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801 BRAXTON PLACE

MADISON, WI null

PATIENT SAFETY

Tag No.: A0286

Based on staff interview, P & P, Incident Report log, incident report, and QAPI (Quality Assurance Process Improvement) meeting minutes the facility failed to develop goals, track, analyze, and implement action plan in adverse medication reactions and medication errors to prevent events from reoccurring in 8 out of 10 incidents reviewed (Pt #1,2,3,4,5,6,7,8). This could potentially effect all patients receiving treatment at this facility.

Findings include:

Review on 2/12/14 beginning at 3:00 PM of P & P titled, "Risk Management Incident Reporting", last revised 10/1/10, states the following:
-The Director of Clinical Services and/or Director of Pharmacy reviews the incident report and investigates the incident, finding and actions taken are then discussed with the Director of Quality Management within 72 hours of the incident.
-Director of Quality categorizes and trends reported incidents and then records information on appropriate logs and reports to Safety/QAPI/OIC committees.

Review on 2/12/14 beginning at 3:00 PM of P & P titled, "Adverse Drug Events" last revised 1/2013, states the following:
-It is the goal of the Adverse Drug Event (ADE) Reporting program to identify, analyze, trend, and reduce the number of adverse events to medications that occur.
-All ADE's must be brought to the immediate attention of the attending physician and documented in the medical record.
-Each ADE is investigated to assess whether the noted patient reaction was actually due to a drug.
-A summary report is presented to the Pharmacy and Therapeutics (P & T) Committee for review and the ADE's are analyzed to determine whether trends or patterns exist. The committee will then determine whether action maybe taken to reduce the incidence of events.

Review on 2/12/14 beginning at 3:00 PM of P & P titled, "Medication Errors" last revised 1/2012, states the following:
-The completed incident report from is forwarded to the Quality Manager, the reports are reviewed, trended, and then reported to the P & T committee.
-A summary report will be presented to the P & T committee and the medication errors are analyzed to determine whether trends or patterns exist.

Review on 2/12/14 beginning at 11:50 am of Pt #1's MR revealed Pt #1 was admitted to the hospital on 11/5/13 at 5:32 PM with a history of Chronic Obstructive Pulmonary Disease, Pneumonia, and a small bowel obstruction; Pt #1 is oxygen dependent. Review of Pt #1's allergy list as of 11/25/13 shows Potassium and Aspirin cause gastrointestinal (GI) discomfort with use. Date of Aspirin side effect noted is 7/12/2008, date of Potassium side effect noted is 3/3/2009. Per review of Pt #1's MR, Pt #1 was admitted to an acute care hospital on 9/20/13 for a small bowel obstruction and was an inpatient there until being transferred to current facility on 11/5/2013. Pt #1 was administered Potassium and Aspirin throughout from 9/20/13 to 11/5/13 with no issues identified in the MR.
Per Pt #1's admission Medication Reconciliation Report signed by physician on 11/5/13, Pharmacist note states, "Aspirin intolerance listed in medical record as GI discomfort, patient is currently receiving Aspirin 325 mg daily, will use enteric coated tablet to minimize discomfort", "Potassium Chloride is listed as an intolerance in the medical record with diarrhea or GI intolerance, patient has been receiving and tolerating Potassium Chloride, we will use the ERT formulation to minimize discomfort."

Per review of Pt #1's incident report dated 11/7/13 at 2:30 PM, RN A documented a potential Adverse Drug Reaction and medication error occurring on 11/6/14 beginning at 10:00 am. Per RN A documentation, Potassium and Aspirin were on Pt #1's allergy list, RN notified Pharmacist and Physician. Physician reviewed allergy list and determined medication was ok to give. RN A administered the medication and then 20 to 30 minutes later Pt #1 complained of shortness of breath and chest pain. Per RN A, Pt #1's oxygen saturation dropped below 85 % on 3 liters of Oxygen, Respiratory Therapist (RT), Physician, and Pharmacist informed and Rapid Response initiated. Per RN A's incident report documentation, Labs drawn, EKG done, non-rebreather oxygen mask placed by RT, and Pt #1 was given Benadryl, Loratidine, and Famatodine. Pt #1 began to stabilize after approximately 1 hour.

Per Pt #1's physician order dated 11/6/13 at 11:30 am, physician ordered the following; Stat EKG, Hold ABG (arterial blood gases) until baseline respiratory status, Hold Aspirin and Potassium, Albuterol nebulizer now. Aspirin and Potassium were not restarted on Pt #1 until 11/13/13 at 11:30 am.

Per interview on 2/12/14 beginning at 9:25 am with QM B, QM B stated Pt #1's incident report submitted by RN A was not added to the incident log due to staff determining the incident was not a medication error or adverse reaction, despite the physician ordering medications for potential allergic reaction and placing Pt #1's Aspirin and Potassium on hold for 7 days after the incident. Per QM B Pt #1's incident was not investigated and no root cause analysis was done to determine if Pt #1's Adverse reaction was related to the medication given or other causes.

Review on 2/12/14 beginning at 3:00 PM of facility Incident Report log related to medication errors revealed the following:
Pt #2:
Per medication error on 11/1/13 at approximately 1:00 PM, RN scanned Lorazepam medication vial and the order on screen said to give 2 mg of IV Lorazepam, RN administered 2 mg of Lorazapam. Pt #2's chart checked later at 6:55 PM showed order written for 0.5 mg Ativan.

