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8050 MEADOWS ROAD

DALLAS, TX null

GOVERNING BODY

Tag No.: A0043

Based on interview and record review, the governing body failed to ensure patient care was provided in a safe and effective manner and complied with state and federal rules.

Findings Included:

1) The Governing Body allowed nonemployee licensed nurses to provide direct patient care without appropriate hospital and specific unit orientation, ensuring competency of skills, evaluation of services provided, and verification of licensure. Allowing these personnel to provide direct patient care was a potential for diminished quality of care. Cross reference: A0398 and A0394

2) The Governing Body allowed nonemployee licensed nurses to provide direct patient care that diverted narcotics. Cross reference: A0398 and A0509

3) The Governing Body did not report and investigate diversions of controlled narcotics. Cross reference: A0398 and A0509

4) The Governing Body did not ensure the Patient Safety Program identified potential and actual safety practices that put the hospital's patient population at risk for injury. Cross reference: A0311

5) The Governing Body did not ensure the hospital-wide Quality Assessment and Performance Improvement (QAPI) program monitor and evaluate compliance with hospital policies to reduce and identify medication diversions or ensure contracted services for nonemployee nurses were provided in a safe and effective manner. Cross reference: A0310, A0508 and A0509

6) The Governing Body failed to ensure patient rights were met in the grievance process. Cross reference: A0123

The "Dallas LTCH, LLC Operational Bylaws", not dated, requires," Is vested with the full and complete authority, power and discretion to manage and control the business, affairs and operations of the long-term acute care hospital ...the Board of Managers shall address the following issues ...evaluation of non-privileged personnel ...review/approve personnel policies...review staff organization ...review responsibilities of any committees or advisory boards ...shall review, revise and adopt the Quality and Assessment and Improvement Plan ...review the results...assess quality assessment and improvement activities...and personnel rendering direct and indirect services to patients ...such reviews may evaluate the (i) critical impact on patient care...review the findings of all outside agencies...assess the adequacy of quality monitors and the timeliness of corrective actions ...shall discuss, review, revise, as appropriate, hospital policies..."

The "Governing Board" meeting minutes dated, "Feb. 25th, 2010 and May 27th, 2010" did not address or show any review or discussion held on the qualifications of the CNO, Nurse Staffing, Non employee licensed nurses, and Narcotic Diversions which directly impact the safety of patient care.

In an interview on 10/08/10 at 8:00 AM, the Chief Executive Officer (CEO), (Personnel #2) verified the above findings were not addressed in the Governing Board meetings.

QAPI

Tag No.: A0263

Based on interview and review of records, the hospital's governing body failed to ensure all hospital departments and services were monitored for safe and effective patient care in the Quality Assurance and Performance Improvement Program (QAPI).

Findings Included:

1) The QAPI program did not monitor and evaluate compliance for nonemployee licensed nurses who provide direct patient care for appropriate hospital and specific unit orientation, ensuring competency of skills, evaluation of services provided, and verification of licensure. Allowing these personnel to provide direct patient care was a potential for diminished quality of care. Cross reference: A0398 and A0394

2) The QAPI program did not identify and monitor for potential diversions of controlled narcotics. Cross reference: A0398 and A0509

3) The QAPI program did not ensure the Patient Safety Program identified potential and actual safety practices that put the hospital ' s patient population at risk for injury. Cross reference: A0311

4) The QAPI program did not monitor and evaluate compliance with hospital policies to reduce and identify medication diversions or ensure contracted services for nonemployee nurses were provided in a safe and effective manner. Cross reference: A0310, A0508 and A0509

5) The QAPI program did not monitor for compliance to ensure patient rights were met in the grievance process. Cross reference: A0123


In an interview on 10/05/10 at 11:15 AM, the Director of Quality Management (Personnel #3) verified the above findings were not addressed in the QAPI Committee meetings.

NURSING SERVICES

Tag No.: A0385

Based on interview and review of records, the hospital failed to ensure nursing services were provided in a safe and effective manner which placed patient safety at a potential for risk or injury.

Findings Included:

1) The CCO (Chief Clinical Officer) allowed nonemployee licensed nurses to provide direct patient care without appropriate hospital and specific unit orientation, ensuring competency of skills, evaluation of services provided, and verification of licensure. Allowing these personnel to provide direct patient care was a potential for diminished quality of care. Cross reference: A0398 and A0394

2) The CCO did not provide adequate supervision of nonemployee licensed nurses to provide direct patient care that controlled narcotics were diverted. Cross reference: A0398 and A0509

3) The CCO did not report and investigate diversions of controlled narcotics as required by state and federal law. Cross reference: A0398 and A0509

4) The CCO did not report incidents of controlled narcotic diversions to the Patient Safety Program to prevent any further potential and/or actual safety practices that put the hospital's patient population at risk for injury. Cross reference: A0311

5) The CCO did not monitor medication diversions or contracted nonemployee licensed nurses in the hospital-wide QAPI program for evaluation of compliance for provision of patient care in a safe and effective manner. Cross reference: A0310, A0508 and A0509

The "Plan for the Provision of Patient Care/Services 2010", under the title, "Nursing", requires, " Dallas LTAC Hospital, as an employer of licensed nurses, adheres to the general provisions and licensing regulations of the Texas Nursing Practice Act. Each licensed nurse is required to submit evidence that he/she is qualified to practice, prior to employment...recognizes the right of all patients to receive nursing care that is defined by professional standards regardless of setting...evaluation process...quality assurance activities...CCO is accountable for establishing systems to assess, monitor, and verify delegation competence...takes responsibility and accountability for the provision of nursing practice ...is dedicated to the provision of competent staff and quality patient care ...compliance with standards is determined through policies, procedures, quality improvement activities and performance appraisals..."

The "Plan for the Provision of Patient Care/Services 2010 " , under the title, "Facility Specific...Chief Clinical Officer", requires, "has the responsibility; authority and accountability for the provisions of quality nursing care, which is delivered by Nursing Department employees on a 24 hour basis. The Director serves to plan, organize, coordinate, and manage activities within the department...coordinates activities between Nursing and other hospital departments..."

In an interview on 10/08/10 at 1:00 P.M., the CCO, (Personnel #1) verified the above findings.

CONTRACTED SERVICES

Tag No.: A0083

Based on interview and record review, the governing body failed to ensure contracted agencies for nonemployee licensed nurses for patient care was provided in a safe and effective manner and comply with state and federal rules.

Findings Included:

1) The hospital allowed nonemployee licensed nurses to provide direct patient care without appropriate hospital and specific unit orientation, ensuring competency of skills, evaluation of services provided, and verification of licensure. Allowing these personnel to provide direct patient care was a potential for diminished quality of care. Cross reference: A0398 and A0394.

2) Two of 2 nonemployee licensed nurses (Personnel #35 and #40) who provided direct patient care diverted narcotics on two separate occasions (4/13/10 and 08/05/10). Cross reference: A0398 and A0509.


The "Dallas LTCH, LLC Operational Bylaws", not dated, requires, "Is vested with the full and complete authority, power and discretion to manage and control the business, affairs and operations of the long-term acute care hospital...the Board of Managers shall address the following issues...evaluation of non-privileged personnel...review/approve personnel policies...review staff organization...review responsibilities of any committees or advisory boards...shall review, revise and adopt the Quality and Assessment and Improvement Plan ...review the results...assess quality assessment and improvement activities...and personnel rendering direct and indirect services to patients...such reviews may evaluate the (i) critical impact on patient care...review the findings of all outside agencies...assess the adequacy of quality monitors and the timeliness of corrective actions...shall discuss, review, revise, as appropriate, hospital policies..."

The "Governing Board" meeting minutes dated, "Feb. 25th, 2010 and May 27th, 2010" did not address or show any review or discussion held on nonemployee licensed nurses and Narcotic Diversions which directly impact the safety of patient care.

In an interview on 10/08/10 at 8:00 AM the Chief Executive Officer (CEO), (Personnel #2) verified the above findings were not addressed in the Governing Board meetings.

PATIENT RIGHTS: NOTICE OF GRIEVANCE DECISION

Tag No.: A0123

Based on interview and record review, the hospital failed to provide written notice of its decision, steps taken, results of the investigation and date of completion to 2 of 2 grievances received from patient's and/or families (Patient's #7 and #8) regarding patient care.

