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Based on review of the Facility's documents, policies and staff interviews, the Facility failed to comply with the condition of Quality Assessment and Performance Improvement (QAPI).

The Facility failed to ensure its QAPI program reflected the complexity of the hospital's services, involved all hospital departments and focused on prevention and reduction of medical errors.

FINDINGS:

A 0266 482.21 (a)(1) MEDICAL ERRORS
The Facility did not have a hospital wide, integrated Quality Assessment Performance Improvement (QAPI) program that identfied and reduced medical errors.

A 0283 482.21 (b)(1)(c) PROGRAM DATA, PROGRAM ACTIVITIES
The Facility did not set priorities for performance improvement that included a focus on new/ high risk/high volume procedures, medication administration or other problem prone areas.

A 0286 482.21 (a)(c)(2)(e) PATIENT SAFETY
The Facility did not conduct ongoing QAPI program that measured, analyzed and tracked quality indicators including adverse patient events.

A 0309 482.21 (e) EXECUTIVE RESPONSIBILITIES
The Facility's governing body, medical staff and administrative officials did not ensure that the Facility's QAPI priorities were defined, implemented and maintained to decrease adverse events and improve patient safety.

Based on staff interview and review of facility documents/ policies and procedures, the facility's governing body failed to ensure that its laboratory services performed were done safe in a safe and effective manner and that a clear design, collaboration, and oversight were in place for Laboratory Services. This failure created the potential for a negative patient outcome due to the lack of oversight and potential for error.

Findings:

1. The facility's policy, titled Laboratory Services, last revised 6/24/11, stated the following, in its procedure section, in part: "Supervision of Service: Contracted laboratory services will be under the administrative supervision of the Laboratory Director and the clinical supervision of the Laboratory Medical Director."

2. a) On 10/01/12, the Chief Executive Officer was stated the Director of Laboratory and Radiology were the same individual. On 10/02/12 at approximately 12:35 p.m., an interview as conducted with the Director of Radiology, who stated s/he was not the Director of Laboratory, but instead over Point of Care testing only. S/he stated the only point of care testing was use of the glucometer for blood sugar. She conducted training on the testing and reviewed critical values to ensure physicians were notified.

b) On 10/02/12 at approximately 1:30 p.m., the Chief Clinical Officer was asked who was responsible Laboratory Services. S/he stated the Respiratory Director was responsible for in-house labs conducted on the IRMA (stat lab processor). S/he stated the Radiology Director, who had already been interviewed, was responsible for the outside lab contract.

c) Interviews were conducted with the Respiratory Director and the Radiology Director on 10/03/12 at approximately 11:00 a.m. The Respiratory Director reviewed the training, machine quality control checks, and processes with use of the IRMA. Although the Radiology Director was aware of the process nurses went through during laboratory sample processing by the contracted lab, s/he referred the surveyor to the nursing supervisor and stated, "This is where it is more of the nursing unit and I'm not really involved." When asked about policies and procedures of blood transfusions, s/he stated, "I don't have involvement with blood transfusion because I'm in outpatient." The Radiology Director stated s/he also checked lab requisitions, however, stated that information was not reported to QAPI (Quality Assessment and Performance Improvement Program). Both Directors stated one of their quality initiatives was reporting critical values. When asked if timeliness of critical value notifications from the contracted lab were checked, they Director of Radiology stated they were not and only the timeliness of the nurses calling the physicians was tracked. When asked who was the liaison between the contracted lab and the facility to ensure QAPI measures were addressed and resolved, s/he stated, "Communication with the reference lab is really with the nursing unit and lab."

d) An interview was conducted with the Director of Education on 10/03/12 at approximately 11:45 a.m. S/he was asked her involvement with the contracted Laboratory. S/he stated, "What I do mostly is the training. If there is an issue with billing, I am usually notified: such as filling out requisitions or how much blood to put in the tube." S/he stated the latter had recently been a complaint from the contracted lab. When asked how the nursing staff would get questions answered, s/he stated there was a "cheat sheet" on the nursing units for guidance or that nursing staff could call the contracted lab. When asked what nursing staff did if there were issues, s/he stated the Director of Radiology and the Radiology Technician had a good rapport with the individual at the contract lab who they would discuss issues with. When asked about issues and oversight with the contracted blood product distributor, s/he stated s/he thought that went to QAPI as s/he did not deal with it. The Director of Education was asked if s/he was aware of any issues with lab services and s/he stated there had not been any except the filling of the blue lab tubes, which s/he educated staff regarding.

e) On 10/03/12 at approximately 3:25 p.m., an interview was conducted with the Infection Preventionist, who had recently begun employment at the facility. S/he was asked her QAPI initiatives and stated the biggest one s/he had noticed so far was contamination of the blood culture bottles, which was twice the usual contamination rate. When asked how s/he became aware of this issues, s/he stated, "The [contracted] lab sends us a report every month. They sent it to me but it is just about blood cultures and microbiology."

