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Based on interview and document review, the hospital failed to ensure two contracted services were initiated and maintained in an appropriate manner. 1. For Contract one, the hospital failed to ensure there was a current agreement with the company providing copies of medical records to requestors. This failure had the potential to jeopardize the confidentiality, security, and availability of medical records. 2. For Contract two, the hospital failed to provide over-sight for the contracted service of dialysis which had the potential to spread infectious disease to the patients receiving dialysis in the hospital.

Findings:

1. During an interview with Staff Health Information Manager (HIM), on the afternoon of 9/26/11, she stated an outside company was used to make copies of medical records from various requestors. The agreement that was provided was dated January 1996 and was with a different company, which she stated had been purchased by one or more successive owners prior to the current company. She was unable to provide a comprehensive written agreement with this current company, other than a business associate agreement, effective 4/1/10; however it had not been signed by a company representative until 9/27/11. Also, the hospital had no mechanism in place to evaluate the quality of this company's performance.



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2. The Association for the Advancement of Medical Instrumentation (AAMI) standards program consists of over 100 technical committees and working groups that produce Standards, Recommended Practices, and Technical Information Reports for medical devices. The AAMI standards for dialysis and RO (reverse osmosis) machines indicated the cultures (a test for bacteria) should have a microbial count lower than 200 CFU/ml (colony forming units per milliliter) and endotoxin (a toxin from bacteria cell wall that cause fever and shock) concentration of lower than 2 EU/ml (endotoxin units per milliliter). Per the AAMI standards, the action level should be when the microbial count was at 50 CFU/ml and the endotoxin level was at 1 EU/ml. (Reference: AAMI RD52:2004)

The culture and endotoxin result binder for the dialysis and reverse osmosis (RO - a machine used to clean the water used for dialysis) machines located in the hospital was reviewed with the Infection Control Nurse (ICN) on 9/29/11 at 9:10 AM. The culture results for Contracted Service A (CS A) indicated dialysis machine 14 had the following laboratory culture results: 3/31/11 - culture result of 200 colony forming units per milliliter (CFU/ML), 6/29/11 - culture result of 5,000 CFU/ML, 7/5/11 - 1,000 CFU/ML. The laboratory test that was reported on 6/29/11 was drawn on 6/27/11. The test was re-drawn on 6/30/11 and the result was reported five days later on 7/5/11. There was no indication in the laboratory result binder if dialysis machine 14 was removed from use on the hospital's dialysis patients between the dates of 6/29/11 and 7/5/11. For RO machine 7 the culture and endotoxin results were as follows: 6/18/11 - endotoxin result was 1.60 EU/ml, 6/30/11 - the culture test was 60 CFU/ml, and on 7/9/11 - the endotoxin result was 5.15 EU/ml. There was no indication in the laboratory result binder that RO machine 7 was removed from patient use between the dates of 6/18/11 and 7/9/11. There was a hand written note on the 7/9/11 laboratory result document indicating RO 7 was pulled out of service on 7/11/11. For RO machine 10 the culture and endotoxin results were as follows: 5/3/11 - culture 90 CFU/ml, 7/9/11 - endotoxin 4.45 EU/ml. For RO machine 11 the culture results were as follows: 3/18/11 - culture 50 CFU/ml.

The ICN verified the above results and stated she did not remember viewing the elevated laboratory results. She stated she does not document that she has viewed the laboratory tests for the dialysis or RO machines. She does not chart what action she had taken to ensure the machines were not used for the hospital patient's dialysis during the time the machines have laboratory tests drawn and the results were reported, or when the machines have elevated laboratory results. She stated she depended on CS A to take the machines out of service. She stated she had not reported the laboratory dialysis and RO machine's results to the infection control committee that meets quarterly.

During an interview with the Quality Director on 9/29/11 at 9:50 AM, she stated her expectation of the ICN would be to report the incidents of elevation cultures during the infection control committee's quarterly meetings, that she would act on the elevated endotoxin and culture tests, and ensure appropriate steps were taken by the contracted dialysis company when the test were above acceptable levels.

Based on interview and record review, the hospital failed to inform two patients (6 and 20) of patient rights information upon admission to the hospital. This failure had the potential to result in a violation of their patient rights.

Findings:

1. During an interview with Patient 6 on 9/26/11 at 2 PM, he stated he did not remember receiving a booklet that explained his rights as a patient of the hospital.

The clinical record for Patient 6 was reviewed with Staff A on 9/26/11 at 2:30 PM. The risk Manager Assistant verified there was no indication in his chart he had received a copy of the booklet explaining patient rights.



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2. The clinical record for Patient 20 was reviewed on 9/27/11. The electronic medical record section indicated the patient's advance directive was found blank. The record did not indicate whether the patient had an advance directive. An "Admission Guide" packet was found in the back of the patient's hard copy chart that provided patient rights information.

During a concurrent interview with the TeleStroke Unit Manager (TSM) and Registered Nurse (RN) 6, on 9/27/11, at 2:15 PM, they both confirmed Patient 20's Admission Guide packet was in his chart. The TSM stated the Admission Guides contain patient rights information. RN 6 stated the Admission Guides are given to the patients or their family members from the admitting registration staff upon admission to the hospital. She stated if she saw a packet (Admission Guide) in the patient's chart, she would deliver it to the patient. She stated Patient 20 was alert and oriented and should have already received his Admission Guide information.

The hospital policy titled "Rights and Responsibilities of Patients", revision date 7/08, indicated a list of patient rights are found in the Admission Guide that is provided to patients at the time of admission.

Based on interview and record review, the hospital failed to provide evidence, in two of 66 (6 and 20) patient records, the patients received information regarding advance directives, which had the potential to violate the patient's right to formulate medical care decisions.

Findings:

1. During an interview with Patient 6 on 9/26/11 at 2 PM, he stated he did not remember receiving a booklet that explained the process of advanced directives.

The clinical record for Patient 6 was reviewed with Staff A on 9/26/11 at 2:30 PM. The Risk Manager Assistant verified there was not an indication in his chart he had received a copy of the booklet explaining advance directives.



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2. The clinical record for Patient 20 was reviewed on 9/27/11. The electronic medical record section that indicated the patient's advance directive was found blank. The record did not indicate whether the patient had an advance directive. An "Admission Guide" packet was found in the back of the patient's hard copy chart that provided patient rights information, that included information about advance directives and decisions about medical treatment.

During a concurrent interview and record review with the TeleStroke Unit Manager (TSM) and Registered Nurse (RN) 6, on 9/27/11, at 2:15 PM, they both confirmed Patient 20's Admission Guide packet was in his chart (not in his possession) and the electronic medical record advance directive section was incomplete. The TSM stated the "Admission Guide" contained patient rights information. RN 6 stated the Admission Guides are given to the patients or their family members from the admitting registration staff upon admission to the hospital. She stated if she saw a packet (Admission Guide) in the patient's chart, she would deliver it to the patient. She stated Patient 20 was alert and oriented and should have already received his Admission Guide information. The TSM stated the electronic medical record was to be checked every shift for completion of required sections, which included the advance directive section.

The hospital policy titled "Rights and Responsibilities of Patients", revision date 7/08, indicated a list of patient rights are found in the Admission Guide that is provided to patients at the time of admission.

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. Failure to evaluate the comprehensive scope of operational processes may result in patient exposure to unsafe food handling practices and/or food production systems that may not meet the nutritional needs of inpatients compromising medical status.

Findings:

On 9/30/11 beginning at 1:30 PM, the quality assurance activities for food and nutrition services was reviewed with Registered Dieticians (RD) 1 and 2. It was noted that while there was the development of performance improvement activities related to food production the quality indicator for 2010 was related to the creation of a weekly cafeteria menu cycle to improve selections for employees and visitors. The quality indictor for 2011 was to improve overall patient satisfaction. There was no development of quality indicators that effectively evaluated the processes related to patient food production activities. In a concurrent interview RD 1 and RD 2 acknowledged there were no performance improvement activities related to the operational processes within dietetic services.

Based on document review and staff interview, the hospital failed to ensure the medical records oversight function was included in the appropriate committee's duties of the medical staff bylaws.

Findings:

On the afternoon of 9/26/11, Staff Health Information Manager (HIM) stated that she reports various medical record information, such as timely completion, to the Clinical Performance Improvement (CPI) committee. The Medical Staff Bylaws, last approved 1/27/10, were reviewed on 9/27/11. The CPI committee's duties did not include the duty to oversee medical records, which was confirmed by Staff Medical Staff Manager (MS) on 9/28/11. Based on a review of the meeting minutes/agenda from June-September 2011, the CPI committee does review medical record information.

Based on interview and document review, the hospital failed to ensure nursing services were provided in accordance with national standards of practice, and in accordance with regulations as evidenced by:

1. Failure to ensure adequate numbers of registered nurses were present when moderate sedation was administered. (Refer to A Tag 392)

2. Failure to provide appropriate nursing care plans. (Refer to A tag 396)

3. Failure to provide evidence of conscious sedation competency for two Registered Nurses in the outpatient, off-campus radiology service. (Refer to A tag 397)

4. Failure to evaluate contracted licensed nurses job performances. (Refer to A tag 398)

5. Failure to ensure medication was verified prior to administration in accordance to facility policy. (Refer to A tag 404)

6. Failure to ensure orders for medications were written by individuals and signed by a practitioner who was authorized to write orders by hospital policy in accordance regulations. (Refer to A tag 406)

7. Failure to ensure blood product transfusion records included two signatures of licensed staff before administration, vital signs were completed at the intervals according to the hospital's policy, and a statement regarding any possible re-actions to the blood product was completed. (Refer to A tag 409)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure that nursing services was provided in a safe manner.

Based on interview and document review, the hospital failed to ensure there were adequate numbers of registered nurses present during the administration of conscious/moderate sedation for three of three patients having moderate sedation at the outpatient radiology department (Patients 60, 61, and 63).

Findings:

The hospital failed to provide conscious sedation (conscious sedation is the use of medication to depress the level of consciousness in a patient while allowing the patient to continually and independently breath and respond appropriately to verbal commands and/or gentle stimulation) to all patients in accordance with national standards of practice.

On 9/28/11 at 8:30 AM, a tour was conducted of the outpatient radiology department. During the tour, the Chief Technologist Supervisor (CTS) was asked about the nursing staff who worked in the area. The CTS stated they had one registered nurse (RN) who worked in the interventional procedure room, and one RN in the recovery room.

On 9/28/11 at 3 PM, the medical records for Patients 60, 61, and 62, were reviewed and documentation in the medical records disclosed:

a. Patient 60 had a radiology procedure performed under moderate sedation on 9/6/11. Documentation in the medical record also revealed that one physician and one RN were the only individuals in the room when the procedure was done. Documentation also showed that the radiology procedure was performed as a surgical procedure.

b. Patient 61 had a radiology procedure performed under moderate sedation on 9/6/11. Documentation in the medical record also revealed that one physician and one RN were the only individuals in the room when the procedure was done. Documentation also showed the radiology procedure was performed as a surgical procedure.

c. Patient 62 had a radiology procedure performed under moderate sedation on 6/7/11. Documentation in the medical record also revealed one physician and one RN were the only individuals in the room when the procedure was done. Documentation also showed the radiology procedure was performed as a surgical procedure.

