HospitalInspections.org

Based on interviews, a tour of the hospital, a review of policies and procedures, and a review of 29 open and closed medical records:

The governing body failed to ensure a safe environment for patients who presented a danger to themselves or others. Cross reference A144.

The governing body failed to ensure the medical staff was accountable to the governing body for the quality of nutrition care being provided to it's patients. Cross reference A049 and A618.

The governing body failed to ensure the quality of social services provided by contract. Cross reference A084.

The governing body failed to ensure that a mechanism to provide safe care for patients in restraints and seclusion was provided. Cross reference A144.

The governing body failed to ensure that the infection control measures being provided at the hospital were consistent with its own policies and procedures and consistent with standards of care described by nationally recognized organizations. Cross reference A749.

The cummulative effect of these systemic practices resulted in the hospital's inability to provide quality care in a safe environment.

Based on medical record and document review and Registered Dietitian and administrative staff interview, the hospital failed to ensure the medical staff was accountable to the governing body for the nutritional quality of care provided to patients by allowing Registered Dietitians (RD) and Registered Nurses (RN) to write physician orders for 5 of 6 nutrition care patient medical records reviewed (I, J, M, X and CC).

Findings:

Patient J was admitted with medical diagnoses including diabetes and chronic obstructive pulmonary disease. Medical record review was conducted on 9/28/10 beginning at 1000 hours. Hospital document dated 9/27/10 and titled "Physician's Admission Order Sheet" noted a telephone order for a Regular, No Concentrated Sweets (NCS) diet.

Review of hospital document titled "Change of Diet" dated 9/27/10 noted that the nurse sent the diet order to the kitchen as a Fortified Regular, NCS diet, large portions with jello three times/day and extra fluid at meals. The document was signed by a RN. There was no physician's order for the diet change (Cross Reference A629).

A follow up physician's order dated 9/28/10 noted an order for a renal diet and a dietary consult. A follow up document dated 9/28/10 and titled "Change of Diet " noted that nursing staff changed the diet order to a Renal NCS diet.

Similarly it was noted that RNs or RDs changed diet orders for Patients I, M, X and CC.

In an interview on 9/29/10 at 1010 hours, with RD A; she was asked to describe the diet order process. She stated that she believed that RDs and RNs had the ability to change the textures of diets without physician approval. She also stated that the hospital's Medical Executive Committee approved the order writing privileges.

In an interview on 9/29/10 at 1100 hours, with the Chief Operations Officer (COO) and the Risk Manager (RM) who were also part of the hospital's performance improvement committee and attended governing body committee meetings; the surveyor asked them to describe the approval for RDs and RNs to write diet orders. They stated that 5-6 years ago the medical staff decided to allow the RDs to change diet orders based on patient needs as a result of physicians not responding to recommended changes. She also stated that she believed the dietary department developed a policy and procedure for the activity. The COO and RM were asked to provide documentation of medical executive committee discussion/approval. As of 9/29/09 at 1700 hours, the facility acknowledged they were unable to provide Medical Executive Comittee approval documentation or a policy and procedure for this process.

Review on 9/29/10 at 1300 hours, of hospital document titled "Medical Staff ByLaws Rules and Regulations," dated 10/26/09, revealed that only members of the medical staff may provide clinical services ..."within the scope of any license, certificate or other legal authorizing practice..." According to State law RDs and RNs may provide clinical services within their scope of practice; however, they may not provide clinical services within the physician scope of practice (California Business and Profession Code, 2010).

Based on interview, the governing body failed to ensure a mechanism was in place for evaluation of the quality and effectiveness of contracted Social Services provided to the hospital's patients. The failure to evaluate each contracted service did not ensure the quality and effectiveness of the services provided and/or recognition of areas for improvement.

Findings:

Interview with DPCS (Director of Patient Care Services) from the contracted service was conducted on 9/28/10 at approximately 0910 hours. The DPCS stated that the Social Service providers were responsible for admission notes within 24 hours as well as the initiation of a master treatment plan. The DPCS representative provided documentation to assess the quality, timing and effectiveness of social services being provided, however, this documentation had never been requested for evaluation by the governing body or QAPI committee at the hospital.

Based on observation, interview and record review, the hospital failed to protect and promote each patient's rights.

On 9/27/10 at 1150 hours, immediate jeopardy was identified regarding environmental hazards for patients on an inpatient, psychiatric unit. The Chairman and Chief Executive Officer (CEO) was made aware on 9/27/10 at 1205 hours. The hospital failed to:

Secure and store patient care equipment out of reach from patients with the potential for harming themselves or others.

Have a functional emergency call light system for the seclusion room, patient rooms, and showers.

Maintain a safe patient room environment as evidenced by non-break away handles on bedside cabinets and protruding sprinkler heads in two rooms. In addition there was vertical non-break away grab bars in the bathrooms.

Cross reference A144.

The cumulative effect of these systematic failures resulted in the hospital's inability to provide quality care in a safe environment.

Based on observations, interviews, and review of hospital policies and procedures, the hospital failed to provide a safe environment for high risk patients on a psychiatric unit. The psychiatric unit contained areas where medical equipment was stored with no security measures in place to prevent patients from accessing the area. Sprinkler heads protruding from the ceiling represented a risk to patients in those rooms. Call-light systems failed in patient care areas, showers, and the seclusion room. Bathroom grab bars or hand rails were not in the breakaway form and represented a risk to patients. Failure to maintain a safe environment puts all patients and staff at risk for harm .

Findings:

On 9/27/10 at 0900 hours, a tour of the hospital was conducted. The following observations were made:

1. The "short hallway" in the hospital revealed an open alcove area situated between room number 5 and room number 6. without a door, to limit access by patients. The alcove contained two mechanical patient lifts, oxygen concentrators, two IV poles, pulse oximetry machines with electrical cords, a disaster preparedness cart, bed scales with chain apparatus, and feeding pumps. There was no security or monitoring of the equipment stored in this area. The tour by surveyors included RN 1. When interviewed, at approximately 0845 hours, RN 1 agreed that the open alcove was a potential safety hazard.

2. The seclusion room had a mattress located on a wood frame that was bolted to the tile floor surface. Inspection of the mattress showed the mattress was dirty with torn areas and with soil marks and stains throughout the mattress. The mattress was removed and underneath the mattress was a wooden-box frame for the mattress to rest in. The frame was inspected and found to have metal fragments and dirt and debris in and around the wooden frame.

3. The seclusion room was in a separate location outside of the locked nursing unit, next to the staff lounge and restroom. RN 1 accompanying the tour was asked about a call light system for the nursing staff who are monitoring patients in seclusion. The staff member stated the call light system was located in the employee restroom.

The restroom emergency call light system for staff was tested and failed to be operational.

4. The restroom emergency call light system was tested in patient rooms 8 and 10. The call light system failed to be operational.

5. Observed in all patient rooms were non-breakaway handles on beside cabinets. The handles were non-breakaway and capable of threading wire cable or cords, through the handle by patients who might have intentions of hurting themselves or attempting suicide.

6. The shower room emergency call system for patient rooms 7 and 8 failed on testing inspection.

Observed in rooms 7 and 8 were vertical handrails or grab bars approximately 18 inches off the floor. The dimension of the bar would permit clothing, linens, rope, twine, and electric cord to be threaded and tied to the unit for patients with the intention of hurting self or attempting suicide.

Patient W and Patient Y were admitted with suicidal ideations and assigned to rooms found to be unsafe.

On 9/27/10 at 1150 hours, an interview with the CEO, COO, and Performance Improvement Director was conducted. They provided information that two patients were in the hospital under suicidal watch as a danger to self, Patient W and Patient Y.

7. Observed in two patient rooms were protruding ceiling sprinklers. Room 9 was noted to contain one protruding ceiling sprinkler head and room 15 was observed to have 3 ceiling sprinkler heads. Cords, twine, or bed linens could be wrapped around the sprinkler unit to be used by patients who were a danger to self.

