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.

BAKERSFIELD HEART HOSPITAL 3001 SILLECT AVENUE BAKERSFIELD, CA 93308 March 16, 2016
VIOLATION: PATIENT SAFETY Tag No: A0286
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record review and interview, the hospital's Quality Assurance and Performance Improvement (QAPI) program failed to identify and clarify the continued risks to one patient (A), after she experienced a severe Adverse Drug Reaction (ADR) to a medication. This failure to clarify her allergies, and to determine how the ADR occurred, had the potential for Patient A to continue to receive drugs she was allergic to while still in the hospital.

Findings:

During an interview with Family B, on 2/26/16, at 3 PM, he indicated Patient A was being seen and treated by Physician 1 for a chronic left leg wound, at a wound care clinic. Family B indicated Patient A fell at her home during the evening of 1/21/16, due to the weak and painful left leg, and was subsequently brought into the hospital that night via an ambulance. Family B indicated he followed the ambulance to the Emergency Department (ED or ER), where Patient A spent the next several hours. Family B indicated he told different healthcare workers at the hospital about Patient A's allergies, as he was asked about them several times. Family B indicated he told them Patient A is allergic to "mycins and penicillin", that she nearly died from mycins in the past, and got a severe reaction to mycins known as "Stevens-Johnso[DIAGNOSES REDACTED] [often an allergic reaction, it is a life-threatening condition, where the cells of the skin die, and skin layers then separate]", and had nearly died from it.

Family B stated "We told everyone, 'penicillin and mycins'. I spoke to the emergency room doctor [Physician 2] specifically about her allergies to penicillin and mycins, and to at least two or three others prior to that conversation. I gave them [Physician 1's] name, and name of [Pharmacy D] to get more information." Family B indicated he notified hospital healthcare workers that Patient A was a patient of Physician 1 (who also works at the same hospital's ED).

Family B indicated he had to leave the ED, but telephoned later, during the morning of 1/22/16, to check up on Patient A. Family B indicated he was told by a hospital nurse that Patient A was currently receiving the intravenous (IV, medication infused directly into the patient's vein via a small tube) antibiotic drug (used to fight infection) vancomycin. Family B indicated he told the nurse on the telephone she needed to stop the administration of vancomycin immediately, that it was one of the "mycin" drugs she was allergic to, and told the nurse that Patient A got a Stevens-Johnson reaction the last time she got that drug. Family B indicated that after speaking to this nurse, and then another, the infusion of vancomycin was stopped.

During an interview with Family C on 3/10/16, at 1:15 PM, she indicated she visited Patient A while in the hospital on [DATE], around 11 AM. Family C indicated during the visit, Patient A was in a gurney in the hallway of the ED, moaning, complaining of pain all over, and itching. Family C indicated she then lifted the blanket from Patient A and looked under it, and saw that Patient A had a red rash over her neck and chest, and described it as "the worst sunburn you ever saw." Family C stated she had seen this reaction 20 years ago, and was informed by physicians then that it was called a 'Stevens-Johnson reaction' to the vancomycin she had been given. Family C indicated she asked the nurse caring for Patient A if she was having an allergic reaction, and that the nurse stated ''We gave her some Benadryl" (a drug commonly used to treat allergic reactions).

During a review of the clinical record for Patient A, the document titled "Emergency Department Triage Report" indicated she arrived there on 1/21/16, at 11:17 PM. Triage was done at 11:45 PM, 28 minutes later. Registered Nurse (RN) 4 documented Patient A "Complains of fall with some bilateral hip pain and left lower leg pain. Patient denies hitting head." The first Vital Signs were documented to be taken at 11:50 PM, 33 minutes after Patient A's arrival via ambulance.

The document titled "Emergency Physician Worksheet", written by Physician 2, indicated Patient A was first seen by a hospital physician on 1/22/16, at 2 AM, 2 hours and 43 minutes after arrival. The document indicated the "Diagnosis/Clinical Impression" was:

"1. Nonhealing left foot wound, rule out osteo[DIAGNOSES REDACTED] [swelling of the bone, usually due to an infection]
2. status post fall
3. right elbow abrasion [scrape of the skin]
4. acute or chronic renal insufficiency [when the kidneys fail to adequately filter toxins from blood]
5. therapeutic INR [a blood test involving blood thinning medications]"

The document indicated Patient A was to be admitted to the hospital, under the care of Physician 3.

The untitled document, commonly known as a 'Facesheet', indicated Patient A was admitted on [DATE], at 5:13 AM.

The document titled "MEDICAL SUMMARY FOR [PATIENT A]", dated 1/22/16, at 8 AM, and written by Physician 1 was noted. Physician 1 was Patient A's own doctor, had been treating a chronic wound on her left leg for years, and had seen her the day before, on 1/21/16. The document from Physician 1 contained 9 pages of detailed medical history and information, including the following:

"ALLERGIES
*****STEVEN JOHNSO[DIAGNOSES REDACTED] - POSSIBLE FATAL REACTION*****
PENICILLIN: SEVERE
Cipro: SEVERE
ULTRAM: SEVERE
VANCOMYCIN - STEVENS/JOHNSO[DIAGNOSES REDACTED]
CLINDAMYCIN - STEVENS/JOHNSO[DIAGNOSES REDACTED]
TYLENOL WITH CODEINE - SEVERE
PT USES [PHARMACY D] ONLY
PLEASE CALL PATIENT'S SON [Family B] FOR ALL QUESTIONS
**FOR ANY MEDICATION CHANGES MUST CONTACT [Family B]**"

The document titled "ER", dated 1/21/16, written by Physician 2, indicated, in part: "ALLERGIES: The patient is allergic to erythromycin and penicillin."

The document titled "CONSULTATION", dated 1/22/16, written by Physician 4, indicated, in part: "ALLERGIES: She is allergic to penicillin, Cipro, Ultram, vancomycin, clindamycin, Tylenol with Codeine and all of these allergies are listed as severe. She has a diffuse [spread out over a large area] rash all over after she was given vancomycin in the ER... Skin: At least at the upper chest, she does have diffuse macular [a small, non-raised area of skin that is a different color than the surrounding area] [DIAGNOSES REDACTED]tous [reddened] rash. Impression: Allergic reaction to vancomycin. At this point, the patient does look quite ill."

