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Based on review of facility documents, medical records (MR), and interview with staff (EMP), it was determined the facility failed to ensure drugs administered intravenously via infusion pumps were provided as prescribed by the physician for two of 77 medical records reviewed (MR64 and MR67).

Findings include:

Review on February 28, 2012, of the facility policy "IV [Intravenous] Therapy Policy [D-16]," last reviewed May 2011, revealed "... III Policy and General Instructions: A. IV therapy is initiated upon the physician's order (or order of a prescriber authorized by the Pennsylvania Nurse Practice Act). The order must state volume and type of fluid, dose of additives, and the rate of infusion. ... F. The following IV medication drips need dosage calculations completed and documented by two professional staff (RN, GN, pharmacist, physician). Chemotherapy, Insulin / Heparin drips, Cardiac drips (weight-based) Narcotic drips, Neuromuscular blocking agents. This verification is accomplished through independent double-checks and requires that: 1. Both professional staff independently review the original physician order. 2. Both professional staff performs independent calculation of the drug concentration / dose and IV rate of infusion. The calculations may be performed by either the handwritten or computer method. 3. Both professional staff compares calculation checks to verify that they are identical. 4. The professional staff will perform a double check of the drug calculation. [1] when the IV medication drip is initially administered [2] when there is a change in concentration. 5. The professional staff will document their double check in the computer or on the paper medication record. 6. On an ongoing basis, the RN (Registered Nurse/ GN (Graduate Nurse) caring for the patient will validate the accuracy of the current IV and rate against the physician order: a. at the beginning of each shift b. whenever the patient transfers to a different level of care. ... O. Use of IV Pumps: ...b. Dose mode is used for all medicated drips in drug library."

1) Review on February 29, 2012, of MR64 revealed a physician order for heparin (an anticoagulation medication) 500 units/hour (5 ml (milliliters) /hour). At the change of shifts, it was noted the heparin was infusing at 5000 units/hr (50 ml/hr). Laboratory testing revealed the patient's partial thromboplastin time (PTT- a blood test that looks at how long it takes for blood to clot) was elevated. The patient required the administration of protamine sulfate (a drug that reverses the anticoagulant effects of heparin).

Review on February 29, 2012, of the facility's investigation revealed the following for MR64: When the nurse tried to access the drug library on the large volume pump to administer the heparin, the drug library would not function. The nurse continued to use this same pump without use of the drug library. The nurse manually programmed the pump to deliver heparin 5000 units/hr (50 ml/hr).

Interview on February 29, 2012, with EMP3 at 10:15 AM confirmed the findings noted above were documented in MR64. EMP3 confirmed that when the nurse tried to access the drug library on the large volume pump, it would not function; the nurse continued to use this same pump without use of the drug library; the nurse manually programmed the pump to deliver heparin 5000 units/hr (50 ml/hr). EMP3 confirmed the physicians order was not followed, and MR64 was administered ten times the amount of heparin as prescribed by the physician. EMP3 confirmed the nurse did not follow the hospital procedure and obtain another pump that was functioning properly; and that Biomed confirmed the pump malfunctioned.

Interview with EMP7 on February 27, 2012, at approximately 11:30 AM, confirmed "when the drug library fell off, the nurse should have got a new pump."

Interview with EMP8 on February 27, 2012, at approximately 11:30 AM confirmed that EMP9 should have got a new pump when EMP9 realized the drug library was not accessible.

2) Review on February 29, 2012, of MR67 revealed on February 7, 2012, the patient was orally intubated following a surgical procedure. The patient was placed on a ventilator in the PACU (Post Anesthesia Care Unit). MR67 was receiving Propofol via IV push. The patient was removed from the ventilator and the intubation tube was removed. While still in PACU, MR67 required reintubation. The patient was then transferred to the Surgical Intensive Care Unit. The nurse taking care of MR67 started the IV infusion of Propofol because the patient became agitated and started reaching for the oral intubation tube. The Propofol via large volume pump was started at 22:00 on February 7, 2012. On February 7, 2012, at 22:20, the nurse documented MR67 was sedated and BP (blood pressure) dropped into the 50's. The Propofol was turned off. The patient required the administration of phenylephrine (medication used to treat a low blood pressure). At this time, the concentration error was discovered by a registered nurse in the Surgical Intensive Care Unit (EMP10).