8. A fire extinguisher cabinet contained a loop handle that could easily facilitate cord, twine, linens being threaded through the opening and used by patients with the intention of hurting self or attempting suicide.

Based on hospital document review and dietary staff interview the hospital failed to ensure an ongoing quality appraisal and performance improvement program that addressed the complexity and scope of Food/Dietetic, nutrition, and social services. This had the potential for missed opportunities for improved patient care.

Findings:

1. During general document review on 9/27/10 beginning at 1400 hours, it was noted that there were no reports made to the performance improvement committee related to dietetic services or clinical nutrition care.

In an interview on 9/28/10 beginning at 1420 hours, the Dietary Supervisor was asked to describe the department's performance improvement plan. She stated that several years ago she did a patient satisfaction survey which resulted in favorable reviews, therefore not requiring any performance activities. She further stated since then she had not implemented any additional evaluation of potential performance improvement measures. The surveyor also asked her to describe any clinical performance improvement activities, to which she replied there were none.

2. Interview with DPCS from the contracted company providing Social Services was conducted on 9/28/10 at approximately 0910 hours. The Social Service lead stated that the Social Service providers were responsible for admission notes within 24 hours as well as the initiation of a master treatment plan. The lead Social Service representative provided documentation to assess the quality, timing, and appropriateness of Social Services being provided, however, this documentation had never been requested for evaluation by the governing body or QAPI committee at the hospital.

Based on interview and record review, the hospital failed to have an infection control program that included observation of staff's implementation of policies and procedures (P&Ps).

Findings:

On 9/29/10 at 1015 hours, during interview with the Infection Control Director/Performance Improvement/Risk Manager (same person), the Director stated infection control surveillance was based on medical record review. The Director collected, recorded, and reported data from the medical record reviews to a contracted service for writing an Infection Control report to present to the Committee of the Whole (governing body, infection control (IC), QAPI, etc.). The Director could not produce documentation of analysis of the data to see if there were actions needed to improve infection rates. She could not produce documentation to show the Infection Control Practitioner, Committee of the Whole and/or designee was monitoring implementation of the P&Ps for hand washing, isolation precautions, or environmental cleaning. There was no documented evidence the committee evaluated infection control performance as part of the QAPI program. Cross reference A 285.

Based on interviews and a review of minutes from the quality assurance, performance improvement (QAPI) and governing body committee minutes for 2009-2010, there was no documentation to indicate that the QAPI committee had focused on investigational drug therapy. Additionally, the hospital failed to ensure that the pharmacy department's performance improvement activities focused on high risk, high volume and problem-prone areas. This had the potential for missed opportunities to improve patient care, identify medication errors, and improve health outcomes.

Findings:

1. Patient AA was a patient who had been placed on an investigational protocol to study psychotropic medications ( a medication used to affect changes in behavior and emotion). When interviewed, on 9/28/10 at approximately 1400 hours, representatives from the QAPI program were unable to provide documentation that Patient AA or prior hospitalized patients had been evaluated for health outcomes or quality of care.


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2. On 9/27/10 at 0925 hours, the DOP stated, the pharmacy maintains its performance improvement activities in binders located in the main pharmacy. They have an ongoing review of antibiotics administered to patients in the hospital. "It's an expense issue. We're looking for the least expensive appropriate antibiotic." On 9/28/10 at 1018 hours, the DOP discussed another audit where the pharmacy reviewed the Medication Administration Record (MAR) against the pharmacy's drug profile to determine if discrepancies existed. This information was not documented and was not presented to the Pharmacy and Therapeutics Committee (P&T) or a similar committee in the hospital called, "Committee of the Whole."

ASHP's (American Society of Healthsystem Pharmacists) article entitled, "ASHP Guidelines on the Pharmacy and Therapeutics Committee and the Formulary System, January 2008 states, "The P&T committee should be responsible for overseeing policies and procedures related to all aspects of medication use within an institution. The P&T Committees have been credited with increasing practitioner's knowledge about drug therapy, improving the safety of drug therapy, and improving outcomes." In addition the article states, "The P&T Committee should conduct targeted quality-improvement projects to improve the safety of specific medications or to evaluate the processes involved."

On 9/28/10 at 1035 hours, the DOP acknowledged, "They have areas to address to improve patient safety and medication effectiveness."

Based on observation, interview and record review, the hospital failed to ensure RNs were supervising and evaluating the patient care for two of 29 sampled patients (Patient R and U). Staff failed to follow policies and procedure for assessing skin integrity and maintianing the cleanliness of respiratory care equipment. This had the potential for worsening of the patients' skin integrity and the potential for patients to develop respiratory tract infections.

Findings:

A review of the hospital's P&P Wound Care 2009, revised 10/2009, showed each patient will have a skin integrity assessment within two hours of admission. RNs would document daily assessment on appropriate flow sheets. RNs are to document a narrative assessment in the Interdisciplinary Progress Note when there is any change in the skin integrity from the time the admission nursing assessment was done. RNs are to reassess each patient at a minimum of every shift; document any changes in the medical record and on the treatment plans indicated, and notify the psychiatrist /Medical Doctor if the assessment indicates further intervention is needed. The nursing staff would take a Polaroid picture of the affected area and place on the Interdisciplinary Progress Note Form. The staff documents on the picture the following : date/time, patient name, area affected. This P&P was not followed for Patient U and R.

1 a. On 9/27/10, a review of Patient U's medical record was conducted. Admission documentation dated 9/20/10, showed skin assessments with photography of pressure ulcers. Documentation showed Patient U was admitted with a stage four pressure ulcer of the coccyx (tail bone). A care plan titled: Medical Treatment Plan for the Skin Impairment for Non-ambulatory Patient, showed the plan was initiated on 9/21/10. Interventions listed on the plan of care included to reposition of the patient every two hours, and a turning schedule would be posted in the patient's room.

On 9/27/10 at 1420 hours, Patient U was observed on her back on an airflow mattress. Heal protectors were observed on both feet. There was no posted sign for a turning schedule in the room. Patient U stated she was not turned every two hours. Patient U stated she could reposition herself; however, the size of the bed made it difficult. She stated the hospital staff did not know how to properly reposition her. Observation by the surveyor showed Patient U was positioned on her pressure ulcer area most of the time.

On 9/28/10 at 1035 hours, Patient U was observed on her back in bed. A concurrent interview with RNA 1 was conducted. The RNA stated Patient U refused to be repositioned. The RNA stated staff would request to reposition Patient U, but Patient U refused most of the time.

On 9/28/10 at 1356 hours, an interview with RN 5 was conducted. RN 5 stated Patient U was uncooperative with care. She stated because Patient U was uncooperative with care, repositioning every two hours could not be implemented. RN 5 was asked about the air mattress and she was unfamiliar with the principles of pressure relief with an air mattress and how to determine the firmness of the mattress. RN 5 was asked to review the medical record to show documentation of when and how often Patient U refused repositioning or that education of Patient U was attempted regarding the disadvantages of not being repositioned. RN 5 could not show documentation to support her statements. Additionally, there was no documentation to show alternative pressure relief measures were considered as a result of her non-compliance with repositioning.

b. On 9/28/10 at 1035 hours, Patient U was observed to have a purple discoloration of the right upper arm, measuring approximately two inches around. Patient U stated she could have bumped her arm on the side rail, however she was not aware she had discoloration on her arm. During an interview with RN 5 at 1356 hours, RN 5 stated she was not aware of the patient's skin discoloration. RN 5 stated she did a skin assessment but stated she was not aware of the skin discoloration. There was no documentation by the staff of skin discoloration of the arm.

2. Patient R's medical record was reviewed on 9/27/10. Patient R was admitted to the hospital on 9/23/10.

a .On 9/27/10 at 1335 hours, Patient R, was observed in the bed with a continuous tube feeding. A concurrent interview with LVN 1 revealed the patient required staff assistance for all her ADL's. The patient had to have the head of the bed up 40 degrees at all times.

