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Based on the manner and degree of deficiencies cited, the hospital failed to be in compliance with the Condition of Participation of Governing Body. The hospital failed to have an effective governing body legally responsible for the conduct of the hospital as an institution that ensured that all patient requirements were met.

The facility failed to meet the following standards under the Condition of Participation of Governing Body:

A 0083 Contracted Services
The facility failed to be responsible for services furnished under contracts in the hospital. The governing body failed to ensure that contractors of services furnished services that permitted the hospital to comply with all applicable conditions of participation and standards for the contracted services.

A 0084 Contracted Services
The governing body of the facility failed to ensure that services performed under contract were provided in safe and effective manner. Specifically, the facility failed to integrate a review of the services provided under contract into the facility's Quality Assessment and Performance Improvement (QAPI) program.

A 0085 Contracted Services
The governing body failed to maintain a list of all contracted services. The list the facility maintained did not include the scope and nature of the services provided.

In addition, the Governing Body of the facility failed to ensure the following other Conditions of Participations were met:

Tag A 0263 - Condition of Quality Assurance/Performance Improvement (QAPI)

Tag A 0431 - Condition of Medical Record Services

Based on review of the facility's documents, staff interview, and the facility's policies/procedures, the facility failed to be in compliance with the Condition of Participation of Quality Assessment and Performance Improvement (QAPI). The facility failed to develop, implement, and maintain an effective, ongoing, hospital-wide, data-driven QAPI program. Specifically, the facility failed to ensure that the QAPI program involved all hospital departments and services (including those services furnished under contract or arrangement).

The findings were:

1. On 9/14/11, the meeting minutes for the quality committee and the quality reports for 2011 were reviewed and revealed that evaluation of the safety and effectiveness of contracted services was not reflected in the activities of the quality committee or in the quarterly reports submitted to the quality committee.

2. On 9/14/11 at approximately 8:00 a.m., the director of quality and risk management was interviewed and acknowledged that the hospital did not track the quality of contracted services in the quality committee or in the quarterly reports submitted to the quality committee. S/he stated that s/he intended to incorporate monitoring of the quality of contracted services into the quality committee and quality reports going forward.

3. Reference Tags A 083 and A 084 for findings related to the hospital's failure to ensure that contracted services were safe and effective and complied with all CMS Conditions of Participation and related standards.

Based on the manner and degree of the deficiencies cited, the facility failed to be in compliance with the Condition of Participation for Medical Record Services. The hospital failed to have a medical record department that demonstrated administrative responsibility for medical records. The facility failed to meet the following standards under the condition of Medical Record Services:

A 0432 Organization and Staffing
The facility failed to ensure that the employees met the educational requirements needed for the Director of HIM (Health Information Services). Specifically, the department Director failed to have the required registrations needed for the position and there was not a timeframe given to obtain the required registrations.

A 0442 Security of Medical Records
The medical record services failed to ensure that unauthorized individuals could not gain access to or alter patient records. Specifically, there was access to patient medical records by the building owner who is not employed by the hospital. The patient medical records were openly displayed to all who entered the department.

An unannounced onsite recertification survey was conducted (see event ID #C7XR21) October 12 through October 13, 2011 by two (2) Life Safety Code Inspectors and included an inspection for compliance with the fire safety requirements of NFPA (National Fire Protection Association) 101, Life Safety Code, (2000 edition) and NFPA 99 Health Care Facilities (1999 Edition). The facility failed to comply with the regulations set forth. Deficiencies were cited under Life Safety Code tags K0018, K0025, K0027, K0029, K0050, K0052, K0056, K0062, K0064, K0076, K0144 and K0147.
See survey event ID #C7XR21 for full details of the cited deficiencies.

Based on review of facility documents, meeting minutes, governing body bylaws, and staff interview the facility failed to be responsible for services furnished under contracts in the hospital. The governing body failed to ensure that contractors of services furnished services that permitted the hospital to comply with all applicable conditions of participation and standards for the contracted services.

The findings were:

Cross Reference to A 0084 Contracted Services: for findings related to the facility's failure to ensure that services performed under contract were provided in safe and effective manner. Specifically, the facility failed to integrate a review of the services provided under contract into the facility's Quality Assessment and Performance Improvement (QAPI) program.

Cross Reference to A 0085 Contracted Services: for findings related to the facility's failure to maintain a list of all contracted services. The list the facility maintained did not include the scope and nature of the services provided.

Based on review of meeting minutes, governing body bylaws, and staff interview the facility failed to ensure that services performed under contract were provided in safe and effective manner. Specifically, the facility failed to integrate a review of the services provided under contract into the facility's Quality Assessment and Performance Improvement (QAPI) program.

