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Based on observation, interview and record review, the facility failed to have an effective Governing Body that was legally responsible for the conduct of the hospital by failing to ensure:

1. Contracted services were provided in a manner that allowed the facility to meet its obligations to provide high quality services (Refer to A 083).

2. Contracted services were subject to quality assurance to ensure their safety and effectiveness (Refer to A 084).

3. That the facility maintained a list of contracted services with the scope and the nature of the services provided (Refer to A 085).

4. That each patient's rights were protected and promoted (Refer to A 115).

5. That the facility developed, implemented and maintained an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program (Refer to A 263).

6. That 24-hour nursing services were furnished or supervised by a registered nurse (Refer to A 385).

7. That all patient care was provided by or in accordance with the orders of a practitioner or an allied health professional who had been granted privileges, and that organized dietary services directed and staffed by adequate personnel (Refer to A 618 and A 629).

8. That complete and accurate medical records were maintained and available for use for every individual evaluated and treated in the hospital (Refer to A 431).

These findings meant that the facility failed to ensure high quality health care provided in a safe environment.

Based on interview and record review, the facility failed to be responsible for the quality of contracted services furnished to the facility by failing to:

1. Ensure the effective and safe implementation of electronic medical record (EMR) system changes, creating a risk of substandard care for all patients.

2. Ensure that contracted nuclear medicine equipment maintenance was being performed per manufacturer recommendations, creating the risk for substandard care for all patients in the facility, and the risk of substandard nuclear medicine study for patients receiving nuclear medicine scans from one gamma camera.

3. Ensure that the nuclear medicine isotope contractor provided calibration data for new isotope supplies, creating the risk of incorrect isotope dosing and substandard health outcomes for patients using the nuclear medicine services of the facility.

Findings:

1. During a review of the medical record of Patient 1 on 3/23/10, an order for wound care therapy was seen in the EMR, but there was no documentation that the order was carried out. During an interview with EMR Consultant 1 on 3/24/10, at 10:45 AM, she stated that the function for ordering wound care consultation had changed via an update from the corporate office. She stated that the physician had ordered the wound care using an older order function. The older order function was still available for use on the system, but when completed the order was not forwarded to the wound care consultant. Patient 1 was discharged without the benefit of a wound care consultation, and no effort had been made to arrange outpatient wound care because the wound care consultation order was missed.

EMR Consultant 1 stated that information about changes in the system were sent to her and EMR Consultant 2 and the "Nurse Champion" via email from the corporate office. EMR Consultant 1 stated that she was not sure if she had received information from the corporate office about the change in the order sets and the possibility of missed orders.

EMR Consultant 2 was interviewed on 3/24/10 at 10:45 AM. She stated that she did not receive written communication regarding the change in order sets (groupings of orders that fall under a catagory) and the possibility of missed orders.

During an interview on 3/24/10 at 11:15 with Administrative Staff RN B, the EMR "Nurse Champion" designated to assist nursing personnel with using the EMR system, stated that she assumed that updates to the EMR system provided by the corporate office were tested and fully functional prior to arriving at the facility . She stated that there was no effort in the facility to test how well the system was functioning after an update. She stated that she believed the wound care order that did not transmit properly to the wound care consultant was an example of a system error that was missed by the EMR developers.

During an interview with the Quality Committee members on 3/19/10 at 9:15, MD 2, the Physician Director of Quality, stated that the QA program did not separately track quality issues related to the EMR.

2. During a tour of the nuclear medicine area of the facility on 3/16/10 at 10:50 AM, the maintenance records of a gamma camera were requested. Nuclear Medicine Supervisor 1 stated that the maintenance was coordinated by the corporate office, and that records were maintained by the corporate regional office, and were accessible by computer from the facility. However, when the computer record for the maintenance was requested, it ended in 2003. Nuclear Medicine Supervisor 1 stated that she received via email updates of the gamma camera maintenance for a time, but that she paid no attention to them as she assumed the maintenance was tracked by the corporate regional office, and she no longer received the maintenance updates. During a concurrent interview with the Director of the Radiology Department, he stated that the maintenance records should be available to the facility via the computer record storage system, but was not able to locate records for maintenance of the machine after 2003.

The Director of the Radiology Department obtained a copy of the maintenance records for the gamma camera from a source outside the facility on 3/19/10. The records indicated that preventive maintenance had been provided for the machine by the outside contractor at intervals ranging from 3 months to 14 months. The contracted maintenance provider indicated in an email to the Director of the Radiology Department on 3/23/10 that preventive maintenance was to be performed on the gamma camera four times annually, and he confirmed that 2 of the 4 annual preventive maintenance checks had been missed in both 2008 and 2009 and that maintenance checks had also been missed in the years 2004-2007.

3. During a tour of the nuclear medicine area of the facility on 3/16/10 at 10:50 AM, the calibration data for nuclear isotopes was reviewed, and it was noted that the calibration data was outside of the limits posted on the wall. The acceptable limits of calibrated activity for Cobalt-57 on the posted " Acceptable Dose Calibrator Limits " was 0.75 to 0.82 for March 16, 2010, while the actual measured activity was 5.25 for the Cobalt-57 in use. During an interview with Nuclear Medicine Supervisor 1, she stated that the contracted radiopharmaceutical provider was to send new calibration data when they sent the new isotope supply, but had failed to send the data with the new isotopes that arrived one month prior. When asked how she determined if the isotope doses were correct to use, she stated that they estimated based on small daily variation, but they were not able to verify the dose calibration was correct.

The facility list of contracted services was requested multiple times during the survey. In response, the facility provided a four-page list of service providers, titled "Kaiser Foundation Hospital - Fontana Medical Center Contract/Registry Agencies 2009", on 3/22/10. The list contained clinical and non-clinical service providers (including maintenance companies) but did not contain information about the service providers for the nuclear medicine department gamma camera maintenance or the radiopharmaceutical provider. A more complete list was requested, and on 3/24/10 the Director of Radiology offered a multiple-page list of radiologic equipment that was serviced by three contractors that were not named on the initial four-page list provided. A more complete list was again requested on 3/24/10 and the Assistant Administrator repeatedly stated on 3/24/10 at 11:10 AM that there were no additional contracted services being used beyond those listed on the initial four page list. On 3/25/10 at 2:15 PM, the COO provided a list of contracted services selected nationally by the facility's corporate organization. The COO did not have a list of contracted services that were used specifically at the facility. The radiopharmaceutical provider was on the list of nationally contracted service providers. There was no evidence that the Governing Body was aware of which of the contracted providers, such as the radiopharmaceutical provider, were providing services at the facility, and therefore no evidence that the facility was providing quality assurance for those contracted providers.

Based on interview and record review, the facility failed to be responsible for the quality of contracted services furnished to the facility by failing to:

1. Ensure the effective and safe implementation of electronic medical record (EMR) system changes, creating a risk of substandard care for all patients.

2. Ensure that contracted nuclear medicine equipment maintenance was being performed per manufacturer recommendations, creating the risk for substandard care for all patients in the facility, and the risk of substandard nuclear medicine study for patients receiving nuclear medicine scans from one gamma camera.

3. Ensure that the nuclear medicine isotope contractor provided calibration data for new isotope supplies, creating the risk of incorrect isotope dosing and substandard health outcomes for patients using the nuclear medicine services of the facility.

Findings:

1. During a review of the medical record of Patient 1 on 3/23/10, an order for wound care therapy was seen in the EMR, but there was no documentation that the order was carried out. During an interview with EMR Consultant 1 on 3/24/10, at 10:45 AM, she stated that the function for ordering wound care consultation had changed via an update from the corporate office. She stated that the physician had ordered the wound care using a older order function (the syntax in which an order is written, that is recognized by the EMR system). The older order function was still available for use on the system, but when completed the order was not forwarded to the wound care consultant. Patient 1 was discharged without the benefit of a wound care consultation, and no effort had been made to arrange outpatient wound care because the wound care consultation order was missed.

EMR Consultant 1 stated that information about changes in the system were sent to her and EMR Consultant 2 and Administrative Staff RN B via email from the corporate office. EMR Consultant 1 stated that she was not sure if she had received information from the corporate office about the change in the order sets and the possibility of missed orders.

EMR Consultant 2 was interviewed on 3/24/10 at 10:45 AM. She stated that she did not receive written communication regarding the change in order sets and the possibility of missed orders.

During an interview on 3/24/10 at 11:15 with Administrative Staff RN B, the EMR "Nurse Champion", designated person to assist nursing personnel with using the EMR system, she stated that she assumed that updates to the EMR system provided by the corporate office were tested and fully functional prior to arriving at the facility . She stated that generally there was no effort by the facility to test how well the system was functioning after an update by corporate. She stated that she believed the wound care order that did not transmit properly to the wound care consultant was an example of a system error that was missed by the EMR developers.

During an interview with Quality Committee members on 3/19/10 at 9:15, MD 2, the Physician Director of Quality, stated that the QA program did not separately track quality issues related to the EMR.

2. During a tour of the nuclear medicine area of the facility on 3/16/10 at 10:50 AM, the maintenance records of a gamma camera were requested. Nuclear Medicine Supervisor 1 stated that the maintenance was coordinated by the corporate office, and that records were maintained by the corporate regional office, and were accessible by computer from the facility. However, when the computer record for the maintenance was requested, it ended in 2003. Nuclear Medicine Supervisor 1 stated that she received via email updates of the gamma camera maintenance for a time, but that she paid no attention to them as she assumed the maintenance was tracked by the corporate regional office, and she no longer received the maintenance updates. During a concurrent interview with the Director of the Radiology Department, he stated that the maintenance records should be available to the facility via the computer record storage system, but was not able to locate records for maintenance of the machine after 2003.

The Director of the Radiology Department obtained a copy of the maintenance records for the gamma camera from a source outside the facility on 3/19/10. The records indicated that preventive maintenance had been provided for the machine by the outside contractor at intervals ranging from 3 months to 14 months. The contracted maintenance provider indicated in an email to the Director of the Radiology Department on 3/23/10 that preventive maintenance was to be performed on the gamma camera four times annually, and he confirmed that 2 of the 4 annual preventive maintenance checks had been missed in both 2008 and 2009 and that maintenance checks had also been missed in the years 2004-2007. According to the Director of Radiology and Nuclear Medicine Supervisor I, there was no evidence of facility quality assurance of the gamma camera because the facility left coordination of the service to others.

3. During a tour of the nuclear medicine area of the facility on 3/16/10 at 10:50 AM, the calibration data for nuclear isotopes was reviewed, and it was noted that the calibration data was outside of the limits posted on the wall. The acceptable limits of calibrated activity for Cobalt-57 on the posted " Acceptable Dose Calibrator Limits " was 0.75 to 0.82 for March 16, 2010, while the actual measured activity was 5.25 for the Cobalt-57 in use. During an interview with Nuclear Medicine Supervisor 1, she stated that the contracted radiopharmaceutical provider was to send new calibration data when they sent the new isotope supply, but had failed to send the data with the new isotopes that arrived one month prior. When asked how she determined if the isotope doses were correct to use, she stated that they were estimated based on small daily variation, but they were not able to verify the dose calibration was correct.

The facility list of contracted services was requested multiple times during the survey. On 3/25/10 at 2:15 PM, the COO provided a list of contracted services selected nationally by the facility ' s corporate organization. The COO did not have a list of contracted services that were used specifically at the facility. The radiopharmaceutical provider was on the list of nationally contracted service providers. There was no evidence that the facility's Governing Body was aware of which of the contracted providers, such as the radiopharmaceutical provider, was providing services at the facility, and no evidence that the facility was providing quality assurance for those contracted providers.

Based on interview and record review, the facility failed to maintain a list of contracted service providers to ensure the delineation of contractor responsibility, creating the risk of substandard services and an unsafe environment that had the potential to affect all patients and staff.

Findings:

The facility list of contracted services was requested multiple times during the survey. In response, the facility provided a four-page list of service providers on 3/22/10. The list did not contain information about the service providers for the nuclear medicine department gamma camera or the radiopharmaceutical provider. A more complete list was requested, and on 3/24/10 the Director of Radiology offered a multiple-page list of radiologic equipment that was serviced by three contractors that were not named on the initial four-page list provided.

A more complete list was again requested on 3/24/10 and the Assistant Administrator repeatedly stated on 3/24/10 at 11:10 AM that there were no additional contracted services being used beyond those listed on the initial four page list. On 3/25/10 at 2:15 PM, the COO provided a list of contracted services selected nationally by the facility's corporate organization. The COO stated that he did not have a list of contracted services that were used specifically at the facility. The radiopharmaceutical provider was on the list of nationally contracted service providers. There was no evidence that the Governing Body was aware of which of the contracted providers, such as the radiopharmaceutical provider, were providing services at the facility, and no evidence that the facility was providing quality assurance for those contracted providers.

Based on observation, interview, and record review the hospital failed to ensure that each patient's rights were protected and promoted.

1. The facility failed to ensure the patient had the right to be free from all forms of abuse for Patient 64. The facility failed to ensure that, after notification of an allegation of financial abuse at home, their policies were followed to assess the allegation and notify the proper authorities. This failure caused the patient to be discharged home to a potentially abusive environment and suffering further abuse up to and including loss of her home. (Refer to A 145)

2. The facility failed to ensure for Patient 80, that the patient's representative was informed of his health status, by failing to notify Patient 80's representative when the patient had a life threatening medical emergency. This failure had the potential to result in the patient's representative not having the information needed to make treatment decisions. (Refer to A 131)

3 a). The facility failed to ensure that the use of restraints, was in accordance with the order of a physician or other licensed independent practitioner (LIP), who were responsible for the care of Patients 64 and 81. This failure had the potential for the patients to be placed in restraints when other forms of treatment may have been indicated and had the potential for the patient to suffer injury from restraints, including death. (Refer to A 168)

3 b). The facility also failed to ensure that they followed hospital policy for physician evaluation of Patient 64 who required restraints every day. This failure had the potential for the patient to be placed in restraints when other forms of treatment may have been indicated and had the potential for the patient to suffer injury from restraints, including death. (Refer to A 168)

4. The facility failed to ensure that the use of restraints were never used on an as needed basis (PRN) for Patient 64. This failure had the potential to cause patients to be restrained without necessity and had the potential to cause injury from restraints including skin breakdown, increase in behaviors, falls, and potential strangulation. (Refer to A 169)

5. The facility failed to ensure that the written information provided to Patients 85 and 86 contained the results of the grievance process and the date of completion. This failure had the potential to result in the patients not being satisfied with actions that were taken on the patient's behalf. (Refer to A 123)

6. The facility failed to ensure that the patient's right to confidentiality of their record was respected by failing to have privacy screens installed that prevented people from viewing the records from the hallway in 5 units. (Units 2 East, 4 East Ward A, Cardiac Care Unit, and Intensive Care Unit) This failure had the potential for any patient in the units to have their records viewed by the public. (Refer to A 147)

7. The facility failed to establish a process for prompt resolution of patient grievances by failing to investigate and provide resolution to three of three grievances reviewed, creating the risk of unmet healthcare needs and substandard healthcare for patients using the grievance process. (Refer to A118)



The cumulative effect of these systemic problems resulted in the facility's inability to ensure the provision of quality health care in a safe environment.

Based on interview and record review, the facility failed to establish a process for prompt resolution of patient grievances by failing to investigate and provide resolution to three of three grievances reviewed, creating the risk of unmet healthcare needs and substandard healthcare for patients using the grievance process.

Findings:

On 3/22/10, three grievances, cases #3502510, 3536589 and 3612530, were randomly selected from the grievance log for review. The first grievance concerned a complaint of lost property. Member Services Staff 1, interviewed on 3/23/10 at 2:25 PM, stated that the standard practice for investigation of lost property was to contact the nurse, security and the department administrator. She was unable to find documentation that the nurse or security had been contacted about the lost property. When asked if the chart had been reviewed to determine if the patient had the property during her stay, she stated that it had not. A resolution letter was mailed to the complainant, denying the request for replacement of the lost property.

The second and third grievances reviewed were quality of care complaints. Member Services Staff 1 stated on 3/24/10 at 1 PM, that when a patient care complaint was received it was reviewed by a case manager who routed the complaint to other departments based upon the substance of the complaint and facility criteria. Once the communication from the Member Services Department regarding the complaint was marked received by other departments, a resolution letter was mailed to the patient. Member Services Staff 1 stated that she did not know if the departments where the complaints were routed discussed or took action on the complaints.

The second grievance, reviewed on 3/24/10, was via telephone from a family member, Complainant 2, regarding patient care, and included multiple allegations and two requests. Additional allegations were made during a second phone call. The allegations in the complaint included:

1. The facility had not provided a clear diagnosis.

2. The facility had not provided information about course of treatment that the discharged patient was to receive.

3. The facility lacked of continuity of care.

4. Dietary instructions provided resulted in electrolyte abnormalities.

5. The patient developmed pressure ulcers while in the facility.

6. The discharge planner had been rude.

7. Discharge from hospital for physician convenience when the patient was not ready for discharge (and therefore was rapidly readmitted).

The grievance also included the following two requests:

1. To be given a clear diagnosis and outpatient course of treatment.

2. To have at least two of the same physicians care for the patient in facility.

Member Services Staff 1 stated that the Member Services Department sent a Request for Investigative Review containing a "case summary" to a clinical reviewer, and sent Complainant 2 a letter stating that the complaint was resolved. Member Services Staff 1 stated, "we don't know that the departments that we sent it to have done anything" before sending the resolution letter to the complainant.

The "Request for Investigative Review" for the second grievance that was sent to the clinical reviewer was seen and contained a "case summary" , which did not contain Complainant 2 ' s entire complaint, and a request for the clinical reviewer to respond to one issue. The "case summary" omitted multiple allegations and the two requests made by the complainant. The allegations omitted from the " case summary " were: Facility not providing information about course of treatment that discharged patient was to receive, development of pressure ulcers in facility, and discharge planner was rude. Member Services Staff 1 stated on 3/16/10 at 1 PM that the communication issues identified during the first phone call from the complainant were omitted in error.

The clinical reviewer, MD 3, was interviewed on 3/24/10 at 1:15 PM regarding her response to the "Request for Investigative Review". She stated that only the " case summary " was provided to her, and that she was unaware of additional allegations or Complainant 2 ' s requests. She stated that she saw the "Request for Investigative Review" on 12/2/09, determined that the grievance should be referred to the Utilization Management (UM) Director, and did not know if any follow-up of the complaint had been done. During an interview with QA Staff 1 on 3/24/10 at 1:20 PM, she stated that there was no record of the complaint being received or reviewed by the UM Director.

According to the Hospital Patient Grievance Policy, effective date 7/1/09, reviewed on 3/24/10, provision 5.8, "A grievance shall be considered 'resolved' when the patient or patient representative is reasonably satisfied with the actions taken by the hospital or the Hospital has taken all reasonable measures to resolve the matter ... " The facility sent a " resolution letter " to Complainant 2 on 12/4/09 which stated, "Your concerns regarding the care provided ....were forwarded to ...the Department Administrator of the Hospital Nursing Staff, and the Assistant Area Medical Director for the Fontana Medical Center for review and appropriate action. " However, the facility failed to ensure that the complaint, including all of the allegations, and the complainant ' s specific requests, were forwarded to those responsible facility representatives or that the facility representatives took appropriate action.

The third grievance, reviewed on 3/24/10, was a telephone call from a family member, Complainant 3, regarding patient care with multiple allegations including that the physician, "threatened to put a feeding tube in the patient" , and "would not listen to the family member concerns" . The possibility of threatening or disruptive behavior by the physician was discussed with the DRM, who was interviewed on 3/24/10. She stated that allegations of possible disruptive physician behavior were to be sent to Risk Management for review, but they had not received the grievance for review. A resolution letter was mailed to Complainant 3 on 11/4/09 which stated in part, " Please be assured that we take your concerns seriously , and the issue you have raised will be addressed by the appropriate department(s) ... " .

Based on interview and record review the facility failed to ensure that the written grievance resolution letter, referencing to the care provided to 2 of 33 sampled patients (Patients 85 and 86), contained the results of the grievance process and the date of completion. This failure had the potential to result in the patients not being satisfied with actions that were taken on the patient's behalf.

Findings:

On 3/25/10 a complaint that was submitted to the facility by a advocate on behalf of Patient 85 was reviewed. The "Case with Notes Report" dated 9/15/09 indicated that Patient 85 was diagnosed and treated by a physician for a urinary tract infection. Patient 85 was shakey at home and was readmitted to the facility. In the complaint it was documented that the daughter stated that the physician threaten to put the patient on a feeding tube because she was not eating. Patient 85 was diagnosed with a neurological disorder by a Neurologist. Patient 85's daughter was unhappy with the primary doctor's care of and conduct toward's her mother.

Further review of the "Case with Notes Report" dated 9/15/09 documented the following as a "Resolution Description", "Member advised her concern has been documented and forwarded to the Chief (physician's name) for the Internal Medicine Department ant Fontana Medical Center for review. Resolution letter sent". The documented resolution date was 11/4/09.

The resolution letter sent to the daughter of Patient 85 was reviewed on 3/25/10. The letter dated 11/4/09 indicated that the daughters concerns had been forwarded to the Chief of Internal Medicine for review. The letter documented the steps taken to investigate the grievance, but there was no documented evidence of the results of the grievance process or the date of completion.

