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.

ARROWHEAD REGIONAL MEDICAL CENTER 400 NORTH PEPPER AVENUE COLTON, CA 92324 March 2, 2015
VIOLATION: NURSING SERVICES Tag No: A0385
The hospital failed to ensure the Condition of Participation: CFR 482.23 Nursing Services was met by failing to:

1. Ensure Registered Nurse's supervised and evaluated the nursing care of patients. (Refer to A-0395)

2. Ensure the patients plan of care was developed, implemented and revised as needed. (Refer to A-396)

3. Ensure nursing staff prepared and administered drugs in accordance with the facility's policy and procedure. (Refer to A-0405)

4. Ensure intravenous (IV) medications were administered in accordance with State law and approved medical staff policy and procedure. (Refer to A-0409)

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.
VIOLATION: RN SUPERVISION OF NURSING CARE Tag No: A0395
Based on interview and record review, the hospital failed to ensure a Registered Nurse (RN) accurately assess and evaluated 1 of 40 patients (Patient 26). This failure occurred when the patient's right hand began to swell, after an intravenous (IV) infiltration (accumulation of fluid under the skin/tissue), became painful developed an infection within the hand and required multiple surgeries and a skin graft.

Findings:

A record review for Patient 26, revealed the patient presented to the emergency department (ED) on March 23, 2014 with a cough and fever. On March 24, 2014 Patient 26 was subsequently admitted to the telemetry unit for possible pneumonia (infection within the lungs). Further documentation revealed Patient 26 had a history of Diabetes Mellitus (abnormal blood sugar levels) and hypertension (high blood pressure).

A review of Patient 26's nursing notes dated March 26, 2014, at 7:30 PM, revealed the following:
"...No IV site at this time. Endorsed by day shift RN that patient pulled out IV..."

A review of the Patient 26's physician's progress notes dated March 27, 2014, revealed "March 27, 2014 at 7 AM, "Ext (extremity): Moderate swelling of (R) right hand beginning at the distal (back) forearm."

A review of Patient 26's nursing notes dated March 27, 2014, revealed no documented evidence could be located to indicate that nursing staff assessed Patient 26's right hand.

Continued review of Patient 26's physician progress notes dated March 29, 2014 at 9 AM, "Pt's (patient's) only complaint is some mild hand pain...Pt complains of (R) hand swelling, but denies swelling elsewhere."

Patient 26's physician progress notes dated March 29, 2014 at 11:35 AM, documentation revealed "(R) hand swelling check d-dimer (a lab test use for the presences of a thrombosis/clot). If (+/positive) u/s (ultrasound)"

A review of Patient 26's nursing notes dated March 28, 2014 and March 29, 2014, revealed no documented evidence could be located to indicate that nursing staff assessed the patient's right hand.

Patient 26's physician progress notes dated March 30, 2014 at 2 AM, revealed "(R) hand and arm 7/10 pressure pain....(R) hand swelling-likely 2/2 (secondary to) infiltrate from IV..."

Additional physician progress notes for Patient 26 dated March 30, 2014 at 12:30 PM, stated "(R) hand pain/swelling...pulled out IV...u/s (R) UE (upper extremity) to be done today 2/2 increased d-dimer...continue ice/elevation. Pulse 2+ and with good cap (capillary) refill."

Nursing notes dated March 30, 2014 for Patient 26, revealed no documented evidence that nursing staff assessed the patient's right hand.

A nursing note dated March 31, 2014 at 3:01 AM revealed "Pt (patient) has a blister-like swelling at the back of his right (R) hand. The area is opened with a skin tear. No additional documentation could be located that nursing staff informed the patient's physician of the blister-like swelling at the back of his right (R) hand.

No additional documentation could be located within Patient 26's medical record from March 26, 2014 to March 31, 2014 to indicate the RNs' caring for the patient assessed the infiltration site.

A review of Patient 26's medical record revealed during the patient's hospital stay March 23, 2014 to May 29, 2014, Patient 26 had 5 surgeries and a skin graft for an infection/abscess of the right dorsal hand and forearm which resulted from the patient pulling out his IV.

On February 25, 2015 at 10:05 AM, an interview was conducted with RN 8, the Assistant Nurse Manager (ANM) of the Telemetry unit, at the time of the incident (March 2014). During the interview with RN 8, RN 8 stated, "Documentation could have been better," in regard to the (R) hand injury.

As the interview continued with the ANM, the ANM was asked if any photos were taken of Patient 26's right hand infection/wound/abscess. The ANM stated "The practice is to take pictures of pressure ulcers," this wasn't a pressure ulcer so no pictures of the patient's right hand/arm were taken."
VIOLATION: NURSING CARE PLAN Tag No: A0396
Based on interview and record review, the hospital failed to ensure the plan of care for 1 of 40 patients (Patient 26) was revised and kept current. This failure occurred when the plan of care was not updated/revised timely following the self removal of the patient's right hand interavenous line (IV - used to administer fluids and medications through a vein), which created right hand swelling, pain, infection over the IV site, and multiple surgeries. This failure had the potential to result in staff not being informed of Patient 26's care needs.

Findings:

A record review for Patient 26, revealed the patient presented to the emergency department (ED) on March 23, 2014 with a cough and fever. On March 24, 2014, Patient 26 was subsequently admitted to the telemetry unit for possible pneumonia (infection within the lungs). Further documentation revealed Patient 26 had a history of Diabetes Mellitus (abnormal blood sugar levels) and hypertension (high blood pressure).

A review of Patient 26's nursing notes dated March 26, 2014, at 7:30 PM, revealed the following:
"...No IV site at this time. Endorsed by day shift RN that patient pulled out IV..."

