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Based on observations, staff interviews, and documents review, the hospital failed to ensure an effective Governing Body, legally responsible for overseeing the conduct of the hospital operations in all departments of the facility and in the provision of patient care as evidenced by deficiencies cited throughout the health survey and Life Safety Code (LSC) survey, resulting in: 1. unsafe medication practices, not following physician orders, 2. failing to clearly designate Pharmacist-in-Charge for pharmaceutical service, 3. failing to provide dietary services to meet the patient's needs, and 4. unsafe environmental conditions that placed patients, staff, family, and visitors at risk.

Findings:

1. The failure of the Governing Body (GB) to ensure that the administration of patients medications were free of errors as evidenced by an 11.9% medication error rate (Cross Reference A404).

2. The failure of the GB to ensure the hospital had clearly designated a Pharmacist-in-Charge, of the day to day supervision, and control of the hospital pharmacy and pharmaceutical services (Cross Reference A490, A492).

3. The failure of the GB to ensure dietary services met the patients needs as evidenced by unsafe food handling practices and lack of supervision and training in the dietary department (Cross Reference A620, A622, A629, and A749)

4. The failure of the GB to ensure the infection control officer developed a system for identifying, reporting, investigating and controlling infections and communicable disease (Cross Reference A749)

5. The failure of the GB to ensure the hospital's environment was maintained in a safe manner to ensure the well being of the patient's. (Cross Reference K046, K048, K051, K052, K054, K062, K064, K078, and K147)

The cumulative effect of these systemic problems resulted in the hospitals' inability to ensure the provision for patient's safety and sanitary conditions in their environment and to further deliver statutorily mandated compliance with the Condition of Participation for Governing Body.

Based on document review, the hospital failed to provide accurate information addressing patients' rights to lodge a grievance with the State Agency. This had the potential to deny patient their rights by not providing them with accurate information on how to file a grievance.

Findings:

Review of the hospital's statement of Patient Rights and Responsibilities on 10/05/10 at 2:30 p.m., demonstrated that the listed address, phone number, and web site for patients to file a complaint with the State Agency was in fact the address, phone number, and web site for the California Hospital Association, a non-governmental entity. In addition, review of hospital policy APPM IV. 1, Patient Rights, Responsibilities, and Restrictions, demonstrated that the State Agency's name for filing a complaint was incorrectly listed as the "State of California, Department of Health Services", and both the phone number and fax number listed were incorrect.

Based on administrative and dietary staff interview and administrative and dietary document review, the hospital failed to ensure there was a hospital wide Quality Assurance Performance Improvement (QAPI) program as evidenced by:


The failure to ensure development of an effective program for the Food and Dietetic Service (Cross Reference A264).


The cumulative effect of the systemic problems resulted in the hospitals' failure to meet statutorily mandated compliance with the Condition of Participation for Quality Assurance Performance Improvement.

Based on administrative and dietary staff interview and administrative and dietary document review, the hospital failed to have an ongoing quality appraisal and performance improvement program that addressed the complexity and scope of Food and Dietetic Services.


Findings:


On 10/5/10 at 11 a.m., the quality appraisal and performance improvement (QAPI) activities were reviewed. In a concurrent interview, Dietary Management Staff J stated that the majority of the improvement activities were related to customer service activities. She also stated that these activities were discussed in weekly foodservice staff meetings.


In an interview on 10/5/10 at 4:20 p.m., with Administrative Staff L, a member of the hospitals' QAPI committee, she was asked how the hospital ensured development of departmental improvement programs that reflected the nature and scope of services. She stated that the committee did not make decisions on the types of activities, rather would rely on departmental leaders to choose the activities. She further stated her expectation for activities would include newly implemented processes as well as corporate requirements. She also stated that departments would have flexibility in choosing projects. Administrative Staff L also acknowledged that there were no performance improvement activities related to their safe food handling practices to ensure the prevention of foodborne illness nor any clinical nutrition activities evaluative the effectiveness of the clinical nutrition care.


There was no documentation that a QAPI program was developed for the scope of the hospitals' food and clinical nutrition areas.

Based on observation of 8 nurses passing medications to 11 patients on two separate days during the morning medication pass on the 4 th floor Medical Surgical Unit, the hospital failed to ensure the following: A. that hospital patients received the medications as ordered by the physician and according to standards of practice. Five errors were observed out of a total of 42 opportunities for errors, including medications ordered but not administered for an error rate of 11.9%. B. Hospital staff also failed to ensure that a medication for Patient 101 was administered in accordance with the physician order when a patient (Patient 101) was identified as having an allergic reaction to acetaminophen (pain reliever) and the patient's physician order contained a prn (as needed) medication for Vicodin, a pain reliever, which contained the ingredient acetaminophen. These failures could potentially compromise patients conditions or lead to potentially serious adverse reactions.

Findings:
A.
1. On 10/6/2010 at 9 a.m. Licensed Staff M administered 30 ml of Milk of Magnesia (MOM) to Patient 400. MOM is a laxative that comes as a suspension that must be shaken prior to administration. The nurse did not shake the unit dose cup before giving it to the patient. Examination of the cup after the patient finished taking her dose indicated that a thin, uneven residue remained in the cup. On 10/6/2010 at 9:48 a.m. an observation of the residue in another cup that had been shaken indicated that a thin even milky residue was left in the shaken cup which was visibly different than the residue in the unshaken cup.

On 10/6/2010 at 10 a.m. a review of Patient 400's clinical record indicated that on 10/4/2010 at 1:50 p.m. a physician ordered that Patient 400 receive 30 ml of MOM daily. Shaking medication suspensions prior to administration evenly distributes the medication in the suspension to ensure that the patient will receive the dose of medication that the physician prescribed. Review of the label on the Milk of Magnesia container, under the heading of "Directions," indicated "shake well before use."

