The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

SAINT AGNES MEDICAL CENTER 1303 E HERNDON AVE FRESNO, CA 93710 Aug. 24, 2018
VIOLATION: GOVERNING BODY Tag No: A0043
Based on observation, staff interviews, clinical record and administrative document review, the hospital failed to have an effective governing body legally responsible for the conduct of the hospital when:

1. A contracted travel nurse (RN 1) working in the hospital did not adhere to the medication policies and procedures of the hospital for one of 35 sampled patients (refer to A 0398);

2. Nursing staff did not adhere to safe medication administration procedures and acceptable standards of practice for safe handling, preparation, and administration of high alert medications (HAM - drugs that bear a heightened risk of causing significant patient harm when they are used in error) for one (Patient 1) of 35 sampled patients (refer to A 0405);

3. Policies and procedures and professional guidelines were not followed to minimize the risk of medication errors when a pharmacist (RPH 1) mislabeled an intravenous (IV - in the vein) bag of norepinephrine (medication that increases the heart rate and the blood pressure) as "azithromycin" (an antibiotic - kills germs) and the mislabeled IV bag was ultimately administered by Registered Nurse (RN) 1 to Patient (Pt) 1 in the Emergency Department (ED) on 7/12/18. (refer to A 0491);

4. Mislabeled drugs were found in 3 of 10 sampled medication storage areas (Main Pharmacy, Telemetry [Cardiac] Pharmacy Satellite, and Cardiovascular Operating Room Pharmacy Satellite) (refer to A 0505);

5. Current drug information was not available to satellite pharmacists related to compounded sterile products and drug therapy throughout pregnancy and lactation in two of seven pharmacy satellites (Emergency Department Pharmacy Satellite and Cardiovascular Operating Room Pharmacy Satellite) (refer to A 0510 ).

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality healthcare in a safe environment.
VIOLATION: NURSING SERVICES Tag No: A0385
Based on interview, medical record and administrative document review, the hospital failed to ensure the provision of nursing services when:

1. Nursing staff did not follow Federal and State regulations and accepted standards of practice for safe handling, preparation, and administration of high alert medications (drugs that bear a heightened risk of causing significant patient harm when they are used in error) for one of 35 sampled patients (refer to A 0405);

2. A contracted travel nurse (RN 1) working in the hospital did not follow the hospital's policies and procedures (refer to A 0398).

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality healthcare in a safe environment.
VIOLATION: SUPERVISION OF CONTRACT STAFF Tag No: A0398
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the facility failed to ensure contracted (temporary) licensed nurses working in the hospital adhered to the policies and procedures of the hospital when Registered Nurse (RN)) 1 did not visually inspect and recognize a mis-labeled intravenous (IV - directly into the vein) medication bag and administered norepinephrine (medication that increases the heart rate and the blood pressure) instead of azithromycin (an antibiotic - kills germs) into one of 35 sampled patients (Patient 1) in the Emergency Department (ED) on 7/12/18.

This failure resulted in Pt 1 becoming critically ill and developing acute renal (kidney) failure and placed all patients who receive high-alert medications (HAMs - drugs that bear a heightened risk of causing significant patient harm when used in error) at risk for adverse outcomes.

Findings:

1. On 8/21/18 at 3:12 p.m., during an interview, registered nurse (RN) 5 stated on 7/12/18 she heard a scream from bed six, but did not recall what time. RN 5 stated Pt 1 complained of headache and her heart was beating very fast. RN 5 stated she became concerned and went to look at Pt 1's bag of medication. RN 5 stated RN 1 was the one who had administered the medication, and she (RN 5) was checking the bag to see what medication was infusing. RN 5 stated she looked at both sides of the medication bag and realized the patient label on the front of the bag indicated the bag contained the antibiotic and the manufacturer's label on the bag indicated the bag contained norepinephrine. RN 5 stated, "I know norepinephrine causes tachycardia [fast heart rate] and in my mind that's what was causing the patient's [Pt 1] symptoms." When asked what happened next, RN 5 stated, "I stopped the pump immediately, knowing it was the wrong medication." RN 5 stated, after the medication was stopped, she notified Pt 1's assigned ED physician (MD 1) via a radio page of "[MD 1] to bed six STAT [immediately]." RN 5 stated MD 1 came immediately and, upon arrival, Pt 1's mental status had changed and she was not responding appropriately. RN 5 stated Pt 1 was then transferred to the red zone (an area in the ED used for patients in critical condition).