f) On 10/03/12 at approximately 3:55 p.m., an interview was conducted with the Chief Clinical Officer (CCO), who was fairly new to the facility. S/he stated s/he was informed the Radiology Director was over lab, the Respiratory Director was responsible for the IRMA machine because only Respiratory Therapists were trained to use it, the Infection Preventionist was responsible for monitoring any blood cultures, and a physician, who was on the medical staff and worked at the contracted lab, was responsible for Quality Assurance sampling. The CCO stated s/he had ultimate responsibility for the lab. At approximately 5:05 p.m., after requested, the facility provided evidence of the contract with their outside blood supplier and documentation which stated that supplier maintained records of all he blood administration for a ten year span. At approximately 5:15 p.m., the CCO provided a two page typed document from a Pathologist. The physician provided a report pertaining to consultative visits s/he made to the hospital on 8/8, 8/16, and 8/24/12. The physician referenced technical issues, the quality assurance plan, internal and external quality control, competency assessment, external proficiency testing, maintenance and temperature recording, CLIA survey, policies/procedures, personnel, the critical care committee, and the medical executive committee meeting. The report appeared comprehensive of all facility laboratory services with the exception of microbiology and blood product transfusion. The CCO stated, "I got the report in the mail today." S/he stated that day s/he had also reached out and called the Laboratory Director at the contracted lab.

g) The facility's internal incidents were reviewed. Two of the incidents referenced blood transfusions. One stated the blood product hung did not match the order and the other stated the blood band was not applied at the time of the type and cross [sample drawn]. Neither incident was reviewed by the Pathologist in the monthly reports or noted in any other laboratory documentation. Although requested, no Laboratory staff meeting agendas or minutes were provided.

h) On 10/04/12, the monthly review reports from the Pathologist were provided and reviewed. An interview was conducted with the CCO and CEO at approximately 12:35 p.m. The CEO stated the Pathologist attended medical executive meeting and critical care meetings. S/he stated the reports had previously gone to the QAPI Director, who no longer worked at the facility. When asked why the report, which was dated 9/18/12 and received 10/02/12, was delayed, the CCO stated the Pathologist did not realize s/he needed a report as well, but it had also been sent to the Director of Respiratory and Director of Radiology. The CCO stated s/he would now take control of oversight of lab services provided to the facility's patients and all information, from microbiology, blood product transfusion, point of care, stat labs, send-out labs, and quality reviews, would be fed to him/her.

Based on interviews and document review, the facility failed to establish a clear process for prompt resolution of patient grievances.

The failure created the potential for patient care issues to be unacknowledged by the facility or to not be responded to promptly by the facility.

Findings:

1. The facility did not ensure that staff identified as being responsible for the investigation, follow-up, communication, and resolution of grievances received by the facility followed a clear process.

a) On 10/02/12 at 10:00 a.m., the facility policy titled, "Patient Complaint and Grievance Process", revised 10/2011, was reviewed. The policy stated that the Governing Board had delegated the grievance process to the Quality Council which had delegated the following responsibilities; the CEO would write and send response letters to complainants and the Director of Quality Management (DQM) would audit, aggregate, and analyze data to present to the Quality Council for review and recommendations regarding grievances. The policy also stated that a written response would be sent to complainants upon the resolution of a grievance. The procedure for documenting complaints included steps that staff would take to complete the facility's grievance form and instruction to forward the form the the Quality Department.

b) On 10/02/12 at 11:00 a.m., the facility document titled, "Grievance Reports" was reviewed. The report documented 2 grievances dated 01/23/12 and 09/12 (an incomplete date). The document contained the following headings; "Date", "Name of Patient", "Complaint received by", "Details", and "Action." The grievance dated 01/23/12 contained no documentation in the "Action" section. The grievance dated 09/12 contained documentation in the "Action" section and stated that the grievance was "pending further investigation."

c) On 10/03/12 at 10:00 a.m., an interview was conducted with the facility's Director of Quality Management (DQM) to review the facility's policy titled "Patient Complaint and Grievance Process", revised 10/2011. The DQM confirmed that this was the policy/procedure currently used by the facility to respond to grievances.

d) On 10/03/12 at 1:30 p.m., an interview was conducted with the facility's Chief Clinical Officer (CCO) to review the facility's "Patient Complaint Log." The log contained a section instructing staff to complete a grievance form and forward it to the DQM if a complainant was not satisfied with a resolution by staff. The CCO confirmed that if a complainant was not satisfied with the outcome of an investigation, it would be forwarded to the DQM for review.

e) On 10/03/12 at 3:00 p.m., the facility's DQM was interviewed. When asked to describe the process that staff would follow if a complaint could not be resolved immediately with a patient/other, the DQM stated that the complaint would be elevated to himself/herself or to the Chief Clinical Officer (CCO) but that s/he was "not beholden to a particular process" and that staff could "grab him/her in the hall or put it in writing."

When asked how staff members report complaints, the DQM stated that there are forms on each nursing unit and it is the responsibility of nurses to make sure that the DQM receives a completed form. The DQM stated that there is no "bin" in which to place the completed forms or a specific area where the completed forms would be collected. The DQM stated that nurses could also call 888, which is a line used to report incidents, and Quality Management is "in charge" of this line. The DQM stated that s/he is unsure of how frequently this phone is answered or if messages are "recorded and reported."

The facility document titled, "Grievance Reports", was reviewed with the DQM. The document contained a grievance received by the facility on 09/12 (no specific date was documented). The DQM stated that he/she was unaware of the grievance until 09/18/12 when he/she was "grabbed in the hallway and pulled into the meeting with the patient's family with no knowledge of the situation." The DQM stated that as of 10/03/12, s/he had conducted no follow-up with the complainant. The DQM confirmed that s/he would be the staff person to receive a grievance form if a complainant was not satisfied with actions taken by staff to resolve patient complaints.