2. On 10/6/2010 at 9:30 a.m. Licensed Staff N passed medications to Patient 401. Paroxetine, an antidepressant, and telmisartan, used to treat high blood pressure, were not among the medications passed to Patient 401. On 10/6/2010 at 10:09 a.m. a review of Patient 401's clinical record indicated that on 10/1/2010 at 8:48 a.m. a physician ordered paroxetine 15 mg orally daily and telmisartan 40 mg orally daily. During an interview of Licensed Staff N at that time, she reviewed the MAR for Patient 401 and then stated she had missed the paroxetine and the telmisartan during the medication pass that morning.

3. On 10/6/2010 at 9:48 a.m., Licensed Staff O passed medications to Patient 402. DynaCirc, used to treat high blood pressure, was not among these medications. On 10/6/2010 at 10:06 a.m. a review of Patient 402's clinical record indicated that on 10/5/2010 at 4:05 a.m. a physician ordered DynaCirc CR 10 mg orally daily. During an interview of Licensed Staff O at that time, she said she had told the physician that DynaCirc was not on the hospital formulary that morning (10/6/2010) but he had not given her an answer. A review of the MAR indicated that on 10/5/2010, staff had not administered the DynaCirc at 9 a.m. as the medication was not in the drawer and at 9 p.m. on 10/5/2010, the DynaCirc was still not available. As the patient did not receive any DynaCirc on the morning of 10/6/2010, 27.75 hours had passed since the order was written and the patient had still not had this issue addressed. On 10/6/2010 at 11:45 a.m., during an interview of Administrative Staff PP, she stated that if a non-formulary drug was ordered and not available in the pharmacy, pharmacy staff would be expected to call the doctor to obtain a substitute medication. No evidence was provided that this was done.

4. On 10/7/2010 at 10:07 a.m. Licensed Staff P administered one Spiriva Capsule (used to improve breathing in patients with restrictive airway disease) to Patient 403 using a hand held inhalation device provided by the manufacturer. Patient 403 put the device in his mouth three times but did not inhale and no sound came from the hand held inhaler device while Patient 403 had the mouthpiece in his mouth. The forth time he inhaled and a vibrating sound emanated from the hand held device. The nurse took the device from the patient and put it away in the medication cart. She did not encourage the patient to take a second inhalation.

On 10/7/2010 at 11:04 a.m. a review of Patient 403's clinical record indicated that on 10/3/2010 at 1 a.m., a physician had ordered that Patient 403 inhale the contents of one Spiriva capsule each day. On 10/7/10 at 12:13 p.m., a review of the patient instructions section, of the product labeling, indicated that the manufacturer documented the following:

"Breath in slowly and deeply so that you hear or feel the SPIRIVA capsule vibrate." (Part of Step 4 in the product labeling).

"To make sure you get the full dose you must breathe out completely, and inhale again as in step 4 above ..."

On 10/7/2010 at 11:56 a.m. during an interview of Licensed Staff P on the fourth floor, she stated she was not aware that the manufacturer stipulated one must inhale twice on one capsule to ensure that all the contents of the capsule was inhaled.



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B.
On 10/7/10 at 7:30 a.m., review of Patient 101's clinical record indicated the patient was admitted to the acute care facility on 10/3/10, due to syncope (fainting) and was discharged on 10/5/10. The patient's scheduled medication sheet indicated that the patient had allergies as a result of taking Tylenol which is the brand name for acetaminophen. The patient's clinical record included a "Bulletin Board" summary of the patient's previous admission to the facility and indicated "Allergies: Tylenol "trouble breathing." Also included in the clinical record was a physician order with a prescription for Vicodin to be administered one every 4 to 6 hours as needed for pain. Vicodin is composed of the ingredients acetaminophen (or Tylenol) and hydrocodone bitartrate (a narcotic drug related to codeine, used for pain relief and cough suppressant.)

On 10/7/10 at 8:20 a.m., Licensed Staff C was interviewed regarding Patient 101's clinical record and physician orders. A physician order for Vicodin was dated 10/4/10, and indicated the medication to be administered one every 4 to 6 hours as needed for pain. Licensed Staff C had initialed the order indicating she had noted the physician order. She was questioned whether the order for Vicodin should have been included in the patient's record and stated that it should not have been. She stated that if she had seen the patient's allergy to the Tylenol, she would have contacted the patient's physician for clarification.

On 10/7/10, review of the facility's policy on Administering Medications, revised 12/09, number 3 of the General Guidelines section A indicated "Verify that there are no known reasons the medication cannot be administered (e.g.allergy, drug-drug interaction, drug-food interaction, visually examine for discoloration or particulates.)" Section G of the Medication Administration Flow Chart also indicated "Check orders against MAR [medication administration record] (initial orders, every 24 hours and verify orders.) The following block indicated "Check for allergies."

Based on observations made in nursing care areas and the pharmacy, clinical record review, document review, and staff interview, the hospital failed to ensure that pharmaceutical services met the patient needs as evidenced by failure to clearly designate a pharmacist-in-charge from July 2010 to the time of the survey, and failure to develop a policy and procedures that ensured patients would be free of medication errors as evidenced by:

1. The failure of the hospital to clearly designate who was the designated Pharmacist-in-Charge of the day to day supervision and control of the hospital pharmacy and pharmaceutical services which could result in failure to meet standards of practice for the pharmaceutical services (Cross Reference A 491 and A 492).

2. The failure of the hospital to develop a system that ensured the safe use of fentanyl patches, which have a boxed warning. As a result a fentanyl patch was placed on a patient who did not meet the opioid tolerance requirements stipulated in the FDA approved product labeling which exposed this patient to the potential development of significant decrease in the rate of her breathing or a cessation of her breathing entirely (Cross Reference A 500, #1)

3. The failure of the hospital to ensure that hospital approved protocols were in place for pharmacist conversion of pain medication orders to another type of pain medication. Furthermore the hospital failed to ensure that the pharmacist was trained or otherwise qualified to do this and failed to approve the conversion tools she used to do this. This could expose patients to the risk of unsafe or ineffective therapy (Cross Reference A500, #2).

