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Based on review of the Governing Body Bylaws, facility documents, facility policies and procedures, medical records (MR), and interviews with staff (EMP), it was determined the Governing Body failed to protect and promote patient's rights (A0115), failed to ensure patients receiving Patient Controlled Analgesia (PCA) received care in a safe setting for three of 10 medical records reviewed (A0144), failed to ensure the nursing staff administered Patient Controlled Analgesia (PCA) in accordance with the facility's nursing policy and procedure (A0385), failed to ensure that the medication was administered according to signed physician orders for three of three medical records (A0404), failed to ensure medication errors were immediately reported to the practitioner, and failed to ensure proper documentation in the patient's medical record in six of 11 medical records reviewed for medication errors (A0580).

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Findings include:

Review of the facility's "Bylaws of the St. Luke's Hospital Board of Trustees," revised May 24, 2010, revealed "... Section 1.3 Purposes. The purposes of the Corporation are: A. To establish and maintain hospitals for the care of persons suffering from illness, disease and disabilities. ... Section 2.1 Board of Trustees ... In addition to the powers and duties conferred on the Board of Trustees under the laws of the Commonwealth of Pennsylvania, the Board of Trustees shall have the power to, subject to Section 1.3, borrow money. ... Section 3.5 Quality and Medical Education Committee. This committee shall: ... 3.5.2. Oversee the Hospital's quality management program. The Committee shall delegate to the Medical Staff and Administration the responsibility for implementation of and reporting on the activities and mechanisms for monitoring and evaluating the quality of patient care, for identifying and resolving problems, and for identifying opportunities to improve patient care. The Committee shall receive regular and timely reports from Administration and monitor quality review activities. ..."

Review of the Governing Body Board of Trustees meeting minutes revealed documentation of meetings for September 26, 2011, June 27, 2011, May 23, 2011, April 25, 2011, and February 28, 2011. There was documentation of discussions of quality reports, Chief Medical Office reports, Bylaw revisions, Medical Staff reports, credentialing, significant events, patient safety reports. Review of the Governing Body Bylaws revealed they were last approved on November 15, 2011. There was no reference in these minutes regarding the facility's follow up with Patient Controlled Analgesia (PCA) pump medication errors.

Cross Reference:
482.13 Patient Rights
482.13(c)(2) Patient Rights; Care in Safe Setting
482.23 Nursing Services
482.23(c) Administration of Drugs
482.25(b)(6) Pharmaceutical Services: Reporting Drug Administration Errors

Based on review of facility documents, facility policy and procedures, medical records (MR), and interview with staff (EMP), it was determined the facility failed to protect and promote patient's rights by failing to ensure patients receiving Patient Controlled Analgesia (PCA) received care in a safe setting for three of 10 medical records reviewed (A0144), failed to ensure medication errors were immediately reported to the practitioner, and failed to ensure proper documentation in the patient's medical record in six of 11 of medical records reviewed for medication errors (A0508).

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure medication was administered in a safe manner.

Cross Reference:
482.13(c)(2) Patient Rights; Care in Safe Setting
482.23 Nursing Services
482.23(c) Administration of Drugs
482.25(b)(6) Reporting Drug Administration Errors

Based on review of policy and procedures, facility documentation, medical records (MR), and interview with staff (EMP), it was determined that the facility failed to ensure patients receiving Patient Controlled Analgesia (PCA) received care in a safe setting for three of 10 medical records reviewed (MR1, MR2 and MR3).

Findings include:

Review of the facility policy "Rights and Responsibilities - Patients," last reviewed October 2011, revealed "St. Luke's health network supports a Patients' Bill of Rights and Responsibilities, believing that observance of these rights and responsibilities will contribute to more effective patient care and greater satisfaction for patients, their physicians and the Hospitals of St. Luke's Network ... Patient Rights 1. A patient has the right to respectful care given by competent personnel. ... 7. The patient has the right to good quality care and high professional standards that are continually maintained and reviewed. ... 18. The patient has the right to expect good management techniques to be implemented within St. Luke's Hospital and Health Network considering effective use of time of the patient and to avoid the personnel discomfort of the patient. ..."

