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Based on the nature of the standard level deficiencies referenced to the Condition, it was determined the Condition of Participation 482.13, PATIENT'S RIGHTS, was out of compliance.

In addition, due to the nature of the survey findings, an Immediate Jeopardy was declared on 01/19/17 at 1:34 p.m. related to the Condition of Participation 482.13, PATIENT'S RIGHTS. The hospital failed to protect and promote patient rights by failing to ensure the safety of all patients in the facility.

A -0144-Standard: Privacy and Safety-The patient has the right to receive care in a safe setting. The facility did not ensure the right of patients to receive safe care when it failed to have an adequate system in place to convey critical results that prevented the initiation of time sensitive interventions.

Based on interviews and record reviews the hospital failed to provide an adequate system process to ensure the communication of critical test results that could have affected patient treatment.

The failure created the potential for patients to have significant test results go unnoticed for extended periods and prevent rapid treatment.

FINDINGS

POLICY

According to Patient Rights and Responsibilities the purpose is to identify and provide patient rights as entrusted by law, regulatory rules, and standards. The scope of the policy applies to system health facilities, practices, entities and services and all associates, employed physicians, contractors, and volunteers. Patient Rights and Responsibilities will be provided in a written format via the Patient Bill of rights document.

According to Critical Value Notification the purpose of the policy is to ensure that prompt notification of clinical caregivers is made after verifying laboratory values in a critical range. Unusual or significant results are defined as those which are not necessarily critical in nature but should be reported to caregivers directly to assist in the rapid treatment of patients. A courtesy call made on values that are not official critical values will be documented. The first Troponin I level performed in the main laboratory is not a critical value but will be called and documented as a courtesy call and all subsequent ones will not be called. Other site-specific calls may be required and are not listed in this policy.

According to the definitions section of Reporting Critical Test Results, critical results are those that fall significantly outside the normal range and may represent life-threatening results which require rapid communication and clinical attention to avert significant patient morbidity or mortality, these include Potassium, Sodium and Troponin lab tests.

REFERENCE

According to the Patient Bill of Rights the hospital supports the rights of all patients across the lifespan and may be exercised through the patient individually or their authorized surrogate decision maker. You have the right to: (16) Receive care in a safe setting.

1. The facility did not support patients' right to safe care when it failed to ensure adequate processes were in place to prevent the recurrence of a significant patient safety event.

a) Review of an occurrence report entered into the facility event reporting system on 07/07/16 at 5:53 p.m. revealed Patient #1 had an elevated Troponin I (lab test used in the diagnosis of myocardial infarction) level of 0.126 which had been collected, resulted and called to the Emergency Department (ED). According to the facility lab expected range, Troponin I levels should remain below 0.046. An ED physician progress note written in the medical record on 07/07/16 stated the patient's Troponin level was mildly elevated and needed to be monitored closely.

Further review of the occurrence report entered by the unit Associate Nurse Manager (RN #23) showed documentation in the Policy section dated 07/12/16 which stated "the issue of elevated troponin levels not being called to nursing had been brought up many times by nursing and the cardiology group agreed all positive troponin lab results should be called to the RN because RN's have missed the subsequent troponin level results".

Patient #1 was transferred to the inpatient cardiac unit at 9:05 a.m. A second Troponin I level was ordered on 07/07/16 at 1:49 p.m. by the inpatient clinician. According to a laboratory internal inquiry, the specimen was collected at 2:22 p.m. and posted to the medical record at 3:34 p.m. The new Troponin I level had increased to 9.050, more than double the previous result.

Patient #1 experienced a myocardial infarction at 4:24 p.m. and expired approximately 1 hour later.