4. The failure of the hospital to ensure that concentrated IV solutions of sodium chloride and if magnesium sulfate for injection were not available in the night locker for after hours use by the nursing staff without concurrent pharmacist oversight of such use by concurrent review of orders for these medications. The use of these medications has been associated with patient injury and death and the availability of these solutions in the Night Locker could have resulted in patient injury or death. Furthermore, no evidence was provided that these solutions had been approved by the P&T Committee to be included in the Night Locker supply of medications (Cross Reference A 500, #3).

5. The failure of the hospital to develop a policy and procedure that would ensure that a patient would receive a non-formulary medication or a substitute medication within a timely period established by the medical staff. As a result a patient did not receive an ordered non-formulary drug or a substitute for over 24 hours which resulted in an error of omission during a medication pass review conducted during the survey (Cross Reference A 500, #4).

6. The failure of the hospital to develop a system to ensure that the "Home Medications Review and order Sheet" was reviewed by the physician for inclusion or exclusion of the listed medications from the hospital medication regimen of one out of eleven patients who received medications during two medication pass observations (Patient 405). This could have resulted in an adverse outcome for this patient or any patient whose list was not reviewed and who otherwise would not receive needed medications (Cross Reference A500, # 5).

7. The failure of the hospital to ensure that medications were secured in 4 out of 9 inspected nursing areas (Nursing Station 5A, 5B, 4D, and the Emergency Department) as well as the Pharmacy which provided non-designated hospital personnel as well as patient visitors potential access to these medications (Cross Reference A 502).

8. The failure of the hospital to ensure that lorazepam for injection (used for seizures and agitated behavior), a controlled substance, was locked in a secure area in 1 out of 9 inspected nursing areas (Nursing Station 5A) (Cross Reference A503).

The cumulative effects of these systemic problems resulted in the hospital's inability to ensure the provision for safe and effective use of drugs to meet the needs of the hospital patients and to minimize drug errors and adverse consequences.

Based on inspection of the Hospital Pharmacy Permit issued by the Board of Pharmacy and interview of one staff member and two administrative staff members, the hospital failed to ensure that the pharmacy administrative personnel and the hospital administrative personnel clearly established who was responsible for administering the pharmacy operations such that all people involved the Pharmacist-in-Charge (PIC) of record, the Regional Pharmacy Director, and the administrator to whom the Director of Pharmacy reported to were all in agreement as to who was responsible for the day to day operation of the on-site pharmacy services . As a result there was no clear established authority overseeing the day to day functioning of the pharmacy department to ensure that quality pharmaceutical services that met regulatory requirements and standards of practice were available to the hospital patient population. The PIC is a legal designation established by pharmacy law. It is the person who is responsible to the Board of Pharmacy for all that goes on in the pharmacy.

Findings:

1. On 10/4/2010 at 2:38 p.m. during an inspection of the pharmacy, a review of the Board of Pharmacy Hospital Pharmacy Permit indicated it was valid until 4/1/2011, and it documented that Pharmacy Staff CC was the PIC.

On 10/4/2010 at 2:46 p.m. during an interview of Pharmacy Staff CC, he said that in February 2010, he became the PIC (as documented on the Hospital Pharmacy Permit). He stated that in July 2010, he received a letter from Administrative Staff QQ thanking him for his leadership role in the pharmacy. He assumed that he was no longer the PIC at that time.

On 10/4/2010 at 2:46 p.m. during an interview of Administrative Staff PP she stated she had spoken to Administrative Staff QQ and had told her that she had not signed on yet as the PIC of this hospital.

On 10/4/2010 at 3:23 p.m. and on 10/5/2010 at 10:32 a.m. during two interviews of Administrative Staff QQ she stated that Administrative Staff PP was the Director of Pharmacy at this hospital. She stated that Pharmacy Staff CC was the PIC in the past but Administrative Staff PP was supposed to have processed the paperwork to become the PIC. Administrative Staff QQ stated that it was clear in her mind that Administrative Staff PP was the PIC but it was not clear in Administrative Staff PP's mind that this was the case. Administrative Staff QQ stated that she was the agent of the corporation that owned the hospital responsible for making sure the process took place and she failed to follow-up. She did not know this had not been done.

Based on inspection of the Hospital Pharmacy Permit issued by the California State Board of Pharmacy and interview of one staff member and two administrative staff members, the hospital failed to ensure that it clearly designated who was responsible for supervising the pharmacy. As a result there was no clear established authority overseeing the day to day functioning of the pharmacy department to ensure that quality pharmaceutical services that met regulatory requirements and standards of practice were available to the hospital patient population.

Findings:

On 10/4/2010 at 2:38 p.m. during an inspection of the pharmacy, a review of the Board of Pharmacy Hospital Pharmacy Permit indicated it was valid until 4/1/2011, and it documented that Pharmacy Staff CC was the Pharmacist-in-Charge (PIC). The PIC is a legal designation established by pharmacy law. It is the person who is responsible to the Board of Pharmacy for all that goes on in the pharmacy.

On 10/4/2010 at 2:46 p.m. during an interview with Pharmacy Staff CC, he stated he had been either a consultant or an employee of the hospital since 1986 and he had worked on and off at the hospital since that time. He said in February 2010 he became the PIC (as documented on the Hospital Pharmacy Permit). He stated that in July 2010, he received a letter from Administrative Staff QQ thanking him for his leadership role in the pharmacy. He assumed that he was no longer the PIC at that time.

On 10/4/2010 at 2:46 p.m. during an interview of Administrative Staff PP she stated she covered three hospitals including the one being surveyed. She stated she came here on 5/17/2010, and she had told Administrative Staff QQ that she could not be the PIC of this hospital as she was the PIC at another hospital. She stated she was no longer the PIC of the other hospital as of July 7, 2010, and since that time she was not the PIC in any hospital. She said she had spoken to Administrative Staff QQ and had told her that she had not signed on yet as the PIC of this hospital.

