HospitalInspections.org

Based on interview and record review, the governing body was not specifying the frequency and detail of data collected for quality assurance purposes, creating the risk of inadequate quality assurance, and substandard health care in the facility.

Findings:

During an interview with the QCO on 4/27/10 at 10:50 AM, she stated that the frequency and detail of data collection was determined by committees formed to review specific issues and by a scoring system that she was using to evaluate quality issues, not the Board of Trustees.

The Board of Trustees meeting minutes for 2009 and 2010 was reviewed on 4/29/10. There was no evidence that the Governing Body was specifying the frequency and detail of data collection for quality assurance.

During a meeting with representatives of the Board of Trustees on 4/29/10 at 12:30 PM, including the Chairperson, Medical Staff President, CEO and other members, the members stated that they reviewed data from the QA Department, but were unable to provide evidence that the Board directed the frequency and detail of data collected by that department.

Based on observation, staff interviews and record review, the facility failed to measure analyze, and track quality indicators including aspects of performance that assess process of care, hospital services and operations as it relates to the food services department.

Findings:

During the survey from 4/26/10 to 4/30/10 deficient practices were observed as it related to the following:
* The Food Service Directors failed to ensure the daily management of dietary services to provide patients, staff and visitors with safe and high quality food due to a lack of monitoring the high risk practice of safe cool down of foods (cross refer A-620).
* The Food Service Directors failed to ensure staff guidance and monitoring of appropriate internal cooking temperature of potentially hazardous foods to prevent the potential for food borne illness (cross refer A-620).
* The Food Service Directors failed to ensure that when pizza was procured from an outside source, that source used safe food handling techniques to prepare and transport the pizza. They further failed to ensure the staff monitored the holding temperature of the pizza during the meal service to prevent the potential for food borne illness (cross refer A-620).
* The Food Service Directors failed to ensure staff guidance and monitoring of the dishmachine and 3 compartment sink sanitizing concentrations and water temperatures for the proper sanitizing of dishware and pots and pans to prevent the potential for food borne illness (cross refer A-620).
* The Food Service Directors failed to monitor and ensure safe dry food storage temperatures to prevent the potential for food borne illness and assure the quality of the dry food and enteral formula products (cross refer A-620).
* The Food Service Directors failed to monitor and ensure proper serving portions of protein-rich foods according to the planned menus to meet the nutritional needs of patients (cross refer A-620).
* The Food Service Directors failed to ensure that adequate disaster food supplies were on hand to meet the needs of the patients, staff and visitors in the event of a disaster according to the hospitals disaster food plan (cross refer A-620).
* The Food Directors and the Clinical Dietitian failed to ensure the nutritional needs of 4 of 7 patients (Patients 21, 22, 25 and 26) reviewed for nutrition care were met in accordance with recognized dietary practices and the facility standards/policy and procedures (cross refer A-630).

According to FSCM B on 4/29/10 at 1:05 PM, the Food Services Department was collecting data on the accuracy of diet orders as a quality improvement project. No study was being conducted or evaluated on any of the above deficient practices identified during the survey.

In an interview with the Quality Manager on 4/29/10 at 1:15 PM, she stated that purpose of the Performance Improvement plan was to maintain an effective system for monitoring and evaluating the quality of services provided throughout the hospital. She further sated that the Quality Improvement committee was not monitoring the above deficient practices.

Based on interview and record review, the facility failed to ensure that the information to be used for consideration, for two physicians under consideration for reappointment, was compiled by the responsible departments and used by the medical staff to consider the qualifications for reappointment. This failed practice had the potential for granting reappointment to an unqualified physician, resulting in substandard medical care.

Findings:

During review of the credential files of MD 1 and MD 2, the files contained Reappointment Physician Performance Profiles forms with spaces for specific pieces of data evaluating aspects of the physicians ' performance, but the forms were largely blank. Nonetheless, reappointment letters were found in the files indicating MD 1 had been reappointed 4/09 and MD 2 was reappointed during 6/08.

During an interview with the QCO on 4/28/10 at 11:50, she stated that the Reappointment Physician Performance Profile should be completed prior to reappointment. She stated that the document was on a shared computer drive, and that different departments were to fill out sections, but that this was not done. She stated that she had not been filling out the sections to be filled out by the QA Department, and neither had her predecessor.

Based on interview and record review the facility failed to supervise and evaluate the nursing care for 3 of 34 sampled patients (Patients 61, 63, 22) and a universe of 13 patients on the 300 hall.

For Patient 61 the facility failed to reassess the patient for pain relief in a timely manner after a narcotic was administered.

For Patient 63 the facility failed to assess the patients risk for developing pressure ulcers on each shift which had the potential to result in the development of pressure sores.

For a universe of 13 patients on the 300 hall the facility failed to ensure that a case manager was competent to relieve the staff nurses, for breaks and lunches.

For Patient 22 the hospital nursing staff failed to obtain a stool sample as ordered and supervise and evaluate Patient 22 for lack of a bowel movement for five days.

These failures had the potential to result in injury or death of the patients due to patient care needs not being met.

Findings:

1. The Clinical record for Patient 61 was reviewed on 4/27/10 at 10:20 AM. The clinical record for Patient 61 noted the patient was admitted to the facility on 4/26/10 with a diagnosis of small bowel obstruction.

Review of Patient 61's physician orders dated 4/26/10 at 0015 (12:15 AM), noted that Patient 61 had an order for Dilaudid 1 mg IV (intravenous) with Zofran 4 mg IVP (intravenous piggy back) as need for severe pain only.

The Medication Administration Record dated 4/26/10 to 4/27/10 noted that patient 61 was medicated with Dilaudid 1 mg IV and Zofran 4 mg IVP for severe pain on 4/26/10 at 8:25 AM and 2:15 PM.

Review of the "Pain assessment/Reassessment Flow sheet" noted that on 4/26/10 at 0800 (8:00 AM) Patient 61 was assessed to have a pain level of 9 on a 0 to 10 pain scale, and assessed to have a pain level of 8 on a 0 to 10 scale at 2:00 PM. There was no documentation on Patient 61's "Pain Assessment/ Reassessment Flow sheet" that noted that Patient 61 had been reassessed for the effectiveness of the Dilaudid 1 mg IV after the medication was administered on 4/26/10 at 8:25 AM and 2:15 PM.

During an interview with Charge Nurse 1 on 4/26/10 at 10:30 AM, Charge Nurse 1 stated that according to the facility policy patients should be reassessed for pain relief 30 minutes after a medication is given IV or IM (intramuscular) and 60 minutes if the medication is given PO (by mouth). During the interview Charge Nurse 1 verified that the "Pain Assessment/Reassessment Flow sheet" noted that on 4/26/ at 0800 (8:00 AM) Patient 1 was assessed to have a pain level of 9 on a 0 to 10 pain scale, and assessed to have a pain level of 8 on a 0 to 10 scale at 2:00 PM. Charge Nurse 1 verified that there was no documentation on the "Pain Assessment/ Reassessment Flow sheet" or in the clinical record that noted that Patient 61 had been reassessed for the effectiveness of the Dilaudid 1 mg IV after the medication was administered on 4/26/10 at 8:25 AM and 2:15 PM.

Further review of the clinical record , noted that Patient 61 had an order for Dilaudid 2 mg IV every four hours as needed for pain dated 2/26/10 at 1615 (4:15 PM).

Further review of the MAR noted that Patient 61 was given Dilaudid 2 mg IV at 1640 (4:40 PM).

Further review of the "Pain Assessment/Reassessment Flow sheet" noted that Patient 61 had been assessed to have a pain level of 9 on a 0 to 10 pain scale at 4:40 PM. There was no documentation on the flow sheet or in the clinical record that noted, that Patient 1, had been reassessed for the effectiveness of the medication, and to ensure that Patient 61 had not been over sedated.

During an interview with Charge Nurse 1 on 4/26/10 at 10:30 AM, Charge Nurse 1 verified that Patient 61 had not been reassessed for the effectiveness of the pain medication, and to ensure that Patient 1 had not been over sedated.

The facility policy titled "Patients Rights and Organizational Ethics, Subject: Pain Management" was reviewed on 4/27/10. The policy noted the following:

"VI. Assessments/Reassessment:"
"Pain medication Reassessment:"
"1. PO/IM 30-60 minutes"
"2. IV dose: 15-30 minutes"

"VII. Documentation:"
"Assessment and measure of pain intensity and quality are recorded on the Pain Assessment/Reassessment Flow sheet".
" Reassessment of pain is noted after the intervention. The patient ' s self-report of pain relief is documented in the shaded box and marked with a circle ".

"VIII. Pain Management Evaluation:"
"The goal of pain management is to evaluate the patient ' s perception of the appropriateness and effectiveness of pain management."

2. The clinical record for Patient 63 was reviewed on 4/27/10 at 2:45 PM. The clinical record noted that Patient 63 was a 67 year old female admitted to the facility on 4/22/10 with diagnoses that included difficulty breathing and pneumonia.

Review of the "24 Hour patient Care Record" from 4/22/10 to 4/26/10, noted that Patient 63 was not assessed for her risk of developing pressure ulcers on the AM shifts on 4/23/10 and 4/24/10.

During an interview with RN 1 on 4/27/10 at 3:50 PM, RN 1 verified that Patient 63 did not have a pressure ulcer risk assessment completed on the AM shifts on 4/23/10 and 4/24/10. RN 1 stated that the registered nurses completed the assessment for the risk of developing a pressure ulcer on admission and once every 24 hours. RN 1 stated that the risk assessment did not have to be completed on each shift.

The facility policy and procedure titled, "Skin Integrity & Wound Care Protocol" dated 1/18/89, was reviewed on 4/27/10, and noted the following:

"A. The risk assessment for acquiring pressure ulcers must be completed on admission. The Braden Scale is nationally recognized, proven and reliable risk assessment for pressure ulcers and will be used. Interventions are planned and implemented based on level of risk assessed."

"B. Ongoing risk assessment in acute care will be completed with each concurrent shift nursing assessment to include a ' head to toe ' skin assessment to promptly identify skin lesions."

During an interview with RN 1, on 4/27/10 at 4:30 PM, RN 1 verified that the facility policy noted that the pressure ulcer risk assessment should be completed by the registered nurse on each shift.

3. During an interview with Charge Nurse 2 while touring the 300 hall, on 4/27/10 at 11:20 AM, Charge Nurse 1 stated that Case Manager 1 relieves the staff nurses for breaks and lunches.

During an interview with Case Manager 1 on 4/27/10 at 11:30 AM, Case Manager 1 verified that she took over the care of patients for the nurses on the 300 hall while the nurses take their breaks and lunches.

The Job description for "Case Manager" was reviewed on 4/27/10. Review of the job description noted that the employee "must possess a current California Registered Nurse license" , but there was no indication that the Case manager would be responsible for providing clinical patient care.

