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CHIEF EXECUTIVE OFFICER

Tag No.: A0057

Based on staff interview, and administrative document review, the governing body failed to ensure that there was safe and effective implementation of the patient food service when hospital failed to identify poor infection control practices in the food service department practiced unsafe food preparation and storage and allowed food service department operation without guidance from the registered dietitian: 1) Failure to implement effective infection control program (Cross Reference 749), Failure to implement an effective quality program for food service (Cross Reference A276), 3) Failure to have organized dietary service (Cross Reference A618, and A620 and A621, A628, A630, A631). These failure placed patients at risk of food borne illness and compromised patient care.

Findings:

On 5/6/2012 beginning at 9:30 a.m., it was determined that the Food Services operation failed to ensure that effective organized food and dietetic services department. The Food and Dietetic Service Director failed to develop and monitor written procedures according to standards of practice for operational processes at the hospital. Failed to ensure the nutritional needs of patients were met in accordance with recognized dietary practices. Failed to ensure the diets prescribed by the practitioners responsible for the care patients were served as planned. Failed to ensure the nutritional needs of patients were met in accordance with recognized dietary practices. Failed to ensure an effective Infection Prevention program that identified unsafe food handling practices that including staff handwashing practices, and developed surveillance program for the high volume, high risk food service department.

On 5/9/2013 at 9:30 a.m., the Interim Administrator was present as the findings of the survey were presented. The Interim Administrator acknowledged there were serious and substantial issues regarding the Food and Dietetic Services. The Interim Administrator acknowledged that the quality appraisal and performance improvement plan for the food service operation was lacking in identifying indicators that would address the complexity of the department and ensure patient were served food as planned, meet nutrient needs, and ensure food safety and complete patient nutrition assessments based on standard of practice.
The Interim Administrator stated that she was the individual in administration who was responsible for the Food and Dietetic Department.

There was no indication that the hospital effectively organized the department to meet safe food handling and standard of practice in the Food and Nutrition Department.

QAPI

Tag No.: A0263

Based on observation , staff interview, and document review the hospital failed to maintain an effective ongoing hospital wide data driven quality assessment program involving the Dietary Department when:

1. There was no analysis or tracking of issues to evaluate scope of Food Services. There were breaks in infection control that could result in patient developing food borne illness when there was inadequate hand washing and ensuring cantaloupe was thoroughly washed before preparation (Cross Reference A620, A628, A749, A276).

2. There was no analysis of tracking or trending of clinical nutrition systems (Cross Reference A630, A631, and A396).

The cumulative effect of these systemic problems resulted in the inability for the hospital ' s quality program to monitor QAPI in such a manner as to ensure that the nutritional needs of the patients were met in accordance with physicians ' orders and acceptable standards of practice.

DATA COLLECTION & ANALYSIS

Tag No.: A0273

Based on observation, staff interview, and document review, the hospital failed to ensure an ongoing quality appraisal and performance improvement program that showed measurable improvement in indicators for which there is evidence that it will improve health outcomes when the quality appraisal and performance improvement (QAPI) program.

The failure to measure, analyze, and track the deficient practices and develop a robust QAPI program in the Dietary Department would allow the failures to continue and compromise patient care.

Findings:

Starting on 5/8/13 starting at 3:00 p.m., the Nutrition Services Manager and Director of Operations were interviewed regarding their quality appraisal and performance improvement plan. The Director of Operations stated they were developing some coordinated plans with nursing and did not have any formalized data and analysis. They presented some data from 2011.

On 6/9/13 at 9:30 a.m., the Director of Operations presented a document with unit refrigerator and freezer logs quality indicators from March 2012 to March 2013. The percent compliance was 13 months at 100 percent. There was a test Tray Audit quality indicator with percent of compliance of 100 percent 11 of 13 months. The third quality indicator reported Tray Line service audits for food appearance, taste and temperature, showed percent compliance at 100 percent from December 2010 to March 2013.

There was no formalized quality performance program presented that evaluated the high risk, high volume clinical nutrition areas.
On 5/8/13 starting at 4:00 p.m., the Quality Management Director was interviewed and stated that the hospital quality program which included the Registered Dietitians in diabetic patient care and care plans but there was not data or report to show the indicators and benchmarks for the Registered Dietitian. She acknowledged there was not much to present for the clinical nutrition or food service quality program.

Review of the Performance Improvement Plan dated 2013 to 2014 marked Draft, effective January 2013, showed the plan was organization wide to establish a planned systematic and interdisciplinary approach to improving care and services. There were no specific identified quality improvement and performance improvement programs included to show what the quality program for the Food and Nutrition Department would include.

NURSING CARE PLAN

Tag No.: A0396

Based on observation, interview, and review of medical records the hospital failed to ensure nursing staff 1. Planned and implemented specific interventions for identified medical needs for three patients, Patient 51 and Patient 9 and 2. Failed to ensure that a multidisciplinary care plan was developed to include individual and measurable goals for one of 6 patients reviewed for nutrition assessment (Patient 23).This failure has the potential to compromise the medical care of the patients.

Findings:

1. During a visit to Unit 2, on 5/9/13 at 3:30 p.m., Patient 51 was observed walking in the hall past the nurse's station into the day room where a group of patients talked and watched TV. Patient 51 was dressed in hospital pajamas, a second hospital gown was worn backwards as a robe. Patient 51 wore slippers and socks. Patient 51's face was clean and his eyes appeared bright. Patient 51 stood momentarily in the doorway to the day room and then walked away down the hall. Several minutes later, Patient 51 again walked to the day room, where he stood just inside the doorway, appearing to watch the TV and other patients. A woman dressed in street clothes followed slowly behind Patient 51, carrying a magazine. The woman sat in a chair along the wall just inside the day room and began to read the magazine. Patient 51 glanced around, made eye contact with the surveyor, smiled and then turned and continued to watch the activity in the room.

During an interview, on 5/9/13 at 3:30 p.m., Registered Nurse AA (RN AA), stated Patient 51 appeared to understand English, as he nodded when asked questions and followed commands, however Patient 51 did not speak. A translator for Patient 51, obtained by the facility spent time every day with him. The translator had told the staff that Patient 51 answered her appropriately, but briefly, when spoken to in his native language. RN AA stated Patient 51 was selectively mute.

The electronic medical record (EMR) for Patient 51 was reviewed on 5/8/13 at 11:10 a.m.

A psychiatric history and examination, dated 5/1/13 described Patient 51 as having a history of multiple hospitalizations for psychiatric illness. The examination noted Patient 51 was mute and admitted to the hospital for possible schizoaffetive disorder, (a mental condition that causes both a loss of contact with reality [psychosis], and mood problems. (www.nlm.nih.gov/medlineplus).

A Patient Data Profile, a nursing assessment tool indicated on 5/1/13 at 7:10 a.m., Patient 51 had a random blood glucose, (blood sugar) noted to be elevated at 268. The physician was notified of the elevated blood glucose. Physician orders were given to start Patient 51 on Metformin, a medication to control blood glucose. Additionally facility staff were to continue to monitor Patient 51's blood glucose. Orders included notification of the physician if Patient 51's blood glucose dropped below 70 or rose above 400.

Blood glucose test measures the amount of a sugar called glucose in the blood. A normal fasting blood glucose is between 70 and 100 milligrams per deciliter (mg/dl). A random blood glucose level depends upon what was last eaten but most often will be below 125 mg/dl. A higher than normal random blood glucose may be a sign of diabetes (usually a lifelong disease in which there are high levels of sugar in the blood), though other medical conditions can affect blood glucose.(www.nlm.nih.gov/medlineplus)

On 5/2/13, a nutritional consult was done and Patient 51 was placed on a carbohydrate controlled diet, standard for diabetes.

Review of subsequent nurse documentation indicated Patient 51 continued to have an elevated blood glucose, on 5/4/13 at 6:30 p.m., the physician was notified that Patient 51's random blood glucose was 416. A physician order was given to start a second oral medication for hyperglycemia (elevated blood glucose), Glipizide. Patient 51 continued to have elevated random and fasting blood glucose levels. On 5/8/13 the physician ordered the start of subcutaneous, (given by injection under the skin), Lantus Insulin, in addition to the oral antihyerglycmic agents, to control Patient 51's continued elevated blood glucose.

Review on 5/9/13 at 4:05 p.m., of the Treatment Plan (plan of care), for Patient 51, indicated Diabetes had been added to Patient 51's problem list on 5/2/13. Problem #5 was preprinted: "Chronic Illness/Major Infection as evidenced by", "abnormal blood sugar readings", was handwritten.
A preprinted Long Term Goal/Discharge Criteria was:"Infection will be resolved or will be appropriately treated during and post hospitalization".
There was not a stated long term goal regarding Patient 51's abnormal blood glucose or diabetes.

