Consent Agreement between
Greater Southeast Community Hospital and
DC Department of Health
August 12, 2003

Government of the District of Columbia
Department of Health

This Consent Agreement is entered into by the Department of Health (hereinafter "DOH") and Greater Southeast Community Hospital (hereinafter "GSCH") and shall become effective immediately upon the execution by the last signatory.

WHEREAS, DOH is the regulatory agency for the District of Columbia charged with licensing health-care facilities, including hospitals.

WHEREAS, GSCH is a hospital that has been licensed by DOH pursuant to the Health-Care and Community Residence Facility, Hospice and Home Care Licensure Act of 1983, D.C. Law 5-48, D.C. Official Code § 44-501 et seq., Title 22 of the District of Columbia Municipal Regulations, Chapters 20-23;

WHEREAS, the Hospital License issued to GSCH expired in 2002 and DOH subsequently issued to GSCH provisional licenses;

WHEREAS, DOH issued provisional licenses based on its finding of a pattern of deficient practices and significant incidents of noncompliance by GSCH;

WHEREAS, based on license inspections, complaint investigations and unusual incidents DOH has found that GSCH remains in noncompliance with licensing standards;

WHEREAS, DOH and GSCH understand and agree that noncompliance with licensing standards subjects GSCH to denial of the renewal of its Hospital License; and

WHEREAS, DOH and GSCH acknowledge and agree that by entering into this agreement, GSCH waives its right to challenge or appeal the decision of DOH with respect to compliance with the terms of this Consent Agreement before any administrative or judicial body, provided that the decision of DOH to deny or place restrictions upon GSCH license is in accordance with the Health-Care and Community Residence Facility, Hospice and Home Care Licensure Act of 1983, D.C. Law 5-48, D.C. Official Code § 44-501 et seq., Title 22 of the District of Columbia Municipal Regulations, Chapters 20-23, this Consent Agreement and other applicable laws and regulations.

WHEREAS, DOH and GSCH agree to all terms and conditions of this Consent Agreement, the parties agree that nothing in this Consent Agreement is intended to be, nor should it be construed as, an admission of any fact or the meaning or application or construction of any statute, rule or regulation, by GSCH, including without limitation, those facts or other statements contained in the "Findings" sections of the Conditions. The parties expressly agree that no statement in this Consent Agreement should have any evidentiary import with respect to any litigation or administrative proceeding initiated by or against GSCH, other than in connection with the enforcement of this Consent Agreement; and the parties agree that the Recitals as set forth herein above are incorporated herein by reference and made a part of the entire Consent Agreement.

NOW THEREFORE, DOH and GSCH agree to the following:

1. GSCH shall provide written proof of full compliance (the "Final Status Report") with Conditions I through V (each, a "Condition," and collectively, the "Conditions") attached hereto and made a part hereof no later than sixty (60) days from the effective date of this Agreement (hereinafter "the 60-day compliance period").

2. GSCH shall provide an "Action Plan" setting forth a compliance timetable for Conditions I – V. DOH and GSCH shall meet bi-weekly, beginning two (2) weeks after the effective date of this Consent Agreement to review efforts to satisfy performance measures for each condition. DOH will provide GSCH with a "Progress Report" on the status of compliance within 30 days from the effective date of the Consent Agreement.

3. Beginning two (2) weeks from the effective date of this Agreement, GSCH shall submit in writing a weekly status report (the "Status Report") to DOH documenting the efforts taken with respect to implementing the "Performance Measures" consistent with the "Reporting Requirements" of each Condition. The first report shall be submitted for the period covering the first week from the effective date. Each subsequent Status Report shall cover the weekly period ending seven (7) days before its submission. There will not be a Status Report for the last week of the 60-day compliance period, as GSCH shall then submit its Final Status Report.

4. This Consent Agreement is not intended as a waiver of any applicable laws and regulations except as expressly agreed to herein. DOH shall continue to act in accordance with its regulatory authority notwithstanding any provision in this agreement. GSCH is subject to compliance inspections at any time during the 60-day compliance period.

5. No provision of this Consent Agreement shall be modified, or amended except in writing by both signatories to this Consent Agreement.

