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Based on interview and record review, the facility failed to implement standards of practice of monitoring for one of one patients (Patient 29) who was administered intravenous (IV - administered through a patient's vein) vancomycin (an antibiotic medication which requires close monitoring to achieve desired therapeutic effects while protecting from adverse health consequences such as drug toxicity) to prevent decline in Patient 29's kidney function when the patient transferred from inpatient (hospital level of care) to swing-bed (skilled nursing level of care). This occurred when the IV vancomycin medication order was continued after transfer without clarification of which health care professional (pharmacy or physician) was monitoring the patient's vancomycin regimen. Patient 29, who had a recent history of acute (condition of patient requires hospitalization) kidney injury was administered IV vancomycin without monitoring the patient's serum creatinine (lab result to assess renal function) for 9 days and without monitoring the patient's vancomycin levels (concentration of drug in the body) for 15 days. This failure resulted in serious disability and harm, including kidney impairment, transfer to a higher level of care to another facility, a procedure to place a catheter [tube inserted into the body] for hemodialysis [process to mimic normal kidney function to filter blood, chemicals, waste, and fluid], and plan for hemodialysis which the patient could not tolerate when started. (Refer to C-0297)

The cumulative effect of these systemic problems resulted in the inability of the hospital's Provision of Services in such a manner to ensure the patient's needs were met in accordance with acceptable standards of practice.

Based on interview and record review, the facility failed to implement standards of practice of monitoring for one of one patients (Patient 29) who was administered intravenous (IV - administered through a patient's vein) vancomycin (an antibiotic medication which requires close monitoring to achieve desired therapeutic effects while protecting from adverse health consequences such as drug toxicity) to prevent decline in Patient 29's kidney function when the patient transferred from inpatient (hospital level of care) to swing-bed (skilled nursing level of care). This occurred when the IV vancomycin medication order was continued after transfer without clarification of which health care professional (pharmacy or physician) was monitoring the patient's vancomycin regimen. Patient 29, who had a recent history of acute (condition of patient requires hospitalization) kidney injury was administered IV vancomycin without monitoring the patient's serum creatinine (lab result to assess renal function) for 9 days and without monitoring the patient's vancomycin levels (concentration of drug in the body) for 15 days. This failure resulted in serious disability and harm, including kidney impairment, transfer to a higher level of care to another facility, a procedure to place a catheter [tube inserted into the body] for hemodialysis [process to mimic normal kidney function to filter blood, chemicals, waste, and fluid], and plan for hemodialysis which the patient could not tolerate when started.

Findings:

Review of Patient 29's "History and Physical [initial clinical evaluation of the patient]" for "Admit Date 2/21/16" was completed by Physician 1 and was electronically signed on 2/24/16. The "Past Medical History" indicated "10. History of urinary [urine] retention [holding]." The section titled "Impression and Plan" indicated "2. Acute on chronic renal [kidney] failure, resolved."

Review of Patient 29's "Note Date: 2/23/16" was completed by Physician 1, and was electronically signed on 2/23/16. The section titled "Assessment/Plan" indicated "5. Acute kidney injury. A [Assessment] - On admission Cr [creatinine] 1.4 [reference range is 0.6 to 1.3 milligram (mg) per deciliter (dl)]. Improved with diuresis [increased urine production]."