The document titled "ER", dated 1/22/16, written by Physician 5, indicated, in part: "I was called to evaluate [Patient A]. Apparently, she had been admitted in the hospital earlier and since that time her condition was gradually decreased. She is currently unresponsive with poor respiratory effort. Apparently she was given vancomycin earlier in the day and she had a severe allergic reaction of vancomycin. When I evaluated her, her skin is quite red, did not see any oral lesion [an area of diseased or injured tissue], no blistering, no uticaria [a rash of round, red welts of the skin that itch intensely], but very warm and red. The patient was closely observed and her condition did not improve. Her breathing was still poor and therefore it was decided that she should be prophylactically [preventively] intubated [where a breathing tube is inserted into a patient's windpipe, and breathing is controlled mechanically, usually through a machine called a ventilator]. Transfer care to [Physician 3] in the ICU [Intensive Care Unit, an area of a hospital reserved for the most critically ill]."

The document titled "CONSULTATION", dated 1/23/16, written by Physician 6, indicated, in part: "She was admitted on [DATE], status post fall and was started antibiotics. After receiving vancomycin she developed pruritic [itchy] rash over her entire torso and subsequently went into respiratory failure. She was intubated on 01/22/16 and moved to the ICU and required pressor support [medications to help control blood pressure]. History was obtained from accompanying medical records and discussion with [Physician 10] as well as her daughter who was present at the bedside, who provided further history. She was given vancomycin in the past and developed Stevens-Johnso[DIAGNOSES REDACTED] with blistering of her lips and per daughter's report almost died . She was then told not to give her any of the mycins. ALLERGIES: Reported Stevens-Johnso[DIAGNOSES REDACTED] reaction to vancomycin, and unknown reaction to penicillin described as severe during childhood. The patient was told not to take of that "mycin" family, and therefore she reports herself as allergic to clindamycin based on the above history. Reported history to Cipro, Ultram, and Tylenol and codeine and reportedly severe reactions to all of the above. ASSESSMENT: Anaphylactic [severe, life-threatening allergic reaction] plus/minus septic shock [a serious medical condition that occurs when sepsis, which is organ injury or damage in response to infection, leads to dangerously low blood pressure and abnormalities in cellular metabolism]. True allergic reaction to vancomycin."

The document titled "CONSULTATION", dated 1/26/16, written by Physician 7, indicated, in part: "[Patient A] was given vancomycin as a part of treatment after which unfortunately she developed an allergic reaction and ended up intubated. ALLERGIES: She is allergic to penicillin, Cipro, Ultram, vancomycin, clindamycin, Tylenol, and codeine."

The document titled "CPOE Orders Report", dated 1/22/16, indicated Patient A was prescribed "Vancocin 500 grams [sic] intravenous every 12 hours." This order was "Entered By" Physician 3, and electronically signed by him at 5:15 AM. The nurse who made the order "Acknowledgement" was Registered Nurse (RN) 2 on 1/22/16, at 6:39 AM. The order was processed on 1/22/16, at 7:35 AM, and was then changed to "Vancomycin 750 milligrams [mg] IVPB [IV Piggy Back, a small bag containing the medication hanging 'piggy-back' a larger IV bag]."

The document titled "Progress Note Inquiry", dated 1/22/16, at 10:53 AM, and written by Pharmacist 1, indicated in part: "vanco per pharmacy. loading dose of 750 mg given."

The document titled "Medication Administration History Report", dated 1/22/16, indicated Patient A began receiving the Vancomycin 750 mg IVPB at 10 AM, and it was stopped at 11:15 AM. The document indicated the person administering, and then stopping, the vancomycin was RN 3.

During an interview with the Risk Coordinator (RC) on 3/7/16, at 1:25 PM, she verified the vancomycin administration times as correct.

The document titled "Daily Focus Assessment Report", dated 1/22/16, at 11 AM, written by RN 3, indicated "Received a call from [Patient A's] Son-in Law [Family B], he said he is the Primary Care Coordinator, he asked what antibiotics the patient had, I told him Levaquin and Vancomycin, he said the patient is allergic to PCN [penicillin] and "Mycins". I immediately stopped the Vanco and called MD. Was able to talk to [Physician 10] and told him [Family B's] concern, he ordered to discontinue Vanco... He also said he will call [Physician 6] for consult. At that time the only recorded allergy to the patient is PCN."

The document titled "Patient Profile Report - Allergies", for Patient A, dated 2/4/16, indicated the following allergies:

Codeine - Severe - entered into the clinical record on 1/22/16 at 11:33 AM

Quinolones - Severe - entered into the clinical record on 1/22/16 at 11:38 AM

ciprofloxacin - Severe - entered into the clinical record on 1/22/16 at 11:33 AM

vancomycin - Severe - entered into the clinical record on 1/22/16 at 11:33 AM

Erythromycin Base - Severe - entered into the clinical record on 1/21/16 at 11:53 PM

Penicillins - Severe - entered into the clinical record on 1/21/16 at 11:53 PM

All of these allergies were listed to have a Stevens-Johnso[DIAGNOSES REDACTED] reaction.

During an interview with the RC on 3/7/16, at 1:25 PM, she was asked why the hospital gave Patient A vancomycin on 1/22/16, when Family B informed several hospital staff she was allergic to mycins. The RC indicated the hospital had investigated this, and during the course of the investigation, had talked to three nurses. The RC indicated that based on their interviews with the three nurses, the family only told them Patient A was allergic to mycins, not vancomycin specifically. The RC indicated their hospital pharmacy had stated vancomycin is not actually a mycin-class drug, and this is why the drug got filled by the pharmacy.

During an interview with the Chief Nursing Executive (CNE), on 3/7/16, at 1:25 PM, she was asked why all the medications listed on as allergies on several of Patient A's physician consultations found in the electronic clinical record did not get added to her "Patient Profile - Allergies" area of the electronic clinical record. The CNE indicated this was because those areas of physician documentation in the electronic clinical record does not communicate with the hospital's "Patient Profile" area of the electronic clinical record.

During an interview with the RC on 3/14/16, at 3:30 PM, she indicated Patient A had been a patient in the hospital before, on 1/6/11.

During a concurrent interview with the Clinical Analyst (CA) on 3/14/16, at 4 PM, and record review, the document titled "Home Medication Reconciliation List", dated 1/6/11, was noted. The CA confirmed the document indicated as allergies: "Penicillin, Cipro, Ultram, Vancomycin, Clindamycin, and Tylenol with Codeine."

