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Based on interview and document review the hospital failed to have an ongoing quality appraisal and performance improvement program that addressed the complexity and scope of Food and Dietetic Services and areas that would improve patient safety.

Findings:

The quality appraisal and performance improvement (QAPI) activities were reviewed on 1/27/11. It was noted that while the department submitted performance improvement information, the submitted report focused on the hospitals ' customer satisfaction indicators, efficiency of the blast chiller, and timeliness of nutrition assessment of patients. All selected activities in the acute care hospital were at the 99%-100% compliance level.
In an interview on 1/27/11 at 9:45 a.m. with Quality Assurance Officer F, which reported to the governing body, she was asked how the hospital ensured development of departmental improvement programs. She stated that that the committee did not make decisions on the types of activities, rather would rely on departmental leaders to choose the activities. There was no documentation provided to ensure the QAPI program was developed for the scope of the hospital food service that included food safety indicators.
Additionally, the hospital failed to identify quality measures for the contracted services provided by outside vendors for the dish washing machine and pest control and that might impact food safety and food borne illness.

Based on observation, record review and interview, the hospital failed to ensure that medications were administered in accordance with physicians ' orders and accepted standard of practice as evidenced by:

1. Patient 3 was not administered Metroniadazole (an antibiotic) for an infected hematoma until 7 hours after the physician ordered the medication.

2. Patient 6 was administered Ranitidine (a medication for treatment and prevention of ulcers or other digestive tract disorders) when there was no physician order for the medication.

3. Patient 2 ' s intravenous line was not flushed after the administration of hydromorphone (a narcotic medication for pain control).

4. RN 7 administered Arixtra (a blood thinner, a high risk medication) to Patient 4 without a second registered nurse performing an independent double check as required by hospital policy.

Findings:

1. A review of Patient 3 ' s clinical record on 1/25/11 showed that the patient was admitted to the hospital for infected hematoma (swelling with accumulation of blood) versus possible early abscess on 1/22/11. Metroniadazole 500mg (an antibiotic) intravenously every 8 hours was ordered by the physician at 10:40 a.m. on 1/23/11. Patient 3 ' s Medication Administration Record (MAR) showed that the first dose of Metroniadazole was administered at 5:51 p.m. on 1/23/11, 7 hours after the medication was ordered.

The hospital policy and procedures titled "Medication Dosage Administration Time" indicated that medications ordered for every 8 hours should be administered at 8:00 a.m., 4:00 p.m. and at 12:00 midnight. The policy also indicated that if a medication is ordered at 10:00 a.m. to be administered every 8 hours, the first dose should be administered "now" and the following dose would be due at 4:00 p.m.

During an interview at approximately 10:25 a.m. on 1/28/11, Physician 1 stated that if she ordered Metroniadazole every 8 hours, she expected the first dose to be administered as soon as possible according to the hospital policy. Physician 1 also stated it would not be acceptable for an order for Metroniadazole to be administered 7 hours later.

2. During medication administration observation at approximately 8:30 a.m. on 1/27/11, RN 4 was observed administering Ranitidine 150mg (milligrams) one tablet to Patient 6.

A review of Patient 6 ' s clinical record with RN 5 at approximately 2:20 p.m. on 1/27/11 showed that Patient 6 did not have an active physician ' s order for Ranitidine. RN 5 acknowledged that the patient did not have a physician ' s order for Rantidine and should not have been administered the medication.

3. During medication administration observation at approximately 8:22 a.m. on 1/27/11, RN 4 was observed administering hydromorphone (a narcotic medication for pain control) 2 milligrams in 1 milliliter to Patient 2 by slow intravenous (IV) push. RN 4 did not flush Patient 2 ' s intravenous line (plastic tubing inserted through the skin and into a blood vessel) with saline solution after the administration of the medication.

During an interview at approximately 10:08 a.m. on 1/28/11, RN 5, a nursing manager, stated that the hospital did not have a written policy and procedure to address flushing of IV lines prior to and after medication to ensure proper administration. RN 5 further stated that it was her expectation that RN flushed Patient 2 ' s IV line after administration of the hydromorphone.

4. During medication administration observation at approximately 9:17 a.m. on 1/27/11, RN 7 was observed administering Arixtra (a blood thinning medication) 2.5mg (milligrams) by subcutaneous injection to Patient 4. RN 7 did not seek an independent double check by another registered nurse prior to the administration of the medication.

The hospital policy and procedure on high-risk medications anticoagulants (blood thinning medications) including Arixtra are considered high-risk medications. Administration of high-risk medication was required by the hospital to have another professional double-check prior to administration.

Based on observation, interview and document review, the hospital failed to ensure that drugs and biologicals were kept in a secure area. A chemo supply cart containing medications was unlocked and left unattended in the hospital hallway.

Findings:

During a tour of the nursing units on the second floor with RN 5 at approximately 9:38 a.m. on 1/27/11, a chemo supply cart was found unlocked and unattended in the hallway between Nursing Unit 2A and 2B. Upon inspection of the chemo supply cart, saline flush syringes and 2 bags of 250-ml normal saline for intravenous infusion were found in the drawers. RN 5 acknowledged that the cart should be locked to prevent unauthorized access to the drug and supply stored in the cart to ensure patient safety.