A review of the patient's medical record on 9/27/10 showed a Medical Treatment Plan, initiated on 9/23/10, for the problem of skin impairment specifically for the non-ambulatory patient and redness of buttocks and groin area. The interventions included to utilize an every two hours repositioning schedule and to post the repositioning program sign in the patient's room.

On 9/28/10 at 1410 hours, interview with LVN 2 revealed there was no sign posted in the patient room nor documented evidence in the record to show the every two hours repositioning plan was implemented for Patient R.

b. A review of Patient R's medical record on 9/27/10 showed photographic documentation, dated 9/23/10 that Patient R had purple skin discoloration on the left chest. Approximately, one third of the chest was affected. On 9/28/10 at 1100 hours, during an interview, RN 5 stated all of the patients should have skin assessments and reassessments to identify any abnormality. RN 5 further stated she admitted the patient, but there was no documented evidence RN 5 or other nursing staff identified the discoloration. The finding was confirmed with RN 1 who was the charge nurse at 1530 hours.

c. On 9/27/10 at 1335 hours, Patient R was observed receiving a hand held nebulizer (HHN) treatment via a mask. The breathing mask had no date label. LVN 1 removed the breathing mask and the tubing from the bedside cabinet top drawer and returned to the drawer when the treatment was complete. A concurrent interview with LVN 1 revealed Patient R received the treatment every four hours. LVN 1 could not identify how long the tubing had been in use and was not aware of the hospital 's P&P for changing the tubing and mask.

On 9/28/10 at 1410 hours, LVN 2 was observed providing the HHN treatment for Patient R. LVN 2 took out the breathing mask and the tubing from the drawer, provided the treatment and returned the equipment to the drawer when the treatment was complete. The breathing mask and tubing failed to show a start date for identifying when the equipment was applied. When interviewed, LVN 2 stated the hospital had a P&P to change the breathing mask. However, LVN 2 could not state whether the mask was to be changed every 48 or 72 hours. LVN 2 further stated because there was no date on the mask she could not identify when the tube was first applied.

Review of the P&P for changing the mask and tubing showed the breathing mask was to be change every 72 hours. On 9/29/10 at 1015 hours, during interview, RN 1 stated the hospital's P&P was to date and change the mask every 72 hours.

On 9/28/10, a review of the hospital P&P titled: Storage of HHN equipment, revised 4/21/10, showed actions to be taken after administering a HHN treatment. The document showed the mouthpiece and tubing was to be placed in a plastic bag. The bag should be labeled with the patient's name, date and time the treatment was performed and their initials. Additionally, the policy showed routine HHN equipment should be changed every 72 hours.

Based on interview and medical record review, the hospital failed to ensure that the physician accurately dated and timed the medication consent form when providing information on mood altering medication(s) to three of 29 sampled patients (Patients B, C, and Y). Dating and timeing a medical record entry establishes a baseline for future actions or assessments and a timeline of events.

Findings:

1. On 9/28/10 at 0942 hours, review of Patient B's medical record revealed orders for Risperidone (a medication to treat mental illness) and Cymbalta (a medication to treat depression). The medication consent form was signed by the physician but not dated and timed.

2. On 9/29/10 at 0823 hours, review of Patient C and Y's medical record revealed a medication consent form that documented the physician provided medication consent information to Patient C on 9/24/10 at 0315 hours for Patient C and on 9/26/10 at 0100 hours for Patient Y.

On 9/29/10 at 0846 hours, an interview with RN 8, a registered nurse who witnessed the informed consent provided by the Chief of Staff, stated the physician spoke with the patient over the telephone. The physician spoke about the medications and told Patient Y that within 24 hours he would be in the hospital to see him and answer questions. RN 8 then stated she filled in the date and time next to where his signature goes on the informed consent form for the Medical Chief of Staff to sign when he arrives at the hospital.

On 9/29/10, review of Patient's C's medical record revealed a medication consent form that documented the physician provided the information on the medications on 9/24/10 at 0315 hours. On 9/29/10 at 0843 hours, RN 1 stated the nurse who witnessed the informed consent writes in the date and time on the form. On arrival at the hospital, the physician signs the form.

On 9/29/10 at 0940 hours, during a interview with the Chief of Staff who stated he was on call and received telephone calls for both Patient C and Y. He provided information about the mood altering medications over the phone to his patients. The witnessing nurse writes in the date and time next to where his signature goes and he signs the informed consent when he arrives at the hospital.

All medical record entries require a date and time to ensure patient safety and quality of care. It also establishes a baseline for future actions or assessments and a timeline of events.

Physician signatures on the informed consent acknowledge the date and time the form was signed. The physician for Patients C and Y signed the document with the date and time listed as several hours earlier. There was no acknowledgement on the form that the information was provided earlier to the patient over the phone.

Based on chart review, the hospital failed to ensure that the prescribing practitioner for two of 29 sampled patients (Patient's B and AA) verified, dated, timed, and signed all verbal orders promptly. The failure to verify and sign verbal orders can lead to potential medication and treatment errors.

Findings:

1 On 9/27/10 at 1408 hours, review of Patient B's medical record revealed one verbal order taken over the telephone for gentamicin (an antibiotic to treat infection) on 9/25/10 at 1230 hours and another verbal order for Lotrisone cream (topical cream to treat fungus rashes) on 9/12/10 at 1745 hours. The verbal orders were not verified, dated, timed, or signed by the prescribing practitioner.

2. On 9/28/10 at 1410 hours, review of Patient AA's medical record revealed one verbal order taken over the telephone for three medications on 9/3/10 at 1630 hours were not verified, dated, timed, or signed by the prescribing practitioner.

California Code of Regulations, Title 22, Section 70362(g) states, "Verbal orders for drugs shall be given only by a person lawfully authorized to prescribe or furnish and shall be recorded promptly in the patient's medical record, noting the name of the person giving the verbal order and the signature of the individual receiving the order. The prescriber or furnisher shall countersign the order within 48 hours."

Based on observation, interview and document review, the hospital failed to ensure there was an approved hospital policy and procedure and training program, as required by State law, before nurses were given access to retrieve and administer medications from the medication night locker (a medication cabinet located outside the pharmacy that stores high usage and emergent medications) when the pharmacy was closed. This had the potential to increase medication errors. The hospital failed to ensure that multiple dose vials were dated and initialed on opening as per the hospital's policy and procedure. This led to the potential for contaminated and/or ineffective medications available for administration to patients.

Findings:

1. On 9/27/10 at 0915 hours, the DOP stated the pharmacy hours were from 0700 to 1430 hours Monday through Friday, 0700 to 1200 hours Saturdays and closed Sundays. The DOP stated, "When the pharmacy is closed, nurses have access to the medication night locker." When the medication is not available in the medication night locker, the "head nurse" has been given authority to enter the main pharmacy to retrieve the medication. The DOP stated, "There is no approved Policy and Procedure (P & P) for nursing to retrieve medications from the medication night locker."

On 9/27/10 at 1051 hours, Staff 18 stated the medication night locker contains different medications including controlled drugs (drugs that may cause abuse and addiction). A list of medications stored in the night locker was provided by LVN 1. There were over 120 different doses of medications. LVN 1 stated when a new medication was ordered or a current medication was missing, nurses retrieve the medication from the night locker when the pharmacy was closed. The nurse documents the removal of the medication(s) on the medication log sheet.

According to the California Code of Regulations, Title 22, Section 71233(2)(d), "There shall be a system maintained whereby no person other than a pharmacist or an individual under the direct supervision of a pharmacist shall dispense medications for use beyond the immediate needs of the patient."

According to ASHP's (American Society of Healthsytem Pharmacists) article entitled, "ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals," September 1995, states, "In the absence of 24 - hour pharmaceutical services, access to a limited supply of medications should be available to authorized nonpharmacists for use in carrying out urgent medication orders. The list of medications to be accessible and the policies and procedures to be used (including subsequent review of all activity by a pharmacist) shall be developed by the pharmacy and therapeutics committee (or its equivalent)."

