The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

METHODIST CHARLTON MEDICAL CENTER 3500 W WHEATLAND ROAD DALLAS, TX 75237 May 18, 2011
VIOLATION: GOVERNING BODY Tag No: A0043
Based on interview and review of records, the governing body failed to ensure patient care was provided in a safe and effective manner and comply with state and federal rules.

Findings included:

1) Nursing services did not have supervisory personnel for each nursing unit to provide, when needed, the immediate availability of an RN to provide care for any patient in the event of an emergency. By failing to follow the nurse staffing level requirements, there was a potential for diminished quality of care provided to patients. Cross reference: A392

2) Medication Adverse Events and possible patient equipment malfunction were not identified, investigated and reported as required by state and federal law. Cross reference: A263, A276, A287, A311, A410, and A508

3) The hospital-wide Quality Assessment and Performance Improvement (QAPI) program did not monitor or evaluate compliance with hospital policies to reduce and identify adverse events and medication errors. The QAPI Program did not identify potential and actual safety practices that put the hospital's patient population at risk for injury. Cross reference: A263, A267, A276, A287, A310, A410, and A508

4) The Governing Body failed to ensure patient rights were met in the grievance process. Cross reference: A123

The "Methodist Bylaws", 05/26/09 requires, "The activities, property and affairs of the Corporation shall be managed by its Board of Directors...The System Quality Review Committee...a standing committee of the Board of Directors....shall...regularly review reports from the medical staff and hospital administration regarding the quality of medical services provided...analyze quality initiatives at each System Institution to assure processes are in place to facilitate the implementation of system-wide best practices...monitor progress with quality initiatives...provide, on behalf of the Board, general governance oversight for the quality of service in the respective System Institutions...assure processes are in place at each System Institution to perform the following functions: report regularly to the System Quality Review Committee on the quality of services provided; assist the System Quality Review Committee in implementing system-wide quality improvement initiatives; review processes and methods used by the medical staff and hospital staff to monitor and improve the quality of service in the respective System Institutions; advise the System Quality Review Committee as to whether monitoring and follow-up programs and activities are effective and whether identified deficiencies in the safety, reliability, effectiveness, and acceptability of hospital and medical care are being addressed...Corporate Medical Board...shall...evaluate and monitor quality monitoring and improvement activities and systems for monitoring and evaluating the quality of patient care and improving patient care in the System Institutions..."


At 10:00 A.M. on 05/17/11, the Director of Quality (Personnel #2) was interviewed. She verified the above findings.
VIOLATION: PATIENT RIGHTS: NOTICE OF GRIEVANCE DECISION Tag No: A0123
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review of records and interview, the hospital failed to provide written notice of its decision, steps taken, results of the investigation and date of completion to 7 of 7 grievances received from patients and/or families (Patients #1, #2, #3, #4, #6, #7, and #8) regarding patient care.

Findings include:

The "Complaint/Grievance Log " dated "September 2010 - April 2011" showed:

09/21/10 - Patient #1 complained of the ED (Emergency Department) not having a technician available to do a CT Scan (computerized tomography), the physician releasing him to go home despite being unable to move any of his limbs and concerns regarding the physician's report.

02/14/11 - Patient #2's family complained about the nurses being rude, security was called on the family and the morphine was dripping faster than it was supposed to be.

03/01/11 - Patient #7's family complained about the nurse discontinuing the intravenous fluids and TPN (total parental nutrition) and contaminating them. The family also complained about not being able to see their daughter in ICU (intensive care unit).

03/23/11 - Patient #4's daughter complained that her mother was discharged too soon. Her mother was discharged on [DATE] and was found dead in her home on 03/14/11.

03/28/11 - Patient #8's daughter complained the communication board was not being updated, the staff taking too long to answer the call for assistance when calling for pain medication or asking for PRN (as needed) medication, addressing her mother's high blood pressure and problems with weekend staffing.

04/20/11 - Patient #6's family complained that they felt like the staff was retaliating against the patient after complaining to the floor manager about the lack of care the patient received.

04/25/11 - Patient #3's daughter complained that her mother was upset, angry and crying when the nurse was too rough and uncompassionate when drawing blood by tying the tourniquet too tight and slapping her mother's arm.

The Hospital Policy, "Complaints/Comments/Grievances" dated 04/30/09 required, "To provide mechanisms for receiving and responding to concerns...A patient grievance is a written or verbal complaint (when the verbal complaint about patient care is not resolved at the time of the complaint by staff present) by a patient, or the patient's representative, regarding the patients care, abuse or neglect, issues related to the hospital's compliance with the CMS Hospital Conditions of Participation...related to rights and limitations provided by 42 Code of Federal Regulations...The following types of concerns should be communicated...They include but are not limited to...Significant or unresolved concerns (also called Grievances)...concerns crossing multiple department lines or processes...allegations of harm...should be responded to in writing and substantively address the areas of concern...If a review and reply cannot be completed within 7 calendar days of receipt...acknowledgement of receipt and a reasonable timeframe to respond to the issues should be communicated to the complainant...complaints about physicians should be forwarded to Medical Staff Services... "

At 10:00 A.M. on 05/17/11, the Director of Quality (Personnel #2) was interviewed. She was asked if she is responsible for the Risk Management process. She stated, " Yes, I supervise the Risk Manager and the Quality Management. " She was asked if the hospital provided written notice of its decision, steps taken, results of the investigation and date of completion on the grievances that were received from the patients or family of Patients #1, #2, #3, #4, #6, #7, and #8. She stated, "No." She was asked if the hospital followed the required grievance process. She stated, "No." She was asked if Patient #1's complaint regarding physician services was forwarded to Medical Staff Services as required. She stated, "No."
VIOLATION: QAPI Tag No: A0263
Based on interview and review of records, the hospital Performance Improvement Program failed to identify the following:
1) Adverse Drug Event involving continuous IV narcotic infusion and possible medical device error was not identified and investigated.
2) The hospital did not have a Safety Committee or an appointed Safety Officer.
3) The hospital Patient Safety Program did not perform root cause analysis for reduction of medication errors.
4) The written notice of it's decision, steps taken, results of investigation and date of completion for patient grievances involving patient care was not complete.

Findings included:

The "Plan for Improving Organization Performance" dated 2010 requires, "This plan defines Methodist Health System's processes and accountability for improving operational and clinical performance...Evaluation and improvement of services will be viewed using a framework including the following characteristics: safe, effective, efficient, timely, equitable, and patient centered....To ensure there are systematic processes for monitoring, analyzing, and improving performance related to the services provided...To identify and prioritize processes and systems which have the greatest potential for improving the quality and safety of services...To plan for and implement actions to improve services and to evaluate results of those improvement actions...To integrate and coordinate performance improvement activities...To provide educational opportunities...To effectively disseminate the findings from performance improvement activities to the appropriate persons and/or committees...to comply with standards from...Medicare/Medicaid, Texas Department of Health and Human Services, other licensing and regulatory bodies...The executive staff and leadership will identify goals for performance improvement annually...Prevention of harm or improved safety...Data will be available for consideration in the establishment and prioritization of performance improvement initiatives...occurrence report data...high risk or problem prone processes...patient complaints...Performance Improvement Scope...will focus on trhe measurement, assessment, and improvement of care, services, and key processes in the following areas...Patient Safety Program...Provision of Care, Treatment and Services of Patients...Medication Management...Medical Equipment Management...Management of Human Resources...Nursing...Authority, Accountability & Communication...The Methodist Health System's Board of Directors...is vested with the responsibility to ensure that a plan for improving organization performance is in place..."