On 8/22/18 at 11:30 a.m., during an interview, the emergency services director (ESD) confirmed RN 1 administered a non-prescribed medication, norepinephrine, instead of the ordered medication, azithromycin, IV in error to Pt 1 on 7/12/18. The ESD was asked what was the expectation of giving an IV medication. The ESD stated the expectation was checking the five patient rights (checking for the correct patient, time, route, drug and dose), checking the clarity of the fluid, and the medication label on the bag. The ESD stated, regarding the medication error, RN 1 told her he followed the steps of medication administration, but did not turn over the IV medication bag.

On 8/22/18 at 3:04 p.m., during an interview, the Director of Pharmacy (DPH) stated "[RN 1] relied on the barcode scanner [system used by nurses to help ensure the correct medications for the correct patient] to verify the correct medication. The nurse made an administration error because he did not conduct a visual inspection of the drug prior to administration. That is a nursing policy."

RN 1 was not available for interview.

A review of Pt 1's "History and Physical" dated 7/12/18, indicated, "Pt 1 presented to the Emergency Department with symptoms including headache, neck pain and shortness of breath .... Pt 1 also had a history of diabetic ketoacidosis [a serious complication of diabetes that occurs when your body produces high levels of blood acids called ketones] .... The plan for [Pt 1] was to be admitted to the hospital as an inpatient for her diabetic ketoacidosis. ... [Pt 1] unfortunately received 159 cc [measurement of volume] of [norepinephrine] approximately 5 g [grams - unit of mass or weight]... became diaphoretic [to stimulate sweating], tachycardic [high pulse rate], and complaining of muscle cramps. Pt 1 transferred to critical area (in the ED) and was given IV fluid, oxygen ...Case discussed with admitting physician who accepted and upgraded [Pt 1] to be admitted to the ICU (Intensive Care Unit - location where critically ill patients are cared for) ..."

A review of Pt 1's "Cardiology Consultation Report" dated 7/13/18, indicated "...[Pt 1] inadvertently was given [norepinephrine]. This was mistaken as azithromycin. With this, she ultimately... suffered with a cardiac arrest [abrupt loss of heart function] with evidence of [DIAGNOSES REDACTED] [very fast heart rhythm in the lower chambers of the heart]. She was seen in consultation by [MD 6], who took her to the catheterization lab [examination room in a hospital with equipment used to visualize the lower heart chambers] and placed a left ventricular support device with [brand name for heart pump] ... secondary to a large bolus[large dose of IV medication] of [norepinephrine] ..."

A review of Patient 1's "Critical Care Progress Note" dated 7/13/18, indicated "... [Pt 1] admitted [DATE] with acute respiratory failure, acute pulmonary edema, suspected aspiration pneumonitis [infection of the lungs caused by inhaling fluid], after presenting with chest pain and shortness of breath ... [Pt 1] inadvertently received [norepinephrine] infusion and was noted to develop worsening respiratory distress, hypoxemia [a dangerous condition that happens when your body does not get enough oxygen], ... and depressed level of consciousness. [Pt 1] subsequently was intubated, and required progressively increasing Fi02 [percentage of oxygen being measured], as well as vasopressor [medication for shock] support ..."

A review of Pt 1's "Operative/Procedure Report" dated 7/13/18, indicated ... "Due to cardiogenic shock [a life-threatening medical condition resulting from an inadequate circulation of blood due to primary failure of the ventricles of the heart to function effectively], Pt 1 was brought to the cardiac catheterization laboratory ... [heart pump] placement was performed via the right femoral artery ... Right heart catheterization [a catheter that is inserted into a [DIAGNOSES REDACTED]] ... with continued ongoing medication for BP [blood pressure] support, to be titrated [adjusted] as needed in the ICU ..."

A review of Patient 1's "Nephrology progress notes" dated 7/15/18, indicated "... due to medication error, [Pt 1] received [norepinephrine] instead of azithromycin and developed cardiogenic shock and ...[DIAGNOSES REDACTED] (temporary weakened heart muscle) secondary to high dose catecholamines (an organic compound)... Pt 1 developed...renal failure now ..."