Review of Patient 29's "History and Physical" for "Admit Date: 2/28/2016" was completed by Physician 2 and was electronically signed on 3/1/16. The "Chief Complaint [initial reason for seeking medical care]" was listed as "skilled nursing admission for IV antibiotics." The "History of Present Illness" indicated, "This 80 year old white female was admitted to acute care at [name of facility] on 2/21/16. She presented with to the emergency department with altered mental status [changes with brain function]. She was found in the emergency department to have left lower lobe pneumonia [lung infection] and hypokalemia [low potassium levels] with a potassium of 1.7 [normal range is 3.5 to 5.2 millimoles (mmol) per liter (L)] and with a hemoglobin [part of blood that carries oxygen to body] of 7.3 [normal range for females is 12 to 15 grams (g) per deciliter (dL)]. She has had recent significant bleeding from varicose veins [enlarged blue blood vessels visible through the skin] in her legs requiring blood transfusion [transfer of blood from one person to another] and has had stasis ulcers [wounds] on her legs due to edema [accumulated fluid], due to her diastolic heart failure [heart pumped out to the body is less than normal]. She was treated in the hospital and was found to have pneumonia which improved. She also was found to be bacteremic [bacteria in the blood] with Bacteroides [a type of bacteria] and it has been recommended that she have six weeks of IV antibiotics. Therefore, she is being transferred to the skilled nursing for this treatment." Patient 29' "Home Medications" included "She is also on vancomycin dosing per pharmacy." The section titled "Assessment and Plan" indicated "Acute kidney injury. This has improved". The section titled "Plan" indicated, "We will admit the patient to Swing Bed for six weeks of IV vancomycin therapy with the dosing per pharmacy ...I anticipate that she will be in the Swing Bed or Skilled Nursing for her six weeks of IV antibiotics."

Review of Patient 29's "Discharge Summary" for "Discharge Date: 3/17/16" was completed by Physician 2 and was electronically signed on 3/24/16. The "Admitting Diagnoses" indicated "Acute kidney injury which had improved." The "Discharge Diagnoses" indicated "Acute renal failure likely due cardiorenal [heart and kidney disorder] failure with possible vancomycin toxicity." The section titled "Hospital Course" indicated "The patient was admitted to the skilled nursing after an episode of acute renal failure and pneumonia ...The vancomycin was started during her acute hospitalization and was monitored by pharmacy ...Her kidney function which had been improving started to worsen again, and she was found to be retaining fluid ...Her kidney function continued to worsen ...Because of her worsening failure that was not responding to either diuretics [treatment to improve diuresis] or IV fluids, it was decided to transfer her to [name of local affiliated hospital] for a nephrology [branch of medicine that deals with kidney disease] consult and possible diuresis to treat her vancomycin levels, her oliguria [production of small amounts of urine], and her kidney failure."

Review of Patient 29's "Medicine Admission Note" was completed by Physician 8 and electronically signed on 3/17/16. The section titled "Assessment" indicated "AKI [acute kidney injury] with oliguria most likely secondary [resulting from] to cardiorenal syndrome and vancomycin nephrotoxicity [toxicity in the kidneys]."

Review of Patient 29's "History and Physical - Admitted: 3/17/16" was completed by Physician 8 and was electronically signed 3/18/16. The "Chief Complaint" was listed as "worsening renal failure and oliguria." The "History of Present Illness" indicated "creatinine level has been gradually increasing ...she was transferred to [name of local affiliated hospital] for further evaluation and treatment and possible dialysis." The section titled "Assessment" indicated "acute kidney injury with oliguria most likely secondary to cardiorenal syndrome and vancomycin nephrotoxicity."

Review of Patient 29's "Note Date: 3/18/16" was completed by Physician 3 and electronically signed 3/18/16. The section titled "Assessment/Plan" indicated "1. AKI (acute kidney injury) A [Assessment]: WORSE - has baseline CKD [chronic kidney disease] III [moderate kidney damage] - likely secondary to vancomycin toxicity and cardiorenal syndrome - has not responded to Lasix [a diuretic medication] gtt [medical abbreviation for drip] and oliguric at this point with continued anasarca [generalized body swelling] ...P [Plan]: I have consulted [name of Physician 4] from Nephrology."

Review of Patient 29's "Consultation Report - Date of Consultation: 3/18/16" was completed by Physician 4 and was electronically signed on 3/19/16. The section titled "Assessment/Plan" indicated "acute renal failure in this patient with anasarca. Suspect that patient has a vancomycin toxicity in the setting of a probable [likely to be the case] cardiorenal syndrome. Patient remains oliguric despite aggressive diuretic therapy. Although patient is satting [refers to normal blood oxygen levels] fairly well and the electrolytes are stable, likely we will need to initiate dialysis for volume control. I will contact [name of Physician 6] for vascular [blood vessels] access and proceed with dialysis. Likely patient will need daily dialysis until volume status is optimized and renal function is recovered."