During an interview on 05/17/11 at 10:00 A.M. with the Director of Quality (Personnel #2), she verified the above listed items were not identified in the Performance Improvement Program.

Cross Reference:
VIOLATION: PROGRAM SCOPE, PROGRAM DATA Tag No: A0273
Based on interview and record review, the hospital did not implement policies and procedures for Performance Improvement activities by failing to:

1. Analyze 1 of 1 adverse drug events that involved an overdose of the narcotic Morphine in 1 of 1 patients (Patient #2).

2. Develop the hospital policies to minimize drug errors with continuous intravenous narcotic infusions.

By failing to analyze the adverse drug event, the hospital did not implement a plan of correction to prevent similar medication errors from happening in the future.

Findings included:

Review of Patient #2's medical record revealed:

The "Doctor's Order" sheet dated 02/13/11 timed at 11:40 A.M. revealed, "1. Morphine drip bolus 2 mg (milligrams) IV then start 2 mg/hr (milligrams per hour). Titrate up by 1 mg every 30 minutes for respiratory distress or pain. Maximum 10 mg/hr...."

The "Nurses Notes" dated 02/14/11 timed at 7:00 A.M. revealed, "Son stated patient was gurgling as if he had phlegm he could not cough up. Informed him I would give patient Atropine gtts (drops) to help with secretions. Med was given. Noted, however, patient was unresponsive. Snoring as if in deep sleep with respiratory rate of 9-10/min. SpO2 (oxygen level) 70%. Placed patient on 100% NRB mask (non rebreather mask) and SpO2 increased to 95%. Patient remained unresponsive to verbal and tactile stimuli. V/S (vital signs) stable 153/66 - 86 - 98.7, strong pulse felt. Checked Morphine drip and setting were changed to 25 ml/hr and almost all of remaining med was gone. Infusion stopped and MD (Personnel #21) paged. Spoke to and informed MD (Personnel #21) of incident. Order received for Narcan (medication to reverse effects of narcotics) IV. Med given. Patient responded to med in less than 1 min. Awake, alert, but confused. Informed house supervisor of incident..."

The Quality Assurance Performance Improvement (QAPI) and Pharmacy and Therapeutics (P&T) Committee notes dated February 2011 through May 2011 did not reflect any references or reports for the narcotic medication error and/or possible medication device error which resulted in patient harm.

The "Occurrence Report" dated 02/14/11 reflected, "Outcome: No harm - Intervention or monitoring required ..."

The hospital did not have a "Medication Occurrence Report" filled out on this incident.

The Hospital Policy, "Occurrence Report" , dated 10/30/07, required, "To provide a mechanism for response/intervention, monitoring, trending, and prevention follow-up of occurrences and near misses...will be investigated to identify processes underlying the potential apparent cause...and to identify those process changes that might reduce the likelihood of a similar sentinel event occurring in the future...Each situation must be evaluated...Adverse Drug Event is any incident in which the use of a medication at any dose, a medical device...may have resulted in an adverse outcome in a patient...An event or potential event...should be...forwarded to the Risk Manager...should begin an initial assessment...conduct a timely, through and credible root cause analysis...implement improvements to reduce risk, monitoring the effectiveness of those improvements, action plan within 45 calendar days of the event or of becoming aware of the event...It is the responsibility of Risk Management to supply the Safety Committee with a summary of patient incidents...Instructions: An occurrence is any event not consistent with routine patient care...A Near Miss is a SIGNIFICANT unintended event in the system of care, which could have resulted in a SERIOUS unanticipated outcome...An Unanticipated Outcome is a result that differs significantly from what was expected by the healthcare provider...to be result of a treatment, medication or procedure...If the occurrence is medical equipment related, secure the equipment and notify Biomed...If the occurrence is medicated related, you must fill out the Medication Occurrence Report Form ...Follow-Up Instructions...Notify...Pharmacy...Biomed...Secure and tag equipment, supplies or medication items if they are related to the occurrence..."

The Hospital Policy, "Disclosure of Unanticipated Outcome Information", dated 05/15/06 required, "Unanticipated Outcomes (UO's) and Near Misses are analyzed through the quality review and occurrence reporting processes of the Quality Review Committee in order to identify actions that will limit, if possible, reoccurrence...All equipment and supplies that might be implicated in the event or near miss should be retained...The Quality Review Committee oversees the investigation of UO's and Near Misses in the hospital and the implementation of processes to assist in the reduction of the causes of such UO's and Near Misses in the future..."

The Hospital Policy, "Continuous Intravenous Narcotic Infusion For Management of Severe Pain in the Adult Patient" dated 08/30/10 did not address safety requirements while infusing continuous narcotics to prevent inadvertent overdose or tampering with the infusion pump.

At 2:40 P.M. on 05/16/11, the Risk Manager (Personnel #6) was interviewed. She was asked if she is responsible for reviewing and investigating occurrences and variances for the hospital. She stated, "Yes." She was asked if it is hospital policy to refer medication errors and adverse drug events to the Pharmacist. She stated, "Yes." She was then asked to review the Occurrence Report for the narcotic overdose on Patient #2. She was asked if the narcotic overdose was an Unanticipated Outcome or Near Miss. She stated, "I did not consider it a Near Miss because there was no harm." She was asked if there was an intervention performed by the nurse in Patient #2's behalf after the Morphine overdose. She stated, "Yes, Narcan was given to reverse the overdose." She was then asked if an overdose of Morphine would be considered an Unanticipated Outcome. She stated, "Yes." She was asked if she had identified the overdose as an Unanticipated Outcome and performed the required investigation or Root Cause Analysis to identify and prevent such occurrences from happening again as required by hospital policy and procedure. She stated, "No." She was asked if she had referred the adverse drug event to Pharmacy or the P&T Committee for investigation. She stated, "No." She was then asked if she had referred the adverse event to the Quality Review or Safety Committee as required. She stated, "No."

At 10:00 A.M. on 05/17/11, the Director of Quality (Personnel #2) was interviewed. She was asked if she is responsible for the hospital QAPI. She stated, "Yes." She was asked if she is responsible for the Risk Management process. She stated, "Yes, I supervise the Risk Manager and the Quality Management." She was asked to review the occurrence report for Patient #2. She was then asked if the hospital followed the required policies for the Risk Management and QAPI Process. She stated, "No." She was asked if an investigation or Root Cause Analysis had been performed on the Morphine overdose. She stated, "No." She was asked if the incident had been referred to the P&T or Quality Review Committees for investigation and review to prevent this type of occurrence from happening again. She stated, "No." She was asked to produce the past year of the Hospital Safety Committee meeting notes. She stated, "We do not have a Hospital Safety Committee at this facility. It is a corporate wide Safety Committee." She was asked if the hospital followed the Safe Medical Device Reporting policy and procedure and reported incident involving the Alaris IV pump to the FDA as required. She stated, "No."