Further review of the medical record revealed a cardiology progress note written on 07/07/16 at 5:45 p.m., which stated, the care team had just been made aware of the second elevated Troponin level.

b) An Interview was conducted with the Director of Laboratory Services (Director #18) on 01/19/17 at 9:54 a.m. S/he verified the lab technician is required to perform one courtesy call when the Troponin I test level is greater than 0.046 but there were no additional courtesy calls made to notify clinical staff when subsequent Troponin I levels increased. Upon review of the Reporting of Critical Test Results facility specific policy, Director #18 stated the staff in the lab did not follow the policy and were likely not aware of the policy. Director #18 emphasized the only policy the lab is required to follow is the lab specific policy which does not require notification of subsequent elevated Troponin I levels.

Director #18 then affirmed it would be understandable for nurses to be confused about the number of notifications to expect with regard to the Troponin I lab test result since the facility policy did not match the lab specific policy.

c) On 01/18/17 at 1:06 p.m., the Quality Manager (Manager #2) stated there should not be competing policies on notification of abnormal and critical lab tests.

d) The Chef Medical Officer (CMO #17) was interviewed on 01/20/17 at 1:40 p.m. During the interview s/he stated there had been meetings with the Cardiac Section Team, the Medical Executive Committee, a Peer review process of the case and a special Group had convened between August and September to discuss the possibility of changes to the Troponin I notification process. According to CMO #17, the clinical leadership committees had decided changes to the notification process required the involvement of the lab quality team to which the case had been referred.

CMO #17 stated s/he did not know where the lab quality team was in the process of implementing the process change which would require notification of all elevated Troponin I test results. CMO #17 confirmed that until January 19, 2017, no process change had been implemented.

e) An interview was conducted with the Clinical Nurse Manger (Manager #13) of the cardiac unit on 01/18/17 at 2:51 p.m. Manager #13 verified the lab is required to call critical test results to the responsible caregiver based on their list of critical values. Manager #13 further explained the policy, which was specific to the lab, was not a policy nursing staff was responsible to follow.

During a second interview with Manager #13 on 01/19/17 at 11:47 a.m. s/he stated in the case of Patient #1, had the lab made a second call to notify the care team of the significant increase in the Troponin I level, additional interventions could have been initiated.

The facility was aware of a patient safety concern for 6 months and failed to implement any process change until a concern was raised by the regulatory agency.

Based on the nature of standard level deficiencies referenced to the Condition, it was determined the Condition of Participation §482.21, Quality Assessment and Performance Improvement Program was out of compliance.

In addition, due to the nature of the survey findings, an Immediate Jeopardy was declared on 01/19/17 at 1:34 p.m. related to the Condition of Participation §482.21, Quality Assessment and Performance Improvement Program. The facility failed to maintain a quality improvement program which supported systems and processes of care to reduce risk of harm to patients. The failure resulted in missed opportunities to provide facility process change for the improvement of clinical outcomes.

A- 0286 - Standard: Patient Safety - Performance improvement activities must track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the hospital. The facility's Quality Assurance and Performance Improvement (QAPI) program failed to ensure quality improvement activities incorporated feedback from designated committees involved in the investigation of significant patient safety events.

Based on interviews and document review the facility failed to implement a necessary process change identified during the investigation of a serious patient safety event, which may have contributed to the death of a patient.

The failure resulted in the risk of the recurrence of negative patient outcomes.

FINDINGS

POLICY

According to Reporting of Critical Test Results, the lab tech will call the patient care nurse or assistant nurse manager on the unit where the patient is located to report the test value(s). Definition of a critical test is one which will always require rapid communication of the results, even if normal, and include the first reported value in the critical range for troponin.

Further, critical results are those which fall significantly outside the normal range and may represent life-threatening results. Such results require rapid communication even if from routine, non-STAT tests and are further defined by the Laboratory Medical Director, in consultation with clinicians served, as life-threatening critical results that require rapid clinical attention to avert significant patient morbidity or mortality and include (3) troponin.

Critical Value Notification defines critical value as a lab result which indicates a patient is in imminent danger unless appropriate therapy is initiated promptly and must be reported within 15 minutes to the responsible caregiver. Calls made on values that are not official Critical values but are to be called and documented are Courtesy calls. Other, site-specific calls may be required and are not listed in this policy.