On 10/4/2010 at 3:23 p.m. during an interview of Administrative Staff QQ she stated that Administrative Staff PP was the Director of Pharmacy at this hospital. She stated that Pharmacy Staff CC was the PIC in the past, but Administrative Staff PP was supposed to have processed the paperwork to become the PIC. On 10/5/2010 at 10:32 a.m., during a second interview of Administrative Staff QQ, she stated Administrative Staff PP was hired to be a full time Director of Pharmacy on 5/16/2010, and that she told Administrative Staff PP on 6/25/2010 she needed to become the PIC but Administrative Staff PP had not followed through on this task. She stated she had met with Administrative Staff PP last night and that Administrative Staff PP had then sent a letter to the Board of Pharmacy informing them she was the PIC and that Pharmacy Staff CC was no longer the PIC. Administrative Staff QQ stated that it was clear in her mind that Administrative Staff PP was the PIC but it was not clear in Administrative Staff PP's mind that this was the case. Administrative Staff QQ stated that she was the agent of the corporation that owned the hospital responsible for making sure the process took place and she failed to follow-up. She did not know this had not been done.

Based on interview of Administrative Staff PP, the pharmacy was not able to keep accurate records of the receipt and disposition of schedule V controlled drugs with the potential result that diversion of these medications within the pharmacy department could go undetected.

Findings:

1. On 10/7/2010 at 1:04 p.m. during an interview with Administrative Staff PP, she stated that controlled drugs in schedules II through IV (Schedule II drugs such as morphine have strong potential for abuse while lower schedules have lesser potential for abuse were tracked in the pharmacy using a perpetual inventory but not controlled drugs in schedule V (the least likely to be abused category). During an interview of Administrative Staff PP at that time, she stated she would try to reconcile the stock she had on hand by comparing it to the last biannual inventory (an inventory of all controlled drug in a pharmacy done every two years as required by Federal Law), adding in all schedule V drugs received by the pharmacy during that period and subtracting all scheduled drugs sent out of the pharmacy for patient use or for destruction, to see if the record balanced with the current inventory.

On 10/8/2010 at 2:51 p.m. during an interview of Administrative Staff PP, she stated she could not locate the last biannual inventory of the controlled drugs in the pharmacy and therefore, she could not reconcile her records for schedule V controlled drugs using the current tracking system to account for controlled drugs in the hospital.

Based on observations made in nursing care areas and the pharmacy, clinical record review, document review, and staff interview, the hospital failed to ensure that drugs were distributed and controlled according to standards of practice, consistent with state law as evidenced by:

1. The failure of the hospital to develop a system that ensured the safe use of fentanyl patches, which have a boxed warning. As a result a fentanyl patch was placed on a patient who did not meet the opioid tolerance requirements stipulated in the FDA approved product labeling which exposed this patient to the potential development of significant decrease in the rate of her breathing or a cessation of her breathing entirely (see #1).

2. The failure of the hospital to ensure that hospital approved protocols where in place for pharmacist conversion of pain medication orders to another type of pain medication. Furthermore the hospital failed to ensure that the pharmacist was trained or otherwise qualified to do this and failed to approve the conversion tools she used to do this. By California Law only a person licensed to prescribe, such as a physician can write orders for medications except under certain defined protocols as stipulated in Health and Safety Code Section 4052.1. This could expose patients to the risk of unsafe or ineffective therapy (see #2).

3. The failure of the hospital to ensure that concentrated IV solutions of sodium chloride and if magnesium sulfate for injection were not available in the night locker for after hours use by the nursing staff without concurrent pharmacist oversight of such use by concurrent review of orders for these medications or other safeguards being in place. The use of these medications has been associated with patient injury and death and the availability of these solutions in the Night Locker could have resulted in patient injury or death. Furthermore, no evidence was provided that these solutions had been approved by the P&T Committee to be included in the Night Locker supply of medications (see #3).

4. The failure of the hospital to develop a policy and procedure that would ensure that a patient would receive a non-formulary medication or a substitute medication within a timely period established by the medical staff. As a result a patient did not receive an ordered non-formulary drug or a substitute for over 24 hours which resulted in an error of omission during a medication pass review conducted during the survey (see #4).

5. The failure of the hospital to develop a system to ensure that the "Home Medications Review and order Sheet" was reviewed by the physician for inclusion or exclusion of the listed medications from the hospital medication regimen of one out of eleven patients who received medications during two medication pass observations (Patient 405). This could have resulted in an adverse outcome for this patient or any patient whose list was not reviewed and who otherwise would not receive needed medications (see # 5).

6. The failure of the hospital to develop a stop order policy that ensured orders for medications would stop after a period established by the medical staff to ensure that medications were not continued beyond a period that they were needed or long enough to cause harm, the failure to ensure this policy addressed all classes of medications, and the failure to develop a process to ensure that the prescriber was contacted prior to the stop to ensure it was his intention that the order was stopped (see #6).

7. The failure of the hospital to ensure the policies for cleaning the laminar air flow hood in the pharmacy was followed as written (see #7).

8. The failure of the hospital to stock two out of two MH (malignant hyperthermia)Carts in the hospital according to AORN standards which hospital staff stated were the standards they followed and for which no reason was given as to why the standards would not be followed (see #8, #9, and #11), the failure to ensure that the contents of two out of two MH Carts matched the posted content list (see #10 and #12), the failure to establish the contents of the MH medication supply via a written policy and procedure, and the failure, based on inspection of two out of twenty Crash Carts, to post the content list on the outside cover of the emergency drug supply as required by state regulation (see #13,14, and 15).

