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Based on document review and staff interview, the hospital failed to maintain a complete list of all contracted services by failing to include two contracts for surgical implant devices and associated services. This failure to include all contracted services, left the governing body's overview of contract services incomplete and therefore incapable of knowingly assuring the quality of related patient care.

Findings:

On 8/6/12 when asked to provide a list of all contracts and agreements, the hospital presented a 6 page document titled "Roseville Quality Dashboard Report Contract Monitoring: 1Q12 (first quarter of 2012)". This list contained the "names" of 65 corporations or other contracted entities, a description of the "service provided (scope)" and one or more "quality indicator(s)" for each of the listed contracts. The hospital's Quality Director (Staff JG) explained that this list was used in conjunction with the hospital's quality assessment and performance improvement (QAPI) program to assist in tracking the performance of each contractor.

On 8/6/12 at 3:30 p.m. senior members of the Perioperative Services were interviewed and the Assistant Physician in Chief of the Perioperative Services (Physician S) explained how surgical implant devices (man-made objects placed inside patients during some types of surgery, such as artificial joints) were selected and utilized. He stated that the national hospital system had established protocols that required the use of only selected devices that were judged to be the very best for surgical implantation into patients. He explained that the every 3 to 5 years, a nationwide evaluation of the quality and safety of each type of implant device was conducted. This evaluation was based upon data obtained related to prior implant surgical cases and the opinions of a wide range of expert surgeons in each of the associated surgical specialties. From this collection of information the best products were selected and their makers were invited to place bids to become one of the few selected makers allowed to provide implant products for the hospitals. The result of this selection process was that currently the hospital has contracts with only two makers of orthopedic implant devices (corporation Z and corporation D). In exchange for these semi-exclusive contracts to have their devices on consignment, the vendors provide the service of always having on hand, in the hospital, a wide selection of implant devices, as well as the needed unique surgical tools and templates required during placement of their implants. The service of these surgical tools and templates are provided to the hospital at no added cost.
On 8/7/12 the hospital's list of contracts was again reviewed and it was noted that Corporations Z & D were not listed. The hospital was asked to provide the available contracts held with each of the corporations. Two contracts written with Corporation Z were provided for review.

On 8/7/12 and 8/8/12 there were multiple discussions with the hospital's Area Quality Leader (Staff LM), the Quality Director (Staff JG) and the Perioperative Services Director (Staff AMH) concerning the hospital's agreements with Corporations Z and D for these surgical implant devices and related services. On 8/8/12 at 10:30 a.m. Staff LM acknowledged that these corporations did provide services to the hospital in addition to the products (implant devices) purchased, and therefore the hospital's list of contracted services was incomplete.

Based on record reviews and staff interviews, the hospital failed to ensure the registered nurse accurately completed the initial nutrition screen on 1 of 6 patients reviewed for nutrition care (Patient 3). This failure had the potential to delay the nutrition assessment and interventions for Patient 3 when the patient had a diagnosis of malnutrition and cachexia (a wasting syndrome characterized by loss of weight, muscle wasting, fatigue, weakness, and significant loss of appetite in someone who is not actively trying to lose weight) and the nutrition problems on the nutrition screen were listed as "none".

Findings:

A review of the medical record for Patient 3 on 8/8/12 revealed the patient was admitted to the hospital on 7/23/12 with diagnoses that included ileus (a partial or complete blockage of the bowel that results in the failure of the intestinal contents to pass through), nausea, vomiting and diarrhea. The patient was admitted from a skilled nursing facility where he had a diagnosis of malnutrition and cachexia. His past medical history included a diagnosis of Crohn's disease (a type of inflammatory bowel disease that may affect any part of the gastrointestinal tract). The patient was six feet tall and weighed 139 pounds. His body mass index (an indicator of body fatness) was 18.9 indicating he was underweight.

A review of the initial nutrition screen on the nursing assessment completed on 7/23/12 revealed the patient's nutrition problems were recorded as "none".

During an interview with the Clinical Nutrition Manager on 8/8/12 at 9:30 a.m., she stated when a nutrition problem was triggered by nursing in the electronic medical record, the registered dietitians (RDs) were alerted through the system and the RDs would then complete a nutrition assessment on the patient on day 2 of the hospital stay. When nursing failed to record nutrition problems in the initial nursing assessment of the patient, it could result in a delay in the RDs assessment and interventions.

During a concurrent interview with the Nurse Manager for Patient 3, at the same date and time, she stated the patient had nutrition problems which should have been identified on the initial nutrition screen of the nursing assessment. She was unable to state why the nutrition screen was not accurate.