During an interview with the Vice President of Quality and Organizational Support (VPQOS), on 3/15/16, at 8:30 AM, she indicated the hospital conducted an investigation of the the incident involving Patient A and the administration of vancomycin, and her allergic reaction to it. The VPQOS indicated this review took place on 1/27/16, and called the review a "Root Cause Analysis", or RCA, and this review was "very definitely" part of the hospital's QAPI process. The VPQOS stated, "This Adverse Drug Reaction [ADR] was significant enough to warrant a review, definitely. But, during which, we didn't look at all the records in our system. We didn't look at all the consults, progress notes, we definitely did not do that. In the future, we would do a more thorough review during RCAs, would now include the entire medical record. Whenever an ADR occurs, we need to update the "Patient Profile" [allergy list] to capture and review all the allergies. Our Director of Pharmacy did participate in the RCA. No corrective action was made after our review. Our analysis missed the boat, our RCA did not go in-depth enough to identify potential areas of risk. We don't know why [RN 4] documented 'Erythromycin Base' in the "Patient Profile" [allergy list] instead of 'mycins'. We didn't ask specifically."

During an interview with the VPQOS on 3/15/16, at 10 AM, she indicated the documents from Patient A's stay on 1/6/11, including her allergies, were also not reviewed in the QAPI review.

During a concurrent record review and interview with RN 4, on 3/15/16, at 4:15 PM, Patient A's allergy documentation was discussed. RN 4 indicated she was on duty in the ED when Patient A arrived there during the late evening of 1/21/16, and RN 4 entered allergies into the electronic clinical record, into the "Patient Profile - Allergies." RN 4 stated "If her family told me she was allergic to mycins, then that would have been too vague. I would have asked for clarification." However, the record review indicated RN 4 documented Patient A was only allergic to "Penicillins" and "Erythromycin Base", and entered this information into the clinical record on 1/21/16, at 11:53 PM. During a second interview with RN 4, on 3/16/16, at 8:50 AM, she indicated she reviewed Patient A's clinical record again and stated "I don't remember the details, usually if there's any question about allergies, I would clarify. I do remember talking to Risk Management on 1/27/16 about this."

During an interview with the RC on 3/7/16, at 1:25 PM, and again on 3/16/16, at 9:30 AM, she indicated in both interviews that she participated in the RCA conducted on 1/27/16 (six days after the event), and interviewed three nurses, including RN 4. The RC indicated in both interviews, all three nurses, including RN 4, unanimously stated the family told them Patient A's allergies were "Penicillins and mycins."
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
Based on observation, interview, and document review, the hospital failed to ensure medications were prepared and administered in a safe manner to protect patients as evidenced by:

Emergency Department (ED) nursing staff was unable to calculate the correct milliliter (ml) of pediatric dose for magnesium sulfate injection. As a result of frequent medication shortages, a medication may not be available in the usual concentration; the nursing staff should be able to calculate the medication volume (milliliters) based on the new concentration.

This failure had the potential to result in pediatric patients receiving the wrong medication dose in an emergency leading to patient's harm.

Findings:

On 3/16/16 at 10:55 AM, during an observation and staff interview on the ED, the ED Charge Registered Nurse (RN) 5 was asked to calculate the magnesium sulfate injection dose for a 13 Kilogram (kg) patient. RN 5 and the Director of ED (RN 6), (who did an independent calculation to double check the dose volume) were unable to come up with the correct volume of magnesium sulfate injection (equivalent to the dose) to give during a period of over 5 minutes.

The Chief Nursing Executive told RN 5 and RN 6 the correct magnesium sulfate injection volume, and she explained to them how to calculate the volume based on the concentration of the magnesium sulfate injection. RN 6 stated the ED had a "Broselow Pediatric Emergency Medication Doses" chart with the dose and volume already calculated based on the patient's weight (from 3 kg to 36 kg) and the usual medication concentration, the nursing staff therefore would not have to do the calculations.
VIOLATION: HOSPITAL PROCEDURES Tag No: A0410
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

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

1. correctly identify the drug allergies of one patient (A). This resulted in Patient A experiencing a potentially life-threatening allergic reaction to a drug administered to her in the hospital; and,

2. adequately assess, monitor and document the effects to two medications given to one patient (A), including one that produced a potentially life-threatening allergic reaction. This had the potential for Patient A to experience undetected, delayed, sub-therapeutic, or adverse reactions to the medications.

Findings:

1. During an interview with Family B, on 2/26/16, at 3 PM, he indicated Patient A was being seen and treated by Physician 1 for a chronic left leg wound, at a wound care clinic. Family B indicated Patient A fell at her home during the evening of 1/21/16, due to the weak and painful left leg, and was subsequently brought into the hospital that night via an ambulance. Family B indicated he followed the ambulance to the Emergency Department (ED or ER), where Patient A spent the next several hours. Family B indicated he told different healthcare workers at the hospital about Patient A's allergies, as he was asked about them several times. Family B indicated he told them Patient A is allergic to "mycins and penicillin", that she nearly died from mycins in the past, and got a severe reaction to mycins known as "Stevens-Johnso[DIAGNOSES REDACTED] [often an allergic reaction, it is a life-threatening condition, where the cells of the skin die, and then skin layers then separate]", and had nearly died from it.

Family B stated "We told everyone, 'penicillin and mycins'. I spoke to the emergency room doctor [Physician 2] specifically about her allergies to penicillin and mycins, and to at least two or three others prior to that conversation. I gave them [Physician 1's] name, and name of [Pharmacy D] to get more information." Family B indicated he notified hospital healthcare workers that Patient A was a patient of Physician 1 (who also works at the same facility's ED).

Family B indicated he had to leave the ED, but telephoned later, during the morning of 1/22/16, to check up on Patient A. Family B indicated he was told by a hospital nurse that Patient A was currently receiving the intravenous (IV, medication infused directly into the patient's vein via a small tube) antibiotic drug (used to fight infection) vancomycin. Family B indicated he told the nurse on the telephone she needed to stop the administration of vancomycin immediately, that it was one of the "mycin" drugs she was allergic to, and told the nurse that Patient A got a Stevens-Johnson reaction the last time she got that drug. Family B indicated that after speaking to this nurse, and then another, the infusion of vancomycin was stopped.

During an interview with Family C on 3/10/16, at 1:15 PM, she indicated she visited Patient A while in the hospital on [DATE], around 11 AM. Family C indicated during the visit, Patient A was in a gurney in the hallway of the ED, moaning, complaining of pain all over, and itching. Family C indicated she then lifted the blanket from Patient A and looked under it, and saw that Patient A had a red rash over her neck and chest, and described it as "the worst sunburn you ever saw." Family C stated she had seen this reaction 20 years ago, and was informed by physicians then that it was called a 'Stevens-Johnson reaction' to the vancomycin she had been given. Family C indicated she asked the nurse caring for Patient A if she was having an allergic reaction, and that the nurse stated ''We gave her some Benadryl" (a drug commonly used to treat allergic reactions).