Findings Included:

The "Complaint/Grievance Log" dated, "August 2010", reflected::

08/20/10-Patient #7's daughter complained about not receiving clinical updates and hospital requesting authorization from another family member for blood transfusion on her mother when other family members do not have authorization.

08/25/10-Patient #8's wife submitted a written grievance about being seen by the "ER physician", inserting a "smaller trach and keeping on breathing machine", "keeping the tube that is sucking the junk of the digestive system...until you had 2 bowel movements...have had more than 2 bowel movements, and yet the tube down your digestive parts stays in place" and a nurse complaint about inappropriate care and language.

In an interview with the Director of Quality and Risk Management [Personnel #3], on 10/6/10 at 1:45 PM. 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 family of Patient #7 and #8. She stated, "No." She was asked if the hospital followed the required grievance process. She stated, "No."

The "Patient Complaint & Grievance" policy, dated 04/20/09, reflected, "The grievance process must include a mechanism for timely referral of patient concerns...a patient care complaint that cannot be resolved at the time of the complaint by the staff present and a written response is required...Level two grievances...requires investigation, further actions for resolution, requires a written response...all verbal or written complaints regarding abuse, neglect, patient harm or hospital compliance with CMS requirements are considered level two grievances..."

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0166

It was determined based on interview and record review, the hospital failed to ensure 1 of 2 Patients (Patient #1's) plan of care was updated to reflect the use of wrist restraints.

Findings Included:

Patient #1's History and Physical dated 09/17/10 reflected, "admitted to ... 09/17/10. Patient #1 on a ventilator, has been treated for multidrug resistant Pseudomonas Sinusitis, has a, Tracheostomy, Gastrostomy...transferred to hospital for further weaning of ventilator, wound care to left lower extremity and broad-spectrum antibiotic treatment..."

On 10/05/10 at approximately 11:00 AM a tour of Intensive Care Unit was conducted with Personnel #1 [Chief Clinical Officer]. Personnel #5, RN Supervisor was asked if the unit had any patients with restraints. Personnel #5 stated Patient #1 had wrist restraints due to pulling out tubes/lines.

Patient #1's restraint orders dated 09/24/10 to 10/04/10, reflected Patient #1 required the use of wrist restraints.

On 10/06/10 at 10:40 AM Personnel #4 was asked by the surveyor to review Patient #1's interdisciplinary plan of care for documentation indicating Patient #1 required the use of wrist restraints. Personnel #4 stated no documentation was found addressing the use of wrist restraints for Patient #1.

The policy and procedure entitled, "Interdisciplinary Plan of Care" dated 02/10 reflected, "The interdisciplinary plan of care [IPC] is individualized to meet the patient's unique needs and circumstances...the IPC will be revised or maintained using an interdisciplinary approach based on the patient's response to care, treatment, and services provided...at any time during the process, the plan may be modified or terminated based on reassessment, the patient's continued need for care, treatment, and services; or the achievement of goals...the goals will be reasonable, measurable, and developed with input from the patient and family when possible...the effectiveness of the IPC will be assessed during the multidisciplinary care management committee, with subsequent review and revision of the plan, and discussion of factors that may affect the need for continued care, treatment, and services and/or the plan for discharge or transfer to another care setting..."

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0170

It was determined based on interview and record review, the hospital failed to ensure the house physician (Personnel #36) consulted with the primary physician (Personnel #45) for 1 of 2 patient's reviewed for the use of wrist restraints for (Patient #1).

Findings Included:

Patient #1's History and Physical dated 09/17/10 reflected, "admitted to ... 09/17/10. Patient #1 on a ventilator, has been treated for multidrug resistant Pseudomonas Sinusitis, has a, Tracheostomy, Gastrostomy...transferred to hospital for further weaning of ventilator, wound care to left lower extremity and broad-spectrum antibiotic treatment..."

On 10/05/10 at approximately 11:00 AM a tour of Intensive Care Unit was conducted with Personnel #1 (Chief Clinical Officer). Personnel #5, RN Supervisor was asked if the unit had any patients with restraints. Personnel #5 stated Patient #1 had wrist restraints due to pulling out tubes/lines.

The restraint orders dated 09/24/10, 09/26/10, 10/01/10, 10/02/10 and 10/04/10 reflected, the house physician (Personnel #36's) signature not Patient #1's primary physician (Personnel #45).

On 10/06/10 at 10:40 AM Personnel #4 was asked by the surveyor to review Patient #1's physician progress notes from both the house physician and primary physician. Personnel #4 informed the surveyor no documentation was found indicating Patient #1 required the use of wrist restraints or that Patient #1's primary physician was consulted about restraint use.

The policy and procedure entitled, "Use of Restraints and Seclusion" with a revision date of April 2009 reflected, "The attending physician must be consulted as soon as possible if the attending physician did not order the restraint or seclusion...the intent of this requirement is to ensure the physician who has overall responsibility and authority for the management and care of the patient is aware of the patient's condition and is aware of the restraint or seclusion intervention..."

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0185

It was determined based on interview and record review, the hospital failed to ensure a description of the patients behavior and interventions attempted were adequately documented for 1 (Patient #1) of 2 patients reviewed for the applications of wrist restraints.

Findings Included:

Patient #1's History and Physical dated 09/17/10 reflected, "admitted to ... 09/17/10. Patient #1 on a ventilator, has been treated for multidrug resistant Pseudomonas Sinusitis, has a, Tracheostomy, Gastrostomy...transferred to hospital for further weaning of ventilator, wound care to left lower extremity and broad-spectrum antibiotic treatment..."

On 10/05/10 at approximately 11:00 AM a tour of Intensive Care Unit was conducted with Personnel #1 [Chief Clinical Officer]. Personnel #5, RN Supervisor was asked if the unit had any patients with restraints. Personnel #5 stated Patient #1 had wrist restraints due to pulling out tubes/lines.

The restraint orders dated 09/24/10, 10/01/10, 10/02/10 and the restraint management documentation dated 09/24/10, reflected the following;

The 09/24/10 restraint order sheet reflected under the section entitled, "Alternatives to restraints Tried", under the procedure section no documentation was found. The restraint management documentation form reflected no documentation from 07:00 AM to 18:00 PM.

The 10/01/10 restraint order sheet reflected no documentation for the type of restraint, no assessment information and no alternatives to restraints. The procedure section was not completed.

The 10/02/10 restraint order sheet reflected no documentation for the type of restraint, no assessment information and no alternatives to restraints. The procedure section was not completed.

On 10/05/10 at approximately 11:30 AM Personnel #1 [Chief Clinical Officer] was asked to review Patient #1's restraint order record and restraint management documentation form. Personnel #1 stated the documents were incomplete and not filled out.

The Policy and Procedure entitled, "Use of Restraints and Seclusion" with revision date of April 2009 reflected, "Each episode of restraint use will be documented in the patient's medical record...significant changes in the patient's condition are documented in the narrative section and physician progress notes..."

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0186

It was determined based on interview and record review, the hospital failed to ensure alternatives or less restrictive intervention were documented before the application of wrist restraints for 1 of 2 patients (Patient #1).

Findings Included:

Patient #1's History and Physical dated 09/17/10 reflected, "admitted to ... 09/17/10. Patient #1 on a ventilator, has been treated for multidrug resistant Pseudomonas Sinusitis, has a, Tracheostomy, Gastrostomy...transferred to hospital for further weaning of ventilator, wound care to left lower extremity and broad-spectrum antibiotic treatment..."

On 10/05/10 at approximately 11:00 AM a tour of Intensive Care Unit was conducted with Personnel #1 (Chief Clinical Officer). Personnel #5, RN Supervisor was asked if the unit had any patients with restraints. Personnel #5 stated Patient #1 had wrist restraints due to pulling out tubes/lines.

The restraint orders dated 09/24/10, 10/01/10 and 10/02/10 reflected the following;

The 09/24/10 restraint order sheet reflected no documentation under the section entitled, "Alternatives to restraints Tried."

The 10/01/10 restraint order sheet reflected, no documentation under the section entitled, "Alternatives to restraints Tried."

The 10/02/10 restraint order sheet reflected, no documentation under the section entitled, "Alternatives to restraints Tried."

On 100/5/10 at approximately 11:30 AM Personnel #1 [Chief Clinical Officer] was asked to review Patient #1's restraint order sheet. Personnel #1 stated the documents were incomplete and not filled out.

The Policy and Procedure entitled, "Use of Restraints and Seclusion" with revision date of April 2009 reflected, "Each episode of restraint use will be documented in the patient's medical record...significant changes in the patient's condition are documented in the narrative section and physician progress notes...other methods used prior to the initiation of restraints or seclusion..."