Patients also received a preprinted Patient Rights and Responsibilities that includes the following: "Receive care in a safe setting free from any form of abuse, harassment, and neglect. Receive kind, respectful, safe, quality care delivered by skilled staff. "

Review on November 16, 2011, of the facility policy "Patient Controlled Analgesia (PCA): Intravenous [D-27]," last reviewed June 2011, revealed "I. 2 RN/GN's are required to to verify the accuracy of PCA pump settings. This verification is accomplished through a system of independent double-checks and requires: 1. Each Rn/Gn's performs an independent check at the bedside to verify the patient, medication drug concentration and PCA pump settings. 2. Both Rn/Gn's compare the checks to the physician order and verify that they are identical. 3. The RN/GN's document the double-check system in the appropriate place in the patient's medical record. When documenting in the computerized medical record, document under Assessment; PCA tab; verify order. The verification of the accuracy of the PCA pump settings must occur: at initial set-up and when reprogramming the pump; with the addition of a new syringe to the PCA pump; at every assignment change; With any change of pump settings/change in physician order/change in drug concentration; When a patient patient transfers to a different level of care/clinical unit. ..."

Review on November 16, 2011, of facility documentation "Patient Controlled Analgesia Pump (PCA Pump) Resource Packet," revised March 2010, revealed "This packet has been developed as a resource for personnel involved in caring for patients with Patient Controlled Analgesia (PCA) pump therapy. The packet may be used for orientation of new personnel or for review with and updating of current employees. ... III. Initiating and Maintaining PCA Pump Therapy Obtain pre-printed/ electronic physician orders to initiate therapy. ... The PCA pump syringes are stored in and obtained from the unit based automated medication dispensing unit. On the patient care units, the PCA pump initiation is documented on the paper or electronic medication administration record. ... B. Set up the PCA pump as follows: 1. Check the PCA syringe and label with the physician's order. ... C. Program the pump as follows: It is required that 2 RNs/GNs verify the accuracy of settings at the time of the initial set-up. This 2 nurse verification is accomplished through a system of independent double checks and requires: Each Rn/Gn perform an independent check at the bedside to verify the patient, medication, drug concentration and PCA pump settings. Both RNs/GNs compare the checks to the physician order and verify that they are identical. The Rns/GNs document the double-check in the appropriate place in the patient's medical record. ..."

Review on November 18, 2011, at 2:45 PM of facility documentation for the read-out from the automated medication dispensing unit revealed 50 ML for 5 MG/ML Morphine Sulfate was wasted at 17:39 on October 16, 2011.

Review of the facility's Patient Safety meeting minutes revealed documentation of meeting minutes on January 26, 2010, February 23, 2010, March 24, 2010, April 27, 2010, May 25, 2010, June 29, 2010, January 25, 2011, February 22,2011, May 24, 2011, June 28, 2011, and August 23, 2011. These minutes included review of patient safety events and actions taken.

Review of the February 23, 2010, Patient Safety meeting minutes documented a PCA pump programming error. Review of the March 23, 2010, minutes revealed the action the hospital took to correct the problem was education of staff at the Bethlehem hospital campus. Review of the April 27, 2010, minutes revealed another programming error involving a PCA pump occurred. Review of the minutes from the August 23, 2011 meeting revealed the hospital was getting new PCA pumps with a medical library, and staff would be educated. This was scheduled to occur in October 2011.

1) Review of MR1 revealed the patient had a physician order dated October 6, 2011, at 12:05 for Morphine 5 MG/ML PCA Bolus 1 MG Delay (Lockout): 6 MIN Basal (Continuous ) Rate: 0 MG / HR Hour Limit: 10 MG/HR Route: IV- Intravenous Indication for use: Severe Pain. Review of the Nursing documentation in MR1 revealed two nurses verified the PCA pump settings on October 6, 2011, at 12:17. The patient was ordered a total of 6 MG of Morphine from 12:17 PM to 2:25 PM. The patient received 30 MG of Morphine in that time period. During the investigation of this medication error by the facility, it was revealed that the two nurses performed the PCA pump setting collaboratively (at the same time). Facility policy required the checks by two nurses to be completed independently.

2) Review of Patient Safety Meeting minutes revealed a programming error occurred for MR2. The physician ordered the patient to receive a 1 MG bolus of Morphine. The pump was programmed to deliver milliliters instead of milligrams. The dosage the pump delivered was 1 ML of Morphine (5 MG). The error was discovered at the change of shift PCA pump check.

