Scope of Services for Pathologist's Services
The St. Joseph Regional Health Center (SJRHC) - Hospital - exclusively engages Brazos Valley Pathologists (BVP) - Pathologists - to provide physicians to perform clinical and anatomic pathology services.
Physician Coverage. Pathologists shall provide physicians and other qualified professionals necessary to complete patient coverage and to provide clinical and anatomic pathology services to patients of the Hospital in a prompt and efficient manner. Pathologists shall make available physicians at reasonable times upon request to act as consultants to members of the medical staff in matters relating to pathology. In order to provide services for the Hospital, Pathologists shall provide coverage and services by physicians who are employed by Pathologists, and such coverage and services shall be provided by full-time employees of Pathologists and part-time employees and independent contractors as may be approved by the Hospital. Pathologists shall be responsible for recruiting, contracting, scheduling, compensating and supervising all such physician employees.
Pathologists will assign to Hospital the number of physicians necessary from time to time to adequately meet the coverage requirements. Other physicians will be sent by Pathologists to provide services at Hospital only as necessary on a temporary basis for after-hours and emergency call coverage and for absences of a regularly assigned physician due to vacation, illness, and/or continuing medical education.
Frozen Section and On-Call Coverage at St. Joseph Regional Health Center. Pathologist shall provide stat frozen section consultation at the St. Joseph Regional Health Center during regular business days and hours Monday through Friday. Frozen section consultation and clinical laboratory consultation during non-business days or hours are provided via "on call" basis. Pathologist shall provide "on call" coverage on a 365 day 24 hours per day basis and be available at Hospital within 30 minutes notice. Pathologists will at all times provide mechanisms for contact of the designated on-call pathologist. Hospital shall at its expense provide and maintain space and equipment on the premises for performing frozen sections.
Frozen Section and On-Call Coverage at other St. Joseph Health System Locations. Frozen section coverage at other hospitals within the network requires advance notification of at least twenty-four (24) hours. Absent notice, Pathologists shall provide "on call" coverage on a 365 day 24 hours per day basis and be available at Hospital within one hour and fifteen minutes of notification. Pathologists will at all times provide mechanisms for contact of the designated on-call pathologist. Hospital shall at its expense provide and maintain space and equipment on the premises for performing frozen sections.
Direction and Supervision of Professional Services. Pathologists shall assume complete direction and supervision of, and responsibility for, the Department in all fields of professional pathology. Pathologists shall be the exclusive Pathology provider at the Hospital and be responsible for providing all pathology services required by patients (both inpatients and outpatients) of the Hospital which can reasonably and practically be performed in the Department. Pathologists shall arrange, at Hospital's expense, for outside reference laboratories to provide esoteric, unusual or other tests that cannot be performed in the Department.
Physician Qualifications and Hospital Appointment. Each physician assigned by Pathologists to practice the medical services required under this Agreement a) shall hold a valid and unlimited license to practice medicine in Texas pursuant to the Medical Practice Act; b) apply for, be awarded, and maintain membership in good standing on the Hospital's Medical Staff with appropriate clinical privileges for pathology practice, and shall be certified or eligible for certification by the American Board of Pathology; d) be, and remain, a participating provider in the Medicare program, Medicaid program, Alliance Health Providers of the Brazos Valley and St. Joseph Physician Alliance, and e) obtain and maintain professional liability coverage. Physicians provided by Pathologists shall have the same privileges as other physicians, shall be bound by all Rules and Regulations promulgated from time to time that apply to physicians on the Medical Staff, and shall serve, on the same basis as other members of the Medical Staff, on such Hospital Medical Staff committees as may be reasonably required. New or temporary physicians are allowed a reasonable time period to become a participating physician within St. Joseph Physician Alliance, if required by Hospital. Medical Staff privileges, membership and appointment expires if the Pathology Services Agreement expires.
Provision of Pathology Services. Pathologists shall provide clinical and anatomic pathology services to patients upon the request of their attending physicians or according to the Hospital policies and procedures. These services shall be consistent with the facilities available and the standards established for the operation of a Department of Pathology in the medical community. Pathologists shall be responsible for the preparation (excluding transcription which is the responsibility of the Hospital) of appropriate reports and medical records in connection with the services of the Department. Pathologists shall provide to patients all medical services involved in anatomic pathology, cytopathological examinations, bone marrow examinations, peripheral blood smears, and clinical laboratory consultations to include lipids and cardiac profiles, electrophoresis, blood bank and microbiology consults. Pathologists shall be responsible for examinations of all tissues removed and shall make written reports available for the Hospital records and for the attending physicians. In accordance with the provisions of state laws, CLIA 88, CAP and JCAHO regulations relating to clinical laboratories, Pathologists shall be responsible for the administration and scientific operation of the laboratory, including supervision of procedures for testing and the reporting of results. Pathologists shall provide to patients all clinical laboratory tests as required and requested by the attending physician or as required by the Rules and Regulations of the Medical Staff of the Hospital and approved by the Hospital. Pathologists shall consult, upon request, with members of the Hospital Medical Staff concerning tests, studies and procedures performed by the Department or by Pathologists. Pathologists agree to abide by the Safety Manual and Infectious Disease Rules as published by Hospital and presented to Pathologists from time to time.