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0208

It was determined based on interview and record review the hospital failed to ensure hospital personnel training records and nonemployee nurses demonstrated competency and attended restraint training for 5 of 5 licensed agency personnel (Personnel #30, #31, #32, #35 and #44) who provided care between 07/16/10 and 09/28/10.

Findings Included:

The "Daily Nursing Assignment" sheet reflected the following nonemployee licensed nurses provided direct patient care on the following dates:

Personnel #30 worked 09/22/10, 09/23/10 and 09/24/10.

Personnel #32 worked 09/17/10 and 09/18/10.

Personnel #32 worked 07/16/10, 07/18/10, 07/22/10, 07/23/10, 7/24/10, 07/25/10, 07/27/10, 08/2/10, 08/6/10, 08/07/10, 08/10/10, 08/12/10, 08/15/10, 08/19/10, 08/20/10, 08/24/10, 08/30/10, 08/31/10, 09/02/10, 09/09/10, 09/13/10, 09/14/10, 09/18/10, 09/21/10, 09/22/10 09/23/10, and 09/24/10.

Personnel #35 worked 08/05/10.

Personnel #44 worked 09/10/10, 09/11/10 and 09/28/10.

On 10/05/10 at approximately 9:30 AM Personnel #7 [Director of Human Resources] was asked for the files on the nonemployee licensed personnel which included verification of current license, hospital and unit specific orientation, competency assessments and evaluations of clinical activities for Personnel #30, #31, #32, #35 and #44. The files were not provided.

On 10/06/10 at approximately 10:00 AM Personnel #7 was asked again for the above files. At approximately 1:30 PM Personnel #7 produced a copy of the non employee licensed personnel #30, #31, #32, #35 and #44 which reflected the license verification result was faxed on 10/06/10 at 12:55 PM from the agency. Personnel #7 stated she did not have any files or verifications from the Nurse Staffing Agency for the nurses, so she had them fax them over 10/06/10.

On 10/06/10 at approximately 9:30 AM, Personnel #2 [Chief Executive Officer] verified the hospital did not have or maintain files on the agency licensed personnel as required. The CEO verified the hospital did not have any documentation for the hospital and unit specific orientation, competency assessments and evaluations of clinical activities for the above personnel. The CEO was asked how nonemployee nurses were oriented, checked off on skills competencies or evaluated. She stated, "We normally do an hour of orientation prior to the start of shift which is done by the House Supervisor. She stated the hospital had been accepting the skills competencies from the agency."

On 10/06/10 at 2:15 PM Personnel #38 [RN] was asked if she had attended restraint training. Personnel #38 stated "No." Personnel #38 was asked whether agency nursing staff were trained on restraints and return demonstration of competency was verified. Personnel #38 stated, "No."

Review of the hospital policy, "Contract/Agency/Shared Employees", with a review/revised date of 04/01/09 reflected, "Purpose: To describe hospital's policy and procedures for ensuring the competence of all contract, agency and shared employees...commitment to quality patient care depends upon the competence of all care givers, including consulting, contracted or agency staff...every patient care giver will be required to provide proof of competence as well as complete a hospital orientation prior to providing patient care...It is the responsibility of the department manager to ensure all required documentation on these individuals is acquired and maintained..."

The policy and procedure entitled, "Use of Restraints and Seclusion"with a revision date of April 2009 reflected, "Staff must be trained and able to demonstrate competency in the application of restraints, implementation of seclusion, monitoring, assessment and providing care for a patient in restraint or seclusion...proof of the fulfillment of the educational requirement shall be documented and retained in the employees Human Resources file..."

LICENSURE OF NURSING STAFF

Tag No.: A0394

Based on interview and record review, the hospital failed to enforce their procedure for verifying that nonemployee licensed nurses have a valid and current license prior to providing direct patient care for 5 of 5 (Personnel #30, #31, #32, #35 and #44) nonemployee licensed nurses (contract/agency/shared employees) did not have verification of current or valid nursing license from 07/16/10 through 09/28/10.

Findings Included:

The "Daily Nursing Assignment" sheet reflected the following no employee licensed nurses provided direct patient care on the following dates:
Personnel #30-09/22/10, 09/23/10, and 09/24/10.
Personnel #31-09/17/10 and 09/18/10.
Personnel #32-07/16/10, 07/18/10, 07/22/10, 07/23/10, 07/24/10, 07/25/10, 07/27/10, 08/2/10, 08/06/10, 08/07/10, 08/10/10, 08/12/10, 08/15/10, 08/19/10, 08/20/10, 08/24/10, 08/30/10, 08/31/10, 09/02/10, 09/09/10, 09/13/10, 09/14/10, 09/18/10, 09/21/10, 09/22/10, 09/23/10, and 09/24/10.
Personnel #35-08/05/10.
Personnel #44-09/10/10, 09/11/10, and 09/28/10

Review of the hospital policy, "Contract/Agency/Shared Employees", last revised 04/01/09 states, "Purpose: To describe the hospital's policy and procedures for ensuring the competence of all contract, agency and shared employees...Triumph Health Care's commitment to quality patient care depends upon the competence of all care givers, including consulting, contracted or agency staff...every patient care giver working at Triumph...It is the responsibility of the department manager to ensure that all required documentation on these individuals is acquired and maintained...Clinical qualifications: a. current licensure/certification verification. The hospital is responsible for obtaining primary source verification on all licenses ...Files for all contract employees should be kept in the clinical department where that contract employee works. These files should contain all the documentation noted above. Managers for each clinical department are responsible for maintaining current information on all contract employees. Managers are responsible for submitting to Human Resources on a monthly basis the number of contract employees utilized during the preceding month in their department(s) along with a written verification that each of those employees was competent as outlined above."

The "Plan for the Provision of Patient Care/Services", dated "2010" (no month), reflected, "The Chief Clinical Officer [CCO] is accountable for establishing systems to assess, monitor, and verify delegation competence."

On 10/05/10 at 10:30 AM, the Director of Human Resources (HR) (Personnel #7) was asked for the files on nonemployee licensed personnel that included verification of current licensure, hospital and unit specific orientation, competency assessments and evaluations of clinical activities for Personnel #30, #31, #32, #35 and #44. The files were not produced.

On 10/06/10 at 10:00 AM, the Director of HR (Personnel #7) was asked again for the files on Personnel #30, #31, #32, #35 and #44. On 10/06/10 at 1:30 PM, Personnel #7 produced a copy of the nonemployee licensed (Personnel #30, #31, #32, #35 and #44) that reflected the license verification results were faxed on 10/06/10 at 12:55 PM from the agency. Personnel #7 was asked if she had a file on each nonemployee nurse prior to today's date. She stated, "No, we did not have any files or verifications from the Nurse Staffing Agency for the nurses so I had the agency fax them over today."

On 10/06/10 at 9:30 AM, the CEO (Personnel #2) verified the hospital did not have or maintain files on the agency nonemployee licensed personnel as required. She also verified the verifications for Personnel # 30, #31, #32, #35 and #44 were received by fax that afternoon.

SUPERVISION OF CONTRACT STAFF

Tag No.: A0398

Based on interview and record review, the hospital failed to enforce their policy and procedure for hospital or unit specific orientation, skills competency and evaluations for 5 of 5 (Personnel # 30, #31, #32, #35 and #44) nonemployee licensed nurses (contract/agency/shared employees) who provided direct patient care from 07/16/10 through 09/28/10.

