HospitalInspections.org

Based upon observations, review of the Medical Staff Bylaws, Rules/Regulations, credential files and staff interviews the facility failed to ensure that the distant-site neurology physicians held a license issued or recognized by the State of Colorado.
The findings were:
The facility's "Medical Staff Bylaws; Rules and Regulations Reviewed/Approved January 27,2009" stated in pertinent part:
"...G .Telemedicine Privileges Revised 6/27/07
Telemedicine privileges may be granted only to physicians who are: Licensed to practice in the State of Colorado as well as the state where the study is being transmitted..."

In an interview with the Director of Cardiopulmonary Services on 2/15/12 at approximately 8:55 am, s/he stated that the EEG (Electroencephalogram) readings were performed by neurology staff at the distant site facility located in Grand Junction, CO. A review of six EEG reports identified the names of the neurologists performing the readings. Every EEG report was signed by one of the two neurologists who had read and dictated the test results. A query of the Colorado Medical Board's Automated License Information System Online (Alison) was conducted on 2/15/12 during the onsite survey by a state surveyor. The query returned no evidence of the neurological physicians having a license to practice in the State of Colorado.
Review of the facility's credential files on 2/15/12 at approximately 10:00 am revealed the two neurologists had not been credentialed or granted privileges by the facility. An interview with the Director of Medical Staff Services was conducted on 2/15/12 at approximately 10:30 am. S/he stated that the facility had no credentialed neurologists.

Based on observations and staff interview the facility failed to ensure that equipment and supplies commonly used in emergencies and patient care were available. Specifically, the facility failed to ensure that expired supplies were removed from patent care areas.

The findings were:

Observations of the Emergency Department were conducted with the Director of Emergency Services and with the Director of Accreditation and Informatics on 2/8/2012 at approximately 1:30 PM. It was discovered during the observations that the department had available for patient use the following expired supplies:
2 - packets of Shurclens antiseptic with a manufacturer's expiration date of January 2012
7 - 2-0 Ethilon sutures with a manufacturer's expiration date of January 2010
Greater than 10 - 4-0 Ethilon sutures with a manufacturer's expiration date of July 2008
3 - 5-0 PDS sutures with a manufacturer's expiration date of January 2001
Greater than 10 - 3-0 Vicryl sutures with a manufacturer's expiration date of July 2008
Greater than 10 - 0 Vicryl sutures with a manufacturer's expiration date of July 2010
Approximately 20 - Xeroform dressings with a manufacturer's expiration date of July 2011
5 packs - Petroleum gauze with a manufacturer's expiration date of May 2011
1 - Iodine swabstick with a manufacturer's expiration date of July 2008
2 - Iodine swabsticks with a manufacturer's expiration date of September 2008
2 - Iodine swabsticks with a manufacturer's expiration date of September 2011
15 - Iodine swabsticks with a manufacturer's expiration date of October 2011
Each expired item was confirmed with the Director of Emergency Services at the time of observation. S/he stated that staff was expected to go through equipment and remove expired supplies from patient care areas on a regular basis.

Observations of the Surgical Department were conducted with the Director of Surgical Services on 2/8/2012 at approximately 3:00 PM. It was discovered during the observations that the department had available for patient use the following expired supplies:
1 box - 4-0 Vicryl sutures with a manufacturer's expiration date of July 2011
1 box - 4-0 Monacryl sutures with a manufacturer's expiration date of January 2011
1 box - 2-0 Ethilon sutures with a manufacturer's expiration date of July 2009
Each expired item was confirmed with the Director of Surgical Services at the time of observation. S/he stated that staff was expected to remove expired supplies from patient care areas when found.

Based on the onsite inspection, completed February 22-23, 2012, the facility failed to comply with the regulations set forth for Life Safety and, therefore, deficiencies were cited under Life Safety Code tags K0018, K0020, K0029, K0038, K0046, K0050, K0051, K0052, K0056, K0062, K0077, K0078, K0130, and K0145. See survey event ID #61J921 for full details of the cited deficiencies.

Based on observations, review of the facility's policies/procedures and staff interview the facility failed to ensure that drugs and biologicals available for patient use were appropriately stored. Specifically, the facility failed to store medications according to policy and failed to remove expired medications from patient care areas.

The findings were:

A facility policy titled "Fluid Warming" last approved by the Pharmacy and Therapeutics/Infection Control committee on 7/7/2011 stated the following, in pertinent parts:
"Policy:
The manufacturer's recommendation for warming of injectable intravenous solutions and irrigation solutions will be followed...
Pour Bottle Irrigation Solutions (PBIS) can be warmed to temperatures not exceeding 66 degrees Celsius (150 degrees Fahrenheit) and for a period no longer than 72 hours. Once the PBIS have been in the warmer, they must be removed and identified as having been warmed. They may be used until manufacturers' labeled expiration date but not warmed more than once."

A tour of the Emergency Department conducted with the Director of Emergency Services on 2/8/2012 at approximately 1:30 PM revealed that the department had a fluid warmer that contained pour bottles of sterile normal saline solution. The bottles within the warmer had no date written on them that indicated when they had been placed into the warmer or when the bottles needed to be removed from the warmer. The Director of Emergency Services removed the pour bottles from the warmer and stated that the bottles should not have been in the warmer.

A tour of the surgical services department conducted with the Director of Surgical Services on 2/8/2012 at approximately 2:35 PM revealed that the department had a fluid warmer that contained pour bottles of sterile normal saline solution. The warming cabinet contained 4 bottles of pour solution. Two of the four bottles were written on with a date of 1/30 and two of the four bottles were written on with a date of 1/31. The warming cabinet had a sign on the outside of the cabinet that stated, in pertinent parts "PLEASE DATE FLUIDS WHEN THEY ENTER THE WARMER...POUR BOTTLES MAY BE warmed to temperatures not exceeding 66 degrees Celsius (150 degrees Fahrenheit) and for a period no longer than 72 hours. RETURN BAGS AND BOTTLES TO PHARMACY WHEN WARMING TIME HAS BEEN DEPLETED." The Director of Surgical Services confirmed that the bottles should have been removed on 2/2 and 2/3/2012 and should not have been in the warmer.



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Reference Tag C 276 for findings related to failure to ensure that medication was secured in a locked cabinet with limited access in the orthopedic clinic. In addition the medication supplies included a medication that did not have an expiration date.


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Cross Reference Tag 226 for findings related to the facility 's failure to maintain temperature tracking logs to ensure that appropriate temperature levels were maintained in all pharmaceutical medication refrigerators.

Based upon observations, tours and staff interviews the facility failed to ensure that proper temperature controls were maintained in all pharmaceutical medication storage refrigerators. Specifically, the pharmacy failed to maintain complete temperature tracking logs to ensure that appropriate refrigerator temperature levels were maintained for patient medications.
The findings were:
In an email message on 2/16/12 at approximately 5:19 pm the Director of Pharmacy stated that there was no facility policy regarding the monitoring of pharmacy medication refrigerators because the facility utilized the Colorado Board of Pharmacy Rules and Regulations which stated: Pharmacy Rule and Regulation 5.01.31 (e) (8) A refrigerator, dedicated to storing only drugs, meeting the compendia requirements and with an accurate thermometer in the refrigerator. The temperature of which shall be maintained between two and eight degrees Celsius (2 and 8 degrees C.) or thirty-six and forty-six degrees Fahrenheit (36 and 46 degrees F.). The temperature shall be either manually or electronically monitored each calendar day.
A review of the pharmacy medication refrigerator logs revealed the facility staff failed to maintain the temperature logs daily. The logs revealed the following:
1 ) temperature log labeled " immunization/vaccine" for a refrigerator located in the pharmacy noted:
November 2011, the temperature was not logged 4 of the 30 days in the month
February 1-8, 2012 the temperature was not logged 3 of the 8 days in the month
2) temperature log labeled "Rx.PM" for a refrigerator located in the pharmacy noted:
September 2011, the temperature was not logged 1 of the 30 days in the month
October 2011, the temperature was not logged 3 of the 31 days in the month
3) temperature log for the pharmacy refrigerator labeled "M/S"( medical surgical); this refrigerator was located on the inpatient care unit:
September 2011 the temperature was not logged 1 of the 30 days in the month
January 2012 the temperature was not logged 4 of the 31 days in the month
February 1-16, 2012 the temperatures were not logged 2 of the 16 days in the month
4) temperature logs labeled "pharmacy" noted:
November 2011, the temperature was not logged 2 of the 30 days in the month
January 2012, the temperature was not logged 2 of the 31 days in the month
5) There were two medication refrigerators in the Operating Room/PACU (Post Anesthesia Care Unit) areas. The temperature logs were labeled "Operating Room Quality Control Log Sheet." This log contained the documentation of medication refrigerator temperatures for Unit A and Unit B. The temperature logs for each refrigerator revealed temperatures were not logged for the following:
September 2011 temperatures were not logged for: Unit A, 12 of the 30 days in the month, Unit B, 12 of the 30 days in the month.
October 2011 temperatures were not logged for: Unit A, 11 of the 31 days in the month, Unit B, 12 of the 31 days in the month.
November 2011 temperatures were not logged for: Unit A, 13 of the 31 days in the month, Unit B, 13 of the 31 days in the month.
December 2011 temperatures were not logged for Unit A, 9 of the 31 days in the month,
Unit B, 9 of the 31 days in the month.
January 2012 temperatures were not logged for: Unit A, 11 of the 31 days in the month, Unit B, 11 of the 31 days in the month.
February 1-16, 2012 temperatures were not logged for: Unit A, 3 of the 16 days in the month, Unit B, 3 of the 16 days in the month

In an interview with the Director of Surgical Services conducted on 2/8/12 at approximately
2:32 pm s/he stated, "The patient medication refrigerators are checked during the day by operating room staff, they are not checked by pharmacy." S/he stated that on the weekends or holidays when the Surgical Services Department was closed refrigerator temperatures were not checked or logged.

The pharmacy director was interviewed on 2/14/12 at approximately 11:10 am. S/he stated that there was no staff assigned to check the medication refrigerators daily. There were no staff assignments made for specific tasks and that there was no system to determine who was working on a specific day. S/he further stated that there was a plan to develop an assignment sheet. The assignment sheet would designate specific daily staff assignments and the sheet would be the method for tracking medication refrigerator temperature checks. The Director stated that there was no one in the pharmacy department who reviewed the logs for completeness and temperature variances.

Based on the manner and degree of deficiencies cited the facility failed to be in compliance with the Condition of Organizational Structure. The governing body of the facility failed to ensure that all requirements related to the organization structure of the facility and all other Conditions of Participation were met.

The facility failed to meet the following standards under the Condition of Organizational Structure:

Tag C 241 - Governing Body of Responsible Individuals:
The governing body of the facility failed to adequately determine, implement and monitor the policies governing the CAH's total operation and to ensure that those policies were administered so as to provide quality health care in a safe environment in multiple departments and functions of the facility and outpatient clinics.