Based on tours/observations and staff interviews, the facility failed to maintain supplies to ensure an acceptable level of safety.

The failure created the potential for negative patient outcomes.

Findings:

1. The facility did not ensure that expired supplies were disposed of so that they would not be used for patient care.

a) On 10/02/12 at 2:00 p.m., a tour of the High Observation Unit (HOU) and the Long Term Acute Care Unit (LTAC) was conducted with Chief Clinical Officer (CCO) and revealed the following:
- A box of Ensure Nutritional Supplement Expiration 04/2012, was found in the first medication room in the LTAC unit
- A box of Nephro Nutritional Supplement, Expiration 09/2012, was found in the second medication room in the LTAC unit
- Pill crushers in all four of the medication rooms toured were covered with a white and brown substance
- Pill cutters in all four of the medication rooms toured were covered with white powder
- Expired laboratory collection tubes in the first medication room in the LTAC unit
- There were 10 medication cups sitting on the counter in the first medication room located in the HOU. The cups were stacked on top of each other and had a red liquid substance on the inside and the outside of them.

b) During the tour the findings were confirmed with the Chief Clinical Officer and the items were removed. The CCO stated that the nursing staff was expected to clean the pill crushers/cutters after use. S/he also stated that s/he did not know what the red substance was on the medication cups, picked them up and threw them in the trash can.

Based on document review and staff interview, the facility failed to provide guidance to staff regarding renewal of restraints for the management of violent or self destructive patients.

The failure created the potential for violent or self-destructive patients to be restrained longer than necessary.

Findings:

1. The facility did not provide guidance to staff regarding time frames for renewal of restraints for violent or self-destructive patients.

a) On 10/02/12 at 12:30 p.m., the facility policy titled, "Restraints", revised 8/2011, was reviewed. The policy contained verbiage in the "Patient Assessment" section regarding "emergency" situations and the application of restraints. In the "Procedure/Process" section, an example of emergency restraint was given for patients who are a "danger to self or others and restraint is necessary to ensure the patient's or other person's physical safety." No verbiage was found in the restraint policy instructing staff on the requirement for renewing orders for these patients every 4 hours, for adults 18 years of age or older, for up to a total of 24 hours.

b) On 10/04/12 at 9:34 a.m., an interview was conducted with the facility's Clinical Educator who stated that s/he provides education to staff on the use of restraints. The Clinical Educator stated that "behavioral restraints" are used in the facility when a patient is "unsafe to self or others" and that behavioral restraints are also referred to as "emergency restraints" in the facility's restraint policy. The Clinical Educator reviewed the facility's restraint policy and confirmed that it contained no guidance to staff regarding the time frame for renewal of this type of restraint for violent or self-destructive patients. The Clinical Educator acknowledged that the facility's restraint policy would need to be changed in order to include the time frame for renewal of this type of restraint as the facility does, at times, use restraints for patients who are violent or self-destructive.

Based on document review and staff interview, the facility failed to provide guidance to staff regarding the required time frame for evaluation, by specified practitioners, of patients who are violent or self-destructive after the initiation of restraints.

The failure created the potential for unnecessary or unsafe restraint for violent or self destructive patients.

Findings:

1. The facility did not provide guidance to staff regarding patients who are violent or self-destructive being seen by a physician or trained registered nurse or physician assistant within 1 hour of the restraint being initiated.

a) On 10/02/12 at 12:30 p.m., the facility policy titled, "Restraints", revised 8/2011, was reviewed. The policy contained verbiage in the "Patient Assessment" section regarding "emergency" situations and the application of restraints. In the "Procedure/Process" section, an example of emergency restraint was given for patients who are a "danger to self or others and restraint is necessary to ensure the patient's or other person's physical safety." No verbiage was found in the restraint policy instructing staff that these patients would be seen face-to-face within 1 hour after the initiation of the restraint by a physician or other licensed independent practitioner, registered nurse, or physician assistant, trained to evaluate these patients.

b) On 10/04/12 at 9:34 a.m., an interview was conducted with the facility's Clinical Educator who stated that s/he provides education to staff on the use of restraints. The Clinical Educator stated that "behavioral restraints" are used in the facility when a patient is "unsafe to self or others" and that behavioral restraints are also referred to as "emergency restraints" in the facility's restraint policy. The Clinical Educator reviewed the facility's restraint policy and confirmed that it contained no guidance to staff regarding the requirement for the patient to be seen face-to-face within 1 hour after the initiation of restraints by a physician, registered nurse, or physician assistant, trained to ensure the safe implementation of restraints for violent or self-destructive patients.

Based on document review and staff interview, the facility failed to provide guidance to staff regarding the evaluation of patients who are restrained due to violent or self destructive behavior.

The failure created the potential for violent or self-destructive patients who are restrained to be without required evaluation of their status.