Based on clinical record review and interviews the hospital failed to administer medications according to physician orders when 2 of the 2 patients in the adult Intensive Care Unit (ICU) receiving intravenous (IV) magnesium sulfate replacement (Patient 10 and Random Patient A) were each administered one dose in error.

Findings:

1) Patient 10 was a 65 year-old admitted 8/3/12. On 8/3/12, Patient 10's physician ordered magnesium replacement according to a protocol which based the amount given on both her body's magnesium level as well as her creatinine level (an indicator of how well the kidneys are filtering waste).

At 10:25 p.m., on 8/3/12 Patient 10's magnesium level was 1.7 milligrams per deciliter (mg/dL) [normal range = 1.6 - 2.3, within normal limits] and her creatinine level was 3.84 [normal range for this patient = less than or equal to 1.11]. The magnesium replacement protocol stated, "For serum creatinine greater than or equal to 2.5 and magnesium less than or equal to 1.4 mg/dL, [give] magnesium sulfate, 1 gram [gm.] intravenous." There were no orders to give magnesium if the magnesium level exceeded 1.4 mg/dL.

Patient 10 was administered 2 gm. of magnesium sulfate at 11:26 p.m., on 8/3/12.

In a 4:39 p.m., 8/7/12 interview, the Director, Adult Clinical Services (DACS) stated, "I don't see another order for magnesium besides the protocol." In an 8:28 a.m., 8/8/12 follow-up interview, the ICU Manager stated, "The nurse [administering the medication] recalled giving 2 grams. It was written up as a medication error."

2) Random Patient A was a 58 year-old admitted 7/31/12. 8/2/12, his physician ordered magnesium replacement according to the protocol which based the amount given on magnesium and creatinine levels.

At 6:30 a.m., 8/5/12, Random Patient A's magnesium level was 1.7 mg/dL and his creatinine level was 2.68 mg/dL [normal range for this patient = less than or equal to 1.34]. The magnesium replacement protocol stated, "For serum creatinine greater than or equal to 2.5 and magnesium less than or equal to 1.4 mg/dL, [give] magnesium sulfate, give 1 gm. intravenous." There were no orders to give magnesium if the magnesium level exceeded 1.4 mg/dL. Random Patient A was administered 1 gm. of magnesium sulfate at 9:07 a.m., 8/5/12.

During an 11:02 a.m., 8/8/12 interview, the DACS was unable to find a physician order outside the protocol for the magnesium given. She concluded, "It shouldn't have been given."

Based on clinical record review and interviews, the hospital failed to maintain clear and accurate medical record documentation for 1 of 32 patients (Patient 10) when six doses of intravenous (IV) potassium chloride given over a three hour period were charted as if given simultaneously. This failure had the potential to increase the risk of medication errors.

Findings:

Patient 10 was admitted 8/3/12. On 8/3/12, Patient 10's physician ordered potassium replacement according to the hospital's standard protocol. On 8/6/12 at 12 p.m., the Intensive Care Unit (ICU) was notified by the hospital's laboratory that Patient 10 had a critically low level of potassium in her blood stream. The physician-ordered potassium replacement protocol indicated Patient 10 should be given 60 mEq/L intravenously (mEq/L is a measurement used for some medications).

On 8/6/12 at 12:55 p.m., the potassium replacement administered to Patient 10 was documented in the electronic medical record as, "10 mEq [C]," with the "C" indicating a comment link. Once accessed, the comment read, "x6 k 1.7" [e.g. 6 doses of potassium replacement were given for a potassium level of 1.7].

During an interview with the ICU Manager on 8/8/12 at 10:31 a.m., she stated that, according to the hospital's Micromedex medication administration guidelines, 20 mEq potassium could safely be given over an hour. The ICU Manager stated Patient 10 had received 2 doses of 10 mEq of potassium simultaneously over one hour for 3 consecutive hours, with the total of 6 doses of potassium infused in the 3 hour time frame.

According to the Institute for Safe Medication Practices' 2011 "Acute Care Guidelines for Timely Administration of Scheduled Medications," a hospital should "require staff who administer medications to document the exact time the drug was administered ..." [http://www.ismp.org/tools/guidelines/acutecare/tasm.pdf].

Based on observation, interview, record review and facility document review the facility failed to label and store a vial of insulin (Novolin-R, a short acting insulin indicated for diabetes mellitus) for one of 32 patients (Patient 11) in accordance with hospital policy. This may have created the potential for a medication error.

Findings:

An inspection of the 2 North nursing unit medication room on 8/6/12 at approximately 3:30 p.m., accompanied by Pharm 1 (Pharmacist 1) and ADOP (Area Director of Pharmacy), revealed a locked cabinet containing tan colored plastic bins affixed with white labels corresponding to patient room numbers in the unit.

