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Based on the nature of deficiencies, the facility failed to be in compliance with the Condition of Participation of Governing Body. Specifically, the facility failed to ensure that all contracted services evaluated for safety and effectiveness, met all standards and conditions of participation and were delineated in a centralized list of contracted services.

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

Tag A 0083 Contracted Services - Conditions of Participation
The governing body failed to ensure that all contracted services permitted the hospital to comply with all applicable conditions of participation and standards for the contracted services of radiology, and laboratory services.

Tag A 0084 Contracted Services - Safe and Effective
The governing body failed to ensure that the contracted services of radiology, laboratory services and Core-Zero response were evaluated regularly to ensure that the services were provided in a safe and effective manner.

Tag A 0085 Contracted Services - List of Contracts
The governing body failed to ensure that the facility maintained a complete and accurate list of contracts that included the scope and nature of services provided, as required.

Based on the nature of deficiencies, the facility failed to be in compliance with the Condition of Participation of Radiologic Services. Specifically, the facility failed to ensure that the radiologic services were provided in accordance with acceptable standards of practice and met the needs of the patients screened and accepted into the facility. The facility failed to assume responsibility for in-house coordination and evaluation of contracted radiologic services, records and staff.

The facility failed to meet the following Standard under the Condition of Radiologic Services:

Tag A 529 Scope of Radiologic Services
The facility governing body and medical staff failed to take actions, in the form of contract review (including quality assurance analysis) and policy/procedure and services review to ensure that the Radiology Services were provided in accordance with acceptable standards of practice.

Based on the nature of deficiencies, the facility failed to be in compliance with the Condition of Participation of Laboratory Services. Specifically, the facility failed to ensure that the laboratory services were provided in accordance with acceptable standards of practice and met the needs of the patients screened and accepted into the facility for treatment. The facility failed to assume responsibility for in-house coordination and evaluation of contracted laboratory services, equipment, supplies and staff.

The facility failed to meet the following Standard under the Condition of Laboratory Services:

Tag A 582 Adequacy of Laboratory Services
The facility failed to maintain a policy and procedure manual for laboratory services. In addition, the hospital failed to have policies/procedures that addressed the testing for the outpatient clinic that was conducted by another contracted commercial lab. The facility governing body and medical staff failed to take actions, in the form of contract review (including quality assurance analysis) and policy/procedure and services review to ensure that the Radiology Services were provided in accordance with acceptable standards of practice.

Based on the onsite validation survey completed, August 2 through August 9, 2011, the facility failed to comply with the regulations set forth for Life Safety Code and, therefore, deficiencies were cited under Life Safety Code tags K0011, K0017, K0018, K0025, K0027, K0029, K0034, K0038, K0050, K0051, K0052, K0056, K0062, K0064, K0071, K0072, K0074, K0076, K0144, K0145, K0147 and K0211.
See survey event ID #77YC21 for full details of the cited deficiencies.

Based on review of the manner and degree of deficiencies cited, the facility failed to be in compliance with the Condition of Participation of Organ, Tissue, and Eye Procurement.

The findings were:

Cross Reference to A 889 - Designated Requestor: for findings related to the facility's failure to ensure it had a clear and fully functioning process for use of a Designated Requestor.

Cross Reference to A 891 - Staff Education: for findings related to the facility's failure to ensure that the hospital educated staff on donation issues. Specifically, although education was provided, it was not fully encompassing of the required information.

Cross Reference to A 892 - Death Record Review: for findings related to the facility's failure to ensure that it had complete policies which encompassed the hospital cooperative role in reviewing death records.

Based on staff interviews and review of facility documents, the governing body failed to ensure that all contracted services permitted the hospital to comply with all applicable conditions of participation and standards for the contracted services.

The findings were:

Reference Tag A 528 regarding the Condition of Participation of Radiologic Services and standard Tag A 529 - Scope of Radiologic Services.

Reference Tag A 576 regarding the Condition of Participation of Laboratory Services and standard Tag A 582 - Adequacy of Laboratory Services.


Reference the following standard under the Condition of Participation of Quality Assurance/Performance Improvement (QAPI):

Tag A 267 QAPI - Quality Indicators for findings related to lack of leadership in Core-Zero responses.

Based on staff/physician interviews and review of facility documents and medical records, the governing body failed to ensure that all contracted services permitted the hospital to comply with all applicable conditions of participation and standards for the contracted services.

Based on staff interviews and review of facility documents, the governing body failed to ensure that the services provided under a contract were provided in a safe and effective manner. Specifically, the governing body failed to ensure that the contracted services of radiology, laboratory services and Core-Zero response were evaluated regularly to ensure that the services were provided in a safe and effective manner.

The findings were:

On 7/27/11, policy titled "HOSPITAL WIDE PLAN FOR PROVISION OF PATIENT CARE," last revised 3/11, was reviewed in detail. The section titled "Scope of Service" stated the following, in pertinent part: "Contracted Services include clinical lab and pathology, diagnostic radiology, MRI, CT, special procedures, organ donation, home health..."

On 7/27/11, the most recent set of annual patient care contract evaluations were provided for review. The review revealed that the facility had a contract with the neighboring acute care hospital for multiple services, including radiology, laboratory services and Core-Zero response. Review of the contract evaluation for that contract revealed that it was a general one-paged "check sheet" evaluation form that reviewed the entire contract, but did not address or evaluate the quality of each individual service provided.

On 7/26/11 at approximately 8:30 a.m., the director of performance improvement and compliance was interviewed about the process for contract evaluation for the master contract with the neighboring acute care hospital. S/he stated that the hospital does not evaluate the individual elements of patient services provided by the neighboring hospital. S/he stated that the Core (cardiopulmonary resuscitation) team does their own debriefing of the Core-Zero responses. S/he stated they "do evaluation of the contract by exception; if there is a concern or a negative outcome."

Reference Tag A 267 QAPI - Quality Indicators for findings related to lack of leadership in Core-Zero responses.

Reference Tag A 529 Scope of Radiologic Services for findings related to the facility's failure to assume responsibility for in-house coordination and evaluation of contracted radiologic services, records and staff.

Reference Tag A 582 Adequacy of Laboratory Services for findings related to the facility's failure to assume responsibility for in-house coordination and evaluation of contracted laboratory services, equipment and supplies and staff.

Based on a review of facility documents and staff interviews, the facility failed to maintain a complete and accurate list of contracts that included the scope and nature of services provided, as required.

The findings were:

1. Review on 7/26/11 of the hospital's list of contracted services, revealed that the list did not include the scope and nature of services provided, as required. On 7/26/11 at approximately 8:30 a.m., the director of performance improvement and compliance confirmed that the list provided was the centralized list of contract that was required to be maintained.

2. On 7/27/11 at approximately 11 a.m., the vice president of finance was interviewed about contract management and s/he stated that the facility had just begun to utilize a new contract management system to be in compliance with the requirements. S/he acknowledged that the list of contracts created by the new system did not include the scope and nature of each contracted service.

Based upon review of patient satisfaction surveys, facility policies and procedures and staff interviews it was determined that the facility failed to ensure a process for recognition, documentation and data collection of patient complaints/grievances. These failures created the potential for negative outcomes and continuance of potential deficient practices.

The findings were:

On 7/26/11 at approximately 8:00 a.m., an interview was conducted with the Director of Quality Management regarding the number of grievances received by the facility. S/he stated, "there had not been a grievance in the past five years. There is no documentation to give you. Our patients are pleased with the care they receive." This answer prompted the question as to what the facility would define as a grievance. Per hospital policy titled: Patient Concerns and Complaints the definition of a "Grievance" states: "A patient grievance is a formal or informal written or verbal complaint (when the verbal complaint about patient care is not resolved at the time of the complaint by staff present) by a patient or patient's representative regarding the patient's care, abuse or neglect issues related to the hospital's compliance with CMS CoP (Centers for Medicare and Medicaid Services Condition of Participation) or a Medicare beneficiary billing complaint related to rights and limitations provided by 42 CFR 489."

An interview with the 2 West Clinical Nurse Coordinator was conducted, on 7/25/11 at approximately 11:30 a.m. When asked about patient complaints, s/he stated, "There is a formal complaint process. I can't even think when that has been utilized. Little things come directly to me or the nurse, in which case the nurse would say to take it to me." When asked about the process with particularly egregious complaints s/he stated, "if egregious, I fill out an incident report...."

Per the hospital policy titled: Risk Management with review date of 4/11 it stated in pertinent part: "The Vice President of Clinical Services is the Risk Manager and Safety Officer. Manages the patient/visitor incident reporting system, complies and analyzes data to identify trends, refers/reports analyses to appropriate Department Directors or committees for assessment, corrective action and follow-up; monitors results." There was no documentation to determine if/when corrective action, follow-up and monitoring of incidences had been done.

