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Based on review of documentation and staff interviews, the governing body failed to ensure services were rendered in a safe and effective manner. The facility failed to provide care in a safe setting for 2 of 19 intensive care patients reviewed as facility staff failed to appropriately monitor the patient's vital functions.


Facility staff failed to set alarm parameters appropriately and ensure that alarms were audible which contributed to a cardiac arrest in the case of patient #1 on 1/14/18 and a delay of care in patient #2 which occurred on 5/17/18. The case of patient #1 was complicated by a monitor technician, staff #20, failing to recognize and report the patients deteriorating condition. Random bedside monitor alarm monitoring conducted by the nursing manager, staff #21, revealed monitors which needed the volume increased to maximum on 2/28/18 and 6/5/18.


Despite the serious adverse event on 1/14/18 where ICU cardiac monitors did not alarm appropriately, the facility failed to have all the ICU monitors inspected by biomed until 4/2/18 except the monitor of patient #1 which was inspected 1/26/18. Patient #1 expired on 1/7/18. These factors contributed to an unsafe setting for intensive care patients.
Cross refer: CFR 482.13(c)(2) Patient Rights: Care in a Safe Setting


In addition, the governing body failed to ensure that the facility notified a family or legally authorized representative of an unanticipated outcome event.


Findings included:


A review of the daily progress note dated 1/15/2018, at 11:56 am, by Staff #3 in the medical record for Patient #1 stated in part, "Interval History: Events from yesterday noted, Unfortunately the patient sustained a cardiac arrest. Since then, over the last 24 hours he has remained unresponsive. We had a detailed family meeting today. The patient's medical power of attorney, his brother (name), along with other family members including his common-law spouse were all in the unanimous agreement that given the patient's significant clinical setback, and his lack of responsiveness on mechanical ventilation, that he would not want continued prolonged mechanical ventilation under the circumstances. In addition indicated that he would not want repeated attempts at resuscitation. As result, we have changed his CODE STATUS to DO NOT RESUSCITATE. We have also placed a consultation for hospice. The family indicates that they would like to focus on his comfort at this time and are considering taking him off of mechanical ventilation."


Review of the Patient Safety Event report on 7/31/18 for Patient #1 revealed that a Serious Patient Safety event occurred on 1/14/2018 at 0923. Reported event was "Monitor tech alerted nurse telemetry was showing asystole at 0923. Two nurses entered the room discovered the patient was blue and disconnected from the vent at the trach site, no vent alarms were sounding. Code Blue initiated, ROSC (return of spontaneous circulation) was achieved at 0932." Review of the medical record for Patient #1 revealed that he died on 1/17/18 at 2324.


There was no documented evidence in the medical record that the family or legally authorized representative was notified of the unanticipated outcome event which resulted in the cardiac arrest of Patient #1. There was no documentation in the medical record of reasons for deferring disclosure of the unanticipated outcome, per the facility policy requirement.


A request was made of the Administrator the morning of 8/1/18 in the facility conference room for an opportunity to interview the physician responsible for communication of unanticipated patient outcomes for Patient #1. At 10:48 am on 8/1/18 in the small conference room, a conference call was arranged with Staff #3, with the Administrator in attendance placing the call. Staff #3 was asked about his involvement with Patient #1 and the notification of the significant unanticipated outcome which occurred on 1/14/18. Staff #3 stated that any communication he conducted was in his notes, that he was not the only physician and not the attending physician for Patient #1, and that he did not know of any unanticipated outcomes prior to when he came on the case as he was a critical care consultant for the patient in the after math of the cardiac arrest. Staff #3 stated that "I cannot say that I understood what or how or why it happened" and that his note (medical record note) would document the full extent of his involvement in the case.


After the conference call was discontinued, Staff #34, the Administrator stated that, "We have not had the family conference." Staff #34 stated that the facility had concerns and the "attorney recommended that we take it slow." Staff #34 stated that this "goes to the Board next week" and that the call to the family will be scheduled.


Facility policy, "System_PCPS003 Communication of Unanticipated Patient Outcomes" Date Revised/Reviewed: 08/31/2016, stated, in part, "I. POLICY/GENERAL STATEMENT, Patients, and when appropriate, their families and other decision-makers shall be informed of all aspects of their care and treatments, including unanticipated outcomes.

Unanticipated outcomes that trigger a discussion per this policy should meet one of two criteria:

(1) An outcome that would not be included in a reasonable informed consent process for treatment of the patient's condition(s) and/or would not be expected during the usual course of treatment; or

(2) An outcome that may have been caused by human or system error (considered a preventable unanticipated negative outcome). The responsible physician has the primary responsibility for ensuring that the patient is informed about outcomes of care/treatment.

II. DEFINITIONS

A. Discussion: Communication of information regarding the results of a diagnostic test, medical, surgical or other interventional treatment.

B. Harm: an injury to the patient during course of treatment and not related to the patient's underlying disease.

C. Harm Scores: Numerical scores assigned to describe the severity of the harm associated with an event. These range from "1" which is the most minor to "9" which is death.

D. Responsible physician: The responsible position is identified as the physician of record and is responsible for the care and supervision of each patient in the hospital for whom they are providing services. The responsible position may be the attending physician, primary attending physician, primary physician, admitting physician or consulting physician.

E. Unanticipated Outcome: An event or result that is not typically associated with the patient's underlying disease.


III. PROCEDURE FOR DISCUSSION OF UNANTICIPATED OUTCOME

A. The responsible physician, department chair and/or the hospital representative are charged with ensuring communication about and apology for the unanticipated outcome to the patient, family or other decision makers. If more than one physician or department is involved, the providers may collaborate. Under some circumstances, a multidisciplinary team may meet to discuss the event and develop a plan for effective communication. Consultation may be obtained from: Chief or Chair of Service, responsible executive, Claims & Litigation, Chief Quality Officer or Patient Safety Officer.

B. Initial disclosure should take place as soon as the unanticipated event is discovered and factual information is obtained. If the patient has impaired decision-making capabilities, disclosure may be made to authorized medical decisions (sic) makers. Special consideration should be made with regard to the potential psychological impact of the disclosure.

C. Disclosure may be deferred to a more appropriate time, but should be initiated no later than the time of discharge. Reasons for deferred disclosure should be documented.

D. Disclosure will include a description of the outcome and a commitment to determine how the event or result occurred.

E. Patients and/or family will be given time and opportunity to ask questions.

F. Documentation of the discussion should include:

-Time, date, and place of discussion,

-Names and relationships of those present at the discussion,

-The discussion of the event,

-Patient reaction,

-Questions asked by the patient or family and responses to the questions, and

-The level of understanding exhibited by the patient and/or family member and/or patient's representative.

G. Follow-up discussions will occur as information becomes available. This includes causation of the event/result.

H. For harm scores 6 through 9 (see Attachment A) the Responsible Physician or designee should discuss the events with appropriate hospital management.

I. A Patient Safety Network report shall be completed.


Attachment A

PATIENT OUTCOME CATEGORIES

Harm Scoring System Used by UHC Patient Safety Net

Harm

9: Death - Dead at time of assessment.

8: Severe permanent harm - Severe lifelong bodily or psychological injury or disfigurement that interferes significantly with functional ability or quality of life. Prognosis at time of assessment.

7: Permanent harm: Lifelong bodily or psychological injury or increased susceptibility to disease. Prognosis at time of assessment.

6: Temporary harm: Bodily or psychological injury, but likely not permanent. Prognosis at time of assessment ...."

The above findings were confirmed with the facility Administrator the morning of 8/1/18 in the small conference room.

The Houston Methodist St. Catherine Performance Improvement Plan 2017 provided to the survey team stated on page 17,


"7. PATIENT SAFETY PROGRAM ...

Disclosure of Unexpected Serious Safety Events - Adverse events will be disclosed to the patient and/or the patient's legally authorized representative in accordance with the System_PCPS003 Communication of Unanticipated Patient Outcomes."


The Houston Methodist St. Catherine Performance Improvement Plan 2017 provided to the survey team stated on pages 5-6 that, "1. Board of Directors Houston Methodist Board of Directors has ultimate responsibility for ensuring the quality of patient care services and operational performance of the Houston Methodist System Entities including receipt of reports at least annually."