The competencies required by the nurses on the 300 hall and the competencies completed by Case Manager 1 were reviewed on 4/27/10. Review of the competencies completed by Case Manager 1 noted that she had not completed competencies for the following:

A. IV Fluids Management Competency
B. Medication Safety Competency
C. Active Surveillance Cultures (ASC) Competency
D. Core Measures Competency
E. Fall Risk Competency
F. Wound Care Web-Based Competency

During an interview with the Interim Medical/Surgical Manager (IMSM) on 4/27/10 at 3:55 PM, the IMSM verified that Case Manager 1 had not completed the equivalent competencies of the nurses she was relieving for breaks and lunches on the 300 hall.





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4. Patient 22 was admitted on 4/20/10. A review of the medication reconciliation orders dated 4/20/10 showed that Patient 22 was on Vicodin ES twice a day prior to admission and had an order for Milk of Magnesia as needed. The physician had ordered for both medication orders to continue during the hospitalization.

Patient 22 had a physician order on 4/21/10 to check for C. Diff stool culture secondary to the multiple loose bowel movements the patient had experienced on 4/21/10.

A review of the laboratory results showed during the medical record review on 4/26/10 that no stool culture had been obtained or results provided. Further review of the record showed that from 4/22/10 to the record review date of 4/26/10, patient 22 had not had a bowel movement.

A review of the Patient Care Plan titled "Alteration in Comfort, Pain" showed that Patient 22 had been educated by staff regarding pain medication side effects at least once daily from 4/20/10 through 4/24/10. A review of the information handout showed that constipation was a common side effect of pain medication.

On 4/26/10 at 4 PM, Patient 22 stated that he had not had a bowel movement for many days.

On 4/26/10 at 4:10 PM, RN A stated the reason the stool culture had not been taken was because Patient 22 had not had a bowel movement. RN A also stated it was a nursing "standard" to ensure patients had a bowel movement at a minimum of once every three days. She was unable to explain why the licensed nurses had not noticed the lack of bowel movement for five days and administer milk of magnesia to address the constipation the patient was having.

Based on interview and record review, for one post-operative orthopedic patient, the nurse failed to implement an order for gait training, and failed to notify the physician that the order was not being carried out, creating a risk for a poor health outcome for that patient.

Findings:

During a review of the medical record of Patient 1 on 4/28/10 at 2 PM, a physician order, dated 4/28/10 at 8:30 AM, for gait training, was seen. There was no evidence that gait training had been performed or that a physical therapist had been summoned.

During an interview with RN 2 on 4/28/10 at 2:20 PM, she stated that she was caring for Patient 1. She stated that she was not sure why the MD ordered the gait training, that she was not able to do gait training and that no gait training was available in the facility. She stated no one had called the ordering physician to let him know that they could not do gait training, and that he should have been contacted.

Based on observation, interview and record review, the Condition of Participation for Medical Records Services was not met.

The hospital failed to:

1. Ensure that medical records stored in the structure adjacent to the parking lot were secure at all times and not accessible to unauthorized persons. (refer to A 0441)

2. Ensure that patient health records were retrieved from the Health Information Department by staff who were authorized by job description and hospital policy to perform these duties. (refer to A 0441)

3. Ensure that physician orders were legible. (refer to A 0450)

4. Ensure that all verbal orders were authenticated within 48 hours. (refer to A 0457)

5. Ensure that informed consent forms were properly executed. (A 0466)

The cumulative effect of theses systemic problems resulted in the hospitals failure to provide accurate and confidential medical record services.

Based on interview and record review the facility failed to ensure that patient confidential health records were retrieved from the Health Information Department by staff who were authorized by either hospital policy or job description. The facility failed to ensure that medical records stored in the structure, located across from the public parking lot, were secured at all times and not accessible to unauthorized persons.

These failures had the potential to impact a universe of 26, and to result in a breach in patient confidentiality and possible identity theft.

Findings:

1. The outside structure storing overflow patient medical records was visited on 4/28/10 at 10:15 AM. Upon approaching the structure, it was observed that the door to the structure was open and unattended. Upon entering the structure, it was observed that there were no facility staff within a visible proximity of the structure door, and confidential patient health information was accessible to anyone who entered the structure. The structure was located in close proximity to the facility parking lot.

During an interview with the Health Information Clerk (HIC) working in the structure with the overflow records, on 4/28/10 at 10:20 AM, the HIC verified that the door to the structure was open and unattended, which allowed access of confidential patient health information to unauthorized persons. The HIC stated that confidential patient health information should be secured, and the door to the structure should be closed and locked at all times.

During an interview with the HIM, on 4/28/10 at 10:23 AM, the HIM verified that confidential patient health information should be stored in a secure manner that prevents access of the PHI to unauthorized persons.

The facility policy and procedure titled "Location and Security of Medical Records" was reviewed on 4/28/10 at 10:30 AM and noted the following:


"It is the policy of this facility that medical records be maintained in a secure and confident manner. Areas housing health information shall be restricted to authorized personnel only and these areas will be secured at all times. The Health Information Management Department (HIMD) will be responsible for the storage and maintenance of medical records (including paper) and/or individual patient reports. The HIM Department will be responsible for ensuring the security of medical records and/ or reports against loss, defacement, tampering, and unauthorized access."


2. On 4/28/10 at 10:00 AM, a tour was conducted of the medical records department.
During the tour, an interview with the Health Information Manager (HIM) on 4/28/10 at 10:10 AM, the HIM stated that after the Health Information Department (Medical Records Department) closes at 5:00 PM, and when a record is needed, a security guard retrieves the patient health information from the Health Information Department.
During the interview, the HIM stated that the security guards had been given patient names and medical record numbers, so that they could locate patient medical records. The HIM stated that once the record had been located, the security guard wrote the date, time, his name, the patient's name and the disposition of the patient information on a log. During the interview the HIM was asked why a security guard is authorized to access patient confidential health information, the HIM stated, " That ' s a good question, I don't know ..., that ' s how we have always done it. "

The sign out logs for the patient medical records were reviewed on 4/28/10, at 10:10 AM. The log sheets noted that from 3/31/10 to 4/27/10 seventy-two medical records were retrieved from the Health Information Department by security guards.

The Job description for the position of security guard was reviewed on 4/28/10 at with the Human Resource Representative. There was no indication in the job description, that security guards would need to have access to confidential patient health information, as part of their job description.

The facility policy and procedure titled "Location and Security of Medical Records" was reviewed on 4/28/10 at 10:30 AM and noted the following:

"It is the policy of this facility that medical records be maintained in a secure and confident manner. Areas housing health information shall be restricted to authorized personnel only and these areas will be secured at all times. The Health Information Management (HIM) Department will be responsible for the storage and maintenance of medical records (including paper) and/or individual patient reports. The HIM Department will be responsible for ensuring the security of medical records and/ or reports against loss, defacement, tampering, and unauthorized access."

"Access to the HIM Department during off hours by facility staff and physicians will be granted by assigning restricted access responsibility to certain individuals, such as a nursing supervisor or a designated individual in the emergency department."

There was no reference in the facility policy that noted that security guards would have access to the Health Information Department and patient confidential medical records.

Based on interview and record review, the facility failed to ensure that physician orders were legible as per policy and procedure regarding legibility in medical records, approved by the Board of Trusties on 4/29/10. This failure could lead to medication errors and adverse patient events for a universe of 31 patients.

Findings:

Medical records for Patient # 69 was reviewed on 4/30/10 at 10:30 AM. The clinical record noted physician's orders dated 4/27/10 at 1720. The medication orders and interventions were not legibly written which could be misread or misinterpreted and may lead to medication errors or delayed provision of care.

Two of the facility nursing staff were requested to read the orders. An interview with the two nurses on 4/30/10 at 10:30 AM revealed, "It's hard to read but we are used to the doctor's handwriting already".

Subsequent interview with two non-nursing facility staff members confirmed the handwriting was difficult to read.

Based on interview and record review the facility failed to ensure that telephone/verbal orders were signed within 48 hours.

This failure posed a potential risk of miscommunication that could result in a medication error, resulting in a patient adverse event.

Findings:

the medical record for unsampled Patient # 82 was reviewed on 4/30/10 at approximately 9:15 AM. The clinical record noted that he was admitted to the facility on 4/20/10.

Review of physician's orders noted that the patient's chart contained the following 3 telephone orders verified ( TOV ) transmitted and recorded by nursing staff.

4/25/10 at 1300 KCL Elixer 20 meq p o ( by mouth ) Q ( every ) 4 hrs x 3 doses then DC ( discontinue ).

4/25/10 at 1600 Give one dose Morphine Sulfate 2 mg ( milligrams ) IV ( through the vein ) now, then discontinue.

4/26 /10 at 0955 Kapidex 60 mg ( milligrams ) p o ( by mouth ) at bedtime x 1 month.

The telephone orders remained unsigned by the ordering physician as of 4/30/10.

Review of the policy and procedure, approved,by the Board of Trustees dated 4/1/10, stated, "All telephone and verbal orders shall be written on the Physician's Order Sheet ...... All telephone medication orders must be authenticated, timed, and dated by the Practitioner within 48 hrs".

In an interview with the charge nurse on duty for Unit 100 on 4/30/10 at 9:15 AM, revealed there was a log to follow up all telephone medication orders to make sure the physicians signed, timed and dated the orders within 48 hrs. The charge nurse confirmed the findings.

Based on record review and interview, the facility failed to ensure that consent for treatment and surgery are properly signed by the patient's legal representative. For Patient 68 the facility failed to ensure that consents for treatment were signed only by a person who had the legal power of attorney to sign for the person receiving the treatment. This failure resulted in the facility providing medical treatment and surgical procedures on Patient 68 without first confirming the person signing the consent for treatment had the legal right to sign the consent forms.

Findings:

On 4/27/10, record review for Patient 68 revealed the consent forms for medical treatment and surgery had not been signed by the patient. The consents had been signed by a person whom wrote next to their signature "power of attorney, care taker" .

Further record review revealed the facility did not have any documentation to confirm the individual signing for Patient 68 had a legal right to sign the consents and/or what if any relationship the person signing the consents had to the patient.

Chief Nursing Officer (CNO) stated, "There should be a form in the front of the chart filled out showing the person who signed the consents is the patient's legal power of attorney. I don't see one in this chart or any other information showing that the person who signed the consents for medical treatment and surgery is the legal power of attorney for this patient. We should have something that shows the person who signed for the patient did have the legal right to sign the consents for them."

Based on document reviews, staff interviews, clinical record reviews, drug storage areas, and policy and procedures reviews on 4/26/2010 - 4/29/2010, the facility failed to ensure that pharmaceutical services were provided in accordance with accepted professional principles by failing to have systems in place to control and distribute drugs in accordance with standards of practice in accordance with State and Federal regulations to ensure patient safety.

This Condition is NOT MET as evidenced by failure to ensure that:

1. Systems used for the review of medication orders is done in a manner to promote patient safety by ensuring that medication orders are reviewed by a registered pharmacist and consistent with state regulations and laws. (Refer to A0500.)

2. Refrigerator temperatures were maintained within 36 - 46 degrees Fahrenheit. (Refer to A0491.)

3. That there was documentation on the preprinted order sheet noting that droperidol (Inapsine) was a high risk drug and guidelines to be listed for monitoring for adverse consequences. (Refer to A0500.)

