Exhibit_A_-_Scope_of_Work.pdf

California Department of Corrections and Rehabilitation (CDCR)/ Proposal Number: SD23-00097 California Correctional Health Care Services (CCHCS) Exhibit A Scope of Work

Rev. 09/19/2024

ON-SITE DIALYSIS SERVICES

1. Introduction

Contractor and/or its subcontractors shall supply dialysis equipment, materials, supplies, labor, staff, and every other item of expense necessary to provide on-site dialysis services to California Department of Corrections and Rehabilitation/California Correctional Health Care Services (CDCR/CCHCS) patients referred for such services at California Health Care Facility (CHCF), Richard J. Donovan Correctional Facility (RJD), San Quentin Rehabilitation Center (SQ), and Wasco State Prison (WSP) hereafter referred to as institutions. Contractor agrees to render contracted on-site services to any patient referred for treatment at the direction/supervision of the institution Chief Executive Officer, Chief Medical Executive, or designee (CEO/CME).

CDCR/CCHCS designee shall be a civil service employee. For purposes of this Agreement, Contractor means the apparent successful bidder who shall be considered provider of dialysis services. Contractor assumes full responsibility for the provision of these services.

Subcontracting is allowed if consistent with the conditions set forth below and all Exhibits included in the Agreement. Contractor will be responsible for ensuring that any and all subcontractors meet all of the conditions set forth in this Agreement. Throughout this Agreement any references made to Contractor shall be interchangeable with the word subcontractor and apply fully to the subcontractor that has been assigned to fulfill that area of the Agreement.

This Agreement is not all-inclusive and CDCR/CCHCS reserves the right to contract with additional contractors as needed to ensure access and continuity of care for patients.

2. General Scope of Services

Contractor shall routinely provide on-site dialysis services to three (3) patients per treatment station per day and will have the capacity to provide on-site dialysis services for a fourth (4th) patient per treatment station per day at the request of CDCR/CCHCS (telephone, facsimile, etc.). Dialysis services will be scheduled in three (3) hour increments and if necessary, four (4) hour increments, to schedule a fourth (4th) patient per treatment station per day. The Contractor shall provide Peritoneal Dialysis assistance, CDCR/CCHCS staff training (as applicable), equipment, and supplies for patients who require this form of treatment daily. CDCR/CCHCS will notify Contractor of new patients who will require dialysis services in writing at least three

(3) business days before the patient’s scheduled dialysis appointment.

Contractor is responsible for ensuring that all applicable laws and regulations, including California Code of Regulations (CCR) Title 22, pertaining to dialysis treatments of patients with any infectious diseases are fully adhered to in order to ensure that all precautions and safeguards are taken. There are two (2) private room dialysis stations for patients at CHCF and at RJD; and one (1) private room dialysis station for patients at SQ and at WSP with special security/confidentiality concerns. If the institution has a Hepatitis B positive patient, and/or patient with any infectious disease, the private room dialysis station(s) is designated for those patients. If there are no Hepatitis B positive patients, or patients with any infectious diseases, the private rooms will be available for use by any patient, including patients with special security/confidentiality medical concerns. The institution will be responsible for thoroughly cleaning the private rooms.

Proposal Number: SD23-00097 CDCR/CCHCS Exhibit A Scope of Work

Rev. 09/19/2024

Contractor shall be prepared to utilize each treatment station at CHCF, RJD, SQ and WSP.

Contractor shall have the capability of increasing capacity at each station from three (3) patients per day to four (4) patients per day by the addition of a fourth (4th) shift. Treatment capacity may be expanded based on patient growth, and CDCR/CCHCS shall provide Contractor with three (3) business days’ notice if a fourth (4th) shift will be needed.

On a routine basis, Contractor will be able to provide on-site dialysis service at least three (3) shifts per day at CHCF, RJD, SQ and WSP. CDCR/CCHCS provides no guarantee as to the number of patients that Contractor will treat or the number of treatments that the Contractor will administer.

Contractor shall provide all water testing and water culturing in accordance with Association of the Advancement of Medical Instrumentation (AAMI), Section RD 52:2004 and Centers for Medicare & Medicaid Services (CMS) conditions for coverage for End Stage Renal Disease (ESRD) facilities dated October 2010 (or most current revision date available) and will make daily and monthly reports of the water testing and water cultures findings immediately available to the institution and the CEO/CME or designee.

Services to be provided under this Agreement will include, but not be limited to, the following:

A. Contractor shall ensure all dialysis treatment services and proposed surgical procedures approved by the CEO/CME or designee shall be scheduled consistent with the severity of the medical need. Once scheduled, services shall be delivered at the time scheduled unless unavoidable circumstances occur.

B. Contractor shall immediately notify the CEO/CME or designee when a patient is or needs to be admitted directly into a licensed inpatient setting and if other consultants are required. In the event a non-contracted consultant is essential to the care of the patient, the CEO/CME or designee shall provide prior approval.

C. Contractor agrees to provide all services contained in this Agreement on an as needed basis. The number of patients, number of days, and hours per week may vary based on institution needs.

D. Contractor will draw all dialysis and transplant labs and process appropriately for the laboratory including centrifuge, refrigeration, filling out requisitions and appropriate packaging and labeling to send to the laboratory. Contractor will utilize the laboratory services specified by CDCR/CCHCS.

