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Based on the number and nature of deficiencies cited, the hospital failed to comply with Condition of Participation of Compliance With Federal State and Local Laws. The hospital failed comply with state (Colorado) licensure requirements for an acute care hospital (Colorado 6 CCR 1011-1 Chapter IV General Hospitals). The facility failed to meet the following standards under the condition of Compliance With Federal State and Local Laws:

C0153 Licensure of the Critical Access Hospital (CAH)
In addition, the facility failed to ensure compliance with regulations under Chapter IV General Hospitals, related to Governing Board, Personnel and Waste Disposal.

C0154 Licensure/Certification/Registration of Staff/Providers
The facility failed to maintain complete and current personnel files of staff/providers, including those operating under a contractual agreement, to ensure that all staff/providers were currently licensed, certified, or registered, as required, by their various disciplines/professions.

Based on review of personnel/credential files, facility documents, policies/procedures and staff interviews, the facility failed maintain accurate and complete personnel/credential files and evaluate contractual agreements on a regular basis, to ensure that patients were receiving care in a safe environment by qualified staff/providers, in order to comply with state (Colorado) licensure requirements for an acute care hospital (Colorado 6 CCR 1011-1 Chapter IV General Hospitals).

The facility failed to comply with the following licensure requirements for Chapter IV:

Chapter IV, 3.102(2)
"(The governing board shall:) be responsible for all the functions performed within the hospital."

Chapter IV, 4.101(2)
"The hospital shall be organized formally to carry out its responsibilities. The administrative officer shall be responsible for developing and implementing a written plan of organization defining the authority, responsibility, and functions of each category of personnel."

Chapter IV, 7.102(1)
"There shall be personnel records on each person of the hospital staff including employment application and verification of licensure, competencies and credentials for medical staff."

Chapter IV, 30.102(1)
PROGRAMMATIC FUNCTIONS
(1) The hospital shall implement written policies and procedures to ensure the safe disposal of waste products. The policies and procedures shall address:...
Chapter IV, 30.102(1)(c)
"...infectious waste. Infectious waste shall be handled and disposed of in accordance with the requirements of C.R.S. 25-15-401, et seq."

Based on a review of personnel and credential files and interviews with staff, the facility failed to assure all personnel records were complete and maintained per regulations. Complete personnel records include verification of current licensure, certification, competencies, and credentials for medical staff.

An interview with the chief executive officer on 4/6/10 at approximately 11:30 a.m., revealed the following: the human resource department of the facility continues to be managed by a human resource manager from Hospital #2 as part of a management contract with that facility. S/he stated that the personnel files were maintained onsite at the facility and s/he had been assured by the human resources staff that all files were complete, as required by the plan of correction.

During the revisit, three personnel files (Sample Employees #1, #2 and #3) were reviewed on 4/6/10 and revealed the following findings:

Three of three personnel (Sample Employees #1, #2 and #3) files sampled contained incomplete or out-dated information.

1. The Personnel File for Sample Employee #1 contained no documentation, in the form of a resume or job application, of education or prior work experience, to establish qualification for his/her position.

2. The Personnel File for Sample Employee #2 contained a professional license that expired 1/31/10, required professional certification that expired 12/31/08, an employment contract (that served as a job description), which was dated 1997, no professional resume or job application to document profession education and prior work experience, and no evidence of current professional malpractice insurance, which was required in the employment contract. The file contained no evidence of a current ACLS (Advance Cardiac Life Support) certification, despite the fact that the employee functioned as a medical provider in the Emergency Department.

3. The Personnel File for Sample Employee #3 contained no documentation, in the form of a resume or job application, of education or prior work experience, to establish qualification for his/her position.

Based on the number and nature of conditions, the facility failed to comply with the Critical Access Hospital (CAH) Condition of Participation of Organizational Structure. The facility's governing body failed to assume responsibility for effectively determining, implementing and monitoring policies governing the total operation of the facility and for ensuring that those policies were administered so as to provide quality health care in a safe environment. Specifically, the governing body, in conjunction with the chief executive officer (CEO), failed to develop, revise and enforce facility policies and procedures in the following areas:
contractual agreements, personnel qualifications/records. The failures created the potential for negative patient outcome.

Findings:

C0241 Governing Body Responsibility for Operation of the CAH
The facility governing body failed to adequately develop, implement and monitor policies and procedures to ensure a safe patient care environment related to contractual agreements, personnel, records of biomedical equipment inspections and safe storage of biohazardous waste awaiting monthly removal by a contracted service.