An interview was conducted with the DON (Director of Nursing) on 7/26/11 at approximately 8:15 a.m. S/he stated that patient complaints were handled by the staff or referred to the person who was the responsible manager. The DON provided "Patient Complaint Log for 2011" which revealed there had been 9 patient complaints for the period, of 2/10/11-6/18/11. The complaints were: inconsistency in staffing, unhappy with the approach a nurse utilized, incompetence of technician, behavior attendant falling asleep, inappropriate behavior between two technicians, patient fall on 5/11/11 related to equipment malfunction, patient's leg bag was placed on their roommate, and an inappropriate comment made in the presence of a patient. The log also documented the follow-up and resolution of each complaint as it related to the nursing department resolution, but incidents were not communicated to other departments. Two examples from these complaints that demonstrate the lack of documentation and follow-up are: 1) there was no documentation in the Craig Hospital May 2011 Falls Incident Report Listing or the Safety Committee minutes dated May 11, 2011 or June 8, 2011 reporting the patient fall related to equipment malfunction, 2) there was no documentation in Infection Control reports related to the incorrect leg bag being given to a patient.

An interview was conducted with the Vice President for Clinical Services, on 7/26/11 at approximately 9:15 a.m. S/he stated, "grievances/complaints are resolved at the lowest levels usually with either a Family Services Counselor or Clinical Nurse Coordinator." In addition, s/he stated there was an unresolved issue 4/11 involving a consulting physician; however, there was no documentation to determine if or how this issue was addressed, monitored or corrected.

An interview was conducted with the Director of Patient & Family Services, on 7/26/11 at approximately 1:30 p.m. S/he stated, "there have not been any grievances in the past five years." Patients/ families are referred to the Patient & Family Services which also serves as patient advocate and or "counselors" if there is a problem or concern. This department then will address or resolve the issue or otherwise refer to the appropriate department for review and resolution. When questioned as to the process for following up with the complainant to see if the resolution was handled to their satisfaction s/he stated, "we ask them and continue to follow up for a couple of weeks to see if they feel the issue has been resolved." When asked, "how these problems/concerns were tracked for trends or procedure review; was there a log or process for documentation," the answer was, "No."

A review of the Negative Comment Reports from the contracted agency for patient satisfaction surveys, noted on patients with dates of service from 11/19/10-3/15/11. There were a total of 21 negative comments. The comments vary in areas of concern including communication between medical team, staff training and discharge planning to name a few. When the Director of Quality Management was asked how these issues are addressed, s/he stated, "there is no way to follow up with the commenter as the comments are anonymous and there is no identifier." In addition, there was no record or log for review of these comments for trending or problem recognition/resolution.

Patient Satisfaction Survey data collection was provided by a contracted provider. In an interview, on 7/27/11 at approximately 10:40 a.m., with the Director of Quality Management, s/he stated the facility had contracted with this provider for surveys since May 2009. A review of the facility Policy/Procedure Subject: Input From Patients & Families, with the facility review date of 10/10 stated in pertinent part: "A survey is distributed to all patients discharged from Craig Hospital ..... " this procedure did not reflect the current procedure for obtaining information from patients discharged from Craig Hospital. Current procedure is a phone call is placed to discharged patients by the contracted provider, and questionnaires are completed without a method for identifying patients. In the same interview the Director of Quality Management s/he stated, "there is no mechanism for the patient name to be obtained or for us to follow-up on the comments." In regard to the policy revision s/he stated, "I just had not had time to update the policy and they are reviewed every three years." It was noted by this surveyor that the policy that was reviewed on 10/10 did not reflect the process that had been in place since the implementation of the contracted provider survey service in May 2009. In a review of the Patient Satisfaction Survey Report there were category headings listed, they were: "Visit Number, MRN (medical record number) and Date," which possibly could provide information for comment follow-up. When the Director of Quality Management was asked if this information could be obtained she did not know. This surveyor noted that this could be a possible means to allow for individual comment follow-up.

In a review of the Policy, Patient Satisfaction Survey with revised date of 06/09 the policy procedure states in pertinent part: "Any poor responses will be forwarded to the appropriate Department Director for follow-up." The Director is expected to make three attempts to contact the patient (different times of the day) and return the form with the patient's responses to Administration within 2 weeks. Again per the response of the Director of Quality Management there was no mechanism for this procedure to be implemented as evidenced by no documentation of follow-up related to patient/family concerns and there was no evidence that this policy/procedure had been reviewed or revised.

The hospital failed to establish a process for identification, documentation, and resolution of patient concerns/grievances. The hospital also failed to review and revise their policies related to obtaining and responding to patient/family concerns or complaints.

Based on review of internal facility documents, medical records, and staff interviews, the facility failed to ensure the application of patient restraints was in accordance with the order of a physician or other licensed independent practitioner who was responsible for the care of the patient as specified under 482.12(c). Specifically, the facility allowed nurses to order the use of restraints on patients. This failure created the potential for a negative patient outcome.

The findings were:

CMS Condition of Participation CFC 482.12(c) states the following:
Every Medicare patient is under the care of:
(i) A doctor of medicine or osteopathy (This provision is not to be construed to limit the authority of a doctor of medicine or osteopathy to delegate tasks to other qualified health care personnel to the extent recognized under State law or a State's regulatory mechanism);
(ii) A doctor of dental surgery or dental medicine who is legally authorized to practice dentistry by the State and who is acting within the scope of his or her license;
(iii) A doctor of podiatric medicine, but only with respect to functions which he or she is legally authorized by the State to perform;
(iv) A doctor of optometry who is legally authorized to practice optometry by the State in which he or she practices;
(v) A chiropractor who is licensed by the State or legally authorized to perform the services of a chiropractor, but only with respect to treatment by means of manual manipulation of the spine to correct a subluxation demonstrated on x-ray to exist; or
(vi) A clinical psychologist as defined in ?410.71 of this chapter, but only with respect to clinical psychologist services as defined in ?410.71 of this chapter and only to the extent permitted by State law.

The facility's "BYLAWS OF THE MEDICAL STAFF," last adopted/ amended January 27, 2011, stated the following, in pertinent part: "6. The term 'practitioner' means an appropriately licensed medical physician, osteopathic physician, dentist or podiatrist."

The facility's "RULES AND REGULATIONS OF THE MEDICAL STAFF," last adopted/ amended January 27, 2011, stated the following, in pertinent part: "7.2 All orders for treatment, diagnostic tests, admission or discharge shall be in writing and must be timed, dated and signed by members of the medical staff, or advance practice registered nurses (APRN) or physician assistants (PA), approved for such privileges by the Board of Directors..." Additionally, it stated, "The term 'Allied Health Professional' shall include persons who are licensed, certified, unlicensed and/ or uncertified. a) Independent Allied Health Professionals have a recognized but limited scope of practice within medicine and are licensed or registered in a recognized jurisdiction, or certified by a recognized national professional organization and are permitted to provide services independently in the hospital, i.e., without the direction or immediate supervision of a physician. b) Physician- Directed (or Dependent) Allied Health Professionals..."

Medical records were reviewed on the unit 2 West with the Clinical Nurse Coordinator on 7/25/11. Three sample medical records evidenced the use of restraint without a physician order.

1. Sample medical record #24 was a patient who had a method of restraint applied on and off starting on 7/20/11. A physician initially ordered the restraint on the "PHYSICIAN'S ORDER" form on 7/20/11 at "6 PM." The ordered stated, "Posey Bed, Supervise [illegible word] & 1:1 if needed." However, no further physician orders for restraint were present in the medical record. Dated 7/20/11 and timed 6:30 p.m., the "ASSESSMENT NOTE FOR RESTRAINT/ SECLUSION PHYSICIAN'S ORDERS & PROGRESS NOTES," was signed by only a RN in the "PRACTITIONER SIGNATURE" section. The "TYPE/ REASON" used was checked as a "Posey bed." The following day, dated 7/21/11 at 3:45 a.m., the same form was only signed by a RN and Posey bed was again checked as the means of restraint. The same form was present for 7/22/11, timed 2:05 a.m., and, as well as Posey bed, the "Safety belt i.e. Posey Belt" was also checked. On 7/23/11, timed 1:20 a.m., both the Posey bed and Posey belt were checked as the methods of restraint. On 7/23/11, timed 11:30 p.m., both methods were again checked as restraints used. The final form was dated 7/25/11 and timed at 53 minutes after midnight. Both the Posey bed and Posey belt were again checked as the method of restraint. Each of the above forms were only signed by a Registered Nurse. The "CRAIG HOSPITAL BA/ RESTRAINT FLOW SHEET" was reviewed for the days the patient was in a form of restraint. On several occasions, the documentation evidenced that one or more forms of restraints ordered were documented "not in use" and on other occasions the hourly section of the forms did not contain the coded letters and instead had just empty spaces or check marks. The forms were difficult to follow to determine when exactly the patient was restrained.