6. At the conclusion of the 60-day compliance period, the Health Regulation Administration ("HRA") shall conduct a final inspection and issue a report on compliance with this Consent Agreement (the "HRA Report") based thereon.

a. If the HRA Report concludes that GSCH is in substantial compliance with all terms and conditions of this Consent Agreement, DOH shall issue to GSCH a license to operate as a hospital in accordance with the Health-Care and Community Residence Facility, Hospice and Home Care Licensure Act of 1983, D.C. Law 5-48, D.C. Official Code § 44-501 et seq., Title 22 of the District of Columbia Municipal Regulations, Chapters 20-23.

b. If the HRA Report concludes that GSCH is not in substantial compliance with any of the terms and conditions of this Consent Agreement, GSCH shall have an opportunity to appeal the HRA Report to the Director of the DOH. If after considering the appeal, the Director of DOH determines that GSCH is in fact in compliance with this Consent Agreement, then DOH shall issue to GSCH a license to operate as a hospital in accordance with the Health-Care and Community Residence Facility, Hospice and Home Care Licensure Act of 1983, D.C. Law 5-48, D.C. Official Code § 44-501 et seq., Title 22 of the District of Columbia Municipal Regulations, Chapters 20-23. If after considering the appeal, the Director of DOH determines that GSCH is not in substantial compliance with this Consent Agreement, then in accordance with District law and regulations, DOH may either:

i. issue a license but place restrictions on such license as may be required to protect public health, safety and welfare; or

ii. revoke such license as may be required to protect public health, safety and welfare by immediately issuing a notice of denial of the pending license application. Any and all provisional licenses shall be deemed immediately revoked upon any such revocation of the license pursuant to this subparagraph (ii). By executing this Consent Agreement, GSCH [will not be able to appeal the final decision of the Director of DOH to any administrative or judicial body or to contest the Director’s final decision in any other manner.

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The emergency room shall be under the direction and supervision of a physician at all times.

Rationale: The Emergency Department (ED) should be adequately staffed by qualified personnel with knowledge and skills sufficient to evaluate and manage those who seek emergency care.

Findings: Triage: ED personnel and nursing staff failed to ensure that patients were triaged according to Policy No. 508.2 ‘Triage Disposition’, Policy No. 505.1 ‘Triage’ and Policy No.1-040 'Patient Assessment'.

Findings of HRA complaint and incident investigations indicate that the failures to follow these policies may have resulted in delay of treatment which may have contributed to at least three (3) deaths in the ED.

Discharge Planning & Patient Education: Medical and nursing staff are not adhering to Policy No.1-005.2 "Discharge of Patient, Discharge Planning and Policy No. 02-015"Patient and Family Education.

(1) At all times at a minimum, two (2) physicians will be available on duty to support twenty-four hour coverage in the ED. One physician (in a 24 hour period) must be board certified.

(2) At all times have a staff person assigned the responsibility for ED discharge planning; including appropriate assessments, educational materials and referrals.

(3) Provide timely re-evaluation of patients awaiting admission to the ED after triage as well as those patients waiting for admission to the hospital.

(1) Provide for the availability of two physicians in the ED at all times.

(2) Provide schedule of planned coverage.

(3) Provide credentials for Board Certified physician.

(4) Provide and maintain staff responsible for discharge planning; focus coverage for the hours of 5pm-10pm and weekends.

(5) Conduct staff training on discharge planning protocols and procedures.

(6) Provide evidence that discharge planning information is in patients’ medical record.

(7) Triage patients within 30 minutes of arrival in the ED.

(8) Provide evidence that re-evaluation on waiting pre-admitted and triaged patients is documented in patients’ medical records per hospital policy.

(9) Provide evidence of orientation to the mission and operating practices for physicians in the emergency department.

Compliance: All nine requirements must be met.

Reporting: Submit weekly reports and related data on the status of performance measures including:

(1) Names and credentials of ED physicians;

(2) Schedules for ED physician coverage;

(3) Name and schedule for ED discharge planner;

(4) Schedule and sign-in sheets for staff training on discharge planning protocols;

(5) Documentation of compliance with hospital policy and timeframes for patients triaged as CORE and ASAP status;

(6) Documentation of notification to DOH within twenty-four (24) hours of any instance of cardiac arrest and/or death that occurs in the ED after triage or before admission to the inpatient hospital;

(7) Method of evaluation and reassessment of staffing requirements for ED; and

(8) Schedule and sign-in sheets for orientation of physicians to mission and operating practices.

Report weekly on the status of ED operations to the Department of Health, Chief Medical Officer, Michael Richardson, MD.

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Must receive certification of the Fire Chief that the premises are suitable (i.e. meet applicable provisions of the Life Safety Code) for the operations of a hospital.

22 DCMR 2303.3

Must provide a secondary source of power.

22 DCMR 2301.1

All equipment in proper operating condition at all times.

Rationale: The proper operation of fire, life support and medical equipment is necessary to protect the health and safety of patients, staff and visitors to the hospital.