A review of Patient 26's physician progress notes revealed the following documentation:
a. March 27, 2014 at 7 AM, "Ext: Moderate swelling of (R) right hand beginning at the distal forearm."

b. March 29, 2014 at 9 AM, "Pt's (patient's) only complaint is some mild hand pain...Pt complains of (R) hand swelling, but denies swelling elsewhere."

c. March 29, 2014 at 11:35 AM, "(R) hand swelling check d-dimer (a lab test use for the presences of a thrombosis/clot). If (+/positive) u/s (ultrasound)"

d. March 30, 2014 at 2 AM, "(R) hand and arm 7/10 (out of) pressure pain....(R) hand swelling-likely 2/2 (secondary to) infiltrate from IV..."

e. March 30, 2014 at 12:30 PM, "(R) hand pain/swelling...pulled out IV...u/s (R) UE (upper extremity) to be done today 2/2 increased d-dimer...continue ice/elevation. Pulse 2+ and with good cap (capillary) refill."

f. March 31, 2014 (no time on progress note), "(R) hand pain/swelling....obtain wound care consult."

g. March 31, 2014 at 10:20 PM, "(R) hand pain, swelling, xray no fracture (break), morphine PRN (as needed), u/s will be done today. Ortho (bone specialist) consult r/o septic joint vs other."

h. April 1, 2014 (no time on progress note), "increased swelling from (R) hand up to the elbow."

i. April 1, 2014 at 10:45 AM, "(R) hand pain/edema, (R) UE u/s negative...possible surgery today if needed for consideration of abscess/septic joint, keep NPO (nothing by mouth)."

j. April 2, 2014 at 7 AM, "(R) hand swelling down..."

k. April 3, 2014 at 11:40 AM, "(R) hand cellulitis/abscess. Yesterday appeared to be responding to abx (antibiotic-Clindamycin), worsening status today, purulent discharge full of pus, + fever, increased WBC (white blood count), disorientation. Will take to OR (operating room) today.

A review of Patient 26's initial plan of care for "Risk for Infection...", dated March 24, 2014, revealed the plan of care was not updated until April 5, 2014, 10 days after the physician first documented in the progress notes that the patient had "Moderate swelling of (R) right hand beginning at the distal forearm," and 2 days after the patient underwent a surgical procedure "Irrigation and debridement (I & D) right dorsal hand and forearm abscesses."

Record reviews on February 25, 2015 of Patient 26's discharge summary, dictated on June 6, 2014, revealed that during the course of the patient's hospital stay, from March 23, 2014 to May 29, 2014, Patient 26 had 5 surgeries and a skin graft for an infection/abscess of the right dorsal hand and forearm which resulted from the patient pulling out his IV.

On February 25, 2015 at 10:05 AM, an interview was conducted with RN 8, the Assistant Nurse Manager (ANM) of the Telemetry unit, at the time of the incident (March 2014). During the interview with RN 8, RN 8 stated, "The care plan should have been updated," in regard to the (R) hand injury.

A review of the hospital's "Policy No. 600.02 Issue 4," titled "Plan of Care-Interdisciplinary," under the "Policy" section revealed the following:

"The development, implementation, and maintenance of the patient's plan of care is an interdisciplinary process.

Further documentation on the P & P revealed:

"c. The RN utilizes the nursing process to develop the Plan of Care as follows:
6) Evaluation: .... The Plan of Care is reviewed daily (every 24 hours in med-surg), every shift, prior to transfer to another unit, with any change in the patient's condition, and prior to discharge."
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on observation, interview and record review, the hospital failed to:

1. Ensure medications were given in accordance with facility policy & procedure and standards of practice.

2. Ensure that medications were administered according to the prescriber's order, 1 of 40 sampled patients were effected by deficient practice at this regulation.

These failures resulted when 1 of 40 sampled patients (Patient 5) was administered three medications ordered to be given by mouth, via an NG tube (naso-gastric tube, a tube inserted through the nose to administer medications and feedings) that did not adhere to hospital policy and procedure. These failures could potentially lead to Patient 5 not receiving the full dose of the medication and not the way the prescriber intended.

3. The hospital also failed to ensure nursing staff prepared and administered drugs in accordance with the facility's policy and procedure.

This failure resulted when 1 of 40 sampled patients (Patient 25) was administered Phenytoin (Dilantin-a medication used for the control of seizures) intravenous push (IVP-medication gets into the bloodstream quickly) on a medical surgical unit, not approved to administer the medication. This failure resulted in Patient 25 developing a right hand soft tissue injury with an unstageable (full thickness skin or tissue loss-depth unknown) wound with superficial necrosis (death of a portion of a tissue due to lack of blood flow) when the IV infusing the Phenytoin extravagated (administered into the skin) and not into the vein.

Findings:

1. On February 25, 2015 at 9 AM, a medication pass was observed in the 2 South unit of the hospital. Registered Nurse (RN) 1 prepared three medications for administration via an NG tube for Patient 5. These medications were ASA (aspirin-a medication used to reduce clotting of the blood) 81 mg (milligram) tablet, enalapril (a medication used to reduce blood pressure) 5 mg tablet, and gabapentin (a medication used for seizures) 300 mg capsule.

The nurse was observed crushing the ASA and enalapril in their unit dose packaging and placing the contents in individual cups. The gabapentin capsule was opened and the contents placed in a cup as well. The nurse then took the cups to the sink and placed each cup under the faucet and turned the water on. Not all water was captured by the cups and the force of the water caused it to splash out of the cup and into the drain, potentially including medication. The nurse then placed the cups on the counter and proceeded to prepare the NG tube.

At the patient's bedside, the nurse used an empty syringe and injected air into the NG tube. She then placed the 3 cups of medication on a tray and pulled the contents of one of the cups into the syringe. She then injected the contents into the NG tube. It was observed that she did not flush (a sudden rush/flow) the tube prior to this first medication. After the contents were injected, the nurse flushed the NG tube with approximately 10 mL (milliliters) of water. The nurse then repeated the procedure for cups 2 and 3, flushing with approximately 10 mL (approximately 200 drops) of water after each medication.

In an interview with RN 1 immediately after the medication pass observation, the RN was asked if she always uses the sink to fill the cups with water and dissolve the medications. She said that she did notice the water splash out and stated, "That was my mistake." She was also asked if she flushed the NG tube prior to the first medication given NG tube, she stated, "No", and indicated that she had done it earlier in the day. When asked how much she used to flush between each medication and the final flush, she stated, "10-20 mL."

In an interview with the Director of Pharmacy and the RN Education Services Supervisor on February 26, 2015 at approximately 9 AM, it was asked if the facility has a policy & procedure on administering medications via NG tube. The RN Education Services Supervisor stated that the facility uses the Perry/Potter Clinical Nursing Skills & Techniques in regards to administering medications via NG tube. This was referenced in a facility policy & procedure #555.01 titled Enteral (within the stomach) Tube Feeding Procedure.

A review of the Perry/Potter Clinical Nursing Skills & Techniques article shows that after checking placement of the NG tube and prior to administering medications, the nurse should "Draw up 30 mL (600 drops) of water into syringe. Reinsert tip of syringe into tube, release clamp, and flush tubing." The article further states, "Follow last dose of medication with 30 to 60 mL of water."

2. On February 25, 2015 at 9 AM, a medication pass was observed in the 2 South unit of the hospital. Registered Nurse 1 administered two medications via an NG tube for Patient 5. These medications were ASA 81 mg tablet, and gabapentin 300 mg capsule.