4. The system to consistently and readily identify employees who should have access to the Automated Distribution Cabinet (ADC), also known as an automated drug distribution cabinets, actively updated changes in personnel status. (Refer to A0503.)

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

Based on observation, documentation review, interview, and policy and procedure review, the facility failed to ensure that refrigerator temperatures for the storage of medications on patient care units and the pharmacy were maintained within the acceptable range of 36 to 46 degrees Fahrenheit.

Findings:

During an interview with the Director of Pharmacy (DOP) and Staff XX in the pharmacy office, and concurrent review of temperature logs for the facility's medication refrigerators located on patient care units (100, 300, Intensive Care) on 4/26/10, at approximately, 11 AM, revealed that the refrigerator log approved for use was inaccurate. The approved log documented an acceptable temperature range as 35-45 degrees Fahrenheit. Per regulatory and manufacturer, refrigerator temperatures are required to be maintained within the acceptable range of 36 to 46 degrees Fahrenheit. In a concurrent interview with Staff XX, she reported that Staff YY, of Environmental Services set the temperatures for storage of products within the facility. The temperature range adopted for medication storage by the facility was 35 to 45 degrees Fahrenheit instead of the regulatory temperatures and manufacturer's specified temperature range of 36 to 46 degrees Fahrenheit.

The instructions to staff as documented on the log states, "In the event that the temperature falls outside the acceptable range of 35 to 45 degrees F (Fahrenheit), please record your corrective actions in the space below. Provide the date of the occurrence, your initials, the actions taken to correct the out of range temperature, and results of a repeat temperature taken after the problem was corrected." No action was taken by staff when temperatures of 35 degree Fahrenheit were recorded because the temperature range adopted for medication storage by the facility was 35 to 45 degrees Fahrenheit instead of the regulatory temperatures and manufacturer's specified temperature range of 36 to 46 degrees Fahrenheit. The facility's specified temperature range of 35 to 45 degrees Fahrenheit was inaccurate.

A review of refrigerator logs for patient care units 100, 300, and ICU revealed temperatures recorded on the following dates as 35 degrees Fahrenheit.


December 2009 - In Unit 100 on the 9th, Unit 300 - 1,2,3,4,10,16, 24, 25, 28, 30, and ICU - 13,27,29,30

January 2010 - Unit 300 = 3, 8,9,11,13, 18, 20, 31; and ICU = 1,2,8,17,27,31

February 2010 - Unit 100 = 23, Unit 300 = 1, 16, 17, 24, and ICU = 1,18,19,20,21

March 2010 - Unit 300 = 9, 25, 26, 27, 28;and ICU = 3,5,7,16,18,25,30

June 2009, Unit 300 = 10, 13, 14, 16

On 6/11/09, the temperature documented on Unit 100 was 32 degrees Fahrenheit, below the acceptable range of of 36 to 46 degrees Fahrenheit for medication storage.

A frequency of temperature and accurate assessment demonstrates that a hospital has implemented a system (e.g. policy and procedure) to ensure safe use of refrigerated medications; in that the medication has been stored properly, and has retained its designated potency, sterility, and is absent of contaminants or is otherwise not considered unusable. To promote safe storage of medication there should be control systems implemented that allow a hospital to demonstrate that refrigerated medications have been stored within the prescribed temperature range at all times from the point of acquisition to disposition (e.g. administration, wastage or return to manufacturer).
Documentation (logging) of refrigerator temperatures is one method to promote safe storage of medications which should be augmented by visual inspection of the medications for particulate matter or discoloration.
The facility's policy and procedure titled, "Refrigerated drug storage and security" documents that, 'drugs are properly stored ...refrigerator temperature range of 36 to 46 degrees Fahrenheit.' The logs used to document refrigerator temperatures within the facility for the storage of medications did not correlate with its policy and procedure.
In the development of a policy and procedure (P&P) related to safe storage of refrigerated medications, the hospital should assess how to rapidly identify variations in temperatures that may result from power interruption, malfunctioning refrigerators, or failure to close refrigerators. It should also ensure that the refrigerator temperature logs used to monitor for consistent temperatures correlate with the P&P, thereby, assuring that staff respond to temperature changes that would impact the potency and/or stability of medications. In addition, the equipment utilized for temperature assessment must also function properly and periodically assessed for accuracy of temperature assessment.

Based on document review, and staff interview, the facility failed to ensure that (1) a policy and procedure was developed and implemented to specify situations where it may be appropriate to administer a medication using the 'override procedure' prior to pharmacist review; that medications approved on the " Override Medications " list would not significantly compromise patient care, and (2) there was documentation on the "Physicians Orders Routine (Critical Care Unit) CCU Orders" pre-printed order sheet indicating that droperidol (Inapsine) was a high risk drug and guidelines to be listed for monitoring for adverse consequences.

Findings:

1. During an interview with the Director of Pharmacy (DOP) on 4/26/10 at approximately 11:30 AM, it was revealed that a policy and procedure had not been developed and implemented to specify situations where it may be appropriate to administer a medication prior to pharmacist review. Neither was there a plan in place to ensure that pharmaceutical services would be available to all patients within the facility post pharmacy hours. The DOP reported that the cost to ensure continuity of pharmaceutical care on a 24-hour basis was prohibitive.

The DOP presented a list titled, "Override Medications" that was approved for use in the facility that was not subject to pharmacist review. A review of the Override Medication list revealed the following:

a. The list contained 404 drugs.

b. Duragesic (Fentanyl) Extended Release Patches - 25, 50, 75 and 100 mcg/hr. This drug carries a Black Box Warning (BBW) from the FDA.

c. There were ORAL (by mouth) dosage forms (tablets, capsules, syrup) of drugs with instructions to give via the injection route. Examples were Promethazine syrup 6.25 mg/5 ml., Benadryl capsules, Simethicone chewable tablets, Guaifenesin Syrup, Hydrochlorothiazide 25 mg tablet, Citrucel, Tylenol tablets and oral solution; In addition, Atenolol 25 mg tablet to be administered via EPIDURAL route. An epidural is a form of regional anesthesia involving the injection of drugs through a catheter placed into the epidural space. The injection can cause both a loss of sensation and a loss of pain by blocking the transmission of nerves in or near the spinal cord.
,
d. INJECTABLE dosage form i.e. heparin, a blood thinner to be administered by mouth

e. SUPPOSITORY (rectal) dosage form i.e. Promethazine to administered by mouth; Tylenol suppository to be administered via injection

f. TRANSDERMAL: : Catapres-TTS-3 Extended Release Patch, a medicated adhesive patch which is placed on the skin to deliver medication through the skin to be administered via injection route.
g. Tablets to be administered via EPIDURAl, Opthalmic (eye) routes,

h. Subcutaneous route: laxatives (Mineral Oil, Fleet Enema)

During a follow-up interview with the DOP on 4/26/10 at approximately 11:35 AM, she reported that the "Override Medications" list would be presented to the Pharmacy & Therapeutics Committee for review. She acknowledged that there are several inaccuracies in terms of routes of administration for the dosage forms listed, and that drugs with Black Box Warnings (BBW), that is, Duragesic (Fentanyl) transdermal patches in the doses available would significantly compromise an opioid naïve patient. An opiod naive patient is someone who has not taken an opioid drug such as morphine in an equivalent dosage of 60 milligrams per day for 7 days.

Pharmacist review of medication orders prior to administration is a key step in medication safety. That process should only be bypassed (overridden) when the clinical status of the patient would be significantly compromised by any delay that would result from the review process, or when an independent practitioner directly controls the medication-use process. The override refers to the pharmacist review process, not the source of the medication. When the override process occurs, the caregiver is accountable to confirm the appropriateness of the drug, dose, route and frequency, as well as screen for allergies, potential drug interactions.... and other contraindications to the drug being administered.

2. A review of a pre-printed order sheet on 4/29/10 at approximately 10 AM titled, "Physicians Orders Routine CCU Orders" , listed droperidol (Inapsine) as a medication choice for the treatment of nausea/vomiting without indicating that it is a high risk drug, or included recommendations that other drugs should be used first.

During an interview with the DOP on 4/29/10 at approximately 11:35 AM, she reported that the pre-printed orders were approved for use within the facility by the Pharmacy and Therapeutics Committee, a function of the Medical Executive Committee. Regulatory stipulation is that, " The committee shall develop policies and procedures for establishment of safe and effective systems " , such systems would include pre-printed orders.

Droperidol (a medication indicated for nausea and vomiting) has a black box warning from the manufacturer.

The black box warning states, "Cases of QT prolongation and/or torsades de pointes have been reported in patients receiving droperidol at doses at or below recommended doses. Some cases have occurred in patients with no known risk factors for QT prolongation and some cases have been fatal. Due to its potential for serious proarrhythmic effects and death, Inapsine (droperidol) should be reserved for use in the treatment of patients who fail to show an acceptable response to other adequate treatments, either because of insufficient effectiveness or the inability to achieve an effective dose due to intolerable adverse effects from those drugs. Cases of QT prolongation and serious arrhythmias (e.g., torsades de pointes) have been reported in patients treated with droperidol. Based on these reports, all patients should undergo a 12-lead ECG prior to administration of Inapsine (droperidol) to determine if a prolonged QT interval (i.e., QTc greater than 440 msec for males or 450 msec for females) is present. If there is a prolonged QT interval, Inapsine (droperidol) should NOT be administered. For patients in whom the potential benefit of Inapsine (droperidol) treatment is felt to outweigh the risks of potentially serious arrhythmias, ECG monitoring should be performed prior to treatment and continued for 2-3 hours after completing treatment to monitor for arrhythmias."

Additionally the manufacturer lists the only indication for use is to reduce the incidence of nausea and vomiting associated with surgical and diagnostic procedures.

Torsades de Pointes is a cardiac arrhythmia, which may cause blackouts or sudden death.

The QT interval represents the duration of ventricular depolarization and subsequent repolarization, a delay in cardiac repolarization creates an electrophysiological environment that favors the development of cardiac arrhythmias, most clearly torsade de pointes (TdP), but possibly other ventricular tachyarrhythmias as well.

Because of its inverse relationship to heart rate, the measured QT interval is routinely corrected by means of various formulas to a less heart rate dependent value known as the QTc interval.

According to the Federal Food and Drug Administration (FDA) MedWatch Program a "Dear Health Care Professional" letter was sent out by the manufacturer of droperidol on December 4, 2001. The letter was to warn all healthcare professionals about the potential of serious and fatal arrhythmias associated with the use of the medication. The exact language of the warning sent was the language printed in the manufacturer's black box labeling information.

More than four years ago the facility, including all of their health care professional staff (e.g. pharmacists, physicians and nurses) were warned about life threatening arrhythmias associated with droperidol and the resultant restriction of its use as a second line agent in the treatment of perioperative nausea and vomiting. In spite of this widely known information the facility failed to revise their preprinted order sets to promote safe use of droperidol consistent with manufacturer and FDA guidance.

Based on documentation review, staff interview, and policy and procedure review, the facility failed to ensure that the system to consistently and readily identify employees who should have access to the Automated Distribution Cabinet (ADC), also known as an automated drug distribution cabinets, actively updated changes in personnel status.

