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Based on the manner of standard level deficiencies referenced to the Condition, it was determined the Condition of Participation 484.13, PATIENT RIGHTS, was out of compliance.

A0147 - Standard: Confidentiality of Records: The patient has the right to the confidentiality of his or her clinical records. The facility failed to ensure patient electronic medical records and patient identifiers were safeguarded from unauthorized use.

A0168 - Standard: Restraint or Seclusion: The use of restraint or seclusion must be in accordance with the order of a physician or other licensed independent practitioner who is responsible for the care of the patient as specified under ?482.12(c) and authorized to order restraint or seclusion by hospital policy in accordance with State law. The facility failed to ensure orders were obtained by a physician, or other Licensed Independent Practitioner (LIP), for 2 of 6 patients who were placed in restraints (Patients #6 and #13).

A0174 - Standard: Restraint or Seclusion: Restraint or seclusion must be discontinued at the earliest possible time, regardless of the length of time identified in the order. The facility failed to ensure restraints were discontinued at the earliest possible time in 1 of 6 restraint records reviewed (Patient #12).

A0175 - Standard: Restraint or Seclusion: The condition of the patient who is restrained or secluded must be monitored by a physician, other licensed independent practitioner or trained staff that have completed the training criteria specified in paragraph (f) of this section at an interval determined by hospital policy. The facility failed to ensure patients placed in restraints were monitored and assessed, per facility policy, to ensure the patient's physical and emotional safety in 4 of 6 restraint records reviewed (Patients #6, #11, #12, and #13).

A0213 - Standard: Death Reporting Requirements: - Hospitals must report deaths associated with the use of seclusion or restraint. The facility failed to adhere to death reporting requirements for a patient who expired within 24 hours of vest restraint use.

Based on observations, interviews, and document review, the facility failed to ensure patient electronic medical records and patient identifiers were safeguarded from unauthorized use.

The failure created the potential for unauthorized individuals to gain access to patient electronic medical records and patient identifiers.

Findings:

According to the policy, Sanctions for Privacy and Information Security Violations, examples of violations include improper protection of sensitive information, and failure to properly sign-off a workstation.

According to patient admission documents, patients have the right to a positive care experience in a safe setting that provides personal privacy.

1. The facility staff did not close screens on patient electronic medical records in patient care units to prevent unauthorized use.

a) On 01/20/15 at 9:27 a.m., a tour of the 4th floor, Medical-Surgical Unit, was conducted with the Director of Quality Improvement (DQI). Registered Nurse (RN) #1 entered patient room 4021, leaving the Bedside Mobile Workstation (BMW) unattended in the hallway. The patient's electronic medical record was open on the computer screen and visible to the surveyors.

b) On 01/20/15 at 9:43 a.m., a continued tour of the 4th floor revealed computer #4WPCL, in the nurses station, was unattended and visible to the surveyors in the nearby hall. Information containing diagnostic imaging with patient identifiers was able to be seen on the computer screen.

c) On 01/20/15 at 1:25 p.m., a second tour of the 4th floor was conducted with the DQI. An unattended BMW was observed in front of the door, outside of patient room 4006. The patient's electronic medical record and patient identifiers were visible on the computer screen. RN #5 came out of room 4006 after approximately one minute and closed the screen.

d) On 01/20/15 at 1:31 p.m., an interview was conducted with RN #5 who stated s/he would typically take the BMW into the patient's room when providing care and generally closed down the screen when the BMW was left in the hallway. The RN stated s/he received education and training on protecting patient confidentiality and closing electronic medical record screens when not present with the BMW.

e) On 01/20/15 at 1:37 p.m., an interview was conducted with RN #1 who stated s/he tried to close the computer screens when s/he walked away from the BMW. RN #1 further stated s/he was unaware the computer screen outside of room 4021 was not closed, and the BMW was left unattended in the hallway.

f) On 01/21/15 at 9:55 a.m., an interview was conducted with the Director of the 4th floor who stated confidentially of patient medical records was talked about ongoing at staff meetings. The Director further stated confidentiality of patient medical records, per facility policy, was also discussed during the new hire orientation and on the first day of unit orientation.

