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Based on observation, record review, and interview, the facility failed to have an effective Governing Body (GB) that met the needs of the patients, in a universe of 191 patients.

1. The GB failed to ensure that the quality assurance and performance improvement program was an effective, ongoing, hospital-wide, data driven program. (Refer to A 263)

1 a). That data was collected to monitor the maintenance of the humidity levels operating rooms in the Outpatient Surgery Pavilion and in a surgery room in Labor and Delivery. The failure to monitor this activity resulted in the humidity being out of range without documented intervention on several days per month from January 2009 through December 2009. (Refer to A 709 and A 267)

1 b). That there was data collected and analyze to ensure adequate numbers of dietitians to provide for the nutritional care of its patients in a universe of 191 patients. This failure caused a delay in dietary intervention and a lack of patient education regarding dietary issues. (Refer to A 621, A 267, A 276)

1 c). That there was data collected and analyzed to ensure that all patients who are likely to suffer adverse health consequences upon discharge are identified at an early stage of hospitalization and for all patients in a universe of 191 patients. (Refer to A 800 and A 267)

1 d). That there was data collected and analyzed to ensure that the discharge planning evaluation included the likelihood of a patient's capacity for self-care or the possibility of the patient being cared for in the same environment that they had before entering the hospital for Patient 71 and 82 and potentially for a universe of 191 patients. (Refer to A 809 and A 267)

1 e). That there was data collected and analyzed to ensure that patient's receiving the antipsychotic drug "Haldol" intravenously (IV) were monitored according to recommendations from the FDA. The drug Haldol used IV had a black box warning from the FDA that required specific heart monitoring to prevent sudden cardiac death. Also the facility failed to collect, analyze, and tract data to ensure that patients receiving Haldol IV were monitored for the use of a chemical restraint. (Refer to A 395, A 160, and A 267)

1 f). That the QAPI committee set priorities that focused on high-risk, high-volume, or problem prone areas for a universe of 191 patients by failing to ensure that that committee monitored the use of their inter-facility transfer physician's orders sheets. (Refer to A 395 and A 285)

2 a).The GB failed to ensure that humidity levels were maintained at 35 % or greater in 3 of 3 operating rooms in the Outpatient Surgery Pavilion and 1 of 1 surgery room in Labor and Delivery. (Refer to A 940)

2 b). The GB failed to ensure that the facility followed their procedure to instruct staff on what to do in the event that the humidity levels in the operating rooms were less than 35%, and to have documentation showing the humidity levels were adjusted into range.(Refer to A 940) (Refer to LSC survey K78)

3. The GB failed to ensure that the food and dietetic service was organized, directed and staffed in a manner that met the nutritional needs of its patients. The hospital also failed to ensure that food and diets served followed acceptable standards of practice and were in accordance with practitioners' orders. (Refer to A 618)

4. The GB failed to ensure that the hospital had a discharge planning process that applied to all patients. (Refer to A 799)

4 a). That all patients who are likely to suffer adverse health consequences upon discharge are identified at an early stage of hospitalization if there was no adequate discharge planning for Patient 71 and potentially all patients in a universe of 191 patients. (Refer to A 800)

4 b). That Patient 71 was evaluated for potential problems with abuse and for suffering aspiration pneumonia prior to discharging him the the same environment. (Refer to A 800)

4 c). That a consistent process for discharge planning was utilized. This had the potential to cause patients to suffer adverse health consequences on discharge.(Refer to A 800)

4 d). That the discharge planning evaluation included the likelihood of a patient's capacity for self-care or the possibility of the patient being cared for in the same environment that they had before entering the hospital for Patients 71, 82, and potentially for a universe of 191 patients. The GB failed to ensure that case management had the tools to ensure that all elements of the discharge process were assessed. (Refer to A 809)

The cumulative effect of these systemic problems resulted in the hospitals's inability to ensure the provision of high quality healthcare services in a safe environment.

Based on interview and record review the facility failed to ensure that the patient or the patient's representative had the right to make informated decisions regarding care for 1 of 50 sampled patients, Patient 74. This failure resulted in the patient consenting for a potenital blood transfusion without receiving all of the information that was required to make an informed decision.

Findings:

A review of the medical record for Patient 74 revealed that he was admitted to the facility on 1/2/10 with diagnoses that included bilateral deep vein thrombosis.

Review of the facility's document titled, "Consent to Blood Transfusion", dated 1/4/10, revealed the following:

"Your signature below indicates that:

1. You have received a copy of the brochure, A Patients Guide to Blood Transfusion..."

Further review of the document revealed that Patient 74 had signed the consent.

An interview with a nurse educator (Staff D) on 1/5/10 at 11 AM was conducted. She stated that the information that the patient was to receive prior to signing the consent for a blood transfusion was on the back of the form that was in the patient's medical record. She indicated that the form was still in the record, so it was not given to the patient.

Based on interview and record review the facility failed to ensure that each patient had the right to formulate an advance directive (AD) for 6 of 50 sampled patients (Patients 71, 73, 72, 1, 2, and 73).

For Patients 71, 73, 72, 1 and 2 the facility failed to ensure that all patients received written information concerning their right to make decisions regarding medical care.

For Patients 73, the facility failed to ensure that information regarding advanced directives was available in the current medical record.

These failures had the potential for patients not to receive the level of life saving care or comfort care that they desire.

Findings:

1. Review of the medical record for Patient 71 revealed that he was admitted to the facility on 1/1/10 with diagnoses that included pneumonia.

A review of the facility document titled, " Advance Directive Acknowledgement", dated 1/1/10, revealed no documented evidence that the patient had been asked if he had an AD or that AD information had been provided to him. The only documentation was "pt (patient) altered (decreased level of consciousness)".

An interview was conducted on 1/4/10 with Staff A (RN) at 2:55 PM. He stated that Patient 71 was awake and alert now. The RN stated that the patient had been awake for "several days". He stated that the staff does not look back at the AD sheet to ensure that the patient gets information on AD or to check to see if the patient has an AD. The charge nurse (Staff B, RN) was present at the same time and stated that the only time the nurses follow up with ADs was by patient request.

An interview was conducted with the Director of Admitting (DOA) on 1/6/10 at 2:15 PM. She stated that the admitting staff asks the patients when they are admitted about their AD. She also stated that the admitting staff provides information to patient's who do not have an AD. The DOA stated that if a patient is not able to get the information on admission, the admitting department relies on nursing to let them know when a patient (or their significant other) is able to receive the information. She stated that there was no written process for either admitting or nursing to follow.

2. Review of the medical record for Patient 73 revealed that he was admitted to the facility on 11/30/09 with diagnoses that included small bowel obstruction.

A review of the facility document titled, "Advance Directive Acknowledgement", dated 1/1/10, revealed no documented evidence that the patient had been asked if she had an AD or that AD information had been provided to him. The only documentation was "patient unable to sign", dated 11/30/09.

An interview was conducted with the Director of Nursing Center of Excellence on 1/7/10 at 3 PM. She confirmed that there was no follow up with the patient or the patient's significant other regarding the patient's wishes for health care decisions.

3. A review of the medical record for Patient 72 revealed that he was admitted to the facility on 1/1/10 with diagnoses that included an acute heart attack.

Further review revealed that there was no information in the medical record regarding the patient's AD and no documentation that indicated that the patient had been given written information.

Accompanying administrative staff 1 reviewed the patient's medical record on 1/4/09 at 2:15 PM and confirmed that there was no AD information.

4. A review of the medical record for Patient 73 revealed that she was admitted to the facility on 12/25/09 with diagnoses that included pneumonia.

Review of the AD information for the patient revealed that she had formulated an AD. The documentation revealed that the patient did not have the AD with her; however, the facility did have a copy from a previous admission.

Review of the patient's current medical record revealed that a copy of her AD was not present in the record.

Accompanying administrative staff 1 reviewed the patient's medical record on 1/4/09 at 2:20 PM and confirmed that there was no copy of the AD in the current record.

An interview was conducted with the Director of Admitting (DOA) on 1/6/10 at 2:15 PM. She stated that the admitting staff should ensure that a copy of a patient's AD is placed on the current medical record if the patient has one on record in the facility. She could not provide information as to why, for Patient 73, there was no AD in her current medical record.




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5 a). Medical Records were reviewed on January 4, 2010 at 3:00 P.M. Patient 1 was an 87 year old individual with a hip fracture. The chart did not contain an Advance Directive Acknowledgement form.

5 b). Patient 2 was a 59 year old with chest pain. This record also did not contain an Advance Directive Acknowledgement form.

The Director of Nursing and Director of Quality were interviewed after the chart review. They reviewed the records and agreed that the form was missing from these two records.

Based on observation and interview patients in hall beds in the Emergency Department (ED) were not receiving treatment in a private setting. There were no privacy screens or curtains separating patients in back-to-back beds. Privacy screens were available but the patients were not automatically offered this option. There was a posting in the waiting room informing the patients they could ask for privacy screens, and they would need to ask to get one. There were many patients in hall beds, none with screens, suggesting that some patients did not know of this option. This resulted in the possibility of patients being examined and treated without privacy, against their wishes.

Findings:

The emergency department was toured on January 4, 2010 at 10:30 A.M. The Director of the ED was present during the tour. The surveyor observed many patients on beds in the hallways of the ED. There were so many that there was sometimes only a few feet between patients. No privacy screens of any kind were in place. The Director of the ED stated that because the ED is always very busy, beyond the capacity of the licensed beds, there are always beds in the halls. I asked if the patients were offered privacy screens or curtains. She said there was a sign posted in the waiting room, and screens were available if the patient requested them. However they were not offered one if they did not ask.

Based on interview and record review the facility failed to ensure that patients had the right to be free from all forms of abuse.

For 1 of 50 patients (Patient 71), the facility failed to ensure that their policy regarding identification of abuse on admission was followed. This failure had the potential to cause the patient to be discharged home to an abusive environment.

The facility failed to ensure that their policy included provisions to direct employees against all forms of abuse and reporting requirement for staff to patient abuse. This failure had the potential to negatively effect a universe of 191 patients at risk of abuse by facility staff.

Findings:

1. A review of the medical record for Patient 71 revealed that he was admitted to the facility on 1/1/10 with diagnoses that included pneumonia and quadriplegia.

A review of the nursing admission form, dated 1/1/10, revealed an area for assessment of the patient social history. Under the social history area there was a question that stated, "Do you feel safe at home?" The documentation revealed that the patient answered, "sometimes". Further review revealed that both a social service and a case management referral were ordered by the admitting RN. The nurses narrative was reviewed for the rest of the day of 1/1/10 through discharge on 1/5/10 and there was no further documentation regarding the patient's statement that he only felt safe at home sometimes.

A review of the facility's case management and social service notes revealed that there was documentation by a MSW (Masters of Social Work) twice on 1/4/10. Both documentation times, 1:56 PM and 3:59 PM stated that the MSW was not able to speak with the patient. The note stated that the MSW would continue to attempt to visit the patient. There were no further notes documented by the MSW. The next note was by a case manager (CM). The note documented discharge information; however, there was no mention of an investigation regarding the patient not feeling safe at home.

A review of the nurses notes on 1/5/10 revealed that the patient was discharged home at 6:30 PM. There was no documentation regarding the patient's statement that he only felt safe at home "sometimes".

A review of the facility policy titled, "Abuse", dated 5/2009, revealed the following:

"When suspected abuse is identified:

A. Alert appropriate staff, (i.e. physician, PCP(s) [primary care provider, primary nurse, Charge Nurse, Administrative Supervisor/Unit Supervisor, Social Worker and Security) of suspicions."

B. Consult with the clinical social worker..."

An interview was conducted with the Director of Nursing Center of Excellence (DO) was conducted on 1/7/10 at 10:30 AM. She confirmed that the facility used the question, "Do you feel safe at home?" to help determine if the patient had suffered abuse outside of the facility. She confirmed that the documentation for Patient 71 stated "sometimes" and required the staff to follow up. She confirmed that the staff had not followed up with the patient and discharged him home to the same environment.

An interview was conducted with the Director of Case Management (DCM) (included social work) on 1/7/10 at 3:10 PM. She stated that the case management department was not open on the weekend, but they did have a case manager on call. She stated that to have someone from the department come in to see a patient on the weekend, a nursing supervisor must call them in. The DCM stated that referrals for the department that are entered into the computer on a weekend or holiday go to the department. The referrals are not picked up until the next regular working day. The DCM reviewed Patient 71's documentation and confirmed that when the referrals were made, it was a long holiday weekend.

2. The facility's policy titled, "Abuse", dated 5/2009, was reviewed and revealed a policy that was directed at patient's who suffer abuse (or suspected abuse) from a source out side of health care workers at the facility. The policy directed staff to report abuse to the Adult Protective Agency (APS). (The APS does not take cases of patient abuse suffered at the hands of a healthcare provider in the hospital.) There was no instruction to the employee to report the suspected abuse to the Department of Public Health. There was no statement of expectation from the facility regarding staff to patient abuse.

An interview was conducted with the CNO on 1/6/10 at 3 PM. She stated that the facility's abuse policy does not address staff to patient abuse or patient to patient abuse. The CNO stated that the focus of the policy was for staff to identify patients that come into the facility who were victims of abuse. The CNO was able to provide an administrative policy, "Conducting an Internal Investigation", dated 5/2009. This policy did outline the steps for investigation and included patient protection.

An interview was conducted with a Nurse Educator (Staff D) on 1/7/10 at 11 AM. She stated that the nursing training for abuse was directed at identifying patients that come into the facility who were the victims of abuse. She confirmed that there was no education on the prohibition of staff to patient abuse, or what an employee was to do if staff to patient abuse was suspected.

Based on interview and record review the facility failed to identify that 1 of 50 sampled patients (Patient 65) was receiving a chemical restraint. For Patient 65 the facility failed to identify that the intravenous administration of HALDOL , which is an off-label use, used to control Patient 65's behavior/agitation was a chemical restraint, which resulted in Patient 65 not being monitored for the use of a chemical restraint.

Findings:

The clinical record for Patient 65 was reviewed on 1/4/10 and 1/6/10. Review of the clinical record indicated that the patient was admitted to the facility on 12/2/09 with diagnoses that included aortic aneurysm and chest pain.

Review of Patient 65's physician's orders revealed the following:

HALDOL 2mg IVP(intravenous push) now, dated 12/28/09 at 0405 (4:05 AM)
HALDOL 1 IV (intravenously) every 8 hours as needed for severe agitation, dated 12/28/09 at 2330 (11:30 PM)
Give HALDOL 2mg IVP "now" and "HALDOL 2mg IV q (every) 6hrs prn (as needed) agitation" dated 12/29/09 at 855 (8:55 AM)
HALDOL 2.5 mg IV q 6hrs dated 1/4/10

Review of the Medication Administration Record (MAR) indicated that Patient 65 received HALDOL IV on the following dates and times.

1mg of HALDOL IV on 12/28/09 at 11:45 PM
2mg of HALDOL IV on 12/29/09 at 4:15 AM, 9:00 AM, 3:00 PM and 9:10 PM
2mg of HALDOL IV on 12/30/09 at 10:15 AM, 4:00 PM and 10:00 PM
2mg of HALDOL IV on 12/31/09 at 2:40 PM,
2mg of HALDOL IV on 1/1/10 at 4:45 AM, 3:30 PM, 9:00 PM
2mg of HALDOL IV on 1/2/10 at 3:30 AM, 10:30 AM and 5:15 PM
2mg of HALDOL IV on 1/3/10 at 5:00 AM and 10:24 PM
2mg of HALDOL IV on 1/4/10 at 4:30 AM and 10:30 AM
2.5mg of HALDOL IV on 1/5/10 at 12:00 PM

The label approved for HALDOL(haloperidol) on 7/19/09, was reviewed on 1/6/10. The label revealed, "HALDOL is indicated for use in treatment of schizophrenia". "HALDOL INJECTION IS NOT APPROVED FOR INTRAVENOUS ADMINISTRATION.

Review of the facility policy and procedure titled, "Restraints, Use of" indicated the following:

"Chemical Restraint is a drug or medication that is used as a restriction to manage the patient's behavior or restrict the patient's freedom of movement and is not a standard treatment or dosage for the patient's condition (Condition of Participation for Hospitals 482.13). A medication is not considered chemical restraint if:

A. The medication is used within the pharmaceutical parameters approved by the Food and Drug Administration (FDA) and the manufacturer for the indications it is manufactured and labeled to address, including listed dosage parameters".

The facility's off-label use of intavenous HALDOL is not recommended by the FDA or manufacture and was used to manage Patient 65's behavior/agitation, therefore would be considered a chemical restraint.

Further review of Patient 65's clinical record indicated that there was no documentation to show that the patient had not been monitored for the use of a chemical restraint.

During an interview with the Registered Nurse in charge of the patients care (Staff E), on 1/6/09 at 11:25 AM, Staff E did not indicate that Patient 65 was being monitored for the use of a chemical restraint.

During an interview with the Intensive Care Unit Team Leader (ICU TL) and the Emergency Department Director (EDD) on 1/6/10 at 11:45 AM the ICU TL verified that Patient 65 had the above listed orders for HALDOL and that Patient 65 had received intravenous does of the drug on the above listed dates and times. During the interview the EDD verified that there was no documentation in the physician's progress notes, or in the clinical record, that discussed the physician's decision to use HALDOL intravenously, which is an off-label use, prior to the administration of the drug by the nursing staff.