Tag C 242 - Disclosure - Board and Financial Interests:
The hospital failed to have a mechanism in place to disclose the names and addresses of its owners, or those with a controlling interest or in any subcontractor in which the hospital directly or indirectly had a 5 percent or more ownership interest, as required.

Reference Tag C 243 - Disclosure - Chief Executive Officer (CEO):
The hospital failed to have a mechanism in place to disclose the name and address of the person principally responsible for the operation of the hospital, as required.

Reference Tag 244 - Disclosure - Medical Direction:
The hospital failed to have a mechanism in place to disclose the name and address of the person principally responsible for medical direction for the facility, as required.

Based on tours/observations, staff/physician interviews and review of medical records and facility documents, the governing body of the facility failed to adequately determine, implement and monitor the policies governing the CAH's total operation and to ensure that those policies were administered so as to provide quality health care in a safe environment in multiple departments and functions of the facility and outpatient clinics. The failures created the potential for negative patient outcomes.

The findings were:

Reference Tag C 197 - Agreements: the facility failed to ensure that the distant-site neurology physicians held a license issued or recognized by the State of Colorado.

Reference Tag C 204 - Medical Equipment and Supplies: the facility failed to ensure that equipment and supplies commonly used in emergencies and patient care were available. Specifically, the facility failed to ensure that expired supplies were removed from patent care areas.

Reference Tag C 224 - Maintenance: the facility failed to ensure that drugs and biologicals available for patient use were appropriately stored. Specifically, the facility failed to store medications according to policy and failed to remove expired medications from patient care areas.

Reference Tag C 226 - Maintenance: the facility failed to ensure that proper temperature controls were maintained in all pharmaceutical medication storage refrigerators. Specifically, the pharmacy failed to maintain complete temperature tracking logs to ensure that appropriate refrigerator temperature levels were maintained for patient medications.

Reference Tag C 261 - Responsibilities of MD or DO: the facility failed to ensure that a periodic, but not less than every 2 weeks, review and countersignature was conducted for a sample of outpatient records of patients cared for by nurse practitioners, clinical nurse specialists, certified nurse midwives, or physician assistants by a physician. Specifically, the facility conducted a review of outpatient records quarterly.

Reference Tag C 272 - Patient Care Policies: the hospital failed to have a process in place for policy development and review that included a group of professional personnel that includes one or more doctors of medicine or osteopathy, one or more physician assistants, nurse practitioners or clinical nurse specialist, if they are on staff, and at least one member who was not a member of the hospital staff.

Reference Tag C 275 - Patient Care Policies: the facility failed to have policies that included guidelines for management of health problems that include the conditions requiring medical consultation and/or patient referral and procedures for the periodic review and evaluation of the contracted clinical services.

Reference Tag C 276 - Patient Care Policies - Safe Medication Storage: the facility failed to ensure that all medications were maintained and stored in accordance with accepted professional principle and their own policies and procedures. Specifically, the hospital failed to ensure that medication was secured in a locked cabinet with limited access in the orthopedic clinic. In addition the medication supplies included a medication that did not have an expiration date. Finally, the hospital failed to ensure that refrigerators for storage of medication were monitored for adequate temperature control. The failures created the potential for negative patient outcome.

Reference Tag C 278 - Patient Care Policies - Infection Control: the facility failed to have a system for identifying, reporting, investigating and controlling infections and communicable diseases of personnel. The facility was also in breach of procedures for infection control in the food and dietary services and the operating room environment.

Reference Tag C 279 - Patient Care Policies - Food and Dietary: the hospital failed to ensure that all food stored in refrigerators, freezers, and in other storage areas was labeled to identify open date, expiration/discard date and manufacturer's expiration date, to prevent use of contaminated or "spoiled" food products in the preparation and serving of meals to patients. The failure created the potential for negative patient outcomes.

Reference Tag C 280 - Patient Care Policies - Annual Provider Review of Policies: the hospital failed to have a process in place for annual policy review by a group of professional personnel that include one or more doctors of medicine or osteopathy, one or more physician assistants, nurse practitioners or clinical nurse specialist, if they are on staff, and at least one member who was not a member of the hospital staff.

Reference Tag C 282 - Direct Services - Laboratory Services: the facility failed to ensure that the outpatient blood draw clinic had policies and procedures for critical lab values that were determined by on-site testing done at the outpatient clinic.

Reference Tag C 284 - Direct Services - Response to Medical Emergencies: the hospital failed to ensure that the outpatient clinics had policies/procedures developed specifically to address the needs and location of the clinics, related to response to medical emergencies. The failure created the potential for a negative patient outcome.

Reference Tag C 291 - Services by Agreement - Contract List: the facility failed to maintain a complete and accurate list of all services furnished under arrangements or agreements, including the nature and scope of the services provided.

Reference Tag C 292 - Services by Agreement - CEO Oversight: the Chief Executive Officer (CEO) of the facility failed to adequately manage the CAH's total operation and to ensure that the policies were administered so as to provide quality health care in a safe environment in multiple departments and functions of the facility and outpatient clinics. The failures created the potential for negative patient outcomes.

Reference Tag C 294 - Nursing Services/Emergency Department (ED) and Emergency Obstetrical Care: the facility failed to ensure that nursing services met the needs of patients. Specifically, the facility failed to ensure that nursing staff in the Emergency Department (ED) and Obstetrical Department were documenting vital signs on patients prior to discharge. Additionally, the facility failed to ensure that nursing staff in the ED completely documented triage assessments on patients by assigning triage acuity scores.

Reference Tag C 295 - Nursing Services/Delegation of Care in ED: the facility failed to ensure that the nursing care of each patient was provided by a Registered Nurse or was assigned to other personnel and provided in accordance with the patient's needs. Specifically, the facility had EMT's performing Emergency Department nursing triage. In one of 20 emergency department records reviewed an EMT performed the nursing triage in a unsatisfactory manner.

Reference Tag C 302 - Records Systems: the hospital failed to ensure that all patient medical records were legible, complete, accurately documented, readily accessible, and systematically organized. Specifically, the hospital failed to ensure that outpatient clinic records were maintained with medical record numbers and were cataloged and supervised and that outpatient clinic information was available to physicians and some hospital departments to ensure continuity of care for clinic patients.

Reference Tag C 308 - Protection of Record Information: the hospital failed to have sufficient safeguards against loss, destruction or unauthorized use of retained patient records. The facility also failed to secure all records and films in the clinics. These breaches created the potential for lack of patient privacy related to their records as well as the opportunity for patient identity theft.

Reference Tag C 333 - Periodic Evaluation: the facility failed to ensure that an evaluation was done at least once a year that included a review of a representative sample of both active and closed clinical records. The facility failed to ensure that members of the medical staff were involved in the annual review.

Reference Tag C 336 - Quality Assurance: the facility failed to ensure that it had an effective quality assurance program to evaluate the quality and appropriateness of the diagnosis and treatment furnished in the CAH and of the treatment outcomes.

Reference Tag C 337 - Quality Assurance: the facility failed to ensure that all patient care services and other services affecting patient health and safety were evaluated.

Reference Tag C 338 - Quality Assurance: the facility failed to ensure that the facility's quality assurance program evaluated medication therapy. Specifically, medication errors that were reported to the Risk Management department were not being communicated and/or not being communicated timely to the system-wide quality assurance program.

Reference Tag C 340 - Quality Assurance: the facility failed to ensure that the facility's quality assurance program evaluated the quality and appropriateness of the diagnosis and treatment furnished by doctors of medicine and osteopathy at the CAH. Specifically, the facility did not have a mechanism in place to evaluate the services provided by teleradiologists and out-of-state neurologists that were interpreting radiology exams and EEGs (electroencephalographs) performed at the facility.

Reference Tag C 342 - Quality Assurance: the facility failed to ensure that the facility's quality assurance program took appropriate remedial action to address deficiencies found through the department's quality assurance program. Specifically, when documentation and care issues were discovered by the Emergency Department's medical record reviews, there was no documentation of remedial action to address the deficiencies found.

Reference Tag C 343 - Quality Assurance: the facility failed to ensure that the facility's quality assurance program documented the outcome of all remedial actions. Specifically, the facility failed to ensure that any remedial actions taken to address documentation issues

Reference Tag C 384 - Swing Beds - Staff Treatment of Residents: the hospital failed to ensure that it complied with the Swing Bed requirement to have policies and procedures that addressed the prevention, identification, investigation and reporting of various forms of patient abuse that could potentially occur while the patient was in the facility. The failure created the potential for negative patient outcomes.


During the course of the survey, the team discovered that the facility had experienced multiple changes of CEO leadership in recent years while under a management agreement with an entity that provided the CEO's for the facility. In July, 2011 the governing directly hired the current CEO to manage the facility and converted the management agreement to a consulting agreement with the entity. The board subsequently hired a new chief financial officer and then many other key department positions, including medical records, risk, quality, medical staff services, outpatient practice manager and medical director of the emergency department. In addition, the board changed to a new accrediting agency for the facility and they had their first survey in January, 2012. Facility leadership staff were just beginning the process of implementing changes, based on the feedback received during the survey, when this survey team entered to conduct a validation survey.

Based on staff interview and medical record review the facility failed to ensure that a periodic, but not less than every 2 weeks, review and countersignature was conducted for a sample of outpatient records of patients cared for by nurse practitioners, clinical nurse specialists, certified nurse midwives, or physician assistants by a physician. Specifically, the facility conducted a review of outpatient records quarterly.

The findings were:

A review of two outpatient records (sample records #17 and #18) was conducted on 2/16/2012. Both patients were seen by physician assistants during the outpatient visits. Neither record contained documentation from a physician that indicated that a review was conducted of the care provided by the physician assistants.

An interview with the Practice Manager was conducted on 2/16/2012 at approximately 9:15 AM. S/he stated that a sample of 10 medical records were reviewed quarterly by a physician for the outpatient clinics that were under the hospital's provider number. S/he stated s/he was unaware that the requirement existed for a review every two weeks or more frequently.

Based on the manner and degree of deficiencies cited the facility failed to be in compliance with the Condition of Participation of Provision of Services. The facility failed to ensure that all clinical services were provided in a safe and effective manner to meet the needs of the patients.

The facility failed to meet the following standards under the Condition of Provision of Services:

Tag C 272 - Patient Care Policies Developed by Professional Staff:
The hospital failed to have a process in place for policy development and review that included a group of professional personnel that includes one or more doctors of medicine or osteopathy, one or more physician assistants, nurse practitioners or clinical nurse specialist, if they are on staff, and at least one member who was not a member of the hospital staff.

Tag C 275 - Patient Care Policies - Guidance for Quality of Care and Evaluation of Contracted Services:
The facility failed to have policies that included guidelines for management of health problems that include the conditions requiring medical consultation and/or patient referral and procedures for the periodic review and evaluation of the contracted clinical services.

