HospitalInspections.org

Based on review of Policy, Procedure, clinical record review, hospital grievance/complaint and incident reporting logs (Patient Safety Reporting System), and interview with hospital staff the hospital failed to ensure drugs were administered in accordance with the orders of the practitioner responsible for the patient's care.

Findings include:

Reviewed four (4) clinical records (P1, P2, P3, P4); one of four (P4) revealed an adverse drug event, which resulted in decreased neurological function in R (right) lower extremity and development of hematoma in R hip requiring return to OR (operating room) for evacuation of hematoma.

P4, a 68 year old female, was admitted on 05/17/2010 with primary diagnosis of osteoarthrosis R hip, a total hip replacement R was performed on day of admission. Additional admitting diagnoses include: atrial fibrillation, chronic, paroxysmal; Diabetes Mellitus (type 2); history of cerebrovascular accident(s), on anticoagulation therapy (warfarin); hyperlipidemia; hypertension.

Post-operative Physician orders on 05/17/2010 included: "Enoxaparin Inj Syg 40mg, every 24 hours".

Physician order on 05/18/2010 at 0833 for: "Enoxaparin (Lovenox) Per Protocol".

Pharm.D order on 05/18/2010 at 0851 for: "Enoxaparin Inj Syg 100mg, every 12 hours".

Pharmacist Progress Note, dated 05/18/2010 at 0859 states: " Warfarin, Lovenox, and renal dosing per protocol. 68 yrs old female is on warfarin for DVT(deep vein thrombosis) prophylaxis and artrial fibrillation, also has Lovenox for bridge therapy........INR of 1.3 is subtherapeutic, increase warfarin to 10mg tonite.....Has not received Lovenox 40mg dose yet, Will change to Lovenox 100mg (1mg/kg) SQ (subcutaneous) Q12h this AM for bridge therapy until INR is therapeutic".

Per review of Medication Administration Record (MAR) Enoxaparin (Lovenox) 100mg was administered twice on 05/18/2010, one dose at 0942 and one dose at 2163.

Review of Patient Safety Event ID: WJN3965993 (filed by registered nurse on 05/19/2010 at 1725) documents: "clarification with pharmacy regarding dosage amount ordered multiple times if this is appropriate dosage, pharmacist explain benefits outweigh risk. Two doses of 100mg enoxaparin given then patient had development of hematoma at surgical site. Requiring transfusions and repeat surgery MD notified regarding 100mg enoxaparin dosage which was inputed by pharmacist and two doses given. Per MD this was not the amount intended by the doctor".

Per above documentation, RN discussed medication dosage with pharmacy, not with prescribing physician until after adverse drug reaction.

Met with I3 on 06/30/2010 at 0910, he/she provided verbal clarification of internal investigation and incident log (Patient Safety Reporting System).

Findings were presented to I1, I2, I4, I6, I7, I8, and I9 on 06/30/2010 at 1150.

Based on review of Policy, Procedure, clinical record review and interview with hospital staff, the hospital failed to ensure all medical records contained a document recording the patient's informed consent for procedures.

Findings include:

Reviewed four (4) clinical records (P1, P2, P3, P4) ; one of four (P4) revealed the lack of a patient's informed consent for surgical procedure (total Hip replacement) performed on May 17, 2010. P4 was discharged from in-patient care on May 26, 2010.

Discussed with hospital staff (I2) on June 29, 2010 at 1230. He/she stated that the informed consent may not have been scanned into the electronic health record (EHR) yet. At 1500, I2 reported that he/she was unable to find hardcopy of informed consent. He/she stated that staff in the operating room (OR) verified that an informed consent was with the medical record at the time patient arrived in OR for surgical procedure.

Findings were discussed with hospital staff I1, I2, I4, I6, I7, I8 and I9 during exit conference on June 30, 2010 at 1150.

Based on review of Policy, Procedure, clinical record review, hospital grievance/complaint and incident reporting logs (Patient Safety Reporting System), and interview with hospital staff the hospital failed to ensure Policy/Procedure were followed to minimize adverse drug events related to high risk medications.