2. Sample medical record #28 contained several forms titled "ASSESSMENT NOTE FOR RESTRAINT/ SECLUSION PHYSICIAN'S ORDERS & PROGRESS NOTES." The forms were each only signed by a RN and stated the patient had the following methods used as restraint: "Safekeeper," "Mitts" right and left, and "Lock belt." The forms were dated/ timed the following: 7/21/11 at 11:20 p.m., 7/22/11 at 4:00 a.m., 7/23/11 at 2:40 a.m., 7/23/11 at 11:25 a.m., and 7/24/11 at 11:10 p.m. No physician order was present for the restraints. Again, it was not always clear when each restraint was in use as some hourly spaces on the forms contained the coded letters, some contained empty spaces, some check-marks, and some dashes.

3. Sample medical record #30 contained several forms titled "ASSESSMENT NOTE FOR RESTRAINT/ SECLUSION PHYSICIAN'S ORDERS & PROGRESS NOTES." The forms were each only signed by a RN. Initially, the forms indicated that the patient was in a Posey bed as a method of restraint, however, on 7/20/11 at "14:00" a physician co-signed an order written by a RN which stated, "Discontinue Posey bed." However, it was evidenced thereafter that other forms of restraint were used, such as a belt, without a physician order.

Documentation in the medical records were confirmed with the unit's Clinical Nurse Coordinator (CNC) as well as the Director of Quality. On 7/25/11 at approximately 12:00 p.m., the CNC stated, "We have special permission by the State to order restraints every 24 hours. You'll have to ask [the Quality Director] about it... The physician never orders [restraints], it is a nursing decision." In a later interview with the Director of Quality at approximately 12:40 p.m., s/he stated, "We had checked with the State. The nurse can initiate the order within her scope of practice. The physician is here and knows it, but that is what we've done for the past eight to ten years. We wrote our policy to go with that... I think our prior DON checked with the nursing Board and then the State..."

The Director of Quality provided an unsigned document from the Colorado State Board of Nursing. S/he stated that this document was what the facility had been using as guidance. The document was addressed to "all interested parties," dated January 18, 2002, and regarding "Registered Nurse as Licensed Independent Practitioners." The document stated the following, in pertinent part:
"At its February 24, 2000 meeting, the Colorado Board of Nursing considered a letter asking for clarification 'whether or not it is within the scope of practice of a registered nurse, in their independent professional judgement, to order the application and if necessary continued application of patient restraints without the requirement for subsequent authorization by a physician.'
The Board believes that the registered nurse in an independent practitioner, practicing nursing independently. The ability to determine the need for restraints is a nursing function and within the basic scope of practice of the registered nurse, but the nurse's ability to determine the need would depend on that individual nurse's knowledge, judgment and skill. The Board did not believe that holding the authorization to prescribe medications necessarily related to the nurse's ability or qualifications to order restraints.
The Board reaffirmed it's position August 30, 2001. Please note the Board is addressing whether determining the need for restraints is within the scope of practice of a registered nurse. The Board is not addressing any other state or federal law that may impact the use of patient restraints within healthcare systems."

In summary, the facility was not following their Medical Staff Rules and Regulations or Bylaws as it allowed RNs to practice as Licensed Independent Practitioners. When defining a practitioner, the Bylaws did not state it was possible for a nurse to be such. Additionally, the Rules and Regulations stated that each order must be done in writing by a PA, APRN, or member of the medical staff. The facility followed a document that was over nine years old, despite that regulations and practice scopes have changed several times over that span. Finally, the document the facility followed specifically stated the following: "The Board is not addressing any other state or federal law that may impact the use of patient restraints within healthcare systems." The document defined that the scope of a registered nurse included determining the need for restraints, however, it did not specifically state that nurses were capable and competent, upon credentialing, to order restraints for patients. Per Centers for Medicare/Medicaid (CMS), Licensed Independent Practitioners are individuals qualified to care for and admit patients. A Registered Nurse is not such an individual.

Based on staff interview, review of medical records and the facility's Medical Staff Rules and Regulations, the facility failed to enforce the rules and regulations regarding medical records in two (#17 and #18) of 32 medical records reviewed. Specifically, the facility failed to ensure that physician verbal/telephone orders were signed no later than 48 hours.

The findings were:

The facility's Medical Staff Rules and Regulations stated in pertinent part: "All verbal orders must be authenticated with time and date of signature by a responsible practitioner as soon as possible and no later than forty eight (48) hours after the order is written."

The following sample medical records were reviewed on 7/25/11. The sample medical records were of two inpatients on the third floor.

1. The patient in sample medical record #17 was admitted to the facility on 7/19/11 and was recovering from a motorcycle accident. The verbal/telephone order for a medication change was written on 7/19/11. As of 7/25/11, the responsible practitioner had not signed the order.

2. The patient in sample medical record #18 was admitted to the facility on 3/7/11 for inpatient rehabilitation following a fall that resulted in spinal cord injury. A verbal/telephone order for a discontinuation of medication was written on 7/16/11. Two verbal/telephone orders for laboratory tests were written on 7/18/11. Another verbal/telephone order for monitoring was written on 7/18/11. As of 7/25/11, the responsible practitioner had not signed the four orders.

The director of the unit was assisting with the reviewing of the medical records. The delayed authentication by the responsible practitioner was brought to her/his attention. The director agreed that the verbal/telephone orders had not been signed.

Based on tours/observations, staff interviews and review of facility policies/procedures, the hospital failed to ensure that patient medical record information was retained for 10 years, as required by state licensure regulations. Specifically, the facility failed to ensure that patient and family services acquired patient information and radiology films and digital reports were retained as a part of the medical record, as required, for 10 years.

The findings were:

1. Review on 7/28/11 of the State Health Facilities licensure regulations titled "6 CCR 1011-1 STANDARDS FOR HOSPITALS AND HEALTH FACILITIES (PROMULGATED BY THE STATE BOARD OF HEALTH), CHAPTER IV GENERAL HOSPITALS, Last amended 05/18/11, effective 06/30/11," revealed the following, in pertinent parts:.
"...Part 8 MEDICAL RECORDS DEPARTMENT
...8.102(2) Medical records shall be preserved as original records, on microfilm or electronically:
(a) for minors, for the period of minority plus 10 years (i.e., until the patient is age 28) or 10 years after the most recent patient usage, whichever is later.
(b) for adults, for 10 years after the most recent patient care usage of the medical record..."

2. Review on 7/27/11 of the facility policy/procedure titled "Management of X-ray Images," last revised 4/11 revealed the following, in pertinent parts:
"...C. All hard copy imaged and CDs will be destroyed after seven and one half years..."

3. During an interview, conducted, on 7/26/11 at approximately 11:15 a.m., with the director of radiology services, s/he stated that the facility policy had previously been to retain radiology films for 10 years. S/he stated that the neighboring contracted hospital, which conducted all of the radiological exams had recently instructed them to change their standard to seven and one half years, stating that was allegedly the new standard for retention of radiology films. S/he stated that the facility had not changed it's actual practice to seven years from 10 years yet, even though the new revised policy went into effect 4/11. This information about the department's past and current practice related to retention of radiology films was also confirmed by the radiology file clerk on 7/27/11 at approximately 10:45 a.m.

4. Interview with the directors of Outpatient Services the Outpatient Clinics conducted, on 7/27/11 at approximately 9 a.m., revealed that the patient and family services department did not have a policy about storage or retention of the records they maintained in that department. On 7/27/11 at approximately 11 a.m., the Director of Outpatient Clinics provided a copy of a facility policy/procedure titled "Storage, Security, Retention and Destruction of Department Working Files with PHI."
Review of the document revealed the following, in pertinent parts:
"...RATIONALE:
To outline the procedures required to insure the security of patient information maintained within departments.
SCOPE:
All departments
DEFINITIONS:
Working Files: Documents containing patient health information information (PHI) maintained in the departments of (the facility). These documents may include the following:
1. duplicate copies of reports in which the original is filed in the medical record maintained by the HIM Department, or in the electronic medical record.
2. other documentation that is kept separate, and is not part of the medical record, but is maintained to assist the department in the ongoing treatment and follow-up of individual patients.
POLICY:
All working files containing patient information maintained in individual departments will have appropriate security measures in place to insure confidentiality. These files are not a part of the medical record or designated record set. Working files will be maintained for three years or less from creation (unless otherwise defined by a particular department and approved). After three years, the information is then destroyed according to the hospital disposal procedures..."

On 7/27/11 at approximately 11 a.m., the Director of Outpatient Clinics stated that the "Storage, Security, Retention and Destruction of Department Working Files with PHI" was sent to each director in the hospital and they were expected to make decisions about which patient information was considered "working files" and which information was to be retained for the medical record. S/he stated, when asked, that the director of health information did not provide ongoing direction or oversight to the Outpatient Clinics or the Patient and Family Services areas related to security and retention of records/files. S/he stated that the director of HIM relied on each department director to implement policies/procedures after they were set out to them.

5. Reference Tag A 811 for findings related to patient and family services staff discarding their assessment notes related to discharge planning and case management for inpatients.