At 10:40 A.M. on 05/17/11, the Director of Pharmacy (Personnel #14) was interviewed. She was asked if the pharmacy has a policy for safety measures to prevent overdose when providing continuous intravenous narcotic infusions. She stated, "No."
VIOLATION: PATIENT SAFETY Tag No: A0286
Based on interview and record review, the hospital did not implement policies and procedures for Performance Improvement activities by failing to:

1. Analyze 1 of 1 adverse drug events that involved an overdose of the narcotic Morphine in 1 of 1 patients (Patient #2).

2. Develop the hospital policies to minimize drug errors with continuous intravenous narcotic infusions.

By failing to analyze the adverse drug event, the hospital did not implement a plan of correction to prevent similar medication errors from happening in the future.

Findings included:

Review of Patient #2's medical record revealed:

The "Doctor's Order" sheet dated 02/13/11 timed at 11:40 A.M. revealed, "1. Morphine drip bolus 2 mg (milligrams) IV then start 2 mg/hr (milligrams per hour). Titrate up by 1 mg every 30 minutes for respiratory distress or pain. Maximum 10 mg/hr...."

The "Nurses Notes" dated 02/14/11 timed at 7:00 A.M. revealed, "Son stated patient was gurgling as if he had phlegm he could not cough up. Informed him I would give patient Atropine gtts (drops) to help with secretions. Med was given. Noted, however, patient was unresponsive. Snoring as if in deep sleep with respiratory rate of 9-10/min. SpO2 (oxygen level) 70%. Placed patient on 100% NRB mask (non rebreather mask) and SpO2 increased to 95%. Patient remained unresponsive to verbal and tactile stimuli. V/S (vital signs) stable 153/66 - 86 - 98.7, strong pulse felt. Checked Morphine drip and setting were changed to 25 ml/hr and almost all of remaining med was gone. Infusion stopped and MD (Personnel #21) paged. Spoke to and informed MD (Personnel #21) of incident. Order received for Narcan (medication to reverse effects of narcotics) IV. Med given. Patient responded to med in less than 1 min. Awake, alert, but confused. Informed house supervisor of incident..."

The Quality Assurance Performance Improvement (QAPI) and Pharmacy and Therapeutics (P&T) Committee notes dated February 2011 through May 2011 did not reflect any references or reports for the narcotic medication error and/or possible medication device error which resulted in patient harm.

The "Occurrence Report" dated 02/14/11 reflected, "Outcome: No harm - Intervention or monitoring required ..."

The hospital did not have a "Medication Occurrence Report" filled out on this incident.

The Hospital Policy, "Occurrence Report" , dated 10/30/07, required, "To provide a mechanism for response/intervention, monitoring, trending, and prevention follow-up of occurrences and near misses...will be investigated to identify processes underlying the potential apparent cause...and to identify those process changes that might reduce the likelihood of a similar sentinel event occurring in the future...Each situation must be evaluated...Adverse Drug Event is any incident in which the use of a medication at any dose, a medical device...may have resulted in an adverse outcome in a patient...An event or potential event...should be...forwarded to the Risk Manager...should begin an initial assessment...conduct a timely, through and credible root cause analysis...implement improvements to reduce risk, monitoring the effectiveness of those improvements, action plan within 45 calendar days of the event or of becoming aware of the event...It is the responsibility of Risk Management to supply the Safety Committee with a summary of patient incidents...Instructions: An occurrence is any event not consistent with routine patient care...A Near Miss is a SIGNIFICANT unintended event in the system of care, which could have resulted in a SERIOUS unanticipated outcome...An Unanticipated Outcome is a result that differs significantly from what was expected by the healthcare provider...to be result of a treatment, medication or procedure...If the occurrence is medical equipment related, secure the equipment and notify Biomed...If the occurrence is medicated related, you must fill out the Medication Occurrence Report Form ...Follow-Up Instructions...Notify...Pharmacy...Biomed...Secure and tag equipment, supplies or medication items if they are related to the occurrence..."

The Hospital Policy, "Disclosure of Unanticipated Outcome Information", dated 05/15/06 required, "Unanticipated Outcomes (UO's) and Near Misses are analyzed through the quality review and occurrence reporting processes of the Quality Review Committee in order to identify actions that will limit, if possible, reoccurrence...All equipment and supplies that might be implicated in the event or near miss should be retained...The Quality Review Committee oversees the investigation of UO's and Near Misses in the hospital and the implementation of processes to assist in the reduction of the causes of such UO's and Near Misses in the future..."

The Hospital Policy, "Continuous Intravenous Narcotic Infusion For Management of Severe Pain in the Adult Patient" dated 08/30/10 did not address safety requirements while infusing continuous narcotics to prevent inadvertent overdose or tampering with the infusion pump.

At 2:40 P.M. on 05/16/11, the Risk Manager (Personnel #6) was interviewed. She was asked if she is responsible for reviewing and investigating occurrences and variances for the hospital. She stated, "Yes." She was asked if it is hospital policy to refer medication errors and adverse drug events to the Pharmacist. She stated, "Yes." She was then asked to review the Occurrence Report for the narcotic overdose on Patient #2. She was asked if the narcotic overdose was an Unanticipated Outcome or Near Miss. She stated, "I did not consider it a Near Miss because there was no harm." She was asked if there was an intervention performed by the nurse in Patient #2's behalf after the Morphine overdose. She stated, "Yes, Narcan was given to reverse the overdose." She was then asked if an overdose of Morphine would be considered an Unanticipated Outcome. She stated, "Yes." She was asked if she had identified the overdose as an Unanticipated Outcome and performed the required investigation or Root Cause Analysis to identify and prevent such occurrences from happening again as required by hospital policy and procedure. She stated, "No." She was asked if she had referred the adverse drug event to Pharmacy or the P&T Committee for investigation. She stated, "No." She was then asked if she had referred the adverse event to the Quality Review or Safety Committee as required. She stated, "No."

At 10:00 A.M. on 05/17/11, the Director of Quality (Personnel #2) was interviewed. She was asked if she is responsible for the hospital QAPI. She stated, "Yes." She was asked if she is responsible for the Risk Management process. She stated, "Yes, I supervise the Risk Manager and the Quality Management." She was asked to review the occurrence report for Patient #2. She was then asked if the hospital followed the required policies for the Risk Management and QAPI Process. She stated, "No." She was asked if an investigation or Root Cause Analysis had been performed on the Morphine overdose. She stated, "No." She was asked if the incident had been referred to the P&T or Quality Review Committees for investigation and review to prevent this type of occurrence from happening again. She stated, "No." She was asked to produce the past year of the Hospital Safety Committee meeting notes. She stated, "We do not have a Hospital Safety Committee at this facility. It is a corporate wide Safety Committee." She was asked if the hospital followed the Safe Medical Device Reporting policy and procedure and reported incident involving the Alaris IV pump to the FDA as required. She stated, "No."