Review of Patient 29's "Consultation Report - Date of Consultation: 3/18/16" was completed and electronically signed by Physicians 6 and 7 on 3/19/16. The section titled "Assessment/Plan" indicated "1. Acute renal failure with anasarca and oliguria ...The patient's acute renal failure is considered likely secondary to the vancomycin, with possible additional cardiorenal etiology [cause] contributing. Nephrology has been consulted and the patient will likely require hemodialysis."

Review of Patient 29's "Operation" was completed by Physician 6 and electronically signed on 3/19/16. The "Pre-Operative Diagnosis" was listed as "AKI (acute kidney injury)" and "Procedure Performed ...5. RIJ [right internal jugular vein] temporary hemodialysis catheter placement."

Review of Patient 29's "Note Date: 3/19/16" was Physician 7 dictating for Physician 6 who electronically signed the note on 3/19/16. The section titled "Assessment/Plan" indicated "A [Assessment]: AKI (acute kidney injury) ...patient requires HD [hemodialysis] access ...will place temporary rather than tunneled HD catheter...P [Plan]: temporary hemodialysis catheter placement to right IJ this AM [morning] in cath [catheterization] lab ...okay to use for dialysis."

Review of Patient 29's "Note: 3/19/16" was completed by Physician 4 and was electronically signed on 3/19/16. The section titled "Assessment/Plan" indicated "AKI (acute kidney injury). A [Assessment]: Due to Vanco toxicity in the setting of probable cardiorenal syndrome. BUN [blood urea nitrogen - test to measure kidney function by measuring waste products] and Cr [creatinine] stable from yesterday but remains oliguric despite IV Lasix. P [Plan]: Will start HD as previously discussed."

Review of Patient 29's "Note Date: 3/19/16" was completed by Physician 3 and electronically signed on 3/19/16. The "Assessment/Plan" indicated "AKI (acute kidney injury). A[Assessment]: WORSE - has baseline CKD III - likely secondary vancomycin toxicity and cardiorenal syndrome - has not responded to lasix gtt and oliguric at this point with continued anasarca - HD catheter Right IJ 3/19 by [name of Physician 6] ...P[Plan]: starting HD today 3/19 - [name of Physician 4] from Nephrology is following."

Review of Patient 29's "Note Date: 3/20/16" was Physician 7 dictating for Physician 6 who electronically signed the note on 3/20/16. The section titled "Assessment/Plan" indicated "1. AKI (acute kidney injury). A [Assessment]: s/p [status post - condition after] R IJ temporary HD catheter placement on 3/19/16 ...P [Plan]: ok to use for dialysis."

Review of Patient 29's "Note Date: 3/20/16" was completed by Physician 3 and electronically signed on 3/20/16. The "Assessment/Plan" indicated "1. AKI (acute kidney injury). A[Assessment]: WORSE - REQUIRES HD ...has baseline CKD III - likely secondary to vancomycin toxicity and cardiorenal syndrome - has not responded to Lasix gtt and oliguric at this point with continued anasarca - HD catheter Right IJ 3/19 by [name of Physician 6] - started HD night of 3/19 but it was stopped after 23 minutes given symptomatic bradycardia [low heart rate] and hypotension [low blood pressure]. P [Plan]: will attempt HD again today - if patient cannot tolerate HD then may consider hospice ...[name of Physician 4] from Nephrology following ...13. P [Plan] - patient is very scared to die ..."

Review of Patient 29's "Notation - Hospital Day 3" was completed by Physician 3 and electronically signed on 3/20/16. The "Notation" indicated "Comfort care as prognosis is dismal ...I [Physician 3] do believe patient is actively dying at this point."

Review of Patient 29's "Notation - Hospital Day 4" was completed by Physician 5 and electronically signed on 3/21/16. The "Notation" indicated "Called by RN [Registered Nurse] that patient died at 9:10 AM."