The findings were:

Review of the facility's Governing Body Bylaws revealed the following, in pertinent part:
"...4.3 Duties and Responsibilities. The Governing Board shall have the following duties and responsibilities:...
R. Ensure that all contractors providing contracted services for the Hospital, including shared services and joint ventures, furnish such services in a safe and effective manner that permits the Hospital to comply with all applicable rules, regulations, and standards for contracted services..."

A review of the facility's QAPI program minutes revealed that the facility did not include services provided by contracted vendors including contracted laboratory, radiology, and biomedical engineering/preventative maintenance services.

An interview with the facility's Director of Quality and Risk Management on 9/14/2011 at approximately 7:45 a.m., revealed that contracted services were not included into the QAPI program but were being integrated into the QAPI program immediately which would include doing audit tools quarterly which would be reviewed by the QAPI program, the medical director, and the CEO. S/he stated that at the time of survey and previously, the facility had done problem driven evaluation of contracted services with a review of the actual contract and need for the contracted service by the Medical Executive Committee and the Governing Body annually.

A review of the facility's Governing Body meeting minutes from the meeting held on February 16, 2011, revealed that an "Annual Review of Contracts" was completed which included 61 contracts. However, there was no specific mention of the quality of any one contracted services provided.

An interview with the facility's Chief Nursing Officer (CNO) on 9/13/2011 at approximately 9:50 a.m., revealed that the facility had been dissatisfied with the quality of the contracted lab service due to results not being reported timely and samples being lost as well as billing issues.

An interview with the facility's Director of Respiratory Therapy on 9/13/2011 at approximately 11:25 a.m., revealed that the facility was dissatisfied with the quality of the contracted laboratory service due to samples not being picked up at agreed upon times and samples being lost. S/he stated that the facility had been in dialogue with the contracted service provider and had been trying to come up with solutions.

An interview with the facility's Director of Plant Operations on 9/13/2011 at approximately 12:50 p.m., revealed that the facility was dissatisfied with the quality of the contracted biomedical engineering/preventative maintenance service due to equipment not being marked as serviced and not completing work according to the agreed upon contract. S/he stated that the facility's corporate staff was working on seeking other contractors as a possibility to solve the facility's concerns.

Based on staff interview and review of facility documents, the facility failed to maintain a list of all contracted services. The list the facility maintained did not include the scope and nature of the services provided.

The findings were:

Upon entering the facility on 9/12/2011, the facility was requested to provide a list of all contracted services. Subsequently, a list of contracts was provided to the surveyors on 9/12/2011. The list contained columns for the "contracting entity," "vendor", "contract type," and "description".

An interview with the facility's Director of Quality & Risk Management conducted on 9/12/2011 at approximately 3:20 p.m., revealed that the list was "a comprehensive list" which should contain all of the contracted services the facility utilized. A subsequent interview on 9/12/2011 at approximately 4:25 p.m., revealed that the list did not contain the company that provided biomedical engineering and preventative maintenance of the facility's patient care equipment. An interview on 9/14/2011 at approximately 10:15 a.m. with the Director of Quality & Risk Management, revealed that a contracted company that performs audits of the facility's medical records regularly was not included on the list provided, but that it "should be on that list."

A review of the list revealed that entries for services did not include the scope and nature of the services provided by the contractor. The facility utilized an outside imaging facility for testing that could not be performed onsite. The contractor listing on the provided list did not have a description and stated that the contract type was a "Professional Services Agreement." Another company that was contracted to bring in equipment and personnel to provide additional diagnostic imaging testing was listed on the provided list but only had "Imaging Services" as a description. The listing did not provide the scope and nature of the services provided. The facility had a contract with a local acute care hospital for radiology testing and laboratory testing. The listing for the facility stated "Hospital Purchased Services" for the description. The listing did not provide the scope and nature of the services provided.

Based on review of medical records and policies/procedures, the hospital failed to ensure that there was a written modification to the patient's plan of care when restraints were utilized in 2 (sample patients #7 and #20) of 29 patients.

The findings were:

1. Review on 9/13/11 of the policy/procedure titled "Restraints" revealed the following, in pertinent parts:
"..Restraints are:
...7. Used in accordance with a written modification to the patient's plan of care...
...D. Guidelines...
...2. Restraint for Acute Medical and Surgical Care
...c. Orders for Restraints
...6. The order must be in accordance with a written modification to the patient's plan of care..."

