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The hospital failed to ensure the Condition of Participation: CFR 482.12 Governing Body was met, in a universe of 153, by failing to:

1. Ensure the Medical Staff developed criteria and had processes in place to grant privileges to pharmacists to write orders for medications without protocols or approved standardized procedures, in a universe of 153. (Refer to A 0049)

2. Ensure all patients' right to be free from harm and failed to provide appropriate and adequate supervision to all patients' in the Behavior Health Unit, when 2 patients (Patients 17 & 18) were in an altercation, as facility staff watched without intervening, in a universe of 153 (Refer to A 0392)


3. Ensure pharmaceutical services had complete oversight by the Governing Body, and that all services were provided in a safe and effective manner, for ordering, adjusting, and initiating medication orders by pharmacist for safe dispensing and administration of medications to the patients, in a universe of 153.
(Refer to A 0049 and A 0500)

The cumulative effect of these systemic practices resulted in the failure of the hospital to deliver care in a universe of 153 patients in compliance with the Condition of Participation, for Governing Body.

Based on observation, interview and record review, the Governing Body of the hospital:

Failed to ensure Medical Staff developed criteria and processes in place to grant privileges to pharmacists to write orders for medications without protocols or approved standardized procedures, in a universe of 153.


This failure created the potential for adverse events and patient safety issues to occur.

Findings:

Review of the facility's policy and procedure titled, "Who May Prescribe Medication" dated "5/70", last revised on "11/14" stipulated the following:

"No drug will be administered to a patient except by authorized, licensed personnel upon the order of a member of the medical staff, or other individual who has been granted privileges order medications...pharmacists may prescribe under protocol approved by a physician with approved staff privileges or as permitted by approved standardized procedure."

During an interview on June 8, 2015, at 3:20 PM, Pharmacist (P1), stated that in addition to Pharmacy monitoring, adjusting doses and ordering laboratory tests per approved protocol, the pharmacists would dose medications ordered by physicians for the pharmacist to dose.

P1 stated that most of the medications the physicians requested for pharmacists to dose were antibiotics, but did not indicate there was a facility approved protocol or guidelines for pharmacists to adjust or initiate a physician order for the pharmacist to dose antibiotics.

P1 indicated that she had received such orders and that they were entered as protocol orders and the physicians would not need to cosign or authenticate such orders.

During an interview on June 9, 2015, at 10:10 AM, P2 stated that she had received "Pharmacy to dose" orders before and that only a few physicians, including an infectious disease physician, would enter the order in the computerized physician ordering system (CPOE). P2 stated that calculations and initial dosing of the requested medications for pharmacy to dose would be done using available drug references and would be entered in CPOE as a protocol order.

During he same interview, P2 also stated that "Pharmacy to dose" orders that were initiated and dosed by a pharmacist did not require physician authentication or co-signature.

During an interview on June 10, 2015, at 5:30 PM, P3 employees with the facility for 13 years, stated that "Pharmacy to dose" orders were always accepted and orders written/entered in CPOE. P3 stated that she was not aware of any protocol that allowed pharmacists to dose antibiotics on behalf of physicians upon "Pharmacy to dose" orders.

During an interview on June 12, 2015, at 10 AM, Director of Pharmacy (DP) acknowledged that the practice initiating and dosing upon physician's "Pharmacy to dose" did not reflect accurately the current facility's policy and procedure.

Review of the facility's policy and procedure titled, "Therapeutic Drug Monitoring" dated "8/94", last revised on "11/14" stipulated,

"The licensed pharmacist is responsible for therapeutic drug monitoring as ordered by the physician.

A pharmacist will monitor therapeutic drug levels, as per approved protocols, ordering necessary laboratory tests, drug levels and making recommendations and appropriate changes in therapy.

All orders written or entered electronically by a pharmacist pursuant to this approved protocol will be signed, in writing or electronically, by the licensed pharmacist, per approved protocol, and do not require a physician co-signature as approved by Pharmacy and Therapeutics and Medical Executive Committees."

The above policy and procedure did not address initiating or dosing by pharmacists per "Pharmacy to dose order" by physicians and the facility did not have a protocol to address such orders.

The hospital failed to ensure the Condition of Participation: CFR 482.13 Patient's Rights was met by:


Failing to ensure all patients' had the right to be free from harm and failed to provide appropriate and adequate supervision to all patients' in the Behavioral Health Unit, when 2 patients (Patients 17 & 18) were in an altercation, as facility staff watched without intervening, in a universe of 153 (Refer to A 0129 and A 0392)


The cumulative effect of this systemic practices resulted in the failure of the hospital to deliver care in compliance with the Condition of Participation: Patient's Rights.

Based on observation, interview and record review, the facility failed to ensure the right to be free from harm was maintained for two of 33 patients (Patients 17 & 18). This failure occurred when facility staff failed to intervene after Patient 17 informed the staff of the intent to kick Patient 18 in the head, for snoring. This failure resulted in an altercation between Patient 17 and Patient 18, and resulted in a lip laceration to Patient 17, which required sutures and Patient 18 sustained a kick to the head.

Findings:

On April 7, 2015 an entity reported incident was reported to the California Department of Public Health Licensing and Certification, regarding two patients who were involved in an altercation with each other in the locked section of the Behavioral Health Unit (BHU). Documentation of the reported event revealed that on March 22, 2015 at approximately 3:48 AM, Patient 17 kicked Patient 18 in the head and an altercation occurred. Patient 17 sustained an injury to the lower lip and was taken to the ED for medical intervention for suturing to the injured area. On April 20, 2015 at 4:43 PM, an interview was conducted with Patient 17. During the interview, Patient 17 stated, "Staff didn't protect me."


On June 9, 2015 at 9:20 AM, an interview was conducted with the Director of Risk Management, Patient Relations and Patient Safety Officer (DRMPRPSO). The DRMPRPSO stated on March 26, 2015 at 2:30 PM she interviewed Patient 17 regarding the altercation. The DRMPRPSO indicated during the interview that Patient 17 informed her that he felt that (BHU) staff did not intervene after the patient informed hospital staff (prior to the altercation), that he was going to kick Patient 18 in the head.

During the interview with the DRMPRPSO on June 9, 2015 at 9:20 AM, the DRMPRPSO stated that Patient 17 had asked staff if he could be moved to the observation room, due to his roommate snoring, he was told "No, it was for emergencies"

The DRMPRPSO further stated, Patient 17 went back to his room and laid on the floor and as staff were making rounds, Patient 17 asked if he could be moved again due to his roommates snoring was keeping him awake. Patient 17 was again told "No." The DRMPRPSO stated that Patient 17 informed the Mental Health Worker (MHW) "Watch what I'm going to do, I am going to kick this dude in the head because he will not stop snoring." Patient 17 informed the DRMPRPSO that staff stated "No you won't." Immediately afterwards, Patient 17 kicked Patient 18 in the head while asleep and a boxing match/altercation between the two patients began, with the two patients fighting in multiple hallways.