Additionally, the first positive Troponin I level performed in the main laboratory is not a critical value but will be called and documented as a courtesy call; subsequent ones will not be called to a responsible caregiver.

1. The facility failed to implement an identified necessary process change in a timely manner to protect the safety of patients.

a) A review of the electronic medical record (EMR) of Patient #1 revealed s/he presented to the Emergency Department (ED) on 07/07/16 at with a complaint of chest and back region pain. During the evaluation of Patient #1's medical complaint a Troponin I (lab value used in the diagnosis of myocardial infarction) level was ordered and the resulted level was 0.126. After the patient was admitted to the telemetry unit, a second Troponin I was ordered on 07/07/16 at 1:58 p.m. with a resulted level of 9.050. Patient #1 experienced a myocardial infarction on 07/07/16 at 4:24 p.m. and subsequently expired.

On 07/07/16 at 5:53 p.m., an occurrence report was entered into the facility event reporting system by the unit Associate Nurse Manager (RN #23) which summarized the events and corrective actions taken. In the Policy section of the occurrence report documentation dated 07/12/16 stated the issue regarding the lack of notification of elevated Troponin levels had been brought up many times by nursing and the cardiology group agreed all positive Troponin lab results should be called to the RN because RN's have missed the subsequent troponin level results.

In the Reviewed by Managers section of the occurrence report a comment was added on 07/25/16 which stated "physicians would like all positive Troponin results to be called to the responsible RN and the significant increase from the previous troponin level in this case should have been called based on common sense." A second comment within the Reviewing Manager's Comments section entered 07/20/16 stated the case was escalated for review by the System Medical Director and the Chemistry Best Practice Team (CBPT).

b) Review of the meeting minutes of the Patient Safety and Quality Committee dated 07/19/16 documented the adverse event was discussed and the two policies concerning critical result notification conflicted. The committee documented the discrepancy between the requirements of the two policies should be considered a factor in the second resulted Troponin level not called to the nurse and any impact it may have had on the patient's outcome. The decision of the committee was to forward the conflicting policies to the Cardiac Section Team for review.

Within 13 days of the report of an adverse event, a patient safety risk was identified, but no change in process was implemented.

d) During the month of August, the Medical Executive Committee and the Cardiac Section Team met to review the lab notification process issue regarding elevated Troponin I levels. Additionally, the Cardiac Section Team minutes revealed the decision for policy change was referred to CBPT.

e) The Director of Laboratory Services (Director #18) was interviewed on 01/20/17 at 12:27 p.m. Director #18 stated s/he was a member of the Chemistry Best Practice Team (CBPT) and the Patient Safety and Quality Committee. S/he stated August 3, 2016 was the first time the CBPT discussed the adverse event that identified a Troponin I notification policy change had been requested. According to Director #18, no policy change occurred in the meeting and it was the responsibility of Director #18 to provide feedback to the Patient Safety and Quality Committee.

Nearly 30 days had passed and no change in process was implemented to prevent the risk of harm to patients.

f) On 9/14/16, special Group convened to discuss the need for a policy change in the notification process of critical test results. The Group minutes showed the decision was made to have the lab and the cardiology group confer on changes to the critical test notification process.

During the same month, the Board of Trustees met on 9/22/16 and were provided an overview of serious safety events that had occurred by the Chief Medical Officer (CMO #17). The meeting minute's documented corrective action had been taken in all events.

g) During an interview with CMO #17 on 01/19/17 at 8:24 a.m., s/he stated although discussions had occurred at the executive levels of the facility regarding the need for a process change to the critical test result notification process no consensus had been achieved on the best way to implement the change.

