed until a determination has been made that the procedure will be offered by the Hospital and until criteria to be eligible to request those clinical privileges have been established. The Credentials Committee and the Executive Committee shall make a preliminary recommendation as to whether the new procedure should be offered, considering whether the Hospital has the capabilities, including support services, to perform the new procedure. If it is recommended that the new procedure be offered, the Credentials Committee shall conduct research and consult with experts, including those on the Medical Staff and those outside the Hospital, and develop recommendations regarding the minimum education, training, and experience necessary to perform the new procedure, and the extent of monitoring and

7 Clinical Service: Formation of a New Page 7 of 9 supervision that should occur if the privileges are granted. The Credentials Committee may also develop criteria and/or indications for when the new procedure is appropriate. The Credentials Committee shall forward its recommendations to the Executive Committee, which shall review the matter and forward its recommendations to the Board for final action. PROVISIONAL PRIVILEGES With appropriate education, training, and experience, a current member of the Medical Staff may apply for new, additional clinical privileges. All grants of increased clinical privileges are provisional, unless otherwise designated by the Credentials Committee and approved by the Medical Executive Committee and the Board. In granting provisional privileges the Credentials Committee may require the applicant to provide a report to the Committee after a specified number of cases. The report will provide a list of the cases performed with patient identifier, a summary of the cases to include any technical difficulties or patient complications, and any other information requested by the Committee. At its discretion, the Credentials Committee may require a specified number of cases to be proctored by a physician appointed by the Committee or its designee to act as a proctor. The physician who is acting as a proctor may be a member of the Active Medical Staff who holds privileges in the procedure being proctored, or may be an external expert approved by the Credentials Committee based on documentation of qualifications and expertise. If cases are to be proctored on-site and the proctor is not a member of the medical staff, the proctor must apply and be approved for temporary, non-applicant staff privileges. The proctor must submit a report to the Credentials Committee addressing the applicant s clinical judgment, technical skill and competence to perform the privilege independently. A Proctor/Preceptor Report Form must be submitted for each case proctored. TRAINING BY APPRENTICESHIP If an applicant meets the education and training criteria for a clinical privilege, but does not have sufficient clinical experience, consideration may be given to approving additional on-site training by apprenticeship to gain the necessary experience to become eligible to apply for the clinical privilege. The Credentials Committee must first determine that it is appropriate for such training to occur at the Medical Center, and that determination must be validated by the Medical Executive Committee and the Board. Requests for training by apprenticeship will be processed in the same manner as requests for clinical privileges and shall be based upon consideration of the applicant s education, training, and experience which may include other related or applicable experience, demonstrated current competence and judgment, and the ability to perform the requested privilege competently and safely under guidance. Physicians who have indicated that they plan to resign from the medical staff within 6 months shall not be eligible to apply for training by apprenticeship. If the Credentials Committee determines to forward a recommendation for approval of training by apprenticeship to the Medical Executive committee, the recommendation will specify the name of one or more physicians to act as a preceptor and the number of cases to be done under the direct supervision of the preceptor. The preceptor will be appointed by the Credentials Committee or designee, and must be a member of the Active Medical Staff who holds privileges for the specific procedure. The preceptor must submit a report to the Credentials Committee addressing the applicant s clinical judgment, technical skill, and competence to perform the privilege independently. A Proctor/Preceptor Report Form must be submitted for each case

8 Clinical Service: Formation of a New Page 8 of 9 performed by the applicant with the preceptor. Based on the results of the preceptor s report, the Credentials Committee will determine the applicant s eligibility to apply for the privilege requested. If the applicant is deemed eligible, the request for privileges will be handled according to the usual process described above. MAINTENANCE REQUIREMENTS Maintenance requirements may be specifically defined as part of Core Privileges or guidelines for Special Request Privileges. Maintenance requirements will be reviewed with each applicant s reappointment unless otherwise defined in the guidelines or Credentials Committee recommendations. PROCTOR/PRECEPTOR GUIDELINES The granting of privileges to perform a procedure does not, of itself, confer to a physician the right to act as a proctor or preceptor for another physician. The ability to act as a proctor or preceptor for another physician is not a privilege, but rather an assigned peer review activity directed by the Credentials Committee or designee. A physician may not arrange for or serve as a proctor or preceptor without appropriate approval. A physician acting as a proctor or preceptor must be prepared to intervene at any time during a procedure if such intervention is necessary to ensure patient safety. A formal request or approval process is not required for a physician to observe a procedure, provided he/she does not assist in the case. Observing Physicians may palpate bony land markers during educational observations if it would enhance their educational experience. (12/07) Physicians may at any time mentor or assist each other in performing procedures for which both currently hold privileges. INVESTIGATIONAL PROCEDURES-INTERVENTIONS-PROTOCALS All investigational procedures- interventions- protocols must be processed through the IRB Committee for approval prior to enrolling patients in the study. In addition, the Credentials Committee must approve privileges for the providers requesting investigational -invasive procedures prior to enrolling patients in studies. It may be determined that the requested procedure is an extension of the privileges previously granted to the provider or the provider must include documentation of additional training prior to approval. If proctoring is required, the proctor must be hands on and ready to intervene if necessary and either currently on staff at the Medical Center with current privileges in the procedure being proctored or meet the credentialing requirements for temporary non-applicant status and attain board approval to proctor at the Medical Center.

9 Clinical Service: Formation of a New Page 9 of 9 APPENDIX C Request for Additional Privileges Date: Applicants Name: New Privilege Request: Is this an extension or variation of a current procedure that you already are privileged to perform. Circle: Yes or No What additional Education or Clinical experience have you had to be able to perform this additional Privilege? Please list below. Is additional training needed for Staff or is additional equipment needed to perform the procedure. If not an extension or a variation of a current procedure that you already are privileged to perform it may be required to have a Proctor. All Proctors must be currently be Credentialed by the Medical Center. Proctor Name: Note: The granting of privileges to perform a procedure does not; of itself confer to a physician the right to act as a proctor for another physician. The ability to act as a proctor is not a privilege, but rather an assigned peer review activity directed by the Credentials Committee. A physician acting as a proctor must be prepared to intervene at any time during a procedure, if such intervention is necessary to ensure patient safety. Signature