E. Contractor acknowledges that CDCR/CCHCS is not obligated to provide or pay for health care services or treatment beyond those which are essential to prevent death, permanent, or severe disability. Dialysis patients may be treated more than three (3) times per week based on a medical need and approved by the CEO/CME or designee.

1. Medically Necessary Services means health care services that are determined by the attending Primary Care Providers (PCP) to be needed to protect life, prevent significant illness or disability, or alleviate severe pain, and are supported by health outcome data or clinical evidence as being an effective healthcare service. (CCR, Title 15, Division 3, Chapter 2, Subchapter 4, Article 1, Section 3999.98, Definitions).

CDCR/CCHCS Exhibit A Scope of Work

Rev. 09/19/2024

2. Nonessential Services means a non-emergency/pre-scheduled admission for medical services when the patient’s condition permits adequate time to schedule the necessary diagnostic workup and/or initiation of treatment, in accordance with CCR, Title 15.

F. Contractor shall provide proper documentation of each dialysis treatment and examination shall be documented electronically directly into the Electronic Health Record System (EHRS) progress note on the day of dialysis treatment. The attending physician’s progress notes for each patient shall be documented electronically in a consultant note directly into the EHRS and be filed under consultation notes within 24 hours of the patient encounter.

G. Contractor shall schedule, develop an agenda, invite attendees, and take and disseminate meeting minutes and action items for a monthly Inter-disciplinary Treatment Team meeting, which includes Contractor’s personnel, CDCR/CCHCS designee, nephrologist and CME or designee.

H. Contractor will provide the following routine reports to the institution Utilization Management

Registered Nurse (RN), Correctional Healthcare Services Administrator (CHSA), and/or CDCR/CCHCS designee:

1. Current staff and patient schedules;

2. Quarterly updates of staff transcripts for mandatory trainings, and license and

Cardiopulmonary Resuscitation (CPR) status;

3. Contractor Governing Body meeting minutes;

4. Notification of any policy and procedure changes;

5. Verbal report of all incidents or adverse occurrences in the dialysis unit, and further information if deemed pertinent;

6. Documentation needed for response to patient’s grievances flow sheets, etc.;

7. Documentation of Plan of Correction with any staff performance issues, including in-service training and proof of corrective actions;

8. Monthly and Quarterly Equipment maintenance reports per Contractor policy and procedures for preventative maintenance and equipment repairs.

I. Contractor will provide the following Quarterly Continuous Quality Improvement (CQI) meeting minutes to include reporting on the following quality measures to the Deputy Medical Executive for Quality Management, Deputy Director of Quality Management, QMStaff@cdcr.ca.gov; CDCR/CCHCS Transplant Program, CEO, CME, and CHSA at each respective institution:

1. Standardized Hospitalization rate;

2. Standardized Mortality rate;

3. Transfusion ratio;

mailto:QMStaff@cdcr.ca.gov

CDCR/CCHCS Exhibit A Scope of Work

Rev. 09/19/2024

4. Percentage of patients with Kt/V > 1.2;

5. Percentage of patients with average calcium > 10.2;

6. Percentage of patients with hemoglobin > 12;

7. Percentage of patients with hemoglobin < 10;

8. Percentage of patients treated with AVF;

9. Percentage of patients with catheter access for > 90 days;

10. Number of patients with positive blood cultures per 100 HD-patient months;

11. Monthly patient outcomes per Kidney Disease Outcome Quality Initiative (KDOQI) guidelines with qualifiers if patient is not meeting the standard and plan of correction;

and

12. Other information needed by the CEO/CME or designee to maintain collaborative, continuous quality patient care and assure survey readiness and compliance with CMS Conditions for Coverage for ESRD Facilities October 2010 (or most current revision date available), KDOQI guidelines for outcomes, AAMI recommendations for water treatment, and Center for Disease Control recommendations, "Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients.”

J. Contractor shall be responsible for immediately reporting any custody and/or security issues in writing and provide supporting documentation to the Warden and/or their designee to ensure timely notification of these concerns or issues. The Warden and/or their designee will work with Contractor to resolve custody and/or security concerns.

3. Services Specific to Each Institution

A. CHCF

Contractor shall provide labor, materials, staff, equipment (including maintenance and supplies), transportation, travel, licenses, permits, certificates and every other item of expense for twenty-nine (29) dialysis stations, two (2) of which shall be in private rooms.

Each station shall have the capability of dialyzing up to four (4) patients per station per day, scheduled in three (3) to four (4) hour increments, based on a six (6) day work week, as identified in Provision 6 Hours of Operation.

Minimum staffing requirements for CHCF shall be no less than seven (7) licensed staff capable of performing dialysis treatment(s), of which shall include three (3) RNs and four

(4) certified hemodialysis technicians (CHT) per twenty-nine (29) patients per shift or the patient count not to exceed a 12:1 patient/RN ratio.

B. RJD

expense for eight (8) dialysis stations, two (2) of which shall be in the private room. Each

CDCR/CCHCS Exhibit A Scope of Work

Rev. 09/19/2024 station shall have the capability of dialyzing up to four (4) patients per station per day, scheduled in three (3) to four (4) hour increments based on the six (6) day work week, as identified in Provision 6 Hours of Operation.

Minimum staffing requirements for RJD shall be no less than three (3) licensed staff capable of performing dialysis treatment(s), of which shall include one (1) RN and two (2) CHT per six (6) patients per shift.

