Code of Maryland Regulations: Commission on Kidney Disease
Index
Title 10 DEPARTMENT OF HEALTH AND MENTAL HYGIENE
Subtitle 30 MARYLAND COMMISSION ON KIDNEY DISEASE
Chapter 01 General Regulations
Authority: Health-General Article, §§13-301—13-316 and 16-204, Annotated Code of Maryland
.01 Purpose.
In recognition of its continuing responsibility to its citizens to aid in reduction of the personal financial hardships associated with end-stage renal disease, the State continues its commitment of resources to the Kidney Disease Program of Maryland. This subtitle is designed so that Maryland may provide help and support for its citizens whose needs are partially or wholly unmet by present federal or private support, or both, for end stage renal disease.
.02 Definitions.
A. In this subtitle, the following terms have the meanings indicated.
B. Terms Defined.
(1) 'Abusive and dangerous patient' means a patient who is physically or verbally threatening to the patient's person, facility staff, or other patients
(2) 'Acute dialysis' means dialysis employed in the treatment of temporary renal failure, with the expectation that dialysis may be necessary for 4 weeks or less because recovery of kidney function is anticipated.
(3) 'Administrator' means an individual appointed by the governing body who is responsible for the facility's daily operations and the duties set forth in COMAR 10.30.02.03F.
(4) 'Certified nursing assistant—dialysis technician' means an individual licensed by the Maryland Board of Nursing to perform nursing tasks delegated by a licensed nurse in the dialysis facility.
(5) 'Certified patient' means a patient who is certified by the Commission on Kidney Disease and is eligible for benefits from the Kidney Disease Program.
(6) 'Chief executive officer' means an individual who meets the requirements set forth in 42 CFR §494.180, which is incorporated by reference;
(7) 'Chronic dialysis' means dialysis employed to compensate for the severe and irreversible loss of renal function and is a permanent treatment modality unless replaced by renal transplantation.
(8) 'Chronic peritoneal dialysis' means dialysis performed repetitively by exchanging large volumes of solution within the peritoneal cavity.
(9) 'Commission' means the Commission on Kidney Disease.
(10) 'Department' means the Department of Health and Mental Hygiene.
(11) 'Dialysis'
(a) 'Dialysis' means the process of filtering waste products and excess fluid from the blood of a patient with severely compromised kidney function.
(b) 'Dialysis' includes the terms hemodialysis and peritoneal dialysis.
(12) 'Governing body' means an identifiable individual or individuals who are designated in writing with full legal authority and responsibility for the governance and operation of the facility.
(13) 'Home dialysis' means chronic hemodialysis or chronic peritoneal dialysis performed regularly in the home by the patient and an assistant, if necessary
(14) 'Home training dialysis' means:
(a) Chronic peritoneal dialysis, including continuous ambulatory peritoneal dialysis and continuous cycling peritoneal dialysis; or
(b) Instructional chronic hemodialysis.
(15) “In-center hemodialysis” means a hemodialysis treatment that:
(a) Lasts 3 to 5 hours;
(b) Is performed on a routine basis, usually three times a week, to treat a chronic condition; and
(c) Is provided in a kidney dialysis facility center during daytime hours.
(16) “In-center nocturnal hemodialysis” means a hemodialysis treatment that:
(a) Lasts 6 to 9 hours;
(b) Is performed on a routine basis, usually three times a week, to treat a chronic condition; and
(c) Is provided in a kidney dialysis facility.
(17) 'Monitoring individual' means an individual who is a direct patient care provider.
(18) 'Nurse manager' means an individual who is responsible for nursing services and provides oversight and direction to all direct care staff that provide dialysis and nursing care in the facility including:
(a) Input into hiring; and
(b) Evaluating staff.
.02-1 Incorporation by Reference.
A. In this chapter, the following documents are incorporated by reference.
B. Documents Incorporated.
(1) 42 CFR §§494.1—494.110, as amended; and
(2) 42 CFR §§494.130—494.180, as amended.
.03 Categories of Dialysis.
A. The categories of dialysis listed in §§B—F of this regulation are recognized on the basis of differing facility requirements.
B. Acute Dialysis. Acute dialysis is not reimbursable under the Kidney Disease Program and nothing in this subtitle is meant to refer to acute dialysis.
C. Chronic Dialysis.
(1) Chronic dialysis may be provided in the dialysis facilities defined and described in this subtitle.
(2) Chronic dialysis may be preceded by adequate studies to confirm that the renal failure is irreversible.
D. Home Dialysis. A period of training in an approved home dialysis training facility is required before a patient can safely undergo dialysis treatments in the home.
E. Home Training Dialysis.
(1) Home training dialysis is usually conducted in a center with simultaneous dialysis and instruction provided to the patient that includes the technique of performing the type of dialysis selected.
(2) The period required for this training differs depending on the individual circumstances, and requires the expertise and equipment necessary for providing adequate home training.
(3) A responsible third party may be included in the training.
F. Chronic Peritoneal Dialysis.
(1) This process can substitute for renal function that has been permanently lost and represents a permanent treatment unless replaced by either hemodialysis or renal transplantation.
(2) Long-term care of end-stage renal disease by chronic peritoneal dialysis may be carried out either in a dialysis facility or in the home.
G. Nocturnal Hemodialysis. Nocturnal hemodialysis may be provided in the dialysis facilities defined and described in this subtitle.
.04 Classifications of Facilities.
A. Renal Transplant Center.
(1) A renal transplant center shall be a physically discrete unit or division within a hospital approved by the Joint Commission on Accreditation of Healthcare Organizations having the staff and facilities capable of evaluating potential candidates for renal transplantation.
(2) Transplantation Service. The transplantation division may be administratively and physically separate from the dialysis division, but shall work in close cooperation with an associated dialysis program.
B. Freestanding Dialysis Facility. The freestanding dialysis facility's functions include:
(1) A dialysis facility capable of providing chronic staff-assisted dialysis which may be performed in a freestanding dialysis facility or in an end-stage renal disease certified hospital based unit;
(2) Referrals provided for operative, X-ray, and laboratory services under arrangement;
(3) Affiliation with a certified dialysis facility for backup purposes; and
(4) Affiliation with a certified transplant center.
C. Home Dialysis Programs. A home dialysis program's functions include a dialysis facility specifically designed and staffed to train patients and patients' helpers to perform dialysis at home.
D. Self-Care Dialysis Facility. A self-care dialysis facility's functions include:
(1) Qualified supervision to patients who perform part or most of the patient's own dialysis treatment; and
(2) Supervision of treatment by qualified staff members of the facility for the protection of the interest of the patient and of the facility.
.05 Patient Selection Standards.
A. General Considerations.
(1) Selection of patients for dialysis and renal transplantation shall be on medical grounds alone.
(2) Selection may not be based on age, race, sex, social background, national origin, religion, or financial resources.
(3) The Kidney Disease Program is financially responsible only for residents of the State who are certified as eligible for participation in the Kidney Disease Program.
(4) Maryland residents treated in dialysis facilities or transplant centers outside the State are not eligible for reimbursement unless the treatment has been preauthorized by the Commission.
(5) The Commission may authorize a treatment for documented reasons of continuity of care, or geographical proximity of the patient's residence to the dialysis facility or transplant center, or both.
(6) Patient selection is the responsibility of the dialysis or transplant centers, or both, but shall conform to the medical guidelines established in §B of this regulation.
(7) Except as provided in §C of this regulation, if a patient is accepted by a facility for dialysis, transplantation, or both, the patient is the responsibility of that facility and the facility's staff until that responsibility is terminated by mutual agreement between the facility and patient.
(8) The Commission shall review each facility's policy regarding discharge of patients from the facility's program.
(9) Any separation that is not mutually accepted shall be documented in writing by the facility and reviewed by the Commission to determine whether there has been a violation of laws or regulations of the State.
B. Medical Guidelines. A patient may be accepted for treatment if the patient meets any of the following criteria:
(1) Has end-stage renal disease requiring renal replacement therapy to sustain life;
(2) A patient who grants informed consent and who has had a thorough medical, psychosocial evaluation indicating a reasonable expectation of benefiting from either chronic dialysis or transplantation;
(3) Has chronic end-stage renal disease and is a qualified resident of this State, except when documented medical reasons contraindicate dialysis; or
(4) Has rejected a transplanted kidney making the patient immediately eligible for consideration for readmission into a chronic dialysis program if the patient is a medically suitable candidate.
C. Abusive and Dangerous Patients.
(1) A facility shall:
(a) Develop policies for the management of abusive and dangerous patients;
(b) Maintain these policies in the policy and procedures manual in the dialysis facility; and
(c) Inform the patient in writing of the facility's policy for the management of abusive and dangerous patients.
(2) Separation or discharge.
(a) A separation or discharge may be implemented by the facility only after the patient has been given written notice by the facility and has had a reasonable opportunity to terminate the abusive and dangerous behavior.
(b) A patient who commits violence in a facility may be discharged.
(c) The Commission shall require documentation of violence to support a discharge.
(3) The Commission shall review each facility's policy for the management of abusive and dangerous patients and the facility's method of implementation of this policy during the Commission's annual survey.