An interview was conducted with the Director of Nursing Centre of Excellence (DON) on 1/7/09 at 3:30 PM. She confirmed that under the facility's policy for chemical restraints, the off label use of IV Haldol would be considered a chemical restraint.

Based on interview and record review the facility failed to ensure that restraints were never used on an as needed (PRN) basis for a universe of 191 patients, by failing to ensure that their policy for restraints prohibited the use of PRN restraints. This failure had the potential for patients to be restrained without complete evaluation of the condition that lead to need for restraints. This failure also had the potential for patients to be in restraints for a longer period of time than was necessary.

Findings:

A review of the facility policy titled, "Restraints, Use OF", dated 5/2009, revealed the following:

"Note: When restraint is removed before the end of the effective period and the same need for restraints becomes evident, the original order may be reapplied for the remainder of the effective period if alternatives remain ineffective."

A interview was conducted with the Director of Nursing Center of Excellence (DON) was conducted on 1/7/10 at 2:30 PM. She confirmed that the policy provided the staff with the ability to reapply restraints without a new LIP (Licensed Independent Practitioner) order. The DON confirmed that (according to regulation) when restraints are discontinued, a new order from a LIP was required prior to the reapplication of restraints. She acknowledged that the reapplication of restraints without a new LIP order constituted a PRN order.

Based on interview and record review the facility failed to ensure that physician and other licensed independent practitioner (LIP) training requirements were specified in hospital policy. This failure had the potential to effect any patient who required the use of restraints in a universe of 191 patients. This failure had the potential to cause patients to be restrained without full evaluation of the need for restraints and had the potential for patients to be in restraints for a longer period of time than was necessary.

Findings:

A review of the facility policy titled, "Restraints, Use OF", dated 5/2009, revealed that there was a statement that "At a minimum, physicians and other Licensed Independent Practitioner authorized to order restraints must have a working knowledge of hospital policy regarding the use of restraints." However, there was no documented training requirements for physicians or LIPs.

An interview was conducted with the Director of Nursing Center of Excellence (DONCOE) was conducted on 1/7/10 at 2:30 PM. She confirmed that the policy did not contain training requirements for physicians or LIPs. She stated that the policy did state a "working knowledge" was required; however, there was no information on how the requirement would be accomplished or ensured.

Based on observation, interview, and record review, the facility failed to ensure that the quality assurance and performance improvement program was an effective, ongoing, hospital-wide, data driven program by failing to ensure that:

1. The facility collected data to monitor the maintenance of the humidity levels in the operating rooms in the Outpatient Surgery Pavilion and in a surgery room in Labor and Delivery. The failure to monitor this activity resulted in the humidity being out of range without documented intervention on several days per month from January 2009 through December 2009. (Refer to A 709 and A 267)

2. There was data collected and analyze to ensure adequate numbers of dietitians to provide for the nutritional care of its patients in a universe of 191 patients. This failure caused a delay in dietary intervention and a lack of patient education regarding dietary issues. (Refer to A 621, A 267, A 276)

3 a).There was data collected and analyzed to ensure that all patients who are likely to suffer adverse health consequences upon discharge are identified at an early stage of hospitalization and for all patients in a universe of 191 patients. Specifically, the discharge planning for Patient 71 did not include his aspiration risk and evaluation of potential for abuse at home. (Refer to A 800 and A 267)

3 b).There was data collected and analyzed to ensure that the discharge planning evaluation included the likelihood of a patient's capacity for self-care or the possibility of the patient being cared for in the same environment that they had before entering the hospital for Patient 71 and 82 and potentially for a universe of 191 patients. (Refer to A 809 and A 267)

3 c). There was data collected and analyzed to ensure that case management had the tools to ensure that all elements of the discharge process were assessed. (Refer to A 809 and A 267)

4 . There was data collected and analyzed to ensure that patient's receiving the antipsychotic drug "Haldol" intravenously (IV) were monitored according to recommendations from the FDA. The drug Haldol used IV had a black box warning from the FDA that required specific heart monitoring to prevent sudden cardiac death. Also the facility failed to collect, analyze, and tract data to ensure that patients receiving Haldol IV were monitored for the use of a chemical restraint. (Refer to A 395, A 160, and A 267)

5. That the QAPI committee set priorities that focused on high-risk, high-volume, or problem prone areas for a universe of 191 patients by failing to ensure that that committee monitored the use of their inter-facility transfer physician's orders sheets. (Refer to A 395 and A 285)

The cumulative effect of these systemic problems resulted in the hospital's inability to develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program in order to achieve high standards of healthcare provided in a safe environment.

Based on interview and record review the hospital failed to ensure that the QAPI program collected data to measure, analyze, and tract hospital operations as follows:

1 a).The facility failed to collect and tract data regarding the maintenance of the humidity levels in 3 of 3 operating rooms in the Outpatient Surgery Pavilion and 1 of 1 surgery room in Labor and Delivery.

1 b). The facility failed to tract data that staff was instructed on what to do in the event that the humidity levels in the operating rooms were less than 35%, and to have documentation showing that the humidity levels were adjusted into range. (Refer to A 709)

2. The facility failed to collect, analyze, and track data to ensure that there was adequate numbers of dietitians to provide for the nutritional care of its patients in a universe of 191 patients. (Refer to A 621)

3 a). The facility failed to collect, analyze, and tract data to ensure that all patients who are likely to suffer adverse health consequences upon discharge are identified at an early stage of hospitalization in a universe of 191 patients. Specifically, the discharge planning for Patient 71 did not include his aspiration risk and evaluation of potential for abuse at home. (Refer to A 800)

3 b). The facility failed to collect, analyze, and tract data to ensure that the discharge planning evaluation included the likelihood of a patient's capacity for self-care or the possibility of the patient being cared for in the same environment that they had before entering the hospital for 2 of 50 patients (Patient 71 and 82) ( Patient 82 was discharged home without home health care and an evaluation for "safety" as ordered by the physician) and potentially for a universe of 191 patients. (Refer to A 809 and A 808)

3 c). The facility failed to collect data to ensure that case management had the tools to ensure that all elements of the discharge process were assessed. (Refer to A 809)

4. The facility failed to collect, analyze, and tract data to ensure that patient's receiving the antipsychotic drug "Haldol" intravenously (IV) were monitored according to recommendations from the FDA. The drug Haldol used IV had a black box warning from the FDA that required specific heart monitoring to prevent sudden cardiac death. Also the facility failed to collect, analyze, and tract data to ensure that patients receiving Haldol IV were monitored for the use of a chemical restraint. (Refer to A 395 and A 160)

These failures resulted in the hospital's inability to identify and correct problems to ensure that the problems do not occur or do not occur again.

Findings:

An interview was conducted with members of the facility's QAPI committee on 1/7/10 at 1:10 PM. The team members included the Director of Quality Management, the CNO, the Vice President of Medical Affairs, and the Director of Cardiac Care. The team was presented with concerns that were identified during the survey process including:

Consistently low OR humidity readings in out patient OR suites and the lack of follow up to the low humidity readings.

Consistent delays in dietary assessment and in too few numbers of dietitians to ensure proper assessment and planning for patients.

No process for ensuring complete discharge planning for all patients being discharged from the facility and specifically for Patient 71 who was discharged home without planning and teaching for his aspiration risk. Also Patient 71 was discharged home without assessment of a statement he made on admission related to not always feeling safe at home.

The use of the medication Haldol, IV without specific heart monitoring as recommended by the FDA and without monitoring for the use of chemical restraints.

The QAPI team stated that they were not previously aware of the concerns that were presented by the survey team. They stated that they had not collected data on the OR humidity, dietary assessments, discharge planning other than for their heart patients, and the use of Haldol IV or other medications that could be considered a chemical restraint.

Based on interview and record review, the hospital failed to report, analyze and act on program data related to the timeliness of Registered Dietitian patient assessment in order to meet the nutritional needs of patients for a universe of 191 patients. This failure had the potential to result in patients at nutritional risk not receiving the nutritional support needed for treatment of their medical condition.

Findings:

1. Record review for Patient #21 revealed that the patient was admitted on 12/26/09 with diagnoses including upper GI bleed, renal failure, respiratory failure and multiple pressure ulcers. Closed record review showed that the patient had several risk factors, medication and therapies that required a dietary consult. These risks or therapies include dependence on ventilator, versed (medication) and pressure ulcers.

A dietary consult was ordered on 12/26/09 at approximately 1300 hours. There was no documented evidence that the consult was completed. Interview on 1/6/2010 at approximately 10:50 am ,with the registered dietitian (RD#2) who was scheduled to work, indicated that the assessment was not completed. She stated that she was unable to complete the assessment due to the large number of patients that she had to see on that day. Patient #21 expired on 12/27/09.

2. Record review for Patient #23 revealed a 59 year old female admitted to the hospital on 1/3/2010 with diagnoses including head injury and renal failure. The physician ordered diet was a renal diet.

Review of the patient's clinical record showed that the patient was not assessed by the nutrition staff because according to the registered dietitian (RD#1) she did not meet their criteria for assessment. In response to a question on description of the hospital's renal diet, she stated that the renal diet consisted of 60 gm protein, 2 gm sodium, 1.5 gm potassium and 1 gm phosphorous. She further explained that the amount of protein could be 80 gm, if the patient was on dialysis.

Patient #23 had a dialysis treatment while in the hospital and it was unclear which of the protein levels of the renal diet she received either a 60 gm protien or an 80 gram protien for dialysis patients.

3. Record review for Patient #22 revealed a 16 month old admitted to the hospital on 1/2/10 with diagnoses including bronchiolitis, asthma and hyperglycemia. Review of clinical record showed that the patient was screened by nursing staff per their policy. But the assessments such as BMI, height, weight were not completed. Growth charts were not plotted and no nutrition assessments were completed by the RD. RD #1 stated that the RDs do not routinely assess or screen pediatric patients until the 4th day of admission unless there is a nurse or MD consult.

Interviews conducted with two of the dietitians on 1/6 and 1/7 2010 and the director of nutritional services on 1/7/2010 revealed that the facility had employed two full-time dietitians, two part-time dietitians and one on-call dietitian.

The dietitians (RD #1 and RD#2) explained that they have three dietitians working on Mondays, Wednesdays and Fridays. Two dietitians work on Tuesdays and Thursdays but there is only one RD on weekends and on holidays. They further explained that one RD generally sees approximately 12 to 18 patients per day. The weekend that ended prior to the start of the validation survey, which was also a holiday weekend, only one RD worked per day. The RD that worked on the Sunday indicated that she had about 45 patients to assess or follow-up and that she was unable to complete all she needed to do and that Patient #21 was one of them.

During the interview of 1/6/2010, the RD explained that they do not have a dietitian to go into NICU to do nutritional assessments because they are only able to do assessments and consults in the medical-surgical floors. In addition, they do not screen pediatric patients until the 4th day. They explained that they no longer do patient screening because the nurses screen all patients including the nutrition within 24 hours of admission. The RDs explained that when they receive referral from the nurses, they do not screen or assess such patients until three days later and that the only patients they see within 24 hours are consults from physicians and patients receiving TPN (Total Parental Nutrition).They do not routinely do discharge education unless it is requested by the physician.

In the same interview the RD's response to questions regarding evaluation of the services provided, RD #2 stated that they did not routinely collect information on number of patients that did not receive nutrition care for analysis. She explained that she could provide the information. Review of the information provided showed that for the last two weeks of December 2009 (December 14-31) a total of 40 patients were not seen at the end of the day by the RD that had been responsible for their care. On the 16th of December, a total of eleven patients were not seen, because only RD was working on a day (Wednesday) when three RDs should have worked. It is unclear how many patients later received services outside of their policy guidelines and how many did not receive any nutrition care because of being discharged.

An interview was conducted with the Director of Nursing (DON) on 1/8/10 at 10:30 AM. She stated that starting on the month of November 2009, nursing had taken over collecting data on the RD's assessment of patients. Prior to November 2009 the process had been done by dietary and dietary had presented to the "Provision of Care" committee (a committee that monitors patient care and presents to the hospital QAPI committee). She stated that prior to November 2009, the numbers presented to the Provision of Care committee were very high and presented a document showing 100% compliance.

The DON stated that since nursing started doing the review the numbers were low for the month of November and December for dietary consults being completed.

In the same interview, the DON stated the the Provision of Care committee meets monthly and did meet in December; however, the information regarding the dietary assessments had not been reported to the committee. She stated that the information should have been presented to the Provision of Care committee and should have been brought forward to the hospital QAPI committee.

Based on interview and record review the facility failed to ensure that the QAPI committee set priorities that focused on high-risk, high-volume, or problem prone areas for a universe of 191 patients by failing to ensure that that committee monitored the use of their inter-facility transfer physician's orders.

This failures resulted in patients being being transferred from one unit to another without a physician review of orders for their care. (Refer to A 457)

Findings:

The clinical record for Patient 67 was reviewed on 1/6/09 (1/6/10). Patient 67 was admitted to the facility on 12/21/09 with diagnoses that included lung cancer. The clinical record indicated that Patient 67 was transferred from the intensive care unit to the telemetry unit on 1/6/10.

Review of the clinical record for Patient 67 revealed a physicians telephone order dated 1/6/09 (1/6/10) at 9:50 AM that indicated, "Downgrade pt. (patient) to telemetry" "BiPAP PRN (as needed) 12/5 if pt. does not tolerate nasal canula." The clinical record revealed that Patient 67 had 5 pages of pre-printed "Ancillary and Nursing Transfer Orders" dated 1/6/09 (1/6/10) at 9:50 AM and 3 pages of pre-printed "Pharmacy Transfer Orders" dated 1/6/09 (1/6/10) at 9:50 AM.

During an interview with Staff F on 1/6/10 at 3:10 PM, Staff F stated that the transferring physician gave telephone orders to transfer Patient 67 to telemetry and to use a BiPAP if the patient doesn't tolerate the nasal canula. Staff F stated that since the physician did not inform his to discontinue any orders that he would assume the physician wanted to continue all pre-existing orders if there were not ICU only protocols. During the interview Staff F verified that he did not read back the 5 pages of pre-printed "Ancillary and Nursing Transfer Orders" dated 1/6/09 (1/6/10) at 9:50 AM, and the 3 pages of pre-printed "Pharmacy Transfer Orders" dated 1/6/09 (1/6/10) at 9:50 AM, to the transferring physician to ensure verification and accuracy of the orders.

An interview was conducted with members of the facility's QAPI committee on 1/7/10 at 1:10 PM. The team members included the Director of Quality Management, the CNO, the Vice President of Medical Affairs, and the Director of Cardiac Care. The team confirmed that they had not collected data or monitored the process for reviewing physician's orders upon transfer to different units in the facility. They stated that all physician's orders should be reviewed and written prior to transfer to ensure that the orders are appropriate for the patient in another unit in the facility. The CNO stated the transfer process that the facility was using was "cumbersome" for the nursing staff. She stated that it should be monitored as it is a problem prone area.

Based on interview and record review the facility failed to ensure that the medical staff bylaws were enforced for 1 of 50 sampled patients (Patient 74). The facility failed to ensure that all previous orders were cancelled when the patient had an invasive procedure. This failure had the potential to cause physicians orders to be continued that are no longer appropriate for the patient's change of condition.

Findings:

A review of medical record for Patient 74 revealed that he was admitted to the facility on 1/2/10 with diagnoses that included bilateral deep vein thrombosis.

A review of the procedure notes revealed that the patient had an invasive procedure performed outside of her patient care unit on 1/4/10. The procedure was the placement of an indwelling filer to prevent potential blood clots from reaching his lungs. The procedure involved inserting a catheter into a large vein.

A review of the post procedure physicians orders revealed that there were short term physicians orders written for the immediate recovery period; however, there were no post procedure physician orders written and the pre procedure orders had not been discontinued.

An interview was conducted with the unit's nurse manager (NM) on 1/5/10 at 11 AM. She stated that the physicians do not discontinue all orders when a patient has an invasive procedure off the unit. She stated that the nurses use the original orders. The NM stated that the physicians just discontinue orders and write new orders when the patient goes to surgery.

A review of the medical staff general rules and regulations, section 3.8 Surgery Orders, revealed that "All previous orders are cancelled when the patient goes into surgery".

An interview was conducted with the Director of Nursing Center of Excellence (DON) on 1/7/10 at 3 PM. She stated that according to facility policy and medical staff bylaws the physician should discontinue all orders when the patient goes off the unit for an invasive procedure, as an invasive proceedure meets the definition of "surgery". She stated that for Patient 74 the pre procedure orders should have been discontinued and new orders should have been written.

Based on interview and record review the facility failed to ensure that an RN supervised and evaluated the nursing care for 4 of 50 sampled patients. (Patient 65, 71, 74 and 83)

For patient 65, the facility failed to ensure that the patient was monitored for an increase in her QT interval while receiving the antipsychotic medication "Haldol" intravenously (IV). (The Haldol label indicated, "Cases of sudden death, QT-prolongation {longer recovery time for the heart after each beat, can cause an early beat to start an erratic heart rhythm}, and Torsades de Pointes {erratic heart rhythm that can not sustain life} have been reported in patients receiving HALDOL. Higher than recommended doses of any formulation and intravenous administration of HALDOL appear to be associated with a higher risk of QT-prolongation and Torsades de Points.) This failure had the potential to cause sudden cardiac death.