Pt #3:
Per medication error on 11/21/13 at approximately 8:00 am, discharged orders were transcribed by pharmacist and printed for prescriber, Metoprolol medication was not included and Prednisone dose was incorrect.

Pt #4:
Per medication error on 11/20/13 at 5:00 PM, orders for admission were entered by technician, Pharmacist went to review and medication did not match all orders. All technician orders were discontinued and Pharmacist entered new orders. Physician later called pharmacist on call and noted that orders were not correct for patient. Later discovered that Pharmacist used wrong patients medication list to enter orders.

Pt #5:
Per medication error on 1/3/14 at 4:00 PM, when reviewing expiring orders RN noticed a medication was suppose to be discontinued on 1/3/14, and the medication was extended to 1/8/14, issue noticed on 1/6/14 and order discontinued.

Pt #6:
Per medication error on 12/19/13 at 5:40 PM, order written at 5:40 PM for pharmacy to dose stat Vancomycin and Zosyn. Order still not in at 8:00 PM.

Pt #7:
Per medication error on 12/2/13 at 6:30 PM, during chart check RN noted medication order to start Warfarin on 12/13/13, however order was entered to start on 12/3/13.

Pt #8:
Per medication error on 1/25/14 at 7:30 PM, order written was for a medication patient did not have an order for, clarification with on call pharmacist and wrote order clarification for Levofloxacin not Levothyroxine.

Per interview with QM B on 2/12/14 beginning at 4:00 PM, QM B was unable to provide evidence of a comprehensive investigation/root cause analysis being done to identify possible causes and system issues to implement preventative actions for the above medication errors identified for Pt #1, 2, 3, 4, 5, 6, 7, 8.

Per review on 2/12/14 beginning at 4:00 PM of QAPI Meeting Notes for 11/11/13 and 12/9/13, the documentation does not show measurable goals, tracking, trending, analyzing and implementing action plans for medication errors and adverse drug reactions in QAPI to ensure staff are recognizing and addressing any process and system issues hospital wide.

Per interview with QM B on 2/12/14 beginning at 4:00 PM, QM B stated Medication Performance Improvement Committee review medication errors and ADE's, however this information is not used in QAPI to develop goals, track, trend, analyze, and implement action plans hospital wide.

CONTENT OF RECORD

Tag No.: A0449

Based on MR review, staff interview, and P & P the facility failed to ensure medical records describe patient condition and response to medication and treatment in 1 of 10 MR's reviewed (Pt #1). This can potentially effect all patients receiving treatment at this facility.

Findings Include:

Per review on 2/12/14 beginning at 3:00 PM of P & P titled, "Change in Patient Condition" last revised 10/2013 states the following:
-A complete head to toe assessment will be performed along with consultation as appropriate among the clinical team.
-A complete set of vitals including accurate temperature.
-The complete assessment should appear on the nursing flow sheet .
-When a Rapid Response Team (RRT) is initiated, utilize the RRT Response Record to document the assessment data, interventions, and physician communication. The white copy is placed in the progress notes, yellow copy goes to Quality Management.

Per review of Pt #1's incident report dated 11/7/13 at 2:30 PM, RN A documented a potential adverse drug reaction and medication error occurring on 11/6/14 beginning at 10:00 am. Per RN A documentation, Potassium and Aspirin were on Pt #1's allergy list, RN notified Pharmacist and Physician. Physician reviewed allergy list and determined medication was ok to give. RN A administered the medication and then approximately 30 minutes later Pt #1 complained of shortness of breath and chest pain. Per RN A, Pt #1's oxygen saturation dropped below 85 % on 3 liters of Oxygen, Respiratory Therapist (RT), Physician, and Pharmacist informed and Rapid Response initiated. Per RN A's incident report documentation, Labs drawn, EKG done, non-rebreather oxygen mask placed by RT, and Pt #1 was given Benadryl, Loratidine, and Famatodine. Pt #1 began to stabilize after approximately 1 hour.
Review of the Pt #1's vital signs on the Clinical Documentation Report dated 11/6/13, reveals no vital signs are documented at the time of the Pt #1's change in condition at approximately 10:30 am until 6:32 PM. Review of Pt #1's 24 Hour Patient Record and Plan of Care dated 11/6/13 shows no documentation of nursing assessments, interventions, and evaluations related to Pt #1's episode of a change in condition, including decreased oxygen saturation level, increased heart rate, shortness of breath, and chest pain.
On 2/12/14 at 2:00 PM, RN D confirmed the lack of vital signs and nursing documentation in Pt#1's MR, RN D was in the room during Pt #1's change of condition and RN D states staff were taking Pt #1's vitals signs every 5 minutes, however this is not documented in Pt #1's MR.

Per interview with QM B on 2/12/13 beginning at 1:30 PM, QM B stated if a Rapid Response is initiated then staff should be filling out the Rapid Response Form. QM B confirmed Pt #1 does not have a Rapid Response Form in Pt #1's medical record.

Per Pt #1's physician order dated 11/6/13 at 11:30 am, physician ordered the following; Stat EKG, Hold ABG (arterial blood gases) until baseline respiratory status, Hold Aspirin and Potassium, Albuterol nebulizer now. Aspirin and Potassium were not restarted on Pt #1 until 11/13/13 at 11:30 am. Per review of Physician Progress notes dated 11/6/13 and 11/7/13 there is no evidence of the physician documenting an assessment and evaluation of Pt #1's change in condition after RN A initiated a rapid response and the physician ordered multiple medical interventions.