A bin labeled "2117A," contained a multiple-dose 10 mL (milliliters) vial of Novolin-R insulin affixed with an orange adhesive label indicating the vial was due to expire 8/30/12; the metal vial top had been removed and the latex stopper was exposed, indicating the vial had been accessed. The vial contained no documentation regarding what licensed nurse had accessed the vial or what patient had received the Novolin-R. During a concurrent interview, Pharm 1 and ADOP confirmed the findings.

Concurrently, Pharm 1 electronically accessed a current list of medications for the patient in 2117A and indicated no physician order for insulin. Pharm 1 and ADOP acknowledged the Novolin-R vial had been incorrectly placed in the bin for the patient in 2117A. This medication was intended for the patient in 2117B.

Review of the facility policy 500.1 "Medication Storage and Preparation Areas," dated 8/9/11, indicated under Procedures, item l: "The medications for each patient shall be stored in a patient-specific location and shall NOT be transferred to another patient."

Pharm 1 searched the ADC (automated drug cabinet, a secure cabinet containing medications accessible by licensed nursing staff) electronic files and confirmed Staff RA had removed a 10 mL vial of Novolin-R on 8/6/12 at 8:14 a.m. for Patient 11, who was in room 2117B during that time.

Review of Patient 11's electronic medical records indicated an order (dated 8/5/12 at 10:37 p.m.) for subcutaneous (injected beneath the skin) Novolin-R insulin (for BS, or blood sugar, assessments before meals and at bedtime).Further review of Patient 11's 8/6/12 electronic medication administration record indicated 4 units of Novolin-R was administered subcutaneously by Staff RA at 8:14 a.m. for an assessed blood sugar of 261 mg/dL.

During an interview on 8/7/12 at 3 p.m. Pharm 1 indicated the pharmacy had dispensed a vial of Novolin-R for Patient 11 on 8/5/12; and was unable to explain why Staff RA did not use the dispensed labeled supply of Novolin-R the morning of 8/6/12 instead of withdrawing a new unlabeled vial from the ADC. Pharm 1 indicated that, in accordance with facility policy, Staff RA should have affixed a "single dose only" auxiliary adhesive label to the Novolin-R vial to alert others that the vial should have been discarded after a dose was withdrawn.

Review of the facility policy 500.6 "Injectable and Ophthalmic Single and Multiple Dose Containers," dated 8/9/11, indicated under item b) Multiple-Dose Containers: "3. It is preferable to utilize opened or needle punctured multiple-dose containers in areas other than Pharmacy as single use containers and discard them after a single use whenever possible. (1) Auxiliary labels stating 'single use only' or some similar language will be affixed to the container as an aid to remind staff to discard the container after a single dose."

During an interview on 8/8/12 at 9:05 a.m. Staff RA confirmed withdrawal of the Novolin-R vial from the ADC on 8/6/12 at 8:14 a.m. and administration to Patient 11. Staff RA indicated she was unable to locate the vial dispensed on 8/5/12 by the pharmacy and stated she needed to administer a dose of Novolin-R to Patient 11 prior to breakfast. Staff RA indicated Patient 11 was discharged from the hospital later that morning; and did not realize the vial of Novolin-R was placed in another patient's bin. Staff RA did not respond when asked about the policy for affixing "single use only" auxiliary labels to multiple-dose vials as an aid to remind staff to discard the container after a single dose.

During an interview on 8/8/12 at approximately 9:15 a.m. Pharm 1 indicated "single use only" auxiliary labels were only available in the pharmacy.

Based on interview, record review and facility document review the facility failed to administer intravenous (I.V.) droperidol (an injectable antinauseant medication) to 1 of 32 sampled patients (Patients 12) in accordance with hospital policy when the pharmacy dispensed and the facility administered droperidol 1.25 mg I.V. to Patient 12 in the presence of a known manufacturer contraindication; and failed to ensure cardiac monitoring was documented for 2 to 3 hours after the dose was administered.

Findings:

On 8/6/12 a list of patients who had received injectable droperidol within the past 90 days was requested from and provided by Pharm 1.

During an interview on 8/6/12 at 4:10 p.m. Pharm 1 indicated injectable droperidol had only been dispensed to ED (emergency department) patients during that period of time due to the prescribing needs of two physicians; and was not available elsewhere in the hospital.

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 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 outweigh 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 ...."

1. Electronic clinical record review revealed Patient 12 was a 51 year-old male admitted to the ED on 6/29/12 at approximately 4 p.m. with a complaint of nausea and vomiting.

Review of Patient 12's Physician Orders indicated an order for I.V. droperidol 1.25 mg (dated 6/29/12 at 4:43 p.m.).