Findings include:

Reviewed four (4) clinical records (P1, P2, P3, P4); one of four (P4) revealed an adverse drug event, which resulted in decreased neurological function in R (right) lower extremity and development of hematoma in R hip requiring return to OR (operating room) for evacuation of hematoma.

P4, a 68 year old female, was admitted on 05/17/2010 with primary diagnosis of osteoarthrosis R hip, a total hip replacement R was performed on day of admission. Additional admitting diagnoses include: atrial fibrillation, chronic, paroxysmal; Diabetes Mellitus (type 2); history of cerebrovascular accident(s), on anticoagulation therapy (warfarin); hyperlipidemia; hypertension.

Post-operative Physician orders on 05/17/2010 included: "Enoxaparin Inj Syg 40mg, every 24 hours".

Physician order on 05/18/2010 at 0833 for: "Enoxaparin (Lovenox) Per Protocol".

Pharm.D order on 05/18/2010 at 0851 for: "Enoxaparin Inj Syg 100mg, every 12 hours".

Pharmacist Progress Note, dated 05/18/2010 at 0859 states: " Warfarin, Lovenox, and renal dosing per protocol. 68 yrs old female is on warfarin for DVT(deep vein thrombosis) prophylaxis and artrial fibrillation, also has Lovenox for bridge therapy........INR of 1.3 is subtherapeutic, increase warfarin to 10mg tonite.....Has not received Lovenox 40mg dose yet, Will change to Lovenox 100mg (1mg/kg) SQ (subcutaneous) Q12h this AM for bridge therapy until INR is therapeutic".

Per review of Medication Administration Record (MAR): Enoxaparin (Lovenox) 100mg was administered twice on 05/18/2010, one dose at 0942 and one dose at 2163.

Physician Progress Note dated 05/19/2010 at 0010 states: " RN called with labs, significant drop in hct since am, right hop [sic] more painful and more tense per RN, also lactate 2.0. A/P 1) decreasing hct, with worsening right hip pain
*PARQ held with daughter and patient, transfuse 2 units PRBC
*RN to call to orthopedic surgeon who will evaluate pt in am
*CT right hip to assess for bleed
*hold Lovenox
*d/c warfarin
*guaiac stools
*SCUDS".

Physician Progress Note dated 05/19/2010 at 0235 states: "Called for decreased urine output; here for hip replacement; has atrial fibrillation, rate currently controlled and per RN lungs are clear. Dropped her pressures today and has had dramatic drop in her h and h. Per the RN her leg is swollen but color and pulse is good. Sensation intact and pain controlled with very small dose of morphine. She has had fluid boluses and is awaiting blood transfusion. Now her urine output is down, will bolus with ns (normal saline) now and then give blood transfusion. Follow up on CT. Ortho aware of issues".

P4 returned to OR on 05/19/2010; dictated Operative Report documents: Pre/Post op diagnosis: Hematoma, right hip. Operation: Evacuation of hematoma, irrigation and closure over drain. Indications: 68-year-old woman is 2 days status post right total hip arthroplasty. Postoperatively, she was documented to have normal neurologic function in her right lower extremity. This morning she was discovered to be unable to dorsiflex her foot had diminished dorsal foot sensation as well as having a tight hematoma. Description of Surgery: ......When the previous subcuticular skin closure was opened it was obvious that there was a large hematoma under pressure and about 300 to 400 mL of liquid blood was evacuated immediately. Clot was debrided".