C. SQ

expense for three (3) dialysis stations, one (1) of which shall be in the private room. Each station shall have the capability of dialyzing up to four (4) patients per station per day, scheduled in three (3) to four (4) hour increments, based on the six (6) day work week, as identified in Provision 6 Hours of Operation.

Minimum staffing requirements for SQ shall be no less than two (2) licensed staff capable of performing dialysis treatment(s), of which shall include one (1) RN and one (1) CHT per three (3) patients per shift.

D. WSP

expense for six (6) dialysis stations, one (1) of which shall be in the private room. Each station shall have the capability of dialyzing up to four (4) patients per station per day, scheduled in three (3) to four (4) hour increments, based on the six (6) day work week, as identified in Provision 6 Hours of Operation.

Minimum staffing requirements for WSP shall be three (3) licensed staff capable of performing dialysis treatment(s), of which shall include one (1) RN and two (2) CHT per six

(6) patients per shift.

4. Patient Dialysis Records

This Agreement may:

A. Permit Contractor to provide data aggregation services relating to the health care operations of the CDCR/CCHCS.

B. Provide that Contractor will:

1. Not use or further disclose the information other than as permitted or required by the Agreement or as required by law;

2. Use appropriate safeguards to prevent use or disclosure of the information other than as provided for by its Agreement;

3. Report to the covered entity any use or disclosure of the information not provided for by its Agreement of which it becomes aware;

CDCR/CCHCS Exhibit A Scope of Work

4. Ensure that any staff, including a subcontractor, to whom it provides protected health information received from, or created or received by the personnel on behalf of the covered entity, agrees to the same restrictions and conditions that apply to Contractor with respect to such information;

5. Make available protected health information in accordance with Code of Federal Regulations (CFR) §164.524;

6. Make available protected health information for amendment and incorporate any amendments to protected health information in accordance with CFR §164.526;

7. Make available the information required to provide an accounting of disclosures in accordance with CFR §164.528;

8. Make its internal practices, books, and records relating to the use and disclosure of protected health information received from, or created or received by Contractor on behalf of the CDCR/CCHCS, available to the CDCR Secretary for purposes of determining the covered entity’s compliance with this subpart; and

9. At termination of the Agreement, Contractor shall make all attempts feasible, to return all health information received from, created or received by Contractor on behalf of the CDCR/CCHCS that Contractor still maintains in any form. If such return is not feasible, extend the protections of the Agreement to the information and limit further uses and disclosures to those purposes that make the return of the information infeasible, and entity agrees to provide copies within twenty-four (24) hours of request of all records maintained during the lifespan of the Agreement for seven (7) years following termination of the Agreement.

10. Contractor shall ensure that the first day of dialysis is determined for each patient by reviewing patient records and/or patient interview. Contractor shall provide a copy of CMS 2728 to the CDCR/CCHCS transplant coordinator within 30 calendar days of the initiation of dialysis, sent via `secured email, to CPHCSTransplantProgramCoordinator@cdcr.ca.gov.

11. All laboratory tests shall be ordered through the CCHCS workflow to ensure all results ordered by the dialysis unit will be electronically uploaded automatically into the EHRS by the lab contractor entity interface.

12. If any requirement set forth in this Provision 4 conflicts with any requirements set forth in Exhibit G, Business Associates Agreement Health Insurance Portability and Accountability Act (HIPAA), the requirement in Exhibit G will govern.

5. Transition Plan Activities

Agreement Commencement

Beginning on the contract effective date, Contractor shall work collectively and cooperatively with CDCR/CCHCS and the current On-site Dialysis Services Provider to implement a ninety

(90) calendar day transition plan to ensure consistency and continuity of patient health care at CHCF, RJD, SQ and WSP. During the transition plan period, Contractor will address staff mailto:CPHCSTransplantProgramCoordinator@cdcr.ca.gov

CDCR/CCHCS Exhibit A Scope of Work

Rev. 09/19/2024 orientation/training and any needed knowledge transfer activities. Contractor will install their own dialysis equipment, including Reverse Osmosis (RO) equipment currently in place, or arrange for the transfer or purchase of the dialysis equipment in an orderly fashion that neither disrupts patient care during the Transition Plan period, nor delays Contractor from completely assuming dialysis services.

The transition plan activities shall provide for the complete transition of dialysis equipment, staff and services, to ensure an effective and efficient transitional process and the continuity of patient health care. The transition plan shall be performed in its entirety no later than ninety (90) calendar days for CHCF, RJD, SQ, and WSP.

Final Year of Agreement

Contractor shall work collectively and cooperatively with CDCR/CCHCS and the newly awarded Contractor to develop and implement six (6) month exiting transition plan that allows the newly awarded Contractor to address staff orientation and any needed knowledge transfer activities.

Contractor will also allow the newly awarded Contractor to install their own equipment or to arrange for the transfer of CDCR/CCHCS’ purchase of Contractors’ dialysis equipment, including RO equipment, in an orderly fashion that neither disrupts patient care during the transitional period, nor delays the newly awarded Contractor from completely assuming dialysis services the first day after the transitional period ends. CDCR/CCHCS reserves the right to exercise the option to purchase installed dialysis equipment at fair market value. Contractor will be advised of CDCR/CCHCS’ decision to purchase installed dialysis equipment including the RO equipment no later than three (3) months prior to the termination date of this Agreement.