Review the dispensing pharmacist's droperidol "black box warning" electronic medical record documentation (dated 6/29/12 at 4:49 p.m.) indicated a "yes" response to preliminary EKG monitoring and monitoring 2 to 3 hours after the last dose of droperidol; the pharmacist documented "NA" (not available) to the prompt requesting the actual QTc interval value.

Review of Patient 12's ED Provider Notes revealed that on 6/29/12 at 4:59 p.m. a 12-lead EKG assessment revealed a QTc of 488 milliseconds, which exceeded the maximum "boxed warning" QTc (for males) by 48 milliseconds; the "EKG Impression" indicated "Borderline prolonged PR interval." The PR interval includes the QT elements of the EKG (ECG) cardiac rhythm (which interprets P, Q, R, S and T waves as line tracings on a graph).

Review of Patient 12's ED medication administration electronic records indicated I.V. droperidol 1.25 mg was administered on 6/29/12 at 5 p.m. The "Admin [administration] Instructions" indicated "Cardiac monitoring required for 2 - 3 hours after administration." Patient 12's ED licensed nurse documented a nursing note at 5:05 p.m. indicating: "Pt [patient] on all monitors. NSR [normal sinus rhythm, indicating a normal electrical pattern] without etopics (sic)." The heart's normal rhythm and rate originates from an electrical impulse from the sinus node in the right atrium; ectopic heartbeats are small variations in an otherwise normal heartbeat that causes an irregular pulse (source: www.webmd.com ).

Patient 12's electronic medical record Flowsheet Data indicated blood pressure and radial pulse assessments were performed on 6/29/12 at 4:09 p.m. and 6:09 p.m.

Patient 12 was discharged from the ED on 6/29/12 at approximately 7:50 p.m.

Review of the facility policy 900.13 "Medications with Black Box Warnings," dated 8/9/11, indicated under item 1a: "There may be clinical situations when there is a need to use a medication in a manner that does not appear to coincide with "Black Box" or boxed warning guidelines. In those instances, documented evidence of the benefits outweighing the risks shall be documented in the medical record." The policy's Black Box Warning Guidelines (900.13a) for droperidol administration indicated the medication was "Contraindicated in patients with known or suspected QT prolongation;" with regard to monitoring parameters, the guidelines indicated: "All patients receiving Droperidol should have an ECG performed prior to treatment and continued for 2 - 3 hours after completing treatment."

During an interview on 8/8/12 at approximately 9:30 a.m. Pharm 1 and Pharm 2 verified Patient 12's clinical record findings and acknowledged the dispensing pharmacist failed to implement the hospital's black box warning policy related to droperidol administration prior to dispensing the medication on 6/29/12 when the EKG result was not obtained. Pharm 1 and Pharm 2 and were unable to provide documentation from Patient 12's electronic medical record that a risk vs. benefit assessment was performed related to Patient 12's QTc prolongation (a contraindication) prior to administering the droperidol (in accordance with facility policy); and that the record did not contain documentation that Patient 12 received ECG monitoring 2 - 3 hours after the medication was administered.

Based on interview, record review and facility document review the facility failed to report an adverse drug event related to Ativan (an anti-anxiety benzodiazepine medication), resulting in significant oversedation and administration of flumazenil (a benzodiazepine reversal medication), to 1 of 32 sampled patients (Patient 14), to the hospital wide reporting system in accordance with hospital policy.

Findings:

Electronic clinical record review revealed Patient 14 was a 66 year-old admitted to the hospital medical unit from the ED late evening 6/16/12 with diagnoses including severe obesity, hyponatremia (low blood sodium level) with weakness and swelling of legs, atrial fibrillation (an irregular heartbeat), chronic obstructive pulmonary disease (COPD) with shortness of breath and anxiety, and obstructive sleep apnea (breathing pauses during sleep due to a narrowed or obstructed airway).

Review of Patient 14's ED Physician Orders revealed a dosage of Ativan 1 mg by mouth was ordered on 6/16/12 at 11:49 p.m.; the ED medication administration record indicated the Ativan was administered for anxiety by ED licensed nursing staff at 11:56 p.m.

Review of Patient 14's inpatient Physician Orders revealed an order (dated 6/17/12 at 12:19 a.m.) an order for Ativan 2 mg by mouth every six hours around the clock for four doses; then 2 mg every 8 hours for three doses; then 2 mg every 12 hours for two doses.

Review of Patient 14's history and physical (dated 6/17/12 at 12:31 a.m.) indicated the admitting physician planned to implement an alcohol withdrawal protocol with the aforementioned around the clock Ativan order. Patient 14's physician also prescribed CPAP (continuous positive airway pressure mask) during sleep (which had also been used prior to admission) related to the diagnosis of sleep apnea.