At 10:40 A.M. on 05/17/11, the Director of Pharmacy (Personnel #14) was interviewed. She was asked if the pharmacy has a policy for safety measures to prevent overdose when providing continuous intravenous narcotic infusions. She stated, "No."
VIOLATION: PROGRAM DATA, PROGRAM ACTIVITIES Tag No: A0283
Based on interview and review of records, the hospital Performance Improvement Program failed to monitor the safety and quality of patient care in that 1 of 1 Adverse Drug Events involving continuous IV narcotic infusion and possible medical device error on 1 of 1 patient (Patient #2) was not identified and investigated to prevent additional errors from occuring in the future.

Findings included:

Review of Patient #2's medical record revealed:

The "Doctor's Order" sheet dated 02/13/11 timed at 11:40 A.M. revealed, "1. Morphine drip bolus 2 mg (milligrams) IV then start 2 mg/hr (milligrams per hour). Titrate up by 1 mg every 30 minutes for respiratory distress or pain. Maximum 10 mg/hr...."

The "Nurses Notes" dated 02/14/11 timed at 7:00 A.M. revealed, "Son stated patient was gurgling as if he had phlegm he could not cough up. Informed him I would give patient Atropine gtts (drops) to help with secretions. Med was given. Noted, however, patient was unresponsive. Snoring as if in deep sleep with respiratory rate of 9-10/min. SpO2 (oxygen level) 70%. Placed patient on 100% NRB mask (non rebreather mask) and SpO2 increased to 95%. Patient remained unresponsive to verbal and tactile stimuli. V/S (vital signs) stable 153/66 - 86 - 98.7, strong pulse felt. Checked Morphine drip and setting were changed to 25 ml/hr and almost all of remaining med was gone. Infusion stopped and MD (Personnel #21) paged. Spoke to and informed MD (Personnel #21) of incident. Order received for Narcan (medication to reverse effects of narcotics) IV. Med given. Patient responded to med in less than 1 min. Awake, alert, but confused. Informed house supervisor of incident..."

The Quality Assurance Performance Improvement (QAPI) and Pharmacy and Therapeutics (P&T) Committee notes dated February 2011 through May 2011 did not reflect any references or reports for the narcotic medication error and/or possible medication device error which resulted in patient harm.

The "Occurrence Report" dated 02/14/11 reflected, "Outcome: No harm - Intervention or monitoring required ..."

The hospital did not have a "Medication Occurrence Report" filled out on this incident.

The Hospital Policy, "Occurrence Report" , dated 10/30/07, required, "To provide a mechanism for response/intervention, monitoring, trending, and prevention follow-up of occurrences and near misses...will be investigated to identify processes underlying the potential apparent cause...and to identify those process changes that might reduce the likelihood of a similar sentinel event occurring in the future...Each situation must be evaluated...Adverse Drug Event is any incident in which the use of a medication at any dose, a medical device...may have resulted in an adverse outcome in a patient...An event or potential event...should be...forwarded to the Risk Manager...should begin an initial assessment...conduct a timely, through and credible root cause analysis...implement improvements to reduce risk, monitoring the effectiveness of those improvements, action plan within 45 calendar days of the event or of becoming aware of the event...It is the responsibility of Risk Management to supply the Safety Committee with a summary of patient incidents...Instructions: An occurrence is any event not consistent with routine patient care...A Near Miss is a SIGNIFICANT unintended event in the system of care, which could have resulted in a SERIOUS unanticipated outcome...An Unanticipated Outcome is a result that differs significantly from what was expected by the healthcare provider...to be result of a treatment, medication or procedure...If the occurrence is medical equipment related, secure the equipment and notify Biomed...If the occurrence is medicated related, you must fill out the Medication Occurrence Report Form ...Follow-Up Instructions...Notify...Pharmacy...Biomed...Secure and tag equipment, supplies or medication items if they are related to the occurrence..."

The Hospital Policy, "Disclosure of Unanticipated Outcome Information", dated 05/15/06 required, "Unanticipated Outcomes (UO's) and Near Misses are analyzed through the quality review and occurrence reporting processes of the Quality Review Committee in order to identify actions that will limit, if possible, reoccurrence...All equipment and supplies that might be implicated in the event or near miss should be retained...The Quality Review Committee oversees the investigation of UO's and Near Misses in the hospital and the implementation of processes to assist in the reduction of the causes of such UO's and Near Misses in the future..."

At 10:00 A.M. on 05/17/11, the Director of Quality (Personnel #2) was interviewed. She was asked if she is responsible for the hospital QAPI. She stated, "Yes." She was asked to review the occurrence report for Patient #2. She was then asked if the hospital followed the required policies for the QAPI Process. She stated, "No." She was asked if an investigation or Root Cause Analysis had been performed on the Morphine overdose. She stated, "No." She was asked if the incident had been referred to the P&T or Quality Review Committees for investigation and review to prevent this type of occurrence from happening again. She stated, "No." She was asked if the hospital followed the Safe Medical Device Reporting policy and procedure and reported incident involving the Alaris IV pump to the FDA as required. She stated, "No."
VIOLATION: PATIENT SAFETY Tag No: A0286
Based on review of records and interviews, the hospital did not identify 1 of 1 medication adverse event (Patient #2) and perform a root cause analysis to identify potential processes for prevention and reduction of medication errors and adverse events. The failure to identify medication errors and adverse events placed the patient population at risk for further harm or injury.

Findings included:

Review of Patient #2's medical record revealed:

The "Doctor's Order" sheet dated 02/13/11 timed at 11:40 A.M. revealed, "1. Morphine drip bolus 2 mg (milligrams) IV then start 2 mg/hr (milligrams per hour). Titrate up by 1 mg every 30 minutes for respiratory distress or pain. Maximum 10 mg/hr...."

The "Nurses Notes" dated 02/14/11 timed at 7:00 A.M. revealed, "Son stated patient was gurgling as if he had phlegm he could not cough up. Informed him I would give patient Atropine gtts (drops) to help with secretions. Med was given. Noted, however, patient was unresponsive. Snoring as if in deep sleep with respiratory rate of 9-10/min. SpO2 (oxygen level) 70%. Placed patient on 100% NRB mask (non rebreather mask) and SpO2 increased to 95%. Patient remained unresponsive to verbal and tactile stimuli. V/S (vital signs) stable 153/66 - 86 - 98.7, strong pulse felt. Checked Morphine drip and setting were changed to 25 ml/hr and almost all of remaining med was gone. Infusion stopped and MD (Personnel #21) paged. Spoke to and informed MD (Personnel #21) of incident. Order received for Narcan (medication to reverse effects of narcotics) IV. Med given. Patient responded to med in less than 1 min. Awake, alert, but confused. Informed house supervisor of incident..."

The Quality Assurance Performance Improvement (QAPI) and Pharmacy and Therapeutics (P&T) Committee notes dated February 2011 through May 2011 did not reflect any references or reports for the narcotic medication error and/or possible medication device error which resulted in patient harm.

The "Occurrence Report" dated 02/14/11 reflected, "Outcome: No harm - Intervention or monitoring required ..."