3) Review of MR3 revealed that on March 11, 2010, the patient received Narcan and oxygen as a result of change in physical status. Review of Patient Safety Meeting Minutes revealed the patient received a Dilaudid 1 MG bolus. The physician ordered Dilaudid 0.1 MG bolus. The PCA pump was programmed incorrectly by the nurse. The PCA pump was programmed to deliver 1 MG/ML. This error was not detected on the initial set-up of the pump or at the change of shift check.

Cross Reference:
482.23 Nursing Services
482.23(c) Administration of Drugs

Based on review of facility documents, medical records, and interviews with staff (EMP), it was determined that the Director of Nursing failed to ensure the nursing staff administered Patient Controlled Analgesia (PCA) in accordance with the facility's nursing policy and procedure, failed to ensure that the medication was administered according to signed physician orders for three of three medical records, and failed to ensure nursing staff reported drug errors immediately to the physician (A0404) (A508).

The cumulative effect of these systemic problems resulted in the Director of Nursing's inability to ensure the provision of adequate and safe nursing care for the administration of medications.

Cross Reference:
482.23(c) Administration of Drugs
482.25(b)(6) Reporting Drug Administration Errors

Based on review of facility policy, facility documents, medical records (MR), and interview with facility staff (EMP), it was determined that the facility failed to ensure medication was administered according to signed physician orders for three of three medical records (MR1, MR2 and MR3).

An Immediate Jeopardy situation to patients was created by this deficiency.

Findings include:

Review on November 16, 2011, of the facility policy "Patient Controlled Analgesia (PCA): Intravenous [D-27]," last reviewed June 2011, revealed "I. 2 RN/GN's are required to to verify the accuracy of PCA pump settings. This verification is accomplished through a system of independent double-checks and requires: 1. Each Rn/Gn's performs an independent check at the bedside to verify the patient, medication drug concentration and PCA pump settings. 2. Both Rn/Gn's compare the checks to the physician order and verify that they are identical. 3. The RN/GN's document the double-check system in the appropriate place in the patient's medical record. When documenting in the computerized medical record, document under Assessment; PCA tab; verify order. The verification of the accuracy of the PCA pump settings must occur: at initial set-up and when reprogramming the pump; with the addition of a new syringe to the PCA pump; at every assignment change; With any change of pump settings/change in physician order/change in drug concentration; When a patient patient transfers to a different level of care/clinical unit. ..."

Review on November 16, 2011, of facility documentation "Patient Controlled Analgesia Pump (PCA Pump) Resource Packet," revised March 2010, revealed "This packet has been developed as a resource for personnel involved in caring for patients with Patient Controlled Analgesia (PCA) pump therapy. The packet may be used for orientation of new personnel or for review with and updating of current employees. ... III. Initiating and Maintaining PCA Pump Therapy Obtain pre-printed/ electronic physician orders to initiate therapy. ... The PCA pump syringes are stored in and obtained from the unit based automated medication dispensing unit. On the patient care units, the PCA pump initiation is documented on the paper or electronic medication administration record. ... B. Set up the PCA pump as follows: 1. Check the PCA syringe and label with the physician's order. ... C. Program the pump as follows: It is required that 2 RNs/GNs verify the accuracy of settings at the time of the initial set-up. This 2 nurse verification is accomplished through a system of independent double checks and requires: Each Rn/Gn perform an independent check at the bedside to verify the patient, medication, drug concentration and PCA pump settings. Both RNs/GNs compare the checks to the physician order and verify that they are identical. The Rns/GNs document the double-check in the appropriate place in the patient's medical record. ..."

Review on November 18, 2011, at 2:45 PM of facility documentation for the read-out from the automated medication dispensing unit revealed 50 ML for 5 MG/ML Morphine Sulfate was wasted at 17:39 on October 16, 2011.