Following the medication pass, the patient's medical record was reviewed with the Director of Pharmacy. The patient's active (current) medication list and physician orders, showed an order for ASA 81 mg PO (by mouth) QD (daily). Also listed as a current medication was gabapentin 300 mg PO TID (3 times daily). The Director of Pharmcy was asked if the pharmacy reviews medication orders for accuracy of route over the period of a patient's admission, he stated they did not.





3. A record review for Patient 25, revealed the patient was admitted to the medical surgical unit of the hospital on February 1, 2015 with aspiration pneumonia (infection in the lungs caused by foreign material, usually food particles). Further documentation revealed Patient 25 had a history of [DIAGNOSES REDACTED] (a disorder affecting muscle tone), seizure disorder, was non-verbal and dependent on others for nutrition and medications.

A review of the admitting physician orders dated February 1, 2015, revealed an order for the patient to receive Phenytoin 100 milligrams (mg) intravenous (IV) Q6hrs (every 6 hours).

A review of nursing notes dated February 8, 2015 at 8:30 AM, documentation revealed the following:

"On assessment, noted right hand swollen, removed IV site dressing and noted reddened, tender to touch. Stopped IVF (fluid) infusion and immediately removed IV. Elevated right hand and applied cold compress. Patient's sister at bedside and made aware that IV infiltrated (administered into the skin, not into the vein) and new IV access needed..."

A review of the hospital's policy and procedure "Policy No. 584.00 Issue 10, Revised 2/1/14, Section: V. General Nursing Policies and Procedures (P&P), Subject: Intravenous Medication Administration," under the "Policy" section documentation states the following:

"Intravenous (IV) medications are administered by Registered Nurses following scope of practice regulations, infection control standards, and patient safety guidelines."

Continued review of the policy and procedure (P & P) documentation under the "Purpose" section states "To provide guidelines for accurate and safe administration of IV medications."

Further review of the P & P under "Approved Drug List for Nursing Intravenous Administration of Drugs," under the "Intravenous Push," section, the column for the medical-surgical unit was blank, which indicated that Phenytoin was not allowed to be given IVP in the medical-surgical units.

Continued review of the P & P under the "Administration/Adverse Reaction/Monitoring section, documentation stated, "Use filtered needle (creates a one-way flow when withdrawing fluid into the syringe, redirects the fluid through a second filter during injection. Medication is filtered both on the way in and out of the syringe)" during the administration of the Phenytoin."

On February 24, 2015 at 9:50 AM, an interview was conducted with Nurse Manager (NM) 2 and Assistant Nurse Manager (ANM) 2. During the interview, ANM 2, confirmed Patient 25 was given Phenytoin IVP by 5 Registered Nurses (RN) while the patient was on the medical-surgical unit. ANM also indicated that the Phenytoin was not supposed to be administered on the medical-surgical unit.

On February 24, 2015 at 3 PM, Patient 25 was in the Internal Medicine Out Patient Clinic for a follow-up visit with her physician following her discharge from the hospital on February 19, 2015. Consent was obtained from the patient's sister and mother to observe the patient's hand. During an interview with the patient's sister (translating for spanish speaking mother), the sister stated the skin on the patient's right hand had been peeling off. When asked if the patient was in pain, the sister asked the patient's mother who stated she gives the patient Ibuprofen (pain medication) approximately 3 times a day. Observation of the patient's hand revealed the hand was purple with a 1 inch by 1 inch dark area noted.

A review of the physician's report dated February 24, 2015 under the "History of Present Illness" section, documentation revealed the following:

"Suffered from R (right) hand soft tissue injury from Rx (prescription-Dilantin) extravasation presents to clinic for post hospital discharge follow up. Per family, the R hand looked increasingly purple for the last few days, it was originally red."

Further documentation of the physicians report dated February 24, 2015 under the "Exam" section, documentation under the "Skin" section stated the following:

"R dorsal (back side) hand 3 centimeters (cm) x 4 cm escar (piece of dead tissue)..."

Continued review of the physician report under the "Assessment/Plan" section revealed the following:

"IV infiltration...R hand cold and cyanotic (blue or purple coloration of the skin or due to the tissues near the skin surface having low oxygen saturation) (Doctor's name) discussed his concerns with (Doctor's name) the ED (emergency department) atttending on duty....request that the pt (patient) needs a hand surgeon...Advised pt and family to seek ER (emergency room ) care ASAP (as soon as possible), clinic nurse will guide pt and family to ER.

A review of the "Emergency Treatment Record, dated February 24, 2015 revealed the following documentation:

"(+) escar 4.5 cm x 2 cm....Necrosis (R) hand....follow up with burn clinic in am."

A review of the "Emergency Department Nursing Notes," documentation under the "Nursing Narrative Notes," dated February 24, 2015 at 5:51 PM, revealed the following:

"(+) necrotic area noted on (R) hand with redness measuring 6 1/2 cm x 4 1/2 cm, necrotic tissue alone measuring 4 1/2 cm x 2 cm, (+) foul odor.

Further review of the "Nursing Narrative Notes," dated February 24, 2015 at 7:10 PM, revealed the following:

"Black escar to top of (R) hand with mild redness....awaiting burn resident for consult."

Continued review of the "Nursing Narrative Notes," dated February 24, 2015 at 7:30 PM documentation revealed "Burn resident (specialist) at bedside examining patient." At approximately 8:50 PM, the patient was discharged from the emergency department, with discharge instructions to contact the burn clinic the following day to schedule a same day appointment.


On February 24, 2015, at 3:30 PM, an interview was conducted with RN 2. During the interview RN 2 confirmed she administered Phenytoin IVP to Patient 25. As the interview continued RN 2 stated she referenced the P & P and understood it (the P & P) that she could give the medication IVP.


As the interview continued with RN 2 on February 24, 2015 at 3:30 PM, RN 2 stated, "I used 2 syringes." RN 2 stated she withdrew 1 milliliter (ml), 1/2 (half) of the Phenytoin from the vial into a syringe and then withdrew 1 ml of normal saline (NS) using the same syringe that contained the 1 mg of Phenytoin in order to dilute the mixture. RN 2 stated she repeated the process for a total use of 2 syringes. RN 2 further stated, "I gave it very slow." RN 2 was asked if she placed a filter on the 2 syringes prior to administering the Phenytoin, RN 2 responded, "No."

No documented evidence could be located which indicated the physician ordered the Phenytoin to be diluted.