1. The facility did not provide guidance to staff regarding patients who are violent or self-destructive being evaluated, face-to-face, within 1 hour by appropriate staff to determine the patient's condition and the need to continue or terminate restraint.
a) On 10/02/12 at 12:30 p.m., the facility policy titled, "Restraints", revised 8/2011, was reviewed. The policy contained verbiage in the "Patient Assessment" section regarding "emergency" situations and the application of restraints. In the "Procedure/Process" section, an example of emergency restraint was given for patients who are a "danger to self or others and restraint is necessary to ensure the patient's or other person's physical safety." No verbiage was found in the restraint policy instructing staff that these patients would be seen face-to-face within 1 hour after the initiation of the restraint and would be evaluated for their immediate status, reaction to being restrained, medical and behavioral condition, and the need to continue or terminate the restraint.

b) On 10/04/12 at 9:34 a.m. an interview was conducted with the facility's Clinical Educator who stated that s/he provides education to staff on the use of restraints. The Clinical Educator stated that "behavioral restraints" are used in the facility when a patient is "unsafe to self or others" and that behavioral restraints are also referred to as "emergency restraints" in the facility's restraint policy. The Clinical Educator reviewed the facility's restraint policy and confirmed that it contained no guidance to staff regarding the requirement for the patient to be seen face-to-face within 1 hour of restraints being initiated and to be evaluated for the 4 specific areas contained in the regulation: immediate status, reaction to being restrained, medical and behavioral condition, and the need to continue or terminate the restraint.

Based on document review and staff interview, the facility failed to provide guidance to staff regarding documentation required in the medical record of patients who are restrained due to violent or self-destructive behavior.

The failure created the potential for the medical records of violent or self-destructive patients who are restrained to be incomplete.

1. The facility did not provide guidance to staff regarding patients who are violent or self-destructive having the 1 hour face-to-face medical and behavioral evaluation documented in the patient's medical record.

a) On 10/02/12 at 12:30 p.m., the facility policy titled, "Restraints", revised 8/2011, was reviewed. The policy contained verbiage in the "Patient Assessment" section regarding "emergency" situations and the application of restraints. In the "Procedure/Process" section, an example of emergency restraint was given for patients who are a "danger to self or others and restraint is necessary to ensure the patient's or other person's physical safety." No verbiage was found in the restraint policy instructing staff to document the 1 hour face-to-face medical and behavioral evaluation in the patient's medical record.

b) On 10/04/12 at 9:34 a.m. an interview was conducted with the facility's Clinical Educator who stated that s/he provides education to staff on the use of restraints. The Clinical Educator stated that "behavioral restraints" are used in the facility when a patient is "unsafe to self or others" and that behavioral restraints are also referred to as "emergency restraints" in the facility's restraint policy. The Clinical Educator reviewed the facility's restraint policy and confirmed that it contained no guidance to staff regarding the requirement for the 1 hour face-to-face medical and behavioral evaluation to be documented in the medical record of patients receiving behavioral restraints.

29034 Federal Register / Vol. 77, No. 95 / Wednesday, May 16, 2012 / Rules and Regulations
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Parts 482 and 485
[CMS-3244-F]
RIN 0938-AQ89
Medicare and Medicaid Programs;
Reform of Hospital and Critical Access
Hospital Conditions of Participation
AGENCY: Centers for Medicare &
Medicaid Services (CMS), Department
of Health and Human Services.
ACTION: Final rule.
Reporting of Restraint-Related Deaths:
We have replaced the requirement that hospitals must report deaths that occur while a patient is only in soft, 2-point wrist restraints with a requirement that hospitals must maintain a log (or other system) of all such deaths. This log must be made available to CMS immediately upon request. We have indicated that the log is internal to the hospital and that the name of the practitioner responsible for the care of the patient may be used in the log in lieu of the name of the attending physician if the patient was under the care of a non-physician practitioner and not a physician....

A. ICRs Regarding Condition of Participation: Patient ' s Rights (? 482.13)Section 482.13g) ... This requirement includes patients who died within 24 hours of having been removed from these types of restraints. In those cases, the hospital must report to CMS by recording in a log or other system the information required at ? 482.13(g)(2)(i) and (ii). We noted this change only for deaths where the patient died while either in soft two-point wrist(s) restraints or within 24 hours of having been removed from soft two-point wrist(s) restraints provided that: (a) There is no reason to believe the death was caused by those restraints, (b) that those were the only restraints used, and (c) that no seclusion was used.

Based on document review and staff interview, the facility failed to maintain a log or other system for documenting deaths which occured when patients were in only soft, 2-point wrist restraints.

Findings:

1. The facility did not maintain a log or other system for documenting the death of a patient which occurred while the patient was in wrist restraints.

a) On 10/02/12 at 9:40 a.m., the facility document titled, "Restraint Log" was reviewed. The log contained hand written information from 02/08/12 through 09/07/12 for patients who were restrained. The log headings were: "Name/Room", "Date Started", "Type of Restraint", "Order Yes/No", and "Discontinue Date." The log contained information for 46 patients.

b) On 10/03/2012 at 10:55 a.m., the facility document titled, "Occurrence Reports 2012 - LTACH" was reviewed. The "Occurrence Report" listed events which occurred in the facility under multiple categories (medication errors, patient falls, delays in treatment, etc). A patient death from 07/22/12 was found in the document which stated, in the description of the occurrence, that the patient died at 7:40 (a.m. or p.m. was not documented) and that the patient was "in wrist restraints at 5:00." The facility's "Restraint Log" was reviewed again and no documentation of this patient was found on the log.

c) On 10/03/12 at 11:00 a.m., an interview was conducted with the facility's Clinical Educator to review the facility's "Restraint Log." The Clinical Educator confirmed that the patient death reverenced above was not included on the facility's "Restraint Log." The Clinical Educator was asked if there was another log or any system where patients who were restrained, including patients who died while in restraints, would be documented. S/he responded that this was the only log that the facility used to document the use of restraints and that inclusion on this log of all patients restrained was an expectation.

d) On 10/04/12 at 2:30 p.m., an interview was conducted with the facility's Chief Clinical Officer (CCO) to review the death of the patient on 07/22/12, while in wrist restraints, and the lack of documentation of this death on the facility's "Restraint Log" or in any other system. The CCO stated that s/he was not aware of this patient death while in wrist restraints and was also not aware that the death was not documented on the facility's "Restraint Log."