Lexi-Comp ONLINE, a nationally recognized medication reference resource, indicated under "Warnings/Precautions" that Ativan should be used with caution in the elderly or patients with respiratory disease (COPD or sleep apnea); and that confusion, sedation, dizziness, falls and traumatic injury could occur; the monograph further indicated, under "Adverse Reactions," a risk of respiratory depression.

Review of Patient 14's electronic medication administration record indicated on 6/17/12 at 2:13 a.m. a licensed nurse administered Ativan 1mg; the nurse documented "1 mg given in ED at midnight, so only 1 mg given now." The document further indicated Ativan 2 mg was administered by licensed nursing staff at 5:32 a.m. and 1:17 p.m. the same day.

Review of Patient 14's electronic clinical record nurse's notes revealed on 6/17/12 at 1:36 p.m. (19 minutes after Ativan was administered) a licensed nurse documented: "Found on floor by staff bleeding due to pt [patient] pulled his 2 new iv site that was just placed....Pt denies any pain/discomfort....left knee noted to have hematoma ice placed Dr....notified but no further orders made...." At 3:54 p.m. (2 hours and 37 minutes after the Ativan was administered) a licensed nurse documented: "During report/change of shift, wife at the bedside with social worker, pt noted to be sleeping heavy with his own cipap [CPAP] on and has bubbling white mucous coming out of his mouth. Tried to wake him but unable to, RRT [respiratory therapist] called and was given flumazenil 0.2 mg ivp [I.V. push] per Dr. [MD name] order with some response , pt has ativan 2 mg po every 6 hours due to heavy drinking lately per wife...."

Review of Patient 14's Physician Orders indicated I.V. flumazenil 0.2 mg was ordered on 6/17/12 at 3:24 p.m. Further review of Patient 14's electronic medication administration record indicated I.V. flumazenil 0.2 mg was administered by licensed nursing staff on 6/17/12 at 3:27 p.m.

Review of Patient 14's electronic physician notes revealed an entry dated 6/17/12 at 3:24 p.m. that indicated: "Patient somnolent. Reportedly clear foam at mouth before CPAP removed and suctioned....fell...2 mg ativan at 13:17 [1:17 p.m.] on CIWA [alcohol withdrawal] protocol....no response to voice...." An entry dated 6/17/12 at 3:30 p.m. indicated: "After flumazenil patient awakened to voice....Confused, thinking wife is his mother." Patient 14's physician note indicated oversedation from the Ativan and a clinical response to I.V. flumazenil; the Ativan was discontinued on 6/17/12 at 3:40 p.m. Patient 14's electronic clinical record indicated he was transferred to the ICU (intensive care unit).

Further review of Patient 14's electronic clinical record indicated a CT scan procedure was performed in the late afternoon on 6/17/12; I.V. Versed (a short acting injectable benzodiazepine) was administered as a sedative. Patient 14's clinical record did not indicate adverse effects to Versed or further administration of flumazenil during or after the procedure.

During an interview on 8/8/12 at approximately 11:15 a.m. Pharm 1 and Pharm 2 verified Patient 14's clinical record findings and confirmed the 6/17/12 adverse event related to Ativan; and the need to report all adverse medication events to the hospital-wide reporting system in accordance with facility policy to increase patient safety.

Review of the facility policy 1100.2 "Adverse Drug Event" indicated a "Responsible Reporting Form" can be completed by any healthcare practitioner; and that the pharmacy staff was alerted to potential adverse drug events by screening medication orders and reviewing lists of antidotes (reversal medications) on a daily basis, including flumazenil. The policy indicated under item 4c: "Any utilization of an antidote or 'rescue' agent determined to be the result of an adverse drug event shall be documented by the pharmacist and reported to the Inpatient Pharmacy Supervisor for QA inclusion in the ADR report.

Pharm 2 provided a copy of the pharmacy's 6/17/12 - 6/18/12 "trigger drug" report that listed licensed nursing staff withdrawals of reversal medications from ADCs throughout the hospital. The report indicated a licensed nurse withdrew a vial of I.V. flumazenil 0.5 mg/5 mL from the 1 Main ADC for Patient 14 on 6/17/12 at 3:27 p.m. Pharm 2 confirmed the reviewing staff pharmacist had written "CT scan procedure" on the document; indicating the adverse event to Patient 14's excessive dose of Ativan had not been considered by the reviewing staff pharmacist.

During an interview on 8/8/12 at 12:55 p.m. Pharm 1 and Pharm 2 confirmed (after contacting the hospital's Risk Management Director) that Patient 14's 6/17/12 adverse drug event was not reported to the hospital-wide reporting system in accordance with hospital policy.