On 3/25/10 a complaint, that was submitted to the facility by an advocate on behalf of Patient 86, was reviewed. The "Case with Notes Report" dated 10/07/09 indicated that the advocate for Patient 86 was dissatisfied with the continuity of physicians who were treating her mother. The report indicated the following regarding the daughter, "She states that all she wants is a proper diagnosis and course of treatment for her mother to be able to care for her properly at home."

Further review of the "Case with Notes Report" dated 10/07/09 documented the following as a "Resolution Description", "Your concerns regarding the care provided to (patient's name) ....were forwarded to the Assistant Department Administrator of the Extended Care Services, the Department Administrator of the Hospital, Nursing Staff, and the Assistant Area Medical Director of the Fontana Medical Center for review and appropriate action. The documented resolution date was 12/4/09.

The resolution letter sent to the daughter of Patient 86 was reviewed on 3/25/10. The letter dated 12/4/09 noted "Your concerns regarding the care provided to (patient's name) by the hospital nursing staff and the Internal Medicine physicians at the Fontana Medical Center Hospital from September 17 through October 12, 2009 and the care provided by the staff at Community Extended Care Hospital beginning October 12, 2009, were forwarded to the Assistant Department Administrator the Hospital Nursing Staff and the Assistant Area Medical Director for the Fontana medical Center for review and appropriate action." The letter documented the steps taken to investigate the grievance, but there was no documented evidence of the results of the grievance process or the date of completion.

During an interview with the Director of Member Services (DMS) and the Member Services Operations Director (MSOD) on 3/25/10 at 11:30 AM, the DMS verified that the resolution letters sent to the advocates of Patient 85 and 86 documented steps taken to investigate the grievances, but did not include documentation of the results of the grievances, or the date of completion of the investigations as required by CMS hospital regulations.

Review of the facility Policy and Procedure titled "Hospital Patient Grievance" revision date 11/09 noted, "Grievance: An issue, concern or complaint, whether expressed verbally or in writing, related to any aspect of care, abuse, neglect or harm arising in connection with a patient's hospitalization, including issues related to the hospital's compliance with CMS Hospital Conditions of Participation and Medicare...

Based on interview and record review, the facility failed to ensure, for 1 of 33 sampled patients, Patient 80, that the patient's representative was informed of his health status, by failing to notify Patient 80's representative when the patient had a life threatening medical emergency. This failure had the potential to result in the patient's representative not having the information needed to make treatment decisions.

Findings:

Complaint #CA00168717

Review on 3/18/10, of Patient 80's record, documented that the patient was 80 years of age, admitted to the facility on 6/17/08 with a diagnosis of hematuria (blood in the urine). The patient was treated for a urinary tract infection and had a high INR (a blood test to check the ability of the blood to clot. A high INR indicates the patient has a high risk of bleeding). Patient 80 had been on a blood thinner (Coumadin) at home.

Review of the nurses flowsheet notes dated 6/18/08 (the date was written on the nursing flowsheet before midnight) at 3:30 AM, the nurse documented that the patient was found unresponsive and slumped over in bed. The patient had no respirations (breathing), with a faint pulse, and no blood pressure. The Code Blue team (emergency response team) was called.

Review of the Patient Resuscitation Record dated 6/18/08 (according to other records in the patient record, the date should have been 6/19/08) at 3:32 AM, showed that the patient was slumped across bed with no respirations and a faint pulse. The vital signs (blood pressure, pulse, respirations) were recorded at 3:30 AM as blood pressure 0, pulse 0, and respirations were left blank. At. 3:40 AM the vital signs were: blood pressure 110/70 (normal 90-120/60-80), pulse 70 (normal 60-100), respirations 18 (normal 12-18). The patient outcome of the Code Blue was "Palpable (able to feel) pulse restored."

There was no documentation found in the record that the patient's family was notified of Patient 80's medical emergency until after a second Code Blue was called on 6/19/08 at 5:45 AM and the patient died at 6:30 AM.

In an interview on 3/23/10 at 10:00 AM with the Administrative Staff RN C, she stated that the physician should have called the family after the 3:30 AM Code Blue. She further stated that there was "no excuse for that."

Based on interview and record review the facility failed to ensure the patient had the right to be free from all forms of abuse for 1 of 33 sampled patients (Patient 64). The facility failed to ensure that, after notification of an allegation of financial abuse at home, their policies were followed to assess the allegation and notify the proper authorities. This failure caused the patient to be discharged home to a potentially abusive environment and suffering further abuse up to and including loss of her home.

Findings:

A review of the medical record for Patient 64 revealed that she was admitted to the facility on 2/19/10 with a chief complaint of confusion and agitation. Her medical history included dementia and diabetes mellitus.

Review of the Case Management Registered Nurse (CMRN) notes, dated 2/23/10 at 1:28 PM, revealed the following statement:

"(Name, patient's daughter) states that patient has been under a lot of stress lately because a group of people has been exerting a lot or (of) pressure on patient for at least 2 months to give them money. To the best of (name, daughter) and (name, son) knowledge, patient has given these people thousands of dollars. Patient was at one point looking at losing her home...(Daughter) found pts (patient's) phone bill to have about $800.00 of charges from Jamaica, and thinks that some people are threatening patient if she declines to send them money."

Review of the facility policy titled "Reportable Injuries/Conditions Resulting for Abuse", dated 12/08, revealed a list of "types of elder or dependent adult abuse" included in the list was Fiduciary (Financial) abuse. The instructions to the employee was that they are mandatory reporters "if in his or her professional capacity or within the scope of his or her employment" he or she was told by an elder or dependent adult that he or she had experienced behavior constituting abuse. The first step in reporting, contact the Social Service Department.

Further review of the CMRN notes revealed that the patient was seen by CM on 2/25/10, 2/26/10, 3/1/10, 3/5/10, 3/9/10, 3/11/10, and 3/12/10. Review of the CM notes revealed no further mention of the allegation of financial abuse. There was no referral to the social worker to follow up on the patient.

The facility administrative staff assisting the survey process were asked for any social worker notes for Patient 64 for the duration of her stay. On 3/23/10 at 2 PM, Administrative Staff A confirmed that there was no social service documentation regarding the patient.

An interview was conducted with CMRN A on 3/22/10 at 11:30 AM. She stated that as a nurse in the facility she had the responsibly to report abuse. She stated that she would report any abuse to the social worker for evaluation and further report to an appropriate agency. CMRN A stated that she was the CM for Patient 64 until 3/12/10 and then she was assigned to another unit. She stated that she did not know why another CM had not documented on the patient since that time. CMRN A reviewed her notes and confirmed that she had written the note regarding the allegation of financial abuse. She stated that she did not report the allegation of abuse to a social worker. She stated that she discussed it with the physician and because the physician was not sure that the patient's daughter was correct, she did not report it further. She stated that she was aware that the patient's daughter had some proof of a problem because she found the telephone bill with $800.00 in charges to Jamaica. CMRN A confirmed that an allegation of abuse should be taken seriously and reported to the social worker as instructed by facility policy.

On 3/22/10 a visit was made to the unit where Patient 64 was admitted with the nursing clinical director (CD) of the unit. A record review for further CM notes was conducted. It was discovered that Patient 64 was discharged from the facility on 3/18/10. A review of the CM notes (discharge note) who discharged the patient, CMRN B, revealed no mention of the allegation of financial abuse or an evaluation of the home regarding the potential for further issues with financial abuse.

An interview was conducted on 3/22/10 at 3:30 PM with CMRN B. She stated that she was not aware of the allegation of financial abuse that was disclosed to the previous CM by the patient's daughter. CMRN B stated that she had not read the previous CM's notes. She stated she would usually review more of the record before discharge, but she did not for this patient. CMRN B was asked if she knew that the patient had an allegation of abuse at home, would she have sent her home without an evaluation of the potential for abuse. She stated that she would have to think about it.

An interview was conducted with the Director of Case Management (DCM) on 3/23/10 at 1:10 PM. She reviewed the case and confirmed that both case managers did not follow hospital policy regarding notification of a social worker and reporting of an allegation of abuse. She confirmed that the patient was discharged home without evaluation of a potentially abusive environment.

Based on observation and interview, the facility failed to ensure that the patient's right to confidentiality of their record was respected by failing to have privacy screens installed that prevented people from viewing the records from the hallway in 5 units. (Units 2 East, 4 East Ward A, Cardiac Care Unit, and Intensive Care Unit) This failure had the potential for any patient in the units to have their records viewed by the public.

Findings:

1. An observation was conducted on 3/15/10 at 3:30 PM on the facility's medical unit, 2 East. There were 2 computer screens that were on a desk that faced out to the hallway of the unit. During the observation, there were staff accessing confidential patient information from the computer. The survey team could read the sensitive patient information on the screen. The information that was available was the patient's name, laboratory values, and assessments that were being entered into the computer.

An interview was conducted at the same time with the Nurse Manager of the unit. She acknowledged that the information on the computer screen was available to anyone walking down the hall.

2. During an observation tour on 3/16/10, at 10:25 AM, of the facility's adult observation unit, Ward A, there were 2 computer screens that were on a desk that faced out to the hallway of the unit. During the observation, there were staff accessing confidential patient information from the computer. The survey team could read the sensitive patient information on the screen.

An interview was conducted at the same time with the Nurse Manager of the unit. She acknowledged that the information on the computer screen was visible to anyone walking down the hall.


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3. During an observation tour on 3/16/10 at 10:35 AM of the facility's cardiac care unit, there were several computer screens in the central nurse's station that faced out to the hallway of the unit. During the observation, there were staff accessing confidential patient information from the computer. The survey team could read the sensitive patient information on the screen.

An interview was conducted at the same time with the Nurse Manager of the unit. She acknowledged that the information on the computer screen was visible to anyone walking in the hall.

4. During an observation tour on 3/16/10 at 10:34 AM of the facility's cardiac care unit, there were several computer screens in the central nurse's station that faced out to the hallway of the unit. During the observation, there were staff accessing confidential patient information from the computer. The surveyor could read the confidential patient information on the screen.

During an interview with the Nurse Manager, of the unit, on 3/16/10 at 10:34 AM, the Nurse Manager acknowledged that the confidential information, on the computer screen, was visible to anyone walking in the hall.

5. During an observation tour of the facility's intensive care unit on 3/16/10 at 2:00 PM, an observation was made of 3 computer screens on the back of the nurse's station.

in an concurrent interview with accompanying staff, the staff member acknowledged that the computer screens were visible to anyone walking by the nurse's station.

Based on observation, interview, and record review the facility failed to ensure that the use of restraints were in accordance with the order of a physician or other licensed independent practitioner (LIP) who was responsible for the care of the patient for 3 of 33 patients. (Patients 64, 81, and 1).

For Patients 64 and 81 the facility failed to ensure that each episode of restraint and each type of restraint was in accordance with a physician's or LIP's order. This failure lead to the patient being restrained without physician or LIP evaluation of other reasons for behaviors leading to the patient being restrained. This failure had the potential to lead to the patient being restrained without necessity, to lead to injury caused by restraints, including skin breakdown, bruising, increase in behaviors, including death from restraints.

For Patient 64 the facility also failed to ensure that they followed hospital policy for physician evaluation of the patient who required restraints every day. This failure had the potential for the patient to be placed in restraints for a longer period of time than necessary. This failure had the potential for the patient to be placed in restraints when other forms of treatment may be indicated and had the potential for the patient to suffer injury from restraints, including death.

For Patient 1 the facility failed to follow the facility's policy for the use of restraints, which resulted in Patient 1, who was able to walk, having the use of four side rails up while in bed, implemented without a physician's order, or an assessment to determine the necessity for the use of the four side rails. this failure had the potential to result in Patient 1 being unnecessarily restrained, injury from entrapment or a fall that could include death.

Findings:


1 a). A review of the medical record for Patient 64 revealed that she was an 81 year old patient who was admitted to the facility on 2/19/10 with a chief complaint of confusion and agitation. Her medical history included dementia and diabetes mellitus.

Observation of the patient on 3/15/10 at 3:30 PM revealed a patients sleeping quietly in bed with all 4 side rails up.

An interview with the charge nurse of the unit (Staff RN A) was conducted on 3/15/10 at 3:30 PM. She acknowledged the use of 4 side rails up for the patient was to prevent her from getting out of bed. Staff RN A stated that the patient often required the use of restraints due to her behaviors of trying to get out of bed and being disruptive during cares. Staff RN A stated that Patient 64 often resists cares provided by the nursing staff.

A review of the physician's restraint orders and nursing documentation regarding type of restraint and duration of restraint resulted in differences between the order and the type of restraint and or duration as follows:

2/22/10:
Physician order:
Bilateral soft wrist restraint, Time Limit 8 hours, at 10:45 PM
Nursing Documentation:
Bilateral soft wrist restraints, documented every 2 hours (the documentation covered a 2 hour period) from 11:49 PM through 2/23/10 at 11 PM
(This represented 16 hours without a physician's order)

2/23/10:
Physician order:
Vest restraint, Time Limit 12 hours, at 11:30 PM
Nursing Documentation:
11 PM, Bilateral soft wrist restraints, Soft ankle restraint left
(This represented 2 types of restraints that were not ordered by a physician)

2/24/10:
Physician order:
Bilateral soft wrist restraint, Time Limit 8 hours, at 4 AM
Nursing Documentation:
Bilateral soft wrist restraint and vest restraint documented every 2 hours from midnight to
to 6 AM, no documentation from 6 AM to 12 PM, from 12 PM to 9 PM vest restraint was documented, at 10 PM bilateral soft wrist and vest restraints were documented as being used.
(This represented 12 hours of a vest restraint without a physician's order and 11 hours of bilateral wrist restraints with a physician's order.)

2/25/10:
Physician order:
Bilateral soft wrist restraint and vest restraint, Time Limit 24 hours, at 4 AM
Nursing Documentation:
Bilateral soft wrist restraints, vest restraint, side rails X (times) 4 were documented every 2 hours from midnight through 10 PM.
(This represented 22 hours of the use of side rails as a restraint without a physician's order.)

2/28/10:
Physician order:
Bilateral soft wrist restraint and vest restraint, Time Limit 8 hours, at 7 AM
Nursing Documentation:
Bilateral soft wrist restraints, vest restraint, side rails X (times) 4 were documented every 2 hours from 7 AM through 3 PM; then, bilateral soft wrist restraints and side rails X (times) 4 were documented every 2 hour from 3 PM through 11 PM.
(This represented 8 hours of the use of wrist restraints and side rails without a physician's order.)

3/1/10:
Physician order:
Bilateral soft wrist restraint and vest restraint, Time Limit 8 hours, at 7:15 AM
Nursing Documentation:
Bilateral soft wrist restraint and side rails X 4 every 2 hours from 1 AM through 10 PM.
(This represented 16 hours of the use of wrist restraints and side rails without a physician's order.)

3/2/10:
Physician order:
Bilateral soft wrist restraint and vest restraint, Time Limit 24 hours, at 12:30 PM
Nursing Documentation:
Bilateral soft wrist restraint and side rails X 4 every 2 hours from 1 AM through 8 PM.
(This represented 12 hours of the use of wrist restraints and side rails without a physician's order.)

3/3/10:
Physician order:
Bilateral soft wrist restraint and vest restraint, Time Limit 8 hours, at 12:30 PM
Nursing Documentation:
Bilateral soft wrist restraint and side rails X 4 every 2 hours from 1 AM through 12 PM and again at 10 PM the use of wrist restraints were documented.
(This represented 2 hours of the use of wrist restraints without a physician's order. This also represented an order for a vest restraint that according to nursing documentation had not been required for 2 days.)

3/4/10:
Physician order:
No physician's order for restraints was found.
Nursing Documentation:
Bilateral wrist restraints were documented every 2 hours from 1 AM through 6 AM.
(This represented 6 hours of the use of wrist restraints without a physician's order.)

3/7/10:
Physician order:
Bilateral soft wrist restraint, Time Limit 8 hours, at 7:45 AM
Nursing Documentation:
At 7:39 a right wrist restraint was applied, at 9:30 AM a left wrist restraints was applied, at 11:29 bilateral wrist restraints were applied, at 11:30 no restraints were documented, then at 8 PM bilateral wrist restraints and side rails X 4 were applied and continued at 10 PM.
(This represented 4 hours of restraints without a physician's order.)

3/8/10:
Physician order:
Bilateral soft wrist restraint and vest restraint, Time Limit 24 hours, at 7:45 AM, another order for the same date and same restraint was found that was written at 10:15 AM for 24 hours.
Nursing Documentation:
Bilateral wrist restraints from 4 AM through 10 PM and side rails from 4 AM through 6 AM.
(This represented 4 hours of the use of wrist restraints and 4 hours of the use of side rails without a physician's order. This also represented an order for a vest restraint that was not necessary according to nursing documentation.)


3/9/10:
Physician order:
No physician's order for restraints was found.
Nursing Documentation:
At midnight there was documentation of soft wrist restraints. At 12 PM there was documentation of bilateral mittens being used as a restraint through 10 PM.
(This represented 10 hours of mitten restraints being used without an order.)

3/14/10:
Physician order:
Bilateral soft wrist restraint and vest restraint, Time Limit 24 hours, at 9 AM
Nursing Documentation:
Bilateral soft wrist restraints, vest restraint, side rails X (times) 4 were documented every 2 hours from 9 AM through 11 PM (wrist restraints were not documented at 11 PM).
(This represented 14 hours of the use of side rails for restraints without a physician's order.)

3/15/10:
There was no physicians order for the use of 4 side rails when observation and interview revealed that side rails were used.

3/16/10:
Physician order:
Bilateral soft wrist restraint, Time Limit 24 hours, at 10:45 AM
Nursing Documentation:
Vest restraint was documented from 1 AM through 3 PM.
(This represented 14 hours of the use of a vest restraint without a physician's order.)

A review of the facility's policy titled "Restraint", dated 12/09, revealed the following:

"5. ORDERS
Restraint shall be initiated or continued upon the order of a treating physician with current privileges....The order for restraint shall include the type and site(s) of restraint to be applied..."

"PROCEDURE:1. Definition
1.4 The use of side rails to prevent a patient from exiting a hospital bed may pose risk to the patient's safety, particularly for frail or elderly patients who may be a risk for injury due to entrapment or climbing over the rails."

An interview was conducted with Administrative Staff RN A on 3/17/10 at 8:30 AM. She confirmed the documentation regarding the physician's orders and nursing documentation of the use of restraint. She acknowledged that frequently the physician's order did not match the restraints that were used. Administrative Staff RN A confirmed the documentation that side rails were being used as a restraints frequently and that there was no physician's order for side rails as a restraint. She confirmed that according to facility policy and regulation there must be a physician's order for the use of restraints.

1 b). A review of the facility's policy titled "Restraint", dated 12/09, revealed the following:

"8. Ongoing in-person physician assessments and continuation of restraint orders.
The treating physician shall perform an in-person assessment of the restrained patient at least once every calendar day, at which time restraint shall be either re-ordered or discontinued as indicated."

A review of the physician's order for restraints for Patient 64 revealed the following days when the physician had documented "no" to the question "Has face to face assessment been done?" The physician progress notes were also review for the dates where the face to face assessment was not conducted the results were as follows:

2/23/10 at 11:30 PM:
Restraint order, vest restraint, face to face assessment, no
Review of physician's progress notes, dated 2/23/10 at 4:50 PM, there was documentation on patient's behavior; however, no mention of restraints.

2/28/10 at 7 AM:
Restraint order, bilateral wrist restraint and vest, face to face assessment, no
Review of physician's progress notes, dated 2/28/10 at 9:50 AM, there was documentation of patient's behavior and a statement, "restraints as needed". There was no documentation of the type of restraint that were needed.

3/4/10 at 11:44 AM:
There was no documented order for restraints and review of nursing documentation on the restraint flow sheet revealed that bilateral wrist restraints were documented every 2 hours from 1 AM through 6 AM. There was no nursing documentation that restraints were on when the physician documented his assessment.
There was a note from the physician that stated, "Restraints as needed. Back on now due to patient's behavior today."

An interview was conducted with Administrative Staff RN A on 3/17/10 at 8:30 AM. She confirmed the documentation regarding the lack of a physician's face to face assessment during each restraint period.





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2. Review on 3/18/10 of Patient 81's record, showed that Patient 81 was 72 years of age and admitted to the facility on 3/14/10 with a diagnosis that included a bleed into the brain. Patient 81 was described as agitated and restless, pulling at lines and tubes.

A review of the physician's restraint orders and nursing documentation regarding type of restraint resulted in differences between the order and the type of restraint as follows:

3/15/10 at 5:31 PM
Physician order: Soft wrist-bilateral (both wrists), vest restraint.
Nurses notes: vest restraint on at 12:47 AM and documented every two hours continuously for the day.
5:48 PM-soft right wrist and soft left wrist
10:30 PM-soft left ankle, vest restraint, discontinued soft left wrist, discontinued soft right wrist. (The soft left ankle did not reflect the physician order)

There was no physician order for restraint for 3/16/10.
Nurses notes: vest restraint discontinued at 8:06 AM, side rails up x 4 (all 4 side rails up on the bed).

In an interview on 3/18/10 at 3:25 PM with Administrative Staff RN A, she acknowledged that there was a problem with the staff following the physician orders for restraints.


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3. The Electronic Medical Record (EMR) for Patient 1 was reviewed on 3/23/10 at 1:00 PM with Administrative Staff A. The EMR indicated that Patient 1 was a 76 year old female admitted to the facility on 3/15/10 with a diagnosis of subdural hematoma.