During a review of the clinical record for Patient A, the document titled "Emergency Department Triage Report" indicated she arrived there on 1/21/16, at 11:17 PM. Triage was done at 11:45 PM, 28 minutes later. Registered Nurse (RN) 4 documented Patient A "Complains of fall with some bilateral hip pain and left lower leg pain. Patient denies hitting head." The first Vital Signs were documented to be taken at 11:50 PM, 33 minutes after Patient A's arrival via ambulance.

The document titled "Emergency Physician Worksheet", written by Physician 2, indicated Patient A was first seen by a hospital physician on 1/22/16, at 2 AM, 2 hours and 43 minutes after arrival. The document indicated the "Diagnosis/Clinical Impression" was:

"1. Nonhealing left foot wound, rule out osteo[DIAGNOSES REDACTED] [swelling of the bone, usually due to an infection]
2. status post fall
3. right elbow abrasion [scrape of the skin]
4. acute or chronic renal insufficiency [when the kidneys fail to adequately filter toxins from blood]
5. therapeutic INR [a blood test involving blood thinning medications]"

The document indicated Patient A was to be admitted to the hospital, under the care of Physician 3.

The untitled document, commonly known as a 'Facesheet', indicated Patient A was admitted on [DATE], at 5:13 AM.

During a review of the clinical record for Patient A, the document titled "MEDICAL SUMMARY FOR [PATIENT A]", dated 1/22/16, at 8 AM, and written by Physician 1 was noted. Physician 1 was Patient A's own doctor, had been treating a chronic wound on her left leg for years, and had seen her the day before, on 1/21/16. The document from Physician 1 contained 9 pages of detailed medical history and information, including the following, partial, list:

"ALLERGIES
*****STEVEN JOHNSO[DIAGNOSES REDACTED] - POSSIBLE FATAL REACTION*****
PENICILLIN: SEVERE
VANCOMYCIN - STEVENS/JOHNSO[DIAGNOSES REDACTED]
PT USES [PHARMACY D] ONLY
PLEASE CALL PATIENT'S SON [Family B] FOR ALL QUESTIONS
**FOR ANY MEDICATION CHANGES MUST CONTACT [Family B]**"

The document titled "ER", dated 1/21/16, written by Physician 2, indicated, in part: "ALLERGIES: The patient is allergic to erythromycin and penicillin."

The document titled "CONSULTATION", dated 1/22/16, written by Physician 4, indicated, in part: "ALLERGIES: She is allergic to penicillin, Cipro, Ultram, vancomycin, clindamycin, Tylenol with Codeine and all of these allergies are listed as severe. She has a diffuse [spread out over a large area] rash all over after she was given vancomycin in the ER... Skin: At least at the upper chest, she does have diffuse macular [a small, non-raised area of skin that is a different color than the surrounding area] [DIAGNOSES REDACTED]tous [reddened] rash. Impression: Allergic reaction to vancomycin. At this point, the patient does look quite ill."

The document titled "ER", dated 1/22/16, written by Physician 5, indicated, in part: "I was called to evaluate [Patient A]. Apparently, she had been admitted in the hospital earlier and since that time her condition was gradually decreased. She is currently unresponsive with poor respiratory effort. Apparently she was given vancomycin earlier in the day and she had a severe allergic reaction of vancomycin. When I evaluated her, her skin is quite red, did not see any oral lesion [an area of diseased or injured tissue], no blistering, no uticaria [a rash of round, red welts of the skin that itch intensely], but very warm and red. The patient was closely observed and her condition did not improve. Her breathing was still poor and therefore it was decided that she should be prophylactically [preventively] intubated [where a breathing tube is inserted into a patient's windpipe, and breathing is controlled mechanically, usually through a machine called a ventilator]. Transfer care to [Physician 3] in the ICU [Intensive Care Unit, an area of a hospital reserved for the most critically ill]."

The document titled "CONSULTATION", dated 1/23/16, written by Physician 6, indicated, in part: "She was admitted on [DATE], status post fall and was started antibiotics. After receiving vancomycin she developed pruritic [itchy] rash over her entire torso and subsequently went into respiratory failure. She was intubated on 01/22/16 and moved to the ICU and required pressor support [medications to help control blood pressure]. History was obtained from accompanying medical records and discussion with [Physician 10] as well as her daughter who was present at the bedside, who provided further history. She was given vancomycin in the past and developed Stevens-Johnso[DIAGNOSES REDACTED] with blistering of her lips and per daughter's report almost died . She was then told not to give her any of the mycins. ALLERGIES: Reported Stevens-Johnso[DIAGNOSES REDACTED] reaction to vancomycin, and unknown reaction to penicillin described as severe during childhood. The patient was told not to take of that "mycin" family, and therefore she reports herself as allergic to clindamycin based on the above history. Reported history to Cipro, Ultram, and Tylenol and codeine and reportedly severe reactions to all of the above. ASSESSMENT: Anaphylactic [severe, life-threatening allergic reaction] plus/minus septic shock [a serious medical condition that occurs when sepsis, which is organ injury or damage in response to infection, leads to dangerously low blood pressure and abnormalities in cellular metabolism]. True allergic reaction to vancomycin."

The document titled "CONSULTATION", dated 1/26/16, written by Physician 7, indicated, in part: "[Patient A] was given vancomycin as a part of treatment after which unfortunately she developed an allergic reaction and ended up intubated. ALLERGIES: She is allergic to penicillin, Cipro, Ultram, vancomycin, clindamycin, Tylenol, and codeine."

The document titled "CPOE Orders Report", dated 1/22/16, indicated Patient A was prescribed "Vancocin 500 grams [sic] intravenous every 12 hours." This order was "Entered By" Physician 3, and electronically signed by him at 5:15 AM. The nurse who made the order "Acknowledgement" was Registered Nurse (RN) 2 on 1/22/16, at 6:39 AM. The order was processed on 1/22/16, at 7:35 AM, and was then changed to "Vancomycin 750 milligrams IVPB."

The document titled "Progress Note Inquiry", dated 1/22/16, at 10:53 AM, and written by Pharmacist 1, indicated in part: "vanco per pharmacy. loading dose of 750 mg given."

The document titled "Medication Administration History Report", dated 1/22/16, indicated Patient A began receiving the Vancomycin 750 milligrams IVPB at 10 AM, and it was stopped at 11:15 AM. The document indicated the person administering, and then stopping, the vancomycin was RN 3.