The above findings were confirmed in an interview with the facility Administrator the morning of 8/1/18 in the small conference room.

Based on review of documentation and interviews with facility staff, the facility failed to provide care in a safe setting for 2 of 19 intensive care patients reviewed. The facility staff failed to appropriately monitor the patient's condition. Facility staff failed to set alarm parameters appropriately and ensure that alarms were audible which resulted in a cardiac arrest in the case of patient #1 on 1/14/18 and a delay of care in patient #2 which occurred on 5/17/18.


In the case of patient #1, a monitor technician, staff #20, failed to recognize and report the patient's deteriorating condition. Random bedside monitor alarm monitoring conducted by the nursing manager, staff #21, revealed monitors which needed the volume increased to maximum on 2/28/18 and 6/5/18. Despite the serious adverse event on 1/14/18 where ICU cardiac monitors did not alarm appropriately, the facility failed to have all the ICU monitors inspected by biomed until 4/2/18 except the monitor of patient #1 which was inspected 1/26/18. Patient #1 expired on 1/7/18. These factors contributed to an unsafe setting for intensive care patients.


The findings were:


The electronic medical record (EMR) of patient #1 from 9/8/17 to 1/17/18 was reviewed with the assistance of RN, staff #24, on 7/31/18. The medical record of patient #1 contained a death summary dated 1/18/18, 0330, by a physician, staff #4, that reflected the patient as a 63-year-old male, who developed gradual progressive weakness since 3/17 after suffering a flulike illness after a flu vaccine in 10/16. He presented to the hospital 5/17 when he was too weak to walk and required BIPAP (Bilevel Positive Airway Pressure) for respiratory support. He experienced respiratory failure, was transferred to another hospital and was intubated. He was extubated but continued to require nasal BIPAP. His diagnosis was felt to be CIPD (Chronic Inflammatory Demyelinating Polyneuropathy) versus another progressive motor neuropathy.


He was transferred to a LTACH (Long Term Acute Care Hospital) and had made improvements with initial therapies including beginning to ambulate. He then was transferred for inpatient rehabilitation. He ended up having chronic hypoxic respiratory failure, was unable to wean off of BIPAP requiring tracheostomy performed 8/18/17 at a hospital. Post-op, he required admission to MICU (Medical Intensive Care Unit) on ventilator support. He was transferred to this LTACH facility on 9/8/17 for continuation of care management. He was unable to be weaned off the ventilator and deemed ventilator dependent. While awaiting placement, he had a cardiac arrest during his stay, and was unresponsive after that. Family decided to pursue hospice. He was taken off the ventilator and expired. The medical record of patient #1 contained a nursing note by RN, staff #18, dated 1/14/18 1100: "Patient code for asystole, compressions were in progress by physician, staff #1, when I arrive in the room at 0915 (according to the patient room wall clock). RN, staff #19, was the one who first responded. According to her patient vent was disconnected & no audible alarm when she arrived. Patient was unresponsive."


From nursing flowsheet for 1/14/18 by RN, staff #18 (! Indicates alarm)

0700: 121/70; HR (heart rate) 61; sat (oxygen saturation) 100

0800: 118/67; 98.2; HR 56; sat 100

0815: HR 56 (only parameter recorded)

0847: sat 98 (only parameter recorded)

0900: 115/68; HR 73 (only parameters recorded)

0930: 41/20!; HR 22!; sat 77!

0935: 79/39!; HR 127; sat 92

0940: 120/58; HR 149; sat 96

0945: 127/60; HR 152!; sat 99


From Nursing Flowsheet for 1/14/18 by RN, staff #18

0705: "Alarm Set and Audible"

0815: "Alarm Set and Audible"

0900: "Alarm Set and Audible"

1000: "Alarm Set and Audible"


From Code Sheet (scanned paper form) recorded by RN, staff #23: Code Blue called 0919

0919: rhythm PEA (pulseless electrical activity) rate 36; Epinephrine 2.5 mg

0920: PEA rate 31; Epinephrine 1 mg

0921: PEA rate 31; Epinephrine 1 mg

0924: PEA rate 77; 158/58; Epinephrine 1 mg

0926: PEA rate 49; 41/20

0928: pulse palpable rate 102

0930: pulse palpable rate 121; 55/--

0931: pulse palpable rate 132; 80/42

0932: pulse palpable rate 142; 89/47

0935: pulse palpable rate 152; 120/56


In an interview with RN, staff #24, on the afternoon of 7/31/18 in the conference room, staff #24 was asked if there was any other documentation of vital signs for the morning of 1/14/18 in the EMR of patient #1. Staff #24 stated, there was no other documentation of telemetry in the EMR. Staff #24 stated that the telemetry monitoring techs use a manual log. In another interview with RN, staff #24, on the afternoon of 7/30/18 during a tour of the ICU, staff #24 stated that blood pressure, heart rate and respirations alarms at the bedside monitor and at the nursing station monitored by the telemetry techs. Staff #24 stated that alarm parameters were set based on patient baselines according the judgement of the nurse caring for the patient. Staff #24 stated that vital sign data was automatically fed into the EMR, but the nurses had to validate the data for it to become part of the permanent record.


A telephone interview was conducted with monitor tech, staff #20, on 7/31/18 at approximately 10:50 am. Staff #20 was asked what happened during 0850 - 0923 on 01/14/18 in regards to patient #1's care and telemetry monitoring. Staff #20 stated, "I do strips around that time. The strips take between 45 minutes to 1 hour. I have to physically print out the strips." Staff #20 stated that he has to review the strips and re-measure to make sure they are correct. Staff #20 stated, he was distracted with the strips and that he was mostly monitoring the heart rate rhythms of the patients. Staff #20 stated, he failed to monitor the oxygen saturation for patient #1. Staff #20 stated, "When I saw patient #1's reading had a long pause between two complexes I immediately told someone to go into the room. The nurse went in his room and found that his ventilator was disconnected and he was unresponsive. She called a code blue and I called the code blue over the overhead system."


An interview was conducted with RN, staff #18, 7/31/18 at 11:00 am in one of the conference rooms in the administration office. Staff #18 said, she was assigned to patient #1 and on the morning of 1/14/2018, she made rounds with the outgoing 7p-7a nurse, spoke to patient #1 who was talkative with no complaints. She said, she assessed the readings from the GE monitor but she did not assess the GE monitor alarms. She said she cannot assess the ventilator alarms, that is done by the RT. She went on to checking her other patients who were in the process of eating breakfast. Staff #18 stated, she went to patient #1's room after breakfast because he liked to take his medication after breakfast. When she arrived in the room the oxygen saturation was 87%, the tape was loose; she retaped the tubing and the sat went up to 100%. Staff #18 said she went back to preparing her medications. While in process of preparing for medicine pass she heard code blue. Staff #18 said she responded to the code and found patient #1 unresponsive. Staff #18 said the ventilator alarms did not work.


An anonymously submitted incident report involving patient #2, occurrence date 5/17/18 1530 reflected in part, "Event Detail: I saw patient son come to the door of room 242. I asked if I could help him. She said that patient needs suctioning, he is trying to cough ...Staff at desk informed patient's primary RN so as I was walking to the room, RN also came. The son said the saturation is 79% and not coming up. Since RN went to suction the patient, I came to the tele monitor to check when the saturation started to drop. There were no audible or visual alarms going off to alert the RN or the monitor tech. Immediately, the beside monitor was checked for the alarm set up and found it was set to low limit for 74%. Alarm limits were corrected in the room." A note in the incident report by ICU/IMU manager, staff #21, dated 5/18/18 0918 reflected in part, "manager checked all room for bedside monitor alarm limits and volume, all other rooms had alarms set, 3 rooms volume need to be increased from 8 to 10."


An interview was conducted with ICU/IMU nurse manager, staff #21, at 9:40 am 7/31/18 in the conference room. Staff #21 said, she performs random checks for GE monitoring in ICU. She stated in-services were performed 2/22/18 for GE monitoring training after the incident involving patient #1. Staff #21 stated, the nurses were instructed the volume level for the GE monitor should never be below 10. Staff #21 stated, she performs random checks verifying the monitor is on the correct setting. Staff #21 did not have a process or procedure for the random checks. One random check was performed in 2/18 and 3/18. 4 random checks were performed on 4/18. Two on 5/18 and 6/18, and one on 7/18. The random checks did not record the time the checks were performed. The random checks of the GE monitors revealed that RN, staff #23, failed to increase the alarm volume to maximum on 2/28/18 and staff #18 failed to increase the alarm volume to maximum on 6/5/18.