Based on interview and document review, the facility failed to ensure orders were obtained by a physician, or other Licensed Independent Practitioner (LIP), for patients who were placed in restraints. No physician or LIP order was found in 2 of 6 medical records reviewed in which patients were placed in restraints (Patients #6 and #13).

This failure created the potential for an unsafe patient care environment in which the responsible ordering physician or LIP was not aware of the patient's medical needs and current health status.

FINDINGS:

According to the policy, Restraint/Seclusion, patient restraints must have an order by a physician or Licensed Independent Practitioner and must include the type of restraint, reason for use, and criteria for removal of restraints. The Registered Nurse (RN) must obtain an order for the restraint of non-violent patients within 4 hours of placement. The RN must obtain a new order for restraints with each restraint episode and each day if patients are in restraints greater than 24 hours. As needed restraint orders are not allowed.

1. The Director of the Intensive Care Unit (ICU) was unaware of the lack of physician or LIP orders for Patients #6 and #13.

a) Review of the medical record for Patient #6 revealed the patient was admitted through the emergency department on 12/11/14 after experiencing cardiac arrest, was sent to the cardiac catheterization lab for stent placement, and was admitted to the ICU at 12:58 a.m. on 12/12/14. Documentation was noted in the medical record that soft wrist restraints were placed by a RN at 2:00 a.m. No order by a physician or LIP was found in the patient's medical record for the restraints. The patient expired in the ICU at 6:45 a.m. on 12/12/14.

b) Review of the medical record for Patient #13 revealed the patient was admitted to the ICU on 10/02/14 after sustaining a hip fracture. An initial restraint order was entered into the electronic system by the unit secretary as a "written" order on 10/05/14 at 12:46 a.m. The actual order was not found in the patient's medical record, although other written orders by a physician were found in the medical record on 10/04/14 through 10/06/14. The patient ultimately expired in the ICU on 10/11/14.

c) On 01/23/15 at 3:35 p.m., the ICU Director was interviewed and stated upon review of the medical record for Patients #6 and #13, s/he was unable to find physician or LIP orders as stated above. The Director stated ICU staff were trained to use the facility's Restraint/Seclusion policy which stated an order must be obtained by a physician or LIP. The Director stated the ICU did not use standing orders for the use of restraints.

The Director stated abbreviated audits of ICU medical records were conducted by nursing staff to look for a variety of requirements in the records. The Director further stated the audits were for short periods of time in each medical record and were not a full review of the records. The Director stated the expectation of nursing staff, per the facility's policy, that restraint orders would be obtained and documented in the medical record of restrained patients was not adhered to. The Director stated s/he was unaware of the missing documentation and did not recognize the lack of documentation as an issue in the unit.

Based on interview and document review, the facility failed to ensure patient restraints were discontinued at the earliest possible time. In 1 of 6 medical records reviewed, in which patients were placed in restraints, there was no documentation that restraints were discontinued (Patient #12).

This failure created the potential for an unsafe patient care environment in which restraints remained present without the necessary physician orders being obtained and without required monitoring by nursing staff.

FINDINGS:

According to the policy, Restraint/Seclusion, patient restraints must have an order by a physician or Licensed Independent Practitioner and must include the type of restraint, reason for use, and criteria for removal of restraints. The Registered Nurse (RN) must obtain a new order for restraints with each restraint episode and each day if patients are in restraints greater than 24 hours. As needed restraint orders are not allowed. Staff shall make efforts to assure that restraint use will be as brief as possible.

1. The Director of the Intensive Care Unit (ICU) was unaware of either the required physician or Licensed Independent Practitioner (LIP) order for restraints, present in patient medical records, or the discontinuation of restraints being documented by nursing staff.

a. Review of the medical record for Patient #12 revealed the patient experienced cardiac arrest, was seen in the cardiac catheterization lab for stent placement, and was admitted to the Intensive Care Unit (ICU). Documentation was present in the medical record stating soft wrist restraints were ordered and placed on the patient in the catheterization lab on 12/19/14 at 3:00 a.m.