Preprinted Short Term Goals (Objectives) were, 1. "Patient will be medically stable (Day 2-5)." The preprinted intervention was, "1. Infection will be evaluated by MD to determine appropriate treatment-as ordered & PRN (as needed). Day 1-3". The preprinted Short Term Goal was, "2. Patient will be able to verbalize an understanding of treatment and will participate in treatment (Day 2-5)" The preprinted intervention was,"Education will be provided to patient re: treatment and prevention at initiation of treatment and ongoing as needed for reinforcement (Day1-3)" The Treatment Plan indicated Registered Nurse staff was responsible for implementing this intervention. There was no individualization of short term goals or interventions, and other than the initial problem statement; "...as evidenced by abnormal blood sugar readings", there was absolutely no indicatioon that Patient 51's had a new diagnosis of diabetes.

Review, of nursing clinical notes for 5/4, 5/6 and 5/10/13, indicated only, "Patient Education documented-diabetes", had been noted regarding diabetes education for Patient 51.

The American Diabetes Association website contains a program to assist patients in dealing with a new diagnosis of diabetes. Control of elevated blood sugar requires information regarding what, how much and when to eat, physical activity, taking medicine, including self injection of insulin if continued by the physician, and self checking blood glucose.

Additional review, of nursing documentation for Patient 51 indicated on admission to the hospital on 4/30/14, Patient 51 had an elevated blood pressure, 165/108 mm Hg, (millimeters of mercury, normal blood pressure ranged between 90/60 to 130/80). Following physician orders, nursing staff continued to moniter Patient 51's blood pressure. On 5/2/13 at 9 a.m., Patient 51 had a blood pressure of 151/83. Documentation on 5/4/13 at 5 p.m., indicated Patient 51's blood pressure was 134/78 while lying down, upon standing Patient 51's blood pressure dropped to 89/50.

A significant drop in blood pressure, called orthostatic or postural hypotension, (defined as a decrease in systolic [upper number]pressure of 20 mmHg, or a decrease in diastolic [bottom number] pressure of 10 mmHg), can cause dizziness, a feeling of lightheadedness and fainting in some people. Fainting increased the risk of falls.

Continued monitoring by nursing staff indicated Patient 51 continued to experience drops in his blood pressure when standing: 5/7/13 at 9 a.m.,
127/76 lying, 88/60 standing, 5/8/13 at 9 a.m., 127/76 lying, 88/60 standing.

During an interview, on 5/9/13 at 3:30 p.m., RN AA stated he was aware of the drop of blood pressure Patient 51 experienced when going from a lying to sitting position. RN AA stated Patient 51 had been instructed to sit on the side of his bed for a few minutes prior to standing up to decrease the drop in blood pressure. RN AA stated Patient 51's risk of falling was low.

Review, of hospital policy and procedure titled, "Fall Reduction Program", last revision dated 2/13/12, indicated risk criteria for falls included, "monitoring patients for orthostatic hypotension".

Review, of Patient 51's Treatment Plan indicated no mention of postural hypotension or the potential increased risks for falls when a patient exhibited orthostatic hypotension.

During a visit to Unit 1, on 5/13/13 at 10:15 a.m., Patient 9 was observed walking past the nurse's station with a walker. A minute later, Patient 9 was heard conversing in a loud voice, with the medication nurse as she stood outside the medication room.

The clinical record for Patient 9 was reviewed on 5/13/13 at 10:25 a.m..

A History and Physical dated 5/8/13 indicated Patient 9 was admitted voluntarily for suicidal feelings. Medical diagnoses included a history of cervical fusion (surgery that joins selected bones in the neck) and chronic pain. The History and Physical noted Patient 9 was taking 60 mg of Oxycodone four times a day. Oxycodone is a narcotic pain reliever. Oxycodone can be used for immediate relief of pain, in doses of 5-20 mg every 4 to 6 hours, but is also available in an extended relief form of 60 or 80 mg, given every 12 hours. (Lexicomp Online, a drug resource for health professionals).

Review, of the Treatment Plan for Patient 9 indicated Patient 9's problem list included Chronic Pain, "as evidenced by client is on muscle relaxers, anti-inflamatories, oxycontin (and Klonopin) for pain..."

The Long Term Goal/Discharge Criteria was, "Develop coping skills and alternative pain management techniques". One pre-printed short term goal was "Patient will identify three alternative methods of pain control". The pre-printed Interventions included, "Education will be provided for nonmedication pain relief", and listed, "Relaxation, Pain Program, Consult, Diverticular Activities". The Treatment Plan had not been individualized to indicate any of these alternative therapies had been offered or discussed with Patient 9.

Review, of daily pain assessment charting for Patient 9 under "Pain Intervention" for back pain, only "Medication" had been entered on 5/7/13, 5/9/13, 5/11/13, 5/12/13, and 5/13/13. There was no indication Patient 9's back pain had been assessed on 5/8/13 or 5/10/13.

During an interview, on 5/13/13 at 3 p.m., the Director of Nursing rolled her eyes and shook her head when the Treatment Plans for Patient 51 and Patient 9 were reviewed.

2. Patient 23 was admitted on 4/25/13 with diagnosis of: tachycardia (fast heartbeat), history of hyperglycemia (high blood sugar), history of diverticulosis (diverticulosis is small, bulging sacs or pouches of the inner lining of the intestine that become inflamed or infected), history of bleeding ulcers, gastro esophageal reflux disease (a condition in which the stomach contents, food or liquid, leak backwards from the stomach into the esophagus [the tube from the mouth to the stomach]), and chronic constipation. The Registered Dietitian (RD) assessment dated 4/27/13 stated nutrition goal was to continue with current plan of care.
Review on 5/8/13 at 9:00 a.m., the history and physical examination dated 4/25/13 showed, low fat meals and history of hyperlipidemia (high fat content in the blood), monitor blood pressure and pulse while here, follow up on labs and recommendations.
Review on 5/8/13 at 9:30 a.m., multidisciplinary treatment plan dated 4/25/13 indicated treatment plan for history of diverticulitis, peptic ulcer (stomach ulcer) disease. Staff will educate patient in items that cause gastric distress, staff will medicate as ordered by the physician. No further nutritional care plan was entered for history of diverticulitis, hyperlipidemia (elevated blood fat), gastrointestinal reflux (digestive acid in throat), and chronic constipation.
During an interview on 5/8/13 starting at 11:00 a.m., Nutrition Services Manager acknowledged that the clinical dietitian should be developing an individualized plan of care for the patient.
Review of the policy titled Clinical coverage and dated 2010, stated that the clinical dietitian is to implement activities that promote provision of quality nutrition care to patients which include assessing patients at nutrition risk and directing provision of care through such instruments as Nutrition Care Plan.
This policy did not include direction for clinical nutrition staff to develop the nutrition plan of care to be included in the multidisciplinary care plan chart section to allow all staff involved with the patient to have knowledge of patient's nutrition care.

ADMINISTRATION OF DRUGS

Tag No.: A0405

Based on observation, interview and record review, the hospital failed to ensure that medications were administered in accordance with hospital policy and procedures, and physician's orders as evidenced by:
1. Patient 1, a patient with a history of misuse of fentanyl patch, was not administered fentanyl patch in accordance with the physician's order to minimize the risk of opiate overdose from misuse of the medication by the patient.
2. The hospital medication administration policy was not consistently implemented when License Psychiatric Technician A (LPT A) did not verify Patient 2 and 3's identity with 2 forms of identifiers prior to medication administration.

Findings:
A review of Patient 1's electronic clinical record on 5/8/13 showed that the patient was admitted to the hospital on 4/30/13. Fentanyl patch 50mcg/hr (micrograms per hour, delivery rate) patch was ordered on 5/1/13 as follows:
Fentanyl 50mcg/hr patch - One patch topically every 3 days. Apply patch between scapulas (shoulder blades).
A note in Patient 1's record from a prior admission in July 2012 showed that the patient was reported by the family as with a history of substance abuse that the patient had in the past chewed fentanyl patches, which posed a risk of opiate overdose from the ingestion of entire reservoir contents of one fentanyl patch which was intended for continuous delivery over 72 hours.

A review of Patient 1's medication administration record with Administrative Staff B showed that fentanyl patch 50 mcg/hr was applied to Patient 41 ' s left anterior chest at 9:00 a.m. on 5/7/13, contrary to application site of between scapulas as ordered by the physician to minimize the risk of misuse or abuse of the medication by the patient.