The hospital policy and procedure titled, "Medication Policies" dated 5/18, indicated "... Policy No.8 - ADMINISTRATION OF MEDICATIONS ... 2 ... Prior to administration, visually inspect the medication for particles or discoloration (e.g. IV solution) and verify that the medication has not expired ... PROCEDURE: 1... A. Read medication label upon taking drug from drawer. B. Read label and compare with medication record when preparing it for administration. C. Read label prior to administration of medication to patient. 2. The nurse is responsible for checking that the right medication is given to the right patient, in the right dose, by the right route and at the right time ..."
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**






Based on interview and record review, the hospital failed to ensure nursing staff adhered to safe medication administration procedures and accepted standards of practice for safe handling, preparation, and administration of high alert medications (drugs that bear a heightened risk of causing significant patient harm when they are used in error) for one of 35 sampled patients, Patient (Pt) 1, when Registered Nurse (RN) 1 administered norepinephrine (medication that stimulates the heart, causing an increase in heart rate), to Pt 1, in error.

This failure resulted in Pt 1 becoming critically ill and developing acute renal (kidney) failure and placed all patients who receive high-alert medications at risk for adverse outcomes.

Findings:

1. On 8/21/18 at 3:12 p.m., during an interview, registered nurse (RN) 5 stated on 7/12/18 she heard a scream from bed six, but did not recall what time. RN 5 stated Pt 1 complained of headache and her heart was beating very fast. RN 5 stated she became concerned and went to look at Pt 1's bag of medication (which had been administered by RN 1). RN 5 stated she looked at both sides of the medication bag and realized the patient label on the front of the bag indicated the bag contained the antibiotic and the manufacturer's label on the bag indicated the bag contained norepinephrine. RN 5 stated, "I know norepinephrine causes tachycardia [fast heart rate] and in my mind that's what was causing the patient's [Pt 1] symptoms."

On 8/21/18 at 4 p.m., during an interview, RN 4 confirmed on 7/12/18 Pt 1 had been given intravenous (IV - in the vein) norepinephrine by RN 1, instead of the physician ordered antibiotic. RN 4 stated it was standard practice and the expectation was for all nurses to verify the medication label and adhere to the five rights of medication administration. RN 4 stated there was no way for RN 1 to know the medication given to Pt 1 was the right medication without inspecting both sides of the medication bag. RN 4 stated RN 1 did not inspect the medication bag to ensure it was the right medication prior to giving it to Pt 1.

On 8/22/18 at 11:40 a.m., during an interview, the director of emergency services (DES) stated on 7/12/18, Pt 1 had a physician order for the administration of an antibiotic. Pharmacy personnel provided RN 1 a medication bag with Pt 1's identification information that indicated the medication in the bag was the antibiotic ordered by the physician. The DES stated RN 1 administered the medication identified as the antibiotic to Pt 1. The DES stated, after the start of administering the medication identified as an antibiotic, RN 5 observed Pt 1's heart rate was abnormally high at 150 beats per minute. The DES stated RN 5 inspected the medication bag during the administration and determined Pt 1 was being given norepinephrine and not the physician ordered antibiotic. Pt 1's identification label with the antibiotic was placed on the norepinephrine by Emergency Department Pharmacist (RPH) 2 in error. The DES stated RN 1 did not look at both sides of the medication bag to make sure it was the right medication. The DES stated hospital policy was to visualize medication bags prior to administration and RN 1 was responsible to ensure medication was administered according to the five rights (recommendations to reduce medication errors and harm: the right patient, the right drug, the right dose, the right route, and the right time) and hospital policy and procedure.

RN 1 was not available for interview.

A review of Pt 1's electronic medical record, Medical Doctor (MD) 2's consultation report titled, "Preliminary Report", dated 7/13/18, indicated, "...Azithromycin was ordered and she [Pt 1] was inadvertently given a large bolus of norepinephrine in the ED [emergency department]. She subsequently developed [DIAGNOSES REDACTED] [a life threatening rapid heart rate], cardiogenic shock [a life threatening medical condition resulting from inadequate circulation of blood due to primary failure of the ventricles of the heart to function effectively], cardiac arrest with associated acute pulmonary edema [fluid filling up in the tissue and air spaces of the lungs] necessitating intubation [medical procedure to place a tube into the windpipe for the purpose of breathing] and Intensive Care Unit [ICU]admission. Echocardiogram [a test of the heart used for determining heart disease] demonstrated wall motion suggestive of Takotsubo [DIAGNOSES REDACTED] [sudden changes in the heart muscle or heart blood vessels that prevent the left lower heart chamber from contracting effectively]. An emergent left ventricular [lower heart chamber] device was appropriately place through the right femoral artery [a large artery in the thigh]..."

