SOW - Pawnee Retinal Consultation 2022.pdf

STATEMENT OF WORK

1. STATEMENT OF WORK

Contractor shall provide Retinal Consultation and Treatment Clinics for the Pawnee Service Unit, which shall include intravitreal injections, laser treatments, pre and post treatment evaluations, and other services dealing with ophthalmological disorders. The clinic shall be provided up to two days monthly, negotiated between contractor and government. The clinics will be held at the Pawnee Indian Health Center, 1201 Heritage Circle, Pawnee, Oklahoma. Service shall include, but not limited to the following:

1. Contractor shall hold a Retinal Consultation and Treatment Clinic at the Pawnee Indian Health

Center, up to two days each month. Contractor's services will include intravitreal injections, laser treatments, pre and post treatment evaluations, and other services dealing with ophthalmological disorders. Treatment provided to patients with diabetic retinopathy will adhere to the current American Academy of Ophthalmology Preferred Patterns of Practice for Diabetic Retinopathy. It is anticipated that approximately twenty (20) individual patient consultations and three (3) laser treatments and ten (10) intravitreal injections will be performed during the course of each one-day clinic.

2. Contractor shall provide portable laser equipment which is compatible with equipment presently in place at the Pawnee Indian Health Center.

3. Contractor and Pawnee Indian Health Center medical staff shall define potential risks and complications associated with any treatment and the associated post-treatment period.

Specific responsibilities and procedures to be followed in the event of complications shall be identified.

4. a) Pawnee Indian Health Center professionals shall participate, as noted in Appendix A, with

Contractor in conducting the Treatment Clinic, including pre-Clinic preparation and post- Clinic activities, to ensure the delivery of quality care in an efficient and timely fashion.

b) Pawnee Indian Health Center shall employ and supervise office personnel for reception, telephone answering, patient scheduling, nursing service, billing, filing and assistance to professionals.

5. Contractor shall document on a timely basis, complete and accurate medical and other records with respect to treatment and consultation services utilizing IHS-803, PCC Ambulatory Encounter Record, furnished by the Government. All such records shall be and remain the property of Pawnee Indian Health Center. While on-site, Contractor shall have access to such records at all times and may use such records and the information therein in connection with its treatment efforts. Contractor acknowledges that the information derived from the treatment and consultation services will remain confidential at all times.

6. Pawnee Indian Health Center will bill third party reimbursement for treatment services provided and rendered by Contractor and shall retain all revenues received from such billings. Contractor shall not directly or indirectly bill any party, other than the Pawnee Indian Health Center, for any services provided. However, should such payments be received by Contractor, Contractor shall promptly remit to the Pawnee Indian Health Center any such amounts received. Contractor shall follow all procedures and protocols established by Pawnee Indian Health Center with respect to billing and shall otherwise cooperate with Pawnee Indian Health Center in the billing and collection of fees for treatment services provided.

7. This contract shall not be construed to create any type of partnership, joint venture or employer-employee relationship between Pawnee Indian Health Center and Contractor.

8. The Contractor shall not assign or transfer their respective rights or obligations under this contract.

9. This contract may be terminated by either party, with or without cause upon 30 days written notice.

a) Notwithstanding anything herein to the contrary, Pawnee Indian Health Center may terminate this contract upon written notice to Contractor stating the effective date of termination if any one or more of the following events occurs:

i. Contractor fails to obtain or maintain membership on the active Medical Staff and/or restricted clinical privileges with Pawnee Indian Health Center.

ii. Contractor fails to maintain an unrestricted license to practice medicine within Oklahoma.

iii. Contractor fails to maintain all customary narcotics and controlled substances numbers and licenses as required by federal, state or local laws and regulations

iv. Contractor breaches this contract; provided however any conduct relating to matters not affecting patient care shall not constitute a breach until Contractor is given notice of such matters and fails to cure same within thirty (30) days; and/or

v. Pawnee Indian Health Center, in good faith and after conducting generally accepted quality review procedures in conjunction with qualified physicians, determines that Contractor is not providing quality patient care, or that the safety of patients is jeopardized by continuing the services of Contractor.

10. This contract may be modified in writing upon agreement of the Pawnee Indian Health

Center and the Contractor.

11. Except for institutional reports, mandatory conflict of interest disclosures, acknowledgment of sponsorship required by guidelines of scientific publications or organizations and federal applications for funding, no advertising, press release, or publicity matters having or containing any reference to the other party shall be used by disclosing party without prior written consent of the other party.