Based on review of medical records, polices/procedures, and staff interviews, the facility failed to ensure that drugs and biologicals not specifically prescribed as to time or number of doses were automatically stopped after a reasonable time that was predetermined by medical staff. Specifically, instead of the traditional stop- order, the facility had a policy and procedure in place to conduct a 30- day medication review, however that process was not effectively carried out on one of two units surveyed. This failure created the potential for a negative outcome.

The findings were:

The facility's policy titled "30- DAY MEDICATION AND TREATMENT REVIEW," last revised 12/10, stated the following, in pertinent part:
"POLICY: All inpatient medications and treatments shall be reviewed every 30 days by the primary active attending physician.
PROCEDURE:
I. The night Unit Secretary/Nurse on Sunday night will print out a progress note for all patients due that week for 30 day review. The note states: "30 day medication/ treatment review - medications and treatments have been reviewed."
II. The primary active attending physician will review all medication and treatments and sign and date the 30-day renewal note on Physician Order form.
III. The physician will monitor the effect of the medications on the patient by gathering the patient's perception of efficacy and/or the patient response to the medications ordered as appropriate.
IV. Any changes in medication or treatment will be noted on the physician order form.
V. Nursing will process new order, per policy.
VI. Nursing will send the 30 day renewal orders to pharmacy.
VII. Nursing/pharmacy will evaluate all medication not used within 14 days and discuss discontinuing these meds with the ordering physician."

An interview with the Director of Pharmacy was conducted, on 7/26/11 at approximately 10:00 a.m. When asked about stop- orders, s/he stated, "They aren't automatic. We have a 30 day review of meds that MDs do ... Most of our patients are chronic ... It is more of a risk to stop [the meds] than it is to go over ... It has always been like that ..." The Director confirmed that stop- orders were "not used on any drugs. "

A tour of 3 West and 2 West units was conducted with the Director of Quality, on 7/26/11 at approximately 10:45 a.m. While on 3 West, one medical records was observed to have a 30 day "medication and treatment" review, which was signed by the physician. The Secretary on 3 West was asked about the process and stated, "The night secretary places it [30 day form] in the chart ... They have a list and go by that every week." The Secretary found the list, which evidenced each patient's name on a different week. When asked about other floor's process, s/he did not know. Two sample medical records, #s 31 and 32, were reviewed for presence of the 30 day medication and treatment review form. Sample medical record #31, admitted 5/2/11, contained no such form. Sample medical record #32, admitted 6/7/11, also did not contain the form. The "thinned" charts of both were reviewed and the Director of Quality confirmed the observations. The unit's Secretary was asked about the process but s/he was unaware of it. When the Director of Quality was asked if this was audited, s/he stated, "I don't audit that anymore ... I'm guessing that it is just this floor ... It looks like the process failed on this unit."

Based on review of facility documents and staff interviews, the facility failed to ensure the radiologic services were appropriate to the scope and complexity of the services offered and to meet the need of the patients screened and accepted for admission and treatment. Specifically, the facility failed to have a policy/procedure manual with a description of services provided that was reviewed by the medical staff to ensure that the services met the needs of the patients. In addition, the governing body of the facility failed to ensure that a process was in place to evaluate the quality of the contracted radiologic services. The failure created the potential for negative patient outcomes.

The findings were:

1. Review on 7/26/11 of the facility contract (signed 9/26/07) with the neighboring acute care hospital for multiple services, including radiology, revealed the following, in pertinent parts: "...1.1 Patient Care Services. The (hospital) hereby engages (the neighboring acute care hospital) to provide certain patient care services to (the hospital) inpatients in accordance with the terms and conditions of this Agreement, including: ...(h) Radiology... Such...services shall be provided upon reasonable request by (the hospital) subject to (the neighboring acute care hospital's) capacity and capability limitations...3.3 Independent Contractors: The parties and their respective personnel are performing the services required hereunder as independent contractors and not as employees, agents, partners of or joint ventures. All personnel assigned pursuant to this Agreement shall, for all purposes under the Agreement, be considered employees of their respective employer only...3.4 Personnel Qualifications and Records. The parties shall maintain personnel files for all personnel providing services pursuant to this Agreement to include the documentation listed in this section 3.4. Complete files and/or a computerized summary of personnel files information shall be readily available to the other party for review upon request...."

A review of an attached contract amendment, dated 5/1/09, revealed the following, in pertinent parts: ...2. Services provided by (the neighboring acute care hospital) to (the hospital's) radiology outpatients will be reimbursed at ...% of charges.

2. Per interview with the quality improvement/compliance officer, on 7/26/11 at approximately 8:30 a.m., s/he confirmed that the radiology services were provided under contract with the neighboring acute care hospital. S/he acknowledged that the annual contract review for quality and contract performance did not involve an evaluation of each of the many services provided under contract, including radiology. Review of the contract evaluation for that contract revealed that it was a general one-paged "check sheet" evaluation form that reviewed the entire contract, but did not address or evaluate the quality of each individual service provided. S/he stated they "do evaluation of the contract by exception; if there is a concern or a negative outcome."
S/he further confirmed that the hospital did not maintain in-house files on the radiology technicians from the neighboring hospital that came over to perform x-rays on their patients in the facility. Finally, s/he confirmed that the scope of services for radiology services was a document from the contracted neighboring acute care hospital, was the only description of the scope of services provided in the hospital related to radiology services.

3. Interviews with the director of radiology services for the hospital, on 7/26/11 at 11:15 a.m., and the radiology filing clerk, on 7/27/11 at 10:40 a.m., confirmed that the department radiology had a few policies that primarily reference the policies and manuals provided by the contracted hospital. They both confirmed that they did not have an in-house scope of services for these areas, they relied on the scope of services from the other contracted hospital. They also confirmed that they did not have an in-house list of radiology procedures that had been approved by the hospital's medical staff. They stated that the information about tests available was accessed through the contracted hospital's computer system and test preparation manuals.

4. Reference Tags A 439 and A 442 for findings regarding retention and security of radiological films/discs.

Based on review of facility documents and staff interviews, the facility failed to ensure the laboratory services were appropriate to the scope and complexity of the services offered and to meet the need of the patients screened and accepted for admission and treatment. Specifically, the facility failed to have a policy/procedure manual with a description of services provided that was reviewed by the medical staff to ensure that the services met the needs of the patients. In addition, the governing body of the facility failed to ensure that a process was in place to comprehensively evaluate the quality of the contracted laboratory services. The facility relied on the policies/procedures developed for laboratory services by the neighboring hospital, which was contracted to provide the majority of inpatient and some outpatient services. In addition, the hospital failed to have policies/procedures that addressed the testing for the outpatient clinic that was conducted by another contracted commercial lab. Finally, the hospital failed to ensure that the in-house staff responsible for laboratory services were aware that the facility was required to hold, and did have a CLIA waiver.

The findings were:

1. During a tour of the outpatient clinics, on 7/26/11 at approximately 9:00 a.m., the lab room for the clinic was toured and the phlebotomist for the clinic was interviewed. The phlebotomist stated that the facility did not have a CLIA (Clinical Laboratory Improvement Act) waiver for point of care testing conducted in the clinic lab, since the facility had a contractual relationship with a neighboring CLIA certified acute care hospital to provide laboratory services. Just prior to the tour, the director of the outpatient clinic, the director of clinical services and the director of quality improvement and compliance all confirmed that the facility did not have a CLIA waiver to cover the point of care testing conducted in the clinic and on the four patient care units. They stated that it was unnecessary, because of their contractual relationship with the neighboring facility for laboratory services. In subsequent interviews with the director of laboratory services, on 7/26/11 at 1:45 p.m. and the lead phlebotomist on 7/28/11 at approximately 8:15 a.m., they also confirmed that the facility did not have, or require, a CLIA waiver

On 8/1/11 at approximately 1 p.m., a telephone interview was conducted with a CLIA surveyor from the Colorado Department of Public Health and Environment regarding the requirements for a CLIA waiver in a facility with a contractual relationship with another CLIA certified hospital to provide laboratory services. S/he stated that the facility still needed to have a CLIA waiver if they were conducting point of care testing in the facility. S/he then checked the status of the facility and determined that the surveyed hospital did have a current CLIA waiver effective 2/10 with an expiration date of 6/22/12. S/he faxed a copy of the documentation of the current waiver for the survey file.

2. During a tour of the outpatient clinics, on 7/26/11 at approximately 9:00 a.m., the lab room for the clinic was toured and the phlebotomist for the clinic was interviewed. The phlebotomist stated that most of the samples for analysis collected at the clinic went to a large outside laboratory company. The centrifuge, which had no preventive maintenance inspection sticker, was supplied to the clinic lab by that company. The phlebotomist stated that s/he worked/consulted directly with the laboratory company related to most of the specimens collected at that location. The phlebotomist stated, when asked, that s/he did not coordinate services with the hospital's director of laboratory services.