On February 25, 2015 at 8 AM, an interview was conducted with RN 3. RN 3 confirmed that she administered Phenytoin IVP to Patient 25. During the interview RN 3 was asked if she referenced the hospital's P & P prior to administering the Phenytoin to Patient 25, RN 3 stated, "No." RN 3 was asked if she contacted pharmacy prior to administering the medication, RN 3 responded, "No."

As the interview continued RN 3 stated she used a 6 cubic centimeter (cc) syringe to administer the Phenytoin. RN 3 further stated, "I mixed the Phenytoin (100 mg in 2 ml) with 4 cc's of NS." During the interview, RN 3 was asked if she placed a filter on the syringe mixture of Phenytoin and NS, RN 3 stated, "No."

No documented evidence could be located which indicated the physician ordered the Phenytoin to be diluted.

On February 26, 2015 at 7:50 AM, an interview was conducted with RN 4. RN 4 confirmed that she administered Phenytoin IVP to Patient 25 while patient was on the medical-surgical floor. During the interview RN 4 was asked if she referenced the hospital's P & P prior to administering the Phenytoin, RN 4 stated, "No." RN 4 was further asked if if she placed a filter on the syringe prior to administering the medication, RN 4, responded, "No."

On February 26, 2015 at 8:18 AM, an interview was conducted with RN 5. RN 5 confirmed that she administered Phenytoin IVP to Patient 25 while the patient was on on the medical-surgical floor. RN 5 was asked if she referenced the hospital's P & P in regard to the administration of Phenytoin, RN 5 stated, "No."

During the interview, RN 5 stated, "I used a 10 cc syringe," further stating that I mixed the Phenytoin 100 mg in 2 ml with 8 cc's of NS for a total of 10 cc's. RN 5 was asked if she placed a filter on the syringe prior to administering Patient 25, the Phenytoin/NS mixture, RN 5 stated, "No."

No documented evidence could be located which indicated the physician ordered the Phenytoin to be diluted.

There was no documented evidence in Patient 25's medical record, to indicate a filtered needle was used in the nurse's administration of the Phenytoin.


On February 25, 2015, Patient 25 was seen in the surgery clinic regarding the wound on her right hand. A review of the "Surgery Clinic Educational Note, dated February 25, 2015 at 1:50 PM, documentation revealed the following:

"Visiting for wound check of (R) dorsal hand necrosis....from IV placement infiltration."

Further review of the "Surgery Clinic Educational Note," revealed the following:

"Unstageable wound with superficial necrosis on posterior (R) hand...daily Santyl application to hand with wet to dry gauze for debridement (the medical removal of dead, damaged, or infected tissue to improve healing)." Clinic follow up in 2 weeks.
VIOLATION: BLOOD TRANSFUSIONS AND IV MEDICATIONS Tag No: A0409
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview and record review, the hospital failed to ensure intravenous (IV-administered into the skin, not into the vein) medications were administered in accordance with the facility's policy and procedure (P &P) as evidenced by:

1. Patient 25, was administered Phenytoin (medication used for control of seizures) via intravenous push (IVP) on a medical surgical floor, which was not allowed per the hospital's P & P. This failure resulted in the patient developing a right hand soft tissue injury with an unstageable (full thickness skin or tissue loss-depth unknown) wound with superficial necrosis when the Phenytoin extravasagated (infiltrated-administered into the skin) and not into the vein.

2. Registered Nurse's preparing/compounding (a practice in which a licensed pharmacist or a person under the supervision of a licensed pharmacist, combines, mixes, or alters ingredients, tailored to the needs of an individual patient), IV medications without the consultation or supervision of pharmacy or complying with the hospital policy and procedures.

These failures caused harm and also placed patients at risk for harm if medications are not prepared and administered properly.

Findings:

1. Patient 25 was admitted to the medical surgical unit of the hospital on February 1, 2015 with aspiration pneumonia (infection in the lungs caused by foreign material, usually food particles). Further documentation revealed Patient 25 had a history of [DIAGNOSES REDACTED] (a disorder affecting muscle tone), seizure disorder, was non-verbal and dependent on others for nutrition and medications.

A review of the admitting physician orders dated February 1, 2015, revealed an order for the patient to receive Phenytoin 100 milligrams (mg) IV Q6hrs (every 6 hours).

A review of nursing notes dated "February 8, 2015 at 8:30 AM, documentation revealed the following:

"On assessment, noted right hand swollen, removed IV site dressing and noted reddened, tender to touch. Stopped IVF (fluid) infusion and immediately removed IV. Elevated right hand and applied cold compress. Patient's sister at bedside and made aware that IV infiltrated and new IV access needed..."

Continued review of the patient's medical record revealed physician notes which document that the patient experienced a Phenytoin extravasation, which resulted in the patient developing a right hand soft tissue injury with an unstageable wound with superficial necrosis, a surgical consult and daily wound care.

On February 24, 2015 at 9:50 AM, an interview was conducted with Nurse Manager (NM) 2 and Assistant Nurse Manager (ANM) 2, at which time ANM 2, confirmed Patient 25 was given Phenytoin IVP by 5 Registered Nurses (RN) while the patient was on the medical-surgical unit.

On February 24, 2015, at 3:30 PM, an interview was conducted with RN 2. During the interview RN 2 confirmed she administered Phenytoin IVP to Patient 25 while the patient was on the medical-surgical unit, RN 2 further stated that she referenced the P & P for the preparation and administration of Phenytoin and understood it (the P & P) that she could give the medication IVP.

During the interview, RN 2 was asked to describe how she administered the IVP Phenytoin, RN 2 stated, "I used 2 syringes." RN 2 stated she withdrew 1 milliliter (ml), 1/2 (half) of the Phenytoin 100 mg/2 ml from the vial into a syringe and then withdrew 1 ml of normal saline (NS) using the same syringe which contained the 1 mg of Phenytoin in order to dilute the mixture. RN 2 stated she repeated the process for a total use of 2 syringes. RN 2 further stated, "I gave it very slow." RN 2 was asked if she placed a filter (creates a one-way flow when withdrawing fluid into the syringe, redirects the fluid through a second filter during injection. Medication is filtered both on the way in and out of the syringe) on the 2 syringes prior to administering the IVP Phenytoin, RN 2 responded, "No."

No documented evidence could be located which indicated the physician ordered the Phenytoin to be diluted.

On February 25, 2015 at 8 AM, an interview was conducted with RN 3. During the interview RN 3 was asked if she referenced the hospital's P & P for the preparation and administration of Phenytoin, prior to actually administering the Phenytoin to Patient 25, RN 3 stated, "No." RN 3 was asked if she contacted pharmacy or spoke with her colleagues prior to administering the medication, RN 3 responded, "No." RN 3 was asked if the patient was on the medical-surgical floor at the time of the IVP Phenytoin administration, RN 3 stated, "Yes."