Review of the facility's investigation revealed the IV Propofol was prepared in the PACU by nursing. MR67 received Propofol via IV bolus by the anesthesiology staff. The nurse manually changed the pre-programmed drug library concentration. The patient was ordered to receive 68 mg/hr. Due to the incorrect concentration set by the nurse, the patient received 680 mg/hr.

Interview on February 29, 2012, with EMP3 at 10:30 AM confirmed the findings noted above were documented in MR67. EMP3 confirmed the IV Propofol was prepared in the PACU by nursing; MR67 received Propofol via IV bolus by the anesthesiology staff; the nurse had manually changed the pre-programmed drug library concentration; the patient was ordered 68 mg/hr and received 680 mg/hr.

The hospital previously provided a Plan of Correction to event ID 7SPK11 for the administration of intravenous medication in patient controlled anesthesia (PCA) pumps with a completion date of January 27, 2012, as follows:

"1. Reeducation of nurses by their clinical manager included a clarification of the definition of an independent double check of the medication rate, expanded the elements that required double checks as well as the personnel that were qualified to participate in the double check process. The process of validation of medication rate was limited to the physician order sheet. This education was concluded on 10/31/11. Physician and pharmacy order sheets and electronic documentation was enhanced by the Network Director of Pharmacy and approved through the Network Forms Committee and Pharmacy and Therapeutics Committee. Audits of PCA documentation to include vital signs, independent double check documentation, and other patient status data were implemented on 10/19/11 and is ongoing.

2. The Chief Nursing Officer sent an electronic communication was sent to all patient care managers, and administrative leaders, and key medical staff regarding policy revisions On November 18, 2011 the Pennsylvania Patient Safety Authority was consulted and per their consultation (as an interim measure) medication ratios were standardized to a 1:1 ratio for analgesia medications. Medication syringes were color coded to differentiate between analgesia medications.

3. Immediate action was taken to revise education and implement the new PCA infusion pumps. Revisions to the Nursing policy, " Adult Patient Controlled Intravenous Analgesia (PCA pump) " were completed by 12/7/11. The drug library was customized by the vendor, nursing and pharmacy departments by 11/27/11. PCA pump alarm parameters and drug library was loaded into new PCA pumps by the Biomedical department on 11/28/11.
Staff education was planned in phases and started on 11/29/11:
Phase I: Classroom RN education on new PCA devices involved hands on classroom experience with pump programming and use.
Phase II: An online tutorial with hands on practice with devices, or attendance at classroom sessions was implemented 12/6/11.
Education included reading and understanding policy and a new PCA tip sheet. Education required completing the requirements and 100% accuracy on the post test. RN ' s are required to complete education by 12/31/11 or prior to caring for a patient with a PCA pump whichever occurs first. Individual employee counseling will occur and be documented for issues of non-compliance. Education for both phases was provided by a combination of vendor representatives and Director, Education Services/designated education specialists.
A Patient Controlled Analgesia competency will be completed by 100% of RN staff by 6/1/12 as a follow up to education to ensure accurate PCA pump programming.
New PCA pumps were implemented on 12/7/11. Implemented 24/7 educational resource for
Nursing staff 12/7-12/23/11. After 12/23, rounding by charge nurse/clinical coordinator/education specialist or supervisor on all PCA pumps will occur to review/confirm pump settings on all shifts. Nursing leaders (patient care manager, charge nurse, educator, hospital supervisor) are assigned to be the third concurrent validator for all PCA programming changes.

4. PCA use audits were implemented on 10/19/11 and updated on 12/5/11 to include a 100% review of every PCA event on a daily basis. Audits include vital sign monitoring and documentation, registered nurse assessment and reassessments, independent double checks of medication dosage at required policy intervals, and documentation of independent double checks. The manager/designee is responsible for the completion of the daily audits on every shift. Monthly employee counseling will occur and be documented. A monthly report will be summarized by the manager on PCA compliance percentages and counseling events to their Director or Vice President who is responsible for this element of the plan of correction. A cumulative performance review of the clinical data audits will be completed monthly at the Network Nursing Executive Committee of which the Chief Nursing Officer is a member. The Vice Presidents of Patient Care Services/Operations are responsible for this element of the plan of correction.