Review of the "Multi-Discipline Progress Note" dated 3/15/10 at 2020(8:20 PM) indicated , "Pt(patient) was up with pt(physical therapy) to day and with assistance she was able to walk..."

The "Mult-Discipline Progress Note" dated 3/16/10 at 0413(4:13 AM) contained the following entries:

"0030(12:30 AM) Pt.(patient) more confused and disoriented, un-cooperative. PT pulling out Foley Cath (indwelling bladder urine drainage tube with collection bag), wants to go out of her room. Notified (MD name here)regarding patient condition. Side rail up 4, nurses to observe behavior. Still confused, out of bed between side rales."

"0130 (1:30 AM) Notified (MD name here), regarding pt uncontrolled behavior, vest jacket restrain was ordered."

The "Flowsheet Data" dated 3/16/10, with Patient 1's shift assessment documented that Patient 1 had all four side rails up for safety on 3/16/10 at the following:
1:00 AM
2:00 AM
3:00 AM
4:00 AM
5:00 AM
6:00 AM
7:00 AM
11:00 AM
11:45 AM

The physician's order order for Patient 1 were reviewed on 3/23/10 and indicated that Patient 1 had an order for a vest rest restraint on 3/16/10, but there was no order for all 4 side rails to be up.

The facility policy titled "Restraint" dated 12/09 was reviewed on 3/23/10. The policy indicated the following.:

"1.4. The use of side rails to prevent a patient from exiting a hospital bed may pose risk to the patient's safety, particularly for frail or elderly patients who may be at risk for injury due to entrapment or climbing over side rails."
"1.4.1. The risk presented by side rail use should be weighted against the risk presented by the patient's behavior as ascertained through individualized assessment."
1.4.2. When the clinician raises all four side rails in order to prevent the patient from freely exiting the bed, the side rails ARE considered a restraint."

"2. INDICATIONS
Prior to the initiation and /or continuation of a medical restraint, the patient must be assessed to the require restraint to ensure the immediate physical safety of the patient, staff member or others."

The policy also indicated that for "Confused patient attempting to crawl out of bed" a bed alarm should be used with "Upper bed split rails." "It is a medical restraint when all four rails are up."

There was no documented evidence in the EMR that Patient 1 had been assessed for the need the use of the four side rails in conjunction with the use of the vest restraint.

During an interview with Administrative Staff RN A on 3/23/10 at approximately 1:45 PM, Administrative Staff RN A verified that the EMR indicated that Patient 1 had been placed in vest restraint and had all four side rails up times four on 3/16/10 at the above listed times, and verified that the staff had used the the side rails as a medical restraint not as a safety device, as stated in the facility's policy. Administrative Staff RN A verified that the use of all four side rails is a medical restraint, and would require a physician's order and ongoing assessment while in use. During the interview, Administrative Staff A verified that there was not documented evidence in the EMR of a physician's order, initial and ongoing assessment, nor evidence of continuous monitoring for the use of the side rails as a medical restraint for Patient 1. Administrative Staff RN A verified that staff did not follow the facility's restraint policy while implementing the use of the side rails for Patient 1.

Based on observation, interview, and record review the facility failed to ensure that the use of restraints were never used on an as needed basis (PRN) for 1 of 32 patients (Patient 64). This failure had the potential to cause patients to be restrained without necessity and had the potential to cause injury from restraints including skin breakdown, increase in behaviors, falls, and potential strangulation.

Findings:

1. A review of the medical record for Patient 64 revealed that she was an 81 year old patient who was admitted to the facility on 2/19/10 with a chief complaint of confusion and agitation. Her medical history included dementia and diabetes mellitus.

Review of the physician's orders for restraints and the nursing documentation regarding restraints revealed the following:

2/21/10:
Physician order:
Bilateral soft wrist restraints, at 4:45 PM
Nursing Documentation:
Bilateral soft wrist restraints on at 4:35 PM, off at 5:10 PM, on at 10 PM.
(No physician's order for the reapplication of restraints.)

2/24/10:
Physician order:
Bilateral soft wrist restraint, Time Limit 8 hours, at 4 AM
Nursing Documentation:
Bilateral soft wrist restraint and vest restraint documented every 2 hours from midnight to
to 6 AM, no documentation from 6 AM to 12 PM, from 12 PM to 9 PM vest restraint was documented, at 10 PM bilateral soft wrist and vest restraints were documented as being used.
(No physician's order for the reapplication of restraints.)


3/3/10:
Physician order:
Bilateral soft wrist restraint and vest restraint, Time Limit 8 hours, at 12:30 PM
Nursing Documentation:
Bilateral soft wrist restraint and side rails X 4 every 2 hours from 1 AM through 12 PM and again at 10 PM the use of wrist restraints were documented.
(No physician's order for the reapplication of restraints.)

3/4/10:
Physician order:
No physician's order for restraints was found.
There was a note from the physician that stated, "Restraints as needed."
Nursing Documentation:
Bilateral wrist restraints were documented every 2 hours from 1 AM through 6 AM.
(No physician's order and physician documented restraints as needed (equals PRN)

3/7/10:
Physician order:
Bilateral soft wrist restraint, Time Limit 8 hours, at 7:45 AM
Nursing Documentation:
At 7:39 a right wrist restraint was applied, at 9:30 AM a left wrist restraints was applied, at 11:29 bilateral wrist restraints were applied, at 11:30 no restraints were documented, then at 8 PM bilateral wrist restraints and side rails X 4 were applied and continued at 10 PM.
(No physician's order for the reapplication of restraints.)

3/9/10:
Physician order:
No physician's order for restraints was found.
Nursing Documentation:
At midnight there was documentation of soft wrist restraints. At 12 PM there was documentation of bilateral mittens being used as a restraint through 10 PM.
(No physician's order for the application or reapplication of restraints.)


A review of the facility's policy titled "Restraint", dated 12/09, revealed the following:

"5. ORDERS
5.1 Each episode of restraint use must be initiated in accordance with the order of an MD (Medical Doctor). Staff cannot discontinue restraints and restart without obtaining a new physician order, as that would be considered a PRN order."

An interview was conducted with Administrative Staff RN A on 3/17/10 at 8:30 AM. She confirmed the documentation regarding the use of restraints as a PRN. She stated that sometimes the nurses documented that the restraints were off because the patient's family was at the bedside; however, she stated that the documentation was not consistent.

Based on interview and record review, the facility failed to develop, implement and maintain an effective, ongoing, hospital- wide, data-driven quality assessment and performance improvement program.

Findings:

The facility did not measure, analyze and track quality indicators, including aspects of performance that assessed processes of care, hospital service and operations, by failing to:

1. Collect and track data regarding the use of PRN restraints and that the restraints had a physician's order. (Refer to, A 168, A 169 and A 267)

2. Collect and track data regarding the accuracy of the telemetry monitoring system used to identify heart problems and the response time of the nurse to the telemetry alarm. (Refer to A 267, A 392)

3. Analyze processes of care such as the treatment of pressure ulcers, creating the risk of substandard care for those patients with pressure ulcers. (Refer to A 267)

4. Measure, track and analyze aspects of the grievance process, resulting in the risk of an ineffective grievance process and substandard patient care. (Refer to A 267)

These failures of the facility to maintain a quality assurance program that reflected the complexity of the hospital's organization and services meant that the facility was unable to provide high quality healthcare in a safe environment.

Based on interview and record review the hospital failed to ensure that the QAPI program collected data to measure, analyze, and tract hospital operations as follows:

A. The facility failed to collect and tract data regarding the use of PRN restraints and that the restraints used had a physician's order. (Refer to A 168 and A 169)

B. The facility failed to collect and tract data regarding the accuracy of the telemetry monitoring system used to identify heart problems and the response time of the nurse to the telemetry alarm. (Refer to A 392)

C. The facility failed to measure, track and analyze processes of care such as the treatment of pressure ulcers, creating the risk of substandard care for those patients with pressure ulcers.

D. The facility failed to use data collected regarding restraint use in the facility to monitor the safety, effectiveness and quality of care of patients who received restraints, resulting in the risk of inappropriate restraint utilization.

These failures resulted in the hospital's inability to identify and correct problems to ensure that the problems did not occur or did not occur again.

Findings:

An interview was conducted with the Quality Assessment Performance Improvement (QAPI) committee on 3/19/10 at 9 AM to 11 AM. The members included the Chair of each Quality Council, Members of the medical executive committee, the Nursing Executive (NE), and the medical/surgical Nurse Manager (NM).

The team confirmed that they were responsible for determining which data the facility collects. They also confirmed that this committee was responsible for measuring, analyzing, and tracking quality indicators that assess the process of care and hospital services and operations.

The team was presented with problems that were identified during the survey process as follows:

1. The use of PRN (as needed) restraints and the lack of a physician's order for the particular restraint that was used.

The team stated that they had been collecting data on restraint usage and that their data had showed a less than 5% usage of restraints. The NE stated that the facility felt that restraints were not being used frequently in the facility, so the facility did not place a priority on restraint monitoring. She confirmed that on the date that the survey team entered the facility, 3/15/10, there was a census of 314 patients, and 29 of these patients were in restraints. The NE confirmed that was well above 5%. The NM stated that the facility was monitoring nursing documentation regarding alternatives attempted, cares provided, and even if there was an order for restraints. However, she confirmed that there was no monitoring done for the use of PRN restraints and if the physician's order matched the type of restraint used. The NE and the NM both acknowledged that they were surprised at the survey teams findings regarding restraint usage.

2. The process for telemetry (heart) monitoring was not continuous as stated in the facility policy.

The NE confirmed that the facility had not done any studies to determine the accuracy of the monitor alarms and the response time of the nurse. She acknowledged that because the facility used remote monitoring of alarms and not the actual patient's heart rhythm, establishing the accuracy of the alarms was very important, as was the nursing response time to the alarms.



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3. On 3/23/10 the medical record of Patient 21 was reviewed. According to the admission assessments, the patient was admitted with a stage III sacral ulcer, and also had a stage III sacral ulcer upon discharge. He arrived on the hospital floor on 12/23/09 at 4:14 PM, and a non-powered mattress was ordered for him and a foam dressing was put in place. The nurse measured the wound on 12/23/09 and a wound care consultation was ordered. The wound was measured again on 12/28/09, but there was no documentation that it was measured thereafter.

During an interview with Risk Management Staff 1 on 3/23/10 at 10:55 AM, she stated that the documentation indicated that the patient was placed on a non powered redistribution mattress initially, which she stated was the Accumax, the facility ' s regular mattress. She stated that was not the correct mattress for a patient with a grade III pressure ulcer. The first time the correct mattress was documented as in use by the patient was on 12/30/09, a week after arriving at the facility.

During an interview with Risk Management Staff 1 on 3/23/10 at 10:20 AM, she was asked how the facility provided review and oversight of its pressure ulcer care processes. She stated that the facility did a survey of the patients who had pressure ulcers, but did not examine whether the dressings and mattresses were selected properly. She stated that appeared to be a gap in their monitoring system.

4. During an interview with the Quality Assessment Performance Improvement (QAPI) committee on 3/19/10 from 9 AM to 11 AM, including the Chair of each Quality Council, Members of the Medical Executive Committee, the Nursing Executive (NE), and the medical/surgical Nurse Manager (NM), the QAPI committee members stated that they had been collecting data on restraint usage, and that their data showed less than 5% rate of restraint usage on patients. The NE stated that the facility felt that restraints were not being used frequently in the facility, so the facility did not place a priority on restraint monitoring.

The NE confirmed that on the date that the survey team entered the facility, on 3/15/10, there was a census of 314 patients and 29 of those patients, 9.2%, were in restraints. She concurred that the number of patients in restraints was well in excess of the expected value of less than 5%.

The NM stated that the facility was monitoring nursing documentation regarding alternatives attempted, care provided, and whether there was an order for restraints. However, she confirmed that there was no monitoring done for the use of "as needed" restraints, and no determination whether the restraint type ordered matched that applied. The NE and the NM both acknowledged that they were surprised by the survey team's findings regarding restraint usage in the facility.

The medical records of Patients 64 and 81 were reviewed on 3/16/10 and 3/17/10. For Patients 64 and 81, the facility failed to ensure that each episode of restraint and each type of restraint was in accordance with a physician's or LIP's order. This failure lead to the patient being restrained without physician or LIP evaluation of other reasons for behaviors leading to the patient being restrained.

For Patient 64, the faciliity also failed to ensure that the staff followed hospital policy for physician evaluation of the patient who required restraints daily.

Based on interview and record review, the hospital failed to ensure the medical staff enforced the hospital's bylaws to carry out its responsibilities when the hospital approved policies that allowed RD's to write orders for nutrition supplements without being privileged.

Findings:

On 3/16/10, Patient 27 ' s and Patient 28 ' s medical records were jointly reviewed with the Assistant Director of Patient Services, and both patients ' medical records indicated nutrition supplements were ordered by a Registered Dietitian. (Cross Reference A- 0629)

On 3/16/10 at 1:40 P.M., the Assistant Director of Patient Services stated that the RD ' s were allowed to enter an order for nutrition supplements which did not require an MD signature, if the patient were consuming less than the physician prescribed diet order or if indicated by a lab value, based on hospital policies that were approved via the Medical Quality Improvement Committee. She stated that she had not been granted privileging by the governing body to write orders. On 3/17/10 at 9:00 A.M., the Assistant Director of Patient Services stated that RD ' s did not receive privileging from the hospital. On 3/17/10 at 10:15 A.M., the COO stated that RDs had not received privileging or credentialing by the governing body. On 3/19/10 at 3:20 P.M., MD 29 stated that RD ' s did not receive privileging by the governing body.

On 3/19/10 at 3:20 P.M., MD 29 held both copies of the hospital ' s policies in front of him, Policy I-MSA-16 and Policy I-MSA-10 that allowed RDs to write nutrition supplement orders, and stated, " The policy is a protocol, and the physician does not have to write an order for a protocol to be implemented." MD 29 stated that " Policy I-MSA-16 and Policy I-MSA-1- " were approved via the Medical Quality Leadership Committee, via the Medical Executive Committee and Governing Body. Policy I-MSA-16 required that a nutritional consult by RD or physician's order. Further the policy allowed the RD to "... access the Amino Acid therapy and adjust intervention as necessary". A review of the facility Diet Manual on 3/16/10, revealed that nutrition supplements including amino acid supplements were not listed in any of the diets.

On 3/16/10 at 1:30 P.M., Patient 27's medical record was reviewed with the Assistant Director of Patient Services. According to the Assistant Director of Patient Services the RD electronically entered the order for Pro-Stat 64 and highlighted an option that indicated " Within Role/Scope (No Co-Sign) ". (Cross Reference A- 0629)

On 3/19/10 at 4:20 P.M., hospital staff provided meeting minutes for the Medical Quality Leadership Committee that indicated " PI workgroup on malnutrition and pressure ulcers presented their action plan for improving care for high risk members, " which was the above two policies, and were reviewed and approved on 4/27/09, and the Medical Executive Committee meeting minutes which included those same policies were reviewed and approved on 6/9/09.

The facility Diet Manual does not list nutrition supplements in any of the therapeutic diets ordered by the practitioner responsible for the care of the patient. The physician or an allied health professional who has been granted privileging for this activity, are the practitioners responsible for diet orders in the facility.

According to the hospital's document entitled The Bylaws Of The Professional Staff Of Kaiser Foundation Hospital Fontana, Section H-7. Allied Health Professionals, "Allied Health Professionals may take independent action affecting patient care, within the scope of their competence and authorization. Where statutes, regulations, or joint agreements govern the activities of such personnel within the hospital, these sources of authority shall limit the scope of practice." The hospital's medical bylaws, under Section H-4. Changes In Privileges further indicated, "The chief of all departments shall maintain a continuing review of the qualifications of staff members, and may at any time during the period for which privileges were granted recommend to the Credentials and Privileges Committee that the privileges of any member be limited or revoked."

According to CMS, whenever a practitioner's privileges are limited, revoked, or in any way constrained, the hospital must, in accordance with state and/or federal laws or regulations, report those constraints to appropriate state and federal authorities. There currently is no dietetic oversight board in California in which to report issues or concerns that could arise from RD's practicing privileging, and therefore, could compromise health and safety of patients.

Based on interview, and record review, it was determined that the hospital failed to ensure that nursing was organized and that the delivery of nursing care was supervised by failing to:

1. Ensure that a registered nurse evaluated the nursing care requirements for 3 of 33 sampled patients.

For Patient 80, the registered nurse failed to advocate for the safety of the patient when the patient had a medical emergency. This failure resulted in the patient not having closer cardiac and respiratory monitoring to be able to respond faster to the patient's change in condition. (Refer to A 0395)

For Patient 64, the facility failed to ensure that a registered nurse supervised and evaluated the nursing care of the patient's nutritional status by failing to ensure that the chain of command was followed for the patient with a very low nutritional intake. They also failed to ensure that nursing supervised and evaluated the nursing care by providing assessments and documentation for the care of a pressure ulcer and excoriated skin. This failure had the potential to cause further skin problems, malnutrition, lethargy, and even death. (Refer to A 0395)

For any patient who had intensive care unit admission orders, the facility failed to provide registered nursing supervision of the patient's status and care by having a medication room that was away from the patient care unit (Refer to A 0395)

For Patient 62, the facility failed to reassess the patient for over-sedation or the effectiveness of the medication in a timely manner after a pain medication was administered. This failure had the potential to result in the patient being over sedated or not having their pain effectively managed to relieve suffering. (Refer to A 0395)

For Patient 62, the facility failed to assess the patient for location and level of pain prior to the administration of a pain medication. This failure had the potential to result in Patient 62 receiving unnecessary pain medication. (Refer to A 0395)

2. Ensure adequate numbers of licensed registered nurses were available to provide nursing care to all patients by failing to make adjustments for nursing staff absenteeism during lunch and breaks, resulting in the potential for patients not having their care needs met. (Refer to A 0392)

The facility also failed to ensure that they had the nursing staff necessary to ensure that continuous telemetry (heart) monitoring was being done for all patients that required the monitoring. This failure had the potential to cause a delay in recognition and treatment of abnormal heart rhythms up to and including heart rhythms that can cause death for all patient who require telemetry monitoring. (Refer to A-392)

3. Ensure that each patient had a care plan that addressed the patient's care needs and that the care plan was kept current for 4 of 39 sampled patients (Patients 64, 78, 81, and 23). The failures were as follows:

For Patient 64, the facility nursing staff failed to develop a care plan to direct how to care for the patient when she refused cares, medication and food. The failure had the potential to result in the patient developing complications such as malnutrition or worsening of the symptoms that the medication was treating. (Refer to A 0396)

For Patient 64, the nursing staff failed to ensure the care plan had goals for the use of restraints, with the potential of the patient being restrained longer than necessary. (Refer to A 0396)

For Patient 78, the nursing staff failed to develop a care plan for skin breakdown prevention with the potential for the patient to develop pressure sores. (Refer to A 0396)

For patient 81, the nursing staff failed to develop a care plan for the use of restraints, with the potential of the patient being put in unnecessary restraints or being in restraints longer than necessary. (Refer to A 0396)

For Patient 23, the nursing staff failed to keep the plan of care current by re-assessing the patient's respiratory status, when the patient developed early signs of respiratory distress. This failure had the potential for the patient's respiratory status to deteriorate further and result in the need for a higher level of care. (Refer to A-396)

4. Ensure that Emergency Department (ED) required the equivalent competencies for RNs as those required in the Intensive Care Unit (ICU) to ensure that ED nurses were competent to care for ICU patients. This failure had the potential for critically ill patients to not receive the care necessary to promote their physical well-being. This failure had the potential for continuous powerful intravenous (IV) medications to be given incorrectly which could lead to the patient becoming more ill and could even cause the patient ' s death. (Refer to (A-397)

5. Ensure that the PACU nurses monitored the medication refrigerator in order to maintain medications within the required temperature parameters. This created the risk of PACU patients receiving frozen or inactive medications. (Refer to A-404)

The cumulative effect of these systemic problems resulted in the facility's failure to deliver patient care in a safe manner and in compliance with the Condition of Participation for Nursing Services.

Based on observation, interview, and record review, the facility failed to ensure adequate numbers of licensed registered nurses were available to provide nursing care to a universe of 314 patients, by failing to make adjustments for nursing staff absenteeism during lunch and breaks, resulting in the potential for patients not having their care needs met.

The facility also failed to ensure that they had the nursing staff necessary to ensure that continuous telemetry (heart) monitoring was being done for all patients that required the monitoring. This failure had the potential to cause a delay in recognition and treatment of abnormal heart rhythms up to and including heart rhythms that can cause death for all patient who require telemetry monitoring.

For Patient 21, who was amitted with a sacral ulcer, the wound care nurse failed to provide a consultation within 48 hours, resulting in inadequate care of his wound.


Findings:

1. On 3/15/10 an initial tour of the facility was conducted, beginning at 3:00 PM. Observation on the telemetry (heart monitoring) units, 2 East and 4 East, showed that some patients on these floors required continuous telemetry monitoring.

An interview was conducted with the charge nurse, Staff nurse B, on 3/15/10 at 3:00 PM. The charge nurse stated the telemetry units have the capability of having 16 of 34 patients being monitored for abnormal heart rhythms. The charge nurse was asked how staff assignments were determined.