During an interview with the Risk Coordinator (RC) on 3/7/16, at 1:25 PM, she verified the vancomycin administration times as correct.

The document titled "Daily Focus Assessment Report", dated 1/22/16, at 11 AM, written by RN 3, indicated "Received a call from [Patient A's] Son-in Law [Family B], he said he is the Primary Care Coordinator, he asked what antibiotics the patient had, I told him Levaquin and Vancomycin, he said the patient is allergic to PCN and "Mycins". I immediately stopped the Vanco and called MD. Was able to talk to [Physician 10] and told him [Family B's] concern, he ordered to discontinue Vanco... He also said he will call [Physician 6] for consult. At that time the only recorded allergy to the patient is PCN."

The document titled "Patient Profile Report - Allergies", for Patient A, dated 2/4/16, indicated the following allergies:

Codeine - Severe - entered into the clinical record on 1/22/16 at 11:33 AM

Quinolones - Severe - entered into the clinical record on 1/22/16 at 11:38 AM

ciprofloxacin - Severe - entered into the clinical record on 1/22/16 at 11:33 AM

vancomycin - Severe - entered into the clinical record on 1/22/16 at 11:33 AM

Erythromycin Base - Severe - entered into the clinical record on 1/21/16 at 11:53 PM

Penicillins - Severe - entered into the clinical record on 1/21/16 at 11:53 PM

All of these allergies were listed to have a Stevens-Johnson reaction.

During an interview with the RC on 3/7/16, at 1:25 PM, she was asked why the hospital gave Patient A vancomycin on 1/22/16, when Family B had informed several hospital staff she was allergic to mycins. The RC indicated the hospital had investigated this, and talked to three nurses. The RC indicated that based on their interviews with the three nurses, the family only told them Patient A was allergic to mycins, not vancomycin specifically. The RC indicated their hospital pharmacy had stated vancomycin is not actually a mycin-class drug, and that is why the drug got filled by the pharmacy.

During an interview with the Chief Nursing Executive (CNE), on 3/7/16, at 1:25 PM, she was asked why all the medications listed on as allergies of Patient A's physician consultations found in the electronic clinical record, did not get added to her "Patient Profile - Allergies" portion of the electronic clinical record. The CNE indicated this was because those areas of physician documentation in the electronic clinical record does not communicate with the hospital's "Patient Profile" area of the electronic clinical record.

During an interview with the RC on 3/14/16, at 3:30 PM, she indicated Patient A had been a patient in the hospital before, on 1/6/11.

During a concurrent interview with the Clinical Analyst (CA) on 3/14/16, at 4 PM, and record review, the document titled "Home Medication Reconciliation List", dated 1/6/11, was noted. The CA confirmed the document indicated as allergies: "Penicillin, Cipro, Ultram, Vancomycin, Clindamycin, and Tylenol with Codeine."

During a concurrent record review and interview with RN 4, on 3/15/16, at 4:15 PM, Patient A's allergy documentation was discussed. RN 4 indicated she was on duty in the ED when Patient A arrived there during the late evening of 1/21/16, and RN 4 entered her allergies into the electronic clinical record, into the "Patient Profile - Allergies." RN 4 stated "If her family told me she was allergic to mycins, then that would have been too vague. I would have asked for clarification." However, the record review indicated RN 4 only documented Patient A was allergic to "Penicillins" and "Erythromycin Base", and entered this information into the clinical record on 1/21/16, at 11:53 PM. During a second interview with RN 4, on 3/16/16, at 8:50 AM, she indicated she reviewed Patient A's clinical record again and stated "I don't remember the details, usually if there's any question about allergies, I would clarify. I do remember talking to Risk Management on 1/27/16 about this."

During an interview with the RC on 3/7/16, at 1:25 PM, and again on 3/16/16, at 9:30 AM, she indicated in both interviews that she participated in the RCA conducted on 1/27/16 (six days after the event), and interviewed three nurses, including RN 4. The RC indicated in both interviews, all three nurses, including RN 4, unanimously stated the family told them Patient A's allergies were "Penicillins and mycins."

The hospital policy and procedure titled "Assessment - Admission", dated 8/25/15, indicated "Patients admitted through the Emergency Department [ED/ER] will have the Admission Assessment initiated and completed by the ER nurse. Once the patient's status changes to inpatient. The ER Nurse will initiate patient profile to include (home medications, height, weight, and allergies). During the assessment interview, the nurse will ask about the allergies, if any, and identify the type of response the patient experiences from the allergy..."

The hospital policy and procedure titled "Medication Administration", dated revised 12/12/12, indicated "Routine medications, including PRN's [medications to be given on a 'as needed' basis] and one time doses are documented on the MAR [Medication Administration Record]. Document patient response and reason for giving, as necessary, after administration."

The hospital policy and procedure titled "Adverse Drug Reaction [ADR] Reporting", dated revised 12/17/09, indicated "A Significant ADR will be defined as any unexpected, unintended, undesired, or excessive response to a drug that: 1. Requires discontinuation of the drug, 2. Requires addition of an "antidote" drug, 3. Requires changing the drug... Antidote drugs used to detect adverse drug reactions - Diphenhydramine [also known as Benadryl]."

The document titled "Medication Administration History Report", dated 1/22/16, indicated Patient A began receiving the vancomycin 750 milligrams (mg) IVPB (IV, or intravenously, directly into the vein of the patient via a small tube, from a small bag hanging 'piggy-back' style atop a larger bag), at 10 AM, and it was stopped at 11:15 AM. The document indicated the person administering, and then stopping, the vancomycin was RN 3.

The document titled "Medication Administration Record", indicated RN 3 also gave Patient A the drug "diphenhydramine [also known as Benadryl]", 25 mg, on 1/22/16, at 12:17 PM.

During a concurrent record review and interview with RN 3, on 3/15/16, at 11:25 AM, she recalled working in the ED on 1/22/16, and caring for Patient A. RN 3 indicated she recalled starting the antibiotic drug "vancomycin" intravenously (IV, where the drug is mixed with saline, a simple salt solution, and infused directly into the patient vein via tubing) for Patient A at about 10 AM that morning, per Physician 10's order. RN 3 indicated she then stopped the infusion after talking with Patient A's son, who had telephoned the hospital and stated she was severely allergic to it. RN 3 indicated she recalled about half of the prescribed amount of vancomycin had been administered to Patient A. RN 3 indicated she then informed Physician 10, who then ordered the vancomycin to be discontinued, and replaced with a new, different drug.