Based on Facility documents and staff interviews the Facility failed to set priorities for its performance improvement activities that focused on high-risk, high volume or problem prone areas. The Facility failed to consider the incidence, prevalence and severity of problems in those areas.

This failure led to the proliferation of medication errors and adverse events that caused harm to patients who required medical intervention.

FINDINGS;

1. The Facility did not set priorities for performance improvement that included a focus on new/ high risk procedures, medication administration or other problem prone areas.

a) Quality Council meeting minutes from 02/16/12 - 07/18/12 were reviewed. P&T, MEC, Facility Leadership, and Department Manager's meeting minutes were also reviewed. The meeting minutes did not reflect an assessment or investigation of the Facility's medication error rates.

b) The meeting minutes did not reflect any tracking, trending, implementation of corrective actions or evaluation of the effectiveness of the corrective actions. There was no evidence that the Director of Quality Management (DQM) set the medication errors and adverse events from the occurrence log as priorities for performance improvement.

c) There was no evidence that the new insulin sliding scale was evaluated for effectiveness and safety after implementation. There was no evidence that an evaluation of the new process/protocol for tacrolimus administration and monitoring was evaluated for effectiveness or safety.

d) Education department training documentation was reviewed. There was no evidence of nursing education related to tacrolimus (prograf) uses, dosages, administration and monitoring. There was no evidence of nursing education related to diabetes treatment or insulin administration.

e) In an interview on 10/03/12 the Director of Quality Management (DQM) stated that the quality department was not directly involved with the tracking and trending at this facility. S/he stated that quality initiatives originate in individual departments and the quality department was not involved in the analysis of the data, did not recommend solutions or evaluate the effectiveness of corrective actions.

Based on Facility documentation and interviews, the Facility failed to conduct an ongoing program that measured analyzed and tracked quality indicators including adverse patient events.

This failure resulted in medication administration errors and other adverse events that required medical intervention.

FINDINGS:

1. The Facility did not investigate or analyze medication administration errors or other adverse events to assess the effectiveness or safety of the processes.

a) Quality Council meeting minutes from 02/16/12 - 07/18/12 were reviewed, P&T meeting minutes, MEC meeting minutes and Department Manager's meeting minutes were also reviewed. The meeting minutes did not reflect an assessment or investigation of the Facility's medication error rates. The meeting minutes did not reflect tracking and trending of errors/adverse events for frequency and severity. The meeting minutes did not reflect implementation of corrective actions and evaluation of the effectiveness of the corrective actions

b) There was no evidence in meeting minutes or other documentation that the new insulin sliding scale was evaluated for effectiveness and safety after implementation. There was no evidence in meeting minutes or other documentation that an evaluation of the new process/protocol for tacrolimus (an anti-rejection drug) administration and monitoring was evaluated for effectiveness or safety.

Education department training documentation was reviewed. There was no evidence of nursing staff education/training or competency related to tacrolimus (prograf) uses, dosages, administration and monitoring. There was no evidence of nursing education/training or competency related to diabetes treatment or insulin administration.

c) In an interview on 10/03/12 the Director of Quality Management (DQM) stated that the quality department was not directly involved with the tracking and trending at this facility. S/he stated that quality initiatives originate in individual departments and the quality department was not involved in the analysis of the data, did not recommend solutions or evaluate the effectiveness of corrective actions.

In an interview on 10/04/12 at 10:00 a.m. the Chief Clinical Officer (CCO) stated that s/he was a new hire as of June 2012 and had not had an opportunity to formulate a plan for his/her "direct reports" including the Education Director. S/he stated that s/he had been functioning as interim Director of Nursing and that there was a lack of resources and time.

In an interview on 10/04/12 at 9:30 a.m., the Education Director produced training documentation. The education department was involved in coordinating new employee orientation and annual skills lab. The list of educational opportunities did not include any training related to medications, medication administration or other adverse events reported on the occurrence log.

Based on Facility document review and interviews the Facility's governing body, medical staff and administrative officials failed to ensure that the Facility's quality improvement program defined priorities and was implemented and maintained to reduce adverse events and improve patient safety.

This failure resulted in medication administration errors and adverse events that caused harm to patients requiring medical intervention.

FINDINGS:

1. The Facility's governing body, medical staff and administrative officials were not involved in the Quality Assessment and Performance Improvement (QAPI) program to ensure focus on high risk and problem prone areas.

a) The Quality Council meeting minutes from 02/16/12-08/16/12 did not reference a schedule for reporting to the governing body and there was no standing agenda item listed for the Chief Executive Officer (CEO). The minutes did not list the CEO, Medical Director or Chief Clinical Officer (CCO) as members present or as guests.