2. PROFESSIONAL QUALIFICATIONS

A. Verification of Licensure

To ensure that physicians providing services under this contract are properly licensed, and that the I.H.S. is made aware of all disciplinary actions taken against such physicians, the Contractor will:

1. Verify through the Federation of State Medical Boards data base, all active, inactive, and lapsed licenses that are held, or have been held, by physicians who would provide services in I.H.S. hospitals and clinics under this contract.

2. Inform the IHS of the status of all licenses for each physician who would provide services under this contract in IHS hospitals and clinics, including all reasons for each inactive or lapsed license.

3. Obtain at least three (3) letters of reference from health care providers whom have knowledge of the applicant's clinical practice skills. One letter must be from the Chief of Staff, or Service, at the hospital where the physician holds, or last held, staff privileges. If the physician has just completed a residency, one letter must be from the residency program director or service chief.

4. Provide all information regarding performance and disciplinary actions that is collected on physicians who would be placed under this contract to the receiving I.H.S.

facility Clinical Director. This includes all information that is collected and compiled on such physicians at the time of initial hire by the Contractor, and/or information that is reported during periods that the Contractor is an agent of such physicians for placement under this contract.

5. Certify that all information obtained on physicians whom they would assign to IHS hospitals and clinics has been reviewed and verified by the Contractor. This certification must include a statement that the Contractor has found no reason to reject the physician's application. The names of the contacts, their titles, telephone numbers, date of contacts, and the names(s) of the Contractor's representative(s) collecting and reviewing such information must be recorded in writing and made available to the I.H.S. by the Contractor.

B. The Contractor shall provide physician(s) who meet(s) the following minimum qualifications and requirements:

(1) Current unrestricted license to practice medicine in the United States.

(2) The Contractor is responsible for obtaining the amount of professional liability insurance of at least $1,000,000.00 per occurrence.

(3) Physician(s) must be professionally certified in Ophthalmology by the American Board of Ophthalmology or have graduated from an approved four-year post-graduate training program. Three of these years must be in a department approved to train in Ophthalmology by the Residency Review Committee for Ophthalmology and the Council on medical Education of the American Medical Association (AMAS) and accredited by the Liaison Committee on Graduate Medical Education (now the Accreditation Counsel for Graduate Medical Education). The other year must have been spent in an AMA approved and recognized internship.

(4) Physician(s) provided by the Contractor must apply and be accepted as

Associate member(s) of the Pawnee Service Unit Medical Staff.

C. Evidence of l, 2 and 3 above must be provided to the Contracting Officer prior to award of contract, however, it is recommended that credential (copies) accompany the bid in order to shorten the evaluation time.

D. In providing such service, the Contractor shall comply with the policies, procedures and by- laws of the Pawnee Service Unit. The Contractor shall also be required to perform this service in compliance with applicable standards of the Joint Commission and Quality Improvement.

3. INDEMNITY AND INSURANCE

The Government assumes no responsibility of negligent acts of the Contractor. Therefore, the Contractor is responsible for obtaining that amount of professional liability insurance coverage of at least $1,000,000.00 per occurrence. The Contractor will keep harmless and indemnify the government against any or all loss, cost, damage, claims, expense or liability whatsoever as a result from the performance of the Contractor.

4. IMMUNIZATION RECORD

Persons born after December 31, 1956, if awarded contract, must provide proof of immunity to

Rubella and Measles prior to award of contract. Serological testing to confirm immunity and/or immunizations will be provided to the Government. Special consideration may be allowed to individuals, who are allergic to component of a vaccine, has history of severe reaction to a vaccine, or who are currently pregnant.

Contractor shall provide documented evidence of annual current season influenza and any other influenza-related vaccination, unless medically contraindicated.

Contractor shall provide documented evidence of COVID-19 Vaccine.

Contractor shall provide a series of three (3) Hepatitis B immunizations or serologic proof of past infection.

5. CONTACT WITH INDIAN CHILDREN:

Individuals providing services which involve regular contact with, or control over, Indian children, are subject to a character investigation. I.H.S. Personnel Offices will conduct these investigations, following award of a personal services contract unless in the judgment of the Contracting Officer, in consultation with the Personnel Officer, investigation may be waived based on prior investigations on file. Until the Contracting Officer has been notified of the result of the investigation, such individuals shall not have unsupervised contact with Indian children.