Findings:

Comparison of a "Pyxis User" list of employees with access to the Pyxis Medstations (automated drug distribution cabinets) provided by the DOP, and the list of employees no longer employed by the facility provided by Human Resources 4/28/10 revealed that licensed staff with termination dates of 6/13/09, 5/30/09,6/16/09, 2/8/10 were documented on the list.

The Pyxis User Report documented user name, areas and functions of access authorization, last activity, access expiration date, and password expiration date. The document provided for review, included staff who no longer worked at the facility. When asked to explain the system in place to notify the pharmacy when a potential or actual separation of service will or has occurred, the DOP reported that Human Resources (HR) would notify the pharmacy via email and the employee's name would be removed from the user report. Interview with the HR Director confirmed the process, yet the employees names were documented on the "Users List" as having access to the ADC.

On 4/28/10, at approximately 2:50 PM, the Pharmacy Manager provided a new list of "Pyxis Users" and asked to exchange the new list for the list that was provided previously and stated that the 'User Report' provided on 4/26 /10 did not reflect current users. The DOP sent an email to HR with a list of 27 RN and LVN names on 4/22/10 at 11:35 AM to to determine their employee status. On 4/26/10 at 10:58 AM, HR sent an email to the DOP noting that the 27 names submitted were terminated employees. Six (6) of the 27 employees listed were documented as "ACTIVE" on the Pyxis User list.

A review of the facility's policy and procedure, 12-04-H dated 10/2009 and titled, "Automated Dispensing Systems: Employee Termination" documented that, "2.1. Once an employee has been terminated, the Human Resources department and Nursing Administration will both immediately send a notice to pharmacy. When this notice is received, the pharmacy will remove privileges of the terminated employee from the Automated Dispensing System to prohibit further access."

In order to remove the employee from the automated drug distribution cabinet in a timely manner, notification by Human Resources, Nurse Manager/Management of the staff with authorized access should occur, then pharmacy in turn could take immediate action to prevent unauthorized access, and maintain accurate Automated Dispensing System records for medication all transactions.

Based on observatio, interview and record review, the facility failed to ensure that source and disposition of all units of blood and blood components were recorded from date of disposition in a manner that permits prompt retrieval. This failure had the potential to delay appropriate action when notified that blood or blood components received by Patient # 67 were at risk of transmitting HIV, or HCV ( medical condition passed from one person to another through blood and blood components ).

Findings:

During the laboratory inspection on 4/27/10 at 3:00 PM , it was noted that the record keeping system was not in place.

The blood transfused on 4/25/10 at 1:03 AM and blood transfused on 4/26/10 at 3:56 AM to Patient # 67 had not been recorded at the time of inspection on 4/27/10 at 3:00 PM.

The manager and the assistant were not able to demonstrate how quickly they can locate the units of blood transfused to a patient by using the log book as reference. The incident revealed that there was no system to promptly determine the disposition of units of blood and blood components that were transfused.

During an interview with the Laboratory Manager (LM) on 4/27/10 at 3:25 PM, the Laboratory Manager stated, "Recording is done by one person on a specific day". The recording person was not available for interview. The Laboratory Manager acknowledged the findings.

Based on observation, staff interviews and record reviews, the hospital condition of participation for food and dietetic services was not met by:

1. The Food Service Directors failed to ensure the daily management of the dietary services to provide patients, staff and visitors with safe and high quality food due to a lack of monitoring the high risk practice of safe cool down of foods (cross refer A-620).
2. The Food Service Directors failed to ensure staff guidance and monitoring of appropriate internal cooking temperature of potentially hazardous foods to prevent the potential for food borne illness (cross refer A-620).
3. The Food Service Directors failed to ensure that when pizza was procured from an outside source, that source used safe food handling techniques to prepared and transport the pizza. They further failed to ensure the staff monitored the holding temperature of the pizza during the meal service to prevent the potential for food borne illness (cross refer A-620).
4. The Food Service Directors failed to ensure staff guidance and monitoring of the dishmachine and 3 compartment sink sanitizing concentrations and water temperatures for the proper sanitizing of dishware and pots and pans to prevent the potential for food borne illness (cross refer A-620).
5. The Food Service Directors failed to monitor and ensure safe dry food storage temperatures to prevent the potential for food borne illness and assure the quality of the dry food and enteral formula products (cross refer A-620).
6. The Food Service Directors failed to monitor and ensure proper serving portions of protein-rich foods according to the planned menus to meet the nutritional needs of patients (cross refer A-620).
7. The Food Service Directors failed to ensure that adequate disaster food supplies were on hand to meet the needs of the patients, staff and visitors in the event of a disaster according to the hospitals disaster food plan (cross refer A-620).
8. The Food Service Directors failed to ensure that department policies and procedures were accurate and that the diet manual had been approved by the medical staff and the information in the diet manual regarding the specific therapeutic diets ordered in the facility was contained in the manual and readily available to medical, nursing and food service personnel (cross refer A 6-20 and A-631).
9. The hospital failed to ensure that the role of Food Service Director was clearly delineated by having 2 staff responsible for the operation of the food services department and no one person having the responsibility and direction of the department (cross refer A-620).
10. The Food Directors failed to coordinate with the Infection Control Practitioner to ensure provisions and criteria for active monitoring and surveillance of high risk food handling procedures were implemented to ensure a sanitary environment and ensure safe infection control handling practices were maintained (active surveillance) (cross refer A-749).
11. The Food Directors and the Clinical Dietitian failed to ensure the nutritional needs of 4 of 7 patients (Patients 21, 22, 25 and 26) reviewed for nutrition care were met in accordance with recognized dietary practices and the facility standards/policy and procedures (cross refer A-630).
12. The Food Directors failed to measure, analyze and track quality indicators that assess the process and safety of the Food Services Department that ensure safe food handling practices are utilized to feed patients, staff and visitors (cross refer A-267).

The cumulative effect of these systemic problems resulted in the facility ' s inability to ensure safe food handling to prevent the potential of food borne illness and to ensure quality and coordinated nutrition care was provided to patient.

Based on observation, staff interviews and document review the hospital failed to have a food service director who ensured the daily management of dietary services to provide patients, staff and visitors with safe and high quality food and ensure the food service can meet the needs of patient, staff and visitors during a disaster.

Findings:

1. During a validation survey from 4/26/10 - 4/29/10 the following deficient practices were found:

a. On 4/26/10, at 11:00 AM, during the initial tour of the kitchen, a previously cooked and frozen meatloaf was observed in the cook ' s refrigerator. The meatloaf was dated 4/17/10. Also observed was a pan of spaghetti measuring approximately 18 " by 12 " with a depth of 2 " in the freezer that was dated 3/28/10.

In a concurrent interview with Cook A, she stated that the dates on these two items indicated the date they were prepared, cooled down and then frozen. She further stated that these items were prepared ahead of time to be reheated and served at a later date.

Review of the HACCP (Hazardous Analysis Critical Control Point) Cooling Logs dated 9/29/09 through 4/23/10 revealed that the spaghetti was prepared on 3/28/10. This log indicated that the cooling of the spaghetti began at 7:30 AM when the temperature reached 135 to 140 degrees. At 9:30 AM, the temperature of the spaghetti was recorded. The next temperature recorded was at 3:30 PM (8 hours after the cooling was initiated). On the form, the " Policy Met " column was checked indicating that the proper cooling procedures were followed and the item was initialed by the Cook A.

Cook A was interviewed on 4/27/10 at 10:45 AM regarding the proper cooling procedure for the spaghetti. She stated that she was busy when she needed to check the temperature of the spaghetti and she recorded the temperature when she had the time. She further stated that if the temperature did not reach the required 2 hour standard of 70 degrees, she would then reheat it to 140 degrees.

Review of the HACCP Cooling Log directed staff to record the temperature of the cooling item 2 hours after reaching 135 to 140 degrees and then again after 6 hours of reaching 135 to 140 degrees. It stated " Cooked foods must be cooled from 135 degrees F to 41 degrees F within 6 hours. " It further directed staff that " food items not rapidly cooled to 70 degrees F in two hours must be reheated to 165 degrees F for 15 seconds within two hours or discarded. "

Further review of the HACCP Cooling Log dated 9/29/09 through 4/23/10 revealed that there were a total of 49 items cooled during that time period of the log. In 31 of the 49 items, the amount of time between temperature monitoring was longer than what was directed by the log.

According to the 2009 " Food Code " published by the Food and Drug Administration showed that Potentially Hazardous Foods (PHF) shall be cooled down within two hours to 70 degrees F and after an additional four hours to 41 degrees F or less. It further stated that safe cooling requires removing heat from food quickly enough to prevent microbial growth. Excessive time for cooling of PHF has been consistently identified as one of the leading contributing factors to foodborne illness.

During an interview with the Food Service CoManager (FSCM) A on 4/27/10 at 10:45 AM, the HACCP Cooling logs were reviewed. She was unable to state how she ensured competence of the staff on cooling procedures. She was further unable to explain why there was a lack of monitoring and corrective action taken when the data showed that the staff was not following the policy.

b. During an observation of lunch preparation on 4/27/10 at 10:50 AM, Cook A was observed removing a large pan of chicken pieces from the conventional oven. She stated that she had previously cooked the chicken pieces in the convection oven and had placed it in the conventional oven for holding. She further stated that she did not check the internal temperature when she removed it from the convection oven.

At that time, Cook A took two separate temperatures of the chicken of 120 degrees F and 144 degrees F. Cook A stated that the chicken must be cooked to an internal temperature of at least140 degrees F. She returned the chicken to the conventional oven to continue cooking.

At 11:20 AM the same chicken was again removed from the oven and the internal temperature was rechecked. The temperature was 141.1 degrees F. Cook A intended to place the chicken on trayline for meal service. The surveyor brought this to the attention of FSCM A who directed Cook A to place the chicken back in the convection oven until an internal temperature of 165 degrees F was reached. At that time FSCM A verified that the internal temperature for poultry should be 165 degrees F to ensure food safety.

Review of posted " Temperature Rules " revealed that staff was directed to cook poultry to an internal temperature of 165 degrees F.

A review of the trayline temperature logs showed that the standard for the holding temp for all entrees was 140 degrees F. There was no place for staff to record the internal cooking temperature had been reached to ensure food safety.

On 4/27/10, at 2:40 PM, FSCM B was shown the logs and she was unable to state how she monitored whether staff was cooking PHF entrees to a safe internal temperature.

On 4/27/10 at 3:10 PM, FSCM B was asked to provide evidence of staff training on appropriate internal cooking temps. She stated that there had been no training provided to staff.

c. During the initial tour of the kitchen on 4/26/10 at 10:30 AM, approximately 30 pizzas were observed in the cook ' s prep area in pizza boxes. A concurrent interview with Cook A revealed that they had just been delivered from Red Baron Pizza. She further stated that they were for the cafeteria (Café) food service for lunch that day.