For Patient 74, the facility failed to ensure that post procedure monitoring was completed and documented as directed by the physician and that nursing assessments were completed and documented as directed by facility policy. This failure had the potential for the patient to have post procedure complications without prompt identification and intervention by the RN.

For Patients 71 and 83, the facility failed to ensure that an RN assessed and evaluated the care of the patient's pressure ulcers as directed by facility policy. This failure had the potential to cause the pressure ulcers to worsen without prompt identification and intervention by the RN.

Findings:

1. The clinical record for Patient 65 was reviewed on 1/4/10 and 1/6/10. Review of the clinical record indicated that the patient was admitted to the facility on 12/2/09 with diagnoses that included aortic aneurysm and chest pain.

Review of Patient 65's physician's orders revealed the following HALDOL orders.
HALDOL 2mg IVP(intravenous push) now, dated 12/28/09 at 0405 (4:05 AM)
HALDOL 1 IV (intravenously) every 8 hours as needed for severe agitation, dated 12/28/09 at 2330 (11:30 PM)
Give HALDOL 2mg IVP now" and "HALDOL 2mg IV q (every) 6hrs prn (as needed) agitation" dated 12/29/09 at 855 (8:55 AM)
HALDOL 2.5 mg IV q 6hrs dated 1/4/10

Review of the Medication Administration Record (MAR) indicated that Patient 65 received HALDOL IV on the following dates and times.

1mg of HALDOL IV on 12/28/09 at 11:45 PM
2mg of HALDOL IV on 12/29/09 at 4:15 AM, 9:00 AM, 3:00 PM and 9:10 PM
2mg of HALDOL IV on 12/30/09 at 10:15 AM, 4:00 PM and 10:00 PM
2mg of HALDOL IV on 12/31/09 at 2:40 PM,
2mg of HALDOL IV on 1/1/10 at 4:45 AM, 3:30 PM, 9:00 PM
2mg of HALDOL IV on 1/2/10 at 3:30 AM, 10:30 AM and 5:15 PM
2mg of HALDOL IV on 1/3/10 at 5:00 AM and 10:24 PM
2mg of HALDOL IV on 1/4/10 at 4:30 AM and 10:30 AM
2.5mg of HALDOL IV on 1/5/10 at 12:00 PM

The manufacturers (Ortho McNeil Janssen) label approved for HALDOL(haloperidol) on 7/19/09, was reviewed on 1/6/10. The label indicated, "HALDOL is indicated for use in treatment of schizophrenia". "Cases of sudden death , QT-prolongation, and Torsades de Pointes have been reported in patients receiving HALDOL. Higher than recommended doses of any formulation and intravenous administration of HALDOL appear to be associated with a higher risk of QT-prolongation a Torsades de Points. Although cases have been reported even in the absence of predisposing factors, particular caution is advised in treating patients with other QT-prolonging conditions (including electrolyte imbalance [particularly hypokalemia and hypomagnesemia], drugs known to prolong QT, underlying cardiac abnormalities, hypothyroidism, and familial long QT-syndrome). HALDOL INJECTION IS NOT APPROVED FOR INTRAVENOUS ADMINISTRATION. If HALDOL is administered intravenously, the ECG should be monitored for QT prolongation and arrhythmias." (Torsades de Points is a type of ventricular tachycardia that has a characteristic twist of the QRS complex that is associated with prolonged QT intervals that are visible on an ECG.) (An electrocardiogram [ECG or EKG] measures the electrical activity of the heartbeat.)

Further review of Patient 65's clinical record indicated that, Patient 65's last ECG was on 12/9/09. There was no documented evidence that Patient 65 had received an ECG after the nursing staff began to administer HALDOL intravenously on 12/28/09.

During an interview with the Registered Nurse in charge of the patients care (Staff E), on 1/6/09 at 11:25 AM, Staff E stated she was not monitoring Patient 65 in regards to the administration of HALDOL intervenously. Staff E did not indicate that she was aware that the administration of HALDOL intravenously was an off-label use, and required monitoring for the prolongation of the QT interval, that could lead to sudden cardiac death.

During an interview with the Intensive Care Unit (ICU) Manager on 1/6/10 at 11:30 AM, the ICU Manager stated that the telemetry monitor technicians do not monitor the QT intervals of the patients who are on continuous telemetry monitoring. The ICU Manager was aware that the recognition of a prolonged QT interval could identify the possible occurance of Torsades de Pointes (a ventricular arrhythmia), but stated that the staff nurses in the ICU may not know to monitor for a prolonged QT interval with the use of intravenous HALDOL that cold indicate Torsades de Pointes.

During an interview with the Intensive Care Unit Team Leader (ICU TL) and the Emergency Department Director (EDD) on 1/6/10 at 11:45 AM the ICU TL verified that Patient 65 had the above listed orders for HALDOL and that Patient 65 had received intravenous does of the durg on the above listed dates and times. During the interview the EDD verified that there was no documentation in the physician's progress notes, or in the clinical record, that discussed the physician's decision to use HALDOL intravenously, which is an off-label use, prior to the administration of the drug by the nursing staff.

During an interview with the Director of Nursing Center of Excellence (DON) on 1/7/10 at 9:20 AM, the DON stated that she was not aware that administering HALDOL intravenously was an off-label use of the drug. The DON was not aware that the use of HALDOL IV required monitoring of the QT prolonged interval by the nursing staff, because of the risk of sudden cardiac death.




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2. A review of the medical record for Patient 74 revealed that he was admitted to the facility on 1/2/10 with diagnoses that included bilateral deep vein thrombosis.

Review of the procedure notes revealed that on 1/4/10 the patient underwent an invasive procedure for placement of a filter to prevent blood clots from going to the patient's lungs. The entry site for the procedure was in the patient's right groin. (This is a procedure that a catheter is passed into a large vein in the groin. Keeping the legs straight for the prescribed amount of time and monitoring of the site is important because there is a high risk for bleeding.)

Review of the physician's orders for post procedure revealed that vital signs (vs) and observation of the procedure site were to be done every 15 minutes X (times) 4 then every 30 minutes X 2, then as unit routine. The physician's orders also stated to keep the right leg straight for 2 hours post procedure (to prevent bleeding at the site).

Review of the nursing documentation for the patient revealed that on 1/4/10 at 3:45 PM the patient completed the procedure and was taken to the post procedure recovery room. VS and a check of the procedure site was documented at that time (3:45 PM). There were no further checks documented of the procedure site during the post recovery stay. VS were taken at 4:00 PM, 4:15 PM, and 4:30 PM; then, the patient was taken back to his previous nursing unit.

Review of the nursing documentation on 1/4/10 revealed that vs were not taken again until 5:00 PM. There was no documentation regarding the procedure site for the rest of the nursing flow sheet or narrative notes (from 4:30 PM through 8 AM on 1/5/10). There was no documentation that the patient's right leg was kept straight for 2 hours as ordered by the physician. There was no documentation of a nursing assessment on the patient until the next morning at 8 AM.

A review of the facility's policy for nursing assessment and reassessment timeframes, dated 5/2009, revealed that reassessment of the patient will conducted by an RN at least once per shift or more often as warranted by the patient's condition.

An interview was conducted with the RN (Staff C) who received the patient from the post procedure recovery room on 1/5/10 at 11:10 AM. She confirmed that she did not document an assessment of the procedure site and that the vs were not carried out as per physician's order. She stated that she also did not document regarding the leg being kept straight for 2 hours.

An interview was conducted with the supervisor of the nursing unit on 1/5/10 at 11:20 AM. She also reviewed the nursing documentation and confirmed that there was no further assessment (since post procedure on 1/4/10 at 3:45 PM through 1/5/10 at 8 AM) of the procedure site. She confirmed that there was no nursing assessment completed for the patient until the next morning. She stated that the facility's policy was for a nursing assessment to be completed by an RN on each 12 hour shift.

3. Review of the medical record for Patient 71 revealed that he was admitted to the facility on 1/1/10 with diagnoses that included pneumonia.

Review of the nursing documentation from the Emergency Department revealed that the patient was admitted to the facility with pressure ulcers. The pressures ulcers were not measured or staged. There were pictures taken of the pressure ulcers, dated 1/1/10.

Review of the nursing documentation on the medical/surgical floor revealed that the documentation started on 1/2/10. There was documentation of 3 pressure ulcers on 1/2/10. There were no measurements or staging done for the pressure ulcers.

A review of the "Alteration in Skin Integrity" document revealed that there was no staging of the ulcers completed (Staging of pressure ulcers is done to determine the severity of the ulcer the range is from Stage I to Stage IV.) and no documentation of measurements of the pressure ulcers from 1/2/10 until review on 1/4/10.

A review of the facility policy titled, "Skin Care/Pressure Ulcer Care", dated 5/2009 revealed the following:

"Size each ulcer/wound once weekly. Only pressure ulcers are staged: Stage weekly."

A review of the "Patient Admission History", dated 1/1/10, completed by the admitting RN revealed that an order had been placed for a consult for the "Wound/Ostomy Nurse". Review of the medical record revealed that no consult by the wound nurse was completed.

An interview was conducted with the charge nurse (Staff B) of the unit on 1/4/10 at 3 PM. She confirmed the lack of measurements and staging of the pressure ulcers. She stated that the reason the wound consult was not done was that the wound care nurse was off on a leave of absence. Staff B stated that physical therapy should do the wound care consult when the wound nurse is not available. She reviewed the medical record and stated that physical therapy had not seen the patient to consult on his pressure ulcers.

4. A review of the medical record for Patient 83 revealed that she was admitted to the facility on 11/30/09 with diagnoses that included small bowel obstruction.

A review of the facility's "Alteration in Skin Integrity" form, dated 12/3/09, revealed that the patient had a pressure ulcer on her coccyx (buttock) area. The form had an area for "Reference Guide" where nursing would add a code for the stage of the ulcer. In the area for staging the nurse documented ST, for skin tear.

Further review of the facility's form revealed that nurses were required to "Measure and photo each wound weekly. Only pressure ulcers are staged." Review of the documentation revealed that the wound was documented as a Stage II pressure ulcer on 12/11/09 and again on 12/12/09. On 12/12/09 the wound was measured. There was no further documentation of the stage or measurements of the pressure ulcer. The patient was discharged to a rehabilitation facility on 12/18/09. There was no information regarding the stage, measurement, or condition of the ulcer on discharge. There was one photo taken of the wound on discovery. Review of the medical record revealed that no further photo documentation was found.

An interview was conducted with the Director of Nursing Centre of Excellence (DON) on 1/7/09 at 3:30 PM. She confirmed that nursing had not documented on the pressure ulcer as directed by the facility policy. She stated that it was not possible to determine the condition of the wound on discharge because the documentation was not clear.

Based on interview and record review the facility failed to ensure that Emergency Department (ED) required the equivalent competencies for RNs as those required in the Intensive Care Unit (ICU) to ensusre that ED nuses were competent to care for ICU patients.

Findings:


The day shift Emergency Department (ED) schedule for 1/4/10, was reviewed on 1/7/10. The ED schedule, indicated that there were 3 ICU status patient holds in the ED.

Review of the Critical Care Registered Nurses (RNs) and Emergency Department (ED) RNs competencies, on 1/8/10, indicated that the the ED competency did not contain performance criteria included in the critical care competency. The ED competency did not include the following:

a. Administers Cardiovascular Drugs Safely
b. Hemodynamic Monitoring
c. Cares for patients with altered hemodynamic status
d. Cares for the patient undergoing cardiac intervention
e. Cares for patient with Acute Coronary Syndrome, MI, CHF, Cardiomyopathy
f. Cares for the patient requiring restraints

During an interview with the Director of the Emergency Department (ED Directer) on 1/8/09 at 2:10 PM, the ED Director stated that ED RNs take care of ICU patients when they are held in the ED due to lack of bed availability in the ICU. The ED Director also stated that ED RNs start hemodynamic drips prior to transferring patients to the ICU. During the interview the ED Director verified that the competencies for critical care nurses was the competency required for ICU RNs. The ED Director verified that the competency for ED and ICU RNs did not contain the same performance criteria

Based on interview and record review the facility failed to ensure that drugs and biologicals were prepared and administered in accordance with the orders of the practitioner responsible for the patient's care and accepted standards of practicefor 2 of 50 sampled patients. (Patients 65 and 42) The facility failed to ensure that:

A. A drug used off label from the manufactures recommendations was monitored for adverse effects for 1 of 50 sampled patients (Patient 65). The facility failed to monitor for prolonged QT intervals when HALDOL (an antipsychotic medication) was administered intravenously, which is an off label use which had the potential to result in sudden cardiac death of the patient.

B. The facility also failed to ensure that Patient 42 received an antibiotic Rocephin in a timely manner.

Findings:

1. The clinical record for Patient 65 was reviewed on 1/4/10 and 1/6/10. Review of the clinical record indicated that the patient was admitted to the facility on 12/2/09 with diagnoses that included aortic aneurysm and chest pain.

Review of Patient 65's physician's orders revealed the following HALDOL orders.
HALDOL 2mg IVP(intravenous push) now, dated 12/28/09 at 0405 (4:05 AM)
HALDOL 1 IV (intravenously) every 8 hours as needed for severe agitation, dated 12/28/09 at 2330 (11:30 PM)
Give HALDOL 2mg IVP now" and "HALDOL 2mg IV q (every) 6hrs prn (as needed) agitation" dated 12/29/09 at 855 (8:55 AM)
HALDOL 2.5 mg IV q 6hrs dated 1/4/10

Review of the Medication Administration Record (MAR) indicated that Patient 65 received HALDOL IV on the following dates and times.

1mg of HALDOL IV on 12/28/09 at 11:45 PM
2mg of HALDOL IV on 12/29/09 at 4:15 AM, 9:00 AM, 3:00 PM and 9:10 PM
2mg of HALDOL IV on 12/30/09 at 10:15 AM, 4:00 PM and 10:00 PM
2mg of HALDOL IV on 12/31/09 at 2:40 PM,
2mg of HALDOL IV on 1/1/10 at 4:45 AM, 3:30 PM, 9:00 PM
2mg of HALDOL IV on 1/2/10 at 3:30 AM, 10:30 AM and 5:15 PM
2mg of HALDOL IV on 1/3/10 at 5:00 AM and 10:24 PM
2mg of HALDOL IV on 1/4/10 at 4:30 AM and 10:30 AM
2.5mg of HALDOL IV on 1/5/10 at 12:00 PM

The manufacturers (Ortho McNeil Janssen) label approved for HALDOL(haloperidol) on 7/19/09, was reviewed on 1/6/10. The label indicated, "Cases of sudden death , QT-prolongation, and Torsades de Pointes have been reported in patients receiving HALDOL. Higher than recommended doses of any formulation and intravenous administration of HALDOL appear to be associated with a higher risk of QT-prolongation a Torsades de Points. Although cases have been reported even in the absence of predisposing factors, particular caution is advised in treating patients with other QT-prolonging conditions (including electrolyte imbalance [particularly hypokalemia and hypomagnesemia], drugs known to prolong QT, underlying cardiac abnormalities, hypothyroidism, and familial long QT-syndrome). HALDOL INJECTION IS NOT APPROVED FOR INTRAVENOUS ADMINISTRATION. If HALDOL is administered intravenously, the ECG should be monitored for QT prolongation and arrhythmias." (Torsades de Points is a type of ventricular tachycardia that has a characteristic twist of the QRS complex that is associated with prolonged QT intervals that are visible on an ECG.) (An electrocardiogram [ECG or EKG] measures the electrical activity of the heart.)

Further review of Patient 65's clinical record indicated that, Patient 65s last ECG was on 12/9/09. There was no documented evidence that Patient 65 had received an ECG after the nursing staff began to administer HALDOL intravenously on 12/28/09.

During an interview with the Registered Nurse in charge of the patients care (Staff E), on 1/6/09 at 11:25 AM, Staff E stated she was not monitoring Patient 65 in regards to the administration of HALDOL intervenously. Staff E did not indicate that she was aware that the administration of HALDOL intravenously was an off-label use, and required monitoring for the prolongation of the QT interval, that could lead to sudden cardiac death.

During an interview with the Intensive Care Unit (ICU) Manager on 1/6/10 at 11:30 AM, the ICU Manager stated that the telemetry monitor technicians do not monitor the QT intervals of the patients recieving intravenous HALDOL, while monitoring patients who are on continuous telemetry monitoring. The ICU Manager was aware that the recognition of a prlonged QT interval could lead to Torsades de Pointes (a ventricular arrhythmia), but stated that the staff nurses in the ICU may not know to monitor for a prolonged QT interval with the use of intravenous HALDOL that cold indicate Torsades de Pointes.

During an interview with the Intensive Care Unit Team Leader (ICU TL) and the Emergency Department Director (EDD) on 1/6/10 at 11:45 AM the ICU TL verified that Patient 65 had the above listed orders for HALDOL and that Patient 65 had received intravenous does of the durg on the above listed dates and times. During the interview the EDD verified that there was no documentation in the physician's progress notes, or in the clinical record, that discussed the physician's decision to use HALDOL intravenously, which is an off-label use, prior to the administration of the drug by the nursing staff.

During an interview with the Director of Nursing Center of Excellence (DON) on 1/7/10 at 9:20 AM, the DON stated that she was not aware that administering HALDOL intravenously was an off-label use of the drug.