A review of Pt 1's "History and Physical" dated 7/12/18, indicated, "... [Pt 1] presented to the Emergency Department with symptoms including headache, neck pain and shortness of breath .... [Pt 1] also had a history of diabetic ketoacidosis [a serious complication of diabetes that occurs when your body produces high levels of blood acids called ketones].... The plan for [Pt 1] was to be admitted to the hospital as an inpatient for her diabetic ketoacidosis.... [Pt 1] unfortunately received 159cc [measurement of volume] of [norepinephrine] approximately 5g [unit of mass or weight]. Became diaphoretic [sweaty], tachycardic [rapid heart rate], and complaining of muscle cramps. [Pt 1] transferred to critical area [in the Emergency Department] and was given IV fluid, oxygen ...Case discussed with admitting physician who accepted and upgraded [Pt 1] to be admitted to the ICU..."

A review of Pt 1's "Cardiology Consultation Report" dated 7/13/18, indicated, "... [Pt 1] inadvertently was given [norepinephrine]. This was mistaken as azithromycin. With this, she ultimately decompensated and suffered with a cardiac arrest with evidence of [DIAGNOSES REDACTED]. She was seen in consultation by [MD 6], who took her to the catheterization lab and placed a left ventricular support device with [brand name- a device used for temporary ventricular support in people with depressed heart function] through the right transcutaneous femoral approach [into the artery in the groin] ...One potential cause of her left ventricular dysfunction is Takotsubo [DIAGNOSES REDACTED] secondary to a large bolus of [norepinephrine]..."

A review of Pt 1's "Critical Care Progress Note" dated 7/13/18, indicated "... [Pt 1] admitted [DATE] with acute respiratory failure, acute pulmonary edema, suspected aspiration pneumonitis [inhalation of sterile gastric contents], after presenting with chest pain and shortness of breath ... [Pt 1] inadvertently received [norepinephrine] infusion and was noted to develop worsening respiratory distress, hypoxemia [a dangerous condition that happens when your body doesn't get enough oxygen], froth pink pulmonary secretions, and depressed level of consciousness. [Pt 1] subsequently was intubated, and required progressively increasing Fi02 [percentage of oxygen being measured], as well as vasopressor [a drug causing the constriction of blood vessels to raise blood pressure when too low] support..."

A review of Pt's 1 "Operative/Procedure Report" dated 7/13/18, indicated "...Due to cardiogenic shock, [Pt 1] was brought to the cardiac catheterization laboratory ...[brand name -a device used for temporary ventricular support in people with depressed heart function] placement was performed via the right femoral artery ...Right heart catheterization with... catheter [a tube that is inserted into a [DIAGNOSES REDACTED]] ...with continued ongoing medication for BP [blood pressure] support, to be titrated [adjusted] as needed in the ICU..."

A review of Pt 1's "Nephrology progress notes" dated 7/15/18, indicated, "...Due to medication error, [Pt 1] received [norepinephrine] instead of azithromycin and developed cardiogenic shock and likely Takotsubo [DIAGNOSES REDACTED] secondary to high dose catecholamines [norepinephrine].. [Pt 1] developed...renal failure now..."

The hospital policy and procedure titled, "Medication Policies" dated 5/18, indicated "... Policy No.8 - ADMINISTRATION OF MEDICATIONS... 2 ... Prior to administration, visually inspect the medication for particles or discoloration (e.g. IV solution) and verify that the medication has not expired ... PROCEDURE: 1... A. Read medication label upon taking drug from drawer. B. Read label and compare with medication record when preparing it for administration. C. Read label prior to administration of medication to patient. 2. The nurse is responsible for checking that the right medication is given to the right patient, in the right dose, by the right route and at the right time ..."

