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Based on observation, interviews and review of the facility's policies & procedures (P&P) and documents, for 2 of 44 sampled patients (17, 18), the facility failed to follow the Medication Reconciliation P&P for medications taken at home. The emergency department (ED) was unable to provide documentation that showed how the staff verified medications during reconciliation and what source was used for the verification.

Findings:

On 7/6/10 at 9:35 a.m., the ED was toured as part of the survey process. At 9:45 a.m., an interview was conducted with one of the on-duty ED Registered Nurse's (RN 2). RN 2 was asked to explain the process for ED patient medication reconciliation (MR). RN 2 stated that when a patient arrives to the ED the medications will be verified by the nurse at triage, or the nurse who brings the patient directly back to the unit. RN 2 was asked to show the MR on her assigned patients. RN 2 accessed the electronic record and showed the MR area of Patient 18 (date of service 7/6/10). A review of Patient 18's MR showed a list of medications and next to each entry there were the initials that RN 2 stated were the night shift nurse's initials. RN 2 was asked how the medications were verified and she stated that the night shift nurse would have done that, however, based on the available documentation, RN 2 could not ascertain how the night shift nurse verified that the medications were current.

A review of Patient 18's MR was conducted using his ED visit of 6/20/10. Patient 18's MR showed the identical names and dosages, which included the same word, "unknown" for Patient 18's last dose for those particular home medications of 6/20/10 and 7/6/10. RN 2 was asked if the two ED visits had been verified and she stated, "Yes." RN 2 was asked to show how the MR for both visits had been verified and she stated she was unable to do that as the system was not set up to indicate that part of the MR process.

On 7/6/10 at 10:10 a.m., the ED Nursing Director (EDD) was interviewed regarding the MR process used in the ED. The EDD was showed Patient 18's 7/6/10 MR and she stated that the nurse's initials indicated that the medications had been verified. The EDD was asked what source was used by the nurse to verify that Patient 18's medications were current and she stated the system did not currently allow the nurses to indicate that on the electronic chart. The EDD was then showed the 6/20/10 MR, which was identical to the 7/6/10 MR and she stated, " The system currently does not allow nursing to indicate how they verified that the medications were current for the patients." The EDD concurred that the present system does not effectively allow the nurse to indicate whether the MR has been verified and what source's the nurse used to ensure the accuracy of the MR.

On 7/6/10 at 1:00 p.m., Patient 17's closed record was reviewed in the ICU. Patient 17 was admitted through the ED on 7/4/10 and discharged from the ICU on 7/6/10. A review of the chart showed an ED MR that had originally been printed and read that Patient 17 had no current home medications. Under that statement was hand written, "Hydrocodone" (pain medication) and "muscle relaxant." The signature area marked, "Nurse Collecting Data" was left blank. The treating ED physician signed and dated the area that read, "Admitting Physician." A review of both nursing and physician documentation read that Patient 17 was on no current medications at home. Further review showed a pharmacy sheet that indicated that 8 of Patient 17's Hydrocodone pills were sent to the pharmacy to be stored while Patient 17 was in the hospital.

On 7/6/10 at 2:30 p.m., the EDD was interviewed regarding Patient 17's ED MR. The EDD stated that probably, the ED staff were unaware that Patient 17 had brought any medication with him until they had completed Patient 17's belongings sheet before admitting him to ICU. The EDD was asked how the staff had verified that Patient 17 was on no home medications and she stated that she could not ascertain that information with the ED's current computer system. After the chart review, the EDD was unable to explain who hand wrote the two medications on Patient 17's MR and how they were verified.

A review of the P&P titled, "Medication Reconciliation," (revised 5/10) read under the, "Emergency Room Process: A. Triage nurse obtains a list of the names of the medications. If Med Host (ED computer system) offers a medication list from a previous visit and the patient and the family are unable to verify accuracy, the list is kept with an additional note stating that the nurse was unable to verify data at this time.B. Once the disposition of the patient has been decided and the patient is going to be a transfer or an admit, the primary nurse is responsible for completion of the Patient Medication List. The completed form should include the dosage, frequency and last dose taken."

Based on observations, staff interview, P&P and medical record review, the hospital failed to ensure that 1 of 44 patients (Patient 8) received sedation medications in accordance with accepted standards of practice and the hospital P&P. Patient 8 was administered sedation medications Versed (sedative) and Ketamine (anesthetic) in the Emergency Department (ED) by Registered Nurse (RN) 1 who had no specialized training to administer anesthesia and no demonstrated competencies documented to administer moderate or deep sedation.

Findings:

The 7/7/10 review of ED physician documentation showed that on 5/28/10 Physician 7 performed a surgical procedure (incision and drainage of an abscess in the suprapubic area) on a 3 year old patient (Patient 8) in the ED. The physician documented on 5/28/10 at 7:57 p.m. that the type of sedation administered was moderate sedation, and that the medications administered were: Ketamine 4 mg/kg and Versed 1 mg, with a nurse at the bedside at all times. Review of the Procedural/Sedation Record showed that on 5/28/10 at 7:45 p.m. RN 1 administered medications Versed 1 mg and Ketamine 72.5 mg intramuscularly to Patient 8 (Patient 8's weight was documented 18.14 kg in the nurse's notes). The sedation record showed the sedation started at 7 45 p.m. and ended at 7:46 p.m. and the procedure started at 7:45 p.m. and ended at 7:58 p.m. The Intra Procedure part of the sedation record showed Patient 8 sedation level was 3 from 7:45 p.m. to 8:25 p.m. The next entry at 8:27 p.m. in the post procedure section indicated the sedation level was 1. Patient 8's discharge time was documented at 9:35 p.m.

Lexi-Comp Online drug reference () retrieved on 7/9/10 indicated that Ketamine is categorized as general anesthetic with labeled indications for induction and maintenance of general anesthesia, with investigational use in analgesia and sedation. In warnings section it was indicted "Experienced physician: should be administered under the supervision of a physician experienced in administrating general anesthetics.

Review of the facility's P&P titled "Moderate and Deep sedation" (rev 5/10) indicated, the P&P applied to all patients receiving sedation in any setting for any purpose, by any route, moderate or deep sedation, as defined in this policy. The policy defined "Moderate sedation/analgesia- a drug induced depression of consciousness during which patients respond purposefully to verbal commands either alone or accompanied by light tactile stimulation ...Deep sedation/analgesia-a drug induced depression of consciousness during which patients cannot be easily aroused but may respond purposefully following repeated or painful stimulation ..." Attachment A of the P&P defined sedation score 2 as "brisk response to tactile stimulation" and score 3 as "sluggish response to tactile stimulation."

Review of the ED record for Patient 8 as described above indicated the patient's sedation score was 3 throughout the procedure consistent with deep and not moderate level of sedation.

The "Moderate and Deep sedation" P&P indicated in section 4. Personnel Requirements: "d. Deep sedation/analgesia is currently outside the scope of practice of a registered nurse. Therefore, deep sedation can only be performed by physicians whose training and privileges specifically include deep sedation ..."

The "Moderate and Deep sedation" P&P section Procedure 2. Intra-procedure Treatment, Monitoring and Documentation, indicated in section "d" that significant changes were to be reported immediately by the registered nurse to the attending practitioner. The changes listed included "change in level of consciousness in which a patient cannot communicate verbally or appropriate for age (sedation level greater than 2, see attachment A)." The P&P section e. "Respiratory Depression/Increased Sedation Treatment" indicated that for patient conditions that included sedation level 3, treatments such as stimulate patient, encourage deep breathing, provide nasal cannula or face mask oxygen 3-6 L/min should be implemented and to monitor the patient every 5 minutes until stable and until sedation level 2 is reached.

Review of the ED record for Patient 8 as described above did not indicate that the patient's sedation level 3 was reported to the physician or that any interventions were implemented until the patient's sedation reached level 2 as per the policy. The sedation record showed that Patient 8 was receiving oxygen via nasal cannula at 1 L/min from 7:45 to 8:25 p.m. and remained at sedation level 3 during that time. The Sedation record showed no IV access was obtained for Patient 8.

In an interview on 7/7/10 at 2:45 p.m. Physician 8 acknowledged that Patient 8's level of consciousness was consistent with deep sedation at level 3. Physician 8 agreed that without an IV access, rescue attempt, if needed, may have been delayed for Patient 8. Ketamine, the medication administered to Patient 8 has no reversal agent.