As the interview continued RN 3 stated she used a 6 cubic centimeter (cc) syringe to administer the Phenytoin. RN 3 further stated, "I mixed the Phenytoin (100 mg/2 ml) with 4 cc's of NS." During the interview, RN 3 was asked if she placed a filter on the syringe mixture of Phenytoin and NS prior to administering the medication, RN 3 stated, "No."

No documented evidence could be located which indicated the physician ordered the Phenytoin to be diluted.

On February 26, 2015 at 7:50 AM, an interview was conducted with RN 4. During the interview RN 4 confirmed that she administered IVP Phenytoin to Patient 25 while the patient was on the medical-surgical unit. RN 4 was asked if she referenced the hospital's P & P prior to administering the Phenytoin, RN 4 stated, "No." RN 4 was also asked if if she placed a filter on the syringe prior to administering the medication, RN 4, responded, "No."

On February 26, 2015 at 8:18 AM, an interview was conducted with RN 5. RN 5 confirmed that she administered Phenytoin IVP to Patient 25 while the patient was on on the medical-surgical floor. RN 5 was asked if she referenced the hospital's P & P in regard to the administration of Phenytoin, RN 5 stated, "No."

During the interview, RN 5 stated, "I used a 10 cc syringe," further stating that I mixed the Phenytoin 100 mg in 2 ml with 8 cc's of NS for a total of 10 cc's. RN 5 was asked if she placed a filter on the syringe prior to administering Patient 25, the Phenytoin/NS mixture, RN 5 stated, "No."

No documented evidence could be located which indicated the physician ordered the Phenytoin to be diluted.

A review of the hospital's policy and procedure "Policy No. 584.00 Issue 10, revised 2/21/14, Section: V. General Nursing Policies and Procedures, Subject: Intravenous Medication Administration," under the "Policy" section documentation states the following:

"Intravenous (IV) medications are administered by Registered Nurses following scope of practice regulations, infection control standards, and patient safety guidelines."

Continued review of the P & P documentation under the "Purpose" section states "To provide guidelines for accurate and safe administration of IV medications."

Further review of the P & P under "Approved Drug List for Nursing Intravenous Administration of Drugs," under the "Intravenous Push," section, the column for the medical-surgical unit was blank, which indicated that Phenytoin was not allowed to be given IVP in the medical-surgical units.

Continued review of the P & P under the "Administration/Adverse Reaction/Monitoring section, documentation stated, "Use filtered needle" during the administration of the Phenytoin."

2. On February 25, 2015 at approximately 9 AM, a preparation and administration of medications for Patient 29 was observed. During the medication preparation and administration Registered Nurse (RN) 6 was observed to draw up Lasix (a diuretic) 40 milligrams (mg)/4 milliliters (ml) into a 6 cubic centimeter (cc) syringe. Immediately after the observation RN 6 was observed to remove the cap from the pre-filled syringe of normal saline (NS) and insert the Lasix filled syringe needle into the small hole of the NS pre-filled syringe and withdraw 2 cc of NS into the Lasix 40 mg/4 ml.

An interview was conducted with RN 6 immediately following the observation of RN 6 placing NS into the Lasix syringe, RN 6 was asked why she added NS to the Lasix syringe, RN 6 responded, "I don't like to give it (the Lasix) raw." RN 6 was asked to explain what "Raw" meant, RN 6 stated, "the medication is too concentrated," further stating I dilute it (the Lasix) so it won's irritate the patient's vein.

On February 25, 2015 at 2:15 PM, an interview was conducted with Nurse Manager (NM) 1. NM 1 was informed of the observation of RN 6 diluting the IV Lasix with NS, and RN 6 stating she doesn't like to give it "Raw." NM 1 was asked if she was aware that RN 6 was administering IV Lasix in that manner and changing the constitution (the structure) of the medication NM 1 stated, "No."

On February 25, 2015 at approximately 2:35 PM, an interview was conducted with RN 6 in the presence of NM 1. RN 6 was asked why she added NS to the Lasix syringe, RN 6 responded, "I don't like to give it (the Lasix) raw," stating that the medication was to concentrated and dilutes it so it won't irritate the patient's vein. RN 6 was asked if the patient's physician was aware that the Lasix was not being administered as prescribed, RN 6 stated, "No, but I don't understand how adding NS is wrong." NM 1 informed RN 6 that she could not change the consistency of the medication without informing the patient's physician.

A review on February 25, 2015, of the hospital policy, "Intravenous Medication Administration, Policy NO. 584.00 Issue 10, revised on 2/1/14", under the section, "IV's WITH MEDICATION", indicated, "The Department of Pharmacy is responsible for compounding IV admixtures 24-hours a day..."
VIOLATION: PHARMACY ADMINISTRATION Tag No: A0491
Based on observation, interview, and record review, the hospital failed to:

Ensure that drugs were only dispensed by a licensed pharmacist and that the pharmacy maintained control (oversight) over medications in drug storage areas.

These failures resulted in medications not being handled according to hospital policy and procedure, and potentially administered to the patient inappropriately, without the oversight of an expert in drug therapy such as a pharmacist.

Findings:

On February 24, 2015 at 8 AM, a tour of the hospital's offsite clinic was conducted. An inspection of the drug storage room included a refrigerator that contained vaccine medications.

In an interview on February 24, 2015 at 8:30 AM, with the Director of Pharmacy and the RN (Registered Nurse) Care Manager for the clinic, the care manager stated they participate in the VFC (vaccines for children) program. When asked what the process was for ordering and receiving the vaccines, she stated, "The nurse orders the vaccines from the program when we get low." She was asked who receives the medication and she stated that a clinic nurse signs for it. When asked what they do with the vaccine after signing for it, she stated that they immediately put it in the refrigerator. When asked if the vaccine is immediately available for patient administration, she stated that it was. The Director of Pharmacy was asked whether the pharmacy was reviewing the medication prior to dispensing and he stated that a pharmacist does come to the clinic once a month to review storage, but that, "We should be looking at it."