Fentanyl transdermal patch is a potent synthetic opioid analgesic for the management of moderate to severe chronic pain. The patch works by releasing fentanyl into body fats through the skin, which then slowly release the drug into the bloodstream over 48 to 72 hours, allowing for long-lasting relief from pain. According to the manufacturer's prescribing information, fentanyl, an opioid agonist and a Schedule II controlled substance with an abuse liability similar to other opioid analgesics. Schedule II opioid substances which include hydromorphone, morphine, oxycodone, fentanyl, oxymorphone and methadone have the highest potential for abuse and risk of fatal overdose due to respiratory depression. Fentanyl transdermal patch can be abused in a manner similar to other opioid agonists, legal or illicit. These risks should be considered when administering, prescribing, or dispensing in situations where the healthcare professional is concerned about increased risk of misuse, abuse, or diversion. Patients should be assessed for their clinical risks for opioid abuse or addiction prior to being prescribed opioids. Routinely monitor all patients receiving opioids for signs of misuse, abuse and addiction since use of opioid analgesic products carries the risk of addiction even under appropriate medical use. Persons at increased risk for opioid abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). Patients at increased risk may still be appropriately treated with modified-release opioid formulations; however these patients will require intensive monitoring for signs of misuse, abuse, or addiction.

2. During a medication administration observation at approximately 9:15 a.m. on 5/7/13, Licensed Psychiatric Technician A (LPT A) was observed administering medications to Patient 2 and Patient 3. Prior to tendering medications to the patients, LPT A asked Patient 2 and Patient 3 to state their names to verify their identities. No other means of identity verification was performed.
A review of the hospital policy and procedure dated May 2012 on medication administration indicated that staff administering medication should use 2 forms of patient identification including photograph, identification armband, asking the patient for full name or birth date.

DELIVERY OF DRUGS

Tag No.: A0500

Based on observation, interviews, and document review, the hospital failed to deliver pharmaceutical services to meet the needs of the patients when medications where not controlled and distributed in accordance with standards of practice as evidenced by:

1. Medications were not dispensed in ready-to-administer form as possible to minimize medication error. Bulk containers of oral liquid medications were used as floor stock with no system to track usage and to ensure accurate dosing of medications. In addition, the use of floor stock was not minimized, contrary to the hospital policy and procedure on floor stock.
2. The use of fentanyl transdermal patch in patient with documented history of opioid abuse was not in accordance with the boxed warning issued by the FDA (the Food and Drug Administration) to ensure patient safety.

Findings:

1. During an inspection of the medication storage room of Unit 2 with Licensed Psychiatric Technician B (LPT B) at approximately 12:15 p.m. on 5/6/13, the following bulk oral liquid medication containers were observed among the hospital floor stock:

Risperidone 1mg/ml (milligram per milliliter, concentration unit) 30-ml bottle
Fluoxetine 20mg/5ml 120-ml bottle
Haloperidol 2mg/ml 120-ml bottle
Fluphenazine 5mg/ml 120-ml bottle

LPT B stated that the bulk containers were floor stock medication for patient use and each bottle could be used for multiple patients.

During an interview at approximately 12:00 p.m. on 5/8/13, the hospital director of pharmacy (DOP) stated that the bulk containers of oral liquid medications were placed in the medication room as floor stock because such products were not available as unit-of-use packaging from the manufacturers. When asked by the surveyors how he could ensure that the correct medication and amount was administered to patients each time, the DOP responded that he did not track and he could not tell if the correct dose of such floor stock liquid medications were administered each time.

A review of the hospital floor stock list showed that a total of 58 different medications were stocked in Unit 1 and 2 as floor stock. Floor stock medications included medications identified by the hospital as high risk/high alert medication such as Valproic acid. In addition, 5 different types of insulin (a hormone for the management of high blood sugar) including Humalog ( a short-acting insulin), Insulin 70/30 (an intermediate acting insulin, Lantus insulin (a long acting insulin), Novolin R (a short-acting insulin) and Novolin N (an intermediate-acting insulin). Insulin for subcutaneous (under the skin) and intravenous use has been widely recognized as a high risk/high alert medication. High-alert medications are drugs that bear a heightened risk of causing significant patient harm when they are used in error. Although mistakes may or may not be more common with these drugs, the consequences of an error are clearly more devastating to patients.

A review of the hospital policy and procedure on floor stock showed that the use of floor stock medications should be minimized and only minimum stock would be kept at each nursing station.

The ASHP (American Society of Health- System Pharmacist) published guidelines on minimum standards for pharmacies in hospital states storage of medications in non-pharmacy areas shall to the extent possible be limited to medications for emergency use and routinely used personal care items (e.g., mouthwash and antiseptic solutions). Access to such medications should be limited to cases in which the committee determines that the urgent clinical need for the medication outweighs the potential patient-safety risks of making the medication accessible.


2. A review of Patient 1 ' s electronic clinical record on 5/8/13 showed that the patient was admitted to the hospital on 4/30/13. Fentanyl patch 50mcg/hr patch was ordered on 5/1/13 as follow:
Fentanyl 50mcg/hr patch - One patch topically every 3 days. Apply patch between scapulas.
A note in Patient 1's record from a prior admission in July 2012 showed that the patient was reported by the family as with a history of substance abuse that the patient had in the past chewed fentanyl patches, which posed a risk of opiate overdose from the ingestion of fentanyl on the patch.

A review of Patient 1's clinical record and medication administration record with Administrative Staff B showed that fentanyl patch 50 mcg/hr was applied to Patient 1's left anterior chest at 9:00 a.m. on 5/7/13, contrary to the application site of between scapulas as ordered by the physician to minimize the risk of abuse of the medication by the patient. In addition, that was no physician order for monitoring for signs of misuse or abuse such as verifying placement of fentanyl patch by care staff. There was no documentation in Patient 1's clinical record indicating nursing staff or care staff were monitoring the patient to prevent misuse of the patch.

Fentanyl transdermal patch is a potent synthetic narcotic analgesic for the management of moderate to severe chronic pain. The patch works by releasing fentanyl into body fats through the skin, which then slowly release the drug into the bloodstream over 48 to 72 hours, allowing for long-lasting relief from pain. According to the manufacturer's prescribing information, fentanyl, an opioid agonist and a Schedule II controlled substance with an abuse liability similar to other opioid analgesics. Schedule II opioid substances which include hydromorphone, morphine, oxycodone, fentanyl, oxymorphone and methadone have the highest potential for abuse and risk of fatal overdose due to respiratory depression. Fentanyl transdermal patch can be abused in a manner similar to other opioid agonists, legal or illicit. These risks should be considered when administering, prescribing, or dispensing in situations where the healthcare professional is concerned about increased risk of misuse, abuse, or diversion. Patients should be assessed for their clinical risks for opioid abuse or addiction prior to being prescribed opioids. Routinely monitor all patients receiving opioids for signs of misuse, abuse and addiction since use of opioid analgesic products carries the risk of addiction even under appropriate medical use. Persons at increased risk for opioid abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). Patients at increased risk may still be appropriately treated with modified-release opioid formulations; however these patients will require intensive monitoring for signs of misuse, abuse, or addiction.

During an interview at approximately 12:00 p.m. on 5/8/13, the DOP stated that he had a discussion with the ordering physician about the potential of fentanyl patch misuse by patient 1 and it was then decided that the patch should be applied between scapulas to prevent the patient from reaching the patch, however the DOP acknowledged that fentanyl patch placed between scapulas was likely still of reach to Patient 1.

UNUSABLE DRUGS NOT USED

Tag No.: A0505

Based on observation, interview and document review, the hospital failed to ensure that medications stored outside of manufacturer ' s recommended storage condition were properly dated with revised expiration dates. Injectable lorazepam (a benzodiazepine for the management of anxiety, seizure, etc) were stored at room temperature with no revised expiration dates on the vials for storage outside of manufacturer's recommendation.

Findings:

During a tour of the Unit 1 of the hospital with Licensed Psychiatric Technician B (LPT B), the hospital director of pharmacy (DOP) and regional director of pharmacy (Regional DOP) at approximately 1:00 p.m. on 5/6/13, seven unrefrigerated vials of lorazepam 2mg/ml (milligrams per milliliter, concentration unit), of which 4 were in a plastic zipper bag and 3 were scattered on the bottom of the drawer, were observed in the controlled substance drawer. All vials were displaying their original expiration dates in 2014 by the manufacturer but none was labeled with updated expiration dates for being stored outside of manufacturer ' s recommended condition. A label " exp. (expires): 7/1/13 " was affixed on the plastic zipper bag. LPT B stated that Lorazepam injectable was used in the unit and pharmacy would restock lorazepam vials in the plastic zipper bag when a few vials had been used. The DOP stated that the injectable lorazepam that the hospital stocked had an expiration date of 60 days upon removal from refrigeration for storage at room temperature.

Lorazepam is a benzodiazepine commonly used for the management of anxiety and seizure, and is also used as a sedative. Lexi-Comp, a recognized drug information provider for health care professionals, indicates that injectable lorazepam should be stored under refrigeration.