Findings included:

The "Daily Nursing Assignment" sheet reflected the following nonemployee licensed nurses provided direct patient care on the following dates:
Personnel #30-09/22/10, 09/23/10, and 09/24/10
Personnel #31-09/17/10 and 09/18/10
Personnel #32-07/16/10, 07/18/10, 07/22/10, 07/23/10, 07/24/10, 07/25/10, 07/27/10, 08/2/10, 08/06/10, 08/07/10, 08/10/10, 08/12/10, 08/15/10, 08/19/10, 08/20/10, 08/24/10, 08/30/10, 08/31/10, 09/02/10, 09/09/10, 09/13/10, 09/14/10, 09/18/10, 09/21/10, 09/22/10, 09/23/10, and 09/24/10
Personnel #35-08/05/10
Personnel #44-09/10/10, 09/11/10, and 09/28/10

Review of the hospital policy, "Contract/Agency/Shared Employees", revised 04/01/09 revealed, "Purpose: To describe the hospital's policy and procedures for ensuring the competence of all contract, agency and shared employees...Policy: Triumph Health Care's commitment to quality patient care depends upon the competence of all care givers, including consulting, contracted or agency staff... every patient care giver working at Triumph...will be required to provide proof of competence as well as complete a hospital orientation prior to providing patient care...It is the responsibility of the department manager to ensure that all required documentation on these individuals is acquired and maintained...Procedure: Job Duty Performance: Job descriptions and competence assessment completed by employing agency which is less than one year old must be provided...Triumph Health Care will be responsible for evaluating all contract staff after completing the first shift. Ongoing evaluations will be conducted at least annually ...Hospital Orientation: All contract employees will be required to read the Employee Annual Review Book prior to providing patient care...Files for all contract employees should be kept in the clinical department where that contract employee works. These files should contain all the documentation noted above. Managers for each clinical department are responsible for maintaining current information on all contract employees. Managers are responsible for submitting to Human Resources on a monthly basis the number of contract employees utilized during the preceding month in their department(s) along with a written verification that each of those employees was competent as outlined above."

On 10/05/10 at 9:30 AM the Director of Human Resources (HR) (Personnel # 7) was asked for the files on non employee licensed personnel that included verification of current licensure, hospital and unit specific orientation, competency assessments and evaluations of clinical activities for Personnel #30, #31, #32, #35 and #44. The files were not produced.

On 10/06/10 at 10:00 AM, the Director of HR (Personnel #7) was asked again for the files on Personnel #30, #31, #32, #35 and #44. On 10/06/10 at 1:30 PM, Personnel #7 produced a copy of the nonemployee licensed Personnel #30, #31, #32, #35 and #44 reflected the license verification results were faxed on 10/06/10 at 12:55 PM from the agency. Personnel #7 was asked if she had a file on each non employee nurse prior to today's date. She stated, "No, we did not have any files or verifications from the Nurse Staffing Agency for the nurses so I had the agency fax them over today."

In an interview on 10/06/10 at 12:45 PM, the Director of Pharmacy (Personnel #27) was asked if there had been any known drug diversions in the past year at this facility. He stated, " I think there has been one. I will have to go back and look at my records." At 1:00 PM, Personnel #27 returned with an incident report that was dated 08/05/10 for "Possible diversion..." which showed, "Operator nurse [Personnel #35] removed 3 Fentanyl 25 mcg [micrograms] patches for a patient who was not assigned to her. [Personnel #35] did not apply the patches to the patient. Patient was on 25 mcg patch every 72 hours. Nursing agency notified and she will not be used her again per Nur. Admin. [Nursing Administration]." Personnel #27 was asked how he was made aware of this narcotic diversion. He stated that he was notified by the House Supervisor the next morning. He was then asked if he had performed an investigation. He stated that he had reviewed the "Operator Transactions" and "Class 2 Transactions" report which showed that Personnel #35 only had access to the 4th floor in the medDispense Station which is where she was working. He stated the records showed Personnel #35 pulled up a patient that was on the 2nd floor that had Fentanyl patches and signed out 3 patches from the 4th floor station. He stated he then went and met with the House Supervisor (Personnel #38) and accompanied the House Supervisor to the patient's room (Patient #4). The House Supervisor checked Patient #4 for the patches and only found the 1 current patch that had been applied to the patient the previous day. He stated that he had notified the CCO (Personnel #1) about the incident and that he was told by the CCO that she would notify the agency and not let that nurse return. He was then asked if he had reported the incident to the Quality Council or the P&T committee's. He stated, "No, I did not." He was asked if he notified the appropriate federal and state agencies. He stated, "No, I have not."

Review of the Nurse Staffing sheets, dated, Thursday, 08/05/10, revealed Personnel #35 worked the 7AM shift on 4th floor.

Review of Patient #4's Medication Administration Record (MAR) dated "08/05/10 @ 0700 thru 08/06/10 @ 0659 " , showed the drug Fentanyl was to be applied TD (transdermal) Q72H (every 72 hours) for severe pain. It was pre-printed across the "First Shift" and "Second Shift" boxes, "NO DOSES DUE."

On 10/06/10 at 9:30 AM, the CEO (Personnel #2) verified the hospital did not have or maintain files on the agency nonemployee licensed personnel as required. She also verified the hospital did not have any documentation for hospital and unit specific orientation, competency assessments and evaluations of clinical activities for Personnel # 30, #31, #32, #35 and #44. She was asked how nonemployee nurses were oriented, checked off on skills competencies and evaluated. She stated, "We normally do an hour of orientation prior to the start of shift which is done by the House Supervisor. We have been accepting the skills competencies from the agency. We have not been evaluating the agency personnel after each shift."

CONTENT OF RECORD: ORDERS DATED & SIGNED

Tag No.: A0454

It was determined based on interview and record review, the hospital failed to ensure physician orders were authenticated by licensed nursing personnel for 1 of 2 patient records reviewed for restraint orders (Patient #1).

Findings Included:

Patient #1's History and Physical dated 09/17/10 reflected, "admitted to... 09/17/10. Patient #1 on a ventilator, has been treated for multidrug resistant Pseudomonas Sinusitis, has a, Tracheostomy, Gastrostomy...transferred to hospital for further weaning of ventilator, wound care to left lower extremity and broad-spectrum antibiotic treatment..."

The restraint orders dated 09/24/10, 09/26/10, 10/01/10 and 10/02/10 reflected a physician signature but no nursing signature verifying the order.

On 10/06/10 at 10:40 AM Personnel #4 was asked by the surveyor to review Patient #1's physician orders for the use of wrist restraints. Personnel #4 stated the restraint orders dated 09/24/10, 09/26/10, 10/01/10 and 10/02/10 had no nursing documentation verifying the order for wrist restraints.

The policy entitled, "Verbal and Telephone Orders" with a revision date of 01/29/08 reflected, "All orders (including verbal require a date, time, and authentication..."

Standard-level Tag for Pharmaceutical Service

Tag No.: A0490

Based on interview and review of records, the hospital failed to ensure pharmaceutical services were provided in a safe and effective manner to prevent potential medication diversion which could place patient safety at a potential for risk or injury.

Findings included:

1) The Director of Pharmacy (Personnel #27) did not report and investigate diversions of controlled narcotics as required by state and federal law. Cross reference: A0398 and A0509
2) The Director of Pharmacy (Personnel #27) failed to supervise and maintain adequate control over the distribution of medications and narcotics. Cross reference A0491 and A0492
3) The Director of Pharmacy (Personnel #27) did not report incidents of controlled narcotic diversions to the Patient Safety Program to prevent any further potential and/or actual safety practices that put the hospital ' s patient population at risk for injury. Cross reference: A0311
4) The Director of Pharmacy (Personnel #27) did not monitor for medication diversions in the hospital-wide QAPI program to ensure compliance for the provision of patient care in a safe and effective manner. Cross reference: A0310, A0508 and A0509
5) The hospital Pharmacy failed to minimize and prevent unauthorized usage and distribution of controlled medications and narcotics. Cross reference A0500


The " Plan for the Provision of Patient Care/Services 2010 " , under the title, " Pharmacy " , requires, " The Department of Pharmacy provides systems-based services including ...drug preparation and distribution ...dosage monitoring services ...medications are reviewed by a pharmacist ...Medication error programs ...policy development and implementation ...appropriate, accurate, and timely dispensing of medications ...regulations set by the Texas State Board of Pharmacy and Federal Government ...professional and ethical practices are maintained at all times through adherence to the department ' s, institution ' s and profession ' s code of professional conduct ...patient care quality measures are reported to the Quality Committee. Among these are medication error and ADR trends, and process improvement projects ...complies with all federal, state, and regulatory standards to guide practice ... "


In an interview on 10/06/10 at 1:00 P.M., the Director of Pharmacy, (Personnel #27) verified the above findings.

PHARMACY ADMINISTRATION

Tag No.: A0491

Based on review of records, and interviews, the Pharmacy failed to adequately supervise narcotic storage and distribution in that 3 of 3 narcotic diversions [03/14/10, 04/13/10 and 08/05/10] were not administered in accordance with state and federal laws to minimize medication errors and prevent medication diversion.