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2. A review of Patient 42 ' s clinical record on 1/5/10 at approximately 1:44 PM revealed an order prescribed on 1/4/10 at 5:40 PM for Rocephin 1 g (gram) IV (intravenous) daily, Ist (first) dose Now.

A review of the Medication Administration Record (MAR) for use during 1/4/10 from 7:01 AM through 7 AM, 1/5/10 revealed that Rocephin was administered at 10 PM on 1/4/10, four (4) hours and twenty (20) minutes after the order was written.

A review of the facility's policy and procedure titled, Medication Administration Hospital Wide Plan documents " To establish safe, effective systems of distribution, dispensing, administration, monitoring and documentation of drugs or chemical within ... " . It further documents that standard times of medication administration shall be utilized unless specifically ordered by the physician ... " . Further review of the policy revealed that ' STAT ' medications are to be administered within 30 minutes. Unlike standard and STAT times, the facility has not established a time frame for 'NOW' medications.

In a concurrent interview on 1/5/10, with the pharmacy director, clinical pharmacy manager, and Chief Nursing Officer, they confirmed that the antibiotic was ordered and administered at the times stated (5:40 PM and 10 PM respectively) as documented in the clinical record. They were unable to determine why the delay in administration occurred four (4) hours and twenty (20) minutes after the order was written.

Based on interview and document review, not all entries to the medical record were complete with a date and time for 6 of 50 Medical records reviewed (1, 2, 5, 6, 8, 9) had incomplete entries. Verbal/telephone orders were also found with an improper authentication, lacking time or date or both. This resulted in the inability to properly sequence events and entries documented in the medical record.

For 1 of 50 sampled patients (Patient 74), the facility failed to ensure that a teaching record, prior to an invasive procedure, was completed as per policy. This failure had the potential to result in the patient not having full understanding of the procedure performed.

Findings:

1. The Medical Staff Rule and Regulations were reviewed on January 3, 2010 at 1:10 P.M. Page 11 states that all medical records shall be completed within 14 days of discharge of the patient.

2. Medical Records were reviewed on January 4, 2010 at 3:00 P.M. continuing the following morning. The record for patient 1 contained a telephone order to discontinue Dilaudid and Darvocet on 10/6/09. The physician had signed the order but there was no date or time of the authentication. A telephone transfer order on 10/4/09 was signed by the physician but with no date and time of signature. Written orders on 10/4/09 for IV change, Foley catheter and medications were dated but not timed. In addition, the transcribed Discharge Summary had not been signed by the physician within 14 days as required by hospital policy and regulation. The patient was discharged 10/8/09 and the record reviewed 1/3/10, almost three months later. The medical record for patient 2 contained a verbal order set on 10/2/09 that was signed by the physician but with no date or time of signature. Patient 5 ' s record had telephone orders on 8/28/09 that contained no time or date of the authenticating physician ' s signature. The record for patient 6 contained a telephone order for OTC Motrin on 12/5/09 that was signed by the physician with no date or time of the signature. There was also a written order 12/4/09 for follow up that was dated but not timed. Three additional written orders had a date but no time. A verbal order of 12/5/09 to remove the Picc line was signed by the doctor with no date or time, and not signed by the nurse. The medical record for patient 8 contained orders from 7/03/09 that were dated and signed but with no time entry by the physician. A verbal order on 7/1/09 was signed by the physician but with no time or date of the authentication. The record for patient 9 contained multiple progress notes that were dated but not timed. Examples are found on 9/5/09, 9/6/09 and 9/7/09.




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3. A review of the medical record for Patient 74 revealed that he was admitted to the facility on 1/2/10 with diagnoses that included deep vein thrombosis.

A review of the facility "Pre-Op Teaching" record (for an invasive procedure that the patient was to have) revealed a series of teaching points. On the top of the form it documented, "Date and initial appropriate columns". Review of the columns revealed a check mark in each column under the heading of "explained" and "states understand". Further review of the form revealed no initials on the form and no signature of who did the teaching. There was also a date at the top of the form; however, no date in the columns to indicate when the teaching was completed.

A review of the facility policy titled, "Charting, General Instructions", dated 5/2009, revealed the following:

"All clinical entries shall be accurately dated and signed."

An interview was conducted with accompanying administrative staff 1 on 1/4/10 at 11 AM. The staff member confirmed that the form was not completed as per hospital policy.

Based on interview and record review the facility failed to ensure that telephone/verbal orders were authenticated for 7 of 50 sampled patients (Patients 65, 67, 1,2,5,6 and 8).

For Patient 65 the facility failed to ensure that telephone/verbal orders were signed and dated within 48 hours which had the potential to result in transcription errors not being identified timely.

For Patient 67 the facility failed to read back intra-facility transfer orders to a physician which had the potential to result in transcription errors not being identified timely.

For five records reviewed (Patients 1, 2, 5 ,6, 8) did not have complete authentications. Many authenticating signatures were not dated or timed. This resulted in an inability of the hospital to ensure that verbal and telephone orders were authenticated by the physician within 48 hours and required by hospital policy and regulation.


Findings:

1. The clinical record for Patient 65 was reviewed on 1/4/10. The clinical record indicated that the Patient 65 was a 73 year old female admitted to the facility on 12/3/09 with diagnoses that included aortic aneurysm and chest pain.

Review of Patient 65's physician's orders indicated the following:

a. A telephone order dated 12/28/09 at 4:05 PM for "Haldol 2 milligrams (mg) IVP now", with no physician's signature as of 1/4/10.

b. A telephone order dated 12/29/09 at 8:55 AM indicating "Give Haldol 2mg IVP now" and "Haldol 2mg IVP q(every) 6 hrs(hours) prn(as needed) agitation" with no physician's signature as of 1/4/10.

c. A telephone order dated 12/29/09 at 4:00 AM, for physical restraints, with no physician's signature as of 1/4/10.

Review of the facility policy and procedure titled "Physician's Orders" indicated, "All physician orders are to be received by a Registered Nurse (RN). Physical Therapist (PT), or Respiratory Care Practitioner (RCP) may receive orders that are within their scope of practice, and must be signed and dated by the ordering physician within 48 hours of the order".

During an interview with Staff H on 1/4/10 at 10:45 AM, Staff H stated that physician telephone and verbal order should be signed by the physician within 48 hours. Staff H verified that Patient 65 had physician telephone orders dated 12/28/09 and 12/29/09 that had not been verified and signed by the physician as of 1/4/10.

2. The clinical record for Patient 67 was reviewed on 1/6/09 (1/6/10). Patient 67 was admitted to the facility on 12/21/09 with diagnoses that included lung cancer. The clinical record indicated that Patient 67 was transferred from the intensive care unit to the telemetry unit on 1/6/10.

Review of the clinical record for Patient 67 revealed a physicians telephone order dated 1/6/09 (1/6/10) at 9:50 AM that indicated, "Downgrade pt. (patient) to telemetry" "BiPAP PRN (as needed) 12/5 if pt. does not tolerate nasal canula." The clinical record revealed that Patient 67 had 5 pages of pre-printed "Ancillary and Nursing Transfer Orders" dated 1/6/09 (1/6/10) at 9:50 AM and 3 pages of pre-printed "Pharmacy Transfer Orders" dated 1/6/09 (1/6/10) at 9:50 AM.

During an interview with Staff F on 1/6/10 at 3:10 PM, Staff F stated that the transferring physician gave telephone orders to transfer Patient 67 to telemetry and to use a BiPAP if the patient doesn't tolerate the nasal canula. Staff F stated that since the physician did not inform his to discontinue any orders that he would assume the physician wanted to continue all pre-existing orders if there were not ICU only protocols. During the interview Staff F verified that he did not read back the 5 pages of pre-printed "Ancillary and Nursing Transfer Orders" dated 1/6/09 (1/6/10) at 9:50 AM, and the 3 pages of pre-printed "Pharmacy Transfer Orders" dated 1/6/09 (1/6/10) at 9:50 AM, to the transferring physician to ensure verification and accuracy of the orders.

Review of the facility policy and procedure titled "Physician's Orders" indicated, "All physician orders received by telephone or verbal order are to be read back to the physician for accuracy and signed as a read back order (RBO)".













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3. The Medical Staff Rule and Regulations were reviewed on January 3, 2010 at 1:10 P.M. Page 5 states that verbal and telephone orders must be signed by the physician within 48 hours.

4. Medical Records were reviewed on January 4, 2010 at 3:00 P.M. continuing the following morning. The record for patient 1 contained a telephone order to discontinue Dilaudid and Darvocet on 10/6/09. The physician had signed the order but there was no date or time of the authentication. A telephone transfer order on 10/4/09 was signed by the physician but with no date and time of signature. The medical record for patient 2 contained a verbal order set on 10/2/09 that was signed by the physician but with no date or time of signature. Patient 5 ' s record had telephone orders on 8/28/09 that contained no time or date of the authenticating physician ' s signature. The record for patient 6 contained a telephone order for OTC Motrin on 12/5/09 that was signed by the physician with no date or time of the signature. A verbal order of 12/5/09 to remove the Picc line was signed by the doctor with no date or time, and not signed by the nurse. The medical record for patient 8 contained a verbal order on 7/1/09 was signed by the physician but with no time or date of the authentication.

Based on observations, record reviews, interviews, document reviews, and policy and procedure reviews, the hospital did not provide pharmaceutical services that met the needs of all of the patients.

1. Pharmaceutical services were not provided according to accepted professional principles. Refer to A 0160, A0404, A0491, A0500

2. Failure to ensure that evaluation of medications stored in the pharmacy ' s refrigerator conformed with state and federal regulations. Refer to A0491

3. Failure to identify that 1 of 50 sampled patients (Patient 65) received IV (intravenous) Haldol (haloperidol) as a chemical restraint, and the lack of monitoring for the high alert medication (Haldol (haloperidol) with a black box warning. Refer to A0160

4. Unusable (outdated) medications and biologics are not available for patient use. Refer to A0505

5. Failure to ensure that parenteral nutrition policies and procedures, and preprinted forms were revised to accurately reflect current practice within the facility by pharmacy and nutrition services. Refer to A0491

6. Failure to ensure that the facility's intravenous preparation area comply with the United States Pharmacopeia 797 (USP) standards for Pharmaceutical Compounding-Sterile Preparations, which sets practice standards to help ensure that compounded sterile preparations are of high quality. Refer to A0491


The cumulative effect of the systemic problems resulted in the hospital ' s inability to ensure the provision of pharmaceutical services in a safe environment.

Based on observation and interview, policies and procedure reviews, the facility failed to ensure that (1)the facility's intravenous preparation area comply with the United States Pharmacopeia 797 (USP) standards for Pharmaceutical Compounding-Sterile Preparations, which sets practice standards to help ensure that compounded sterile preparations are of high quality. (2) The facility also failed to ensure that the pharmacy's refrigerator temperatures were consistently recorded, and (3) that parenteral nutrition policies and procedures were revised to accurately reflect current practice within the facility by pharmacy and nutrition services.

Findings:

1. During an inspection of the pharmacy on 1/4/10 at approximately 11 AM, it was observed that the IV preparation area was not separated into a clean and non-clean (buffer, ante) area. USP 797 addresses facilities in which sterile products are prepared according to the manufacturers' labeling and where manipulations are performed during the compounding of sterile products which increase the potential for microbial contamination of the prepared products. It delineates what training is needed, how the preparation area should be designed, equipment type, and quality control program formalized in writing.

In an interview with the Director of Pharmacy he reported that the facility's intravenous preparation area does not comply with the United States Pharmacopeia 797 (USP) standards for Pharmaceutical Compounding-Sterile Preparations, and the request was submitted.

2. During an inspection of the pharmacy on 1/4/10 at approximately 11 AM, it was observed that the refrigerator temperatures were not consistently logged, i.e. frequently assessed on a daily basis. A review of the refrigerator temperature logs for July 2009 through December 2009, revealed that 7/1/09, the themperature was 35 degrees Fahrenheit (F) (normal range 36-46 degrees F) and 7/27/09 the temperature was not recorded. On 10/7, 24, and 25/09 the temperatures were 35 degrees Fahrenheit and 10/30/09 the temperature was not recorded. On 11/8, 17, 22, 24, 30/2009 the temperature was 35 degrees F. On 12/11/09 the temperature was 34 degrees Fahrenheit.

Further review of the temperature log revealed that the temperature range documented as 34 degrees Fahrenheit to 47 degrees Fahrenheit (normal range 36-46 degrees F), therefore, when the temperatures fell outsite of the normal range, maintenance was not notified to adjust or check the refrigerator temperatures.

A frequency of temperature assessment demonstrates that a hospital has implemented a system (e.g. policy and procedure) to ensure safe use of refrigerated medications; in that the medication has been stored properly, and has retained its designated potency, sterility, and is absent of contaminants or is otherwise not considered unusable. To promote safe storage of medication there should be control systems implemented that allow a hospital to demonstrate that refrigerated medications have been stored within the prescribed temperature range at all times from the point of acquisition to disposition (e.g. administration, wastage or return to manufacturer).
Moreover, in the development of a policy and procedure related to safe storage of refrigerated medications a hospital should assess how to rapidly identify variations in temperatures that may result from power interruption, malfunctioning refrigerators or failure to close refrigerators. Additionally, the equipment utilized for temperature assessment must be functioning properly and periodically assessed for accuracy of temperature assessment.
Documentation (logging) of refrigerator temperatures is one method to promote safe storage of medications which should be augmented by visual inspection of the medications for particulate matter or discoloration.
In a concurrent interview, the Director of Pharmacy acknowledged that the temperature log lacked correct instructions, temperatures were not consistently recorded, and the instances when the temperatures were documented as abnormal, no action was consistently taken.

3. Parenteral nutrition policies and procedures were not revised to accurately reflect current practice within the facility by pharmacy and nutrition services as follows:

a. Review of the facility ' s policy and procedures (P&P) on 1/ 6 /10 at approximately 2 PM titled, " Medication Administration Hospital wide Plan " , a policy which would reflect the practices of the facility revealed that the medication dispensing function during the hours of 11 PM to 7 AM is provided by a contracted service as documented on pages 3 and 5. A review of correspondence dated 7/3/2009 documents discontinuation of the external service effective 9/2/2009.

In an interview conducted 1/ 6 /10 at approximately 2 PM, the Director of Pharmacy (DOP) reported this service to be provided by the pharmacy, not outsourced as documented in the current P&P titled, " Medication Administration Hospital wide Plan " . The policy and procedure was reviewed on 12/2009; not revised to reflect the change in service.

b. A review of Patient 45 ' s clinical record revealed TPN orders written by the pharmacist 1/5/10 at 1200 (12 PM) per protocol. The protocol allows the pharmacist to initiate and monitor TPN therapy in accordance with the physician ' s order written on 1/4/10. Review of the pharmacy provided facility ' s policy and procedures (P&P) on 1/ 7 /10, at approximately 3 PM titled, " Total Parenteral Nutrition (TPN) " , states, " Any change in the TPN formula should be written and received in the Pharmacy by 1100 (11AM) daily. " When asked, pharmacy management reported that the ' cut off ' time to receive TPN orders in pharmacy is 12 noon, and that deliveries are made by AAAA at 6 PM daily.

A review of the " IV SERVICES CONTRACT " on 1/6/10 which includes the provision of TPNs to the facility revealed in Section VI. SERVICE LEVELS, that " AAAA will guarantee a monthly service level of 100% of all orders received prior to the cut off time ' as mutually agreed to in writing ' . " This would indicate that there is a specific cut off time agreed upon by the contracted service and pharmacy management. Pharmacy management was unable to provide written documentation of the cut off time per the IV SERVICES CONTRACT and confirmed that the current policy and procedure reviewed 5/2009 did not reflect actual practice.

c. Review of a facility policy and procedures (P&P) titled, " Nutrition Support and Formulary " on 1/6/10 revealed that it was revised 5/2009. The P&P documents that " patient evaluation will be completed within 24 hours of notification of the patient being started on TPN by the Dietitian. " A review of the Parenteral Nutrition Order Form used to initiate the TPN protocol documents, " Nutrition assessment (evaluation) of all patients receiving parenteral nutrition will be done within 48 hours of initial order (except weekends and holidays) by the Clinical Dietician. " When asked, pharmacy and nurse managements confirmed that the current policy and procedure did not reflect actual practice.

Based on record review, interview, and policy and procedure review, the facility failed to ensure that (1) Patient 42 received an antibiotic Rocephin in a timely manner, (2) medications brought to the facility for Patient 44 were secured per policy and procedure, and (3) the facility failed to ensure that the use of Promethazine was evaluated by the medical staff committee.

Findings:

1. A review of Patient 42 ' s clinical record on 1/5/10 at approximately 1:44 PM revealed an order prescribed on 1/4/10 at 5:40 PM for Rocephin 1 g (gram) IV (intravenous) daily, Ist (first) dose Now.

A review of the Medication Administration Record (MAR) for use during 1/4/10 from 7:01 AM through 7AM, 1/5/10 revealed that Rocephin was administered at 10 PM on 1/4/10, four (4) hours and twenty (20) minutes after the order was written. When asked, the clinical pharmacy manager presented a document showing that the pharmacy entered the order into their system at 5:54 PM on 1/4/10 with a scheduled administration time of 6 PM.