D. Complaints.
(1) The Commission shall investigate complaints received from patients, providers, anonymous persons, and other interested parties including family members.
(2) The Commission shall consider all complaints submitted to the Commission office for further investigation.
.06 Reimbursement Principles.
A certified facility and recipient shall comply with COMAR 10.20.01 and with the requirements of this chapter to be eligible for reimbursement.
.07 Procedures for Certification of Facilities.
A. Providers or consumers of medical care contemplating development of a transplant center or a dialysis facility shall notify the Commission within 30 days of applying for licensure or certification with the Office of Health Care Quality of the Department.
B. The Department or the Commission, or both, shall:
(1) Review the facility application; and
(2) Survey for compliance with this subtitle.
C. The Commission, through the Department, shall certify the dialysis facilities and transplant centers once the standards have been met as set forth in this subtitle.
D. Certified patients are eligible for reimbursement of medical care only after a dialysis facility or transplant center has received certification.
E. Programs denied certification on the basis of a failure to meet the Commission's standards may file an appeal with the Commission for a specific interpretation of the standards applicable in that individual case.
.08 Affiliation Guidelines.
A. To assure quality and continuity of patient care, formal affiliation agreements shall be negotiated as required in the standards and guidelines of the Commission. The affiliation agreement shall be constructed so no entity benefits financially.
B. Affiliation agreements shall include, but not necessarily be limited to, the:
(1) Means by which patients may be transferred between the affiliated institutions for the purpose of providing dialysis, transplantation services, or other medical care;
(2) Conditions under which dialysis facilities, hospitals, and transplant centers agree to provide medical backup facility to assure optimal patient care;
(3) Mechanisms for assuring quality of care including provisions for consultative help and review of patient progress;
(4) Provisions of or referral to a certified home dialysis training program with specific mechanisms for ensuring adequate supervision and assistance for patients on home dialysis; and
(5) Specific provisions by hospitals to end-stage renal disease patients for dialysis services as well as adequate:
(a) Laboratory services;
(b) Social services; and
(c) Dietetic services;
C. The primary dialysis facility shall review and revise the affiliation agreements periodically and if a change in ownership or other details of operation change during the period while the affiliation agreement is in force.
.09 Residency Requirements.
To be eligible for the Kidney Disease Program, an individual shall be one of the following:
A. A citizen of the United States residing in Maryland;
B. An alien lawfully admitted for permanent residence or otherwise permanently residing in the United States under color of law, including an alien who is lawfully present in the United States pursuant to 8 U.S.C. §1101 et seq. and who is residing in Maryland; or
C. An alien lawfully admitted under authority of the Indo-China Migration and Refugee Assistance Act of 1975 and who is residing in Maryland.
.10 Certification and Revocation.
A. Certification.
(1) The Commission, through the Department, shall certify a facility or center to perform dialysis upon determination that the facility or center meets the standards adopted by the Commission, including:
(a) 42 CFR §§494.1—494.110, as amended; and
(b) 42 CFR §§494.130—494.180, as amended.
(2) The certification of the facility or center shall continue in effect unless suspended or revoked by the Secretary as recommended by the Commission.
B. Revocation of Certification or Suspension of Payments.
(1) The Secretary shall delegate to the Commission the performance of periodic surveys of dialysis facilities or transplant centers.
(2) The Commission shall immediately report to the Secretary if patient safety and welfare are compromised at the facility. However, this reporting does not preclude the Commission from taking immediate independent corrective action.
(3) The Commission may, by vote of the majority of the members in attendance, recommend to the Secretary to revoke or suspend payments to a dialysis facility or transplant center not in compliance with this subtitle.
(4) Reimbursements may not be made during the term of the suspension or revocation.
C. The Secretary may revoke the certification of a dialysis facility or transplant center to participate in the Kidney Disease Program at any time for failure to comply with this subtitle.
D. The Commission may review any revocation or proposed revocation of certification and make an independent recommendation to the Secretary.
E. In accordance with the Maryland Administrative Procedure Act, a person aggrieved by a decision of the Secretary is entitled to a hearing in accordance with COMAR 10.01.03.
.11 Miscellaneous Items.
A. A serious occurrence which threatens the safety and health of the patients shall be reported immediately by a facility to the Commission, local health department, and the Office of Health Care Quality of the Department.
B. In the event of a natural disaster or other imminent threat to the safety or health of a group of dialysis patients, the Secretary may immediately authorize, with timely notification of all involved professional personnel and patients, the:
(1) Relocation of an existing dialysis facility or center; and
(2) Transfer of dialysis patients in accordance with medical needs.
C. Emergency Management.
(1) A kidney dialysis facility shall have an emergency plan.
(2) An emergency plan shall include policies and procedures that will be followed before, during, and after an emergency to address:
(a) The safe management of individuals who are receiving services at the kidney dialysis facility when an emergency occurs;
(b) Notification of patients, families, staff, and licensing authorities regarding actions that will be taken concerning the provision of dialysis services to the individuals served by the kidney dialysis facility;
(c) Staff coverage, organization, and assignment of responsibilities; and
(d) The continuity of operations, including procedures to secure access to essential goods, equipment, and dialysis services.
(3) This regulation does not prohibit a kidney dialysis facility from applying for and receiving reimbursement:
(a) Under any applicable insurance policy; or
(b) From any State or federal funds that may be available due to a declared State or federal emergency.
(4) A kidney dialysis facility is solely responsible for any financial obligation arising from voluntary or mandatory activation of any aspect of the emergency plan developed by the kidney dialysis center under this regulation.
(5) For purposes of coordinating local emergency planning efforts, a kidney dialysis facility shall provide access to the emergency plan developed under this regulation to local organizations for emergency management.
(6) A dialysis provider shall provide to the Commission a 24/7 live operational contact phone number.
(7) Information Regarding the Status of Generators. A kidney dialysis center shall have:
(a) An on-site generator;
(b) The capacity to hook up a generator; or
(c) A contract with a company who will provide a generator in the event of an emergency, if there is no on-site generator.
(8) If the center has no plan to use the services of a generator, the center shall provide to the Commission a copy of the center's emergency plan that will demonstrate that all measures possible are in place to avoid disruption of dialysis services to patients.
Administrative History
Effective date: July 1, 1972
Regulations .01—.09 repealed and new regulations .01—.09 adopted effective July 19, 1982 (9:14 Md. R. 1431)
Regulations .04, .05, and .07L amended effective August 1, 1983 (10:15 Md. R. 1350)
Regulation .07B amended effective February 27, 1984 (11:4 Md. R. 314); August 20, 1987 (14:16 Md. R. 1775); November 16, 1987 (14:23 Md. R. 2414)
Regulation .07B and Q amended as an emergency provision effective January 1, 1987 (14:6 Md. R. 711, 14:9 Md. R. 1077); emergency status expired August 20, 1987 (Emergency provisions are temporary and not printed in COMAR)
Regulation .07Q amended effective July 2, 1984 (11:13 Md. R. 1777); August 20, 1987 (14:16 Md. R. 1775)
Regulation .07Q amended as an emergency provision effective July 2, 1984 (11:15 Md. R. 1327); adopted permanently effective December 19, 1984 (11:23 Md. R. 1992)
Regulation .07R adopted effective August 1, 1983 (10:15 Md. R. 1350)
Regulation .07S adopted as an emergency provision effective September 14, 1983 (10:20 Md. R. 1781); emergency status expired January 31, 1984 (Emergency provisions are temporary and not printed in COMAR)
Regulation .10 adopted effective December 20, 1982 (9:25 Md. R. 2484)
Regulations .11 and .13 adopted effective August 1, 1983 (10:15 Md. R. 1350)
Regulation .11 amended effective November 3, 1986 (13:22 Md. R. 2399)
Regulation .12 adopted effective June 4, 1984 (11:11 Md. R. 962)
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Chapter revised effective October 31, 1988 (15:22 Md. R. 2556)
Regulation .04A amended effective April 15, 1991 (18:7 Md. R. 773); May 20, 1996 (23:10 Md. R. 732)
Regulation .04C adopted effective May 20, 1996 (23:10 Md. R. 732)
Regulation .05 amended effective December 19, 1994 (21:25 Md. R. 2105)
Regulation .06F amended effective December 19, 1994 (21:25 Md. R. 2105)
Regulation .07 repealed and new Regulation .07 adopted effective December 19, 1994 (21:25 Md. R. 2105)
Regulation .07A and M amended effective April 15, 1991 (18:7 Md. R. 773)
Regulation .11C amended effective December 19, 1994 (21:25 Md. R. 2105)
Regulation .14 amended effective December 19, 1994 (21:25 Md. R. 2105)
Regulation .15 adopted as an emergency provision effective July 1, 1992 (19:13 Md. R. 1200); emergency status expired November 8, 1992 (Emergency provisions are temporary and not printed in COMAR)
Regulation .15 adopted effective May 9, 1994 (21:9 Md. R. 751)
Regulation .15 repealed and new Regulation .15 adopted effective October 24, 1994 (21:21 Md. R. 1814)
Regulation .15F repealed effective August 23, 1999 (26:17 Md. R. 1323)
Regulation .16 adopted effective December 19, 1994 (21:25 Md. R. 2105)
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Regulations .01—.16 repealed and new Regulations .01—.11 adopted effective December 22, 2003 (30:25 Md. R. 1846)
Regulation .02B amended effective April 5, 2010 (37:7 Md. R. 571)
Regulation .02-1 adopted effective April 5, 2010 (37:7 Md. R. 571)
Regulation .08B amended effective April 5, 2010 (37:7 Md. R. 571)
Regulation .10A amended effective April 5, 2010 (37:7 Md. R. 571)
Regulation .03G adopted effective March 16, 2015 (42:5 Md. R. 486)
Regulation .08B amended effective April 5, 2010 (37:7 Md. R. 571)
Regulation .10A amended effective April 5, 2010 (37:7 Md. R. 571)
Regulation .11C adopted effective March 16, 2015 (42:5 Md. R. 486)
Chapter 02 Physical and Medical Standards
Authority: Health-General Article, §§13-301—13-316 and 16-204, Annotated Code of Maryland
.01 Repealed.