FOOD AND DIETETIC SERVICES

Tag No.: A0618

Based on observation, interview and document review the hospital failed to ensure that dietary services met the needs of all patients as evidenced by failure to:
1. Ensure the Nutrition Service Manager developed and monitored written procedures according to standards of practice for operational processes at the hospital and ensure staff compliance (Cross Reference A620).

2. Ensure that a qualified dietitian collaborated with other hospital services like nursing and social services, and supervised the nutritional aspects of patient care that included planning and implementing medical nutrition therapy necessary to meet the nutritional needs of one patient (Cross Reference A621 A396).

3. Ensure menus and recipes are followed to ensure patient nutritional and medical status is not compromised (Cross Reference A628).

3. Ensure the regular and therapeutic menus met the nutritional components to meet the current national standards including the RDA (Recommended Dietary Allowances) and DRI (Dietary Recommended intakes) of the Food and Nutrition Board of the National Research Council (Cross Reference A630).
4. Ensue a therapeutic diet manual that accurately reflected physician ordered diets and current standards of practice (Cross Reference A631).
5. Monitor performance improvement activities that reflected the scope and nature of the services and that identified opportunities for improvement (Cross Reference A273).
6. Ensure an effective Infection Prevention program for identifying unsafe food handling practices that involved following ice machine manufacturer's directions, procedures and staff knowledge to thoroughly clean cantaloupe, and ensure staff compliance to hand washing procedures (Cross Reference A749).


The cumulative effect of these systemic problems resulted in the inability of the hospitals' food and nutrition services to ensure that food was served in a safe and sanitary manner, and the nutritional needs of the patients were met in accordance with practitioners' orders and acceptable standards of practice. The system problems resulted in the hospital's inability to meet the Condition of Participation for Food and Dietetic Services

DIRECTOR OF DIETARY SERVICES

Tag No.: A0620

Based on observation, interview and record review, the hospital failed to ensure that the Food and Dietetic Service Director developed and monitored written procedures, according to standards of practice for operational processes as evidenced by failure to ensure safety practices for food handling. Failure to develop and monitor standardized procedures may result in patients being exposed to foodborne illness and cross contamination which may further compromise medical status.
Findings:
1. During several interviews with the Nutrition Service Manager from 5/6/13 to 5/9/13, there were observations made that reflected lack of oversight of food service operations. During the interviews conducted with the Nutrition Services Manager, she indicated that while she bore the ultimate responsibility of foodservice operations, she managed the day to day foodservice operations and was responsible for the clinical nutrition for patients 4 days per week.
2. As a result of this management organization, the Nutrition Service Manager was not fully aware of the issues that affected safe food handling practices. For example, cantaloupe was not being thoroughly washed and food preparation and serving was not meeting specific portions. Ice machine cleaning practices identified during the survey process revealed deficient practices when the service technician was not following manufacturer ' s directions (Cross Reference A749).
3. During random review of selected departmental policies and procedures related to identified deficient practices in dietetic services, it was noted that policies did not consistently provide sufficient procedural guidance that reflected current standards of practice or the department had not developed procedural guidance for all functions.
a. There was no procedure that provided comprehensive guidance to staff on the proper washing of produce (specifically items such as cantaloupes that can be considered potentially hazardous foods)
b. There was no documented monitoring of preparation and serving of correct portion of food.
c. There was no complete nutritional analysis of menus.
d. There was no diet manual reflective of hospital diets.
4. In an interview with the Nutrition Services Manager on 5/8/13 at 9:05 a.m., and concurrent review of performance indicators, revealed that the dietary department was submitting data on multiple processes within the department. (Cross Reference A273). The Nutrition Services Manager acknowledged that all of the indicators of the department were meeting departmental set thresholds. It was noted that while the department was monitoring some food service performance indicators, there was no evaluation of safe food handling systems, or other practices within the department.
5. The following were observed in the kitchen on 5/6/13 starting at 10:00 a.m. and concurrent interviews with the Nutrition Services Manager:
a. The floor space between two reach-in freezer units (Freezer 3 and Freezer 4), had visible accumulation dust and black debris. The Nutrition Service Manager acknowledged that she did rounds in the kitchen almost daily and had not noticed the dirty grime covered floor space. She acknowledged this area need to be cleaned.
b. The metal shelving above the dish machine counter, next to reach in cooler (Milk Cooler), had visible rust in multiple areas. The Nutrition Services Manager acknowledged that the rusted shelving was not cleanable and would be replaced. The Food Service Manager stated that she had not noticed the uncleanable rusted state of the shelving used to store clean food trays and equipment
c. One stainless steel shelf directly adjacent to the dish machine, two plastic serving pitchers were observed in poor repair (1 with cracks on the bottom, and 1 with a worn, cloudy appearance), and 1 metal serving pitcher was observed with a reddish residue on the bottom inside of the container.
The Food Service Manager acknowledged the equipment was cloudy and cracked and would be replaced.

QUALIFIED DIETITIAN

Tag No.: A0621

Based on staff interview, and document review, the hospital failed to ensure qualified dietitians met the needs of all 61 patients with oversight of their individual care with the potential for compromised medical and nutrition status.

Findings:
Patient 23 was admitted on 4/25/13 with diagnosis of tachycardia (abnormal fast heartbeat), history of hyperglycemia (high blood sugar), history of diverticulosis (outpocketings of the intestine wall), history of bleeding ulcers, gastro esophageal reflux disease (stomach contents (food or liquid) leak backwards from the stomach into the esophagus (the tube from the mouth to the stomach)., (and chronic constipation. The Registered Dietitian (RD) assessment dated 4/27/13 stated nutrition goal was to continue with current plan of care.
Physician diet order was low fat (50 grams fat) high fiber, large portions, no milk to drink, no chicken, no egg product, no red meat, no lactose, ensure with lunch and dinner.
Review on 5/8/13 at 9:00 a.m., the history and physical examination dated 4/25/13 showed, low fat meals and history of hyperlipidemia (high fat in blood), monitor blood pressure and pulse while here, follow up on labs and recommendations.
Review of Nutrition initial assessment dated 4/28/13 stated patient had poor appetite with 40 percent average intake past 4 days. Reviewed labs- low albumin (marker of nutrition status), recommend continue with current plan of care and follow up in 4 days. Assessment also stated " No reported food allergies. "
The initial nutrition assessment did not address the low albumin lab, poor intake, restrictions of milk, chicken, red meat and egg products on nutritional status.
The clinical nutrition note dated 5/2/13 stated " low to moderate po (oral) intake and consuming approximately 42 percent average meals past 3 days, and question accuracy of flow sheet.
Interview with the Nutrition Services Manager on 5/8/13 at 11:00 a.m., who is Registered Dietitian, stated that she had questioned the flow sheet and had not evaluated the inaccuracy or documented a corrected intake if there was one. Nutrition Service Manager stated that the assessment were not complete in assessing all of the nutrition related medical nutrition therapy (therapeutic approach to treating medical conditions) concerns of this patient. Nutrition Service Manager acknowledged that there were concerns of poor intake, low albumin values, medical related diagnosis, and multiple food restrictions that should have been addressed to ensure patient's nutrition status was addressed.

No Description Available

Tag No.: A0628

Based on observation, record review and interview the hospital failed to ensure that a standardized process was in place to maintain consistency in portions of food served to that of the actual menus and diet orders of the patients.
Lack of consistency in the food portions can put patients at potential risk for compromised nutrition status.
Findings:
1. Observation in foodservice kitchen on 5/7/13 at 9:30 a.m. with Nutrition Services Manager (NSM) of Food Service Worker (FSW) 1 ' s preparation of strawberries for fruit-cup menu item revealed FSW1 was placing sliced fruit into 6-oz Styrofoam cups for lunch service. FSW 1 stated that the portion size was ? cup. The observation included that the FSW 1 was not using a measure to ensure the ? cup portion. Concurrent interview with NSM stated that appropriate serving size for fruit-cup menu item was 11/4 cup referring to the Production Tally at the work station.
Nutrition Service Manager stated concurrently that the tally sheet was correct and had the FWS 1 correct the portion size. NSM could not state why there was a discrepancy in the portion sizes on the tally and policy. NSM stated that they did not verify the food service staff was preparing the correct portions as stated on the daily production tally.
Concurrent review of the production tally sheet stated strawberry portion was 11/4 cup. Review of the policy titled Standard Portions not dated, showed the serving of sliced strawberries was 1 cup.
2. Observation of trayline activities in foodservice kitchen on 5/7/13 at 11:45 a.m., revealed Cook 1 placing 2 pieces of cooked chicken Adobo (two legs or one leg and a thigh per plate) onto patient trays. Observation of foodservice cafeteria buffet service on 5/7/13 at 12:15 p.m. revealed one food service worker served one thigh of chicken Adobo onto patient trays.
Record review of policy and procedure manual on 5/8/13 at 9:00 a.m. indicated that facility standard portion size for chicken was 3 oz. serving. In subsequent interview with NSM on 5/8/13 at 3:30 p.m., NSM stated that to make the recommended 3 oz. portion per P & P, that 2 pieces of chicken-one thigh, one leg is to be used.
Review of the Adobo chicken recipe and menu for the day showed the portion size as " one piece. " This did not direct staff to serve the portions to meet patient needs.