A review of the facility ' s policy and procedure titled, Medication Administration Hospital Wide Plan documents " To establish safe, effective systems of distribution, dispensing, administration, monitoring and documentation of drugs or chemical within ... " . It further documents that standard times of medication administration shall be utilized unless specifically ordered by the physician ... " . Further review of the policy revealed that ' STAT ' medications are to be administered within 30 minutes. Unlike standard and STAT times, the facility has not established a time frame for ' NOW ' medications.

In a concurrent interview on 1/5/10, with the pharmacy director, clinical pharmacy manager, and Chief Nursing Officer, they confirmed that the antibiotic was ordered and administered at the times stated (5:40 PM and 10 PM respectively) as documented in the clinical record. They were unable to determine why the delay in administration occurred four (4) hours and twenty (20) minutes after the order was written.

2. A medication observation pass conducted on 1/5/10 at approximately 10:18 AM, revealed a tackle box containing nine (9) prescription medications and two (2) over the counter drugs had been placed on the bedside table of Patient 44. The tackle box also contained Vicodin tablets, a controlled substance. The drugs were not secured or managed according to the facility's policy and procedure titled, 'Patient's Own Medications'.

During the medication observation pass, the facility staff consisting of the nurse, nurse management, and pharmacy management were interviewed regarding the management of medications brought to the facility. The nurse who is responsible for activities surrounding the care of patients reported that the patient's wife brought the tackle box and placed it on the bedside table, and that she was not aware that medications were in the tackle box. The family member had not been questioned regarding the content of the tackle box therefore, the medications were left unsecured and available to staff and visitors.

3. The medication administration record (MAR) of Patient 46 ' s dated 12/25/09 - 12/26/09 and reviewed on 1/6/10 at approximately 2:13 PM documented that Patient 46 was administered promethazine 25 mg/IV ( milligrams/ intravenous) at 3:15 AM for nausea and vomiting. Upon interview, pharmacy management reported that the committee had not re-evaluated its use based on the FDA ' s determination that promethazine IV required a black box warning.
Food and Drug Administration (FDA) Special Alerts - Promethazine Injection: Serious Tissue Injury - September 2009. The U.S. Food and Drug Administration (FDA) is requiring manufacturers to revise the labeling for promethazine injection and is alerting healthcare professionals to new prescribing information. The FDA has received reports of severe tissue injury (including gangrene) requiring fasciotomy, skin graft, and/or amputation following the intravenous administration of promethazine. Severe tissue injury can occur from perivascular extravasation, unintentional intra-arterial administration, and intraneuronal or perineuronal infiltration. In addition, the agency has received numerous reports of injection site pain, phlebitis, cyanosis, swelling, blistering, necrosis, and nerve damage with promethazine administration.
As a result, the FDA has requested that a Boxed Warning emphasizing the risk of serious tissue injury be added to the labeling and that the Dosage and Administration section be revised. Due to the risk of tissue injury, deep intramuscular injection is the preferred route of administration. Intra-arterial and subcutaneous administration of promethazine are contraindicated. In addition, promethazine should not be administered to patients <2 years of age because of the risk of fatal respiratory depression. If intravenous administration is required, the recommended maximum concentration is 25 mg/mL and the maximum rate of administration is 25 mg/minute into a properly functioning I.V. line. Healthcare providers should monitor patients for signs and symptoms of potential tissue injury including burning or pain at the injection site, phlebitis, swelling, and blistering. The injection should be discontinued immediately if the patient complains of pain during administration. Side effects may occur immediately or may develop hours to days after an injection.
The facility MAR did not contain warnings that IV promethazine is a high alert medication with a black box warning from the Food and Drug Administration, to communicate the update to nursing staff.

Based on observation, interview, document review, and policy and procedure review, the facility failed to ensure that expired drugs were removed from the pharmacy's medication refrigerator, intravenous ( IV) compounding (preparation) area, and Patient 43's room.

Findings:
1. A tour of the pharmacy was conducted on 1/4/10 at approximately 10:50 AM. Inspection of the pharmacy's refrigerator revealed that the following drugs had expired:
- Chlorambucil 2 mg (milligrams), a drug used in the management of chronic lymphocytic leukemia (CLL), Hodgkin's lymphoma, non-Hodgkin's lymphoma (NHL) expired 9/28/09
-Thyrolar 3 tablets (a replacement or supplemental therapy in hypothyroidism) expired 10/09.
2. Inspection of the IV (intravenous) compounding area within the pharmacy on 1/4/10, at approximately 11 AM revealed the following:
- A liter bag of 0.45% sodium chloride opened and used in the preparation of parenteral solutions on 1/3/10 was not discarded.
- Intralipid 20%, a brand for fat emulsion, opened and used in the preparation of total parenteral nutrition on 1/2/10 at 7:50 PM was not discarded within 24 hours.
3 During the medication observation pass conducted on 1/5/10 at approximately 9:55AM, IV (intravenous) solutions consisting of 0.9% sodium chloride, one 250 milliliters, and one liter respectively were observed on the Patient 43's IV pole. There were other IV solutions hanging from the pole.
Inspection of the IVs and their attached tubings revealed that the 250 milliliter bag of 0.9% sodium chloride opened on 1/1/10 remained on the IV pole. In addition, the tubing attached to the one liter IV solution of 0.9% sodium chloride labeled 'remove of Monday' which should have been removed Monday, 1/4/10 was available for patient use. When asked, why the IV's and tubing were not removed in a timely manner to be unavailable for use, and to allow for sufficient space, the nurse confirmed the dates opened, tubing labeled, then gathered the IVs and tubing and removed them from the pole.
The facility's policy and procedure titled, ' Intravenous Therapy' documents that IV tubing should be labeled with date, time and initials of the nurse and changed every 72 hours.. and "hang time maximums: standard IV solutions - 24 hours, parenteral nutrition fluids including those containing lipids - 24 hours".
In an interview with the Director of Pharmacy (DOP), he acknowledged that expired medications and devices for administration should not be available for patients.

Based on observation, clinical record reviews, review of hospital policies and procedures and staff interviews, the hospital failed to ensure that its food and dietetic service was organized, directed and staffed in a manner that met the nutritional needs of its patients. The hospital also failed to ensure that food and diets served followed acceptable standards of practice and were in accordance with practitioners' orders.

Findings:

Observations made from January 4-7, 2010, revealed several deficient practices in the areas of food service and nutrition care. These deficient practices identified included the fact that the hospital lacked a diet manual from which physician and nursing and dietary staff could be as guidance or basis for ordering and patient diets. (Cross refer A0631)

The hospital lacked a policy and system to ensure that patients, for whom thickened liquids were ordered, received the correct consistency. Patient #71 who had a thickened liquid ordered as part of his diet, may not have received the proper consistency to meet his needs. The patient was not assessed for the proper consistency, it could not be determined what consistency was prepared because the kitchen did not prepare it and nurses interviewed either did not prepare it or prepared it incorrectly. Interviews from nursing staff revealed that they had not been trained by either dietary, nursing or speech therapy staff on the proper consistency. (Cross refer A0629)

During tray line observations on January 4-5, 2010, it was determined that the dietary staff served patients amounts of food less than was planned by the dietitian or ordered by their physician because of use of incorrect scoop sizes and poor staff knowledge . This resulted in some patients receiving less protein and calories than was required for the meal. (Cross refer A0630)

The hospital ' s nutrition care policy allows nutrition assessment of patients to occur up to 3 days after admission. Four of six clinical record reviewed Patients # 71,**** showed nutrition assessment conducted on the third day, only one patient was seen within 24 hours and one patient was not assessed within 24 hours according to their policy. The screening criteria limit the numbers of patients that are seen by the dietitian. According to hospital policy, nursing staff screens all patients for risk factors including nutrition and when patients meet the specified criteria (Priority 1), they are referred to the RD. However, when nursing screens result in referral to the dietitian, these patients are not assessed until the third day of the referral or 4th day of admission. This practice and policy in the nutrition services departments is in conflict with a nursing policy which indicated that initial assessments by the nutritional services will be completed within 24 hours. The average length of stay for some of these patients was 4 days, this policy does not allow the RD to timely provide care and evaluate care provided before discharge. (Cross refer A0621)

The hospital lacked adequate staff to cover the patients that meet the criteria for nutrition assessment timelines. There is no RD providing service to the hospital's NICU (newborn intensive care unit) and have limited service in the pediatric unit and patient discharge education. Nutrition services department failed to evaluate the number of patients not assessed by the RD in order to determine staff needs. Nursing staff do not consistently refer all eligible patients to the dietitian. The study that identified this problem was not shared with the hospital QAPI. (Cross refer A0621 and A0630)

One of the infection control policies allowed the practice of wiping down patient trays with kitchen towels when wet. The explanation given by the Foodservice manager in an interview on January 6, 2010 at approximately 3:00 pm was that the practice was acceptable because the tray is not a food contact surface. The infection control nurse was also interviewed regarding this policy. She stated on January 7, 2010 at approximately 9:00 am that she could not find evidence to support the practice. (Cross refer A622)

Food service staff did not correctly demonstrate how to test the chemical sanitizers in three-compartment sink and low temperature dish machine. (cross refer A0622)

Nursing staff order therapeutic without physician ' s order or clarification of unspecific diet orders such as DFA (diet for age), DAT (diet as tolerated), renal diet and thickened liquid. (Cross refer A0630)

The cumulative effect of these deficient practices resulted in the hospital failing to ensure that the food and nutrition department was properly organized to provide for the nutritional needs of its patients.

Based on review of clinical records, facility documents and staff interviews, it was determined that the hospital failed to ensure that there were adequate dietitians to provide for the nutritional care of its patients in a universe of 191 patients.

Findings:

1. Patient #21 was admitted on 12/26/09 with diagnoses including upper GI bleed, renal failure, respiratory failure and multiple pressure ulcers. Closed record review showed that the patient had several risk factors, medication and therapies that required a dietary consult. These risks or therapies include dependence on ventilator, versed (medication) and pressure ulcers.

A dietary consult was ordered on 12/26/09 at approximately 1300 hours. There was no documented evidence that the consult was completed. Interview on 1/6/2010 at approximately 10:50 am ,with the registered dietitian (RD#2) who was scheduled to work, indicated that the assessment was not completed. She stated that she was unable to complete the assessment due to the large number of patients that she had to see on that day. Patient #21 expired on 12/27/09.

2. Patient #23 is a 59 year old female admitted to the hospital on 1/3/2010 with diagnoses including head injury and renal failure. The physician ordered diet was a renal diet.

Review of the patient ' s clinical record showed that the patient was not assessed by the nutrition staff because according to the registered dietitian (RD#1) she did not meet their criteria for assessment. In response to a question on description of the hospital ' s renal diet, she stated that the renal diet consisted of 60 gm protein, 2gm sodium, 1.5 gm potassium and 1 gm phosphorous. She further explained that the amount of protein could be 80 gm, if the patient was on dialysis.

Patient #23 had a dialysis treatment while in the hospital and it was unclear which of the protein levels of the renal diet she received.

Further review of the record showed that patient #23 was served an 1800 cal ADA renal diet on 01/05/2010 not a renal diet as ordered by the physician on 01/03/2010. The RN was interviewed on the diet served as there was no order in the record for the 1800 cal ADA component of the diet. She stated that the patient had diabetes as an additional diagnosis. No nutrition assessment was conducted on the patient by the RD so the adequacy and appropriateness of her diet could not be evaluated.

3. Patient #22 is a 16month old admitted to the hospital on 1/2/10 with diagnoses including bronchiolitis, asthma and hyperglycemia. Review of clinical record showed that the patient was screened by nursing staff per their policy. But the assessments such as BMI, height, weight were not completed. Growth charts were not plotted and no nutrition assessments were completed by the RD. RD #1 stated that the RDs do not routinely assess or screen pediatric patients until the 4th day of admission unless there is a nurse or MD consult.

4. Patient #25 was admitted on1/5/10 with diagnoses including ulcerative colitis. According to the hospital policy patients who have GI diagnoses will be screened

Interviews conducted with two of the dietitians on 1/6 and 1/7 2010 and the director of nutritional services on 1/7/2010 revealed that the facility had employed two full-time dietitians, two part-time dietitians and one on-call dietitian.

The dietitians (RD #1 and RD#2) explained that they have three dietitians working on Mondays, Wednesdays and Fridays. Two dietitians work on Tuesdays and Thursdays but there is only one RD on weekends and on holidays. They further explained that one RD generally sees approximately 12 to 18 patients per day. The weekend that ended prior to the start of the validation survey, which was also a holiday weekend, only one RD worked per day. The RD that worked on the Sunday indicated that she had about 45 patients to assess or follow-up and that she was unable to complete all she needed to do and that Patient #21 was one of them.

During the interview of 1/6/2010, the RD explained that they do not have a dietitian to go into NICU to do nutritional assessments because they are only able to do assessments and consults in the medical-surgical floors. In addition, they do not screen pediatric patients until the 4th day. They explained that they no longer do patient screening because the nurses screen all patients including the nutrition within 24 hours of admission. The RDs explained that when they receive referral from the nurses, they do not screen or assess such patients until three days later and that the only patients they see within 24 hours are consults from physicians and patients receiving TPN (Total Parental Nutrition).They do not routinely do discharge education unless it is requested by the physician.

In response to questions regarding evaluation of the services provided, RD #2 stated that they did not routinely collect information on number of patients that did not receive nutrition care for analysis. She explained that she could provide the information. Review of the information provided showed that for the last two weeks of December 2009 (December 14-31) a total of 40 patients were not seen at the end of the day by the RD that had been responsible for their care. On the 16th of December, a total of eleven patients were not seen, because only RD was working on a day (Wednesday) when three RDs should have worked. It is unclear how many patients later received services outside of their policy guidelines and how many did not receive any nutrition care because of being discharged.

The hospital has not had a Clinical Nutrition Manager (CNM) since July 2009. The CNM is the nutrition professional designated in most hospitals as responsible for ensuring that current nutritional standards in the hospital and competencies are maintained. Interviews and document reviews with the Chief of Human Resources and director of Nutrition services on 1/6 and 1/7/2010 respectively, showed that the hospital has been attempting to recruit for this position for almost a year. They both indicated that up to 50% of this position would be responsible for direct patient care. The lack of this position of leadership has resulted in lack of evaluation of the effectiveness of medical nutrition therapy, provision of nutrition care in all areas of the hospital where it is needed.
The hospital failed to ensure that there were sufficient dietitians hired to meet the nutritional needs of its patients.

Based on observation, review of facility logs, policies and procedures, interviews with chemical company representative and hospital staff, the hospital failed to ensure that food service staff were competent to properly demonstrate how to test sanitizer concentrations in the dish machine and three compartment sink. One employee was not able to log the thermometer according to hospital policies.

Findings:
During the initial tour of the kitchen, on 1/4/10, at 11:05 AM, a bag containing three individual frozen pizzas and another bag containing six individual frozen pizzas were observed in the cook ' s reach in freezer. The bags were not dated.
During an interview with the Dietary Services Supervisor (DSS), at the time of the observation, she stated that it is the practice of the dietary staff to date the bags of frozen pizza when any pizzas are removed from a bag of six. She further stated that the pizzas are shipped frozen, six to a bag, with multiple bags in a case. The cases are labeled with the expiration date of the pizzas, not the individual bags. These cases are stored in the walk-in freezer. She confirmed that once the bags are removed from the case sand placed in the cook ' s reach-in freezer, there is no way for the staff to know the expiration date.
Continuing on the initial tour of the kitchen, during an interview with FSW I, she was asked to explain the procedure for ware washing in the three compartment sink. She stated that to determine that the sanitizer concentration was adequate, she needed to place the test strip in the solution in the sanitizer sink for ten seconds. She was then observed to place the test strip in the solution of the sanitizer sink for approximately five seconds. She then removed the strip and checked the color of the strip against a chart on the wall adjacent to the sink.
During an interview with FSW 2 on 1/4/10, at 2:20 PM, in the dishwashing area, she was asked to show how she knows the dishwasher is sanitizing the dishes properly. She stated that the correct procedure to test the chlorine sanitizer concentration in the dishwasher. She further stated that after she tests the concentration, she must have another FSW compare the strip to a chart to determine if the concentration of the solution is adequate. She stated that the strip should indicate that the chlorine concentration in the dishwasher is 50 parts per million (ppm) to sanitize the dishes.
She showed the test strip to FSW 3. FSW 3 stated that the strip indicated that the concentration of the sanitizer was 200 ppm. An observation of the test strip indicated that the concentration of the sanitizer in the dishwasher was 50 ppm. During a concurrent interview with the DSS, she confirmed that the test strip read 50 ppm. The food service employees were able to correctly state the correct procedures but were unable to correctly demonstrate the process.
During another kitchen observation, on 1/4/10, at 2:30 PM, FSW 4 was observed using a terrycloth towel to dry patient meal trays before placing the placemats on them. FSW 4 was interviewed, at the time of the observation, and she stated that she dries the patient meal trays, because they are still wet when she needs to place the paper placemats on them. During a subsequent interview with the FM, she stated that the trays should air dry and should not be dried with a cloth. She confirmed that drying the patient meal trays with a cloth increased the risk for transferring infectious agents from one tray to all the others.
During an interview with chemical company representative, on 1/7/10, at 9:30 AM, he stated that the patient meal trays are placed on a rack above the dishwasher after they are cleaned. He further stated that the steam from the dishwasher does not allow the trays to adequately dry. He also stated that he had done an inservice with the staff, the day before, for the staff to remove the trays from this area to allow for air drying. A concurrent observation showed the trays continued to be stored on the same rack above the dishwasher. This was confirmed by the technician.
During an observation of the kitchen, on 1/4/10, at 2:40 PM, the interior (or ambient) thermometer in reach-in refrigerator was hanging from the ceiling of the refrigerator. The thermometer was read 28 degrees Fahrenheit. During a concurrent interview with the FSM, she stated the dietary staff is supposed to record the temperature displayed on the outside of the refrigerator. The refrigerator temperature log for that refrigerator was displayed on the door of the refrigerator and was reviewed. It stated that the ambient temperature (temperature measured on a thermometer inside the refrigerator) is to be recorded on the log. The DSS then confirmed that the ambient temperature should be recorded on the log.
During a concurrent interview with FSW 5, he stated that he records on the log the temperature that is displayed on the inside of the refrigerator. When asked to read the thermometer on the inside of the refrigerator he stated that it read zero degrees. When asked where he saw zero degrees, he indicated the temperature reading on the centigrade and not Fahrenheit portion of the thermometer. He verified that the temperature recorded on the log was in Fahrenheit. When asked if he uses the thermometer inside the refrigerator, he stated he logs the temperature on the outside but verified it against the thermometer reading on the inside. This was another employee who was able to state the correct procedure but unable to correctly demonstrate.