A facility policy and procedure regarding Pharmaceutical Purchasing, titled "Receiving of Medication Shipments," dated May 2014, and numbered 9.9 issue 2, states, "Non-controlled (drugs/medications not held under strict governmental control) and controlled (a drug/medication-commonly understood to include narcotics, which have a potential for abuse or addiction and is held under strict governmental control), medication shipments are reviewed and signed by a pharmacist immediately upon arrival and in the presence of a courier." During an interview with the Director of Pharmacy on February 25, 2015 at 3 PM, he was asked if the facility was compliant with their facility policy & procedure 9.9 issue 2. he stated, "No", and that they were looking at ways to receive the vaccines at the pharmacy and deliver them to the clinic instead.
VIOLATION: PHARMACIST RESPONSIBILITIES Tag No: A0492
Based on observation, interview, and record review, the hospital failed to follow hospital policy and procedure and ensure that a pharmacist was involved in routine competency assessment of nursing personnel performing medication compounding (to combine, mix, or alter medications). This resulted in the potential for nursing personnel to not be trained in compounding of medications which could lead to medication errors.

Findings:

On February 25, 2015, at 9 AM, a medication pass observation was conducted. Registered Nurse (RN) 1 was observed preparing a sterile compound of Phenytoin (a medication used for seizures) 100 mg (milligram)/2 mL (milliliter) single dose vial and a bag of 100 mL normal saline (a fluid used for diluting medications to give via the vein) for Patient 5.

A review of a facility policy & procedure regarding IV admixture, titled "Intravenous Admixture (the action of mixing) Service," revised April 2014, numbered 6.1 issue 3, has a section titled "Personnel Training and Evaluation in Aseptic (preventing infection Manipulation Skills". Under a subsection titled "Nursing Personnel Orientation & Education," the policy states, "The Director of Pharmacy in collaboration with Nursing leadership determine procedures for providing training, education and competency assessment of nursing staff preparing compounded sterile products."

In an interview with the Director of Pharmacy and RN Education Services Supervisor on February 27, 2015 at 11:45 AM, the Director of Pharmacy was asked how he collaborates with nursing leadership to determine procedures for competency assessment of nurses that prepare compounded sterile products. He stated that pharmacy routinely does in-services to nursing regarding drug issues. When asked if pharmacy is involved in assessing competency of nurses compounding sterile products, he answered that he was not aware. The RN Education Services Supervisor was asked whether nurses are routinely assessed for competency of preparing sterile products. She shook her head that they were not.
VIOLATION: PATIENT SAFETY Tag No: A0286
Based on observation, interview and record review, the hospital's Quality Assessment and Performance Improvement (QAPI) program, failed to identify, measure, track and reduce patient safety, medical errors and adverse patient events as evidenced by:

1. The QAPI program failed to analyze and investigate adverse events.

2. Failed to ensure nursing policy and procedures were followed, which lead to the infiltration of an intravenous medication, causing harm to a patient.

3. Failed to ensure a written contract/agreement regarding the provisional services between the hospital and deputies caring for patients in custody was in existence.

These failures created harm and the potential for harm to occur if not identified and investigated.

Findings:

1. On February 27, 2015 at 2:10 PM, an interview was conducted with members of the hospitals QAPI committee. During the meeting the QAPI members were asked if they were aware of a case involving Patient 26, in which the patient developed an infection to his right hand from an infiltrated IV, Patient 26 underwent 5 irrigations/debridements (the surgeon reopens an already present wound which is infected, washes it out with a sterile solution, removes any dead tissue that is causing the infection, and closes the wound again) and a skin graft (a patch of skin that is removed by surgery from one area of the body and transplanted (attached) to another area) surgery.

The QAPI members who included the Chief Nursing Officer, Quality Improvement Manager, Medical Staff Services Manager, the President-Elect of QMC and the Patient Safety physician, stated they became aware of the incident but only after the survey team identified the issue.

As the interview continued with the QAPI committee, the members were asked if any photos were taken of Patient 26's right hand infection/wound/abscess. The members confirmed no photos were taken, further stating the hospital's protocol per their policy and procedure stated photos were only taken for pressure ulcers.

The QAPI committee members stated the standard for an unusual occurrence is any provider can report and then it is reviewed by Risk Management and elevated as needed.

On February 24, 2015 at 2 PM, an interview was conducted with the Assistant Hospital Administrator (AHA). During the interview with the AHA, the AHA was asked if the unusual occurrence event had been reported to the California Department of Public Health (CDPH). The AHA stated, "It did not come across my desk," the AHA further stated a report of the incident was never made to CDPH..

2. During an interview with the members of the QAPI committee conducted on February 27, 2015 at 2:10 PM, the members were informed an observation, interview, and record review for Patient 25 was conducted.

During the record review it was confirmed that Patient 25 was administered Phenytoin IV push, while on the medical-surgical unit. The QAPI members were also informed that hospital policy and procedure prohibited nursing staff to administer Phenytoin IVP on the medical-surgical unit.

The QAPI members were asked if prior to the immediate jeopardy being called in regards to nursing staff administering Phenytoin IVP on medical-surgical units if the QAPI committee members had identified the practice of administering IVP Phenytoin, the QAPI members stated, "It was not identified until the survey team identified the practice."

3. During the QAPI meeting held on February 27, 2015 at 2:10 PM, confirmation was received which indicated a written contract/agreement regarding the provisional services between the hospital and deputies caring for patients in custody was not in existence until the survey team identified the issue. The AHA replied "we do not have one. The Deputies are County employees and as a result there has never been a contract with the Sheriff's Department."

A review of the hospital's policy and procedure, entitled "Prisoners in Detention Unit-Management of," with revision date of February 22, 2011, it is stipulated under Procedures 2, "The County Deputy Sheriff will: J. Deputy Sheriffs assigned to the Medical Center guard detail will be expected to comply with regulations governing hospital employees."
VIOLATION: PHARMACEUTICAL SERVICES Tag No: A0490
The hospital did not ensure the Condition of Participation: CFR 482.25 Pharmaceutical Services was met by failing to:

1. Ensure nursing staff prepared and administered drugs in accordance with the facility's policy and procedure and standards of practice. (Refer to A-0405, A-0409)

2. Ensure drugs were only dispensed by a licensed pharmacist and that the pharmacy maintain control over drugs and biologicals in medication storage areas. (Refer to A-0491)

3. Follow the facility's policy and procedure and ensure that a pharmacist was involved in the routine assessment of nursing personnel performing medication compounding. (Refer to A-0492)

4. Ensure that compounding of medications (a practice in which a licensed pharmacist or a person under the supervision of a licensed pharmacist, combines, mixes, or alters ingredients, tailored to the needs of an individual patient), was done under the supervision of a pharmacist. (Refer to A-0501)

5. Ensure that outdated medications weren't available for patient use. (Refer to A-0505)

On February 26, 2015 at 10:15 AM, an Immediate Jeopardy was called in the presence of the Chief Nursing Officer, Assistant Hospital Administrator (AHA)-Accreditation and Licensure, and the Pharmacy Director due to the facility's failure to ensure medications were prepared and administered according to the facility's policy and procedure. This failure resulted in a patient developing a right hand soft tissue injury with an unstageable wound with superficial necrosis.