During the same interview, the DRMPRPSO stated, she and the Director of the BHU, reviewed the video footage of the altercation between the two patients. The DRMPRPSO further stated, "No one (staff) intervened to stop the fight."


On June 9, 2015 at 7:29 AM, an interview was conducted with the Charge Registered Nurse (CRN 1), on duty the night of March 22, 2015, at approximately 3:48 AM, in the BHU locked unit. CRN 1 was asked to describe the incident on the morning of March 22, 2015. CRN 1 stated, (Patient 17's name) wanted to switch rooms because his roommate (Patient 18) was snoring, (Patient 17's name) was told he could not be moved because it wasn't an emergency. The MHW was making rounds and I heard her say, "He just kicked him in the head."

During the interview, CRN 1 stated, "The fight was intense, Patient 18 was not listening at all, a "Code Gray" (security emergency) was called." CRN 1 stated, "Blood was flying everywhere."

CRN 1 was asked if she intervened to break up the fight, CRN 1 stated, "I yelled to stop, they stopped for a while but they began again around the corner."

On June 9, 2015 at 7:43 AM, an interview was conducted with Licensed Vocational Nurse (LVN) 1. During the interview, LVN 1 stated he was in the nursing station when he heard someone scream. I saw two patients (Patient 17 and Patient 18) come out of the room punching each other, using fists. LVN 1 further stated, "A 'Code Gray (security assistance),' was called, they (referring to Patients 17 & 18) weren't listening."

During the interview, LVN 1 was asked if BHU staff are taught techniques to intervene in instances where patients are fighting, LVN 1 stated, "We try to calm them (referring to Patients 17 & 18) down verbally, but they weren't listening." LVN 1 stated that they (staff) were trained in CPI/Non-violent crisis intervention (Crisis Prevention Institute - techniques used to safely manage patients who demonstrate disruptive and assaultive behavior) techniques, but we are "Not supposed to touch the patient." LVN 1 stated, "They looked at me and had clenched fists, I backed off, we had no help, we were short staffed." LVN 1 further stated, "Staff were scared."

On June 9, 2015 at 8:10 AM, an interview was conducted with Registered Nurse (RN 1). RN 1 stated she was coming back from break, a patient was asking to change rooms, a little while later I heard staff yelling, "Help, help."

RN 1 further stated during the interview, "The patient's were angry and irritable, we attempted to verbally deescalate, they resisted and it was too dangerous for staff to intervene." RN 1 was asked if she had CPI training, RN 1 stated, "It doesn't allow to physically intervene."

On June 10, 2015 at 8:15 AM, an interview was conducted with the Vice President of Behavioral Health Services (VPBHU). The VPBHU was asked if CPI allowed "Hands on," the VPBHU stated, "You can do hands on if needed."


A review of the facility's policy and procedure "Patient Rights" for the "Behavioral Health Services," under the "Procedure" section revealed the following:

"4.0 Patient's also have Constitutional Patient Rights as listed below:

4.2 It is the intent of the legislature that persons with mental illness shall have right including, but not limited to the following:

4.2.3 A right to be free from harm..."

A review and observation of the video footage was conducted with the Director or Risk Management, for March 22, 2015 (the day of the altercation). The video footage revealed that at approximately 3:48 AM an altercation between Patient 17 and Patient 18 occurred. The altercation ended when security arrived at approximately 3:52 AM and separated the two patients. CPI techniques to protect the patients and to restrain Patients 17 & 18, were not performed by hospital staff.

On June 12, 2015 at 9 AM, an interview was conducted with the Interim Vice President of Patient Care Services and Chief Nursing Officer (IVPPCSCNO). The IVPPCSCNO stated, "I think the staff was afraid."
The IVPPCSCNO also stated, "Patient's have rights."

The hospital failed to ensure the Condition of Participation: CFR 482.23 Nursing Services was met by:

Failing to ensure all patients' right to be free from harm and failed to provide appropriate and adequate supervision to all patients' in the Behavior Health Unit, when 2 patients (Patients 17 & 18) were in an altercation, as facility staff watched without intervening, in a universe of 153 (Refer to A 0392)



The cumulative effect of these systemic practices resulted in the failure of the hospital to deliver care in compliance with the Condition of Participation: Nursing Services.

Based on observation, interview and record review, the facility failed to provide appropriate and addequate supervision for two of 33 patients (Patients 17 & 18). This failure occurred when facility staff failed to intervene after Patient 17 informed the staff of the intent to kick Patient 18 in the head, for snoring. This failure resulted in an altercation between Patient 17 and Patient 18, and resulted in a lip laceration to Patient 17, which required sutures and Patient 18 sustained a kick to the head.


Findings:

On April 7, 2015, it was reported that two patients (Patient 17 and Patient 18) in the locked section of the Behavioral Health Unit (BHU), had an altercation (a heated argument) with each other. Continued documentation of the reported event revealed that on March 22, 2017, Patient 17 kicked Patient 18 in the head. Patient 17 sustained a laceration (a deep cut on the skin) to the lower lip and was taken to the ED for medical intervention and suturing (stitching) to the injured area.During an interview, on April 20, 2015 at 4:43 PM, Patient 17 stated, "Staff didn't protect me, I felt provoked into doing it (altercation)" Patient 17 was asked to explain why he felt provoked. Patient 17 stated, "I asked if I could sleep in the observation room because my roommate was snoring, I was told no." Patient 17 further stated, I went back to my room and laid on the floor. I asked again, they wouldn't move me. I told them, watch, I'm gonna kick my roommate in the head. They (staff personnel) said, 'No you won't'. I told them watch me. Patient 17 further stated, "I got angry when they told me they wouldn't move me."A review of the clinical record for Patient 17 was conducted on June 8, 2015. A review of Patient 17's face sheet (a document usually placed at the front of a patient's clinical record that provides detailed information on the patient (such as, date of birth, diagnoses, personal contacts, and billing information) from the facility indicated the patient was admitted to the behavior health unit (BHU) locked unit on March 9, 2015, with a diagnosis of schizophrenia (a mental disorder characterized by abnormal social behavior and failure to recognize what is real).

A review of Patient 17's psychiatric evaluation (a method of testing people about their behavior, personality, and capabilities), dated March 10, 2015 at 9:16 AM, under the "Mental Status Examination," documentation revealed the following: "...Perceptual disturbance: Disorganized thoughts and behavior. Speech rambling. Memory poor. Insight and judgment poor."