The National Center for Biotechnology Information, U.S. National Library of Medicine report titled "The Five Rights" dated 10/2010 indicated, "...errors in drug administration pose a great risk to patients. Most health care professionals, especially nurses, know the "five rights" of medication use: the right patient, the right drug, the right time, the right dose, and the right route-all of which are generally regarded as a standard for safe medication practices."
VIOLATION: Condition of Participation: Pharmaceutical Se Tag No: A0489
Based on observation, interviews and record reviews, the hospital failed to have a pharmacy under the competent supervision of a pharmacist who coordinated activities with other hospital leaders to remedy causative factors in order to prevent medication errors when:

1. Policies and procedures and professional guidelines were not followed to minimize the risk of medication errors when a pharmacist (RPH 1) mislabeled an intravenous (IV - in the vein) bag of norepinephrine (medication that increases the heart rate and the blood pressure) as "azithromycin" (an antibiotic - kills germs) and the mislabeled IV bag was ultimately administered by Registered Nurse (RN) 1 to Patient (Pt) 1 in the Emergency Department (ED) on 7/12/18. (refer to A 0491)

2. Mislabeled drugs were found in 3 of 10 sampled medication storage areas (Main Pharmacy, Telemetry [Cardiac] Pharmacy Satellite, and Cardiovascular Operating Room Pharmacy Satellite). (refer to A 0505).

3. Current drug information was not available to satellite pharmacists related to compounded sterile products and drug therapy throughout pregnancy and lactation in two of seven pharmacy satellites (Emergency Department Pharmacy Satellite and Cardiovascular Operating Room Pharmacy Satellite) (refer to A 0510 ).

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality healthcare in a safe environment.
VIOLATION: PHARMACY ADMINISTRATION Tag No: A0491
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on interview and record review, the hospital failed to ensure pharmaceutical policies and procedures and professional guidelines were followed to minimize the risk of medication errors when a pharmacist (RPH 1) mislabeled an intravenous (IV - in the vein) bag of norepinephrine (medication that increases the heart rate and the blood pressure) as "azithromycin" (an antibiotic - kills germs) and the mislabeled IV bag was ultimately administered by Registered Nurse (RN) 1 to Patient (Pt) 1 in the Emergency Department (ED) on 7/12/18.

This failure resulted in Pt 1 becoming critically ill and developing acute renal (kidney) failure and placed all patients who receive high-alert medications (HAMs - drugs that bear a heightened risk of causing significant patient harm when used in error) at risk for adverse outcomes.

Findings:

On 8/21/18 at 9 a.m., during a concurrent interview and record review with the Director of Pharmacy (DPH) in attendance, the Medication Safety Coordinator (RPH 2) stated, "We found issues with the storage and labeling that we could improve on." RPH 2 stated the error was associated with storage of HAMs in an overcrowded refrigerator; not heeding the warning labels; labeling the wrong drug; not comparing the drug to the order; not visually inspecting the bag; and dispensing the bag to the nurse in error." The DPH stated, "During the verification process, she [pharmacist - RPH 1] transcribed the norepinephrine...label onto the azithromycin label in the compounding log [document used to assist staff in identifying specific ingredients used]... Norepinephrine was not dispensed in accordance with the orders of a practitioner and accepted standards... It was clearly not the right medication ... [RN 1] let the scanner [process used by nurses to help ensure the correct medications for the correct patient] do the thinking for her. Scanning technology is no substitute for critical thinking ... The ED satellite pharmacy (smaller pharmacy that is located elsewhere from the main pharmacy) refrigerator is small ... We do not have separate bins for IVs ..." A review of the photocopy of the mislabeled IV bag associated with the medication error, an inspection of the pharmacy's labels, and a review of the compounding log substantiated the DPH's account that the pharmacist mislabeled and dispensed the HAM in error, and did not maintain an accurate record in the compounding log.

