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Based on interview, medical record review, and document review, the facility failed to ensure pain was assessed and interventions documented as required by the hospital policy for 1 of XX patients. (Patient 33)

Findings:

On 5/16/13 the hospital's pain management policy was reviewed. The undated Policy titled "Pain Management" reads in part "A pain rating scale will be used to measure the patient's report of pain...the pain scale will be documented in the appropriate area of the medical record...some tools that may be used for pain screening include the following...1)Numeric scale 2) Faces scale..." Additionally the procedure requires the licensed nurse to perform a pain assessment that include the pain intensity, the location of the pain, a description of the pain, alleviating factors and aggravating factors. The requirement for monitoring and documenting the pain assessment is as follows: "A. With physical assessment, with routine vital signs and as needed,. B. At regular intervals appropriate for the specific patient and C. With each new report of pain.. The procedure also requires documentation of pain scoring before and after as needed pain medication is administered.

Review of Patient 33's medical record disclosed a section for pain assessment that read Pain (0-10), indicating the nurse was to rate the pain on a 0 - 10 scale. The documented pain ratings for Patient 33 on 5/15/13 between 10:30 am and 11:30 am was "0", indicating no pain. In the section for medication administration there is documentation Patient 33 received Fentanyl (a pain medication) 25 mcg intravenously 5 times between 11 am and 11:45 am. Additional documentation on the medication area reads y/y after the 11 am, 11:05 am and 11:10 am medication administration and y/n after the 11:15 and 11:45 am medication administration. In an interview with RN 1 on 5/15/13 at 2:30 pm, RN 1 stated he had used a yes/yes or yes/no rating when Patient 33 had pain. RN 1 acknowledged he had not used the pain scale of 0 - 10

Based on interview and record review, the facility failed to describe one of 160 sampled patient's progress and response to services when a licensed nurse failed to document the reason for not administering a prescribed medication for chest pain. (Patient 22) This failure had the potential for unrecognized assessments and improper interventions to occur.

Findings:

Patient 22 was admitted to the hospital on 5/9/13 with diagnoses that included respiratory failure.

A Nurses Note dated 5/12/13 at 10:41 am, disclosed that Registered Nurse (RN) 3 notified Patient 22's physician that she was having complaints of "severe chest pain" and that her telemetry (a heart monitor) read that Patient 22 was having a run of premature ventricular contractures (PVC'S, extra abnormal heart beats). "New nitro (nitroglycerin, medication for acute chest pain) orders were received."

On 5/14/13 at 11:25 am, a physician's "Verbal Order Form" dated 5/12/13 at 10:15 am, was reviewed by RN 3. The verbal order indicated to administer Nitro 0.4 milligrams (mg) sublingual (under the tongue) every 5 minutes, for three doses, as needed for chest pain.

Concurrently Patient 22's medication administration record (MAR) was reviewed with Registered Nurse Informatics (RN-Info) 1. She confirmed that the ordered Nitro was not signed out and administered to Patient 22 for her chest pain and that there was no further documentation as to why it was not administered. RN 3 was not available for an interview.

On 5/15/13 at 2:30 pm, Registered Nurse Manager (RNM) 2 stated that she spoke to RN 3 about the Nitro medication and that RN 3 had informed her that when she went to administer the Nitro medication to Patient 22, that she was no longer having the chest pain so it was not given. RNM 2 confirmed there was no documentation as to why the medication was not administered or that the physician was notified.

A policy, "Medication Administration, Documentation and Monitoring", dated 2/3/12, disclosed for any omission of a medication, including held or refused medication, the licensed nurse would circle the entry time, initial, and then document the reason the medication was held or refused. The policy further indicated that the physician would be notified of the medication being held or refused, along with documentation in the patients medical record of the significant clinical events and any actions taken.

Based on observation, interview, and document review, the facility failed to ensure medical records were complete for two of 160 sampled patients. (Patients 74 and 75) The failure to maintain complete patient records may lead to miscommunication, unnecessary repeated assessments, and delay of treatments.

Findings:

1. On 5/15/13 at 8:15 am, Patient 75 was observed arriving in the Post Anesthesia Care Unit after having bilateral tubes placed in his ears. Review of the nursing assessment before the procedure did not have documented evidence that the lungs were assessed prior to the procedure by the Registered Nurse (RN).

In an interview on 5/15/13 at 8:40 am, RN 22 stated that she had taken care of Patient preoperatively and forgot to document his lung assessment before surgery.

2. On 5/15/13 at 9:20 am, Patient 74 was observed leaving the facility via wheelchair after having an upper endoscopy (visual inspection from the mouth to the lower area of the stomach). There was no documented evidence that the Mallampati Classification (visual inspection of the anatomy of the mouth to predict the ease of placing a breathing tube down the throat) had been assessed by the Medical Doctor.

According to American Society of Anesthesiologists, "Statement on Granting Privileges for Administration of Moderate Sedation to Practitioners who are not Anesthesia Professionals," dated 10/19/11, pages 5 and 6, read under Education and Training, "The following subject areas should be included: ...3. Skills for obtaining the patient's medical history and performing a physical examination to assess risks and co-morbidities (two or more coexisting medical conditions or disease processes that are additional to an initial diagnosis), including assessment of the airway for anatomic and mobility characteristics suggestive of potentially difficult airway management."

Based on interview and record review, the hospital failed to ensure that nine of 160 sampled patient's verbal orders were authenticated (signed) by the prescribing physician within 48 hours. (Patients 2, 4, 5, 10, 22, 23, 26, 66 and 68) This failed action had the potential for transcription errors to occur presenting a risk to patient safety.

Findings:

An undated hospital policy titled, "Verbal Orders," indicated that all verbal orders must be authenticated or countersigned by the practitioner within 48 hours.

The Medical Staff Rules and Regulations, approved March 2012, were reviewed on 5/15/13. Section C. 2 . states: "...All verbal orders, including telephone orders, must be countersigned within forty-eight (48) hours...."

1. Patient 22 was admitted to the hospital on 5/9/13 with diagnoses that included respiratory failure.

On 5/14/13 at 11:25 am, a physician's "Verbal Order Form" dated 5/12/13 at 10:15 am, was reviewed with Registered Nurse Informatics (RN-Info) 1. The verbal order indicated to administer Nitro (nitroglycerin) 0.4 milligrams (mg) sublingual (under the tongue) every 5 minutes, for three doses, as needed for chest pain. At this time RN-Info 1 confirmed that this verbal order had not been signed by the physician within 48 hours.