Based on record review and staff interviews, the hospital failed to ensure the nutrition needs of 1 of 6 patients reviewed for nutrition care were monitored and met (Patient 6). Patient 6 had minimal nutrition intake for 11 days and was not assessed by the registered dietitian (RD) until day 8 of the admission. This failure had the potential for the nutrition needs of the patient to not be met in a timely manner and further compromise the nutrition and medical status of the patient.

Findings:

A review of the medical record for Patient 6 on 8/7/12 revealed the patient was admitted from the emergency department to observational status on 7/23/12. The patient was then admitted to in-patient status on 7/25/12 with diagnoses that included abdominal pain. The physician's orders revealed the patient remained NPO, or nothing by mouth, with no nutrition support for 11 days, except for occasional orders for clear liquid or sips of liquid. A clear liquid diet provided only minimal nutrition.

A review of the nutrition notes by the RD showed a nutrition assessment was not completed until 7/30/12, on day 8 of the patient's hospital stay.

During an interview with the Clinical Nutrition Manager on 8/7/12 at 10:15 a.m., she stated it was the hospital's policy that patients who remain NPO and/or on a clear liquid diet for 5 days will be assessed by the RD to determine appropriate interventions and a nutrition plan of care. She stated Patient 6 was not seen by the RD in a timely manner because the computer system listed the patient's admission date as 7/25/12 instead of 7/23/12. She stated it was a problem they needed to resolve. When a patient was admitted on observational status, the RDs were not alerted to the date of this admission, only the in-patient date of admission.

The patient was started on TPN (total parenteral nutrition - liquid nutrition given directly into the blood stream) on 8/2/12, 10 days after admission.

Based on observation, record reviews and interviews, the hospital failed to ensure there were infection control measures in place to prevent the development of food borne illness and cross contamination with regards to food service. Also, the hospital failed to have a thorough infection control surveillance system that monitored the conditions and practices of the dietetics services staff. By not having these measures and a thorough surveillance system, potentially hazardous foods were stored, prepared and distributed under unsafe and unsanitary conditions and there was potential for such continuation in the absence of identification and remediation.

Findings:

1. According to the 2009 FDA Food Code, cooked, potentially hazardous food (PHF) shall be cooled within 2 hours from 135 degrees Fahrenheit (F) to 70 degrees F, and within a total of 6 hours from 135 degrees F to 41 degrees F. It further states if food is not cooled in accordance to this Code requirement, pathogens may grow to sufficient numbers to cause food borne illness.

During a tour of the cafeteria kitchen on 8/6/12 at 11:05 a.m., two pans of cooked meat were observed in the walk-in freezer. One was labeled barbeque pork, 7/31/12, and the other was labeled chicken fajitas, 8/3/12.

During a concurrent interview with the Cafeteria Manager (CM), he stated the two items were cooked and then cooled on the dates written on them. He further stated there was no documented safe cool down of the two cooked meats. He stated the staff were instructed to use a cooling chart to log safe cooling of PHF, but they were not doing it.

A review of the cafeteria's "Cooling Chart" logs showed that only two charts were filled out. These charts were filled out on 9/25/11 and 9/27/11 and neither was complete.

During further interview with the CM, same date and time, he stated the staff were trained on safe cooling of PHF.

A review of the hospital's "In-Service Education for May 2011" dated 5/2/11, revealed the topic was "Safe Food Handling." It stated that one of the rules for Safe Food Handling included "Chill cooked food to 40 degrees F (Fahrenheit) within four hours." It did not indicate that cooked PHF needs to be chilled to 70 degrees F within two hours first.

According to the 2009 Food Code, the initial two hour rapid cool period is a critical step in the cooling process. If the initial rapid cooling to 70 degrees F or less is not achieved within two hours, food safety hazards may not be adequately controlled.

Food served in the hospital cafeteria could potentially be fed to patients and needs to be prepared and stored under sanitary conditions to avoid food borne illness.

2. During a tour of the cafeteria kitchen on 8/6/12 at 11:25 a.m., the high temperature dishwasher was run consecutively three times and the rinse temperatures were observed to be 176, 170 and 172 degrees F during the three runs.

During a concurrent interview with the Cafeteria Manager (CM), he stated to effectively sanitize the utensils, the water must reach 180 degrees F. He stated he would call the engineering staff to check it. He also stated the temperature of the rinse was 182 degrees F at 8:00 a.m. that day.

A review of the Cafeteria's "Dishwashing Machine Temperature Log", dated August 2012 (specific times were not recorded on the Log), under 8/6/12, showed the rinse temperature was documented at 182 degrees F sometime prior to the 11:25 a.m. interview.