Based on observation and interview, the hospital failed to ensure that outdated or otherwise unusable drugs were not available for patient use as evidenced by:

1. Mulitidose medication vials were not dated after initial opening in the medication room of Nursing Unit 2B.

2. Expired drugs were found in the anesthesia cart available for patient use.

3. Succinylcholine (a paralyzing agent to induce muscle relaxation for tracheal intubation) was stored at room temperature in the anesthesia cart in Operating Room 3 with no indication of removal date from refrigeration or revised expiration date.

Findings:

1. During a tour of the medication storage room of Nursing Unit 2B with Administrative Staff 1 at approximately 11:05 a.m. on 1/25/11, one opened vial of 20-ml (milliliters) lidocaine (a local anesthetic) 1 % was found in Patient 1 ' s medication drawer with no indication of opening date or revised expiration date.

A review of the hospital multidose medication vials policy and procedures on 1/26/11 showed that the individual who first punctured the vial must label the vial with the new expiration date 28 days after the initial opening date.

2. During an inspection of the anesthesia cart in Operating Room 3 at approximately 10:00 a.m. on 1/27/11, one 20-ml vial of lidocaine 1 % with an expiration date of 1/11/11 and one vial of flumazenil (a reversing agent for sedative overdose) 5mg/0.5 ml with an expiration date of 1/24/11 were found in the anesthesia cart available for patient use. Operating Room Administrative Staff 3 stated that the expired drugs should have been removed from the cart.

3. During an inspection of the anesthesia cart in Operating Room 3 at approximately 10:00 a.m. on 1/27/11, two 10-ml vials of succinylcholine 20mg/ml were found in the medication drawer of the cart at room temperature. There was no revised expiration date or any indication on the vials of the date when the medications were removed from refrigeration. Operating Room Administrative Staff 3 stated that the identified succinylcholine were not suitable for patient use.

According to Lexi-Comp, a drug information provider for health care professionals, succinylcholine is recommended by the manufacturer to be stored under refrigeration at 2?C to 8?C (36?F to 46?F) and may be stored at room temperature for 14 days.

Drugs and biologicals should be stored according to the predetermined conditions as supported by stability data. The failure of the hospital to store drugs at their recommended storage condition had the potential of impacting the safety and effectiveness of the drug products.

Based on observation, interview and document review the hospital failed to ensure that dietary services met the needs of all patients by handling food safely to prevent foodborne illness; follow and implement food safety indicators; availability of a diet manual as reference for ordered therapeutic diets.
Findings:
1. The hospital failed to provide organized dietetic services as evidenced by findings of unsafe food handling practices and supervision of the dietary department (Cross Reference A620).
2. Develop performance improvement activities that reflected the scope and nature of the services and that would include food safety indicators (Cross Reference A264).
3. Ensure a diet manual for medical nutrition therapy that provides guidance on the therapeutic diets provided by the hospital and specific to the patient population and has been approved by the medical staff and the registered dietitian and has been revised within the past five years(Cross Reference 631).
4. Ensure the development of comprehensive policies and procedures that reflected the scope and nature of services (Cross Reference A 619, A620, A749)

The cumulative effect of these systemic problems resulted in the inability of the hospitals ' food and nutrition services to direct and staff in such a manner to ensure that the nutritional needs of the patients ' were met in accordance with practitioners ' orders and acceptable standards of practice.

Based on observation, interview and medical record review the hospital failed to ensure that 1 patient (Patient 20) in a sample of 2 patients reviewed for nutrition care received their physician ordered nutritional intervention because the facility did not have a diet manual that was approved by the dietitian and the medical staff. Failure to provide for identified nutritional needs may result in further compromise of medical status.

Findings:

Patient 20's medical record was reviewed on 1/26/11 at 11:45 AM. Patient 20 had a diagnosis of end stage renal disease and had a Physician's order for renal diet. During a concurrent interview with the surveyor regarding what foods would be allowed on a renal diet, Dietary Staff B stated her expectation would be 60 grams of protein, low potassium and low phosphorus. "However" she stated, "I'm not sure exactly what the computer would say, because there was no diet manual. We would have to print out a tray card and then see what it says." DS B stated there was a diet manual several years earlier but it was no longer there. DS B said the computer program is being used to print tray cards.

At 2:45 p.m. on 1/26/11 DMS A acknowledged the lack of a hospital diet manual that had been approved by the registered dietitian and the medical staff and revised every five years at a minimum and provide guidance to dietary staff on the foods to be provided to patients with medical diagnoses to complement the medical condition. During a concurrent interview, DS B stated the foods served to patients were not correct, particularly for diabetic and renal patients.

Based on observation, interview and document review the facility failed to develop and implement safe food storage and food preparation systems to avoid sources and transmission of infections as evidenced by:

1. Failure to provide safe/effective dietetic services as evidenced by findings of unsafe food storage and handling practices (Cross Reference A620 and A749).

2. Failure to provide a hospital wide infection control program to conduct effective surveillance that would prevent the transmission of food borne infections in the dietary department (Cross Reference A 749)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.