.02 Transplant Centers.
A. Location and Program Affiliation.
(1) Centers seeking certification as transplant centers, under Health-General Article, Title 13, Subtitle 3, Annotated Code of Maryland, shall be located in hospitals that are accredited by the Joint Commission on Accreditation of Healthcare Organizations and participate in a patient registry program with a certified organ procurement organization.
(2) An agreement shall exist with an established functioning tissue typing laboratory providing 24-hour-a-day service.
(3) The hospital shall provide an active nephrology service to provide for continuity of care.
(4) The transplantation program shall conform to generally accepted medical standards for tissue typing and for transplantation.
(5) For the purpose of protecting patient safety and welfare, a transplant center may not discontinue or phase out patient services until:
(a) The transplant center has notified the Commission of the transplant center's intention;
(b) Patients being treated by that transplant center have been transferred to another transplant center;
(c) Patients' continuing care has been assured to the satisfaction of the patient and the Commission;
(d) The transplant center submits to the Commission evidence that the transfer of patients to another transplant center has been satisfactorily accomplished; and
(e) Patients being treated in a transplant center that is withdrawing from the Kidney Disease Program are provided continued access to the same reimbursement principles of the Kidney Disease Program.
B. Physical Standards. The transplant center shall be located in a hospital that is participating as a provider of services in the Medicare program and is approved by Centers for Medicare and Medicaid Services as a renal transplantation center.
C. Staffing.
(1) Director of Transplantation Center. The renal transplantation center shall be under the general supervision of:
(a) A UNOS qualified transplantation surgeon (42 CFR §405.2102) and a qualified transplant nephrology physician director; or
(b) Another physician meeting UNOS criteria as a physician director for kidney transplantation (42 CFR §405.2102).
(2) The director shall be responsible for planning, organizing, conducting and directing the transplant center and devoting sufficient time to carry out these responsibilities, which include but are not limited to:
(a) Coordinating with the hospital in which the transplant center is located to ensure adequate training of nursing staff and clinical transplant coordinators in the care of transplant patients and living donors;
(b) Ensuring that tissue typing and organ procurement services are available through a UNOS associated OPO and an ASHI certified laboratory;
(c) Ensuring that transplantation surgery is performed by, or under the direct supervision of, a UNOS qualified transplant surgeon; and.
(d) Ensuring that the transplant center shall have an adequate number of clinical transplant coordinators to ensure the continuity of care of patients and living donors during the:
(i) Pre-transplant, transplant, and discharge phases of transplant; and
(ii) Donor evaluation, donation, and discharge phases of donation.
(3) The clinical transplant coordinator shall:
(a) Be a registered nurse or clinician licensed by the state in which the clinical transplant coordinator practices; and
(b) Have experience and knowledge of transplantation and living donation issues.
(4) The clinical transplant coordinator's responsibilities include, but are not limited to:
(a) Ensuring the coordination of the clinical aspects of transplant patient and living donor care; and
(b) Acting as a liaison between kidney transplant centers and dialysis facilities.
(5) The transplant center that performs living donor transplantation shall identify either an independent living donor advocate or an independent living donor advocate team to ensure the protection of the rights of living donors and prospective living donors.
(6) The living donor advocate or living donor advocate team may not be involved in transplantation activities on a routine basis.
(7) The kidney transplant center shall:.
(a) Directly furnish transplantation and other medical and surgical specialty services required for the care of ESRD patients; and
(b) Have written policies and procedures for ongoing communications with the dialysis patients' local dialysis facilities.
D. Additional Transplant Program Requirements.
(1) Sufficient skilled personnel shall be available to provide 24-hour-a-day coverage for the transplantation service.
(2) A transplantation team shall exist in a certified transplant center consisting of:
(a) The transplant center director;
(b) The director's assistant; and
(c) A UNOS certified transplant surgeon, if not the transplant center director, and a UNOS certified physician director (a transplant nephrologist or physician meeting UNOS criteria to be a physician director for a kidney transplant program).
E. Physical and Medical Standards. The transplant center shall:
(1) Provide support services in clinical immunology, infectious diseases, and immunopathology; and
(2) Be an administratively separate and distinct division or unit.
F. Transplant Activity.
(1) For optimum performance and success of the transplant procedure, transplant centers shall perform a minimum of 10 transplants per year.
(2) The Commission recognizes that the number of transplants performed depends on many variables and the standard specified in §F(1) of this regulation serves only as a guideline.
(3) The guideline specified in §F(1) of this regulation is established to indicate that transplant centers shall remain active in order to improve the success rate and to lower costs.
G. The transplant center shall make arrangements for medical records, patient care policies, dietetic services, sanitation standards, and fire and life safety standards as referenced in Regulation .01B of this chapter and this subtitle.
H. Patient Selection.
(1) In general, the patient selection standards as established for the dialysis program shall apply to the transplantation program, recognizing that constant improvements in the immunology and treatment of the rejection process are increasing the number of disease processes in which transplantation is applicable.
(2) Written recommendations about the mode of therapy shall be kept on file for the review of the Commission.
(3) Since transplantation is at present the best means of treating most patients with irreversible renal failure, transplantation shall be considered for all patients accepted into this program when reasonable benefit and success are anticipated. However, candidacy for transplantation may not be a basic criteria for selection into the overall Kidney Disease Program.
(4) A patient rejecting a transplanted kidney shall automatically receive assistance to gain entry into a dialysis program.
I. Administration.
(1) The transplant center shall have sufficient social service and dietetic staffing by licensed and trained professionals available to meet the needs of the transplant patients.
(2) Before placement on the center's waiting list, a prospective transplant candidate shall:
(a) Receive a psychosocial evaluation; and
(b) Ensure that the candidate's medical record contains documentation that the candidate's blood type has been determined.
(3) When a patient is placed on a center's waiting list or is selected to receive a transplant, the center shall document in the patient's medical record the patient's selection criteria used.
(4) The transplant center shall provide a copy of its patient selection criteria to a transplant patient, or a dialysis facility, as requested by a patient or dialysis facility.
(5) The transplant center shall have written patient management policies for the transplant and discharge phases of transplantation. If a transplant center performs living donor transplants, the center also shall have written donor management policies for the donor evaluation, donation, and discharge phases of living organ donation.
(6) The transplant center's patient and donor management policies shall ensure that:
(a) Each transplant patient is under the care of a multidisciplinary patient care team coordinated by a physician throughout the transplant and discharge phases of transplantation; and
(b) If a center performs living donor transplants, each living donor is under the care of a multidisciplinary patient care team coordinated by a physician through the donor evaluation, donation, and discharge phases of donation.
(7) A transplant center shall keep their waiting lists up to date on an ongoing basis including:
(a) Updating of waiting list patients' clinical information;
(b) Removing patients from the center's waiting list if a patient receives a transplant or dies, or if there is any other reason the patient should no longer be on a center's waiting list;
(c) Notifying the Organ Procurement and Transplant Network not later than 24 hours after a patient's removal from the center's waiting list; and
(d) Notifying the patient and dialysis facility if applicable if the patient is removed from the center's waiting list.
(8) The transplant center shall develop guidelines to ensure adequate patient and freestanding dialysis facility notification of change in patient transplant status.
(9) The transplant center shall maintain up-to-date patient management records for each patient who receives an evaluation for placement on a center's waiting list and who is admitted for organ transplantation.
(10) The transplant center shall make social services available, furnished by qualified social workers, to transplant patients, living donors, and their families.
(11) The transplant center shall develop, implement, and maintain a written comprehensive data driven Quality Assessment and Performance Improvement (QAPI) program designed to monitor and evaluate performance of all transplantation services. The QAPI program shall include:
(a) Patient and donor selection criteria;
(b) Accuracy of the waiting list;
(c) Assurance of donor and recipient matching;
(d) Patient and donor management;
(e) Consent practices;
(f) Patient education;
(g) Patient satisfaction; and
(h) Patient rights.
(12) The transplant center shall take actions that result in performance improvements and track performance to ensure that improvements are sustained.