The "Moderate and Deep Sedation" P&P indicated in section 4 e. "The registered nurse administrating medications, monitoring and recovering the moderate sedation patient must demonstrate current competence in moderate sedation and advanced cardiac life support (ACLS or PALS, as appropriate)."

On 7/7/10 at 10:45 a.m. the EDD stated that the hospital was in process of training and evaluation of competencies of the ED nursing staff for moderate sedation but not all RNs were currently evaluated nor had demonstrated competencies. The ED Manager stated that RNs who did not have demonstrated competencies evaluated were not being assigned to administer and/or monitor patients receiving sedation. The ED Manager presented a list of RNs working in the ED indicating which RNs completed the sedation training with demonstrated competencies. RN 1 was not one of those RN who had demonstrated competencies in administration of moderate sedation before 5/28/10.

The 7/7/10 personnel files reviewed for RN 1 showed no record of demonstrated competencies for moderate sedation administration, rescue and monitoring prior to the administration of sedation to Patient 8 on 5/28/10.

The position statement titled Conscious Sedation by the California Board of Registered Nursing (BRN) retrieved at www.rn.ca.gov, in part, indicated: In administering medications to induce conscious sedation, the RN is required to have the same knowledge and skills as for any other medication the nurse administers ... National guidelines for administering conscious sedation should be consulted in establishing agency policies and procedures ...The institution should have in place a process for evaluating and documenting the RNs demonstration of the knowledge, skills, and abilities for the management of clients receiving agents to render conscious sedation. Evaluation and documentation of competency should occur on a periodic basis ..."

The 2010 edition of Perioperative Standards and Recommended Practices published by the Association of periOperative Registered Nurses (AORN) made the following recommendations related to Moderate (conscious) Sedation/Analgesia:
Recommendation I:
The perioperative registered nurse administering moderate sedation/analgesia must practice within the scope of nursing practice as defined by his or her state and should be compliant with state advisory opinions, declaratory rules, and other regulations that direct the practice of the registered nurse. The methods of monitoring used with patients who receive moderate/analgesia, the medications selected and administered and the interventions taken must be within the legal definitions of the scope of practice of the registered nurse.
Recommendation IX Competency:
The periopreative registered should be clinically competent, possessing the skill necessary to manage the nursing care of the patient receiving moderate sedation/analgesia. Competency assurance verifies that personnel have an understanding of moderate sedation; the risks of unplanned, deeper sedation; and the safe use of monitoring equipment. This knowledge is essential to minimize the risks of moderate sedation and provide safe care. IX.a. The competency of the perioperative registered nurse to administer moderate sedation/ analgesia should be assessed, demonstrated, documented, and maintained.

Review on 7/9/10 of the American Association for Nurse Anesthetists (AANA) Practice Policy titled Considerations for Policy Guidelines for Registered Nurses Engaged in the Administration of Sedation and Analgesia, revised June 2003, indicated that sedation and analgesia (moderate sedation) was defined as a medically controlled state of depressed consciousness that allowed protective reflexes to be maintained. AANA further documented, "Those patients whose only response is reflex withdrawal from a painful stimulus are sedated to a greater degree than encompassed by sedation/analgesia." AANA listed various tasks that properly trained registered nurses could be authorized to perform under section B. Management and Monitoring. Item B.3., however, specifically excluded registered nurses who were not qualified anesthesia providers to administer agents classified as anesthetics, "including but not limited to Ketamine, Propofol, Etomidate, Sodium Thiopental, Methohexital, Nitrous oxide and muscle relaxants."



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Based on observation, interview and record review the facility failed to follow policies and procedures for safe and effective medication use when one dose of intravenous droperidol was administered in the presence of a contraindication (prolonged QTc interval) and cardiac monitoring was not performed after droperidol administration for 1 of 44 sampled patients (Patient 48).

Findings:

1. Closed record review on 7/8/10 revealed that Patient 48 was a 40 year-old female who presented to the emergency department (ED) on 5/10/10 at 10:37 p.m. with complaints of nausea and vomiting.

Review of Patient 48's ED Physician Orders revealed Zofran 4 mg (an injectable antinauseant) was ordered and administered intravenously (over 2 minutes) at 11:02 p.m. At 11:34 p.m., an EKG (electrocardiogram, an assessment of the electrical conduction of the heart) was ordered. At 11:53 p.m., Inapsine 1.25mg (also known as droperidol, an injectable antinauseant) was ordered and administered intravenously (rate unspecified).

Review of Patient 48's EKG assessment (performed on 5/10/10 at 11:43 p.m.) revealed a QTc interval of 478 milliseconds. At 12:17 a.m. (24 minutes after the intravenous Inapsine was administered), the ED physician noted in the clinical record, "QT interval is normal."

Patient 48 was discharged from the ED on 5/11/10 at 12:53 a.m. (one hour after the intravenous droperidol was administered).

Droperidol's "black box" warning indicated that the drug carries a significant risk of serious or even life-threatening adverse effects. The U.S. Food and Drug Administration (FDA) could require a pharmaceutical company to place a "black box" warning on the labeling of a prescription drug, or in literature describing the drug. It is the strongest warning the FDA required and emphasized potentially life-threatening adverse effects for prescription drugs. The FDA required that "black box" warnings be separated from other text in the package insert labeling and was typically framed with a black box border.

Following is an excerpt of the "black box" warning for droperidol (brand name Inapsine):

"Cases of QT prolongation and/or torsades de pointes [a potentially fatal abnormal cardiac rhythm] have been reported in patients receiving Inapsine at doses at or below recommended doses. Some cases have occurred in patients with no known risk factors for QT prolongation and some cases have been fatal.

"Due to its potential for serious proarrhythmic effects and death, Inapsine should be reserved for use in the treatment of patients who fail to show an acceptable response to other adequate treatments; either because of insufficient effectiveness or the inability to achieve an effective dose due to intolerable adverse effects from those drugs (see Warnings, Adverse Reactions, Contraindications and Precautions).

"Cases of QT prolongation and serious arrhythmias (e.g., torsades de pointes) have been reported in patients treated with Inapsine. Based on these reports, all patients should undergo a 12-lead ECG (electrocardiogram) prior to administration of Inapsine to determine if a prolonged QT interval (i.e., QTc greater than 440 milliseconds for males or 450 milliseconds for females) is present. If there is a prolonged QT interval, Inapsine should NOT be administered. For patients in whom the potential benefit of Inapsine treatment is felt to outweight the risks of potentially serious arrhythmias, ECG monitoring should be performed prior to treatment and continued for 2 - 3 hours after completing treatment to monitor for arrhythmias.

"Inapsine is contraindicated in patients with known or suspected QT prolongation, including patients with congenital long QT syndrome."

Review of the facility policy Droperidol (Inapsine), Guidelines for Use of (dated 3/03) indicated under Policy: "Due to droperidol's potential for serious proarrhythmic effect it should be reserved for patients who fail to show an acceptable response to other adequate treatments. It is recommended that a 12-Lead EKG be performed prior to droperidol administration. If a prolonged QT interval (greater that 450 milliseconds in females and 440 milliseconds for males) is present then droperidol should not be administered. For patients in whom the potential benefit of droperidol is felt to outweigh the risks, then continuous cardiac monitoring should be continued for 3 hours after completing the treatment. Droperidol should be administered with extreme caution to patients who may be at risk for prolonged QT syndrome and/or torsades de pointes (i.e., CHF [congestive heart failure], bradycardia [slow heart rate], use of diuretic [water pills], cardiac hypertrophy [enlargement of the heart], hypokalemia [low blood potassium], hypomagnesia [low blood magnesium], or administration of other drugs known to increase the QT interval)."

During an interview on 7/8/10 at 3:25 p.m. the Emergency Department Director (EDD) confirmed that Patient 48's QTc interval (478 milliseconds) was prolonged (as compared with 450 milliseconds for females as advised by facility policy and the manufacturer's "black box" warning information). EDD further confirmed that Patient 48's ED physician did not document acknowledgement of her prolonged QTc interval, nor did the ED physician document risk/benefit of droperidol use in the presence of a prolonged QTc interval. EDD acknowledged that Patient 48 did not receive cardiac monitoring for 3 hours after the intravenous droperidol was administered (per facility policy), as she was discharged one hour after the medication was administered.