The exiting transition plan shall be performed in its entirety no later than two weeks prior to the expiration date of this Agreement. The transition plan shall provide for the complete transition of dialysis equipment and services, to ensure an effective and efficient transitional process and the continuity of patient health care.

A. If CDCR/CCHCS does not exercise the option to purchase installed dialysis equipment at fair market value, allow the newly awarded Contractor to either purchase Contractor’s existing dialysis equipment at fair market value or install their own dialysis equipment to be completed in its entirety no later than sixty (60) calendar days after contract award.

B. If the newly awarded Contractor installs their own RO equipment, Contractor agrees to continue treating patients on portable RO machines while the newly awarded Contractor installs permanent RO equipment. The newly awarded Contractor will work with CDCR/CCHCS in assigning patients up to four (4) shifts per day, as CDCR/CCHCS deems necessary, during the transition phase while the RO equipment is installed.

6. Hours of Operation

Contractor agrees to provide services six (6) days per week (Monday through Saturday) between the hours of 6:00 a.m. to 12:00 midnight or when treatment is completed for the last patient for the day. Thanksgiving Day, Christmas and New Year’s Day may require dialysis services to be administered on the Sunday prior to or following the holiday.

Contractor also agrees that circumstances may require differing schedules. Contractor and CEO/CME or designee shall meet and arrange a mutually acceptable schedule. Contractor shall provide services within twenty-four (24) hours following notification by CDCR/CCHCS of

CDCR/CCHCS Exhibit A Scope of Work

Rev. 09/19/2024 adjustment to regular treatment schedules.

7. Scheduling

At the time of scheduling, CDCR/CCHCS shall provide Contractor with the following information:

A. The number of patients requiring services; and

B. The days and hours per week when services can be scheduled. This is a good faith estimate based on the circumstances known to CDCR/CCHCS at the time of the request. If the mutually agreed upon schedule needs to be changed, CDCR/CCHCS shall attempt to notify Contractor not less than twenty-four (24) hours before the requested change. The request shall be documented in writing by the institution’s CEO/CME or designee.

CDCR/CCHCS designee will work with Contractor to utilize treatment chairs in the most efficient way for cases where patients are not present, (hospitalized or out to court, etc.), as well as ensure optimum use for maximum utilization and cost efficiency.

8. Request for Services

Contractor shall have available a contact person with twenty-four (24) hour telephone availability. Telephone answering devices (e.g., message machines) are not acceptable. The initial contact will be by telephone; however, CDCR/CCHCS shall follow-up with an email message. Contractor shall provide the CDCR/CCHCS designee with an email address for this purpose. Contractor shall review and respond to CDCR/CCHCS’s patient placement and/or treatment requests within twenty-four (24) hours of receipt of written notification. Dialysis services shall commence as soon as possible and no more than forty-eight (48) hours after acceptance. If Contractor has concerns or issue with a specific patient placement and/or start of treatment, Contractor shall provide in writing, via email, any concerns or issue to the institution Utilization Management RN no later than twenty-four (24) hours after notification by CDCR/CCHCS. CDCR/CCHCS will review Contractor’s written concerns and make determination if the forty-eight (48) hour requirement will need to be extended for patient placement and/or treatment services. Contractor shall provide services at the institution treatment site within the timeframes specified by the CEO/CME or designee. Contractor shall make every attempt to provide the same designated personnel each week during any given month to provide continuity of care.

9. Equipment Provided by Contractor

Contractor shall be responsible for quality calibration, maintenance and repair to regulatory standards of all equipment at Contractor’s expense. In the event of an interruption of dialysis service due to Contractor’s failure to provide services (excluding any force majeure event or other causal events beyond Contractor’s control), all patients shall receive dialysis treatment within the CDCR/CCHCS dialysis program, and the hours of operation may be extended to accommodate the treatments. If an alternative dialysis treatment site is required, all costs in excess of Contractor’s bid rates (Exhibit B-2 Rate Sheet), including, but not limited to custody costs, will be deducted from Contractor’s subsequent billings.

A. Reuse of dialyzers is prohibited including when patients are treated outside the institution.

CDCR/CCHCS Exhibit A Scope of Work

Rev. 09/19/2024

B. Contractor shall provide the following backup dialysis machines, chairs, and water treatment equipment for all sites when deemed necessary by CDCR/CCHCS to ensure continuing patient care.

1. CHCF shall have four (4) backup treatment chairs and backup reverse osmosis treatment equipment capable of providing dialysis services for up to sixteen (16) patients per day.

2. RJD shall have two (2) backup treatment chairs with dialysis delivery systems and portable backup reverse osmosis treatment equipment capable of providing dialysis services for up to eight (8) patients per day.

3. SQ shall have one (1) backup treatment chair with dialysis delivery systems and portable backup reverse osmosis treatment equipment capable of providing dialysis services for up to four (4) patients per day.

4. WSP shall have two (2) backup treatment chairs with dialysis delivery systems and portable backup reverse osmosis treatment equipment capable of providing dialysis services for up to eight (8) patients per day.

In the event of an emergency situation, which results in the need for back-up treatment options, Contractor may be required to provide dialysis services at the patient’s current location utilizing a portable RO machine.

C. Contractor shall give at least twenty-four (24) hours notice prior to bringing into the institution any medical/surgical equipment that has not specifically been authorized by the institution’s custody services.