(13) The transplant center shall establish and implement written policies to address and document adverse events that occur during any phase of an organ transplantation case.
(14) The hospital shall provide designated administrative personnel to keep the necessary records as well as other information needed for accurate determination of cost.
(15) The hospital or transplant center administration shall assure that patients are informed of the center's internal and external grievance mechanisms.
J. Compliance. Transplant centers shall comply with the provisions set forth in Regulation .01B of this chapter, and with the requirements of this subtitle.
.03 Freestanding Dialysis Facilities — General.
A. Location and Program Affiliation.
(1) Freestanding dialysis facilities seeking a certification as a freestanding dialysis facility, under the terms of Health-General Article, Title 13, Subtitle 3, Annotated Code of Maryland, shall have, for the diagnosis and treatment of irreversible renal failure and its complications, arrangements with:
(a) A laboratory that meets the needs of end-stage renal disease patients;
(b) A hospital that can provide acute care services to meet the needs of end-stage renal disease patients;
(c) A backup dialysis facility; and
(d) Transplant services.
(2) A freestanding dialysis facility desiring to phase out or discontinue dialysis services shall notify the Commission as soon as the decision to withdraw the facility from the Kidney Disease Program has been made by the administration of the facility.
(3) A freestanding dialysis facility withdrawal from the Kidney Disease Program may not be accomplished until:
(a) Patients being treated by that freestanding dialysis facility have been transferred to another facility or the patients' continuing care assured to the satisfaction of the patient and the Commission;
(b) The freestanding dialysis facility has submitted to the Commission evidence that transfer of patients to another facility has been satisfactorily accomplished; and
(c) Patients previously certified and being treated in a freestanding dialysis facility that is being withdrawn from the Kidney Disease Program have continued access to the same reimbursement principle of the Kidney Disease Program.
B. Physical Standards. The freestanding dialysis facility shall:
(1) Have usable floor space of at least 80 square feet per patient station that may include bed or chair space, nursing space, and work area but excludes storage space;
(2) Have at least 20 square feet of the patient station floor space available on the side of the patient to be occupied by the dialysis assembly;
(3) Arrange the space to be sufficiently flexible to provide access to any of the four extremities;
(4) Contain a nursing station and be designed for patient privacy, surveillance, and isolation when indicated;
(5) Provide refrigerated and nonrefrigerated storage space;
(6) Provide sufficient area and space for:
(a) Maintenance of equipment;
(b) Storage of the equipment and supplies; and
(c) Preparing and testing dialyzers;
(7) Utilize water of sufficient purity, according to current Association for the Advancement of Medical Instrumentation's recommendations which are incorporated by reference in Regulation .01B(4) and (5) of this chapter to prevent bacterial or endotoxin contamination or toxic accumulation of trace elements in patients undergoing long-term dialysis;
(8) Comply with medical records, patient care policies, sanitation standards, and fire and life safety standards as defined in Regulation .01B of this chapter and this subtitle; and
(9) Comply with the quality assurance program as identified in Regulation .04B(3)(s)of this chapter and provide:
(a) Summarized format documentation, upon request, of the facility’s quality assurance program; and
(b) Written documentation of the facility’s meeting attendance, goals, outcomes, and action plans, including evaluation and revision of the plans, as appropriate
C. Administration.
(1) The freestanding dialysis facility shall be under the supervision of the governing body. The governing body shall:
(a) Identify the center administrator who has been given the authority and responsibility for the overall policy and fiscal management of the facility; and
(b) Develop a written organizational plan.
(2) The freestanding dialysis facility administration shall:
(a) Be under the supervision of the governing body; and
(b) Provide a copy of the Medicare cost report to the Department, or the Department's duly authorized agents, upon request.
(3) The freestanding dialysis facility shall provide designated administrative personnel to keep necessary records as well as other information for accurate determination of costs.
(4) The freestanding dialysis facility administration shall assure that patients are informed of the facility's internal and external grievance mechanisms.
D. Compliance. Freestanding dialysis facilities shall comply with:
(1) The provisions set forth in Regulation .01B of this chapter;
(2) Regulation .04 of this chapter; and
(3) The requirements of this subtitle for certification purposes with the Commission.
E. Governing Body. The governing body shall:
(1) Identify the facility administrator who has been given the authority and responsibility for the overall policy and fiscal management of the facility; and
(2) Develop a written organizational plan.
F. Administrator.
(1) Qualifications.
(a) The kidney dialysis facility administrator, if not the chief executive officer, shall at a minimum:
(i) Be 21 years old or older;
(ii) Possess a high school diploma or a high school equivalency diploma and have experience to conduct the responsibilities specified in §B(2) of this regulation;
(iii) Have at least 1 year of dialysis experience; and
(iv) Have no criminal conviction or other criminal history that indicates behavior that is potentially harmful to patients, documented through either a criminal history records check or a criminal background check completed within 1 month before employment.
(b) The administrator, if not the chief executive officer, shall have knowledge in:
(i) Infection control;
(ii) Principles of dialysis;
(iii) Water treatment;
(iv) Reuse;
(v) Data collection and quality assurance;
(vi) Emergency procedures;
(vii) Fiscal operations, including business management and personnel;
(viii) Regulations; and
(ix) Policies and procedures.
(2) Duties.
(a) The administrator shall be on site or available on call.
(b) The administrator shall have overall responsibility for:
(i) Implementing the facility's policies and coordinating the provision of services that the facility provides;
(ii) Organizing and coordinating the administrative functions of the facility;
(iii) Establishing procedures for the accountability of those personnel involved in patient care;
(iv) Familiarizing the staff with the facility's policies and procedures, and with applicable federal, State, and local laws and regulations;
(v) Participating in the development, negotiation, and implementation of agreements or contracts into which the facility enters;
(vi) Participating in the development of organizational and fiscal planning for the facility;
(vii) Implementing and evaluating, under the direction of the clinical team, the patient care plan and the long-term care program for each patient; and
(viii) Informing patients of the availability of emergency services.
(3) Waiver of Requirements for Administrator.
(a) The Department may grant a kidney dialysis facility a waiver, with or without conditions, for a center that operates an administrator-in-training program.
(b) A facility with an administrator-in-training program shall submit to the Department the:
(i) Administrator-in-training curriculum, including course outline and supporting materials;
(ii) Facility requirements for individuals who are selected to participate in the administrator-in-training program; and
(iii) Protocols in place that assure that the approval of the waiver will not adversely affect the quality of care received by patients.
(c) In evaluating a waiver request submitted under this regulation, the Department shall review the statements in the application and may:
(i) Inspect the kidney dialysis center; or
(ii) Confer with the governing body.
(d) Grant or Denial of Waiver. The Department may grant a waiver request if it determines that:
(i) The administrator-in-training program sufficiently meets the requirements of this regulation; and
(ii) A waiver will not adversely affect patients.
(e) If the Department determines that the conditions of §F(1) and (2) of this regulation are not met, the Department shall deny the request for a waiver. The denial of a waiver may not be appealed.
(f) Written Decision.
(i) The Department shall issue and mail to the licensee a final written decision regarding a waiver request submitted under this regulation within 45 days from receipt of the request.
(ii) If the Department grants a waiver, the written decision shall include the waiver's duration and any conditions imposed by the Department.
(g) If a licensee violates any condition of the waiver, or if it appears to the Secretary that the health or safety of patients will be adversely affected by the continuation of the waiver, the waiver may be revoked. The revocation of a waiver may not be appealed.
(h) Any substantive changes to the administrator-in-training program shall be submitted to the Department for prior approval.
(4) Policies and Procedures. The administrator shall:
(a) In consultation with the governing body, develop and implement policies and procedures governing the operation of the facility, which include at a minimum those items in §F(1) and (2) of this regulation; and
(b) Ensure that all policies and procedures are:
(i) Reviewed by staff at least annually and are revised as necessary;
(ii) Available at all times for staff inspection and use; and
(iii) Appropriate personnel implement all policies and procedures adopted.
.04 Freestanding Dialysis Facilities — Staffing.
A. Nephrologist or Physician.
(1) The director of a freestanding dialysis facility shall be a nephrologist or a physician with at least 1 year of experience in chronic hemodialysis.
(2) Each freestanding dialysis facility shall have at least one additional nephrologist or physician trained in dialysis techniques to provide adequate continuous coverage.
B. Medical Director.
(1) Each freestanding dialysis facility shall appoint a medical director.
(2) The medical director shall be a physician who is board eligible or board certified by the American Board of Internal Medicine or the American Board of Pediatrics and:
(a) Has at least 12 months of experience or training in the care of patients at end-stage renal disease facilities; or
(b) Has served at least 12 months as a director of a dialysis or transplantation program before 1976.