Tag C 276 - Patient Care Policies - Safe Storage of Medications:
The facility failed to ensure that all medications were maintained and stored in accordance with accepted professional principle and their own policies and procedures. Specifically, the hospital failed to ensure that medication was secured in a locked cabinet with limited access in the orthopedic clinic. In addition the medication supplies included a medication that did not have an expiration date. Finally, the hospital failed to ensure that refrigerators for storage of medication were monitored for adequate temperature control.

Tag C 278 - Patient Care Policies - Infection Control:
The facility failed to ensure that infection control standards were maintained in food and nutrition, the outpatient clinics, surgery and with regard to employee health programs.

Tag C 279 - Patient Care Policies - Food and Dietary:
The facility failed to ensure that all food stored in refrigerators, freezers, and in other storage areas was labeled to identify open date, expiration/discard date and manufacturer's expiration date, to prevent use of contaminated or "spoiled" food products in the preparation and serving of meals to patients.

Tag C 280 - Patient Care Policies - Annual Review:
The facility failed to have a process in place for annual policy review by a group of professional personnel that include one or more doctors of medicine or osteopathy, one or more physician assistants, nurse practitioners or clinical nurse specialist, if they are on staff, and at least one member who was not a member of the hospital staff.

Tag C 282 - Direct Services - Laboratory Services
The facility failed to ensure that the outpatient blood draw clinic had policies and procedures for critical lab values that were determined by on-site testing done at the outpatient clinic.

Tag C 284 - Direct Services - Response to Medical Emergencies:
The facility failed to ensure that the outpatient clinics had policies/procedures developed specifically to address the needs and location of the clinics, related to response to medical emergencies.

Tag C 291 - Services Provided Through Agreement/Arrangement - List of Contracted Services:
The facility failed to maintain a complete and accurate list of all services furnished under arrangements or agreements, including the nature and scope of the services provided.

Tag C 292 - Services Provided Through Agreement/Arrangement - CEO Accountability for Services Provided:
The Chief Executive Officer (CEO) of the facility failed to adequately manage the CAH's total operation and to ensure that the policies were administered so as to provide quality health care in a safe environment in multiple departments and functions of the facility and outpatient clinics.

Tag C 294 - Nursing Services - Meets Needs of Patients:
The facility failed to ensure that nursing services met the needs of patients. Specifically, the facility failed to ensure that nursing staff in the Emergency Department (ED) and Obstetrical Department were documenting vital signs on patients prior to discharge. Additionally, the facility failed to ensure that nursing staff in the ED completely documented triage assessments on patients by assigning triage acuity scores.

Tag C 295 - Nursing Services - Patient Care Assignments:
The facility failed to ensure that the nursing care of each patient was provided by a Registered Nurse or was assigned to other personnel and provided in accordance with the patient's needs. Specifically, the facility had EMT's performing Emergency Department nursing triage. In one of 20 emergency department records reviewed an EMT performed the nursing triage in a unsatisfactory manner.

Based on staff interviews and review of facility documents, the hospital failed to have a process in place for policy development and review that included a group of professional personnel that includes one or more doctors of medicine or osteopathy, one or more physician assistants, nurse practitioners or clinical nurse specialist, if they are on staff, and at least one member who was not a member of the hospital staff.

The findings were:

1. Review of policy/procedure entitled "Preparing and Reviewing Policies" revealed that document did not describe a group of professional personnel, as described in the regulation, which was charged with developing and reviewing all policies for the CAH. The policy/procedure included a description of the very limited areas of policy development and review that involved the professional staff. The document contained a chart describing the minimum final approvals required for various types of policies. The chart stated that the medical executive committee was only responsible for reviewing/approving medical staff policies and hospital plan documents. It indicated that no medical executive committee involvement was required for many other types of key hospital policies, such as patient rights policies, nursing policies, clinical policies, departmental policies and health information management policies. This was confirmed by the Director of Clinical Informatics/Accreditation on 2/9/12 at 8:35 a.m.. This was confirmed by the Director of Medical Staff Services on 2/15/12 at 3:00 p.m.. This was confirmed by the Director of Acute Care on 2/8/12 at approximately 2:30 p.m..

2. On 2/8/12 at approximately 2:30 p.m., the Director of Acute Care Services, which also included the Post Acute Care Services (Swing Beds) services and policies/procedures. S/he described the development of the swing bed policies process. S/he stated that s/he reviewed the policies/procedures for swing beds and then forwarded them electronically to the medical director of the swing bed area for review and feedback. S/he stated that the policies were developed/reviewed between the two of them. S/he stated that the two of them were considered the "Post Acute Care Committee, even though they did not meet as a formal committee. S/he stated that once the polices/procedures were reviewed, that there was no presentation to the medical executive committee for input or approval. S/he was unaware of any medical staff involvement in additional development or review of the swing bed policies.

3. On 2/15/12 at 3:00 p.m., the Director of Medical Staff Services was interviewed about any medical staff involvement in development and review of hospital policies. S/he stated that the medical executive committee did review only medical staff policies, as outlined in the policy "Preparing and Reviewing Policies." S/he was unaware of any medical staff involvement in development of non-medical staff policies. In discussing the example of policies generated by the director who covered the swing bed area and the medical director of the swing beds, s/he was unaware of those policies going before any group of the medical staff for further input, review or approval.

Based on staff/physician interviews and review of facility documents, the facility failed to have policies that included guidelines for management of health problems that include the conditions requiring medical consultation and/or patient referral and procedures for the periodic review and evaluation of the contracted clinical services.

The findings were:

1. Lack of Quality/Performance Review of Contracted Clinical Services:
On 2/9/12 at approximately 2 p.m., the chief clinical officer/director of nursing was interviewed about the facility's process for management of contracts, maintenance of a centralized contract list and evaluation of contracts. S/he described the process in which the contracts clerk maintains a list of contracts and when the contracts are due for review. S/he stated that the evaluation process for contracts involves reviewing the legal language of the contract and reviewing evaluation data provided by the contractor. S/he acknowledged that the facility did not have a current system in place to conduct an in-house analysis of contract performance at the current time. S/he also stated that they did respond to problems as they arose with a contractor, but did not have a system in place to routinely and regularly evaluate contracts for quality/performance. S/he stated that the facility was working to put such a system in place.

Review of facility meeting minutes revealed no evidence of routine evaluation of contracted clinical services for quality/performance.

These findings were confirmed by hospital management staff at an end of day wrap-up conference on 2/9/12 at approximately 5 p.m.. They also reiterated that they will be putting in place an in-house contract evaluation process.




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2. Policy/Guidelines for Management of Health Problems:
An interview with the Director of Accreditation and Informatics conducted on 2/8/2012 at approximately 11:40 AM revealed that the facility did not have a policy that addressed guidelines for the medical management of health problems that included the conditions requiring medical consultation and/or patient referral. S/he stated that s/he was unable to find such a policy.

A subsequent interview with the Director of Accreditation and Informatics along with the Chief Nursing Officer conducted on 2/16/2012 at approximately 8:45 AM confirmed that there was not a policy that addressed guidelines for the medical management of health problems that include the conditions requiring medical consultation and/or patient referral. The Chief Nursing Officer referred to the ICU admission policy which was provided and reviewed with the two staff members. They confirmed that the policy did not address the requirements.

A review of the facility's policy titled "Admission Criteria for ICU" was reviewed with the Director of Accreditation and Informatics along with the Chief Nursing Officer on 2/16/2012 at approximately 8:50 AM. The policy addressed the criteria that was required to necessitate an admission to the ICU, but did not place restrictions on what the facility was able to care for and what needed additional consultation or referral to another facility.

An interview with one of the hospital's Hospitalist physicians was conducted in the presence of the Director of Accreditation and Informatics on 2/16/2012 at approximately 10:30 AM. S/he stated that the hospital was currently addressing what could be performed at the hospital as opposed to what needed to be referred out to another facility or that required consultation of a specialist. S/he stated that there was not currently a policy that s/he was aware of that stated the guidelines for the medical management of health problems that included the conditions requiring medical consultation and/or patient referral.

Based on tour/observation and staff interviews, the facility failed to ensure that all medications were maintained and stored in accordance with accepted professional principle and their own policies and procedures. Specifically, the hospital failed to ensure that medication was secured in a locked cabinet with limited access in the orthopedic clinic. In addition the medication supplies included a medication that did not have an expiration date. Finally, the hospital failed to ensure that refrigerators for storage of medication were monitored for adequate temperature control. The failures created the potential for negative patient outcome.

The findings were:

1. On 2/9/12 at approximately 11:15 a.m., the outpatient orthopedic clinic was toured with the Practice Manager and the Director of Clinical Informatics/Accreditation. During the tour it was observed that the medications, including the emergency medication kit were stored on a shelf in an unlocked lateral file cabinet. In addition, an Epi-pen unit with no expiration date was found in the supply of medications in the unlocked cabinet. Per interview with the radiology technician at the clinic during the tour, s/he stated that s/he was responsible for ordering the medications from the pharmacy. S/he also stated that all medications at the clinic were administered by the physician. S/he stated that the cabinet was routinely left unlocked, in fact, s/he was not sure that the clinic had a working key for the lock on the lateral file cabinet. The lateral file cabinet containing all of the medications was in an unlocked storage room of the facility that was not secured during office hours or when the clinic was closed. The office staff also confirmed that the clinic was cleaned by a cleaning crew when the clinic was closed and staff were not present.

2. The Director of Clinical Informatics/Accreditation confirmed the findings during the tour and the fact that the medications should have been secured in a locked cabinet with limited access. S/he further confirmed that an expiration date for the Epi-pen should have been provided to ensure that and expired drug did not get utilized in an emergency situation with a patient.

3. The policy/procedure "Pharmacy Security" contained the following, in pertinent parts:
"POLICY:
Security of the Pharmacy shall be maintained in accordance with federal, state and local laws. All personnel on duty shall protect Pharmacy assets and records and guard against the theft or diversion of drugs...
OUTSIDE OF PHARMACY:
-All meds locked...
BIBLIOGRAPHY:
Colorado Board of Pharmacy Regulations"

4. The policy/procedure "Drug Cabinet Keys" contained the following, in pertinent parts:
"Purpose:
Proper security for medications should be provided as interpreted by the Director of Pharmacy, who is responsible for the pharmacy license.

Policy:
The Director of Pharmacy is responsible for security of drugs (both scheduled and non-scheduled) and keys for stock areas in the hospital, under the following procedure.

Procedure:
1. Security for drugs on a nursing unit or ancillary department shall be adequate as deemed by the Director of Pharmacy in consultation with the manager of that area and the Safety/Security Officer of the hospital.
2. Since the security of keys and locks depends so greatly upon the nurses and personnel working in stock areas. The in-house handling of keys will be up to the unit manager with approval of the Director of Pharmacy...
Bibliography
Colorado Revised Statutes
Colorado State Board of Pharmacy Rules and Regulations
Controlled Substance Act"












30484

5. Reference Tag 226 for findings related to the facility's failure to maintain temperature tracking logs to ensure that appropriate temperature levels were maintained in all pharmaceutical medication refrigerators.