During an observation on 4/26/10 at 1:35 PM, the temperature of the pizza was checked and was 93.6 degrees F. During a concurrent interview with FSCM B, she stated that the Café hours were from 11:30 AM through 1:30 PM and lunch meal service had just ended.

On 4/26/10 at 1:45 PM, FSCM B stated that it was the departments practice to check the temperature of the hot food twice during the lunch meal service: at the beginning and midway through the lunch hours to ensure the safety of the food. This was the expectation for the pizza too.

Review of the Cafeteria Service Temperature Checklist revealed that there were no temperatures recorded on the form for the pizza for that day. The section where temperature was to be recorded was crossed off and the word " Pizza " was written across it. Further review of this log indicated that the standard for the holding temperature for entrees was 135 degrees F.

FSCM B further revealed that the hospital did not have a contract with Red Baron Pizza to ensure the quality of the pizza or that it was prepared and transported in a manner that promoted food safety. She further stated that no one from the Food Service Department had conducted a site visit or inspection of the restaurant to ensure that they used safe food handling techniques.

Further review of the Cafeteria Service Temperature Checklist revealed that there were many blanks on the forms where temperature monitoring was required. For only the lunch meal, there was missing temperatures as follows: January 2010, 13 out of 31 days; February 2010, 9 out of 28 days; March 2010, 12 out of 31 days; and April 2010, 13 out of 26 days. The form directs the staff to record the temperature of hot food items twice during lunch.

On 4/26/10 at 2:00 PM, FSCM B was shown the logs and she stated that she reviews the logs monthly. She was unable to state what action she had taken over the three and one half months to ensure safe holding temperatures in the Café. She further stated that no staff training had occurred as a result of the incomplete temperature monitoring logs.

d. Review of the Dishmachine Temperature Log on 4/27/10 revealed that the target temperature range for the rinse cycle was 120 - 150 degrees F, and the sanitizer target concentration was 50 - 100 PPM (parts per million). Further review of the logs showed that between 3/1/10 and 4/26/10, 85 out of 159 rinse temperatures recorded were greater than or equal to 160 degrees F. On 4/26/10 at breakfast the sanitizer concentration was listed as zero. Lunch and dinner concentrations were not recorded. Under the column titled " Action Taken " adjacent to the zero sanitizer concentration it stated that a call to Eco-Lab had been placed to check sanitizer.

An interview on 4/27/10 at 12:00 PM was conducted with the Eco-Lab technician. He stated that with low temperature dishmachines, such as the one in this kitchen, rinse temperatures at 160 degrees F or greater caused the chlorine based sanitizer to evaporate. This evaporation lowered the concentration of the rinse to below what is required to sanitize the dishes.

During an interview on 4/27/10 at 2:40 PM with FSW A, she stated that on 4/26/10, while washing dishes from breakfast, the test strip she used to test the concentration of the sanitizer indicated zero. She further stated that she told FSCM A who called Eco-Lab and was told that a technician couldn ' t come out until the following day. She stated that the dishmachine was used to wash dishes for breakfast, lunch and dinner on 4/26/10 despite inadequate sanitizer concentration.

The Dishwashing Machine Temperature & Sanitizer Policy and Procedure, (reviewed by hospital 7/31/07), was reviewed on 4/27/10. It stated, " Temperature control for the dishwashing machine is necessary to ensure sanitary dishware. Dishwasher is chemically controlled; therefore, temperatures are lower ...Rinse cycle will be maintained at 140 degrees F. Sanitizer reading should be 50 ppm - 200 ppm. " It further stated that, " Temperatures falling below the minimum temperature allowed will be reported to the food service manager and appropriate action will be taken. " There was no indication of action to be taken if rinse temperatures were too high.

The Dishmachine Temperature Logs were reviewed with FSCM A on 4/27/10 at 2:40 PM. She stated that she was unaware that the rinse temperature should not be greater than or equal to 160 degrees F to ensure proper sanitation of dishes. She further stated that there had not been staff training regarding monitoring of dishwasher rinse temperatures of 160 degrees F or greater.

e. Cook B was interviewed on 4/28/10 at 11:00 AM regarding ware washing procedures in the 3 compartment sink. She stated that the sanitizer concentration for the final rinse should be between 100 and 200 PPM (parts per million). She further stated that a concentration of 100 PPM was " ok to sanitize " the pots and pans.

Review of the posted instructions for Ware Washing in the 3 compartment sink stated that the sanitizer concentration for the quaternary solution used needs be 200 PPM to effectively sanitize pots and pans.

Review of the Pots and Pans & Sanitizing Solution Policy and Procedure (reviewed by hospital 7/31/07) on 4/28/10 stated that for 3 compartment sink use, " Add sanitizing agent to the third tank (sink) according to manufacturer ' s direction ...50 PPM is required concentration of sanitizer to water. "

During a concurrent interview with FSCM B, she verified that the concentration of the sanitizer should be 200 PPM to effectively sanitize pots and pans. She verified that the policy and procedure incorrectly stated 50 PPM concentration. She was unable to explain why the policy was incorrect. She further stated that there had not been staff training regarding the proper concentration of sanitizer for the 3 compartment sink.

f. During the initial tour of the kitchen on 4/26/10 at 11:00 AM, the following was observed: a box of frozen macadamia nut cookie dough in the freezer left was open and unsealed; a box of frozen mixed vegetables in the freezer was left open and unsealed; 3 trays of biscuits were in the cook ' s refrigerator with no label and date; 7 trays of bacon were in the cook ' s refrigerator with no label and date; 8 trays of sausage were in the cook ' s refrigerator with no label and date; a bag of frozen waffles was in the cook ' s refrigerator with no date; 2 pans of individually wrapped Cornish game hens were in the cook ' s refrigerator with no date; a bag of frozen chicken breasts was in the cook ' s refrigerator with no date; and a box of powder sugar was left open and unsealed under the trayline table in the cook ' s prep area with no date.

During a concurrent interview with Cook A, she stated that she was not aware that she needed to label and date items in the cook ' s refrigerator. She further stated that the macadamia nut frozen cookie dough and the frozen mixed vegetables should be sealed.

During a concurrent interview with FSCM A, she stated that it was the department practice to cover, label and date all opened containers with the date they were opened. She further was unable to explain why staff was not following department practice.

g. During the initial tour of the kitchen on 4/26/10 at 11:10 AM, the dry storage area which contained various canned and shelf stable items and enteral formula bottles
was observed to be hot. The observation was verified by FSCM A who stated, " It ' s always hot in here because the oven is so close. " She further stated that there was no thermometer in this dry storage area and therefore no monitoring of the temperature.

Maintenance Worker A was interviewed on 4/28/10 at 10:55 AM. He stated that the vent in the ceiling of the dry storage area was not working. He further stated that if the vent was working properly, it would function to cool the dry storage area. He was unable to state how long the vent was not working properly or whether or not the parts had been ordered to fix it.

FSCM A was again interviewed on 4/28/10 at 11:00 AM and stated she was unaware that the vent was not working properly. She was also unable to explain why there was no thermometer in the dry storage area to monitor the temperature in light of the problem identified of the area being too hot.

Review of the manufacturers guidelines for storage of enteral formula indicated that the product should be stored in cool, dry area, 55 to 75 degrees F was ideal.

According to the National Restaurant Associations ServSafe Essentials, fourth edition, " Keep storerooms cool and dry. Moisture and heat are the biggest danger to dry and canned foods. For optimal quality and to assure safety, the temperature of the storeroom should be between 50 and 70 degrees F. "

h. Review of the Serving Temperatures Policy and Procedure dated 2/14/1990 on 4/27/10 stated, " Food will be served at temperatures below 41 degrees F or above 135 degrees F. "

Review of the Food Serving and Display Policy and Procedure dated 2/14/1990 on 4/27/10 stated, " All potentially hazardous food, when placed on display for service, shall be kept hot or cold as required hereafter: If served hot, the temperature of such food shall be kept at 135 degrees F or above. "

The above policies were reviewed with FSCM B on 4/28/10 at 11:15 AM. She was unable to explain why the policy directed staff to maintain hot food at 135 degrees F when Title 22 requires 140 degrees F.

According to Title 22, 72073(k)(3) , " [potentially hazardous food] shall be maintained at temperatures of 45 degrees F or below, or at 140 degrees F or above, at all times ... "

i. During trayline observation on 4/27/10 at 12:10 PM, Cook A served 2 slices of roast beef, chopped on a plate with gravy for Mechanical Soft diets.

At 12:20 PM Cook A weighed out a 3 ounce portion of the same roast beef which was 4 slices. She stated that she was told not to serve as much meat to patients on a Mechanical Soft diet and to serve more gravy.

Review of the menu spreadsheets for that meal revealed that patients on a Mechanical Soft diet would receive a #8 scoop (4 ounces) of roast beef.

During an interview with FSCM B she stated that normally the staff used a scale on trayline to weigh out the correct portion of meat that was served.

RD A was interviewed on 4/27/10 at 3:10 PM. She stated that the purpose of the menus and the corresponding portion sizes was to ensure the facility was meeting the nutritional needs of the patients. She further stated that the FSCM ' s were responsible for monitoring that the staff were serving the correct portion sizes to ensure the nutritional needs of the patients were met.

Review of the facility ' s policy titled Portion Control (reviewed 7/31/07) on 4/27/10 revealed the " Potion size for menu items has been established to assure uniform, adequate servings ... " It further stated that " The Food Service Director is responsible for teaching portion control to employees and for monitoring and evaluating portions served. " FSCM B stated that there had been no training provided to staff.


j. On 4/28/10 at 10:20 AM, the hospital " Food Service Disaster Plan " (reviewed by hospital 7/31/07) was reviewed with FSCM A and FSCM B. According to FSCM B, the plan was to meet the needs of 150 to 200 persons at each meal. Three day Emergency Disaster Menus for both Regular and Renal diet were attached to the plan. There was no emergency supply list attached to verify appropriate quantities of food were available.

Review of the Emergency Disaster Menus revealed that chicken salad sandwiches would be served for lunch on one day of the menu. Review of the chicken salad available in the facility ' s disaster supply showed that only 58 three ounce servings or 87 two ounce servings were available. Tuna salad sandwiches were to be served for lunch on another day. Review of the tuna available revealed that only 48 three ounce servings or 72 two ounce servings were available. Beef stew was to be served for a dinner meal and only 48 one cup servings or 60 three quarter cup servings were available. For ravioli, to be served at one dinner, there were 72 one cup servings or 108 three quarter cup servings.

FSCM B stated that it was the responsibility of the FSCM ' s to maintain disaster food supplies to meet the planned meals. She confirmed that the facility did not have adequate supplies of many of the foods that provided a major source of protein.

k. The hospital failed to ensure that the diet manual had been approved by the medical staff and the information in the diet manual regarding the specific therapeutic diets ordered in the facility was contained in the manual and readily available to medical, nursing and food service personnel (cross refer A-631)

2. An interview on 4/26/10 at 1:30 PM with FSCM A and FSCM B revealed that they both were Co-Managers of the Food Service Department. They stated that they both hold equal responsibility for the department and they report directly to the CNO (Chief Nursing Officer). They were unable to produce an organizational chart for the department.