(3) The medical director shall:
(a) Assure that quality medical care and technical expertise are provided in the freestanding dialysis facility;
(b) Supervise and be responsible for the overall medical, technical, and administrative functions of the freestanding dialysis facility including creation and enforcement of the freestanding dialysis facility's standards of care and basic operating procedures;
(c) Coordinate the comprehensive renal health care team to assure quality of care;
(d) Assure there are written policies which address a long term patient care plan to select the appropriate end stage renal disease modality;
(e) Assure that there are written policies outlining the freestanding dialysis facility's programs for in-center hemodialysis, home hemodialysis, and peritoneal dialysis modalities as applicable to that facility;
(f) Assure that the end stage renal disease patient has appropriate consultation with a renal dietitian, renal social worker, and other individuals as needed;
(g) Assure the appropriate execution of the dialysis orders and day to day patient care policy by the nursing and technical staff;
(h) Assure attending physician education and compliance with the freestanding dialysis facility policies on patient care and technical aspects;
(i) Participate in the selection of available treatment modalities and dialysis supplies to be offered by the freestanding dialysis facility and advise attending physicians;
(j) Approve policies and procedures ensuring the adequate training of nurses and technicians in dialysis science and techniques;
(k) Supervise the development of a dialysis water standards policy including implementation, monitoring, and enforcement;
(l) Supervise the development of a freestanding dialysis facility-specific policy on the adequacy of dialysis, which complies with State and federal guidelines;
(m) Supervise the development of a freestanding dialysis facility-specific policy on the administration of epogen and intradialytically administered medications;
(n) Assure that there are written policies regarding patient medical records, physical environment, fire safety, and emergency preparedness of the freestanding dialysis facility;
(o) Assure that there are written policies regarding patient care and facility personnel organization;
(p) Assure that there are written policies regarding patient education;
(q) Assure that there are written policies regarding medical staff bylaws and physician credentialing;
(r) Assure that there are written policies regarding freestanding dialysis facility-specific policies for dialyzer reuse/reprocessing, anemia management, adequacy of dialysis measures, dialysis water standards, immunization guidelines for Hepatitis B, influenza, and pneumococcal vaccines, and use of I.V. Vitamin D analogues and monitoring parameters associated with the development of renal osteodystropy;
(s) Assure quality improvement programs to monitor the policies listed in §B(3)(n)—(r) of this regulation and actively participate in the facility's quality improvement program;
(t) Assure attending physicians comply with State and federal mandates applicable to the freestanding dialysis facility;
(u) Assure attending physicians round on their patients at least monthly and document such on the patient's progress notes; and
(v) Establish documented practice goals within the freestanding dialysis facility, which should exceed minimal requirements to assure optimal patient care.
C. Nursing Services.
(1) Nurse Manager. The facility shall have a nurse manager responsible for nursing services in the facility that:
(a) Is a full time employee of the facility;
(b) Is a registered nurse;
(c) Has at least:
(i) 12 months of experience in clinical nursing; and
(ii) An additional 6 months experience in providing nursing care to patients on maintenance dialysis; and
(d) Participates in the facility's Quality Assessment and Performance Improvement Program.
(2) Charge Nurse. The charge nurse responsible for each shift:
(a) Shall be a registered nurse;
(b) Shall be on duty in the treatment area, at all times when patients are being treated, except for while on breaks, when the charge nurse shall be readily available;
(c) Shall have at least 12 months experience in providing nursing care, including 6 months of experience in providing nursing care to patients on maintenance dialysis; and
(d) May not be included in the staffing ratio except:
(i) When there are nine or fewer patients; or
(ii) In the event of an emergency.
(3) Staffing Exception Reporting.
(a) The freestanding dialysis facility shall have a staffing exception reporting protocol in a format approved by the Department for reporting to the governing body when emergency staffing situations arise that require the charge nurse to be included in the staffing ratio. The report shall include:
(i) The date and shift of the exception;
(ii) A description of the emergency staffing situation;
(iii) Actions taken in response; and
(iv) Any measures taken to ensure the center's future compliance.
(b) The exception reporting protocol shall be included in the center's quality assurance process.
(c) The staffing exception reports shall be made available to the Office of Health Care Quality and the Commission on Kidney Disease when they are conducting an inspection or survey of the center to assure compliance with §F(1) of this regulation.
D. Direct Patient Care Providers.
(1) Staffing Ratio.
(a) The monitoring individual-to-patient ratio at each facility shall be:
(i) A minimum of one staff member to three participants; and
(ii) Sufficient to meet the needs of patients.
(b) The facility shall establish provisions for back-up staff coverage during unexpected illnesses, vacations, and holidays.
(2) A monitoring individual shall:
(a) Be trained in dialysis procedures and may be a:
(i) Physician;
(ii) Physician assistant;
(iii) Nurse practitioner;
(iv) Registered nurse;
(v) Licensed practical nurse; or
(vi) Certified nursing assistant—dialysis technician; and
(b) Provide direct patient care during treatment, which shall include at a minimum:
(i) Initiation of treatment;
(ii) Termination of treatment; and
(iii) Monitoring vital signs.
(3) The Commission shall decide if this minimum standard may be too low for a particular freestanding dialysis facility.
E. Technical assistance by qualified personnel shall be available for the repair and maintenance of equipment.
F. The freestanding dialysis facility shall have sufficient social service and dietetic staffing by licensed and trained professionals available to meet the needs of the dialysis patients.
G. Psychiatric services may be obtained by referral to a licensed psychiatrist.
H. Social Worker.
(1) The social worker shall conduct comprehensive psychosocial assessment within 30 days of the patient initiating treatment at the dialysis facility.
(2) Annual Psychosocial Update.
(a) A comprehensive annual psychosocial update shall be conducted annually or more often if indicated.
(b) The annual psychosocial update shall include, at a minimum, the issues below:
(i) Review of treatment options;
(ii) Vocational rehabilitation;
(iii) Adjustment to illness issues;
(iv) Patient behaviors that may warrant discharge; and
(v) Any changes in the patient's relationships, living situation, and living wills.
(c) The annual psychosocial update may be included as quarterly documentation for psychosocially stable patients.
(3) The social worker shall document progress notes:
(a) At least quarterly for stable patients; and
(b) At least monthly or more frequently for unstable patients including, but not limited to, patients experiencing:
(i) Adult Protective Services or Child Protective Services involvement;
(ii) Housing crisis or change;
(iii) Change in support system if patient is a vulnerable adult or child;
(iv) Violent or abusive behaviors or events;
(v) Emotional or psychological crisis including suicidal tendencies or emotional distress;
(vi) Death or major illness in the family;
(vii) Financial crisis interfering with the patient's ability to secure food, transportation, or medication;
(viii) Extended or frequent hospitalizations;
(ix) Marked deterioration in health status or in functional status; or
(x) Situations that would warrant social work intervention.
(4) The social worker's progress notes shall contain, at a minimum:
(a) Documentation of the patient's adjustment to dialysis;
(b) Patient behaviors that may warrant discharge;
(c) Any referrals made to outside agencies; and
(d) Follow-up of psychosocial issues identified in previous social work notes or the assessment or update.
(5) The social worker shall:
(a) Recommend changes in treatment based on the patient's psychosocial needs;
(b) Provide case work and group work services to patients and their families in dealing with the special problems associated with end stage renal disease;
(c) Identify community agencies and other resources and assist patients and families in accessing and utilizing them; and
(d) Participate in continuous quality improvement activities and patient care planning
.05 Nocturnal Hemodialysis Programs.
A. Nephrologist or Physician
(1) The director of a freestanding dialysis facility shall be a nephrologist or a physician with at least 1 year of experience in chronic hemodialysis.
(2) A freestanding dialysis facility shall have at least one additional nephrologist or physician trained in dialysis techniques to provide adequate continuous coverage.
B. Medical Director.
(1) A freestanding dialysis facility shall appoint a medical director.
(2) The medical director shall be a physician who is board eligible or board certified by the American Board of Internal Medicine or the American Board of Pediatrics.