6. GOVERNMENT FURNISHED FACILITIES/EQUIPMENT/SUPPLIES

A. FACILITIES

The Government will provide the facilities of the Pawnee Indian Health Center at 1201 Heritage Circle, Pawnee, Oklahoma for use by the Contractor in performance of the contract.

Government facilities shall include the patient clinic areas within the facility which shall be used by the contractor.

B. EQUIPMENT

Contractor shall provide portable laser equipment which is compatible with equipment presently being utilized at the Pawnee Indian Health Center. All maintenance records for contractor provided equipment shall be provided to facility upon request. Equipment should be maintained according to manufacturer and Joint Commission Standards. The Government will provide the equipment, furnishings and supplies for use by the Contractor for the performance of services required by the Contract.

7. WORK SCHEDULE

The contractor shall conduct monthly Retinal Treatment and Consultation Clinics from 8:00 A.M. to 4:30 P.M. with mutually agreed upon clinic dates.

Any change to a scheduled clinic dates will be as mutually agreed upon between Pawnee Indian Health Center staff and the Contractor.

8. PERIOD OF PERFORMANCE

The period of performance will be one year from approximate date of award.

9. REPORTING REQUIREMENTS

A. Reporting requirements shall include all patient care information required in performance of physician services in the individual patient charts utilizing form I.H.S-

803, PCC Ambulatory Encounter Record, furnished by the Government.

B. The Contractor shall be required to provide an original and two (2) copies of invoices to Oklahoma City Area Indian Health Service, Division of Financial Management, 701 Market Drive, Oklahoma City, OK 73114.

C. Each invoice shall include the following information:

(1) Contractor's name and Invoice Date

(2) Contract Number or other Authorization or delivery of services.

(3) Description, price and quantity of services actually rendered.

(4) Name, title, phone number, and complete mailing address of official to whom payment is to be sent.

D. Invoice shall be submitted no later than ten (10) calendar days following last calendar day of the month.

10. OTHER FACTORS

Contractor shall be required to develop familiarity with current policies, procedures, by- laws, and regulations of the clinical and medical staff of the

Pawnee Service Unit. These are available upon request to Michelle Kimmel, M.D., Service Unit Clinical Director at the Pawnee Indian Health Center, 1201 Heritage Circle, Pawnee, Oklahoma 74035. The telephone number to contact Dr. Kimmel is

(918) 762-6534.

11. CONTRACT EVALUATION

Pawnee Indian Health Center shall periodically evaluate the performance and quality of services provided through supervisory spot checks. These checks are to ensure the adherence to required policy and procedures. Deviations or performance issues are communicated with vendor either by written or verbal notice and will be documented on contract evaluation form.

12. REFERENCE MATERIALS

The Contractor shall be required to perform services in accordance with the policies, procedures, and by-laws of the Medical-Dental Program of the Pawnee Service Unit.

Copies of these items are available upon telephone request to Michelle Kimmel, M.D., Service Unit Clinical Director at (918)762-6534.

The Contractor shall also be required to perform services in compliance with applicable standards of the Joint Commission which are available to the general public and the I.H.S Professional Services Manual.

Dr. David Doss, Chief Optometrist CDR Seneca Smith, CEO

Appendix A

Pre and Post-Clinic Activities:

Day before Clinic:

The day before Clinic, patient's records are copied from the electronic health record (EHR) and the SOAP (Subjective Objective Assessment Plan) entry format is initiated on the PCC. The following information is entered under the"S" heading: reason for visit, diabetic history, eye treatment history and pertinent past eye findings. The day of the visit, the VA, lOP, iris evaluation (pre/post dilation) and the medications used for dilation (1% tropicamide and 2.5% phenylephrine) as well as the time of installation are recorded.

EHR is utilized to print off past examination notes to be used as reference materials. The purpose of this activity is to assist Contractor in efficiently finding his way through the patient's record. This process takes a considerable amount of time; several hours should be scheduled on the day prior to Clinic.

Charts are then arranged in order according to time of appointment.

All supplies needed for possible treatments are checked, to include but not limited to: 2% xylocaine without epinephrine, 5ml disposable syringes, 1" #18 gauge or similar needles (drawing xylocaine into syringes), 1-1/4" #27 gauge needles (retrobulbar injection), DacrioseTM or similar eye wash, 500 mg acetaminophen tablets1,1eye patches, paper tape, Avastin, betadine, Goniosol, Benadryltablets,Triesence, eyelid speculums, gloves, tetracaine.