On 4/28/10 at 1:40 PM, the CNO confirmed that FSCM A and FSCM B were Co-Managers and both had responsibility and authority for the direction of the food and dietary service. There was no clear delineation of authority for the department.

Based on record review and interviews, the facility's dietitian failed to provide a timely dietary consultation to meet the needs of all the patients. For Patient 76 the facility failed to ensure that a registered dietitian assessed the patient's nutritional needs or provide any recommendations during his first 5 days of hospitalization

This failure to assess and/or ensure the nutritional needs for Patient 76 were provided for during the first 5 days of his hospitalization had the potential to exasperate his current medical conditions, as well as his nutritional and hydration status.

Findings:

On 4/28/10 at approximately 3:20 PM, record review for Patient 76 revealed, he was a male patient admitted to the facility on 4/23/10 for GI bleeding, having black stools for 3 days, and with a current medical history of a left leg fracture (4/15/10), diabetes, and constipation.

Further record review revealed Patient 76's blood hemoglobin was 7.7 when admitted (males average normal range is 14 - 18). The patient had been given two units of blood on 4/23/10.

On the next day, 4/24/10 the patient was screened by the Diet Clerk with a plan to refer the patient to the RD, based on diagnosis per protocol.

On 4/28/10 further record review revealed the patient after being admitted had been further diagnosed with fluid overload, Clostridium difficile (a bacterium that causes symptoms ranging for diarrhea to life threatening inflammation of the colon) and was experiencing excoriation (redness and wearing down of the outer layer of skin) to his buttock.

On 4/28/10 record review of the 24 hour patient care records, revealed Patient 76's appetite had been poor since his admission showing at many meals he eat less than 50% of the meal, and on a few occasions he had refused his meals altogether. There were no records of the Patient 76 receiving nutritional supplements when he refused his meals or ate less then 50% of his meal.

Review of the 24 hour patient care records for Patient 76 revealed the following:
On the day of his admission 4/23/10, the only meal recorded on the 24 hour patient care records was for dinner, he ate less than 50% of the meal and there is no record of a night time snack.
On 4/24/10, he ate his breakfast and lunch but there is no record recorded for dinner or a night time snack.
On 4/25/10, he refused his breakfast and the night time snack. He ate less than 50% of his lunch and dinner meals on that date.
On 4/26/10, he ate between 50% to 89% of his breakfast and dinner. He ate less than 50% of his lunch and there is no record of his night time snack.

On Wednesday 4/28/10, at approximately 3:30 PM, the RD stated, "I have not seen this patient yet. He was on my list for Monday (4/26/10). I was busy and did not get to his chart. Sometimes when I come to look at the patient their chart is missing and I don't get around to looking at them that day. This patient was listed as a moderate risk; I have 3 to 5 days to get to the chart."

On 4/28/10 at approximately 3:30 PM, the RD further stated, " I am available by fax when I am not here. The facility could fax me the information. They didn't fax me anything about this patient. When this evaluation was done by the Dietary Clerk given the information she had at the time of the evaluation he was not a high priority. We don't have any system after the initial evaluation that the Dietary Clerk made that
would go back to the chart and make the patient a higher priority to be seen by me. Knowing all his medical conditions at this time would have put him at a higher priority to be seen."

On 4/28/10 at approximately 3:30 PM the RD further acknowledged the patient should have been seen and evaluated for his nutritional needs stating, "He properly should have been offered supplements. I will have to get to his chart today."

Based on observation, staff interviews and record reviews the hospital failed to ensure that the nutrition needs of 4 of 7 patients (Patients 21, 22, 25 and 26) reviewed for nutrition care were met in accordance with recognized dietary practices.

Findings:

Nutrition chart review was conducted on 4/26/10, 4/28/10 and 4/29/10.

1. The record for Patient 21 was reviewed on 4/29/10. The record revealed a male who was admitted on 4/22/10 with a diagnosis of low sodium, ascites (accumulation of fluid in the abdomen associated with liver failure), alcohol addiction with a history of abuse and cirrhosis (a disease that causes hardening of the liver).

According to the Nursing Assessment dated 4/22/10, the patient was 6 foot 4 inches tall and weighed 207 pounds. It further showed that the patient had chewing and swallowing problems.

Review of the Initial Nutrition Assessment by the Registered Dietitian (RD) dated 4/23/10 showed that patient ' s weight was 103% of his Ideal Body Weight (IBW) and his Body Mass Index (BMI) (a means of determining desirable weight for height) was 25.2 and was " appropriate. "

The RD Initial Nutrition Assessment further revealed that the patient ' s estimated nutrition needs were based on 20 - 25 calories per kilogram which calculated out to 1880 - 2350 calories per day.

According to the standard of practice provided by the RD on 4/29/10 for " Calculating Nutritional Requirements for Adults " (undated), in calculating caloric needs for a patient, " At desirable body weight: (use) 30 - 35 calories per kilogram. " Use of this calculation would estimate the calorie needs at 2823 - 3293 calories per day.

Further review of the RD Initial Nutrition Assessment showed a question mark for chewing and swallowing problems even though the Nursing assessment had already stated that the patient had chewing and swallowing problems.

Review of the nursing notes from admission to 4/29/10 (7 days) revealed that all meal intake evaluations were listed as poor or refused except one day when his intake was listed as good for all three meals.

Interview of the patient on 4/29/10 at 10:45 AM, revealed that he did not have any lower teeth and was having difficulty chewing the food that was served to him.

During an interview with the RD on 4/29/10 at 11:00 AM, she was unable to explain why she did not use the standard of practice for calculating the caloric need for this patient and underestimated his needs by about 1,000 calories a day. She further was unable to explain why she had not obtained further information on the patient ' s ability to chew and swallow to ensure that the texture of the food was appropriate for his needs.

2. The record for Patient 22 was reviewed on 4/26/10. The record revealed a male who was admitted on 4/20/10 with a diagnosis of acute DVT (deep vein thrombosis - a blood clot that forms in a vein mostly in the lower leg or thigh) and hyperglycemia. According to the history and physical the patient had a history of type 2 diabetes mellitus.

According to the Nutrition Screening form dated 4/21/10 completed by FSCM B, the patient was not referred to the RD for assessment and follow-up even though he had a diagnosis of hyperglycemia.

During an interview with the RD on 4/26/10 at 3:50 PM, she stated that the needs of this patient were " probably not met " due to the patient not being referred to her for assessment and follow-up.

3. The record for Patient 25 was reviewed on 4/26/10. The record revealed a male admitted on 4/10/10 with a diagnosis of atrial fibrillation (irregular heart beat) and pneumonia.

According to the Nursing Assessment dated 4/10/10, the patient was 5 feet 5 inches tall and weighed 114.8 pounds.

According to the Nutrition Screening completed by FSCM B on 4/11/10, the patient was referred to the RD for assessment and follow-up.

According to the Initial Nutrition Assessment dated 4/11/10 completed by the RD offsite and faxed to the hospital, the patient ' s weight was 85% of his ideal body weight (IBW). She further assessed his calorie needs at 1300 - 1550 calories a day based on 25 - 30 calories per kilogram.

According to the standard of practice provided by the RD for " Calculating Nutritional Requirements for Adults " (undated), in calculating caloric needs for a patient, " Underweight: (use) 35 - 40 calories per kilogram. " Use of this calculation would estimate the calorie needs at 1826 - 2087 calories per day.

During an interview with the RD on 4/26/10 at 4:00 PM, she stated that when she is not in the hospital when a consult is received, FSCM B faxes her the information she needs to complete an assessment and she faxes the completed assessment to FSCM B who places it in the medical record. She was unable to explain how she was able to conduct a visual assessment or interview of the patient in order to complete an accurate assessment and estimation of the nutrition needs of the patient. She further was unable to explain why she did not follow the standards of practice for estimating the calorie needs for this patient and underestimated his needs by about 500 calories a day.

4. The record for Patient 26 was reviewed on 4/28/10. The record revealed a male who was admitted on 4/12/10 with a diagnosis of large bowel obstruction, hypokalemia (low blood levels of potassium) and dehydration.

According to the physician orders the patient was started on Total Parenteral Nutrition (TPN - nutrition by intravenous route) on 4/15/10 after undergoing an exploratory laparoscopy (bowel surgery) on 4/14/10. He was kept NPO (nothing by mouth). On 4/16/10 and 4/23/10, an oral liquid diet was attempted but not tolerated and TPN had to be continued to provide nutrition. On 4/25/10 an oral liquid diet was again attempted and by 4/27/10 the patient was able to tolerate a solid food diet and the TPN was discontinued.

According to the Nursing Assessment the patient was 6 feet tall and weighed 172.6 pounds. It further showed that the box was checked indicating that the patient had a loss of appetite, N/V (nausea/vomiting), and/or diarrhea x (times) 3 days.

Review of the Initial Nutrition Assessment dated 4/14/10 completed by the RD showed that the patients weight was 97% of his ideal body weight (IBW). It further showed the estimated calorie needs for the patient were 1550 - 1960 calories per day assessed using 20 - 25 calories per kilogram.

According to the standard of practice provided by the RD for " Calculating Nutritional Requirements for Adults " (undated), in calculating caloric needs for a patient, " At desirable body weight: (use) 30 - 35 calories per kilogram. " Use of this calculation would estimate the calorie needs at 2353 - 2745 calories per day.

Review of the Department of Pharmacy TPN record for this patient showed that the calculations for TEE (total energy expenditure or calorie needs) was 2450 calories. It also shows that the calories provided by the TPN ranged from 820 calories a day to 2040 calories a day from 4/14/10 - 4/26/10 and never reached the patient ' s estimated needs of 2450 calories.

Review of the Department of Pharmacy Parenteral Nutrition Guidelines (undated) on 4/28/10 showed that patient monitoring was to include daily measurements of weight.

Further review of the record showed that there were no follow-up weights recorded after the initial weight was taken to monitor the effectiveness of the nutrition plan of care. There also was no protein status marker such as preablumin level to determine if protein needs were being met by the TPN. The RD notes did not indicate that she had requested that these be monitored.

During an interview with the RD on 4/28/10 at 5:00 PM, she stated that in the past, when she requested a follow-up weight for patients receiving TPN, she didn ' t get it so she stopped requesting it. She further stated that they didn't do weights here except for on admission. She was unable to explain why she had not requested a prealbumin level for this patient.

Based on staff interview and document review, the hospital failed to ensure that the diet manual had been approved by the medical staff and the information in the diet manual regarding the specific therapeutic diets ordered in the facility was contained in the manual and readily available to medical, nursing and food service personnel for a universe of 22.

Findings:

On 4/27/10 at 3:10 PM, the Consultant RD (RD A) was interviewed. The RD A stated the diet manual was available to all staff on-line and had gone through the Medical Staff Committee System for approval. At that time, evidence that the diet manual had been presented and reviewed by the medical staff was requested.

On 4/29/10, Patient 21 had a physician order for a hepatic (referring to the liver) diet (a diet low in protein and salt). At 11 AM, the RD was asked what the food service staff was sending to comply with the physician order. RD A stated the definition of the diet meant 50 grams of protein and two grams of sodium would be sent since there was no specific amount of the nutrients specified in the order. At that time, RD A verified that other generic orders such as renal (referring to the kidneys) and diabetic diet would also be subject to specific nutrient definition as well.