A review of Patient 17's nursing notes, from the date of admission to the BHU, on March 9, 2015 through March 21, 2015, revealed the following:

"March 10, 2015 at 1:14 AM-Patient is easily agitated and uncooperative during the assessment".

"March 10, 2015 at 4:33 PM-Remains paranoid (showing extreme and irrational fear or distrust of others), intrusive and unpredictable".

Further review of the nursing notes indicated, on "March 12, 2015, at 2:31 PM-Patient stating, "I don't want Iran, Iraq's and Syria or any Middle Eastern to be my doctor," patient walked out of room...noted to be aggressive and challenging staff, patient was very explosive/hostile with poor impulse control...Patient attacked a staff hitting him on the chest..."

On "March 12, 2015, at 6:49 PM-Still irritable, verbally aggressive with floor staff...cussing and hostile, don't talk to me I don't like you, remained scatted and disorganized in thoughts, started to pace rapidly in the hallway, angry, argumentative verbally threatening, 'If you keep on harassing me, I will fight you guys.' Patient very paranoid".

Nursing staff documented on "March 13, 2015 at 10:09 AM-Patient was seen by the doctor and was verbally insulting, making racial comment towards the doctor, patient stated, "I don't want Iran, Iraq and Sabas to be my doctor, I don't want to talk to him." Patient became selectively mute and walked out of the room. Patient remain disorganized with scattered thoughts, remain hostile/aggressive, verbally threatening staff, cursing and banging the phone".

Further review revealed on "March 13, 2015 at 5:26 PM-Patient was agitated, taking off his scrubs out on the unit. Patient then went over to the wall clock and attempted to pull it off the wall...patient began trying to harder to pull it off. Patient began threatening staff and posturing. Patient unable to be redirected".

Nursing staff also documented the following, "March 14, 2015 at 1:36 PM-Patient stated that he feels like hurting someone, but was not specific. Patient was agitated, took his scrub shirt off and threatening peers..., March 15, 2015 at 12:06 PM-Patient is easily irritated with poor impulse control and poor coping skills..., March 16, 2015 at 2:24 PM-Patient was involved in a verbal altercation with his roommate..., March 16, 2015 at 4:32 PM-Patient is anxious and restless pacing the unit...impulsive and unpredictable..., March 17, 2015 at 1:12 PM-Patient was seen by the doctor and remains easily irritated with poor impulse control..."

Documentation also revealed on "March 18, 2015 at 2:42 PM-Patient is hyper verbal, with rapid speech. Patient is child like. Intrusive, in need or redirection many times..., March 19, 2015 at 1:57 PM-Patient remains very delusional and disorganized with scattered thoughts..., March 20, 2015 at 2:17 PM-Continues to be disorganized/delusional with scattered thought process..., March 21, 2015 at 11:15 AM-Patient is guarded. Paranoid. Flat affect."

On June 9, 2015 at 7:29 AM, an interview was conducted with the Charge Registered Nurse (CRN 1), on duty the night of March 22, 2015, at approximately 3:48 AM, (on the day that Patients 17 & 18 were in an altercation), in the BHU locked unit. CRN 1 was asked to describe the incident on the morning of March 22, 2015. CRN 1 stated, (Patient 17's name) wanted to switch rooms because his roommate (Patient 18) was snoring, (Patient 17's name) was told he could not be moved because it wasn't an emergency. The medical healthcare worker (MHW) was making rounds and I heard her (MHW) say, "He just kicked him in the head. (referring to Patient 17 kicking patient 18 in the head)"

During the interview, CRN 1 further stated, "The fight was intense, Patient 18 was not listening at all, a 'Code Gray' (security assistance) was called." CRN 1 stated, "Blood was flying everywhere." CRN 1 further stated, "I yelled to stop, they stopped for a while but they began again (referring to fighting) around the corner."

On June 9, 2015 at 7:43 AM, an interview was conducted with Licensed Vocational Nurse (LVN 1). During the interview, LVN 1 stated he was in the nurses station when he heard someone scream. "I saw two patients (Patient 17 and Patient 18) come out of the room punching each other, using fists. LVN 1 further stated, "A Code Gray" was called, they (referring to Patients 17 & 18) weren't listening".

During the interview, LVN 1 was asked if BHU staff are taught techniques to intervene when patients are fighting. LVN 1 stated, "We try to calm them (referring to patients) down verbally, but they (referring to Patients 17 & 18) weren't listening." LVN 1 stated that they (staff) were trained in CPI/Non-violent crisis intervention (Crisis Prevention Institute - techniques used to safely manage patients who demonstrate disruptive and assaultive behavior) techniques, but we are not supposed to touch the patient." LVN 1 also stated, "They (referring to Patients 17 & 18) looked at me and had clenched fists, I backed off, we had no help, we were short staffed." LVN 1 also stated, "Staff were scared."


On June 9, 2015 at 8:10 AM, an interview was conducted with Registered Nurse (RN 1). RN 1 stated she was coming back from break (on the date of the patient altercation, March 22, 2015), a patient (referring to Patient 17) was asking to change rooms, a little while later I (RN 1) heard staff yelling, 'Help, help'."

RN 1 further stated during the interview, "The patients' (Patients 17 & 18), were angry and irritable, we attempted to verbally deescalate, they resisted and it was too dangerous for staff to intervene." RN 1 was asked if she had CPI training, RN 1 stated, "It doesn't allow to physically intervene."

On June 10, 2015 at 8:15 AM, an interview was conducted with the Vice President of Behavioral Health Services (VPBHU). The VPBHU was asked if CPI allowed "Hands on," the VPBHU stated, "You can do hands on if needed."

A review of the facility's policy and procedure "Patient Rights" for the "Behavioral Health Services," under the "Procedure" section revealed the following:

"4.0 Patient's also have Constitutional Patient Rights as listed below:

4.2 It is the intent of the legislature that persons with mental illness shall have right including, but not limited to the following:

4.2.3 A right to be free from harm..."

A review of the video footage was conducted with the Director of Risk Management, for March 22, 2015, the day of the altercation, revealed at approximately 3:48 AM an altercation between Patient 17 and Patient 18 occurred. The altercation ended when security arrived at approximately 3:52 AM and separated the two patients. Facility staff did not perform CPI techniques to restrain Patients 17 & 18.

The Director of Risk Management, Patient Relations and Patient Safety Officer (DRMPRPSO) stated on March 26, 2015 at 3:30 PM, she and the Director of the BHU, reviewed the video footage of the altercation between the two patients. The DRMPRPSO further stated, "No one (staff) intervened to stop the fight."

On June 12, 2015 at 9 AM, an interview was conducted with the Interim Vice President of Patient Care Services and Chief Nursing Officer (IVPPCSCNO). The IVPPCSCNO stated, "I think the staff was afraid."