During a continued interview, EDD confirmed that intravenous droperidol was available to licensed nursing staff in the ED automated dispensing cabinet (a locked cabinet used for control and distribution of medications accessible to licensed staff after electronic code entry). During a demonstration of the steps required to withdraw droperidol from the cabinet, EDD noted a "pop-up" electronic screen indicating that an EKG (electrocardiogram) assessment should be done, droperidol should be avoided in cardiac patients and the EKG should be monitored for QTc prolongation. EDD acknowledged the "pop-up" screen did not specify the facility policy's QTc thresholds for males and females, nor did it specify the duration of EKG monitoring.

Based on observation, interview and record review the facility failed to properly secure 1 of 44 sampled patient's (Patient 23) antibiotic eye medication in accordance with their policy, making it available to unauthorized staff and visitors.

Findings:

1. On 7/7/10 at approximately 9:50 a.m., during an observation of medication administration, RN 4 was observed to administer neomycin-bacitracin-polymixin eye ointment (also known as Neosporin, a prescription antibiotic ointment) to Patient 23's right eye, then return the multi-use tube to the manufacturer's box supplied by the pharmacy and place it on top of one of the bedside stands adjacent to Patient 23's bed.

Review of Patient 23's clinical record revealed that he was a 68 year-old admitted to the facility on 6/27/10 with diagnoses including Alzheimer's dementia, bacteremia (bacterial infection in the blood); clostridium difficule (C. difficile) colitis (an intestinal bacterial infection characterized by frequent diarrhea episodes) and right eye conjunctivitis (bacterial infection).

Review of Patient 23's Physician Orders included an order (dated 7/1/10) for C. difficile contact precautions (gowning of staff, handwashing and other precautions to prevent the spread of infection to others); and an order (dated 6/28/10) for Neosporin eye ointment to Patient 23's right eye 3 times daily.

Review of Patient 23's 7/6/10 and 7/7/10 computer-generated Medication Administration Record (MARs) revealed, adjacent to the neomycin-bacitracin-polymixin eye ointment order, a handwritten notation indicating "at bedside."

During an interview on 7/7/10 at 2:40 p.m. RN 4 confirmed that she had placed Patient 23's supply of prescription antibiotic eye ointment on the bedside stand adjacent to his bed after she administered the medication at 9:50 a.m. She explained that, since Patient 23 had an order for contact precautions, nursing staff had decided to leave the ointment in his room (instead of taking it back to the locked medication room where the other patient's multi-use medications were stored in bins). RN 4 acknowledged that, by leaving Resident 23's prescription antibiotic eye ointment on top of the bedside stand in his room, it was available to non-licensed staff and family members. When asked facility policy regarding personnel having access to medication, RN 4 stated "licensed nursing staff and pharmacy staff."

Review of the facility policy Administration, Storage and Security of Pharmaceuticals (revised 1/10) indicated under item II.A.1, Storage and Security: "All drugs will be stored in lockable containers, carts, dispensing machines, or specific medication storage areas." Under item II.A.5, the policy indicated: "Medications shall be accessible only to responsible personnel designated by the hospital or to the patient when ordered by the bedside."

During an interview on 7/7/10 at approximately 2:45 p.m. Nurse Manager (NM) acknowledged that only licensed nursing staff and pharmacy staff are authorized to have access to medication throughout the hospital. NM indicated that there is currently no locked area for medication storage in any patient rooms.

During an interview on 7/8/10 at 12:30 p.m. the Director of Pharmacy acknowledged that only licensed nursing staff and pharmacy staff are authorized to have access to medication throughout the hospital.

Based on observation, interview and record review the facility failed to implement their policy regarding expired medications when:
1. Three expired medications in the pharmacy were not sequestered and were available to be dispensed.
2. One vial of expired NPH insulin in the medical-surgical unit medication room was not removed from stock and discarded and was available for use.

Findings:

1. On 7/6/10 at 11:15 a.m. an inspection of the inpatient hospital pharmacy revealed, on a shelf designated for injectable products, a vial of Chloroprocaine 400 mg/20 mL (an injectable local anesthetic used in surgical procedures) in its original manufacturer packaging. Affixed to the lower left corner of the box was a round yellow sticker with a handwritten date of 6/10. Closer inspection of the box and enclosed vial revealed the Chloroprocaine had expired in June 2010 (six days prior to the date of inspection).

During an interview at 11:20 a.m., Pharmacist 1 (Pharm 1) confirmed that the vial of Chloroprocaine had expired at the end of June. Pharm 1 explained that a designated pharmacist inspects the pharmacy monthly for expired medications. Pharm 1 further explained that a sticker is affixed to the product with the month of expiration in advance of the month of expiration; the product is then sequestered prior to expiration. Referring to the expired Chloroprocaine, Pharm 1 indicated that the pharmacist responsible for inspection of the pharmacy "must have overlooked this."

On 7/6/10 at 11:26 a.m. further inspection of the inpatient hospital pharmacy revealed, on a shelf designated for antibiotic suspensions, a manufacturer's white plastic bottle containing Augmentin ES 600 mg/5 mL 75 mL (when reconstituted) powder for oral suspension (an antibiotic). Affixed above the manufacturer's label was a round yellow sticker with a handwritten date of 6/10. Closer inspection of the manufacturer's label revealed the Augmentin ES 600 mg/5 mL powder for oral suspension revealed an expiration date of June 2010 (six days prior to the date of inspection).

At 11:28 a.m., on a shelf designated for external medications, two boxes containing tubes (19.8 grams each) of Tucks anti-itch ointment each revealed a round yellow sticker (affixed to the end of the box) with a handwritten date of 6/10. Closer inspection of the two boxes and enclosed tubes revealed the Tucks anti-itch ointment had expired in June 2010 (six days prior to the date of inspection).

During an interview at 11:30 a.m. Pharm 1 confirmed that the bottle of Augmentin ES 600 mg/5 mL powder for oral suspension and two tubes of Tucks anti-itch ointment had expired at the end of June 2010.

Review of the facility policy Pharmacy Inspections (revised 2/09) indicated under item B: "Inspections shall be completed every 30 days and shall be documented on the Offsite Clinic Medication Inspection sheet (Attachment 1), the Inpatient Pharmacy Area Monthly Inspection sheet (Attachment II) or the Patient Care Area Medication sheet (Attachment III)." Under item E7, the policy indicated: "Drugs shall not be kept in stock within two months of the expiration date on the label and no contaminated or deteriorated drugs shall be available for use (see policy and procedure ADMINISTRATION, STORAGE AND SECURITY OF PHARMACEUTICALS."

During an interview on 7/6/10 at 2:10 p.m. the Director of Pharmacy (DOP) confirmed that the pharmacist responsible for inspection of the pharmacy did review the pharmacy in June 2010. When asked for written verification of the pharmacist's June 2010 inspection (the Inpatient Pharmacy Area Monthly Inspection sheet), the DOP was unable to provide the form summarizing the pharmacy area inspection. The DOP indicated that the Inpatient Pharmacy Area Monthly Inspection sheet had not been completed in several months.

2. On 7/7/10 at 9:35 a.m. an inspection of the medical surgical unit medication room (accompanied by Registered Nurse(RN) 3) revealed a plastic container affixed to the wall with individualized compartments containing multi-dose vials of various types of insulin for injection; all had the metal cap removed (indicating the contents of the vials had been accessed through the rubber stopper); all had auxiliary labels affixed to the vials indicating date of first use or expiration. One of the individualized compartments contained a multi-dose vial of Novolin-N U-100 insulin (NPH, a long-acting insulin indicated for diabetes), original quantity 10 mL. The auxiliary label affixed to the vial indicated that the date of first use was 5/15/10 (53 days prior to the date of the inspection). When asked regarding the facility policy for expiration dating of multi-dose vials of insulin, RN 3 indicated that the vials were "good 30 days only," and confirmed that the Novolin-N vial of insulin (which indicated the date of first use was 5/15/10) was expired. RN 3 indicated that Novolin-N insulin is not used frequently, and the expired vial of insulin would have been discovered the next time a dose was administered by licensed nurses.

Review of the facility policy Administration, Storage and Security of Pharmaceuticals, revised 1/10, indicated under item C, Product Dating and Expiration: "Ongoing checks for expired medications will be conducted by nursing and pharmacy services." Under item II.C.1.d., Multi-Dose Vials, the policy indicated: "Discard when empty, when suspected or visible contamination occurs, or expiration date (28 days from the date opened) or the manufacturer's expiration date, whichever is shortest."