(3) The medical director shall:
(a) Assure that the facility has documented selection criteria for the nocturnal dialysis patient;
(b) Determine the patient’s appropriateness for nocturnal hemodialysis by considering and documenting the patient’s:
(i) Overall medical condition, including whether the patient is hemodynamically stable;
(ii) Expectations for care;
(iii) Response to in-center, daytime hemodialysis; and
(iv) Availability of transportation;
(c) Document the patient’s appropriateness for nocturnal hemodialysis in the patient’s medical record, including assessments and plans of care;
(d) Assure that an order from a physician, nurse practitioner, or physician assistant for nocturnal hemodialysis is written;
(e) Assure that only patients accepted into a nocturnal hemodialysis program shall dialyze on a nocturnal dialysis shift;
(f) Assure that quality medical care and technical expertise are provided in the freestanding dialysis facility;
(g) Supervise and be responsible for the overall medical, technical, and administrative functions of the freestanding dialysis facility including creation and enforcement of the freestanding dialysis facility's standards of care and basic operating procedures;
(h) Coordinate the comprehensive renal health care team to assure quality of care;
(i) Assure there are written policies which address a long term patient care plan to select the appropriate end-stage renal disease modality;
(j) Assure that there are written policies outlining the freestanding dialysis facility's programs for in-center hemodialysis, home hemodialysis, and peritoneal dialysis modalities as applicable to that facility;
(k) Assure that the end-stage renal disease patient has appropriate consultation with a renal dietitian, renal social worker, and other individuals as needed;
(l) Assure the appropriate execution of the dialysis orders and day-to-day patient care policy by the nursing and technical staff;
(m) Assure attending physician education and compliance with the freestanding dialysis facility policies on patient care and technical aspects;
(n) Participate in the selection of available treatment modalities and dialysis supplies to be offered by the freestanding dialysis facility and advise attending physicians;
(o) Approve policies and procedures ensuring the adequate training of nurses and technicians in dialysis science and techniques;
(p) Supervise the development of a dialysis water standards policy, including implementation, monitoring, and enforcement;
(q) Supervise the development of a freestanding dialysis facility-specific policy on the adequacy of dialysis, which complies with State and federal guidelines;
(r) Supervise the development of a freestanding dialysis facility-specific policy on the administration of epogen and intradialytically administered medications
(s) Assure that there are written policies regarding patient medical records, physical environment, fire safety, and emergency preparedness of the freestanding dialysis facility;
(t) Assure that there are written policies regarding patient care and facility personnel organization;
(u) Assure that there are written policies regarding patient education;
(v) Assure that there are written policies regarding medical staff bylaws and physician credentialing;
(w) Assure that there are written freestanding dialysis facility-specific policies for:
(i) Dialyzer reuse or reprocessing;
(ii) Anemia management;
(iii) Adequacy of dialysis measures;
(iv) Dialysis water standards;
(v) Immunization guidelines for Hepatitis B, influenza, and pneumococcal vaccines;
(vi) Use of I.V. Vitamin D analogues; and
(vii) Monitoring parameters associated with the development of renal osteodystropy;
(x) Assure quality improvement programs to monitor the policies listed in §B(3)(o)—(s) of this regulation and actively participate in the facility's quality improvement program;
(y) Assure attending physicians comply with State and federal mandates applicable to the freestanding dialysis facility;
(z) Assure attending physicians round on their patients at least monthly and document such on the patient's progress notes; and
(aa) Establish documented practice goals within the freestanding dialysis facility, which should exceed minimal requirements to assure optimal patient care.
C. Nursing Services.
(1) Nurse Manager. The facility shall have a nurse manager responsible for nursing services in the facility who:
(a) Is a full-time employee of the facility;
(b) Is a registered nurse;
(c) Has at least:
(i) 12 months of experience in clinical nursing; and
(ii) An additional 6 months of experience in providing nursing care to patients on maintenance dialysis; and
(d) Participates in the facility's Quality Assessment and Performance Improvement Program.
(2) Charge Nurse. The charge nurse responsible for each shift shall:
(a) Be a registered nurse;
(b) Be on duty in the treatment area at all times when patients are being treated, except for while on breaks when the charge nurse shall be readily available; and
(c) Have at least 12 months of experience in providing nursing care, including 6 months of experience in providing nursing care to patients on maintenance dialysis.
D. Direct Patient Care Providers.
(1) Staffing Ratio.
(a) Nocturnal Hemodialysis. When nocturnal hemodialysis is performed, the monitoring individual-to-patient ratio at each center for in-center nocturnal hemodialysis:
(i) Shall be a minimum of one staff member to five participants; and
(ii) May be sufficient to meet the needs of the patients.
(b) The center shall establish provisions for back-up staff coverage during unexpected illnesses, vacations, and holidays.
(c) The charge nurse may not be included in the staffing ratio except when there are nine or fewer patients.
(2) A monitoring individual shall:
(a) Be trained in dialysis procedures and may be a:
(i) Physician;
(ii) Physician assistant;
(iii) Nurse practitioner;
(iv) Registered nurse;
(v) Licensed practical nurse; or
(vi) Certified nursing assistant—dialysis technician; and
(b) Provide direct patient care during treatment, which shall include, at a minimum:
(i) Initiation of treatment;
(ii) Termination of treatment; and
(iii) Monitoring vital signs.
(3) The Commission shall decide if this minimum standard may be too low for a particular freestanding dialysis facility.
E. Technical assistance by qualified personnel shall be available for the repair and maintenance of equipment.
F. The freestanding dialysis facility shall have sufficient social service and dietetic staffing by licensed and trained professionals available to meet the needs of the dialysis patients.
G. Psychiatric services may be obtained by referral to a licensed psychiatrist.
H. Social Worker.
(1) The social worker shall conduct comprehensive psychosocial assessment within 30 days of the patient initiating treatment at the dialysis facility.
(2) Annual Psychosocial Update.
(a) A comprehensive annual psychosocial update shall be conducted annually or more often if indicated.
(b) The annual psychosocial update shall include, at a minimum, the following issues:
(i) Review of treatment options;
(ii) Vocational rehabilitation;
(iii) Adjustment to illness issues;
(iv) Patient behaviors that may warrant discharge; and
(v) Any changes in the patient's relationships, living situation, and living wills.
(c) The annual psychosocial update may be included as quarterly documentation for psychosocially stable patients.
(3) The social worker shall document progress notes:
(a) At least quarterly for stable patients; and
(b) At least monthly or more frequently for unstable patients, including but not limited to, patients experiencing:
(i) Adult Protective Services or Child Protective Services involvement;
(ii) Housing crisis or change;
(iii) Change in support system if patient is a vulnerable adult or child;
(iv) Violent or abusive behaviors or events;
(v) Emotional or psychological crisis including suicidal tendencies or emotional distress;
(vi) Death or major illness in the family;
(vii) Financial crisis interfering with the patient's ability to secure food, transportation, or medication;
(viii) Extended or frequent hospitalizations;
(ix) Marked deterioration in health status or in functional status; or
(x) Situations that would warrant social work intervention.
(4) The social worker's progress notes shall contain, at a minimum:
(a) Documentation of the patient's adjustment to dialysis;
(b) Patient behaviors that may warrant discharge;
(c) Any referrals made to outside agencies; and
(d) Follow-up of psychosocial issues identified in previous social work notes or the assessment or update.
(5) The social worker shall:
(a) Recommend changes in treatment based on the patient's psychosocial needs;
(b) Provide case work and group work services to patients and their families in dealing with the special problems associated with end-stage renal disease;
(c) Identify community agencies and other resources and assist patients and families in accessing and utilizing them; and
(d) Participate in continuous quality improvement activities and patient care planning.
.06 Home Dialysis Programs.
A. Location and Program Affiliation.
(1) Home hemodialysis or peritoneal dialysis programs, or both, may be situated in either a dialysis facility or hospital, as long as the appropriate standards are satisfied.
(2) To assure quality and continuity of patient care, the home dialysis program shall negotiate a formal affiliation agreement compliant with COMAR 10.30.01.08.
(3) The home dialysis program shall be affiliated with a certified transplantation center.
(4) Home dialysis programs shall provide sufficient backup dialysis stations through specific affiliation agreements with certified dialysis facilities.
(5) Home dialysis training performed by dialysis centers or facilities shall also meet the standards established in this regulation.
(6) Home dialysis programs shall make arrangements for appropriate medical records, patient care policies, dietetic services, social services, sanitation standards, and fire and safety standards.
(7) Patients dialyzing at home shall keep records of dialysis treatments and supplies used.
B. Physical and Medical Standards.
(1) Home dialysis programs shall:
(a) Contain a dialysis station for training with either beds or chairs;
(b) Contain floor space that assures usable space of at least 80 square feet of floor space per patient station that may include bed or chair space, nursing space, and work area, but excludes storage space;
(c) Contain space to be sufficiently flexible to provide access to any of the four extremities;
(d) Provide appropriate provisions to assure patient privacy;
(e) Provide refrigerated and nonrefrigerated storage space;
(f) Provide sufficient area and space for:
(i) Maintenance of equipment;
(ii) Storage of the equipment and supplies; and
(iii) Preparing and testing dialyzers;
(g) Utilize water of sufficient purity to prevent bacterial contamination, endotoxin, or toxic accumulation of trace elements; and
(h) Provide adequate backup center dialysis.
(2) Training.
(a) The home dialysis program shall maintain a written training manual and program that shall be available and approved by the Commission.
(b) The home dialysis program shall have patient training manuals available for patient utilization at times other than the dialysis procedure.
(c) The home dialysis program shall provide visual aids to complement instructional programs.
(d) It is generally accepted that training periods will vary depending on the needs of the patient and on the intensity and planning of the program.
(e) The training program shall also test the availability and purity of the water supply in the patient's home before home hemodialysis is instituted.
(f) The Commission shall review the training manual and program to determine if the length of training time is sufficient.
C. Staffing.
(1) Nephrologist or Physician.
(a) The director of the home dialysis program shall be a nephrologist or a physician with at least 1 year of experience in chronic dialysis including experience in home dialysis training.
(b) One additional nephrologist or physician shall be available to provide adequate continuous coverage.
(2) Medical Director. A home dialysis program shall appoint a medical director with the qualifications and responsibilities set forth in Regulation .04B(2) and (3) of this chapter.
(3) Additional Home Dialysis Program Requirements.
(a) Home dialysis programs shall maintain a minimum nursing staff requirement of one nurse per two training stations.
(b) The nurse in charge of training shall have at least 12 months experience in providing nursing care including 6 months of experience in dialysis and 3 months of experience in the specific modality for which the nurse will provide self-care training.