Dictated Physician Discharge summary dated 05/26/2010 at 1139 documents: "Primary Discharge Diagnoses:
1. Post-operative hematoma requiring evacuation
2. OA right hip s/t THA 5/17/10
3. Atrial fibrillation, chronic, paroxysmal
4. Acute renal insufficiency, peak Cr 2.9, resolved
5. Elevated cardiac troponin (3.99), without acute coronary syndrome
Hospital Course:
Post-operatively, the plan was to use DVT prophylaxis dose of Lovenox and immediately resume warfarin (due to PAF and hx of CVA when off warfarin in past). She developed a hematoma with right footdrop so was taken back to the OR for hematoma evacuation on POD#2 (5/19/2010) with full recovery of RLE neurologic function. She was hypotensive and developed acute kidney injury with Cr 2 and Trl 3.99 and CK elevation but no wall motion abnormalities on ECHO and negative MB/RI. She was transfused 3 or 4 units RBCs and 5 units FFP and 1 unit platelets and Hct stabilized at 36%. Metoprolol and cozaar were held while hypotensive but were eventually resumed with good effect. She was in ICU from 5/20 - 5/22.
.......There was no evidence of ongoing bleeding during the remainder of her stay and she had started to make progress with physical therapy. Telemetry showed paroxysmal atrial fibrillation/flutter but no other arrhythmia of note".

P4 was discharge to skilled placement on 05/26/2010.

Reviewed Policy/Procedure: Administrative Manual; Title: Patient Safety Reporting and Just Culture Policy; Issued: 04/03; Purpose: "This hospital encourages patient safety and just culture reporting of health care errors (adverse events and/or close calls) as a means to assess and improve processes and provide a safe environment for patient care. The purpose of reporting errors is to learn about their causes and enhance systems to reduce errors".

Reviewed Patient Safety Reporting System log for incidents reported between March 01, 2010 and May 31, 2010; revealed four incident reports related to the administration of injectable anticoagulants for P4:
*Adverse Drug Reaction, filed by pharmacist on 5/19/201 at 1625, Event ID: VJN3965914;
*Medication Error, filed by registered nurse on 05/19/2010 at 1725, Event ID: WJN3965993;
*Medication Error, filed by [XXX, no discipline documented] on 05/20/1855; Event ID: PEC3968600;
*Adverse Drug Reaction, filed anonymously on 05/21/2010 at 1150; Event ID: ZMU3970078.

Reviewed Policy/Procedure; Department: Inpatient Pharmacy; Title: Injectable Treatment Anticoagulation Protocol (Excluding Unfractionated Heparin); Section: 5.27; Issued: 08/08; which states: "The following is the current approved Kaiser Injectable Treatment Anticoagulants Pharmacy Protocol for the use of injectable anticoagulants (excluding UFH). Deviation from protocol is allowed based on an individual patient basis and after the pharmacist has discussed with the physician. This protocol is intended for adult patients>18 years of age". "The following orders will be initiated upon receiving an order for "Fondaparinux, Enoxaparin, or Dalteparin per Pharmacy Protocol": MD needs to specify preferred anticoagulant and indications".

Reviewed Policy/Procedure; Department: Inpatient Pharmacy; Title: Renal Adjustment Protocol; Section: 5.30; Issued: 10/08; Purpose: To minimize patient related toxicity secondary to medications that require renal dose adjustments. This will compliment measures to improve patient safety by allowing pharmacists to renally adjust medications. Standardized guidelines will minimize interpretation and thus reduce the frequency of dosing errors. Procedure: Initiation of Renal Adjustment Protocol; Staff Responsibilities A. Physician/Licensed Independent Practitioner 1. The physician/practitioner shall initiate the Renal Adjustment Protocol by ordering "Pharmacy to adjust all medications based upon renal functions".

Discussed findings with I2 on 06/29/2010 at 1300. He/she stated an internal investigation had been done; he/she would provide additional documentation related to internal investigation.

Further discussion with I2 on 06/30/2010 at 0810, he/she stated I5 had reviewed investigation documents, had not documented his/her findings, but wanted to meet to verbally present his/her findings. Met with I5 on 06/30/2010 at 0820.

Discussed with I3 at 0910, he/she provided verbal verbal clarification of internal investigation documentation.

Findings were presented to I1, I2, I4, I6, I7, I8, and I9 on 06/30/2010 at 1150.