Findings Included:

Review of Pharmacy Incident Reports showed the following:

1) On 03/14/10, Personnel #15 took 10 Morphine CR 30 mg tablets from the 2nd floor medDispense Station.
2) On 04/13/10, Personnel #40 was searched by the House Supervisor (Personnel #43) and found a used 2 mg Morphine syringe and a 4 mg Morphine syringe in her bag.
3) On 08/05/10, Personnel #35 took 3 Fentanyl 25 mcg patches from the 4th floor medDispense Station.


The " Plan for the Provision of Patient Care/Services 2010 " , under the title, " Pharmacy " , requires, " The Department of Pharmacy provides systems-based services including ...drug preparation and distribution ...dosage monitoring services ...medications are reviewed by a pharmacist ...Medication error programs ...policy development and implementation ...appropriate, accurate, and timely dispensing of medications ...regulations set by the Texas State Board of Pharmacy and Federal Government ...professional and ethical practices are maintained at all times through adherence to the department ' s, institution ' s and profession ' s code of professional conduct ...patient care quality measures are reported to the Quality Committee. Among these are medication error and ADR trends, and process improvement projects ...complies with all federal, state, and regulatory standards to guide practice ... "


In an interview on 10/06/10 at 1:00 P.M., the Director of Pharmacy, (Personnel #27) verified the above findings.

PHARMACIST RESPONSIBILITIES

Tag No.: A0492

Based on review of records, and interview, the Director of Pharmacy failed to supervise and maintain adequate control over the distribution of medications and narcotics of the electronic medication dispensing systems in 2 of 2 (2nd and 4th medical floors) medication storage areas in order to prevent medication diversions.

Findings Included:

Review of Pharmacy Incident Reports showed the following:

1) On 03/14/10, Personnel #15 took 10 Morphine CR 30 mg tablets from the 2nd floor medDispense Station.
2) On 04/13/10, Personnel #40 was searched by the House Supervisor (Personnel #43) and found a used 2 mg Morphine syringe and a 4 mg Morphine syringe in her bag on 2nd medical floor.
3) On 08/05/10, Personnel #35 took 3 Fentanyl 25 mcg patches from the 4th floor medDispense Station.

The hospital policy on " Controlled Substances " , Revised date " July 2010 " , requires, " Controlled drugs shall be distributed, administered, and accounted for in accordance with federal laws, rules, and regulations and the laws, rules, and regulations of this state, and other applicable law ...The Pharmacist in Charge is designated by the State Board of Pharmacy as the individual responsible for carrying out State and Federal laws regarding the control of controlled drugs ...The Pharmacist in Charge, acting as the facility ' s agent, shall ensure that the distribution and administration of controlled drugs are documented adequately by pharmacy, nursing service, and other involved services or personnel in accordance with federal laws and the laws of this state ...If theft or significant loss of any amount of controlled substances is suspected, the Pharmacist in Charge and the Nurse Executive should notify hospital administration and the hospital division Director of Pharmacy. Confirmed theft or significant amounts of controlled substances requires immediate notification of the DEA, the State Board of Pharmacy, and other regulatory agencies as required by State Board of Pharmacy Law ... "

In an interview on 10/06/10 at 12:45 pm, the Director of Pharmacy (Personnel #27) was asked if he is responsible for all medication storage areas and supervision of the activities of the hospital pharmacy services. He stated, " Yes, I am. "

DELIVERY OF DRUGS

Tag No.: A0500

Based on review of records, and interview, the hospital pharmacy failed to minimize and prevent unauthorized usage and distribution of controlled medications/narcotics in that 3 of 3 narcotic diversions occurred from 03/14/10 through 08/05/10.

Findings Included:

Review of Pharmacy Incident Reports showed the following:

1) On 03/14/10, Personnel #15 took 10 Morphine CR 30 mg tablets from the 2nd floor medDispense Station.
2) On 04/13/10, Personnel #40 was searched by the House Supervisor (Personnel #43) and found a used 2 mg Morphine syringe and a 4 mg Morphine syringe in her bag on 2nd medical floor.
3) On 08/05/10, Personnel #35 took 3 Fentanyl 25 mcg patches from the 4th floor medDispense Station.

The hospital policy on " Controlled Substances " , Revised date " July 2010 " , requires, " Controlled drugs shall be distributed, administered, and accounted for in accordance with federal laws, rules, and regulations and the laws, rules, and regulations of this state, and other applicable law ...The Pharmacist in Charge is designated by the State Board of Pharmacy as the individual responsible for carrying out State and Federal laws regarding the control of controlled drugs ...The Pharmacist in Charge, acting as the facility ' s agent, shall ensure that the distribution and administration of controlled drugs are documented adequately by pharmacy, nursing service, and other involved services or personnel in accordance with federal laws and the laws of this state ...If theft or significant loss of any amount of controlled substances is suspected, the Pharmacist in Charge and the Nurse Executive should notify hospital administration and the hospital division Director of Pharmacy. Confirmed theft or significant amounts of controlled substances requires immediate notification of the DEA, the State Board of Pharmacy, and other regulatory agencies as required by State Board of Pharmacy Law ... "

In an interview on 10/06/10 at 12:45 pm, the Director of Pharmacy (Personnel #27) verified the above findings.

PHARMACY: REPORTING ADVERSE EVENTS

Tag No.: A0508

Based on review of records, and interviews, the hospital failed to identify 3 of 3 narcotic diversions 03/14/10, 04/13/10 and 08/05/10] as a significant patient safety problem and report it to the hospital Performance Improvement Program to address, implement a corrective action plan and monitor for compliance.

Findings Included:

Review of Pharmacy Incident Reports showed the following:

1) On 03/14/10, Personnel #15 took 10 Morphine CR 30 mg tablets from the 2nd floor medDispense Station.
2) On 04/13/10, Personnel #40 was searched by the House Supervisor (Personnel #43) and found a used 2 mg Morphine syringe and a 4 mg Morphine syringe in her bag.
3) On 08/05/10, Personnel #35 took 3 Fentanyl 25 mcg patches from the 4th floor medDispense Station.

Review of "Pharmacy & Therapeutic Indicators" for "2009 through 2010" did not show any drug diversions identified or addressed as a patient safety concern or potential for patient safety concern.

Review of the "Patient Safety Meetings , dated, "04/19/10 and 06/29/10" did not show any drug diversions identified or addressed as a patient safety concern or potential for patient safety concern.

Review of the "Quality Council" meetings, dated, "01/19/10, 02/16/10, 03/16/10, 04/20/10, 06/15/10, and 07/20/10" did not show any drug diversions identified or addressed as a patient safety concern or potential for patient safety concern.

Review of "Pharmacy and Therapeutics Committee" (P&T) meeting notes, 01/27/10 and 03/04/10 did not address or identify any incidents of drug diversions.

In an interview on 10/05/10 at 11:15 AM, the Director of Quality Management (Personnel #3) was asked if any drug diversions had been reported or identified in the Pharmacy, Safety or Quality Council meetings. She stated, "No, there have been no drug diversions identified and reported to any of the meetings." She was then asked if the incident reports filled out by the pharmacist [Personnel #27] had been turned in to the Quality and Risk department. She stated, "No, there are no records or incidents from the Pharmacy or Nursing for medication diversions."

In an interview on 10/06/10 at 12:45 PM, the Director of Pharmacy [Personnel #27] was asked if he had identified any drug diversions in the Pharmacy, Safety or Quality Council meetings. He stated, "No, I have not." He was asked if a drug diversion is considered a medication error and reportable to the respective committee's. He stated, "Yes, they should have been reported."

Cross Reference: A0404

REPORTING ABUSES/LOSSES OF DRUGS

Tag No.: A0509

Based on interview and record review, the hospital failed to report 3 of 3 narcotic diversions [03/14/10, 04/13/10 and 08/05/10] by 3 of 3 nurses [Personnel #15, #35 and #40] to the appropriate federal and state agencies.

Findings Included:

Review of Pharmacy Incident Reports revealed the following:

1) On 03/14/10, Personnel #15 took 10 Morphine CR 30 mg tablets from the 2nd floor medDispense Station.
2) On 04/13/10, Personnel #40 was searched by the House Supervisor (Personnel #43) and found a used 2 mg Morphine syringe and a 4 mg Morphine syringe in her bag.
3) On 08/05/10, Personnel #35 took 3 Fentanyl 25 mcg patches from the 4th floor medDispense Station.