2. Medical Record Reviews:

On 9/14/11, the medical record for sample patient #7 was reviewed. It revealed the patient was transferred from an acute care hospital to the facility on 8/3/11 with the primary diagnoses of bacteremia, diskitis with osteomyelitis and renal insufficiency. The patient had a feeding tube and was placed in restraint mitten on 9/9/11 through 9/11/11 to prevent patient attempts to remove the feeding tube. The patient expired on 9/12/11 secondary to bacteremia. Review of the "Transdisciplinary Plan of Care" revealed that the Problem #17 on the standardized form was for Restraints. The review indicated that the care plan was not modified to note that the patient was placed in bilateral mitten restraints on 9/9/11 through 9/11/11.

On 9/14/11, the medical record for sample patient #20 was reviewed. It revealed the patient was transferred from an acute care hospital to the facility on 9/8/11 with the primary diagnoses of aspiration pneumonia and respiratory failure. The patient had a feeding tube, tracheostomy tube, other medical lines and required ventilation support. On 9/11/11, the patient was placed in bilateral soft wrist restraints. Review of the "Transdisciplinary Plan of Care" revealed that the Problem #17 on the standardized form was for Restraints. The review indicated that the care plan was modified to note that the patient was placed in bilateral wrist restraints on 9/11/11, but no modification to the care plan was done when the patient was continuing in restraints or removed from restraints as of 9/13/11.

Based on review of medical records and policies/procedures and staff interviews, the hospital failed to ensure that each application of restraints for medical purposes was ordered by a physician and renewed, if needed, every 24 hours, as required in two (sample patients #20 and #29 of 29 patients.

The findings were:

1. Review on 9/13/11 of the policy/procedure titled "Restraints" revealed the following, in pertinent parts:
"...D. Guidelines...
...2. Restraint for Acute Medical and Surgical Care
...c. Orders for Restraints
1. All restraints are use only upon the individual order of a physician...
6. The order must be in accordance with a written modification to the patient's plan of care...
7. The physician order should not exceed a period of 24 hours.
8. Continued use of the restraint beyond the first 24 hours is authorized by a physician by using a new order if the restraint continues to be clinically justified...
...Procedure...
...C. Physician's order must be written before application of restraint except in emergency. Physician's order must include time, date, type of restraint, clinical indication and duration of the order."

2. Medical Record Reviews:

On 9/14/11, the medical record for sample patient #20 was reviewed. It revealed the patient was transferred from an acute care hospital to the facility on 9/8/11 with the primary diagnoses of aspiration pneumonia and respiratory failure. The patient had a feeding tube, tracheostomy tube, other medical lines and required ventilation support. On 9/11/11, the patient was placed in bilateral soft wrist restraints. Review of the restraint order for that day revealed that the physician order did not include the purpose for the restraint. Nursing documentation on the "Critical Care Flow Sheet" stated that the patient was experiencing marked agitation, confusion, making attempts to pull out tubes/lines, including feeding tube, oxygen and airway.

Review of the "Physician's Order Sheet: Restraints Orders," under the section "2. Purpose for restraints:" with included a check-off option for "Prevention of traumatic removal of medical devices; i. e. catheters IV lines, extubation," the physician did not check that or document any other reason for restraint application, as required with the order.

On 9/14/11, the medical record for sample patient #29 was reviewed. It revealed the patient was transferred from an acute care hospital to the facility on 8/12/11 with the primary diagnosis of subarachnoid hemorrhage/intraventricular hemorrhage due to cerebellar aneurysm rupture with residual encephalopathy and seizure activity. The patient had medical lines and tubes including a feeding tube and urinary catheter. The patient was placed in bilateral soft wrist restraints and four side rails for safety related to seizure precautions and to prevent patient removal of tubes/lines on 8/12/11 through 8/14/11. Review of the "Physician's Order Sheet: Restraints Orders," under the section "4. Examination: Based upon examination of the patient, I order the application of the specific restraints," revealed that no physician signature ordering restraints was found on the order sheet for 8/14/11 and there was no "Physician's Order Sheet: Restraints Orders," completed for 8/13/11.

3. On 9/14/11 at approximately 1:30 p.m., the Director of Nursing was interviewed. The Director of Nursing reviewed the medical record for sample patient #29 and confirmed the findings, there were no physician orders for restraints on 8/13/11 and the order was not signed by a physician on 8/14/11.

Based on review of sample medical records, policies/procedures and staff interviews, the hospital failed to ensure that nursing staff developed, and kept current, a nursing care plan for each patient, as required in seven (sample patients #2, #3, #4, #10, #14, #16, and #19) of 29 sample records reviewed.