2. Patient 23 was admitted to the hospital on 5/3/13 with diagnoses that included colitis (inflammation of the colon).

On 5/15/13 at 3:30 pm, a physician's "Verbal Order Form" dated 5/10/13 at 7:45 pm, was reviewed with the Quality Managment Coordinator (QMC). The verbal order instructed to use Patient 22's current peripherally inserted central catheter (PICC) line for her total parenteral nutrition (TPN, an intravenous drip for patients that can not get nutrition through eating).
The verbal order was three days late from being signed by the physician.

Another telephone order dated 5/10/13 at 7:50 pm, instructed to administer Hydromorphone (Dilaudid, a medication used for pain management) 0.2 mg intravenously every ten minutes with a maximum dose of 4 mg in four hours through a patient controlled analgesia (PCA) pump. The verbal order was three days late from being signed by the physician.

On 5/15/13 at 3:30 pm, the QMC confirmed that these two physician orders had not been signed by the physician within 48 hours.

3. Patient 26 was admitted to the hospital on 5/3/13 with diagnoses that included .

On 5/14/13 at 1:30 pm, a physician's "Verbal Order Form" dated 4/19/13 at 6:58 pm, was reviewed with RN-Info 1. The verbal order indicated to administer a bolus (a large, rapid dose) of normal saline (an intravenous solution), 250 milliliters (ml) once at a rate of 150 ml an hour, and to notify the physician for a systolic blood pressure of less than 100. The physician had signed this verbal order on 4/25/13 at 11 am, six days, 144 hours later.


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4. Patient 2's record was reviewed with RN-Info 1 on 5/14/13.

Patient 2 was admitted to the hospital on 2/1/13 with diagnoses that included progressive kidney failure.

On 2/13/13 at 11:52 am, pre-printed physician's orders titled, "Comfort Care" were verbally obtained. These orders were signed electronically by the ordering physician on 2/25/13 at 8:25 am, 10 days late.

During a concurrent interview and record review on 5/15/13 at 8:30 am, the Quality Management Coordinator confirmed that the verbal order had not been signed by the physician within 48 hours.

5. Patient 4's record was reviewed with RN-Info 1 on 5/15/13.

Patient 4 was admitted to the hospital on 5/10/13 with diagnoses that included a partial small bowel obstruction.

On 5/10/13, multiple verbal orders were obtained from Patient 4's physician. These orders were signed by the ordering physician on 5/14/13 8:40 am, 2 days late.

During a concurrent interview and record review on 5/15/13 at 10:20 am, RN-Info 1 confirmed that the verbal order had not been signed by the physician within 48 hours.

6. Patient 5's record was reviewed with RN-Info 1 on 5/15/13.

Patient 5 was admitted to the hospital on 5/5/13 with diagnoses that included weakness.

Multiple verbal orders were obtained on 5/5, 5/8, 5/9 and 5/11 from Patient 5's physician. As of 5/15/13, these orders had not been signed by the ordering physician, 3 to 13 days late.

During a concurrent interview and record review on 5/15/13 at 11:30 am, Registered Nurse Manager 3 confirmed that these verbal orders had not been signed by the physician within 48 hours.

7. Patient 10's record was reviewed with RN-Info 1 on 5/15/13.

Patient 10 was admitted to the hospital on 3/13/13 with diagnoses that included small bowel resection.

Multiple verbal orders were obtained on 3/29, 3/31, 4/16, 4/29 and 5/6 from Patient 10's physician. As of 5/15/13, these orders had not been signed by the ordering physician, 7 to 45 days late.

Patient 10's physician had signed verbal orders on 5/8 and 5/9, but did not include the date and time with his signature.

During a concurrent interview and record review on 5/15/13 at 10 am, RN-Info 1 confirmed that these verbal orders had not been signed by the physician within 48 hours.


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8. On 5/15/13 at 2:35 pm, Record 66 were reviewed with the Director, Health Information Management (DHIM). Record 66 contained 3 verbal orders given on 3/23/13 that had been electronically authenticated by the physician on 4/3/13,9 days late. This patient died in the hospital on 3/24/13. This finding was confirmed concurrently with Staff DHIM.

9. On 5/15/12 at 2:45 pm, Record 68 were reviewed with the DHIM. The record contained 2 verbal orders given on 4/29/13 which was one day before the patient was discharged from the hospital. These orders were electronically authenticated by the physician on 5/8/13, 7 days late. This finding was confirmed concurrently with Staff DHIM.

Based on staff interview and medical record review, the facility failed to ensure that 95 of 95 medical records contained a discharge summary within 14 days of discharge. This failure had the potential to result in vital medical information not being available for continuing care of patients recently discharged from the hospital.

Findings:

The Medical Staff Rules and Regulations, approved March 2012, were reviewed on 5/15/13. Section B. 18 states: "The patient's medical record shall be complete within 14 days of discharge, including progress notes, final diagnosis and discharge note or summary...."

On the morning of 5/14/13, the Director, Health Information Management (DHIM) presented a "Deficiency Summary Report" that had been prepared on 5/13/13 at 1:03 pm. This report revealed that there were 95 delinquent discharge summaries (those not completed within 14 days of the patient's discharge). When asked for a more detailed listing, DHIM presented another report which was prepared and discussed on the afternoon of 5/15/13. This report, the "Clinician Deficiency List" for Physician Assistant (PA) 1 revealed that this one practitioner had 22 delinquent discharge summaries yet to complete. The oldest one, Patient 69, a patient discharged on 1/12/13, over 4 months ago, was reviewed on 5/16/13. The patient had a hospital stay of about 30 days, with surgeries performed. DHIM further explained that PA 1 was currently on "suspension;" however this disciplinary action had no consequences, since he did not admit patients.