Based on interview and document review, the hospital failed to ensure that the medical record contained a discharge summary in one inpatient surgical record within 14 days of discharge. This resulted in the inability for reviewers to have access to a summary of the patient's hospitalization.

Findings:

A concurrent interview and record review were conducted on June 10, 2015 at 9:30 AM with the Director of Health Information. The Medical Record for Patient 8 was reviewed. The electronic record was viewed on a computer with the Director of Health Information. The record was greater than 15 days post discharge. No discharge summary was present. The Director stated that, at that time, there was a problem accessing some portions of many electronic records due to the inability to transfer the records between programs.

The hospital failed to ensure the Condition of Participation: CFR 482.25 Pharmaceutical Services was met by failing to:

1. Review and update the content of emergency medications in crash carts and Malignant Hyperthermia (MH) Carts located throughout the facility and ensure the carts' content matched the committee approved list for immediate provision and administration of emergency medications. The failure to provide inadequate and inconsistent supply of emergency medications would potentially delay administration of the medications to patients undergoing cardiopulmonary arrest or facing life-threatening rapidly rising body temperature. (Refer to A 0500)

2. Develop and implement hospital's committee approved policies and procedures and necessary protocols for ordering, adjusting, and initiating medication orders by pharmacist for safe dispensing and administration of medications to the patients. (Refer to A 0500)

3. Investigate and maintain accurate records of the movement of the controlled substances in accordance with the facility's policy and procedure on controlled substance wastage. (Refer to A 0494)

4. Keep unusable medications away from patient use. (Refer to A 0505)

5. Store medications in accordance with manufacturer's directions. (Refer to A 0491)

On June 9, 2015 at 5:55 PM, Immediate Jeopardy was called in the presence of the facility President, Director of Quality Management, Vice President of Support and Clinical Services, Chief Operating Officer, Chief Medical Officer and the Vice President of Behavioral Health Services due to the hospital's failure to ensure that emergency carts were stocked with emergency medications according to the hospital's emergency kit medication list located with the carts and in the hospital's policy and procedure.

On June 10, 2015 at 3:50 PM, the Immediate Jeopardy was abated in the presence of the facility President, Senior Director of Quality/Infection Control, Interim Vice President of Patient Care Services and Chief Nursing Officer and the Corporation's Regulatory Readiness representative after an acceptable corrective action plan was presented and validated by the survey team.

The cumulative effect of this systemic practices resulted in the failure of the hospital to deliver care in compliance with the Condition of Participation: Pharmaceutical Services.

Based on observation, interview, and document review, the hospital failed to store four different medications in accordance with manufacturer's directions. This failure has the potential to expose patients that require antibiotics (medications to treat infections), have low blood sugar, need treatment for bone deterioration and migraine headaches, to medications that may not have the same potency or integrity intended by the manufacturer if stored under proper conditions. Medications not stored under proper conditions may not provide the desired effect which can lead to patient harm.

Findings:

During a tour of the Pharmacy Department on June 8, 2015, at 10:40 AM, the following medications were observed to be stored on the pharmacy medication area storage shelves available for patient use:

-Twenty-one (21) vials of ceftriaxone (a medication used to treat infections) 2 gm (gram) powder for injection in the pharmacy medication storage area shelf exposed to light.
-One vial of ceftriaxone 1 gm powder for injection on the shelf exposed to light.
-One vial of ceftriaxone 250 mg (milligram) powder for injection on the shelf exposed to light.
-Two (2) vials Glucagen (a medication used to treat low blood sugar) powder for injection on the shelf exposed to light.
-Three (3) sumatriptan (a medication used to treat migraine headaches) 6 mg syringes on the shelf exposed to light.
-One box of calcitonin salmon (a medication used to treat osteoporosis (a disease in which bone deteriorates)) nasal spray on the shelf at room temperature.

According to the current 2015 package insert (a document from the manufacturer providing detailed information regarding the medication) for the ceftriaxone observed on the shelf, manufactured by Hospira, Inc., under the section for "Storage", it stipulates, "Powder for injection: Prior to reconstitution ...... Protect from light."
According to the current 2015 package insert for Glucagen observed on the shelf, manufactured by Bedford Laboratories, under the section "Storage", it stipulated , "Before reconstitution: .......Keep in the original package to protect from light."
According to the current 2015 package insert for sumatriptan observed on the shelf, manufactured by Sagent Pharmaceuticals, under the section for "Storage", it stipulates, "Protect from light."
According to the current 2015 package insert for calciton salmon observed on the shelf, manufactured by Apotex Corp., under the section for "Storage", it stipulates, "Store unopened bottle under refrigeration at 2°C (Celsius) to 8°C (36°F (Fahrenheit) to 46°F); do not freeze."

During a concurrent interview, the Manager of Pharmacy (MP) acknowledged that the ceftriaxone, Glucagen, and sumatriptan were exposed to light and should have been placed back in their respective boxes or light protective containers. He stated, "I will talk with the technicians about putting those meds back on the shelf", referring to these medications that require protection from light. When discussing calciton salmon in the presence of MP and Director of Pharmacy (DP), they acknowledged that the medication should be stored in the refrigerator prior to use by a patient. MP stated, "We didn't receive it in a refrigerated container" indicating that they cannot determine how long the medication has been out of refrigeration.

Review of the hospital's policy & procedure titled, "Safe Storage of Medications", Policy No.8390.222 with the effective date of "6/74" and revised date of "1/15", stipulated under the "Policy" section: "Medications will be stored under appropriate conditions to maintain medication integrity..... All medications will be stored in accordance with all applicable laws and regulations and manufacturer's guidelines." Further, under the section "Procedures", subsection 3.0, it stipulates, "Medications requiring refrigeration will be stored at the appropriate temperature as per manufacturer's guidelines."

Based on interview and document review, the facility failed to ensure accurate accounting of controlled substances was kept by investigating and resolving two discrepancies in waste documentation in a timely manner in accordance with the facility's policy and procedure to potentially minimize the drug diversion. This deficient practice had the potential to result in controlled substance diversion not being identified which could lead to health care practitioner substance abuse. Health care practitioners under the influence of controlled substances has the potential to lead to patient harm for the patients they are treating.

Findings:

Review of the facility's policy and procedure titled, "Controlled Substances" indicated as one of the monitoring of controlled substance, controlled substance waste documentation audit would be conducted monthly to ensure waste of controlled substances would be accurately documented and accounted for. It also stipulated, "Diversion monitoring reports will also be sent to the Nurse Manager (or designee) for investigation and follow up. The Nurse Manager will review and investigate and report all findings to the Director of Pharmacy (DP) or Designee within 7 days..."

Review of the audit records for March 2015, and April 2015, and May 2015, identified discrepancies in documented administration of controlled substances without proper waste documentation indicating that identified discrepancies were not followed up with the respective manager of the nursing unit.