A review of the [name of local affiliated hospital]'s "Release of Body" form dated 3/21/16 at 9:10 a.m. indicated "Diagnosis: Vanco [vancomycin] toxicity."

Review of Patient 29's "Discharge Summary" was completed by Physician 3 and was electronically signed on 4/17/16. The "Causes of Death" were listed "1. Cardiovascular collapse; 2. Multisystem organ failure; 3. Acute on chronic kidney disease, presumed cardiorenal syndrome; 4. Systolic congestive heart failure, chronic; 5. Pulmonary hypertension, chronic." The section titled "Brief Hospital Summary" indicated, "This 80-year old female was transferred from [name of facility] on 3/17/16 secondary to worsening renal failure and oliguria. She was seen in consultation by [name of Physician 4] and we were to pursue dialysis. Unfortunately, patient had episodes of bradycardia and hypotension, though at times spontaneously resolve. Unfortunately, she could not tolerate dialysis. Ultimately, she was transitioned to comfort care and patient passed away the morning of March 21st."

Review of the package insert (approved document on the safe use of the medication) obtained from the facility for vancomycin dated 8/14, indicated "ADVERSE REACTIONS ...Nephrotoxicity - Renal failure, principally manifested by increased serum creatinine or BUN concentrations... Most of these have occurred in patients who were given aminoglycosides [a type of antibiotic] concomitantly [at the same time] or who had preexisting kidney dysfunction." The section titled "Patients with Impaired Renal Function and Elderly Patients" indicated, "Dosage adjustment must be made in patients with impaired renal function. In the elderly, greater dosage reductions than expected may be necessary because of decreased renal function. Measurement of the vancomycin serum concentrations can be helpful in optimizing therapy, especially in seriously ill patients with changing renal function."

Review of the "Therapeutic Monitoring of Vancomycin in Adult Patients: A Consensus of the American Society of Health-System Pharmacists, the Infectious Disease Society of America, and the Society of Infectious Diseases Pharmacists" dated 2009, in the section titled "Vancomycin Toxicity" indicated on page 602, "A patient should be identified as having experienced vancomycin-induced nephrotoxicity if multiple (at least two or three consecutive) high serum creatinine concentrations (increase of 0.5 milligram (mg) per deciliter (dL) or >= 50% increase from baseline, whichever is greater) are documented after several days of vancomycin therapy in the absence of an alternative explanation." On page 596, it indicated, "Monitoring is also recommended for patients with unstable (i.e., deteriorating or significantly improving) renal function and those receiving prolonged courses of therapy (more than three to five days) ...Once-weekly monitoring is recommended for hemodynamically [stable blood flow and circulation] stable patients. More frequent or daily trough [lowest concentration of medication in the blood] monitoring is advisable in patients who are hemodynamically unstable."

Review of the "ASHP [American Society of Health-System Pharmacy] Guidelines: Minimum Standard for Pharmacies in Hospital" dated 2013, on page 523 in the section titled "Continuity of Care" indicated "Pharmacists should assume responsibility for continuity of care patients' medication therapy. Pharmacists and pharmacy departments should take a leadership role in developing and implementing policies and procedures for admissions, discharges, and transfers sot that patients' medication therapy is well managed regardless of patient transitions across care settings ..."

The facility policy and procedure titled, "Pharmacokinetic (evaluation of how the specified medication(s) is absorbed, distributed, metabolized, and excreted in the patient's body) Monitoring" dated 5/6/13, indicated "POLICY ...The Pharmacy will assist in the determination of a proper dosing regimen with the final decision being that of the physician."

During an interview on 1/31/17 at 2:35 p.m. with the Clinical Informatics Manager (ADM 7) and Vice President Quality (ADM 27), ADM 7 stated "the error primarily was when physician wrote order but not for pharmacy to dose and check level from 2/28 to 3/11/16." ADM 7 and ADM 27 acknowledged that there were no labs for Patient 29 between 3/2 to 3/9/16.