The medication night locker is being used without an approved hospital P & P, and to dispense medications for all patient needs and not just to treat an immediate need of the patient.

2. On 9/27/10 at 1101 hours, during inspection of the medication room refrigerator there were multiple dose vials of the following medications, Lantus (insulin to treat high blood sugar levels), Novolog (insulin to treat high blood sugar levels), and Novolin (insulin to treat high blood sugar levels) that were not initialed by the nurse when the vial was opened. Located on the wall next to the refrigerator was a sign entitled, "Multi-Dose Injectable Expirations" which states, "Always date, time and initial when opening any injectable vial(s)."

Based on interview and document review, the hospital failed to ensure that accurate records of investigational drugs were maintained in the pharmacy, and failed to establish and implement a written policy so that each patient received at the time of discharge, information regarding medications dispensed, as required by State law.The hospital also failed to ensure that routine medications returned in cassettes were followed up on daily to determine the reason they were not given, and medications brought into the hospital by physicians for patient use were stored in accordance with hospital policies and procedures, State law, and standards of practice.The hospital failed to ensure there was a policy and procedure when physicians bring medications in for patient use. Storing medications without a label that contains a lot number limits the pharmacy's ability to determine if the medication is on a recall list or discontinued by the manufacturer or if it is a counterfeit medication.

Findings:

1. On 9/27/10 at 0915 hours, the DOP stated there are two patients on investigational drugs. The drugs, which are both psychotropics (to treat mental disorders) were stored on the nursing unit in the medication cart. On 9/27/10 at 1008 hours, the DOP produced a copy of the investigational protocol, Study number RCH-MD-11. He stated he could not locate the information on the second patient receiving an investigational drug.

On 9/27/10 at 1335 hours, RN 1 stated there was only one patient who received an investigational drug in the hospital at the time. The investigational drug was being given to Patient AA. The Study number RCH-MD-36 was different than what the main pharmacy had in their records.

California Code of Regulations, Title 22, Section 71233 (o) states, "Investigational drug use shall be in accordance with applicable state and federal laws and regulations and policies adopted by the hospital. The pharmacist shall be responsible for the proper labeling, storage and distribution of such drugs pursuant to the written order of the investigator."

According to ASHP's (American Society of Healthsytem Pharmacists) article entitled, "ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals," September 1995, states, "The pharmacist shall ensure that policies and procedures for the safe and proper use of investigational drugs are established and followed. The pharmacy shall be responsible for overseeing the distribution and control of all investigational drugs."

The pharmacy department was not up to date on the number of patients receiving investigational drugs in the hospital and their study numbers.

2. On 9/29/10 at 0931 hours, the DOP stated he thought there was an approved hospital policy to provide medication education to patients being discharged. He stated pharmacy was not involved in developing the policy and suggested speaking to the Performance Improvement Manager. On 9/29/10 at 1010 hours, the Performance Improvement Manager stated the hospital drafted a policy and procedure to provide education on medications to patients when discharged but it hasn't been approved by the hospital's "Committee of the Whole" and is not currently in use.

California Health and Safety Code, Section 1262.5(e) states, "a hospital must establish and implement a written policy to ensure that each patient receives, at the time of discharge, information regarding each medications dispensed." In March, 2009, the Department of Public Health issued an AFL (All Facility Letter) to notify the hospitals of the regulation requiring a written discharge medication policy that ensures each patient receives at time of discharge, information regarding each medication dispensed pursuant to California Health and Safety Code Section 1262.5(e).

3. On 9/27/10 at 1028 hours, the DOP stated he performs audits on medications returned in cassettes approximately every month to determine why they were not administered. The pharmacy technician writes the number and circles the doses returned in the cassette each day on the fill list. Reviewing Patient CC's cassette that was returned to the pharmacy, there were 3 different medications that were not given.
Amlodipine 10 milligram (mg) tablet - medication to lower blood pressure,
Divalproex 125 mg sprinkles - medication to treat mental illness,
Diovan 80 mg tablet - medication to lower blood pressure,
All three of the above medications are needed to treat Patient CC's medical and mental illnesses.

The DOP stated the average length of stay for patients is approximately 12 days which was told to him by the Performance Improvement Manager. Waiting 30 days before following up on returned medications allows the patient to be discharged by the time the audit was done. The pharmacy did not investigate the cause of why the medications were not given while the patient was still in the hospital to determine if the patient refused the medications, if there was a clinical or treatment reason the medications were not given, or if the medications were not administered due to an error.

4. On 9/27/10 at 1051 hours, the DOP stated that the Medical Director (Psychiatry) often brought his own medications into the hospital for patient use. The DOP stated the hospital did not have an approved policy or procedure for physicians to provide their own medications from their office supply for administration to patients in the hospital. He stated, this is being done by one doctor only and the medications were stored in the medication night locker under lock and key. There were five medications currently being dispensed from the Psychiatry Medical Director's supply. All five medications were classified as controlled substances (medications that may cause abuse and addiction) and one medication was stored in a plastic ziplock bag with no name or with any information on the outside of the bag. The DOP did not know what the medication was. There were two other medications stored in a prescription bottle with a label stating, "For Office Use." These two medications were removed from their prescription bottles and stored in plastic ziplock bags with no label or information on the outside of the bag. The five medications were:

1.Chloral Hydrate (medication for sleep) 500 milligrams (mg) capsules,
2. Lorazepam (medication for nerves and anxiety) 1 mg tablets stored in a prescription bottle with the Psychiatry Medical Director's name on the outside and "For Office Use," and in a plastic ziplock bag with no information on the outside,
3 .Gray capsules in a plastic ziplock bag without a label and unknown to the DOP,
4. Ambien (medication for sleep) 10 mg tablets stored in a prescription bottle with the Psychiatry Medical Director's name on the outside and "For Office Use," and in a plastic ziplock bag with no information on the outside,
5. Valium 5 mg tablets stored in four plastic ziplock bags with no name or with any information on the outside of the bags.

On 9/27/10 at 1055 hours, LVN 1 stated the medications were administered to the Medical Directors' patients and the dose was documented on the patient's MAR (Medication Administration Record).

According to ASHP's (American Society of Healthsystem Pharmacists) article entitled, "ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals," September 1995, states, "Drug products brought into the hospital shall be identified by the pharmacy and documented in the patient's medical record if the medications are to be used during hospitalization. They shall be administered only pursuant to a prescriber's order and according to hospital policies and procedures." In addition, "Medications shall be stored and prepared under proper conditions of sanitation, moisture, ventilation, and security to ensure medication integrity and personnel safety."

Based on observation and interview, the hospital failed to remove expired nutritional supplements from their medication cart and leaving them available to be used for one of 29 sampled patients (Patient F).

Findings:

On 9/28/10 at 0921 hours, during a medication pass observation, LVN 2 was pouring Pro Stat (a protein supplement) for Patient F. After she poured 30 milliliters of the supplement in a cup, she was informed that the supplement had expired in April 2010 (five months ago). LVN 2 stated she was unaware that the supplement was expired.

Based on interview and document review, the hospital failed to ensure that personnel entering the pharmacy to remove medication(s) when the pharmacy was closed received a training program and there was an approved hospital policy and procedure which included the personnel designated to enter the pharmacy.

Findings:

On 9/27/10 at 0915 hours, the DOP stated that when the pharmacy was closed and a nurse needed a medication that was not available in the medication night locker, the nursing supervisor had authority to enter the pharmacy to retrieve the medication. The DOP stated the pharmacy's hours were from 0700 to 1430 hours Monday through Friday (7.5 hours), 0700 to 1200 hours Saturdays (5 hours) and closed Sundays. The DOP stated he did not have a policy and procedure specific for training nurses or a policy and procedure which would include describing the requirements that need to be met when removing a drug from the pharmacy.

On 9/27/10 at 1028 hours, the DOP stated he monitors the medication removal but does not document this activity and correlate the removal with the current medication orders and the MAR (Medication Administration Record).