Findings:

1. The fentanyl transdermal system (brand name is Duragesic) also called a fentanyl patch contains fentanyl, a potent synthetic opiate medication used to treat pain. This medication has a boxed warning (also called a "black box" warning) which is the most serious warning required by the Food and Drug Administration to be placed in the product labeling (also called the package insert) for a medication. Boxed warnings document potential problems that can lead to serious injury or death. The boxed warning for the fentanyl patch documents that it has an associated risk of fatal overdose due to respiratory depression. It documents that the fentanyl patch is indicated for the management of persistent moderate to severe chronic pain that requires continuous around-the-clock opioid (narcotic pain relievers derived from or having the pain relieving action of opium) administration for an extended period of time and that cannot be managed by other pain medications such as non-steroidal antiinflammatory medications which include ibuprofen (Motrin), combinations of acetaminophen and opiates such as Vicodin and Percocet, or pure opiates such as morphine. It documents that use of this patch to treat patients who are not opioid-tolerant is contraindicated because serious or life-threatening respiratory depression can occur. It documents that it should only be used in patients who are opioid-tolerant which is defined in the boxed warning as those patients who have taken at least 60 mg of oral morphine, 30 mg of oral oxycodone, or 8 mg of oral hydromorphone (opiate medications used to treat pain) daily for a week or longer or an equianalgesic dose of another opiate medication. It documents that a patient who has taken the equivalent of 60 mg of oral morphine for seven days can use a 25 mcg/hr fentanyl patch. There is no indication in the product labeling for initiation of therapy with a 12 mcg patch (which is an available dosage form to bridge dosage increases between the 25, 50, 75, and 100 mcg/hr patches based on supplemental immediate release narcotic use).

On 10/8/2010 at 11:53 p.m. a review of Patient 404's clinical record indicated that the patient was admitted on 8/30/2010 at 1:31 p.m. A review of the Home Medication List in the clinical record indicated it did not document that Patient 404 took opioid pain control medications at home.

On 8/30/2010 at 5 p.m. a physician ordered that Patient 404 receive Dilaudid 0.5 mg IV push every 3 hours as needed for pain, Darvocet N-100 1 to 2 capsules every 4 hours as needed for pain, and a B&O (belladonna and opium) suppository 1 rectally every 24 hours as needed for sever bladder spasm.

On 9/1/2010 at 7:25 a.m. a physician ordered a Duragesic 12.5 mcg patch be placed on Patient 404.

On 9/1/2010 at 11:09 a.m. a pharmacist ordered Roxanol 5 mg orally every 2 hours as needed for pain subsequent to a physician's order of Roxanol per pharmacy ordered by a physician on 9/1/2010 at 10:55 a.m.

A review of the medication administration records (MARs: used by nurses to accurately medicate their patients and to document the date and time a dose of medication was administered) in Patient 404's clinical record revealed that Patient 404 received the following controlled drugs up to the time that the fentanyl patch was placed on Patient 404 at 5:20 p.m. on 9/1/2010:

Dilaudid IV: 0.5 mg at 7:30 a.m. on 8/31/2010

Roxanol oral solution: 5 mg at 11:25 a.m. on 9/1/2010

Fentanyl IV 25 mcg at 5:28 p.m., 5:50 p.m., and 8:20 p.m. on 8/30/2010 plus two 50 mcg doses intra-operatively on 8/30/2010 for at total daily dose of 175 mcg on 8/30/2010 (this information was taken from the "Post-Anesthesia Care Unit Record" and the "Anesthesia Record" respectively).

B&O (belladonna and opium) suppository: one per rectum at 5:46 p.m. on 8/30/2010.

Converting these medications to oral morphine doses, Patient 404 received a total of 20 mg of oral morphine on 8/30/2010 and 5 mg of oral morphine on 9/1/2010 before the Duragesic patch was placed on Patient 404 (there are no conversion tables for injectable fentanyl to oral morphine or for the opium in the B&O suppository to oral morphine).

The patient was not opioid tolerant as defined in the product labeling when the Duragesic patch was placed on Patient 404.

On 10/8/2010 at 1:55 p.m. during an interview of Pharmacy Staff MM she state she was the pharmacist who entered the fentanyl patch order into Patient 404's computerized pharmacy patient medication profile on 9/1/2010 at 8:49 a.m. The surveyor verified this by reviewing Patient 404' s computerized pharmacy patient medication profile. She stated it was her habit to check the opioid tolerant status of patients for whom a physician has written a fentanyl patch order. She had done this for Patient 404 and realized the patient did not meet the product labeling requirements for opioid tolerance which she identified as taking 60 mg of oral morphine daily for 7 days. Pharmacy Staff MM stated she dispensed the fentanyl patch for Patient 404 because the order was for a 12 mcg/hr patch and because the patient would be a hospice patient when the patient went home. She state there was no hospital policy regarding the issue of prescribing and dispensing fentanyl patches.

At this time Administrative Staff PP was asked for any policy and procedures regarding black box warnings. At 12:33 p.m. on 10/8/2010, she produced a Policy and Procedure PHM IV.B.15 entitled "Drug Warnings" which outlined a general process for sending black box warnings to the Medical Executive Committee for "appropriate action" but it did not provide any specific guidance for staff regarding the use of drugs with black box warnings and specifically nothing was available regarding the use of fentanyl patches.

The hospital did not provide any evidence it had a process in place to ensure the safe use of fentanyl patches in patient admitted to the hospital.

2. On 10/8/2010 at 11:53 a.m. a review of Patient 404's clinical record indicated that on 9/1/2010 at 11:09 a.m. a pharmacist, Pharmacy Staff MM, ordered Roxanol 5 mg orally every 2 hours as needed for pain "for Dr. (Physician NNN)" secondary to an order of "Roxanol per pharmacy" ordered via a telephone order by Physician NNN on 9/1/2010 at 10:55 a.m. The patient received one 5 mg dose at 11:25 a.m. on 9/1/2010. The physician countersigned this order but it was not clear if he did so on 9/1 or 9/22/2010. It was not clear if he countersigned the order before the first dose was given.