RD A was asked to access this information on the nursing unit computer. RD A was unable to show that the specific hepatic diet as well as other definitions were contained in the on-line manual and was readily accessible to medical and nursing personnel.

A review of the facility policy and procedure titled " Diet manual - On-line " (approved on 3/31/10) showed that the manual shall be approved by the medical staff and Chief Nursing Officer and was the guide from which modified diets were written. In addition, a hard copy was maintained which was dated and signed to identify review and revisions were made and approved.

A review of the Diet Manual signature page showed the manual had been reviewed and approved by RD A and the CNO by 3/31/10. The signature line showing MEC (Medical Executive Committee) Approval was blank. No medical staff committee minutes or agenda had been provided to the survey team by the exit date of April 30, 2010 which showed that the current manual being utilized on the nursing units had been reviewed and approved by the medical staff.

During an interview with RD a on 4/27/10 at 3:10 PM, she confirmed that the Diet Manual had not been reviewed or approved by the medical staff.

Based on observation, staff interviews and record review, the facility failed to maintain the food service ice machine to ensure food safety by creating cross-contaminating conditions.

Findings:

During the initial tour of the kitchen on 4/26/10 at 11:15 AM, the ice machine was noted to have crumbs around the ledge of the ice bin. Also noted were white hardened deposits on the bin interior surface that FSCM A stated was lime scale build-up.

An interview with FSCM A revealed that it was the department practice to clean the ice machine inside and out weekly. She further stated that the lime scale build-up was because the machine was old and the staff used " Lime-Away " to remove the scale.

Review of the " Dietary Department Ice Machine Checklist " showed that the last time the ice machine had been cleaned was 4/7/10, two and one half weeks earlier.

FSCM A stated that she reviews the " Dietary Department Ice Machine Checklist " but was unable to explain why it had not been cleaned since 4/7/10.

Review of the manufacturer ' s maintenance instructions for the ice machine stated, " Ice machine cleaner (Manitowoc Ice Machine Cleaner) is used to remove lime scale or other mineral deposits. It further cautions the user to " use only Manitowoc approved Ice Machine Cleaner. "

Based on observation and interviews, the facility failed to maintain proper ventilation and temperature control in the dry food storage area in the kitchen to ensure food product quality (Cross refer A-620).

Findings:

During the initial tour of the kitchen on 4/26/10 at 11:10 AM, the dry storage area which contained various canned and shelf stable items and enteral formula bottles
was observed to be hot. The observation was verified by FSCM A who stated, " It ' s always hot in here because the oven is so close. " She further stated that there was no thermometer in this dry storage area and therefore no monitoring of the temperature.

Maintenance Worker A was interviewed on 4/28/10 at 10:55 AM. He stated that the vent in the ceiling of the dry storage area was not working. He further stated that if the vent was working properly, it would function to cool the dry storage area. He was unable to state how long the vent was not working properly or whether or not the parts had been ordered to fix it.

FSCM A was again interviewed on 4/28/10 at 11:00 AM and stated she was unaware that the vent was not working properly. She was also unable to explain why there was no thermometer in the dry storage area to monitor the temperature in light of the problem identified of the area being too hot.

Review of the manufacturers guidelines for storage of enteral formula indicated that the product should be stored in cool, dry area, 55 to 75 degrees F being ideal.

According to the National Restaurant Associations ServSafe Essentials, fourth edition, " Keep storerooms cool and dry. Moisture and heat are the biggest danger to dry and canned foods. For optimal quality and to assure safety, the temperature of the storeroom should be between 50 and 70 degrees F. "

Based on interview and record review, the Condition of Participation for Infection Control was not met.

The hospital failed to:

1. Ensure that the Infection Control Nurse (ICN)/Infection Control Officer (ICO) developed and implemented policies and procedures for caring for patients with Clostridium difficile. (Refer to A 0748)

2. Ensure that it had an effective and qualified IICN/ ICO. (Refer to A 0749)

3. Ensure that the ICN kept accurate records of employee PPD TB skin tests. (Refer to A 0749)

4. Ensure that the ICN monitored the cleaning practices of the housekeeping staff to ensure that the sanitation techniques, of environmental surfaces, were effective in reducing the risk of the spread of infection in the facility. (Refer to A 0749)

5. Ensure the food service department created policies and procedures to ensure food safety and quality and provided provisions to monitor compliance with food service infection control policies. (Refer to A 0749)

6. Ensure the correct use of chemical disinfectants. (Refer to A 0749)

7. Ensure that the facility practice of random culturing of one endoscope monthly was carried out. (Refer to A 0749)

8. Maintain a log of incidents and communicable diseases that occurred in the facility. (Refer to A 0750)

The cumulative effect of these systemic problems resulted in the hospital's failure to provide an active Infection Control Program to prevent, control and investigate infections and communicable diseases.

Based on interview and record review the facility failed to ensure that the Infection Control Nurse (ICN) developed and implemented policies and procedures for caring for patients with Clostridium difficile (A bacteria that can cause life-threatening inflammation of the colon and diarrhea. The bacterium forms spores that can be resistant to some cleaning disinfectants.).

This failure had the potential to result in the spread of Clostridium difficile to patients in the facility due to ineffective infection control practices.

Findings:

The clinical record for Patient 76 was reviewed on 4/28/10 at approximately 3:20 PM.
The clinical record noted that Patient 76 was an 87 year old male admitted to the facility on 4/23/10 for GI bleeding. The clinical record noted that Patient 76 had tested positive for Clostridium difficile (C-difficile).

The facility's Infection Control policy and procedure manual was reviewed on 4/29/10 at 3:30 PM. Review of the manual revealed that the facility did not have approved polices and procedures specific to C-difficile to prevent or reduce the risk of the spread of C-difficile infections in the facility.

During an interview with the ICN on 4/29/10 at approximately 4:30 PM, the ICN verified that she was aware that Patient 76 had a diagnosis of C-difficile. The ICN verified that the facility had no approved policies and procedures specific to C-difficile, to prevent or reduce the risk of the spread of C-difficile infections in the facility.

The employee file for the Infection Control Nurse (ICN) was reviewed on 4/30/10 at 9:30 AM with the Human Resource Director (HRD). The job description for the position of "Infection Control Officer/Employee Health Nurse" indicated that the ICN would be responsible for the following:

A. "... reviewing and revising Infection Control and Procedure manuals."
B. "... written policies defining the specific indications for isolation requirements in relation to the medical condition involved."

2. During an interview with Housekeeper 1(HK 1) on 4/29/10 at approximately 11:00 AM, HK 1 was asked how she would clean the environmental surfaces in a room, that was previously occupied by a patient diagnosed with Clostridium difficile? HK 1 stated she would use a solution comprised of 1 cup of bleach and 10 cups of water to wipe down the surfaces. HK 1 stated that it would be ok if the solution dried on the surfaces in 5 minutes.

The facility policy and procedure titled "Hospital Disinfectant and Cleaning Agents" dated 8/19/92, was reviewed on 4/29/10. The policy noted the following:

"Blood or Body Fluid"
"Bleach 1:10 dilution (freshly prepared)"
3. "Flood with appropriate disinfectant"
4. "Wait 10 minutes"

The employee file for the Infection Control Nurse (ICN) was reviewed on 4/30/10 at 9:30 AM with the Human Resource Director (HR). The job description for the position of "Infection Control Officer/Employee Health Nurse" indicated that the ICN was responsible for, "Periodic review of cleaning procedures and schedules in use throughout the hospital, and consultation relative to any major changes in cleaning products or techniques."


Review of the facility policy titled "Infection Prevention and Control and Performance Improvement Plan" dated 7/10/97, on 4/30/10, noted that the duty of the ICN included the following:

"11. Make environmental rounds with the Environment Care team in all patient care areas, and otherwise collaborate with staff of other departments to increase compliance with infection control techniques and policies."

During an interview with the ICN on 4/29/10 at 10:00 AM, the ICN stated that she did not provide education to the housekeeping staff, or monitor the cleaning techniques of the housekeeping staff to ensure that environmental surfaces were being sanitized to prevent the spread of infection in the facility.

Based on interview and record review the facility failed to ensure that it had an effective Infection Control Nurse (ICN)/ Infection Control Officer (ICO).

The facility failed to ensure that the ICN kept accurate records of employee PPD TB skin tests. This failure had the potential to result in injury or death to patients and employees, from the spread of active Tuberculosis disease in the facility.

The facility failed to ensure that the Infection Control Nurse (ICN) was qualified for the position as documented in the facility's job description. This failure had the potential to result in the ICN not being knowledgeable of effective infection control practices.

The facility failed to ensure that the ICN monitored the cleaning practices of the housekeeping staff to ensure that the sanitation techniques, of environmental surfaces, were effective in reducing the risk of the spread of infection in the facility. This failure had the potential to result in environmental surfaces contributing to the spread of infection to patients, visitors and employees in the facility.

The hospital infection control officer failed to ensure the food service department created policies and procedures to ensure food safety and quality (cross refer A-620), provided provisions to monitor compliance with food service infection control policies (active surveillance).

The facility failed to ensure the correct use of chemical disinfectants. This failure had the potential to increase the spread of disease in the facility.

The facility failed to ensure that the facility practice of random culturing of one endoscope monthly was carried out, creating the risk of infectious diseases in staff, patients and visitors.

Findings:

1. The employee PPD TB skin tests on and the "TB Screening" forms were reviewed on 4/30/10 at 10:20 AM. Of the approximate 240 "TB Screening" forms reviewed, 7 did not have documented results of the PPD TB skin test that was taken by the employee.

During an interview with the Infection Control Nurse (ICN) on 4/30/10 at 10:30 AM, the ICN verified that 7 employees PPD TB skin tests had no documented result on the "TB Screening" form.

Review of the electronic flow sheet maintained by the ICN, noted that the ICN had recorded that those 7 employees had "negative" PPD TB skin tests, even though there was no documented results of the test on the "TB Screening" forms.

During an interview with the ICN on 4/30/10 at 10:30 AM, the ICN stated that she had relied upon the verbal statements of the facility staff that the PPD TB skin tests on the "TB Screening" were negative, and stated that she had not reviewed the results on the "TB Screening" forms. During the interview, the ICN stated that it was her responsibility to review the results of each "TB Screening" and to keep accurate records based on the results of the screenings. The ICN stated that she had no documented evidence to show that the employees had tested negative for exposure to active TB disease.

The facility policy and procedure titled "Tuberculosis Prevention" dated 9/22/92, was reviewed on 4/30/ 10 at 9:00 AM. The policy indicated the following:

"Tuberculosis Surveillance among Employees"
"A. All employees with a previous negative PPD TB skin test will be re-tested at the time of hire and during their annual evaluation" .

"Purpose"
"A. To monitor the presence or absence of M. Tuberculosis in previously negative employees.
B. To prevent the spread of active M. Tuberculosis in the Health Care Facility.
C. To monitor employees who have been exposed to active M. Tuberculosis within the Health care Facility" .