On 9/27/10 at 1335 hours, RN 1 stated that nursing supervisors are authorized to enter the pharmacy to retrieve medications when the pharmacy was closed. They document on a log the medications they remove. She was not aware of any specific approved hospital policy and procedure for this.

On 9/28/10, the Policy and Procedure (P & P) entitled, "Administration of Medication" was reviewed. The P & P states the "House supervisor enters the pharmacy and logs any entry and removes only needed medication." The policy and procedure does not describe the specific requirements and precautions that must be enforced and does not list the designated individuals by name and their qualifications.

Based on dietetic services observation, medical record and document review and staff interview the hospital failed to ensure an organized dietary service that was directed by a qualified dietitian (RD).

1. The hospital failed to have systems in place to prevent cross contamination of ice intended for patient use, a comprehensive system to ensure the freshness of spices; assurance of a safe disaster water supply and effective sanitation of utensils and equipment. Cross reference A749 #4, 5, 6 and 7.

2. The hospital failed to ensure the department was effectively organized as evidenced by a policy and procedure manual that did not reflect current scope of practice of the department of a current diet manual. Cross reference A 619, A620 and A631.

3. The hospital failed to ensure an ongoing quality appraisal and performance improvement that addressed the complexity and scope of Food and Dietetic services. Cross reference A264 #1.

4. The hospital failed to ensure that diets were ordered by the physician responsible for the care of the patient. Cross reference A630.

5. The hospital failed to ensure dietary staff provided diets as ordered by the physician. Cross reference A629.

The cumulative effect of these systemic practices resulted in the inability of the hospital to ensure the accurate and coordinated provision of nutrition care and safe dietary services.

Based on dietary document review and administrative staff interview, the hospital failed to ensure dietary services was organized in an effective manner as evidenced by food service policies and procedures that had not been reviewed and did not include procedures that reflected current departmental activities. This resulted in the potential for cross contamination of utensils, lack of acceptable preparation/storage of foods and food borne illness.

Findings:

During dietary document review on 9/28/10 from 1000 -1200 hours, it was noted that many of the departments' policies did not reflect current dietary activities as reflected in the absence of a manual dishwashing policy, an ice machine sanitation policy, an effective policy for storage/holding times of foods used to prepare patient meals, or guidance on the proper washing of fruits/vegetables.

Review of the dietary policy and procedure revealed that many of the policies were related to administrative functions of the department such as position descriptions of dietary staff. The manual did not reflect current staff practices or standards of practice within the food service industry.

Review of the cover sheet for the dietary policy and procedure manual revealed that the documents had not been reviewed by administration, medical staff, the Registered Dietitian, Dietary Services Supervisor or the Governing Body since January 2007.

In an interview with the Risk Manager 9/29/10 at 0900 hours. she stated the hospital review process for policies was yearly. A hospital document titled "Medical Staff Bylaws" and dated 10/29/2009, section 9.41(e) confirmed that the hospital process for review of departmental polices was yearly.

Based on food storage observations, dietary staff interview, and dietary document review, the hospital failed to ensure expired spices were discarded. Failure to ensure freshness of foods may result in decreased food palatability (tastiness).

Findings:

During general kitchen observation on 9/27/10 beginning at 1300 hours, the following was noted:

In the food production area there were spices such as nutmeg, mustard, onion powder, poultry seasoning, curry and cayenne pepper that were held for greater than one year. In a concurrent interview with Dietary Staff (DS) 1 he stated that he was unsure of the amount of time spices could be held and acknowledged that some of the spices were up to 5 years old.

In a follow up interview on 9/28/10 at 1000 hours, with the Dietary Supervisor she stated that the hospital did not have a food holding policy, with the exception of a 3-day hold time for perishable foods. She further stated that she thought the spices should have been removed 12 months after being opened.

Review of hospital dietetic services policy and procedure manual on 9/28/10 beginning at 1500 hours, confirmed the hospital did not have a policy to guide staff on spice storage practices.

Based on dietary staff interview and dietary document review the hospital failed to ensure dietary staff was trained in fire safety and manual dishwashing procedures. Staff that is not fully trained may result in putting patients at risk in the event of a fire, and dietetic practices resulting in cross contamination and the potential of food borne illness.

Findings:

1. During review of emergency preparedness procedures on 9/29/10 at 1000 hours, DS 3 was asked to describe what she would do in the event of a fire. She described the notification process as well as the process to activate the fire suppression system. The surveyor also asked if there was anything else she would do. She replied that she would also shut off the gas. The surveyor asked DS to locate the gas shut off valve. It was noted that she was unable to locate the valve without the assistance of the Maintenance Supervisor (MS).

In a concurrent interview with MS the surveyor asked to describe the training for location of the gas valve. He stated that the policy was distributed to employees and they were responsible for reviewing it.

2. During general kitchen review on 9/27/10 at 1400 hours, DS 3 was asked how the hospital would wash dishes in the event the dishwasher malfunctioned. She stated that she would rinse the dishes under the sprayer, wipe them with detergent after which she would sanitize the dishes and rinse them off. The standard of practice would be to wash, rinse, then sanitize dishes as the final step using an immersion process (U.S.Food Code, 2009).

Review of the hospital's policy and procedure manual on 9/28/10 beginning at 1000 hours, revealed that there was no procedure for manual dishwashing. In an interview on 9/29/10 at 1300 hours, with DS 1 he was asked if there was a procedure to guide staff, to which he stated he was unsure and stated that if it was not in the manual he would not know where else there was guidance.

Review of hospital records of dietary inservices for 2010 revealed there was no documentation that training was provided for manual dishwashing.

Based on medical record review and Registered Dietitian (RD) and administrative staff interview, the hospital failed to ensure only practitioners responsible for the care of patients ordered changes in diets as evidenced by the implementation of diet order changes by RDs and RNs for 5 of 6 sampled patients reviewed for nutrition care (Patients I, J, M, X and CC). Failure to ensure that only qualified practitioners made changes to physician ordered diets may result in changes in patient conditions, further complicating their medical status.

Findings:

Patient J was admitted with medical diagnoses including diabetes and chronic obstructive pulmonary disease. A hospital document dated 9/27/10 and titled "Physician's Admission Order Sheet," noted a telephone order for a Regular No Concentrated Sweets (NCS) diet.

Review of hospital document titled "Change of Diet" dated 9/27/10 noted that the nurse sent the diet order to the kitchen as a Fortified Regular, NCS diet, large portions, with jello three times/day and extra fluid at meals. The document was signed by a Registered Nurse. There was no physicians' order for the diet change.

A follow up physician's order, dated 9/28/10, noted an order for a renal diet and a dietary consult. A follow up document dated 9/28/10 and titled, "Change of Diet," noted that nursing staff changed the diet order to a Renal NCS diet.

In an interview on 9/29/10 at 1330 hours, RN 5 was asked to describe the interpretation of the diet order. She stated that Patient J recently had lab work drawn that indicated impairment in renal function. She stated she called the physician who ordered a renal diet. The surveyor asked her to describe why she added fortification to the diet she replied, "I thought he needed it." There was no documentation that the physician had ordered a fortified diet.

A comprehensive nutrition assessment dated 9/28/10 and completed by the Registered Dietitian (RD) revealed the current diet order to be Renal NCS. The assessment noted that the patient was consuming 100 percent of his meals and the renal diet was appropriate. It was also noted that the RD stated she would provide the current diet and would also include the fortified meals to increase his weight. There was no documentation that either nursing staff or the RD obtained a physician's order prior to implementing the change.

In an interview on 9/29/10 at 1010 hours, with RD A; she was asked to describe the diet order process. She stated that if the physician was at the hospital she would discuss it with him/her at which point the physician wrote an order. If the physician was not at the hospital she would leave recommendations for the physician and she would fill out a diet order change with the expectation that the change would be implemented with the next meal. She further stated that on occasion she would verbally give the recommendation for a diet order change to nursing staff who would in turn fill out the diet order change. She also stated that she believed that RNs had the ability to change the textures of diets without physician approval. She also stated that the hospital's Medical Executive Committee approved the order writing privileges.