Based on tours, staff interviews and review of meeting minutes, contracts/agreements, credential/personnel files, governing body bylaws and medical staff bylaws/rules/regulations, policies/procedures and other facility documents, the governing body failed to assume responsibility for effectively determining, implementing and monitoring policies governing the total operation of the facility and for ensuring that those policies were administered so as to provide quality health care in a safe environment.

Specifically, the governing body, in conjunction with the chief executive officer (CEO), failed to develop, revise and enforce facility policies and procedures in the following areas: contractual agreements, personnel qualifications/records, records of biomedical equipment inspections and safe storage of biohazardous waste awaiting monthly removal by a contracted service. The failures created the potential for negative patient outcome.

Findings:

1. CONTRACTUAL AGREEMENTS:
The governing body, in conjunction with the chief executive officer (CEO), failed to adequately develop, revise and enforce facility policies and procedures in the area of contractual agreements. They failed to ensure that contracts for human resources and overall management of the facility were adequately delineated in policies and procedures to ensure the provision of quality health care in a safe environment.

Reference Tag C0293 findings.

2. PERSONNEL FILES:
The governing body, in conjunction with the chief executive officer (CEO), also failed to establish and enforce policies/procedures regarding personnel records, including current licensure/certification, evidence of orientation/competencies, references, job descriptions, on all employees, including contract employees. They failed to ensure files were complete, up-to-date, and maintained by, and at the facility, as required.

Reference Tag C0293 findings regarding personnel files and Tags C0153 and C0154 regarding state licensure regulations related to personnel file documentation.

3. PATIENT/STAFF/VISITOR SAFETY MEASURES:
The governing body, in conjunction with the chief executive officer (CEO), failed to ensure that policies/procedures related to maintaining records of biomedical equipment inspections and providing for safe storage, by adequate refrigeration, of biohazardous waste awaiting monthly removal by a contracted service.

On 4/6/10 at approximately 11 a.m., the manager for environmental services was interviewed and stated the biomedical equipment inspections were completed by a contractual agreement with Hospital #2. When asked to provide a record of inspection of the equipment, s/he stated that those records were not provided to the facility. S/he agreed to contact the manager at Hospital #2 that was responsible for the biomedical inspections, to try to gain access to the inspection records. S/he later returned to state that the manager at Hospital #2 had stated that the records were maintained at Hospital #2, per their (Hospital #2's) policies and procedures. The manager stated that any information requested by the surveyor would be provided and left a phone number to be contacted. At approximately 2 p.m. the surveyor contact the manager at Hospital #2 by telephone and clarified that the records of biomedical inspections needed to be maintained by Hospital #1 and needed to be provided on an ongoing basis. S/he agreed to compile a record of inspections that was to be brought to the surveyor on 4/7/10. On 4/7/10, the manager from Hospital #2 brought a record of all biomedical equipment inspections for 2009-10 for review. It was clarified that since the inspections were a contracted service, they were required to provide a copy of the inspection reports, which was as much a part of the work product being provided, as the inspections and the affixing of the new stickers to the equipment. The manager agreed to provide inspection reports to the facility for their records, as inspections were completed.

During the 4/6/10 interview with the manager for environmental services, s/he provided documentation that biomedical waste was being collected and removed from the facility on a monthly basis by an outside contractor. During the interview, appropriate storage of the biomedical waste between monthly pick-ups was discussed. The manager was aware from contacts with the Hazardous Materials Division of the Colorado Department of Public Health and Environment, that there were safety standards for storage of biomedical waste. S/he stated that the standard provided that division was that any biomedical waste stored for more than 48-hours should be stored at a refrigerated temperature of 40 degrees Fahrenheit or lower. S/he stated that the hospital had no facilities for refrigeration of the stored biomedical waste, as required.

Based on the number and nature of conditions, the facility failed to comply with the Critical Access Hospital (CAH) Condition of Participation for Provision of Services. The facility's governing body and administrator/chief executive officer (CEO) failed to adequately manage, review and enforce the terms of contracts and agreements to ensure that a safe patient environment was maintained and the best interests/viability of the facility/hospital district were protected. The failure created the potential for negative patient outcome.

Findings:

C0292 Responsibility for All Services Provide By Contract/Agreement
The facility governing body and CEO failed to monitor services provided by contract/agreement for the purpose of ensuring that a quality patient care environment was maintained.

C0293 Compliance with CAH Conditions of Participation with Services Provided by Contract/Agreement
The facility governing body and CEO failed to monitor services provide by contract/agreement to ensure compliance with all applicable CAH Conditions of Participation.

Based on staff interviews and review of the contracts, facility documents, and meeting minutes, the chief executive officer failed to adequately oversee contractual services provided in the hospital and satellite facilities to ensure quality patient care and services. The failure created the potential for negative patient outcomes.