On 10/8/2010 at 1:55 p.m. during an interview of Pharmacy Staff MM she stated that when a physician wrote an order "per pharmacy" for pain medication, she would research what the patient taking and the convert it to the new requested drug at an equivalent dose. She pointed out Patient 404 had an order for Dilaudid 0.5 mg IV every 3 hours as needed for severe pain and she converted that to the Roxanol order using a conversion table available in the pharmacy. She stated she received no training from the hospital to do this and she said there was no hospital approved protocol to do this. She did not feel that the Pharmacy and Therapeutic (P&T) Committee approved the conversion table that was available in the pharmacy.

On 10/8/2010 at 2:40 p.m. during an interview of Administrative Staff PP, she stated that there was no hospital approved policy and procedure allowing pharmacists to write orders for pain medications using conversion tables available in the pharmacy.

3. On 10/6/2010 at 1:39 p.m., during an interview of Administrative Staff PP she stated that the pharmacy was open between 6:30 a.m. and 9 p.m. Monday through Friday and 7 a.m. to 6 p.m. on Saturday and Sunday. She stated that nurses could obtain medications from the night locker via the night nursing supervisor. She also stated that a pharmacist was on-call each night. A review of Policy and Procedure PCM VI.B.5 entitled "Pharmacy Night Locker" at this time indicated it did not establish the list of medications stored in the night locker. California Code of Regulations Title 22, Section 70263(c)(1) stipulates that the P&T Committee must develop written policies establishing safe and effective systems for the distribution and dispensing of drugs and Title 22, Section 70263(n) stipulates that the hospital would establish a supply of medications which is accessible without entering the pharmacy when the pharmacy is closed. It would be expected that the P&T Committee would approve the medications to be stored in the after hours locker and that this list would be part of any policy the hospital established.

On 10/6/2010 at 1:53 p.m., an inspection of the night locker on the third floor indicated that it contained one 500 ml IV bag of 3% sodium chloride. There were no special warnings or direction to staff with this bag. It also contained four 2 ml vials of 50% magnesium sulfate. The bin had a label that stipulated "Must be diluted prior to use".

The Institute for Safe Medical Practices (ISMP), a nationally recognized organization that promotes safe medical practices with the aim to reduce medication errors and medication adverse outcomes, has placed both of these medications on it "High Alert" list of medications due to adverse outcomes associated with these medications. Administrative Staff PP was able to access this list electronically during the inspection of the night locker. She stated at this time she did not feel the concentrated 3% sodium chloride IV bag should be in the Night Locker and she removed it at that time. She did not know why the magnesium vials were in the locker as it also contained pre-mixed IVPB bags of magnesium sulfate that would not be given IV push inadvertently.

On 10/7/2010 at 1:04 p.m., during an interview of Pharmacy Staff EE in the pharmacy, she stated that the vials of 50% magnesium sulfate for injection were placed in the night locker prior to the availability of the pre-mixed IVPB bags of magnesium sulfate and the vials were never pulled.

4. On 10/6/2010 at 09:48 a.m., Licensed Staff O passed medications to Patient 402. DynaCirc, used to treat high blood pressure, was not among these medications. On 10/6/2010 at 10:06 a.m. a review of Patient 402's clinical record indicated that Patient 402 was admitted to the facility on 10/5/2010 and on the same day at 4:05 a.m. a physician ordered DynaCirc CR 10 mg orally daily. During an interview of Staff O at this time, she said she had told the physician that DynaCirc was not on the hospital formulary on the morning of 10/6/2010 but he had not given her an answer. A review of the MAR indicated that on 10/5/2010, staff had not administered the DynaCirc at 9 a.m. as the medication was not in the drawer and at 9 p.m. on 10/5/2010, the DynaCirc was still not available. As the patient did not receive any DynaCirc on the morning of 10/6/2010 27.75 hours had passed since the order was written and the patient had still not had this issue addressed.

On 10/6/2010 at 11:45 a.m. a review of Policy and Procedure PHM 1.4 entitled "Formulary, Hospital" (written 8/1984 and revised 11/2003) indicated that it stipulated a physician could order a non-formulary medication but he would have to fill out a Non-formulary Drug Request Form. Administrative Staff PP could provide no evidence that such a form was filled out. During an interview of Administrative Staff PP at that time, she stated that if a non-formulary drug was ordered and not available in the pharmacy, pharmacy staff would be expected to call the doctor to obtain a substitute medication. No evidence was provided that this was done. No such procedure was outlined in the policy and Administrative Staff PP was not able to find any other policy regarding this issue.

5. On 10/7/10 at 10:50 p.m. a review of Patient 405's clinical record indicated it contained a "Home Medication Review and Order Sheet" that contained orders for Plavix (used to prevent blood clots), Sinemet (used to treat Parkinson's disease) and AcipHex (used to lower stomach acid). The sheet had columns for the physician to check if he wanted to continue or discontinue these home medications as well as an area for the physician to sign and date these orders. The columns and signature areas were blank. A review of the patient's current hospital record indicated that Patient 405 was not currently on these three medications.

On 10/7/2010 at 12:41 p.m. a review of Policy and Procedure PCM IV.B.2 entitled "Medication Reconciliation" (written 10,/2005 and revised 1/ 2007) indicated it stipulated: "The physician is responsible for reviewing the Home Medications Review and Order Sheet as soon as possible following patient admission and prior to ordering hospital mediations ....If the physician reviews the Home Medications Review and Order Sheet in the medical record, he/she can check the 'Continue' or 'Stop' box to indicate hospital orders. If the physician reviews the form on-line, he/she will need to write orders on the physician order sheet." It further stipulated: "A licensed Pharmacist is responsible for reviewing the home medications for each patient admitted to the hospital ...In the event there is any need for clarification related to medication orders ...the Pharmacist will follow hospital procedure for clarifying orders with the ordering physician."