Based on observation, interview, and record review, the hospital failed to store Boostrix (a combined vaccine to prevent bacterial infections of Tetanus, Diphtheria Pertussis) vaccines according to accepted professional principles, as stipulated in guidelines published by the government agency Centers for Disease Control (CDC). Specifically, the hospital did not ensure twice daily monitoring of refrigerators containing vaccine in order to maintain drug integrity, stability, and effectiveness between 1/1/15 and 5/15/13 (four-and-a-half months). As a direct result, the hospital potentially exposed 114 patients in six patient care areas to the ineffective prevention of serious infections due to the use of expired and/or less than labeled strength (Patients 81-195).

Findings:

1. According to the government agency Centers for Disease Control (CDC), "Tetanus, diphtheria and pertussis can be very serious diseases. Tetanus (Lockjaw) causes painful muscle spasms and stiffness, usually all over the body. It can lead to tightening of muscles in the head and neck so the victim cannot open his mouth or swallow, or sometimes even breathe. Tetanus kills about 1 out of 5 people who are infected. Diphtheria can cause a thick membrane to cover the back of the throat. It can lead to breathing problems, paralysis, heart failure, and even death. Pertussis (Whooping Cough) causes severe coughing spells, which can lead to difficulty breathing, vomiting, and disturbed sleep. It can lead to weight loss, incontinence, rib fractures and passing out from violent coughing. Up to 2 in 100 adolescents and 5 in 100 adults with pertussis are hospitalized or have complications, including pneumonia and death." (Reference: http://www.cdc.gov/vaccines/pubs/vis/downloads/vis-td-tdap.pdf).

During a tour on 5/13/13 at 11:25 am, with Registered Nurse Manager, Emergency Department (RNM 1), vials of T-dap (Tetanus-Diphtheria-Pertussis) were stored in the POD-3 medication refrigerator. Tdap was a vaccine used to prevent Tetanus-Diphtheria-Pertussis (all infectious diseases).

During that observation on 5/13/13 at 11:25 am, the Medication Refrigeration Temperature Log, Emergency Department (ED) POD-1 Med Room, dated May 2013 Days 1-15, was attached to the refrigerator. The log was missing documentation of 10 daily temperatures on 5/1/13, 5/2/13, 5/3/13, 5/4/13, 5/5/13 5/6/13, 5/9/13, 5/10/13, 5/11/13, and 5/12/13.

A review of the hospital's current policy, Enloe Medical Center Maintenance of Medication Refrigerators, undated, showed, "Medication refrigerators that store vaccines will have the temperatures measured and recorded twice daily." The policy also showed, "The charge nurse or other responsible party) will assure the daily refrigerator temperature checks...are completed."

The CDC recommends that vaccines stored under refrigeration be checked twice daily at a minimum. This standard was reflected in the hospital's written policies and procedures. On 5/13/13 a review of the hospital's current policy, Enloe Medical Center Maintenance of Medication Refrigerators, undated, showed, "Medication refrigerators that store vaccines will have the temperatures measured and recorded twice daily." The policy also showed, "The charge nurse (or other responsible party) will assure the daily refrigerator temperature checks...are completed."

According to the manufacturer, Boostrix was a vaccine indicated for active booster immunization against tetanus, diphtheria, and pertussis. Reference: www.glaxosmithkline.com.

On 5/16/13 at 9:05 am in an interview, Director of Pharmacy (DPH) described the hospital's investigation of vaccines potentially stored under conditions of indeterminate temperature controls. He said,"We have eight refrigerators where we may have stored vaccines out of the manufacturers' ranges for short periods of time."

On 5/16/13, a review of refrigerator logs, dated between 1/1/13 and 5/15/13 inclusive, showed incomplete documentation in six units PROMPT CARE-EOC (Enloe Outpatient Center), ED MAIN, ED-Chest Pain, ED-POD 3, ED-POD 4, Los Molinos Clinic, and Gridley Clinic as follows:

A review of the Medication Refrigeration Temperature Log, PROMPT CARE-EOC, dated January 2013 Days 16-31, was missing documentation of two daily temperatures on 1/21/13 and 1/22/13.

A review of the Medication Refrigeration Temperature Log, PROMPT CARE-EOC, dated February 2013 Days 16-31, was missing documentation of two daily temperatures on 2/25/13.

A review of the Medication Refrigeration Temperature Log, ED-Med Room (ED Main), dated April 2013 Days 1-15, was missing documentation of 12 daily temperatures on 5/1/17, 5/2/13, 5/3/13, 5/4/13, 5/5/13, 5/6/13, 5/7/13, 5/8/13, 5/9/13, 5/10/13, 5/11/13, 5/12/13 and 5/15/13.

A review of the Medication Refrigeration Temperature Log, ED-Med Room (ED Main), dated April 2013 Days 16-31, was missing documentation of 12 daily temperatures on 5/16/17, 5/17/13, 5/18/13, 5/19/13, 5/20/13, 5/21/13, 5/23/13, 5/24/13, 5/25/13, 5/26/13, 5/29/13, and 5/30/13.

A review of the Medication Refrigeration Temperature Log, ED-POD 2 Chest Pain, dated April 2013 Days 1-15, was missing documentation of 10 daily temperatures on 5/1/13, 5/2/13, 5/3/13, 5/4/13, 5/6/13, 5/7/13, 5/9/13, 5/10/13, 5/11/13, and 5/12/13.

A review of the Medication Refrigeration Temperature Log, ED-POD 2 Chest Pain, dated April 2013 Days 16-31, was missing documentation of 12 daily temperatures on 5/17/13, 5/18/13, 5/19/13, 5/20/13, 5/21/13, 5/23/13, 5/24/13, 5/25/13, 5/27/13, 5/28/13, 5/29/13, and 5/30/13.

A review of the Medication Refrigeration Temperature Log, ED-POD 3, dated April 2013 Days 1-15, was missing documentation of 11 daily temperatures on 5/1/13, 5/2/13, 5/3/13, 5/4/13, 5/6/13, 5/7/13, 5/8/13, 5/9/13, 5/10/13, 5/11/13, and 5/12/13.

A review of the Medication Refrigeration Temperature Log, ED-POD 3, dated April 2013 Days 16-31, was missing documentation of 10 daily temperatures on 5/16/17, 5/17/13, 5/18/13, 5/19/13, 5/20/13, 5/21/13, 5/24/13, 5/25/13, 5/29/13, and 5/30/13.