The hospital did not have a "Medication Occurrence Report" filled out on this incident.

The Hospital Policy, "Occurrence Report" , dated 10/30/07, required, "To provide a mechanism for response/intervention, monitoring, trending, and prevention follow-up of occurrences and near misses...will be investigated to identify processes underlying the potential apparent cause...and to identify those process changes that might reduce the likelihood of a similar sentinel event occurring in the future...Each situation must be evaluated...Adverse Drug Event is any incident in which the use of a medication at any dose, a medical device...may have resulted in an adverse outcome in a patient...An event or potential event...should be...forwarded to the Risk Manager...should begin an initial assessment...conduct a timely, through and credible root cause analysis...implement improvements to reduce risk, monitoring the effectiveness of those improvements, action plan within 45 calendar days of the event or of becoming aware of the event...It is the responsibility of Risk Management to supply the Safety Committee with a summary of patient incidents...Instructions: An occurrence is any event not consistent with routine patient care...A Near Miss is a SIGNIFICANT unintended event in the system of care, which could have resulted in a SERIOUS unanticipated outcome...An Unanticipated Outcome is a result that differs significantly from what was expected by the healthcare provider...to be result of a treatment, medication or procedure...If the occurrence is medical equipment related, secure the equipment and notify Biomed...If the occurrence is medicated related, you must fill out the Medication Occurrence Report Form ...Follow-Up Instructions...Notify...Pharmacy...Biomed...Secure and tag equipment, supplies or medication items if they are related to the occurrence..."

The Hospital Policy, "Disclosure of Unanticipated Outcome Information", dated 05/15/06 required, "Unanticipated Outcomes (UO's) and Near Misses are analyzed through the quality review and occurrence reporting processes of the Quality Review Committee in order to identify actions that will limit, if possible, reoccurrence...All equipment and supplies that might be implicated in the event or near miss should be retained...The Quality Review Committee oversees the investigation of UO's and Near Misses in the hospital and the implementation of processes to assist in the reduction of the causes of such UO's and Near Misses in the future..."

At 2:40 P.M. on 05/16/11, the Risk Manager (Personnel #6) was interviewed. She was asked if she is responsible for reviewing and investigating occurrences and variances for the hospital. She stated, "Yes." She was asked if it is hospital policy to refer medication errors and adverse drug events to the Pharmacist. She stated, "Yes." She was then asked to review the Occurrence Report for the narcotic overdose on Patient #2. She was asked if the narcotic overdose was an Unanticipated Outcome or Near Miss. She stated, "I did not consider it a Near Miss because there was no harm." She was asked if there was an intervention performed by the nurse in Patient #2's behalf after the Morphine overdose. She stated, "Yes, Narcan was given to reverse the overdose." She was then asked if an overdose of Morphine would be considered an Unanticipated Outcome. She stated, "Yes." She was asked if she had identified the overdose as an Unanticipated Outcome and performed the required investigation or Root Cause Analysis to identify and prevent such occurrences from happening again as required by hospital policy and procedure. She stated, "No." She was asked if she had referred the adverse drug event to Pharmacy or the P&T Committee for investigation. She stated, "No." She was then asked if she had referred the adverse event to the Quality Review or Safety Committee as required. She stated, "No."

At 10:00 A.M. on 05/17/11, the Director of Quality (Personnel #2) was interviewed. She was asked if she is responsible for the hospital QAPI. She stated, "Yes." She was asked if she is responsible for the Risk Management process. She stated, "Yes, I supervise the Risk Manager and the Quality Management." She was asked to review the occurrence report for Patient #2. She was then asked if the hospital followed the required policies for the Risk Management and QAPI Process. She stated, "No." She was asked if an investigation or Root Cause Analysis had been performed on the Morphine overdose. She stated, "No." She was asked if the incident had been referred to the P&T or Quality Review Committees for investigation and review to prevent this type of occurrence from happening again. She stated, "No." She was asked to produce the past year of the Hospital Safety Committee meeting notes. She stated, "We do not have a Hospital Safety Committee at this facility. It is a corporate wide Safety Committee." She was asked if the hospital followed the Safe Medical Device Reporting policy and procedure and reported incident involving the Alaris IV pump to the FDA as required. She stated, "No."
VIOLATION: EXECUTIVE RESPONSIBILITIES Tag No: A0309
Based on review of records and interviews, the Governing Body failed to ensure the hospital-wide Quality Assessment and Performance Improvement (QAPI) program was implemented in that it did not identify, monitor or evaluate adverse events and medication errors in 1 of 1 medication adverse events (Patient #2).

Findings:

Review of Patient #2's medical record revealed:

The "Doctor's Order" sheet dated 02/13/11 timed at 11:40 A.M. revealed, "1. Morphine drip bolus 2 mg (milligrams) IV then start 2 mg/hr (milligrams per hour). Titrate up by 1 mg every 30 minutes for respiratory distress or pain. Maximum 10 mg/hr...."

The "Nurses Notes" dated 02/14/11 timed at 7:00 A.M. revealed, "Son stated patient was gurgling as if he had phlegm he could not cough up. Informed him I would give patient Atropine gtts (drops) to help with secretions. Med was given. Noted, however, patient was unresponsive. Snoring as if in deep sleep with respiratory rate of 9-10/min. SpO2 (oxygen level) 70%. Placed patient on 100% NRB mask (non rebreather mask) and SpO2 increased to 95%. Patient remained unresponsive to verbal and tactile stimuli. V/S (vital signs) stable 153/66 - 86 - 98.7, strong pulse felt. Checked Morphine drip and setting were changed to 25 ml/hr and almost all of remaining med was gone. Infusion stopped and MD (Personnel #21) paged. Spoke to and informed MD (Personnel #21) of incident. Order received for Narcan (medication to reverse effects of narcotics) IV. Med given. Patient responded to med in less than 1 min. Awake, alert, but confused. Informed house supervisor of incident..."

The Quality Assurance Performance Improvement (QAPI) and Pharmacy and Therapeutics (P&T) Committee notes dated February 2011 through May 2011 did not reflect any references or reports for the narcotic medication error and/or possible medication device error which resulted in patient harm.

The "Occurrence Report" dated 02/14/11 reflected, "Outcome: No harm - Intervention or monitoring required ..."

The hospital did not have a "Medication Occurrence Report" filled out on this incident.

The Hospital Policy, "Occurrence Report" , dated 10/30/07, required, "To provide a mechanism for response/intervention, monitoring, trending, and prevention follow-up of occurrences and near misses...will be investigated to identify processes underlying the potential apparent cause...and to identify those process changes that might reduce the likelihood of a similar sentinel event occurring in the future...Each situation must be evaluated...Adverse Drug Event is any incident in which the use of a medication at any dose, a medical device...may have resulted in an adverse outcome in a patient...An event or potential event...should be...forwarded to the Risk Manager...should begin an initial assessment...conduct a timely, through and credible root cause analysis...implement improvements to reduce risk, monitoring the effectiveness of those improvements, action plan within 45 calendar days of the event or of becoming aware of the event...It is the responsibility of Risk Management to supply the Safety Committee with a summary of patient incidents...Instructions: An occurrence is any event not consistent with routine patient care...A Near Miss is a SIGNIFICANT unintended event in the system of care, which could have resulted in a SERIOUS unanticipated outcome...An Unanticipated Outcome is a result that differs significantly from what was expected by the healthcare provider...to be result of a treatment, medication or procedure...If the occurrence is medical equipment related, secure the equipment and notify Biomed...If the occurrence is medicated related, you must fill out the Medication Occurrence Report Form ...Follow-Up Instructions...Notify...Pharmacy...Biomed...Secure and tag equipment, supplies or medication items if they are related to the occurrence..."