Two months had passed since the initial identification of the patient safety concern, yet no process change was initiated to protect the safety of patients.

h) In an interview with the Chief Nursing Officer (CNO #1) on 01/20/17 at 9:33 a.m. s/he verified the Patient Safety and Quality Committee should have followed up on the proposed process change and stated "I don't know where the wheels fell off the wagon in the process". CNO #1 stated no changes to the process occurred until 01/19/17 when the surveyors raised concerns for patient safety.

i) The CBPT (Lab Committee) met on 12/07/16. At that time the Team agreed the best practice would be to call all Troponin level results that increased by 100% or more in value and established computer changes were required to implement the new process.

From July to December 2016, six committees discussed the Troponin I critical test result notification process, however, not one of the committees implemented a process change to prevent the recurrence of negative patient outcomes.

j) A subsequent meeting of the CBPT occurred on 01/04/17. Review of the meeting minutes revealed a proposal was presented to change to call prompt within the lab computer system for increased Troponin I levels. The minutes stated a request was made on 01/04/17.

k) A second interview was conducted with CMO #17 on 01/20/17 at 1:40 p.m. Upon review of the December and January 2016 meeting minutes of the CBPT, CMO #17 stated s/he was not aware of any process change planned for the lab system or policy changes until the surveyors arrive at the facility.

The facility Quality Assurance and Performance Improvement process failed to implement an identified process change to protect the safety of its patients.

Based on the nature of standard level deficiencies referenced to the Condition, it was determined the Condition of Participation §482.23, NURSING SERVICES was out of compliance.

A-0395 - Standard: A registered nurse must supervise and evaluate the nursing care for each patient. The facility failed to monitor critical test results in 1 of 11 medical records reviewed (Patient #1) and failed to provide nursing pain assessments according to the needs of the patient and facility policy in 2 out of 11 medical records reviewed (Patient #1 and #5). The failure impeded the communication of critical test results to ensure rapid clinical attention was given to patients and the provision of pain medication was delayed when needed by the patient.

Based on interviews and record reviews the facility failed to monitor critical test results in 1 of 11 medical records reviewed (Patient #1) and failed to provide nursing pain assessments according to the needs of the patient and facility policy in 2 out of 11 medical records reviewed (Patient #1 and #5).

The failure impeded the communication of critical test results for to ensure rapid clinical attention was given to patients and the provision of pain medication was delayed when needed by the patient.

FINDINGS

POLICY

According to Documentation of Patient Care reassessment of the hospitalized patient is a continuous ongoing process based upon department specific assessment parameters as well as in response to changes in diagnosis, treatments, procedures and the plan of care. Patient condition and ongoing changes in status warrant more frequent reassessment. Documentation should reflect that the caregiver was aware of the patient's condition throughout their working shift.

According to Pain Management the provision and documentation of pain assessment and reassessment is driven by the scope of care, treatment, services provided and are based on individual patient assessment and interventions. Comprehensive pain assessment is completed and documented on admission and at least once a shift.

Further, reassessment timeframe and/or interval will be determined by clinical judgement of the RN (based on patient assessment and intervention provided). Documentation of reassessment will be within 2 hours of PRN (as needed) pain medication.

1. The facility failed to monitor ordered lab test results for Patient #1.

a) A review of the electronic medical record (EMR) of Patient #1 revealed Patient #1 arrived at the emergency department (ED) on 07/07/16 at 4:54 a.m. During the medical examination in the ED it was noted Patient #1 had a positive Troponin I level of 0.126 (lab test used in the diagnosis of myocardial infarction). The facility lab expected range for Troponin I was less than 0.046. The Ed physician documented there was an elevated Troponin level and the Troponin level would need to be monitored closely.

Patient #1 was transferred from the ED to an inpatient telemetry unit on 07/07/16 at 9:05 a.m. At 1:48 p.m. a Troponin I lab test was ordered to be drawn every 8 hours. The assigned Registered Nurse (RN #19) acknowledged receipt of the order at 2:00 p.m. The EMR showed the test sample was collected on 07/07/16 at 2:22 p.m. and the test result of 9.050 was in the EMR at 3:34 p.m.