On 8/22/18 at 9:59 a.m., during a concurrent interview and review of Pt 1's clinical record, cardiologist and physician (MD 2) who consulted after the medication error was discovered stated, "There was an apparent [norepinephrine] bolused [large dose of IV medication] given to [Pt 1]." MD 2 stated, "Serious injuries were caused by or aggravated by norepinephrine... [Pt 1] came in [to hospital] with some illness. The med [medication] error contributed to cardiogenic shock [condition in which the heart suddenly cannot pump enough blood to meet the body's needs]... [Pt 1] ... may have died ." MD 2 stated Pt 1's cardiac condition normalized prior to discharge but she continued on dialysis (a process used to purify the blood of persons whose kidneys are not working normally). Pt 1's clinical record indicated, after the administration of norepinephrine, she immediately complained of a severe headache. MD 2 stated a second nurse (RN 5) noticed the patient deteriorating (excessive heart rate over 150 beats per minute), identified the mislabeling error, stopped the infusion, and notified the nurse manager, who directed staff to sequester (isolate) the infusion and medication pump and notify the physician and the pharmacist. MD 2 stated Pt 1 experienced a potentially fatal cardiac condition, respiratory failure, and required intubation (tube inserted into the lungs for help with breathing). MD 2 stated Pt 1 was diagnosed with [DIAGNOSES REDACTED]

On 8/22/18 at 10:15 a.m., during an interview, the Risk Manager (RM) stated the hospital's investigation determined Pt 1 sustained "[DIAGNOSES REDACTED] and renal failure." The RM stated Pt 1 required dialysis as an outpatient for two weeks after discharge. The RM stated she was directed by the hospital's Quality Forum to report the incident in a report titled, "Care Management Event Associated Serious Injury Associated with a Medication Error." The RM stated the hospital conducted a Root Cause Analysis (an approach for identifying the underlying causes of an incident so the most effective solutions can be identified and implemented) as well as a written plan in response to the incident. The RM stated the hospital determined contributing factors to the error were, "The way the [medication] refrigerator was set up, no visual cue ... the performance of two staff [RPH 1] and [RN 1], and over-reliance on technology ..." The RM stated there was a policy implementation failure and added, "Our policy says to inspect the bag."

On 8/22/18 at 11:46 a.m., during an interview, the DPH said, "We have not done or had a requirement for inspecting satellite pharmacies ..." The DPH provided no records or recordkeeping process to substantiate stocks in Pharmacy satellites were routinely inspected and he provided no evidence that all stocks of medications stocked in pharmacy satellites were routinely inspected to ensure the absence of outdated, unusable, or mislabeled products.

On 8/22/18 at 2:10 p.m., during an interview, RPH 2 said, "She [RPH 1] did not follow the policy and procedures for checking the final IV on page seven of the Compounding policy." RPH 2 stated, "The refrigerator in the Emergency Department Pharmacy Satellite ...over time was added for drug shortage, or convenience, it was crowded. The azithromycin was next to the norepinephrine."

On 8/22/18 at 2:56 p.m., during an interview, RPH 2 stated, "There was a dispensing error because it was mislabeled by the pharmacist ... Our policy requires a physical inspection and accuracy check ...to ensure the final compounded product matches the compounding label."

On 8/22/18 at 4:13 p.m., during an interview with the DPH in attendance, the Director of Employee Relations/Diversity (DERD) from Human Resources stated RPH 1 was unavailable for interview during the survey. The DERD stated she interviewed RPH 1, who acknowledged the mistake was caused by multiple labels came out ... and in haste she put the antibiotic label on the norepinephrine bag. The HRD confirmed RPH 1 was involved in a previously reported HAM medication mislabeling error and stated, "I think it was insulin or KCL [potassium chloride - an electrolyte supplement]. Risk Management knew about it."

On 8/22/18 at 4:30 p.m., during an interview, when asked to describe what the hospital did to ensure the supervision of RPH 1 after the first HAM mislabeling error, the DPH replied, "We told her not to hurry ad nauseam."

On 8/23/18 at 10:30 a.m., during a concurrent interview and review of medication error reports from 2/1/18 to 6/30/18, RPH 2 described medications errors associated with HAMs analyzed by the hospital's Pharmacy and Therapeutics (P&T) Committee. One error in March and one error in April involved mislabeled norepinephrine. The Chair of the P & T Committee was unavailable for interview during the survey.

RPH 1 was not available for interview.

The hospital policy and procedure titled, "Purchasing and Storage of Medications and Supplies" revised 2/2017, indicated "All drugs, chemicals, and biologicals stocked must meet national standards of quality, and be clearly and accurately labeled as to contents ... Medications that are easy to confuse... are segregated."

The Institute for Safe Medication Practices (ISMP), a nationally-recognized patient safety organization, in their publication titled, "ISMP List of High-Alert Medications in Acute Care Settings" dated 2018, defined norepinephrine as a HAM.