Based on observation review of the hospital menu and staff interviews, the hospital failed to ensure that the menu met the needs of the patients in a universe of 191 patients.

Finding:

The hospital did not have a complete nutrient analysis of all of its diets to validate that it is nutritionally balanced and meeting the dietary needs of the patients. The hospital did not have a diet manual that describes the diets served in the hospital and their nutritional adequacy.

1. During lunch tray line observation on 1/4/10 at approximately 12:10 PM, the following hot entree items were served to patients on the regular diet: Chicken with bowtie pasta served in a cream sauce with asparagus and tomato bisque. Patients on low sodium diets received a modified version of the same items. According to the production sheet the serving size for the chicken with bowtie pasta is 4oz pasta 1/3 cup and 4 oz asparagus.

The cook was observed to serve the chicken inconsistently with some patients being served significantly less portions than planned on the menu. On such patient tray was examined; based on the modification of the diet, the patient was allowed 2oz of chicken on her diet but was served 1.6 oz of chicken before the tray was stopped from being sent to the patient.

In addition, the low sodium cream sauce looked significantly different than the regular sauce. It did not have the herbs and spices visible in the other sauce. The cook was also observed to serve this sauce to other patients there were not on low sodium diets such as soft, no gastric, bland and calculated diets.

The Foodservice manger (FM) and cook were interviewed on 1/4/10 at approximately 12:45 PM on preparation methods of both sauces. The cook stated in the interview that he had followed the recipe that had been developed. The FM stated that if they were to prepare a different sauce for each of the different diets that that there will be a lot of containers on the steam table. She denied the sauce was prepared for the convenience of the facility staff.

Other errors were identified on trays of patients on pureed diet. According to the production sheet, these patients should have received 4oz pureed chicken (#8 scoop), 1/3 c bowtie pasta (#12 scoop), 4oz mashed potato(#8 scoop),4oz puree asparagus (#8 scoop) and 2 oz puree dinner roll (#16 scoop). The cook served the patients using a #12 scoop, the incorrect size, resulting in the patients receiving smaller amount of food than was planned except for the bread where they received slightly more than was planned. Overall patients on pureed diet received less protein and calories than was planned.

The following day, on 1/5/10, at approximately 12:00 PM, another lunch tray line observation was made. Spinach Quiche was served as an entree item. According to the production sheet, the serving size was 1/6th of the pie. A patient ' s tray was observed with a " sliver " of pie. According to the menu card on the patient ' s tray, the patient was supposed to receive an equivalent of 2 oz protein. The cook weighed and served the patient 2oz of pie which was the equivalent of 1/16th of the pie. The resulting size was about a one third of what the patient was to receive. It is unknown how many patients received the incorrect quiche size prior to the intervention by the surveyors.

The food service manager, who was present during the observation, stated that she could not explain why the staff measured the Quiche instead of serving by size described on the production sheet. The hospital failed to provide patients with diets that meet their nutritional needs or ordered by their physicians.

Review of the menu showed that pasta was served four of seven days for lunch and dinner either in its main entrees or soups. On a regular diet, these dishes may appear like different items, but for patients on pureed diet the look and taste of the noodle is the same. Therefore, these patients would be receiving the same item twice a day in some cases. The FM had no explanation for the high number of times that pasta was served on the menu.

Based on observation, review of clinical records and staff interviews, the hospital failed to ensure that the therapeutic diet served to three of five patients (Patient # 23, 71,)was prescribed by their physician.

1. Patient #23 is a 59 year old female admitted to the hospital on 1/3/2010 with diagnoses including head injury and renal failure. The physician ordered diet was a renal diet.

Further review of the record showed that she was served an 1800 cal ADA renal diet on 01/05/2010 not a renal diet her physician ordered on 01/03/2010. The RN was interviewed on the diet served as there was no order in the record for the 1800 cal ADA component of the diet. She stated that the patient had diabetes as an additional diagnosis and so she asked the physician if 1800cal ADA could be added to the renal diet. There was neither a verbal order nor a written order for this new diet. But it was entered in the hospital ' s diet order system and was served.

2. Patient # 71 was admitted on 1/1/10 with diagnoses including pneumonia and history of quadriplegia. As a result of a swallow evaluation by the speech therapist (ST), on 1/2/10, the physician ordered diet on 1/3/10 was a 2 gm sodium, Mechanical Soft diet. In addition to a Mechanical Soft diet, the ST recommended thin liquids with assistance/supervision at meals. On 1/4/10, the patient's diet was changed to a pureed diet after nurse described him as choking on his medication and food. Patient #71's diet was changed to 2 gm sodium pureed diet with thickened liquids.

The Food service manager was interviewed on 1/6/10 at 10:50 AM on the consistency of thickened liquid that was prepared for the patient. She stated that the dietary department does not prepare thickened liquids and has not since she had been in the hospital for over 10 years. She stated that a container of thickener is sent to the nursing station where the patient is located and that nursing prepares the thickened liquid.
There are three commonly recognized consistencies for thickened liquids, nectar-thick, honey-thick and pudding-thick. The consistency of thickened liquid that was written as part of the diet order was not specified nor clarified by the nursing or dietary staff. In an interview with the Speech Therapist on 1/7/10, at 2:20 PM, she stated that her expectation was that the patient would have been referred back to her for reassessment in order that she determines the appropriate consistency of thickened liquid.

In an interview on 1/6/10 at 2 PM with a licensed nursing staff (RN-Staff A) regarding what was prepared for patient #71. He stated that he does not prepare any thickened liquid for patients because dietary prepares the thickened liquid. Another RN (Staff G) interviewed on 1/6/10 at 3 PM stated that she prepared it the consistency of "applesauce". The consistency of applesauce is thicker than "nectar" and not as thick as honey. The patient ' s thickened liquid was improperly prepared.

On 1/5/10 the patient was discharged with diagnoses of aspiration pneumonia, malnutrition and diet order for mechanical soft diet. Clinical record review showed that the patient's discharge instruction was for a pureed diet. There was no documented evidence that the pureed diet was ordered by the patient's physician for discharge.

3. Patient #22 is a 16 month old admitted to the hospital on 1/2/10 with diagnoses including bronchiolitis, asthma and hyperglycemia. Her physician diet order was DFA (diet for age) aspiration precautions. On 1/5/10, DAT (diet as tolerated) was the diet ordered by the same physician.

The charge nurse was interviewed on 1/5/10 on what kind of diet child received when it is written as DFA or DAT. She stated that a pediatric diet was requested from the kitchen. She had no explanation for why clarification for a specific diet was not requested.

The Director of Nutrition Services was interviewed on 1/7/10 at approximately 10:00 AM on the diets ordered by the physician. She stated that the hospital did not have DFA or DAT diets and that the hospital physicians have been educated in the past on writing diets.

Patient #22 received diets not specified by the physician but left to the discretion of the nursing and dietary staff.

Based on observation, review of policies and procedure, hospital menu, clinical record and staff interviews, it was determined that the hospital failed to ensure that policies were in accordance with recognized dietary practices and the nutritional needs of patients and the orders of their physicians in a universe of 191 patients. This failure had the potential to result in patients at nutritional risk not receiving the nutritional support needed for treatment of their medical condition.

Finding:

Interviews with a hospital dietitian (RD#1) on January 5, 2010 revealed the initial screening of patients was completed by the nurse within 24 hours of admission. Risk factors developed by the nutrition care staff is used to identify patients who are at nutrition risk. Patients who are identified as high risk are referred to the RD for consult. She stated that these patients are not assessed until up to three days later. She further explained that patients who are seen within 24 hours are those with physician referrals or who are on TPN.

Two of five clinical records reviewed indicated that assessments were not completed until three days after admission or referral. Review of hospital policies and procedure titled " Assessment/Reassessment, Patient Care " indicated that the time frame for documentation of initial assessment by nutritional services was within 24 hours of referral. Interview with random nursing staff in different units on January 5 and 6, 2010 showed that there were discrepancies on what criteria nursing staff referred to the RDs.

The screening criteria used to determine what patients were considered to be at high risk were reviewed. The policy and procedure titled " Nutrition Therapy Plan " listed fourteen diagnoses or medical conditions that met these criteria. According to this policy these patients would be assessed within 1 - 3 days after admission.
No professional source was provided to explain how the dietitians arrived at this stringent list of conditions.

The RD did not routinely conduct assessments on pediatric patients, newborn intensive care patients. These patients were not identified in the policy. Interview revealed that they did not provide medical nutrition therapy to these categories of patients. In addition if additional diagnoses are determined during the patient ' s stay, there was no mechanism to inform the RDs and so, some patients who meet these criteria (based on diagnosis) are not assessed because the new or updated diagnoses was not the documented on admission when nursing staff determined the nutrition risk factor.

For example, Patient #22 was admitted with diagnoses of bronchiolitis, RSV negative. The diagnosis of hyperglycemia was added during her stay. RD #1 stated that the diagnosis of hyperglycemia would have resulted in an assessment or further screening by the RD but they were not aware of it. The Patient did not receive any assessment during her stay in the hospital.

Some of the patients admitted did not receive the proper diets as served or as ordered by their physicians Patient #23 is a 59 year old female admitted to the hospital on 1/3/10 with diagnoses including head injury and renal failure. The physician ordered diet was a renal diet. She was served an 1800 cal ADA renal diet on 01/05/10 not a renal diet as ordered on 01/03/10. No nutrition assessment was conducted on the patient by the RD so the adequacy and appropriateness of her diet could not be evaluated.

3. Review of the medical record for Patient # 71 revealed that he was admitted on 1/1/10 with diagnoses including pneumonia and history of quadriplegia.
A review of the nursing and speech therapy notes was conducted from admission through discharge (1/1/10 through 1/5/10) and the following problems with swallowing and aspiration were documented:

1/1/10 at 10:30 AM (admission), "Nutrition - Difficulty eating - Problems swallowing"

1/1/10 at 7 PM, "...Dr (name) notified that patient had difficulty swallowing tea and potatoes. Swallowing evaluation ordered."

1/2/10, Swallowing Evaluation: "Living at home (with) wife. Regular Diet...Recommendations: Mech (Mechanical - cut up) soft diet..."

1/2/10 at 9:15 PM, "...Fed food, small bites, gets choked easily..."

1/3/10 at 10 PM, "...Pt (patient) had trouble swallowing KCL 40 meq PO (potassium supplement is a large, dry, pill)...contacted pharmacist, suggested dissolving pill in water..."

1/4/10 at 3:45 PM, Notified Dr. (name) regarding patient's diet D/T (due to) aspirations new order obtained for thickened liquids and puree diet..."

A review of the physician's orders dated 1/4/10 revealed that the patient's diet was changed to a low sodium, pureed diet, with thickened liquids.

A review of the physician's discharge notes, dated 1/5/10 at 11 AM, revealed the following: "...Able to tolerate mechanical soft diet...back to his clinical baseline."

A review of the physician discharge orders, dated 1/5/10 at 11:36 PM, revealed an order for a low sodium mechanical soft diet.

A review of the nursing discharge instruction, dated 1/5/10 at 4 PM, revealed the discharge diet as "pureed". There were no further instructions on preparation of diet, regarding low sodium, or notes that indicated the physician had ordered a mechanical soft diet from nursing or the RD.

A review of the patient education documentation was conducted for the length of his hospital stay. On 1/1/10 and 1/2/10 there was patient education noted on nutrition; however, there was no documentation regarding a swallowing problem or aspiration precautions. There was no education documented that was directed at the patient's wife and caregiver by nursing or the RD.

An interview was conducted with the DON on 1/7/010 at 3:30 PM. The DON confirmed the documentation regarding the patient's aspirations in the facility and the lack of documentation on education to the patient's caregiver regarding preparation of his food. She also confirmed that there was no education given to the caregiver regarding a swallowing problem or aspiration precautions by nursing or the RD.

(cross refer A0629, 0621, 0628, 0800)

Based on observation, review of facility documents and staff interview, it was determined that the hospital failed to obtain a current therapeutic manual that could be used as guidance or basis for ordering and preparing therapeutic diets. This failure had the potential to result in patients at nutritional risk not receiving the nutritional support needed for treatment of their medical condition.

Finding:

During interview on January 7, 2010 at approximately 10:35 am with the Director of Nutritional Services, she indicated that the hospital subscribed to the American Dietetic Association Nutrition Care Manual (NCM).

The NCM is an internet based nutrition information manual which the ADA described as " a professional resource " . Review of the NCM on line did not provide information on the specific kinds of diet that was provided by the hospital. It could not be used as guidance for ordering patients ' diets.

When nutrition adequacy of the hospital menu was being evaluated, the NCM could not be used as it did not provide specifics on the caloric and nutrient content of the meals being provided in this hospital or any other hospital. The nutrient adequacy of the menu therefore remained unanswered.

For a pediatric patient, (Patient #21) the diets ordered by the physician included DFA (Diet for age) and DAT (diet as tolerated), the NCM did not provide information on how these diets could be prepared or served to the patient. For patient #71 for whom a thickened liquid diet was ordered and served, the definition of " thickened liquid " as served by the hospital could not be validated using the manual. Hospital staff described thickened liquid as Nectar-thick consistency. This definition did not match the different levels described in the NCM.

The DNS stated that she had believed that the Nutrition Care Manual complied with the regulations.

Based on interview and document review, the facility failed to maintain the humidity levels at 35 % or greater in 3 of 3 operating rooms in the Outpatient Surgery Pavilion and 1 of 1 surgery room in Labor and Delivery.

The facility failed to provide evidence that the low humidity levels identified were adjusted to 35% or greater. (Refer to A0709)

The facility failed to follow the procedure instructing staff on what to do in the event that the humidity levels in the operating rooms were less than 35%, and to have documentation from facilities showing the humidity levels were adjusted into range. (Refer to A0709)

The cumulative effect of these systemic problems resulted in the hospitals failure to demonstrate the ability to ensure the provision of quality health care in a safe environment (Refer to LSC survey K78).

Based on document review and interview, the facility failed to maintain the operating rooms humidity levels in accordance with NFPA 99, Health Care Facilities (1999), and to provide evidence that when the humidity level was less than 35%, the facility adjusted the humidity to 35% or greater.

Findings:

The facility failed to maintain the humidity levels at 35% or greater in 3 of 3 operating rooms in the outpatient surgery pavilion for:

1. January 2009, OR 1 for 16 of 17 days, OR 2 17 of 17 days, OR 3 12 of 17 days, 30th no documentation of humidity levels was provided.
2. February 2009, OR 1 18 of 19 days, OR 2 17 of 19 days, OR 3 12 of 19 days.
3. March 2009, OR 1 18 of 18 days, OR 2 18 of 18 days, OR 3 17 of 18 days, 13th no documentation of humidity levels was provided.
4. April 2009, OR 1 18 of 18 days, OR 2 18 of 18 days, OR 3 18 of 18 days.
5. May 2009, OR 1 15 of 17 days.
6. June 2009, OR 1 11 of 22 days, OR 2 11 of 22 days, OR 3 8 of 22 days.
7. July 2009, OR 1 6 of 19 days, OR 2 9 of 19 days.
8. August 2009, OR 1 16 of 18 days, OR 2 15 of 18 days, 18 of 18 days, 4th and 12th no documentation of humidity levels was provided.
9. September 2009, OR 1 17 of 18 days, OR 2 12 of 17 days, OR 3 17of 18 days, 3rd and 25th no documentation of humidity levels was provided.
10. October 2009, OR 1 15 of 19 days, OR 2 12 of 19 days, OR 3 16 of 19 days, 2nd and 5th no documentation of humidity levels was provided.
11. November 2009, OR 1 18 of 18 days, OR 2 18 of 18 days, OR 3 18 of 18 days, 4th, 5th and 25th no documentation of humidity levels was provided.
12. December 2009, OR 1 14 of 14 days, OR 2 14 of 14 days, OR 3 14 of 14 days. No documentation of humidity levels for December 7 through 11th 2009 and December 18th was provided.
And 1 of 1 surgery room in labor and delivery.
1. January 2009, 18 of 31 days.
2. February 2009, 25 of 28 days.
3. March 2009, 22 of 31 days.
4. April 2009, 12 of 31 days.
5. May 2009, 5 of 31 days.
6. September 2009, 9 of 31 days.
7. October 2009, 21 of 31 days.
8. November 2009, 26 of 30 days.
9. December 2009, 25 of 31 days.