On 9/29/11 at 8:30 AM, a second tour of the outpatient radiology department was conducted. During the tour, Off-site Imaging Manager (OIM) was asked about the number of RN's available when patients had radiology procedures performed under conscious sedation. The OIM replied the department had two RN's, one RN was in the procedure room, and one RN was in the recovery room.

On 9/29/11 at 10 AM, the hospital's 1/12/11, policy and procedure titled, "Moderate Sedation Management" was reviewed. Direction on page three of the policy and procedure specified that a physician and one RN needed to be present when conscious sedation was administered. In addition, under the section titled, "Administration of Medications", direction under item three, was, "The RN monitoring the patient receiving procedural sedation is present to continuously monitor the patient throughout the procedure. Monitoring is a dedicated responsibility, though the nurse may assist with minor , interruptible tasks...."

On 9/29/11 at 2 PM, the 2011 Perioperative Standards and Recommended Practices, published by the Association of Perioperative Registered Nurse (AORN) were reviewed. On page 329, under Recommendation IV, AORN recommended, "The perioperative registered nurse monitoring the patient receiving moderate sedation/analgesia should have no other responsibilities that would require leaving the patient unattended or would compromise continuous monitoring during the procedure." Under recommendation IV.b., AORN recommended that, "An additional perioperative registered nurse should be assigned to the circulating role during the administration of moderate sedation."

Based on medical record review and nursing staff interview, the hospital failed to ensure the comprehensive shift assessment of fluid intake for one patient (68) who was on dialysis treatments and had a physician ordered fluid restriction. Failure to provide comprehensive assessment of patient status may result in excess and/or inadequate fluid intake. Unbalanced fluid status may result in over and/or under hydration further compromising patients' medical status.

Findings:

Patient 68 was admitted with diagnosis including nausea/vomiting and end stage renal disease. Admission physician orders dated 9/24/11 were for an 1800 calorie renal diet as well as dialysis treatments (a method of removing waste products and water from the blood). A follow up order dated 9/25/11 implemented a 2000 milliliter (mL) fluid restriction. A comprehensive nutrition assessment dated 9/28/11 noted the patient had inadequate intake. The assessment also noted the patient's fluid needs were between 1491-1789 ml of fluid/day with an explanation that the patient had increased needs due to dialysis treatments.

Review on intake/output documentation for 9/26-9/29/11, noted fluid intakes (a combination or oral and IV fluids) of 2116 mL, 3080 mL, 1334 mL and 2049 mL's respectively. It was noted that with the exception of one day, Patient 68 exceeded the physician ordered fluid restriction. In an interview on 9/29/11 at 3:30 PM, Registered Nurse (RN) 21 was asked if there was a method for shift assessment with respect to fluid intake. She stated nursing staff entered fluid intake into the electronic medical record; however she stated that to her knowledge there was no policy for shift assessment of fluid intake. In a follow-up interview on 9/30/11 with the Chief Nursing Officer she stated the hospital did not have a nursing assessment policy with respect to evaluation of fluid intake for patients' on fluid restriction.

Based on interview and record review, the hospital failed to provide appropriate nursing care plans for four out of 70 sampled patients (6, 12, 15, and 23), which resulted in:

1. Patient 6 not receiving pain relief.
2. The potential for Patient 12 not receiving appropriate interventions for her diabetes (a chronic disease in which there are high levels of sugar in the blood) and high blood pressure.
3. For Patient 15; the potential for inconsistent care for her diabetes.
4. For Patient 23; the potential for inconsistent care regarding adequate nutrition, pressurized oxygen delivery, interventions for diabetes and ostomy (an opening into the bowel) care.

Findings:

1. During an interview with Patient 6 on 9/26/11 at 2 PM, he stated he takes pain medication at home for his chronic back pain and for arthritis. He stated he did not understand why the nurses would not give him any pain medication when he complained of pain.

The clinical electronic record for Patient 6 was reviewed on 9/26/11 at 2:15 PM. The emergency department physician notes dated 9/23/11 indicated Patient 6 had a history of arthritis, knee surgery, chronic back pain, and was taking pain medication at home. The electronic medication administration record indicated Patient 6's physician had ordered pain medication for moderate and severe pain. The electronic nurses notes dated 9/24/11 at 2:10 AM and 8 AM indicated Patient 6 complained of pain at "seven" on a pain scale of between one and ten. Both times the area which read "Pain intervention" was left blank. The electronic medication record for 9/24/11 indicated Patient 6 did not receive any pain medication that day. The electronic nurses notes dated 9/26/11 at 1:53 PM indicated Patient 6 complained of pain at "seven" on a pain scale of between one and ten. Under the area which read "Pain intervention" the intervention was "distraction." The electronic medication record indicated Patient 6 did not receive pain medication as of 2:57 that day.

During a concurrent electronic record review and interview with the Intensive Care Unit Manager (ICUM) on 9/26/11 at 2:30 PM, she stated Patient 6's electronic clinical record did not contain a nursing care plan for his pain issues. She stated a nursing care plan for pain should have been developed for Patient 6.

The hospital policy and procedure titled "Pain Management-Assessment" revised 3/15/11, read "Administer prescribed analgesics (pain medication) and other modalities in a timely and coordinated manner."

2. During an interview with Patient 12 on 9/27/11 at 9:35, she stated she has a history of diabetes and high blood pressure. Patient 12's medication profile indicated she was taking medication for both the above medical conditions. The electronic medication administration record indicated the licensed staff was administering this medications to her.

During a concurrent interview with Registered Nurse (RN) 5 and electronic clinical record review for Patient 12 on 9/27/11 at 10 AM, RN 5 stated Patient 12's clinical record did not contain a nursing care plan for her diabetes or high blood pressure. He verified she had been receiving medications for these two medical conditions while in the hospital.



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3. The clinical record for Patient 15 was reviewed on 9/27/11. Patient 15 was admitted with diabetes and a history of noncompliance with her medical care.

During a concurrent interview and electronic medical record review for Patient 15, with RN 8, on 9/29/11 at 10:30 AM, she confirmed there was no diabetes care plan for Patient 15. She stated "she should have a care plan (for diabetes)...I've initiated it now."

4. The clinical record for Patient 23 was reviewed on 9/27/11. The patient was admitted to the hospital on 9/11/11 with a small bowel obstruction, an ileostomy (a surgical opening into a section of the bowel that drains fecal material), esophageal (the tube that carries food and liquid to the stomach) ulcers, thrombocytopenia (a bleeding disorder), diabetes, and possible multi-organ failure.

During a concurrent interview and electronic medical record (EMR) review for Patient 23, with RN 7, on 9/29/11, at 10:10 AM, the record indicated Patient 23 was receiving intravenous nutrition (TPN) and clear liquids by mouth and was on CPAP (pressurized oxygen delivered through the nose or mouth). The EMR indicated a nursing nutritional care plan was planned but not initiated. A care plan for CPAP, diabetes or ostomy care was not found. RN 7 stated the electronic medical record contained care plan templates that nurses select based upon the patient's individual needs, and Patient 23 should have had nursing care plans for his diabetes management, nursing nutritional care, management of his CPAP and ostomy care (for his ileostomy).

Based on observation, interview, and record review, the hospital failed to provide evidence of conscious sedation competency for two of two Registered Nurses in the outpatient, off-campus radiology service. This failure had the potential to adversely affect the safe and efficient care of patients receiving conscious sedation in the outpatient radiology department.

Findings:

During an observation of the off campus, outpatient radiology facility with the Chief Tech of Outpatient Radiology (CTOP), on 9/28/11, at 8:40 AM, two staff members were observed, wearing scrubs, in the nursing area. Registered Nurse (RN) 18 was caring for a patient in a curtained gurney area.

During an interview with the CTOP, on 9/28/11, at 8:45 AM, he stated one RN (17) worked in the procedure room for interventional procedures and another RN (18), worked in the post-procedure area. He stated the RNs were Advanced Cardiovascular Life Support (ACLS) certified.

During an interview with the Accrediting/Special Projects Manager (ASP), on 9/28/11, at 9:45 AM, she stated the off campus radiology facility had "only two RNs" staffed for that facility.

During a concurrent interview and personnel record review with the Human Resources Director (HRD), on 9/29/11, at 10:45 AM, no competencies (the quality of being competent or capable of performing an allotted function) for conscious sedation (conscious sedation is the use of medication to depress the level of consciousness in a patient while allowing the patient to continually and independently breath and respond appropriately to verbal commands and/or gentle stimulation) were found for RN 17 and RN 18. He stated department competencies were not in the human resource file. At 12:45 PM, the HRD stated he did not have competencies for the Imaging Manager for the hospital campus radiology department and did not have any competencies for the off campus radiology department at all..."do not have any."

Based on interview and record review, the hospital failed to evaluate contracted licensed nurses job performances, which had the potential for adverse nursing care events for the hospital's patient population.

Findings:

During an interview with the Staffing Office Manager (SOM) on 9/27/11 at 9 AM, he stated he oversaw the contracted nurses. He ensured their training was up-to-date and they had current competencies (the quality of being competent or capable of performing an allotted function). He stated the hospital did not have a qualified person in the area of dialysis to evaluate the contracted dialysis (a process of filtering and removing waste products from the blood) nurses.

The list of current contracted dialysis nurses and selected personnel records were reviewed on 9/27/11 at 3 PM. The list indicated Registered Nurse (RN) 9 worked for the hospital and two contracted dialysis companies. The staff files for RNs ten through 16 were reviewed. These staff files did not contain annual performance evaluations by hospital staff for contracted RNs ten through 16.

During a concurrent interview with the SOM and the Clinical Finance Director (CFD) and review of the contracted RNs files on 9/27/11 at 3:20 PM, the SOM stated the hospital depends on the contracted dialysis companies to evaluate the performance of the their dialysis nurses. Both the SOM and the CFD verified annual performance evaluations were not done by hospital staff for the contracted dialysis nurses.

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

1. Ensure medication was verified prior to administration in accordance to facility policy.

2. Ensure medication was administered in accordance to manufacturer's guidelines.

3. Ensure one sampled patient had been administered Potassium Chloride as ordered by the patient's physician.

These failures had the potential to cause significant harm to patients receiving an incorrect dose of medication and loss of integrity of the medications and potentially harm patients by not providing the expected therapeutic effect.

Findings:

1. Review of the clinical record for patients who were given insulin infusion (medication to maintain blood sugar) while in the medical intensive care unit (ICU) with Pharmacist 1 (Pharm 1) and the Intensive Care Unit Manager (ICUM) revealed Patient 36 was ordered an insulin infusion and this infusion was to be administered to maintain blood sugar at the target range of 120 to 150.

Further review of the insulin infusion flowsheet with ICUM showed there was only one nurse's signature (nurse initial verifying the correctness of the medication which indicated he or she had calculated the insulin dose with the latest blood glucose) at each of the following time 3 AM, 4 AM and 6 AM on 9/26/11. However, the second nurse's signature which indicated he or she had independently verified the calculation done by the first nurse was missing on the same flowsheet.