On February 27, 2015 at 3:42 PM, the Immediate Jeopardy was abated in the presence of the AHA after an acceptable corrective action plan (a plan developed by the facilty to remove the immediacy of the situation) was presented to the survey team.

The cumulative effect of these systemic practices resulted in the failure of the hospital to meet the pharmaceutical needs of the hospital's patients in accordance with the Condition of Participation: Pharmaceutical Services.
VIOLATION: GOVERNING BODY Tag No: A0043
The hospital failed to ensure the Condition of Participation: CFR 482.12 Governing Body was met by failing to:

1. To ensure that a written contract/agreement regarding the services between the hospital and deputies caring for patients in custody was in existence. (Refer to A-0083, A-0286)

2. Inform custodial patients or their representative, of their rights, prior to receiving care. (Refer to A-0117)

3. To ensure custodial patients were free from unnecessary restraints. (Refer to A-0154)

4. To ensure the QAPI program analyzed and investigated adverse events. (Refer to A-0286, A-0395, A-0396)

5. Failed to ensure nursing staff prepared and administered drugs in accordance with the facility's policy and procedures and standards of practice. (Refer to A-0286, A-0405)

6. Ensure Registered Nurse's supervised and evaluated the nursing care of patients. (Refer to A-0395)

7. Ensure the patients plan of care was developed, implemented and revised as needed. (Refer to A-0396)

8. Ensure intravenous (IV) medications were administered in accordance with State law and approved medical staff policy and procedure. (Refer to A-0405, A-0409)

9. Ensure drugs were only dispensed by a licensed pharmacist and that the pharmacy maintain control over drugs and biologicals in medication storage areas. (Refer to A-0491)

10. Follow the facility's policy and procedure and ensure that a pharmacist was involved in the routine assessment of nursing personnel performing medication compounding. (Refer to A-0492)

11. Ensure that compounding of medications was done under the supervision of a pharmacist. (Refer to A-0501)

12. Ensure that outdated medications weren't available for patient use. Refer to A-0505)

The cumulative effect of these systemic practices resulted in the failure of the hospital to deliver care in compliance with the Condition of Participation: Governing Body.
VIOLATION: CONTRACTED SERVICES Tag No: A0083
Based on interview and record review the hospitals Governing Body failed to ensure a signed agreement and/or a contract was in effect for the provision of services for patients in custody between the hospital and the Sheriff's Department. This failure had the potential to cause patient harm due to inconsistencies in care and responsibilities.

Findings:

On February 25, 2015 at approximately 10 AM the Assistant Hospital Administrator (AHA) was asked for a copy of the contract with the Sheriff's Department for the provision of custodial services (maintaining watch/guard duties) for patients in custody. The AHA replied "we do not have one. The Deputies are County employees and as a result there has never been a contract with the Sheriff's Department."


On February 25, 2015 at 3:45 PM, an interview was conducted with a Deputy (D1) on duty for the custodial patients on 5-North. Deputy 1, was asked how assignments are determined and who was responsible for oversight of custodial patients. D1 replied, "depending on who is on that day and how many inmates (patients in custody) we have, we will evenly distribute the load." D1 was asked if there was an agreement/contract in place between the hospital and the Sheriff's Department. D1 replied, "I don't know of one."

On February 27, 2015 at approximately 10:30 AM, an interview was conducted with the Hospital Risk Manager regarding if the Governing Body was aware there was no contract/agreement in place between the hospital and the Sheriff's Department.


During record review of hospital Policy and Procedure, entitled "Prisoners in Detention Unit-Management of," with revision date of February 22, 2011, it is stipulated under Procedures 2, "The County Deputy Sheriff will: J. Deputy Sheriffs assigned to the Medical Center guard detail will be expected to comply with regulations governing hospital employees."
VIOLATION: PATIENT RIGHTS Tag No: A0115
The hospital failed to ensure the Condition of Participation: CFR 482.13 Patient's Rights was met by failing to:

1. Inform custodial patients (individuals who are guarded by law enforcement) or their representative, of their rights, prior to receiving care. (Refer to A-0117)

2. To ensure that custodial patients were free from unnecessary restraints (a device used to keep one from moving an extremity). (Refer to A-0154)

The cumulative effect of these systemic practices resulted in the failure of the hospital to deliver care in compliance with the Condition of Participation: Patient's Rights.
VIOLATION: PATIENT RIGHTS: NOTICE OF RIGHTS Tag No: A0117
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the hospital failed to inform 5 custodial patient's (individuals who are guarded by law enforcement-Patients 8, 11, 12, 17 and 19) or their representative, in a universe of 40 sampled patients, of their rights, prior to receiving patient care. This failure had the potential to not allow patients to exercise their rights to receive and/or discontinue treatment.

Findings:

On February 24, 2015 at 1:57 PM, a concurrent record review and interview with the Assistant Nurse Manager (ANM) 1 of 5-North. ANM 1 stated that the consent to treat in the medical record for Patient 8 was not signed. Patient 8 had been admitted to the hospital on February 17, 2015, alert and oriented and had the ability to sign a consent.

On February 24, 2015 at 3:40 PM, a concurrent record review and interview with the Nurse Manager (NM) 1 for 5-North, stated that for Patients 11 and 12, that their medical records did not have signed consents to treat. Patient 11 had been admitted to the hospital on February 18, 2015, and had the ability to sign a consent at that time. Patient 12 was admitted on [DATE], and had the ability to sign a consent the following day. NM 1 stated that Patients' 11 and 12's medical records did not have signed consents.

On February 25, 2015 at 1:55 PM, a meeting was conducted with Hospital Admitting Manager (HAM) regarding Patient 17 and 19 who did not have signed consents to treat in their respective charts. Patient 17 had been admitted on [DATE] and had the ability to sign a consent at that time. Patient 19 had been admitted to the hospital on January 5, 2015, was unable to sign a consent to treat, however his family member had signed for a subsequent procedure (a gastrostomy feeding tube), but did not sign a consent form. The admission log was requested, however; the HAM did not provide a copy of the admission log for review but stated, "we will follow up on all consents and get their signatures."