The findings were:

1. A facility policy titled "Transdisciplinary Care Planning," which was last revised July 2005, stated the following in pertinent parts:
"...Policy
Patient care needs are identified and prioritized and a plan of care, which appropriately addressed priority needs, is initiated within 24 hours of admission. Following the evaluations by other disciplines, the Transdisciplinary Care Team will meet formally (within 72 hours of admission) to further develop the plan.
At least every two weeks thereafter, the Transdisciplinary team will meet to revise and update the established care plan and to discuss discharge options and needs...
Procedure
A. Upon admission, an initial assessment is completed.
1. Based on prioritization of patient care needs identified, an appropriate care plan will be initiated by the RN.
2. Pre-printed care planning tools may be utilized as a basis for developing an individualized plan of care.
3. The Transdisciplinary team will assess the pre-admission data provided in preparation for the further development of the care plan...
B. Following the initial assessment, each clinical discipline will screen data collected to determine the need for further assessment and planning...
G. At every subsequent team meeting, at least every two weeks, specific goals and target dates will be addressed and progress toward goals will be measured and documented as well as appropriateness of chosen interventions..."

2. Medical Record Review:

Sample patient #2 was an adult admitted 8/31/2011 for a Calcaneal (Heel) fracture. S/he had a History of Left Above Knee Amputation, Diabetes, Hypertension, Obesity, Renal disease, DVT (deep vein thrombosis: blood clot). Record review determined s/he continued to be an inpatient on 9/14/11. Six problems were identified by a R.N. (Registered Nurse) at approximately 6:40 p.m. on the (TPC) "Transdisciplinary Plan of Care" form, dated 8/31/11. Two of the six problems identified (pain management and infection) were found to have no evidence of further evaluation notes or updated notations in the TPC that might indicate if there was or was not a continued problem. One of the six problems identified and also, dated 8/31/11, was skin integrity. No documentation regarding where the wound was located, size, appearance, assessment or implementation of Skin care Algorithm. Also missing was the continuing wound healing assessment and evaluation notes.

Sample patient #3 was an adult patient that was admitted to the hospital on 9/3/2011 with a diagnosis of pneumonia and carcinoma. The patient continued to be an inpatient at the time of the record review on 9/14/2011. A review of the patient's "Transdisciplinary Plan of Care" form indicated that multiple problems were identified by the facility's staff to be addressed during the patient's hospital course. Six problems were identified upon admission by the admitting RN on 9/3/2011 at approximately 12:00 p.m. Two (skin integrity and cognition) of the six problems identified on admission had no plan documented on the corresponding documentation area for the problems. The patient was receiving wound care services while hospitalized, but the Transdisciplinary plan of care did not have any interventions of expected outcomes documented for the patient's skin problems.

Sample patient #4 was an adult patient that was admitted to the hospital on 8/31/2011 with a diagnosis of osteomyelitis of the skull and psychiatric symptoms. The patient continued to be an inpatient at the time of the record review on 9/14/2011. A review of the patient's "Transdisciplinary Plan of Care" form indicated that multiple problems were identified by the facility's staff to be addressed during the patient's hospital course. Five problems were identified upon admission by the admitting RN on 8/31/2011 at approximately 2:00 p.m. Three of the five problems identified on admission had no update to their status or revision to the plan after initiation nor were the problems deemed to be resolved by documentation.

Sample patient #10 was an adult patient that was admitted to the hospital on 8/19/2011 with a diagnosis of altered mental status, pneumonia, and foot wounds after being hospitalized at an acute care hospital for withdrawal. The patient was discharged to a skilled nursing facility on 9/14/2011. A review of the patient's "Transdisciplinary Plan of Care" form indicated that multiple problems were identified by the facility's staff to be addressed during the patient's hospital course. Nine problems were identified upon admission by the admitting RN on 8/19/2011 at approximately 6:00 p.m. Four of the nine problems identified on admission did not have a plan of care documented to address the problems. One of the problems was skin integrity which did not have a projected outcome nor did the plan include any interventions to resolve the patients skin integrity issues.

Sample patient #14 was an adult patient that was admitted to the hospital on 8/25/2011 with a diagnosis of failure to thrive after being hospitalized at an acute care hospital for cellulitis to a right leg amputation site. The patient was discharged on 9/13/2011. A review of the patient's "Transdisciplinary Plan of Care" form indicated that multiple problems were identified by the facility's staff to be addressed during the patient's hospital course. Eight problems were identified and plans of care were initiated for the problems on 8/25/2011. Four out of the eight problems had no update to their status or revision to the plan after initiation nor were the problems deemed to be resolved by documentation.