According to the facility, policy insulin was on the high alert medication list and the process of administering insulin infusion required the checking by two licensed staff. Review of the facility policy entitled "Addendum II Medication Administration Regulations" on page three read, "The following medications will be double checked by two RNs in the hospital including the physician orders ...6. Insulin infusions, including drug, concentration and pump rates."

Interview with the ICUM on 9/26/11 at 3:42 PM, she acknowledged the second nurse failed to verify and to document the insulin calculation on Patient 36's flowsheet during those times.

2. During a medication pass observation on 9/27/11 at 10:13 AM on the third floor of the medical surgical unit, Registered Nurse (RN) 22 was observed to administer Diltiazem ER (extended release) 180 mg (milligrams) (a generic form of Tiazac; a medication to lower blood pressure) to Patient 37. Review of Patient 37's clinical record showed that she was ordered to be on nothing by mouth (NPO) since 9/22/11 at 5 PM. All of her oral tablet medications needed to be crushed in order to administer via the nasogastric tube (NG tube) according to RN 22. Among the medications about to be crushed by RN 22 was the Diltiazem 180 mg ER. And according to the manufacture packet insert, Diltiazem 180 mg ER is a long acting form of Tiazac which should not be opened, chewed, or crushed.

During the interview with RN 22 on 9/27/11 at 10:21 AM, he stated he was not aware the medication was an extended release formulation of Diltiazem which according to the manufacture it should not be crushed or opened. Review of the patient's medication administration record (MAR) showed that the Diltiazem 180 mg ER formulation had been given daily via NG tube to Patient 37 since 9/21/11.

In the interview with Pharm 1 on 9/27/11 at 10:33 AM, he acknowledged the medication should not have been crushed and he would inform the physician to have it changed.

3. Review of the clinical record for Patient 38 on September 27, 2011 at 11:12 am revealed this patient's physician had written the following Potassium Chloride orders for this patient:

a) Potassium Chloride 40 meq/30 ml (40 milliequivalents per 30 milliliters) oral solution for Serum (blood level) of Potassium (K) between 3 to 3.6 give one (40 mEq) dose, this order was written on September 19, 2011;

b) Potassium Chloride 20 meq/15 ml oral solution for Serum (blood level) of Potassium (K) between 3.7 to 4.0 give one (20 mEq) dose, this order was written on September 19, 2011;

c) Potassium Chloride 10 meq/100 ml bag by Peripheral I.V. (intravenous-through a vein) as needed, with Serum K 2.0 to 3.0 give over 1 hour for four doses; for Serum K 3.1 to 3.6 give over 1 hour for three doses; for Serum K 3.7 to 4.0 give over 1 hour for two doses, also written on 9/19/11.

Further review of the clinical record for Patient 38 on 9/27/11 showed on 9/20/11 at 7:35 AM. Patient 38 had a Serum K level of 3.8. Based on the physician's orders above, this patient should have been administered Potassium Chloride yet during an interview at 11:23 am on 9/27/11, none of the hospital's nursing staff or the hospital's medical surgical nurse manager were able to locate any documentation indicating any Potassium Chloride had been administered to this patient on 9/20/11. Review of the patient's clinical record revealed no Potassium Chloride had been administered to Patient 38 on 9/20/11 as ordered by the patient's physician.

Review of the hospital's policy and procedure entitled: "Medication Administration" it read under administration, "2. Nursing staff assumes the responsibility of administering medications from written Physician Orders. This includes: a. Transcribing medication orders onto the Medication Administration Record (MAR) for new admissions and new medication orders after the MAR has been posted ... c. Administering medications as ordered."

Based on interview and document review, the hospital failed to ensure orders for drugs were written and signed by a practitioner who was authorized to write orders by hospital policy and in accordance with regulations, for one patient (53).

Findings:

On 9/26/11 at 3 PM, Patient 53's medical record was reviewed. Documentation in the medical record showed the patient was admitted to the hospital on 9/22/11 for cardiac surgery.

A review of the admission orders included orders for intravenous solution, preoperative antibiotics (Cefazolin and Gentamycin), nitroglycerine, and medications for nausea and vomiting. It was noted the orders were written as verbal orders. It was noted the individual who wrote the admission and medication orders signed as MA (medical assistant). It was also noted the orders were not cosigned by the physician.

During a concurrent interview, the Quality Director (QD) stated the individual who wrote the admission and medication orders was not an employee of the hospital and the individual worked for the physician. When asked if the hospital had a policy and procedure directing who could take and write verbal orders for medications, the QD replied no.

Based on interview and record review, the hospital failed to ensure blood product transfusion records included two signatures of licensed staff before administration, vital signs at the intervals according to the hospital's policy, and a completed statement regarding any possible reactions to the blood products for two of 74 sampled patients, which had the potential for the patient to receive the wrong blood products and for adverse blood product reactions to go untreated. (25 and 30)

Findings:

1. The clinical record for Patient 25 was reviewed with the Intensive Care Unit Manager (ICUM) on 9/29/11 at 2:15 PM. She confirmed two fresh frozen plasma (FFP-the liquid portion of human blood that has been frozen and preserved for human donation) transfusion records located inside Patient 25's clinical record contained only one licensed staff's signature instead of two. She also verified the hospital form titled "Patient-Product Inquiry" for Patient 25 indicated he received those two units of FFP.

The hospital policy and procedure titled "Blood administration: Process Management Procedure" revised 3/11, read "Two licensed staff are responsible for patient identification when hanging the blood product for transfusion. The signatures of both licensed staff (nurses or physician) who verified the patient and blood identification are required on the blue transfusion slip in the medical record."



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2. The clinical record for Patient 30 was reviewed on 9/28/11. The "Transfusion Record", dated 9/21/11 at 1:17 PM, showed no documentation of patient's reaction for the following times: pre-transfusion, 15 min after start time, and end of transfusion. There was no documentation of "End Time". The "Transfusion Record" dated 9/21/11 at 1:34 PM, showed no documentation at end of transfusion for reaction. The record also had no date, start time, or end time.

The facility policy and procedure titled "Blood Administration: Process Management Procedure" Effective date: 11/09, 7/2011; Revision date: 3/2011, indicated in the section "Documentation" Step 1 a. "Record on blue transfusion slip...date, component, start time..." Step 2. b. "Record any transfusion reaction on the blue laboratory slip in the column marked RXN..." Step 3. b. "Record on blue transfusion slip the stop time of the transfusion and transfusion reaction status (if not recorded previously).

Based on document review and staff interview, the hospital failed to ensure employees received annual performance appraisals for one of six Health Information Management (HIM) staff, and one employee's job description was not reflective of specific duties and qualification requirement.

Findings:

On the afternoon of 9/27/11, the human resources files of six HIM employees were reviewed. The Health Information Manager had not received a performance appraisal since the period ending 12/31/09. This finding was confirmed concurrently by the Human Resources Director. The hospital's Policy 220.10, "Employee Performance Appraisal," last approved 5/23/10, indicated in section B. "Employees will receive an annual evaluation." In addition, the same employee's job description was a generalization for all the hospital's department directors (both clinical and non-clinical). It did not include the certification requirement or the privacy officer skills and duties.

Based on medical record review and staff interview, the hospital failed to ensure entries were legible, complete, dated, and timed in seven of nine records.

Findings:

Medical records were reviewed on 9/28-29/11 and the following findings were discussed and confirmed concurrently by Staff Clinical Information Systems Educator:

1. Pre-printed forms contained sections that were left blank, such as: informed consent discussion (Patient 40); type of anesthesia planned (Patient 42); patient condition on discharge (Patients 44 and 46).

2. Pre/post anesthesia order/notes were not timed when written (Patients 41, 43, and 48).

3. Conditions of Registration form was not dated, timed, or signed by the witness (Patient 43).

4. Policy 116.34, "Abbreviations and Symbols", last approved 11/10, was reviewed 9/28/11. The hospital used a resource book as their list of approved abbreviations that may be used in medical record entries. However, since the book contained many possible meanings for an abbreviation, the policy did not state the process for clarifying abbreviations when the meaning was not clear.

Based on interview and record review, the hospital failed to ensure anesthesia orders for one sampled patient (31) was authenticated by the provider. This failure had the potential to adversely affect patient care.

Findings:

The clinical record for Patient 31 was reviewed on 9/27/11. The Anesthesia Protocol (orders required by anesthesia department for all surgery patients) dated 9/26/11, at 5:20 AM was not signed by the anesthesia provider.

During an interview with Registered Nurse (RN 4), on 9/26/11, at 8:25 AM, RN 4 was questioned about the unsigned Anesthesia Protocol, and she stated, "This should be signed. It's not a verbal order."

The clinical record for Patient 31 was reviewed on 9/28/11. The Anesthesia Protocol dated 9/26/11 remained unsigned.

Based on interview and record review, the hospital failed to ensure verbal or telephone physician's orders were authenticated within 48 hours of when the orders were given to the hospital staff for ten sampled patients (18, 16, 8, 22, 19, 15, 24, 40, 45, and 46), which had the potential for transcription errors to adversely affect patient safety.

Findings:

1. During a concurrent clinical record review for Patient 18 and interview with the Risk Management Assistant on 9/27/11 at 10:30 AM, she confirmed the physicians for Patient 18 had not authenticated the following verbal/telephone orders: three orders dated 9/13/11, two orders dated 9/14/11, one order 9/19/11, and two orders dated 9/20/11.

2. During a concurrent clinical record review for Patient 16 and interview with the Neonatal Intensive Care Unit Manager (NICUM) on 9/27/11 at 1:50 PM, she confirmed the physician for Patient 16 had not authenticated the following verbal/telephone orders: one order dated 9/14/11, one order dated 9/21/11.

3. During a concurrent clinical record review for Patient 8 and interview with the NICUM on 9/27/11 at 2:15 PM, she confirmed the physician for Patient 8 had not authenticated the following verbal/telephone orders: one order dated 9/12/11, two orders dated 9/14/11, and one order dated 9/15/11.



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4. During a concurrent interview and record review with Registered Nurse (RN) 19, on 9/26/11, at 9:55 AM, Patient 22's hard copy record on the telemetry unit had a telephone order written on 9/24/11, at 12:30 PM, for pain medication and an inhaler. The order had not been authenticated by the physician prescriber. RN 19 stated, "It will be signed within 48 hours" per policy. She stated hard copy charts are scanned by hospital staff and if an order is not signed, a message is sent to the prescriber and the order will be electronically signed by the prescriber.

During a record review on 9/29/11, Patient 22's physician order dated 9/26/11, at 12:30 PM had not been scanned and did not have an authenticated signature from the physician.

5. The clinical record for Patient 19 was reviewed on 9/29/11, at 12:45 PM. A telephone order for a medication was written on 9/23/11, at 3:55 PM. The authentication was signed on 9/26/11, at 11:55 AM, twenty hours after the required 48 hour authentication. Four additional telephone orders on 9/26/11 at 8:23 PM, 9/26/11 at 3 PM, 9/26/11 at 1:14 PM, and 9/26/11 at 6:50 AM, were not authenticated within the required 48 hour timeframe.