Findings:

Reference Tag C0293

Based on a staff interviews, and a review of personnel files, credential files, contracts, and meeting minutes, the chief executive officer (CEO) failed to adequately oversee contractual services provided in the hospital and satellite facilities ensuring quality patient care and enabling the Critical Access Hospital to comply with all applicable conditions of participation and standards for the contracted services. The failures created the potential for negative patient outcome.

Findings:

MANAGEMENT CONTRACTS WITH HOSPITAL #2:

On 8/19/09, during the previous survey, three of the contractual agreements between Hospital #1 and Hospital #2 were reviewed and revealed the following findings:

1. "Management Services Agreement," effective 5/29/03, in which Hospital #2 agreed to manage Hospital #1, as defined, in pertinent parts:
"...Section 1.02 Authority and Responsibility of the Manager (Hospital #2)"..."to conduct the day-to-day business of the Corporation (Hospital #1), (including licensing, financial management, budgeting, purchasing, billing and accounts receivable, bookkeeping and accounting, public relations, staffing and marketing activities)..."
"(h) recruitment, hiring, discharge, supervision and management of all persons employed by the Corporation (Hospital #1), and establishing all personnel policies for such employees including, but not limited to, working hours, wages, benefits, and personnel qualifications and criteria for hiring;..."

"Section 1.09 Limitations on the Duties and Authority of the Manager (Hospital #2)..."
"(b) Notwithstanding the authority granted to the Manager under this Agreement, in no event shall the Manager have any authority:
(i) to participate in any manner in the exercise of nursing, EMT or medical judgement...(xiii) to take any action or fail to take any action, or operate the Corporation in a manner that...(C) could cause the Corporation to be in violation of any other law or regulation which if violated, could cause a material adverse effect to the Corporation or any member or affiliate thereof..."

"Section 2.01 Administrator.
(a) During the Term of this Agreement, the Manager will provide a qualified Administrator who shall be responsible for the day-to-day administration of the Corporation (Hospital #1) subject to the approval of the Board. The Administrator shall maintain an office at the Corporation and shall spend substantially all of his or her working time at the Corporation. The Administrator shall have such specific duties as the Manager (Hospital #2) may assign from time to time. As part of his or her duties, the Administrator will have the authority to direct and manage the work activities of the staff of the Corporation, including the scheduling of work times, vacations and other matters.
(b) The Administrator will be and remain a direct employee of the Manager (Hospital #2). The Manager will be solely responsible for the payment of all salaries, bonuses, benefits, employment taxes, insurance and other costs associated with the Administrator and the Corporation shall have no liability therefor...
(d) The Administrator shall coordinate all services provided in connection with the Hospital and related health care facilities..."

"Section 6.09 Notices of Violations.
In the event the Corporation or the Manager, as the case may be (the 'Notified Party'), receives written notice of a violation, an alleged violation (or any findings relating thereto) (a 'Violation Notice") of any law, rule regulation, ordinance or other obligation imposed by any federal, local or other governmental or quasi-governmental authority, regarding the Corporation, the operation of the Corporation, or the Manager's right to manage the Corporation, then (a) the Notified Party shall provide written notice to the other party of the Violation Notice within five business days of such Notified Party's receipt of same; (b) the Manager shall take any and all actions reasonably necessary to correct the violation(s) or alleged violation(s) (and/or any findings of same) set forth in the Violation Notice; and (c) the Manager shall take any and all additional reasonable actions or steps necessary to attempt to prevent a recurrence of the events giving rise to such violation(s) (or findings). The Manager shall notify the Corporation, in writing, when such corrective actions have been taken, and shall provide to the Corporation the documentation received by the Manager (from the authority delivering such Violation Notice) evidencing that such corrective actions have been taken..."

"Section 6.26 No Obligation To Refer.
Each party acknowledges that neither party, nor any individual or institutional health care provider employed or otherwise engaged by or affiliated with either party in any way, is required as a condition of this Agreement or any other agreement between the parties to refer any patient to the Hospital or other person or entity for delivery of health care services..."