1) Review of MR1 revealed the patient had a physician order dated October 6, 2011, at 12:05 for Morphine 5 MG/ML PCA Bolus 1 MG Delay (Lockout): 6 MIN Basal (Continuous ) Rate: 0 MG / HR Hour Limit: 10 MG/HR Route: IV- Intravenous Indication for use: Severe Pain. Review of the Nursing documentation in MR1 revealed two nurses verified the PCA pump settings on October 6, 2011, at 12:17. The patient received 30 MG of Morphine in that time period instead of the 6 MG intended. During the investigation of this medication error by the facility, it was revealed that the two nurses performed the PCA pump setting collaboratively (at the same time). Facility policy required the checks by two nurses to be completed independently.

2) Interview with EMP4 on November 18, 2011, at 1:45 PM confirmed that EMP4 found the medication error, and the patient received 30 MG of Morphine from 12:17 PM to 2:25 PM instead of the 6 MG intended.

EMP4 determined the waste from the automated medication dispensing unit was less than anticipated. The PCA pump was quarantined. The PCA pump history was recovered and printed out. The print out confirmed the pump was incorrectly programmed. The pump was programmed to deliver 1 MG per 1 ML. The concentration of Morphine the hospital pharmacy supplied was 5 MG per ML. MR1 received 30 MG of Morphine from 12:17 PM to 2:25 PM instead of the 6 MG intended.

3) Interview with EMP5 on November 18, 2011, at 2:45 PM, confirmed that the Morphine Sulfate that was wasted for MR1 was correctly documented by the automated medication dispensing unit. The waste that was documented was 41 ML. MR1 received 30 MG of Morphine from 12:17 PM to 2:25 PM instead of the 6 MG intended.

4) Interview with EMP6 on November 16, 2011, at 9:45 AM confirmed the PCA competency was not required on an annual basis. EMP6 confirmed the entire facility had a PCA competency in 2010.

5) Interview with EMP8 on November 17, 2011, at 11:00 AM confirmed the medication error for MR1 was found by EMP4 on October 7, 2011. EMP4 was investigating the unusual incident for MR1. MR1 was 38 years old and expired a day after undergoing a hernia repair. EMP4 determined the waste from the automated medication dispensing unit was less than anticipated. The PCA pump was quarantined. The PCA pump history was recovered and printed out. The print out confirmed the pump was incorrectly programmed. The pump was programmed to deliver 1 MG per 1 ML. The concentration of Morphine the hospital pharmacy supplied was 5 MG per ML. MR1 received 30 MG of Morphine from 12:17 PM to 2:25 PM, instead of the 6 MG intended.

6) Interview with EMP10 on November 17, 2011, at 2:30 PM confirmed there were two similar instances with PCA pumps at the Bethlehem campus in 2010. The hospital's Action Plan only took place at the Bethlehem campus. The action plan included: Policy Review, Educational Packet, Attestation statement signed by staff after being reeducated, and labels were added to the pumps.

EMP10 confirmed not all staff had been re-educated. EMP10 could not provide a percentage of how many staff remained to complete the education.

The 2011 Action Plan included the following: 1) Expanded definition of independent double check. 2) One on one policy review with RN and manager / clinical educator. 3) Second check to be done by nurse leader (e.g. manager, clinical coordinator, supervisor). This changed from the original plan. It was only checked by a nurse leader if it was a initial setup, the order for medication dosage changed or the patient was transferred to another unit. The shift change checks were being done by two staff nurses. 4) Bethlehem and Allentown staff signed attestation statements. 5) Audit of documentation (this had not been completed, as it was too soon after the initiation of the 2011 Action Plan). Limited validation documentation to physician order. 6) Enhanced physician order / pharmacy order screens (The surveyors requested an explanation and were told the drug concentration previously did not appear on the physician screen. It only appeared on the Pharmacy computer screen.) 7) Provided event transparency to staff. 8) Expanded elements that require double check to include: Initial set-up, when programming the pump, addition of a new syringe, at every assessment change, change in pump settings, change in physician order, change in drug concentration, transfer to a different level of care, and transfer to a different clinical unit.

Due to the third medication error in October 2011, changes were being made to the Action Plan that was prepared by the hospital, for the same problem that had occurred in 2010. There were plans to have new PCA pumps with drug libraries. The hospital planned to have these PCA pumps in use by October. These PCA pumps were not in use as of November 17, 2011.