During an interview on June 12, 2015, at 3 PM, DP stated that the identified discrepancies for above months were not communicated to the nursing manager and there was no follow up.

Based on observation, interview, and document review, the facility failed to ensure the Pharmacy controlled and distributed medications in a safe manner to protect patients, in a universe of 153 by:

1. Failing to review and update the content of emergency medications in 28 emergency supply carts, including adult and pediatric "crash carts", and Malignant Hyperthermia (MH-a life-threatening condition in which certain medications can trigger a hypermetabolic state characterized by increased temperature, heart rate, and respiratory rate) carts located throughout the facility. The hospital also failed to ensure the carts' content matched the Pharmacy & Therapeutics Committee approved list of emergency medications. This failure to provide adequate and consistent supplies of emergency medications would potentially delay or allow incorrect dose administration of medications to patients with life-threatening cardiopulmonary (heart and lungs) events.

On June 9, 2015 at 5:55 PM, Immediate Jeopardy was called in the presence of the facility President, Director of Quality Management, Vice President of Support and Clinical Services, Chief Operating Officer, Chief Medical Officer and the Vice President of Behavioral Health Services due to the hospital's failure to ensure that emergency carts were stocked with emergency medications according to the hospital's emergency kit medication list located with the carts and in the hospital's policy and procedure.

On June 10, 2015 at 3:50 PM, the Immediate Jeopardy was abated in the presence of the facility President, Senior Director of Quality/Infection Control, Interim Vice President of Patient Care Services and Chief Nursing Officer and the Corporation's Regulatory Readiness representative after an acceptable corrective action plan was presented, validated, and approved, by the survey team.

2. Develop and implement hospital's committee approved policies and procedures and necessary protocols for ordering, adjusting, and initiating medication orders by pharmacist for safe dispensing and administration of medications to the patients.


Findings:

1. Emergency crash carts contain emergency medications and supplies necessary for immediate treatment of emergency cardiac (heart) or respiratory (lungs) events. Malignant Hyperthermia (MH) carts contain medications and supplies necessary for immediate treatment of rapid rise in body temperature and increased heart/respiratory rate that could result in patient death if not treated.

On June 8, 2015, at 4 PM, it was observed that the Crash Cart located in PACU (Post-Anesthesia Care Unit-an area where patients recover after surgical procedures) the following differences between the actual medication content of the Crash Cart and the content list provided outside the cart were noted:

Crash Cart Medications Drawer #1 listing:
Two Sodium Bicarbonate (a medication used to adjust a patient's acid/base ( acidity of the blood balance) 7.5% 50 ml (milliliter) syringes.

Observed to be available in the drawer:
One Sodium Bicarbonate 8.4% 50 ml syringe and one 7.5% 50 ml syringe.

Crash Cart Medications Drawer #2 listing:
Two Naloxone (a medication used for narcotic drug overdose) 1 mg (milligram)/ml, 1 ml amp(ule).
Five Amiodarone (a medication used for abnormal heart rhythm) 150 mg.

Observed to be available in the drawer:
Two Naloxone 0.4 mg/ml, 1 ml vials.
Four Amiodarone 150 mg injectable vials.

Crash Cart Medications Pediatric Drawer listing:
Two Sodium Bicarbonate 7.5% Adult, 50 ml syringes.
Two Lidocaine (a medication used for abnormal hearth rhythm) 2% 100 mg 10 ml syringes.

Observed to be available in the drawer:
Two Sodium Bicarbonate 8.4% 50 ml syringes.
Two Lidocaine 2% 100 mg 5 ml syringes.

Also observed in the cart were two vials of Adenosine (a medication used for abnormal heart rhythm) 6 mg/2 ml which matched the content list.

The content list outside the MH Cart indicated that five Sodium Bicarbonate 7.5% 50 ml syringes, two from the Crash Cart and another three from the Omnicell (an automated drug dispensing cabinet containing medications).

During a concurrent interview, the Pharmacy Manager (PM), stated that the medication content of the crash carts were based on ACLS (Advanced Cardiac Life Support-a set of interventions for life-threatening emergency medical situations) guidelines.

The PM also stated that "1 amp" meant 50 ml of sodium bicarbonate irrespective of the strength of the medications and that 7.5% and 8.4% were interchangeable.

The Manager of Pharmacy (MP) acknowledged that content list did not match the actual medications kept inside the Crash Cart.

The MP did not indicate he was aware of the ACLS guidelines dosing (which recommend three vials) of Adenosine and know why there was only two vials of Adenosine 6 mg/2 ml in the Crash Cart.

On June 9, 2015, at 10:30 AM, a Crash Cart located in GI (Gastrointestinal) Lab Unit was inspected and it was observed there were two 8.4% Sodium Bicarbonate 50 ml syringes instead of 7.5% on the content list, four vials of amiodarone 150 mg instead of five vials, two vials of naloxone 0.4 mg/ml instead of two vials of naloxone 1 mg/ml.

During a concurrent interview, the MP acknowledged that there were inconsistencies between the actual medication content in the Crash Cart and the content list.

On June 9, 2015, at 9:51 AM, the crash cart in the Intensive Care Unit 1 was inspected. It was observed that it contained one Dopamine 400 mg/250 ml injection instead of Dopamine 250 mg/250 ml on the content list, four Amiodarone 150 mg/3 ml vials instead of five vials on the content list, and two Naloxone 0.4 mg/ml vials instead of 2 naloxone 1 mg/ml ampules on the content list.

During a concurrent interview with the DP, in regards to the naloxone, she stated, "That should not be in there. I'm going to speak with my technician about that." She then removed the tray label with technician identifying information (date filled, initials).

On June 9, 2015, at 10:14 AM, the crash cart in the Pediatrics Unit was inspected. The following observations were made:

Crash Cart Pediatrics Drawer listing:
One Lidocaine 2% 10mL syringe
Two Sodium Bicarbonate 7.5% 50mL ampule

Observed to be available in the drawer:
Two Lidocaine 2% 5mL syringes
Two Sodium Bicarbonate 8.4% 50mL ampules

Crash Cart Drawer #2 listing:
One Dopamine 250mg/250mL bag
Two Naloxone 1mg/mL ampules
Five Amiodarone 150mg vials

Observed to be in the drawer:
One Dopamine 400mg/250mL bag
Two Naloxone 0.4mg/mL vials
Four Amiodarone 150mg vials

On June 9, 2015, at 10:32 AM, the crash cart in the Couplet Care Unit was inspected. The following observations were made:

Crash Cart Pediatrics Drawer listing:
One Lidocaine 2% 10mL syringe
Two Sodium Bicarbonate 7.5% 50mL ampule