The "Methodist Bylaws", 05/26/09 requires, "The activities, property and affairs of the Corporation shall be managed by its Board of Directors...The System Quality Review Committee...a standing committee of the Board of Directors....shall...regularly review reports from the medical staff and hospital administration regarding the quality of medical services provided...analyze quality initiatives at each System Institution to assure processes are in place to facilitate the implementation of system-wide best practices...monitor progress with quality initiatives...provide, on behalf of the Board, general governance oversight for the quality of service in the respective System Institutions...assure processes are in place at each System Institution to perform the following functions: report regularly to the System Quality Review Committee on the quality of services provided; assist the System Quality Review Committee in implementing system-wide quality improvement initiatives; review processes and methods used by the medical staff and hospital staff to monitor and improve the quality of service in the respective System Institutions; advise the System Quality Review Committee as to whether monitoring and follow-up programs and activities are effective and whether identified deficiencies in the safety, reliability, effectiveness, and acceptability of hospital and medical care are being addressed...Corporate Medical Board...shall...evaluate and monitor quality monitoring and improvement activities and systems for monitoring and evaluating the quality of patient care and improving patient care in the System Institutions..."


At 10:00 A.M. on 05/17/11, the Director of Quality (Personnel #2) was interviewed. She was asked if she is responsible for the hospital QAPI. She stated, "Yes." She was then asked if the hospital followed the required policies for QAPI Process. She stated, "No." She was asked if an investigation or Root Cause Analysis had been performed on the Morphine overdose. She stated, "No." She was asked if the incident had been referred to the P&T or Quality Review Committees for investigation and review to prevent this type of occurrence from happening again. She stated, "No."
VIOLATION: EXECUTIVE RESPONSIBILITIES Tag No: A0309
Based on review of records and interviews, the Patient Safety Program was not implemented in that the governing body did not ensure prevention and reduction of medical errors and adverse events in that 1 of 1 medication adverse events (Patient #2) was not identified and investigated to identify process changes that might reduce the likelihood of a similar event from occurring in the future.

Findings:

Review of Patient #2's medical record revealed:

The "Doctor's Order" sheet dated 02/13/11 timed at 11:40 A.M. revealed, "1. Morphine drip bolus 2 mg (milligrams) IV then start 2 mg/hr (milligrams per hour). Titrate up by 1 mg every 30 minutes for respiratory distress or pain. Maximum 10 mg/hr...."

The "Nurses Notes" dated 02/14/11 timed at 7:00 A.M. revealed, "Son stated patient was gurgling as if he had phlegm he could not cough up. Informed him I would give patient Atropine gtts (drops) to help with secretions. Med was given. Noted, however, patient was unresponsive. Snoring as if in deep sleep with respiratory rate of 9-10/min. SpO2 (oxygen level) 70%. Placed patient on 100% NRB mask (non rebreather mask) and SpO2 increased to 95%. Patient remained unresponsive to verbal and tactile stimuli. V/S (vital signs) stable 153/66 - 86 - 98.7, strong pulse felt. Checked Morphine drip and setting were changed to 25 ml/hr and almost all of remaining med was gone. Infusion stopped and MD (Personnel #21) paged. Spoke to and informed MD (Personnel #21) of incident. Order received for Narcan (medication to reverse effects of narcotics) IV. Med given. Patient responded to med in less than 1 min. Awake, alert, but confused. Informed house supervisor of incident..."

The Quality Assurance Performance Improvement (QAPI) and Pharmacy and Therapeutics (P&T) Committee notes dated February 2011 through May 2011 did not reflect any references or reports for the narcotic medication error and/or possible medication device error which resulted in patient harm.

The "Occurrence Report" dated 02/14/11 reflected, "Outcome: No harm - Intervention or monitoring required ..."

The hospital did not have a "Medication Occurrence Report" filled out on this incident.

The Hospital Policy, "Occurrence Report" , dated 10/30/07, required, "To provide a mechanism for response/intervention, monitoring, trending, and prevention follow-up of occurrences and near misses...will be investigated to identify processes underlying the potential apparent cause...and to identify those process changes that might reduce the likelihood of a similar sentinel event occurring in the future...Each situation must be evaluated...Adverse Drug Event is any incident in which the use of a medication at any dose, a medical device...may have resulted in an adverse outcome in a patient...An event or potential event...should be...forwarded to the Risk Manager...should begin an initial assessment...conduct a timely, through and credible root cause analysis...implement improvements to reduce risk, monitoring the effectiveness of those improvements, action plan within 45 calendar days of the event or of becoming aware of the event...It is the responsibility of Risk Management to supply the Safety Committee with a summary of patient incidents...Instructions: An occurrence is any event not consistent with routine patient care...A Near Miss is a SIGNIFICANT unintended event in the system of care, which could have resulted in a SERIOUS unanticipated outcome...An Unanticipated Outcome is a result that differs significantly from what was expected by the healthcare provider...to be result of a treatment, medication or procedure...If the occurrence is medical equipment related, secure the equipment and notify Biomed...If the occurrence is medicated related, you must fill out the Medication Occurrence Report Form ...Follow-Up Instructions...Notify...Pharmacy...Biomed...Secure and tag equipment, supplies or medication items if they are related to the occurrence..."

The Hospital Policy, "Disclosure of Unanticipated Outcome Information", dated 05/15/06 required, "Unanticipated Outcomes (UO's) and Near Misses are analyzed through the quality review and occurrence reporting processes of the Quality Review Committee in order to identify actions that will limit, if possible, reoccurrence...All equipment and supplies that might be implicated in the event or near miss should be retained...The Quality Review Committee oversees the investigation of UO's and Near Misses in the hospital and the implementation of processes to assist in the reduction of the causes of such UO's and Near Misses in the future..."

At 2:40 P.M. on 05/16/11, the Risk Manager (Personnel #6) was interviewed. She was asked if she is responsible for reviewing and investigating occurrences and variances for the hospital. She stated, "Yes." She was asked if it is hospital policy to refer medication errors and adverse drug events to the Pharmacist. She stated, "Yes." She was then asked to review the Occurrence Report for the narcotic overdose on Patient #2. She was asked if the narcotic overdose was an Unanticipated Outcome or Near Miss. She stated, "I did not consider it a Near Miss because there was no harm." She was asked if there was an intervention performed by the nurse in Patient #2's behalf after the Morphine overdose. She stated, "Yes, Narcan was given to reverse the overdose." She was then asked if an overdose of Morphine would be considered an Unanticipated Outcome. She stated, "Yes." She was asked if she had identified the overdose as an Unanticipated Outcome and performed the required investigation or Root Cause Analysis to identify and prevent such occurrences from happening again as required by hospital policy and procedure. She stated, "No." She was asked if she had referred the adverse drug event to Pharmacy or the P&T Committee for investigation. She stated, "No." She was then asked if she had referred the adverse event to the Quality Review or Safety Committee as required. She stated, "No."