During an interview of Administrative Staff PP at that time she stated she could not find a copy of Patient 405's Home Medications Review and Order Sheet in the pharmacy.

No evidence was provided that the physician reviewed this sheet as stipulated by hospital policy and procedure and no evidence was provided that the pharmacy contacted the physician to clarify this issue. The current policy did not ensure that the physician had reviewed these orders for inclusion or exclusion from the hospital drug regimen and that the pharmacist had followed up on this sheet.

6. On 10/6/2010 at 2:43 p.m. a review of Policy and Procedure PCM VI.A.8 entitled "Stop Orders/Dates" (written 1/1986 and revised 2/2001) indicated it provided for a seven day stop period for oncology drugs (used to treat cancer and which can have significant toxicity on bone marrow and other organs). During an interview of Administrative Staff PP at that time she stated that oncology orders were entered as one time orders unless a physician specified a specific duration of therapy. The policy did not match the actual practice in the hospital regarding these drugs.

7. Laminar air flow hoods are used to compound IV solutions for patient use in a clean environment. A high efficiency particulate air (HEPA) filter is used to clean dust out of the air that is then blown into the hood which bathes any item in the hood in clean air without dust particles (which could contaminate IV solutions with bacteria). The interior of the hood is commonly cleaned with water to remove any spilled substances or dust in the hood and is then sanitized with an alcohol solution.

On 10/4/2010 at 1:53 p.m. during an inspection of the IV Room (a place in the pharmacy were IV solutions for patient use are compounded) a 500 ml plastic pour bottle of sterile water for irrigation was observed sitting on top of a shelf above the laminar air flow hood in which pharmacy staff manufactured IV solutions for patient use. It had the hand written date "9/28" written on the front label. During an interview of Staff CC at this time he stated it was pharmacy procedure for staff to date this bottle when it was opened and to use it to wash out the laminar flow IV hood (followed by an alcohol wash) at the beginning of the shift. He said it was a pharmacy procedure to throw out the opened bottle at the end of the shift on the same day that it was opened.

On 10/4/2010 at 2:20 p.m. a review of policy and procedure PHM.VI.3 entitled "Laminar Flow Hood" (Written 12/88 and revised 11/03) indicated it stipulated that staff were to clean the work surfaces of the hood with sterile water for irrigation followed by a wipe-down with 70% isopropyl alcohol. It stipulated that the surfaces to be cleaned included the "...workstation surface, Plexiglas and panels, ceiling and HEPA (high efficiency particulate air) filter protective grid ..."

During an interview of Pharmacy Staff Members DD, EE, and FF at this time they said the following:

Pharmacy Staff DD stated she was trained by other technicians 6 years ago and was told at that time to use only alcohol, not water, to clean the hood.

Pharmacy Staff EE stated she was taught to use sterile water to clean the Plexiglas walls and to use alcohol to clean the back wall (grid over the HEPA filter), the metal bar in the hood (used to hang IV bags in the hood), and the counter top (workstation surface). She stated she was observed by a pharmacist doing this when she first came to work at the hospital in 1997.

Pharmacy Staff FF stated she had worked in the hospital for six months. She stated she cleaned the ceiling, walls, and countertop in the Laminar Air Flow Hood but not the back wall. She stated she only used alcohol to do this, not the sterile water for irrigation. She stated she was observed by a staff pharmacist doing this procedure when she first came here.

Three out of three interviewed pharmacy technicians did not follow the hospital policy regarding the cleaning of the laminar air flow hood.

8. On 10/5/2010 at 1:41 p.m. an inspection of the MH Cart in the Surgery Department indicated it contained two 5 ml prefilled syringes of lidocaine 20 mg/ml. During an interview of Administrative Staff RR at this time she stated the hospital used AORN guidelines for managing MH at the hospital and she produced a copy of the 2010 AORN guidelines for stocking a MH Cart. A review of the document at this time indicated it recommended that three such syringes be stored in the MH Cart. During an interview of Administrative Staff PP and RR at this time neither of them could give a reason as to why the hospital would not follow the AORN guidelines that the hospital had elected to follow.

9. On 10/5/2010 at 1:41 p.m., a review of the 2010 AORN guidelines for stocking an MH Cart indicated that AORN recommended stocking six units each of 1000 ml and 3 liter bags of NS under refrigeration. During an interview of Administrative Staff RR at this time she stated that she felt there was refrigerated NS in the refrigerator. Inspection of the refrigerator in the Surgery Department indicated that it did not contain any refrigerated NS which would be used to cool a patient with MH in the Surgery Department.

10. On 10/5/2010 at 1:41 p.m., an inspection of the MH Cart in the Surgery Department indicated it contained five IV bags of NS while the MH Cart content list documented it contained three such bags. It contained one 250 ml IV bag of 5% dextrose in water. This item did not appear on the MH Cart content list. It contained one 1000 ml IV bag of 0.45% sodium chloride. This item did not appear on the content list. It is a standard of practice to stock an emergency cart as stipulated on the hospital approved content list. If staff feel items should be added to an emergency supply, these items would need to be approved by the P&T Committee before the item was added to the hospital approved content list and to the emergency supply itself.

11. On 10/7/2010 at 2:35 p.m. an inspection of the MH Cart in the Pavilion Outpatient Surgery Department indicated it contained two 5 ml prefilled syringes of lidocaine 20 mg/ml. During an interview of Administrative Staff RR on 10/5/2010 at 1:41 p.m. in the Surgery Department she stated the hospital used AORN guidelines for stocking the MH Cart. A review of the document at that time indicated it recommended that three such syringes be stored in the MH Cart. During an interview of Administrative Staff PP and RR at that time neither of them could give a reason as to why the hospital would not follow the AORN guidelines that the hospital had elected to follow.