DIETS

Tag No.: A0630

Based on staff interview and medical record review the hospital failed to ensure the nutritional needs of patients were met in accordance with recognized dietary practices. The menus were not analyzed to ensure they met the Recommended Daily Dietary Allowance (RDA) or the Dietary Reference Intake (DRI), as adopted by the Food and Nutrition Board of the National Research Council of the National Academy of Sciences. Lack of nutrient analysis of patient menus could potentially place patients at risk of not receiving required nutrients and compromising medical care.
Findings:
Document review on 5/7/13, at 3:45 p.m., of facility provided documents related to nutrient analysis showed a nutrient analysis of some of the diets including regular and 4 therapeutic diets (modifications of normal diet used to improve specific health conditions). The analysis did not contain all of the required nutrients, analysis of all diets for gender and age groups served by the hospital.
In interview on 5/8/13 at 9:00 a.m., Nutrition Services Manager (NSM) confirmed that they did not have a complete nutrient analysis of patient menus for all diets including therapeutic diet compared for age and gender. NSM stated that she would need to contact corporate Registered Dietitian for assistance in completing the nutrition analysis.
Review of the policy titled menu cycle and production sheets reviewed 2011, stated that " all menus are planned to meet current recommended dietary allowances. "

THERAPEUTIC DIET MANUAL

Tag No.: A0631

Based on observation, interview, and document review, the hospital failed to have a therapeutic diet manual including the diets offered met the current standards of practice and included a comprehensive description of the therapeutic diets offered by including the purpose of the diet, indications of the diet, nutritional adequacy of the diet, and sample menu plans and standard of practice references.

Lack of comprehensive diet manual that reflected the hospital-developed diets may result in inaccurate guidance to dietary and hospital staff when following physician ordered diet to meet the nutritional needs of the patient and further compromising medical status.

Findings:

Starting on 5/8/2013 at 9:00 a.m., the hospital diet manual was reviewed with concurrent interviews with the Director of Operations and Nutrition Services. The diet manual was titled Diet Manual a Comprehensive Nutrition Care Guide by Becky Dorner dated 2011.

1. Review of the policy titled Diet Manual dates 2010 stated " The American dietetic Association Manual of Clinical dietetics " is the diet manual adopted by Adventist Nutrition services Department. The intent stated " reference guide for physicians to use when ordering nutritional care and diets that are provided for patients. "

2. Review of Policy Menu Development stated " the approved diet manual (the nutrition adequacy of modified diets is also described in the Manual of Clinical dietetics) " .

3. Review of the provided Diet Manual a Comprehensive Nutritional Guide showed:

a. The diet manual did not contain all of the required elements for each routinely ordered diet which would allow the hospital and/or dietary staff to use the document as a comprehensive resource to order and/or prepare the patients diets. The diet manual did not have the nutritional adequacy for diets listed, as examples for the high calorie/high protein diet, high fiber diet, and low fiber diet.

b. There were no guidelines for pediatric diet, including comprehensive description, for the age group of 6 to 9 year old that the Director of Operations confirmed the hospital serves on.

3. The Director of Operations and Nutrition Services Manager stated on 5/8/13 starting at 9:00 a.m., that the hospital had just initiated 10 days ago a new electronic physician medical entry system. Review of the diets offered for selection included high protein diet, low protein diet, 6 varieties of a standard or low or high consistent carbohydrate and 12 renal diet selections. There were also additions of bariatric diet, high calcium, high fiber, and advance at tolerated diet (ADAT)
a. review of the policy titled interpretation of diet orders dated 2010 stated " diet orders must be specific. Examples of nonspecific diets are " diet as tolerated. " Nonspecific diet must be clarified by using standard terminology as specified in the diet manual ... "

The Director of Operations and Food Service Director confirmed that the new ordering system was implemented and they had not planned or coordinated the physician order system prior to the implementation or the diet terminology. The Director of Operations acknowledged that there were diets in the new system that were not used at this hospital and were not allowed as nonspecific. The Director of Operations acknowledged diet order terminology did not match the menu system and there the many different diet terminology between the physician entry system and diet manual and dietary menu system that required correction. The Nutrition Services Manager acknowledged the menus and diet manual and physician order system should use consistent terminology and definitions Nutrition Services Manager acknowledged the diet manual should include all diets regularly ordered by the physicians.

The diet manual would ensure the diets offered met the current standards of practice and included a comprehensive description of the therapeutic diets offered by including the purpose of the diet, indications of the diet, nutritional adequacy of the diet, and sample menu plans and standard of practice references.

FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE

Tag No.: A0724

Based on observation, record review and interview, the hospital failed to ensure adequate maintenance of facility kitchen equipment. Lack of oversight in this area has the potential to increase risk of foodborne illness in patients.
Findings:
1. Observation on 5/6/13 at 9:20 a.m. with concurrent interview with the Nutrition Services Manager, showed torn gaskets in right- door for both freezers #2 and #3.
Nutrition Services Manager confirmed that she had not seen these tears when she inspected the kitchen each day but would have then replaced.
2. Observation on 5/6/13 at 9:30 a.m. , of two chest freezers (small ice cream reach in and larger white reach in) in the foodservice area showed significant amount of (up to 2 inches thick at thickest point of ice cream reach in) ice buildup on interior wall of both units.
Nutrition Service Manager stated that the small ice cream freezer was maintained by the ice cream company delivery person. Nutrition Service Manager stated that this was not a large build up as it did not reach the top and obstruct the closing. Nutrition Service Manager stated there was no regular maintenance schedule to ensure the two chest freezers were maintained in safe working order and the buildup of interior ice in kept at a minimum to ensure proper operation.
3. Observation on 5/7/13 at 11:30 a.m. of large white chest freezer by food prep area showed cracks in plastic rim of freezer (surface that contacts rubber gasket/seal along the approximately 5 foot length.
Director of Operations acknowledged concurrently that this there were significant cracks on the surface under the lid and that they were not cleanable. The freezer chest was to be replaced.

INFECTION CONTROL PROGRAM

Tag No.: A0749

Based on observation, record review, and interview, the hospital failed to ensure the hospital's Infection Prevention Manager (IPM) developed an effective system for:
1. Maintaining the kitchen and cafeteria ice machines clean and sanitized per manufacturer's directions.
2. Ensuring staff competencies for hand washing practices in food preparation areas.
3. Ensuring ground grown fruit with rough and netted exterior were prepared to minimize the potential of contamination to patients.
This presents a potential of food borne illness and cross contamination when food equipment including ice machines are not maintained clean and sanitary, staff was not maintaining handwashing standards, and fruit was not thoroughly cleaned.
Findings:
1. Observation and concurrent interview with Guido ' s Cleaning service technician, on 5/7/13 at 10:00 a.m., service technician stated that he "uses 3-4 ounces of a 5.25% sodium hypochlorite solution in a bucket of water". Service technician described the bucket as small and maybe one gallon of water. Service technician stated that this was the chemical concentration he used to sanitize the ice machine.
Document review of manufacturer's instructions for sanitizing the ice machine showed the following in Section III-1, page 12, Step 1: Dilute the solution with water as follows: 2.5 fluid ounces of IMS-II Sanitizer or a 5.25% sodium hypochlorite solution with 5 gallons of water.
Interview on 5/7/13 at 10:15 a.m., Nutrition Service Manager confirmed that ice machine service technician not following manufacturer's guidelines for sanitizing the ice machine.
The hospital was not monitoring the contracted service to ensure the correct chemical concentration of sanitizer was used to clean food service kitchen and cafeteria ice machines.
2. On 5/7/13 at 10:30 a.m., Cook 1 was observed washing her hands. This consisted of dispensing soap onto hands, then immediately placing hands under running water to "lather". Cook 1 stated concurrently that she washed her hands according to written and posted policy of "washing hands under running water."
Document review on 5/8/13 at 3:30 p.m., of facility policy and procedures for hand hygiene practices, page 3, section B2 indicates: When washing hands with soap and water, wet hands first with water, apply an amount of product recommended by the manufacturer to hands, and rub hands together vigorously for at least 15 seconds, covering all surfaces of the hands and fingers. Rinse hands with water and dry thoroughly with a disposable towel.
3. Food service worker 1 was observed preparing cantaloupe on 5/7/13 at 9:45 a.m. Food Service Worker 1 stated that she used the "Victory Wash " (a fruit and vegetable wash solution) according to manufacturer recommendations which was to dip the fruit in the mixture for 90 seconds and , and rinse outside surface of cantaloupe under running water.,
In concurrent interview on 5/7/13 at 9:45 a.m., Nutrition Services Manager stated that they did not have specific directions for cleaning cantaloupe the included the Food and Drug Administration Food Code 2009 directions for thoroughly cleaning the exterior of the cantaloupe,
Review of the FDA Food Code 2009 stated that raw fruits and vegetables should be thoroughly washed in water to remove soil and other contaminants before being cut, combined with other ingredients, cooked, served, or offered for human consumption in ready to eat form.