D. CDCR/CCHCS shall provide space for the cleaning, maintenance and repair of the dialysis machines for on-site dialysis locations. All cleaning, maintenance and repair activities shall meet the licensing and infection control requirements as described in CMS regulations “Conditions for Coverage for ESRD Facilities” effective April 15, 2008, which cite infection control according to “Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients” developed by the Center for Disease Control RR05, (April 27, 2001 or most current update).

E. Contractor shall provide and maintain computers, printers, scanners and a stand-alone Internet Service Provider connection and self-contained network with hard-wired WAN connectivity to support efficient dialysis treatment and medical record keeping. All medical records related to dialysis services shall be electronically documented in the EHRS within twenty-four (24) hours of the encounter. If Contractor does not have their own electronic interface, they shall document directly into the EHRS if allowed by CDCR/CCHCS. If not allowed, Contractor shall obtain one that will have the ability to interface to the CCHCS electronic medical records system and/or laboratory system at the future request of CDCR/CCHCS. If a future system interface is implemented, Contractor agrees that CDCR/CCHCS reserves the right to exercise the option to purchase the system interface at fair market value. The requirements in this paragraph shall not apply to Contractor’s proprietary software.

F. Contractor shall provide the following medications and dialysis equipment, materials, supplies, and every other item of expense necessary to provide on-site dialysis services:

CDCR/CCHCS Exhibit A Scope of Work

Permanent Reverse Osmosis (RO) Machines including TDS meter, all filters necessary to attain dialysis quality water per water quality analysis for the institution

Face shields

Portable Backup Reverse Osmosis Machines Masks Dialysis Delivery Machines including the full complement of supplies and equipment necessary to perform dialysis including dialysis lines, transducers, blood pressure cuffs and stethoscopes

Tape

Full complement of all equipment, supplies, and parts necessary to repair and maintain Reverse Osmosis and Dialysis delivery machines and dialysis loop

Syringes and needles all types necessary for dialysis process, medicating patients and drawing lab samples

Backup Dialysis Delivery Machines, if needed Band aids Dialyzers Sure seals Conductivity meters Disposable washcloths Conductivity meter quality control solutions Peroxide Chlorimeters and testing supplies Alcohol pads, alcohol Swab sticks Biomedical technician tools required to repair and maintain dialysis delivery machines and RO Povidone Iodine pads and Swab sticks pH testing equipment or strips and quality control solutions if indicated

All solutions necessary to prep dialysis insertion sites per policy (Ex sept etc.)

Glucometer Hibiclens, if applicable Chlorine/Chloramine and Chlorine residual test strips Hand soap Hemastix Alcohol hand washing gel

Water hardness testing supplies Water culture sample vials and equipment

Appropriate sterilant presence and residual testing strips Heparin

Appropriate sterilant solutions for RO and Dialysis delivery systems and dialysis loop (e.g. bleach, renalin, etc.)

Heparin replacement medications as applicable for medical and religious contraindications to Heparin usage

Vinegar Lidocaine Citric acid Normal Saline Citrasate dialysate, if applicable IV administration sets Dialysate solutions Suture removal sets Bicarbonate solutions Staple removal sets If applicable, Dialysate mixing equipment and Acid Concentrate mixing equipment and all supplies necessary to repair, maintain, and utilize this equipment

Garbage bags for clean and biohazardous waste

Salt pellets Transducer protectors Backup DI tanks Stethoscopes All filters required for maintenance and repair of RO, water room equipment and all dialysis delivery machines

Blood pressure cuffs both dialysis delivery machine cuffs and manual blood pressure cuffs

Gloves Blood lines

Gauzes Fistula needles all gauges ordered and buttonhole fistula needles and kits

Transparent dressings Recirculators

CDCR/CCHCS Exhibit A Scope of Work

Rev. 09/19/2024

Chux or dental towels Transparent dressings

Fluid impervious gowns All office supplies except fax toner and copier toner cartridges

Nasal Cannula Scale Peritoneal Dialysis Cycler Peritoneal Dialysis Cycler cart OHAUS spring scale Stay-Safe organizer holder IV pole Stay-Safe caps Peritoneal Dialysis solution (1.5%, 2.5%, 4.25%) Cycler sets Drain lines Drain sets Dialysis catheter extension sets Dialysis catheter stabilizing belt

10. Contractor Staffing Requirements

Contractor shall provide and ensure training for contracted staff to be in compliance with all applicable laws and regulations. Contractor shall ensure that the appropriate staff will attend the monthly inter-disciplinary treatment meetings. All training will be maintained and documented by Contractor. Contractor has the responsibility to maintain all policies and procedures consistent with Title 22 and CMS Conditions for Coverage for ESRD facilities licensing requirements. Licensed Clinical Social Workers (LCSW) and Registered Dietitians (RD) shall be at the treatment sites at a minimum consistent with CMS guidelines to interact with patients.

Contractor staffing information at each treatment site shall be made available to the Dialysis Administrator/CCHCS designee on a daily basis. Contractor shall pay liquidated damages in the amount of One Thousand Dollars and No Cents ($1,000.00) for each day that Contractor does not meet the staffing requirements set forth in the Agreement.