2. "Administrative Agreement/Medical Staff Credentialing," effective 12/29/2003, in which Hospital #2 agreed to provide medical staff credentialing services for Hospital #1, as defined, in pertinent parts:
"WHEREAS, (Hospital #1) desires to hire (Hospital #2), under the terms of this Agreement, to provide Medical Staff Credentialing services for the Hospital (#1);
NOW, THEREFORE, is consideration of the premises and the obligations undertaken by the parties pursuant hereto, (Hospital #1) and (Hospital #2) hereby agree as follows:
1. (Hospital #1's) Authority. (Hospital #1) shall retain responsibility and authority over the Hospital (#1) credentialing process except as specifically delegated to (Hospital #2) hereunder.
2. Authority and Responsibilities of (Hospital #2). (Hospital #2) shall provide (Hospital #1) with Medical Staff Credentialing Services for the Hospital (#1) as set forth below:
(a) Services at (Hospital #1)
(i) (Hospital #2) shall be responsible for the day-to-day credentialing function of the medical staff including initial and reappointment of Hospital (#1) medical staff members.
(ii) The Chief Quality Officer at (Hospital #2) will have administrative responsibility for the Medical Staff Credentialing process. The Chief Quality Officer will have dual reporting responsibility to the administrator/CEO and the CEO of (Hospital #2).
(iii) The Medical Staff Coordinator at (Hospital #2) will complete the day-to-day activities for the medical staff function at (Hospital #1). These activities will be completed at (Hospital #2) using (Hospital #1) medical staff files.
(iv) (Hospital #2) will develop a credentialing policy and procedure ...for (Hospital #1) HR (Human Resources) policies and procedures. Any recommendations for changes, improvements &/or deletions shall be presented to the Administrator/CEO for final approval.
(v) All files of (Hospital #1) medical staff members will remain the property of (Hospital #1) and be kept in a secured cabinet in (Hospital #1) administrative offices.
(vi) The Chief Quality Officer (of Hospital #2) and/or the Medical Staff coordinator will present files at the medical staff meeting and the meeting of the board.
(vii) Joint Commission on Accreditation Standards will be followed for credentialing purposes.
(viii) (Hospital #2) and (Hospital #1) shall mutually agree on job duties and responsibilities of the Medical Staff Coordinator (of Hospital #2).
(ix) (Hospital #1) and (Hospital #2) agree to determine reasonable performance standards for provision of credentialing services..."

3. "Administrative Services Agreement/Human Resources," effective 9/1/03, in which Hospital #2 agreed to manage the human resources (HR) functions of Hospital #1, as defined, in pertinent parts:
"WHEREAS, (Hospital #1) desires to hire (Hospital #2), under the terms of this Agreement, to provide Human Resources administrative services for the Hospital (#1);
NOW, THEREFORE, in consideration of the premises and the obligations undertaken by the parties pursuant hereto, (Hospital #1) and (hospital #2) hereunder.
Section 1. (Hospital #1's) Authority. (Hospital #1) shall retain responsibility and authority over the Hospital except as specifically delegated to (Hospital #2) hereunder.
Section 2. Authority and Responsibilities of (Hospital #2). (Hospital #2) shall provide (hospital #1) with human resources services...for the Hospital (#1) as set forth below.
(a) Staffing of HR Office at (Hospital #1).
(i) (Hospital #2) shall be responsible for the day-to-day operations and function of the Human Resources (HR) function at (Hospital #1). The Chief Quality Officer at (Hospital #2) will have administrative responsibility for the HR function and activities. The Chief Quality Officer will have dual reporting responsibility to the (Hospital #1)/CEO and the CEO of (Hospital #2).
(ii) General description of activities under this agreement are as follows:
(a) Advise (Hospital #1) on legal and regulatory matters....
(d) HR staff will generally utilize and 'ok' (Hospital #1) HR policies and procedures. Any recommendations for changes, improvements &/or deletions shall be presented to the Administrator/CEO for final approval.
(iii) (Hospital #2) shall provide to (Hospital #1) an HR staff member with an office in Hospital (#1). The hours of the staff member will be 8:00-17:00 daily. Staff member shall have a dual reporting responsibility to the CEO/Administrator at (Hospital #1) and the Assistant Director of Human Resources at (Hospital #2). All office supplies, computer, printer and telephone shall be provided by (Hospital #1). All software shall remain the property of (Hospital #1).
(iv) The Assistant Director of Human Resources from (Hospital #2) may be physically present at (Hospital #1) up to 16 hours per week. Other activities may be done by telephone/computer. The Assistant Director will audit payroll and be assigned by the Board as one of the plan administrators for any retirement plans at (Hospital #1).
(v) (Hospital #2) staff member will maintain the payroll and benefits program. Recommendation for addition, changes, deletions in any of the benefits &/or pay will be shared with the CEO/Administrator for final approval.
(vi) (Hospital #2) and (Hospital #1) shall mutually agree on job duties and responsibilities of the HR staff member.
(vii) (Hospital #1) and (Hospital #2) agree to determine reasonable performance standards for provision of Human Resources services...."
"Section 3. Responsibilities of (Hospital #1). At all times during the term of this Agreement, (Hospital #1) shall ensure that the Hospital (#1) operates a hospital facility in accordance with all applicable federal and state laws and regulations. In the event that any disciplinary actions or other actions are initiated against (Hospital #1), (Hospital #1) shall immediately inform (Hospital #2) of such action and the underlying facts and circumstances...."