The facility practice did not adequately clean the cantaloupe or other membranous or ground grown vegetable to ensure the imbedded dirt and debris was removed to prevent growth of microorganisms from the surface of the vegetables and fruit prior to cutting and preparing for service.

SPECIAL MEDICAL RECORD REQUIREMENTS

Tag No.: B0103

Based on observations, record review and interviews, the facility failed to:

I. Ensure that Master Treatment Plans (MTPs) identified patient-related long-term and short-term goals stated in observable, measurable, and behavioral terms for all 8 active sample patients (A1, A2, A3, A4, B1, B2, B3 and B4). The treatment plans were generated from a standard program that included pre-selected lists of goals for identified problems. The goals were the same for all patients with the same problems. This failure hinders the ability of the treatment team to measure change in the patient as a result of treatment, and may contribute to failure of the team to modify plans in response to patient needs. (Refer to B121)

II. Ensure MTPs included individualized interventions to address specific treatment needs of all 8 active sample patients (A1, A2, A3, A4, B1, B2, B3 and B4). The treatment plans were generated from a standard program that included pre-selected lists of interventions for identified goals. The interventions were the same for all patients with the same goals, and were routine, generic discipline functions that lacked any focus for individualized treatment. No additional interventions were added to the MTPs based on individual patients assessed needs. In addition, the MTPs failed to list any interventions provided by a psychiatrist. These deficiencies result n lack of guidance to staff in providing individualized, coordinated treatment and can result in prolonged hospitalizations for patients. (Refer to B122)

III. Ensure active treatment measures for 3 of 4 active sample patients on the adult units (A1, A3 and A4) and other non-sample patients on the adult units. The scheduled groups failed to relate to the special needs and problems of these patients who were assigned to the groups, and suitable alternative interventions were not provided.

Sample patients A1, A3, and A4 frequently refused to attend scheduled modalities and alternative treatment was not provided to meet their individual treatment goals. Sample patients A1 and A3 functioned at low cognitive and social levels; the facility did not provide the needed structured treatment and alternative modalities for these patients. Patients' lack of participation in assigned modalities, and the facility's failure to provide alternative activities, impairs patients' attainment of treatment goals, and may prolong hospitalization. (Refer to B125)

PLAN INCLUDES SHORT TERM/LONG RANGE GOALS

Tag No.: B0121

Based on record review and interviews, the facility failed to provide Master Treatment Plans (MTPs) that identified patient-related long-term and short-term goals stated in observable, measurable, behavioral terms for all 8 sampled patients (A1, A2, A3, A4, B1, B2, B3 and B4). The treatment plans were generated from a standard program that included pre-selected lists of goals for identified problems. The goals were the same for all patients with the same problems. This failure hinders the ability of the treatment team to measure change in the patient as a result of treatment interventions, and may contribute to failure of the team to modify plans in response to patient needs.

Findings include:

A. Record Review:

All 8 sample patients (A1, A2, A3, A4, B1, B2, B3 and B4,) had the same long term and short term goals that were generic and non-specific. The MTPs were generated from a standard computer program that included lists of Long Term Goals (LTGs), and Short-Term Goals (STGs). The LTGs and STGs were not age-specific and both adult and child/adolescents had identical goals.

1. For the problem "Medication Adherence": for Patient A1 MTP (dated 4/11/13); Patient A2 MTP (dated 4/28/13); Patient A3 MTP (dated 4/29/13); Patient A4 MTP (dated 5/1/13); Patient B1 MTP (dated 4/29/13); Patient B2 MTP (dated 5/5/13); Patient B3 MTP (dated 4/24/13) and Patient B4 MTP (dated 5/1/13) goals included:

a. LTG "Patient will take medications as prescribed and expressed willingness to continue to take medications after discharge."

b. STGs "Patient verbalize willingness to take psychotropic medication after discharge", "Patient takes psychotropic medications as prescribed while in the hospital", "Patient/parent signs consent to receive psychotropic medications", "Patient is free of symptoms of Neuroleptic Malignant Syndrome", "Patient is free of symptoms of Serotonin Syndrome", "Patient/family verbalized understanding of medication plan."

2. For the problem "Danger to Self": for Patient A2 MTP (dated 4/28/13); Patient A4 MTP (dated 5/1/13); Patient B1 MTP (dated 5/5/13); Patient B2 MTP (dated 4/29/13); and Patient B3 MTP (dated 4/24/13) goals included:

a. LTG "Patient's behavior is safe with no self-injurious behaviors." The "self-injurious behaviors" were not specified.

b. STGs "Patient's behavior is safe with no self-injurious behavior for 3 consecutive days", "Patients exhibits no impulsive behavior for 3 consecutive days", "Patient agrees to tell staff if feeling unsafe", "Patient denies current suicidal thoughts", "Patient verbalized understanding of coping strategies", "Patients verbalizes understanding of regimen to prevent recurrence of illness", "Patient identifies their strengths", and "Patient sleeps for 6 to 8 hours each night for three consecutive nights."

3. For the problem "Discharge Readiness": for Patient A1 MTP (dated 4/11/13); Patient A2 MTP (dated 4/28/13); Patient A3 MTP (dated 4/29/13); Patient A4 MTP (dated 5/1/13); Patient B1 MTP (dated 4/29/13); Patient B2 MTP (dated 5/5/13); and Patient B3 MTP (dated 4/24/13) goals included:

a. LTG "Patient will be return to pre-morbid level of functioning and verbalize safety plan and discharge readiness."

b. STGs, "Patient family indicates questions regarding care are answered", "Patient has appropriate living arrangements for discharge", "Patient has follow-up services in the community", "Patient identifies community resources", "Patient verbalizes a safety plan", "Smoking Cessation counsel/material has been given (if indicated)", "Patient verbalizes understanding of medication regimen."

4. For the problem "Danger to others": for Patient A3 MTP (dated 4/29/13); Patient B1MTP (dated 4/29/13); Patient B3 MTP (dated 4/24/13) and Patient B4 MTP (dated 5/1/13) goals included:

a. LTG "Behavior will be safe. No violent or threatening behavior." There was no specific behavior described for each patient.

b. STGs "Patient exhibits no impulsive behavior for 3 consecutive days;", "Patient's behavior is safe; no aggression, threats, or property damage for 3 consecutive days;", "Patient's behavior is free from paranoia or hostility;", "Patient is calm with no apparent psychomotor agitation;", "Patient verbalizes of the regimen to prevent reoccurrence of illness;", "Patient verbalizes understating of the regimen to prevent reoccurrence of illness;", "Patient is oriented to time, plane, person and situation, with intact memory;", "Patient participates in 50% of group activities for three consecutive days."

B. Interviews:

1. In an interview 5/6/2013 at 2 p.m. the Medical Director was asked about the LTGs and STGs on sample patients. The Medical Director agreed with the findings and stated, "I did not know we had those goals and if we do that is ridiculous."

2. In an interview 5/7/2013 at 1 p.m. the Director of Nursing (DON) was asked about LTGs and STGs on the sample patients. The DON agreed with the findings that the goals were not individualized or measurable. She stated, "I know" meaning that she understood these were problematic.

PLAN INCLUDES SPECIFIC TREATMENT MODALITIES UTILIZED

Tag No.: B0122

Based on interview and record review, the facility failed to develop Master Treatment Plans (MTPs) that identified physician, nursing, social work and rehabilitation staff interventions to address the specific treatment needs of all 8 active sample patients (A1, A2, A3, A4, B1, B2, B3 and B4). The treatment plans were generated from a standard program that included pre-selected lists of interventions for identified goals. The interventions were the same for all patients with the same goals, and were routine, generic discipline functions that lacked any focus for individualized treatment. No additional interventions were added to the MTPs, based on individual patients assessed needs.

In addition, the MTPs failed to list any interventions provided by a psychiatrist. These deficiencies result in lack of guidance to staff in providing individualized, coordinated treatment and can result in prolonged hospitalizations for patients .

Findings include:

A. Record Review:

Review of the sample patients ' computerized MTPs revealed that the plans included pre-selected lists of generic nursing, social work, and recreational therapy interventions for the listed problems of "Medication Adherence"; "Discharge Readiness"; "Danger to Self"; and "Danger to Others." The interventions were the same for each patient with these identified problems. There were no listed interventions provided by psychiatrist on any of the patients' treatment plans. There was no differentiation for age specific interventions for developmental functioning.