Operation of Department. Pathologists shall operate the Department in accordance with the Bylaws, Rules and Regulations of the Medical Staff and the Hospital Policies and Procedures. Pathologists shall be responsible for the proper selection of procedures and the maintenance of an adequate quality control program as it relates to the provision of pathology services in compliance with the requirements of the Joint Commission on Accreditation of Healthcare Organizations or other appropriate public or private licensing or accrediting organization. Pathologists shall also endeavor to perform all functions within the Department as may be necessary to maintain Hospital's compliance with applicable guidelines issued by Medicare and Medicaid, and with all applicable rules and regulations promulgated by local, state and federal regulatory agencies.
Performance of Autopsies. Pathologists (or duly licensed contractors directed by Pathologists) shall, where appropriate and upon receipt of written authorization by the next of kin, perform autopsies on deceased Hospital patients. Pathologists will also perform autopsies as requested by Hospital or other third party entities. Pathologists and its physician employees may use facilities designated by the Hospital to perform Hospital autopsies.
Pathologists shall name a qualified physician, employed by Pathologists, as Director of the Department. The initial Director named by Pathologists shall be Michael Cohen, M.D. Pathologists shall secure the consent of the Hospital with respect to any changes in the person holding the position of Director. The Director shall serve as liaison between the Hospital and Medical Staff and the Department. See Exhibit A for responsibilities of Director.
In performance of all work, duties and obligations under this Agreement, Pathologists are at all times acting and performing as independent contractors practicing the profession of medicine. The Hospital shall have no control or direction over the methods by which Pathologists performs the work and functions required by this Agreement. The primary interest and responsibility of the Hospital is to assure that the Department of Pathology and services covered by this Agreement are performed in a competent, efficient and satisfactory manner. Pathologists have sole responsibility for the recruitment and retention of physicians serving under this agreement. However, both parties recognize the importance of requiring input and feedback from each other in order to make effective, efficient decisions, and to maintain a productive relationship.
FEES FOR SERVICES OF PATHOLOGISTS
Laboratory Director's Compensation. With respect to the Laboratory Director services performed by Pathologists to Hospital including Medicare/Medicaid patients, the Hospital shall pay Pathologists a Director's Fee.
Billing for Professional Services. With respect to all other anatomic and clinical pathology services performed by Pathologists:
1. Pathologists shall bill directly for professional components in its own name for all anatomic, clinical and clinical consult services.
2. The Hospital shall supply all information necessary for Pathologists to bill and collect said charges including, but not limited to, furnishing to Pathologists on at least a bi-weekly basis a copy of each patient's admission form, including a designation of the responsible party and/or type of insurance and address for billing purposes. Such information shall be furnished in an electronic format. Pathologists understand that not all facilities may have the capability of submitting billing information electronically, but that Facility will make all reasonable attempts to accomplish such task.
3. Pathologists shall bill each patient at the Hospital receiving service from Pathologists for such services. Pathologists' charges for professional services performed or procedures performed by Pathologists shall be established by Pathologists. Such charges shall be consistent with standards in the community.
ACCESS TO RECORDS
In accordance with the provisions of 42 U.S.C. Section 1395x(v)(1)(T) and 42 C.F.R. Section 420-300 et seq, Pathologists shall make available upon the written request of the Secretary of Health and Human Services or the Comptroller General of the United States, or any of their duly authorized representatives, this Agreement and any other books, records and documents of Pathologists that are necessary to certify to such persons the nature and extent of costs incurred by the Hospital for services furnished by Pathologists for which payment may be made under Medicare, Medicaid or other federal reimbursement programs. The obligation of Pathologists to make records available shall extend for seven (7) years after the furnishing of such services pursuant to this Agreement.
LABORATORY SPACE, EQUIPMENT AND SUPPLIES
Provision of Space, Equipment and Supplies. The Hospital shall make adequate provision for the proper functioning of the Department by providing space, equipment and fixtures as are mutually agreed to be adequate to meet the needs of the Department, including but not limited to the following:
(1) Office, laboratory and storage space;
(2) All utilities;
(3) Building maintenance;
(4) Housekeeping services;
(5) Such scientific and nonscientific equipment, facilities and fixtures required for the proper and adequate practice of pathology at the Hospital including microscopes, and such equipment and fixtures required for the Frozen section facilities; and
(6) Such supplies as Pathologists may need in providing pathology services in the Department.