5. The Board of Trustees will be made aware of compliance with the Plan of Correction through the reports of the Patient Safety Committee and Quality and Medical Education subcommittee of the Board. The Chief Quality Officer and Chief Nursing Officer are responsible for this element of the plan of correction.

6. The President, St. Luke ' s Allentown Campus and Chief Operating Officer, St. Luke ' s Bethlehem Campus are responsible for the overall plan of correction."

This is a continuing deficiency, see event ID 7SPK12

Based on review of facility documents, observation, and interview with staff (EMP), it was determined the facility failed to maintain the laboratory environment in a manner that assured the safety and well-being of patients.

Findings include:

Review on February 29, 2012, of the "Lab and Pharmacy Schedule" revealed "Lab Everyday ... Dry mop and wet mop the following areas: lab floor ..."

Observation tour of the Laboratory on February 29, 2012, at approximately 1:30 PM, revealed the following:

1. The big refrigerator, across from the automated chemistry area, had a buildup of dust, dirt and debris on the top of it.

2. There were numerous clumps of dust under the table next to the small refrigerator located across from the automated chemistry area.

3. There was a buildup of clumps of dust under the ice machine, behind the printer, and on the table where the printer was located.

4. There was dirt, dust, and debris behind the Chemistry Analyzer machine.

5. There was a 2' x 8' section, immediately outside of the supervisor's office of dirt, dust, and debris on the floor with clumps of dust.

6. There was a darkened buildup of dirt, dust, and debris between the two refrigerators in the anatomic pathology area.

Interview with EMP6 on February 27, 2012, at approximately 1:30 confirmed the big refrigerator, across from the automated chemistry area, had a buildup of dust, dirt and debris on the top of it; there were numerous clumps of dust under the table next to the small refrigerator located across from the automated chemistry area; there was a buildup of clumps of dust under the ice machine, behind the printer, and on the table where the printer was located; there was dirt, dust, and debris behind the Chemistry Analyzer machine; there was a 2' x 8' section, immediately outside of the supervisor's office of dirt, dust, and debris on the floor with clumps of dust; and there was dirt, dust, and debris between the two refrigerators in the anatomic pathology area.

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21280

Based on review of facility documents, observation of the Pediatrics Unit, and interview with staff (EMP), it was determined the facility failed to ensure that identification badges were not shared between employees.

Findings include:

Review on February 28, 2012, of the facility document "Photograph Identification Badge," reviewed April 2011, revealed "... 14. Employees are not to allow other employees or non-employees to use their Photo ID [identification] Badge for any reason."

Observation on February 27, 2012, of the Pediatrics Unit at approximately 11:30 AM revealed EMP4 requested and used EMP5's identification badge to exit and reenter the secured unit.

Interview on February 27, 2012, at 11:35 AM with EMP3 confirmed EMP4 obtained and used another employee's identification badge to exit and reenter the secured Pediatrics Unit.

Based on review of facility documents, observation, and staff interview (EMP), it was determined the facility failed to implement the infection control policy for pet visitation.

Findings include:

Review of the facility's administrative policy and procedure revealed "Pet Visitation (#30)," revised January 2010, "I. Purpose: to provide direction to employees when patients request a visit from their pet. 1. Approval must be obtained from the patient's attending physician for pet visitation only. 2. Nursing must review this policy with the patient or handler prior to the pet visitation. ... 12. The visit is limited to the patient's room ..."

Observation of the Priscilla Payne Hurd Pavillion floor 8 on February 27, 2012 at 2:15 PM revealed a patient, visitor and a small white dog on a leash walking in the hallway.

Interview with EMP6 on February 27, 2012, at 2:20 PM revealed visitor did not have physician approval to bring the dog to visit the patient. Further interview confirmed the nursing staff did not review the pet policy with the visitor prior to bringing the pet to visit. EMP6 stated "We could have done a better job."