The lab did contain some blood collection tubes for the adjacent acute care hospital lab also. In addition, the lab contained a glucometer that was apparently monitored by the lab at the adjacent acute care hospital.

3. Review on 7/26/11 of the facility contract (signed 9/26/07) with with the neighboring acute care hospital for multiple services, including radiology, revealed the following, in pertinent parts: "...1.1 Patient Care Services. The (hospital) hereby engages (the neighboring acute care hospital) to provide certain patient care services to (the hospital) inpatients in accordance with the terms and conditions of this Agreement, including: ...(e) Laboratory...Such...services shall be provided upon reasonable request by (the hospital) subject to (the neighboring acute care hospital's) capacity and capability limitations...3.3 Independent Contractors: The parties and their respective personnel are performing the services required hereunder as independent contractors and not as employees, agents, partners of or joint ventures. All personnel assigned pursuant to this Agreement shall, for all purposes under the Agreement, be considered employees of their respective employer only...3.4 Personnel Qualifications and Records. The parties shall maintain personnel files for all personnel providing services pursuant to this Agreement to include the documentation listed in this section 3.4. Complete files and/or a computerized summary of personnel files information shall be readily available to the other party for review upon request...."

4. Per interview with the quality improvement/compliance officer, on 7/26/11 at approximately 8:30 a.m., s/he confirmed that the laboratory services were provided under contract with the neighboring acute care hospital. S/he acknowledged that the annual contract review for quality and contract performance did not involve an evaluation of each of the many services provided under contract, including radiology and nuclear medicine. Review of the contract evaluation for that contract revealed that it was a general one-paged "check sheet" evaluation form that reviewed the entire contract, but did not address or evaluate the quality of each individual service provided. S/he stated they "do evaluation of the contract by exception; if there is a concern or a negative outcome." S/he further confirmed that the hospital did not maintain in-house files on the phlebotomists from the neighboring hospital that came over to draw blood.

5. In interviews with the director of laboratory services, on 7/26/11 at 1:45 p.m., and the lead phlebotomist, on 7/28/11 at approximately 8:15 a.m., they also confirmed that the laboratory services list of policies was from the contracted hospital and was accessed through the other hospital's computer system. When asked for policies and procedures for laboratory services, the lead phlebotomist provided a list of policies/procedures for laboratory services that contained the letterhead of the contracting hospital. S/he also provided an in-house waived testing policy, which was attached to a waived testing policy from the contracted hospital, a look-back policy that was attached to a look-back policy from the contracted hospital, a policy on lab order entry into the contracted hospital and a blood glucometer policy from the contracted hospital. They both confirmed that they did not have and in-house scope of services for laboratory services. They stated they relied on the scope of services from the other contracted hospital. They also confirmed that they did not have an in-house list of laboratory procedures that had been approved by the hospital's medical staff. They stated that the information about tests available was accessed through the contracted hospital's computer system and test preparation manuals. The lead phlebotomist and the director of laboratory services both confirmed that they had no involvement or oversight over the laboratory testing conducted in the outpatient department that was conducted by a large outside laboratory.

Based on the food and dietary tour, staff interview and review of the facility's manual, the facility failed to ensure that food and dietetic services organization requirements were met. Specifically, the facility failed to ensure that monitoring requirements were met.

The findings were:

Documentation in the facility's dietary manual relating to thermometers stated the following in pertinent part: "Each mechanically refrigerated...food storage unit storing potentially hazardous food shall be provided with a numerically scaled indicating thermometer. Thermometers used to measure the air temperature of cold holding units shall be conspicuously located in the upper one-third of the unit..."

A tour of the food and dietary areas was conducted, on 7/26/11 at approximately 9:00 a.m. The primary food preparation area was located on the lower level of the hospital. It was noted during the tour of this area that a freezer, a walk-in freezer and a walk-in refrigerator failed to contain a back-up thermometer inside the units. The daily temperatures were being documented using the outside thermometer only.

The failure to have back-up thermometers in three units was discussed with the dietary manager during the tour on 7/26/11. The manager did not know why the inside thermometers for these particular units were missing and thought perhaps they were no longer a requirement and stated he would check the new dietary manual. Later in the day the manager provided information to affirm that back-up thermometers were still a requirement in cold holding units.

Based on staff interview and review of medical records and facility policies/procedures, the facility failed to ensure that medical records contained adequate, up-to-date documentation of the discharge planning process in two (#11 and #14) of 32 medical records reviewed. Specifically, the discharge evaluations were not being documented in the medical record in a timely fashion. Furthermore, the facility's policy/procedure did not address the admission/discharge of patients that were in the facility for less than two weeks.

The findings were:

The facility's policy and procedure entitled, "Guide for Assessment, Reassessment and Discharge," stated the following in pertinent part:
"Initial Evaluation - The Patient and Family Service Counselor will complete an initial evaluation. This information will be contributed to the interdisciplinary record, and to the patient and family conference held within 2 weeks of admission...
Discharge - The discharge summary should include the information obtained from the initial evaluation and re-assessments throughout. The document should be completed no later than one week following the patient's discharge."

1. Patient sample #11 was admitted to the facility, on 5/22/11, with chronic respiratory failure with the placement of a diaphragm pacer performed at a nearby hospital on 5/23/11. The patient returned to the facility on the same day and was discharged on 5/28/11. The medical record was reviewed on 7/27/11 as a closed electronic medical record (EMR). Upon review of the discharge planning, it was noted that the discharge documentation was inputted into the EMR on 6/20/11 with the following documentation: "(Patient's name) is a 29 year old male with a history of SCI and is well known in the Craig system. He comes to Craig on this occasion for a placement of a diaphragm pacer." The other documentation was a form that directed the reviewer to answer questions on advance directives, discharge destination, insurance, etc. This discharge information was documented into the EMR approximately three weeks after the patient had been discharged.

2. Patient sample #14 was admitted to the facility, on 2/9/11, with cerebrovascular disease and transferred to another hospital on 2/12/11. The discharge summary was documented into the EMR on 2/24/11 and stated the following: "(Patient's name) was transferred to (hospital name) ICU. Please see d/c summary." This discharge information was documented into the EMR approximately one and a half weeks after the patient had been discharged.

An interview was conducted with the Director of Patient and Family Services, on 7/25/11 at approximately 2:40 p.m., regarding the discharge planning process utilized in the facility. The Director stated that discharge planning began on admission "because we have to." The assessments are done and in two weeks put into the system. The social workers make hand written notes when the patients are assessed; however, a summary from the notes are documented in the EMR and the hand written notes are destroyed. The Director further stated that everyone does the process differently.

In summary, the patient sample medical records #11 and #14 did not have timely discharge documentation in the EMR. Furthermore, the discharge planning documentation in the EMR did not reflect the hand written notes that were created by the social workers. There were no dates/times of when the patient was seen, only a brief synopsis of the assessment was documented. Also, there were no policies/procedures that addressed a time frame for the patients that have less than a two week admission.

Based on staff interview, review of policies/procedures and staff education, the facility failed to ensure it had a clear and fully functioning process for use of a Designated Requestor. Specifically, the Director of Quality and DON were unaware of the role of a Designated Requestor and such role was not educated to staff, provided clearly within the facility, or stated specifically within any facility policies. This failure did not ensure that the process of approaching potential donor families to request organ and/or tissue donation was done appropriately and efficiently and created the potential for a negative outcome.

The findings were:

After entrance to the facility, on 7/25/11, the Director of Quality was asked who the Designated Requestor for Organ Transplant/ Donation was at the facility. The Director stated that would be the Director of Nursing. An interview with the Director of Nursing was conducted, on 7/27/11 at approximately 8:00 a.m. When asked about his/her role as the Designated Requestor, s/he stated, "Typically I would be the one." When asked about education s/he had received, s/he stated that s/he knew the policy. S/he continued, "Seven years ago I had a walk through with the CNO then and we went through the process... I had hands on experience... We approach the family and talk if they are interested in donating organs... We had that conversation with the MDs and myself..." When asked if s/he had ever taken a specific course on being a Designated Requestor, s/he stated, "No... It is not routine practice [deaths at the facility]." The DON was informed that a course was required and asked if anyone else in the facility had done that, such as the chaplain. The DON and Director of Quality were unaware.

An interview with the facility's Chaplain was conducted, on 7/27/11 at approximately 9:00 a.m. S/he stated that s/he was a "Certified Requestor for Donor Alliance." S/he stated that s/he would be getting recertified this fall. S/he stated, "[The neighboring hospital] Chaplains cover for me when I'm not available... The code team consists of a [the neighboring hospital] Chaplain on- call for the day, but I'm notified by our nursing staff..." The Chaplain was asked to provide his/her certification. Later that day at approximately 3:30 p.m., s/he stated that s/he could not find the certification and had called Donor Alliance. S/he stated, "My certification has lapsed. Donor said 'we haven't had a referral from you' and that it wasn't required because we are stated as a Rehab Hospital. They feel that the neighboring contracted hospital will take over with their Chaplains... It lapsed in '08 or '09..." It was again confirmed, however, that the Chaplain had done the required training in the past to become a Designated Requestor.