A review of the Medication Refrigeration Temperature Log, ED-POD 4, dated April 2013 Days 1-15, was missing documentation of 11 daily temperatures on 4/1/13, 4/2/13, 4/3/13, 4/4/13, 4/6/13, 4/7/13, 4/8/13, 4/9/13, 4/10/13, 4/11/13, and 4/12/13.

A review of the Medication Refrigeration Temperature Log, ED-POD 4, dated April 2013 Days 16-31, was missing documentation of 11 daily temperatures on 5/16/13, 5/17/13, 5/18/13, 5/19/13, 5/20/13, 5/21/13, 5/23/13, 5/24/13, 5/25/13, 5/29/13, and 5/30/13.

A review of the Medication Refrigeration Temperature Log, Prompt Care-Enloe Outpatient Care (EOC), dated April 2013 Days 1-15, was missing documentation of two daily temperatures on 4/7/13 and 4/10/13.

A review of the Medication Refrigeration Temperature Log, Prompt Care-EOC, dated April 2013 Days 16-31, was missing documentation of two daily temperatures on 4/16/13 and 4/27/13.

A review of the Medication Refrigeration Temperature Log, ED-POD 2, dated May 2013 Days 1-15, was missing documentation of 8 daily temperatures on 5/1/13, 5/4/13, 5/5/13, 5/6/13, 5/10/13, 5/11/13, 5/12/13, and 5/15/13.

A review of the Medication Refrigeration Temperature Log, ED-POD 3, dated May 2013 Days 1-15, was missing documentation of 8 daily temperatures on 5/1/13, 5/4/13, 5/5/13, 5/6/13, 5/10/13, 5/11/13, 5/12/13, and 5/15/13.

A review of the Medication Refrigeration Temperature Log, ED-POD 4, dated May 2013 Days 1-15, was missing documentation of 8 daily temperatures on 5/1/13, 5/4/13, 5/5/13, 5/6/13, 5/10/13, 5/11/13, 5/12/13, and 5/15/13. An annotation on the form dated 5/13/13 showed, "Vaccine removed and sent to pharmacy for replacement, education sent out."

A review of the Medication Refrigeration Temperature Log, Los Molinos, dated May 2013 Days 1-15, was missing documentation of three daily temperatures on 5/6/13, 5/8/13, and 5/9/13.

A review of the Medication Refrigeration Temperature Log, Gridley, dated May 2013 Days 1-15, was missing documentation of five daily temperatures on 5/2/13, 5/4/13, 5/5/13, 5/11/13, and 5/12/13.

On 5/13/13 at 11:25 am in an interview, Registered Nurse Manager (RNM 1) described the hospital's process for ensuring vaccines were maintained according to the hospital's policies and procedures. She said, "We have an audit process for charge nurses to round daily to ensure medications are stored and documentation done." She elaborated, "The rounds were not done or the element was missed."

On 5/13/13 at 1:30 pm in an interview, Registered Nurse, Relief Charge Nurse, Emergency Department (RN 1) said, "May sixth I was on duty. I was charge nurse. I did not do it myself (the daily refrigerator audit) and I did not delegate." I am not sure that checking refrigerator logs is part of my responsibility.

On 5/13/13 at 2:30 pm in a subsequent interview, RNM 1 said of the daily audit process, "I can't be sure I communicated that to our relief charge nurses."

On 5/13/13 at 2:30 pm in an interview, Vice President, Patient Care Services (VP-PCS) said, "I was not aware this was an issue. Pharmacy did not report it as an irregularity from their monthly unit inspections." VP-PCS indicated nursing had not reported it up the chain of command either.

On 5/13/13 at 2:45 pm in an interview, Quality Management Manager, Registered Nurse (QMM) said, "The inpatient rounding form for audits - there is no written one for ED. She elaborated that, (VP-PCS) received "copies of the inpatient rounding forms."

On 5/16/13 at 9:05 am in an interview, Director of Pharmacy (DPH) acknowledged in light of the CDC's recommendations, and in accordance with the hospital's policies, the hospital had determined "medication errors on about a hundred and twenty patients." He said the hospital's investigation was ongoing and he was uncertain of the exact number, and that he contacted the vaccine manufacturers and the hospital's quality team was in the process of determining further steps.

A review of the hospital's occurrence reports and discussion with the DPH indicated the patients received vaccines in error on the following dates in their respective patient care areas of service (Emergency Department and Prompt Care-EOC) when the hospital did not ensure policies were implemented to ensure safe vaccine storage under refrigeration:

On 4/1/13, Patient 81 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the Emergency Department Chest Pain (ED Chest Pain) refrigerator.

On 4/2/13, Patient 82 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in Emergency Department Main (ED Main) refrigerator.

On 4/2/13, Patient 83 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in Emergency Department Area 3 (ED Area 3) refrigerator.

On 4/2/13, Patient 84 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 4/2/13, Patient 85 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 4/3/13, Patient 86 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Area 3 refrigerator.

On 4/3/13, Patient 87 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Chest Pain refrigerator.

On 4/6/13, Patient 88 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 4/6/13, Patient 89 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 4/6/13, Patient 185 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Area 3 refrigerator.

On 4/6/13, Patient 186 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 4/6/13, Patient 187 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Chest Pain refrigerator.

On 4/6/13, Patient 188 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Area 3 refrigerator.

On 4/6/13, Patient 189 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 4/6/13, Patient 185 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Area 3 refrigerator.

On 4/6/13, Patient 186 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in ED Main refrigerator.

On 4/6/13, Patient 187 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Chest Pain refrigerator.

On 4/6/13, Patient 188 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Area 3 refrigerator.

On 4/6/13, Patient 189 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in D Main refrigerator.

On 4/7/13, Patient 190 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 4/7/13, Patient 191 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED POD 4 refrigerator.

On 4/7/13, Patient 192 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 4/7/13, Patient 193 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 4/7/13, Patient 194 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Area 3 refrigerator.

On 4/7/13, Patient 190 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 4/7/13, Patient 191 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED POD 4 refrigerator.

On 4/7/13, Patient 192 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 4/7/13, Patient 193 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 4/7/13, Patient 194 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Area 3 refrigerator.

On 4/7/13, Patient 90 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in Prompt Care.

On 4/8/13, Patient 91 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 4/8/13, Patient 92 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED POD 4 refrigerator.