The American Society of Health-System Pharmacists (ASHP) publication titled, "ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals" date 4/2012, indicated "Standard I - Section for Leadership and Practice Management ..., Appropriate mechanisms to ensure compliance with the policies and procedures should be established ... Standard IV - Section Medication Distribution and Control ...The pharmacy shall be responsible for the procurement, distribution, and control of all drug products used in the hospital for inpatient and ambulatory patients ... Medication shall be stored and prepared under proper conditions of ... and security to ensure medication integrity ... Ongoing monitoring and review of medication errors with corresponding appropriate action should be maintained. All stocks of medications shall be inspected routinely to ensure the absence of outdated, unusable, were mislabeled products ... Standard V - Section for Facilities, Equipment, and Information Resources ...Facility shall exist to enable the storage in preparation of medications under proper conditions of segregation, and security to ensure medication integrity and personal safety throughout the hospital."
VIOLATION: UNUSABLE DRUGS NOT USED Tag No: A0505
Based on observation, interview, and record review, the hospital failed to ensure that mislabeled (unusable) drugs were not available for patient use when medications in 3 of 10 sampled medication storage areas (Main Pharmacy, Telemetry [Cardiac] Pharmacy Satellite, and Cardiovascular Operating Room Pharmacy Satellite) were found that were not labeled properly

This failure had the potential for all patients (census 304) to receive incorrect medications and not benefit from prescribed therapy..

Findings:

1. On 8/21/18 at 11:57 a.m., during an inspection in the Main Pharmacy with a pharmacist and Medication Safety Coordinator (RPH 2), an amber vial contained three blue pills in stock on a shelf and did not have a legible label. On the same shelf, an amber vial contained 21 blue and orange capsules. The drug name was handwritten directly on the vial with a black marker and was smudged and illegible.

On 8/21/18 at 11:57 a.m., during a concurrent interview, RPH 2 stated, "Those vials don't have all the information they should have. They should not be in our stock like that."

2. On 8/22/18 at 3:47 p.m., during an inspection of medication stock in the Telemetry Pharmacy Satellite, staffed by a pharmacist (RPH 8), a bag of intravenous normal saline 0.9% 100 mL (milliliters) National Drug Code (NDC) 0338-0049-18 was in stock with the overwrap removed and with no pharmacy-assigned label affixed indicating the expiration date.

On 8/22/18 at 3:47 p.m., during a concurrent interview, RPH 8 stated, "It should not be in stock 30 days after overwrap is removed." He stated it is the hospital's policy to apply a 30-day expiration date to intravenous bags when they are removed from their protective outer wrap. He stated the overwrap prevents evaporative losses and, over time, has the potential to concentrate the solutions. RPH 8 stated, "Usually if I open a pack of four I get a date gun and date each individual bag with 30 days."

3. On 9/23/18 at 8:50 a.m., during an inspection of medication stock in the Cardiovascular Operating Room Pharmacy Satellite staffed by a pharmacist (RPH 9), an opened single-dose vial of preservative-free normal saline, 10 mL (salt water used to dilute medications) was in stock.

On 9/23/18 at 8:50 a.m., during an interview RPH 9 stated, "I can't use it (opened vial) because it's a single-dose vial and we can't reuse. It's a single-dose vial it should be thrown away."

A review of the hospital's policy titled, "Purchasing and Storage of Medications and Supplies reviewed February 2017 indicated, "Single dose vials may not be reused. The policy showed as its purpose, "To provide at all times and adequate stock of therapeutically necessary pharmaceuticals." The policy indicated, "All drugs, chemicals, and biologicals stocked must meet national standards of quality, and be clearly and accurately labeled as to contents." The policy indicated, "All expired, damaged, and/or contaminated medications are segregated until they are removed the hospital." The policy showed, "Medications that are easy to confuse... are segregated." A review of the policy showed minimum requirements for labeling medications on the sterile field with the medication name, strength, amount, and expiration date. The hospital did not provide policies and procedures which address labeling requirements for medications off the sterile field or labeling requirements for repackaged medications.
VIOLATION: STAFF ACCESS TO DRUG INFORMATION Tag No: A0510
Based on observation, interview, and record review, the hospital failed to ensure current drug information was available to satellite pharmacists related to compounded sterile products and drug therapy throughout pregnancy and lactation in two of seven pharmacy satellites (Emergency Department Pharmacy Satellite and Cardiovascular Operating Room Pharmacy Satellite) when:

1. An outdated 2010 drug reference book titled, "Handbook of Injectable Drugs" 16th edition (ISBN 1- -250-2) maintained in the Emergency Department Pharmacy Satellite did not reflect current information on drug therapy.