On 7/27/11, the education provided to the staff on organ donation was reviewed. The Director of Quality stated that a computer based "Net Learning" program was done by each staff member and that greater than 90% compliance was required. The Director also stated that each employee is provided with a "Culture of Excellence" book, which contains information on Organ Donation. The Net Learning program stated the following: "- In the event of a patient death, the Death and Organ Donation Policy will be followed. When applicable, a coroner's release is needed - At time of death, families shall make the ultimate decision regarding donation - It is the physician's responsibility to notify the Donor Alliance - The Donor Alliance contacts the family regarding organ and tissue donation." The "Organ/ Tissue Donor Policy" in the "Culture of Excellence" book stated the following: "- In the event of a patient death, the RI 05 Death and Organ Donation policy will be followed. When applicable, a coroner's release is needed. - At time of death, families shall make the ultimate decision regarding donation. - It is the physician's responsibility to notify the Donor Alliance. - The Donor Recovery Coordinator contacts the family regarding organ and tissue donation." The education did not describe the role of a Designate Requestor.

The facility's policy titled "DEATH AND ORGAN/ TISSUE DONATION," last reviewed 4/11, stated the following, in pertinent part:
"POLICY: A patient's death will be handled with dignity and respect for the patient and family. Any potential donor must be considered for organ/tissue donation.
PROCEDURE:
I. Nurse Responsibility in event of a patient death.
A. Notify attending physician and all consulting physicians, nurse manager (or nurse on-call) family service counselor, psychologist, chaplain, PT, OT, ST, TR, Business Office, Admissions, HIM, and Switchboard.
B. Call the Arapahoe County Coroner immediately after expiration at [phone number] to determine if the death is reportable (see Attachment A) and complete Worksheet for Coroner's Cases (Attachment B) if needed.
C. Complete the Death Summary Form (RI05F2), which includes documentation of the report of death, contact with the coroner, donor agency and family.
1. Document time and name of the Coroner contacted, if the death is a Coroner's case, and if body was released by the Coroner.
2. Document contact with the Donor Referral agency to determine donor suitability, prior to death, if possible. [phone number] Have the age, time of death, and medical history available for the procurement agency staff. Document if patient is or is not a donor candidate and name of donor staff contacted.
3. Maintain patient as potential organ donor adequately to ensure organ viability until Donor Alliance determines medical suitability and/or family has made a decision about donation. If patient is a done, complete..."
The policy did not state any further practice guidance regarding Designated Requestor responsibilities or the organ donation request process.

The facility's policy titled "EMERGENCY RESPONSE - CHANGE IN PATIENT CONDITION, EMERGENCY STAT, AND CODE BLUE," last revised 3/10, stated the following in "THE ROLES AND RESPONSIBILITIES OF THE RESUSCITATION TEAM" section, in pertinent part: "12. Chaplain, Family Service Counselor: Supports family, other patients and staff, as indicated. Family Service Counselors and Chaplain are to be contacted at home if the CODE BLUE occurs on their off-duty hours." The policy did not specify if the Chaplains/ Counselors of the facility's or of [the neighboring ] Hospital's staff were to be contacted.

Another interview with the Director of Quality was conducted, on 7/28/11 at approximately 8:45 a.m. S/he was informed that none of the staff education or policy specified the procedure for the Designated Requestor and exactly who was to be doing that role within the facility. S/he was informed that the Chaplain's certification had lapsed. S/he stated, "I was not aware of that term [Designated Requestor] before... It is not in [the Chaplain's] job description to do that." When asked why the surveyors were informed upon entrance that the DON was the Designated Requestor, s/he stated [The DON] knows about organ donation and usually takes care of that."

Finally, after exit from the facility, the policy titled "HOSPITAL WIDE PLAN FOR PROVISION OF PATIENT CARE," last revised 3/11, was reviewed in detail. The section titled "Scope of Service" stated the following, in pertinent part: "Contracted Services include clinical lab and pathology, diagnostic radiology, MRI, CT, special procedures, nuclear medicine, organ donation, home health..."

Based on review of staff education and staff interview, the facility failed to ensure that the hospital educated staff on donation issues. Specifically, although education was provided, it was not fully encompassing of the required information. This failure created the potential for a negative outcome.

The findings were:

On 7/27/11, the education provided to the staff on organ donation was reviewed. At approximately 9:10 a.m., the Director of Quality stated that a computer based "Net Learning" program was done by each staff member and that greater than 90% compliance was required. The Director also stated that each employee is provided with a "Culture of Excellence" book, which contains information on Organ Donation.

The Net Learning program stated the following: "- In the event of a patient death, the Death and Organ Donation Policy will be followed. When applicable, a coroner's release is needed - At time of death, families shall make the ultimate decision regarding donation - It is the physician's responsibility to notify the Donor Alliance - The Donor Alliance contacts the family regarding organ and tissue donation."

The "Organ/ Tissue Donor Policy" in the "Culture of Excellence" book stated the following: "- In the event of a patient death, the RI 05 Death and Organ Donation policy will be followed. When applicable, a coroner's release is needed. - At time of death, families shall make the ultimate decision regarding donation. - It is the physician's responsibility to notify the Donor Alliance. - The Donor Recovery Coordinator contacts the family regarding organ and tissue donation."

An interview with the Director of Quality was conducted, on 7/27/11 at approximately 2:30 p.m. S/he was informed that the education provided to staff was not encompassing of all the required information. S/he stated, "But they [staff] are referred back to the policy." Although this is accurate, it does not ensure that the education is provided as part of the facility's training program.

The education did not clearly specify the following required information:
- Consent process;
- Importance of using discretion and sensitivity when approaching families;
- Role of the designated requestor;
- Quality improvement activities.

Based on review of facility contracts, policies/procedures and staff interview, the facility failed to ensure that it had complete policies which encompassed the hospital cooperative role in reviewing death records. This failure created the potential for a negative outcome.

The findings were:

The facility's policy titled "DEATH AND ORGAN/TISSUE DONATION," last reviewed 4/11, did not state any policy or procedure for the review of death records by the designated OPIO, tissue bank, and/or eye bank.

The facility's contract with the eye bank stated the following in relation to the review of death records, in pertinent part: "2.3 Accessibility to CH [Craig Hospital] death records to evaluate the effectiveness of [the company] education and eye recovery programs. CH and patient confidentiality shall be maintained at all times with respect to the above information..."

The facility's contract with Donor Alliance Inc. stated the following in relation to the review of death records, in pertinent part: "Hospital agrees to the following... Cooperate in routine review of medical records conducted by Donor Alliance personnel, to assist in identifying Hospital's potential organ and tissue donor pool and educational needs. Donor Alliance personnel will have access to and maintain the confidentiality of medical information in accordance with applicable law..."

An interview with the Director of Quality was conducted, on 7/27/11 at approximately 2:30 p.m. S/he was informed that the facility's organ donation policy did not encompass the procedure for the review of death records. S/he stated, "But our contract states we will." Although this is accurate, not all staff are familiar with contract specifics and this process did not ensure there was a clear and fully functioning procedure which would permit the Organ Procurement Organization (OPO), tissue bank, and eye bank access to death record information that would allow the OPO, tissue bank and eye bank to assess the hospital's donor potential, assure that all deaths or imminent deaths are being referred to the OPO in a timely manner, identify areas where the hospital, OPO, tissue bank and eye bank staff performance might be improved. Additionally, the facility's policy did not address how patient confidentiality will be maintained during the death review process.

Based on tours/observation, review of facility documents staff/physician interviews, the hospital failed to ensure that outpatient services were appropriately organized and integrated with inpatient services. The failure created the potential for negative patient outcomes.

The findings were:

Reference Tag A 439 Medical Records - Retention of Records for findings related to medical records, failure to ensure that all patient information and records were retained in the outpatient services, including the patient and family services.

Reference Tag A 442 Medical Records - Security of Medical Records for findings related to medical records failure to ensure that all patient information and records were securely stored, to protect patient privacy, in the outpatient services, including the patient and family services.

Reference Tag A 582 Laboratory Services - Adequacy of Laboratory Services for findings related to failure to provide in-house coordination and evaluation of contracted laboratory services, equipment and supplies and staff for the outpatient clinics.

Based on facility policies/procedures, staff interviews, and review of internal documents, the facility failed to take a proactive approach in measurement, analyzation, and tracking of quality indicators, even when an issue had been identified within the facility. Specifically, the facility identified that the Code Blue process had a lack in leadership, however, the facility did not change its policy or comprehensively review each Code Blue to ensure patient care was not affected due to the lack in leadership. This failure created the potential for a negative patient outcome.