There was no documentary or other evidence that the governing body, Medical Director, Medical Executive committee (MEC), CEO or CCO defined, monitored or otherwise maintained the QAPI program's priorities.

b) In an interview on 10/04/12 at 1:00 p.m., the Chief Executive Officer (CEO) stated that the Director of Quality Management (DQM) reported to the CEO. S/he stated that the CEO and the DQM met daily to review performance improvement plans but admitted that s/he did not attend Quality Council meetings.

The CEO stated that incidences were to be sent to the CEO for coordination and followup, however, the CEO was newly hired in May 2012. S/he stated that the DQM was a newly hired in May of 2012 as an interim DQM, a contracted employee. The CEO admitted that s/he was not involved in data tracking and measuring improvement.

c) In an interview on 10/04/12 the Medical Director admitted that s/he had not attended Quality Council meetings. S/he acknowledged that Quality Council meeting minutes were not covered in the MEC meetings. The Medical Director admited that s/he did not involve nursing in the new transplant patient/medication process/protocol.

d) In an interview on 10/04/12 the Chief Clinical Officer (CCO) stated that the DQM was not his/her direct report and that if occurrences came to his/her attention s/he would resolve the issue and forward to the DQM. The CCO stated that s/he was newly hired in June 2012.

Based on facility tour, interview, and review of policy/procedure, the facility failed to ensure cooled and frozen food items were maintained in a safe manner with use of back-up thermometers, frozen food items were labeled with the date received to ensure timely use, and perishable food items on nursing units were appropriately stored and labeled. These failures created the potential for contamination of food items and did not ensure an effective infection control program was instituted within the Food and Dietary Department.

The findings:

1. The facility failed to utilize back-up thermometers to ensure cooled items were properly maintained.

a) Tour of the Food & Dietary Department, including the facility's kitchen, was conducted on 10/02/12 at approximately 10:00 a.m. The kitchen had three walk-ins: two refrigerators and one freezer. One of the two refrigerators only had one thermometer within for recording and ensuring adequate storage temperatures. When asked if it had wired-in (hard-wired) temperature monitoring, the Interim Kitchen Director stated, "It is not wired-in and that is why we have multiple [thermometers]." The only walk-in freezer also had a singular thermometer for monitoring temperatures.

b) The facility's policy, titled Food Safety in Receiving and Storage, last revised 8/24/12, stated, in part, "Cold Food Storage - a. Ambient temperatures in refrigerators/ coolers remain between 34 - 41 degrees. b. Ambient temperatures in freezers remain at 0 degrees or lower. Document temperatures at least twice daily on a posted log and report any problems immediately to the Dietary Manager/ Maintenance."

2. The facility failed to label frozen food items with the date received to ensure timely use.

a) Within the walk-in freezer were several large slabs of meat that were not labeled with the date received. The Kitchen Director was asked how they were kept track of and s/he stated that was done mentally. The Director stated that the turkey breast had been received on the 29th, but the sticker had come off. Nine pork roasts were not labeled with their date of receipt either.

b) The facility's policy, titled Food Safety in Receiving and Storage, last revised 8/24/12, stated, in part, "Date food as to date received." Additionally, it stated, "Use frozen meat within 6 months of delivery date."

3. The facility failed to appropriately store and label perishable food items on the nursing units.

a) Tour of the nursing units was conducted with the Chief Clinical Officer on 10/02/12. At approximately 3:15 p.m., a portion of a bread loaf was found in a cabinet in the nutrition kitchen behind one of the nurse's stations. The Chief Clinical Officer confirmed the bread was for patient consumption, however, it was unlabeled in any manner, remained in its original packaging, and not wrapped or secured tightly in order to prevent contamination.

b) The facility's policy, titled Storage of Refrigerated Food Items and Dry Goods, last reviewed 8/24/12, stated, in part, "All opened containers will be resealed, labeled and dated the day of opening and discard date. Products such as canned and bagged items will be placed in a clean and sanitized resalable container or wrapped in plastic, labeled and dated the day of opening."

Based on review of facility documents and policies/procedures, tour, and staff interview, the facility failed to ensure outpatient services, specifically the Pulmonary Rehabilitation Unit, were organized and appropriately integrated with the inpatient services. The failure created the potential for a negative patient outcome due to the lack of oversight and potential for error.

Findings:

1. Integration

Upon entrance to the facility on 10/01/12, the Chief Executive Officer explained the outpatient services that were offered: Pain Clinic/Special Procedures, Pulmonary Rehabilitation, and Physical Rehab. The Chief Executive Officer stated the Radiology Director was responsible for the Pain Clinic, the Respiratory Director was responsible for Pulmonary Rehabilitation, and the Nursing Home Administrator was responsible for the off-site Physical Rehab Clinics.

a) A review of the Pulmonary Rehab Unit's policies and procedures was conducted. The Coordinator stated many of the policies and procedures were through the host company. The host company and the facility were in a contractual agreement to provide the Pulmonary Rehab services on an outpatient basis. Document review revealed that, although several of the policies were the facility's, an equal amount were from the contracted company or had no ownership header on them. It was unclear which policies were current to be followed during care in the Pulmonary Rehab Unit.