On 4/10/13, Patient 93 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 4/10/13, Patient 94 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 4/10/13, Patient 95 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 4/10/13, Patient 96 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 4/11/13, Patient 97 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 4/11/13, Patient 98 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 4/11/13, Patient 99 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 4/12/13, Patient 100 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED POD 4 refrigerator.

On 4/12/13, Patient 10 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in ED POD 4 refrigerator.

On 4/12/13, Patient 102 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Area 3 refrigerator.

On 4/12/13, Patient 103 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 4/12/13, Patient 104 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 4/13/13, Patient 105 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 4/13/13, Patient 106 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 4/13/13, Patient 107 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 4/13/13, Patient 108 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 4/14/13, Patient 109 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 4/14/13, Patient 110 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 4/14/13, Patient 111 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 4/14/13, Patient 112 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 4/16/13, Patient 113 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Area 3 refrigerator.

On 4/16/13, Patient 114 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 4/16/13, Patient 115 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 4/16/13, Patient 116 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Chest Pain refrigerator.

On 4/16/13, Patient 117 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 4/16/13, Patient 118 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Chest Pain refrigerator.

On 4/16/13, Patient 119 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Chest Pain refrigerator.

On 4/16/13, Patient 120 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 4/17/13, Patient 121 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 4/17/13, Patient 122 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 4/17/13, Patient 123 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 4/18/13, Patient 124 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Chest Pain refrigerator.

On 4/18/13, Patient 125 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 4/18/13, Patient 126 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Chest Pain refrigerator.

On 4/18/13, Patient 127 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Chest Pain refrigerator.

On 4/18/13, Patient 128 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Chest Pain refrigerator.

On 4/18/13, Patient 129 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 4/18/13, Patient 130 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Chest Pain refrigerator.

On 4/18/13, Patient 131 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Chest Pain refrigerator.

On 4/18/13, Patient 132 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Chest Pain refrigerator.

On 4/19/13, Patient 133 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED POD 4 refrigerator.

On 4/19/13, Patient 134 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 4/19/13, Patient 135 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Area 3 refrigerator.

On 4/19/13, Patient 136 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 4/19/13, Patient 137 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED POD 4 refrigerator.

On 4/20/13, Patient 138 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED POD 4 refrigerator.

On 4/20/13, Patient 139 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 4/21/13, Patient 140 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 4/21/13, Patient 141 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Chest Pain refrigerator.

On 4/21/13, Patient 142 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 4/22/13, Patient 143 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Chest Pain refrigerator.

On 4/23/13, Patient 144 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 4/24/13, Patient 145 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Area 3 refrigerator.

On 4/24/13, Patient 146 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Area 3 refrigerator.

On 4/24/13, Patient 147 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Area 3 refrigerator.

On 4/24/13, Patient 148 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Chest Pain refrigerator.

On 4/25/13, Patient 149 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 4/25/13, Patient 150 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Chest Pain refrigerator.

On 4/25/13, Patient 151 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Chest Pain refrigerator.

On 4/25/13, Patient 195 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 4/26/13, Patient 152 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 4/26/13, Patient 153 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 4/27/13, Patient 154 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Chest Pain refrigerator.

On 4/27/13, Patient 155 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Chest Pain refrigerator.

On 4/27/13, Patient 156 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the Prompt Care refrigerator.

On 4/27/13, Patient 157 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the Prompt Care refrigerator.

On 4/27/13, Patient 158 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the Prompt Care refrigerator.

On 4/28/13, Patient 159 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Chest Pain refrigerator.

On 4/29/13, Patient 160 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Chest Pain refrigerator.

On 4/29/13, Patient 161 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Department refrigerator.

On 4/29/13, Patient 162 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 4/29/13, Patient 163 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 4/30/13, Patient 164 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 4/30/13, Patient 165 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 4/30/13, Patient 166 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 5/1/13, Patient 167 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 5/1/13, Patient 168 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 5/1/13, Patient 169 E was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 5/1/13, Patient 170 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 5/1/13, Patient 171 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 5/2/13, Patient 172 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 5/3/13, Patient 173 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 5/3/13, Patient 174 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 5/3/13, Patient 175 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 5/4/13, Patient 176 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Chest Pain refrigerator.

On 5/4/13, Patient 177 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 5/4/13, Patient 178 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Chest Pain refrigerator.

On 5/4/13, Patient 179 E was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in D POD 4 refrigerator.

On 5/4/13, Patient 180 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 5/5/13, Patient 181 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Chest Pain refrigerator.

On 5/5/13, Patient 182 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Main refrigerator.

On 5/5/13, Patient 183 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Area 3 refrigerator.

On 5/5/13, Patient 184 was administered a Boostrix vaccine after it was stored under conditions which did not meet hospital standards in the ED Chest Pain refrigerator.

Based on observation, staff interviews, nutrition care review and review of hospital documents, the hospital failed to: 1) ensure an effective system, based on standards of practice, for evaluation of medical nutrition therapy interventions for 2 of 5 patients reviewed for nutrition care (Patients 51 and 55); and 2) ensure the puree, renal, low residue/gastrointestinal soft, and mechanical soft menus were analyzed for the nutritional components to meet the current national standards including the RDA (Recommended Dietary Allowances) and the DRI (Dietary Reference Intake) of the Food and Nutrition Board of the National Research Council. Failure to implement timely and effective systems for evaluation of medical nutrition therapy may result in further compromising nutritional and medical status for at risk patients. Failure to have a nutrient analysis that meets the RDAs and DRIs for the menu has the potential for the patients in the hospital to receive inadequate nutrition.

Findings:

1. Patient 51 was admitted on 5/7/13 with diagnoses that included sepsis secondary to an epidural abscess. The Medical Review was conducted on 5/15/13. Review of the physician's orders dated 5/8/13 showed a Consistent Carbohydrate Standard (CCS) diet was ordered.

Review of the Nutrition intake dated 5/9/13 showed the dinner meal intake was at 10%. There were no other entries in the medical record for meal intake for that day.