The findings were:

A "Nursing Peer Review Referral Form" stated the following, in pertinent part: "...CODE BLUE was called... began compressions... bagging the pt... gained IV access. Pt was then intubated by... Zoll pads applied, the contracted hospital's Code Blue Team was somewhat late to respond. By the time the contracted hospital Team arrived, pt had BP & Pulse. The contracted hospital Team took over drug administration..." The "Area of Concern/ Reason for Referral" portion of the form stated the following, in pertinent part: "Code Blue handled extremely well by staff, process went smoothly and the contracted hospital Code Blue Team later commented about how well incident had been handled prior to their arrival..."

The facility was asked to provide a review of all their Code Blue events. On 7/26/11, the Director of Quality Management was asked where Codes are tracked and stated, "Through Nurse Practice Council and each would be as an incident report." A Peer Review Binder was provided as evidence of such. However, this binder did not contain a formal review of each Code Blue, such as the above described Code. On 7/26/11 at approximately 9:00 a.m., when the Director of Quality Management was asked about this patient's Code, s/he stated, "I doesn't look like a peer review was done.... We don't do nursing peer review on each code. They select cases they are going to review..." When asked if Code Blue issues were ever cohesively looked at, s/he stated they would be done so in the annual report of the board of system failures.

On 7/26/11 at approximately 1:00 p.m., one of the Clinical Nurse Manager's stated, "I sit on the Code Blue Committee over there [at the neighboring acute care hospital]. We are represented." S/he stated that the Director of Respiratory/ Radiology also attended the Code Blue Committee meetings at the contracted hospital. During this interview, the Code Blue form/ sheet to evidence further documentation on the patient addressed in the Nursing peer Review Referral Form was requested from the Director of Nursing. Throughout the survey, the patient's Code Blue documentation was requested several additional times. The Director of Quality stated that it was not present in the medical record, so they were going to contact the contracted hospital's Health Information Management Department to see if it was in the medical record there. The Director of Quality was asked a final time about the record/ documentation, on 7/28/11 at approximately 7:40 a.m., and s/he stated s/he had not heard back from the facility's own HIM Director as to if the facility had received the documentation from the contracted hospital, and s/he stated s/he would check and let the surveyor know if they had. No Code Blue record was presented to the surveyor prior to exit from the facility.

The annual report of the board referenced by the Director of Quality, titled "BOARD REPORT, SYSTEM/ PROCESS FAILURES, SENTINEL EVENTS," was reviewed. The cases documented within the review included Root Cause Analyses, Interdisciplinary Case Reviews, and Nursing Peer Reviews. The Interdisciplinary Case Review section stated the following: "Trends indicate need to continue training staff response to Code Blue and developing staff that can assume leadership role in Code Blue. In addition, need to improve communication among RN, RT, and MD staff with changes in patient condition has been noted..." A review of one of the cases stated that areas for improvement were: "family in room, too many staff in room; lack of leadership of Code Blue response, confusion regarding who could administer medications." That same case stated that the process improvements completed were: "planning emergency response team; RNs who take lead in a Code Blue to be ACLS certified; RN staff education, RNs to do COR cart checks." In addition, the "BOARD OF DIRECTORS Medical Care and Administrative Committee Minutes" from November 17, 2010 stated the following, in pertinent part: "PERFORMANCE IMPROVEMENT REPORT - [Quality Director] reviewed the minutes from the October Quality Council meeting. [S/he] noted that three improvement projects are being considered for the next year: improve response to emergency state and code blue calls..."

An interview with the Director of Quality, on 7/27/11 at approximately 2:45 p.m., revealed that Code Blue response was not one of the facility's 2011 performance initiatives, as suggested in the Medical Care and Administrative Meeting. The "PERFORMANCE IMPROVEMENT AND SAFETY MANAGEMENT PLAN" stated the following, in pertinent part: "Monitoring and Measurement Processes; The following important functions, processes and outcomes will be included in the monitoring and measurement process. Trends and patterns will be analyzed by the designated committees or processes to determine opportunities for improvement and will include: ...Outcomes related to resuscitation..."

The Director was asked about the identified concerns and need for staff training, as stated in the Board Report, and asked how those concerns were identified. On 7/27/11 at approximately 11:00 a.m., s/he stated, "We are training ACLS to staff... We are planning to do code drills... That has been the plan. The issue is that when there are ten to twelve codes per year, each nurse doesn't have experience... We were thinking the lead needs to come from CVC or RT... When ours happen, they had trouble assuming leadership. That was the problem we were having of who was going to delegate the orders. Nobody said, 'you do this, you do this." When asked if the contracted hospital's Code Team's arrival time had been assessed, s/he stated it had not. When asked how the facility would know if there had been issues, s/he stated it would be on the "what went wrong" portion of the form. It was noted that the contracted hospital's Code Team may have to travel far distances, for example through the underground tunnel, up the elevator/stairs, over the bridge to the facility's second building, and then up to another level to the third floor. The Director was asked about the facility's policy, which did not specifically designate who was to lead the code. S/he stated that s/he felt the policy meant that the "First R.N. on the scene" should be the lead of the code. When asked, the Director confirmed that the no change in the policy had yet been considered.

The facility's policy titled, "EMERGENCY RESPONSE - CHANGE IN PATIENT CONDITION, EMERGENCY STAT AND CODE BLUE," last revised 3/10, stated the following in the "POLICY" section, in pertinent part:
"I. The primary nurse is responsible within their scope of practice to monitor changes in patient condition, and encouraged to call for assistance when a patient appears to be deteriorating.
II. Only a physician, nurse or respiratory therapist can activate a CODE BLUE. Any staff member may call an EMERGENCY STAT.
III. CODE BLUE is the term used to activate the nursing staff, physicians, respiratory therapists and cardiopulmonary resuscitation team from the (contracted hospital).
IV. Cardiopulmonary Resuscitation (CPR) efforts are initiated immediately upon discovery of a cardiopulmonary arrest on all patients unless there is a current written order by the physician on the patient's chart indicating otherwise..."
The procedure sections within the policy were separated into six parts, the first three which were "PROCEDURE FOR RESPONDING TO CHANGE IN PATIENT CONDITION," "PROCEDURE FOR EMERGENCY STAT," and "PROCEDURE FOR CODE BLUE." Each of these definitions were a separate process within the facility. The latter procedure for Code Blue explained in detail how the elevator would be held during day and night hours in order for "personnel from the contracted hospital" to quickly access the location/floor of the code. It also stated the following, in pertinent part:
"8. The following personnel will respond to the CODE BLUE page:
a. From the contracted hospital, the CODE Team includes
1. ICU R.N. who serves as the team leader and conducts Advanced Life Support procedures, as necessary.
b. From Craig Hospital
1. Any any available physician
2. All RN staff on unit and one from another unit
3. Available Nursing Leadership Staff
4. Respiratory Care (will also bring EKG machine)
5. Other nursing staff as requested
9. Because of the high number of personnel who respond to a CODE BLUE, it is necessary for one Registered Nurse on the scene to designate another nurse to relay commands and regulate access of personnel to the emergency..."
The procedure section titled "THE ROLES AND RESPONSIBILITIES OF THE RESUSCITATION TEAM" stated the following, in pertinent part:
"1. Hospital Personnel First at the Scene:
a. Determine type of emergency situation and activate appropriate response: Emergency Stat or CODE BLUE...
4. Registered Nurses (all on floor to respond & one R.N. from other inpatient units to respond)
a. First R.N. on the scene assesses the patient' condition. Determines the need for calling a CODE BLUE and assures that this is paged.
b. Coordinates and delegates roles to other RNs or nursing staff:
1. One person to ventilate patient.
2. One person to do cardiac compression.
3. One person to coordinate access of needed personnel to and from CODE BLUE site.
5. One RN or LPN to do Recorder functions...
6. When CODE team arrives: the patient's nurse informs the team leader of pre arrest events, patient diagnosis, history, medications, etc...
9. Physicians:
a. Respond to page CODE BLUE, when available.
b. Assist RNS and assume direction of team, as needed...
10. Respiratory Therapist (ALL TO RESPOND)
a. Manages airway by..."
The facility's policy pertaining to Code Blues was very complex and only one area within the policy clearly delineated the "leader" of the code, who was to be the ICU RN from the contracted hospital.

Further topics in regards to Code Blues were addressed via interview. When asked about physician presence during a Code, nursing leadership, and nursing administration of ACLS drugs, the Director of Quality stated, on 7/26/11 at approximately 8:30 a.m., "Codes happen night and weekends and the contracted hospital has a physician on then but we don't in-house... The other advantage is that is gives us access to an ICU bed and we may not have that otherwise..." The Director of Respiratory stated, on 7/26/11 at approximately 11:20 a.m., "We are not guaranteed a physician response [from the contracted hospital], but everytime we've asked for one, we've gotten one... Respiratory Therapy runs Codes almost always at Craig until the contracted hospital's RNS get here..." The Director of Respiratory, as well as the Director of Quality, confirmed that the staff nurses would wait to push/ give ACLS medications until the contracted hospital ICU RN/ Code Team arrived. Both confirmed that there had been no adverse outcomes due to a Code Blue situation. The Director of Quality stated, at approximately 11:30 a.m., "We've reviewed codes in Nurse Practice and talked about how nurses aren't comfortable to push meds..." However, the Director had previously stated that each Code was not reviewed, which s/he later confirmed again on 7/27/11 at approximately 2:45 p.m. Therefore, it is not fully known if adverse outcomes had occurred.