At 4:24 p.m. a Code Blue was initiated due to Patient #1's sudden change in condition. The telemetry monitor which kept track of the patient's heart rate and rhythm showed pauses in the rhythm followed by a temporary slow rhythm until a sudden absence of cardiac activity.

Resuscitation efforts continued for 1 hour when Patient #1 expired.

b) An interview was conducted with RN #12 on 01/18/17 at 2:43 p.m. RN #12 stated for Troponin I lab results the lab will only call to alert the nurse for the first positive result, all subsequent results are posted to the EMR and it was the responsibility of the nurse to check for new results.

c) On 01/18/17 at 3:12 p.m. RN #14 from the oncology unit was interviewed. According to RN #14 it was the nurse's responsibility to check for any new Troponin I test results in the EMR because only the first positive result would be reported to the nurse by phone.

d) RN #19, the primary nurse of Patient #1 was interviewed on 01/19/17 at 11:48 a.m. According to RN #19 lab results should be checked throughout the day based on the patient's orders and reason for admission. RN #19 reviewed the EMR of Patient #1 at this time and stated although s/he performed hourly rounds to monitor patients s/he did not document every time the room was entered and interaction with the patient occurred. RN #19 stated s/he did not have knowledge of the test result until the Code Blue was in progress.

e) An interview was conducted with the telemetry unit Nurse Manager (Manager #13) on 01/19/17 at 11:47 a.m. Manager #13 stated each nurse is responsible to know the plan of care for their patient, including any pending lab tests to be drawn, and were expected to log into the EMR to check for lab results "every few minutes". Patient #1's Troponin I lab results were available for at least 50 minutes before medical staff aware the value.

2. The facility failed to perform assessments of pain as required by patient need and facility policy.

a) According to the medical record, Patient #5 entered the ED on 01/12/17 with a 1-week history of circumferential abdominal and lower back pain. Patient #5 was documented to exhibit left lower quadrant tenderness on examination and had received 2 doses of the opioid intravenous (IV) pain reliever Dilaudid. The patient was admitted to a medical unit at 5:13 p.m. Patient #5 received a pain assessment at 5:29 p.m. at which time the pain level was rated 4/10. No further pain assessments were documented until 10:00 p.m., nearly 5 hours later, at which time Patient #5's pain was rated 7/10 and s/he was administered IV Dilaudid.

On 01/13/17 Patient #5 was assessed for pain at 8:54 a.m., provided Tylenol at 9:34 a.m. and was not reassessed for pain again for nearly 7 hours when at 4:14 p.m. a second dose of Tylenol was administered. There were no documented assessments of pain level again until 9:24 p.m. Patient #5 was provided Tylenol at 9:44 p.m. Again, there were no documented reassessments within the required 2 hour timeframe to show whether the intervention addressed Patient #5's pain adequately.

Similar omissions of pain reassessments occurred on 01/14/17-01/16/17 for Patient #5 with reassessments of pain interventions documented, on average, 4 hours later instead of the 2 hour timeframe required by facility policy.

b) Patient #1 was admitted to the telemetry unit on 07/07/16 at 0905 a.m. for treatment of abdominal pain. Patient #1 was assessed and provided the opioid IV pain reliever Dilaudid at 10:33 a.m. Patient #1 was reassessed for pain at 11:33 a.m. There were no further pain assessments documented on Patient #1, but s/he was given IV Zofran (a medication used to treat nausea) at 3:08 p.m. and there was no documentation to show why Patient #1 was given the medication intervention as required by the Documentation of Patient Care policy.

c) During an interview on 01/18/17 at 2:30 p.m., RN #10 stated pain assessments were done at least once a shift. S/he further stated if a patient required pain medication, reassessments for pain were needed every two hours.

d) During an interview on 01/18/16 at 2:43 p.m., RN #12 stated s/he needed to reassess a patient's pain within the hour if the patient requested pain medicine.