Review of the Nutrition intake dated 5/10/13 showed the dinner meal intake was at 0%. There were no other entries in the medical record for the meal intake for that day. Review of the Nutrition intake dated 5/11/13 showed the breakfast meal intake was 50%, lunch meal intake was 50%, and dinner meal intake was 35%. Review of the Nutrition intake dated 5/12/13 showed the dinner meal intake was 60%. There were no other entries in the medical record for the meal intake for that day. Review of the Nutrition intake dated 5/13/13 showed the dinner meal intake was 20%. There were no other entries in the medical record for the meal intake for that day. Review of the Nutrition intake dated 5/14/13 showed the breakfast meal intake was 75%, lunch meal intake was 75%, and dinner meal intake was 20%. Review of the Nutrition intake dated 5/15/13 showed the breakfast meal intake was 75%.

Review of the nutrition assessment dated 5/10/13 showed Patient 51 was 6 '1" and admission weight was 103.3 kilograms (227 pounds) and most recent documented weight was 102.5 kilograms (kg) (225.5 pounds). The Registered Dietitian (RD) noted Patient 51's ideal body weight was 83.64 kg (184 pounds). The RD noted Patient 51's estimated needs were 2024 calories to 2576 calories and 92 grams to 119.6 grams of protein per day. The RD noted the average meal intake was on 5/9/13 with 10% of dinner consumed and noted no other documentation was in the electronic medical record system. The RD noted the Nutritional Problems were inadequate oral intake related to unknown etiology and questioned a decreased appetite as evidenced by documented oral intake less than goal. The RD noted the goals were glucose levels between 70-150; oral intake at 75% or greater; and a bowel movement within two to three days. The RD noted her interventions/plan: 1) recommend to add Glucerna (Diabetic nutrition supplement) three times a day with meals; 2) continue the CCS diet and encourage oral intake; 3) consider insulin adjustment per the physician; 4) monitor labs, weight, and oral intake. The RD noted the patient was a Priority 2 level and the next assessment would be on 5/16/13 (6 days after assessment).

Review of the Notes dated 5/10/13, the RD put a note for the physician with her recommendation of Glucerna. Review of the physician's orders showed no order for Glucerna.

On 5/15/13 at 10:10 am, an interview was conducted with RD 1. RD 1 stated the RDs would put their recommendations in the notes section to communicate with the physician. RD 1 stated they would not follow up on if their intervention/recommendation was done until their next follow up.

Review of the hospital's policy and procedure titled, Nutrition Care Prioritization and Assessment Guidelines revised 6/30/11, showed the reassessment time frames for Priority 1 (high risk) was one to four days; Priority 2 (moderate risk) was four to six days; and Priority 3 (low risk) was six to nine days.

The community standard is that the intervention or recommendation would be followed up on the next day and if the physician did not want to order the nutrition supplement then the RD would have to reassess and change the intervention.

On 5/15/13 at 10:12 am, an interview was conducted with RNM 3. RNM 3 stated every eight hours nursing should enter in the oral intake. RNM 3 stated the Catering Associates record the oral intake on a form then the nurse will enter that into the electronic medical record. RNM 3 stated after that day they throw away the paper form. It is unclear if the Catering Associates are not filling in the paper forms or if the nurse is not entering in the data into the electronic medical record.

Review of the hospital's policy and procedure titled, Intake and Output, revised 4/13, showed the Nutrition assistant records the amount of the meal taken on the worksheet.

On 5/14/13 at 3:35 pm, an interview was conducted with the Clinical Nutrition Manager (CNM). The CNM stated she was revising the nutrition prioritization policy, but it was still in draft form and was concerned that once they tightened up their time frames to better meet the patient's nutrition needs that she may not have enough staffing to do so.

2. Patient 55 was admitted to the hospital on 5/8/13 with a diagnosis of neck stab wound. The Medical Record Review was conducted on 5/15/13. Review of the Consultation note dated 5/10/13 showed Patient 55 had Brown-Sequard syndrome (characterized by loss of motor function or hemiplegia), status post stab wound to the neck, and multiple stab wounds. Review of the physician's orders dated 5/8/13 showed a standard diet (regular diet).

Review of the Nutrition intake dated 5/8/13 showed the breakfast meal intake was at 100%. There were no other entries in the medical record for meal intake for that day. Review of the Nutrition intake dated 5/9/13 showed the breakfast meal intake was at 100%, and the lunch meal intake was 75%. There were no other entries in the medical record for meal intake for that day. Review of the Nutrition intake dated 5/10/13 showed the dinner meal intake was at 60%. There were no other entries in the medical record for the meal intake for that day. Review of the Nutrition intake dated 5/11/13 showed the breakfast meal intake was 50%, lunch meal intake was 0%, and dinner meal intake was 5%. Review of the Nutrition intake dated 5/12/13 showed the breakfast meal intake was 0%, lunch meal intake was 15%, and dinner meal intake was 10%. Review of the Nutrition intake dated 5/13/13 showed the breakfast meal intake was 0%, lunch meal intake was 0%, and dinner meal intake was 10%. Review of the Nutrition intake dated 5/14/13 showed the breakfast meal intake was 0%, lunch meal intake was 0%, and dinner meal intake was 100%.

Review of the nutrition assessment dated 5/10/13 showed Patient 55 was 5'6" and admission weight was 69.5 kg (152.9 pounds). The Registered Dietitian (RD) noted Patient 55's ideal body weight was 64.55 kg (142 pounds). The RD noted Patient 55's estimated needs were 1946 calories to 2432 calories and 83 grams to 104 grams of protein per day. The RD noted the patient was not interviewed. The RD noted the average meal intake data was based on three meals. The RD noted under malnutrition classification there was insufficient data. The RD noted there were No Nutritional Problems requiring intervention at this time. The RD noted the plan was to continue the regular diet. The RD noted the patient was a Priority 3 level and the next assessment would be on 5/19/13 (9 days after the assessment).

When the RD did the nutrition assessment on 5/10/13 at 1:39 pm, there should have been eight meals eaten however only three meals were documented. It is unclear if the patient had eaten any of those meals or had refused them. The RD did not speak with the patient to find out more information about the undocumented meals. The RD assessed the patient at low nutrition risk based on three out of eight meals being recorded then would not reassess the patient for nine days.

On 5/16/13 at 11:00 am, an interview was conducted with the Regional Clinical Manager (RCMN) and Director of Food and Nutrition Services regarding Patient 55's medical record. The RCNM stated poor oral intake should be high risk. The RCNM acknowledged the three meals may not have accurately reflected the patient's true oral intake since it was only three of the eight meals therefore the patient may not have really been at a low nutrition risk. The RCNM acknowledged nine days as a reassessment was long but that was why they were going to revise the policy.