During an interview with the CM on 8/6/12 at 1:30 p.m., he stated the engineering staff had checked the machine and determined that it needed to be run a few more times and then the temperature would reach 180 degrees F. He stated when the machine was not run for a while, the water cools and the machine needs to run several times before the rinse cycle reached 180 degrees F.

During an interview with Cafeteria Staff (CS) on 8/6/12 at 1:35 p.m., he stated it was his job to wash the cafeteria dishes. He further stated when he washed dishes, he ensured the temperature of the water reached 165 to 170 degrees F. He was unable to state the rinse temperature should reach 180 degrees F. He further stated he was not trained to wash dishes and did not know the water should reach 180 degrees F during the rinse cycle.

A review of the cafeteria's policy titled, "Sanitary Facilities and Equipment" dated 8/25/11, revealed that for sanitation of trays, utensils, pots, pans and cooking equipment in the automatic dishwasher, the final rinse temperature should be 180 degrees F. It stated the purpose of the policy was to ensure that trays, utensils, pots, pans and other cooking equipment were properly sanitized.

When kitchen equipment is not properly sanitized, there is the potential for disease causing pathogens to contaminate food being served which could result in food borne illness.

3. During a tour of the cafeteria kitchen on 8/6/12 at 11:00 a.m., the table mounted can opener was observed to have a significantly worn blade. The blade was chipped and nicked on the piercing and cutting edges. There were also metal shavings present.

During a concurrent interview with the Cafeteria Manager (CM), he verified the observation. He stated the blade was cleaned daily in the dish machine. He also stated the blade was changed every six months.

A review of the cafeteria policy titled, "Policy for Space/Equipment/Utensils" dated 5/1/12, revealed that all utensils, counters, shelves, and equipment were to be maintained in good repair and were to be free from corrosion, open seams, cracks and chipped areas.

According to the 2009 Food Code, the cutting or piercing part of can openers shall be kept sharp to minimize the creation of metal fragments that can contaminate food when the container is open. It further stated multiuse food contact surfaces shall be smooth and free of crevices. Surfaces which have imperfections such as cracks, chips or pits allow microorganisms to attach and form biofilms that can release pathogens in the food. Biofilms are highly resistant to cleaning and sanitizing efforts.

These biofilms have the potential to cause food borne illness in patients.

4. During a tour of the hospital kitchen on 8/6/12 at 10:20 a.m., seven six-ounce containers of vanilla yogurt were noted to have a sell by date of 7/14/12.

During a concurrent interview with the Food Service Manager (FSM), she verified the sell-by date and stated these were a new product and she did not know the expiration or use-by dates for the yogurts. She pointed out a posted chart staff were directed to use to determine the shelf life for food items stocked by the hospital.

A review of the posted "Shelf Life" chart in the kitchen, dated 6/14/12, indicated for yogurt, staff were directed to use the expiration date stamped on the item. There was no direction to staff that the sell-by date was different than the use-by or expiration date. There was also no direction to staff regarding how long the shelf life of the yogurt was after the sell-by date.

During a follow-up interview with the FSM on 8/6/12 at 3:40 p.m. she stated she contacted the yogurt manufacturer and determined the yogurt had a 7 day shelf life after the sell-by date. Seven days after the sell-by date on this yogurt was 7/21/12. The yogurt had been expired for 16 days when it was observed in the kitchen. She was unable to explain why it had not been discarded.

Consuming expired dairy products can cause food borne illness, especially in an already compromised patient population.

During an interview with the FSM on 8/8/12 at 1:00 p.m., she stated she conducted monthly sanitation inspections in the cafeteria. She stated she monitored for evidence of proper cooling during these inspections, but had not noted an issue prior to this survey. She further stated she monitored the equipment in the cafeteria kitchen for cleanliness and sanitation, but had not noted the chipped and worn can opener blade before this survey. She also stated she reviewed the dish machine temperature logs, but had not interviewed the dish washing staff to ensure proper knowledge of effective sanitizing temperatures for the dish machine.

During an interview with the Regional Infection Control Prevention (RICP) on 8/9/12 at 9:50 a.m., the Environment of Care (EOC) team reported to the Infection Control (IC) Team on their rounds. She further stated the EOC team conducted inspections in the cafeteria one to two times a year. In addition, she stated she did informal rounds in the cafeteria two to four times a week. She stated she also relied on sanitation inspections completed by the FSM that are reported to the IC Team. According to the RICP, the above deficient practices were not identified prior to this survey.

A review of the hospital's "2012 Infection Prevention and Control Program Strategic Plan and Goals" revealed the purpose of the Infection Prevention and Control Program was to support a collaborative approach for prevention and control of healthcare associated infections across the continuum of care through the standardization and optimization of infection control activities.