Further documentation was found in the record showing the presence and monitoring of the patient and the restraints through 12/19/14 at 6:27 p.m. At this time, an RN documented "continued use of restraints" was necessary, however, no further documentation was found in the medical record that the restraints were present, that the patient was being assessed by nursing staff regarding restraints, or that the restraints had been discontinued. The death summary found in the patient's medical record stated the patient died within 24 hours of restraint use. The patient expired on 12/21/14 at 10:27 am in the ICU.

b. On 01/23/15 at 1:41 p.m., the Director of the ICU was interviewed and stated s/he could find no documentation in the patient's medical record, after 12/19/14 at 6:27 p.m., that the restraints were continued and monitored by nursing staff, per the facility's policy, or that the restraints were discontinued. The Director reviewed the death summary and stated from this document, the patient died while in soft wrist restraints. The Director stated if the restraints remained present on the patient, nursing staff should have noted the presence of the restraints every 2 hours per facility policy and if the restraints were removed by nursing staff, this also should have been documented in the patient's record.

The Director stated abbreviated audits of ICU medical records were conducted by nursing staff to look for a variety of requirements in the records. The Director further stated the audits were for short periods of time in each medical record and were not a full review of the records. The Director stated the expectation of nursing staff, per the facility's policy, that restraint orders would be obtained and documented in the medical record of restrained patients, or that restraints would be discontinued at the earliest possible time and documented, was not adhered to. The Director stated s/he was unaware of this missing documentation and did not recognize this lack of documentation as an issue in the unit.

Based on interview and document review, the facility failed to ensure patients who were placed in restraints were monitored and assessed, per facility policy, to ensure the physical and emotional safety of the patients. In 4 of 6 medical records reviewed of patients who were restrained, there was lack of documentation that patients were monitored and assessed (Patients #6, #11, #12, and #13).

This failure created the potential for an unsafe patient care environment in which the physical and emotional safety and needs of patients were not met.

FINDINGS:

According to the policy, Restraint/Seclusion, the procedure for restraint of non-violent or non-self-destructive patients, stated Registered Nurses (RNs) will monitor and assess patients every 2 hours and document a minimum of 10 items in the patient record, describing the patient's physical and emotional needs while restrained. Vital signs and assistance with meals and snacks will be documented every 4 hours, and personal hygiene and toileting will be documented every 12 hours.

1. The Director of the Intensive Care Unit (ICU) was unaware of the lack of documentation by nursing staff of patient monitoring and assessment of patients in restraints.

a) On 01/21/15, the medical record for Patient #6 was reviewed. The patient was admitted through the emergency department on 12/11/14 after experiencing cardiac arrest, was sent to the cardiac catheterization lab for stent placement, and was admitted to the ICU at 12:58 a.m. on 12/12/14. Documentation was noted in the medical record that soft wrist restraints were placed by a Registered Nurse (RN) at 2:00 a.m. No further documentation was found in the medical record that nursing staff monitored and assessed the patient with regard to the use of restraints. Vital signs were present in the record, per the facility's policy. The patient expired in the ICU at 6:45 a.m. on 12/12/14.

b) On 01/22/15, the medical record for Patient #11 was reviewed. The patient was seen in the Emergency Department on 06/19/14 and was admitted to the ICU at 10:36 a.m. Documentation was found in the record that a restraint vest was placed shortly after admission to the ICU. Beginning 06/20/14 at 2:00 a.m. until 06/20/14 at 8:00 a.m., there was no documentation of RN monitoring and assessment of the patient (a period of 6 hours). Vital signs were present in the record, per the facility's policy. The record revealed the restraint vest was discontinued on 06/20/14 at 8:00 a.m. and the patient expired on 06/20/14 at 2:29 p.m.

c) On 01/23/15, the medical record for Patient #12 was reviewed. The patient experienced cardiac arrest, was seen in the cardiac catheterization lab for stent placement, and was admitted to the Intensive Care Unit (ICU). Documentation was present in the medical record which stated soft wrist restraints were ordered and placed on the patient in the catheterization lab on 12/19/14 at 3:00 a.m. The last RN documentation in the medical record regarding the presence of restraints and the patient's status while in restraints was at 6:27 p.m. on 12/19/14. Vital signs were present in the record, per the facility's policy. The patient expired on 12/21/14 at 10:27 a.m.

d) On 01/23/15, the medical record for Patient #13 was reviewed. The record revealed the patient was admitted to the ICU on 10/02/14 after sustaining a hip fracture. The record revealed soft wrist restraints were placed on the patient on 10/05/14 just after midnight. There was no documentation the patient was monitored every two hours as required. As example,

- Restraint monitoring was documented on 10/06/14 at 4:00 a.m. and then at 8:22 a.m., a period of over 4 hours with no restraint monitoring.