Based upon review of policies & procedures, observations and staff interviews it was determined that the facility failed to have a system for identifying, reporting, investigating and controlling infections and communicable diseases of personnel. The facility was also in breach of procedures for infection control in the food and dietary services and the operating room environment.

The findings were:
1. Lack of employee health tracking
A facility policy titled "Employee Exposure to Communicable Disease" dated July 7, 2011 stated in pertinent part: "Employees exposed,or believed to have been exposed to any communicable diseases shall report the incident promptly to their immediate supervisor and/or Infection Control Practitioner."

In an interview with the Infection Control Officer on, 2/14/12 at approximately 10:30 am, s/he stated these reports were not being done and the policy was not being followed. S/he further stated that the facility was aware of this failure and had been engaged in meetings in the past thirty days to develop a system for implementing this policy.

In an interview with the Chief Clinical Officer, on 2/15/12 at approximately 8:15 am, s/he stated that there was no mechanism in place to track employee/personnel illnesses. S/he confirmed that the facility did not have a department for employee health services. Employee illnesses/injuries were tracked by the unit manager and the Human Resources department. Treatment options for employee services and urgent care were variable to include contacting the Infection Control Officer, who was a staff pharmacist, or the individual employee seeking care by a physician on their respective units. S/he stated that when an employee desired to return to work the Human Resources Department reviewed the physicians release. The Human Resources Department determined if the return to work was approved and assigned the appropriate employee benefit of sick time or workmen's compensation. S/he confirmed that the Human Resources personnel were not expected to review the reason for the absence from work nor was the information forwarded to the Infection Control Officer.
An interview with the Infection Control Officer, a staff pharmacist,was conducted on 2/14/12 at approximately 10:30 am. S/he stated that only employee PPD tests and readings were performed and filed within the pharmacy department and flu shots were given to employees in the pharmacy. S/he stated employees were directed to Human Resources for extended illnesses due to the involvement of employee benefits for time off or workmen's compensation benefits.

The Director of Human Resources was interviewed on 2/16/12 at 9:20 am. S/he stated the process for employees to return to work, after a possible communicable disease related diagnosis, was for the employee to present the doctor's release to return to work to the Human Resources department. S/he stated. "We feel that if the doctor says it is okay and signs the release it should be okay." S/he confirmed that the employee releases for return to work were maintained in the employee Human Resources file and that the information was not shared with the Infection Control Officer.



19816

2. Food and Nutrition Infection Control Breaches:
Reference Tag C-279 related to improper labeling and storage of food, which created the risk of spoilage or contamination of patient food.

3. Outpatient Clinics Infection Control Breaches:
On 2/9/12 at approximately 11:15 a.m., the outpatient orthopedic clinic was toured with the Practice Manager and the Director of Clinical Informatics/Accreditation. During the tour it was observed that there were no cleaning wipes in any of the patient care areas to disinfect equipment and supplies between patients. When the staff of the clinic were questioned, they stated that they did not have the disinfectant wipes and were unaware of policy that directed them to use them in their clinic. Tour of the other clinics that day revealed that the disinfectant wipes were available in the other clinics, but they did not have clinic-specific policies for cleaning their patient care areas and equipment, including exam tables. They stated that they referred to the hospital wide policy, which did not address clinic issues. Some clinic specific policies were found for the primary care clinic, but not the other clinics.




29147

4. Surgical Services Infection Control Breaches:
Observations of the Surgical Services Department were conducted with the Director of Surgical Services on 2/8/2012 at approximately 2:35 PM. Observations of the area utilized for the disinfection of endoscopes was conducted and an interview with the RN responsible for scope disinfection was conducted concurrently with observations. The nurse was asked the procedure for the pre-cleaning of endoscopes prior to automatic reprocessing. S/he stated that seven pumps of the detergent were added to approximately four inches of water. When asked how much water the four inches equated to, s/he stated that s/he did not know and was not aware that it had ever been measured. Review of the manufacturer instructions for the enzymatic detergent revealed that the instructions stated that 1-2 squirts were to be added to each gallon of water to ensure the proper dilution for pre-cleaning of endoscopes.

Observations in the restricted surgical area were conducted with the Director of Surgical Services on 2/8/2012 at approximately 3:15 PM. In a sub-sterile area adjacent to one of the operating suites there was a personal beverage noted to be present next to the door of the operating suite that was being cleaned from a previous surgery. The beverage was brought to the attention of the Director of Surgical Services who then took the beverage away from the area. It was later determined by the Director of Surgical Services that the beverage belonged to a staff member that was not in the immediate area.

Based on tours/observation, staff interviews and review of facility policies/procedures, the hospital failed to ensure that all food stored in refrigerators, freezers, and in other storage areas was labeled to identify open date, expiration/discard date and manufacturer's expiration date, to prevent use of contaminated or "spoiled" food products in the preparation and serving of meals to patients. The failure created the potential for negative patient outcomes.

The findings were:

1. Review on 2/16/12 of food and nutrition policies/procedures revealed the following findings:

The Policy/Procedure entitled "Food Handling" contained the following, in pertinent parts:
"POLICY:
Food products will be purchased from approved vendors providing safe wholesome food and will be stored, prepared and served in such a manner to prevent/minimize the risk of contamination.
POLICY:
To prevent the spread of infection.
To avoid cross contamination.
PROCEDURE:
...3. Food products will be stored in a manner so as to minimize the risk of spoilage or contamination...
13. All prepared food will be dated and labeled when stored..."

2. On 2/16/12 at 9:30 a.m., a tour of the Food and Nutrition Department of the hospital was conducted with the Director of Food and Nutrition, a dietary supervisor and the Director of Quality. During the tour, the Director of Food and Nutrition stated that the standard discard date for food after it had been opened or for prepared food was 7 days, but s/he later stated that "cheeses are an aged food product and are good indefinitely." S/he stated that s/he had been meeting with his/her staff because s/he recognized that the manner of labeling opened/prepared food was inconsistent. S/he stated that s/he expected staff to put an open date on food and an expiration/discard date. S/he stated that fresh fruit and vegetables were labeled when received, but that there were no real standards for how long they could be kept. S/he stated that "we use our judgement about whether something is still good and we consult with one another if we have a question if something is still good to use."

The findings in the refrigerator pantries were:
- A large bag of shredded jack cheese, with a label saying it had been opened 2/7/12, was cinched together with a strip of cling wrap used as a tie. The bag was not tightly sealed by the tie. Looking down into the bag where it was cinched, revealed an opening into the bag approximately the size of a half dollar coin, leaving the food contents exposed to airborne contaminates. The bag had been opened more than 7 days.
- A large bag of crumbled blue cheese that was nearly empty with an open date of 1/11/12. The bag was placed inside a sealed zip-locked plastic bag. The bag had been opened for over a month.
- A large bag of shredded Mozzarella cheese that was labeled as opened 2/13/12 also cinched together with a strip of cling wrap used as a tie. It was loosely tied but was not as obviously open to the air as the previous bag of jack cheese. The bag had been opened less than 7 days.
- A large zip-locked bag of sliced jack cheese was found with an open date of 2/1/12 and a discard date of 2/15/12. The discard date was for the previous day.
- A 1 pound stick of butter was partially used and covered with a small piece of cling wrap. The wrapping of the open butter stick did not appear to use enough of the wrap or another securing device to ensure that the open end of the butter stick remained sealed/covered to protect it from airborne or contact contamination. The stick was labeled with an open and discard date that indicated the product was still within the 7 day use range.
- 2 open quarts of half and half were found open and not dated with an open date or discard date in two separate refrigerators.
- Individual cream cheese packets were found in two topless boxes that were stacked on top of each other in the refrigerator. Neither large box, nor any of the individual packets contained expiration dates by the manufacturer or a received date. There was no way to determine the age or discard or "best when used" date for the two cases of cheese. In addition, there was a shallow metal rectangular tray containing additional cream cheese packets sitting in the same area next to the boxes. The tray contained packets from the two manufacturers of the two open cases, but it also contained packets from additional manufacturers. There was no manufacturer's date on any of the packets. The staff present were unsure how long the various brands of cream cheese had been in the refrigerator or to determine a discard date.
- A large plastic container of sour cream that appeared to be half full, was not labeled with an opened or discard date. The opening date was unknown to staff present.
- A plastic gallon jug of orange juice that was opened and appeared to have just 1-2 inches of juice in the bottom of the jug was marked as opened 2/7/12 with no discard date. The juice had been opened more than 7 days.
- A large pitcher of ice tea, with the tea bags still in the pitcher, and covered with cling wrap, was also found in a refrigerator. The pitcher was labeled with a date the tea was prepared, but no discard date.
- Many trays of prepared foods in the refrigerators were covered with cling wrap and had prepared dates, but no discard dates.
- During a tour of the shelf-stable food storage room, a large square bin of rice was found on a shelf with the lid ajar, creating a risk of airborne or vermin contamination. The lid was placed back on the bin to close it, but it appeared to be a loose-fitting lid that could easily become ajar again if bumped. The lid did not appear to have a tight sealing design.
- During a tour of one large refrigerated pantry a large square plastic container, which appeared to contain recently prepared stock was found sitting in the unit next to a large stack of trays of pasteurized raw eggs. The Director of Food and Nutrition determined that the container was still too warm to be placed in the refrigerator and in too large a container to ensure that the stock cooled more quickly and continued to cool quickly when finally placed in the refrigerator. S/he removed the container and said the stock would be divided into smaller containers and then placed in the refrigerator when they were not as warm, to prevent bacteria growth in the stock and to maintain the appropriate temperature in the refrigerated pantry and the food stored nearby the stock in the unit.
- On a counter near a refrigerator pantry, 3 cases of individual serving juices were observed to be stacked and the boxes appearing cool to the touch. The Director of Food and Nutrition stated that they had received a delivery this morning from their supplier. (The surveyors had observed the supply truck unloading supplies as they entered the building at approximately 8:00 a.m.) S/he stated that the juice would be placed in a refrigerator within the hour. When asked to show where the juice would be stored, s/he opened the nearby unit and pointed to shelves that already appeared full of juice. S/he stated that the unit would have space for the new juice when some of the other juice was removed and stored in other areas, such as in the dining area and on the nursing unit. S/he again stated that the new juice cases would be refrigerated within the hour.
- While touring the unit that contained juices, one of the previously identified cartons of half and half was found open and unlabeled. When the Director of Food and Nutrition was observed to hand the carton to another staff member and told to tell a third staff member to put a date on the carton, the surveyor asked the manager what date they were going to put on the container. S/he responded that "this was (the third employee)'s refrigerator and s/he would know when the carton was opened."
- During a tour of one of the freezer pantries, a opened quart-sized carton of ice cream was observed. It appeared to have been opened and there was no date on the carton. The Director of Food and Nutrition removed the carton and said s/he would put a date on it. When asked about the the date, s/he stated s/he knew the date because s/he placed the ice cream there him/herself the day before.
- Spice shelves over the pots/pans sinks appeared to have some spice containers an a large aluminum shaker containing paprika that were covered with old kitchen grease/dust.