RN 3 indicated she did not perform a nursing assessment on Patient A after stopping the infusion of vancomycin, to check for presence of an allergic reaction, e.g., changes in breathing, presence of rash, skin color changes, complaints of itchiness. When asked a second time, RN 3 stated "Well, I did, but I didn't document it."

RN 3 indicated Patient A "had started to complain of an itch on her chest" after the infusion had been stopped. RN 3 indicated that she informed Physician 10 of this development, and he ordered the drug "diphenhydramine" to be given to Patient A for the itchiness. RN 3 could not locate any documentation in Patient A's clinical record of the effect, if any, of the diphenhydramine on Patient A's complaints of itchiness.

During an interview with Family C on 3/10/16, at 1:15 PM, she indicated she visited Patient A while in the hospital on [DATE], beginning around 11 AM. Family C indicated during the visit, Patient A was in a gurney in the hallway of the Emergency Department, moaning, complaining of pain all over, and itching. Family C indicated she then lifted the blanket from Patient A and looked under it, and saw that Patient A had a red rash over her neck and chest, and described it as "the worst sunburn you ever saw." Family C indicated she asked the nurse caring for Patient A if she was having an allergic reaction, and that the nurse stated ''We gave her some Benadryl."

*During an interview with Physician 6, on 3/15/16, at 2 PM, she stated she saw Patient A's rash. Physician 6 stated this "This [rash] lasted longer than one day. She had a true allergic reaction to the vancomycin." Physician 6 indicated she learned of Patient A's allergies by reading Physician 1's notes [the document titled "MEDICAL SUMMARY FOR [PATIENT A]", dated 1/22/16, at 8 AM].

During an interview with the Vice President of Quality and Organizational Support (VPQOS), on 3/15/16, at 8:30 AM, she stated, "This Adverse Drug Reaction was significant enough to warrant a review, definitely."

During a concurrent Patient A record review and interview, with the Chief Nursing Executive (CNE), and Risk Coordinator (RC), on 3/16/16, at 4 PM, the CNE stated "If a nurse gives Benadryl, or any medication, I'd expect the nurse to document the reason why it was given. If an allergic reaction is suspected, I'd expect the nurse to do an assessment of the patient."

The document titled "Vital Signs Report" indicated Patient A had her vital signs (blood pressure, heart rate, breathing rate, body temperature, and pain level) assessed and documented on the following dates and times:

1/21/16 at 11:50 PM
1/22/16 at 5:35 AM
1/22/16 at 12:14 PM (incomplete: no body temperature recorded)
1/22/16 at 2 PM
1/22/16 at 4 PM

The CNE indicated Patient A should have had her vitals signs assessed and documented no less frequently than every four hours, based upon her acuity on 1/21/16 and 1/22/16. The RC confirmed the dates and times of the vital signs as correct. The RC indicated Patient 4 should have had vital signs taken on 1/22/16, no later than 9:35 AM, and that the 1/22/16 set of vital signs (missing the body temperature) taken at 12:14 PM, were taken almost three hours late.
VIOLATION: MEDICAL RECORD SERVICES Tag No: A0450
Based on document review and staff interview, the hospital failed to ensure physicians noted the time Patient 10's treatment and care services progress were documented in the clinical record. These failures had a potential to result in a delay in providing timely assessment and interventions due to the inability to establish a timeline of events.

Findings:

On 3/16/16 at 3:45 PM, a review of Patient 10's medical record dated 3/14/16, showed untimed progress notes by the hospitalist and the pulmonologist. This made it impossible to establish the sequence of events regarding the interventions recommended.

The Chief Nursing Executive acknowledged the progress notes were not timed.

Review of the hospital's Policy & Procedures titled "Patient Specific Data & Information", dated 1/2016, read in part "...All entries in the patient's medical record must be dated, timed, and authenticated by the person making the entry..."
VIOLATION: CONTENT OF RECORD - OTHER INFORMATION Tag No: A0467
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record review and interview, the hospital failed to document assessment data for one patient (A), following a potentially life-threatening, severe, allergic reaction to one drug, and, to a second drug given as an antidote to the first drug, and to document thorough and timely vital signs during these issues. These failures had the potential to negatively impact care to Patient A.

Findings:

The hospital policy and procedure titled "Medication Administration", date revised 12/12/12, indicated "Routine medications, including PRN's [medications given on an 'as needed' basis] and one time doses are documented on the MAR [Medication Administration Record]. Document patient response and reason for giving, as necessary, after administration."

The hospital policy and procedure titled "Adverse Drug Reaction [ADR] Reporting", date revised 12/17/09, indicated "A Significant ADR will be defined as any unexpected, unintended, undesired, or excessive response to a drug that: 1. Requires discontinuation of the drug, 2. Requires addition of an "antidote" drug, 3. Requires changing the drug... Antidote drugs used to detect adverse drug reactions - Diphenhydramine [also known as Benadryl]."

The document titled "Medication Administration History Report", dated 1/22/16, indicated Patient A began receiving the vancomycin 750 milligrams (mg) IVPB (IV, or intravenously, via a small tube directly into the patient's vein, from a small bag hanging 'piggy-back' style atop a larger IV bag) at 10 AM, and it was stopped at 11:15 AM. The document indicated the person administering, and then stopping, the vancomycin was Registered Nurse (RN) 3.

The document titled "Medication Administration Record", indicated RN 3 also gave Patient A the drug "diphenhydramine [or Benadryl]", 25 mg, on 1/22/16, at 12:17 PM.

During a concurrent record review and interview with RN 3, on 3/15/16, at 11:25 AM, she recalled working in the Emergency Department (ED) on 1/22/16, and caring for Patient A. RN 3 indicated she recalled starting the antibiotic drug "vancomycin" intravenously for Patient A at about 10 AM that morning, per Physician 10's order. RN 3 indicated she then stopped the infusion after talking with Patient A's son, who had telephoned the hospital and stated she had a severe allergy to it. RN 3 indicated she recalled about half of the prescribed amount of vancomycin had been administered to Patient A. RN 3 indicated she then informed Physician 10, who then ordered the vancomycin to be discontinued, and replaced with a new, different drug.

RN 3 indicated she did not perform a nursing assessment on Patient A after stopping the infusion of vancomycin, to check for presence of an allergic reaction, e.g., changes in breathing, presence of rash, skin color changes, complaints of itchiness. When asked a second time, RN 3 stated "Well, I did, but I didn't document it."

RN 3 indicated Patient A "had started to complain of an itch on her chest" after the infusion had been stopped. RN 3 indicated that she informed Physician 10 of this development, and he ordered the drug "diphenhydramine (also known as "Benadryl") to be given to Patient A for the itchiness. RN 3 could not locate any documentation in Patient A's clinical record of the effect, if any, of the diphenhydramine on Patient A's complaints of itchiness.