Staff #21 stated, the weekly huddle is used for communication with staff. The staff not present receives the weekly huddle in their emails. Review of the weekly huddle meetings 01/20-07/22/18 stated, alarms are to be checked at bedside shift report. Alarm volumes must be at 10. Weekly huddle 4/23/18, 5/6/18, 5/21/18, stated Patient safety: Vent alarms being ignored. Not answering call lights in a timely manner. 5/21/18, 5/29/18, highlighted in yellow; all alarms on monitors must be ON at all times. Check at Bedside shift report. Alarm volumes must be at 10. SPO2 limit should NOT be set <88%. Staff #21 said, she has developed "Bedside Shift Report Inpatient Areas" form for rounding, effective August 2018. The form included section reminding the nursing staff to check and confirm bedside monitor alarm settings and volume.


The facility policy entitled "Centralized Telemetry Monitoring" System_PCPS129 revised/reviewed date 8/17 reflected in part, "Monitor alarms will be on at all times. Alarm limits will be set according to default values and to the individual patient needs ...Monitor Tech or telemetry tech may consult with the RN to change alarm limits as indicated by patient trends and individual tracings. Adjustments will be approved by the RN. The telemetry tech or Monitor Tech will use the following levels to guide communication with the nurse caring for the patient ...Level One Alarms, a. Escalation Plan to include up to a "Code Blue" ...to rapidly assess a patient with the following rhythms ...Asystole ...Level Two Alarms Notifications, The Monitor Tech or telemetry tech will notify the nurse regarding the EKG change via the nurse's communication system ...Level Two Alarms ...f. brady-dysrhythmias (slow heart rate) ...k. Systolic blood pressure <90 ...p. O2 saturation <90%..."


Review of the biomedical records for the GE/CARESCAPE B650 Physiological Monitors in use in the ICU revealed that the monitor in use by patient #1 had a biomedical inspection on 1/26/18 and the record reflected "Checked out alarm function, No Failure." The record reflected the GE/CARESCAPE B650 Physiological Monitors in use in the ICU "PM completed and passed, No Failure" with open date of 4/2/18 and close dates ranging from 5/4-31/18.


In an interview with biomedical inspector, staff #29, and the director of facility services, staff #30, on 7/31/18 at 11:30 am, staff #29 reviewed the maintenance records for biomedical checks for the facility's medical equipment with the surveyor, confirming that all the facility cardiac monitors were inspected beginning on 4/2/18. Staff #30 also clarified that the staff can adjust the cardiac monitor alarm volume and only the biomed department can set the default minimum volume using a maintenance code.


The facility policy entitled Clinical Alarm Systems # System_PCPS125 with an effective date 9/25/15 reflected in part "D. Patient caregivers will verify that the alarm is on, volume is appropriate for the setting and that parameter limits are appropriately set ... F. Alarms may be temporarily disabled or silenced only in the following situation. 1. The patient caregiver is immediately available to investigate the cause of the alarm. 2. The patient caregiver will immediately assess the clinical condition of the patient. When alarm condition is eliminated, the patient caregiver will validate that the alarm is on, volume appropriate, and that parameter limits are appropriately set."


Review of the facility report "LTAC East Random Bedside Monitor Alarm Monitoring" revealed that on 6/26/18 and 7/17/18 four patient rooms were audited and there were no issues documented with the bedside cardiac monitors.


A tour of ICU was conducted on the morning of 8/1/2018, accompanied by nursing manager, staff # 21. Four patients with ventilators and GE cardiac monitors were observed. At the time of the tour the alarm volumes on the GE cardiac monitors and the ventilators were on and turned up to appropriate volume settings. The respiratory therapist assigned to ICU demonstrated the volume accuracy.

Based on interview and document review, the Governing Body failed to ensure the facility implemented and maintained an ongoing, data driven Quality Assessment and Performance Improvement program. Review of the facility's patient safety event reports revealed that the facility failed to ensure that serious patient safety events were reported immediately or completed via the facility system as there were incomplete reports and reports which were inaccurate. The facility failed to ensure that a facility event report was initiated immediately or upon discovery of a serious patient safety event and failed to complete the report. The facility failed to ensure that action plans after a serious patient safety event had a timeline and failed to monitor the resulting action plans. Facility safety event reports were incomplete and managers did not document review of the events, resulting in 36 incomplete and overdue patient safety event reports.


Findings included:


Patient Safety Event reports provided to the survey team were reviewed with Staff #11 on 7/31/18 in the conference room.


Review of the Patient Safety Event report for Patient #1 revealed that a Serious Patient Safety event occurred on 1/14/2018 at 0923, Reference number SI-60394. Reported event was "Monitor tech alerted nurse telemetry was showing asystole at 0923. Two nurses entered the room, discovered the patient was blue and disconnected from the vent at the trach site, no vent alarms were sounding. Code Blue initiated, ROSC (return of spontaneous circulation) was achieved at 0932." This event that occured on 1/14/18, was not reported or entered into the system immediately or upon discovery of the event as required by facility policy. The event was not entered into the system until 5/16/18 at 12:35.


In an interview with Staff #11, Performance Improvement Coordinator, on 7/31/18, she stated that no one ever entered the event into the facility system at the time it occurred, so she entered it in May. The event report was reviewed with Staff #11, which revealed that the report was incomplete and had not been reviewed or completed as of 7/31/18 for the event which occurred on 1/14/18.


Review of the report SI-60394 revealed that the "Harm Score" entered into the system on 5/16/18 was "6 - Temporary harm" even though the patient suffered a cardiac arrest on 1/14/18 due to the event, never gained consciousness and died on 1/17/18 per the medical record. When asked by the survey team about the harm score, Staff #11 stated that the harm score was "7" for "permanent harm" and indicated that "7 permanent harm" was written in pencil on the form, however, the form in the system was not updated to indicate that the harm score was "9 - Death" per the investigation. Review of facility documentation of the Serious Safety Event revealed a documented Harm Score of "9 - Death". Staff #11 confirmed that the entry in the system was still incorrectly entered "6- Temporary harm".


The "Harm Score" section of the report SI-60394 was incomplete, as the question, "Was any intervention attempted to prevent, reverse, or halt the progression of harm?" was left blank. The space for "Nature of injury" was left blank.


The section entitled, "Misc Info" of the report SI-60394 was left blank and was incomplete, including responses to "Who was notified?" Does the event involve a RESEARCH device or equipment? What is the age of the person involved?"


The section entitled, "Manager Review for Event" of the report SI-60394 was incomplete and left blank, including responses on the form for the questions, "What was the remedy or corrective action plan to reduce the likelihood for its recurrence? How preventable was the incident? Assessment of Additional Costs Incurred, Probability of event recurring, Severity of effect resulting from recurrence of event." Contributing factors notes were left blank and was incomplete.


The "Event Detail" for the report SI-60394 stating, "Describe any factors contributing to the event, lessons learned, and/or recommendations to prevent recurrence" was left blank and was incomplete.


The Q/R Manager Review fields were left blank and therefore incomplete for the following items:

Does this qualify as a Serious Safety Event? Yes/No

Does this qualify as an NQF (National Quality Forum) event? Yes/No

Does this qualify as a Texas DSHS Preventable Adverse Event (PAE)? Yes/No

Root Causes Select All that apply (there were no root causes selected on the form).

There were no items selected on the form.


During a review of patient safety event reports selected for sample by the survey team the afternoon of 7/31/18 in the facility conference room, 3 out of 7 event reports reviewed by the survey team had not been completed by 7/31/18, as follows:


SI-55467 - reported date 2/12/18 at 16:58; status on 7/31/18 was "Additional manager reviews" which was incomplete. Reported event was, "call light in CCU AND ICU front 237 was place on night mode sound to laud, vents did not alarm in those areas." On 2/12/18 at 16:58, an email notification was sent to the Nurse Manager, the Director of Patient Care, and the Manager-Nursing LTACH. On 3/8/2018 at 9:23:02, the Director of Patient Care added a note to the nurse manager and the respiratory manager which stated, "Did we resolve or address this concern". There was no documented follow up for SI-55467 to determine if the event was reviewed, investigated, resolved, or completed. The report form was incomplete. Current approval status on 7/31/18 was "Additional manager reviews".