22233

2. On initial observation of the medical unit on 3/15/10 at 3 PM, 2 East of the facility it was noted that there were telemetry (heart) monitors on the unit. There was no one watching the patients' cardiac monitors. It was further observed that there were 13 patients being monitored, and the unit had a total of 31 patients.

An interview was conducted with the charge nurse of the unit, Staff RN A, at the same time. She stated that no one watches the telemetry continuously. She stated that each nurse has a beeper that alarms when the heart monitors alarm. The nurse is responsible to answer the alarm and check the patient. She stated that a nurse can be responsible for up to 4 patients with heart monitors.

The beepers were observed at this time. The beepers had a read out that told the nurse what the telemetry alarm said; there was no rhythm for the nurse to look at remotely.

Further observation of the unit revealed that there were 10 patients in isolation. The charge nurse confirmed that when a patient was in isolation, the nurse may have to put on a gown, gloves, and mask before entering the room. She stated the nurse would have to take off all of the isolation gear and wash her hands before being able to see what type of heart problem the patient was having. She confirmed that this would take several minutes to do and that a patient having a problem with their heart would have to wait. She stated that all the nurses help each other, so someone else would probably answer the patient's alarm. She confirmed that for a patient having a problem with their heart, this could be a long wait time and could delay the patient's treatment.

A review of the nursing assignment sheets for the unit on 3/15/10 revealed that there were 3 nurses that had 2 telemetry patients and 2 isolation patients. There were also 2 nurses that had 2 telemetry patients and 1 isolation patient.

The nurse manager (NM) of the unit was present during the interview and confirmed the process for telemetry monitoring. She confirmed that the all the patients on telemetry monitoring would have a physician's order for telemetry monitoring and the expectation for the monitoring would be "continuous". She stated that all of the units in the facility that offered telemetry monitoring were done in this manner.

A review of the facility's policy for Telemetry monitoring, dated 1/09, revealed the following purpose for the policy, "To provide continuous cardiac monitoring via telemetry for the purpose of diagnostic information, treatment and documentation of dysrhythmias (abnormal heart rhythm).

An interview was conducted with the Nurse Executive (NE), the Nurse Manger (NM) of medical/surgical services, and the Associate Hospital Administrator (AHA) on 3/17/10 at 1 PM. They acknowledged that the process for telemetry monitoring utilized a beeper system with no actual viewing of the patient's heart rhythm. They stated that the telemetry monitoring was the same in all the units of the facility that had telemetry capability, that would include all of their medical/surgical units and step down (from intensive care) units.

The NE stated that the facility had not done any studies on the particular type of telemetry monitoring to determine if the monitor picked up on all of the abnormal rhythms that a patient had or if the machine was correct in determining the patient's heart rhythm. She stated that they had not done studies to check nurse response time to the telemetry alarms.

The NE and the NM acknowledged that a nurse could have 4 patients on telemetry monitoring and have isolation patients and that it would be difficult to answer the alarms. They also stated that when a nurse was on lunch break, she gives her beeper to another nurse. This gave a nurse the responsibility to answer the alarms of up to 8 patients. The NM acknowledged that a nurse could miss (or delay in recognizing) a heart problem, that could have been identified by having someone watch the telemetry monitors.








26881

3. On 3/23/10 the medical record of Patient 21 was reviewed. According to the admission assessments, the patient was admitted with a stage III sacral ulcer, and also had a stage III sacral ulcer upon discharge. He arrived on the hospital floor on 12/23/09 at 4:14 PM, and according to nursing notes in the electronic medical record, a non-powered mattress was ordered for him and a Mepelex foam dressing was put in place. The nurse measured the wound on 12/23/09 and a wound care consultation was ordered on 12/23/09. The wound was measured again on 12/28/09, but there was no documentation that it was measured thereafter.

During an interview with Risk Management Staff 1 at 10:55 AM, she stated that the documentation indicated that the patient was placed on a non powered redistribution mattress initially, which she stated was the Accumax, the facility ' s regular mattress. She stated that was not the correct mattress for a patient with a grade III pressure ulcer. Patient 21's medical record read that the first time the correct mattress was documented as in use was on 12/30/09, a week after arriving at the facility.

RN 23 was also asked to review the wound care policy for the correct dressing. She stated that according to the policy, Mepelex dressing was for a stage II, not a stage III wound.

RN 23 stated that a wound care consultation for Patient 21 was ordered on 12/23/09, but that she did not see the patient until 12/30/09. She stated that usually the wound care consultants needed to see the patients within 48 hours, but due to the holiday schedule, there was no wound care nurse available to see the patient sooner than 7 days after admission.

Based on interview and record review, the facility failed to ensure that a registered nurse evaluated the nursing care requirements for 3 of 33 sampled patients.

For Patient 80, the registered nurse failed to advocate for the safety of the patient when the patient had a medical emergency. This failure resulted in the patient not having closer cardiac and respiratory monitoring to be able to respond faster to the patient's change in condition.

For Patient 64, the facility failed to ensure that a registered nurse supervised and evaluated the nursing care of the patient's nutritional status by failing to ensure that the chain of command was followed for the patient with a very low nutritional intake. They also failed to ensure that nursing supervised and evaluated the nursing care by providing assessments and documentation for the care of a pressure ulcer and excoriated skin. This failure had the potential to cause further skin problems, malnutrition, lethargy, and even death.

For any patient who had intensive care unit admission orders, the facility failed to provide registered nursing supervision of the patient's status and care by having a medication room that was away from the patient care unit.

For Patient 62, the facility failed to reassess the patient for over-sedation or the effectiveness of the medication in a timely manner after a pain medication was administered. This failure had the potential to result in the patient being over sedated or not having their pain effectively managed to relieve suffering.

For Patient 62, the facility failed to assess the patient for location and level of pain prior to the administration of a pain medication. This failure had the potential to result in Patient 62 receiving unnecessary pain medication.

The facility failed to ensure that a wound care nurse was available to evaluate and institute nursing interventions for one patient who was admitted with a stage III pressure ulcer, resulting in substandard wound care management for that patient.


Findings:

1. Complaint #CA00168717

Review on 3/18/10, of Patient 80's record, showed that rhe patient was 80 years of age, admitted to the facility on 6/17/08 with a diagnosis of hematuria (blood in the urine). The patient was treated for a urinary tract infection and had a high INR (a blood test to check the ability of the blood to clot-a high INR indicates the patient has a high risk of bleeding). Patient 80 had been on a blood thinner (Coumadin) at home.

Review of the nurses flowsheet notes dated 6/18/08 (the date was written on the nursing flowsheet before midnight) at 3:30 AM, the nurse documented that the patient was found unresponsive and slumped over in bed. The patient had no respirations (breathing), with a faint pulse, and no blood pressure. The Code Blue team (emergency response team) was called.

Review of the Patient Resuscitation Record dated 6/18/08 (according to other records in the patient record, the date should have been 6/19/08) at 3:32 AM, showed that the patient was slumped across bed with no respirations and a faint pulse. The vital signs (blood pressure, pulse, respirations) were recorded at 3:30 AM as blood pressure 0, pulse 0, and respirations were left blank. At. 3:40 AM the vital signs were: blood pressure 110/70 (normal 90-120/60-80), pulse 70 (normal 60-100), respirations 18 (normal 12-18). The patient outcome of the Code Blue was "Palpable (able to feel) pulse restored."

There was no documentation found in the record that Patient 80 was placed on cardiac and respiratory monitoring after the medical emergency. The community standard is to closely monitor a patient that had an episode of instability (the Code Blue), to be able to respond quickly to a change in the cardiac rhythm or any respiratory changes.

A review of the facility policy titled, Escalation Policy-Methodology for Resolving Questions Concerning Medical Care" dated 12/09, revealed that "Any member of the health care team who has a concern regarding patient safety is obliged to escalate (take up the chain of command) the issue until the concern is resolved."

Review of the second Patient Resuscitation Record dated 6/19/08 at 5:46 AM, showed that Patient 80 was unresponsive and was in cardiac arrest. The patient died at 6:30 AM.

In an interview on 3/23/10 at 3:00 PM with the Director of Quality, he agreed that if Patient 80 was placed on cardiac and respiratory monitoring after the first emergency, a cardiac rhythm disturbance or a decrease in breathing, leading to loss of consciousness and no vital signs may have been discovered earlier and allowed for a quicker response to the patient's change of condition.





22233

2 (a.) A review of the medical record for Patient 64 revealed that she was admitted to the facility on 2/19/10 with a chief complaint of confusion and agitation. Her medical history included dementia and diabetes mellitus.

A review of the patient's dietary intake was as follows:
(patient had 0 intake for other meals that are not noted)

2/21/10, 6 PM - 85%
2/22/10, 7:50 AM - 5%, 6 PM - 100%
2/23/10, 8 AM -95%, 1 PM - 100%
2/24/10, 12:30 PM - 50%, 6 PM - 90%
2/25/10, 2:25 PM - 70%
2/26/10, 0%
2/27/10, 0%
2/28/10, 12:30 PM - 98%, 6 PM - 50%
3/1/10, 9:30 AM 60%
3/2/10, 0%
3/3/10, 0%
3/4/10, 7:30 PM - 100%
3/5/10, 0%
3/6/10, 0%
3/7/10, 6 PM - 5%
3/8/10, 0%
3/9/10, 0%
3/10/10, 0%
3/11/10, 0%
3/12/10, 0%
3/13/10, glycotrol (tube feeding) given, not documented how much
3/14/10, 0%
3/15/10, 8 PM - 100%

A review of the weights documented for Patient 64 were as follows:

No admission weight was documented
3/4/10, 115 pounds
3/5/10, 119 pounds
No further weights were documented at the review date of 3/16/10

A review of the Registered Dietitian (RD) notes revealed that the patient was seen on 2/24/10 and assessed as a "moderate risk" for dietary problems. The patient was seen again on 3/4/10, 3/8/10, 3/10/10, and 3/14/10. On 3/10/10 and 3/14/10, there were notes from the RD regarding a tube feeding that the RD documented the patient was receiving. On 3/14/10 the RD documented that a discussion was held with the Registered Nurse (RN) regarding weight orders. There was no other documented discussion with nursing regarding this patient's nutritional status.

A review of the nurse's narrative notes from admission until review on 3/16/10 revealed no discussion with the RD or with the physician regarding a plan for the patient's nutritional needs. There were notes describing a nasogastric (feeding tube) being placed and a smaller feeding tube being placed; however, the patient pulled out these tubes. A nurses documentation on 3/10/10 at 11:23 PM revealed, "tried to insert ng tube (feeding tube through the nose) pt (patient) agitated and said 'it hurt'. also noticed blood from her nostril"

The documentation on the patient's dietary intake revealed that the patient received nutrition through the tube on one day, 3/13/10.

The medical record review of the nutritional intake, RD notes, and weights was confirmed by Administrative Staff RN A on 3/16/10 at 11:30 AM.

An interview was conducted with the charge nurse (Staff RN A) on the unit that the patient was placed on 3/15/10 at 3 :30 PM. Staff RN A stated that the patient often refuses cares, medications, and food. She stated that the physician for the patient did not want another feeding tube placed. She stated that the plan for the patient was to send her home on hospice care; however, the family had not agreed to hospice at this time.

A review was conducted of the patient's plan of care with Staff RN A and the Nursing Director of the unit on 3/15/10 at 3:40 PM. There was no care plan to direct the nursing staff on how to care for the patient when she refused cares, medication, and food. The accompanying staff acknowledged that there was no care plan developed and that a nursing plan may have helped the staff care for this patient.

On 3/17/10 at 11 AM an interview was conducted with Staff RN B who was taking care of Patient 64. She stated that the nursing plan for the patient's poor nutritional intake was to wait until the afternoon when the patient's daughter comes in. She stated that sometimes the patient will eat for the daughter.

A review of the facility policy titled, Escalation Policy -Methodology for Resolving Questions Concerning Medical Care" dated 12/09, revealed that "Any member of the health care team who has a concern regarding patient safety is obliged to escalate (take up the chain of command) the issue until the concern is resolved."

On 3/23/10 at 2 PM the medical record was reviewed with Administrative Staff RN B. She confirmed that the nursing documentation did not contain any reference a discussion between the RD or the physician and the RN about a plan for the continuing low nutritional intake. Administrative Staff RN B also confirmed that there was no documentation regarding nursing following the chain of command regarding the lack of nutrition for Patient 64. She confirmed that this event was serious enough for the patient that nursing staff should have followed the facility's escalation policy to see what other interventions could have helped the patient.

2 (b). A Review of the medical record for Patient 64 revealed a picture taken on 3/1/10 of a Stage 11 pressure ulcer on the patient's right buttocks.

A review of the notes revealed an assessment conducted by the wound care consultant on 3/1/10. The wound was described as a Stage 11 ulcer measuring approximately 1 x 2 centimeters.

Further review revealed another picture taken on 3/3/10 of the same area. Review of the nurse's notes from 3/3/10 revealed no description of the wound, a picture taken, and no measurements for this date.

There was no further documentation on the pressure ulcer. There was no follow up by the wound care nurse documented.

Another picture taken on 3/10/10, it revealed a large area from the buttock to the lower back that was excoriated. The documentation that was with the picture read, "Moisture induced excoriation."

A review of the facility policy, titled "Pressure Ulcer Assessment and Management", dated 7/08, revealed that "Each wound will be assessed at the time of dressing change and findings documented in the medical record." The policy further listed the following requirements for documentation:

Time assessed, Location, Stage, Measurements, Appearance, Drainage and/or odor, Periwound (around the wound) skin assessment, and any change in pain level associated with the ulcer.

On 3/17/10 at 11 AM an interview was conducted with Staff RN B who was taking care of Patient 64. She confirmed that there was no further documentation regarding the pressure ulcer and no follow up by the wound care nurse. Staff RN B confirmed that the nursing documentation did not follow hospital policy. She stated that now the area appears to be a large area that is excoriated (red, raw skin) from being wet. She stated that the pressure ulcer was not apparent at this time. The RN confirmed that it was difficult to tell if the pressure ulcer was still there and hidden by the area of excoriation.

On observation of the area was conducted on 3/17/10 at 12:20 PM with Staff RN B. The area appeared smaller than in the picture taken 7 days prior and was over the patient's buttock and 2 inches up the back. The area was still red. Staff RN B confirmed that it was still difficult to tell if the pressure ulcer was still hidden by the area of excoriation.

3. An observation was conducted of the Emergency Department (ED) on 3/16/10 at 11 AM. Observation revealed that there were 4 patients that had intensive care unit (ICU) admission orders being taken care of in an area superficially designed for ICU bed hold patients in the ED. Further observation revealed an RN, who was taking care of 2 ICU patients, went out of the unit and down a hall (approximately 20 feet) to a room where the door closed behind him. There was no one watching the heart monitors at the desk. There was another RN in the unit; however, she was behind a curtain taking care of another patient.

An interview was conducted with the charge nurse of the unit, EDRN 1 at the same time. She stated that the room was the medication room. She stated that anytime the patient needed medications (other than a code blue, heart or breathing stopped), the nurses had to leave the room with patients and get the medications. She confirmed that a nurse in the medication room could not observe or hear what was happening in the patient care unit. She stated that the other nurse could watch all the patients. She was asked if the facility had a procedure where the nurses alerted each other when they were out of the unit and she stated that they did not. She stated that the ED frequently had patients that were in this area awaiting an ICU bed. She confirmed that the practice of leaving the unit for medications happened many times during each shift and that each time the patients were not being monitored during this time.



25629

4 (a). The clinical record for Patient 62 was reviewed on 3/18/10 at 8:50 AM with the Clinical Director of Maternal and Child Department (CDMC). The clinical record indicated that Patient 62 was a 6year old male admitted to the facility, on 2/27/10 with a diagnosis of status post appendectomy for perforated (ruptured) appendicitis.

Review of the "Pediatric Hospital Admission History and Physical" dated 2/27/10, indicated that patient 62 had a laparoscopic appendectomy at another facility on 2/25/10.

Review of the physician's orders for Patient 62 indicated that the patient had an order for Tylenol with Codeine 120-12mg (milligrams)/5 ml (milliliters) oral elixir with an administration dose of dose12mg=5ml, to be taken by mouth every four hours as need for mild pain (a pain scale of 1-3), or moderate pain (a pain scale of 1-4).

During an interview with the CDMC on 3/18/10 at 9:15 AM, the CDMC stated that the licensed staff had used the FLACC with Patient 62 because of his medical history of autism. ( The FLACC [Face, Legs, Activity, Cry, Consolability] scale is a behavioral pain scale used with non-verbal patients unable to verbally report pain, total pain score total is between 0 and 10. This pain scale is used for pediatric patients, cognitively impaired patients, and those unable to verbally report pain.)

Review of Patient 62's "Flow sheet Data" reports, that documented the patient's pain assessments, and review of Patient 62's Medication Administration Records (MARs) dated 2/28/10 to 3/17/10 revealed the following information.

On 2/28/10 at 1828 (6:28 PM), Patient 62's pain level was assessed at 5 on a 0-10 score. There was no documentation of the location or the source of the patient's pain. Patient 62 was medicated with 5 ml of Tylenol with Codeine at 6:28 PM. The patient was not reassessed for over-sedation or the effectiveness of the medication until 2008 (8:08 PM), which is does not met the time frame of 30 to 60 minutes.

On 3/1/10 at 9:32 AM Patient 62's pain level was assessed at 4 on a 0-10 pain score, the patient was medicated with Tylenol with Codeine at 9:32 AM in the morning, and was not reassessed for the effectiveness of the medication. There is no documented evidence that Patient 62 was reassessed for over-sedation or the effectiveness of the medication.

On 3/2/10 at 12:35 AM, Patient 62's pain level was assessed at 5 on a 0-10 pain score, the patient was medicated with Tylenol with Codeine at 12:41 AM. There is no documented evidence that Patient 62 was reassessed for over sedation or the effectiveness of the medication.

On 3/2/10 at 1359 (1:59 PM), Patient 62's pain level was assessed at 5 on a 0-10 score. There was no documentation of the location or the source of the patient's pain. Patient 62 was medicated with 5 ml of Tylenol with Codeine at 1:59 PM. There is no documented evidence that Patient 62 was reassessed for over-sedation or the effectiveness of the medication.

On 3/12/10 at 2136 (9:36 PM), Patient 62's pain level was assessed at 5 on a 0-10 pain score. There was no documentation of the location or the source of the patient's pain.
Patient 62 was medicated with 5ml of Tylenol with Codeine at 9.36 PM. There is no documented evidence that Patient 62 was reassessed for over sedation or the effectiveness of the medication.

On 3/4/10 at 12:00 PM, Patient 62's pain level was assessed at 0 (having no pain) on a 0-10 pain score, and the MAR indicates that the patient was medicated with 5 ml of Tylenol with Codeine at 12:00 PM even though the patient had been assessed as having 0 (no) pain. There is no documented evidence that Patient 62 was reassessed for over sedation after the medication was administered.


Review of the facility policy and procedure titled, " Pain Assessment Documentation " dated 08/08 indicated the following:

" 2. Comprehensive pain assessments will include patient ' s acceptable pain level, current pain level, source, location and intervention " .


Review of the facility policy and procedure titled, "Pain Management" dated 12/09, indicated the following:

"3. Patients will be assessed and reassessed at appropriate interval for the prevention and management of opioid induced side effects which may include, but not limited to:"

"4. Alteration of mental status, respiratory depression, nausea, vomiting, purities and constipation."

"6. Patients will have their pain assessed and /or self-reported:
6.1 On admission
6.2 At the time routine vital signs are taken
6.3 Prior to the initiation of patient controlled analgesia
6.4 Following an intervention (30-60 minutes is suggested)
6.5 Until an acceptable level of pain is achieved, as defined by the patient, or the patient requests that there will be no further intervention."

During an interview with the CDMC on 3/18/10 at 10:30 AM, the CDMC verified that licensed staff had not reassessed Patient 62 for over sedation or the effectiveness of the Tylenol with Codeine each time the medication was administered. During the interview the CDMC stated that the licensed staff had not managed Patient 62's pain in accordance to the facility's policy in-order to evaluate the effectiveness of the intervention of the administration of medication.




4 (b). Review ofPatient 62's physician's orders indicated that the patient had an order for Tylenol with Codeine 120-12mg (milligrams)/5 ml (milliliters) oral elixir with an administration dose of dose12mg=5ml, to be taken by mouth every four hours as need for mild pain (a pain scale of 1-3), or moderate pain (a pain scale of 1-4).

During an interview with the CDMC on 3/18/10 at 9:15 AM, the CDMC stated that the licensed staff had used the FLACC with Patient 62 because of his medical history of autism. ( The FLACC [Face, Legs, Activity, Cry, Consolability] scale is a behavioral pain scale used with non-verbal patients unable to verbally report pain, total pain score total is between 0 and 10. This pain scale is used for pediatric patients, cognitively impaired patients, and those unable to verbally report pain.)

Review of Patient 62's clinical record indicated that Patient 62 had been administered 5 ml of Tylenol with Codeine on the following dates and times without having been assessed for level, and location of pain, prior to or after the administration of the medication.

3/2/10 at 10:14 PM,
3/3/10 at 5:53AM and 3:33 PM
3/6/10 at 12:00 PM,
3/7/10 at 10:38 PM,
3/8/10 at 8:03 PM,
3/09/10 at 2:35 AM and 6:05 AM

There was no documented evidence in the clinical record that indicated that Patient 62 had been assessed for level, and location of pain, prior to or after the administration of the medication on the above listed dates and times.