Patient health care is of paramount importance. Accuracy in communications is critical to ensure that timely, correct care is provided. All providers and/or staff shall be able to speak, understand oral and written communication and write effectively, in the English language. All providers and/or staff who fail to meet the minimum qualifications shall not be permitted to perform services. The CEO/CME or designee shall state in writing the reason(s) the provider and/or staff does not meet the minimum qualifications. After notification of failure to meet minimum qualifications has been provided, CDCR/CCHCS shall not pay Contractor for any additional hours worked by the provider identified as not meeting the minimum qualifications.

Contractor’s staff are not considered by CDCR/CCHCS to be State employees. Any actions claimed and filed by Contractor’s staff for unemployment, tax withholdings, lost wages or revenues, workers’ compensation, injuries or illness are to be considered the responsibility of Contractor to defend and pay all costs associated with that defense or settlement of those claims.

Contractor shall obtain at least two (2) reference checks for each provider and maintain records of verification. These records shall be available to the CDCR/CCHCS designee upon request.

Such records shall include the following:

1. Name of person contacted and date;

2. Name of previous areas/units worked (including other CDCR institutions);

3. Length of employment;

CDCR/CCHCS Exhibit A Scope of Work

Rev. 09/19/2024

4. Released from other Contractor or registry, date of release and reason for release;

5. Rehire status; and

6. Possible reprimands, violations, and/or disciplinary actions.

Staffing shall reflect the patient needs in addition to what is required for safe licensed dialysis units. Staff shall include and be responsible for:

A. Facility Administrator (FA)

Per CMS guidelines, the FA provides full-time operational oversight and management of the dialysis unit such as staffing, patient care, and conducting quality assessment and improvement meetings and implementation. The FA shall have at least twelve (12) months experience in nursing with an additional six (6) months experience in providing nursing care to patients on maintenance dialysis. The FA shall monitor water and dialysate culturing; address any problematic areas and collaborates with the CDCR/CCHCS CME and/or designee; intermittently surveys dialysis unit to ensure staff are following Contractor’s policies and procedures; ensures all staff remain credentialed and receive appropriate continuing education and yearly laboratory work; oversees the Bone Mineral Metabolism and Anemia Management programs; ensures ten percent (10%) of charts are audited each month for accuracy and efficiency, and are CMS compliant; assists CDCR/CCHCS in processing appeals for dialysis patients by supplying supporting evidence, lab work, etc.; and ensures required evaluations necessary to consider patients for renal transplantation are completed in a timely manner. FA is expected to be a cooperative part of a patient care coordination team that includes Contractor’s clinical staff, institutional staff, and CDCR/CCHCS. FA shall respond to communication from CDCR/CCHCS transplant team or other CDCR/CCHCS staff within 72 hours of receipt of the correspondence and have coverage during time off. FA shall use medical records and/or patient interviews to determine the first day of dialysis for each patient and shall be shared with the CDCR/CCHCS transplant coordinator via secure email to cphcstransplantprogramcoordinator@cdcr.ca.gov, within 30 days of initiating dialysis.

B. Registered Nurse (RN)

Shall be on-site at the institution at all times to provide direct supervision to licensed nurses and/or CHT when dialysis services are provided. RNs shall have at least twelve (12) months in clinical nursing with an additional six (6) months experience in providing nursing care to patients on maintenance dialysis. All RN positions including charge nurse and floor nurse will meet and perform according to CMS Conditions for Coverage Sec. 494.140.

The dialysis RNs shall document a brief progress note directly into the EHRS when patients miss or end dialysis treatments early. If two (2) or more consecutive sessions, or more than four (4) sessions in one month, are missed or cut short, the PCP and dialysis unit nephrologist shall be notified. Notification documentation shall be maintained and the Against Medical Advice form shall be scanned into the EHRS within twenty-four (24) hours of the effected session.

Any time a patient is sent to higher level of care from the dialysis unit, the dialysis RN shall notify the dialysis nephrologist and the PCP with receipt of the notification documented.

mailto:cphcstransplantprogramcoordinator@cdcr.ca.gov

CDCR/CCHCS Exhibit A Scope of Work

C. Certified Hemodialysis Technicians (CHT)

Shall be on-site at the institution at all times to provide dialysis treatment according to Title

22 requirements. The CHT shall have qualifications and perform in accordance with CMS Conditions for Coverage dated October 2010 (or most current revision date available).

The CHT shall also be licensed in California and hold National Certification concurrently per CMS Conditions of Coverage dated October 2010 (or most current revision date available). The CHT will work under the direct supervision of a dialysis trained RN and the CDCR/CCHCS contracted Board Certified Nephrologist (licensed physician) who oversees the on-site dialysis facility.

D. Licensed Clinical Social Worker (LCSW)

The LCSW shall have two (2) years as a social worker, one (1) of which is in a dialysis or a transplantation program. LCSW shall provide weekly counseling with all dialysis patients at a frequency that meets or exceeds CMS Medicare guidelines and ensures patient needs are met. The weekly counseling sessions shall include a plan of care, transplant screening, counseling and crisis intervention to facilitate optimal social and mental health for the dialysis patient. The LCSW shall have qualifications and perform in accordance with CMS Conditions of Coverage dated October 2010 (or most current revision date available).

The LCSW will be responsible for ensuring that all patients preparing to parole have the necessary information to receive treatment in the area to which they parole. Additionally, the LCSW will assist the dialysis contractor’s clinical staff in finding placement for patients to receive dialysis when needed after parole. If no chronic facility has accepted the patient, the LCSW will ensure that the patient has all necessary information to report to the nearest county hospital for treatment. Additionally, the LCSW will contact the county’s local health department and the hospital to inform them that the patient will require dialysis.