6. The clinical record for Patient 15 was reviewed on 9/27/11, at 3:30 PM. A telephone order for medication was written on 9/16/11, at 9:30 PM. The order was electronically signed by the physician on 9/26/11, at 12:55 PM, 10 days after the order had been written. The order was not authenticated within the required 48 hour timeframe.



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7. The clinical record for Patient 24 was reviewed on 9/29/11. The verbal order written on 9/27/11 at 10:15 AM had not been signed by the physician.

During an interview with RN 3, on 9/29/11, at 10:05 AM, she was asked about follow up for verbal orders that are not signed by the physician. RN 3 stated, "The physicians are called if orders are not signed in 48 hours." RN 3 reviewed the verbal order from 9/27/11 and stated, "He was notified, but hasn't come in."

8. Patient 40's record was reviewed on 9/28/11. The telephone order of 8/31/11 was not signed and had not been flagged during discharge analysis for the physician to sign, as confirmed by Staff Health Information Management on 9/28/11.

9. Patient 45's record was reviewed on 9/29/11. There were three telephone orders from 8/18/11, but they had not been electronically signed until 8/25/11.

10. Patient 46's record was reviewed on 9/29/11. There were three telephone orders from 9/4/11, but they had not been electronically signed until 9/12/11. These findings were confirmed by Staff Clinical Information Systems Educator.

The hospital policy and procedure titled "Giving/Receiving/Authenticating Verbal and Telephone Orders" dated 6/11, read "Verbal and telephone medication orders shall be signed, dated and timed by the prescribing physician within 48 hours."

Based on observation, review of clinical records, hospital documents and staff interviews, the hospital failed to ensure the medical record of one patient (72) accurately documented the presence of a wound. This failure resulted in inaccurate information that was used by the registered dietitian in her nutrition assessment and the potential for over feeding due to increased protein and caloric supplementation due to inaccurate information.

Findings:

Patient 72 was admitted to the hospital on 9/28/11 with diagnoses including first, second and third degree burns, emphysema, abscess right buttocks, dementia and chronic obstructive pulmonary disease, a lung disease that makes breathing difficult.

Review of the electronic medical record on 9/28/11 revealed documentation by a nurse the presence of two pressure ulcers. One pressure ulcer was described as a sacrum pressure ulcer staged as "unstagable to Stage IV (full thickness tissue loss), measuring 3 x 4 x 3 cm (centimeters). The second pressure ulcer was described as Stage II (partial tissue loss), 2 x 2 cm. The wound description continued to be assessed with changes in size and treatment being documented at four hour intervals on 9/28/11.

Review of the registered dietitian's assessment dated 9/28/11 revealed she calculated increased need for protein due to "further compromised skin integrity" the presence of two pressure ulcers Stage IV (sacrum) and Stage II (buttocks) in addition to the burns. She recommended Pro Mod, a protein supplement, tid (three times a day) (30 ml [milliliters] = 300 kcal [calories], 30 g [grams] Protein).

Interview with the Nursing Manager on 9/28/11 at approximately 1:30 PM revealed the patient had only one pressure ulcer/wound. She re-examined the patient and stated there was only one wound.

During interview with the Director of Nursing on 9/29/11 at approximately 11:20 PM, she indicated the nurse who documented the wounds was interviewed by telephone and stated the patient had only one wound but had made a mistake on the electronic record and was unable to edit or remove it from the patient's clinical record. There was no documentation anywhere in the record that indicated that she had made the error.

During this interview, it was revealed that the electronic record system did not allow changes to be made in the field where wounds are documented, even if it was an error. The hospital failed to ensure that Patient 72's clinical record was accurate, and failed to maintain an electronic record system that ensured accuracy of the patient record.

Based on document review and staff interview, the hospital failed to ensure medical records were completed within 14 days following discharge, in accordance with the medical staff bylaws. This failure had the potential to result in records lacking vital information for continuity of patient care.

Findings:

The Medical Staff Bylaws, Rules and Regulations, last approved 1/27/10, were reviewed on 9/27/11. Article VIII, d. stated that physicians must complete all medical records within fourteen (14) days after discharge of the patient. On the afternoon of 9/29/11, Staff Health Information Management (HIM) presented and discussed a report, Delinquent Records by MD (medical doctor), By Type. Delinquent records are those that are still incomplete more than fourteen (14) days after discharge of the patient. This report revealed there were 287 records that needed to be signed by physicians and 202 reports needed to be dictated by physicians. A breakdown of these undictated reports was as follows: 138 discharge summaries, 22 history and physical examinations; 17 emergency department visit reports, and 25 operative/procedure reports. The oldest record listed was 79 days after the patient's discharge.

Based on observation, interview, and record review, the hospital failed to store medication according to manufacturer recommendation which had the potential for unauthorized usage and distribution.

Findings:

During an observation on 9/29/11, at 12:15 PM, in the Surgery Department with Registered Nurse (RN) 1 and the Surgical Services Manager two boxes of Stryker/Orthopaedics Simplex P with Tobramycin (antibiotic used to treat infection) was found in warmer unit #070995. The warmer unit was located in substerile Room 2 and had a temperature reading of 90-105 degrees Farenheit (F) on the door.

During an interview with RN 1, on 9/29/11, at 12:15 PM, she indicated, "I think they are in there for the next surgery case."

The Simplex P with Tobramycin boxes, Catalog number 6197-9-001, Lot: MBS016 indicated under warning #4 "Store in a cool, dry, dark place."

Stryker Orthopaedics pamphlet titled "Bone Cement Matters Simplex P Bone Cements" copyright 2008, indicated to store Simplex at the higher end of the recommended storage temperature range of 43-74 degrees F.

The hospital policy and procedure titled "Storage of Medications" revision date 6/2011, effective date 7/2011, indicated under section A. 2. "Medications are stored under conditions suitable for product stability from receipt of the medication by an individual health care provider and medication administration to insure: a. safe storage, b. safe handling..."

Based on observation and interview, the hospital failed to securely store medication located in one hospital area and to prevent access to it by unauthorized individuals.

Findings:

On 9/26/11 at 2:50 PM, during an inspection of the Medical Intensive Care Unit on the second floor a syringe contained epinephrine (medication to treat anaphylactic reaction) was found inside an unlocked storage cabinet next to the Omnicell (automatic dispensing cabinet). The medication was stored in a manner where anyone entering the unit had access. In the interview with the Intensive Care Unit Manager at 2:55 PM, she stated the medication should not have been stored there. Review of the hospital policy entitled "storage of medications" on page 1, it read, "The hospital stores all medications and biological, including controlled (scheduled) medications in a secured area to prevent diversion, ..."

Based on observation and interview, the hospital failed to ensure outdated and contaminated medications were removed from one location in the hospital.

Findings:

On 9/27/11 at 10:52 AM, during an inspection of Patient 37's room on the third floor, one bag of intravenous (IV) medication was found inside the L-cart. The medication was Metronidzole (antibiotic) 500 mg (milligrams) in 100 ml (milliliters) 0.9% sodium chloride with a due date of 9/25/11 at 5 PM. Review of Patient 37's clinical record indicated the medication was discontinued on 9/26/11 at 9:30 p.m. When Registered Nurse (RN) 22 was asked why the medication was still in the L-cart, he acknowledged it should have been removed from the L-cart and placed it into the pharmacy return bin inside the medication room for pharmacy technicians to pick up. Review of the hospital policy entitled "medication administration" on page 2 it reads, "8. All discontinued IV medications will be picked up by the Pharmacy Technician during their next scheduled rounds."

Based upon observation, interview, and record review, the hospital failed to provide evidence of competency qualifications for the staff in the outpatient, off-campus radiology service. This failure had the potential to adversely affect the safe and efficient care of patients receiving services in the outpatient radiology department.

Findings:

During an observation of the off-campus, outpatient radiology/imaging department with the Chief Technologist of Outpatient Radiology (CTOP), on 9/28/11, at 8:40 AM, two staff members were observed, wearing scrubs, in the nursing area. Registered Nurse (RN) 18 was caring for a patient in a curtained gurney area.

During an interview with an Outpatient Ultrasound Technologist (OPUT) at the off-campus radiology/imaging department, on 9/29/11, at 9 AM, she stated the Cidex OPA solution (a disinfecting solution used to clean the interventional probes used during pelvic ultrasounds) mixed in the ultrasound room was not changed for 60 days. Upon review of the Cidex OPA solution label, it indicated the mixed solution was not to be reused beyond 14 days. The OPUT reviewed the disinfection log sheet and noted that the solution expiration date was logged as 14 days and stated "I change the solution before 14 days."

During a concurrent interview and personnel record review with the Human Resources Director (HRD), on 9/29/11, at 10:45 AM, he stated department competencies were not in the Human Resources (HR) file. The HR files were reviewed for RN 17, RN 18, CTOP, Imaging Manager (IM), and OPUT. No competencies were found in any of the files reviewed. At 12:45 PM, the HRD stated he did not have competencies for the IM for the hospital campus radiology department and did not have any competencies for the off campus radiology department at all..."do not have any."

The hospital policy titled "Scope of Services" for all off campus (radiology) imaging services departments, with an effective date of 11/10, indicated "All individuals who provide technical diagnostic services are licensed or registered (according to applicable state law and regulation) and have the appropriate training and competence.

Based on observation, interview and document review, the hospital failed to ensure dietary services met the needs of all patients as evidenced by failure to:

1. Provide organized dietetic services as evidenced by findings of unsafe food handling practices and supervision of the dietary department (Cross Reference A619, A749).

2. Ensure comprehensive disaster planning (Cross Reference A701, A703).

3. Develop performance improvement activities that reflected the scope and nature of the services (Cross Reference A264).

4. Ensure safe and effective food storage/production practices (Cross Reference A749).

5. Ensure the development of comprehensive menu analysis, 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 dietetic services observations, dietary staff interview and dietary document review, the hospital failed to ensure comprehensive organization of dietetic services as evidenced by: 1) inaccurate nutritional analysis of patient menus; 2) lack of consistence guidance for patient meal preparation and plating; 3) implementation of a hand hygiene policy did not meet food service standards of practice; and, 4) lack of development of comprehensive policies related to safe food handling practices. Failure to ensure safe and effective dietetic services resulted in patients not receiving their physician ordered diets, being exposed to potential cross contamination and put patients at risk for foodborne illness, further compromising patient medical status.

Findings:

1. During trayline observations on 9/28 and 9/29/11 it was noted dietary staff were not preparing patient meals according to the hospital standardized recipe which resulted in patients receiving diets that were not within the parameters of the physician ordered diets (Cross Reference A630).