"Responsibility"
"1. The infection Control Officer will provide the supervisory responsibility for the TB Control Program."


2. The employee file for the Infection Control Nurse (ICN) was reviewed on 4/30/10 at 9:10 AM with the Human Resource Director (HRD). The job description for the position of "Infection Control Officer/Employee Health Nurse" required the following:

"A. BS (Bachelors) degree in Health Sciences
B. One year experience in Infection Control is desirable or a basic training in infection control approved by APIC (Association for Professionals in Infection Control and Epidemiology).
C. Certification in Infection Control desirable or a minimum of a basic class in infection control approved by APIC."

During an interview with the HRD on 4/30/10 at 9:10 AM, the HRD stated and verified that the ICN did not have a Certification in Infection Control, evidence of a basic class in infection control approved by APIC, or evidence of a Bachelors degree in Health Science, in her employee file. During the interview the HRD verified that based on the job description for the job position "Infection Control Officer/Employee Health Nurse" , the current ICN was not qualified for the position.

During an interview with the ICN on 4/30/10 at 10:30 AM, the ICN verified that she did not currently possess a BS in the Health Sciences, was not certified in infection control and had not attended a basic class in infection control approved by APIC. The ICN stated that she had been in the position of the ICN, at the facility, since February of 2010, and did not have previous experience as an INC.

3. During an interview with Housekeeper 1(HK 1) on 4/29/10 at approximately 11:00 AM, HK 1 was asked how she would clean the environmental surfaces in a room, that was previously occupied by a patient diagnoses with Clostridium difficile? HK 1 stated she would use a solution comprised of 1 cup of bleach and 10 cups of water to wipe down the surfaces. HK 1 stated that it would be ok if the solution dried on the surfaces in 5 minutes.

The facility policy and procedure titled "Hospital Disinfectant and Cleaning Agents" dated 8/19/92, was reviewed on 4/29/10 at approximately 11:00 AM. The policy indicated the following:

"Blood or Body Fluid"
"Bleach 1:10 dilution (freshly prepared)"
3. "Flood with appropriate disinfectant"
4. "Wait 10 minutes"

During an interview the interview the ICN on 4/29/10 at 10:00 AM, the ICN stated that she did not provide education to the housekeeping staff, or monitor the cleaning techniques of the housekeeping staff to ensure that environmental surfaces were being sanitized to prevent the spread of infection in the facility.


The employee file for the Infection Control Nurse (ICN) was reviewed on 4/30/10 at 9:30 AM with the Human Resource Director (HRD). The job description for the position of "Infection Control Officer/Employee Health Nurse" indicated that the ICN was responsible for, "Periodic review of cleaning procedures and schedules in use throughout the hospital, and consultation relative to any major changes in cleaning products or techniques."


Review of the facility policy titled "Infection Prevention and Control and Performance Improvement Plan" dated 7/10/97, on 4/30/10, indicated that the duty of the ICN included the following:

"11. Make environmental rounds with the Environment Care team in all patient care areas, and otherwise collaborate with staff of other departments to increase compliance with infection control techniques and policies."









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5. During an interview with the EVS Director on 4/24/10 at 10:30 AM, she was questioned about the correct use of the surface cleaning and disinfecting chemicals used in the facility and specifically about the contact time required for the disinfectants to work. She stated that there were three different surface disinfectant cleaners used at the facility, and that the chemicals were applied to the surfaces, and were to remain in place for 10 minutes or until dry. She stated that it was okay if the chemical dried in less than 10 minutes and that rewetting was not needed. The EVS Director stated that she trained the housekeeping staff on the policies, including the correct use of cleaning agents, at staff meetings, and performed competency testing.

During a review of the 2009 EVS staff meetings and training documentation, the EVS staff competency tests (undated) regarding the use of cleaning chemicals were seen. A competency question regarding the use of cleaning chemicals was, " How long does it take for Neutral & TB Stat to kill germs and dry? " The answer, " 10 minutes or until dry " , had been scored as the correct answer. There was no answer choice available for " the chemical should remain wet for 10 minutes " .

During a review, with the EVS Director, of the product labels and directions, the manufacturer directions for TB Stat and Neutral disinfectant cleaners read that the treated surface should remain wet with the chemical for 10 minutes.

During a follow-up interview with the EVS Director on 4/24/10 at 10:45 AM, she stated that she had been in error about the duration of contact time required for the use of the cleaning chemicals.

During a concurrent interview with the ICN, she stated that she had not been monitoring EVS training or visually monitoring the EVS cleaning process, and that she was not involved in training the EVS staff.

6. During an interview with the OR Manager on 4/28/10 at 11:45, she stated that it was the facility ' s practice to culture one scope monthly to ensure that no disease-causing bacteria were present on the scope. During a second interview, on 4/29/10 at 10 AM she presented one scope culture result from 1/10 and another from 3/10, and stated that the culture had not been done in February.

During an interview with the previous ICN on 4/29/10 at 9:45 AM, he stated that scope cultures were to be done monthly, and that the Infection Control Department was supposed to oversee that activity.

The facility policy, Endoscope Cultures, GI-7, rev 7/8/09, was reviewed on 4/29/10. The policy stated, " Cultures will be obtained on all scopes used, once a month to protect patients against the risk of cross-contamination.





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4. During the survey there was an identified lack of food service guidance, staff monitoring systems in place and infection control quality assurance to ensure safe food handling standards were planned and implemented (cross refer A-620).

On 4/28/10 at 1:45 PM the ICP was interviewed. The ICP confirmed that she was responsible to ensure the prevention of food borne illness through policy and procedure review and surveillance through rounds.

The " Infection Control Manual " (reviewed 9/10/09) did not provide any guidance:
· To ensure the system for cool down of PHF (potentially hazardous foods) was being implemented according to the facility policy and monitoring of the cool down logs for proper implementation was being assured (cross refer A-620)
· To ensure proper internal cooking temperatures were being adhered to and monitored to prevent food borne illness (cross refer A-620)
· To ensure food provided by outside services met proper food handling standards with proper holding temperature monitoring (cross refer A-620)
· To ensure that dishmachine temperature logs were being reviewed and that staff was knowledgeable regarding proper rinse temperatures to maintain proper sanitizer concentrations for dishwashing and proper sanitizer concentrations for the 3 compartment sink (cross refer A-620)
· To ensure proper storage of PHF with appropriate cover, label and dating and temperature controls in the dry storage area (cross refer A-620)
· On the role of the ICP regarding active monitoring and surveillance of the department to ensure a sanitary environment and ensure safe food handling.

The ICP stated that she had held her current position for 2 months and had conducted a " walk through " of the kitchen 3 times during this time. She further stated that she and the ICP who held the position before her had done no infection control surveillance in the food service department.

According to the 2008 Year End Evaluation of the facility ' s Infection Control Program, " The purpose of the infection Prevention and Control program is to improve the ability of the facility to provide the best patient care in the safest possible environment. This is accomplished initiating collaborative, organization-wide infection control and prevention practices that are evidence based, and according to all accrediting and regulatory standards, regulations, and guidelines. "

Based of interview and record review the facility's Infection Control Officer (ICO)/ Infection Control Nurse (ICN), failed to maintain a log of incidents and communicable diseases that occurred in the facility.

This failure had the potential to result in the facility not being able to track infectious diseases within the facility inorder to control the spread of infections in the hospital.

Findings:

During an interview with the Infection Control Officer (ICO)/ Infection Control Nurse (ICN), on 4/30/10 at 10:30 AM, the ICO stated that she did not keep a log to track incidents related to infections and communicable diseases that occurred in the facility.

The facility's "Infection Prevention and Control and Performance Improvement Plan" dated 7/10/97, was reviewed on 4/30/10 at 10:45 AM. The "Infection Prevention and Control and Performance Improvement Plan" indicated that activities of the Infection Control Officer included, "Maintain a monitoring program for the correct application of infection control strategies." "Conduct and participate in surveillance activities, both targeted and for the presence of hospital acquired infections."

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

1. Maintain operating room humidity within federal requirements, within professional standards and in accordance with its own policy.

2. Ensure the humidity levels in the ORs were adequately monitored, creating an increased risk of adverse events such as operating room fire and infection.

Findings:

1. During a tour of the OR on 4/26/10 at 11:10 AM, the humidity registered on the gauge in OR 1 was observed to be 26%. The OR humidity was concurrently discussed with the OR Manager. She stated that in an attempt to control the OR humidity, humidifiers were being brought to the OR overnight.

The humidity gauge in OR 2 was observed on 4/27/10 at 12:35 PM to register 25%. The humidity was recorded at 40% at 6:45 AM that morning. The OR log was examined, and surgeries continued to be performed on that day. Subsequently, the facility obtained additional gauges for measuring humidity which registered higher humidity levels.

The facility policy, "Maintaining a Safe and Functional Environment" , EC 45 (undated copy) was reviewed on 4/30/10. Table 1.1 on page 2 indicated the humidity for the operating room was to be kept at 30-60 percent relative humidity.

2. On 4/26/10 at 11:10 AM the humidity log for OR 1 was reviewed and the humidity level recorded on 4/7/10, 4/8/10 and 4/21/10 were 21%. No evidence that Plant Operations was informed were seen. The times of humidity assessment were not noted.

During an interview with the OR Manager on 4/27/10 at 12:35 PM, she stated that surgeries continued to be performed on those dates.

The facility policy, "Maintaining a Safe and Functional Environment" , EC 45 (undated copy) was reviewed on 4/30/10. Section 7C stated, ... "humidity conditions observed outside of the permissible AIA ranges shall be reported to Plant Operations immediately."

Based on interview and record review, the facility failed to ensure that the anesthesiologists completed a post anesthesia assessment and documented the assessment with enough detail to establish the condition of the patient at the time of the assessment, creating the risk of a poor post-anesthesia outcome for patients who received anesthesia services.

Findings:

During a review of the medical record of Patient 2 on 4/27/10 at 12:00 PM, the record contained an "Anesthesia Pre-op/Recovery Area/Post-op Form" with a section for "Recovery Area" filled out with the patient ' s blood pressure, pulse and respiratory rate, but no other details regarding the patient's condition such as oxygen saturation, neurological status, hydration or pain level. The section was signed by the anesthesiologist.

A second component of Patient 2's medical record was the "Anesthesia Record" , which provided a small box for writing in information about post anesthesia, but did not provide room for noting the time, pain level, or hydration status, all details that are recommended for inclusion according to the American Society of Anesthesiologists' Practice Guidelines for Post-anesthetic Care, Anesthesiology, vol 96, no 3.

During an interview with RN 9 on 4/29/10 at 12:35 PM, he stated that some of the anesthesiologists sometimes came to assess the patients postoperatively.

During an interview with MD 2, he stated that he was not aware of guidelines for what should be included in the post-anesthesia assessment.

The facility policy, Patient Assessment and Reassessment effective 8/1982, page 20 read, " A post-anesthesia evaluation will be completed and documented by an anesthesiologist within 48 hours after surgery on all patients. "