SI-59884 - reported date 5/5/18 at 17:28; status on 7/31/18 was "Additional manager reviews" which was incomplete. Reported event was related to a patient's unplanned extubation discovered with O2 sats in the mid 70's. On 5/5/18 at 17:28, an email notification was sent to the Respiratory Manager, Nurse Manager, Director Patient Care, Manager-Nursing LTACH and others. On 5/6/18 at 19:18, the Director of Patient Care added a note to the nurse manager which stated, "[Name] - please investigate and enter your findings." On 5/7/18, the Respiratory Manager responded to the event in a note. There was no documented follow-up for SI-59884 by the nurse manager to determine if the event was reviewed, investigated, resolved, or completed. The report form was incomplete. Current approval status on 7/31/18 was "Additional manager reviews".


SI-60590 - reported date 5/20/18 at 17:48; status on 7/31/18 was "Additional manager reviews." Reported event was rapid response team initiated for a patient with agonal breathing and difficulty breathing and O2 sat of 61%. On 5/20/18 at 17:48, an email notification was sent to Pharmacy staff/managers, Respiratory managers, Nurse Manager, Director of Patient Care, Manager-Nursing LTACH. On 5/20/18 at 17:57, Respiratory manager entered a note about the patient's order. On 5/20/18 at 19:27, Director-Patient Care added a note to the nurse manager to "please investigate" and entered a question about rounding to the Respiratory manager. There was no documented evidence that the nurse manager investigated or the respiratory manager responded to the question about rounding. On 6/6/18 at 13:42 the Director of Pharmacy "reviewed" the event entry.
On 6/23/18 at 12:10, the Pharmacy Manager "reviewed" the event entry. There was no documented follow-up for SI-60590 by the nurse manager, respiratory manager, or pharmacy manager to determine if the event was reviewed, investigated, resolved, or completed. The report form was incomplete. Current approval status on 7/31/18 was "Additional manager reviews".


In an interview with Staff #21, Nurse Manager, the morning of 8/1/18 in the facility conference room, she stated that she did not always enter the results of her investigation or her follow up, stating that she "just took care of it."


In an interview with Staff #11, Performance Improvement Coordinator, the afternoon of 7/31/18 in the facility conference room, when asked when the event reports reviews should be addressed by management, she stated "around 2 weeks." Staff #11 stated that an email is sent out to the managers to complete the entries, however that is the only follow up. Staff #11 provided an email dated 7/31/18 with an attachment listing all the overdue event reports as follows:


Review of a report of 36 overdue, incomplete event reports included the following:

(Highlighted red) Greater than 180 days to 90 days: (from 1/11/2018 to 4/23/2018) there were 22 incident event reports which had not been completed.

(Highlighted red) Greater than 60 days: (from 5/5/2018 to 5/21/2018) there were 9 incident event reports which had not been completed.

(Highlighted yellow) Greater than 30 days: (from 6/6/2018 to 6/30/2018) there were 5 incident event reports which had not been completed.


Also attached to the report was a list of managers to whom reminder emails to for the managers to complete event reports had been sent on February 15, March 5, April 9, May 14, and July 31 of 2018.


Review of the "Medical Equipment Management Plan" provided to the survey team the morning of 7/31/18 revealed the following:

"d. Employees are responsible for reporting adverse occurrences as outlined in the Patient/Visitor Event Reporting Procedure, PC/PS38. The Safety Intelligence, computerized reporting system is used to report all adverse occurrences. For occurrences that involve medical equipment or devices, employees should follow the steps:

· Immediately remove the device from service. Sequester the equipment, supplies and accessories.

· Tag the sequestered items with an Equipment Repair/PSN STARR tag. Do not clean or change control settings.

· Place the sequestered items in a secure area and hold for Biomedical Engineering

· Report the event in Safety Intelligence/PSN

· Report as a "PSN Event" to Biomedical Engineering by calling Central Dispatch at [phone number]...

· Biomedical Engineering will receive any Safety Intelligence/PSN reports that involve medical equipment and will investigate the incident, and complete the Ancillary Manager section of the report providing information found during the investigation."


Review of the Patient Safety Event report for Patient #1 revealed that a Serious Patient Safety event occurred on 1/14/2018 at 0923. Reported event was "Monitor tech alerted nurse telemetry was showing asystole at 0923. Two nurses entered the room, discovered the patient was blue and disconnected from the vent at the trach site, no vent alarms were sounding. Code Blue initiated, ROSC (return of spontaneous circulation) was achieved at 0932." Review of the medical record for Patient #1 revealed that he died on 1/17/18 at 2324.


The event report was not reported or entered into the system until 5/16/18 at 12:35 for an even which occurred on 1/14/18.


Review of the event report revealed that Biomedical Engineering was not notified of the event involving medical equipment or devices, including a ventilator alarm that was reported disabled and a cardiac monitor that reportedly did not alarm during a serious patient safety event.


In an interview with Staff #29, contracted Biomedical Inspector, and Staff #30, Director, Facility Services, at 9:20 am on 7/31/18 in the facility conference room, Staff #29 stated that if there is an incident or a problem with equipment, the piece of equipment will be taken out of service and sequestered. When asked who makes the decision for sequestering medical equipment, Staff #29 stated that, "Quality/Risk determines what equipment will be sequestered." Staff #29 stated that there were no vents sequestered in the last year and that he was not notified to sequester any vents in the past year. Staff #29 stated that, "We were not made aware that there was an incident." Staff #30 stated also, "We were not notified there was an incident."


Staff #22, Respiratory Care Manager, was interviewed in the conference room on the afternoon of 7/30/18, at approximately 3:30 pm, by the survey team. Staff #22 was asked if biomed had checked the ventilator in use with Patient #1 and she stated, she notified biomed by e-mail on 1/26/18 after he had been taken off of it. She stated, biomed found no issues with the ventilator. She was asked if the ventilator was used for another patient and she stated, it was not used again until biomed checked it. Staff #22 was asked if they had biomedical records for that ventilator and she stated, she would get them.


Staff #22 was interviewed again in the conference room on the morning of 7/31/18, at approximately 9:00 am, by the survey team. Staff #22 showed the biomedical record for the Hammed/C1 ventilator, control number 403332779 that Patient #1 was using. She stated the record showed that she asked biomed to check out the machine on 1/26/18 and the work was complete on 2/6/18. She stated, the report showed the machine passed all passed all pre-checks except CO2 (carbon dioxide) and needed a cable replaced which was done. She was asked what the CO2 function was, and she stated it measures end tidal carbon dioxide which is not a mandatory parameter. She stated the end tidal CO2 is not set by the ventilator but just monitored.


Review of the medical record for Patient #1 revealed that the date of death was 1/17/18, however the ventilator was not reported to the biomedical department until 1/26/18. Per Staff #29, the ventilator was not immediately sequestered per facility policy.


In an interview with Staff #11, Performance Improvement Coordinator, on 7/31/18, she was asked if the Biomedical department was involved in the RCA or investigation, to which she replied, "No." When asked if staff from the Biomedical Department was consulted at all about the equipment during the investigation, Staff #11 stated, "No." When asked if the ventilator used by Patient #1 was sequestered per the Quality Department, Staff #11 stated, "No."


The facility root cause analysis action plan was reviewed with Staff #11 on 7/31/18 in the conference room and notes were taken of the plan. The action plan revealed an action item for nursing management to "check all bedside alarm monitors for volume alarm settings" and to educate all staff to "keep alarm levels on at high settings." The facility action plan stated, "Checked monitor, contacted [biomed contractor] to check all bedside monitors." The plan stated that staff were educated about checking bedside monitor alarm settings, with "ongoing evaluation with skills performance and competency; visual observation by nursing leadership for bedside alarm setting." Action Plan included "Nursing mgmt. reinforced to all staff that bedside alarms should not be turned off or lowered volume; bedside shift report to include alarm check; and random alarm audits by manager."