b) On 10/03/12 at approximately 12:35 p.m. tour was conducted of the Pulmonary Rehab Unit with the Coordinator as well as the Respiratory Director. When asked the scope of the service, the Coordinator stated it included exercise rehab and exercise stress testing. The Coordinator stated s/he reported to the Respiratory Director. When asked how s/he received information and updates from the Director, the Coordinator stated the Director would forward minutes or policies to him/her. When asked if they had any set meeting, the Coordinator stated there was not but they usually met once a month. The Pulmonary Rehab Unit was a new unit which started several months prior and consisted of only one employee, the Coordinator. The unit staff and manager did not maintain regular meetings or records of items/issues addressed and discussed. Additionally, the unit staff did not routinely attend inpatient meetings, such as the Respiratory or Quality Assessment Performance Improvement Meeting.

2. Organization

a) Tour of the Pulmonary Rehab Unit on 10/03/12 revealed several items which had not received scheduled preventative maintenance (PM), including an oxygen concentrator with a PM sticker dated as done 9/10/11, a portable suction machine with a PM sticker dated as due 7/12, an oxygen concentrator with no PM sticker, a compressor used with nebulizers treatments with a PM sticker as done 9/10/11, and a portable percussor with a PM sticker as done 9/10/11. When asked about the preventative maintenance on the items, the Coordinator stated the contracted company owned the items. S/he stated the last service person from the company was at the facility 4/24/12. S/he stated that s/he kept record of the two oxygen concentrators and the hours of oxygen used and would then send the concentrators in for service after a certain number of hours. In an interview later that day with the Coordinator, at approximately 4:55 p.m., s/he stated that, according to the contracted company, the suction and compressor did not required preventative maintenance, despite the stickers on the machines. S/he stated the oxygen concentrators were not due for preventative maintenance due to the numbers of hours used, despite the stickers on the machines, however, the contracted company would now send him/her the equipment to conduct annual PMs on the concentrators. On 10/04/12, an interview was conducted with the Physical Environment Director on 10/04/12 at approximately 8:45 a.m. S/he stated they were only responsible for the treadmill and the electrical in the Pulmonary Lab and the contracted company was responsible for maintenance on all other items. Another interview as conducted with the Pulmonary Lab Coordinator on 10/04/12 at approximately 12:25 p.m. S/he stated suction machine did not belong to the contracted company after all, but instead belonged to the facility. S/he also stated the PMs on the oxygen concentrators had been checked several months prior when the Pulmonary Function Lab opened and s/he was not sure why the stickers did not reflect that information. Prior to exit from the facility, it was still not clear who owned what equipment and when preventative maintenance should be conducted.

The facility's policy titled Medical Equipment Management Plan, last revised 8/11, stated the following, in part, "Preventative maintenance of medical equipment will be completed through a contract with an outside vendor. Preventative maintenance of medical equipment will occur in accordance with the manufacturer's instructions."

b) On 10/04/12 at approximately 12:25 p.m., when asked what physician oversight occurred for the exercise stress tests, wherein patients' vital signs, specifically heart rate, may significantly increase and patients may exhibit symptoms, the Coordinator stated s/he would come to work and see what physician was in house that day. The Coordinator stated that prior to the stress test, s/he would "make a phone call and speak with the physician in house," however s/he confirmed that this was not documented and there was no formal policy to reference regarding this practice or physician oversight of the Pulmonary Lab to ensure patient safety. S/he stated, "We don't have it in writing that I call the physician and, if needed, they [the physician/s] get called overhead." The policy titled, "Physical Performance Test," last reviewed 10/08, did not direct staff to notify a physician prior to the procedure, despite that there was only one staff member in the room during the procedure and the staff member was a Respiratory Therapist. The policy also did not provide any reference regarding physician oversight during the procedure.

Based on Facility document review and interviews, the Facility failed to ensure that the Quality Assurance and Performance Improvement (QAPI) program was integrated into all departments so that adverse events and medical errors could be identified and medical errors reduced.

This failure resulted in medication administration errors and other adverse events that caused harm to patients and required medical intervention.

FINDINGS:

1. The Facility did not have a complete and consistent mechanism to investigate the causes of medication administration errors and adverse events, to implement corrective action or evaluate the effectiveness of the corrective action.

a) The Facility's 2012 Performance Improvement Plan (PI Plan) stated that the Facility would establish a hospital wide Quality Council to oversee performance improvement. The Quality Council would assess and prioritize performance improvement activities. The Quality Council would collect data to identify high risk, high volume and problem prone areas and identify processes and outcomes for improvement.

b) A review of internal facility documents revealed that from 05/01/12-09/16/12 the facility had a total of 159 reported medical errors. Of the total number, 87 were medication errors, 15 of the medical errors were related to insulin administration and more than one patient required medical intervention.