3. On 2/16/12 at approximately 9:30 a.m., during a tour of the obstetrical area with the obstetrics coordinator, it was observed that the patient food refrigerator contained two salads from Food and Nutrition that were not labeled with an expiration date. The findings were confirmed with the coordinator, who stated that they should have been labeled. S/he removed them from the refrigerator. S/he stated that the salads were for serving candlelight dinners to couples after each birth.

Review on 2/16/12 of the policy/procedure "Pantry Refrigerators," revealed the following, in pertinent parts:
"...PURPOSE:
To avoid cross contamination.
To avoid the spread of infection.
PROCEDURE:
...4. All food must be labeled and dated and any (of) these foods must be checked daily and not remain in the refrigerator longer than 7 days..."

Based on staff interviews and review of facility documents, the hospital failed to have a process in place for annual policy review by a group of professional personnel that include one or more doctors of medicine or osteopathy, one or more physician assistants, nurse practitioners or clinical nurse specialist, if they are on staff, and at least one member who was not a member of the hospital staff.

The findings were:

Reference Tag C 272 for findings related to lack of medical staff involvement in policy review.

Base on tours/observation and staff interviews, the facility failed to ensure that the outpatient blood draw clinic had policies and procedures for critical lab values that were determined by on-site testing done at the outpatient clinic.

The findings were:

1. On 2/9/12 at approximately 2:30 p.m., during a tour of the outpatient blood draw clinic, it was determined that the clinic did not have any guidelines from the laboratory department for reporting critical lab values that were achieved by on-site testing. The lab technician stated that s/he would call the laboratory for direction in the event of a critical lab value.

2. Those findings were also confirmed by the Director of Clinical Informatics/Accreditation, who accompanied the surveyor on the tour of the area. No related policies/procedures were subsequently provided related to critical lab values in the clinic.

Based on tours/observations and staff interviews, the hospital failed to ensure that the outpatient clinics had policies/procedures developed specifically to address the needs and location of the clinics, related to response to medical emergencies. The failure created the potential for a negative patient outcome.

The findings were:

1. On 2/9/12 at approximately 2:30 p.m., during a tour of the outpatient blood draw clinic, it was determined that the clinic did not have any guidelines for response to a medical emergency in the clinic. The laboratory technician stated that they would refer to the hospital policies/procedures, but acknowledged that the hospital lab relied on the emergency code team in the hospital and the fact that the lab was adjacent to the emergency department for immediate assistance. S/he stated that they would have to call 911 for help and stated that s/he did not have BLS (Basic Life Support) training to respond until an community emergency response team/vehicle arrived. S/he stated that s/he would like to have that training but had been told it was not available for his/her job category. During the tour another laboratory technician arrived and also stated s/he did not have BLS training. Both acknowledged that the response to a medical emergency in the clinic had not been addressed in a policy for the clinic.

2. Those findings were also confirmed by the Director of Clinical Informatics/Accreditation, who accompanied the surveyor on the tour of the area. No related policies/procedures were subsequently provided related to critical lab values in the clinic.

3. During tours of three other outpatient clinics on 2/9/12 with the outpatient clinic Practice Manager and the Director of Clinical Informatics/Accreditation, it was confirmed that the clinics relied on the hospital emergency policies, which did not address the needs of the remotely located clinics to respond to a medical emergency.

Based on a review of facility documents and staff interviews, the facility failed to maintain a complete and accurate list of all services furnished under arrangements or agreements, including the nature and scope of the services provided.

The findings were:

1. On 2/7/12 it was determined that the contracted physicist and the contractor that processed the radiology dosimetry badges were not listed on the contracts list. That was confirmed by the director of clinical informatics/accreditation on 2/7/12 at approximately 3 p.m..

2. On 2/8/12 it was determined that the contract for the eye bank, as a part of the organ/tissue/eye procurement requirements, was not listed on the contracts list. That was confirmed by the Director of Clinical Informatics/Accreditation on 2/8/12 at approximately 8 a.m..

3. On 2/16/12 at approximately 2:45 p.m., the Director of Plant Operations was interviewed about environment compliance requirements. During the interview, it was determined that contracts were in place for trash removal, biohazardous waste materials, supplying emergency water by tanker truck and supplying emergency bottled water by a local large retail store. Review of the contract list on 2/16/12 at approximately 3:15 p.m. revealed that none of those contracts were listed.

Based on tours/observations, staff/physician interviews and review of medical records and facility documents, the Chief Executive Officer (CEO) of the facility failed to adequately manage the CAH's total operation and to ensure that the policies were administered so as to provide quality health care in a safe environment in multiple departments and functions of the facility and outpatient clinics. The failures created the potential for negative patient outcomes.

The findings were:

Reference Tag C 197 - Agreements: the facility failed to ensure that the distant-site neurology physicians held a license issued or recognized by the State of Colorado.

Reference Tag C 204 - Medical Equipment and Supplies: the facility failed to ensure that equipment and supplies commonly used in emergencies and patient care were available. Specifically, the facility failed to ensure that expired supplies were removed from patent care areas.

Reference Tag C 224 - Maintenance: the facility failed to ensure that drugs and biologicals available for patient use were appropriately stored. Specifically, the facility failed to store medications according to policy and failed to remove expired medications from patient care areas.

Reference Tag C 226 - Maintenance: the facility failed to ensure that proper temperature controls were maintained in all pharmaceutical medication storage refrigerators. Specifically, the pharmacy failed to maintain complete temperature tracking logs to ensure that appropriate refrigerator temperature levels were maintained for patient medications.

Reference Tag C 261 - Responsibilities of MD or DO: the facility failed to ensure that a periodic, but not less than every 2 weeks, review and countersignature was conducted for a sample of outpatient records of patients cared for by nurse practitioners, clinical nurse specialists, certified nurse midwives, or physician assistants by a physician. Specifically, the facility conducted a review of outpatient records quarterly.

Reference Tag C 272 - Patient Care Policies: the hospital failed to have a process in place for policy development and review that included a group of professional personnel that includes one or more doctors of medicine or osteopathy, one or more physician assistants, nurse practitioners or clinical nurse specialist, if they are on staff, and at least one member who was not a member of the hospital staff.

Reference Tag C 275 - Patient Care Policies: the facility failed to have policies that included guidelines for management of health problems that include the conditions requiring medical consultation and/or patient referral and procedures for the periodic review and evaluation of the contracted clinical services.

Reference Tag C 276 - Patient Care Policies - Safe Medication Storage: the facility failed to ensure that all medications were maintained and stored in accordance with accepted professional principle and their own policies and procedures. Specifically, the hospital failed to ensure that medication was secured in a locked cabinet with limited access in the orthopedic clinic. In addition the medication supplies included a medication that did not have an expiration date. Finally, the hospital failed to ensure that refrigerators for storage of medication were monitored for adequate temperature control. The failures created the potential for negative patient outcome.

Reference Tag C 278 - Patient Care Policies - Infection Control: the facility failed to have a system for identifying, reporting, investigating and controlling infections and communicable diseases of personnel. The facility was also in breach of procedures for infection control in the food and dietary services and the operating room environment.

Reference Tag C 279 - Patient Care Policies - Food and Dietary: the hospital failed to ensure that all food stored in refrigerators, freezers, and in other storage areas was labeled to identify open date, expiration/discard date and manufacturer's expiration date, to prevent use of contaminated or "spoiled" food products in the preparation and serving of meals to patients. The failure created the potential for negative patient outcomes.

Reference Tag C 280 - Patient Care Policies - Annual Provider Review of Policies: the hospital failed to have a process in place for annual policy review by a group of professional personnel that include one or more doctors of medicine or osteopathy, one or more physician assistants, nurse practitioners or clinical nurse specialist, if they are on staff, and at least one member who was not a member of the hospital staff.

Reference Tag C 282 - Direct Services - Laboratory Services: the facility failed to ensure that the outpatient blood draw clinic had policies and procedures for critical lab values that were determined by on-site testing done at the outpatient clinic.

Reference Tag C 284 - Direct Services - Response to Medical Emergencies: the hospital failed to ensure that the outpatient clinics had policies/procedures developed specifically to address the needs and location of the clinics, related to response to medical emergencies. The failure created the potential for a negative patient outcome.

Reference Tag C 291 - Services by Agreement - Contract List: the facility failed to maintain a complete and accurate list of all services furnished under arrangements or agreements, including the nature and scope of the services provided.

Reference Tag C 294 - Nursing Services/Emergency Department (ED) and Emergency Obstetrical Care: the facility failed to ensure that nursing services met the needs of patients. Specifically, the facility failed to ensure that nursing staff in the Emergency Department (ED) and Obstetrical Department were documenting vital signs on patients prior to discharge. Additionally, the facility failed to ensure that nursing staff in the ED completely documented triage assessments on patients by assigning triage acuity scores.

Reference Tag C 295 - Nursing Services/Delegation of Care in ED: the facility failed to ensure that the nursing care of each patient was provided by a Registered Nurse or was assigned to other personnel and provided in accordance with the patient's needs. Specifically, the facility had EMT's performing Emergency Department nursing triage. In one of 20 emergency department records reviewed an EMT performed the nursing triage in a unsatisfactory manner.

Reference Tag C 302 - Records Systems: the hospital failed to ensure that all patient medical records were legible, complete, accurately documented, readily accessible, and systematically organized. Specifically, the hospital failed to ensure that outpatient clinic records were maintained with medical record numbers and were cataloged and supervised and that outpatient clinic information was available to physicians and some hospital departments to ensure continuity of care for clinic patients.

Reference Tag C 308 - Protection of Record Information: the hospital failed to have sufficient safeguards against loss, destruction or unauthorized use of retained patient records. The facility also failed to secure all records and films in the clinics. These breaches created the potential for lack of patient privacy related to their records as well as the opportunity for patient identity theft.

Reference Tag C 333 - Periodic Evaluation: the facility failed to ensure that an evaluation was done at least once a year that included a review of a representative sample of both active and closed clinical records. The facility failed to ensure that members of the medical staff were involved in the annual review.

Reference Tag C 336 - Quality Assurance: the facility failed to ensure that it had an effective quality assurance program to evaluate the quality and appropriateness of the diagnosis and treatment furnished in the CAH and of the treatment outcomes.

Reference Tag C 337 - Quality Assurance: the facility failed to ensure that all patient care services and other services affecting patient health and safety were evaluated.

Reference Tag C 338 - Quality Assurance: the facility failed to ensure that the facility's quality assurance program evaluated medication therapy. Specifically, medication errors that were reported to the Risk Management department were not being communicated and/or not being communicated timely to the system-wide quality assurance program.

Reference Tag C 340 - Quality Assurance: the facility failed to ensure that the facility's quality assurance program evaluated the quality and appropriateness of the diagnosis and treatment furnished by doctors of medicine and osteopathy at the CAH. Specifically, the facility did not have a mechanism in place to evaluate the services provided by teleradiologists and out-of-state neurologists that were interpreting radiology exams and EEGs (electroencephalographs) performed at the facility.