7) Review of Patient Safety Meeting minutes revealed a programming error occurred for MR2. The physician ordered the patient to receive a 1 MG bolus of Morphine. The pump was programmed to deliver milliliters instead of milligrams. The dosage the pump delivered was 1 ML of Morphine (5 MG). The error was discovered at the change of shift PCA pump check.

8) Review of MR3 revealed that on March 11, 2010, the patient received Narcan and oxygen as a result of change in physical status. Review of Patient Safety Meeting Minutes revealed the patient received a Dilaudid 1 MG bolus. The physician ordered Dilaudid 0.1 mg bolus. The PCA pump was programmed incorrectly by the nurse. The PCA pump was programmed to deliver 1 MG/ML. This error was not detected on the initial set-up of the pump or at the change of shift check.

Cross Reference:
482.13 Patient Rights
482.13(c)(2) Patient Rights: Care in Safe Setting
482.23 Nursing Services

Based on review of facility policies and procedures, facility documents, medical records (MR), and interview with staff (EMP), it was determined the facility failed to ensure medication errors were immediately reported to the practitioner and failed to ensure proper documentation in the patient's medical record in six of 11 of medical records reviewed for medication errors (MR1, MR2, MR3, MR11, MR13, MR14).

Findings include:

Review of the facility policy "Medication Errors," reviewed June 2011, revealed "... III. Medication Error Reporting: Medication errors will be reported immediately to the physician who is responsible for the patient's care ... The medication variance shall be recorded in the patient's medical record."

The Medication Errors report for October 2011 was requested from the facility. This was not provided.

1) Review of MR1 revealed a physician order on October 6, 2011, at 12:05 for Morphine 5 MG/ML PCA Bolus 1 MG Delay (Lockout): 6 MIN Basal (Continuous ) Rate : 0 MG / HR Hour Limit : 10 MG/HR Route: IV- Intravenous Indication for use: Severe Pain. The medication error was discovered October 7, 2011, by EMP4. The PCA pump was programmed and delivered 30 MG of Morphine from 12:17 PM until 2:25 PM to MR1 instead of the 6 MG intended. There was no documentation in MR1 of the medication error.

2) Review of the facility document "Medication Errors" revealed that on March 23, 2010, the patient in MR2 was ordered a 1 MG bolus of Morphine. The pump was set up to deliver milliliters not milligrams. MR2 was administered a 5 MG bolus of Morphine. There was no documentation in MR2 that the physician was notified that a 5 MG bolus of Morphine was administered. The error was discovered at the change of shift PCA pump check.

3) Review of the facility document "Medication Errors" revealed that on March 11, 2010, the patient in MR3 was ordered Dilaudid 0.1 MG bolus via Patient Controlled Analgesia (PCA) pump. The patient received a Dilaudid 1 MG bolus. The PCA pump was programmed incorrectly by the nurse. The PCA pump was programmed to deliver 1 MG / ML. This error was not detected on the initial set-up of the pump or at the change of shift check. The error was discovered when the patient's physical status changed. The patient received Narcan and oxygen as a result of change in physical status. Continued review of MR11 revealed no documentation the physician was notified that the patient received Dilaudid 1 MG. The only documentation in the medical record was that the patient had a change in physical status.

4) Review of the facility document "Medication Errors" revealed the following Pharmacy Profile error. On December 5, 2010, the patient in MR11 was ordered Lipitor 60 mg twice per day by the physician. Per the Pharmacy Profile error, Lipitor was to be ordered once per day. Review of MR11 revealed the patient received the medication twice daily. There was no documentation in MR11 that the physician was notified that the medication was ordered incorrectly.

5) Review of the facility document "Medication Errors" revealed that on August 31, 2011, the patient in MR13 was ordered Dilaudid orally. The Dilaudid was administered as IV [intravenously]. Review of MR13 revealed no documentation the physician was notified that the patient received the medication IV instead of orally as ordered by the physician.

6) Review of facility document "Medication Errors" revealed that on September 20, 2011, the patient in MR14 was ordered a stat [immediate] dose of Axitra. The medication was not administered. Review of MR14 revealed no documentation the physician was notified that the patient did not receive the stat dose of Axitra.

7) Interview with EMP6 on November 18, 2011, at approximately 2:45 PM confirmed there was no documentation in MR1, MR2, MR3, MR11, MR13, MR14 that the physicians were notified of the medication errors.