1. Patient A1 MTP (dated 4/11/13); Patient A2 MTP (dated 4/28/13); Patient B1 MTP (dated 4/29/13); Patient B2 MTP (dated 5/5/13); Patient B3 MTP (dated 4/24/13) and Patient B4 MTP (dated 5/1/13): for the problem "Medication Adherence" the interventions included:

"Provide daily mediation education", "Monitor medication compliance", "Verify that the patient/parent has signed psychotropic medication consent", "Assess for Neuroleptic Malignant Syndrome", "Assess for Serotonin Syndrome", "Patient/family has confirmed resources to obtain medications", "Confirm that patient has resources to obtain medications at the time of discharge."

2. Patient A2 MTP (dated 4/28/13); Patient A4 MTP (dated 5/1/13); Patient B1 MTP (dated 4/29/13); Patient B2 MTP (dated 5/5/13); and Patient B3 MTP 9 dated 4/24/13): for the problem "Danger to Self" the interventions included:

"Provide the level of observation ordered by the physician", "Suicide/Self-Harm assessment on admission and per protocol", "Provide relaxation groups", "Provide symptom management education", "Assess mental status daily", "Provide coping skills education", "Educate patient about relapse prevention", "Help patient identify and support strengths", "Provide groups which facilitate self awareness", "Provide leisure skills education", and "Monitor sleep/reset patterns nightly."

3. Patient A1 MTP (dated 4/11/13); Patient A2 MTP (dated 4/28/13); Patient A3 MTP (dated 4/29/13); Patient A4 MTP (dated 5/1/13); Patient B1 MTP (dated 4/29/13); Patient B2 MTP (dated 5/5/13); Patient B3 MTP (dated 4/24/13) and Patient B4 MTP (dated 5/1/13): for the problem " Discharge Readiness " interventions included:

"Encourage questions to ensure that family/patient understand care received", "Review discharge plan with patient/legal representative and ensure understanding", "Complete psychosocial screening", "Evaluate housing needs and living arrangements", "Facilitate family meetings", "Contact community resources", "Encourage patient to verbalize specific plans to prevent recurrence of issues resulting in hospitalization", "Ensure patient is able to verbalize a sufficient safety plan to keep self safe after discharge", "Provide Smoking Cessation counsel/material given (if indicated [this was not indicated for this child])", "Review and reconcile discharge medications", "Provide discharge medication education for all new medications", "Provide a list of discharge medications to patient family", "Review discharge planning with patient family and/or caregiver."

4. Patient A3 MTP (dated 4/29/13); Patient B1 MTP (dated 4/29/13); Patient B3 MTP (dated 4/24/13) and Patient B4 MTP (dated 5/1/13): for the problem "Danger to Others" the interventions included:

"Provide the level of observation ordered by the physician", "Daily assault/violence assessment", "Provide the least restrictive alternatives to help patient control aggression behavior", "Provide anger management education", "Provide coping skills education", "Educate patient about relapse prevention", "Help patient identify and support strengths", "Assess mental status daily", "Provide groups which facilitate self-awareness", "Provide relaxation groups", "Provide leisure skills education."

5, Patient A1 MTP (dated 4/11/13); Patient A2 MTP (dated 4/28/13); Patient A3 MTP (dated 4/29/13); Patient A4 MTP (dated 5/1/13); Patient B1 MTP (dated 4/29/13); Patient B2 MTP (dated 5/5/13); Patient B3 MTP (dated 4/24/13) and Patient B4 MTP (dated 5/1/13) did not have any interventions by a psychiatrist.

B. Interviews:

1. In the interview 5/6/2013 at 2 p.m. the Medical Director was asked about the psychiatrist interventions and agreed there were no interventions provided by psychiatrists on the MTPs.

2. In the interview 5/7/2013 at 1 p.m. the Director of Nursing (DON) was asked about nursing interventions for sample patients. The DON agreed with the findings that the interventions were not individualized or specific. She stated, "I know" meaning that she understood these were problematic.

TREATMENT DOCUMENTED TO ASSURE ACTIVE THERAPEUTIC EFFORTS

Tag No.: B0125

Based on observations, medical record review and interviews the facility failed to:

I. Provide active individualized treatment for 3 of 4 active sample patients on the adult units (A1, A3, and A4). The scheduled groups failed to relate to the special needs and problems of these patients who were assigned to the same groups as all other patients, and suitable alternative interventions were not provided.

Sample patients A1, A3, and A4 frequently refused to attend scheduled unit modalities and alternative treatment was not provided to meet their individual treatment goals.

Sample patient A1 and A3 functioned at low cognitive and social levels; the facility did not provide the needed structured treatment and alternative modalities for these patients.

Patients' lack of participation in available unit modalities, and the facility's failure to provide alternative activities, impairs patients' attainment of treatment goals, and may prolong hospitalization .

Findings include:

Lack of individualized active treatment for 3 of 8 active sample patients (A1, A3 and A4).

A. Observations

1. On 5/6/2013 at 10:30 a.m. on Unit Adult 1 the surveyor observed sample patient A1 lying in bed and not attending the scheduled Creative Therapy group.

2. On 5/6/2013 at 10:30 a.m. on Unit Adult 1 with a census of 23 patients the surveyor observed 6 other patients lying in beds and not participating in the group that was taking place at the time and 10 other patients were wandering the halls or sitting in a day room without interactions with staff.

3. On 5/7/13 at 10:30 AM on Unit Adult 1 with a census of 23 patient the surveyor observed 13 other patients lying in beds and not participating in the group that was taking place at the time and 10 other patients were wandering the halls or sitting in a day room with interactions with staff.

4. On 5/7/13 at 10:15 a.m. on Unit Adult 1 the surveyor observed sample patient A1 lying in bed and not attending the scheduled Creative Therapy group.

5. On 5/7/13 at 10:30 a.m. on Unit Adult 2 the surveyor observed that sample patient A3 was standing in the hallway and not attending either group offerings listed on the white board for the daily group schedule, which were Music Group Therapy or Psychiatric Intern Group. (Groups are listed on the board, but not in patients' treatment plans; neither group was on the patient's treatment plan as a specific choice for him/her.) The Music Group had 2 patients present, with one staff member playing music from an iPhone.

6. On 5/6/13 at 2:30 p.m. on Unit Adult 2 the surveyor observed sample patient A3 lying in bed and not attending afternoon group offerings.

B. Record Review

1. None of the treatment plans for patients specified which specific modalities any individual patient should attend. (Refer to B122)

2. Patient A1was diagnosed with chronic paranoid schizophrenia with catatonic component according to the psychiatric evaluation completed on 4/12/2013. Based on A1's functional level s/he was not able to participate in the scheduled group activities. No alternative treatment was documented.

3. According to the group flow sheet from 4/12/2013 to 5/6/2013, patient A1 attended fewer than 25% of scheduled groups.

4. Patient A3 was diagnosed with psychosis, NOS (not otherwise specified), learning disorder, NOS, and borderline intellectual functioning according to the psychiatric evaluation completed on 4/30/2013. Based on A3's functional level s/he was not able to participate in the scheduled group activities. No alternative treatment was documented.

5. According to the group flow sheet from 4/29/2013 to 5/6/2013 patient A3 attended fewer than 25% of scheduled groups.

6. Patient A4 was diagnosed with bipolar disorder, alcohol abuse, and suicide attempt according to the MTP dated 5/6/2013. According to the group flow sheet from 5/1/2013 to 5/6/2013 patient A4 attended fewer than 25% of scheduled groups and no alternatives were documented.

C. Interviews:

1. On 5/6/2013 at 10:25 a.m. on Unit Adult 1 in the day room MHT1 was asked about the patients who were not attending groups and what options were offered to the patients. MHT1 stated, "People can't be forced to attend groups. Patients can't have the TVs on and there is a day room with a piano, games and puzzles if the patients want." When asked if staff lead these activities, MHT1 stated "No."

2. On 5/6/2013 at approximately 10:45 a.m. on Unit Adult 1 at the nurses' station RN1 was asked about the patients who were not attending scheduled groups and what actions she takes. RN1 stated, "We can't force patients to attend groups, they can refuse just like they can refuse medications." RN1 stated, "It is documented (in the shift report and in the group flowsheet) that the patient refuses, the nurse verbally reports this information to the next shift, and to the doctor." RN1 confirmed there were no alternatives offered to patients.

3. On 5/6/2013 at 11:00 a.m. on Unit Adult 1 the Director of Nursing was asked about the number of patients in bed and what active treatment they were receiving. DON stated, "We can't force them to go to group." DON agreed that there were no alternatives or other staff-led groups when patients did not attend the scheduled groups.