During electronic clinical record review and concurrent interview on 3/6/17 at 8:15 a.m. with the Director of Pharmacy (DOP), the facility's Pharmacist-In-Charge (PIC), and the Medication Safety Coordinator (MSC), Patient 29's vancomycin regimen was reviewed. The clinical record indicated the patient was admitted to inpatient status on 2/21/16. For the inpatient admission, the clinical record indicated on 2/23/16 at 2:54 p.m., Physician 1 ordered IV vancomycin "pharmacy to dose." The clinical record indicated the patient was discharged from inpatient status and was admitted to swing-bed care on 2/28/16. For the swing-bed admission, the clinical record indicated on 2/28/16 at 9:30 a.m., Physician 1 ordered IV vancomycin 1 gram every 24 hours until 4/7/16. The clinical record indicated the patient was discharged from swing-bed care on 3/17/16 and transferred to a local affiliated hospital for a higher level of care. The electronic clinical record indicated the following measured serum creatinine while the patient was in swing-bed care: 3/1/16 = 0.8 mg/dl; 3/10/16 = 1.5 mg/dl; 3/12/16 = 1.7; 3/13/16 at 5:30 a.m. = 1.8 mg/dl; 3/13/16 at 12:30 p.m. = 1.9 mg/dl; 3/14/16 = 1.8 mg/dl; 3/15/16 = 1.9 mg/dl; 3/16/16 = 2 mg/dl; and 3/17/16 = 2.1 mg/dl. While the patient was in swing-bed care, the time period calculated between first (3/1/16) and second (3/10/16) measured serum creatinine was 9 days. The electronic clinical record indicated the followed measured vancomycin trough levels (target reference range is 10 - 20 mg/liter (L)) while the patient was in the facility: 2/26/16 = 14 mg/L; 3/12/16 = 41 mg/L; 3/13/16 = 43 mg/L; and 3/17/16 = 32 mg/L. The time period calculated between the first (2/26/16) and second (3/12/16) measured vancomycin troughs was 15 days. When the PIC was asked how the patient's renal function was evaluated while on vancomycin regimen, the PIC stated "through the serum creatinine." The PIC acknowledged there was no serum creatinine measured from 3/2/16 to 3/9/16. When asked about the time period between 2/26/16 to 3/12/16 measured vancomycin troughs, the PIC stated "14 - 15 days." The PIC stated there was no "pharmacy to dose" vancomycin order when the patient transferred to swing-bed care. She acknowledged the 2/28/16 vancomycin order from Physician 1 when the patient transferred from inpatient to swing-bed care, it was not clear if it was Pharmacy or the Physician following the vancomycin regimen. When asked "what are risk factors for vancomycin toxicity?", the PIC stated "renal function problems." She acknowledged the "PK [Pharmacokinetic] Monitoring Sheet [facility document to evaluate Patient 29's vancomycin dosing, frequency, renal function, and vancomycin levels]" was being filled out by Pharmacist 2 and the PIC while the patient was under the facility's care. She acknowledged that Pharmacist 2 and the PIC could visualize on the "PK Monitoring Sheet" when the last serum creatinine was collected when completing the "PK Monitoring Sheet."

During an interview on 3/6/17, at 11:20 a.m., with the PIC, the PIC was asked "What do you think about continuity of care as described in ASHP Guidelines: Minimum Standard for Pharmacies in Hospital?" the PIC stated "I agree. Pharmacy should be involved in the transitions of care." The PIC stated for patient safety, it should be clarified who is responsible for vancomycin regimen.

During a group interview on 3/6/17 at 1:37 p.m. with Physician 2, she stated she was "under the assumption that Pharmacy was managing" vancomycin regimen when Patient 29 transfered to swing-bed care.

During an interview on 3/6/17, at 3:30 p.m., with the DOP, PIC, and MSC, the group was asked "What is your understanding about the risk of nephrotoxicity with respect to patients on vancomycin as described in the vancomycin package insert?" the DOP stated there is higher possibility if renal function is compromised to start.