Reference Tag C 342 - Quality Assurance: the facility failed to ensure that the facility's quality assurance program took appropriate remedial action to address deficiencies found through the department's quality assurance program. Specifically, when documentation and care issues were discovered by the Emergency Department's medical record reviews, there was no documentation of remedial action to address the deficiencies found.

Reference Tag C 343 - Quality Assurance: the facility failed to ensure that the facility's quality assurance program documented the outcome of all remedial actions. Specifically, the facility failed to ensure that any remedial actions taken to address documentation issues

Reference Tag C 384 - Swing Beds - Staff Treatment of Residents: the hospital failed to ensure that it complied with the Swing Bed requirement to have policies and procedures that addressed the prevention, identification, investigation and reporting of various forms of patient abuse that could potentially occur while the patient was in the facility. The failure created the potential for negative patient outcomes.


During the course of the survey, the team discovered that the facility had experienced multiple changes of CEO leadership in recent years while under a management agreement with an entity that provided the CEO's for the facility. In July, 2011 the governing directly hired the current CEO to manage the facility and converted the management agreement to a consulting agreement with the entity. The board subsequently hired a new chief financial officer and then many other key department positions, including medical records, risk, quality, medical staff services, outpatient practice manager and medical director of the emergency department. In addition, the board changed to a new accrediting agency for the facility and they had their first survey in January, 2012. Facility leadership staff were just beginning the process of implementing changes, based on the feedback received during the survey, when this survey team entered to conduct a validation survey. In addition to the above findings that still need correction, the survey team identified conditions that appeared to violate EMTALA (Emergency Medical Treatment and Active Labor Act) regulations. A concurrent EMTALA investigation, with deficient practice findings, was conducted.

Based on staff interview, medical record review, and review of the facility's policies/procedures the facility failed to ensure that nursing services met the needs of patients. Specifically, the facility failed to ensure that nursing staff in the Emergency Department (ED) and Obstetrical Department were documenting vital signs on patients prior to discharge. Additionally, the facility failed to ensure that nursing staff in the ED completely documented triage assessments on patients by assigning triage acuity scores.

The findings were:

The facility's Medical Staff Bylaws, Rules and Regulations, were last reviewed and approved 1/27/2009. The Rules and Regulations included a Medical Staff policy titled "Emergency Services" which was last approved by the Governing Body and Medical Staff on 1/26/2010. The policy stated, in pertinent parts:
"1. All patients presenting to the Emergency Department will be evaluated. Only licensed physicians can perform medical screening exams to rule out emergent medical conditions. In addition, OB nurses who have completed OB unit competency requirements are authorized by the medical staff to perform assessment of active labor ...
3. a) All patients presenting to the Emergency Department will have a nursing triage. After the emergency room nurse has performed a nursing assessment, the appropriate physician will be contacted ..."

A facility policy titled, "Emergency Department Routine Protocol", stated in pertinent parts:
" ...Procedure:
1. Patients will be triaged upon arrival to the ED. This will include vital signs, chief complaint and classification of patient (per Triage policy) ...
2. After medical triage, the Admissions Clerk will obtain all pertinent information for ED admission ...
6. A Triage Sheet shall be completed and the ED physician notified.
7. Vital signs will be repeated hourly (more often if the patient's condition warrants) and recorded ..."

A facility policy titled, "Emergency Department Outpatient Policies and Procedures", stated in pertinent parts:
" ...Procedure ...
Staffing
A. Patients who present to the ED will be seen by the ED Physician. The exception will apply if a primary physician has arranged to meet the patient in the ED
Emergency Department Records ...
C. Check vital signs (blood pressure, temperature, pulse, respirations, pulse oximetry and pain scale) and record on ED form. Also make any nursing notes that are significant (i.e., patient's appearance, color, state of consciousness, etc.). Follow Triage Policy ..."

A facility policy titled, "Triage of Emergency Patients", stated in pertinent parts:
" ...Procedure:
When the patient arrives at the registration desk, the clerk shall inform the Registered Nurse on duty that a patient has presented for emergency care. All persons presenting to the Emergency Department will be triaged within 20 minutes of arrival to the area, and before the registration clerk elicits financial information. Ideally, this triage interview should be performed by a Registered Nurse; but at times, due to patient volume and/or acuity, thin interview may be performed by an EMT, EMT-I, or Paramedic trained in emergency care. The EMT or Paramedic will immediately report to the RN on duty, as verified as part of the EMT competency.
If the patient is not emergent and is able to wait in the waiting area, the patient will be assessed every 15 minutes while in the waiting area ...
...Patients waiting in the ED should be reassessed on a timely basis to identify the deterioration of an urgent or non-urgent patient ..."

A facility policy titled, "Triage of the Obstetric Patient", stated in pertinent parts:
" ...Policy:
Obstetric patients presenting to the Emergency Department will be screened and referred/treated appropriately. The obstetric trauma patient will be provided with the appropriate interventions as early as possible.
Procedure:
1. Obstetric patient presenting at greater than 20 weeks gestation with chief complaint of abdominal cramps or pain, with or without vaginal bleeding or contractions will be triaged to Labor & Deliver. The Emergency Department will notify Labor & Deliver of triage and provide patient name and physician name if available. The Labor & Deliver environment will provide Perinatal support and appropriate interventions and education ..."

A facility policy titled, "Guidelines for Discharging Patients from the Emergency Department", stated in pertinent parts:
"Policy:
Assist in the discharge process of Emergency Department (ED) patients.
Purpose:
To discharge patient according to condition - satisfactory, fair, poor, or critical.
To assist the ED staff (Registered Nurse) in ascertaining the readiness of a patient to be discharged.
Definitions:
1. Critical condition
a. Immediate life-threatening illness or injury.
b. Vital signs are not within normal range and fluctuate:
1) + or - 20 points for blood pressure;
2) + or - 20 points for pulse;
3) + or - 10 respirations/minute; and
4) + or - 2 degrees for temperature.
2. Poor condition
a. Possible life-threatening illness or injury.
b. Vital signs are not within normal limits but stable.
c. Needs frequent observation by trained personnel.
3. Fair condition
a. Injury or illness is serious but not likely to be life-threatening.
b. Vital signs fluctuate within 10% of patient's normal limits and are stable.
c. Observation is needed but may be done by untrained personnel.
4. Satisfactory condition
a. No life-threatening illness or injury.
b. Vital signs within normal limits and stable.
c. Requires no observation by other personnel.
Procedure:
The Emergency Room staff registered nurse shall assess a patient for discharge according to the above definitions. If the patient is in a critical or poor condition, the registered nurse shall inform the patient's personal physician. If the personal physician wishes to discharge the patient after being notified that the patient is in a critical or poor condition, the staff registered nurse shall inform the Medical Chief of Service about the case. The Chief of Service and the personal physician shall confer and determine the patient's disposition ..."

Review of 20 Emergency Department and 5 OB records conducted from 2/7/2012 through 2/16/2012 revealed the following:
In all 5 (sample patients #37, 38, 39, 40, and 41) of the 5 OB records reviewed, the records did not have complete vital signs documented upon presentation.
In 3 (sample patients #37, 38, and 40) of the 5 OB records reviewed, the records did not have vital signs documented upon discharge to show the patient was stable for discharge.
In 7 (sample patients #19, 28, 30, 31, 32, 33, and 34) of the 20 ED records reviewed, the records did not have a complete triage assessment documented according the facility's policy.
In 9 (Sample patients #19, 20, 23, 24, 34, and 36) of the 13 ED records reviewed that patients were treated and discharged on a physician's order, the records did not have vital signs documented upon discharge to show the patient was stable for discharge according to the facility's policy.

On 2/8/2012 at approximately 1:26 PM a tour of the Emergency Department (ED) was conducted with the Director of the Emergency Department. S/he stated during the tour that the RN performs triage if available, otherwise patient triage was being performed by EMT's. When asked to clarify, she stated that all levels of EMT's within the ED (Basics, Intermediates, and Paramedics) "all are qualified" to perform triage. S/he stated that if the EMT has questions the EMT will consult the RN or physician. S/he stated that the MSE (medical screening examination) is only "done by a physician."

An interview with a staff nurse in the Emergency Department was conducted on 2/14/2012 at approximately 3:00 PM. S/he confirmed what had been said of how patients were triaged. S/he stated that "nurses typically do triage, EMT's assist" and further stated that EMT's usually get there first and will take the patient's vital signs. S/he stated that the nurse was ultimately responsible for the patient's triage.

An interview with the Medical Director of the Emergency Department was conducted on 2/15/2012 at approximately 7:45 AM. The Risk Manager and Director of Medical Staff Services were present as well. The care of sample patient #32 was discussed. The patient was a five year old that presented to the ED at 5:21 PM with hip pain after a fall from 5 feet. It was determined by staff present in the interview that the patient was triaged by an EMT upon arrival. The triage documentation did not include any vital signs and did not include a triage acuity determination. There was no indication that the patient was placed in a room nor was the patient monitored or given any care. The patient "LBS" (left without being seen) at approximately 6:45 PM. There was no physician documentation. The Medical Director stated that s/he was "perturbed by the lack of vital signs" and was not pleased by the lack of documentation and care.

An interview with the Director of Emergency Services was conducted on 2/15/2012 at approximately 1:15 PM. S/he confirmed the findings of incomplete documentation on triage notes and for vital signs upon discharge. S/he that the expectation was for all patients to have a complete triage assessment (including a triage acuity score and vital signs) as well as vital signs prior to discharge. S/he stated that s/he had been aware of incomplete documentation by the ED staff and had to frequently remind staff to complete portions of the record and stated that s/he had to call an employee to return to the department to complete a record on at least one occasion. S/he stated that the department would be increasing chart auditing and monitoring of the documentation of vital signs upon discharge and completion of triage assessments. When asked about the cause of the incomplete documentation and if the department needed more nursing staff, s/he stated that s/he did not think that the lack of documentation was "due to the staff being overworked." S/he stated that s/he had not had progressive follow-up/discipline of staff that was found to continue to document inadequately.

Based on medical record review, staff interview, and review of the facility's policies/procedures the facility failed to ensure that the nursing care of each patient was provided by a Registered Nurse or was assigned to other personnel and provided in accordance with the patient's needs. Specifically, the facility had EMT's performing Emergency Department nursing triage. In one of 20 emergency department records reviewed an EMT performed the nursing triage in a unsatisfactory manner.

The findings were:

The facility's Medical Staff Bylaws, Rules and Regulations, were last reviewed and approved 1/27/2009. The Rules and Regulations included a Medical Staff policy titled "Emergency Services" which was last approved by the Governing Body and Medical Staff on 1/26/2010. The policy stated, in pertinent parts:
"1. All patients presenting to the Emergency Department will be evaluated. Only licensed physicians can perform medical screening exams to rule out emergent medical conditions. In addition, OB nurses who have completed OB unit competency requirements are authorized by the medical staff to perform assessment of active labor ...
3. a) All patients presenting to the Emergency Department will have a nursing triage. After the emergency room nurse has performed a nursing assessment, the appropriate physician will be contacted ..."