On 9/30/11 beginning at 12:30 PM, the hospitals' diet manual and menu analysis was reviewed in the presence of Registered Dieticians (RD) 1 and 2. RD 1 and RD 2 were asked to demonstrate the nutritional analysis of several diets. The first diet reviewed was the high fiber diet. In a concurrent interview with RD 1 and RD 2, they stated the high fiber diet contained a minimum of 25 grams of fiber; however the analysis failed to provide an analysis of the diets' fiber content. It was also noted that the goal for the low, standard and high carbohydrate (any of a group of organic compounds that includes sugars, starches, celluloses, and gums and serves as a major energy source in the diet) diets was to achieve a total of 254 grams of carbohydrate; there was no difference in the goal level of carbohydrates for the three different diets. The hospital document dated 9/29/11 titled "Calorie Count Analysis Report" for the carbohydrate consistent-low, standard and high levels noted carbohydrate levels of 129, 195 and 268 grams respectively.

Review of hospital document titled "Abbreviated Version of C-CHO Patterns for Physician Education" dated 7/8/11 and developed by the dietary department advised the physicians that "The recommended dietary allowance of carbohydrate ...is 130g [grams]/day. Dietary department correspondence to physicians dated 6/21/11 recommended that in order to preserve protein stores, the body required 250-275 grams of carbohydrate per day. RD 1 and RD 2 acknowledged that the menus, diet manual and information to physicians was inconsistent and it was not possible to determine an accurate nutritional analysis of the hospitals' diets.

2. During trayline observations on 9/28 and 9/29/11 it was noted the dietary staff were not preparing patient meals according to the hospital standardized recipe (a recipe that has been tested for consistency of product and yield) resulting in patients receiving diets that were outside the parameters of the physician ordered diets (Cross Reference A630).

On 9/29/11 beginning at 5 PM, the hospitals' therapeutic spreadsheet and menu analysis was reviewed. It was noted the portion on the standardized recipe was not consistent with the portion on the therapeutic spreadsheet for regular, low sodium and low fat versions of the macaroni and cheese. The portion size on the recipe was noted to be ? cup and the therapeutic spreadsheet portion was noted to be ? cup. Similarly, the recipe for the enchilada verde noted that the standardized recipe would yield 50 enchiladas; however the recipe did not delineate the portion size that would be given to patients.

Review of the hospital spreadsheet on 9/27/11 at 3:45 PM, for the evening meal revealed the entree was intended to be pizza. In a concurrent interview with RD 1, she stated the diet aide responsible for menu production changed the entree item to enchilada verde since there was an overall lack of patient acceptance for the pizza. She also stated the diet aide left for vacation prior to changing the therapeutic spreadsheets. The surveyor asked RD 2 if he approved the change prior to implementation. He stated he could not recall for sure and was unsure when the menu item changed.

3. During review of patient meal delivery activities it was noted there were identified issues surrounding hand hygiene (Cross Reference A749). During review of the dietary departments' policy and procedure manual it was noted that while the hospital had a hand hygiene policy, the policy was limited to hand hygiene activities relevant to direct patient care activities. It was noted the policy affected all patient care departments including dietary. The hand hygiene policy did not reflect hand hygiene requirements in dietetic services. For example, the policy guided that "The use of alcohol gel products instead of hand washing is preferred in situations where the hands are not visibly soiled with body fluids or physical dirt ..." While use of alcohol gel products may be used in dietetic services they may only be used after hands are thoroughly washed with soap and water (Food Code, 2009).

4. During food production observations on 9/28/11 between the hours of 10 AM and 4 PM, it was noted that dietary staff were not effectively monitoring time/temperature control of previously cooked potentially hazardous foods (Cross Reference A749). In an interview on 9/28/11 at 3:10 PM, with Dietary Staff (DS) 3 he stated he completed the peppers on 9/28/11 by 9:30 AM. He also stated he did not take any temperatures of the items and was not concerned about the length of time the food was held because the item would be gone before the end of the day. DS 2 also stated he would not be concerned with stuffed peppers because they were not filled with meat, rather filled with a soy based meat substitute (a food made from non-meats, sometimes without other animal products such as dairy).

Review of the departments' policy and procedures manual revealed that there were only five documents related to safe food storage and handling, one of which was titled "Preventing Foodborne Illness." It was also noted this policy provided general guidelines for time/temperature control of foods; however the policy did not delineate foods that would require monitoring.

During an interview with RD 2 on 9/30/11 at 11:30 AM, he acknowledged the department did not have a comprehensive Hazard Analysis Critical Control Plan (HACCP). A HACCP plan is a systematic approach to identifying, evaluating, and controlling food safety hazards (a biological, chemical, or physical agent in,or condition of, food with the potential to cause an adverse health effect) (Food Code, 2009).

Based on food production observations, dietary staff interview and dietary document review, the hospital failed to ensure adequate oversight into food production activities as evidenced by observation of deficient practices related to food production and/or food storage activities. Failure to ensure adequate oversight of departmental activities by the director of food services may result in: 1) food service systems that do not effectively ensure the nutritional needs of patients are met and 2) food production activities that put patients at risk for foodborne illness, further compromising patient medical status.

Findings:

1. During review of dietetic services from 9/28-9/30/11 deficient practices were identified with respect to the accuracy of food production activities and patient meal service (Cross Reference A 630); safe food handling practices (Cross Reference A749); development of a comprehensive facility specific diet manual (Cross Reference A630); storage of disaster food supplies (Cross Reference A701 and 703) and development of a quality assurance program that reflected the scope of dietetic services (Cross Reference A264).

In an interview on 6/29/11 at 10 am, Registered Dietician (RD) 2 was asked to describe the process for RD oversight in food production activities. He stated between himself and the clinical nutrition manager they were responsible for oversight into food services. He also stated he assigned the responsibility of "food safety officer" to the clinical nutrition manager. In an interview with RD 1 on 9/29/11 at 11:30 AM she was asked to describe her responsibilities. She stated her primary function was to be the clinical nutrition manager; however she sat on multiple hospital committees such as pharmacy and therapeutics; developed policies and procedures; and completed performance improvement activities. She also acknowledged she provided some oversight into food service activities.

Review of an undated position description titled "Director of Nutritional Services" with a job code of 621 indicated this position was responsible for the overall operation of the department. This position also had the responsibility and accountability of system functions. It was also noted this position was primarily responsible for administrative functions such as budget planning, leadership capacity, safety and legal, staff development, staffing, standards and policies, strategic planning and working relations. There was no indication this position was responsible for providing day to day guidance and oversight for ensuring effective food production systems.

Review of undated position description titled "Clinical Nutrition Manger-Medical Nutritional" with a job code of 450 noted that the summary of job duties for this position was responsibility for directing, mentoring and assuring that quality nutritional care is provided to all patients. There was no indication this position was responsible to provide day to day guidance and oversight into patient food services.

Based on medical record review and nursing staff interviews, the hospital failed to ensure three patient records (67, 68 and 70) reviewed for nutrition care received diets per their physicians' order. Failure to follow physician prescribed nutritional treatments may result in compromise of patients' medical status.

Findings:

1. Patient 67 was admitted with diagnosis including failure to thrive and dehydration. Admission diet order dated 9/23/11 was for a regular diet. A comprehensive nutrition assessment dated 9/23/11 noted the patients' calorie requirements were 1274-1557 calories/day. It also noted that Patient 57 was eating less than 25%. The Registered Dietitian (RD) recommended a puree diet as well as placement of a tube in the stomach to begin tube feeding. A follow up nutrition assessment dated 9/25/11 recommended initiation of tube feeding with a continuation of the pureed diet.

Hospital document titled "Orders Re-Cap" dated 9/27/11 at 1404 hours noted the patients' physician ordered diet was NPO (nothing by mouth). Review of the diet order list for 9/28/11 noted that the dietary department continued to send a pureed diet despite the physician ordered NPO diet. There was no indication that the physician ordered the continuation of the pureed diet.

In an interview with Registered Nurse (RN) 20 on 9/29/11 at 2:30 PM, she stated nursing staff was responsible for entering diet orders into the electronic medical record which would then be transmitted to the dietary department. She also acknowledged there was no physicians' order to continue the recommended pureed diet.

2. Patient 68 was admitted with diagnosis including nausea/vomiting and end stage renal disease. Admission physician orders dated 9/24/11 was an 1800 calorie renal diet and dialysis treatments (a method of removing waste products from the blood). A follow up order dated 9/25/11 implemented a 2000 calorie diabetic diet. A comprehensive nutrition assessment dated 9/28/11 noted the patient had inadequate intake. Review of the hospital document titled "Census Report with Notes" dated 9/28/11 revealed Patient 68 was receiving a standard carbohydrate consistent diet.

In an interview with RD 1 on 9/28/11 at 3 PM, she stated several years earlier the hospital changed how diabetic diets were ordered, rather than following specific calorie levels they changed the diets to low, standard and high carbohydrate consistent (diets that are based on the carbohydrate value of foods) diets. She also stated the standard diet had a calorie range of 1800- 2000 calories and acknowledged that the standard diet was not consistently 2000 calories as per the physicians' orders. There was no indication either nursing staff or an RD attempted to clarify or obtain an order for a consistent carbohydrate diet prior to diet implementation.

Review of the hospital's document titled "Calorie Count Analysis" for the 7-day menu cycle revealed that the caloric content for the standard carbohydrate consistent diet ranged from 1571-1865 per day, none of which met the physician ordered 2000 calorie diet.

3. Patient 70 was admitted with diagnoses including chest pain. Admission diet order dated 9/27/11, written as a telephone order by the nurse was a pureed, consistent cardiac diet. Review of the hospital document titled "Census Report" dated 9/29/11 revealed nursing staff entered the physicians' order as a pureed standard consistent carbohydrate cardiac diet. There was no indication the nursing staff clarified the order prior to entry into the electronic medical record system. There was no documentation the physician ordered a consistent carbohydrate diet.

In an interview on 9/28/11 at 4:15 PM, with RN 21, she stated that if she saw a consistent cardiac diet she would interpret the order as a consistent carbohydrate diet with cardiac restrictions. Review of the hospitals' therapeutic spreadsheet and diet manual revealed that there was no diet identified as consistent carbohydrate diet with cardiac restrictions.

Based on observation, staff interview, and hospital and manufacturer's document review, the hospital failed to ensure three of 74 sampled patients' (72, 73, and 68) nutritional needs were met in accordance with recognized dietary practices and physicians' orders as evidenced by lack of effective systems to ensure: 1) dietary staff prepared patient foods according to standardized recipes; and, 2) the nutritional needs of Patient 72, Patient 73, and Patient 68 were met. The hospital did not ensure a system was in place to ensure nutrients contained in the breast milk for patients in the newborn intensive care unit were not destroyed during reheating. Excessive heat would result in the destruction of nutrients and antibody properties of breast milk which would not meet recognized dietary guidelines. Failure to ensure patient nutritional needs were met may compromise the nutritional and medical status of patients.

Findings:

1. Patient 72 was admitted to the hospital on 9/28/11 with diagnoses including first, second and third degree burns, emphysema, abscess right buttocks, dementia and chronic obstructive pulmonary disease, a lung disease that makes breathing difficult.

A review of his medical record showed that he was assessed by the Registered Dietitian (RD) on 9/28/11. The RD made recommendations including " .... advance to a high calorie/high protein diet. In addition, she recommended a multivitamin with minerals via IV (intravenous). The physician accepted these recommendations by checking off a box next to each of the recommendations and signature.