The LCSW will also assist in completion of renal transplantation documents including the psycho-social evaluation for appropriately selected dialysis candidates, to be scanned into the CDCR/CCHCS Electronic Health Record System (EHRS) within three (3) weeks from the time of notification.

The CDCR/CCHCS LCSW shall chart directly in the EHRS within twenty-four (24) hours of the encounter and include within the Medical LCSW section in the EHRS. If the patient has any concerns or questions regarding transplant, the LCSW shall communicate with the Renal Transplant Team within forty-eight (48) hours of the encounter via the CCHCS transplant coordinator inbox at cphcstransplantprogramcoordinator@cdcr.ca.gov.

E. Registered Dietitian (RD)

The RD shall have a minimum of one (1) year professional work experience in clinical nutrition as a RD. RD shall provide an initial dietary assessment, counseling, and education for all new dialysis patients, with follow-up assessments in accordance with CMS Conditions for Coverage for ESRD services dated October 2010 (or most current revision date available). The RD shall counsel all patients at a frequency that meets Medicare guidelines (preferably on a weekly basis). The RD shall meet qualifications and mailto:cphcstransplantprogramcoordinator@cdcr.ca.gov

CDCR/CCHCS Exhibit A Scope of Work

Rev. 09/19/2024 perform in accordance with CMS Conditions for Coverage dated October 2010 (or most current revision date available).

The RD shall chart directly in the EHRS within twenty-four (24) hours of the encounter and filed within the Dietary section in the EHRS. The RD will communicate and coordinate with the CDCR/CCHCS RD regarding the care plan as needed to ensure the patients’ optimal health and effective problem solving. The dialysis unit nephrologist will be able to order nutritional and dietary supplements for patients as deemed clinically necessary, without requiring approval from the CDCR/CCHCS Dietary department.

F. Contractor agrees to allow CDCR/CCHCS, in CDCR/CCHCS’ sole discretion, the right to:

1. Approve any of Contractor’s staff in advance of the personnel being used to render services under the Agreement;

2. Disapprove the initial or continuing use of Contractor’s staff due to the personnel violating the terms of this Agreement;

3. Disapprove the initial or continuing use of Contractor’s staff when personnel violate

CDCR/CCHCS custody and/or safety requirements and rules, along with having criminal convictions, actions pending and/or in process;

4. Disapprove the initial or continuing use of a Contractor’s staff who has been terminated from and/or in process of being terminated from a State, County or local agency when done for disciplinary reasons as an employee;

5. Disapprove the initial or continuing use of Contractor’s staff due to personnel having been released from providing contracted services with another State, County, or local agency for violating the terms of the contracts, or failure to perform services as needed; and

6. Authorize termination of the Agreement, if CDCR/CCHCS determines Contractor has violated a material term of the Agreement.

11. CDCR/CCHCS Responsibilities

A. The institution shall provide the following:

1. Sufficient space suitable for administration of in-house dialysis treatment and lockable adjacent space for storage of equipment and supplies;

2. All laboratory testing and medications not specifically noted in Section 9.G. of this

Agreement;

3. Sharp’s containers and hazardous waste removal;

4. Utilities including, but not limited to, electricity, heating and air conditioning, potable water that meets State water quality standards, with a line pressure to the hemodialysis clinic(s) sufficient to support the dialysis process;

CDCR/CCHCS Exhibit A Scope of Work

Rev. 09/19/2024

5. Copier machine;

6. For six (6) days per week: All dietary, laundry, housekeeping, x-ray, laboratory, plant maintenance, pharmacy and other necessary support;

7. Access to a telephone with outside capability near the treatment area;

8. Annual fire drills;

9. Disaster recovery testing (generator test) at least monthly; and

10. Adequate security warranted by each situation. The Warden at each institution is responsible for all custody and security operations and decisions. The Warden and/or their identified designee shall act as the liaison for any custody and/or security issue raised by Contractor.

B. A CDCR/CCHCS designee shall provide day-to-day operational management and oversight of the dialysis program including quality of care for the patients.

C. Nephrologist shall provide clinical care and medical evaluation for the patients and in conjunction with the CDCR/CCHCS designee provide operational oversight for the dialysis program.

D. CDCR Supplied Items:

Glucometer, testing strips and quality control solutions (due to performing under our labs clinical license)

Ophthalmoscope

O2 Concentrators and maintenance, or piped medical oxygen Otoscope

O2 cylinders, or piped medical oxygen Refrigerators for staff lounge, medication and laboratory

IV pumps and maintenance Centrifuge Emergency cart Scale with wheelchair platform AED and maintenance Shelving

Concentrate dolly Biohazardous waste containers including step cans on treatment floor

Conference room chairs, table Flashlight CPR backboard Non biohazardous trash cans Nurses station desk chairs Recycle bins if applicable Stools with casters Shredder bins if applicable

Suction machine and maintenance Storage space for equipment, machine repair, and Biohazardous waste

Locked cabinets and drawers Toner for copier and fax machine

Lockers All medications not listed in contractor provided items

Appropriate office furniture Lab sample tubes and packaging Hoyer lift with slings and in-service for staff to use that particular brand of Hoyer lift

E. CHCF shall provide a minimum of three (3) Custody Officers (CO) in the dialysis location to monitor patient activity. CHCF custody shall provide one (1) additional CO to monitor

CDCR/CCHCS Exhibit A Scope of Work

Rev. 09/19/2024 patient activity in the private room when maximum custody patients are being dialyzed.