3. a. On 5/13/12 at approximately 1pm, the hospital's nutrient analysis for the regular and therapeutic diet menus were reviewed. The Reference Range for the Dietary Reference Intakes (DRIs): Recommended Dietary Allowances and Adequate Intakes for Vitamins, Elements, and Macronutrients were Females 51-70 years of age. The DRI of fiber was 21 grams per day. It was noted that the fiber content of the renal, puree, and mechanical soft menus ranged from 11-16 grams (g) (52%-76%) of fiber depending on the menu. The hospital menus for renal, puree, and mechanical soft were inadequate in Fiber.

Further review of the nutrient analysis revealed the following: for the puree diet showed it was only meeting 47% of the RDA for Niacin, 53% for Folate, 53% for Magnesium, and 82% for Zinc; for the renal diet showed it was only meeting 54% of Magnesium, and 80% for Zinc; the Low Residue and Mechanical soft diet showed it was only meeting 79% Magnesium.

On 5/16/13 at 11am, an interview was conducted with the Director of Food and Nutrition Services (DFNS). The DFNS stated they got data from the hospital regarding what the majority of their patient population was and this is how they determined their reference population. The DFNS did not indicate how they would meet the needs of the patients who were not in this population group. The DFNS stated they were planning on rolling out a new patient menu in June and hoped the new menu would be adequate and meet the needs of the patients. The DFNS stated the puree diet uses molded foods and some of those items do not have a complete nutrient analysis.

b. On 5/13/13 at approximately 11:05 am, a lunch trayline meal service observation was conducted. The trayline steam table was observed to have the following items: spaghetti noodles, meat sauce, mashed potatoes, chicken gravy, green salad. Review of the lunch meal for the regular diet showed the following: green salad, meat sauce over spaghetti. Review of the puree diet for the lunch meal on 5/13/13 showed the following: tapioca pudding, puree chicken, chicken gravy, whipped potatoes, pureed peas.

Further review of the puree menu showed there was only one meal choice for the puree diet. It showed the breakfast food items were the same every day of the week. It showed every day for lunch and dinner the patients would get mashed potatoes. The lack of variety of food items shown on the puree menu and the nutrient analysis indicates the menu is inadequate to meet those patients nutrition needs while they are in the hospital.

On 5/16/13 at 11am, an interview was conducted with the DFNS. The DFNS stated they are planning to have a new menu rollout and it should have more variety of foods and be closer to what the regular diet food items are getting. The DFNS stated the puree diet uses molded foods and some of those items do not have a complete nutrient analysis.

Based on staff interview and record review, the facility failed to ensure that the hospital's approved diet manual, reflected a low fiber or low residue diet that was not consistent with what their menu provided. Failure to not have a diet manual may result in the inability to provide appropriate nutrients for healing and strength.
Findings:
Review of the hospital's approved diet manual indicated the low fiber diet restricts dietary fiber and provides less than 10 grams per day. Further review of the diet manual indicated the Gastrointestinal (GI) Soft diet contains only moderate amounts of fiber. It did not indicate what moderate amounts of fiber meant. Review of the nutrient analysis for their "GI soft/Low residue diet" indicated the average dietary fiber was 16 grams (g). Further review of the nutrient analysis indicated the daily g per day ranged anywhere from 12.6 g to 19.2 g of fiber per day.

On 5/16/13 at 11am, an interview was conducted with the Director of Food and Nutrition Services (DFNS) and the Regional Clinical Nutrition Manager (RCNM) regarding the diet manual and nutrient analysis. The RCNM stated the low fiber diet is the same as low residue diet. The DFNS acknowledged the menu was not consistent with the diet manual.

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

Findings:

On 5/13/13 beginning at 1:45 pm, food service for disaster preparedness was reviewed. In a concurrent interview with the Director of Food and Nutrition Services (DFNS), she stated all the water and nutrition supplements for their 4 day disaster plan for the Esplanade campus was stored at the Cohasset campus approximately 1.5 miles away. The DFNS stated it was only nutrition supplements and there was no real food on their plan.

On 5/13/13 at 2:55 pm, the water and nutrition supplements were observed at the Cohasset campus. All of the water supplies were in 20 ounce bottles and were in pallets. Further review of the disaster plan for food and water, indicated how much water per person per day but not how much would be given at each meal period. It indicated each person would get two cans of ensure for each meal.

Based on observation, staff interviews and review of hospital documents, the hospital's Infection Prevention coordinator failed to develop an effective system for identifying and ensuring: 1) chemicals were not being stored next to food items; 2) scoops were not stored inside the containers of Thickener; 3) the clean food carts were stored in a room without open pipes containing fuel; and 4) the soda beverage syrup were stored in a room with cleaning supplies.
Failure to ensure a hospital wide infection control program including the high risk high volume food service operation that serves the patient and hospital wide staff had the potential of food borne illness and compromised patient care.

Findings:

1. On 5/14/13 at 10:55 am, the dry food storage area in the dietetic service space at the Cohasset Campus was observed to have four cases "TB Disinfectant Cleaner" next to the dry food items.

Review of the hospital's policy and procedure titled Food and Supply Storage Procedures dated 5/95, revised 6/12, indicated to store cleaning supplies separately from food and paper.

2. On 5/13/13 at 10:15 am, during the initial tour of the kitchen at the Esplanade campus, two cans of thickener were observed with scoops laying down in the thickener. A concurrent interview was conducted with the Director of Food and Nutrition Services (DFNS). The DFNS stated the scoops should not be in the cans and the cans would have to be thrown out.

Review of the hospital's policy and procedure titled Food and Supply Storage Procedures dated 5/95, revised 6/12, indicated that scoops may be stored in bins on a scoop holder and the food level must be no closer than one-inch below the handle of the scoop.

3. On 5/13/13 at approximately 3:40 pm, the new area for the clean cart storage was observed. When the surveyor looked up at the ceiling there were many pipes visible with no protection to the dietetic space, two of which were labeled as "fuel".

On 5/14/13 at 10:20 am, an observation with interview was conducted with the Director of Facilities. The Director of Facilities stated the pipes contained oxygen lines, fire protection which was water and the fuel oil return and supply lines.