Review of the action plan revealed that there was no timeline for when the plan would be implemented or reported to whom, and no strategies for measuring the effectiveness of the actions. The action plans included items such as, "conduct audits," "verify responsiveness," "review reports," "develop training plan,, "discuss at future meeting," and "education and training when checklist is ready". In an interview with Staff #11 regarding the lack of a timeline for reporting and reporting accountability of these items on the action plan to measure the effectiveness of the actions, Staff #11 confirmed the action plans did not have a time line and stated, "That's a good idea" and stated that she would start adding a timeline to the action plans. When asked if she conducted any type of follow-up on the items in the action plan or required managers to report back on assignments from the action plan, Staff #11 stated, "I'm going to do that" and "That's what we're going to do." Staff #11 confirmed that there was no required reporting or follow up on the assigned action items, resulting in a lack of oversight of the action plan.


In an interview on 8/1/18 in the small conference room with Staff #35, Director of Nursing, when asked about a timeline for the action items on the facility action plan, such as alarm monitoring, she stated, "there is no timeline, it's ongoing. We don't want to set a deadline."


Review of the document provided to the survey team by staff #21, nurse manager, entitled, "LTAC East Random Bedside Monitor Alarm Monitoring" revealed that 4 different rooms were audited each on the following dates: 2/28/18, 3/1/18, 4/2/18, 4/9/18, 4/19/18, 4/24/18, 5/6/18, 5/15/18, 6/5/18, 6/26/18, and 7/17/18.


The document reflected that on 2/28/18, the alarm in room 242 had been turned down, and on 6/5/18, the alarm in one of the rooms (which was not identified) had been turned down by Staff #18, the nurse that Patient #1 was assigned to on 1/14/18. There was no documentation to reflect the times the monitors were checked to ensure that all shifts were checked on a random basis.


In an interview the morning of 8/1/18 in the small conference room with Staff #21 Nurse Manager, she stated that she was randomly auditing the bedside monitor alarms as a result of the event involving Patient #1. Staff #21 stated that there were no specific requirement or instructions given to her on the monitoring expectations; she stated, "No one told me to do it. I just started doing it." Staff #21 stated that she did not know if or when or to whom, if anyone, she was supposed to report the results of the clinical alarm monitoring. Staff #21 confirmed that the alarms were not on high on 2 different dates during her audits, on 2/28/18 and as recently as 6/5/18. Staff #21 stated that the alarms should always be at the highest volume.


Facility policy, "System_PCPS087 Serious Safety Events (SSE) and Root Cause Analysis (RCA)" stated in part,

"F. The multi-disciplinary committee will be responsible for conducting a root cause analysis ...

The primary purpose and goal of any RCA team is to determine the root cause(s) of an event, and to develop a thorough and credible comprehensive systematic analysis and action plan to facilitate and implement system changes, which will prevent future occurrences of similar events ...

The action plan developed by the committee should address, at a minimum:

-Who is responsible for implementation;

-When the actions will be implemented with a timeline;

-Oversight responsibility; ...

-Strategies for measuring the effectiveness of the actions ...


G. At the conclusion of the committee's investigation and at other appropriate intervals, the PSO, or designee, will report findings and actions taken as a result of the RCA review to the Quality and Patient Safety Committee ..."


The Houston Methodist St. Catherine Performance Improvement Plan 2017 provided to the survey team stated on page 11,

"6. PERFORMANCE IMPROVEMENT PROGRAM ...

DESIGN The measurement of quality entails a process of collecting, analyzing, and communicating information regarding performance ...The program includes, but is not limited to the following:

c. Measurement, monitoring, and analysis of quality and patient safety indicators, including serious safety events (SSE), and other aspects of performance to assess processes of care, treatment, services, and operations provided."


Houston Methodist St. Catherine Performance Improvement Plan 2017 provided to the survey team stated on page 14,

"MEASURING, MONITORING AND ANALYSIS

The following process is utilized to measure, monitor, analyze and continually improve health outcomes and reduce risks to patients:

1. Data is collected to measure, monitor and analyze the stability and effectiveness of processes ... and corrective or preventive actions taken to continually improve quality of care, treatment and service and patient safety processes.

2. Performance data results are obtained as follows: ...

b. Measurement of the effectiveness of corrective or preventive actions: ...

5. The effectiveness of corrective actions are measured and monitored to sustain improvement."


The Houston Methodist St. Catherine Performance Improvement Plan 2017 provided to the survey team stated on page 15,

"7. PATIENT SAFETY PROGRAM ...

Leaders within the organization ...They are to review all action plans to ensure they are thorough and credible. We request that all events of harm and/or unexpected outcomes be reported via our Patient safety Net (PSN) program found online on the Houston Methodist intranet. This may be done anonymously if the user desires ...If an employee fails to report a known event to their chain of command, they will be subject to the process outline in System_HR01 MANAGING FOR PERFORMANCE POLICY."


The Houston Methodist St. Catherine Performance Improvement Plan 2017 provided to the survey team stated on page 17,

"7. PATIENT SAFETY PROGRAM ...

Root Cause Analysis ...and debriefings are all tools used to review events of harm. The action plans will be followed by the hospital's quality department and follow up reporting done to the hospital leadership to ensure that they are complete or in need of editing. The status of the action plan for all serious safety evens will be reported back to SQIC (System Quality Integration Committee) at 45 days.

Disclosure of Unexpected Serious Safety Events - Adverse events will be disclosed to the patient and/or the patient's legally authorized representative in accordance with the System_PCPS003 Communication of Unanticipated Patient Outcomes."


The Houston Methodist St. Catherine Performance Improvement Plan 2017 provided to the survey team stated on page 18,

ROLES AND RESPONSIBILITIES

I. HMSTC Board of Directors is responsible and accountable for ensuring an effective and ongoing hospital-wide, patient safety program is defined, implemented and maintained

...4. Actions taken for improvement are monitored, measured, analyzed and evaluated for effectiveness.

II. Quality & Patient Safety Steering Committee

1. Reviews corrective and preventive actions taken in response to serious safety events (SSE) or potential risk conditions, and evaluates the effectiveness of the actions taken ....

III. Director of Quality and Clinical Effectiveness - The Director has administrative responsibility to include the following:..

3. Facilitates assessment and appropriate response to events in accord with the System PCPS087 Serious Safety Events ...

1. Monitor event analysis and resulting action plans."


Facility policy, "System_PCPS038 Patient/Visitor Event Reporting" stated, in part, "I. RESPONSIBILITIES

A. Any employee, physician or volunteer is responsible for ensuring patient safety via proactive risk identification and open reporting of any/all risk situations ...

IV. EVENT REPORTING PROCEDURE

A. Complete a PSN Event Report for all actual or potential events immediately or upon discovery of the event. When in doubt, complete an Event Report.

B. Complete all applicable sections of the PSN report. Include complete, concise, and factual information."


Facility policy, "System_PCPS125 Clinical Alarm Systems" stated, in part, "This policy and procedure was developed to assure that alarms are activated with appropriate settings and are sufficiently audible with respect to distances and competing noise within the area of use ...

II. DEFINITIONS

Clinical Alarm: Alarm that is triggered by physical or physiologic monitoring of the patient by variations in measured parameters of medical equipment directly applied to the patient, or self-actuated by the patient. The alarm is intended to protect the patient receiving care or alert the staff that the patient is at increased risk and needs immediate assistance. Examples include cardiac monitor alarms, ... alarms associated with measuring gas pressure or concentration going directly to or coming from a patient on mechanical ventilation ...

III. PROCEDURE ...

D. Patient caregivers will verify that the alarm is on, volume is appropriate for the setting and that parameter limits are appropriately set ...

F. Alarms may be temporarily disabled or silenced only in the following situation.

1. The patient caregiver is immediately available to investigate the cause of the alarm.

2. The patient caregiver will immediately assess the clinical condition of the patient. When alarm condition is eliminated, the patient caregiver will validate that the alarm is on, volume appropriate, and that parameter limits are appropriately set."