The deficient practices observed during the survey were not being monitored to ensure the prevention of food borne illness to an already compromised patient population.

Based on interviews and review of facility documents and clinical records, the emergency department (ED) medical staff failed to assess whether all of the established policies and procedures (P&P) related to the medical care provided in the ED were carried out as designed. A review of two ED clinical records showed that nurses were having patients who were treated but no longer wanted to remain in the ED sign an AMA (against medical advice) form without the physician explaining the risks of leaving prior to signing as per the ED's Policy & Procedure.

Findings:

On 8/7/12 at 11:30 a.m., Patient B's ED record was reviewed. Patient A was admitted to the ED on 6/24/12 at approximately 9:11 p.m. from a crisis center. The patient had been discharged from the crisis center due to a possible theft incident and was sent to the ED for a psychiatric exam to establish if he was stable to be out on his own. Upon arrival to the ED Patient A was placed on a 1799 hold (24-hour hold) by the ED physician for, "a danger to others, or flight risk." On 6/24/12 during the course of his ED stay, Patient B was then placed on a 72-hour mandatory 5150 hold in the ED.

On 6/25/12 at 12:07 a.m., Patient B was medically cleared. On 6/25/12 at 10:46 a.m., nursing documentation showed that Patient B's 5150 hold had been lifted by the psychiatrist after evaluation and that the ED physician was notified of this. Additional documentation on that date showed that Patient A had nowhere to go and the discharge planning department was notified to seek placement for him. Subsequent documentation showed that Patient B was medically cleared, on no psychiatric hold and at 3:16 p.m., verbally expressed that he wanted to leave the ED and "walk to a friend's house." Documentation by the nurse read that the ED doctor had discussed this case with the psychiatrist and that there was no reason to hold him against his will. A nurse documented at 4:36 p.m. that Patient B, "willingly signed AMA form."
A review of the AMA form read that the facility's obligation for treatment, stabilization and transfer was explained to Patient A. In addition, the area that indicated that Patient A had been advised of the risks of leaving were explained such as, "Potential threat to life, limb, and/or safety, including death or permanent disability." The form was signed by the nurse and Patient A.

A review of the facility's P&P titled, "Against Medical Advise, Leaving Hospital or Emergency Department", (last reviewed 7/12/2011), read that if a patient elects to leave the ED after being seen by a physician, staff will ask the patient to wait until the ED physician is notified so that he/she may discuss the risks of leaving against medical advice and alternatives to treatment.

On 8/7/12 at 2:30 p.m., the ED Nursing Director (EDD) was interviewed about Patient B's chart. The EDD stated that Patient A was well known to them and that even though he had no psychiatric hold on him, the ED was attempting to find a place for him to go to. The EDD was asked why he was signed out AMA and what kind of risks were explained to the patient by the nurse? The EDD stated that the staff would have preferred that he had been able to go to another crisis center and felt uncomfortable with him leaving the ED, even though the ED physician stated that there was no reason to hold him. The EDD stated that nursing staff always told patients that leaving AMA could result in, "potential threat to life and limb including and up to death." After review of the P&P, the EDD concurred that it indicated that the physician and not the nurse was to discuss the risks of leaving AMA.

On 8/8/12 at 12:10 p.m., Patient C's chart was reviewed. Patient B presented to the ED on 8/7/12 at 9:40 a.m. with complaints of upper gastric pain with nausea. Further review showed an AMA form timed at 11:15 a.m., which indicated that Patient B was leaving AMA due to the, "length of wait" in the ED. Once again the form was marked in the same areas as Patient A's with Patient C's and a nurse's signature. A review of the ED physician's note read that although blood tests were pre-ordered per Patient C's chief complaint, the patient, "had already left AMA after signing the form. I had no opportunity to personally evaluate or visit with this patient to discuss alternatives to his leaving before completion of evaluation and treatment."

On 8/8/12 at 1:25 p.m., an interview was conducted with the EDD and the ED Medical Director (MD) in the presence of the Risk Manager. The EDD stated that once again, the staff had explained the risks of leaving to include, "threat to life, limb and up to death." The MD was asked if it was the responsibility of nursing to convey the medical risks and alternatives to treatment to a patient who signs out AMA and he stated, "Someone must do that." The MD stated that the ED physician can become very busy and may not be able to speak with the patient right away. The EDD was asked if nursing discussed the risks based on the patient's presenting complaints and she stated that they all discussed the verbiage indicated on the form, which was not specific to any chief complaint. The EDD and MD concurred that the P&P indicated that it was the physician's responsibility to explain the risks and alternatives and that nursing was to encourage patients to stay, notify the physician as quickly as possible and document what occurred.