Any concerns with staffing levels below this requirement will need to be reported to the Warden or his/her representative immediately upon incident.

F. RJD shall provide a minimum of two (2) CO and one (1) relief CO in the dialysis location to monitor patient activity. RJD custody shall provide one (1) additional CO to monitor patient activity in the private room when maximum custody patients are being dialyzed.

Any concerns with staffing levels below this requirement will need to be reported to the Warden or his/her representative immediately upon incident.

G. SQ shall provide a minimum of two (2) CO and one (1) relief CO in the dialysis location to monitor patient activity. SQ custody shall provide one (1) additional CO to monitor patient activity in the private room when maximum custody patients are being dialyzed. Any concerns with staffing levels below this requirement will need to be reported to the Warden or his/her representative immediately upon incident.

H. WSP shall provide a minimum of two (2) CO and one (1) relief CO in the dialysis location to monitor patient activity, including the private room when maximum custody patients are being dialyzed. Any concerns with staffing levels below this requirement will need to be reported to the Warden or his/her representative immediately upon incident.

12. On-Site Licensing Services

A. Contractor acknowledges CDCR/CCHCS is the holder of the license for dialysis services.

In coordination with the CEO/CME or the CDCR/CCHCS designee, Contractor is responsible for maintaining conditions in dialysis units to ensure continued licensure.

Contractor shall assist CDCR/CCHCS in addressing any issues that may lead to licensure questions or deficiencies affecting licensure identified by the licensing agency.

B. The CDCR/CCHCS designee shall be the single point of contact for California Department of Public Health (CDPH) licensing and oversight activities. Contractor shall provide all documentation necessary to prepare for and comply with CDPH licensing surveys.

C. The CDCR/CCHCS designee may inspect any and all aspects of the dialysis treatment program to ensure compliance with Federal and State rules and regulations.

D. Contractor shall be present and participate in the CDPH dialysis licensing and license maintenance process including but not limited to completion of CDPH Form 215, in conjunction and with the approval of the CEO/CME or designee. To ensure that all requirements and corrective actions for licensing are met in a timely manner, Contractor shall meet with the CEO/CME or designee to develop a workable timeline to address corrective actions.

In preparation for a licensing survey, Contractor shall provide to the CDCR/CCHCS designee the following:

1. All policies and procedures relating to dialysis services and to the provision of services within a correctional setting shall be completed, approved by the CEO/CME or designee and available for the licensing review. The policies and procedures shall meet the requirements set forth in Title 22 of the CCRs specific to dialysis services

CDCR/CCHCS Exhibit A Scope of Work

Rev. 09/19/2024 and clinics and AAMI RD 52:2004 regulations and CMS Conditions for Coverage for ESRD facilities put into effect October 2010 (or most current revision date available).

2. Policies and procedures for medical records procedures shall be completed by

Contractor and approved by the CEO/CME or designee, including each time Contractor updates them.

3. An emergency plan shall be developed and approved by the CEO/CME or designee.

4. Contractor shall provide licenses and certifications for all proposed staff to the

CEO/CME or designee.

5. All Contractor’s staff shall participate in the institution orientation, be oriented to the dialysis policies and procedures and to the provision of services within a correctional setting and be available for the dialysis licensing review by the CDPH.

6. Institution management will ensure that all correctional staff assigned to the dialysis unit shall be trained and oriented to the policies and procedures of the dialysis unit.

13. Licenses/Permits/Certification/Registration

Contractor shall comply with all CMS Conditions for Coverage for ESRD Facilities effective October 2010 (or most current revision date available), Federal, State and local requirements including Title 22 of the CCRs as applicable to dialysis services and clinics and that the unit and services continue to be licensed by the CDPH in order to perform these services.

Contractor shall possess and maintain throughout the term of this Agreement a current and valid license to conduct the services required in connection with this Agreement in the State of California and shall obtain at Contractor’s expense any and all necessary license(s), permit(s), certification(s) and registration(s) required by law for accomplishing any work required in connection with this Agreement.

Contractor shall ensure that copies of current and valid licenses, registrations and certifications, for all staff assigned to a licensed CDCR/CCHCS health care facility, are provided to the CDCR/CCHCS designee and the institution’s contract liaison prior to providing services.

Contractor is responsible for verifying through the appropriate licensing board that no adverse actions have been taken by the State licensing authorities against any personnel assigned to a licensed CDCR/CCHCS health care facility, and that all licenses/certifications are active and void of misconduct at all times during the Agreement. Contractor is required to notify CDCR/CCHCS of any license status changes upon notification from the licensing entity.

CDCR/CCHCS may, at its discretion, verify the current status of personnel assigned.

14. Orientation and Training Requirements

At the discretion of each CDCR/CCHCS institution, Contractor agrees that prior to reporting to work at the institution; all staff shall complete orientation/training as specified in A. or B. below at Contractor’s sole expense:

A. On-site Institution Orientation/Training

CDCR/CCHCS Exhibit A Scope of Work

Contractor agrees staff shall attend on-site orientation and any other required training (i.e.

annual block training,…