- Restraint monitoring was documented on 10/08/14 at 00:20 a.m. and at 4:00 a.m., a period of over 3 ? hours with no restraint monitoring.

- On 10/09/14 restraint monitoring was documented at 4:00 p.m. and at 8:00 p.m., 4 hours with no restraint monitoring.

Additionally, vital signs for the patient were not found documented in the patient's record and were not provided after requesting all parts of the record be copied and given to the surveyors. The patient ultimately expired in the ICU on 10/11/14.

e) On 01/23/15 at 1:41 p.m., the Director of the ICU was interviewed and stated s/he could find no documentation in the medical records of Patients #6, #11, #12, and #13 of the required RN monitoring and assessment of the restrained patients. The Director stated the expectation of nursing staff, per the facility's policy, that monitoring and assessment would be conducted every 2 hours and documented in the medical record of restrained patients was not adhered to.

The Director stated abbreviated audits of ICU medical records were conducted by nursing staff to look for a variety of requirements in the records. The Director further stated the audits were for short periods of time in each medical record and were not a full review of the records. The Director stated s/he was unaware of this missing documentation and did not recognize this lack of documentation as an issue in the unit.

Based on interviews and document review, the facility failed to adhere to death reporting requirements for the Centers for Medicare and Medicaid Services (CMS). The death of a patient who expired within 24 hours of restraint, by use of a vest restraint, was not reported to CMS.

This failure created a situation in which CMS had no knowledge of a reportable patient death and was therefore unable to investigate the death to ensure the safe application and use of certain patient restraint devices, such as vest restraint.

FINDINGS:

According to policy, Restraint/Seclusion, non-soft wrist restraint deaths will be reported to CMS via telephone, fax, or electronically, no later than the close of the next business day, based on the following requirements; death while in restraints or seclusion (except soft wrist), death within 24 hours after restraints were removed (except soft wrist), and death within 7 days after restraints were removed (except soft wrist). The date and time the death was reported to CMS will be documented in the patient's medical record (within 7 days).

1. The Director of Quality Improvement (DQI) did not contact CMS, and did not direct his/her staff to contact CMS, to report a patient death within 24 hours of the use of a vest restraint.

a) On 01/22/15 at 8:32 a.m., the document titled, "Restraint Death Log," was reviewed. Documented on the log was the death of Patient #11, on 06/20/14, with further documentation that the patient was in a vest restraint prior to expiring. The section of the log which stated, "CMS notified if restraints other than soft wrist were used; Y/N," was marked "N/A." The death was documented on the log on 06/25/14.

b) On 01/22/15 at 2:37 p.m., an interview was conducted with the Patient Safety and Performance Excellence Coordinator who stated part of his/her job role was to keep the Restraint Death Log current. The Coordinator stated s/he obtained information regarding patient deaths, while in restraints or within 24 hours of being in restraints, from the shift managers report which was emailed to him/her each day. The Coordinator stated s/he received training and education regarding completing the Restraint Death Log from his/her previous direct supervisor. The Coordinator stated s/he had not received instruction from his/her previous or current supervisor to look for this type of patient death or to contact CMS to report this type of patient death. The Coordinator stated the log was available on a common computer drive used by his/her department and it was his/her responsibility to keep the log current.