During an interview with Family C on 3/10/16, at 1:15 PM, she indicated she visited Patient A while in the hospital on [DATE], beginning around 11 AM. Family C indicated during the visit, Patient A was in a gurney in the hallway of the Emergency Department, moaning, complaining of pain all over, and itching. Family C indicated she then lifted the blanket from Patient A and looked under it, and saw that Patient A had a red rash over her neck and chest, and described it as "the worst sunburn you ever saw." Family C indicated she asked the nurse caring for Patient A if she was having an allergic reaction, and that the nurse stated ''We gave her some Benadryl."

During an interview with Physician 6, on 3/15/16, at 2 PM, she stated she saw Patient A's rash. Physician 6 stated this "This [rash] lasted longer than one day. She had a true allergic reaction to vancomycin." Physician 6 indicated she learned of Patient A's allergies by reading Physician 1's notes, [the document titled "MEDICAL SUMMARY FOR [PATIENT A]", dated 1/22/16, at 8 AM].

During an interview with the Vice President of Quality and Organizational Support, on 3/15/16, at 8:30 AM, she stated, "This Adverse Drug Reaction was significant enough to warrant a review, definitely."

During a concurrent Patient A record review and interview, with the Chief Nursing Executive (CNE), and Risk Coordinator (RC), on 3/16/16, at 4 PM, the CNE stated "If a nurse gives Benadryl, or any medication, I'd expect the nurse to document the reason why it was given. If an allergic reaction is suspected, I 'd expect the nurse to do an assessment of the patient."

The document titled "Vital Signs Report" indicated Patient A had her vital signs (blood pressure, heart rate, breathing rate, body temperature) assessed and documented on the following dates and times:

1/21/16 at 11:50 PM
1/22/16 at 5:35 AM
1/22/16 at 12:14 PM (no body temperature recorded)
1/22/16 at 2 PM
1/22/16 at 4 PM

The CNE indicated Patient A should have had her vitals signs assessed and documented no less frequently than every four hours, based upon her acuity on 1/21/16 and 1/22/16. The RC confirmed the dates and times of the vital signs as correct. The RC indicated Patient 4 should have had vital signs taken on 1/22/16, no later than 9:35 AM, and that the 1/22/16 set of vital signs (missing the body temperature) taken at 12:14 PM, were taken almost three hours late.

According to the document titled "Medication Administration History Report", dated 1/22/16, Patient A began receiving the vancomycin 750 milligrams IVPB at 10 AM, and it was stopped at 11:15 AM. The document indicated the person administering, and then stopping, the vancomycin was RN 3.
VIOLATION: PHARMACY ADMINISTRATION Tag No: A0491
Based on observation, interview, and document review, the hospital failed to store medications in accordance with the manufacturer's specifications. These failures had the potential to result in patients not receiving the intended benefit from the medications.

Findings:

On 3/14/16 at 4 PM, during an observation in the Pharmacy department, the following medications had not been protected from light:

Six vials of lidocaine 2 % hydrochloride (HCL)/epinephrine 1:100,000 units 20 milliliters (ml, for infiltration and nerve block).

Six vials of lidocaine 1 % HCL/epinephrine 1:100,000 units 20 ml.

21 vials of nicardipine hydrochloride 25 mg/10 ml (for short term treatment of hypertension when oral therapy is not feasible).

Six vials of bupivacaine 0.25 %/epinephrine 1:200,000 units 30 ml (for local/regional anesthesia or analgesia for surgery).

During the concurrent staff interview, the Director of Pharmacy acknowledged the medications were not protected from light.

Review of the hospital's Policy & Procedure titled "Drug Storage and Inventory Management", dated 2/23/12, read in part "...The Department of Pharmacy Services shall be responsible for assuring that all drugs are properly labeled and stored ..."

Review of the manufacturer's product insert for Lidocaine HCL and epinephrine injection dated 3/2010, stated to protect from light.

Review of the manufacturer's product insert for nicardipine HCL dated 2/2012, read in part "...Protect from light. Store vials in carton until used..."

Review of the manufacturer's product insert for bupivacaine HCL/epinephrine dated 1/2013, read in part "...Solutions of bupivacaine that contain epinephrine should not be autoclaved [heated via steam under pressure] and should be protected from light..."
VIOLATION: DELIVERY OF DRUGS Tag No: A0500
Based on observation, interview, and document review, the hospital failed to ensure pharmaceuticals were controlled and distributed in a safe manner to protect patients as evidenced by:

1. Sterile water for injection, one liter bag (which had intravenous (IV) delivery set ports and looked similar to the IV solutions for hydration and electrolyte replacement such as normal saline, dextrose % in water, Lactated Ringer's) was available in a patient care area without appropriate safeguards in place to prevent inadvertent intravenous administration of the product. This failure had a potential to result in serious patient harm from hemolysis (breakdown of red blood cells).

2. The emergency medications in the adult crash carts (wheeled carts used in emergency resuscitations) did not match the Pharmacy and Therapeutics (P&T) committee approved emergency medication list. Also the concentration of atropine syringe (to treat heart rhythm problems and reduce saliva production during surgery) on the emergency medication list posted outside the pediatric crash cart did not match the concentration of atropine syringe inside the pediatric crash cart. These failures had the potential to result in emergency medication not available in a timely manner, leading to delayed treatment in an emergency and may also result in pediatric patient receiving the wrong medication dose in an emergency leading to patient's harm.

3. Patient 10 had a medication at her bedside. This failure had the potential to result in a patient using medication that health care providers were not aware of, and may comprise the patient's treatment.

Findings:

1. On 3/16/16 at 11:10 AM, during a concurrent observation and interview in the Operating Room (OR) suite, with the Registered Nurse (RN) OR Manager (RN 7), one liter bag of sterile water for injection (SWFI) was identified in the sub sterile room between OR 1 and OR 2. The SWFI bag looked similar to the plain IV solutions available in the sub sterile room. The SWFI had same bag size (1 liter) and colorless solution as the other IV solutions, except the SWFI was labeled in red. Also the SWFI bag could accommodate regular IV tubing making it easier to mistakenly infuse intravenously.

During the concurrent interview, RN 7 stated the SWFI bag was being used during surgery for irrigation. RN 7 stated the tubing being used did not fit the sterile water irrigation bottle, however it worked well with the sterile water for injection bag.

2. The emergency crash cart is used for storing emergency medications and medical supplies needed for immediate treatment of cardiac or respiratory events.