The Houston Methodist St. Catherine Performance Improvement Plan 2017 provided to the survey team stated on pages 5-6 that, "1. Board of Directors Houston Methodist Board of Directors has ultimate responsibility for ensuring the quality of patient care services and operational performance of the Houston Methodist System Entities including receipt of reports at least annually. In discharging this responsibility, the Board of Directors shall approve the Performance Improvement Plans through which it shall delegate to the president and chief executive officers and to the medical staffs of this System the responsibility for ensuring that the Performance Improvement Plans are implemented."


The above findings were confirmed in an interview with the facility Administrator the afternoon of 8/1/18 in the conference room.

Based on review of documentation and interviews with facility staff, the facility failed to provide care in a safe setting for 2 of 19 intensive care patients reviewed as facility staff failed to appropriately monitor the patient's condition. Facility staff failed to set alarm parameters appropriately and ensure that alarms were audible which contributed to a cardiac arrest in the case of patient #1 on 1/14/18 and a delay of care in patient #2 which occurred on 5/17/18. The case of patient #1 was complicated by a monitor technician, staff #20, failing to recognize and report the patients deteriorating condition. Random bedside monitor alarm monitoring conducted by the nursing manager, staff #21, revealed monitors which needed the volume increased to maximum on 2/28/18 and 6/5/18. Despite the serious adverse event on 1/14/18 where ICU cardiac monitors did not alarm appropriately, the facility failed to have all the ICU monitors inspected by biomed until 4/2/18 except the monitor of patient #1 which was inspected 1/26/18. Patient #1 expired on 1/7/18. These factors contributed to an unsafe setting for intensive care patients.


The findings were:


The electronic medical record (EMR) of patient #1 from 9/8/17 to 1/17/18 was reviewed with the assistance of RN, staff #24 on 7/31/18. The medical record of patient #1 contained a death summary dated 1/18/18 0330 by physician, staff #4, that reflected he was a 63-year-old male who developed gradual progressive weakness since 3/17 after suffering a flulike illness after a flu vaccine in 10/16. He presented to the hospital on 5/17 when he was too weak to walk and required BIPAP (Bilevel Positive Airway Pressure) for respiratory support. He experienced respiratory failure, was transferred to another hospital and was intubated. He was extubated but continued to require nasal BIPAP. His diagnosis was felt to be CIPD (Chronic Inflammatory Demyelinating Polyneuropathy) versus another progressive motor neuropathy.


He was transferred to a LTACH (Long Term Acute Care Hospital) and had made improvements with initial therapies including beginning to ambulate. He then was transferred for inpatient rehabilitation. He ended up having chronic hypoxic respiratory failure, was unable to wean off of BIPAP requiring tracheostomy performed 8/18/17 at a hospital. Post-op, he required admission to MICU (Medical Intensive Care Unit) on ventilator support. He was transferred to this LTACH facility on 9/8/17 for continuation of care management. He was unable to be weaned off the ventilator and deemed ventilator dependent. Awaiting placement, he had a cardiac arrest and was unresponsive after that. Family decided to pursue hospice. He was taken off the ventilator and expired. The medical record of patient #1 contained a nursing note by RN, staff #18 dated 1/14/18, 1100, "Patient code for asystole, compressions were in progress by physician, staff #1 when I arrive in the room at 0915 (according to the patient room wall clock). RN, staff #19 was the one who first responded. According to her patient vent was disconnected & no audible alarm when she arrived. Patient was unresponsive."


From nursing flowsheet for 1/14/18 by RN, staff #18 (! Indicates alarm)

0700: 121/70; HR (heart rate) 61; sat (oxygen saturation) 100

0800: 118/67; 98.2; HR 56; sat 100

0815: HR 56 (only parameter recorded)

0847: sat 98 (only parameter recorded)

0900: 115/68; HR 73 (only parameters recorded)

0930: 41/20!; HR 22!; sat 77!

0935: 79/39!; HR 127; sat 92

0940: 120/58; HR 149; sat 96

0945: 127/60; HR 152!; sat 99


From Nursing Flowsheet for 1/14/18 by RN, staff #18

0705: "Alarm Set and Audible"

0815: "Alarm Set and Audible"

0900: "Alarm Set and Audible"

1000: "Alarm Set and Audible"


From Code Sheet (scanned paper form) recorded by RN, staff #23: Code Blue called 0919

0919: rhythm PEA (pulseless electrical activity) rate 36; Epinephrine 2.5 mg

0920: PEA rate 31; Epinephrine 1 mg

0921: PEA rate 31; Epinephrine 1 mg

0924: PEA rate 77; 158/58; Epinephrine 1 mg

0926: PEA rate 49; 41/20

0928: pulse palpable rate 102

0930: pulse palpable rate 121; 55/--

0931: pulse palpable rate 132; 80/42

0932: pulse palpable rate 142; 89/47

0935: pulse palpable rate 152; 120/56


In an interview with RN, staff #24, on 7/31/18 in the conference room, staff #24 was asked if there was any other documentation of vital signs for the morning of 1/14/18 in the EMR of patient #1. Staff #24 stated, there was no other documentation of telemetry in the EMR. Staff #24 stated that the telemetry monitoring techs use a manual log. In another interview with RN, staff #24, on 7/30/18 during a tour of the ICU, staff #24 stated that blood pressure, heart rate and respirations alarms at the bedside monitor and at the nursing station monitored by the telemetry techs. Staff #24 stated that alarm parameters were set based on patient baselines according the judgement of the nurse caring for the patient. Staff #24 stated that vital sign data was automatically fed into the EMR, but the nurses had to validate the data for it to become part of the permanent record.


A telephone interview was conducted with monitor tech, staff #20, on 7/31/18 at approximately 10:50 am. Staff #20 was asked what happened during 0850 - 0923 on 01/14/18 in regards to patient #1's care and telemetry monitoring. Staff #20 stated, "I do strips around that time. The strips take between 45 minutes to 1 hour. I have to physically print out the strips." Staff #20 stated that he has to review the strips and re-measure to make sure they are correct. Staff #20 stated he was distracted with the strips and that he was mostly monitoring the heart rate rhythms of the patients. Staff #20 stated he failed to monitor the oxygen saturation for patient #1. Staff #20 stated, "When I saw patient #1's reading had a long pause between two complexes I immediately told someone to go into the room. The nurse went in his room and found that his ventilator was disconnected and he was unresponsive. She called a code blue and I called the code blue over the overhead system."


An interview was conducted with RN, staff #18, on 7/31/18 at 11:00 am in one of the conference rooms in the administration office. Staff #18 said, she was assigned to patient #1 and on the morning of 1/14/2018 she made rounds with the outgoing 7p-7a nurse, spoke to patient #1 who was talkative with no complaints. She said she assessed the readings from the GE monitor but she did not assess the GE monitor alarms. She said she cannot assess the ventilator alarms, that is done by the RT. She went on to checking her other patients who were in the process of eating breakfast. Staff #18 stated, she went to patient #1's room after breakfast because he liked to take his medication after breakfast. When she arrived in the room the oxygen saturation was 87%, the tape was loose; she retaped the tubing and the sat went up to 100%. Staff #18 said, she went back to preparing her medications. While in process of preparing for medicine pass she heard code blue. Staff #18 said, she responded to the code and found patient #1 unresponsive. Staff #18 said, the ventilator alarms did not work.


An anonymously submitted incident report involving patient #2, occurrence date 5/17/18 reflected in part, "Event Detail: I saw patient son come to the door of room 242. I asked if I could help him. She said that patient needs suctioning, he is trying to cough ...Staff at desk informed patient's primary RN so as I was walking to the room, RN also came. The son said the saturation is 79% and not coming up. Since RN went to suction the patient, I came to the tele monitor to check when the saturation started to drop. There were no audible or visual alarms going off to alert the RN or the monitor tech. Immediately, the beside monitor was checked for the alarm set up and found it was set to low limit for 74%. Alarm limits were corrected in the room." A note in the incident report by ICU/IMU manager, staff #21, dated 5/18/18 0918 reflected in part, "manager checked all room for bedside monitor alarm limits and volume, all other rooms had alarms set, 3 rooms volume need to be increased from 8 to 10."