4. On 5/13/13 at approximately 3:20 pm, a dietary services storage closet at the Esplanade campus was observed to contain boxes of food beverage syrup with a dispensing spout as well as cleaning supplies. The DFNS confirmed during interview on 5/14/13 at 2 pm, that the cleaning supplies were not stored correctly.

Based on observations, staff interviews and document review, the hospital failed to maintain a system for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel, as evidenced by:

1. Hinged instruments were sterilized in the closed position;

2. The hospital did not ensure that 1 of 4 Physician Assistants (PA 1) and 1 of 10 nursing staff (RN 2) adhered to CDC recommendations related to annual screening for communicable diseases.

Findings:

1. During a tour of the Sterile Processing area on 5/15/13 at 11:20 a.m. with the Infection Control RN (ICRN) and the sterile processing supervisor (SPS1), 23 peel packs of scissors and a variety of clamps and needle holders were observed in the closed position. Multiple bins of additional scissor, clamps and needle holders in peel packs were also noted in the closed position. In a concurrent interview ICRN and SPS 1 acknowledged the instruments needed to be sterilized in the open position. SPS 1 stated it appeared the packages were too small for the instruments to held in the open position.

Review of the hospital's policy titled "Assembly and wrapping of instruments for steam sterilizers,"dated 4/13 and presented as current, stipulated, "Open or disassemble instrument to permit sterilant to contact all surfaces"

The 2012 Perioperative Standards and Recommended Practices published by AORN were reviewed. Direction was given that, "Cleaned surgical instruments should be organized for packaging in a manner to allow the sterilant to contact all exposed surfaces and instruments with hinges should be opened..."

Failure of the hospital to sterilize hinged instruments in accordance with nationally accepted infection control guidelines placed surgical patients at risk for exposure to serious life-threatening infectious agents.

2. Review of Health Care Personnel health files disclosed 1 of 4 Physician Assistants (PA1) and 1 of 10 Nursing Staff (RN2) did not have documented evidence of immunity or a signed declination form.
PA1's filed did not contain documented evidence of immunity, to measles, mumps, rubella or varicella, RN 1's file did not contain documented evidence of immunity, immunization or declination of immunization to varicella.

The Centers for Disease Control and Prevention (CDC) Morbidity and Mortality Report (MMWR Volume 46, Number RR-18, December 26, 1997) documented on page 24: "Persons who work within medical facilities should be immune to measles and rubella. Immunity to mumps is highly desirable for all Healthcare Workers. Because any HCW (i.e., medical or nonmedical, paid or volunteer, full time or part time, student or nonstudent, with or without patient-care responsibilities) who is susceptible can, if exposed, contract and transmit measles or rubella, all medical institutions (e.g., inpatient and outpatient, public and private) should ensure that those who work within their facilities are immune to measles and rubella. Likewise, HCWs have a responsibility to avoid causing harm to patients by preventing transmission of these diseases on page 25, the MMWR documented: "All HCWs should ensure that they are immune to varicella."

In an interview on 5/15/13 at 4:00 pm, ICRN, stated the hospital based infection control guidelines on CDC and OSHA recommendations.



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3. During the tour of the Oncology and Pediatric Unit on 5/13/13 at 10:45 am with Registered Nurse Manager (RNM)s 5 and 6. The following items were observed in the linen and supply room as follows:
a. One bin had culture swabs that had expiration dates of 2014 placed in the front and on top of other culture swabs with the expiration dates of 2013 and
b. Another bin had One-half Normal Saline liter bags for intravenous fluid in front with the expiration date of 9/14, while the bags on the bottom and back area had the expiration date of 12/13.

In a concurrent interview, RNM 5 stated that the expected practice was that items were rotated first come, first out per facility's policy.

According to the policy, "Materials Management Distribution Center - Housekeeping Procedure, undated, under Procedure, fourth item, "Stock will be rotated, permitting items to be issued on a first-in first-out basis."

Based on interview, observation and document review, the hospital failed to ensure that in-house preparation of radio-pharmaceuticals where always prepared under the direct supervision of an appropriately trained and certified pharmacist or physician. This failure could possibly result in the uses of improperly prepared radio-pharmaceuticals during clinical studies.

Findings:

On 5/16/13 at 9:45 am, during a tour of the nuclear medicine studies suite, the Lead Nuclear Medicine Technician (NMT1) explained and demonstrated how radioactive materials were received, cataloged and handled in the nuclear medicine laboratory (hot lab: a secure and shielded space where radioactive materials are kept and processed). He explained that the great majority of radioactive materials were received as pre-prepared unit doses of radio-pharmaceuticals that had been ordered for scheduled studies. However, for some types of studies, the material cannot be prepared ahead of time or outside of the hospital and for other studies, some done emergently, there is not sufficient time allotted to obtain unit doses. For those studies, bulk radioactive materials are kept available in the hot lab and the Nuclear Medicine Technicians do the preparation of the radio-pharmaceuticals as ordered, using the specified bulk radioactive material.

On 5/16/13 at 12:35 pm, during an interview with the Manager of Medical Imaging (Radiology Manager: RM) and the NMT1, they acknowledged that the hospital did not have a system in place to assure that an appropriately trained pharmacist or physician was always available to directly supervise the preparation of radio-pharmaceuticals. To their knowledge the hospital did not have a pharmacist who was qualified to supervise the preparation of radioactive pharmaceuticals. Many of the radiologists are qualified to prepare and/or supervise preparation of radio-pharmaceuticals, however often the preparation takes place after hours, when those radiologists may not be available. The RM explained that, because of a memorandum published by CMS, dated 2/5/13, he understood that CMS was calling for a revision of CFR 482.53 to remove the "Direct" supervision requirement. Since seeing this memorandum the RM had not sought a change of the current protocol. He did not understand that the regulation was still in effect, could only be changed by the US Congress and it would therefore take some time before the proposed change would be in effect.

The procedure for preparation is defined in a policy titled "Nuclear Medicine Preparation and Administration of Radiopharmaceuticals" which was first written in 2/90 and last revised in 2/12. The policy does not call for any direct or indirect supervision, by a qualified physician or pharmacist, when radio-pharmaceuticals are the prepared or administered.