An internal facility document stated that Sample Patient # 31 missed 2 weeks of evening doses of tacrolimus (prograf), an anti-rejection medication used for organ transplant patients. The patient was sent to another facility for biopsy and further treatment.

c) A review Sample patient # record revealed that the physician had incorrectly written the order, which was not recognized as an incorrect order by pharmacy or nursing staffs. Nursing was not educated about, or involved in, any data collection on patients receiving tacrolimus or the significance of an adequate systemic level of the medication to prevent organ rejection.

d) In an interview on 10/04/12 at 10:30 a.m., the Medical Director stated that he developed a new process/protocol for tacrolimus (prograf) administration. S/he admitted that nursing staff was not involved or educated about the new process/protocol by the medical staff or education department.

e) In an interview the Director of Pharmacy noted variances and adverse drug reactions related to patients having severe hypoglycemia after insulin administration and developed a new insulin sliding scale dosing regimen. Nursing staff/department was not involved in the development of the new regimen, nor was nursing staff educated about diabetes or insulin, its effects, dosages and proper administration.

f) A review of the Pharmacy and Therapeutics (P&T) meeting minutes revealed that pharmacy implemented a new insulin sliding scale that was approved by the medical executive committee (MEC) in July 2012.

Quality Council meeting minutes from 02/16/12 - 08/16/12 were reviewed. Meeting minutes for Facility Leadership, P&T, Medical Executive Committee (MEC), and Department Managers were also reviewed. The meeting minutes did not reflect an assessment or investigation of the Facility's medication errors, or the frequency and severity of the errors. The meeting minutes did not reflect implementation of corrective actions or evaluation of the effectiveness of the corrective actions.

There was no evidence that the new insulin sliding scale was evaluated for effectiveness and safety after implementation. There was no evidence that an evaluation of the new process/protocol for tacrolimus administration and monitoring was evaluated for effectiveness or safety.

Education department training documentation was reviewed. There was no evidence of nursing education related to tacrolimus (prograf) uses, dosages, administration and monitoring. There was no evidence of nursing education related to diabetes treatment or insulin administration.

g) In an interview on 10/03/12 at 1:00 p.m., the Director of Quality Management (DQM) stated that s/he was a contracted employee hired as interim in May 2012. The DQM acknowledged the log and admitted that not all of the occurrences on the log had been investigated, and not all categories of occurrences of any kind were investigated or measured to determine frequency and severity.

The DQM stated that "goals are determined by the departments." S/he stated that the "lower departments" identify errors through department performance improvement (PI) plans and report them to the quality committee. The DQM admitted that the quality department is not "completely involved in trending for this specific facility."

The DQM did not have information regarding how the data reported to the quality committee would be used. S/he acknowledged the number of medication administration errors reported but s/he did not have information regarding why the issues were not investigated and why there was no assessment, measurement, tracking or trending of the adverse events reported.

Based on observation and interviews, the Facility failed to ensure the security of patient medical records.

This failure created the potential for unauthorized access of personal health information.

FINDINGS:

1. The Facility did not ensure that patient records kept in the medical records department, radiology department and on nursing units were secured when unattended.

a) On 10/02/12 at 11:00 a.m., an interview and a tour of the medical records department was conducted with the Health Information Director (HIM). The HIM Director stated and demonstrated that medical records were secured behind the locked door to which only the physicians and HIM staff have access.

The inside of the room was secured with a half door that was latched at the bottom. The medical records would be accessible through the top half of the door. Portions taken out of the record to "thin" the size of the record were kept in drawers at the nurses station that s/he believed would be unlocked. A tour of the nursing station confirmed that the records were unlocked and unattended.

b) A tour of the radiology department was conducted with the Director of radiology on 10/02/12 at approximately 12:45 p.m. An unlocked room in the main hallway of the Facility, which would be passed by patients and visitors going to other separately licensed facilities in the building, was where the facility stored their portable x-ray machine. Within this room, the facility also had floor to ceiling shelving which contained old radiology films.

The Radiology Technician and the Director if radiology stated the films dated back to 2003. "These [the records] just need to be thinned because at this point they will just be melted," stated the Radiology Technician. The films were stored in manila sleeves and labeled with the patient's date of birth, name, physician's name, and date seen. The Director of radiology stated that s/he, three radiology technicians, and plant operations staff had keys to the room, however, the room was routinely unlocked throughout the day.

c) A tour of the nursing units was conducted with the Chief Clinical Officer (CCO) on 10/02/12 at approximately 2:00 p.m. Several multiple drawer file cabinets were found throughout the nursing units.

The file cabinets were unlocked and contained current patient medical records thinned from the charts or medical records from the patients' previous hospital admissions. The physicians' dictation room contained one cabinet, which could not be locked. The CCO stated the room was only locked when physicians were not at the facility working, so the room may even stay unlocked throughout the evening.

d) The Director of Nursing's office was adjacent to the physicians' dictation room. The Director's office contained several piles of lab requisition forms, each approximately four feet tall equaling hundreds of sheets. Each lab requisition form contained a patient label, a patient's name, social security number, physician name, and laboratory tests conducted. The room also had several small stacks of forms which contained patients' names, room numbers, and administration information regarding numbers of patient hours. The room was not ever locked, as it contained the refrigerator used to store laboratory samples, such as blood or urine, prior to pick-up from the contracted lab.

e) A unit named "HOU" had two nurses' stations, each with a large file cabinet containing patients' medical records. The first station had a delegated telemetry technician always posted there and the cabinet was behind the station. The second station, however, did not have any delegated staff there and was frequently observed to have no staff. The file cabinet at the station was unlocked and unsecured.

f) The other unit, called either the 200 wing or the "LTAC," also contained a file cabinet, with three drawers, behind the nurse's station. This nurses station had a secretary throughout the day, but no secretary or telemetry monitor at night.