Sample #16 was an adult patient admitted to the hospital on 9/5/11 with a diagnosis of respiratory failure. The patient continued to be an inpatient at the time of the record review on 9/14/2011. A review of the patient's "Transdisciplinary Plan of Care" form on 9/5/11, indicated that multiple problems were identified by the facility's staff to be addressed during the patient's hospital course. Six problems had been identified as "Active" problems on 9/05/2011 with no further documentation to update their status or revision to the plan after initiation nor were the problems deemed to be resolved. Four problems were identified on 9/6/11 with only one problem being noted as remaining "active" 9/6/11-9/13/11 with an evaluation note 9/6/11. One problem was identified on 9/7/11 with only one evaluation note written stating the plan for patient discharge. Another problem was initiated on 9/8/11 with only noting one intervention. There was no documentation in the Plan of Care Re-Evaluation or Evaluation Notes for any of the identified problems.

Sample patient #19 was an adult admitted 7/11/11 for Respiratory Failure; Chemical Dependency. S/he required tube feedings using a PEG (Percutaneous Endoscopic Gastrostomy) tube and was on a Ventilator to assist breathing. Record review on 9/14/11 determined s/he was discharged on 9/13/11. Ten problems were identified on the "Transdisciplinary Plan of Care" (TPC) form on 7/11/11 by an R.N. at approximately 8:00 p.m. Five of the ten problems were found to have no evidence of further evaluation notes or updated notations in the TPC that might indicate if there was or was not a continued problem. One of the five also noted Isolation status being standard with no notation as to why patient was in isolation. The sixth significant problem was identified as Pulmonary/Respiratory Function and was never initiated as part of the TPC to address outcome, basic care, other interventions or evaluations for this patient who was in respiratory failure and was on a Ventilator.

Reference Tag A 166 for additional findings related to failure to modify care plans when restraints were utilized.

Based on review of personnel files and staff interviews, the facility failed to ensure that the manager of the medical records department met the professional qualifications outlined in the job description for that position.

The findings were:

1. On 9/14/11, a the personnel file for the manager of the medical records department was reviewed and revealed the following findings:

The job description titled "Health Information Management Manager" contained the following, in pertinent parts:
"Education: High school diploma or equivalent is required. Completed coursework in an approved educational program for a Registered Health Information Administrator (RHIA) or a Registered Health Information Technician (RHIT) required. Degree in Health Information Management desired...
Licensure/Certification: Registered with the American Information Management Association..."

Review of the employee's resume revealed the following, in pertinent parts:
"...EDUCATION:
(local community college)
Currently pursuing Registered Health Information Technician (RHIT) Degree/Certification..."

Review of the personnel file revealed no evidence of completion of all coursework for a RHIA or RHIT or registration with the American Health Information Management Association (AHIMA) as required.

2. On 9/14/11 at approximately 3:00 p.m., the director of quality and risk confirmed that the medical records manager was still working on his/her required coursework to qualify to take the exam for registration with the AHIMA. S/he stated that the manager expected to have completed the coursework by the end of the next academic semester and would then take the examination to become registered with AHIMA.

Based upon review of policies and procedures, staff interviews, tours of the medical records department and annex storage areas it was determined that the facility failed to ensure that unauthorized individuals could not gain access to or alter patient records. These failures created the potential for negative outcomes.

The findings were:

An interview with the Director of HIM (Health Information Management) was conducted on 9/13/11 at approximately 1:30 p.m. When asked who had keys to the HIM department for after business hours access, s/he stated: s/he(the director), the department coordinator, the CEO (Chief Executive Officer), the Director of Nursing, the director of Risk Management, the Facilities Manager and Security. The department coordinator was asked by the Director to join this interview and s/he stated that the building owner also had a key. During the tour of the medical records department, patient records were observed stored on open shelving with direct visibility to each patient record. The Director stated only the current year records were kept in this area and records from previous years were housed in the "department annex" located on the second floor of the facility. A tour of the annex area determined the system used for filing in the medical records department was also utilized in the annex. Medical Records were observed in open shelving with direct visibility and access to each patient record. Also observed were records labeled for the year 2009 in open boxes awaiting transport to the off site storage facility.

During the survey exit conference on 9/14/2011 at approximately 5:15 p.m., the Director of Risk Management stated that the key access to medical record services would only be given to security, the director and coordinator of HIM, the facilities manager and the building owner.

The revision of personnel with access to medical records was not addressed regarding the key provided to the building owner and the direct visibility and access to each patient medical record for all persons with keys to the Medical Records areas.