A facility policy titled, "Emergency Department Routine Protocol", stated in pertinent parts:
" ...Procedure:
1. Patients will be triaged upon arrival to the ED. This will include vital signs, chief complaint and classification of patient (per Triage policy) ...
2. After medical triage, the Admissions Clerk will obtain all pertinent information for ED admission ...
6. A Triage Sheet shall be completed and the ED physician notified.
7. Vital signs will be repeated hourly (more often if the patient's condition warrants) and recorded ..."

A facility policy titled, "Emergency Department Outpatient Policies and Procedures", stated in pertinent parts:
" ...Procedure ...
Staffing
A. Patients who present to the ED will be seen by the ED Physician. The exception will apply if a primary physician has arranged to meet the patient in the ED
Emergency Department Records ...
C. Check vital signs (blood pressure, temperature, pulse, respirations, pulse oximetry and pain scale) and record on ED form. Also make any nursing notes that are significant (i.e., patient's appearance, color, state of consciousness, etc.). Follow Triage Policy ..."

A facility policy titled, "Triage of Emergency Patients", stated in pertinent parts:
" ...Procedure:
When the patient arrives at the registration desk, the clerk shall inform the Registered Nurse on duty that a patient has presented for emergency care. All persons presenting to the Emergency Department will be triaged within 20 minutes of arrival to the area, and before the registration clerk elicits financial information. Ideally, this triage interview should be performed by a Registered Nurse; but at times, due to patient volume and/or acuity, thin interview may be performed by an EMT, EMT-I, or Paramedic trained in emergency care. The EMT or Paramedic will immediately report to the RN on duty, as verified as part of the EMT competency.
If the patient is not emergent and is able to wait in the waiting area, the patient will be assessed every 15 minutes while in the waiting area ...
...Patients waiting in the ED should be reassessed on a timely basis to identify the deterioration of an urgent or non-urgent patient ..."

Review of 20 Emergency Department records revealed that in 1 (sample number 32) of the 20 medical records, the triage was performed by an EMT without evidence of oversight by a registered nurse. Sample patient #32 was a pediatric patient that presented with hip pain after a five foot fall. The triage notes were written by an employee that was identified as an EMT. The notes did not include any vital signs. The patient was sent to the waiting room after the incomplete triage and left without being seen approximately 1 ? hours later. There was not additional documentation to reflect that the patient was re-checked every 15 minutes according to the facility's policy, nor was there nursing documentation to demonstrate oversight of the EMT's performance of the nursing triage that was required according to the facility's policy.

On 2/8/2012 at approximately 1:26 PM a tour of the Emergency Department (ED) was conducted with the Director of the Emergency Department. S/he stated during the tour that the RN performs triage if available, otherwise patient triage was being performed by EMT's. When asked to clarify, she stated that all levels of EMT's within the ED (Basics, Intermediates, and Paramedics) "all are qualified" to perform triage. S/he stated that if the EMT has questions the EMT will consult the RN or physician. S/he stated that the MSE (medical screening examination) is only "done by a physician."

An interview with a staff nurse in the Emergency Department was conducted on 2/14/2012 at approximately 3:00 PM. S/he confirmed what had been said of how patients were triaged. S/he stated that "nurses typically do triage, EMT's assist" and further stated that EMT's usually get there first and will take the patient's vital signs. S/he stated that the nurse was ultimately responsible for the patient's triage though.

An interview with the Medical Director of the Emergency Department was conducted on 2/15/2012 at approximately 7:45 AM. The Risk Manager and Director of Medical Staff Services were present as well. The care of sample patient #32 was discussed. The patient was a five year old that presented to the ED at 5:21 PM with hip pain after a fall from 5 feet. It was determined by staff present in the interview that the patient was triaged by an EMT upon arrival. The triage documentation did not include any vital signs and did not include a triage acuity determination. There was no indication that the patient was placed in a room nor was the patient monitored or given any care. The patient "LWBS" (left without being seen) at approximately 6:45 PM. There was no physician documentation. The Medical Director stated that s/he was "perturbed by the lack of vital signs" and was not pleased by the lack of documentation and care.

An interview with the Director of Emergency Services was conducted on 2/15/2012 at approximately 1:15 PM. S/he confirmed the findings of incomplete documentation on triage notes. S/he confirmed that sample patient #32's record did not contain documentation that the nurse saw the patient and that the EMT had performed an incomplete triage assessment by not taking vital signs and not assigning a triage acuity scale.

Based on the manner and degree of the deficiencies cited, the facility failed to be in compliance with the Condition of Participation for Clinical 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 Clinical Record Services.

Tag C 302 Records Systems: The hospital failed to ensure that all patient medical records were legible, complete, accurately documented, readily accessible, and systematically organized. Specifically, the hospital failed to ensure that outpatient clinic records were maintained with medical record numbers and were cataloged and supervised and that outpatient clinic information was available to physicians and some hospital departments to ensure continuity of care for clinic patients

Tag C 308 Protection of Record Information: The hospital failed to have sufficient safeguards against loss, destruction or unauthorized use of retained patient records. The facility also failed to secure all records and films in the clinics. These breaches created the potential for lack of patient privacy related to their records as well as the opportunity for patient identity theft.

Based on tours/observations, review of medical records and staff interviews, the hospital failed to ensure that all patient medical records were legible, complete, accurately documented, readily accessible, and systematically organized. Specifically, the hospital failed to ensure that outpatient clinic records were maintained with medical record numbers and were cataloged and supervised and that outpatient clinic information was available to physicians and some hospital departments to ensure continuity of care for clinic patients.

The findings were:

1. On 2/8/12 at approximately 10:15 a.m., the Practice Manager for the outpatient clinics was interviewed about the lack of medical record numbers on outpatient clinic medical records and the contents of those medical records. The manager stated that the patients are assigned a medical record number through their electronic medical system. S/he acknowledged that the medical record number was not being placed in the record. S/he stated that the hospital's Director of Health Information Management had no oversight or involvement in the outpatient clinic records. S/he acknowledged that the clinic staff person that was involved in managing the medical records had no medical records training or credentials. S/he stated that her training was from working at the hospital, but she stated that she did not work with or get training from the Director of Health Information Management.

2. On 2/9/12, initial review of medical records sample patients #17 and
#18, two records of patients from a walk-in outpatient clinic was conducted and revealed that neither record had a medical record on the file or on any of the contents of the medical record.

3. On 2/9/12, at approximately 10:15 a.m., the outpatient primary care clinic was toured with the Practice Manager and the Director of Clinical Informatics/Accreditation. During the tour it was determined that medical records did not have medical record numbers in the charts or on any of the contents of the medical records.

On 2/9/12 at approximately 11:15 a.m., the outpatient orthopedic clinic was toured with the Practice Manager and the Director of Clinical Informatics/Accreditation. During the tour it was determined that medical records did not have medical record numbers in the charts or on any of the contents of the medical records. During the tour it was determined that the clinic conducted flat plate x-rays which were read by the orthopedic surgeon. The films were all stored on-site in open shelves in the radiology room. Interview with the radiology technician during the tour revealed that the films were not maintained in an organized fashion with an inventory of the records. The technician confirmed that the records were not inventoried by the medical records department of the hospital. The technician had no information about how many patient films were in the clinic and how old the records were.

On 2/9/12 at approximately 1:30 p.m., the outpatient walk-in clinic was toured with the Practice Manager and the Director of Clinical Informatics/Accreditation. During the tour it was determined that medical records did not have medical record numbers in the charts or on any of the contents of the medical records.

On 2/9/12 at approximately 2:30 p.m., the outpatient blood-draw clinic was toured with the director of regulatory compliance. During the tour it was determined that medical records did not have medical record numbers in the charts or on any of the contents of the medical records.

During the tours, the outpatient clinics practice manager confirmed that they did not have a system for cataloging all of the records in a medical records in the clinics.

4. During a tour on 2/8/12 at 8:30 a.m. in the medical records department with the department manager and the director of quality, the manager confirmed that s/he has had no oversight or involvement with medical records and x-ray films in the outpatient clinics. S/he stated that s/he was instructed not to involve him/herself with the outpatient clinic records, when she was hired approximately 6 months ago. S/he stated that s/he has no information/catalog of the patient records maintained by those clinics.

5. An interview on 2/9/12 with a staff member working with a new electronic records system for the clinic, s/he stated that s/he was not aware that the medical records did not have records numbers in them nor on the contents of the records. During the interview it was determined by the director of regulatory compliance that the main hospital electronic medical records system did not interface with the electronic system for the clinics. It was further determined that the "electronic records" for the clinic did not contain records of "contacts" (visits), the content of the medical records, and was not accessible to the rest of the hospital including the emergency department. If a patient presented to the emergency department, the staff would have no way of determining if the patient was a clinic patient, when the last visit occurred or what the patient's history and treatment in the clinic involved. It was determined that the new electronic record currently only contained a medical record number and minimum data base information and that it was a separate system from the rest of the hospital. The staff member working with the clinic records system stated that the system would eventually contain more information and would be accessible to the hospital and the physicians and would be ready to provide those capabilities by Fall, 2012. S/he stated that they would be looking at ways to increase the interface with the hospital sooner in more key functions, such as medical record numbers and access by some hospital departments and physicians.

Based upon facility tours, observations and staff interviews the hospital failed to have sufficient safeguards against loss, destruction or unauthorized use of retained patient records. The facility also failed to secure all records and films in the clinics. These breaches created the potential for lack of patient privacy related to their records as well as the opportunity for patient identity theft.

The findings were:
1. Failure to secure retained patient records
An interview was conducted with the Director of Medical Records on 2/8/12 at approximately 11:30 am. S/he stated that the retained medical records were stored offsite at the facility's Annex. S/he further stated to gain access to the Annex basement Plant Operations must be is called to unlock the door to the basement. S/he was unsure of the number of keys assigned to Plant Operations for access to the basement.

A telephone interview was conducted on 2/8/12 at approximately 11:45 am with the Plant Operations Manager and the Director of Medical Records. The Plant Operations Manager stated that there were a total of nine plant operations employees who had a key for access to the basement. The Plant Operations Manager further stated that the nine employees had keys to the "cage" where the medical records were kept and that the plant operations staff must be called to meet individuals at the Annex to let them in for access to retained information.
A tour of the Annex on 2/9/12 at approximately 8:30 am with the Plant Operations Manager and the Director of Quality revealed: a full sized basement of a former furniture store utilized for facility storage of outdated equipment and retained patient records. The Plant Operations Manager stated there were medical records, pharmacy records, lab, patient charges, claims/billing and therapy records kept in the cages. A tour of the area revealed approximately 25 boxes of records on the floor unsecured and not in cages. Some boxes were labeled: EMS(Emergency Medical Services) Reports, Inpatient/Outpatient Home health, PT (Physical Therapy) 1994, Hospice "Deceased", and 1993 discharges. Random review of these records was conducted with hospital personnel present. The records contained vital patient information consisting of patient names, social security numbers and insurance information.