During an interview on 7/7/10 at 12:10 p.m. the DOP indicated that the expiration date of multi-dose vials had "always been" 28 days, not 30 days as indicated by RN 3. The DOP indicated that it is the responsibility of licensed nursing staff to monitor for expiration dating on open multi-dose vials (on the nursing units), and that the monthly surveillance by the pharmacist only includes vials that are intact (not open) in medication storage areas outside of the pharmacy. The DOP acknowledged that the multi-dose vial of Novolin-N insulin observed in the medical surgical unit medication room that morning (that had a date of first use indicating 5/15/10, 53 days prior to the date of the inspection) was expired and available for use.

Based on interview, record review and facility document review the facility failed to ensure an adverse drug reaction (hypoglycemia) was reported for 1 of 44 sampled patients (Patient 47) when a reversal agent (D50W injection) was administered.

Findings:

1. Closed record review on 7/8/10 revealed that Patient 47 was an 84 year-old female admitted to the facility through the emergency department (ED) on 5/24/10 with multiple diagnoses including hypoglycemia, Type II diabetes mellitus and Alzheimer's dementia.

Review of Patient 47's History and Physical (dated 5/25/10) revealed she had been living in an apartment and her son had been assisting her with medication administration once daily in the morning. Review of her admission diabetes medications included Glucophage XR 1000 mg (an extended release form of metformin) orally every morning and Lantus insulin (a long-acting insulin) 35 units subcutaneously (injected under the skin) every morning. Under Assessment and Plan, the document indicated Patient 47 had previously been in the hospital ED on 4/22/10, 5/12/10, 5/18/10, 5/23/10; the document further indicated that, "according to her son, at least 3 of those episodes were for hypoglycemia."

Review of Patient 47's 5/24/10 ED Nurse's Notes indicated that, prior to her arrival at the hospital, she had been treated with Glucagon 2 mg intramuscularly (an injectable reversal agent for hypoglycemia) and oral glucose 15 grams (by emergency medical staff, or EMS) for a blood sugar (BS) of 43 mg/dL (normal fasting blood sugar is 70 to 100 mg/dL) and altered level of consciousness. Patient 47 arrived in the ED at 4:33 p.m. via ambulance and was admitted to the medical surgical unit at 8:30 p.m. A 4:56 p.m. fingerstick BS assessment in the ED was 169 mg/dL. Patient's ED record did indicate any oral intake of food (including the "SBAR [Situation-Background-Assessment-Recommendation/Plan of Care] ER Hand Off" document from the ED nurse to the medical surgical unit nurse).

Review of Patient 47's Medication Reconciliation Form summarizing her medications prior to admission (dated 5/24/10 at 5:50 p.m.) indicated that she had received Glucophage XR 1000 mg orally the morning of 5/24/10. The form did not specify when Patient 47 received her last dose of subcutaneous Lantus insulin 35 units (which was ordered daily in the morning).

Review of Patient 47's admission Physician Orders (dated 5/24/10 at 6:50 p.m.) included Glucophage XR 1000 mg every morning and a Moderate Sliding Scale subcutaneous regular insulin regimen before meals and at bedtime as follows: 2 units for BS 150 - 199 mg/d; 4 units for BS 200 - 249 mg/dL; 6 units for BS 250 - 299 mg/dL; 8 units for BS 300 - 349 mg/dL; 10 units for BS 350 - 399 mg/dL; and 12 units for BS above 400 mg/dL (with instructions to call the physician). Patient 47's admission diet order indicated " Diabetic 2000 calorie, Cardiac 2 gram Sodium."

Review of Patient 47's 5/24/10 Medication Administration Record (MAR) revealed that she received 2 units of regular insulin at 9:50 p.m. for a blood sugar of 176 mg/dL. Patient 47's intake/output summary (beginning the evening of 5/21/10) did not indicate any oral intake of food.

Review of the facility policy Diabetes Management (revised 4/2010) indicated under item 2a: "The patient that presents with abnormal glucose levels and/or is receiving subcutaneous insulin resulting in potential changes in glucose levels will be followed closely for symptoms of hypoglycemia in order to maintain blood glucose between 90 - 130 mg/dL during acute illness/hospitalization."

Lexi-Comp ONLINE, a nationally recognized drug reference, indicated in its monograph that metformin is substantially eliminated by the kidneys, and should not be initiated in patients greater than 80 years of age unless normal kidney function is established. The monograph further indicated that metformin is "more likely to induce hypoglycemia when calorie [food] intake is insufficient, when the medication is combined with other oral diabetic medications (or insulin), or in the elderly.

Patient 47's 5/25/10 laboratory assessment revealed a GFR (glomerular filtrate rate, a standard assessment of kidney function based on age, gender and laboratory assessment of creatinine) of 68. Creatinine is a by-product of muscle metabolism and is mainly filtered out of the body through the kidneys (by glomerular filtration). The creatinine clearance (ability of the kidneys to filter creatinine from the blood) reflects the glomerular filtration rate. According to the National Kidney Foundation (a national research group focused on the identification and treatment of chronic kidney disease), a GFR of 60 to 90 indicates mild impairment of renal function.

Continued review of Patient 47's clinical record revealed that a nurse's note was written at 6:05 a.m. on 5/25/10 indicating "Pt. [patient] found unresponsive to verbal/painful stimuli but breathing, Rapid Response Team called and in room with Pt., VSS [vital signs stable], BG [BS] 60, Pt. given 1 amp Dextrose [50 mL intravenous Dextrose 50% solution, or D50W], will page MD."

Patient 47's 5/25/10 physician progress note indicated "DM2 [diabetes mellitus type II] - hypoglycemia this AM - no meds given here, think Glucophage XR 1000 mg + Lantus 35 U [units] given yest [yesterday] AM, glucagon given here, no further meds...nutrition to follow." Due to Patient 47's altered mental status, her physician ordered a CT scan and to rule out CVA (stroke, or bleeding in the brain). Patient 47's physician held then discontinued her Glucophage XR on 5/25/10.

Review of Patient 47's CT scan result (dated 5/25/10) indicated no evidence of intracranial hemorrhage (bleeding in the brain).

Review of the pharmacy's "trigger drug" report (used to evaluate use of reversal agents for identification of potential adverse drug reactions) dated 5/25/10 indicated documentation that the pharmacist had spoken with RN 4 regarding Patient 47's order for intravenous D50W (which had been withdrawn from the automated drug cabinet at 6:10 a.m. the same day) and had concluded "probably not an ADR [adverse drug reaction]."

Review of the facility report, "Reported Medication Events and Near Misses," dated May 2010 (which included a summary of medication errors and adverse drug reactions) did not include Patient 47's 5/25/10 incident involving hypoglycemia and use of intravenous D50W as a reversal agent. The report had been provided by the DOP on 7/8/10 at 9:55 a.m., who indicated the summary included all adverse drug reactions for May 2010.

Review of the facility policy Adverse Drug Reactions (revised 6/06) indicated under item 4: "Every employee including temporary personnel are responsible to prevent, identify, report adverse drug reactions, and make interventions to minimize their impact." The policy further indicates under Procedure: A. Definition of an Adverse Drug Reaction: "A response to a medication that is undesired, unintended, or unexpected in doses recognized in accepted medical practice, that may require treatment with additional medication and resulting in one or a combination of the following: 1. Changing the drug; 2. Stopping the drug; 3. Reducing the drug; 4. Prolonging hospital stay; 5. Administration of another drug; 6. An effect complicating the diagnoses disease state (i.e., untoward side effect, injury, toxicity, sensitivity reaction or significant failure of expected pharmacological action)."

Patient 47 was transferred from the hospital to a skilled nursing facility on 6/5/10.

Patient 47's transfer summary, completed by her physician 6/5/10, indicated under Transfer Diagnoses: "1. Altered mental status, cleared here, thought secondary to low sugars and Alzheimer's dementia. She was cleared by neurology and did not have a cerebrovascular accident (CVA)...2. Type 2 diabetes, uncontrolled. She was thought to have an altered mental status here from hypoglycemia. Given her decreased creatinine clearance, she has been put back only on Glucophage 500mg daily. Lantus [insulin] 10 units was started and increased to 12 units, but was still needing to be titrated." The summary futher indicated, under Hospital Course: The patient cleared slowly over the next 2 or 3 days [referring to the days following the 5/25/10 hypoglycemia reaction], which really led to us thinking hypoglycemia continued to be the culprit and potentially her Glucophage had hung around longer given her reducted creatinine clearance."