The hospital policy on "Controlled Substances",dated "July 2010", reflected, "Controlled drugs shall be distributed, administered, and accounted for in accordance with federal laws, rules, and regulations and the laws, rules, and regulations of this state, and other applicable law...The Pharmacist in Charge is designated by the State Board of Pharmacy as the individual responsible for carrying out State and Federal laws regarding the control of controlled drugs...The Pharmacist in Charge, acting as the facility's agent, shall ensure that the distribution and administration of controlled drugs are documented adequately by pharmacy, nursing service, and other involved services or personnel in accordance with federal laws and the laws of this state...If theft or significant loss of any amount of controlled substances is suspected, the Pharmacist in Charge and the Nurse Executive should notify hospital administration and the hospital division Director of Pharmacy. Confirmed theft or significant amounts of controlled substances requires immediate notification of the DEA, the State Board of Pharmacy, and other regulatory agencies as required by State Board of Pharmacy Law..."

In an interview on 10/06/10 at 12:45 PM, the Director of Pharmacy (Personnel #27) was asked if he notified the appropriate federal and state agencies of the the three drug diversions above. He stated, "No, I have not."

In an interview on 10/08/10 at 1:30 PM, with the CEO (Personnel #2), she was asked if she was aware of the drug diversions by Personnel #15, #35 and #40. She stated, "I was made aware of the drug diversion made by [Personnel #15] and I take full responsibility for that one since it was the CCO's [Personnel #1] transition period at that time. I was not aware of the other diversions that were made by [Personnel #35 and #40]. She was asked if the drug diversions were reported to the appropriate authorities. She stated, "No, not that I know of. I self-reported to the BON this morning in regard to the drug diversion by [Personnel #15]. I hired him and allowed him to work that weekend without the required drug screen because we were in dire straights and did not have enough staff for the amount of patient's that we had." She was asked if there was any documentation regarding the drug diversions from the Nursing Peer Review Committee. She stated, "No, we did not have any Peer Review meetings."

During this same interview with the CEO (Personnel #2), she produced 3 different letters for each of the 3 drug diversions [by Personnel #15, #35 and #40] from the Director of Pharmacy (Personnel #27) dated "October 7, 2010." The letter reflected Personnel #27 had reported the diversions to the "DEA [Drug Enforcement Agency] Dallas Division, Texas State Board of Pharmacy and Texas Department of Public Safety." She also stated Personnel #27 reported himself to the Texas State Board of Pharmacy for failing to report the drug diversions as required by law.

Cross Reference: A0404

No Description Available

Tag No.: A0267

Based on interview and record review, the hospital Performance Improvement Program failed to identify the following: 1) Nonemployee licensed nurses were not adequately oriented, evaluated and verification of license was not performed. 2) Drug diversions of controlled substances were not identified and reported. 3) Nurse staffing levels were not determined by patient acuity and intensity of care. 4) The physician orders and assessment on patient restraints were not documented in the patient's medical record for 1 of 2 patients reviewed (Patient #1).

Findings Included:

1) On the morning of 10/06/10, the CEO (Personnel #2) was asked if the Nursing Department monitored the orientation, evaluation and licensure of nonemployee licensed nurses in the Performance Improvement Program. She stated, "No." Cross refer A0394 and A0398.

2) In an interview on 10/06/10 at 12:45 P.M., the Director of Pharmacy (Personnel #27) was asked if he had identified any drug diversions in the Pharmacy, Safety or Quality Council meetings. He stated, "No, I have not." He was asked if a drug diversion is considered a medication error and reportable to the respective committees. He stated, "Yes, they should have been reported." Cross refer A0508 and A0509

3) In an interview with the CCO (Personnel #1) on the morning of 10/06/10, she was asked if the nurse staffing levels were monitored in the performance improvement plan. She stated, "No, not that I know of." She was asked if the nursing department was monitoring for the required physician orders and assessment on patient restraints in the performance improvement program. She stated, "No, we are not."

In an interview on 10/05/10 at 11:15 AM, the Director of Quality Management (Personnel #3) was asked if any drug diversions had been reported or identified in the Pharmacy, Safety or Quality Council meetings. She stated, "No, there have been no drug diversions identified and reported to any of the meetings." She was then asked if the incident reports filled out by the pharmacist (Personnel #27) had been turned in to the Quality and Risk department. She stated, "No, there are no records or incidents from the Pharmacy or Nursing for medication diversions." A0404, A0508, and A0509

4) On 10/05/10 at approximately 11:30 AM Personnel #1 (Chief Clinical Officer) was asked to review Patient #1's restraint order record and restraint management documentation form. Personnel #1 stated the documents were incomplete and not filled out.

On 10/06/10 at 10:40 AM Personnel #4 was asked by the surveyor to review Patient #1's interdisciplinary plan of care for documentation indicating Patient #1 required the use of wrist restraints. Personnel #4 stated no documentation was found addressing the use of wrist restraints for Patient #1. Cross refer to A0166, A0170, A0185, A0186 and A0208.

No Description Available

Tag No.: A0310

Based on review of records and interview, the hospital Performance Improvement Program failed to identify the following: 1) Nonemployee licensed nurses were not adequately oriented, evaluated and verification of license was not performed. 2) Drug diversions of controlled substances were not identified and reported. 3) Nurse staffing levels were not determined by patient acuity and intensity of care. 4) The physician orders and assessment on patient restraints were not documented in the patient's medical record.

Findings Included:

On the morning of 10/06/10, the CEO (Personnel #2) was asked if the Nursing Department monitored the orientation, evaluation and licensure of non employee licensed nurses in the Performance Improvement Program. She stated, "No." Cross refer A0394 and A0398

In an interview on 10/06/10 at 12:45 PM, the Director of Pharmacy (Personnel #27) was asked if he had identified any drug diversions in the Pharmacy, Safety or Quality Council meetings. He stated, "No, I have not." He was asked if a drug diversion is considered a medication error and reportable to the respective committees. He stated, "Yes, they should have been reported." Cross refer A0508 and A0509

In an interview with the CCO (Personnel #1) on the morning of 10/06/10, she was asked if the nurse staffing levels were monitored in the performance improvement plan. She stated, " No, not that I know of." She was asked if the nursing department was monitoring for the required physician orders and assessment on patient restraints in the performance improvement program. She stated, " No, we are not." Cross refer

In an interview on 10/05/10 at 11:15 AM, the Director of Quality Management (Personnel #3) was asked if any drug diversions had been reported or identified in the Pharmacy, Safety or Quality Council meetings. She stated, "No, there have been no drug diversions identified and reported to any of the meetings." She was then asked if the incident reports filled out by the pharmacist (Personnel #27) had been turned in to the Quality and Risk department. She stated, "No, there are no records or incidents from the Pharmacy or Nursing for medication diversions."

4) On 10/05/10 at approximately 11:30 AM Personnel #1 (Chief Clinical Officer) was asked to review Patient #1's restraint order record and restraint management documentation form. Personnel #1 stated the documents were incomplete and not filled out.

On 10/06/10 at 10:40 AM Personnel #4 was asked by the surveyor to review Patient #1's interdisciplinary plan of care for documentation indicating Patient #1 required the use of wrist restraints. Personnel #4 stated no documentation was found addressing the use of wrist restraints for Patient #1. Cross refer to A0166, A0170, A0185, A0186 and A0208.

No Description Available

Tag No.: A0311

Based on interview and record review, the hospital failed to identify and address 3 of 3 narcotic diversions (03/14/10, 04/13/10 and 08/05/10) as a significant patient safety problem and implement a corrective action plan to prevent any further incidences.

Findings Included:

In an interview on 10/05/10 at 10:00 AM, The Director of Quality and Risk Management (Personnel #3) was asked for the hospital's Incident and/or Variance log. She stated that they do not have a log and brought the surveyor individual folders with incidents labeled, " March 2010 through October 2010." She was asked if the folders contained any reports of incidents with medication or narcotic diversions. She reviewed the folders and stated, "No, there are no narcotic diversions in the folders." She was asked if there had been any narcotic diversions, should they have been logged into and addressed in the hospital Risk Management and Patient Safety System. She stated, "Yes, they should have been reported and addressed by Risk Management and Patient Safety."

Review of Pharmacy Incident Reports revealed the following:

1) On 03/14/10, Personnel #15 took 10 Morphine CR 30 mg tablets from the 2nd floor medDispense Station.
2) On 04/13/10, Personnel #40 was searched by the House Supervisor [Personnel #43] and found a used 2 mg Morphine syringe and a 4 mg Morphine syringe in her bag.
3) On 08/05/10, Personnel #35 took 3 Fentanyl 25 mcg patches from the 4th floor medDispense Station.