In an interview on 9/29/10 at 1100 hours, with the Chief Operations Officer (COO) and the Risk Manager (RM) who were also part of the hospital's performance improvement committee and attended governing body committee meetings were asked to describe how the order writing privileges were approved. They stated that 5-6 years ago the medical staff decided to allow the RDs to change diet orders based on patient needs as a result of physicians not responding to recommended changes. She also stated that she believed the dietary department developed a policy and procedure for the activity. The COO and RM were asked to provide documentation of Medical Executive Committee discussion/approval. As of 9/29/10 at 1700 hours, the facility acknowledged they were unable to provide Medical Executive Committee approval documentation or a policy and procedure.

It was noted that RNs or RDs also changed diet orders for Patients I , M, X and CC indicating that this was a standard of practice within the hospital.

Based on medical record review, nursing and dietary staff interview the hospital failed to ensure physicians' diet orders were followed for 2 of 6 patient charts (Patients R and S) reviewed for nutrition care. Failure to ensure physicians ' orders were followed may result in further compromising medical status.

Findings:

1. Patient R was admitted with diagnoses that included dementia. Physician's orders dated 9/24/10 noted an order to start Jevity 1.2. A follow up order also dated 9/24/10 noted a change to Glucerna at a rate of 75 cc/hour for 24 hours.

During general hospital observation on 9/27/10 beginning at 1425 hours, it was noted that Patient R was being fed via enteral feeding (a tube through the stomach for nutrition). It was noted that the tube feeding was hung on 9/26 at 1630 hours, and the flow rate of the pump was set at 75 ccs/hour. It was additionally noted that 1470 ccs were delivered by 1434 hours, 22 hours after the feeding was hung. A tube feeding that was hung at 1630 hours, the previous day should have a total feeding volume of 1650 cc 22 hours later. There was a shortage of 180 cc.

A follow up observation on 9/28/10 beginning at 0915 hours, noted that a new bottle was hung on 9/27/10 at 1600 hours. It was also noted the bottle had 400 cc left. Similarly a bottle that was hung 17 hours earlier should have 225 cc left in the bottle rather than the observed 400 cc.

In an interview on 9/27/10 at 1425 hours, LVN 4 was asked to describe how nursing staff tracked the amount of feeding delivered. She stated that information would be recorded in the medication administration record (MAR) by the medication nurse. In an interview on 9/28/10 at 1005 hours, and concurrent MAR review, RN 3 was asked how the hospital recorded the amount of feeding delivered. She stated that the medication administration record recorded only that nursing had checked the enteral feeding site for any signs of infection and to make sure the feeding continued to flow. She stated she did not record the volume of tube feeding on the MAR; however, it would be recorded in the patient's medical record on an intake/output record. Review on 9/27/10 of Patient R's input/output records from 9/24 - 9/26/10 revealed the only documentation was the amount of free water that was given.

A final observation on 9/29/10 at 1235 hours, noted that Patient R's pump and enteral feeding was sitting in the hallway and Patient R was observed to be in bed. In a concurrent interview, RN 1 was asked how long the pump was disconnected from the patient. She replied she was unsure. She also acknowledged that the absence of a method to record feedings may result in patients not receiving the full physician ordered enteral feeding.

On 9/29/10 the hospital's policy titled Tube Feeding, dated 7/1/10, failed to guide staff to document the amount of feeding that was delivered.

2. Patient S was admitted with diagnoses including diabetes and obesity. The admission diet order dated 9/18/10 was noted to be a 1600 calorie, no concentrated sweets diet.

During general hospital observation on 9/27/10 at 1500 hours, it was noted that dietary staff brought a meal tray of snacks to the nursing station. It was noted that there was a half of a banana with Patient S's name.

During trayline observation on 9/28/10 beginning at 1130 hours, it was noted that dietary staff was plating the meal tray. It was noted that Patient S received the same meal as the other patients with the exception of a smaller portion of the entree. In an interview on 9/29/10 at 1400 hours, Dietary Staff 1 was asked to describe how he followed the physician's order for a 1600 calorie diet. He stated that he generally used the column for the 1500 calorie meal plan.

In an interview on 9/29/10 at 1300 hours, DS 3 was asked how snacks were prepared. She stated that each patient received a snack and that she placed a variety of snacks on the tray according to the physician ordered diet.

In an interview on 9/29/10 at 1330 hours, CNA 2 was asked to describe how she determined which patient would receive snacks. She stated that the kitchen prepared snacks three times/each day for all patients and the snacks came from the kitchen with each patient's name.There was no documentation that the hospital adjusted Patient S's meal tray to accommodate for 3 snacks/day and continue to meet the physician ordered 1600 calorie diet. In an interview on 9/29/10 at 1445 hours, with RN 5 she acknowledged that if the patient received 3 snacks/day this likely exceeded the physician ordered diet.

Review on 9/29/10 at 1445 hours, of Patient S's medical record revealed that since the time of admission nursing staff recorded 100% consumption of snacks 2-3 times/daily.

Review on 9/29/10 of the hospital policy titled, "Nourishments ...for ...Patients with Special Dietary Needs," dated 11/05, revealed that patients on modified diets and patients with special dietary needs, will receive a nourishment that is planned according to the patient's diet and approved by the RD. There was no documentation that Patient S's snacks were planned according to the physician ordered diet or reviewed by the RD.

Based on hospital document review and Dietary Services Supervisor and nursing staff interview, the hospital failed to ensure a current therapeutic diet manual was available to instruct staff in meeting the diet needs of patients. Potential health complications may arise for patients not on therapeutic diet regimens when ordered by the physician.

Findings:

During document review on 9/28/10 beginning at 1030 hours, it was noted that while the hospital had a diet manual, the manual was published in 2000. It was also noted that the last time the manual was reviewed by administrative, medical staff, and the Registered Dietitian was in 2007.

In a concurrent interview with RN 5 she stated that to her knowledge this was the manual that would be utilized by medical and nursing staff as a reference to order patient diets.

Hospital policy titled "Diet Manual," dated 6/03, noted that the manual will be revised to keep abreast of modern dietetic findings ..." In the hospital document titled "Medical Staff By Laws," dated 10/2009, section 9.41(3) noted that hospital policies/procedures would be reviewed annually. There was no documentation that the manual was revised within the past 10 years.

Based on interviews, a tour of the hospital conducted at 0835 hours on 9/27/10, and a review of policies and procedures, the hospital failed to ensure that the hospital was maintained in a manner to ensure patient safety. There was patient care equipment stored in areas accessible to patients who were a danger to self or others creating the potential for the equipment to be used to do harm to patients, visitors and our staff. The lack of hand washing and hand hygiene supplies led to failure of the staff to promptly wash their hands after patient contact and the potential for the spread of infection.

Findings:

The hospital failed to provide an environment to ensure safety of patients who were deemed a danger to self. Cross reference A144.

The hospital failed to provide handwashing facilities or hand sanitizers to ensure appropriate hygiene and infection control to meet the needs of its patients. Cross reference A749.

The cumulative effect of these deficient practices resulted in the inability of the hospital to provide quality care in a safe environment.

Based on a tour of the hospital conducted at 0835 hours on 9/27/10, interviews with representatives from the hospital and a review of policies and procedures, the hospital failed to ensure that supplies, and equipment had been stored and maintained in a manner to meet an acceptable level of safety for of its patients.

Findings:

The hospital failed to ensure that the environment was free from devices that might be used for self injurious or assaultive behavior by its patients. Patients who are not monitored and have access to medical devices and equipment found in the environment may use these devices to harm or injure themself or others. Cross reference A144.

The hospital failed to ensure appropriate handwashing and sanitizing equipment to meet the needs of its staff and patients. Cross reference A749.