Upon record review of the hospital Policy and Procedure entitled "Admission and Authorization Procedures," with a last revision date of April 2, 2014, under Procedure B. Patient General Consent for Treatment (Inpatient or Outpatient) documentation revealed the following:

7. "Note If 'general consent for treatment' is not obtained secondary to emergent situation with patient and/or patient unable to sign--this information is documented in both the Admission Log (for inpatients only) and in Meditech (medical information technology).

9. Supervision and/or Lead clerical staff audit the inpatient admission log daily and proactively work to obtain consent on admitted patients who were unable to sign consent at the onset of admission. At the earliest possible opportunity, the lead clerk in Bed Management is notified of any inpatient still needing signed consent. Lead clerk in Bed Management facilitates this 'late' consent process."
VIOLATION: USE OF RESTRAINT OR SECLUSION Tag No: A0154
Based on observation and interview, the facility failed to ensure that 2 custodial patients (individuals who are guarded by law enforcement-Patients 11 and 19) were restrained by shackles (similiar to handcuffs) to only one extremity per the hospitals policy and procedure. This failure had the potential to cause harm and delay in release of shackles during emergent situations, putting custodial patients in jeopardy (danger).

Findings:

On February 24, 2015 at 3:15 PM, during an interview with Nurse Manager (NM 1) of 5-North regarding custodial patients being shackled. When asked if custodial patients were shackled to one extremity per hospital policy and procedure, NM 1 replied "the deputies apply shackles to both ankles then attach the shackle to the bed. They (the deputies) started doing this (shackles to both ankles) after one prisoner escaped--he had on only one ankle shackle."


On February 25, 2015 at 1:55 PM, during an observation custodial Patients 11 and 19 were shackled on both ankles and to the bed.


On February 25, 2015 at 1:45 PM, an interview was conducted with Deputy (D2) in the jail ward. D2 demonstrated how shackles were applied to both ankles, then the shackle was attached to the patients bed. D2 stated that "We (deputies) make rounds at a minimum of every two hours to those custodial patients not in the jail ward. At the time of our rounds we also check that the shackles are secure to both ankles."

During review of hospital Policy and Procedure entitled "Prisoners in Detention Unit-Management of," revision date of February 22, 2011, under Procedures documentation revealed the following:

"The County Deputy Sheriff will...
C. Patients are shackled to their bed using only one extremity for access to sitting and standing aside bed only."
VIOLATION: QAPI Tag No: A0263
The hospital failed to ensure the Condition of Participation: CFR 482.21 Quality Assessment and Performance Improvement Program was met by failing to develop, implement and maintain an effective on-going hospital wide data quality assessment and performance improvement program as evidenced by:

1. The QAPI program failed to analyze and investigate adverse events. (Refer to A-0286, A-0395, A-0396)

2. Failed to ensure nursing policy and procedures were followed, which lead to the infiltration of an intravenous medication, causing harm to a patient. (Refer to A-286,
A-0405, A-0409)

3. Failed to ensure a written contract/agreement regarding the provisional services between the hospital and deputies caring for patients in custody was in existence. (Refer to A-0286, A-0083)

The cumulative effect of these systemic practices resulted in the failure of the hospital to deliver care in compliance with the Condition of Participation: Quality Assessment and Performance Improvement Program.
VIOLATION: PHARMACIST SUPERVISION OF SERVICES Tag No: A0501
Based on observation, interview and record review, the hospital failed to follow hospital policy and procedure and ensure that compounding of drugs was done under the supervision of a pharmacist. This failure resulted in the potential for medications to be improperly prepared which could lead to infection, incorrect dosing, or medication errors.

Findings:

On February 25, 2015, at 9 AM, a medication pass observation was conducted. Registered Nurse (RN) 1 was observed preparing a sterile compound of Phenytoin (a medication used for seizures) 100 mg (milligram)/2 mL (milliliter) single dose vial and a bag of 100 mL normal saline (a fluid used for diluting medications to give via the vein) for Patient 5.

On February 25, 2015, at 3 PM, an interview was conducted with the Director of Pharmacy. He was asked what is considered compounding at Arrowhead Regional Medical Center. He stated they use the "State Board of Pharmacy" definition. Further discussion included a review of USP (United States Pharmacopeia-an organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements) 797 (a document produced by USP that discusses standards for compounding medications). When asked whether the facility uses one or the other, he said, "We use both."

A review of the California Board of Pharmacy law, California Code of Regulations 1735(a)(2) indicates that compounding is "Altering the strength of a drug ".

A review of USP 797 in Chapter 1 under the Introduction states, "CSPs (compounded sterile products) include any of the following: Manufactured sterile products that are either prepared strictly according to the instructions appearing in manufacturers' approved labeling (product package inserts) or prepared differently than published in such labeling."

A review of the hospital's policy & procedure regarding General Nursing Policies and Procedures, titled Intravenous Medication Administration, dated February 2014 and numbered 584 Issue 10, indicates under Section I that "The Department of Pharmacy is responsible for compounding IV admixtures 24 hours a day." Section II(G) indicates there are exceptions allowed "due to the limited stability of the drug or the urgent nature of the medication needed." Numerous antibiotics, miscellaneous cardiovascular (heart) and vasoactive (increase of blood flow) drugs, labor & delivery and post-partum (after birth) drugs, and additional medications such as Penicillin (an antibiotic used for bacterial infections) are listed as exceptions. It is noted that phenytoin was not listed as an exception. Under Section III(E), the policy & procedure states "Other medications for intravenous administration are prepared in the pharmacy."
VIOLATION: UNUSABLE DRUGS NOT USED Tag No: A0505
Based on observation and interview, the hospital failed to ensure outdated drugs were not available for patient use. This failure resulted in the potential for patients to receive expired medications that could be less effective or dangerous.

Findings:

On February 24, 2015 at 10:45 AM, a tour of the 6 South unit was conducted. A bag of D5W (dextrose 5% in water-a medication used for hydration given via the vein) 500 mL (milliliters) was found in a cabinet in the medication storage area. The manufacturer expiration date on the bag was January 2015. The bag was given to the Director of Pharmacy, he confirmed the expiration date, and asked where it was found.

On February 27, 2015 at 9:45 AM, a tour of the main inpatient pharmacy was conducted. Refrigerators in the storage room area were inspected. A box of Avonex (a medication used for multiple sclerosis-a nervous system disease) vial packs, NDC (National Drug Code) -0001-03, was found with a manufacturer's expiration date of August 2014. In addition, 4 boxes of Aranesp (a medication used to treat anemia (low red blood cell amount)) 40 micrograms/0.4mL, NDC -0021-04, were found with a manufacturer's expiration date of June 2014. During the same tour, the boxes were given to the Director of Pharmacy and he confirmed the expiration dates.