The Coordinator stated s/he was responsible for documenting a note in the medical record of patients who expired while in restraints or within 24 hours of being in restraints, but s/he was unaware of the requirement to document a note in the record stating when CMS was notified of these patient deaths. The Coordinator stated s/he did not attend meetings in which patient restraint use was discussed.

c) On 01/23/15 at 2:40 p.m., and interview was conducted with the DQI who stated s/he was the person responsible for reporting patient deaths while in restraints or within 24 hours of being restrained, to CMS. The DQI stated this reporting was required for patients restrained with devices other than soft wrist restraints. The DQI stated s/he was unaware of the death of Patient #11 until 01/21/15 when the surveyor showed him/her the Death Restraint Log. The Director stated s/he could view the Death Restraint Log on the common computer drive at any time and that s/he typically viewed the log once each month. The Director stated s/he "missed" seeing this death on the Death Restraint Log. The Director stated s/he was aware of the requirement by CMS to report this category of patient death and confirmed the facility's policy, which stated this requirement.

The Director stated "we don't really review the Death Restraint Log" in the Quality Department even though his/her employee, the Patient Safety and Performance Excellence Coordinator, was responsible for keeping the log current. S/he stated instead, cases from this log were reviewed by billing and by the Medical Staff for compliance with the medical component of restraint use.

Based on interviews and document review, the facility failed to act on data collected by the quality department which showed lapses in required documentation for restraint use. This data was not acknowledged by the quality department and used to ensure patient safety for patients in restraints.

This failure created a potentially unsafe care environment for patients in restraints. The lack of required restraint documentation indicated unsafe restraint practices.

FINDINGS:

According to policy, Restraint/Seclusion, the facility collects data on the use of restraints in order to monitor and improve its performance of processes that involve risks or may result in sentinel events. The facility collects restraint data to ascertain that restraints are used only as emergency interventions, identify opportunities for improving the rate and safety of restraint use, and to identify any need to redesign care processes. Data collected will be reported to the Clinical Quality Council.

Patient restraints must have an order by a physician or Licensed Independent Practitioner and must include the type of restraint, reason for use, and criteria for removal of restraints. The Registered Nurse (RN) must obtain an order for restraint of non-violent patients within 4 hours of placement. The RN must obtain a new order for restraints with each restraint episode and each day if patient are in restraints greater than 24 hours. As needed restraint orders are not allowed. Staff shall make efforts to assure that restraint use will be as brief as possible.

1. The Director of Quality Improvement (DQI) did not act upon restraint data obtained by his/her staff from May 2014, through December 2014, that revealed lack of complete documentation of restraint use in the facility.

a) On 01/23/15 at 2:40 p.m., the DQI was interviewed to discuss how the quality department reviewed the use of patient restraints. The Director presented a document titled, "Restraint Review," which s/he stated reflected medical record reviews, conducted by his/her staff, of patients who were in restraints while in the facility.

The document revealed that from May 2014, through August 2014, the medical records of all patients in restraints were reviewed in order to ensure all areas of required restraint documentation was present in the records. From September 2014, through December 2014, the document revealed a sample of at least 10 medical records of all patients in restraints were reviewed.

The areas reviewed for the presence of restraint documentation were: criteria for restraint use, restraint orders received within 4 hours of placement of restraints for non-violent patients, the presence of an order for each day a patient was in restraints, the date and time of the initiation of restraints, and the date and time of the discontinuation of restraints.

Data collected during the medical record reviews revealed the following lapses in documentation:
No documented restraint order within 4 hours of placement of restraints:
May 2014: 8% of records reviewed
June 2014: 5.6% of records reviewed
July 2014: 11/1% of record reviewed
August 2014: 5.9% of records reviewed

No documented restraint order for each day a patient was in restraints:
July 2014: 14.8% of records reviewed
August 2014: 5.9% of records reviewed

No documented date and time of the initiation of restraints:
July 2014: 11.1% of records reviewed
August 2014: 17.6% of records reviewed

No documented date and time of the discontinuation of restraints:
May 2014: 72% of records reviewed
June 2014: 5.6% of records reviewed
July 2014: 22.2% of records reviewed
August 2014: 41.2% of records reviewed
September 2014: 25% of records reviewed
October 2014: 20% of records reviewed
November 2014: 60% of records reviewed
December 2014: 30% of records reviewed

b) During the interview with the Director on 01/23/15, s/he further stated s/he had not given his/her staff expectations or instructions on restraint review or on how the data would be used in the quality department. The Director stated s/he had not directed members of the quality department to review a certain number or percent of medical records each month to confirm restraint documentation was present. The Director stated the data collected was reviewed each month within the quality department but s/he did not respond to the areas identified as lacking restraint documentation, per the facility's policy.