Review of the facility policy and procedure titled, "Pain Management" dated 12/09, indicated the following:

"4. Pain will be assessed prior to the initiation of any pain management intervention."

During an interview with the CDMC on 3/18/10 at 10:30 AM, the CDMC verified that the clinical record indicated that Patient 62 been administered Tylenol with codeine without first having been assessed for level, and location of pain, prior to or after the administration of the medication. During the interview the CDMC stated that the licensed staff had not managed Patient 62 ' s pain in accordance to the facility ' s policy in-order to evaluate the effectiveness of the intervention of the administration of medication and to ensure that the patient did not receive unnecessary medications.




26881

5. On 3/23/10 the medical record of Patient 21 was reviewed. According to the admission assessments, the patient was admitted with a stage III sacral ulcer, and also had a stage III sacral ulcer upon discharge. He arrived on the hospital floor on 12/23 at 4:14 PM, and a non-powered mattress was ordered for him and a Mepelex foam dressing was put in place. The nurse measured the wound on 12/23 and a wound care consultation was ordered. The wound was measured again on 12/28, but not thereafter.

During an interview with Risk Management Staff 1 on 3/23/10 at 10:20 AM, she stated that mattresses were selected by the nursing staff according to a mattress selection algorithm.

During a second interview with Risk Management Staff 1 at 10:55, she stated that the documentation indicated that the patient was placed on a non powered redistribution mattress initially, which she stated was the Accumax, the facility ' s regular mattress. She stated that was not the correct mattress for a patient with a grade III pressure ulcer. She concurred that the first time the correct mattress was documented as in use was on 12/30/09, a week after Patient 21's arrival at the facility.

RN 23, a wound care consultant, was interviewed on 3/23/10 at 11:15 AM, and she stated that the correct mattress choice for a patient with a stage III ulcer would have been a low airloss mattress. RN 23 was also asked to review the wound care policy for the correct dressing. She stated that according to the policy, Mepelex dressing was for a stage II, not a stage III wound.

Based on observation, interview, and record review the facility failed to ensure that each patient had a care plan that addressed the patient's care needs and that the care plan was kept current for 4 of 33 sampled patients (Patients 64, 78, 81, and 23). The failures are as follows:

For Patient 64, the facility nursing staff failed to develop a care plan to direct how to care for the patient when she refused cares, medication and food. The failure had the potential to result in the patient developing complications such as malnutrition or worsening of the symptoms that the medication was treating.

For Patient 64, the nursing staff failed to ensure the care plan had goals for the use of restraints, with the potential of the patient being restrained longer than necessary.

For Patient 78, the nursing staff failed to develop a care plan for skin breakdown prevention with the potential for the patient to develop pressure sores.

For patient 81, the nursing staff failed to develop a care plan for the use of restraints, with the potential of the patient being put in unnecessary restraints or being in restraints longer than necessary.

For Patient 23, the nursing staff failed to keep the plan of care current by re-assessing the patient's respiratory status, when the patient developed early signs of respiratory distress. This failure had the potential for the patient's respiratory status to deteriorate further and resulted in the need for a higher level of care.

Findings:
1 (a). A review of the medical record for Patient 64 revealed that she was admitted to the facility on 2/19/10 (review started on 2/21/10) with a chief complaint of confusion and agitation. Her medical h included dementia and diabetes mellitus.

A review of the patient ' s dietary intake revealed that there were 12 days during her hospitalization from 2/19/10 (review started on 2/21/10) through 3/18/10 where she had no nutritional intake. Review of the other days during her stay revealed 6 days with only one meal documented, 1 day with a tube feeding documented, and 4 days with 2 meals documented. There were 0 days with 3 meals documented.

An interview was conducted with the charge nurse (Staff RN A) on the unit that the patient was placed on 3/15/10 at 3:30 PM. Staff RN A stated that the patient often refuses cares, medications, and food. She stated that physician for the patient did not want another feeding tube placed. She stated that the plan for the patient was to send her home on hospice care; however, the family had not agreed to hospice at this time.

A review was conducted of the patient plan of care with Staff RN A and the Nursing Director of the unit on 3/15/10 at 3:40 PM. There was no care plan to direct the nursing staff on how to care for the patient when she refused cares, medication and food. The accompanying staff acknowledged that there was no care plan developed and that a nursing plan may have helped the staff care for this patient.

1 (b). A review of the medical record for Patient 64 revealed that the care plan for restraints did not include goals for the patient. (A nursing care plan includes a problem, goals, interventions, and evaluation.)

A review was conducted of the patient ' s plan of care with Staff RN A and the Nursing Director of the unit on 3/15/10 at 3:40 PM. The facility staff acknowledged that the plan of care for Patient 64 requiring restraints did not include goals. They confirmed that the reason that goals were important was to help the nurses plan for the patient ' s needs to prevent problems associated with restraints usage and to reduce the amount of time that restraints were required.



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2. Review on 3/17/10, of Patient 78's record, showed that the patient was 92 years of age and admitted to the facility on 3/13/10 with diagnoses that included acute myocardial infarction (heart attack), and pneumonia.

Review of the emergency department physician admission note dated 3/13/10, showed that Patient 78 had a decubitus ulcer (bedsore or skin breakdown) Stage 1 (reddened skin, non- blanchable) on buttocks.

There was no care plan found in the record for skin breakdown prevention.

In an interview on 3/17/10 at 11:15 AM with Administrative Staff RN C, she acknowledged that there should have been a care plan developed for skin breakdown prevention for Patient 78.

3. Review on 3/18/10, of Patient 81's record showed that Patient 81 was 72 years of age and admitted to the facility on 3/14/10 with a diagnosis that included a bleed into the brain. Patient 81 was described as agitated and restless, pulling at lines and tubes.

Review of Patient 81's nursing care plan showed that there was no care plan developed for the use of restraints.

In an interview on 3/18/10 at 3:25 PM, with Administrative Staff RN A, she acknowledged that there should have been a care plan for restraints for Patient 81.



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4. Patient 23 was an inpatient who experienced a drop in oxygen saturation. The nursing documentation indicated a drop from over 90% to 80% saturation on 2/16/10 at 2:44 PM. There was no follow-up documentation of oxygen saturation until 5:24 PM.

At 5:24 PM, the nurse note read in part, " Patient ' s VS is stable " . However at 5:31 the patient was breathing at 28, and at 4:25 the physician noted the patient was in respiratory distress and ordered the rapid response team, which documented the patient as " tachypnic " at 4:33 and the physician ordered transfer of the patient for a higher level of care.

During an interview with RN 25, on 3/17/10 at 1:30 PM, she stated that the patient should have been reassessed in a timely manner and the reassessment documented by the nurse.

Based on interview and record review the facility failed to ensure that Emergency Department (ED) required the equivalent competencies for RNs as those required in the Intensive Care Unit (ICU) to ensure that ED nurses were competent to care for ICU patients. This failure had the potential for critically ill patients to not receive the cares necessary to promote their physical well-being. This failure had the potential for continuous powerful intravenous (IV) medications to be given incorrectly which could lead to the patient becoming more ill and could even cause the patient's death.

Findings:

Observation on 3/16/10 at 11 AM in the ED revealed 4 patients in the area designated for patients requiring intensive care to be held until a bed becomes available. The 4 patients had admission order for ICU and they were being cared for by ED nurses.

An interview was conducted with the ED charge nurse ENRN 1 on 3/16/10 at 11:10 AM. She stated that ED nurses were randomly assigned to care for the ICU patients. She stated that ED nurses did not have any special competencies to care for the ICU patients. EDRN 1 stated that the facility tried to keep to the 1 nurse to 2 patients staffing that was required for ICU; however, they were not always able to maintain that ratio. She stated that on this day they did meet the ratio.

ON 3/22/10 at 2 PM a review of the competencies that are required for ICU nurses and the competencies required for ED nurses was conducted with the Nurse Educator from ED. The following examples of areas of competencies for ICU nurses were not required for ED nurses were identified:

Titrates vasoactive drugs safely (Vasoactive drugs that are given by IV are very potent and can cause severe, unwanted, changes in blood pressure and heart rate if not titrated {increased or decreased} properly.

Infuses and monitors titratable drugs safely.

Manages central and arterial lines safely (specialized IV lines and monitoring lines).

Identifies normal and abnormal hemodynamic waveforms (specialized monitoring lines).

Temporary transvenous pacemaker (short term heart pacemaker).

Monitor and manage patients requiring mechanical ventilation (artificial breathing) and endotracheal tubes (tubes placed into the lungs for mechanical ventilation).

Performs oral care for patients with endotracheal tubes (very important to help stop ventilator acquired infection).

Monitor and manage patients with chest tubes, and Critical care level of nursing assessment for body systems including the heart, lungs, kidneys, and digestive systems.

In the same interview the Nurse Educator stated that it was difficult for the ED nurses to take care of ICU patients because they were not specially trained and the usual process of care was different in the ICU and the ED. She stated that the ED nurses do the best job that they can; however they are not trained as ICU nurses. She confirmed that a patient can be held in the ED waiting for an ICU bed for up to 2 days.

A review of the 4 ICU patients who were being cared for in the ED was conducted on 3/23/10 at 8:30 AM with Administrative Staff RN B. Review of the medical records were as follows:

Patient 66 was admitted to the facility on 3/15/10 at 6:50 PM as an ICU patient in the ED. He remained in the ED until transfer to ICU on 3/17/10 at 3:44 PM. During the time he required 2 medications, Dobutamine and Phenylephrine, that were both powerful, titratable, IV medications.

Patient 65 was admitted to the facility on 3/16/10 at 5:56 AM as an ICU patient in the ED. He remained in the ED until transfer to ICU on 3/16/10 at 4:40 PM. The Patient required an Amiodarone drip (this medication is not titrated frequently, but works on the heart and requires intensive monitoring). The patient also required mechanical ventilation.

Patient 67 was admitted to the facility on 3/15/10 at 10:10 PM as an ICU patient in the ED until transfer to ICU on 3/17/10 at 3:25 AM. The patient required the IV medication Dopamine as a continuous infusion, a very potent medication that required titration and was on mechanical ventilation.

Patient 68 was admitted to the facility on 3/15/10 at 8:31 PM as an ICU patient in the ED. He remained in the ED until transfer to ICU on 3/16/10 at 11:54 AM. The patient required a nitroglycerin IV drip, that was titratable.

In an interview, at the same time as review of the records, Administrative Staff RN B Acknowledged that these 4 patients required specialized ICU monitoring and that they were being taken care of by ED nurses who did not have the competencies to meet all of the patient's needs.

Based on observation, interview and record review the facility failed to ensure that the PACU nurses monitored the medication refrigerator in order to maintain medications within the required temperature parameters. This created the risk of PACU patients receiving frozen or inactive medications.

Findings:

During a tour of the fourth floor PACU on 3/15/10 at 3:30 PM, the medication refrigerator temperature log contained temperatures out of range on 28 of 51 days recorded in 2010, and down to 32 degrees on multiple occasions. There was no evidence that the temperature had been rechecked on those dates. The refrigerator contained liquid medications, including Ancef 2g/100ml and 5% dextrose solution and Diltiazem Hcl 25m/5ml.

According to the directive written on the log, " acceptable ranges are as follows: Medications Refrigerator 36 degrees to 46 degress F. " The log also directed, " If temperature is outside of range recheck temperature in 20 minutes, if still outside of range then notify your manager, Pharmacy and Engineering Department to correct " .

RN 21 stated that the refrigerator temperature was to be checked by the first person in for the day, and she was one of the staff members who checked the refrigerator temperature. When asked the temperature that it should be, she stated it should be between 34 and 40 degrees. When asked what she did if the temperature was out of range, RN 21 stated she that she was adjusting and rechecking the temperature, and she did not notify the pharmacy or engineering or check to see if the liquid medications were frozen.

The facility policy, Refrigerator or Freezer Temperatures, reviewed on 3/16/10, indicated that the medication refrigerator temperature range was 36-46 degrees F, and if outside of that range it should be rechecked with 20 minutes and reported to Pharmacy, Plant Services and the Nursing Manager if still out of range.

RN 22, the department manager was interviewed on 3/15/10 at 3:30 PM. He stated that he had not been informed of the problem with the medication refrigerator temperatures.

Based on observation, interview and record review, the facility failed to create , store and rapidly retrieve a complete and accurate medical record because of limitations in the EMR system and its implementation including:

1. Outdated order entry sets remained available for use, but the orders did not promulgate through the system to the service provider.
2. Equipment used for the electronic medical records was subject to recurrent failure, resulting in interruption of medical record information retrieval and data input and the loss of input data.
3. Locations of order and other records in the system have not been standardized for rapid retrieval.
4. Terminology available in the EMR system did not match that in facility policies.

1. During a review of the medical record of Patient 1 on 3/23/10, on order for wound care therapy was seen in the EMR but there was no documentation that the order was carried out. During an interview with EMR consultant 1 on 3/24/10 at 10:45 AM, she stated that the function for ordering wound care consultation had changed via an update from the corporate office. She stated that the physician had ordered the wound care using a older order function. The older order function was still available for use on the system, but when completed the order was not forwarded to the wound care consultant. Patient 1 was discharged without the benefit of a wound care consultation, and no effort had been made to arrange outpatient wound care because the wound care consultation order was missed.

2A. During an interview with Labor and Delivery nurse RN 26 on 3/23/10 at 2 PM, she stated that several areas of the department had poor reception for the EMR system, and that while she was charting, the information she was inputting would disappear. She stated that this occurred multiple times each shift. She stated that when she reported the problem to the supervisor, the it department was summoned and made a temporary correction of the problem, which would soon recur. She stated that the " crashing " problem with the EMR had existed for two years.

During an interview with RN 27 on 3/23/10 at 2:30 PM, she stated that in the NICU computers would freeze and shut down, but that data in the computer was not usually lost. She agreed that there was no problem with such " crashes " in the hard-wired computers, only in the mobile computers.

2B. During an attempted record review with RN 28, a nurse who did chart sudits for the QA department, on 3/18/10 at 10:15, she was unable to obtain access to a record of a discharged patient. RN 28 stated that she was surprised that she was unable to access the record. During her attempt, the computer froze and had to be " rebooted " .

3A. The safety scores given by Labor and Delivery staff to their own department was noted to be below 40% on an annual survey, reviewed on 3/23/10. During a discussion with the DON, she stated that she believed one cause for the scores was physician orders for cesarean sections were going into the EMR system in a different way than expected, and that the nurses could not see the orders to carry them out.

During an interview with MD 8, the co chair of the perinatal quality committee, on 3/23/10 at 8:45 AM, he was also asked the reason for the low safety scores in the Labor and Delivery department. Dr. Ruiz stated that the EMR navigation system was difficult to use , and that this contributed to the impression of poor safety.

3B. Patient 23 was an inpatient who experienced a drop in oxygen saturation. The nursing documentation indicated a drop from over 90% to 80% saturation on 2/16/10 at 2:44 PM. During interviews with the facility ' s designated Licensing and Accreditation staff member, and with RN 25 , on 3/17/10 at 1:15 and 1:30, they were unable, during a 30 minute search, to locate a reassessment of the oxygen saturation in the EMR prop to 5:31. Later in the afternoon, the designated Licensing and Accreditation staff Member provided a printout of a brief summary placed in the EMR by the nurse at 5:24 on 2/16/10 which included an oxygen saturation level. She stated that she had continued to search for the information and finally located it in a place she had not expected.

4. During an interview with RN 23 on 3/23/10 at 10:55 Am she stated that the EMR of Patient 21 listed that he was on a " low bed " , which did not appear to be a correct designation for use with that patient. She stated that the nurse may have intended " low bed " to mean " low airloss mattress " but the burse confused about how to document in the EMR. She stated that the specialty beds named in the algorithm for bed section were different from the beds name choices available in the EMR, and that disparity may have been a source of confusion.

Based in interview and record review the facility failed to ensure that all electronic physicians orders were communicated to the appropriate departments and or staff, to ensure that all patient care needs were met for 1 of 33 sampled patients (Patient 1) and for a universe of 343 inpatients.

For Patient 1 the facility failed to ensure a older order function for ordering wound care was not still available for use on the Electronic Medical Records System EMR [Health Connect System]), that resulted in a wound care order not being forwarded to the wound care consultant. This facility failure resulted in Patient 1 not receiving care for an unstagable (stage III of IV) wound, with black eschar (dead tissue) located on the coccyx (tail bone) area prior to discharge from the facility as ordered by the physician.

For a universe of 343 inpatients, the facility failed to ensure that all physician's orders processed via the EMR were forwarded to the appropriate departments and or consults, which had the potential to result in patient care needs not being met.

Findings:

1. The EMR clinical record for patient 1 was reviewed on 3/23/10 at 1:00 PM with Administrative Staff A. The clinical record indicated that Patient 1 was a 76 year old female admitted to the facility on 3/15/10 with a diagnosis of subdural hematoma. Patient 1 was discharged home on 3/16/10 after a hematoma evacucation.

Review of the "Multi-Discipline Progress Note dated 3/15/10 at 0421 (4:20 AM) indicated "received from Kaiser Riverside ER via ambulance, alert and oriented X 4 (times four) verbalized lives with son, appears cachectic, protruding bony prominence. 2.5 cm (centimeter) black eschar noted on coccyx area, linear black dry scabs on upper back and R (right) arm. Bil (on each side) heels with dry skin." The entry also indicated that pictures were taken of the coccyx area.

Review of the "Photographic Wound Documentation" dated 3/15/10, indicated that Patient 1 had a 2..5 cm x 2.5 cm unstagable wound (stage III or IV) with 2.5 cm (centimeter black eschar to the tail bone area.

Review of the physician's orders for Patient 1, indicated that the physician wrote an order for an "In Patient Wound Therapy Consult" on 3/15/10, but there was no documented evidence in the clinical record that Patient 1 had received a wound therapy consultation.

During an interview with Administrative Staff RN A on 3/23/10 at approximately 11:00 AM, Administrative Staff A verified that there was no documented evidence in the clinical record that inidicated that Patient 1 had been seen by the Wound Care Ostomy Nurse (WCON) prior to discharge on 3/16/10.

During an interview with the WCON on 3/23/10 at approximatelt 11:30 AM, the WCON stated that Patient 1's physician's order for an "In Patient Wound Therapy Consult" was not forwarded to her in-box by the EMR system. The WCON stated that the order had to read "Inpatient Skin Wound Consult" for the order to be forwarded to her in-box. The WCON stated that she did not evaluate Patient 1's wound prior to her discharge because she was unaware of the order for the consult. During the interview the WCON observed Patient 1's "Photographic Wound Documentation" dated 3//15/10. The WCON stated that based on the photographs, she wound have debrided (removal of dead skin) Patient 1's wound and recommended home follow up treatment for wound care. The WCON verified that Patient 1 had not received wound care based on her needs as ordered by the Physician, due to the fact that the EMR system did not forward the wound care consult to her.

During an interview with the Electronic Medical Records Consultant 1 (EMR Consultant 1) on 3/23/10 at 4:50 PM, the EMR Consultant 1, stated that the EMR system had monthly order changes and order set updates. The EMR consultant 1 stated that she is notified by email when there has been an update to the EMR system. The EMR Consultant 1 stated that she sends email out to all the physicians to notify them of the changes so that they can update their order list, because some of the providers will orders services form a saved "favorites" list that will not automatically be updated. The EMR Consultant 1 stated that she did not have system in place to verify that all physicians had acknowledged her email that change ordering services in the EMR system had occurred. During the interview the EMR Consultant 1 stated that "In Patient Wound Therapy Consult" to "Inpatient Skin Wound Consult" was an example of an order change that occurred within an order set. The EMR Consultant 1 stated that it was her responsibility to communicate to the physicians that a change in ordering wound care had occurred. She said that she believed she had received an email regarding the order change, but would have to check her records again to be certain. When asked if the facility has identified any other orders that were not bein forwarded to consultants or departments by the EMR system, the EMR Consultant 1 stated "no" . When asked if the facility has a system in place to identify other orders, that had the potential not to be carried out because they were not to be forwarded to consults or departments, due to an update in the EMR system the EMR Consultant 1 stated, "no" .

During an interview with Administrative Staff RN A on 3/23/10 at5:15 PM, Administrative Staff RN A stated that after a provider (physician) inputs an order, in Health Connect, it is accessible to licensed staff, who is required to acknowledge the order. Administrative Staff RN stated that the licensed staff is not required by policy to review the electronic medical record every 12 to 24 hours to ensure that all patient care orders have been carried out.

On 3/23/10 at 6:45 PM the Facility's executive staff was notified that that an Immediate Jeopardy had been identified, based on the fact that the facility had failed to ensure that electronic medical records system (EMR [Health Connect]) forwarded all physicians orders appropriated departments and or staff, to ensure that all patient care needs were met. The executive staff was also informed that facility had dialed to ensure that physician's order for a wound consult, processed via the Health Connect System, was forwarded to the appropriate staff which resulted in Patient 1 not receiving care for an unstagable (stage III or IV) wound, with black eschar (dead tissue) located on the coccyx (tail bone) area, prior to discharge from the facility. The executive staff was informed that the facility had also failed to identify any other orders that had the potential not to be forwarded to the appropriate consultant or department to ensure that all patient care needs were met and that the facility had no system in place to ensure that all patient care orders were carried out.