An interview was conducted with ICU/IMU nurse manager, staff #21, at 9:40 am on 7/31/18 in the conference room. Staff #21 said, she performs random checks for GE monitoring in ICU. She stated in-services were performed 2/22/18 for GE monitoring training after the incident involving patient #1. Staff #21 stated, the nurses were instructed the volume level for the GE monitor should never be below 10. Staff #21 stated, she performs random checks verifying the monitor is on the correct setting. Staff #21 did not have a process or procedure for the random checks. One random check was performed in 2/18 and 3/18. 4 random checks were performed in 4/18. Two in 5/18 and 6/18 and one in 7/18. The random checks did not record the time the checks were performed. The random checks of the GE monitors revealed that RN, staff #23, failed to increase the alarm volume to maximum on 2/28/18 and staff #18 failed to increase the alarm volume to maximum on 6/5/18.


Staff #21 stated, the weekly huddle is used for communication with staff. The staff not present receives the weekly huddle in their emails. Review of the weekly huddle meetings 01/20-07/22/18 stated, alarms are to be checked at bedside shift report. Alarm volumes must be at 10. Weekly huddle 4/23/18, 5/6/18, 5/21/18, stated Patient safety: Vent alarms being ignored. Not answering call lights in a timely manner. 5/21/18, 5/29/18, highlighted in yellow; all alarms on monitors must be ON at all times. Check at Bedside shift report. Alarm volumes must be at 10. SPO2 limit should NOT be set <88%. Staff #21 said she has developed "Bedside Shift Report Inpatient Areas" form for rounding, effective August 2018. The form included section reminding the nursing staff to check and confirm bedside monitor alarm settings and volume.


The facility policy entitled "Centralized Telemetry Monitoring" System_PCPS129 revised/reviewed date 8/17 reflected in part, "Monitor alarms will be on at all times. Alarm limits will be set according to default values and to the individual patient needs ...Monitor Tech or telemetry tech may consult with the RN to change alarm limits as indicated by patient trends and individual tracings. Adjustments will be approved by the RN. The telemetry tech or Monitor Tech will use the following levels to guide communication with the nurse caring for the patient ...Level One Alarms, a. Escalation Plan to include up to a "Code Blue" ...to rapidly assess a patient with the following rhythms ...Asystole ...Level Two Alarms Notifications, The Monitor Tech or telemetry tech will notify the nurse regarding the EKG change via the nurse's communication system ...Level Two Alarms ...f. brady-dysrhythmias (slow heart rate) ...k. Systolic blood pressure <90 ...p. O2 saturation <90%..."


Review of the biomedical records for the GE/CARESCAPE B650 Physiological Monitors in use in the ICU revealed that the monitor in use by patient #1 had a biomedical inspection on 1/26/18 and the record reflected "Checked out alarm function, No Failure." The record reflected the GE/CARESCAPE B650 Physiological Monitors in use in the ICU "PM completed and passed, No Failure" with open date of 4/2/18 and close dates ranging from 5/4-31/18.


In an interview with biomedical inspector, staff #29, and the director of facility services, staff #30, on 7/31/18 at 11:30 am, staff #29 reviewed the maintenance records for biomedical checks for the facility's medical equipment with the surveyor, confirming that all the facility cardiac monitors were inspected beginning on 4/2/18. Staff #30 also clarified that the staff can adjust the cardiac monitor alarm volume and only the biomed department can set the default minimum volume using a maintenance code.


The facility policy entitled Clinical Alarm Systems # System_PCPS125 with an effective date 9/25/15 reflected in part "D. Patient caregivers will verify that the alarm is on, volume is appropriate for the setting and that parameter limits are appropriately set ... F. Alarms may be temporarily disabled or silenced only in the following situation. 1. The patient caregiver is immediately available to investigate the cause of the alarm. 2. The patient caregiver will immediately assess the clinical condition of the patient. When alarm condition is eliminated, the patient caregiver will validate that the alarm is on, volume appropriate, and that parameter limits are appropriately set."


Review of the facility report "LTAC East Random Bedside Monitor Alarm Monitoring" revealed that on 6/26/18 and 7/17/18 four patient rooms were audited and there were no issues documented with the bedside cardiac monitors.


A tour of ICU was conducted on the morning of 8/1/2018 accompanied by nursing manager, staff # 21. Four patients with ventilators and GE cardiac monitors were observed. At the time of the tour the alarm volumes on the GE cardiac monitors and the ventilators were on and turned up to appropriate volume settings. The respiratory therapist assigned to ICU demonstrated the volume accuracy.

Based on observation, review of documentation and interviews with the nursing staff, the chief nurse officer (CNO) failed to appropriately supervise the nursing staff. Staff #18 RN and staff #2 monitor tech failed to monitor the telemetry and GE monitor settings for patient #1.


Findings were:


In an interview conducted with staff #18 at the facility on 7/31/2018 at 11:00 am, staff #18 said, she failed to check the alarm volume for the GE monitor when making rounds 1/14/18 on patient #1.


In an interview with staff #21, manager for ICU department, the surveyor asked how do you perform corrective actions for the nursing staff. Staff #21 said, the first step is verbal coaching, the second step is written coaching which goes in their personnel file.


Review of staff #18 personnel file did not reveal any written corrective actions. Review of random checks performed for GE monitors by staff #21 reveal staff #18 did not check her GE volume alarm setting on 6/5/18. Staff #18 attended the GE monitor training in May 2015 and again in February 28, 2018.


In an interview with staff #21 at the facility on 7/31/18 the findings were confirmed.


On 7/31/18, at approximately 10:50 am, a phone interview was conducted with the Telemetry Monitor Tech, Staff #20. Staff #20 was asked if he could tell the surveyor what happened during 0850 - 0923 on 01/14/18 in regards to Patient #1's care and telemetry monitoring. Staff #20 stated "I do strips around that time. The strips take between 45 minutes to 1 hour. I have to physically print out the strips." Staff #20 stated that he has to review the EKG strips and re-measure to make sure they are correct. Staff #20 stated he was distracted with the EKG strips and that he was mostly monitoring the heart rate rhythms of the patients. Staff #20 stated he failed to monitor the oxygen saturation for Patient #1. Staff #20 stated "When I saw (Patient #1's) reading had a long pause between two complexes I immediately told someone to go into the room. The nurse went in his room and found that his ventilator was disconnected and he was unresponsive. She called a code blue and I called the code blue over the overhead system."


When Staff #20 was asked what were his duties on 01/14/18, he stated that his duties were to "monitor heart rhythms, oxygen saturations, blood pressure. If the O2 rate is decompensating I will tell staff to go check on the patient." When Staff #20 was asked how he can tell if a patient's ventilator becomes disconnected, he stated "When a ventilator comes off I can hear the alarm and I will tell staff to go and check on the patient. I will call the patient's nurse, respiratory therapist, or any other staff close by to check on the patient." Staff #20 stated that his duties also included unit secretary tasks that included answering phone calls. He stated, the physicians sit in the area to chart on patients and he answered questions the physician's might have. Staff #20 was asked if changes had been made to his job duties since Patient #1's incident on 1/14/18. Staff #20 stated that now his job description is only monitor tech duties. He stated "The staff secretary helps with the telephone calls and other unit tasks."


A review of the personnel folder for Telemetry Monitor Tech, Staff #20 was performed on the morning of 8/1/18 in the hospital conference room. The folder contained a form titled "2018 Annual Competency Skills Validation" dated "7-19-18." Included in the folder was a form titled "DISCIPLINARY/COUNSELING REPORT" dated 01/25/18. The form stated in part "DETAILS OF ISSUE(S):

(Staff #20), Telemetry Monitor Tech, failed to monitor oxygen saturation alarms (SPO2) and inform staff about the abnormal alarm in a timely manner which resulted in a delay in initiating standard protocol for patient safety.

On 1/14/2018, (Staff #20) failed to acknowledge that the SPO2 alarms on the patient had dropped at 8:50am. The SPO2 level further decreased to a point where it was not recordable and the patient's heart rate dropped. (Staff#20) did not notify the staff to check on the patient until 9:23am when the heart rhythm was irregular. When the RN went to check on the patient, he was disconnected from the ventilator and was pulseless and unresponsive-a code blue was initiated.