The facility staff failed to follow the policy of notifying facilities and noting the time on the monthly log for temperature and humidity. The facilities department failed to provide evidence that the humidity levels were adjusted to 35% or greater, stating that each staff has their own log book where they log their daily assignments in and they would have to go through each book to find out which staff was assigned to go to the OR's and adjust the humidity levels.

An interview was conducted on 1/5/10 at 3:15 PM with the Manager of Out Patient Surgery, the Director of Peri-Operative Services, the CNO, and QAPI representatives. They confirmed the findings regarding the OR humidity and the lack of documentation of any adjustment to the humidity. They stated that the surgery suites would be closed down until the problem with humidity could be fixed. The group acknowledged that the low humidity in these OR suites had the potential to cause a fire especially with the use of oxygen, cautery, and alcohol prep in the OR.

Based on observation, and interview the facility failed to ensure that isolation precaution signs were printed in a font that was easily visible to staff and visitors, which had the potential to result in staff and visitors not taking the necessary precautions to prevent the spread of infections and communicable diseases for a universe of 191 patients. The facility further failed to ensure that unused clean biohazard containers were not stored with used dirty linen, which had the potential to spread infection to patient care areas.

Findings:

1. During a tour of the Telemetry Unit on 1/4/10 at 11:15 AM, a cart containing isolation protective equipment was observed in front of patient room 212. There was no sign located out side of room 212 to indicated to staff and visitors that precautions need to be taken before entering the room to prevent the spread of infection.

During an interview with a Staff I, on 1/4/10 at 11:15 AM, Staff I stated that that the sign informing visitors and staff that precautions needed to be taken before entering the patients room, to prevent the spread of infection, was located inside the patients room on the door. Staff I verified that the instructions on the green contact isolation sign was not easily read form the corridor because of the small font. During the interview the Staff I verified that staff and visitors would have to enter the room in order to read the sign.

During an interview with the Infection Control Program Manager (ICPM),on 1/6/10 at 1:50 PM, the ICPM verified that the lettering on the isolation signs was not large enough to be to catch the attention of staff and visitors prior to entering the room of a patient on isolation precautions.





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2. During an observation on 1/6/10 at 11:10 AM of an outside storage area near the human resources department, four large bins with bagged used dirty linen was observed directly next to clean new biohazard containers.

In an interview on 1/6/10, with the EVS Manager, he stated on the other side of the hospital they have a dirty linen cage for storage of the dirty linen. They had been putting the dirty linen in the storage area near human resources for convenience, as the EVS staff on the side of the hospital oposite the dirty linen cage would have to take the linen all the way to the other side of the hospital. He further stated that EVS takes the biohazard containers and places them in patient rooms, but they are in a holder behind a door, but sometimes they are not in the holders. The EVS Manager agreed that the biohazard containers could present an infection hazard to patients.

Based on observation, interview and document review, the hospital 's infection control officer was not monitoring compliance with policies regarding the aseptic cleaning and sterilization of instruments. Surgical instruments used in the Outpatient Surgery Pavilion and in the Obstetrics Caesarian Section room were cleaned and disinfected using an incorrect dilution of the enzymatic cleaning solution. This resulted in the possibility that not all of the biological material on the instruments was removed prior to sterilization. Also in the Outpatient Surgery suite, Flash Sterilization was used excessively for an instrument used in Eye surgery. The OR staff were Flash Sterilizing (a rapid sterilization procedure to be used infrequently when an instrument is dropped or clean ones are otherwise not available) an instrument named IA Phaco several times a day on days that eye procedures were scheduled. The hospital stocked four of these instruments at the Outpatient Surgery Pavilion, but needed eight on eye surgery days. They were flashing the device for half of the procedures. The infection control officer did not have knowledge of these deficient practices and did not have a system in place for identifying issues such as these. This resulted in the use of a rapid, but less effective sterilization of these instruments on a regular basis, and in increased risk of transmitting infectious agents to patients.

Findings:

1. The Outpatient Surgery Center was toured on January 6, 2010 at 11:00 A.M. The log for the Flash Sterilizer was reviewed. It was noted that on most days, very few items were flash sterilized. However, on certain days, four of the same item were flashed. The log showed that on January 6, 2010, this item was flashed 4 times. The item was the IA Phaco. The manager for the Surgery Center was questioned about this and stated that on days in which eye surgeries were scheduled, there would be about 8 cases requiring the IA Phaco. However, the Surgery Center only had four in stock. Most eye surgery days, the four instruments had to be flash sterilized for use later that day.

2. The surgical technician for the Outpatient Surgery Center was also interviewed during the tour. She was questioned about how she mixes the enzymatic cleaning solution, used in the first step of processing instruments; soaking and hand scrubbing. She stated that she would fill her basin about halfway with water and add 4 pumps of one ounce each of cleaner. The staff could not state the volume of the basin or how they arrived at the use of four ounces of enzymatic cleaner. The label on the bottle stated that it should be mixed ? to 1 gallon of water.

3. The Obstetrics area was visited and the Operating room for Caesarian Births inspected on January 14, 2010 at 10:15 A.M. The surgical technician was asked about the use of the enzymatic instrument cleaner, ProEz. He showed us a basin that he filled with water and described how he would add 180 oz. (about 1.4 gallons) of water to the basin. He would then add 2-3 pumps of the cleaner. The label on ProEz instructs the mixing to be ? to 1 oz per gallon, with one pump equaling one ounce. The actual process resulted in about 1 1/3 to 2 ounces per gallon of water. This resulted in a higher concentration of the cleaner than recommended by the manufacturer.

4. When asked for the policy for disinfection and sterilization of surgical instruments, the facility provided a Policy and Procedure entitled " Instruments, Cleaning of, from Other Departments. " This policy applies when instruments and trays are used in departments outside of surgery. No policy was supplied that dealt with instruments in the surgical areas.

Based on interview and record review, it was determined that the facility failed to ensure that they had a discharge planning process that applied to all patients in a universe of 191 patients.

1. The facility failed to ensure that all patients who are likely to suffer adverse health consequences upon discharge are identified at an early stage of hospitalization. Specifically, there was incomplete discharge planning for Patient 71 and potentially all patients in a universe of 191 patients.

1 a). The facility failed to ensure that Patient 71 was evaluated for potential problems with abuse and for suffering aspiration pneumonia prior to discharging him the the same environment.

1 b). The facility failed to ensure that a consistent process for discharge planning was utilized. This had the potential to cause patients to suffer adverse health consequences on discharge. (Refer to A 0800)

2. The facility failed to ensure that discharge planning included an evaluation of the availability of post-hospital services for Patient 82. This failure caused the patient to be discharged home without home health care and an evaluation for "safety" as ordered by the physician. (Refer to A 808)

3. The facility failed to ensure that the discharge planning evaluations included the likelihood of a patient's capacity for self-care or the possibility of the patient being cared for in the same environment that they had before entering the hospital for Patients 71, 82, and potentially for a universe of 191 patients. The facility failed to ensure that case management had the tools to ensure that all elements of the discharge process were assessed.

3 a). The facility failed to ensure Patient 71 had a review of his home environment and caregivers needs. This failure caused the patient to be discharged home to an environment that he stated he only felt safe in "sometimes" and without teaching for aspiration precautions when he was admitted for aspiration pneumonia.

3 b). The facility failed to ensure that Patient 82 had a review of is home care needs, including social worker evaluation and evaluation of his need for home health. This failure caused the to be discharged home without follow up from home health and without a safety evaluation at home.

3. c). The facility failed to ensure a process to ensure that all patients had a complete review of their needs prior to discharge. This failure had the potential to cause patients to be discharged home without full evaluation for their continuing care. (Refer to A 0809)

4. The facility failed to ensure that the patient's discharge plan was reassessed and appropriate for Patient 81. The facility failed to ensure that the patient was given discharge instructions that related to her clinical condition on discharge. This failure had the potential to cause the patient excessive pain and delay healing of a surgically repaired fractured hip. (Refer to A 0821)

The cumulative effect of these systemic problems resulted in the facility's discharge planning process failure to ensure the provision of quality health care in a safe environment.

Based on interview and record review the facility failed to ensure that all patients who are likely to suffer adverse health consequences upon discharge are identified at an early stage of hospitalization. Specifically the discharge planning was not complete for 1 of 50 patients (Patient 71) and potentially all patients in a universe of 191 patients.

For Patient 71, the facility failed to ensure that he was evaluated for potential problems with abuse and for suffering aspiration pneumonia prior to discharging him the the same environment.

For all patients the lack of a consistent process for discharge planning had the potential to cause patients to suffer adverse health consequences on discharge.

Findings:

1 a). A review of the medical record for Patient 71 revealed that he was admitted to the facility on 1/1/10 with diagnoses that included pneumonia and quadriplegia.

A review of the nursing admission form, dated 1/1/10, revealed an area for assessment of the patient social history. Under the social history area there was a question that stated, "Do you feel safe at home?" The documentation revealed that the patient answered, "sometimes". Further review revealed that both a social service and a case management referral were ordered by the admitting RN. The nurses narrative was reviewed for the rest of the day of 1/1/10, on 1/2/10, 1/3/10, 1/4/10, and 1/5/10; there was no further documentation regarding the patient's statement that he only felt safe at home "sometimes".

A review of the facility's case management and social service notes revealed that there was documentation by a MSW (Masters of Social Work) twice on 1/4/10. Both documentation times, 1:56 PM and 3:59 PM stated that the MSW was not able to speak with the patient. The note stated that the MSW would continue to attempt to visit the patient. There were no further notes documented by the MSW. The next note was by a case manager (CM). The note documented discharge information; however, there was no mention of an investigation regarding the patient not feeling safe at home.

A review of the nurses notes on 1/5/10 revealed that the patient was discharged home at 6:30 PM. There was no documentation regarding the patient's statement that he only felt safe at home "sometimes".

An interview was conducted with the Director of Nursing Center of Excellence (DON) on 1/7/10 at 10:30 AM. She confirmed that the facility used the question, "Do you feel safe at home?" to help determine if the patient had suffered abuse outside of the facility. She confirmed that the documentation for Patient 71 stated "sometimes" and required the staff to follow up. She confirmed that the staff had not followed up with the patient and discharged him home to the same environment.

An interview was conducted with the Director of Case Management (DCM) (included social work) on 1/7/10 at 3:10 PM. She stated that the case management department was not open on the weekend, but they did have a case manager on call. She stated that to have someone from the department come in to see a patient on the weekend, a nursing supervisor must call them in. The DCM stated that referrals for the department that are entered into the computer on a weekend or holidays go to the department. The referrals are not picked up until the next regular working day. The DCM reviewed Patient 71's documentation and confirmed that when the referrals were made, it was a long holiday weekend.

1 b). A review of the history and physical, dated 1/1/10, revealed "...chest x-ray evidence of left pneumonia. Clinically, this appears to more likely an aspiration pneumonia." (Aspiration pneumonia is inflammation of the lungs and airways to the lungs from breathing in foreign material, often times food particles and liquids.)

A review of the physician's progress notes revealed that on 1/4/10 the pneumonia was confirmed by the physician as aspiration pneumonia.

A review of the nursing and speech therapy notes was conducted from admission through discharge (1/1/10 through 1/5/10) and the following problems with swallowing and aspiration were documented:

1/1/10 at 10:30 AM (admission), "Nutrition - Difficulty eating - Problems swallowing"

1/1/10 at 7 PM, "...Dr (name) notified that patient had difficulty swallowing tea and potatoes. Swallowing evaluation ordered."

1/2/10, Swallowing Evaluation: "Living at home (with) wife. Regular Diet...Recommendations: Mech (Mechanical - cut up) soft diet..."

1/2/10 at 9:15 PM, "...Fed food, small bites, gets choked easily..."

1/3/10 at 10 PM, "...Pt (patient) had trouble swallowing KCL 40 meq PO (potassium supplement is a large, dry, pill)...contacted pharmacist, suggested dissolving pill in water..."

1/4/10 at 3:45 PM, Notified Dr. (name) regarding patient's diet D/T (due to) aspirations new order obtained for thickened liquids and puree diet..."

A review of the physician's orders dated 1/4/10 revealed that the patient's diet was changed to a low sodium, pureed diet, with thickened liquids.

A review of the physician's discharge notes, dated 1/5/10 at 11 AM, revealed the following: "...Able to tolerate mechanical soft diet...back to his clinical baseline."

A review of the physician discharge orders, dated 1/5/10 at 11:36 PM, revealed an order for a low sodium mechanical soft diet.

A review of the nursing discharge instruction, dated 1/5/10 at 4 PM, revealed the discharge diet as "pureed". There were no further instructions on preparation of diet, regarding low sodium, or notes that indicated the physician had ordered a mechanical soft diet.

A review of the medications prescriptions, that the patient was given to go home with, revealed KCL 40 meq with food daily. There were no further instructions on how to dissolve the pill or that the pill needed to be dissolved.

A review of the Case Management (CM) notes, dated 1/4/10 at 4:33 PM revealed no documentation regarding the patient's aspiration and difficulty in swallowing. The note entered by CM and it stated that the patient was "completely dependent on wife for survival". There was no follow up provided to address the patient having had aspiration episodes in the hospital with trained staff feeding him. There was no assessment of the care provided or education needed by the patient's wife, as the patient was admitted with pneumonia (later determined to be from aspiration).

An interview was conducted, on 1/7/10 at 2 :20 PM, with the Speech Therapist 1 who evaluated Patient 71. She stated that the reason that she did not recommend a pureed diet for the patient was that he would not eat it. She stated that she recommended a mechanical soft diet because that was the safest, least restrictive diet that he would tolerate. She stated that the facility should have called for another speech therapy evaluation after the patient aspirated on 1/4/10.

An interview was conducted with the patient's RN (Staff A) on 1/6/10 when he had an aspiration on 1/4/10 at about 2 PM. He stated that the patient aspirated his lunch that day, both solid and liquids, so he called the MD and obtained an order for a change in diet. There was no order for another swallow evaluation.

An interview was conducted on 1/6/10 at about 3 PM with the patient's RN (Staff G) who discharged him home. She stated that the patient's wife was not present on discharge and that the patient was sent home in an ambulance. Staff G stated that she read the discharge instructions to the patient's wife over the telephone. She stated that she had given the wife incorrect information regarding the patient's diet. Staff G stated that the diet she told the wife was a pureed diet and the order was for a mechanical soft diet. She stated that she did not tell the wife about the sodium restriction or tell her how to prepare the food since the RN thought that the patient had been on a soft diet at home. (The patient was on a regular diet at home as stated in the Speech Therapy evaluation, listed in above.) Staff G stated that she read the medications that the physician had ordered to the patient's wife; however, she did not discuss the preparation of the medications, such as dissolving the potassium. She stated that she thought that the patient's wife knew to crush his pills since she is his caregiver.

A review of the patient education documentation was conducted for the length of his hospital stay. On 1/1/10 and 1/2/10 there was patient education noted on nutrition and on 1/4/10 there was patient education noted on medication; however, there was no documentation regarding a swallowing problem or aspiration precautions. There was no education documented that was directed at the patient's wife and caregiver.

An interview was conducted with the DON on 1/7/010 at 3:30 PM. The DON confirmed the documentation regarding the patient's aspirations in the facility and the lack of documentation on education to the patient's caregiver regarding preparation of his food and medications. She also confirmed that there was no education given to the caregiver regarding a swallowing problem or aspiration precautions.

2. A review of the facility's policy for discharge planning, dated 5/2009, revealed that Care Management (Case Management) was responsible for review of the medical record for continued acute care needs, to provide assessment of psychosocial needs, home potential, and family and resources that would impact discharge. The policy further gave the responsibly to care management for "documentation, assessment, and interventions".

An interview was conducted with the Director of Case Management (DCM) (included social work) on 1/7/10 at 3:10 PM. She stated that the case management department was not open on the weekend, but they did have a case manager on call. She stated that to have someone from the department come in to see a patient on the weekend, a nursing supervisor must call them in. The DCM stated that referrals for the department that are entered into the computer on a weekend or holidays go to the department. The referrals are not picked up until the next regular working day.

In the same interview the DCM stated that the facility had no tool or documentation form to ensure that all of the elements of the discharge process were assessed by the discharge planner. She stated that the discharge planners documented what they determined as discharge problem areas; however, there was no way to determine what information was included in their assessment. The DCM stated that if all areas of the medical record was reviewed prior to discharge, the discharge planner should have determined that Patient 71 needed follow up for his safety prior to discharge.

Based on record review and interview the facility failed to ensure that discharge planning included an evaluation of the availability of post-hospital services for 1 of 50 patients (Patient 82). This failure caused the patient to be discharged home without home health care and an evaluation for "safety" as ordered by the physician.

Findings:

A record review was conducted for Patient 82 and revealed that he as admitted to the facility on 11/28/09 with diagnoses that included congestive heart failure, pneumonia, and diabetes mellitus. The patient was discharged home on 12/14/09.

A review of the physician's discharge orders revealed an order that documented,"OK to d/c (discharge) home (with) home health safety eval (evaluation)."

A review of the discharge planning completed by case management revealed the following:

On 12/10/09 at 1:59 PM the case manager documented "...Pt (patient) is MIA (means no ability to pay) but should start disability..."