During an interview with EMR Consultant 1 on 3/24/10 at 10:45 AM, she stated that the function for ordering wound care consultation had changed via an update from the corporate office. She stated that the physician had ordered the wound care using a older order function. The older order function was still available for use on the system, but when completed the order as not forwarded to the wound care consultant. Patient 1 was discharged without the benefit of a wound care consultation and no effort had been made to arrange outpatient wound care because the wound care consultation order was missed.

EMR Consultant 1 stated that information about changed in the system were sent to her and EMR Consultant 2 and the "Nurse Champion" via email from the corporate office. EMR Consultant 1 stated that she was not sure if she had received information from the corporate office about the change in the order sets and the possibility of missed orders.

EMR Consultant 2 was interviewed on 3/24/20 at 10:45 AM. She stated that she did not receive written communication regarding the change in order sets and the possibility of missed orders.

During an interview on 3/24/10 at 11:15 with RN 5, the EMR "nurse champion" designated to assist nursing personnel with using the EMR system, she stated that she assumed that updates to the EMR system proceeded by the corporate office were tested and fully functional prior to arriving at the facility. She stated that generally there was no effort in the facility to test how well the system was functioning after an update. She stated that she believed the wound care order that did not transmit properly to the wound care consultant was an example of a system error that was missed by the EMR developers.

During an interview with Quality Committee members on 3/19/10 at 9:15, MD 2, the Physician Director of Quality, stated that the QA program did not separately track quality issues related to the EMR.

Based on interview and record review, for one patient in the cardiac catheterization laboratory, the record failed to contain evidence of a signed discharge order and a follow-up physician visit for a patient who experienced a post procedure complication, creating the risk of a poor health outcome for that patient.

Findings:

On 3/17/10 at approximately 11 AM the medical record of Patient 22 was reviewed. The chart included evidence of post-procedure bleeding documented by the nurse and by the physician in the procedure note, but no evidence of follow-up visit by the physician to reassess the patient following the bleeding, and no signed discharge order. During a concurrent interview with RN 24 from the cardiac catheterization laboratory recovery unit, she stated that a physician visit was required for cases with post-procedure complications and the physician visit and the discharge order should have been documented.

Based on record review and staff interview, the hospital failed to ensure that patient records contained documented evidence of physician follow-up on registered dietitian (RD) recommendations made in response to a nutrition consult request by a nurse for Patient 25. The hospital failed to have a system in place for the RD to know if the physician acknowledged a recommendation, or declined to implement.


Findings:

On 2/24/10 a nurse ordered a nutrition consult for Patient 25 due to "pt appears cachectic and has poor po (oral) intake."

On 3/19/10 at 12:25 P.M., Dietitian 26 stated that she had assessed the nutritional needs of Patient 25 on 2/24/10, and had recommended an oral nutrition supplement three times a day. Dietitian 26 stated that she paged the MD to obtain an order for the oral nutrition supplement on 3/4/10, since the MD had not ordered the nutrition supplement 7 days later. Dietitian 26 stated, "I'm surprised it took me 7 days to follow up, I usually do not wait that long. I guess I assumed the MD would order the supplement since the patient used to drink the supplement at home."

Patient 25's medical record indicated that on 3/8/10 Dietitian 26 recommended Vitamin C 500 mg daily. On 3/10/10, Dietitian 26 re-recommended Vitamin C 500 mg daily, and left a "Dear Doctor" note that indicated "Vit C 500 mg daily. Request updated prealbumin, daily Wt." On 3/19/10 at 12:30 P.M., Dietitian 26 stated that she did not know if MD read the recommendations or " Dear Doctor " note, or not. Dietitian 26 stated that as of 3/19/10, Vitamin C had not been ordered. Dietitian 26, and the Assistant Director of Patient Services, acknowledged that there was not a system in place for the dietitian ' s to know if the MD was aware of the recommendations and chose not to implement.

On 3/19/10 at 10:30 A.M., the Assistant Director of Patient Services stated that as a result of an internal audit that she conducted in 11/09, MD's carried out approximately 50% of the RD's recommendations for patient's based upon their assessed needs and medical status. She stated tht the 50% included those orders that were not fully implemented per RD's recommendations, but were partially carried out. She was not able to ascertain if the MD's read the nutrition recommendations, or what the root cause of the problem was.

A lack of a communication system in regard to results of consultative evaluations could delay in modifying nutrition intervention recommendations, as a result of time spent on repetitive recommendations, which could affect a patient's medical status.

Based on observation, interview and record review, the facility failed to ensure:

1. The PACU medication refrigerator was regulated to maintain medication within the required temperature parameters.

2. that the OR solution warmer was regulated to maintain solutions at the proper temperature.

3. That solutions stored in the warmer were correctly dated.

4. ER trauma room medications were secured. This created the risk of PACU patients receiving frozen or inactive medication and OR patients receiving solutions that were too warm or posed an infection hazard to patients due to being in the warmer for too long, and a risk of theft or unmonitored use of ER trauma room medications.

5. The facility to maintain a medication-storage refrigerator within the temperature range required to ensure stability of refrigerated drugs.

6. The Facility failed to ensure patient safety in accordance with pharmacy standards of practice when the facility allowed two conflicting oral analgesic order sets to appear concurrently on the Medication Administration Record (MAR). All together, three analgesic drugs were ordered with a total of five different doses for various levels of pain. The orders did not clearly indicate which specific level of pain.

Findings:

1. During a tour of the fourth floor PACU on 3/15/10 at 3:30 PM, the medication refrigerator temperature log contained temperatures out of range on 28 of 51 days recorded in 2010, and down to 32 degrees on multiple occasions. There was no evidence that the temperature had been rechecked on those dates. The refrigerator contained liquid medications, including Ancef 2g/100ml and 5% dextrose solution and Diltiazem Hcl 25mg/5ml.

According to the directive written on the log, "acceptable ranges are as follows: Medication Refrigerator 36 degrees to 46 degrees F. The log also directed, "If temperature is outside of range, recheck temperature in 20 minutes, if still outside of range then notify your manager, Pharmacy and Engineering Department to correct."

RN 21 stated that the refrigerator temperature was to be checked by the first person in for the day, and she was one of the staff members who checked the refrigerator temperature. When asked the temperature that it should be, she stated it should be between 34 and 40 degrees. When asked what she did if the temperature was out of range, RN 21 stated she that she was not adjusting and rechecking the temperature , and she did not notify the pharmacy or engineering or check to see if the liquid medications were frozen.

The facility policy, Refrigerator or Freezer Temperatures, reviewed on 3/16/10, indicated that the correct medication refrigerator temperature range was 36-46 degrees F.

2. During a tour of the OR sterile hallway area on 3/16/10 at 2 PM, a solution warming cabinet was noted to have the temperature 136 degrees F registered on the gauge outside the unit. The sign on the unit read, "max temperature is 115" . The documentation for the unit was reviewed, and no effort to report or correct the unit ' s temperature was seen. The facility policy, "Warmed Irrigation Solution" , revised 12/08, was reviewed on 3/16/10. The policy stated that solution cabinets should be kept at <114 degrees F, and that a higher temperature should be reported to the engineering department.

3. The solution warming cabinet was opened, and contained plastic containers of solutions. The label on one container of solutions. The label on one container of solutions read, " change Friday " and the date, "3/16" . The label on another container read, "change Thursday" and the date "3/18" . 3/16/10 was a Tuesday, and 3/18/10 was a Thursday. The policy, "warmed Irrigation Solution" revised 12/08 was reviewed on 3/16/10. The policy read that the solution containers should be labeled with a "72 hour change day and time."

4. During a tour of the ER trauma room on 3/16/10 at 8:35, the mediation cabinet was found unlocked and unattended. During a concurrent interview with RN 32, she stated that the cabinet should be locked


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5. On 3/16/10 at 3:05 PM the Neonatal Intensive Care Unit (NICU) Satellite Pharmacy refrigerator temperature log was observed and reviewed.

The following temperatures during January through March, 2010 were outside the required temperature range as noted on the refrigerator temperature log.

Date: Temperature:
January 5: 34 F
January 19: 34 F
January 25: 34 F
February 10: 32 F
March 1: 32 F
March 2: 34 F
March 13: 34 F
March 14: 32 F
March 15: 35 F

A review of California Code of Regulations, Title 22, 70263 (q)(6) indicated, "Drugs shall be stored at appropriate temperatures. Refrigerator temperature shall be between 2.2 C(36F) and 7.7 C (46 F) ... "

Out of 75 days during January through March when daily refrigerator temperatures were recorded, 9 daily refrigerator temperature were outside the temperature range required by the California Code of Regulations, Title 22. According to the Temperature Fail codes listed on the NICU Refrigerator Temperature Log, only 2 of the 9 errant temperatures were reported to the hospital ' s plant services or rechecked as required on the temperature log.

The Kaiser Permanente Medical Center Policy and Procedure for Medication Storage and Security indicates, "Medication storage and preparation areas throughout the Medical Center shall be under the supervision of the Inpatient Pharmacy Director or designee. Medications will be stored within the appropriate temperature ranges: refrigerator temperature will be between 2.2 C (36 F) and 7.7 C (46 F)."

On 3/16/10 at 3:10 PM, the IDOP and RPh1 were interviewed. They each acknowledged that the temperatures in the refrigerator had been outside the acceptable range on the specific days noted during January through March, 2010.

6. On 3/18/10 at 8:45 AM, the record of Patient 91 was reviewed.

The following order sets for the treatment of pain appeared on the Medication Administration Record (MAR) for Patient 91

Order written on 3/16/10 at 6:12 PM: Acetaminophen 650mg (milligrams) every 4 hours by mouth as needed for mild pain (1-3 on a pain scale of 0-10)

Order written on 3/16/10 at 6:12 PM, "Tylenol #3(acetaminophen 300 mg with Codeine 30mg) 1 tablet by mouth every 4 hours as needed for moderate pain (4-6 on a pain scale of 0-10)"

Order written on 3/16/10 at 6:12 PM, "Tylenol #3(acetaminophen 300 mg with Codeine 30mg) 1 tablet by mouth every 4 hours as needed for severe pain (7-10 on a pain scale 0-10)"

Order written on 3/17/10 at 5:27 PM, Vicodin 5-500 mg (hydrocodone-acetaminophen) 1 tablet by mouth every 6 hours as needed for mild pain (1-3 on a pain scale of 0-10)."

Order written on 3/17/10 at 5:27 PM, Vicodin 5-500 mg (hydrocodone-acetaminophen) 1 tablet by mouth every 6 hours as needed for moderate pain (4-6 on a pain scale of 0-10)."

a. There were two different medications ordered for mild pain (1-3 on pain scale of 0-10). The orders did not clearly specify how the nurse should choose between acetaminophen 650 mg and Vicodin 1 tablet for mild pain.

b. There were two different medication ordered for moderate pain(4-6 on a pain scale of 0-10). The Orders did not clearly specify how the nurse should choose between Tylenol #3 - 1 tablet, and Vicodin 2 tablets for moderate pain.

Lexicomp's Drug Reference Handbook was reviewed. According to this reference, acetaminophen is an analgesic (non-narcotic), used to treat mild to moderate pain. The combination of acetaminophen and codeine (Tylenol #3) is a narcotic analgesic for the treatment of mild to moderate pain. And, Lexicomp indicates the combination of acetaminophen and hydrocodone (vicodin) s a narcotic analgesic for the treatment of moderate to severe pain.

On 3/18/10 at 8:45 AM, the "Order Summary" for Patient 91 was reviewed . On the Order summary was a " Duplicate Therapy Alert" which calls to the pharmacist's attention that two different analgesics had been ordered for the same level of pain. The order summary also indicated that RPh3 reviewed the "Duplicate Therapy Alert" and overrode the alert on 3/17/10 at 5:36 PM. The reason for the override stated on the "Order Summary" was, "Benefits outweigh risks".

On 3/18/10 at 9 AM, RN 1 was interviewed. RN 1 stated that she believed there were two different order sets for pain because an anesthesiologist ordered pain medication when Patient 91 was transferred from the operating room to 4-East on 3/16/10. Later, a staff physician ordered additional pain medications on 3/17/10 after Patient 91 had been transferred to 4-East. The two different order sets for pain medication were in conflict.

On 3/18./10 at 9:10 AM, RN 2 was interviewed. RN2 stated that when Patient 91 indicated a need for pain medication, RN would make a decision on whether to use acetaminophen, Vicodin or Tylenol #3 based upon Patient 91's pain level and Patient 91's wants and needs. (the choices were Acetaminophen 650 mg versus Vicodin 1 tablet for mild pain; and Tylenol #3, 1 tablet versus Vicodin 2 tablets for moderate pain).

Based on observation, interview, and record review, the facility (1) failed to maintain a medication-storage refrigerator within the temperature range required to ensure stability of refrigerated drugs, and (2) failed to ensure patient safety in accordance with pharmacy standards of practice when the facility allowed two conflicting oral analgesic order sets to appear concurrently on the Medication Administration Record (MAR). All together, three analgesic drugs were ordered with a total of five different doses for various levels of pain. The orders did not clearly indicate which specific drug and dose should be used for each specific level of pain..

Findings:

1. On 3/16/10 at 3:05 P.M. the Neonatal Intensive Care Unit (NICU) Satellite Pharmacy refrigerator temperature log was observed and reviewed.

The following temperatures during January through March, 2010 were outside the required temperature range as noted on the refrigerator temperature log.

Date: Temperature:
January 5: 34? F
January 19 34? F
January 25 34? F
February 10 32? F
March 1 32? F
March 2 34? F
March 13 34? F
March 14 32? F
March 15 35? F



A review of California Code of Regulations, Title 22, 70263(q)(6) indicated, "Drugs shall be stored at appropriate temperatures. Refrigerator temperature shall be between 2.2?C (36?F) and 7.7?C (46?F) ..."

Out of 75 days during January through March when daily refrigerator temperatures were recorded, 9 daily refrigerator temperatures were outside the temperature range required by the California Code of Regulations, Title 22. According to the Temperature Fail codes listed on the NICU Refrigerator Temperature Log, only 2 of the 9 errant temperatures were reported to the hospital's plant services or rechecked as required on the temperature log.

The Kaiser Permanente Medical Center Policy and Procedure for Medication Storage and Security indicates, "Medication storage and preparation areas throughout the Medical Center shall be under the supervision of the Inpatient Pharmacy Director or designee. Medications will be stored within the appropriate temperature ranges: refrigerator temperature will be between 2.2? C (36? F) and 7.7? C (46? F)."

On 3/16/10 at 3:10 P.M., the IDOP and RPh1 were interviewed. They each acknowledged that the temperatures in the refrigerator had been outside the acceptable range on the specific days noted during January through March, 2010.



2. On 3/18/10 at 8:45 A.M., the record of Patient 91 was reviewed.

The following order sets for the treatment of pain appeared on the Medication Administration Record (MAR) for Patient 91:

Order written on 3/16/10 at 6:12 P.M.: Acetaminophen 650mg (milligrams) every 4 hours by mouth as needed for mild pain (1-3 on a pain scale of 0-10)

Order written on 3/16/10 at 6:12 P.M., "Tylenol #3 (acetaminophen 300mg with Codeine 30mg) 1 tablet by mouth every 4 hours as needed for moderate pain (4-6 on a pain scale of 0-10)"

Order written on 3/16/10 at 6:12 P.M., "Tylenol #3 (acetaminophen 300mg with Codeine 30mg) 2 tablets by mouth every 4 hours as needed for severe pain (7-10 on a pain scale of 0-10)"

Order written on 3/17/10 at 5:27 P.M., "Vicodin 5-500 mg (hydrocodone-acetaminophen) 1 tablet by mouth every 6 hours as needed for mild pain (1-3 on a pain scale of 0-10)".

Order written on 3/17/10 at 5:28 P.M., "Vicodin 5-500 mg (hydrocodone-acetaminophen) 2 tablets by mouth every 6 hours as needed for moderate pain (4-6 on a pain scale of 0-10)".

a. There were two different medications ordered for mild pain (1-3 on a pain scale of 0-10). The orders did not clearly specify how the nurse should choose between acetaminophen 650 mg and Vicodin 1 tablet for mild pain.

b. There were two different medications ordered for moderate pain (4-6 on a pain scale of 0-10). The orders did not clearly specify how the nurse should choose between Tylenol #3 - 1 tablet, and Vicodin 2 tablets for moderate pain.

Lexicomp's Drug Reference Handbook was reviewed. According to this reference, acetaminophen is an analgesic (non-narcotic), used to treat mild to moderate pain. The combination of acetaminophen and codeine (Tylenol #3) is a narcotic analgesic for the treatment of mild to moderate pain. And, Lexicomp indicates the combination of acetaminophen and hydrocodone (Vicodin) is a narcotic analgesic for the treatment of moderate to severe pain.

On 3/18/10 at 8:45 A.M., the, "Order Summary" for Patient 91 was reviewed. On the Order Summary was a "Duplicate Therapy Alert" which calls to the pharmacist's attention that two different analgesics had been ordered for the same level of pain. The Order Summary also indicated that RPh3 reviewed the, "Duplicate Therapy Alert" and overrode the alert on 3/17/10 at 5:36 P.M. The reason for the override stated on the "Order Summary" was, "Benefits outweigh risks".

On 3/18/10 at 9 A.M., RN 1 was interviewed. RN 1 stated that she believed there were two different order sets for pain because an anesthesiologist ordered pain medication when Patient 91 was transferred from the operating room to 4-East on 3/16/10. Later, a staff physician ordered additional pain medications on 3/17/10 after Patient 21 had been transferred to 4-East. The two different order sets for pain medication were in conflict.

On 3/18/10 at 9:10 A.M., RN 2 was interviewed. RN 2 stated that when Patient 91 indicated a need for pain medication, RN 2 would make a decision on whether to use acetaminophen, Vicodin or Tylenol #3 based upon Patient 91's pain level and Patient 91's wants and needs. (The choices were Acetaminophen 650mg versus Vicodin 1 tablet for mild pain; and Tylenol #3, 1 tablet versus Vicodin 2 tablets for moderate pain).










26881

Based on observation, interview, and record review, the facility failed to ensure that outdated medications would be unavailable for patient use.

Findings:

a. On 3/15/10 at 2:45 P.M. the Main Inpatient Pharmacy was visited concurrently with IDOP and RPh1. The following outdated medications were observed in the refrigerator:

1 Opened Vial, Novolin N insulin Expiration date: 3/2/10
1 Opened Vial, Novolin R insulin Expiration date: missing
1 Opened Vial, Novolin R insulin Expiration date: 2/27/10
1 Opened Vial, Novolin 70/30 insulin Expiration date: 3/13/10
1 Opened Vial, Novolog 100 Expiration date: 3/10/10
1 Opened Vial, Humulin R U-500 Expiration date: 1/21/10

b. On 3/15/10 at 3:35 P.M. the Peds Satellite Pharmacy was visited concurrently with IDOP and RPh1. The following outdated medications were observed to be available in the Peds Satellite Pharmacy's current stock.

2 Vials, pantoprazol (Protonix) IV 40mg (milligrams) Expiration date: 2/10
1 Vial, pantoprazol (Protonix) IV 40mg Expiration date: 11/09
6 Vials, furosemide (Lasix) 20mg. Expiration date: 2/1/10
2 Vials, promethazine 25mg/ml (milliliter) Expiration date: 2/10
6 Vials, promethazine 25mg/ml Expiration date: 1/10
1 Vial, Ampicillin 2 Gm. IV (intravenous) Expiration date: 12/09

On 3/15/10 at 3:45 P.M. the IDOP was interviewed. IDOP and RPh1 inspected each of the expired medications found on 3/15/10 and acknowledged these medications should not have been available for use after their respective expiration dates.


c. On 3/16/10 at 9:50 A.M. the 2-East Satellite Pharmacy was visited concurrently with IDOP and RPh1. The following outdated medications were observed in the refrigerator:

1 Opened Vial, Novolin N insulin Expiration date: 2/1010
1 Opened Vial, Novolin N insulin Expiration date: 2/2/10
1 Opened Vial, Novolin R insulin Expiration date: 3/1/10

Additionally, the following medications were observed in the Satellite Pharmacy:

3 tablets, Alendronate 10mg oral table (unit dose) Expiration date: 1/10
6 Vials, Ampicillin 2 Gram IV Expiration date: 12/09


d. On 3/16/10 at 11:20 A.M. the 2-East Satellite Pharmacy was visited concurrently with IDOP and RPh1. The following outdated medications were observed:

3 Vials, dobutamine 250mg/20ml Expiration date: 2/2010

e. On 3/16/10 at 1:15 P.M. the 4th Floor Satellite Pharmacy was visited concurrently with IDOP and RPh1. The following outdated medications were observed:

1 opened Vial, Novolin N (refrigerator) Expiration date: 2/27/10
1 Vial Vancomycin 500mg. Expiration date: 1/10

f. On 3/16/10 at 3 P.M. the Neonatal Intensive Care (NICU) Satellite Pharmacy was visited concurrently with IDOP and RPh1. The following outdated medications were observed:

1 Vial Hepatitis B Vaccine(Merck) Expiration date: 19 Feb 10
1 Vial betamethasone (Celestone) Soluspan 6mg Expiration date: 9/2010
Vial was opened and undated/unrefrigerated.
1 Vial Omnipaque 180 mg/ml Expiration date: 11 Dec 09
1x15 ml bottle Caffeine Citrate Expiration date: 3/13/10
1x60 ml digoxin liquid Expiration date: Jan, 10
1 bottle clindamycin (Cleocin) 75mg/ml Expiration date: 6/26/09
1 bottle safflower oil (medicinal) Expiration date: 2/6/10

On 3/16/10 at 3:30 P.M. the IDOP and RPh1 were interviewed. IDOP and RPh1 inspected each of the expired medications found on 3/16/10 and acknowledged these medications should not have been available for use after their respective expiration dates.