Additional review of this agreement revealed no language defining the expectations/standards for maintaining complete and up-to-date personnel files, onsite, for all staff of Hospital #1, including contract staff, as required by state (licensure) and federal (CMS) regulations.

Review of the above management contracts, as well as other contracts revealed the following failures to monitor and enforce contracts that led to non-compliance with some CAH Conditions of Participation and their underlying standards.

Additional Findings Related to Regulatory Non-compliance:

Evaluation and Enforcement of Contracts:

1. On 4/6/10 at approximately 11 a.m., the manager for environmental services was interviewed and stated the biomedical equipment inspections were completed by a contractual agreement with Hospital #2. When asked to provide a record of inspection of the equipment, s/he stated that those records were not provided to the facility as a part of contracted service being provided.

2. Review of management/contractual agreements with Hospital #2, meeting minutes and personnel/credential files and staff interviews revealed the contracted services were not being consistently provided according to the terms of the agreements. The findings, in pertinent parts, were:

DAY-TO-DAY MANAGEMENT:
In addition, the management agreements stated the day-to-day operation of the facility (Hospital #1) would be provided by Hospital #2. Based on numerous interviews with Hospital #1 administrative staff, including the CEO, the director of nursing and the director of quality/safety/risk and several department managers that have dual responsibilities at Hospital #1, it was determined that many of the departments heads for Hospital #1 were really Hospital #2 department heads providing limited onsite direction to the departments at Hospital #1.

Specific areas of concern were the human resources manager and the medical records manager, who were both employees of Hospital #2.
- The human resources director infrequently attended management meetings at Hospital #1. During and interview with the manager on 4/6/10 at approximately 2 p.m., it was revealed that s/he relied on the onsite human resources clerk to manage the department. S/he stated that s/he was unaware that onsite personnel files were incomplete. The surveyor clarified that 3 of 3 personnel files (Sample Employee files #1, #2 and #3) reviewed were incomplete. It was clarified with the manager that under the contractual agreement between the two facilities, Hospital #2 was being paid by Hospital #1 to provide human resources department management and expertise to Hospital #1. It was clarified that Hospital #1 was still out of compliance with state licensure and CMS requirements related to personnel files because, of the failure to provide the human resources oversight and expertise that Hospital #1 had been paying for.
- The medical records director, an employee of Hospital #2, had the special Health Information certification and training that Hospital #1 relied on to be in compliance with medical records requirements, since the onsite employee was a medical records coder. During the survey, management meeting minutes were reviewed and revealed that the medical director did not attend management meetings at Hospital #1. A packet of e-mails and other paperwork was provided to the surveyor as evidence of the director's management of Hospital #1's medical records department from the Hospital #2 campus. Review of the packet on 4/7/10 revealed only evidence or oversight of coding, billing and reimbursement issues. The packet contained no evidence of medical records policy/procedure development, review or implementation. There was no evidence of monitoring or physician compliance with medical record completion requirements. There was no evidence of participation in discussions or planning related to centralized patient information data bases and electronic medical record acquisition, both of which the CEO stated s/he was addressing for future planning, in an interview on 4/6/10.

MAINTENANCE OF PERSONNEL FILES/INCLUDING LICENSURE/CERTIFICATION:
In addition, the management agreements stated that Hospital #2 would provide all human resource services for the hospital staff, including contracted staff, of Hospital #1.

During the revisit, three personnel files (Sample Employees #1, #2 and #3) were reviewed on 4/6/10 and revealed the following findings:

Three of three personnel (Sample Employees #1, #2 and #3) files sampled contained incomplete or out-dated information.

1. The Personnel File for Sample Employee #1 contained no documentation, in the form of a resume or job application, of education or prior work experience, to establish qualification for his/her position.

2. The Personnel File for Sample Employee #2 contained a professional license that expired 1/31/10, required professional certification that expired 12/31/08, an employment contract (that served as a job description), which was dated 1997, no professional resume or job application to document profession education and prior work experience, and no evidence of current professional malpractice insurance, which was required in the employment contract. The file contained no evidence of a current ACLS (Advance Cardiac Life Support) certification, despite the fact that the employee functioned as a medical provider in the Emergency Department.

3. The Personnel File for Sample Employee #3 contained no documentation, in the form of a resume or job application, of education or prior work experience, to establish qualification for his/her position.