2. An outdated 2011 drug reference book titled, "Drugs in Pregnancy and Lactation" 9th edition (ISBN ) maintained in the Emergency Department Pharmacy Satellite did not reflect current information on drug therapy.

3. An outdated 2002 drug reference book titled, "Handbook of Injectable Drugs", 12th edition (ISBN 1- -041-0) maintained in the Cardiovascular Operating Room Pharmacy Satellite did not reflect current information on drug therapy.

The hospital had no downtime procedures in the event of an Internet outage and the only current hardcopies of the above references were maintained in the main pharmacy.

The hospital's failure to provide all satellite pharmacists with current drug therapy information placed all patients (patient census 304) at risk for adverse outcomes as a result of preventable medication use errors.

Findings:

1. On 8/21/18 at 2:00 p.m., during an inspection of the Emergency Department Pharmacy Satellite with a staff pharmacist (RPH 5), the Director of Pharmacy (DPH), and a pharmacist and Clinical Coordinator (RPH 4), a drug reference book titled, "Handbook of Injectable Drugs" 16th edition (ISBN 1- -250-2) published in 2010 was observed on the shelf above the computer used for drug order entry. RPH 5 stated, "The satellite has been open roughly 5 years. RPH 5 stated, "Trissel's [also known as "Handbook of Injectable Drugs"] ... it is out of date." He stated the book did not reflect current information on drug therapy. RPH 5 stated, "Trissel's is online. We would not be able to access those if the power went out."

2. On 8/21/18 at 2:00 p.m., during a concurrent inspection of the Emergency Department Pharmacy Satellite and interviews with a staff pharmacist, RPH 5, the Director of Pharmacy (DPH), a pharmacist and Clinical Coordinator (RPH 4), and the pharmacist and Medication Safety Coordinator (RPH 2), a drug reference book titled, "Drugs in Pregnancy and Lactation" 9th edition, (ISBN ) published in 2011 was observed on the shelf above the computer used for drug order entry.

In the same interview the DPH stated, "Our Pregnancy and Lactation is not the latest one. We buy new ones [books] every year. I guess we did not realize they were out of date down here [emergency department]. [RPH 4] is responsible for ensuring updated references are available." RPH 5 stated, "These two books have not been replaced since the satellite opened."

3. On 8/23/18 at 9:00 a.m., during an inspection of the Cardiovascular Operating Room Pharmacy Satellite with the DPH and a staff pharmacist (RPH 9), a drug reference book titled, "Handbook of Injectable Drugs" 16th edition (ISBN 1- -250-2) published in 2010 was observed on the shelf. RPH 9 and both RPH 9 and the DPH indicated the reference was
outdated.

On 8/23/18 at 1:00 p.m., during an interview with a physician and Chief Medical Officer (CMO), RPH 2 and the DPH, the CMO stated, "We use evidence-based medicine here." RPH 2 stated, "We do not have a downtime procedure for ensuring access to drug information and current reference for pharmacists in all the satellites. He stated there was one each of the current hardcopy drug references in the main pharmacy but that might not be sufficient in a disaster or mass casualty. He stated, "We could have server problems." The DPH stated, "We have no rationale for outdated references. We could have an error and cause patient harm using outdated drug information."

A review of the hospital's policies and procedures did not show any process for inspecting pharmacy satellites to ensure that outdated drug reference books would not be maintained to prevent medication errors. The hospital did not provide policies and procedures for how they would ensure information related to drug therapy and medication use would be available to the professional staff in the event of internet downtime or disaster to prevent medication errors.

According to the American Society of Health-Systems Pharmacists (ASPH), the "Handbook of Injectable Drugs" 19th edition published in 2017 "includes 27 new injectable drug monographs ...and 276 new references." The printed 20th edition is on backorder and will be available 10/2018. [Reference: www.ashp.org]

According to the American Society of Health-Systems Pharmacists (ASPH), "Drugs in Pregnancy and Lactation" 11th edition ISBN published in 2017 includes "more than 140 new drugs included in this edition."