On 3/16/10 the Kaiser /Ontario Medical Center Administrative Policy and Procedure (P&P) Manual, "Medication Storage and Security" was reviewed. The P&P indicated,
"(12.) Medications that are contaminated, deteriorated, improperly labeled, illegibly labeled, recalled, outdated, or otherwise unusable shall be returned to the inpatient pharmacy." And ..."(16.) All medication storage areas are inspected at least monthly to assure medications are stored properly. Stock shall be reviewed and outdated, damaged, recalled or mislabeled items shall be removed at the time of inspection by the Inpatient Pharmacy. These items shall be segregated from the pharmacy stock and stored in a designated area until proper disposition."

On 3/16/10 the Kaiser/Ontario Medical Center Administrative Policy and Procedure (P&P) Manual, "Medication Administration" was reviewed. The P&P indicated, "(14.1) Multiple dose vials may be utilized up to 28 days after opened."

Based on observation, interview and record review, the hospital failed to ensure organized dietary services by:

1. Lacked integrated RD oversight over food service operations in accordance with State law. (Cross reference A- 0620)

2. Lacked integration of the food service operations into the hospital-wide Infection Control Programs. (Cross reference A - 0749)

3. The Food and Nutrition Services department provided nutrition supplements to patients without practitioners' orders who were responsible for prescribing diet orders. (Cross reference A -0353, A-0629)

The cumulative effects of these systemic problems resulted in the hospital's inability to ensure the provision of dietetic services for the health and safety needs of patients.

Findings:

Based on food service observation, interview and record review, the hospital failed to ensure safe food handling practices as evidenced by: 1) Dietary staff failed to wear a hair restraint during food preparation, 2) Issues surrounding storage of patient foods, 3) Freezer #4 was not maintained in good condition, 4) Dietary staff failed to sanitize the food contact surfaces according to the hospital ' s Department of Food & Nutrition Services policy and procedure, 5) Lack of comprehensive sanitation of the ice-machine and 6) Dented pediatric nutrition supplement cans were on the lunch production countertop for patient use. (Cross Reference A-0620)

On 3/19/10 at 11:00 A.M., the Director of Food and Nutrition Services stated that the Director of Patient Services, RD was responsible for clinical nutrition services, and was unable to demonstrate RD involvement in providing oversight over food safety and sanitation of the food service operation.

On 3/19/10 at 11:50 A.M., the Director of Patient Services, RD stated that she provided oversight over tray line operations to assure patient meal accuracy in accordance with the prescribed therapeutic diet, but that she did not provide oversight over safe food handling, or sanitation of the food service operations. When asked if she had previously identified any of the unsafe practices that were identified during the course of the survey, she stated, "I was not aware because there is no mechanism in place that would have me look at food safety or sanitation issues. I am supposed to do a safety checklist once a month, but it is more about office safety, and doesn't have to do with safe food handling, or sanitation."

According to State law, 70275 (a), and state Health and Safety Code 1265.4, an RD should provide frequently scheduled consultation, or guidance to the dietary services supervisor (ie: Director of Food and Nutrition Services, in this case), and dietary staff, to ensure safe food service operations.

2. The Director of Food & Nutrition Services, and the Assistant Director of Patient Services stated that the Food and Nutrition Services department did not routinely participate in a hospital wide infection control committee as directed to do by their hospital's policy and procedure. Further, the Director of Food & Nutrition Services stated that the hospital's infection control preventionist involvement in food service operations was limited to an in-service that was provided to dietary staff on hand washing.

3. On 3/15/10 during lunch trayline, a nutritional supplement (Arginaid) was observed on multiple patient trays, and the Director of Food & Nutrition Services stated that the Arginaid nutrition supplement requires a physician's order.

On 3/16/10, the Assistant Director of Patient Services stated that the hospital's RD's are allowed to order Arginaid according to a hospital's policy and procedure, without a specific physician's order. (cross reference A -0353, A-0629).

On 3/19/10 at 11:30 A.M., the Director of Food & Nutrition Services stated that he was responsible for the hospital's Food & Nutrition Services department, and he was in charge of the Assistant Director of Patient Services. However, the Director of Food & Nutrition Services was unaware that the Food & Nutrition Services department provided patients' nutrition supplement without practitioners' orders who were responsible for prescribing diet orders.

The hospital's Food & Nutrition services department was not a comprehensive organized dietetic services department as evidenced by the Assistant Director of Patient Services, whom was an RD, was limited to responsibilities over the Clinical Nutrition Services Dietitians, with some guidance limited to trayline staff in terms of patient meal accuracy. The Director of Food & Nutrition Services was focused on the daily food service operations, and therefore, was unaware of the clinical nutrition services aspect as it related to a policy and procedure on providing Arginaid by RD order. Although the Director of Food & Nutrition Services and the Assistant Director of Patient Services, RD stated they had an open door style of communication amongst each other, there was no formal, demonstrated evidence of a collaborative effort to provide an organized dietary services department.

Based on food service observation, interview and record review, the hospital failed to ensure safe food handling practices as evidenced by: 1) Dietary staff failed to wear a hair restraint during food preparation, 2) Issues surrounding storage of patient foods, 3) Freezer #4 was not maintained in good condition, 4) Dietary staff failed to sanitize the food contact surfaces according to the hospital ' s Department of Food & Nutrition Services policy and procedure, 5) Lack of comprehensive sanitation of the ice-machine and 6) Dented pediatric nutrition supplement cans were on the lunch production countertop for patient use.

Findings:

1.) On 3/15/10 at 2:00 P.M., a joint observation with the Director of Food and Nutrition Services was made of dietary Staff 21 preparing produce for a salad without wearing a hair restraint.

According to the Food & Nutrition Services Policy and Procedure entitled Department Goals & Objectives (MSA-01), "Food is prepared in a wholesome, appetizing and sanitary manner according to federal, state and local public health guidelines."

According to standards of practice in the food service industry, food employees shall wear hair restraints to effectively keep their hair from contacting exposed food (Food Code 2009, 2-402.11 [A]).

2.) On 3/15/10 at 2:10 P.M., in a walk-in refrigerator there were 36 individual containers of egg custard with a "Best by " date of 11-17-09 printed on the container by the manufacturer. The Director of Food and Nutrition Services stated, "Those need to be thrown out."

A "Best by" date is recommended for best flavor or quality per the USDA Food Safety and Inspection Service. Eggs and dairy products are a potentially hazardous food that is capable of supporting bacterial growth associated with food borne illness.

On 3/15/10 at 2:30 P.M., in walk-in refrigerator #6 there were 7 quart sized cartons of liquid egg product that had a printed date from the manufacturer that indicated "Feb 24-10 Expired" . The Director of Food and Nutrition Services stated the liquid egg cartons would be tossed out. Eggs are a potentially hazardous food that is capable of supporting bacterial growth associated with food borne illness.

On 3/15/10 at 2:35 P.M., in reach-in freezer #7 there was a plastic grocery bag that contained a food item. The Director of Food and Nutrition Services stated that the bag was a personal item that belonged to a dietary employee and "should not be in there." According to standards of practice in the food service industry, storage of personal food with food from approved sources is a potential for cross contamination (Food Code 2009).

On 3/16/10 at 9:15 A.M., in a reach-in refrigerator, located near tray line, there were approximately two cases of carton health shakes (a nutritional supplement) that felt thawed to touch. At this time, the Director of Food and Nutrition Services checked the internal temperature of one of the carton health shakes which was 42.5 degrees F. The health shakes had a sticker date attached that indicated "4/5/10" . The Director of Food and Nutrition Services stated that the sticker date of "4/5/10" meant that the health shakes could be served until that date. He further stated that the health shakes were good for 14 days once thawed per manufacturer, and that he trained the staff to give two additional days for the thawing process. The Director of Food and Nutrition Services stated that the date of "4/5/10" was incorrect, and past the use by date per the manufacturer's recommendations.

The Director of Food and Nutrition Services provided a document for the health shake that indicated, "1 year frozen, 14 days thawed."

According to the hospital's policy and procedure entitled HACCP Based SOP Date Marking Ready-To-Eat, Potentially Hazardous Food (D-MSA-06), "Refrigerate all ready-to-eat, potentially hazardous foods at 41 degrees F or below." Dairy products are a potentially hazardous food that is capable of supporting bacterial growth associated with food borne illness.

3.) On 3/15/10 at 2:20 P.M., in walk-in freezer #4 there was frost build-up on the ceiling and floor. On 3/16/10 at 9:00 A.M., the Chief Engineer stated that he was not notified of the frost build-up in freezer #4 until yesterday.

On 3/16/10 at 9:10 A.M., the Director of Food and Nutrition Services stated that he expected for the supervisor's of food service, and the storeroom clerks, to have immediately reported the frost build-up to maintenance. The Director of Food and Nutrition Services was unable to locate any report of the frost build up via their manual reporting log, or electronically via the EasyNet system.

According to the Food & Nutrition Services Policy & Procedure entitled Preventive Maintenance and Equipment Repair (G-MSA-08), "The Supervisor of Food Services or Administrative Clerk is responsible for notifying Engineering either via the EasyNet system, or by telephone in an emergency.

4.) On 3/15/10 at 2:50 P.M., dietary Staff 22, whom held a supervisor position, was asked how she knew if a sanitizing solution was effectively sanitizing. She went to a wall that had two different dispensers attached, one of which contained Encompass detergent, and the other dispenser contained Ster-Bac (quaternary ammonium liquid sanitizer). Dietary Staff 22 filled a green bucket with Encompass detergent and then put a chem. strip, which was designed to test the concentration of quaternary ammonia, into the detergent in which the chem. strip did not change color (had no reaction).

On 3/16/10 at 9:28 A.M., dietary Staff 23 had a green bucket next to her work station which she stated she used to sanitize the countertops used for food production. When asked how she knew if the solution in her bucket was effectively sanitizing she stated "the Director of Food and Nutrition Services is here so I know that it is sanitizing because the supervisors check the solution." She proceeded to point to the wall mounted dispenser that she used to fill her green bucket with which was Encompass detergent, and not the Ster-Bac sanitizer. The Director of Food and Nutrition Services acknowledged that dietary Staff 23 filled her bucket with detergent, and not the sanitizer solution.

The Director of Food and Nutrition Services stated that he expected staff to fill the green buckets with the Ster-Bac sanitizer and change the solution at least every two hours, and when the food contact surfaces were soiled.

According to the hospital's policy and procedure entitled HACCP based SOP Cleaning & Sanitizing Food Contact Surfaces (D-MSA-02), "To prevent foodborne illness by ensuring that all food contact surfaces are properly cleaned and sanitized ..., Sanitize surface using a sanitizing solution mixed at a concentration specified on the manufacturer's label."


5.) On 3/15/10 at 3:00 P.M., Staff 22 stated that she used a lime-a-way product in the ice-machine bin, and then used Ster-Bac (quaternary ammonium liquid sanitizer) to sanitize the ice-machine bin. Staff 22 stated that the maintenance/engineering department cleaned the internal components of the ice-making apparatus.

On 3/15/10 at 3:30 P.M., Staff 24 stated that he used a lime- a-way product to clean, and he did not use any other products to sanitize. Staff 24 did not have a sanitizing component that he conducted on the ice-machine. At this time, the ice-machine manufacturer's guidelines were requested.

On 3/16/10 at 8:40 A.M., the Director of Food and Nutrition Services stated that he received the ice-machine manufacturer's guidelines, and stated, "We should be using bleach to sanitize the ice-machine."

According to the ice-machine manufacturer's guidelines, Lime-A-Way is the cleaning solution and should be used to "remove lime deposits in the water system." The guidelines further indicated to sanitize the ice-machine internal components and bin with "2.5 fl.oz. of a 5.25% sodium hypochlorite solution (chlorine bleach) with 5 gal. of water." The ice-machine manufacturer's guidelines contained a warning that indicated, "To prevent injury to individuals and damage to the icemaker, do not use ammonia type cleaners."

Ice machines in health care establishments have been implicated in outbreaks of infection and as potential reservoirs of infectious agents according to the Centers for Disease Control and Prevention.

6.) On 3/16/10 at 9:37 A.M., a joint observation with the Director of Food and Nutrition services was made of nutrition supplement cans that were on the counter on tray line. Two cans of oral nutrition supplements designed for children had dents along the rims of the cans. The Director of Food and Nutrition Services stated, "Those should not be used."

According to standards of practice in the food service industry, dented cans should be discarded as they may present a serious potential hazard (Food Code 2009).

Based on observation, interview, and record review the hospital failed to ensure that dietary Staff 22, and dietary Staff 23, were fully trained in sanitizing food contact surfaces.

Findings:

On 3/15/10 at 2:50 P.M., dietary Staff 22, whom held a supervisor position, was asked how she knew if a sanitizing solution was effectively sanitizing. She went to a wall that had two different dispensers attached, one of which contained Encompass detergent, and the other dispenser contained Ster-Bac (quaternary ammonium liquid sanitizer). Dietary Staff 22 filled a green bucket with Encompass detergent and then put a chem. strip, which was designed to test the concentration of quaternary ammonia, into the detergent in which the chem. strip did not change color (had no reaction).

On 3/16/10 at 9:28 A.M., dietary Staff 23 had a green bucket next to her work station which she stated she used to sanitize the countertops used for food production. When asked how she knew if the solution in her bucket was effectively sanitizing she stated "the Director of Food and Nutrition Services is here so I know that it is sanitizing because the supervisors check the solution." She proceeded to point to the wall mounted dispenser that she used to fill her green bucket with which was Encompass detergent, and not the Ster-Bac sanitizer. The Director of Food and Nutrition Services acknowledged that dietary Staff 23 filled her bucket with detergent, and not the sanitizer solution.

The Director of Food and Nutrition Services stated that he expected staff to fill the green buckets with the Ster-Bac sanitizer and change the solution at least every two hours, and when the food contact surfaces were soiled.

The Director of Food and Nutrition Services provided a document entitled Towel Sanitizing Solution which indicated that dietary staff was trained to "Use Ster Bac Blu and clean towel from dish room for sanitizing workstation. You must use test strips for Red bucket sanitizer buckets ..., change chemical every two hours sanitizing solution when it becomes cloudy or when it contains excessive food particles or meat juices, and always change the solution when the sanitizer falls below 100 ppm chlorine or 200 ppm quats." According to the document, this training was provided to dietary staff on June 28, 2009, and the speaker was dietary Staff 22.

According to the Director of Food and Nutrition Services job description, representative duties include "Recruits, orients, trains, and evaluates ...staff."

Based on interview and record review, the hospital failed to ensure that an amino acid supplement for Patient 27, and a nutrition supplement for Patient 28 was ordered by a practitioner responsible for the care of the patient.

Findings:

On 3/16/10 at 1:30 P.M., Patient 27's medical record was reviewed with the Assistant Director of Patient Services. On 3/12/10 an initial nutrition assessment was completed for Patient 27 that indicated Patient 27 was status post partial foot amputation The nutrition assessment indicated that the pt was on an 1800 calorie diabetic, cardiac diet, had a Braden score of 19, and had a prealbumin of 5 (lab dated 3/10/10). The nutrition assessment indicated, "Nutrition: ADEQUATE" , and according to the Assistant Director of Patient Services the determination of "adequate" related to the Braden score of 19. Under the intervention section of the nutrition assessment, the RD indicated, "Will add Pro-stat 64 once daily to provide extra 15 gm protein for wound healing. "

According to the Assistant Director of Patient Services the RD electronically entered the order for Pro-Stat 64 and highlighted an option that indicated "Within Role/Scope (No Co-Sign)" . According to the electronic record the RD wrote the order for Pro-Stat 64 and the order was released immediately. The Assistant Director of Patient Services stated that when the order was entered into the electronic data base, and released, then the nutrition supplement order was electronically transmitted to the diet office to be implemented. On 3/17/10 at 10:15 A.M., the Chief Operating Officer (COO) of the hospital stated, "There is no such thing as pending orders for the RD. Once you write the order it is official."

On 3/16/10 at 1:40 P.M., the Assistant Director of Patient Services stated that the RD's were allowed to enter an order for nutrition supplements which did not require an MD signature, if the patient is consuming less than the physician prescribed diet order or if indicated by a lab value, based on hospital policies that were approved via the Medical Quality Improvement Committee. She stated that she had not been granted privileging by the governing body to write orders.

According to the hospital's policy entitled Use Of Amino Acid Supplement (Arginaid) In Patients With Non-Healing Wounds (I-MSA-16), "Amino acid supplement may be added to the nutrition care plan for patients with Stage III and IV pressure ulcers and non-healing wounds per selection criteria." Patient Selection Criteria for Amino Acid Supplement Administration (any of the following): a) Stage III and IV Pressure Ulcer, b) Non-healing Wounds, c) Pre-Albumin of < (less than) 10/dl). The policy further indicated, "Amino acids supplements require a nutritional consult by RD or physician ' s order, ...The physician or Registered Dietitian will access the Amino Acid therapy and adjust intervention as necessary."

On 3/16/10 at 8:20 A.M., the Assistant Director of Patient Services was unable to utilize the hospital ' s on-line ADA Nutrition Care Manual to demonstrate how the diet manual was used as guidance in preparing patient meals. The hospital ' s on-line ADA Diet Manual was not customized to be hospital specific, and did not indicate that within a physician prescribed diabetic diet with a specified calorie level, an RD may provide a patient with Arginaid, or a glucose control nutrition supplement.

Patient 28's medical record contained an order, ordered and released by an RD, for a nutritional supplement glucose control for breakfast and lunch, according to the Assistant Director of Patient Services. The Assistant Director of Patient Services stated that the hospital had a policy that allowed RD ' s to "order a nutritional supplement if the patient is consuming less than the physician prescribed diet order."

According to the hospital ' s policy entitled Nutrition Support - Oral Nutrition Supplements (I-MSA-10), "The Registered Dietitian can initiate the use of oral nutrition supplements to assist in meeting patient ' s estimated nutritional needs ..., RD may initiate supplement and/or snack order if the patients are not consuming adequate amount of the MD prescribed diet ..., RD may change or discontinue an existing supplement and/or snack order ..., RD will monitor patient ' s response to oral supplements/snacks and revise plan of care as needed ..."

The facility Diet Manual, reviewed on 3/16/10 at 1:40 P.M., does not list specific nutrition supplements such as oral supplements, protein supplements, or specific amino acid supplements in the list of food items in any of the diets within the manual. The patient diet ordered by the practitioner responsible for the care of the patient is limited to the diet as identified in the physician approved facility Diet Manual.

On 3/17/10 at 9:00 A.M., the Assistant Director of Patient Services stated that RD's did not receive privileging from the hospital. On 3/17/10 at 10:15 A.M., the COO stated that RDs had not received privileging or credentialing by the governing body. On 3/19/10 at 3:20 P.M., MD 29 stated that RD's did not receive privileging by the governing body. The physician is the practitioner responsible for diet orders in the facility.

Patient 27's and Patient 28's nutrition supplements were not prescribed by the practitioner responsible for the care of the patients.

Based on observation, interview, and record review, the hospital failed to customize their on-line diet manual to be hospital specific to ensure that therapeutic diet orders, and modifications, were approved by the hospital ' s staff of physicians, and in conformance with physician diet orders.

Findings:

On 3/16/10 at 8:20 A.M., the Assistant Director of Patient Services stated that the hospital ' s diet manual was an on-line " ADA Nutrition Care Manual " . She further stated that the on-line diet manual could not be customized to be hospital specific because ADA (American Dietetic Association) owned the publication. (The following information was available on-line pertaining to customization of the on-line ADA Nutrition Care Manual: NCM Administrator Tutorial : This Webinar tutorial walks through administrative tasks including managing subscription contacts, customizing the formulary database, adding sticky notes, highlighting and more.)

The hospital ' s Diet Order Census Report, printed on 3/15/10, indicated there were physician prescribed diet orders that included diabetic 1800 calories, diabetic 2000 calories with 60 grams of protein, 2 grams of potassium, low phosphorus, and two grams of sodium restrictions, and a cardiac low cholesterol/2 gram sodium diet. The Director of Patient Services was unable to utilize the on-line ADA Nutrition Care Manual to demonstrate how the hospital would prepare the patient diets to meet those diet orders. The Director of Patient Services had a carbohydrate meal pattern plan posted in the dietary department for various caloric levels of diabetic diets that physicians ordered. She stated, " The dietary staff uses this carbohydrate pattern to guide accuracy of meal selection during menu reviews, and on tray line. " This actual practice of how the pattern of caloric levels of diabetic diets would be used to guide the preparation of patients meals was not incorporated into the hospital ' s diet manual.