(c) Technical assistance by qualified personnel shall be available for the repair and maintenance of dialysis equipment in the home dialysis program and homes.
(d) Home dialysis programs shall assure that adequate personnel are available to provide periodic follow-up home visits to patients on home dialysis programs.
(e) The training programs shall have adequate social services and dietetic staffing by licensed and trained professionals.
(f) Psychiatric services may be obtained by referral to a licensed psychiatrist.
(g) In dialysis programs providing home dialysis training, dialysis personnel responsible for staffing the dialysis programs may participate in home dialysis training as long as the staffing ratio standards are met.
(4) Social Worker. The social worker shall comply with the duties and responsibilities set forth in Regulation .04G of this chapter.
D. Administration.
(1) The administration of the home dialysis program shall provide a copy of the Medicare cost report to the Department, or the Department's duly authorized agents, upon request.
(2) The home dialysis program shall provide designated administrative assistance to keep the necessary records as well as other information needed for accurate determination of cost.
E. Compliance. Home dialysis programs shall comply with the provisions set forth in Regulation .01B of this chapter, and with the requirements of this subtitle for certification purposes with the Commission.
.07 Self-Care Dialysis Facilities.
A. Location and Program Affiliation.
(1) Self-care dialysis facilities may be situated in free-standing dialysis facilities as long as appropriate standards are satisfied.
(2) To assure quality and continuity of patient care, including backup dialysis, the self-care dialysis facility or a hospital shall negotiate a formal affiliation agreement compliant with COMAR 10.30.01.08.
(3) Self-care dialysis facilities shall make arrangements for appropriate medical records, patient care policies, sanitation standards, and fire and life safety standards as defined in federal regulations for Medicare Programs and those of the Commission.
(4) Self-care dialysis facilities shall keep records of dialysis frequency and other factors relating to cost determination.
(5) For the purpose of protecting patient safety and welfare, a self-care dialysis facility may not withdraw or phase out services until:
(a) The self-care dialysis facility has notified the Commission as soon as possible of the self-care dialysis facility's intention to discontinue services;
(b) Patients being treated by that self-care dialysis facility have been transferred to another facility or the patients' continuing care assured to the satisfaction of the patients and the Commission;
(c) The self-care dialysis facility submits to the Commission evidence that transfer of patients to another facility has been satisfactorily accomplished; and
(d) Patients previously certified and being treated in a self-care dialysis facility that is being withdrawn from the Kidney Disease Program continue to have access to the same reimbursement principles of the Kidney Disease Program.
B. Physical Standards.
(1) A self-care dialysis facility shall:
(a) Make available adequate floor space that may include bed or chair space, nursing space, and work area, but excludes storage space;
(b) Arrange the space to be sufficiently flexible to provide access to any of the four extremities;
(c) Provide patient privacy and comfort;
(d) Provide refrigerated and nonrefrigerated storage space;
(e) Provide sufficient work area and space for:
(i) Maintenance of equipment;
(ii) Storage of equipment and supplies; and
(iii) Preparing and testing dialyzers; and
(f) Utilize water of sufficient purity, according to current Association for the Advancement of Medical Instrumentation recommendations which are incorporated by reference in Regulation .01B(4) and (5) of this chapter, to prevent bacterial contamination, endotoxin, or toxic accumulation of trace elements in patients undergoing long-term dialysis.
(2) Training. Self-care dialysis facilities shall provide training that includes:
(a) Visual aids to complement the instructional program; and
(b) Training periods that vary depending on the various needs of the patient and training program of the self-care dialysis facility.
C. Staffing.
(1) Nephrologist or Physician.
(a) The director of the self-care dialysis facility shall be a nephrologist or a physician with at least 1 year of experience in chronic dialysis.
(b) At least one additional nephrologist or a physician trained in dialysis shall be available to provide adequate continuous coverage.
(2) Medical Director. A self-care dialysis facility shall appoint a medical director with the qualifications and responsibilities set forth in Regulation .04B(2) and (3) of this chapter.
(3) Additional Self-Care Dialysis Facilities Requirements.
(a) Direct patient care providers shall be trained in dialysis procedures and may be a:
(i) Registered nurse;
(ii) Licensed practical nurse; or
(iii) Certified nursing assistant—dialysis technician.
(b) A charge nurse:
(i) Shall be a registered nurse;
(ii) Shall be on duty in the treatment area, except for while on breaks, when the charge nurse shall be readily available, at all times when patients are being treated;
(iii) Shall have at least 12 months experience in providing nursing care, including 6 months of experience in providing nursing care to patients on maintenance dialysis; and
(iv) May not be included in the staffing ratio except when there are nine or fewer patients or in the event of an emergency.
(c) Staffing Exception Reporting. The facility shall have a staffing exception reporting protocol in a format approved by the Department for reporting to the governing body when emergency staffing situations arise that require the charge nurse to be included in the staffing ratio. The report shall include, at a minimum:
(i) The date and shift of the exception; and
(ii) A description of the emergency staffing situation.
(d) Additional staffing may be achieved with the use of licensed practical nurses or certified nursing assistant—dialysis technicians.
(e) Supervisory nursing personnel, which includes the charge nurse, may not be included in the calculation of staff/patient ratio if the supervisory nursing personnel do not participate in the monitoring of dialysis.
(4) Technical assistance by qualified technicians shall be available for the repair and maintenance of equipment.
(5) In addition, the self-care dialysis facility shall have sufficient social service and dietetic staffing by licensed and trained professionals available to meet the needs of the dialysis patients.
(6) The self-care dialysis facility shall have psychiatric services available to patients by referral.
(7) Social Worker. The social worker shall comply with the duties and responsibilities set forth in Regulation .04G of this chapter.
D. Administration.
(1) The administration of the self-care dialysis facility shall provide a copy of the Medicare cost report to the Department, or the Department's duly authorized agents, upon request.
(2) The self-care dialysis facility shall provide designated administrative assistance to keep the necessary records as well as other information needed for accurate determination of cost.
E. Compliance. Self-care dialysis programs shall comply with the provisions set forth in Regulation .01B of this chapter and with the requirements of this subtitle for certification purposes with the Commission.
Administrative History
Effective date: December 22, 2003 (30:25 Md. R. 1846)
Regulation .01 repealed effective April 5, 2010 (37:7 Md. R. 571)
Regulation .02 amended effective April 5, 2010 (37:7 Md. R. 571)
Regulation .03 amended effective April 5, 2010 (37:7 Md. R. 571)
Regulation .04 amended effective April 5, 2010 (37:7 Md. R. 571)
Regulation .04C amended effective April 24, 2006 (33:8 Md. R. 733)
Regulation .04G adopted effective April 24, 2006 (33:8 Md. R. 733)
Regulation .05C amended effective April 24, 2006 (33:8 Md. R. 733); April 5, 2010 (37:7 Md. R. 571)
Regulation .06C amended effective April 24, 2006 (33:8 Md. R. 733); April 5, 2010 (37:7 Md. R. 571)
Chapter revised effective March 16, 2015 (42:5 Md. R. 486)
Chapter 03 Transmissible Diseases
Authority: Health-General Article, §§13-301—13-316 and 16-204, Annotated Code of Maryland
.01 Incorporation by Reference
Control of Communicable Diseases Manual which can be found in depository libraries under COMAR 10.06.01.01-1 is incorporated by reference.
.02 Patient Selection — Unrestricted Access to Care.
A. An end stage renal disease patient with any transmissible disease, may not be denied dialysis or transplantation by a certified Maryland dialysis or transplantation facility solely because of the potential for transmission of the transmissible disease, to other patients or treatment personnel.
B. If tours of the dialysis facility take place, the facility shall inform visitors of the risk of transmissible disease exposure and encourage thorough hand washing at the end of the tour.
.03 Preventive Measures.
A. A facility shall follow the infection control procedures established in the Control of Communicable Diseases Manual designed by the Centers for Disease Control (CDC) to control the spread of transmissible diseases.
B. General.
(1) The cardinal measure for preventing the spread of transmissible diseases is an understanding on the part of dialysis and transplantation personnel that each end-stage renal disease patient is potentially a transmitter of transmissible diseases.
(2) Hand Washing.
(a) Dialysis personnel shall practice thorough hand washing, per the Control of Communicable Diseases Manual, between successive contacts with dialysis patients.
(b) Dialysis facilities and transplant centers shall contain adequate hand washing facilities within the patient care area.
(3) Dialysis facilities and transplant centers shall conduct an in-service training session for transmissible disease including hepatitis and the control of hepatitis for newly employed dialysis personnel before the dialysis personnel may participate in patient care, and at least annually for all dialysis personnel.
(4) Dialysis facilities and transplant centers shall establish and enforce written procedures to implement the control of transmissible disease including viral hepatitis as set forth in the Control of Communicable Diseases Manual.
(5) Hepatitis B vaccine is recognized to be effective in producing immunity and is recommended for all staff and patients who are susceptible to hepatitis B virus infection.
(6) Dialysis facilities and transplant centers shall document testing to demonstrate active immunity by appropriate antibody titers.