Day of Clinic:

When patients arrive, their charts are arranged in order of arrival. An effort is made to maintain that order when calling patients.

Contractor arrives at 8:00AM and assembles the laser and has it inspected by BioMed. Examinations begin around 8:20 AM. Multiple examination lanes are used on a rotating basis; as Contractor evaluates a patient in one lane, the next patient is being seated in the other lane. If time permits while Contractor is evaluating a patient in one lane, additional patients are brought into the other lane for preliminary tests and dilation then returned to the waiting area.

A critical element is educating the patients in advance that they should plan to be in the eye clinic all day.

Even though many of them will not, it is important to help them be mentally and logistically prepared. Certainly, they should be informed that they may be in the eye clinic all morning. Let them know that two, three, or possibly more visits are being condensed into one day. Also emphasize the geographical convenience of having total onsite care from initial evaluation through treatment and subsequent follow-up. Explain that this Clinic has been organized to prevent the number one cause of blindness in Americans ages 20 - 74 years. Waiting time is substantial; preparing patients will help the patients and the providers throughout a busy day.

Informed consent forms for treatment and consultation, laser logs and/ or flow sheets are placed into their charts, which are set aside in a surgery queue.

Once surgery is complete, the patient is released to the Center's optometrist who completes the post-operative protocol (see below).

Any and all treatments are performed in order as the clinic schedule and patient needs determine.

The Center's optometrist must be available to his/her facility the day following laser surgery in case the patient develops post-surgical complications such as increased intraocular pressure or pain not relieved by

Tylenol, If alternative arrangements for emergency eye care have been made for that facility, these must be clearly communicated to each patient. Contractor must be available, 24 hours a day, 7 days a week, thru a cellphone or after-hours call service. Should they be unavailable, the operator will contact the physician providing coverage for their patients.

Retrobulbar Anesthetic Block

(All of the blocks for one day may be prepared at one time.)

1) Check the expiration date on a bottle of2% xylocaine without epinephrine to confirm it has not expired.

2) Clean the rubber top of the bottle with an alcohol swab and let air dry.

3) Draw 4 ml of 2% xylocaine into a 5 ml syringe using a disposable #21 gauge needle.

4) Carefully remove the needle used in step 3) and dispose in an approved container. DO NOT

REPLACE THE CAP ON THE NEEDLE.

5) Place a capped 1 1/4" #27 gauge needle on the syringe.

6) I f multiple syringes are prepared, label each syringe, using paper tape: "2% xylocaine without epinephrine.”

Post Laser Protocol

1) Meet patient, as soon as surgery is complete, in the laser surgery room.

2) Rinse contact lens gel from eye using Dacriose or equivalent eyewash and dry periocular area.

3) If patient had retrobulbar anesthetic block: apply moderate pressure patch adequate to prevent lid opening.

4) If patient had PRP AND IS NOT ALLERGIC to Tylenol, give patient two (2) extra-strength (500 mg) acetaminophen (Tylenol) tablets with a small amount of water.

5) Give patient the following discharge instructions:

a) If the patient had PRP: Take two (2) extra-strength (500 mg) acetaminophen (Tylenol) tablets every four hours while awake for two days to prevent discomfort.

b) If the eye is patched, remove the patch in six to eight hours or no later than the following morning.

c) Call the appropriate number, day or night, if they experience pain not controlled by the acetaminophen, or notice worsening of their vision or increasing redness, in either case worse than when they remove the patch or the morning after surgery if the eye wasn't patched (MPC).

6) Offer to answer any remaining questions from the patient or family.

7) Offer to have Contractor discuss any areas of concern with the patient or family.

8) Staff will Schedule and inform the patient of their follow up appointment.

Post Intravitreal Injection Protocol

1) Meet patient soon after the procedure is performed

2) Rinse the treated eye with saline solution or equivalent eyewash

3) The intraocular pressure is checked periodically until it returns to pre-treatment levels

4) Staff will schedule and inform the patient of their follow up appointment

5) Staff will contact the patient by phone two (2) days following treatment to inquire if they are having any concerns such as: decreased vision, pain, redness, or discharge. The procedure form is completed accordingly. If no concerns, form is routed to HIM for processing. If there were concerns, those are shared with the staff Optometrist immediately for management