During in interview on 7/8/10 at 2:15 p.m. NM confirmed the clinical record findings, and acknowledged all licensed staff are responsible for detecting and reporting adverse drug reactions. NM further acknowledged the pharmacist did not document consideration of Patient 47's home diabetic medications, bedtime insulin dose or dietary intake when evaluating the use of D50W administered the morning of 5/25/10 as it related to a potential adverse drug reaction. NM further confirmed that the facility report, "Reported Medication Events and Near Misses," dated May 2010, did not include Patient 47's 5/25/10 incident involving hypoglycemia and use of intravenous D50W as a reversal agent, indicating it had not been identified or reported by any other licensed staff.

Based on observation, interview, and document review, the hospital failed to ensure policies and procedures were developed and implemented governing control of infections and communicable diseases.

* Failure to ensure that intravenous (IV) fluids were administered within an hour of being spiked (when infusion tubing is inserted into the IV fluids), and were safe to administer to patients (Item 1).
* Failure to ensure that transmission based precautions were implemented for 4 of 4 patients treated in the emergency department (ED), with infectious/communicable diseases (Patients 34, 35, 37, and 39) (Item 2).
* Failure to ensure that hand hygiene was performed before and after gloves were removed, and that hand hygiene was in accordance with current guidelines to reduce the risk of cross contamination of spore causing bacteria (Item 3).
* Failure to ensure compliance with the hospital's surgical attire policy and procedure (Item 4).
* Failure to ensure that a physician, with authority to order the insertion and removal of central venous catheters (CVC), assessed, and documented that the continued use of the CVC was medically necessary (Item 5).
* Failure to provide evidence that 3 of 3 patients or the patient's representative was notified of the positive results for methicillin resistant staphylococcus aureus (MRSA), and when discharged patients were given verbal or written instructions on aftercare to prevent spread of infection to others (Patients 44, 45, and 46). (Item 6)

Findings:

1. The hospital failed to implement their policy and procedure ensuring that IV solutions were administered within one hour of being spiked .

On 7/6/10 at 9:25 am, a tour was conducted of the emergency department (ED). During the ED tour the medication room was inspected. Three - 1000 ml (milliliter) bags of normal saline IV solution was observed hanging by the medication room door. Inspection of the three bags of IV solution disclosed:
One was labeled as being spiked 7/5/10 at 0654
One was labeled as being spiked 7/6/10 at 0715
One was labeled as being spiked 7/6/10 at 0930

During a concurrent interview, EDD was asked to explain the infusion time limit for IV fluids after the solution has been spiked for administration. The EDD stated that she was not aware of an administration time limit.

On 7/8/10 at 9:40 am, the Infection Preventionist (IP), was interviewed. During the interview the IP was asked if the hospital had a policy and procedure directing administration time, after the IV solution had been spiked? The IP stated yes, the hospital had a policy and procedure. The IP also stated the one hour limit was included in the hospital's injection competency.

On 7/8/10 at 11 am, the US Pharmacopeial Convention, (USP), Inc, 797 calls for "Immediate-use CSPs" (compounded sterile preparations). USP,797, requires a 1-hour limit from completing preparation (eg,spiking an IV bag) until beginning administration of the immediate-use CSPs to patients. Their rationale is that the 1-hour limit is expected to preclude microbial population increase when accidental contamination of such drugs occurs with small quantities of microorganisms. Once microbial contamination occurs, the organism replication can begin within 1 to 4 hours with exponential growth occurring rapidly afterward.

2. The hospital failed to implement their policy and procedure ensuring that all patients with infectious or communicable diseases were placed in transmission based precautions.

On 7/6/10 at 5 pm, the medical records for Patients 34, 35, 37, and 39, were reviewed, and the following was noted:

a. Patient 35 presented to the ED on 6/11/10 at 2:23 pm complaining of a sore throat and body rash. Documentation in the medical record showed that the patient (age 24) was screened for Streptococcus A Antigen and the results were positive. Patient 35 was diagnosed with scarlet fever

On 7/6/10 at 6 pm, the hospital's policy and procedure titled, "Transmission based precautions" dated 6/29/10 was reviewed. On page two of the policy and procedure under the section titled, "Droplet precautions" direction is given that respiratory droplets carrying infectious pathogens transmit infection when they travel from the respiratory tract of the infectious individual to susceptible mucosal surfaces of the recipient, generally over short distances, necessitating facial protection......Historically, the area of defined risk has been a distance of less than three feet, some studies suggest that it can be as much as six feet. Under item 3, the policy and procedure lists "Other serious bacterial respiratory infections spread by droplet transmission including: .....Streptococcal pharyngeal, pneumonia, scarlet fever."

A review of the clinical notes section of Patient's 35's medical record contained no documentation showing that Patient 35 was placed in transmission precautions while in the ED.

A review of Patient 35's discharge instructions contained no evidence that the patient was educated on methods that would reduce the transmission of the bacteria.
In 4/08, CDC, published an article titled, Scarlet fever. Documentation in the article showed that Scarlet fever is transmitted by contact with the sick person, because this germ is carried in the mouth and nasal fluids. The disease can be spread through contact with droplets shed when an infected person coughs or sneezes. If you touch your mouth, nose, or eyes after touching something that has these fluids on them, you may become ill.

b. Patient 34 presented to the ED on 6/10/10 at 1 pm, complaining of a headache for the past three days, which became worse later that day and she also had nausea. The patient was diagnosed with bacterial versus viral meningitis (awaiting laboratory results).

A review of the clinical notes section of the medical record showed that on 6/10/10 at 7:55 pm, (almost seven hours after presenting to the ED), Patient 34 was admitted to the medical unit. There was no documentation showing that Patient 34 was placed in transmission based precautions while she was in the ED.

On 7/6/10 at 6 pm, the hospital's policy and procedure titled, "Transmission based precautions" dated 6/29/10 was reviewed. On page two of the policy and procedure under the section titled, "Droplet precautions" direction is given that respiratory droplets carrying infectious pathogens transmit infection when they travel from the respiratory tract of the infectious individual to susceptible mucosal surfaces of the recipient, generally over short distances, necessitating facial protection......Historically, the area of defined risk has been a distance of less than three feet, some studies suggest that it can be as much as six feet. Under item a, Examples of infections requiring droplet precautions include, is not limited to 1. Invasive haemophilus influenza, including meningitis.....2. Invasive Neisseria meningitides, including meningitis.... On page three a table labeled as, "Most common bugs" isolation table listed Meningitis (Bacterial), patient would be placed in droplet precautions.

In 2005, CDC published an article titled, Meningococcal Disease, documentation in the article showed that bacterial meningitis is contagious. Documentation in the article demonstrated that Meningococci are transmitted by droplet aerosol or secretions from the nasopharynx of colonized persons. The bacteria attach to and multiply on the mucosal cells of the nasopharynx. Documentation also showed that the bacteria are spread through the exchange of respiratory and throat secretions (i.e., coughing, kissing).

c. Patient 37 presented to the ED on 6/21/10 at 9:24 pm, stating she had a painful rash on the right side of her abdomen, and mid back for a couple of days. The patient also stated that she has right sided facial pain. In addition, the patient informed the ED staff that she was seen at a clinic earlier, and they thought she might have shingles.

Documentation in the clinical notes section of the medical record disclosed that the patient's rash was vesicular (blister-like lesions). Patient 37 was diagnosed with Shingles Herpes Zoster. The medical record contained no evidence that Patient 37 was placed in transmission based precautions.

On 7/6/10 at 6 pm, the hospital's policy and procedure titled, "Transmission based precautions" dated 6/29/10 was reviewed. On page two of the policy and procedure under the section titled, "Contact precautions" direction is given that contact precautions is the most common mode of transmission. Contact transmission is divided into two subgroups: direct contact and indirect contact. Under the section titled, "Direct contact" transmission occurs when microorganisms are transferred from one infected person to person without a contaminated intermediate object or person. On page three a table labeled as, "Most common bugs" isolation table listed Herpes Zoster (Shingles), patients would be placed in contact precautions.

In 5/11/2008, CDC, published in an article titled, Shingles disease, (Herpes Zoster), that documented shingles is a reactivation of the VZV (varicella zoster virus). Shingles cannot be passed from one person to another. However, the virus that causes shingles, VZV, can be spread from a person with active shingles to a person who has never had chickenpox through direct contact with the rash. The person exposed would develop chickenpox, not shingles. A person with shingles can spread the disease when the rash is in the blister-phase. Once the rash has developed crusts, the person is no longer contagious. A person is not infectious before blisters appear or with post-herpetic neuralgia (pain after the rash is gone).

d. Patient 39 presented to the ED on 7/5/10 at 6:01 pm, complaining of rash on his legs, feet and arms. Documentation in the clinical notes section of the medical record showed that the patient was diagnosed as having scabies. Documentation in the clinical record section of the medical records contained no evidence that Patient 39, was placed in transmission based precautions.