At 10:00 A.M. on 05/17/11, the Director of Quality (Personnel #2) was interviewed. She was asked if she is responsible for the hospital QAPI. She stated, "Yes." She was asked if she is responsible for the Risk Management process. She stated, "Yes, I supervise the Risk Manager and the Quality Management." She was asked to review the occurrence report for Patient #2. She was then asked if the hospital followed the required policies for the Risk Management and QAPI Process. She stated, "No." She was asked if an investigation or Root Cause Analysis had been performed on the Morphine overdose. She stated, "No." She was asked if the incident had been referred to the P&T or Quality Review Committees for investigation and review to prevent this type of occurrence from happening again. She stated, "No." She was asked to produce the past year of the Hospital Safety Committee meeting notes. She stated, "We do not have a Hospital Safety Committee at this facility. It is a corporate wide Safety Committee." She was asked if the hospital followed the Safe Medical Device Reporting policy and procedure and reported incident involving the Alaris IV pump to the FDA as required. She stated, "No."
VIOLATION: STAFFING AND DELIVERY OF CARE Tag No: A0392
Based on review of records and interview, the hospital did not have a Supervisory RN (Registered Nurse) immediately available on each nursing unit to provide nursing care to 1 of 1 (F4E unit) Medical Surgical inpatient units where patients were present for 4 of 4 shifts from 02/13/11- 02/14/11.

The RN Charge Nurse had patient assignments and did not have at least one RN immediately available in the event of an emergency where patients were present.

The lack of adequate nurse staffing created a potential for patient harm.

Findings included:

Review of Patient #2's medical record reflected he was admitted to the hospital's F4E Medical-Surgical (Med-Surg) inpatient unit on 02/13/11 for hospice care. The nursing notes revealed the patient was receiving continuous intravenous (IV) Morphine via an IV pump. On 02/14/11 at 7:00 A.M., Personnel #19 documented that Patient #2 received an overdose of Morphine when the IV pump was changed from the ordered 2 ml/hr (milliliters per hour) to 25 ml/hr.

Review of the "Daily Assignment Sheet" dated 02/13/11, 7:00 P.M. - 7:00 A.M. reflected the RN Charge Nurse (Personnel #19) was assigned patient rooms #3, #4, #33, and #37.

The "Daily Assignment Sheet" further revealed the RN Charge Nurse had the following assignments:

02/13/11, 7:00 A.M. - 7:00 P.M. shift, the RN Charge Nurse (Personnel #22) was assigned patient rooms #21, #31, #32 and #33.

02/14/11, 7:00 A.M. - 7:00 P.M. reflected the RN Charge Nurse (Personnel #23) was assigned patient rooms #17, #18, #20 and #22.

02/14/11, 7:00 P.M. - 7:00 A.M. reflected the RN Charge Nurse (Personnel #24) was assigned patient rooms #15, #17, #32 and #33.

The "Department of Nursing Plan for Staffing" not dated, requires, "Staffing patterns have been developed for each unit...Nursing Supervisor reevaluates staffing at a minimum of each shift...Staffing plans for each nursing unit are determined by: patient requirements, staff expertise, intensity and variability of care, number of patient visits/census, safe practice,...patient needs, staff skill mix, volume, and nursing judgement...The staffing plans shall be consistent with standards established by...regulatory and accrediting bodies...monitoring of the use of personnel resources will be done on a shift-by-shift basis by the Charge Nurse..."

The "Nurse Staffing Plan" dated 12/30/09 requires, "To comply with those portions of Chapter 257 of the Texas Health Safety Code and those state regulations promulgated in connection with such chapter...all hospitals within the system comply with Texas laws and rules as related to nurse staffing...The Nurse Staffing Plan is determined...number of patients (including admissions, discharges, and transfers); Patient characteristics, including intensity and variability; scope of services provided; departmental characteristics; nursing staff characteristics (education, skill mix, skill/competency, tenure, support staff utilization)..."

The "Plan for the Provision of Patient Care", not dated, requires, "The department director has 24 hour accountability for the operational, administrative and financial responsibility of the nursing departments and is accountable to ensure that staffing and shift coverage is sufficient within patient care areas...The RN professional staff supervises patient care. The charge nurse has accountability for patient care on their respective shift, and is responsible for patient care assignments based upon staff skill mix and the acuity level of the patients..."

During an interview with the RN Charge Nurse (Personnel #19) on 05/18/11 at 9:30 A.M., she verified she was the RN Charge Nurse on 02/13/11 - 02/14/11 for F4E Medical Surgical inpatient unit. Personnel #19 was asked if she was the primary care nurse for Patient #2 during the 7:00 P.M. - 7:00 A.M. shift when the medication error occurred. She stated, "Yes."

During an interview with the CNO (Personnel #1) on 05/16/11 at 3:00 P.M., she verified the above findings.
VIOLATION: HOSPITAL PROCEDURES Tag No: A0410
The hospital failed to enforce the policies and procedures for reporting 1 of 1 medication errors to the hospital QAPI (quality assurance and performance improvement) program that involved an overdose of the narcotic Morphine on a continuous IV infusion on 1 of 1 patients (Patient #2).

Findings included:

Review of Patient #2's medical record revealed:

The "Doctor's Order" sheet dated 02/13/11 timed at 11:40 A.M. revealed, "1. Morphine drip bolus 2 mg (milligrams) IV then start 2 mg/hr (milligrams per hour). Titrate up by 1 mg every 30 minutes for respiratory distress or pain. Maximum 10 mg/hr...."

The "Nurses Notes" dated 02/14/11 timed at 7:00 A.M. revealed, "Son stated patient was gurgling as if he had phlegm he could not cough up. Informed him I would give patient Atropine gtts (drops) to help with secretions. Med was given. Noted, however, patient was unresponsive. Snoring as if in deep sleep with respiratory rate of 9-10/min. SpO2 (oxygen level) 70%. Placed patient on 100% NRB mask (non rebreather mask) and SpO2 increased to 95%. Patient remained unresponsive to verbal and tactile stimuli. V/S (vital signs) stable 153/66 - 86 - 98.7, strong pulse felt. Checked Morphine drip and setting were changed to 25 ml/hr and almost all of remaining med was gone. Infusion stopped and MD (Personnel #21) paged. Spoke to and informed MD (Personnel #21) of incident. Order received for Narcan (medication to reverse effects of narcotics) IV. Med given. Patient responded to med in less than 1 min. Awake, alert, but confused. Informed house supervisor of incident..."

The Quality Assurance Performance Improvement (QAPI) and Pharmacy and Therapeutics (P&T) Committee notes dated February 2011 through May 2011 did not reflect any references or report for the narcotic medication error and/or possible medication device error which resulted in patient harm.