(7) Hepatitis testing shall be conducted on patients and staff according to the Control of Communicable Diseases Manual.
C. Infection Control and Hygiene.
(1) To the extent possible, the dialysis facility shall physically separate, in time or space, patients who are antigen positive from those who are antigen negative.
(2) Dialysis personnel shall:
(a) Wear personal protective equipment (PPE) at all times while providing patient care;
(b) Be properly bandaged to prevent contact with blood or other bodily fluids, if dialysis personnel have lesions on any body parts;
(c) Wear PPE in activities and situations where contact with blood or other potentially infectious secretions may occur;
(d) Dispose of used gloves immediately upon completion of any procedure and practice thorough hand washing before any other patient contact;
(e) Take necessary precautions to avoid contact with contaminated surfaces and clothing and carefully clean contaminated surfaces with a suitable disinfectant immediately after the patient's dialysis session is ended; and
(f) Remove, dispose of, and replace patient linen and other station coverings immediately after the patient's dialysis session has ended.
(3) A dialysis facility may not permit staff members or visitors to eat, drink, or smoke in the treatment area.
(4) A dialysis facility shall follow the Control of Communicable Diseases Manual recommendations for staff immunization and surveillance for hepatitis B.
D. Disposal.
(1) Dialysis facilities shall assure that waste and disposable items are packaged or wrapped on the premises of the facility in plastic-lined containers which shall be clearly identified as possibly contaminated materials either by labels or color-coding.
(2) Before including used needles in the specially identified containers described in §D(1) of this regulation, dialysis personnel shall place these needles in separate, rigid containers.
(3) The dialysis facility shall incinerate or make arrangements for the incineration of the dialysis facility's waste in accordance with local, State, or federal regulations.
E. Decontamination. The dialysis facility shall assure that personnel place used linens, scrub clothes, gowns, and laboratory coats in transport bags clearly identified as possibly contaminated material either by labels or color-coding, and that:
(1) Individuals subsequently handling these materials are aware of potential contamination; and
(2) Specimens issuing from dialysis facilities are appropriately treated and identified as possibly contaminated material either by labels or color-coding.
.04 Detection Measures.
Dialysis facilities and transplant centers shall develop quality assessment and performance improvement (QAPI) measures for the surveillance of infection control practices.
Administrative History
Effective date: December 22, 2003 (30:25 Md. R. 1846)
Regulation .01 amended effective April 5, 2010 (37:7 Md. R. 571)
Regulation .02 amended effective April 5, 2010 (37:7 Md. R. 571)
Regulation .03 amended effective April 5, 2010 (37:7 Md. R. 571)
Regulation .04 amended effective April 5, 2010 (37:7 Md. R. 571)
Chapter 04 Dialyzer Reuse and Water Standards
Authority: Health-General Article, §§13-301—13-316 and 16-204, Annotated Code of Maryland
.01 Incorporation by Reference.
A. In this chapter, the following documents are incorporated by reference.
B. Documents Incorporated.
(1) 42 CFR §494.40, as amended; and
(2) 42 CFR §494.50, as amended.
.02 Dialyzer Reuse Standards.
A. Patient Information.
(1) The freestanding dialysis facility shall:
(a) Provide information to the patient or, if appropriate, the patient's health care decision maker concerning the center's reuse of dialysis supplies, including hemodialyzers and tubing and their suitability for reuse; and
(b) Obtain the patient's or, if appropriate, the patient's health care decision maker's informed consent regarding the reuse of dialysis supplies.
(2) The signed informed consent form shall be maintained in the patient's medical record.
B. Standards. If the freestanding dialysis facility reuses dialysis supplies, the medical director shall:
(1) Develop a dialysis reuse policy in accordance with 42 CFR §494.50, which is incorporated by reference; and
(2) Ensure compliance with the policy.
.03 Water Standards — Water Treatment System — Dialysis Facilities.
A. The dialysis facility shall record in a log system malfunctions or temporary failures to meet standards. Extended failure of 1 day or longer is unsuitable and out of compliance with these regulations.
B. The dialysis facility shall report system malfunctions at once to:
(1) The Office of Health Care Quality of the Department;
(2) The supplier as to the unprotected state of the dialysis facility; and
(3) The Commission.
C. If the freestanding dialysis facility experiences a water system failure that may threaten patient health or safety, the facility shall cease operations and implement its policies and procedures for handling emergencies, as provided in 42 CFR §494.40, which is incorporated by reference.
D. Each freestanding dialysis facility shall communicate water treatment issues with their local health emergency management agency and their local health officer.
E. Boiled Water Advisory.
(1) A facility may dialyze patients under a boiled water advisory if the water treatment components in use protect the product water from having chemical and microbial contamination.
(2) The facility shall have policies and procedures in place to identify the person responsible for monitoring the water quality and how often the treated water will be monitored.
(3) The medical director shall assure close monitoring of the product water under the boiled water advisory.
(4) If a deionization (DI) unit is being used as the main water treatment system, a submicron or endotoxin/ultrafilter downstream of the DI unit, diverted to the drain, shall be in place.
(5) If a deionization (DI) unit is being used as the main water treatment system:
(a) The deionization systems shall be monitored continuously:
(i) To produce water of one megohm/cm or greater specific resistivity; and
(ii) Using resistivity monitors that compensate for temperature and are equipped with audible and visual alarms which are audible in the patient care area;
(b) The audible and visible alarm shall be activated when the product water resistivity falls below 1.0 megohm/cm and the product water shall be prevented from reaching any point of use; and
(c) A submicron or endotoxin/ultrafilter downstream of the DI unit shall be in place.
(6) If an ultraviolet (UV) irradiator is used, the ultrafilter shall be:
(a) Located after the UV irradiator; and
(b) Monitored to detect any decrease in treated water quality.
(7) The facility shall perform weekly microbial assessment of the product water during the boiled water advisory.
(8) The facility shall maintain contact with the municipal water supplier in the event the water supplier chooses to 'shock' treat (hyperchlorinate) the distribution system to bring it back into compliance with the acceptable standards for drinking water.
(9) The facility shall contact the municipal water supplier at least annually in writing to identify their location, contact information and the needs of the dialysis facility during any water service interruption.
(10) Shocking of Water System.
(a) In the event the municipal water supplier 'shocks' the water system, chlorine/chloramine break through may occur. Water system testing procedures shall be reviewed with staff by the medical director to alert them for potential chlorine/chloramines break through so that patients will be protected from exposure to chlorine/chloramine.
(b) Every half-hour, the facility shall:
(i) Monitor the feed water for any increase in chlorine/chloramine; and
(ii) Test for chlorine/chloramine breakthrough after the first carbon filter.
(c) The half-hour testing described in §E(9)(b) of this regulation shall continue until 24 hours after feed water results return to normal.
Administrative History
Effective date: December 22, 2003 (30:25 Md. R. 1846)
Regulation .01B amended effective April 5, 2010 (37:7 Md. R. 571)
Regulation .02 repealed and new Regulation .02 adopted effective April 5, 2010 (37:7 Md. R. 571)
Regulation .03 amended effective April 5, 2010 (37:7 Md. R. 571)
Chapter 05 Fee Schedule
Authority: Health-General Article, §§13-301—13-316 and 16-204, Annotated Code of Maryland
.01 Scope.
This chapter governs dialysis facilities and transplant centers, except those exempted by statute, that are certified by the Commission for eligibility for reimbursement by the Kidney Disease Program for performance of dialysis or transplantation on certified patients with end-stage renal disease.
.02 Fees.
The following certification fees are established by the Commission and may be prorated for initial certification of a partial year:
A. Facilities with 0—39 patients ... $693;
B. Facilities with 40—49 patients ... $1,274;
C. Facilities with 50 or more patients ... $1,500;
D. Late fee ... 10 percent of fee; and
E. Facility roster fee (fee may be waived for patients) ... $55.
.03 Terms.
A. A facility shall pay to the Commission the certification fees set forth in Regulation .02 of this chapter within 30 days of the date that they are billed.
B. The Commission shall bill a facility within 30 days of the facility's certification or verification of the facility's certification by the Commission.
C. Billing shall be done on an annual basis.
D. The term of the certification is 1 year and is renewed on an annual basis.
E. Initial certification is only for the term of the current certification year.
F. A late fee of 10 percent of the assessed certification fee shall be charged in addition to the certification fee if payment is received more than 30 days after the due date.
G. A facility that fails to pay the certification fee, plus the late fee, more than 60 days after the due date shall be decertified.
H. The facility may not charge the patient for those fees which the Kidney Disease Program would have paid, had the facility complied with this subtitle.
.04 Prohibitions.
A facility or center may not receive funds from the Kidney Disease Program for certified services rendered, unless the facility is certified by the Commission and has paid in full the fee assessed it by the Commission in the time limit set forth by the Commission.
.05 Fund Administration.
The Chairman of the Commission or the Chairman's designee shall administer the Kidney Disease Fund as established under Health-General Article, §13-310.1, Annotated Code of Maryland.
Administrative History
Effective date: December 22, 2003 (30:25 Md. R. 1846)