Based on observation, interview, record review, and hospital credential file review, the hospital failed to provide a sanitary environment to avoid cross contamination and transmissibility of infections and communicable disease. There was not an active program for prevention, control, and investigation of infections and communicable diseases as evidenced by:

Failure to ensure staff washed their hands after having direct or indirect patient contact.

Failure to implement isolation precautions for one of 29 sampled patients (Patient U).

Failure to properly sanitize patient care equipment.

Failure to properly sanitize and clean patient rooms and furniture.

Failure to use the correct amount of sanitizing solution for cleaning based on the manufacturer's recommendation.

Failure to sanitize the hospital's ice machine.

Failure to ensure health care workers providing direct patient care had annual tuberculosis screening.

Failure to ensure the CEO, Medical Director, and DON addressed problems identified by the infection control officer and incorporate plan and surveillance through the hospital's quality assurance and performance improvement program.

Failure to follow nationally recognized standards for implementing and maintaining infection control
prevention and surveillance.

Cross Reference A749.

The cummulative effect of these systemic problems resulted in the inability of the hospital to provide quality care in a safe environment.

Based on interview and record review, the hospital failed to have an infection control program that included analysis of infection control data and observation of the staff's implementation of policies and procedures (P&Ps).

Findings:

On 9/29/10 at 1015 hours, during interview, the Infection Control Director/Performance Improvement/Risk Manager stated infection control surveillance was based on medical record review. The Director collected, recorded, and reported data from the medical record reviews to a contracted service for writing an Infection Control report to present to the Committee of the Whole (governing body, infection control (IC), QAPI, etc.). The Director could not produce documentation of analysis of the data to see if there were actions needed to improve infection rates. She could not produce documentation to show the Infection Control Practitioner, Committee of the Whole and/or designee was monitoring staff's implementation of the P&Ps for hand washing, isolation precautions, or environmental cleaning. Cross reference A749.

Based on observation, interview, record review, and credential file review, the hospital failed to have a system for surveillance, investigation and controlling of communicable diseases of patients and personnel. Staff members failed to wash their hands or use hand sanitizer after patient contact during medication pass and after having direct patient contact for a patient in contact isolation. EVS (environmental services) staff failed to know the correct dilution measurements for cleaning/disinfection solutions being used. The hospital failed to ensure dietetic services practices that minimized the potential for food borne illness as evidenced by lack of sanitation of the hospital's ice machine per manufacturer's guidance; presence of an air gap in the food production sink; fruits were not washed prior to preparation; lack of a food grade water hose for the disaster water supplies; and ineffective cleaning of patient medical equipment. Without surveillance and monitoring for infection control practices and P&P implementation by all staff, patients are placed at risk for acquiring infections as a result of the potential for transmissibility of disease through cross contamination by health care workers.

Findings:

1. In 2007, the Centers for Disease Control (CDC) published an article titled: Prevention of Transmission of Infectious Agents in Health Care Settings. The article documents hand hygiene being cited as the single most important practice to reduce the transmission of infectious agents in health care settings. The article adds that during patient care, transmission of infectious organisms can be reduced by adhering to principles of working from "clean" to "dirty" and confining and limiting contamination of surfaces that are directly needed for patient care. It may be necessary to change gloves during the care of a single patient to prevent cross contamination of body sites.

Hand hygiene following glove removal further ensures hands will not carry potentially infectious material that might have penetrated through unrecognized tears or that could contaminate the hand during glove removal. In addition, the article documents improvement requires that the organizational leadership make prevention an institutional priority and integrate infection control practices into the organization's safety culture.

The CDC article (2007) addressed contact precautions and showed healthcare personnel caring for patients on Contact Precautions should wear a gown and gloves for all interactions that may involve contact with the patient or potentially contaminated areas in the patient's environment.

a. On 9/27/10 at 0935 hours, a tour of the nursing unit was conducted. A door to a patient's room (Patient U) was closed and a handwritten sign was taped to the door that showed, "Respiratory Isolation." Outside the room entrance was a bedside table with a box of masks and gloves placed on top.

An interview on 9/27/10 at 0940 hours, with CNA 3 showed Patient U was admitted with MRSA (methicillin-resistant Staphylococcus aureus) of the nares. She stated the staff were instructed to wear a mask and gloves when caring for Patient U. During the tour of the unit an interview with RN 1 was conducted on 9/27/10 at 1000 hours. RN 1 stated Patient U was positive for MRSA of the nares and respiratory isolation meant contact isolation. RN 1 prepared to go into the isolation room and put on a mask and gloves, but no gown. RN 1 was observed to clip an alarm on Patient U's gown and push the patient's table next to the bed. Prior to exiting the room, RN 1 removed the mask and gloves and threw them into a trash container next to the bed. The trash container was approximately six feet from the door entrance. RN 1 opened the door with bare hands and exited the room without washing her hands. RN 1 went to the nursing station and was observed to use the hand sanitizer located there. There was no sink available for the staff to use for handwashing with soap and water.

On 9/27/10 at 1500 hours, a contact isolation sign was observed on Patient U's door that replaced the respiratory isolation signage. The sign showed instructions for staff and visitors of what protective equipment was to be worn prior to entering the room. The sign showed mask, gloves and gown would be required of those entering the room.

A concurrent interview with the Infection Control Officer revealed isolation precautions for Patient U would require PPE's that included a mask, gloves and a gown. If Patient U left the room, the patient would wear a mask.

The hospital's P&Ps for infection control showed contact isolation required a physician's order.

On 9/27/10, a review of Patient U's medical record showed no documentary evidence of a physician's order for either respiratory isolation or contact isolation.

The hospital P&Ps for standard precautions indicated routine hand washing, using soap, running water and friction must be strictly adhered to. Masks are worn when it is anticipated splashing with body fluids might occurred. Gowns are to be worn when soiling of the health care worker's clothes is possible during care.

b. On 9/28/10 at 0715 hours, CNA 1 was observed bringing a meal tray to Patient U's room. The patient was on contact isolation precautions for MRSA of the nares. CNA 1 put gloves and mask on and entered the room with the meal tray. Upon exiting the room CNA 1 was wearing no gloves and did not wash her hands. CNA 1 carried documents in one hand and with her other hand CNA 1 touched the staff restroom door to open it and throw her mask away. She preceded to go to a cabinet in the nursing station to place the documents in the cabinet. CNA 1 did not wash her hands.

Interview with CNA 1 on 9/28/10 at 0730 hours, showed she was not aware to wash her hands at anytime after leaving a isolation room. She was asked about the documents she was transporting from the room. She stated the patient wanted information on the documents to be given to a social service representative. CNA 1 was unaware of cross contamination of carrying documents from a isolation room and placing them in a cabinet in the nursing station. CNA 1 was asked about what she should have done upon exiting the isolation room and she replied, "I don't know."

c. On 9/28/10 at 0859 hours, after observing LVN 2 pass medications to Patient C she left the room and removed Ativan (a medication for anxiety) for Patient AA from the medication cart. She proceeded to walk into Patient AA's room and handed the medication to him which he swallowed. LVN 2 did not sanitize her hands before entering Patient AA's room. The hospital's policy and procedure entitled, "Hand Washing," states "Before preparing or serving food or medications, alcohol based waterless antiseptic agents are encouraged for routine decontamination of hands in all clinical situations when hands are not visibly soiled."

2. On 9/27/10, a review of the hospital housekeeping wall & ceiling vent cleaning P&P showed the directive to mix cleaning solutions according to label directions.

a. On 9/27/10 at 0940 hours, EVS 1 was observed cleaning the wall in room 10. EVS 1 wore a pair of gloves, sprayed solution from a bottle to a rag, cleaned the wall, went into the restroom, flushed the toilet, cleaned the wall in the restroom, came out cleaned the wall in the patient's room, the door frame and then moved to the outside of the hallway. There was no changing gloves or rag noted. EVS 1 was sneezing during the cleaning work and used their shirt to wipe the nasal discharge. A review of the spray bottle showed the solution was for high speed floor cleaning.

b. On 9/27/10 at 1005 hours, EVS 2 was observed mopping the floor in the public area. During interview, EVS 2 stated she mixed a bucket of water with "a little" disinfectant. EVS 2 stated the EVS Supervisor prepared the disinfectant and she added a little in the water. EVS 2 stated "too much" disinfectant could make the floor sticky. However, EVS 2 could not demonstrate the proportion between the water and the disinfectant used.