The "Occurrence Report" dated 02/14/11 reflected, "Outcome: No harm - Intervention or monitoring required..."

The hospital did not have a "Medication Occurrence Report" filled out for this incidence.

The Hospital Policy, "Occurrence Report ", dated 10/30/07, required, "To provide a mechanism for response/intervention, monitoring, trending, and prevention follow-up of occurrences and near misses...will be investigated to identify processes underlying the potential apparent cause...and to identify those process changes that might reduce the likelihood of a similar sentinel event occurring in the future...Each situation must be evaluated...Adverse Drug Event is any incident in which the use of a medication at any dose, a medical device...may have resulted in an adverse outcome in a patient...An event or potential event...should be...forwarded to the Risk Manager...should begin an initial assessment...conduct a timely, through and credible root cause analysis...implement improvements to reduce risk, monitoring the effectiveness of those improvements, action plan within 45 calendar days of the event or of becoming aware of the event...It is the responsibility of Risk Management to supply the Safety Committee with a summary of patient incidents ...Instructions: An occurrence is any event not consistent with routine patient care...A Near Miss is a SIGNIFICANT unintended event in the system of care, which could have resulted in a SERIOUS unanticipated outcome...An Unanticipated Outcome is a result that differs significantly from what was expected by the healthcare provider...to be result of a treatment, medication or procedure...If the occurrence is medical equipment related, secure the equipment and notify Biomed...If the occurrence is medicated related, you must fill out the Medication Occurrence Report Form...Follow-Up Instructions...Notify...Pharmacy...Biomed...Secure and tag equipment, supplies or medication items if they are related to the occurrence... "

The Hospital Policy,"Disclosure of Unanticipated Outcome Information", dated 05/15/06 required, "Unanticipated Outcomes (UO's) and Near Misses are analyzed through the quality review and occurrence reporting processes of the Quality Review Committee in order to identify actions that will limit, if possible, reoccurrence...All equipment and supplies that might be implicated in the event or near miss should be retained...The Quality Review Committee oversees the investigation of UO's and Near Misses in the hospital and the implementation of processes to assist in the reduction of the causes of such UO's and Near Misses in the future..."

On 05/16/11 at 3:00 P.M, the CNO (Personnel #1) was interviewed. She was asked if the the Nursing Department identified the medication adverse event and reported it in the QAPI process. She stated, "No." She was asked if the Nursing Department followed the policies and procedures for identifying and reporting medication adverse events. She stated, "No.
VIOLATION: REPORTING ADVERSE EVENTS Tag No: A0508
The hospital failed to enforce the policies and procedures for reporting adverse drug events in 1 of 1 patients (Patient #2) to the hospital QAPI program that involved an overdose of the narcotic Morphine on a continuous IV infusion pump.

Findings included:

Review of Patient #2's medical record revealed:

The "Doctor's Order" sheet dated 02/13/11 timed at 11:40 A.M. revealed, "1. Morphine drip bolus 2 mg (milligrams) IV then start 2 mg/hr (milligrams per hour). Titrate up by 1 mg every 30 minutes for respiratory distress or pain. Maximum 10 mg/hr...."

The "Nurses Notes" dated 02/14/11 timed at 7:00 A.M. revealed, "Son stated patient was gurgling as if he had phlegm he could not cough up. Informed him I would give patient Atropine gtts (drops) to help with secretions. Med was given. Noted, however, patient was unresponsive. Snoring as if in deep sleep with respiratory rate of 9-10/min. SpO2 (oxygen level) 70%. Placed patient on 100% NRB mask (non rebreather mask) and SpO2 increased to 95%. Patient remained unresponsive to verbal and tactile stimuli. V/S (vital signs) stable 153/66 - 86 - 98.7, strong pulse felt. Checked Morphine drip and setting were changed to 25 ml/hr and almost all of remaining med was gone. Infusion stopped and MD (Personnel #21) paged. Spoke to and informed MD (Personnel #21) of incident. Order received for Narcan (medication to reverse effects of narcotics) IV. Med given. Patient responded to med in less than 1 min. Awake, alert, but confused. Informed house supervisor of incident..."

The Quality Assurance Performance Improvement (QAPI) and Pharmacy and Therapeutics (P&T) Committee notes dated February 2011 through May 2011 did not reflect any references for the narcotic medication error and/or possible medication device error which resulted in patient harm.

The "Occurrence Report" dated 02/14/11 reflected, "Outcome: No harm - Intervention or monitoring required ..."

The hospital did not have a "Medication Occurrence Report" filled out on this incident.

The Hospital Policy, "Occurrence Report" , dated 10/30/07, required, "To provide a mechanism for response/intervention, monitoring, trending, and prevention follow-up of occurrences and near misses...will be investigated to identify processes underlying the potential apparent cause...and to identify those process changes that might reduce the likelihood of a similar sentinel event occurring in the future...Each situation must be evaluated...Adverse Drug Event is any incident in which the use of a medication at any dose, a medical device...may have resulted in an adverse outcome in a patient...An event or potential event...should be...forwarded to the Risk Manager...should begin an initial assessment...conduct a timely, through and credible root cause analysis...implement improvements to reduce risk, monitoring the effectiveness of those improvements, action plan within 45 calendar days of the event or of becoming aware of the event...It is the responsibility of Risk Management to supply the Safety Committee with a summary of patient incidents...Instructions: An occurrence is any event not consistent with routine patient care...A Near Miss is a SIGNIFICANT unintended event in the system of care, which could have resulted in a SERIOUS unanticipated outcome...An Unanticipated Outcome is a result that differs significantly from what was expected by the healthcare provider...to be result of a treatment, medication or procedure...If the occurrence is medical equipment related, secure the equipment and notify Biomed...If the occurrence is medicated related, you must fill out the Medication Occurrence Report Form ...Follow-Up Instructions...Notify...Pharmacy...Biomed...Secure and tag equipment, supplies or medication items if they are related to the occurrence..."

The Hospital Policy, "Disclosure of Unanticipated Outcome Information", dated 05/15/06 required, "Unanticipated Outcomes (UO's) and Near Misses are analyzed through the quality review and occurrence reporting processes of the Quality Review Committee in order to identify actions that will limit, if possible, reoccurrence...All equipment and supplies that might be implicated in the event or near miss should be retained...The Quality Review Committee oversees the investigation of UO's and Near Misses in the hospital and the implementation of processes to assist in the reduction of the causes of such UO's and Near Misses in the future..."

At 10:40 A.M. on 05/17/11, the Director of Pharmacy (Personnel #14) was interviewed. She was asked if the Pharmacy tracks medication errors and adverse drug events in the QAPI process. She stated, "Yes." She was asked if the Pharmacy policies and procedures required medication errors and adverse drug events to be reported to the QAPI Committee. She stated, "Yes." She was asked if she had received a Medication Occurrence report involving the adverse medication event. She stated, "No." She was asked if the adverse drug event with the Morphine drip on Patient #2 was reported to the QAPI or P&T Committee. She stated, "No."