A joint interview was conducted with the Director of Nursing (DON) and the Nursing Educator on 7/27/11 at approximately 12:45 p.m. The DON confirmed that telemetry was a new thing to the hospital and they had just started it approximately five months prior. When asked about ACLS drug administration during a Code, s/he stated, "We have almost progressed to the point where we want to change the policy..." The Nursing Educator confirmed that all staff caring for telemetry patients had ACLS training. S/he stated that the plan for the upcoming skills day was to develop a mandatory Code skills, but that currently Code training was done on a voluntary basis every month for all nurses except new graduates, for whom it was mandatory. When asked why nurses did not push drugs, as many within the hospital, approximately 88 RNs in inpatient/ outpatient, had current ACLS certification and education, the Nursing Educator stated s/he had though it was because it had not been approved by the Medical Staff. When asked about physician coverage from the contracted hospital, the DON stated, "We're not ensured a physician." After these interviews, the Director of Quality stated, "We're not tying to run our own Codes... Nurses have not decided they want to do that," in regards to pushing drugs.

In summary, the facility did not proactively address each Code Blue and instead relied on the contracted hospital to evaluate all, despite that the contracted hospital staff was not involved in the Codes until minutes after initiation. The facility had identified, with a Nursing Peer Review Referral Form, that the contracted hospital team had come late on one occasion to a Code, however, such was not addressed any further by QAPI or any other committee and documentation of the Code Blue form could not be found. Additionally, the facility identified that there was a lack of leadership by staff within Codes, however, the facility's policy had not been changed to further designate a specific leader prior to the contracted hospital's Code Team's arrival.

Based on review of facility internal documents, policies/ procedures, and staff interviews, the facility failed to identify opportunities for improvement and changes that will lead to improvement. Specifically, the facility stated they had no grievances and therefore such was not investigated as part of the Quality Assessment and Performance Improvement Program. This failure created the potential for a negative outcome.

The findings were:
An interview with the Director of Quality was conducted, on 7/27/11 at approximately 2:45 p.m. When the Director was asked if grievances would be filtered through the Quality Assessment and Performance Improvement Program, s/he stated that they would, although the facility doesn't "have grievances."

Cross Reference to A 118 - Patient Rights: Grievances for findings related to the facility's failure to ensure a process for recognition, documentation, and data collection of patient complaints/grievances.

Based on staff interview, tour observations, review of facility policies/procedures and the Board of Director meeting minutes, the facility failed to assure that unauthorized individuals could gain access to or alter patient records. Specifically, the following areas failed to maintain adequate security and confidentiality of patient medical records:
1. Carts that contained outpatient medical records wheeled into the HIM (Health Information Management) office during off business hours failed to be secured when housekeeping cleaned the area.
2. Radiology film stored in the basement in the east complex building failed to be maintained in a manner that insured confidentiality.
3. Patient and Family Services staff kept "working files" with patient information, were not secured when the department was closed after business hours and on weekends and when housekeeping cleaned the area.

The findings were:

The facility's policy and procedure entitled, "Storage, Security, Retention, and Destruction of Medical Records," stated the following in pertinent part: "All medical records containing patient information maintained under the control of the HIM Department will have appropriate security measures in place to insure confidentiality."

The Board of Directors meeting minutes referenced a standard of practice in the "Colorado Trustee" in regards to the security of medical records. The article entitled, "Protecting Your Hospital's Confidential Patient Health Information: What Trustees Need to Know," stated the following in pertinent part: "Trustees are responsible for protecting both the hospital and its patient community, and data breaches threaten both. Lost or compromised patient information can lead to financial identity theft, insurance fraud, or to medical identity theft that can plague victims' medical and financial lives for years. It can result in erroneous entries in a person's existing medical records or fictitious medical records in the victim's name. As medical information is shared among hospitals, physicians and insurers, false information can propagate far and wide, leading to life-threatening misdiagnoses or denial of coverage...Privacy breaches can also threaten the short and long term financial health of the hospital. The hospital board has responsibility for compliance..."

1. Outpatient Medical Record Carts:
An interview was conducted with the Director of HIM, on 7/26/11 at approximately 8:15 a.m., regarding the security of medical records. The Director stated that all inpatient records are a combination of EMR and paper and the paper portion is scanned into the EMR upon the patients' discharge. The outpatient medical records are placed on a cart and wheeled into the HIM department at the end of each business day. Housekeeping comes in after hours and cleans the area and no one from HIM is in the department.


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2. Long-term Radiology Storage:
On 7/27/11 at approximately 12:30 p.m., a tour area allocated for the long term storage of radiology films was conducted in a locked suite of storage rooms in the basement of the east hospital building. The pharmacist accompanied the surveyor and the director of quality improvement/compliance, because s/he had a key to the area. The area was entered by a locked door. Inside the area, there was a locked door to the right which entered into a large IT (information technology) storage area. Right across from the main door to the suite of rooms was an enclosed area that was for pharmacy storage. A wooden storage enclosure for pharmacy had a locked door and chicken wire over the top of the enclosure (since the enclosure did not go all the way to the ceiling). The pharmacist stated that only pharmacy had access to the locked pharmacy storage area. To the left of the pharmacy enclosure were rows of floor to ceiling shelving. The first several rows contained miscellaneous pharmacy storage which did not include medications. There were also boxes of what appeared to be Christmas decorations. The rest of the shelving and aisles contained folders with multiple radiology films and a cart with boxes of radiology films for a research project. The radiology filing clerk later confirmed (on 7/28/11 at approximately 8:30 a.m.) that the research was an ongoing project. The last several shelves in the radiology storage area contained storage boxes with manila folders with patient names and multiple compact discs that the radiology filing clerk later confirmed were digital copies of radiologic and nuclear medicine testing for their patients that had been done prior to admission at other facilities. When the radiology filing clerk was interviewed, s/he stated that s/he was unaware that IT storage and pharmacy storage had been added to that area. S/he stated that the radiology records needed to be secured so that the other departments that now had access to the area did not have access to the patient radiologic and nuclear medicine testing discs and films. S/he was unaware of how many people had keys to that area.

Review on 7/27/11 of the facility policy/procedure titled "Management of X-ray Images," last revised 4/11 revealed the following, in pertinent parts:
"...I. On-Site Storage
A. hard copy outside images and CDs, except for current inpatients and outpatients, will be located in (the facility') basement storage area.
B. The East Building x-ray storage room will be locked at all times. keys have been provided to the following: (Neighboring contracted hospital) x-ray file room, (facility) Health Information Management, (facility) Engineering, (facility) Outpatient Department, and (facility) Radiology team members...
II. (Facility) File Clerk Responsibilities:
...J. A key to the basement storage area is available at (Neighboring contracted hospital) file room to provide emergency access should retrieval be required on evenings/nights/weekends..."

3. Patient and Family Services Files:

During a tour of the outpatient services areas of the facility, which was conducted, on 7/26/11 at approximately 9 a.m., it was observed that staff kept "working files" with patient information, including ongoing discharge planning information in unlocked lateral files in the main hallway of their suite of offices. The files also contained ongoing case management information for outpatients seen in the outpatient services areas. Per interview with a staff member from patient and family services during the tour and with the director of the outpatient clinic, the director of clinical services and the director of quality improvement and compliance it was confirmed that these files were not locked after business hours and when housekeeping cleaned the area. The patient and family services staff member stated that s/he was often still in the area at the end of the day when the housekeeping staff arrived, but s/he could not ensure that the housekeeping staff were never alone in the department with the unsecured patient information files. S/he also stated that even though the cabinets containing the records could be closed and had locks, they had no keys to lock the files.

Interview with the directors of Outpatient Services the Outpatient Clinics conducted, on 7/27/11 at approximately 9 a.m., revealed that the patient and family services department did not have a policy about storage or retention of the records they maintained in that department.

On 7/27/11 at approximately 11 a.m., the Director of Outpatient Clinics provided a copy of a facility policy/procedure titled "Storage, Security, Retention and Destruction of Department Working Files with PHI."
Review of the document revealed the following, in pertinent parts:
"...POLICY: All working files containing patient information maintained in individual departments will have appropriate security measures in place to insure confidentiality...
I. Storage - Storage of patient specific information in department working files will be locked in office files located in each department area...
II. Security - Working files are locked when unattended. Keys for storage areas are available only to the department director and designated department staff..."