Further review of the record showed the patient only received multivitamin without the mineral component. The nurse present during the interview explained the order was changed via telephone order to the physician because the pharmacy informed the nurse that the multivitamin formulation did not come with added minerals. In addition, there was no order written for the high calorie high protein diet that had been ordered by the physician.

RD 3 stated she did not realize that it did not come as she had ordered. She also stated she had not been informed the patient was not able to receive the minerals she had initially recommended. RD 3 was also not aware the diet had not been ordered.

Review of the hospital policy titled "Standards of Nutrition Care for Pressure Ulcers " dated 3/10 indicated: "Nursing shall notify dietitian of any undesirable changes in skin impairment, supplement/formula or significant change in weight or/or oral intake." It did not state which manner this notification would be implemented but there was no documented evidence the nursing staff informed the RD when there were changes made to the recommendation she had made.

2. Patient 73 is a 55 year old admitted to the hospital on 9/13/11 with diagnoses including acute abdominal pain, Chronic Kidney Disease (a progressive loss of kidney function over a period of months or years), hypertension (abnormally high blood pressure), and morbid obesity (a medical condition in which excess body fat has accumulated to the extent that it may have an adverse effect on health).

On 9/14/11 a RD conducted a nutritional assessment and made the following recommendations: Enlive, (a clear liquid nutritional supplement); advance diet as tolerated to renal; and Nephrovite, a multivitamin for patients with kidney disease. Review of clinical record on 9/28/11, two weeks after the recommendations were made, showed the physician did not respond to the recommendations. There was no evidence the RD followed upon the lack of response by the physician.

In an interview with the Assistant Director of the Department, on 9/29/11 at approximately 12 PM she stated there are no set guidelines on when RDs follow up on all patients. The follow-up time frames are left to the discretion of the individual RD. She stated the department had an on-going performance improvement project which included reassessment time frames for patients receiving parenteral nutrition but not for other patients.

This lack of a stipulated time frame for follow up and reassessment resulted in patients not receiving diets as ordered or not having physicians order diets at all.

3. During an observation on 9/28/11 at approximately 1 PM, in the newborn intensive care unit, there was on a counter, a piece of equipment with a bag in one of the wells containing a white liquid sitting in water that appeared to be heated. Nursing staff and the RD present during the observation stated the equipment was a warmer used for the warming of breast milk.

According to the "Human Milk Banking Association of North America: Best practice for Expressing, Storing, and Handling Human Milk in Hospitals, Homes and Child Care Settings", breast milk should be heated in the range of body temperature, between 95 to 97 degrees Fahrenheit. Warming at temperatures above 120 degrees Fahrenheit destroys the immunological properties of breast milk and could result in burns. The nurse was asked how the unit ensures that the breast milk temperature does not exceed the recommended temperature. She stated the nurse would be able to determine by touching the milk.

At approximately 2:45 PM on 9/28/11, the employee responsible for ensuring the equipment was safe was interviewed. He stated the warmer was fairly new and it was tested prior to being used. He further stated he had since not re-tested the machine because it had not met the criteria for preventive maintenance, which is every six months. He acknowledged there was no way to determine if the warmer malfunctioned in a manner that resulted in overheating in between the preventive maintenance testing periods.

The nurse manager stated they did not check the temperature of liquids placed in the warmer to ensure that it does not over heat resulting in loss of nutrients. A review of the manufacturer's instructions showed testing should be done in a two-step process. The second process included the use of temperature checks of water simulating breast milk using a thermometer. A review of the undated "hospital policy and procedure titled" Breast Milk Storage and Dispensing did not include any instructions on the use of this equipment, neither did it specify how nursing staff should warm the milk and ensure the warmer operated in a safe manner.

The hospital failed to ensure it had a system in place to ensure that breast milk was prepared (warmed) in a manner that would ensure that nutrients and immunological properties were maintained.



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4. During trayline observation on 9/28/11 at 11:30 AM, it was noted that the house menu for the noon meal consisted of meatloaf and Au Gratin potatoes. It was also noted that patients' had additional choices of macaroni and cheese as well as mashed potatoes. Concurrent review of the diet spreadsheet for 9/28/11 revealed for specialized diets such as cardiac, 2 gram sodium restriction and renal diets the menu required additional specialized items such as low salt, low fat (LSLF) macaroni and cheese, LSLF Au Gratin Potatoes LS macaroni and cheese and LS Au Gratin potatoes. These additional items were not prepared, rather dietary staff used the items for the regular diets when plating therapeutic diets.

In an interview on 9/28/11 with Dietary Staff (DS) 1, she was asked to describe the preparation process for the macaroni and cheese. She stated she cooked the pasta and added a canned cheese sauce. It was noted that ? cup of the cheese sauce contained 420 milligrams of sodium. It was also noted the hospital used a dehydrated potato product for the Au Gratin potatoes that contained 590 milligrams of sodium per 1/2 cup serving.

During food production observation on 9/28/11 at 3:30 PM, DS 2 was observed preparing the evening entree. In a concurrent interview he stated the item was a cheese enchilada. It was also noted he prepared 2 full pans and 2 one-half pans. He stated the full pans were for the regular diets and the ? pans were for the low salt diets. He further stated the only difference in the ingredients was the amount of salt in the enchilada sauce.

A follow up observation on 9/29/11 at 11:45 am, noted that the house diet for the noon meal included a hot turkey sandwich with mashed potatoes. In a concurrent interview with DS 3, he stated the mashed potatoes were prepared from a dehydrated potato convenience item. He also stated for the past five years the macaroni and cheese as well as the Au Gratin potatoes were prepared from convenience products. Concurrent review of the label revealed that ? cup of the dry product contained 450 milligrams of sodium.

In an interview on 9/29/11 at 9:15 AM, with RD 2 and DS 4, they were asked to provide the regular and therapeutic recipes and nutrient analysis for the macaroni and cheese, Au Gratin potatoes and enchiladas served on 9/28/11. It was noted the recipe for the Au Gratin potatoes guided staff to prepare the item from scratch rather than preparation from a dehydrated convenience product. Similarly, review of the nutritional analysis of the low sodium mashed potatoes revealed the intended sodium content was 20 milligrams, rather than the 450 milligrams in the dehydrated product.

Review of the recipes for the regular and low salt enchilada verde revealed the ingredients for both of the recipes included low salt, low fat cheese; however DS 4 acknowledged they did not have that item available. Similarly, the recipe for the macaroni and cheese guided staff to prepare the item from scratch utilizing low salt/low fat cheese. RD 2 and DS 4 acknowledged dietary staff was not preparing patient food items according to the recipes which resulted in the dietary department not providing food per the physician ordered diets for all inpatients with cardiac, renal, and 2-gram sodium physician ordered diets.

5. Patient 68 was admitted on 9/24/11, with symptoms including nausea/vomiting and a diagnosis of end stage renal disease. Admission physician orders dated 9/24/11 was an 1800 calorie renal diet and dialysis treatments (a method of removing waste products from the blood). A follow up order dated 9/25/11 implemented a 2000 calorie diabetic diet. A comprehensive nutrition assessment dated 9/28/11 noted the patient had inadequate intake. The assessment also noted a recommendation for a nutritional supplement twice/day and renal vitamin daily. It was noted a physician signed the recommendation; however did not indicate whether the order was accepted or declined. In a concurrent interview with RD 1, she was asked to describe the follow-up process once a nutrition assessment was completed. She stated upon completion of the assessment the RD would determine the length of time for the follow-up visit. She further stated in this case the follow-up would not occur until five days after the initial assessment. She also stated the average length of stay for patients was approximately 4 days and acknowledged it would be likely the patient would be discharged prior to follow-up by the RD. She additionally stated there was no set guideline for patient follow-up for nutrition interventions; rather it was up to the individual RD to determine when a follow-up would be scheduled. She also acknowledged in this instance there was a delay in the implementation of recommended nutrition interventions.

Review of the undated hospital policies titled "Medical Nutrition Therapy for patients at Nutritional Risk" and "Nutritional Care" revealed while the hospital developed basic guidelines for medical nutrition therapy, the policy did not address assurances to ensure patients receive timely nutrition interventions or monitoring of effectiveness of interventions. It was also noted the nutrition care policy guided that it was the responsibility of nutritional services, the physician and nursing services to provide and monitor appropriate nutritional care during the patients' stay.

Based on trayline observations, dietary staff interview, and dietary document review, the hospital failed to have a therapeutic diet manual that accurately reflected the most commonly physician ordered diets. Lack of a comprehensive diet manual that reflected the hospital diets may result in inaccurate guidance to dietary and hospital staff when meeting the nutritional needs of patients.

Findings:

During trayline observation on 9/28/11 beginning at 11:30 am, it was noted Patient 39 had a standard consistent carbohydrate diet and Patient 65 had a 60 gram protein, cardiac diet. Similarly Patient 66 had a physician ordered standard consistent carbohydrate, low cholesterol, 2 gram sodium restricted diet. It was noted while the three patients had different diet orders, the meals being plated were similar consisting of meatloaf, potatoes and vegetables.

In an interview with Registered Dietician (RD) 1 on 9/28/11 at 11 AM, she stated the hospital utilized a combination of a hospital developed diet description and the American Dietetic Association (ADA) Nutrition Care Manual as the diet manual. In a follow up interview with RD 1 and RD 2 on 9/30/11 beginning at 12:30 PM, the surveyor asked RD 1 to locate descriptions of the above named diets that included guidance for nursing, physicians and dietary staff specific to the hospitals' menu. They acknowledged the information in the hospitals' manual provided general descriptions and guidelines for therapeutic diets; and the manual did not offer diet patterns for the commonly physician ordered diets served at the hospital.

It was also noted that while the ADA nutrition care manual had sections on each of these diets, the information in the manual was not specific to the hospitals' routinely ordered diets and menu. For example, the section of the manual titled Carbohydrate Control Diet was a conceptual description of the diet. The manual did not delineate meal patterns for the low, standard and high consistent carbohydrate diets that the hospital offered. While the nutrition care manual may provide descriptions of diets the majority of the manual provided evidenced based nutrition care information for diseases with nutritional components.

Based on observation and dietary staff interview of emergency preparedness, the hospital failed to ensure the required food supplies planned for use in a disaster: 1) were stored within the certified hospital; and, 2) were adequate to meet the hospital developed plan. Failure to ensure adequate food supplies were located within the hospital may result in unavailability of the supplies in the event of a disaster.

Findings:

On 9/29/11 beginning at 3:45 PM, food service for disaster preparedness was reviewed. It was noted that the majority of the food supplies were not stored within the hospital rather was stored one block away from the hospital, in a metal container. Concurrent review of the hospitals' disaster menu noted the plan included the provision to provide 858 meals, three times/day; 2500 meals per 24- hour period for four days. A random comparison of the hospital developed inventory and available food supplies revealed there was inadequate supplies of items such as cereal (16 cases short) and vegetarian protein sources such as vegetarian franks. In a concurrent interview with Dietary Staff 5, she stated while there were some supplies in the main hospital building those supplies would be used as regular stock and it was unsure if these items would be fully available in a disaster.