4. On 5/7/2013 at 10:15 a.m. on Unit Adult 1 RN1 was asked about patient A1 and the lack of active treatment provided. RN1 stated A1 "does not go to groups and does not participate and the groups are not appropriate." RN1 agreed that there were no alternatives for the patient.

5. On 5/7/2013 at approximately 11:00 a.m. on Unit Adult 1, RN2 was asked about active treatment for patient A3. RN2 stated, "[A3] is lower functioning and the patient doesn't feel comfortable in groups." RN2 stated, "[A3] would go to group but would get lost and intimidated with the content because [A3] was not able to process and track the content of the group." RN2 agreed that there were no alternatives for the patient.

6. On 5/7/2013 at approximately 11:30 a.m. the Director of Social Work was asked about active treatment because she was responsible for part of therapeutic activities. During the interview the Director of Social Work agreed with the findings and confirmed that there were no alternatives for patients who could not attend groups or refused. She agreed that there was no individualized treatment offered to patients A1 and A3 who were not able to attend scheduled groups.

7. On 5/7/2013 at 1:00 p.m. the Medical Director agreed with the finding that active treatment was not provided to all the patients on adult units and there were no alternatives offered to patients when they could not participate in the scheduled groups.

MONITOR/EVALUATE QUALITY/APPROPRIATENESS OF SERVICES

Tag No.: B0144

Based on observation, record review and interview, the Medical Director failed to adequately ensure the quality and appropriateness of services provided by the medical staff. Specifically, the Medical Director failed to:

I. Ensure that MTPs identified patient-related long-term and short-term goals stated in observable, measurable, and behavioral terms for all 8 active sample patients (A1, A2, A3, A4, B1, B2, B3 and B4.) The treatment plans were generated from a standard program that included pre-selected lists of goals for identified problems. The goals were the same for all patients with the same problems. This failure hinders the ability of the treatment team to measure change in the patient as a result of treatment, and may contribute to failure of the team to modify plans in response to patient needs. (Refer to B121)

II. Ensure that MTPs included individualized interventions to address specific treatment needs of all 8 active sample patients (A1, A2, A3, A4, B1, B2, B3 and B4). The treatment plans were generated from a standard program that included pre-selected lists of interventions for identified goals. The interventions were the same for all patients with the same goals, and were routine, generic discipline functions that lacked any focus for individualized treatment. No additional interventions were added to the MTPs, based on individual patients assessed needs. In addition, the MTPs failed to list any interventions provided by psychiatrist. These deficiencies result in lack of guidance to staff in providing individualized, coordinated treatment and can result in prolonged hospitalizations for patients. (Refer to B122)

III. Ensure active treatment measures for 3 of 4 active sample patients on the adult units (A1, A3 and A4) and other non-sample patients on the adult units. The scheduled groups failed to relate to the special needs and problems of these patients who were assigned to the groups, and suitable alternative interventions were not provided.

Sample patients A1, A3, and A4 frequently refused to attend scheduled modalities and alternative treatment was not provided to meet their individual treatment goals. Sample patients A1 and A3 functioned at low cognitive and social levels; the facility did not provide the needed structured treatment and alternative modalities for these patients.

Patients' lack of participation in assigned modalities, and the facility's failure to provide alternative activities, impairs patients' attainment of treatment goals, and may prolong hospitalization. (Refer to B125)

PARTICIPATES IN FORMULATION OF TREATMENT PLANS

Tag No.: B0148

Based on interview and document review, the Director of Nursing failed to:

I. Develop Master Treatment Plans that identified nursing interventions to address the specific treatment needs of 8 out of 8 active sample patients (A1, A2, A3, A4, B1, B2, B3 and B4). The treatment plans were generated from a standard program that included pre-selected lists of interventions for identified problems. The use of preprinted problem sheets and preprinted interventions allowed the nursing staff to select identical treatment goals for each of the above patients. The nursing interventions were the same for all patients with the same problem(s), and were routine, generic discipline functions that lacked any focus for individualized treatment. No additional interventions were added to the MTPs, based on individual patients assessed needs.

Findings include:

Record Review

1. For patients A3, B1, B3 and B4, for the problem "Danger to other", nursing interventions were "Provide the level of observation by the physician"; "Daily Assault/Violence assessment"; "Provide the least restrictive alternatives to help patient control aggression behavior"; "Assess mental status daily"; "Help patient identify and support strengths."

2. For patients A2, B1, B2, B3 and B4, for the problem "Danger to self", nursing interventions were "Provide the level of observation ordered by physician"; "suicide/self-harm assessment on admission and per protocol"; "Assess mental status daily"; "Help patient identify and support strengths".

3. For patients A1, A2, A3, B1, B2, B3 and B4, for the problem "Medication Adherence" nursing interventions were "Provide daily medication education"; "Monitor medication compliance"; "Verify that the patient/parent has signed psychotropic medication consent"; "Assess for neuroleptic malignant syndrome"; "Assess for serotonin syndrome".

II. Assure patients participated in available treatment modalities for 3 of 8 active sample patients (A1, A3, and A4) and other non-sample patients on the unit. Sample patients A1, A3, and A4 frequently refused to attend unit modalities and alternative treatment was not provided to meet their individual treatment goals. Other patients were observed wandering the unit rather than attending scheduled modalities. The DON and nursing staff did not have means to motivate them to become involved. In addition, when patients were not involved in scheduled treatment groups, they were observed in bed or wandering the halls, without nursing staff interacting with them. The facility did not provide the needed structured treatment and alternative modalities for these patients, which can result in the patients being hospitalized without all interventions for recovery being provided and result in delayed improvement.

Findings include:

A. Observations

1. On 5/6/2013 at 10:30 a.m. on Unit Adult 1 the surveyor observed sample patient A1 lying in bed and not attending the Creative Therapy group that A1 was scheduled to attend at that time according to the nursing staff.

2. On 5/6/2013 at 10:30 a.m. on Unit Adult 1 with a census of 23 patients the surveyor observed 6 other patients lying in beds and not participating in the group that was taking place at the time and 10 other patients were wandering the halls or sitting in a day room without interactions with staff. No specific groups are listed on any patient's treatment plan to guide staff in assuring patient participation.

3. On 5/7/13 at 10:30 a.m. on Unit Adult 1 the surveyor with a census of 23 patient the surveyor observed 13 other patients lying in beds and not participating in the group that was taking place at the time and 10 other patients were wandering the halls or sitting in a day room with interactions with staff.

4. On 5/7/13 at 10:15 a.m. on Unit Adult 1 the surveyor observed sample patient A1 lying in bed and not attending the scheduled Creative Therapy group.

5. On 5/7/13 at 10:30 a.m. on Unit Adult 2 the surveyor observed that sample patient A3 was standing in the hallway and not attending either group offerings listed on the white board for the daily group schedule, which were Music Group Therapy or Psychiatric Intern Group.

6 On 5/6/13 at 1430 on Unit Adult 2 the surveyor observed sample patient A3 lying in bed and not attending afternoon group offerings.

B. Interviews:

1. On 5/6/2013 at 10:25 a.m. on Unit Adult 1, MHT1 was asked about the patients who were not attending groups and what options were offered to the patients. MHT1 stated, "People can't be forced to attend groups. Patients can't have the TVs on and there is a day room with a piano, games and puzzles if the patients want." When asked if staff lead these activities, MHT1 stated "No."

2. On 5/6/2013 at approximately 10:45 a.m. on Unit Adult 1, RN1 was asked about the patients who were not attending unit scheduled groups and what actions she took. RN1 stated, "We can't force patients to attend groups, they can refuse just like they can refuse medications." RN1 stated, "It is documented (in the shift report and in the group flowsheet) that the patient refuses, and the nurse verbally reports this information to the next shift, and to the doctor." RN1 confirmed there were no alternatives offered to patients.

3. On 5/6/2013 at 11:00 a.m. on Unit Adult 1 the Director of Nursing (DON) was asked about the number of patients in bed and what active treatment they were receiving. DON stated, "We can't force them to go to group." DON agreed that there were no alternatives or other staff-led groups when patients did not attend the scheduled groups.

4. On 5/7/2013 at 10:15 a.m. on Unit Adult 1 RN1 was asked about patient A1 and the lack of active treatment provided. RN1 stated A1 "does not go to groups and does not participate and the groups are not appropriate." RN1 agreed that there were no alternatives for the patient.

5. On 5/7/2013 at approximately 11:00 a.m. on Unit Adult 1, RN2 was asked about active treatment for patient A3. RN2 stated, "[A3] is lower functioning and the patient doesn't feel comfortable in groups." RN2 stated, "[A3] would go to group but would get lost and intimidated with the content because [A3] was not able to process and track the content of the group." RN2 agreed that there were no alternatives for the patient.