On 1/23/18, management discussed the concerns with (Staff #20). He acknowledged his actions and understands his expectations.
(Staff #20) is expected to communicate with nursing staff regarding any patient change in telemetry monitoring in a timely manner according to Houston Methodist's expectations for patient safety. In an effort to make (Staff #20) aware of his conduct regarding not following standard protocol for patient safety and to help him improve conduct and communication, he is being issued this Disciplinary/Counseling Report.


EXPECTATIONS:

(Staff #20) is expected to monitor all alarms including oxygen saturation alarms and inform staff about any abnormal alarms in a timely manner according to Houston Methodist standards of patient safety. Any further incidents of misconduct will result in further disciplinary actions, up to and including termination."

(Staff #20) personnel folder also included a document dated June 8, 2018 that stated in part "As of 6/15/2018, all current Monitor Technicians and Lead Monitor Technicians will have one year to become certified. You will have until 6/15/2019, to obtain ONE (1) of the following credentials: CCT: Certified Cardiographic Technician; CET: Certified EKG Technician; CMT-BC: Cardiac Monitor Technician-Board Certified; NRCEKG: Nationally Registered Certified EKG Technician"

Based on review of documentation and interviews with facility staff, the facility failed to provide respiratory care services appropriate to the scope and complexity of services offered at this hospital. A respiratory therapist, staff #13, failed to engage appropriate ventilator alarms with a Passy-Muir speaking valve in use in the case of patient #1 on 1/14/18 which potentially contributed to the patient's cardiac arrest. The competency list for use of the Passy-Muir Valve for Ventilated Patients in use on 1/14/18 did not specify that ventilator alarms should not be turned off. There was significant delay in implementing corrective actions as the facility failed to have a detailed policy in place for use of the Passy-Muir speaking valves until 5/23/18. The facility policy for mechanical ventilation was revised 7/18 specifying that ventilator alarms should never be disabled. Documentation of the auditing of patients with Passy-Muir Valves did not start until July 2018. Revised competencies for the use of Hamilton C1 Ventilator and Passy-Muir Valve which were used on patient #1 will not be implemented with the respiratory staff until August 2018. These delays in corrective actions could potentially lead to other adverse events involving ventilated patients using speaking valves.


The findings were:


Review of the electronic medical record of patient #1 was done on the afternoon of 7/30/18 with the assistance of the respiratory care manager, staff #22. Review of the record revealed the following data.

From Respiratory Flowsheet, Ventilator Master for 1/14/18

0629: Vent Alarm Audible? Yes;

0809: Vent Alarm Audible? Yes

0812: Vent Alarm Audible? Yes

0900: Vent Alarm Audible? Blank

0930: Vent Alarm Audible? Blank

0935: Vent Alarm Audible? Yes


From Respiratory Flowsheet, Ventilator Master for 1/14/18

0629: Vent Alarms MV (Minute Volume = Respiratory Rate X Tidal Volume) Low (L/min) 0.1

0809: Vent Alarms MV Low (L/min) Blank

0812: Vent Alarms MV Low (L/min) Blank

0900: Vent Alarms MV Low (L/min) Blank

0935: Vent Alarms MV Low (L/min) 0.1


The respiratory care manager, staff #22, was interviewed on the afternoon of 7/30/18 in the conference room. Staff #22 stated, staff #12 was the respiratory therapist (RT) during the night on 1/14/18 and the record showed the ventilator alarm was audible at 0629, and that the low minute ventilation alarm was on set at 0.1 liters/min. Staff #22 was asked what the low minute ventilation alarm was and she stated, it was respiratory rate times the tidal volume and if the patient drops below a safe level, the alarm would go off. She stated staff #13 was the RT starting at 0700. Staff #22 stated, that it was documented that the ventilator alarm was audible at 0809 and 0812, however, the low minute ventilation alarm boxes were blank which she stated meant that the low minute ventilation alarm parameter was not on.


Further review of the electronic medical record of patient #1 was done the morning of 7/31/18 in the conference room with the assistance of RN, staff #24. A Nursing Note by RN, staff #18, on 1/14/18 1100 reflected "Patient code for asystole, compressions were in progress by physician, staff #1 when I arrive in the room at 0915 (according to the patient room wall clock). RN #19 was the one who first responded. According to her patient vent was disconnected & no audible alarm when she arrived. Patient was unresponsive."


A telephone interview was conducted with RT, staff #13, on 7/31/18 at approximately 11:45 am. Staff #13 was asked what prompted her to disable patient #1's ventilator alarm when she received the patient on 1/14/18. She stated, "When I received him as a patient he already had the valve in line." When staff #13 was asked if the ventilator alarms were disabled when she received patient #1, she stated "No. I did that myself because that was what we were supposed to do. I didn't want the machine to alarm needlessly and cause chaos so I turned them off." Staff #13 was asked if the ventilator would alarm when she turned the two alarms off. Staff #13 stated, "At that time I could not wrap my head around why the machine was not alarming and it was still cycling when I responded to the Code Blue. Now I say No."


The respiratory care director, staff #26, was interviewed on 7/31/18 at approximately 9:45 am. Staff #26 stated it, was basic to the training of respiratory therapists and a standard of practice that ventilator alarms should not be turned off. Staff #26 stated, all the other respiratory therapists on staff kept ventilator alarms on. Staff #26 stated that RT, staff #13, was given a "Communication Record" which was a documented counseling regarding disabling alarms. Staff #26 stated that it was the consensus of the group working on the root cause analysis of the incident involving patient #1 that staff #13 not be reported to the Texas Board of Medical Examiners which licenses respiratory care practitioners.


The respiratory care director, staff #26, was interviewed on 7/31/18 at approximately 11:45 am in the conference room. Staff #26 was asked how a ventilator circuit could come off the tracheostomy. Staff #26 stated, the circuit was attached to a plastic hub on the tracheostomy and can pop off with patient movement or a violent cough usually to clear secretions. Staff #26 stated, sometimes the ventilator high pressure alarm would go off with a cough. In another interview with staff #26 on 7/31/18, at approximately 4:50 pm, in the conference room, staff #26 stated that patient #1 had an order to put the patient on the speaking valve during the day and was put on the speaking valve at 0629 on 1/14/18 by RT, staff #12. Staff #26 stated that the speaking valve policy was changed to require staff to be present when the speaking valve was in place after the incident with patient #1 and officially approved 5/18.


A competency check off sheet entitled "Passy-Muir Valve for Ventilated Patients" dated 7/18/17 for RT, staff #13 reflected in part "9. Adjusts ventilator alarms as needed" which was checked as met." The form was signed by staff #13 and by Lead RT, staff #14 and dated 7/21/17. The form did not specifically state ventilator alarms should not be turned off.


The respiratory care director, staff #26, was interviewed on 7/31/18,. Staff #26 stated that competency check off for the RT's was done annually, but the form in use in 2017 did not list item by item specifics about the ventilator. Staff #26 stated, a new competency form that has more detail regarding the ventilator alarms will be used in August 2018 for RT competency check off. Staff #26 also stated that a more detailed competency form for the Passy-Muir Valve was being worked on.


The facility policy entitled "Speaking and Swallowing Valves" RT010 effective date 5/23/18 and revised date 7/18 reflected in part, "j. RCP (Respiratory Care Practitioner) to adjust the ventilator alarms ensuring they are safe and effective. Never disable ventilator alarms ...n. The initial trial should include SLP (Speech Language Pathologist) and RCP. If trial is successful subsequent trials will be supervised at all times by medical personnel (SLP, RCP or RN). The patient will always have supervision when wearing the in line Passy Muir Valve."


The facility policy entitled "Mechanical Ventilation" RT009 effective date 7/18 reflected in part "IV. Procedure ...D. The alarms should be set and adjusted ensuring they are safe and effective and so the RCP will be notified of any changes in lung compliance and resistance. Never disable ventilator alarms."


A facility form entitled In Line PMV (Passy-Muir Valve) Audits dated 7/18 listed 4 patient observations dated from 7/2/18 to 7/30/18 which had documentation of the vent mode for trial, alarms set for trial and clinicians present. In an interview with the respiratory care manager, staff #22 on the morning of 7/31/18 in the conference room, staff #22 was asked if there was documentation from previous months and staff #22 stated they started these observations in July, 2018.