Findings: District of Columbia Fire and Emergency Medical Services Department (FEMS) has not certified that GSCH is in compliance with the Fire and Safety Code requirements for licensure. Medical equipment is not properly operating at all times which results in a delay in treatment and delivery of services.

(1) Ensure that there is a fully functioning secondary power source.

(2) Design, install and maintain commercial suppression cooking per BOCA 1996 and NFPA 96.

(3) Provide an adequate and reliable water supply source for the sprinkler system which is under continuous and automatic pressure.

(4) Ensure that the Computerized Axial Tomography (CAT) scanner is in proper operating condition at all times.

(5) Ensure that patient monitors and printers are in proper operating condition at all times.

(1) provide evidence that GSCH has received Fire Department certification of compliance with the following:

(a) Submit a revised GSCH Project Management Plan ("Plan") that prioritizes the tasks to be accomplished, in order from the greatest scope of severity to least; The Plan must include a performance schedule that contains milestones and tracks the progress of completion for all items included in the Plan. The Plan will list the contractors hired for each component and state the estimated start and completion date for each project;

(b) Installed and test commercial kitchen suppression system; and

(c) Ensure the proper functioning of the secondary power supply (emergency generator). GSCH must submit an action plan that includes estimated start and completion dates.

(2) Provide evidence that the CAT scanner is in proper operating condition.

(3) Provide evidence of maintenance contracts that are current and in effect for the CAT-SCAN

(4) Maintain patient monitors/printers in the ED

(5) Maintain fetal and cardiac monitors/printers in the OB/GYN and L&D areas that function properly at all times.

Compliance: All five requirements must be met.

Reporting: Submit weekly reports on status of performance measures 1-5.

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Each hospital shall provide a nursing staff that is adequate for the diagnostic facilities and services, and rehabilitation facilities and services that the hospital undertakes to provide.

22 DCMR 2112.9

All nursing personnel shall be qualified by education, experience and demonstrated ability for the positions to which they are assigned.

Rationale: Competency of nursing staff is enhanced through a well-trained consistent workforce, knowledgeable of the hospital’s policies and procedures.

Findings: DOH/HRA monitors have confirmed that nursing staff for the emergency department and critical care units are primarily agency nurses. The result is a nursing staff that is not familiar with the policies, procedures and protocols of GSCH, which impacts the continuity of care for patients. The inability to staff these units results in the ED going to ‘reroute status’ and delay in admitting of patients to the hospital. Based on findings of HRA complaint and incident investigations these factors may have contributed to the two (2) transfusion deaths and at least three (3) ED patients’ deaths.

(1) GSCH will secure a contract with a primary and secondary nurse staffing agency to establish a core staff assigned to the ED and critical care units in 13 week increments.

(2) Develop and implement programs (didactic and competency based) to increase nursing staff competency in both critical and non-critical care units/areas.

(3) Establish a mandatory hospital, nursing, and unit specific orientation for all agency staff utilized by GSCH.

(1) Document efforts to increase the number of GSCH nursing staff, including recruitment and retention activities, i.e., advertising, interviews, contracts and track disposition data.

(2) Establish a mandatory nursing orientation and training competency program for all nursing staff.

(3) Establish a mandatory orientation program for nursing staff in unit specific practice areas.

(4) Develop and implement a critical care program, for newly hired staff, to include ICU and emergency room curriculum within 30 days.

(5) Document a staffing pattern for GSCH nursing staff in the emergency department and critical care units.

(6) Performance evaluations will be conducted for each agency nurse at the end of each 13-week period or the length of time the agency nurse works at GSCH, whichever is shorter.

Compliance: All five requirements must be met.

Reporting: Submit weekly documentation of:

(1) Number of potential nursing candidates interviewed;

(2) Number of nursing staff hired;

(3) Copies of advertisements for recruitment of staff;

(4) Retention initiatives;

(5) Copies of Hospital, nursing and unit orientation materials;

(6) Copies of all nursing staff competencies;

(7) Documentation of all agency nursing staff orientation;

(8) Submit copy of curriculum for critical care course; and

(9) Evidence that all nursing staff have met the identified Competencies.

(b) Adopt administrative policies and rules for the operation of the hospital;

(c) Establish a medical staff composed of physicians and other allied practitioners who accept the responsibility for the medical and dental of care the patients; and

(d) Require the medical staff to be organized with a chief of staff, president, or chairperson, and to be governed by written bylaws.

22 DCMR 2101.1

Each hospital shall have a medical staff that shall be responsible for carrying out the provisions of the bylaws, and shall recommend to the governing body bylaws, or amendments to the bylaws, as they deem appropriate to the operation of the particular hospital.