On 9/29/10 at 0935 hours, during interview, the Maintenance Supervisor (MS) stated EVS 2 was supervising EVS 1's work. MS checked their jobs on a quarterly bases. MS stated the manufacturer's recommendation for mixture of the disinfectant was to use 2 ounces of disinfectant with one gallon water. MS asked EVS 2 to demonstrate the measurement of two ounces. EVS 2 filled approximately one third of an eight ounce cup (approximately 2.5 ounces) and was not able to state how much water would be added to dilute the disinfectant. MS stated that "was about it."

3. On 9/28/10, a review of the hospital housekeeping P&P for Care of Suction Units, Infusion Pump (IMED) & Other Equipment, dated 4/07, indicated infusion pumps would be thoroughly examined for cleanliness prior to use. The P&P stated the housekeeping staff could perform decontamination for used pumps and then take them back to the clean equipment room.

a. On 9/29/10 at 0900 hours, one IMED was observed being used in a patient's room for intravenous infusion treatment. A corner area of the top of the pump was covered with some solid light orange residue. When interviewed, MS revealed there was no method or documented evidence to show the EVS staff cleaned the pump.

b. On 9/29/10 at 0930 hours, during a tour of the temporary equipment cleaning room with MS, one of five oxygen concentrators was inspected. On the back of the concentrator, a ventilation filter was blocked with dust. The compressor pump base was dusty. One of three IMEDs was dusty on top and there was a spot of blood residual on the drip sensor chamber. The MS stated the equipment had been cleaned and was ready for patient use.

4. On 9/27/10 beginning at 1400 hours, the Maintenance Supervisor (MS) was asked to describe the ice machine cleaning process. He stated that on a quarterly basis he removed the front panel of the machine, took the ice out and rinsed the ice producing mechanism and the ice holding bin with vinegar. He further stated that he would also pour vinegar into the water reservoir and allow it to circulate through the tubing.

Review on 9/27/10 at 1530 hours, of the manufacturers' guidance for the ice machine revealed that the recommended process for cleaning and sanitizing the ice machine was to utilize an "approved ice machine cleaner" followed by a "sodium hypochlorite food equipment sanitizer to form a solution with 100 to 200 ppm (parts per million) free chlorine yield." MS acknowledged this was not the process he was using.

5. During general food production observations on 9/27/10 beginning at 1415 hours, DS 1 was asked to describe which sink would be utilized for food production activities. He pointed to a 2-compartment sink that was near the dish machine. It was also noted that one side of the sink was labeled "meats" and the other side was labeled "vegetables." It was also noted that this sink did not have an air gap, rather was plumbed directly into the waste water system. The purpose of an air gap is to ensure there is no cross contamination of food preparation areas in the event of sewage back flow (U.S. Food Code, 2009).

In an interview on 9/28/10 with MS the surveyor asked if the hospital had changed any of the plumbing lines, to which he replied that he was unsure; however he did not recall any work being done during the time he worked at the hospital.

6. During general kitchen observations on 9/27/10 beginning at 1300 hours, it was noted that dietary staff was utilizing fresh fruits, such as melons. Additional observation on 9/28/10 at 1000 hours, noted that dietary staff had cut the melons for the noon meal. In a concurrent interview with DS 2 she was asked to describe the process for preparing the melons. She stated that she would take the melons from the storage area, place them on the green cutting board, would peel them and dice them. The surveyor asked if there were any other steps that were taken to which she replied "no."

Review of the hospital's policy and procedure DI-15.7, dated 12/99 and titled "Sanitation," revealed that while the policy included basic food preparation techniques there was no procedure describing acceptable methods for washing fruits/vegetables. The standard of practice for handling melons, in particular cantaloupe would be to wash them under running water with a vegetable brush (Centers for Disease Control, 2001).

7. During review of disaster preparedness activities on 9/28/10 at 1015 hours, MS was asked to describe how the hospital would ensure adequate water supplies for food production, patients and staff. He stated that the hospital maintained adequate supplies in 50-gallon barrels. The surveyor asked him to describe how he would fill the barrels. He replied that they were filled using a garden hose. The surveyor also asked him if the hospital had a policy/procedure for filling the barrels, to which he stated they did not.

The standard of practice would be to utilize a hose designed specifically for the transfer of potable (drinkable) water (Red Cross, 2009) to ensure there was no leaching of contaminants from the hose to the water supply.

8. During general observations on 9/28/10 beginning at 1130 hours, RN 3 was observed taking the blood glucose of an inpatient using a glucometer (a portable blood sugar testing device). She was observed carrying a plastic case into the patient's room, placing it on the over bed table and proceeding to perform the blood test. She then replaced the equipment back in the box and left the patient's room.

In a concurrent interview the surveyor asked RN 3 to describe the cleaning process for the machine. She stated that the policy was to wipe it down using alcohol wipes between patient use.

In 4/10 the American Journal of Infection Control published an article written by the Association of Professionals in Infection Control and Epidemiology, on page 171, under the section titled, "Blood Glucose Monitoring Devices" direction was given, "Assign a glucometer to each individual if possible. Clean and disinfect glucometers if they must be shared between patients ..." Disinfect the exterior of the glucometer after each use following manufacturer's guidance. Use an Environmental Protection Agency registered disinfectant Hepatitis B, Hepatitis C, HIV, or a 1:10 bleach solution (1 part bleach: 9 parts water)."

9. The CDC's 2005, Guidelines for Preventing the Transmission of Mycobacterium Tuberculosis (TB) in Healthcare Settings was reviewed. On page three of the document the CDC recommends that healthcare workers (HCW), "Refers to all paid and unpaid persons working in a health care setting who have the potential for exposure to M. tuberculosis through air space shared with persons with infectious TB disease. Part time, temporary, contract and full-time HCW's should be included in a TST screening program...." A review of CDC's list of HCW's who should be included in a TST screening program included, "Physicians, Physicians's Assistants, Attending Physicians, fellows, residents, or interns, including anesthesiologists, pathologists, psychiatrists, psychologists..." TST negative employees should have a single TST and a symptom-screen questionnaire annually.

On 9/29/10, a review of the hospital's P&P Post Offer Physical and Annual Health Screening of Employees was conducted and showed all employees will be screened annually for Tuberculosis. The document showed all hospital employees, staff physicians, and volunteers shall be screened for TB on hire or when applying for hospital privileges and at least annually thereafter. The policy further documents that all current employees with no history of positive skin test will have annual skin test and symptom review.

On 9/29/10, review of employee health screening files showed eight of 30 employees were not current with their annual TST requirement of the hospital.

Documentation showed RN 1 was due for her annual TST examination and testing. Documentation showed RN 1 was due for her TST on 4/10/10, however there was no evidence the testing had been completed.

Documentation showed RNA 2 was due for his annual TST on 7/21/10, however there was no evidence current TST examination was completed. The RNA worked a total of 60 shifts without a current TST.

Documentation showed RN 7 was due for her annual TST on 5/11/10, however there was no evidence a TST examination was completed.

Documentation showed CNA 4 was due for her annual TST on 5/7/10, however there was no evidence a TST examination was completed.

Documentation showed dietary staff (DS 1) was due for his TST on 6/10/10, however there was no evidence the TST examination was completed.

Documentation showed DS 3 was due for her TST on 6/4/10, however there was no evidence a TST examination was completed.

Documentation showed EVS 3 was due for a TST on 6/4/10, however there was no evidence the TST examination was completed.

Documentation showed the Performance Improvement Director was due for TST on 6/18/10, however there was no evidence the TST had been completed.