On 7/6/10 at 6 pm, the hospital's policy and procedure titled, "Transmission based precautions" dated 6/29/10 was reviewed. On page two of the policy and procedure under the section titled, "Contact precautions" direction is given that contact precautions is the most common mode of transmission. Contact transmission is divided into two subgroups: direct contact and indirect contact. Under the section titled, "Direct contact" transmission occurs when microorganisms are transferred from one infected person to person without a contaminated intermediate object or person.

CDC, documented in an article titled "Prevention and control," dated 11/2008, that scabies is transmitted by the transfer of the impregnated females during person-to-person, skin-to-skin contact. Occasionally transmission may occur via fomites (e.g., bedding or clothing). Human scabies mites often are found between the fingers and on the wrists.

On 7/7/10 at 8 am, the EDD was interviewed. The EDD was asked about the process for documenting transmission based precautions for ED patients. The EDD stated that the electronic medical records did not have a box to check showing that patients were placed in transmission based precautions. EDD stated that ED staff had to enter transmission based precautions in a section of the medical record that was designated for free text. The medical records for Patients 34, 35, 37, and 39, were given to the EDD, and was she was asked to check the free text sections of the medical records to verify that the four patients had been placed in transmission based precautions. The EDD reviewed the medical records and verified that the free text section of the medical records contained no documentation showing that transmission based precautions were implemented for the four ED patients.

3. The hospital failed to ensure that hand hygiene was performed with soap and water, not ABHR, when caring for patients with Clostridium difficile.

On 7/7/10 at 8:45 am, Patient 23's medical record was reviewed. Documentation in the medical record showed that the patient was admitted to the hospital on 6/27/10 at 12:43 pm.
A review of the laboratory section of the medical record showed that on 6/30/10 at 1:30 pm, the patient was diagnosed with Clostridium difficile (C. difficile). C. difficile is a spore-forming, gram-positive anaerobic bacillus that produces two exotoxins: toxin A and toxin B. It is a common cause of antibiotic-associated diarrhea (AAD).

On 7/7/10 9:05 am, a sign posted outside the door, indicating the patient was in contact transmission based precautions. An isolation cart (cart used to store isolation supplies such as gowns, gloves, and protective masks) was observed sitting outside the patients room. A round container of alcohol based hand rub (ABHR) was observed sitting on top of the isolation cart.

Inside the room, a registered nurse (RN) 4, was observed administering medications to Patient 23. RN 4 was wearing an isolation gown and gloves. RN 4 was observed going to the waste receptacle, removing and discarding her gloves. RN 4 was then observed donning a new pair of gloves, without performing hand hygiene.

On 7/7/10 at 9:05 am, RN 4 was observed discarding her isolation gown and gloves, and exiting the patient's room. Immediately after exiting Patient 23's room, RN 4 was observed performing hand hygiene using the ABHR.

In 6/2010, SHEA (Society of Healthcare Epidemiology of America) published in the periodical, Infection Control Today, that, hand hygiene is considered to be one of the cornerstones of prevention of nosocomial transmission of C. difficile as it is for many healthcare acquired infections. Studies have confirmed that handwashing will reduce infections, but studies have also revealed that healthcare compliance with hand hygiene is poor. Alcohol-based hand hygiene products have been viewed as a breakthrough for compliance and ease of hand hygiene. Unfortunately, the C. difficile spore is highly resistant to killing by alcohol. Mechanically washing with soap and water is much more effective, but even then only removes around 90 percent of the organism.

4. The hospital failed to implement their surgical attire policy and procedure.

On 7/7/10 at 12:45 pm, a female was observed walking down the hallway, towards the cafeteria. It was noted that the female was wearing surgical attire, including a disposable hood that covered her hair. It was also noted that the female was wearing a surgical mask that was pulled down under her chin.

Approximately 10 minutes later the female was observed walking toward the surgical service area carrying food in a to-go container.

On 7/7/10 at 4:40 pm, a male wearing surgical attire, including disposable shoe covers, was observed walking out of the hospital through the main lobby entrance. The male in surgical attire was then observed getting into a silver/gray Toyota Land Cruiser, that was parked to the left of front of the hospital. The male was then observed driving the automobile off hospital property.

On 7/7/10 at 6 pm, the hospital's policy and procedure, dated 4/2010, titled, "Personnel attire-dress code," was reviewed. On page two, under section F, item 1, hospital staff were directed that all boots/shoe covers will be removed prior to leaving the surgery department.
Under section G, items 2 and 3, hospital staff were directed that a clean, new mask must be worn for each operative procedure, and masks are either on or off; they are not to be saved.

On 7/8/10 at 9:45 am, the Infection Preventionist (IP), was interviewed. The IP was asked if: Surgical masks could be worn out of the surgical services area, and under a chin; If surgical attire including shoe covers, could be worn outside the hospital? The IP replied that the occurrences did not comply with the hospital's surgical attire policy and procedure.

5. The hospital failed to ensure that a physician performed a daily assessment and documented that the continued use of the CVC was medically necessary.

Patient 19's medical record was reviewed on 7/6/10 at 1:30 pm. Documentation showed that the patient was admitted to the intensive care unit (ICU) on 6/30/10 at 2:56 am. Documentation in the medical record also showed that after admission to ICU, a CVC was inserted.

A review of the physician progress notes section of the medical record contained no documentation showing that a physician had assessed the CVC, and determined that the continued use was medically necessary.

During a concurrent interview, the ICU charge nurse was asked if the physician documented either in the medical record, or on a log, that continued use of Patient 19's CVC was medically necessary? The ICU charge nurse stated that she was not aware that a physician was required to perform a daily assessment of the CVC.

On 7/8/10 at 9:50 am, the IP was interviewed. When asked if the hospital had a process in place to ensure that a physician performed a daily assessment of the CVC, to determine the use was medically necessary? The IP stated that the hospital did have a process in place and it included the use of pink stickers that were to be placed in the process notes section of the medical record. The IP stated that, after nursing staff placed the pink stickers in the patients' medical record, the physician was responsible for completing the information on the sticker and signing it. The IP was notified that Patient 19's medical record contained no evidence of pink stickers. The IP replied that use of the pink stickers was the hospital's process.

Beginning 7/1/08, hospitals were mandated to report central line insertion practices (CLIP), into the National Healthcare Safety Network (NHSN), a branch of CDC, with the goal of reducing the number of central line associated blood stream infections. In addition, all hospitals were required to develop and implement a process to ensure daily assessment of central line necessity for all patients on units under surveillance and to be able to present results of that process to surveyors. Daily assessment of line necessity by a licensed care giver (defined as a person with the authority to order insertion or discontinuation of a central line) is strongly associated with reduction of infection risk because it prompts the removal of lines sooner than later. This activity is separate from inspection of the line insertion site which is a routine part of daily nursing care.

6. The hospital failed to develop and implement a policy and procedure ensuring that when a patient tests positive for MRSA, the attending physician informed the patient or the patient's representative immediately or as soon a practically possible, and prior to discharge, the hospital provided oral or written instruction to patient regarding aftercare and precautions to prevent the spread of infection to others.

On 7/7/10 at 4 pm, the medical records for Patients 44, 45, and 46 were reviewed and the following was noted:

a. Patient 44 was admitted to the ICU 6/28/10, at 7:17 pm. Documentation in the medical record showed that the patient was discharged 6/30/10 at 7 pm.

A review of the laboratory section of the medical record showed that the patient was screened for MRSA on 6/28/10 at 10:33 pm. Documentation in the medical record disclosed that the screen was positive for MRSA on 6/28/10 at 11:47 pm.

A review of the physician progress notes contained no evidence that the patient, or the patient's representative, had been notified of the positive MRSA screen. In addition, the written discharge instructions contained no documentation showing that the patient was instructed on aftercare and precautions to prevent the spread of the infection to others.

b. Patient 45 was admitted to the hospital on 6/25/10, at 11:02 am. Documentation in the medical record showed the patient was discharged 6/30/10.

A review of the laboratory section of the medical record showed that the patient was screened for MRSA on 6/25/10 at 6:40 pm. Documentation in the medical record disclosed that the screen was positive for MRSA on 6/26/10 at 12:05 am.