The "Dallas LTAC Patient Safety Plan 2010", reflected..."Upon the authority of the Governing Board, a hospital wide integrated system that encompasses all areas of patient safety ...with prevention practices to provide a safe, risk-free environment...identify and report potential or actual occurrences that may lead to a risk or a loss...through identifying, investigating, analyzing, reducing and/or preventing risk ...reportable event-a medical error or adverse event or occurrence which the hospital is required to report to the Department of Health, other state department..."

cross reference: A0385, A0263 and A0490

No Description Available

Tag No.: A0404

Based on interview and record review, the hospital failed to ensure administration of narcotics was in accordance with federal and state laws and regulations in that 3 of 3 licensed nurses (Personnel #15, #35 and #40 (nonemployee)) who were providing direct patient care diverted narcotics on 3 separate dates (03/14/10, 04/13/10 and 08/05/10).

Findings Included:

1) Review of, "Incident Reports" from 01/2010 through 10/2010 did not reveal any incidents of drug diversions.

Review of Pharmacy Incident Reports revealed the following:

1) On 03/14/10, Personnel #15 took 10 Morphine CR 30 mg tablets from the 2nd floor medDispense Station.
2) On 04/13/10, Personnel #40 was searched by the House Supervisor [Personnel #43] and found a used 2 mg Morphine syringe and a 4 mg Morphine syringe in her bag.
3) On 08/05/10, Personnel #35 took 3 Fentanyl 25 mcg patches from the 4th floor medDispense Station.

Review of "Quality Council" meeting notes dated 01/19/10, 02/16/10, 04/20/10, 06/15/10, and 07/20/10 did not address any incidents of drug diversions.

Review of "Pharmacy and Therapeutics Committee" (P&T) meeting notes, dated 01/27/10 and 03/04/10 did not address or identify any incidents of drug diversions.

On 10/05/10 at 11:15 AM, the Director of Quality Management (Personnel #3) was asked for a list or log of any identified drug diversions for the past year. She stated, "We do not have any incidents listed for drug diversion for the past year."

On 10/05/10 at 11:30 AM, the Chief Clinical Officer (CCO) (Personnel #1) was asked if there had been any drug diversions in the past year at this facility. She stated, "No, none that I know of."

2) On 10/06/10 at 12:45 PM, the Director of Pharmacy (Personnel #27) was asked if there had been any known drug diversions in the past year at this facility. He stated, "I think there has been one. I will have to go back and look at my records." At 1:00 PM, Personnel #27 returned with an incident report that was dated 08/05/10 for "Possible diversion." which showed, "Operator nurse [Personnel #35] removed 3 Fentanyl 25 mcg [micrograms] patches for a patient who was not assigned to her. [Personnel #35] did not apply the patches to the patient. Patient was on 25 mcg patch every 72 hours. Nursing agency notified and she will not be used her again per Nur. Admin. [Nursing Administration]." Personnel #27 was asked how he was made aware of this narcotic diversion. He stated that he was notified by the House Supervisor the next morning. He was then asked if he had performed an investigation. He stated that he had reviewed the "Operator Transactions" and "Class 2 Transactions" report which showed Personnel #35 only had access to the 4th floor in the medDispense Station which was where she was working. He stated that the records showed Personnel #35 pulled up a patient that was on 2nd floor that had Fentanyl patches and signed out the 3 patches from the 4th floor station. He stated that he then went and met with the House Supervisor (Personnel #38) and accompanied the House Supervisor to the patient's room Patient #4. The House Supervisor checked Patient #4 for the patches and only found the 1 current patch that had been applied to the patient the previous day. He stated that he had notified the CCO (Personnel #1) about the incident and that he was told by the CCO that she would notify the agency and not let that nurse return. He was then asked if he had reported the incident to the Quality Council or the P&T committee's. He stated, "No, I did not." He was asked if he notified the appropriate federal and state agencies. He stated, "No, I have not."

Review of the Nurse Staffing sheets, dated, Thursday, 08/05/10, revealed Personnel #35 worked the 7AM shift on 4th floor.

Review of Patient #4's Medication Administration Record [MAR] dated "08/05/10 @ 0700 thru 08/06/10 @ 0659", showed the drug Fentanyl was to be applied TD (transdermal) Q72H (every 72 hours) for severe pain. It was pre-printed across the "First Shift" and "Second Shif " boxes, "NO DOSES DUE."

3) During this same interview with the Director of Pharmacy on 10/06/10 at 12:45 PM, he was asked if he knew of any known drug diversions with Personnel #15, on or about 03/14/10. He stated, he was not sure and had to check. He returned back from the pharmacy with an "Incident Report" and "medDispense Drug Transaction Report" dated 03/14/10. The Incident Report reflected, "Discrepancy of a controlled substance." Description showed, "2nd floor automated dispensing machine [ADM] for narcs had 7 doses of morphine CR 30 mg. On 3/14/10 at 4:48 PM, pharmacist loaded 20 more doses...This increased the count to 27...Approximately 5 hours later at 10:16 PM, nurse [Personnel #15] changed the count to 17...without calling the pharmacist on-call to discuss why count needs to be changed...he never received any calls...Corrective Action: Disciplinary action was taken against the LVN involved after he received counseling..." The "Drug Transaction Report showed, "Morphine 30 mg CR 30 mg tablets, System Amount 27, Corrected Amount 17" by Personnel #15 on 03/14/10 at 10:16:27 PM. The Director of Pharmacy (Personnel #27) was asked if he notified anyone of this incident. He stated, "Yes, the Director of Quality Management [Personnel #12]. He was then asked if he notified the appropriate federal and state agencies. He stated, "No, I have not."

The Nurse Staffing sheets, dated, Sunday, 03/14/10, reflected Personnel #15 worked the 7PM shift on 2nd floor.

Review of the "Verified Results of Controlled Substances Testing", performed by an outside agency, dated 03/18/10 for Personnel #15 revealed, "Positive Amphetamines and Methamphetamines."

In an interview on 10/07/10 at 2:00 PM, with the House Supervisor (Personnel #38), she was asked if she knew of any drug diversions in the past year. She stated, "Yes, I know of two. One was with [Personnel #40] back in March which involved Morphine and another with [Personnel #35] when she was working on the 4th floor, ICU and pulled up a patient on 2nd floor and signed out 3 Fentanyl patches. She did not have the assignment and no other patients with Fentanyl patches were assigned to her. She stated she notified [Personnel #35's] agency and the CCO [Personnel #1] and wrote an incident report and put it in the CCO's box in administration." She stated, "I talked to the CCO about reporting it to the Board of Nursing and the CCO told me that the Nursing Agency had been notified and that they did not need to." She was then asked about the incident with Personnel #40 back in March. She stated, "I did not work that night but the House Supervisor [Personnel #43] worked."

4) In an interview on 10/07/10 at 3:00 PM, with the Director of Pharmacy (Personnel #27), he was asked if he was aware of a drug diversion of Morphine with Personnel #40. He stated, "No, I was not aware. I will check my records." At 3:30 PM, Personnel #27 returned and stated he had not received any report on this incident.

In an interview on 10/08/10 at 09:50 AM, staff nurse (Personnel #41), was asked if she knew of any drug diversions in the past year. She stated, "Yes, I was off that night and [Personnel #39] called me and told me there were a lot of discrepancies in narcotics going on this night. She said she was not comfortable working with this agency nurse [Personnel #40]. I was called into work to relieve [Personnel #40] around 10:00 PM that night and took report from her [Personnel #40]. I saw two tubex tips sticking out from under her paperwork. After report, I saw her put the paperwork and the narcs in her bag. I notified the House Supervisor [Personnel #43] and she came down and caught her [Personnel #40] at the elevator and asked her to empty her pockets and then asked her if she could search her bag and she said, "yes." The House Supervisor [Personnel #43] found the two Morphine tubex's in her bag and took them from her."