Observed to be available in the drawer:
Two Lidocaine 2% 5mL syringes
Two Sodium Bicarbonate 8.4% 50mL ampules

Crash Cart Drawer #2 listing:
One Dopamine 250mg/250mL bag
Two Naloxone 1mg/mL ampules
Five Amiodarone 150mg vials

Observed to be in the drawer:
One Dopamine 400mg/250mL bag
Two Naloxone 0.4mg/mL vials
Four Amiodarone 150mg vials

On June 9, 2015, at 11:00 AM, the crash cart in the Neonatal Intensive Care Unit was inspected. The following observations were made:

Crash Cart Drawer #1 listing:
Two Sodium Bicarbonate 7.5% 50mL ampule

Observed to be available in the drawer:
Two Sodium Bicarbonate 8.4% 50mL ampules

Crash Cart Drawer #2 listing:
One Dopamine 250mg/250mL bag
Two Naloxone 1mg/mL ampules
Five Amiodarone 150mg vials
Two Magnesium Sulfate 50% 10mL vial

Observed to be in the drawer:
One Dopamine 400mg/250mL bag
Two Naloxone 0.4mg/mL vials
Four Amiodarone 150mg vials
One Magnesium Sulfate 50% 20mL vial


On June 9, 2015, at 3 PM, a Crash Cart in ED (Emergency Department) was inspected and it was observed there were two Sodium Bicarbonate 8.4% 50 ml syringes instead of two Sodium Bicarbonate 7.5% 50 ml syringes on the content list, one bag of Dopamine (a medication used to increase blood pressure) 400 mg/250 ml instead of one bag of Dopamine 250 mg/250 ml, only two vials of adenosine 6 mg/2 ml, four vials of naloxone 0.4 mg/ml instead of two vials of naloxone 1 mg/ml, and four vials of amiodarone 150 mg instead of five vials.

It was also observed in the same cart a pediatric tray containing two vials of atropine 0.4 mg/ml to replace the two unavailable pediatric atropine 0.25 mg/5ml syringes due to drug shortage.

During a concurrent interview with Registered Nurse 4 (RN 4), he was asked to calculate atropine dose for a 15 kg patient using the two vials of atropine available in the pediatric medication tray. RN 4 retrieved a Broselow tape (a color-coded tape measure that relates a child's height as measured by the tape to his/her weight to provide medication dosages) from the cart, placed a paper hand towel on the patient bed, and began calculating the dose. Once completed, he stated, "I don't think I have enough" and left the room to speak with another nurse. It took RN 4 approximately 3 minutes to correctly calculate the dose. RN 4 was asked again to calculate a dose for a 37 kg patient. He calculated the dose and stated, "I want to confirm the dose with another nurse", and left the room. Upon returning, he supplied the correct answer, but asked, "Is that correct?", indicating that he was not sure of the answer. The process also took several minutes.

On June 12, 2015, 1:45 PM, RN 4's personnel record was reviewed which indicated RN 4's ACLS and PALS (pediatric Advanced Life Support) certification were up to date.

During an interview on June 9, 2015, at 3:30 PM, the Emergency Department Director (EDD) was interviewed. He was asked why the crash carts in the facility have only 2 vials of Adenosine 6mg/2mL (12mg total) instead of the recommended 18mg in current ACLS guidelines. He stated that he did not follow the ACLS guidelines and that for non-life-threatening supraventricular tachycardia with narrow complex (an abnormal heart rhythm typically identified by an elevated heart rate), he would use a Adenosine 12 mg dose only because that first dose "will tell me if it works or not". The EDD was also asked whether he was concerned about having only two vials of naloxone 0.4mg (0.8mg total) in the crash carts instead two ampules of naloxone 1mg on the content list and recommended by ACLS guidelines. The EDD stated that he would only use 0.4 mg of naloxone which would be "more than enough" and would not use any more than that due to withdrawal symptoms.

When asked about the references and/or literature supporting the different dosing of above medications, the EDD was not able to provide the supporting document for use of emergency medications that didn't correspond with the ACLS guidelines.

The EDD also stated that he was part of the committee that approved the Crash Cart content list which required crash carts to contain the specific medications listed.

During a concurrent interview, RN 5 stated that in code situation, the physician would call out 1 amp of "bicarb" to indicate 50 ml of Sodium Bicarbonate 8.4% and that he would not use the 7.5% and was not aware that strength existed.

During a concurrent interview, EDD also agreed that 1 amp of "bicarb" would mean one 50 ml 8.4% Sodium Bicarbonate syringe and that 8.4% and 7.5% Sodium Bicarbonate are not the same.

Review of the facility's policy and procedure titled, "Code Blue/Do Not Resuscitate (DNR) Protocol" dated 05/89, last revised on 4/14 stipulated,

"Cardiopulmonary Arrest - Patient Care Area
Team Leader...Takes ACLS medications from cart as appropriate...
ED RN attends all Code Blue (a medical emergency in which a team of medical health personnel work to revive an individual in cardiac arrest) code used in hospitals calls house wide with the exception of Code Blue calls in the ICCU (Intensive Critical Care Unit)...
In the absence of a physician, interprets cardiac (heart) rhythm, follows ACLS guidelines as related to treatment of arrhythmia (irregular heartbeat), defibrillates (apply electric shock to the chest to restore a regular heartbeat) if necessary..."

Review of the facility's policy and procedure titled, "Emergency Drug Supply" dated 7/85, last revised on 3/15 stipulated,

"To provide a supply of drugs for use in emergency situations that will be secure and readily available in all patient care areas.

Pharmacy restock of medication containers for the cart.

The pharmacy will restock each portable container with the appropriate medication upon its return."

In 2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science Part 8: Adult Advanced Cardiovascular Life Support
2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care, "Adenosine. If PSVT (Paroxysmal supraventricular tachycardia - episodes of rapid heart rate that start in a part of the heart above the ventricles {2 large chambers of the heart which collect and expel blood}) does not respond to vagal maneuvers (an action used to slow down the heart rate by stimulating the vagus nerve), give 6 mg of IV (intravenous - in the vein) adenosine as a rapid IV push through a large (eg, antecubital) vein followed by a 20 mL saline flush (Class I, LOE B (guidelines to assist in decision making for emergency cardiac events)). If the rhythm does not convert within 1 to 2 minutes, give a 12 mg rapid IV push using the method above."

According to nationally recognized drug reference & the hospital's electronic drug reference, Lexicomp, and the manufacturer's package insert, naloxone is given for opioid (a specific human body receptor that relays pain) medication overdose with standard ACLS protocols,

"IV (intravenous - in the vein), IM (intramuscular - in the muscle), SubQ (subcutaneous - below the skin): Initial: 0.4 to 2 mg; may need to repeat doses every 2 to 3 minutes; after reversal, may need to readminister dose(s) at a later interval (ie, 20 to 60 minutes) depending on type/duration of opioid. If no response is observed after 10 mg total, consider other causes of respiratory depression."