A review of the physician's progress notes contained no documentation showing that the patient, or the patient's representative, was notified of the positive MRSA screen. In addition, the written discharge instructions contained no documentation showing that the patient was instructed on aftercare and precautions to prevent the spread of the infection to others.

c. Patient 45 was admitted to the hospital on 6/2/10 at 10:45 am. Documentation in the medical record showed that the patient was discharged on 7/5/10 at 3:10 pm.

A review of the laboratory section of the medical record showed that the patient was screened for MRSA 6/2/10 at 7:11 pm. Documentation in the medical record disclosed that the screen was positive for MRSA on 6/2/10 at 6:24 pm.

A review of the physician's progress notes contained no documentation showing that the patient or the patient's representative, was notified of the positive MRSA screen. In addition, the written discharge instructions contained no documentation showing that the patient was instructed on aftercare and precautions to prevent the spread of the infection to others.

On 6/8/10 at 10 am, the IP was interviewed. The IP stated that the it was the hospitals' policy to screen all inpatients for MRSA. The IP, replied, no, when asked if the attending physician was responsible for notifying the patient or the patient's representative that the patient had tested positive for MRSA.

On 6/8/10 at 11 am, the hospital's policy and procedure titled, "Management of patients colonized or infected with multi drug resistant organisms (MDRO), was reviewed. It was noted that the was reviewed on 6/15/10. Under the section titled, "Active surveillance," direction was given that all patient admitted to the hospital would be screened for MRSA. Under the section titled, "Patient / family education," direction was given, "Written material - see patient and family education pamphlet will be available on clinical units." Under the section titled, Discharge, direction was given that, "Notify receiving facility of resistant organisms. e.g. Long term care and home health."


22710

20245

Based on observation, interview and document review, the hospital failed to ensure food was stored following safe, sanitary procedures as evidenced by there were potentially hazardous foods not dated, covered, or stored following facility food handling policies and procedures. Additionally the food policies and procedures manual had not been reviewed and approved within three years as required by hospital policy. Unsafe food storage has the potential to cause food borne illness which can further compromise the health of patients.

Findings:

On 7/6/10 between 9:15 a.m. to 11:30 a.m. during kitchen observations with dietary supervisory staff 1 (DSS 1), the following was observed:

1. In the reach in refrigerator there were 13 turkey sandwiches, wrapped and dated 7/5/10. During a concurrent interview, DSS 1 stated the hospital policy was to put the "pull" (last day to use) date on foods.

2. A clear plastic container with a brownish granular product inside labeled "Power Pudding" and dated 7/15/10. DSS 1 stated this pudding was made of equal parts of applesauce, prune juice and bran cereal. Later that day, DSS 1 provided the hospital document "Standards of Practice Holding Times for Perishable Foods" rev. 11/11/08 which revealed canned opened fruit should be kept five days and then discarded.

3. A clear plastic container, covered, labeled "Blueberry Topping" dated 7/15/10, and another covered plastic container labeled "Cherries" dated 7/20/10. The holding time for opened pie fillings based on the hospital standards of practice was seven days.

4. Two bags of thawed, raw hamburger patties dated 7/13/10. Facility policy revealed the holding time was 1-2 days when thawed.

5. Raw, undated chicken pieces in a zip lock bag. Facility hospital revealed a three day refrigerator holding time.

In the reach-in freezer there was:

1. A stainless steel pan of sliced salami covered loosely with a thin plastic wrap. The salami had ice crystals surrounding the individual pieces. The surveyor requested DSS 1 to determine whether the plastic wrap was intended for freezer use. On 7/6/10 at 2:00 p.m. DSS 1 stated the vendor for the plastic wrap informed him it was not intened for wraping food to be frozen.

2. Four garden burgers, with the wrap open to the freezer air. Review of the hospital policy titled, "Refrigerated Storage" (reviewed 12/06/08) revealed "all items frozen should be thoroughly covered or wrapped in freezer paper."

On 7/6/10 at 2:30 p.m. reivew of the dietary food services manual revealed it had last been approved by the medical director on 7/7/03. During an interview on 7/7/10 at 9:00 a.m. Hospital Managemnt Staff 2 stated all policies and procedures were reviewed and approved by hospital management staff "at least every three years". HMS 2 acknowledged the food services manual had not been approved as required.

22710

Based on staff interviews, medical record and document reviews, the hospital failed to ensure that all surgical procedures were performed by practitioners with current surgical privileges for 1 of 44 sampled patients (Patient 8) in accordance with acceptable standards of practice and hospital policy. Patient 8 underwent a surgical procedure that utilized a general anesthetic agent for sedation (ketamine) but the procedure was performed by a physician who was not privileged to administer deep sedation or general anesthesia (Physician 7).

Findings:

In an interview with the emergency department (ED) manager on 7/7/10 at 9:45 a.m., the ED manager stated that no deep sedation (a drug-induced depression of consciousness during which patients cannot be easily aroused but may respond purposefully following repeated or painful stimulation; the ability to independently maintain breathing function may be impaired) was being used in the ED. She also indicated that ED physicians had had their deep sedation privileges suspended until the medical staff could define a plan for safe administration of deep sedation for procedures performed in the ED.

In an interview with Administrative Staff (AS) 20, who managed the credentialing and privileging processes of the medical staff, on 7/8/10 beginning at 10:30 a.m., AS 20 indicated that on 5/11/10 deep sedation privileges were suspended for all non-anesthesiologist medical staff members, including all emergency department physicians. Review of the medical staff file for Physician 7 with AS 20 confirmed that Physician 7 was an emergency department physician who had previously been granted a privilege to perform "deep sedation for adults" (and not for children), but this privilege was suspended on 5/11/10. Review of the medical staff files for Physicians 1, 2, and 3 (emergency department physicians) similarly showed previous deep sedation privileges that were suspended on 5/11/10.

On 7/6/10 AS 1 presented a document titled "Sedation Roster," which listed 38 physicians possessing sedation privileges (18 were emergency department physicians). AS 1 indicated all 38 physicians had completed and passed a training course for moderate sedation, and were permitted to perform surgical procedures that utilized moderate sedation.

In an interview with Physician 8 who served as the Director of Anesthesia Services on 7/7/10 at 2 p.m., Physician 8 indicated that the medical staff had not agreed to limit the use of deep sedation agents for procedures performed in the emergency department. Some ED physicians wished to administer deep sedation agents with only the presence of one ED physician and one registered nurse. Physician 8 did not agree, and until a plan was negotiated, procedures performed in the ED were supposed to be done with only minimal or moderate sedation (a drug induced state of consciousness not to impair purposeful responses to verbal commands or light touch stimulation, and not requiring interventions to maintain breathing or heart and circulation function). If deep sedation was used, an anesthesiologist was to be called to monitor the patient. Although some emergency department physicians were considered by their department director to be qualified to administer and supervise the administration and monitoring of deep sedation agents, they were not currently qualified or privileged to administer general anesthesia. Physician 8 acknowledged that sedation-analgesia treatments affected patients along a continuum from minimal drowsiness to an unresponsive state seen in general anesthesia. Practitioners were expected to be able to recognize and rescue patients who slipped beyond the intended state to the next or deeper state of consciousness, which required specialized education and training. Deeply sedated patients were at risk to slip into a state of general anesthesia. ED physicians were not trained or experienced to treat patients in general anesthesia.

Physician 8 also agreed that licensed registered nurses (with specialized sedation education, training, and demonstrated competency) could be qualified to administer moderate sedation, but not deep sedation or general anesthesia. Physician 8 indicated that sedation oversight was included in the overall hospital-wide anesthesia services oversight, for which he was responsible. Physician 8 indicated that he relied on nationally recognized standards for anesthesia and sedation care (such as the American Society for Anesthesiologists-ASA), as well as state standards.

Lexi-Comp Online drug reference () retrieved on 7/9/10 indicated that Ketamine was listed as a high alert medication, carrying a heightened risk of causing significant patient harm when used in error, by the Institute for Safe Medication Practices (ISMP). Ketamine was categorized as a general anesthetic agent with labeled indications for induction and maintenance of general anesthesia. Use for sedation was considered unlabeled and investigational. Ketamine disrupted the brain's recognition of the surrounding environment. Adverse reactions included heart rate and rhythm disturbances, obstruction of the airway and reduction in the ability to breathe, and an increase in brain pressure. When administered into a muscle (IM), its effects lasted from 12 to 25 minutes. The Warnings section documented, "Experienced physician: should be administered under the supervision of a physician experienced in administering general anesthetics."