On 3/15/16 at 4:25 PM, during an observation on the medical surgical unit, and concurrent interview with the Chief Nursing Officer (CNE), the emergency medications in the adult crash carts did not match the emergency medication lists posted outside the adult crash carts. The medication lists outside the crash cart listed epinephrine 30 milligram (mg)/30 milliliters (ml) injection and naloxone 0.4 mg/1 ml injection, however there was no epinephrine 30 mg/30 ml injection and naloxone 2 mg/2 ml injection inside the crash carts.

The CNE acknowledged the medications inside the adult crash carts did not match the medication lists posted outside the crash carts. She also stated the medications inside the crash cart were correct, the medication list posted outside the crash cart should not be there.

On 3/16/16 at 10:25 AM, during a concurrent observation in the Emergency Department (ED), with the CNE and the Director of ED (RN 6), epinephrine 30 mg/30 ml injection (used in medical emergency to improve perfusion pressure to the brain and heart, increase heart rate and heart muscle contractility) and naloxone 0.4 mg/1 ml injection (to reverse the effects of opioid medication) were listed outside the adult crash cart, however there was no epinephrine 30 mg/30 ml injection and naloxone 2 mg/2 ml injection was inside the adult crash cart.

Atropine 0.1 mg/10 ml injection was listed outside the pediatric crash cart, however atropine 1 mg/10 ml was inside the pediatric crash cart.

The CNE and RN 6 both acknowledged the medications inside the adult crash cart and the pediatric crash cart did not match medication lists posted outside the crash carts.

During staff interview on 3/16/16 at 9:30 AM, the CNE provided documentation for the P&T review on 5/3/12 of the emergency medications list posted outside the adult crash cart, but was unable to provide evidence the P&T approved the emergency medications inside the adult crash cart.

During the staff interview on 3/16/16 at 4:30 PM, the Director of Pharmacy acknowledged she was unable to find documentation for the P&T approval of the emergency medications inside the adult crash cart.

Review of the hospital's policy and procedures titled "Crash Cart - Checking/Restocking" dated 12/2013, read in part "... List of medication listed on outside of crash cart ... Ensure that the crash cart medication sheet is prominently displayed on the outside of the crash cart ..."

3. On 3/15/16 at 8:45 AM, RN 10 was observed in the process of administering medications to Patient 10 in the medical surgical unit. An Albuterol inhaler (for shortness of breath) was identified in Patient 10's purse which was on her lap. Patient 10 stated the Albuterol inhaler was her medication from home which she always kept in her purse.

During the staff interview on 3/15/16 at 9:10 AM, RN 10 stated Patient 10 was not supposed to have any medication at the bedside and he was not aware the Albuterol inhaler was in her purse.

Review of the hospital's Policy & Procedures (P&P) titled "Patient's Own Medication (Home Medication)" dated 12/2011, read in part "...When patients bring their own medication into the hospital, the home medication list should be compiled, verified, and then the medications sent home with the family member. If there is no one to send the medications with, they shall be sequestered in a..., stored in Pharmacy Services, and returned upon day of hospital discharge..."

Review of the hospital's P&P titled "Medication Administration" dated 12/2012, read in part "... Self-administration of medication by patient is not permitted ..."

Review of the hospital's P&P titled "Patient Self-Administration of Medications (bedside medications)" dated 2/2012, read in part "...the hospital does not permit patient to self-administer their own (home) medication during their entire hospital stay ..."
VIOLATION: UNUSABLE DRUGS NOT USED Tag No: A0505
Based on observation, staff interview, and document review, the hospital failed to ensure outdated, mislabeled, and unusable medications were not available for patients' use. These failures had the potential to result in patients receiving medications which may not provide the intended benefit, and may lead to patients' harm.

Findings:

1. On 3/16/16 at 10:05 AM, during a concurrent observation and interview in the Emergency Department (ED) with the Chief Nursing Executive (CNE), and the Registered Nurse (RN) Director of ED (RN 6), one bag of 0.9 % sodium chloride (normal saline used to hydrate) 250 milliliters (ml) was observed to have an expiration date of 1/2016. A bag of normal saline 50 ml mini bag was observed on top of the bin without the over wrap, a second bag of normal saline 50 ml mini bag without the over wrap was identified at the bottom of the bin under the mini bag packages. A bag of normal saline 250 ml without the over wrap was also identified in another bin. These solutions without the over wrap were not labeled by the hospital with the expiration date.

The CNE and RN 6 acknowledged the expired bag of normal saline 250 ml. RN 6 stated a pharmacy technician usually labeled the intravenous solutions with no over wrap with expiration date every morning. RN 6 was unable to verify how long the mini bag with no over wrap had been at the bottom of the bin.

During an interview on 3/16/16 at 2 PM, the Director of Pharmacy stated normal saline mini bag 50 ml and normal saline 250 ml were given 28 days expiration date once out of the over-wrap. She also stated a pharmacy technician labeled the intravenous (IV) solutions out of the over wrap in the ED with expiration date every morning, however she was unable to verify how long the IV solution bags had been out of the over-wrap.

Review of the hospital's Policy & Procedures titled "Drug Storage and Inventory Management" dated 2/2012, read in part, "... Expired, damaged, or contaminated medications will be removed from drug storage areas throughout the hospital ..."

2. On 3/16/16 at 11:15 AM, during a concurrent observation and interview in Operating Room (OR) 2, with the OR Manager (RN 7), the intravenous fluid warmer in OR 2 contained the following items:

One bag of Lactated Ringers (LR) solution 1000 milliliters (ml, for hydration) with the expiration date of 4/11/16.

One bag of Lactated Ringers (LR) solution 1000 ml with the expiration date of 4/12/16.

Two bags of 0.9 % sodium chloride injection 1000 ml (hydration) with the expiration date of 4/6/16.

One bottle of 0.9 % sodium chloride irrigation 1000 ml with the expiration date of 4/6/16.

Two bottles of 0.9 % sodium chloride irrigation 1000 ml with the expiration date of 4/11/16.

One bag of 0.9 % sodium chloride irrigation 3000 ml with the expiration date of 4/12/16.

During the interview, RN 7 stated the solutions were good for 28 days in the warmer.

Review of the manufacturer's letter provided by the hospital dated 3/16/16, showed the solutions could be warmed for a period no longer than 14 days.

During an interview on 3/16/16 at 3:45 PM, the CNE stated the hospital changed the solution supplier last year, however the OR staff were not aware of the change. The prior IV solution manufacturer's solution was good for 28 days in the warmer.