On 12/14/09 at 11:27 AM the case manager documented "...plan for pt to be d/c home. I explained the doctor order(ed) home health. I explain(ed) his insurance will not cover home health. he can pay for home health if he choice (chooses). pt and father both stated no at this time...I ask(ed) (name) SW (social worker) to met (meet) with pt."

A review of the nurses notes revealed that the patient was discharged home on 12/14/09 at 2:30 PM in the care of his family.

A review was conducted on the case management notes, nurses notes, physician progress notes, and physician orders for 12/14/09 and there was no further mention of availability of home health for the patient. There was no mention of a safety evaluation conducted for the patient. There were no further notes from the SW regarding the lack of ability for home heath care. There was no mention of notification to the physician that the patient would not have home health and a safety evaluation completed, as this was a condition that the physician had documented in his discharge order.

A review of the facility's policy for discharge planning, dated 5/2009, revealed that Care Management (Case Management) was responsible for review of the medical record for continued acute care needs, to provide assessment of home potential, and family and resources that would impact discharge, and involve appropriate healthcare staff to determine needs. The policy further gave the responsibly to care management to "document assessment and interventions".

An interview was conducted with the Director of Case Management (DCM) (included social work) on 1/7/10 at 3:10 PM. The DCM confirmed the physician's orders for a home health evaluation. She confirmed the documentation regarding the lack of availably for the patient to receive home health services and a safety evaluation. She confirmed that the case manager had requested a SW to follow up and that there was no follow up completed.

An interview was conducted with the Director of Nursing Center of Excellence (DON) on 1/7/10 at 3:30 PM. She confirmed that nursing had discharged the patient home without home health services and without contacting the physician regarding his order for home health and a safety evaluation.

Based on interview and record review the facility failed to ensure that the discharge planning evaluation included the likelihood of a patient's capacity for self-care or the possibility of the patient being cared for in the same environment that they had before entering the hospital for 2 of 50 patients (Patient 71 and 82) and potentially for a universe of 191 patients. The facility failed to ensure that case management had the tools to ensure that all elements of the discharge process were assessed.

For Patient 71, this failure caused the patient to be discharged home to an environment that he stated he only felt safe in "sometimes" and without teaching for aspiration precautions when he was admitted for aspiration pneumonia.

For Patient 82 this failure caused the to be discharged home without follow up from home health and without a safety evaluation at home.

For all patients this failure had the potential to cause patients to be discharged home without full evaluation for their continuing care.

Findings:

1 a). A review of the medical record for Patient 71 revealed that he was admitted to the facility on 1/1/10 with diagnoses that included pneumonia and quadriplegia.

A review of the nursing admission form, dated 1/1/10, revealed an area for assessment of the patient social history. Under the social history area there was a question that stated, "Do you feel safe at home?" The documentation revealed that the patient answered, "sometimes". Further review revealed that both a social service and a case management referral were ordered by the admitting RN.

A review of the facility's case management and social service notes revealed that there was documentation by a MSW (Masters of Social Work) twice on 1/4/10. Both documentation times, 1:56 PM and 3:59 PM stated that the MSW was not able to speak with the patient. The note stated that the MSW would continue to attempt to visit the patient. There were no further notes documented by the MSW. The next note was by a case manager (CM). The note documented discharge information; however, there was no mention of an investigation regarding the patient not feeling safe at home.

1 b). A review of the history and physical, dated 1/1/10, revealed "...chest x-ray evidence of left pneumonia. Clinically, this appears to more likely an aspiration pneumonia." (Aspiration pneumonia is inflammation of the lungs and airways to the lungs from breathing in foreign material, often times food particles and liquids.)

A review of the physician's progress notes revealed that on 1/4/10 the pneumonia was confirmed by the physician as aspiration pneumonia.

A review of the Case Management (CM) notes, dated 1/4/10 at 4:33 PM revealed no documentation regarding the patient's aspiration and difficulty in swallowing. The note entered by CM and it stated that the patient was "completely dependent on wife for survival". There was no assessment of the care provided or education needed by the patient's wife, as the patient was admitted with pneumonia (later determined to be from aspiration).

An interview was conducted on 1/6/10 at about 3 PM with the patient's RN (Staff G) who discharged him home. She stated that the patient's wife was not present on discharge and that the patient was sent home in an ambulance. Staff G stated that she read the discharge instructions to the patient's wife over the telephone. Staff G stated that the diet she told the wife was a pureed diet and the order was for a mechanical soft diet. She stated that she did not tell the wife about the sodium restriction or tell her how to prepare the food since the RN thought that the patient had been on a soft diet. Staff G stated that she read the medications that the physician had ordered to the patient's wife; however, she did not discuss the preparation of the medications, such as dissolving the potassium. She stated that she thought that the patient's wife knew to crush his pills since she is his caregiver.

A review of the patient education documentation was conducted for the length of his hospital stay. On 1/1/10 and 1/2/10 there was patient education noted on nutrition and on 1/4/10 there was patient education noted on medication; however, there was no documentation regarding a swallowing problem or aspiration precautions. There was no education documented that was directed at the patient's wife and caregiver.

A review of the facility's policy for discharge planning, dated 5/2009, revealed that Care Management (Case Management) was responsible for review of the medical record for continued acute care needs, to provide assessment of psychosocial needs, home potential, and family and resources that would impact discharge. The policy further gave the responsibly to care management to "document assessment and interventions".

An interview was conducted with the Director of Case Management (DCM) (included social work) on 1/7/10 at 3:10 PM. She stated that the case management department was not open on the weekend, but they did have a case manager on call. She stated that to have someone from the department come in to see a patient on the weekend, a nursing supervisor must call them in. The DCM stated that referrals for the department that are entered into the computer on a weekend or holidays go to the department. The referrals are not picked up until the next regular working day. The DCM reviewed Patient 71's documentation and confirmed that when the referrals were made, it was a long holiday weekend.

In the same interview the DCM stated that the facility had no tool or documentation form to ensure that all of the elements of the discharge process were assessed by the discharge planner. She stated that the discharge planners documented what they determined as discharge problem areas; however, there was no way to determine what information was included in their assessment. The DCM stated that if all areas of the medical record was reviewed prior to discharge, the discharge planner should have determined that Patient 71 needed follow up for his safety prior to discharge and for aspiration precautions.

2. A record review was conducted for Patient 82 and revealed that he as admitted to the facility on 11/28/09 with diagnoses that included congestive heart failure, pneumonia, and diabetes mellitus. The patient was discharged home on 12/14/09.

A review of the physician's discharge orders revealed an order that documented,"OK to d/c (discharge) home (with) home health safety eval (evaluation)."

A review of the discharge planning completed by case management revealed the following:

On 12/10/09 at 1:59 PM the case manager documented "...Pt (patient) is MIA (means no ability to pay) but should start disability..."

On 12/14/09 at 11:27 AM the case manager documented "...plan for pt to be d/c home. I explained the doctor order(ed) home health. I explain(ed) his insurance will not cover home health. he can pay for home health if he choice (chooses). pt and father both stated no at this time...I ask(ed) (name) SW (social worker) to met (meet) with pt."

A review of the nurses notes revealed that the patient was discharged home on 12/14/09 at 2:30 PM in the care of his family.

A review was conducted on the case management notes, nurses notes, physician progress notes, and physician orders for 12/14/09 and there was no further mention of availability of home health for the patient. There was no follow up completed by the SW regarding the patient's home heath. There was no mention of a safety evaluation conducted for the patient. There was no mention of notification to the physician that the patient would not have home health and a safety evaluation completed, as this was a condition that the physician had documented in his discharge order.

An interview was conducted with the Director of Case Management (DCM) (included social work) on 1/7/10 at 3:10 PM. She confirmed the documentation regarding the lack of availably for the patient to receive home health services and a safety evaluation. She confirmed that the case manager had requested a SW to follow up and that there was no follow up completed. She confirmed that there was no notification to the physician regarding the lack of home health services and a safety evaluation for the patient prior to discharge.

Based on record review and interview the facility failed to ensure that the patient's discharge plan was reassessed and appropriate for 1 of 50 patients (Patient 81). The facility failed to ensure that the patient was given discharge instructions that related to her clinical condition on discharge. This failure had the potential to cause the patient excessive pain and delay healing of a surgically repaired fractured hip.

Findings:

A review of the medical record for Patient 81 revealed that she was admitted to the facility on 10/3/09 with diagnoses that included left hip fracture.

Review of the operative notes revealed that the patient had a surgical repair of her hip completed on 10/5/09.

A review of the physician's discharge summary, dated 10/8/09, revealed that the patient was stabilized, cleared for surgery by Cardiology (heart specialty), and did well.

A review of the discharge plan completed by case management revealed that the patient required and was discharge to a rehabilitation facility for rehabilitation of her hip fracture.

A review of the discharge instructions that were given to the patient by nursing revealed a sheet that gave instructions for "Cardiac-cardiovascular discharge instructions". The instructions included "Begin a walking program or follow your doctors's activity instruction. Aerobic activity is best..."

A review of the patient education sheet revealed that the patient received education on congestive heart failure; however there was no documentation on education given specific to her hip fracture. On 10/7/09 there was documentation that stated education was given by nursing on "activity"; however, there was no documentation stating what type of education was given. This documentation also stated that additional instruction was needed. There was no further documentation regarding activity instruction.

An interview was conducted with the Director of Nursing Center of Excellence (DON) on 1/7/10 at 3:30 PM. She confirmed that nursing had discharged the patient to a rehabilitation facility for her fractured hip with cardiac discharge instructions. She confirmed that the patient should only be starting a walking program when cleared by rehabilitation and the physician. She confirmed that the patient was not given the correct discharge information and that there was no documented education given specific to her hip fracture and that the patient was discharged without a follow up reevaluation of her discharge needs.

Based on observation, interview and document review, surgical services were not provided in accordance with acceptable standards of practice. The three operating rooms in the Ambulatory Surgery Center were maintained at humidity in the range of 20% for several months. The facility was not aware that this was a problem until informed by the survey team. The recommended range for OR humidity from most of the professional literature and current standards is 30-60%. Higher humidity can result in increased microbial (bacterial, fungus) growth. Lower humidity, as in this case, can result in an increased risk of OR fires, especially with any combination of alcohol skin preps, electrocautery, and Oxygen use. The hospital failed to ensure that surgical instruments were properly disinfected and sterilized. Both the Ambulatory Surgery Center(ASC) and the Obstetric OR (for Caesarian Births) used incorrect mixtures of enzymatic cleaners in the processing of instruments. The ASC was also using the flash sterilization excessively for one type of instrument used in eye surgery.

Findings:

1. The facility failed to maintain the humidity levels at 35 % or greater in 3 of 3 operating rooms in the Outpatient Surgery Pavilion and 1 of 1 surgery room in Labor and Delivery.
The facility failed to provide evidence that the low humidity levels identified were adjusted to 35% or greater. (Refer to A 709)

The facility failed to follow the procedure instructing staff on what to do in the event that the humidity levels in the operating rooms were less than 35%, and to have documentation from facilities showing the humidity levels were adjusted into range. (Refer to A 709)

2. The hospital did ensure the proper sterilization and disinfection of surgical instruments. (Refer to A-0951)

The cumulative effect of the systemic problems resulted in the hospital's inability to ensure the provision of surgical services in a safe environment.

Based on observation, interview and document review, the hospital did ensure the proper sterilization and disinfection of surgical instruments. Surgical instruments used in the Outpatient Surgery Pavilion and in the Obstetrics Caesarian Section room were cleaned and disinfected using an incorrect dilution of the enzymatic cleaning solution. This resulted in the possibility that not all of the biological material on the instruments was removed prior to sterilization. Also in the Outpatient Surgery suite, Flash Sterilization was used excessively for an instrument used in Eye surgery. The OR staff were Flash Sterilizing (a rapid sterilization procedure to be used infrequently when an instrument is dropped or clean ones are otherwise not available) an instrument named IA Phaco several times on days that eye procedures were scheduled. The hospital stocked four of these instruments at the Outpatient Surgery Pavilion, but needed eight on eye surgery days. They were flashing the device for half of the procedures. This resulted in the use of a rapid, but less effective sterilization of these instruments on a regular basis, and in increased risk of transmitting infectious agents to patients.

Findings:

1. The Outpatient Surgery Center was toured on January 6, 2010 at 11:00 A.M. The log for the Flash Sterilizer was reviewed. It was noted that on most days, very few items were flash sterilized. However, on certain days, four of the same item were flashed. The log showed that on January 6, 2010, this item was flashed 4 times. The item was the IA Phaco. The manager for the Surgery Center was questioned about this and stated that on days in which eye surgeries were scheduled, there would be about 8 cases requiring the IA Phaco. However, the Surgery Center only had four in stock. Most eye surgery days, the four instruments had to be flash sterilized for use later that day.

2. The surgical technician for the Outpatient Surgery Center was also interviewed during the tour. She was questioned about how she mixes the enzymatic cleaning solution, used in the first step of processing instruments; soaking and hand scrubbing. She stated that she would fill her basin about halfway with water and add 4 pumps of one ounce each of cleaner. The staff could not state the volume of the basin or how they arrived at the use of four ounces of enzymatic cleaner. The label on the bottle stated that it should be mixed ? to 1 gallon of water.

3. The Obstetrics area was visited and the Operating room for Caesarian Births inspected on January 14, 2010 at 10:15 A.M. The surgical technician was asked about the use of the enzymatic instrument cleaner, ProEz. He showed us a basin that he filled with water and described how he would add 180 oz. (about 1.4 gallons) to the basin. He would then add 2-3 pumps of the cleaner. The label on ProEz instructs the mixing to be ? to 1 oz per gallon, with one pump equaling one ounce. The actual process resulted in about 1 1/3 to 2 ounces per gallon of water. This resulted in a higher concentration of the cleaner than recommended by the manufacturer.

4. The facility provided a Policy and Procedure entitled " Instruments, Cleaning of, From Other Departments. " This policy applies when instruments and trays are used in departments outside of surgery. No policy on Instrument processing in the OR was provided, although requested.

Based on interview and record review the facility failed to organize the speech/language therapy service to provide services according to the facility scope of services offered statement, by not ensuring there was speech/language therapy staff available Monday through Friday from 8:00 AM to 4:30 PM. This failure had the potential to result in patients not receiving needed speech /language therapy services in a universe of 191 patients.

Findings:

Review of the Rehabilitation Services Scope of Service document on 1/8/10, shows that the Speech/Language Pathology hours of operation are seven days a week, Monday through Friday 8:00AM to 4:30 PM, Saturday and Sunday on call.

During an interview on 1/8/10 at 9:50 AM with the Director of Rehabilitation Services (DRS), he stated that the full-time Speech/Language Therapist's last working day was 12/18/09, as she had resigned her position.When asked how their department was staffing to provide speech/language services, the DRS stated that they had shut down the outpatient speech/language therapy department except for seeing 2 to 3 patients, and three on-call therapists to see the patients in the hospital that needed speech therapy.
He further stated that when a physician ordered speech therapy services they received a print out of the order in the therapy department. They then call the three on-call therapists to see who will come in. When asked how the therapists know when they are on call, the DRS stated, "They all know..."

In an interview with the Human Resource Manager (HRM) on 1/8/10 at 1:00 PM, she stated that an employee in an on call position is required to work 16 hours per month. They are put on the department's work schedule. There is no policy for this on call position.

The hospital had no way to insure the availability of a speech therapist during the hours stated in their scope of service.

The DRS was asked to provide a Rehabilitation Services schedule and timesheets that included the speech/language therapy department for the past three months.

Review of the Rehabilitation Services schedules for October, November, and December 2009, showed a written schedule for the physical therapy department and the occupational therapy department. The schedule for the staff of the speech/language therapy department was blank for all three months.

Review of the Speech Therapy timesheets for October, November, and December 2009, showed the following:

Friday, 10/9/09, no one was on duty from 8:00 AM to 4:30 PM.
Thursday, 10/22/09, no one was on duty from 2:18 PM to 4:30 PM.
Friday, 10/23/09, no one was on duty from 8:00 AM to 9:58 AM and from 1:05 PM to 4:30 PM.
Friday 11/6/09, no one was on duty from 8:00 AM to 11:04 AM.
Monday 11/9/09, no one was on duty from 8:00 AM to 3:57 PM.
Tuesday 11/10/09, no one was on duty from 8:00 AM to 12:05 PM.
Friday 11/13/09, no one was on duty from 12:15 PM to 4:30 PM.
Monday 11/16/09, no one was on duty from 8:00AM to 11:55 AM.
Friday 12/4/09, no one was on duty from 2:52 PM to 4:30 PM.
Tuesday 12/15/09, no one was on duty from 8:00 AM to 4:30 PM.
Monday 12/21/09, no one was on duty from 8:00 AM to 2:41 PM.
Tuesday 12/22/09, no one was on duty from 8:00 AM to 2:11 PM.
Wednesday 12/23/09, no one was on duty from 8:00 AM to 2:07 PM.
Thursday 12/24/09, no one was on duty from 8:00 AM to 2:10 PM.
Monday 12/28/09, no one was on duty from 8:00 AM to 10:56 AM, and from 1:00 PM to 4:40 PM.
Tuesday 12/29/09, no one was on duty from 8:00 AM to 2:49 PM.
Wednesday 12/30/09, no one was on duty from 8:00 AM to 2:42 PM.