In an interview on 10/08/10 at 10:00 AM, staff nurse (Personnel #39), she was asked if she knew of any drug diversions in the past year. She stated, "Yes, I was working one evening with another nurse [Personnel #40] which was the first time I had ever worked with her. Approximately 5 minutes after shift change, she said she had a drug discrepancy on Ativan and wanted me to clear it with her. I told her I could not, that she would have to call the House Supervisor [Personnel #43]. The House Supervisor came up and cleared the discrepancy and returned the Ativan. This night patient's that never call for pain meds kept calling saying that they needed their pain meds. These patient's were her [Personnel #40] patients. I kept thinking that something was not right. I noticed that she had pulled the narcotics on all of her patients. I saw some meds sticking out from under her MAR's [Medication Administration Records]. She pushed them back under the MAR's. I told [Personnel #41] about it and she saw them sticking out from under the MAR's also. [Personnel #41] saw her put the paperwork and the two tubex ' s in her bag. She [Personnel #41] called the House Supervisor [Personnel #43] and I witnessed the House Supervisor finding the two Morphine tubex's in [Personnel #40's] bag."

In an interview on 10/08/10 at 10:10 AM, with the House Supervisor (Personnel #43), she was asked if she knew of any drug diversions in the past year. She stated, "Yes, [Personnel #40], an agency nurse was seen putting some Morphine tubex's in her bag by another nurse [Personnel #39]. She notified me. I stopped her [Personnel #40] when she was getting ready to leave and I asked to search her bag. I found 2 Morphine tubex's in her bag and I took them from her. I wrote an incident report and reported it to her agency and the CCO [Personnel #1] and the Clinical Coordinator [Personnel #4]." She was asked if she was ever interviewed by anyone regarding an investigation of this incident. She stated, "No."

Review of the Nurse Staffing sheets, dated, Tuesday, 04/13/10, reflected Personnel #40 worked the 7PM-11PM shift on 2nd floor.

5) In an interview on 10/08/10 at 12:55 PM, with the CCO (Personnel #1), she was asked about the 3 different narcotic diversions. She was asked if she was notified regarding the drug diversion by Personnel #15. She stated, "I was in Houston on March 15th. I was not notified of it." She was asked if she received an incident report on the narcotic diversion by [Personnel #15]. She stated, "I do not remember a specific incident report. If I had, I would have acted on it."

In this same interview, the CCO was then asked if she was notified and received an incident report regarding the narcotic diversion with Personnel #35. She stated, "The House Supervisor [Personnel #38] came up to me on that Friday and told me we had a diversion. The Pharmacist [Personnel #27] and I did an investigation. I called the agency and told them about it and made her a DNR [do not return]. She was asked if she ever received an incident report from [Personnel #38]. She stated, "No, I never did get one."

The CCO was asked if she could produce the documentation regarding the investigation's on the narcotic diversions. She stated, "No, I don't have any documentation on it." She was then asked if she had reported the nurses (Personnel #15, #35, and #40) to the Texas Board of Nurses as required by the Nurse Practice Act. She stated, " No, I reported [Personnel #35] and [Personnel #40] to their agencies like our Peer Review policy says to. I also told the agency to make them a DNR [do not return]. I was in my transition period when [Personnel #15] was here and I did not report him because I was not responsible for it at the time." She was asked if it was her responsibility as the CCO and acting Nurse Executive to know and conform to the Board of Nursing (BON) Nurse Practice Act (NPA). She stated, "Yes, it is." She was asked if it was her responsibility as the CCO and acting Nurse Executive to properly investigate and document the drug diversions. She stated, "Yes, it was." She was asked if she had reported it to the Nursing Peer Review Committee as required. She stated, "No." She stated that she self-reported to the BON this morning for failing to report [Personnel #35] and [Personnel #40] to the BON for drug diversion.

In an interview on 10/08/10 at 1:30 PM, with the CEO (Personnel #2), she was asked if she was aware of the drug diversions by Personnel #15, #35 and #40. She stated, "I was made aware of the drug diversion made by [Personnel #15] and I take full responsibility for that one since it was the CCO's [Personnel #1] transition period at that time. I was not aware of the other diversions that were made by [Personnel #35] and [Personnel #40]. She was asked if the drug diversions were reported to the appropriate authorities. She stated, "No, not that I know of. I self-reported to the BON this morning in regard to the drug diversion by [Personnel #15]. I hired him and allowed him to work that weekend without the required drug screen because we were in dire straights and did not have enough staff for the amount of patient's that we had." She was asked if there was any documentation regarding the drug diversions from the Nursing Peer Review Committee. She stated, "No, we did not have any Peer Review meetings."

The "Drug Free Workplace" policy, revision date 05/01/09, reflected, "All hospital division new hires and re-hires must successfully complete a pre-employment drug screen...Candidates for employment in the hospital division must complete the pre-employment drug screen within 24-48 hours of receiving the appropriate paperwork from Human Resources ...Once a conditional offer has been made, failure to complete a pre-employment drug screen in the timeframe required, refusal to submit to a drug screen, or testing positive, will result in withdrawal of the offer of employment..."

The "Controlled Substances" Policy, revision date 07/2010, reflected, "Appropriate and safe ordering, control, and distribution of controlled substances...Controlled drugs shall be distributed, administered, and accounted for in accordance with federal laws, rules, and regulations of this state, and other applicable law...The pharmacist in charge is designated by the State Board of Pharmacy as the individual responsible for carrying out state and federal laws regarding the control of controlled drugs...shall ensure that the distribution and administration of controlled drugs are documented adequately by pharmacy, nursing service ...in accordance with federal laws and the laws of this state...Theft: If theft or significant loss of any amount of controlled substances is suspected, the Pharmacist in charge and the Nurse executive should notify hospital administration and the hospital division Director of Pharmacy. Confirmed theft or significant amounts of controlled substances requires immediate notification of the DEA, the State Board of Pharmacy, and other regulatory agencies as required by State Board of Pharmacy law."

The "Peer Review: Nursing" policy, revision date 10/28/09, reflected, "Reportable Conduct to the BON...is defined as conduct by a nurse that: violates the Nursing Practice Act (NPA) or a Board rule...causes a person to suspect that the nurse's practice is impaired by chemical dependency or drug or alcohol abuse...Reporting of Incidents: ...To State Authorities: Nurses, physicians, the hospital and others may be required by law to report reportable conduct to certain state authorities...Nothing in this plan is intended to prevent anyone from reporting a potential violation directly to the BON..."

According to the Texas Board of Nursing rules ?217.11. Standards of Nursing Practice.
The Texas Board of Nursing...The standards of practice establish a minimum acceptable level of nursing practice in any setting for each level of nursing...
(1) Standards Applicable to All Nurses. All vocational nurses, registered nurses and registered nurses with advanced practice authorization shall:
(A) Know and conform to the Texas Nursing Practice Act and the board's rules and regulations as well as all federal, state, or local laws, rules or regulations affecting the nurse's current area of nursing practice;...
(K)Comply with mandatory reporting requirements of Texas Occupations Code Chapter 301 (Nursing Practice Act), Subchapter I, which include reporting a nurse:...
ii)whose conduct causes a person to suspect that the nurse's practice is impaired by chemical dependency or drug or alcohol abuse;
iii)whose actions constitute abuse, exploitation, fraud, or a violation of professional boundaries...
(U) Supervise nursing care provided by other for whom the nurse is professionally responsible; and...

?217.12. Unprofessional Conduct.
The unprofessional conduct rules are intended to protect clients and the public from incompetent, unethical, or illegal conduct of licensees. The purpose of these rules is to identify unprofessional or dishonorable behaviors of a nurse which the board believes are likely to deceive, defraud, or injure clients or the public. Actual injury to a client need not be established. These behaviors include but are not limited to:
(1) Unsafe practice-actions or conduct including, but not limited to:...
(C) Improper management of client records;...
(2) Failure of a chief administrative nurse to follow appropriate and recognized standards and guidelines in providing oversight of the nursing organization and nursing services for which the nurse is administratively responsible...
(6) Misconduct-actions or conduct that include, but are not limited to:
(A) Falsifying reports, client documentation, agency records or other documents;...
(G) Misappropriating, in connection with the practice of nursing, anything of value or benefit...
(H) Providing information which was false, deceptive, or misleading in connection with the practice of nursing;...
(8) Drug Diversion-diversion or attempts to divert drugs or controlled substances ...
(10) Other Drug Related-actions or conduct that include, but are not limited to: ...
(B) Falsification of or making incorrect, inconsistent...entries in agency, client, or other record pertaining to drugs or controlled substances...
(E) Obtaining or attempting to obtain or deliver medications(s) through means of misrepresentation, fraud, forgery, deception and/or subterfuge...
(11) Unlawful Practice-actions or conduct that include, but are not limited to:...
(D) Failing to report violations of the Nursing Practice Act and/or the Board's rules and regulations..."