The Director stated the lack of documented discontinuation of restraints in patients' medical records was concerning as one would have to assume patients stayed restrained and restraints could have been present at the time patients' expired. The Director stated s/he did not think about the ramifications of this lapse in documentation and "what it meant" and s/he did not "put the pieces together" with the requirements for restraint use and documentation.

The Director stated the lapses in documentation discovered through medical record reviews of restrained patients were not reported to the Clinical Quality Council as required by the facility's policy.

Based on observations and interviews, the facility failed to supervise the nursing care provided to patients on a Medical-Surgical Unit of the facility. Patient medications were observed in public hallways, unattended by nursing staff.

These failures created the potential for negative patient outcomes. Medications left in a public hallway, unattended, could have been tampered with or could have been taken by unauthorized persons.

FINDINGS:

1. Registered Nursing staff (RNs) left patient medications unattended in public hallways on patient care units.

a) On 01/20/15 at 9:27 a.m., the 4th floor, Medical-Surgical Unit was observed with the Director of Quality Improvement (DQI). RN #1 was observed placing patient medications, which were labeled with the patient's name and other identifiers, on top of a Bedside Mobile Workstation (BMW), outside of patient room #4021 (Patient #16). RN #1 left the BMW unattended in the hallway, entered the patient's room in order to meet with the patient's physician, and closed the door to the room. The RN was in the room for 5 to 6 minutes. One of the medications left unattended was a 500 mg/ml solution of Metronidazole, to be administered intravenously. The second medication was a 5 mg tablet of Amlodipine.

b) On 01/20/15 at 1:37 p.m., RN #1 was interviewed and stated the BMWs no longer had locking drawers under the top, computer workstation of the cart, on the 4th floor. RN #1 stated, because there were no drawers on the portable carts, nurses placed patient medications on top of the carts prior to administering the medications. RN #1 stated s/he should have taken the cart into room 4021 instead of leaving the cart and medications in the hallway, unattended. RN #1 stated s/he could also have placed the patient's medications back in the medication room and stored them securely in this locked room until s/he could administer them. RN #1 stated his/her training was to always keep patient medications secured until time to administer the medications.

c) On 1/20/15 at 9:29 a.m., the 5th floor, Medical-Surgical Unit was observed with the Director of Quality Improvement (DQI). At 10:15 a.m., at the back pod of patient rooms, a BMW was observed with patient medications on top of the workstation, unattended, in the public hallway. A RN was observed inside the nearby patient room. One of the medications observed on top of the cart was insulin.

d) On 01/21/15 at 8:55 a.m., the 4th floor, Medical-Surgical Unit was observed with the Quality Performance and Improvement Coordinator. RN #6 was observed administering medications to the patient in room 4020. After medication administration was completed, RN #6 rolled the BMW from the patient's room into the hallway, and walked away from the cart leaving a medication, eyedrops, unattended on top of the cart. RN #6 stated s/he should have taken the eyedrops back to the locked medication room until time to administer the drops in order to secure the medication. RN #6 stated this was the unit's process and was typically what s/he would do to secure medications.

e) On 1/21/15 at 9:44 a.m., the Director of the 4th floor, Medical-Surgical Unit was interviewed. The Director stated RNs received education and training regarding the security of patient medications on the 4th floor patient care unit. The Director stated that recently, s/he had the storage drawers on the BMWs on the 4th floor removed because medications were found remaining in the drawers after RN shifts. The Director stated removing the drawers was part of his/her attempt to reinforce expectations regarding RN medication administration practices. The Director stated patient medications could be placed on the top of the BMWs prior to medication administration, for 1 patient at a time, but that RNs should never leave the medications unattended. The Director stated RNs were also trained to take patient medications back to the locked medication room for storage if unable to administer the medications as planned.