In an interview with Physician 8 who served as the Director of Anesthesia Services on 7/7/10 at 2 p.m., Physician 8 indicated that ketamine had unique drug properties that impaired the ability to respond to verbal commands and light touch, but did not usually impair function of the heart, lungs and circulation. Physician 8 indicated that patients given ketamine often exhibited a level of consciousness between 2 and 3. Physician 8 acknowledged that at level 3, a patient was not responsive to verbal commands and light touch, and a practitioner could not be certain that the patient was not in a state of deep sedation.

Review on 7/7/10 of the medical record for Patient 8 indicated that Patient 8 was 3 years old and admitted to the ED for a skin abscess. A surgical procedure to drain the abscess was performed by Physician 7. The medications administered for sedation included Ketamine 72.5 milligrams (mg) IM (4 milligrams per kilogram), and Versed (a labeled sedation agent) 1 mg. The documentation indicated that Physician 7 ordered the medications and RN 1 administered the medications, and no other supervising physicians were present. No tube for administering fluids or medications directly into Patient 8's vein (IV), should Patient 8 require rescue interventions, was documented. Although the procedure took 12 minutes to perform, sedation monitoring was documented for 40 minutes. Patient 8's sedation level was documented as 3 for the entire 40 minutes. Ten minutes following administration of Ketamine and Versed, Patient 8's Aldrete score (an assessment scale to measure the effects of anesthesia and sedation) fell from 10 (maximum, fully awake) to 6 (consciousness level was no response to any stimulation, activity level was no movement). Thirty minutes following administration, Patient 8's Aldrete score was 7 (no response to stimulation, moving only 2 of 4 extremities). Complete sedation recovery was documented at 73 minutes after administration of Versed and Ketamine.

In the interview with Physician 8 above, Physician 8 reviewed Patient 8's medical record. Physician 8 agreed that Patient 8's level of consciousness was consistent with deep sedation, in that Patient 8 was not arousable and responsive to stimulation for a prolonged period, a period consistent with the drug effects of ketamine. Physician 8 agreed that without an IV, rescue attempts, had they been needed, may have been delayed for Patient 8. Physician 8 indicated that ketamine had no reversal agent, unlike Versed and other sedation and pain medications used for moderate sedation.

Review of the facility's P&P titled "Moderate and Deep Sedation" (rev 5/10) indicated that it applied to all patients receiving sedation in any setting for any purpose, by any route, moderate or deep sedation, as defined in this policy. The policy defined "Moderate sedation/analgesia-a drug induced depression of consciousness during which patients respond purposefully to verbal commands either alone or accompanied by light tactile stimulation ... Deep sedation/analgesia-a drug induced depression of consciousness during which patients cannot be easily aroused but may respond purposefully following repeated or painful stimulation ..." Attachment A of the P&P defined a sedation score of 2 as "brisk response to tactile stimulation" and score 3 as "sluggish response to tactile stimulation."

The P&P section Procedure, item 2. Intra-procedure Treatment, Monitoring and Documentation indicated in section d. that significant changes were to be reported immediately by the registered nurse to the attending practitioner: "4. Change in level of consciousness in which a patient cannot communicate verbally or appropriate for age (sedation level greater than 2, see attachment A)." The P&P section e. Respiratory Depression/Increased Sedation Treatment indicated that for patient conditions that included sedation level 3, rescue treatments and monitoring were to be implemented until sedation level 2 was reached.

Review of the ED record for Patient 8 as described above did not indicate that the patient's sedation level 3 was reported or treated as per policy.

The Moderate and Deep Sedation policy indicated in section 4. Personnel Requirements: "d. Deep sedation/analgesia is currently outside the scope of practice of a registered nurse. Therefore, deep sedation can only be performed by physicians whose training and privileges specifically include deep sedation ... The physician who holds deep sedation clinical privileges, shall have no other responsibilities other than medication administration, patient monitoring, and airway management. A second licensed independent practitioner must be present to perform the procedure for which the deep sedation is required." Section 5(a)(2) limited the administration of deep sedation to qualified anesthesiologists and emergency physicians (RNs not included).

In the interview with Physician 8 on 7/7/10 at 2 p.m., Physician 8 indicated that the ED physicians insisted on categorizing ketamine as both a moderate and deep sedation drug. Physician 8 was aware that some ED physicians were claiming to use ketamine for moderate sedation, despite the clinical appearance of the patient as deeply sedated, so that they avoided having a second qualified practitioner participating in the procedure as required for deep sedation. Physician 8 indicated that the dose of ketamine used for Patient 8 (4 mg per kg) was borderline high, in that the dose was typical of what was used for induction of general anesthesia. Since the effects of sedation/analgesia medications range from minimal sedation to complete absence of responsiveness and breathing, the practitioner must be prepared to rescue any sedation patient from a deeper level than that intended by standard or published doses.

Review on 7/9/10 of the 2010 Association for peri-Operative Registered Nurses (AORN) practice statement titled Recommended Practices for Managing the Patient Receiving Moderate Sedation/Analgesia indicated that the characteristics of moderate sedation/analgesia included the ability to respond purposefully to verbal commands or light tactile stimulation, the ability to maintain protective reflexes, and the ability to communicate verbally.

Review on 7/9/10 of the American Association for Nurse Anesthetists (AANA) Practice Policy titled Considerations for Policy Guidelines for Registered Nurses Engaged in the Administration of Sedation and Analgesia, revised June 2003, indicated that sedation and analgesia was defined as a medically controlled state of depressed consciousness that allowed protective reflexes to be maintained. AANA referred to the American Society of Anesthesiologists (ASA) Task Force on Sedation and Analgesia as the nationally recognized source for guiding sedation/analgesia, also known as moderate sedation. AANA further documented, "Those patients whose only response is reflex withdrawal from a painful stimulus are sedated to a greater degree than encompassed by sedation/analgesia." AANA listed various tasks that properly trained registered nurses could be authorized to perform under section B. Management and Monitoring. Item B.3., however, specifically excluded registered nurses who were not qualified anesthesia providers to administer agents classified as anesthetics, "including but not limited to Ketamine, Propofol, Etomidate, Sodium Thiopental, Methohexital, Nitrous oxide and muscle relaxants."

Review on 7/9/10 of the 10/18/06 ASA Statement on Granting Privileges to Nonanesthesiologist Practitioners for Personally Administering Deep Sedation or Supervising Deep Sedation by Individuals who are not Anesthesia Professionals documented "Because of the significant risk that patients who receive deep sedation may enter a state of general anesthesia, privileges to administer deep sedation should be granted only to practitioners who are qualified to administer general anesthesia or to appropriately supervised anesthesia professionals."

Review on 7/9/10 of a Survey and Certification letter 10-09 for hospitals from the Center for Medicare and Medicaid Services, dated 12/11/09, indicated that guidance for anesthesia regulations for hospitals was revised. Specifically for the Code of Federal Regulations [42 CFR 482.52(a) and (c)], "general anesthesia, regional anesthesia and monitored anesthesia, including deep sedation/analgesia, may only be administered by (1) a qualified anesthesiologist; (2) an MD or DO (licensed physician or osteopathic doctor, other than an anesthesiologist); (3) a dentist, oral surgeon or podiatrist who is qualified to administer anesthesia under State law; (4) A CRNA (certified registered nurse anesthetist) who is supervised by the operating practitioner or by an anesthesiologist who is immediately available if needed; or (5) an anesthesiologist's assistant under the supervision of an anesthesiologist who is immediately available if needed." In addition, the guidance for 42CFR 482.52(b)(1) indicated that deep sedation/analgesia was included in monitored anesthesia care (MAC), that the administration and monitoring of deep sedation/analgesia must be delivered or supervised by a practitioner as specified in 42CFR 482.52(a). A sedation agent that caused a patient to have decreased movement in order to perform a procedure more effectively required monitoring by such a qualified practitioner (and not a registered nurse).

In a 9/95 position statement titled "Conscious Sedation" (same as sedation/analgesia) from the California Board of Registered Nursing (BRN) retrieved at www.rn.ca.gov on 7/9/10, the right and obligation of the RN caring for a sedation patient was documented as "to act as the client's advocate by refusing to administer or continue to administer any medication not in the client's best interest; this includes medications which would render the client's level of sedation to deep sedation and/or loss of consciousness." The BRN statement directed institutions that utilized registered nurses to administer conscious (moderate) sedation to consult with national guidelines in establishing facility policies and procedures.