(7) Transcription Services
(8) Phones, phone lines and other basic communication equipment
Maintenance and Repair. The Hospital shall maintain and reasonably repair all said equipment facilities and fixtures, including the maintenance and repair of scientific equipment, using maintenance services satisfactory to Pathologists and to the Hospital. Any alteration or major renovation in the Department shall be done only after consultation with Pathologists.
Personnel. The Hospital shall furnish all paramedical, clerical and technical personnel required for the efficient operation of the Department. Decisions with respect to the selection and retention of laboratory personnel shall be made by Hospital with input from the Pathologists. The Hospital rules, regulations and policies shall be followed in the hiring, promotion and termination of laboratory personnel and the furnishing of employee benefits.
Hospital Employees. All laboratory personnel shall be considered as employees of the Hospital, and the Hospital shall be responsible for withholding all taxes and providing all normal institutional benefits to such employees.
Supervision of Department Employees. Pathologists shall assist with, as requested, the overall supervision of laboratory support personnel functions and in the selection, evaluation of competency and retention.
Personnel Qualifications and Compensation. The Hospital shall employ only individuals who meet the standards of training, experience and ability agreed upon jointly by Pathologists and the Hospital. It shall set salary ranges at levels sufficient to attract quality personnel.
Pathologists' Insurance. Pathologists shall at its own expense carry for each of its employed physicians professional liability insurance with limits of liability in amounts not less than five hundred thousand dollars ($500,000) per occurrence and one million dollars ($1,000,000) annual aggregate. As evidence of such coverage, Pathologists shall furnish Hospital with a certificate of insurance prior to commencing its services under this Agreement and annually thereafter.
Hospital's Insurance. The Hospital shall carry adequate liability insurance for the premises of the Department and adequate liability and malpractice insurance for all Hospital employees, including all technicians, and all students or trainees in the Department, with limits of liability in amounts not less than one million ($1,000,000) per occurrence. It shall upon request, submit evidence of such insurance, to Pathologists.
Federal Eligibility. The Hospital and its local companies are committed to corporate integrity through their mission, values, and corporate compliance program. No organization shall knowingly employ or contract with, with or without compensation, any individual or entity listed by a federal agency as excluded, debarred, suspended or otherwise ineligible to participate in federal programs. The Hospital and its local companies shall make reasonable inquiry into the status of any prospective employee, consultant or contractor. At a minimum, inquiry will be made by (a) review of the Health and Human Services - Office of Inspector General Cumulative Sanctions Report, (b) the General Services Administration List of Parties Excluded from Federal Procurement and Non-Procurement Programs, and (c) such other avenues deemed by the Hospital as appropriate.
RESPONSIBILITIES OF LABORATORY MEDICAL DIRECTOR
A. The laboratory medical director is responsible for providing one or more duly licensed pathologists to perform the duties of the medical director hereunder. The medical director is responsible for performing its duties in full compliance with all applicable federal and state regulations.
B. The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under federal regulations, 42 C.F.R. Secs. 493.1447, 493.1453, 493.1459, and 493.1487, respectively.
C. If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed.
D. The laboratory director must be reasonably accessible to the laboratory to provide onsite, telephone or electronic consultation as needed.
E. The laboratory director will provide advice and recommendations to --
(1) Ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing;
(2) Ensure that the physical plant and environmental conditions of the laboratory are appropriate for the testing performed and provide a safe environment in which employees are protected from physical, chemical, and biological hazards;
(3) Ensure that:
(i) The test methodologies selected have the capability of providing the quality of results required for patient care;
(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; and
(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results;
(4) Ensure that the laboratory is enrolled in an HHS-approved proficiency testing program for the testing performed and that:
(i) The proficiency testing samples are tested as required under federal regulations;
(ii) The results are returned within the time frames established by the proficiency testing program;
(iii) All proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require corrective action; and
(iv) An approved corrective action plan is followed when any proficiency testing result is found to be unacceptable or unsatisfactory;
(5) Ensure that the quality control and quality assurance programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur;
(6) Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system;
(7) Ensure that all necessary remedial actions are taken and documented whenever significant deviations from the laboratory's established performance characteristics are identified, and that patient test results are reported only when the system is functioning properly;
(8) Ensure that reports of test results include pertinent information required for interpretation;
(9) Ensure that consultation is available to the laboratory's clients on matters relating to the quality of the test results reported and their interpretation concerning specific patient conditions;
(10) Ensure that a general supervisor provides on-site supervision of high complexity test performance by testing personnel qualified under 42 C.F.R. Sec. 493.1489(b)(4);
(11) Ensure that the Hospital employs a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests and report test results in accordance with the personnel responsibilities described in this subpart;
(12) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results;
(13) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills;
(14) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; and
(15) Establish, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results.