The California Department of Public Health issued a guidance in 2005 in regards to the provision of emergency medication in the AFL (All Facilities Letter) 05-02 which stipulated,

"This letter is intended to provide guidance for the establishment, storage and use of emergency medications.

Ensure approved policies and procedures are developed establishing the content of emergency supplies, procedures for use, restocking and sealing the emergency supply. The policies and procedures should be current, based on clinical standards of practice and periodically reviewed.

The type and quantity of emergency medications should be sufficient to manage different patient types (neonatal (recently born), pediatric, adult), weights and clinical conditions (i.e. malignant hyperthermia, cardiac or pulmonary resuscitation).

If clinical guidelines are used to facilitate medication and dosage selection (e.g., Pediatric Advance Life Support, Broselow ®, Advanced Cardiac Life Support, etc.) the medications contained in each cart must match the clinical guidelines.

The emergency medications contained in each cart should contain standard concentrations to prevent confusion in dosage calculations.

The content list must accurately and comprehensively reflect all medications in the cart.

All personnel who might utilize emergency medication carts should be familiar with the contents and how to use the medications and supplies."

The Broselow system for pediatric resuscitation is a color coded tape system that uses a child's body length to determine their weight in kilograms (kg), the correct medication doses to be used, and the appropriate sized supplies to use when resuscitation is necessary.

ISMP (Institute for Safe Medication Practices) is the nation's only nonprofit organization devoted entirely to medication error prevention and safe medication use. From the ISMP Medication Safety Alert! Acute Care Edition, February 10, 2011 issue, safe practice recommendations to reduce potential medication errors from the use of emergency medication supplies:

"Require the pharmacy & therapeutics (P&T) or critical care committee to approve emergency drug references provided on carts and the emergency medications stocked in the carts, including concentrations, container sizes, and quantities.

Provide drugs in ready-to-use syringes/premixed solutions as much as possible to avoid error-prone calculations and mixing of medications during codes. Limit the availability of multiple-dose vials.

Provide all medications required in current ACLS/PALS protocols in code carts. Do not stock medications not required in protocols if they can easily be accessed from the unit stock.

Stock pediatric and neonatal emergency drug exchange trays/drawers with pediatric-specific and neonatal specific formulations of drugs (e.g., atropine, sodium bicarbonate, dextrose) that match pediatric and neonatal protocols and dosing guidelines (e.g., Broselow tape) used in the organization."

Due to the failure to maintain accurate emergency medications in Crash Carts in the hospital to immediately treat victims of cardiopulmonary emergencies in accordance with the nationally recognized organizations and the facility's policy and procedure, and failure to bring the policy and procedure that reflected the most current standards for provision of emergency medications and their use that could potentially delay timely administration of emergency medications, an IJ (Immediate Jeopardy) was called on June 9, 2015 at 5:55 PM, in the presence of the facility President, Director of Quality Management, Vice President of Support and Clinical Services, Chief Operating Officer, Chief Medical Officer and the Vice President of Behavioral Health Services.


On June 10, 2015 at 3:15 PM, hospital administration provided an acceptable plan of immediate action that included:

The emergency Drug Supply policy was revised to include the updated content lists to be posted on the outside of the emergency carts.

The revised policy was reviewed and approved by the Chief Nursing Officer, Director Pharmacy/Pharmacy and Therapeutics, Medical Executive Committee and Governing Body.
Pharmacy staff were provided education regarding the revisions crash cart policies and procedure related to Emergency Drug Supply and medication content lists.

100% (28) crash carts were inventoried and the revised medication content lists were place on each art and the medications were reconciled.

Crash cart medication memorandum was developed and distributed to all medical staff, nursing staff, pharmacy staff and cardiopulmonary staff advising of the key crash cart changes: Adenosine 6 mg/2 ml vial quantity increased to 5 vials, Sodium Bicarbonate prefilled syringe concentration changed to 8.4%. The 0.4 mg/ml of Narcan (naloxone) was replaced by a Narcan 1 mg/ml. The Code Blue Team (ED Physician, ED RN, Respiratory Therapist and House Supervisor and Public Safety Officer) received Just in Time training to reinforce the key crash cart changes: Adenosine 6 mg/2 ml vial quantity increased to 5 vials, Sodium Bicarbonate prefilled syringe concentration changed to 8.4%.

Nursing Huddles were conducted to provide verbal updates to reinforce the key crash cart changes: Adenosine 6mg/2ml vial quantity increased to 5 vials, Sodium Bicarbonate prefilled syringe concentration changed to 8.4%.

After verification of the changes to the content of the Crash Carts, staff education records and revisions of policy and procedure were reviewed, the IJ was abated on June 10, 2015 at 3:50 PM, in the presence of the facility President, Senior Director of Quality/Infection Control, Interim Vice President of Patient Care Services and Chief Nursing Officer and the Corporation's Regulatory Readiness representative.

2. During an interview on June 8, 2015, at 3:20 PM, Pharmacist (P1) stated that in addition to Pharmacy monitoring, adjusting doses and ordering laboratory tests per approved protocol, the pharmacists would dose medications ordered by physicians for the pharmacist to dose.

P1 stated that most of the medications the physicians requested for pharmacists to dose were antibiotics, but did not indicate there was a facility approved protocol or guidelines for pharmacists to adjust or initiate a physician order for the pharmacist to dose antibiotics.

P1 indicated that she had received such orders and that they were entered as protocol orders and the physicians would not need to cosign or authenticate such orders.

During an interview on June 8, 2015, at 3:30 PM, MP stated that the facility did not have a renal (kidney) dosing guidelines or protocols for antibiotics based on the patient's kidney function.

During an interview on June 9, 2015, at 10:10 AM, P2, a pharmacist, stated that she had received "Pharmacy to dose" orders before and that only a few physicians, including an infectious disease physician, would enter the order in the computerized physician ordering system (CPOE). P1 stated that calculations and initial dosing of the requested medications for pharmacy to dose would be done using available drug references and would be entered in CPOE as a protocol order.

P2 also stated that "Pharmacy to dose" orders that were initiated and dosed by a pharmacist did not require physician authentication or co-signature.

Review of Patient 29's electronic medical record indicated that there was a physician order for "Pharmacy to dose" Levaquin (a medication to treat infections) IV (intravenous - in the vein) on June 5, 2015, at 2:45 PM. There was an order entered by a pharmacist as a protocol order on June 5, 2015, at 2:58 PM for Levofloxacin (generic name for Levaquin)/D5W (5% dextrose in water) 500mg (milligram)/100ml (milliliters) to be infused every 48 hours.