22 DCMR 2101.2

The medical staff of each medical service, surgical service, obstetric service, pediatric service, psychiatric service, roentgenological service, and anesthesiological service shall be organized under the directorship of an internist, surgeon, obstetrician, pediatrician, psychiatrist, roentgenologist, and anesthesiologist respectively, each of whom shall be responsible for the polices, procedures, and supervision of the medical work in his or her respective service.

Rationale: Medical leadership is necessary for effective implementation and sustainability of all performance improvement activities.

Findings: Medical staff have failed to endorse the policy titled "Plan for the Provision of Care" No. 12-001, Section Eleven (11) titled "Administrative Responsibility" which states "the Chief Operating Officer and the President of the Medical Staff have day-to-day responsibility for administering this policy."

(1) Develop and approve policies and procedures for restraints, pain management, conscious sedation, anesthesia, and infection control.

(2) Physician membership is present on all GSCH standing committees.

(3) Medical Executive Committee (MEC) and Greater Southeast Community Hospital (GSCH) Administration will meet regularly.

(1) Provide a copy of written recommendations from all standing hospital committees that have been provided from the Medical Executive Committee to the GSCH Board and Administration.

(2) Provide a list of all hospital standing committees and identify the physician membership of each committee.

(3) Provide outcome measures for all policies developed and reviewed by the Medical Executive Committee with method of evaluation.

Compliance: All three requirements must be met.

Reporting: Submit weekly reports on status of performance measures 1-3.

Condition V: PERFORMANCE IMPROVEMENT

Standard(s): 22 DCMR.2100.2 (b)

The governing body shall adopt administrative policies and rules for the operation of the hospital.

Rationale: A functioning hospital performance improvement program is necessary for ensuring compliance with accepted medical and public health practices and standards.

Findings: The hospital lacks evidence that a performance improvement program has been integrated and implemented.

Quality Improvement Program : Effective as of May 3, 2003 the following policies have not been implemented: Policy No. 12-001- "Plan for the Provision of Care Policy"; No. 12-002- "Quality Performance Improvement and Patient Safety"; Policy No 12-003- "Process Improvement, Design Development Methodology and Tool."

Patient Rights Informed Consent: Medical and nursing staff failed to adhere to the policy titled "Documentation of Informed Consent for Surgery, Anesthesia, Special Procedure or Blood Products" No. 6-005, Section One and Section Three, "A separate consent form shall be obtained for each procedure. Where anesthesia is required, informed consent for anesthesia shall be given and a separate consent for anesthesia shall be obtained."

Pain Management Assessments: Nursing staff failed to adhere to the following policies- "Pain Assessment Scales /Pain Flow Sheet, "Policy No. 5-501, Purpose, "To assure the patient’s right to appropriate assessment and management of pain." Section three of policy titled "Vital Signs", No.1-045 which stipulates, "Pain assessment should occur at least at the beginning of the shift and prn (as needed)."

Skin Integrity Assessment & Wound Care: Nursing staff failed to adhere to the policy titled "Skin & Wound Care 7-011.0 and Patient Database GSCH Form 214."

Infection Control: GSCH does not have an identified infection control program or infection control practioner.

(1) Provide a full-time Director for Performance Improvement.

(2) Establish a Performance Improvement Committee (PIC) to review and monitor the implementation of a performance improvement program.

(3) Demonstrate implementation of the GSCH Performance Improvement program by the end of sixty (60) days.

(4) GSCH shall identify a GSCH personnel to work with the consultant on implementing the program.

Performance Measures: Provide the following:

(1) Evidence that PIC Committee has been established;

(2) Evidence of implementation of a Performance Improvement Plan to address comprehensively pain management, wound care, informed consent, and infection control at the end of sixty (60) days; and

(3) Evidence of staff training sessions for the following areas: pain management, wound care, informed consent, and infection control at the end of sixty (60) days.

Compliance: All three requirements must be met.

Reporting: (1) Submit weekly:

(a) A listing of the patients currently in restraints; along with the rationale for use of the restraint.

(b) The number of nutritional assessments initiated and documentation of follow-up completed;

(c) A list of all patients with hospital acquired nosocomial infections and wounds; and

(d) Current list of all physicians trained and certified in the use of conscious sedation.

(e) Provide documentation of informed consents and pain assessments for all applicable patients subject to review by DOH/HRA monitors.

Standard Met

Date

Standard Unmet

Date

BY signing below, the parties agree to all terms and conditions stated herein.

Signed on this the 12 day of August, 2003.

by: James Buford

Title: Director, Department Of Health

Signed on this the 12 day of August, 2003.

by: Joan Phillips

Title: Administrator, Greater Southeast Community Hospital