Based on observation review of the emergency preparedness and administrative interview, the hospital failed to ensure adequate water supplies that would be required in the event of a disaster was available within the certified hospital. Failure to ensure adequate water supplies may result in unavailability of the supplies in the event of a disaster compromising the ability of hospital staff to access water for hydration and basic patient care needs which may further compromise the medical status of patients.

Findings:

On 9/29/11 at 3:45 PM, disaster preparedness was reviewed. It was noted while the hospital had 312 gallons of bottled water within the hospital, the hospital developed disaster plan provided for two gallons of water/person/day to meet hydration and patient care needs. It was also noted the hospital committed to provide disaster water to 1765 people/day for a period of 4 days. This commitment would require 7,060 gallons. It was noted while the hospital had a 9,000 gallon storage tank it was one-block away, not located within the certified hospital campus.

In an interview with the Project Manager on 9/29/11 at 8:40 AM, he acknowledged in previous recertification surveys it was noted the emergency water was not located at the campus.

Based on food service observations and interview, the hospital failed to ensure prompt removal of trash generated during food production activities as evidenced by the presence of a large rolling storage bin adjacent to the dishwashing area. Failure to ensure prompt removal of food production waste may attract pests which may result in contamination during food production activities.

Findings:

During observation on 9/28/11 at 2 PM, during dishwashing it was noted there was a large rolling storage bin filled with 55-gallon individual, sealed trash bags. It was also noted the bin remained in the kitchen throughout the kitchen observation from 2-3:30 PM. A follow-up observation on 9/30/11 at 10 AM, noted the bin was again filled with individual sealed, trash bags. In a concurrent interview with Dietary Staff 6, he stated the bags were stored in the container and would be emptied three times/day, generally after breakfast, lunch and prior to closing. While the facility had an undated policy titled "Pest Control/Trash Removal ..." , the policy did not address prompt removal as it guided staff to remove waste on a daily basis.

During review of fire preparedness and interview, the hospital failed to ensure one staff member was competent in fire safety. Failure to ensure competency of all staff in fire safety may result in placing all hospital occupants at risk in the event of a fire.

Findings:

On 9/28/11 at 3:30 PM, fire safety procedures were reviewed with Dietary Staff 2. He stated he was unsure of what he would do in the event of a fire but would probably use a fire extinguisher. He further stated he would activate the fire suppression system, located over the stove, by pressing buttons on a unit that was adjacent to the oven. In a concurrent interview with Registered Dietician (RD) 1, she stated this unit was not the fire suppression system, rather was the steam generation system for the cooking equipment.

Review of the undated departmental policy and procedure manual revealed while there was a fire prevention policy that included safety tips; however did not provide guidance on the use and location of fire suppression equipment within the department. In an interview with RD 2 on 9/30/11 at 10 AM, he stated there were no other delineated procedures for dietary staff to follow in the event of a fire.

Based on observation of food holding equipment and interview, the hospital failed to ensure maintenance of equipment (a portable oven) as evidenced by melted gaskets. Failure to maintain equipment may result in compromised equipment function which may fail to maintain required safe food temperatures putting patients at risk of foodborne illness.

Findings:

During the initial tour on 9/28/11 at 10 AM, it was noted the 2-door hot box located adjacent to the food production area had melted gaskets on both doors. In a concurrent interview with Registered Dietician 1, she acknowledged the gaskets were compromised. She also stated if equipment required repair the department would complete a work order; but was unsure if one was completed. As of 9/30/11 at 2 PM, the hospital was unable to verify the compromised equipment was previously identified.

Based on observation, interview, and document review, the hospital failed to provide a sanitary environment to avoid sources and transmission of infections and communicable diseases as evidenced by:

1. Failure to develop nursing care plans for patients in isolation with infections, directing hospital staff on specific actions to take to reduce the risk of transmitting infections and communicable diseases to other patient, health care workers, and visitors (Refer to A Tag 748, item 1).

2. Failure to ensure that sterilizers were cleaned according to manufacture instructions, and were used in accordance with national standards of practice (Refer to A Tag 748, item 2).

3. Failure to routinely clean ultrasonic cleaners ensuring that surgical instruments were thoroughly cleaned after use (Refer to A Tag 748, item 3).

4. Failure to ensure the Infection Control Nurse reviewed and acted on elevated culture and endotoxin results for one dialysis machine and three reverse osmosis (RO) machines (Refer to A tag 749, item 1).

5. Failure to ensure comprehensive safe food handling practices (Refer to A tag 749, item 2).

6. Failure to properly store unused compressed air and oxygen tanks (Refer to A tag 749, item 3).

The cumulative effect of these system problems resulted in the hospital's inability to provide a sanitary environment and placed all patients and staff at risk of developing infectious and communicable diseases.

Based on observation, interview, and document review, the hospital failed to implement policies and procedures governing control of infections.

Findings:

1. The hospital failed to develop infection control care providing direction to staff on specific actions to take for patients in isolation to reduce the risk of exposing other patients and health care workers to infectious and communicable diseases.

On 9/26/11 at 10 AM, a tour was conducted of the fifth floor medical unit.

a. A sign posted on Patient 50's door indicated the patient was in airborne isolation (prevent transmission of infectious agents that remain infectious over long distances when suspended in the air [mycobacterium tuberculosis-the bacterium that causes tuberculosis, chicken pox-a highly infectious viral disease, and measles-a highly infectious viral disease]). It was also noted the patient was placed in a negative pressure room (a ventilation system that removes exhaust air from the room, ensuring that the air in the room is not shared with other patients).

On 9/26/11 at 10:15 PM, Patient 50's medical record was reviewed. Documentation in the medical record disclosed the patient was diagnosed with mycobacterium tuberculosis (TB), in 2004. Documentation in the medical record also showed laboratory cultures (A culture is the propagation of microorganisms in a growth media) were being performed to determine if the patient had active TB.

A review of the nursing care plans (set of actions the nurse will implement to resolve/support nursing diagnoses identified by nursing assessment. The creation of the plan is part of the nursing process, and it guides the ongoing provision of nursing care and assists in the evaluation of that care), in the patient's medical record revealed no care plan had been developed directing hospital staff on what specific actions (including use of a respiratory mask when entering the patient's room), to reduce the risk of transmitting the infectious disease to hospital staff, other patients, and visitors.

During a concurrent interview, the Clinical Nurse Specialist (CNS), verified there was no evidence a care plan had been developed directing hospital staff on how to care for the patient in airborne isolation. The CNS stated it was standard of practice to develop a care plan providing hospital staff with direction on how to care for the patient in isolation.

b. A sign posted on Patient 51's door indicated the patient was in airborne isolation. It was also noted the patient was placed in a negative pressure room.

On 9/26/11 at 11 PM, Patient 51's medical record was reviewed. Documentation in the medical record showed the physician had ordered for respiratory isolation be implemented. Documentation in the medical record also showed the physician was ruling out TB.

A review of the nursing care plans in the patient's medical record revealed no care plan had been developed directing hospital staff on specific actions (including wearing a respiratory mask when entering the patient's room), to reduce the risk of transmitting the infectious disease to hospital staff, other patients, and visitors.

During a concurrent interview, the CNS verified there was no evidence a care plan had been developed directing hospital staff on how to care for the patient in airborne isolation. The CNS stated it was standard of practice to develop a care plan providing hospital staff with direction on how to care for the patient in airborne isolation.

c. On 9/26/11 at 1:50 PM, a tour was conducted of the third floor medical unit. During the tour it was noted a sign posted on Patient 52's door indicated the patient was in contact precautions (Contact Precautions are utilized when patients known or suspected to be infected or colonized with epidemiologically important microorganisms that can be transmitted by direct or indirect contact).

On 9/26/11 at 2:05 PM, Patient 52's medical record was reviewed. Documentation in the patient's medical record disclosed the patient had a wound infected with methicillin resistant staphylococcus aureus (MRSA-a bacteria that is resistant to antibiotics).

A review of the nursing care plans in the patients medical record revealed no care plan had been developed directing staff on specific actions [including use of personal protective equipment (Specialized clothing or equipment worn by employees for protection against health and safety hazards) when in contact with the infected wound], to reduce the risk of transmitting the infectious disease to hospital staff, other patients, and visitors.

During a concurrent interview, the Quality Director (QD) confirmed the patient's medical record contained no evidence a care plan had been developed for the patient directing hospital staff on specific steps to take to reduce the risk of transmitting the MRSA to hospital staff, other patients, and visitors.

d. On 9/26/11 at 2:45 PM, a tour was conducted of the intensive care unit. During the tour, it was noted a sign was posted on Patient 53's door indicating the patient was in contact isolation.

During a concurrent interview, the Intensive Care Unit Manager stated the patient was in contact isolation for clostridium difficile (spore forming bacterial infection of the colon resulting in watery loose stools).

A review of the nursing care plans in the patient's medical record revealed no care plan had been developed, directing staff on specific actions (including not to use alcohol based hand rubs), to reduce the risk of transmitting the infectious disease to hospital staff, other patients, and visitors.

On 9/26/11 at 3:30 PM, an interview was conducted with the QD. During the interview, the QD stated since an isolation sign was posted on the patients door, the hospital did not feel they needed to develop a nursing care plan providing direction on what specific actions to take, when providing care for patients in isolation.

2. The hospital failed to follow the manufacturer's maintenance schedule ensuring the sterilizers were maintained as recommended, and were used in accordance with national standards of practice.

a. On 9/26/11 at 2 PM, the sterile processing area (area where surgical instruments are cleaned and sterilized), was toured. During the tour, signs were posted beside each of the three sterilizers. Documentation on the three signs revealed the inside of the sterilizers were cleaned in 2/11.

During a concurrent interview, the Sterile Processing Technician (SPT) was asked to explain the process and frequency for cleaning the inside of the sterilizers. The SPT stated they used to clean the sterilizers once a week, but they had problems with excessive moisture and leaking, and had stopped cleaning inside the sterilizers in February.

On 9/26/11 at 2:05 PM, a request was made to review the manufacturer's instructions for care and use of the sterilizers. The document was provided and reviewed. Under section 7, titled, "Routine Maintenance" the manufacturer recommended that, the interior chamber, accessories, and door gaskets, were to be cleaned weekly.

On 9/26/11 at 5 PM, the 2011, Perioperative Standards and Recommended Practices, published by the Association of perioperative Registered Nurse (AORN) were reviewed. On page 466, under recommendation III.c.1., AORN recommended that "... Wet packs may be a result of excessive wet steam, poor loading techniques, or a true sterilizer malfunction." On page 482, under Recommendation XVI.i.1, AORN recommended that, "Inspection and cleaning should be performed as outlined in the manufacturer's written instructions..."

b. a. On 9/26/11 at 2 PM, the SPT was asked to explain the hospital's practice after the sterilizer cycle was complete. The SPT stated after the sterilization cycle was complete, the sterilizer door was opened to facilitate the cooling process. When asked if it was usual practice to open the sterilizer door at the end of each sterilizer load, he stated it was.