Review of Patient 30's electronic medical record indicated that there was a physician order for "Pharmacy to dose" TB (tuberculosis - a bacterial infection typically affecting the lungs) medications, INH (isoniazid), rifampin, PZA (pyrazinamide) and ethambutol by mouth now and daily on June 4, 2015, at 3:25 PM. There were four orders entered by a pharmacist as protocol orders on June 4, 2015, at 3:36 PM.:

Ethambutol 400 mg tablet, three tablets (1200 mg total) by mouth daily.
Pyrazinamide (PZA) 500 mg tablet, three tablets (1500 mg total) by mouth daily.
Rifampin 300 mg capsule, two capsules (600 mg total) by mouth daily.
Isoniazid (INH) 300 mg tablet, one tablet (300 mg total) by mouth daily.

During an interview on June 10, 2015, at 5:30 PM, P3, stated that "Pharmacy to dose" orders were always accepted and orders written/entered in CPOE. P3 stated that she was not aware of any protocol that allowed pharmacists to dose antibiotics on behalf of physicians upon "Pharmacy to dose" orders.

During an interview on June 12, 2015, at 10 AM, DP acknowledged that the practice initiating and dosing upon physician's "Pharmacy to dose" did not reflect accurately the current facility's policy and procedure.

Review of the facility's policy and procedure titled, "Therapeutic Drug Monitoring" dated "8/94", last revised on "11/14" stipulated,

"The licensed pharmacist is responsible for therapeutic drug monitoring as ordered by the physician.

A pharmacist will monitor therapeutic drug levels, as per approved protocols, ordering necessary laboratory tests, drug levels and making recommendations and appropriate changes in therapy.

All orders written or entered electronically by a pharmacist pursuant to this approved protocol will be signed, in writing or electronically, by the licensed pharmacist, per approved protocol, and do not require a physician co-signature as approved by Pharmacy and Therapeutics and Medical Executive Committees."

The above policy and procedure did not address initiating or dosing by pharmacists per "Pharmacy to dose order" by physicians and the facility did not have a protocol to address such orders.

The Policy and Procedure references California Business and Professions Code 4052.1 and 4052.2 which stipulated,

"4052.1(a) Notwithstanding any other provision of law, a pharmacist may perform the following procedures or functions in a licensed health care facility in accordance with policies, procedures, or protocols developed by health professionals, including physicians, pharmacists, and registered nurses, with the concurrence of the facility administrator:
(4) Initiating or adjusting the drug regimen of a patient pursuant to an order or authorization made by the patient ' s prescriber and in accordance with the policies, procedures, or protocols of the licensed health care facility.
(b) Prior to performing any procedure authorized by this section, a pharmacist shall have received appropriate training as prescribed in the policies and procedures of the licensed health care facility.

4052.2(a) Notwithstanding any other provision of law, a pharmacist may perform the following procedures or functions as part of the care provided by a health care facility... in accordance with the policies, procedures, or protocols of that facility...
Initiating or adjusting the drug regimen of a patient pursuant to a specific written order or authorization made by the individual patient ' s treating prescriber, and in accordance with the policies, procedures, or protocols of the health care facility...
Prior to performing any procedure authorized by this section, a pharmacist shall have done either of the following:
(1) Successfully completed clinical residency training.
(2) Demonstrated clinical experience in direct patient care delivery."

American Society of Health-System Pharmacists (ASHP), a respected nationally recognized pharmacist organization, stated in its publication, ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals,

"Medication Therapy Decisions. The pharmacist's prerogatives to initiate, monitor, and modify medication therapy for individual patients, and to order laboratory tests to exercise those responsibilities, consistent with laws, regulations, and hospital policy, shall be clearly delineated and approved by the appropriate committee (e.g., P&T, patient care, or medical executive committee)."

Review of the facility's policy and procedure titled, "Who May Prescribe Medication" dated "5/70", last revised on "11/14" stipulated,

"No drug will be administered to a patient except by authorized, licensed personnel upon the order of a member of the medical staff, or other individual who has been granted privileges order medications...pharmacists may prescribe under protocol approved by a physician with approved staff privileges or as permitted by approved standardized procedure."

On June 12, 2015, at 1:30 PM, review of the Pharmacy Department's Pharmacist Annual Competency for 2013, 2014, and 2015 for P3, and for 2015 for P1 did not indicate "Pharmacy to dose" was addressed.

Based on observation, interview, and document review, the facility failed to ensure three unusable medications were not available for patient use by removing them from the current active and available medication storage area/shelves. This failure had the potential to expose patients requiring hydration and mineral replacement or breathing treatment, to medications that may not have the same potency or integrity intended by the manufacturer due to medications being used past their expiration date. Expired medications may not provide the desired effect which can lead to patient harm.

Findings:

During a tour of the Pharmacy Department on June 8, 2015, at 10:40 AM, the following medications were identified as either expired or not usable on the Pharmacy shelves along with other usable medications:

-One 1000 ml (milliliter) large injectable bag containing Normal Saline (NS-a fluid used for improving hydration in a patient) with 20 MEq (milliequivalents) Potassium Chloride (KCl: a medication used to supplement potassium) without the protective outer plastic wrap.
-One 1000 ml large injectable bag containing 40 MEq KCl in 5% (percent) Dextrose and 0.45% NS (with the labeled date of May 6, 2015.
-Five 3 ml plastic vials containing Levalbuterol (inhalation solution for patients having difficulty breathing) 0.63 mg (milligrams) inside the open foil pouch without the open date.

During a concurrent interview, the Director of Pharmacy (DP) acknowledged that the medications should not have been kept beyond what the manufacturers' recommendation.
According to the facility provided letter dated, June 27, 2006 from the manufacturer of NS with 20 MEq KCl 1000ml bag, B. Braun,

"The EXCEL 500 ml and 1000 ml size containers without any additions can be stored at 25°C (degree centigrade) for three months without their plastic overwraps..."

According to the facility provided letter dated, October 4, 2013,from the manufacturer of D5%-0.45%NS with 40 MEq KCl, Baxter Healthcare Corporation, the maximum time out of overwrap for container volume 100 ml or greater was 30 days.

According to the current 2015 package insert (a document produced by the manufacturer that includeds detailed information for the use of a medication) for Levalbuterol, the solution for nebulization,

"Store in protective foil pouch at 20°C to 25°C (68°F to 77°F). Protect from light and excessive heat. Vials should be used within 2 weeks after opening protective pouch."

Review of the facility's policy and procedure titled, "Outdated Drug Control" stipulated,

"The Department of Pharmacy will ensure that no outdated medications are dispensed for patient use or allowed to remain in the dispensing are of the pharmacy or in a patient care area of the hospital."