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2. During tours/observations of the four outpatient clinics conducted throughout the day on 2/9/12 with the clinic Practice Manager and the Director of Clinical Informatics/Accreditation, it was determined that all of the clinics had patient medical records that were not secured in locked cabinets when the clinics were closed for business. It was determined that the clinics were cleaned by housekeeping crews when no staff were present and that the crews had ready access to the unsecured records. In addition, the orthopedic clinic also had unsecured radiology films filed with patient names on open shelving. The failure to secure all records and films in the clinics created the potential for breaches of patient privacy related to their medical records as well as the opportunity for patient identity theft.

Based on the manner and degree of deficiencies cited the facility failed to be in compliance with the Condition of Participation of Periodic Evaluation and Quality Assurance Review. The facility failed to ensure that it had an effective and comprehensive program to periodically evaluate the care provided in the CAH as well as conduct quality assurance activities that were required in these regulations.

The facility failed to meet the following standards under the Condition of Periodic Evaluation and Quality Assurance Review:

Reference Tag C 335 - Periodic Evaluation: the facility failed to ensure that an evaluation was done at least once a year that included a review of a representative sample of both active and closed clinical records. The facility failed to ensure that members of the medical staff were involved in the annual review.

Reference Tag C 336 - Quality Assurance: the facility failed to ensure that it had an effective quality assurance program to evaluate the quality and appropriateness of the diagnosis and treatment furnished in the CAH and of the treatment outcomes.

Reference Tag C 337 - Quality Assurance: the facility failed to ensure that all patient care services and other services affecting patient health and safety were evaluated.

Reference Tag C 338 - Quality Assurance: the facility failed to ensure that the facility's quality assurance program evaluated medication therapy. Specifically, medication errors that were reported to the Risk Management department were not being communicated and/or not being communicated timely to the system-wide quality assurance program.

Reference Tag C 340 - Quality Assurance: the facility failed to ensure that the facility's quality assurance program evaluated the quality and appropriateness of the diagnosis and treatment furnished by doctors of medicine and osteopathy at the CAH. Specifically, the facility did not have a mechanism in place to evaluate the services provided by teleradiologists and out-of-state neurologists that were interpreting radiology exams and EEGs (electroencephalographs) performed at the facility.

Reference Tag C 342 - Quality Assurance: the facility failed to ensure that the facility's quality assurance program took appropriate remedial action to address deficiencies found through the department's quality assurance program. Specifically, when documentation and care issues were discovered by the Emergency Department's medical record reviews, there was no documentation of remedial action to address the deficiencies found.

Reference Tag C 343 - Quality Assurance: the facility failed to ensure that the facility's quality assurance program documented the outcome of all remedial actions. Specifically, the facility failed to ensure that any remedial actions taken to address documentation issues.

Based on review of facility documents and staff interview the facility failed to ensure that an evaluation was done at least once a year that included a review of a representative sample of both active and closed clinical records. The facility failed to ensure that members of the medical staff were involved in the annual review.

The findings were:

An interview with the Director of Quality was conducted on 2/16/2012 at approximately 3:20 PM revealed that the facility conducted a periodic review but that the review did not include a review of open and closed records, but that it was planned to occur for the next periodic review. S/he stated that specifically the Emergency Department (ED) thought that the Medical Records (MR) Department was reviewing medical records and that the MR Department thought that the ED was reviewing medical records. S/he stated that the Quality Department thought that both departments were reviewing medical records. S/he stated that neither departments were reviewing medical records. S/he stated that a physician had not been involved in the annual review, but that the facility had planned to include the Medical Director in the next annual review.

A review of the facility's Periodic Evaluation and Quality Assurance documentation confirmed that there was not evidence that reviews of a representative sample of both active and closed medical records had occurred. Additionally, documentation confirmed that there was not evidence that the medical staff was involved in the facility's annual review.

Based on facility documents and staff interview the facility failed to ensure that it had an effective quality assurance program to evaluate the quality and appropriateness of the diagnosis and treatment furnished in the CAH and of the treatment outcomes. The facility failed to include the following required elements:

Reference Tag C 337 - Quality Assurance: the facility failed to ensure that all patient care services and other services affecting patient health and safety were evaluated.

Reference Tag C 338 - Quality Assurance: the facility failed to ensure that the facility's quality assurance program evaluated medication therapy. Specifically, medication errors that were reported to the Risk Management department were not being communicated and/or not being communicated timely to the system-wide quality assurance program.

Reference Tag C 340 - Quality Assurance: the facility failed to ensure that the facility's quality assurance program evaluated the quality and appropriateness of the diagnosis and treatment furnished by doctors of medicine and osteopathy at the CAH. Specifically, the facility did not have a mechanism in place to evaluate the services provided by teleradiologists and out-of-state neurologists that were interpreting radiology exams and EEGs (electroencephalographs) performed at the facility.

Reference Tag C 342 - Quality Assurance: the facility failed to ensure that the facility's quality assurance program took appropriate remedial action to address deficiencies found through the department's quality assurance program. Specifically, when documentation and care issues were discovered by the Emergency Department's medical record reviews, there was no documentation of remedial action to address the deficiencies found.

Reference Tag C 343 - Quality Assurance: the facility failed to ensure that the facility's quality assurance program documented the outcome of all remedial actions. Specifically, the facility failed to ensure that any remedial actions taken to address documentation issues.

Based on review of facility documents and staff interview the facility failed to ensure that all patient care services and other services affecting patient health and safety were evaluated.

The findings were:

An interview with the Director of Quality, in the presence of the Director of Compliance and Risk Management, conducted on 2/16/2012 at approximately 1:45 PM revealed that the facility had currently evaluated the quality assurance program and had made changes to the program. S/he stated that the facility had not been evaluating all patient care services as an organization. S/he stated that recently the system-wide quality program had asked for each department of the hospital to communicate what quality monitoring was currently being conducted. S/he stated that the groundwork had been laid out to have a system that met the requirement, but stated that it was not yet evident in the minutes or data/activities that were currently documented.

A review of the facility's quality assurance program documentation and meeting minutes was concurrently conducted with the Director of Quality. The review confirmed that the minutes and documentation did not reflect that all patient care services and other services affecting patient health and safety were evaluated.

Based on review of facility documents and staff interview the facility failed to ensure that the facility's quality assurance program evaluated medication therapy. Specifically, medication errors that were reported to the Risk Management department were not being communicated and/or not being communicated timely to the system-wide quality assurance program.

The findings were:

On 2/7/2012 at approximately 9:45 AM, the facility's Director of Compliance and Risk Management was requested to provide a list of reports that had been received from staff that would include medication errors. S/he stated that the facility was unable to generate a report that would separate the different type of reports received into the reporting systems.

A subsequent interview with the facility's Director of Compliance and Risk Management conducted on 2/8/2012 at approximately 9:00 AM revealed that reports received were presented to the quality committee as numbers of type of report, and were not reviewed in depth at the quality committee.

An interview with the Director of Quality, in the presence of the Director of Compliance and Risk Management, conducted on 2/16/2012 at approximately 1:45 PM revealed that there were times when medication errors were not being reported to the hospital's quality assurance program or were not being reported timely to the hospital's quality assurance program from the risk management system.

Based on review of facility documents and staff interview the facility failed to ensure that the facility's quality assurance program evaluated the quality and appropriateness of the diagnosis and treatment furnished by doctors of medicine and osteopathy at the CAH. Specifically, the facility did not have a mechanism in place to evaluate the services provided by teleradiologists and out-of-state neurologists that were interpreting radiology exams and EEGs (electroencephalographs) performed at the facility.

The findings were:

An interview with the facility's CEO conducted on 2/7/2012 at approximately 4:15 PM revealed that the hospital's radiology department had teleradiologists reading studies at times. S/he stated that the hospital did not have a contract with the teleradiologists directly.

An interview with the Director of Quality conducted on 2/16/2012 at approximately 2:15 PM revealed that the facility did not have quality measures in place to evaluate the quality of the interpreting of studies by the teleradiologists. S/he also stated that the hospital did not have quality measures in place to evaluate the quality of the interpreting of studies by the neurologists of EEG studies performed at the hospital.

A review of the facility's periodic review and quality assurance program documentation with the Director of Quality on 2/16/2012 at approximately 2:15 PM revealed that the facility did not have an quality review performed of the teleradiologists or the neurologists that performed interpretation of studies performed at the facility.

Reference to tag C 197 - Agreements for findings related to the facility's failure to ensure that the distant-site neurology physicians held a license issued or recognized by the State of Colorado.

Based on review of facility documents and staff interview the facility failed to ensure that the facility's quality assurance program took appropriate remedial action to address deficiencies found through the department's quality assurance program. Specifically, when documentation and care issues were discovered by the Emergency Department's medical record reviews, there was no documentation of remedial action to address the deficiencies found.

The findings were:

Cross Reference to C-294 Nursing Services for findings related to the facility's failure to ensure that nursing services met the needs of patients. Specifically, the facility failed to ensure that nursing staff in the Emergency Department (ED) and Obstetrical Department were documenting vital signs on patients prior to discharge. Additionally, the facility failed to ensure that nursing staff in the ED completely documented triage assessments on patients by assigning triage acuity scores.

Cross Reference to C-295 Nursing Services for findings related to the facility's failure to ensure that the nursing care of each patient was provided by a Registered Nurse or was assigned to other personnel and provided in accordance with the patient's needs. Specifically, the facility had EMT's performing Emergency Department nursing triage. In one of 20 emergency department records reviewed an EMT performed the nursing triage in a unsatisfactory manner.

Based on review of facility documents and staff interview the facility failed to ensure that the facility's quality assurance program documented the outcome of all remedial actions. Specifically, the facility failed to ensure that any remedial actions taken to address documentation issues

The findings were:

Cross Reference to C-342 Quality Assurance for findings related to the facility's failure to ensure that the facility's quality assurance program took appropriate remedial action to address deficiencies found through the department's quality assurance program. Specifically, when documentation and care issues were discovered by the Emergency Department's medical record reviews, there was no documentation of remedial action to address the deficiencies found.

Based on review of policies/procedures and staff interviews, the hospital failed to ensure that it complied with the Swing Bed requirement to have policies and procedures that addressed the prevention, identification, investigation and reporting of various forms of patient abuse that could potentially occur while the patient was in the facility. The failure created the potential for negative patient outcomes.

The findings were:

1. Review of all Swing Bed policies/procedures during the survey revealed that the facility did not appear to have a policy/procedure that addressed the prevention, identification, investigation and reporting of various forms of patient abuse that could potentially occur while the patient was in the facility.

2. On 2/14/12, a copy of the facilities patient abuse policy was requested. Review of the policy revealed that the policy addressed reporting child abuse, elder abuse and other forms of abuse that staff became aware of when the patient presented at the hospital, but did not address the abuse of patients by staff or others once a patient came into the hospital. This was confirmed by the Director of Clinical Informatics/Accreditation and the Chief Clinical Officer/Director of Nursing on 2/14/12 at approximately 3 p.m..