When asked to see the location in the on-line diet manual that would indicate how the hospital would prepare a patient diet for a 60 gram protein, 2 gram potassium, low phosphorus, 2 gram sodium diet, a document was provided entitled Nutrition Keynotes; Guidelines for Individuals with Decreased Kidney Function", which did indicate a sample menu. A Clinical RD stated that she would use the document to educate a patient that had a 60 g pro, 2 gm K+, low phosphorus, 2 gm NA+ diet order, but stated she did not know if the sample menu listed would calculate to meet that specific diet order, and added that the sample menu was not used for patient meal preparation. The Director of Patient Services stated that the Nutrition Keynotes; Guidelines for Individuals with Decreased Kidney Function document came from another location on their internal computer system, such as their HealthConnect or CBORD data, and not from their on-line Diet Manual. She further stated that CBORD does allow for menu pattern fixing, but that is a separate component from the on-line diet manual.

On 3/16/10 at 8:35 A.M., the Director of Patient Services stated, " I agree that we do not have an ADA on-line diet manual that shows how we implement and prepare patient diets. " She further stated that there was information in the Kaiser Fontana system on how diets were implemented, but the information was fragmented and dispersed in a variety of locations in their electronic system, and was not easily identifiable or accessible to the health professionals. In addition, the non-customized, generic on-line diet manual did not include a list of the different types of therapeutic diets routinely ordered at the hospital.

The hospital ' s Kaiser Permanente Fontana Medical Centers Food & Nutrition Services ADA Nutrition Care Manual that was reviewed and approved in April 2008 was the original version that was purchased, and was not customized to include the actual practice that the hospital used to carry out a variety of diet orders.

According to the hospital ' s policy & procedure entitled Diet Manual Approval (I-MSA-19), " Purpose: ...To serve as a method of communication among physicians, nurses and Dietitians, and as a guide to diet orders as well as menus and kinds/amounts of foods served to patients. "

Based on observation and interview, the facility failed to monitor temperature and humidity in the "old" cardiac catheterization laboratory, and failed to maintain humidity within the standard range, creating the risk of fire from a low humidity.

Findings:

On 3/17/10 at 8:30 AM the "old" cardiac catheterization laboratory was toured. The gauge on the wall of the room indicated a temperature of 68.2 degrees F, and a humidity of 25 percent. When asked for the log of the humidity, RN 34 stated that Cath Lab Technician 1 would have the log. However, Cath lab Technician 1 did not have the log, and said that no log was being maintained. RN 34 also stated that cautery and alcohol based preparations were used in the OR, augmenting the risk of fire.

From PERIOPERATIVE STANDARDS AND RECOMMENDED PRACTICES - 2009 EDITION, Section III - Recommended Practices for Perioperative Nursing Patient and Worker Safety: V.c.1. Temperature should be maintained between 68? F to 73? F (20? C to 23? C) within the operating room suite. American Institute of Architects Academy of Architecture for Health (AIAAAH) recommends a humidity range of 30% to 60% for the OR.

Based on observation, interview, and product label review, the facility failed to:

1. Ensure that two environmental services attendants used a cleaning chemical correctly when cleaning operating room surfaces, creating the risk of infection for patient and staff members using those areas.

2. Ensure that ICU nursing staff was familiar with the correct color-coded isolation precaution sign to be used for a patient with a Clostridium difficile infection, creating the risk of inadequate infection control response to a patient with that infection and the spread of infection to other patients and staff.

3. Ensure that sterile processing single use brushes were used only once, creating the risk of inadequately sterilized equipment.

4. Ensure preventive maintenance was done on sterile processing department equipment in accordance with the manufacturer's directions, creating the risk of inadequate sterility of equipment and the spread of infection to patients and staff coming into contact with that equipment.

5. Ensure that a clock was visible from the scrub sink outside the "old cath" laboratory, creating the risk of inadequate staff scrubbing prior to procedures and the spread of infection.

6. Ensure that an expired cardiac catheter had been removed from a patient care area where it presented an increased risk of infection if used on a patient.

7. Ensure on going integration of an infection control program involving food service and sanitation to ensure the safety and sanitation of food service operations.


Findings:


1.On 3/16/10 at 1:45 PM, Environmental Services Attendant 1 was observed cleaning an OR table between cases in the main OR. She applied a chemical, Virex, to the surface and the chemical was observed to dry in approximately two minutes. She did not reapply the chemical, and no further cleaning of the OR table surface was done.


During an interview with Environmental Services Attendant 2, he stated that the chemical used to clean the OR surfaces was Virex. When asked the directions for use, he was not able to identify a time that the chemical had to stay wet in order to disinfect the surface. The container for Virex was examined and the instructions for use included that the surface must remain wet for 10 minutes for disinfection. Enviromental Services Attendant 2 stated that he did not know that the surface had to reamin wet with the chemical for 10 minutes for disinfection.


Virex is an Environmental Protection Agency registered disinfectant and by law must be used per manufacturer ' s directions.


2. On 3/16/10 at 1:10 PM the ICU was toured and different isolation precaution signs were noted on patients ' doors, and alcohol based disinfectant skin rub dispensers were located outside the patient rooms. Alcohol based skin rubs are not effective disinfectant for Clostridium difficile infections. RN 29 was asked what type of sign would be displayed for a patient with a Clostridium difficile infection. She stated that the patient would have a contact precaution sign, but was unable to specify any additional information that would be on the sign or the correct color of the sign. RN 30 was also asked what type of sign would be exhibited for patient with this infection, and she stated that a yellow contact precaution sign would be used. During an interview with RN 31, she stated that a special "enhanced precaution" sign was used for identifying Clostridium difficile infections and that the sign was green. The light green contact "enhanced precaution" sign was observed.


3.Sterile Processing Tech 1 was interviewed on 3/17/10 at 9 AM. He stated that Medisafe brushes were being reused 2 to 3 times on different instruments, and that between used the brushes were subjected to pressure cleaning but not sterilization. On 3/18/10 at 11:40 AM, Sterile Processing Supervisor 1 stated that the Medisafe brushes were intended to be used only once.


4. During an interview with Sterile Processing Supervisor 1 on 3/18/10 at 11:40 AM, he stated that the preventative maintenance records for the Belimed washer could not be found for some time periods.


5. During a tour of the cardiac catheterization laboratory on 3/17/10 at 8:30 AM, no clock was observed to be visible from the scrub sink outside the "old cath" lab. During a concurrent interview with RN 34, she stated that the clock had recently been removed, and agreed that it might be difficult for a surgeon to time the scrub without a clock.


6. During a tour of the cardiac catheterization laboratory on 3/17/10 at 8:30 AM, a cardiac catheter labeled with the expiration date February, 2010 was found available for use on a shelf. During an interview with RN 33, she stated that the expired catheter should have been disposed of.



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7. During the course of the survey, the following unsafe practices were identified: 1) Dietary staff failed to wear a hair restraint during food preparation, 2) Issues surrounding storage of patient foods, 3) Freezer #4 was not maintained in good condition, 4) Dietary staff failed to sanitize the food contact surfaces according to the hospital's Department of Food & Nutrition Services policy and procedure, 5) Lack of comprehensive sanitation of the ice-machine and 6) Dented pediatric nutrition supplement cans were on the lunch production countertop for patient use. Failure to provide a safe and sanitary environment may result in foodborne illness, and may further compromise patients medical status. (Cross Reference A-0620)
On 3/19/10 at 11:00 A.M., the Assistant Director of Patient Services stated that she had been employed by the hospital for two years. She stated that she does not regularly attend an Infection Control Committee, and could not recall attending one in the past year. On 3/19/10 at 11:50 A.M., the Assistant Director of Patient Services (RD) stated that she was not responsible for supervision of diet aides, and that there was not a mechanism in place in which she would have identified the food service sanitation concerns.
On 3/19/10 at 11:05 A.M., the Director of Food & Nutrition Services stated that he had been employed by the hospital for over two years. He stated that he did not regulalry attend an Infection Control Meeting, unless he had a topic to present, and could not recall attending one in the past year. He further stated that an infection control preventionist had never observed the actual food service operations in the kitchen, but had in the past, conducted in-services to the dietary personnel on hand washing.
According to the hospital's policy and procedure entitled Inter-departmental Meetings And Relationships (A-MSA-05), "The Director of Food & Nutrition Services or his/her designee represents the Department at committee meetings as required by the Department, Medical Center and or Southern Region,... The purpose is to facilitate inter-departmental communications, performance improvement, policy development, and decision-making,... Food & Nutrition Services representative attends meeting, ...A listing of all standing meetings attended by Department representatives follows:...Fontana Infection Control Meeting (Director Food & Nutrition/Assistant Director of Public Services)."
According to the hospital's policy and procedure entitled Infection Control Plan In Food And Nutrition Services (F-MSA-01), "Purpose: To define in writing the role and scope of participation of Food and Nutrition Service (including Cafeteria Retail area) in Kaiser Permanente Medical Center Infection Prevention and Control Activities. Food and Nutrition Service collaborates with Infection Control in the development of all pertinent policies in the Infection Control Manual. To ensure maintenance of safe, healthful environment for the preparation and service of food. To prevent the occurrence and spread of food-borne illness, by mnimizing the possibility of contamination and transfer of infection through safe food handling procedures and following Standard (Universal) Precautions."
Although the hospital did identify a mechanism for reporting of infection control involving Food & Nutrition Services Departmental concerns via a committee, this was not being accomplished on a regular basis.
There was not a system in place to identify food sanitation and infection control concerns as evidenced by deficient practices that were identified during the course of the survey.

Based on interview and record review the facility failed to ensure that a complete discharge planning evaluation was completed for 2 of 33 sampled patients (Patient 64 and Patient 1).

For Patient 64 this failure resulted in the patient being discharged home without evaluation of a potentially abusive environment. This had the potential for the patient to suffer further financial abuse up to and including loss of her home. The facility also failed to ensure that an assessment was conducted regarding the use of restraints in the facility and the potential for injury at home. This failure had the potential to cause injury to the patient including falls, bruising, and bone fracture.

For Patient 1 the facility failed to ensure an order wound care was forwarded to and carried out by the wound care consultant which resulted in Patient 1 being discharged home without her wound care needs being evaluated. This facility failure resulted in Patient 1 not receiving care for an unstagable (stage III of IV) wound, with black eschar (dead tissue) located on the coccyx (tail bone) area prior to discharge from the facility.

Findings:

1 a). A review of the medical record for Patient 64 revealed that she was admitted to the facility on 2/19/10 with a chief complaint of confusion and agitation. Her medical history included dementia and diabetes mellitus. Review of the Case Management Registered Nurse (CMRN) notes, dated 2/23/10 at 1:28 PM, revealed the following statement:

"(Name, patient's daughter) states that patient has been under a lot of stress lately because a group of people has been exerting a lot or (of) pressure on patient for at least 2 months to give them money. To the best of (name, daughter) and (name, son) knowledge, patient has given these people thousands of dollars. Patient was at one point looking at losing her home ...(Daughter) found pts (patient's) phone bill to have about $800.00 of charges from Jamaica, and thinks that some people are threatening patient if she declines to send them money."
Further review of the CMRN notes revealed that the patient was seen by CM on 2/25/10, 2/26/10, 3/1/10, 3/5/10, 3/9/10, 3/11/10, and 3/12/10. After 3/12/10 there were no further notes documented. Review of the CM notes revealed no further mention of the allegation of financial abuse. There was no referral to the social worker to follow up on the patient.

The facility administrative staff assisting the survey process were asked for any social worker notes for Patient 64 for the duration of her stay. On 3/23/10 at 2 PM, Administrative Staff A confirmed that there was no social service documentation regarding the patient.

And interview was conducted with CMRN A on 3/22/10 at 11:30 AM. She stated that she would report any abuse to the social worker for evaluation and further report to an appropriate agency. CMRN A stated that she was the CM for Patient 64 until 3/12/10 and then she was assigned to another unit. CMRN A reviewed her notes and confirmed that she had written the note regarding the allegation of financial abuse. She stated that she did not report the allegation of abuse to social worker.

On 3/22/10 a visit was made to the unit where Patient 64 was admitted with the nursing clinical director (CD) of the unit. A record review for further CM notes was conducted. It was noted that Patient 64 was discharged from the facility on 3/18/10. A review of the CM notes (discharge note) who discharged the patient, CMRN B, revealed no mention of the allegation of financial abuse or an evaluation of the home regarding the potential for further issues with financial abuse.

An interview was conducted on 3/22/10 at 3:30 PM with CMRN B. She stated that she was not aware of the allegation of financial abuse that was disclosed to the previous CM by the patient's daughter. CMRN B stated that she had not read the previous CM's notes. She stated she would usually review more of the record before discharge, but she did not for this patient.

An interview was conducted with the Director of Case Management (DCM) on 3/23/10 at 1:10 PM. She confirmed that the patient was discharged home without evaluation of a potentially abusive environment.

1 b). A review of the medical record for Patient 64 revealed that she had required restraints on and off during the duration of her hospital stay from 2/19/10 to 3/18/10.

A review nursing documentation regarding type of restraint was as follows:

2/22/10:
Bilateral soft wrist restraints, documented every 2 hours (the documentation covered a 2 hour period) from 11:49 PM through 2/23/10 at 11 PM.

2/23/10:
11 PM, Bilateral soft wrist restraints, Soft ankle restraint left.

2/24/10:
Bilateral soft wrist restraint and vest restraint documented every 2 hours from midnight to 6 AM, no documentation from 6 AM to 12 PM, from 12 PM to 9 PM vest restraint was documented, at 10 PM bilateral soft wrist and vest restraints were documented as being used.

2/25/10:
Bilateral soft wrist restraints, vest restraint, side rails X (times) 4 were documented every 2 hours from midnight through 10 PM.

2/28/10:
Bilateral soft wrist restraints, vest restraint, side rails X (times) 4 were documented every 2 hours from 7 AM through 3 PM; then, bilateral soft wrist restraints and side rails X (times) 4 were documented every 2 hour from 3 PM through 11 PM.

3/1/10:
Bilateral soft wrist restraint and side rails X 4 every 2 hours from 1 AM through 10 PM.

3/2/10:
Bilateral soft wrist restraint and side rails X 4 every 2 hours from 1 AM through 8 PM.

3/3/10:
Bilateral soft wrist restraint and side rails X 4 every 2 hours from 1 AM through 12 PM and again at 10 PM the use of wrist restraints were documented.

3/4/10:
Bilateral wrist restraints were documented every 2 hours from 1 AM through 6 AM.

3/7/10:
At 7:39 a right wrist restraint was applied, at 9:30 AM a left wrist restraints was applied, at 11:29 bilateral wrist restraints were applied, at 11:30 no restraints were documented, then at 8 PM bilateral wrist restraints and side rails X 4 were applied and continued at 10 PM.

3/8/10:
Bilateral wrist restraints from 4 AM through 10 PM and side rails from 4 AM through 6 AM.

3/9/10:
At midnight there was documentation of soft wrist restraints. At 12 PM there was documentation of bilateral mittens being used as a restraint through 10 PM.

3/14/10:
Bilateral soft wrist restraints, vest restraint, side rails X (times) 4 were documented every 2 hours from 9 AM through 11 PM (wrist restraints were not documented at 11 PM).

3/16/10:
Vest restraint was documented from 1 AM through 3 PM.

3/17/10:
Bilateral wrist restraints and side rails X 4 from 2 PM through 10 PM

On 3/18/10 there was documentation that at 2:32 AM that the patient was found climbing out bed and the nurse obtained an order for 4 side rails. Another nurses note written on 3/18/10 revealed that the patient continued to attempt to climb out of bed. Review of the restraint flow sheet revealed that on the day of discharge, the patient required the use of side rails as a restraint from 2:29 AM through 6 PM.

Review of the Case Manager's (CM) discharge note revealed no mention of the need for restraints for the patient on discharge. There was no documentation of evaluation of restraints or education to the family of the patient continuing to climb out of bed.

Review of the nurses discharge note written at 10:49 PM revealed no mention of the patient continuing to climb out of bed earlier the same day. The only mention of family teaching was "instructions given to the ambulance staff to be given to the daughter at home." There was no documentation of what instructions were given.

An interview was conducted on 3/22/10 at 3:30 PM with CMRN B. She stated that she usually reviewed the medical record for patient needs prior to discharge. She stated she would usually review more of the record before discharge, but she did not for this patient.

An interview was conducted with the Director of Case Management (DCM) on 3/23/10 at 1:10 PM. She confirmed the documentation regarding restraints for Patient 64 and confirmed that the patient required side rails for climbing out of bed on the day of discharge. She stated that the CM should have realized that the patient required restraints and planned for the education of the family.







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2. The EMR clinical record for patient 1 was reviewed on 3/23/10 at 1:00 PM with Administrative Staff A. The clinical record indicated that Patient 1 was a 76 year old female admitted to the facility on 3/15/10 with a diagnosis of subdural hematoma. Patient 1 was discharged home on 3/16/10 after a hematoma evacucation.

Review of the "Multi-Discipline Progress Note" dated 3/15/10 at 0421 (4:20 AM) indicated "received from Kaiser Riverside ER via ambulance, alert and oriented X 4 (times four) verbalized lives with son, appears cachectic, protruding bony prominence. 2.5 cm (centimeter) black eschar noted on coccyx area, linear black dry scabs on upper back and R (right) arm. Bil (on each side) heels with dry skin." The entry also indicated that pictures were taken of the coccyx area.

Review of the "Photographic Wound Documentation" dated 3/15/10, indicated that Patient 1 had a 2..5 cm x 2.5 cm unstagable wound (stage III or IV) with 2.5 cm (centimeter black eschar to the tail bone area.

Review of the physician ' s orders for Patient 1, indicated that the physician wrote an order for an "In Patient Wound Therapy Consult" on 3/15/10, but there was no documented evidence in the clinical record that Patient 1 had received a wound therapy consultation.

During an interview with Administrative Staff RN A on 3/23/10 at approximately 11:00 AM, Administrative Staff A verified that there was no documented evidence in the clinical record that inidicated that Patient 1 had been seen by the Wound Care Ostomy Nurse (WCON) prior to discharge on 3/16/10. Administrative Staff RN A

Based on observation, interview and record review, the facility failed to maintain a pediatric crash cart in the main OR area, creating the risk of unmet emergency needs for pediatric patients using that area.

Findings:

On 3/16/10 at 3 PM, during a tour of the OR suite, RN 20 and RN 19, the interim OR Manager, identified the adult OR crash cart as the cart that would be used for pediatric emergencies. During an interview with MD 6, the Director of the Anesthesiology Department, and RN 28 on 3/18/10 at 1:45 PM, they stated that pediatric surgeries were being done in the OR, that there was no pediatric crash cart, and that the medications and supplies for pediatric emergencies were available in the OR but might need to be drawn from several locations, including the anesthesia cart, the pediatric supply cart and the adult crash cart in the OR in the event of a pediatric emergency.

The facility policy, "Emergency Crash Cart (Maintenance and Checks)", rev 5/08, was reviewed on 3/18/10. The policy read in part, "All emergency equipment shall be appropriately adaptable for the needs of any type/age patient treated in that area."

Based on interview and record review, the facility failed to ensure accurate calibration of nuclear medicine isotopes, creating the risk of incorrect isotope dosing and overdosing or underdosing of patients requiring nuclear medicine isotopes.

Findings:

During a tour of the nuclear medicine area of the facility on 3/16/10 at 10:50 AM, the calibration data for nuclear isotopes was reviewed, and it was noted that the calibration data was outside of the limits posted on the wall. The acceptable limits of calibrated activity for Cobalt-57 on the posted "Acceptable Dose Calibrator Limits" was 0.75 to 0.82 for March 16, 2010, while the actual measured activity was 5.25 for the Cobalt-57 in use. During an interview with Nuclear Medicine Supervisor 1, she stated that the contracted radiopharmaceutical provider was to send new calibration data when they sent the new isotope supply, but had failed to send the data with the new isotopes that arrived one month prior. When asked how she determined if the isotope doses were correct to use, she stated that they estimated based on small daily variation, but they were not able to verify the dose calibration was correct.

Based on interview and record review, the facility failed to maintain one gamma camera according to manufacturers recommendations, creating the risk of substandard imaging for patients imaged with that gamma camera.

Findings:

During a tour of the nuclear medicine area of the facility on 3/16/10 at 10:50 AM, the maintenance records of a gamma camera were requested. Nuclear Medicine Supervisor 1 stated that the maintenance was coordinated by the corporate office, and that records were maintained by the corporate regional office, and were accessible by computer from the facility. However, when the computer record for the maintenance was consulted, it ended in 2003. Nuclear Medicine Supervisor 1 stated that she received via email updates of the gamma camera maintenance for a time, but that she paid no attention to them as she assumed the maintenance was tracked by the corporate regional office, and she no longer received the maintenance updates. During a concurrent interview with the Director of the Radiology Department, he stated that the maintenance records should be available to the facility via the computer record storage system, but was not able to locate records for maintenance of the machine after 2003.

The Director of the Radiology Department obtained a copy of the maintenance records for the gamma camera from a source outside the facility on 3/19/10. The records indicated that preventive maintenance had been provided for the machine by the outside contractor at intervals ranging from 3 months to 14 months. The contracted maintenance provider indicated in an email to the Director of the Radiology Department on 3/23/10 that preventive maintenance was to be performed on the gamma camera four times annually, and he confirmed that 2 of the 4 annual preventive maintenance checks had been missed in both 2008 and 2009 and that maintenance checks had also been missed in the years 2004-2007.