On 9/26/11 at 5 PM, the 2011, Perioperative Standards and Recommended Practices, published by the Association of perioperative Registered Nurse (AORN) were reviewed. On page 466, under recommendation III.c.1., AORN recommended, "Steam sterilizer doors should not be left ajar to cool loads following a cycle. Removing the sterilizer load from the sterilizer as soon as possible after steam sterilization allows the cooling process to begin earlier. Cracking the sterilizer door may hinder the drying process...."

3. The hospital failed to implement a system ensuring all ultrasonic cleaners were routinely cleaned to ensure surgical instruments were thoroughly cleaned after use.

On 9/27/11 at 3 PM, the gastrointestinal procedure area was toured. During the tour, the decontamination area (area where instruments and supplies are cleaned after use), was inspected. An ultrasonic cleaner (device that uses ultra sound waves to clean surgical instruments prior to sterilization) was observed on the counter. Inspection of the metal pan (pan where instruments are placed during the cleaning process), inside the ultrasonic cleaner revealed the entire lip of the metal pan was covered with rust. When asked about the cleaning schedule for the ultrasonic machine, the Surgical Services Manager stated she was not sure. A request was made to review the manufacturer's instructions for use and care of the Ultrasonic cleaners. Hospital staff were unable to provide a copy of the manufacturer's instruction manual.

On 9/27/11 at 5 PM, the 2011, Perioperative Standards and Recommended Practices, published by the Association of perioperative Registered Nurse (AORN) were reviewed. On page 436, under recommendation X.c.11., AORN recommended that, "Ultrasonic cleaners should be emptied, cleaned, rinsed with sterile water, and the chamber wiped with alcohol, or other disinfectant, as recommended by the equipment manufacturer, when visibly soiled and at least daily."

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

1. Ensure the Infection Control Nurse (ICN) reviewed and acted on elevated culture and endotoxin results for one dialysis machine (14) (a machine and process used for removing waste and excess water from the circulatory system) and three reverse osmosis (RO) machines (7, 10, and, 11) (a machine that provides pure water for dialysis) which had the potential for the spread of infection to the hospital's dialysis patient population.

2. To ensure comprehensive safe food handling practices as evidenced by: 1) lack of comprehensive cool-down monitoring of potentially hazardous foods; 2) storage of shelf-stable food items in original packaging after opening; 3) lack of hand hygiene during patient meal delivery; and, 4) lack of air gaps in four food production sinks and one piece of food production equipment. Failure to ensure safe food handling practices during storage and production may result in patient exposure to foodborne illness and contamination, further compromising medical and nutritional status.

3. To properly store cleaned compressed air and oxygen tanks found in the dirty utility room which had the potential to spread infection to the hospital's patient population.

Findings:

1. The Association for the Advancement of Medical Instrumentation (AAMI) standards program consists of over 100 technical committees and working groups that produce Standards, Recommended Practices, and Technical Information Reports for medical devices. The AAMI standards for dialysis and RO machines indicated the cultures should have a microbial (bacteria) count lower than 200 CFU/ml (colony forming units per milliliter) and endotoxin (bacteria cell parts which cause fever and shock) concentration of lower than 2 EU/ml (endotoxin units per milliliter). Per the AAMI standards, the action level should be when the microbial count was at 50 CFU/ml and the endotoxin level was at 1 EU/ml. (Reference: AAMI RD52:2004)

The culture and endotoxin result binder for the dialysis and RO machines located in the hospital was reviewed with the ICN on 9/29/11 at 9:10 AM. The culture results for Contracted Service (CS) A indicated dialysis machine 14 had the following laboratory culture results:

a. 3/31/11 - culture result of 200 CFU/ML

b. 6/29/11 - culture result of 5,000 CFU/ML (drawn on 6/27/11)

c. 7/5/11 - culture result of 1,000 CFU/ML (drawn 6/30/11). There was no indication in the laboratory result binder if dialysis machine 14 was removed from use on the hospital's dialysis patients between the dates of 6/29/11 and 7/5/11.

For RO machine 7 the culture and endotoxin results were as follows:

a. 6/18/11 - endotoxin result was 1.60 EU/ml

b. 6/30/11 - the culture test was 60 CFU/ml

c. 7/9/11 - the endotoxin result was 5.15 EU/ml. There was no indication in the laboratory result binder that RO machine 7 was removed from use on the hospital's dialysis patients between the dates of 6/18/11 and 7/9/11. There was a hand written note on the 7/9/11 laboratory result document indicating RO 7 was pulled out of service on 7/11/11.

For RO machine 10 the culture and endotoxin results were as follows:

a. 5/3/11 - culture 90 CFU/ml

b. 7/9/11 - endotoxin 4.45 EU/ml

For RO machine 11 the culture results were as follows:

a. 3/18/11 - culture 50 CFU/ml

The ICN verified the above results and stated she did not remember viewing the elevated laboratory results. She stated she does not document she has viewed the laboratory tests for the dialysis or RO machines. She does not chart what action she had taken to ensure the machines were not used for the hospital patient's dialysis during the time the machines have laboratory tests drawn and the results were reported, or when the machines have elevated laboratory results. She stated she depended on CS A to take the machines out of service. She stated she had not reported the laboratory dialysis and RO machine's results to the infection control committee that meets quarterly.

During an interview with the Quality Director (QD) on 9/29/11 at 9:50 AM, she stated her expectation of the ICN would be to report the incidents of elevation cultures during the infection control committee's quarterly meetings, that she would act on the elevated endotoxin and culture tests, and to ensure appropriate steps were taken by the contracted dialysis company when the test were above acceptable levels.



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2. a. During the initial tour on 9/28/11 at 10:30 AM, it was noted in the walk-in refrigerator there was a pan of stuffed peppers that appeared to be filled with a ground beef mixture. Stuffed peppers are considered a potentially hazardous food (PHF). PHF's are foods capable of supporting bacterial growth associated with foodborne illness. Safe food handling practices would ensure that PHF's under refrigeration are maintained below 41?F (Food Code, 2009).

In a follow up observation on 9/28/11 beginning at 3:10 PM, it was noted the peppers were still in the refrigerator. The temperature of the peppers was taken in the presence of Registered Dietician (RD) 1 and was noted to be 50?F. In an interview with Dietary Staff (DS) 2 on 9/28/11 at 3:10 PM, he was asked to describe how, as a cook, he ensured that leftover food was safe to be used after refrigerated storage. He stated he would check the expiration date of the item, and as long as it was not outdated the product would be safe to use. He also stated when he had leftover items from the dinner meal he would place it in a smaller pan, enter the trayline temperature of the item in the cool-down log, label and date it and then place it in the freezer after which he would leave for the evening. The standard of practice would be to ensure that cooling be accomplished in accordance with time and temperature criteria by using one or more methods, based on the type of food, such as placing the food in shallow pans, separating into smaller or thinner portions, using rapid cooling equipment adding ice as an ingredient or other effective methods. Time/temperature control parameters would ensure that PHF's are cooled from 135-70?F within 2 hours and to 41?F within an additional 4 hours for a total not to exceed 6 hours (Food Code, 2009).

Concurrent review of the hospital document titled "Cool Down Temperature Record" beginning 9/6/11, in the presence of RD 1, revealed there were 11 entries, all of which had a single temperature entry ranging from 140-185?F, with a comment that the item was left in the freezer. The cool-down log also guided staff to complete temperature monitoring while food was being cooled. In a concurrent interview with RD 1, she stated she was aware this was the process and she thought it would be acceptable to place the item in the freezer without further monitoring. RD 1 also acknowledged with this process it was not possible to determine whether the items met time/temperature controls for food safety.

In an interview with DS 2 on 9/28/11 at 3:10 PM, he stated he prepared the peppers in the morning. He also stated he completed the process between 9:30 and 9:45 AM at which time he placed them in the refrigerator. He also stated he did not take any temperatures of the items and was not concerned about the length of time the food was held because the item would be gone before the end of the day. DS 2 also stated he would not be concerned with stuffed peppers because they were not filled with meat, rather filled with a soy based meat substitute.

Undated hospital policy titled "Refrigerator and Frozen Food Storage" guided staff that potentially hazardous foods would be cooled from 140-70?F within 2 hours and to 41?F within an additional 4 hours.

b. During general food production observations on 9/29/11 at 2:30 PM, it was noted dietary staff was storing flour, brown and white rice, beans and rolled oats, in storage containers, in the original bag after being opened. In a concurrent interview with RD 1, she stated this was the usual storage practice for these items. RD 1 also acknowledged the exterior of the bags were not protected during transportation and were not considered clean. It would be the standard of practice to ensure that food was protected from miscellaneous sources of contamination (Food Code, 2009).

c. On 9/28/11 at 11:40 AM, patient meal delivery was observed. It was noted DS 7 was delivering meals to multiple rooms. DS 7 would remove the patient meal tray from the cart, deliver the meal to the patient; arrange the meal on the patients' over-the-bed table by touching the table and/or handle the patients' privacy curtain. It was also noted, with the exception of one instance, there was no observation of hand washing or use of hand sanitizer gel. It was also noted there were wall mounted hand sanitizer dispensers outside each patient room. Above the dispenser there was guidance for staff to utilize hand sanitizer before and after entering patient rooms.

In a concurrent interview with RD 1, she acknowledged DS 7 should have used the hand sanitizer before and after entering patient rooms. She also stated prior to delivering meal trays, dietary staff would receive mentor training from a more experienced staff member after which they would complete the task independently. She also stated each staff, responsible for meal delivery would receive a competency evaluation. The hospital's document titled "Department Specific Competency" dated 8/5/11 revealed DS 7 did receive training on hand hygiene and was observed to be competent in this task.

d. On 9/28/11 beginning at 2:30 PM, dietary staff was observed preparing raw squash by rinsing it off in the designated food production sink. Removal of the panel in front of the production sink revealed that the sink did not have an air gap, rather was directly plumbed into the hospitals' waste water system. It was also noted there were an additional three sinks within the kitchen that had similar plumbing. Additionally it was noted, in the area adjacent to the stove, there was a floor sink with three copper pipes which were drains for food production equipment. It was also noted one of the drains was installed below the rim level of the floor sink.

In an interview with Plant Operations Staff on 9/28/11 at 2:50 PM, he confirmed the sinks were directly plumbed into the waste water system and that there was no air gap. It would be the standard of practice to ensure the presence of an air gap between the water supply inlet and the flood level rim of the equipment or plumbing fixture (Food Code, 2009).



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3. During an observation on 9/26/11, at 10:02 AM, in the Post Partum Unit, the soiled utility room was observed to have nine unused tanks (four compressed air tanks and five oxygen tanks) stored inside.

During an interview with Registered Nurse ( RN) 2, on 9/26/11, at 10:05 AM, she stated, "They (tanks) shouldn't be stored in here. This is the soiled utility room."

During an interview with Respiratory Therapy (RT), on 9/26/11, at 10:12 AM, he stated, "I'm not sure where to store them (tanks)... they come from outside."

The policy and procedure for storage of tanks (compressed air and oxygen) and soiled utility room was requested. The requested policy was not received.