12. On 10/7/2010 at 2:35 p.m., an inspection of the refrigerator in the Pavilion Outpatient Surgery Department indicated it contained four 1000 ml plastic pour bottles of NS (normal saline) labeled for use with the MH Cart in the Pavilion Outpatient Surgery Department. It also contained a vial of regular insulin (used with 50% dextrose in water to lower the elevated potassium serum levels that can occur in an MH case). Inspection of the content list posted outside of the MH Cart in the Pavilion Outpatient Surgery Department indicated neither of these items appeared on the content list. California Code of Regulations, Title 22, Section 70263(f)(2) stipulates that a content list be posted outside the portable container that contains an emergency drug supply. It is a standard of practice that the content list documents all the medication items in the cart (or in this case the refrigerator as the medication needed to be refrigerated and therefore, while part of the emergency supply, could not be located physically in the emergency cart).

13. On 10/7/2010 at 2:52 p.m. a review of Policy and Procedure SUM IV.A.9 entitled "Malignant Hyperthermia" (written 3/2001 and revised September 2005) indicated that it did not establish the contents of the cart. California Code of Regulations, Title 22, Section 70263(f)(1) stipulates that "Written policies and procedures establishing the contents of the (emergency drug) supply ...shall be developed".

14. On 10/7/2010 at 2:35 p.m., an inspection of the Crash Cart in the Pre-Op and Post-0p Area of the Pavilion Surgery Department indicated that it did not have a content list posted outside the cart as required by California Code of Regulations, Title 22, Section 70263(f)(2).

15. On 10/6/10 at 10:20 a.m., observation of the 5 th floor Crash Cart labeled Crash Cart 4 was observed and did not have a content list of the medications or supplies which were to be included on the cart. At 10:55 Licensed Staff O stated there was supposed to a medication list of the medication directly taped on the inside medication drawer. He did not know why the list was not included in the cart.

At 10:55 Licensed Staff P stated a list or the crash cart contents should be on the top of the cart so that anyone that used the cart had immediate access to the list (which would have met the requirements of California Code of Regulations, Title 22, Section 70263(f)(2)).






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2. On 10/6/10 at 10:20 a.m., observation of the 5th floor crash cart (movable cart with supplies and medications used in an emergency situation) labeled Crash Cart 4 was observed and did not have a content list of the medications or supplies which were to be included on the cart. At 10:55 Staff O stated there was supposed to a medication list of the medication directly taped on the inside medication drawer. He did not know why the list was not included in the cart.

At 10:55 Staff P stated a list or the crash cart contents should be on the top of the cart so that anyone that used the cart had immediate access to the list.

Based on observation of nursing stations on the fourth and fifth floor, and the pharmacy and interview of hospital staff, the hospital failed to ensure that all medications were in a secure area such that they were not available to unlicensed staff or the public.

Findings:

On 10/4/2010 at 11:07 a.m., an inspection of Nursing Station 5B revealed eighteen 30 ml of bacteriostatic water for injection were stored openly on a shelf and one 3 ml vial of Humalog Insulin 100 units/ml was stored in an unlocked refrigerator. During an interview of Licensed Staff NN at this time (she was the only nurse in that nursing station) she said if she left to do patient care the station would be open (the doors to the station would not be closed).

On 10/4/2010 at 11:20 a.m., an inspection of Nursing Station 5A indicated the door to the station was open and there was no staff in the station at that time. Twenty-nine 30 ml vials of bacteriostatic NS for injection were on a countertop. An open locker with an unlocked roll-away door contained 3 ml, 5 ml, and 10 ml syringes. An unlocked refrigerator contained one 10 ml vial of Lantus Insulin (a long acting insulin used to control blood sugar levels in diabetic patients), one 3 ml vial of Humulin R insulin (a short acting insulin), and eight 1 ml vials of lorazepam 2 mg/ml (a controlled substance used to treat seizures and agitated patients). The nursing station remained empty for nine minutes at which time two nurses entered the station. The above mentioned medications were not secured.

On 10/5/2010 at 12:48 p.m., while standing in the hallway outside the pharmacy, the surveyor was able to reach through the pharmacy window and pick up a vial of folic acid 5 mg/ml for injection that was lying on the counter on the pharmacy side of the window. This would have been available to any person passing the window. There were staff in the pharmacy but they were not looking at the counter area at that time.

On 10/6/2010 at 11:38 a.m., while standing in the hallway outside the pharmacy, the surveyor was able to reach through the pharmacy window and pick up one out of four syringes of influenza virus vaccine that was lying on the counter on the pharmacy side of the window. This would have been available to any person passing the window.

On 10/6/2010 at 9:34 a.m., the surveyor observed a 30 ml unit dose cup of Milk of Magnesia (a laxative) on top a medication cart in Nursing Station 4 D and an IVPB bag of levofloxacin 50 mg (an antibiotic) in 100 ml of 5% dextrose in water for Patient 402 on the Nursing Station 4 D counter. The nursing station was open to the hallway and was empty of staff until 9:40 a.m.

On 10/7/2010 at 4:15 p.m. during an inspection of the Emergency Department (ED) the surveyor observed one 60 ml bottle of diphenhydramine 12.5 mg/5 ml solution for oral administration (an antihistamine used to treat the symptoms of allergies) lying on top of a medication cart in an open hallway area that would be accessible to patients and visitors of patients in the ED.

Based on inspection of Nursing Station 5A and staff interview, the hospital failed to ensure that controlled drugs were kept in a locked storage area.

Findings:

On 10/4/2010 at 11:20 a.m. an inspection of Nursing Station 5A indicated the door to the station was open and there was no staff in the station at that time. An unlocked (it had a hasp and an open padlock) refrigerator contained eight 1 ml vials of lorazepam 2 mg/ml (a controlled substance used to treat seizures and agitated patients). A hasp is a latch consisting of a metal plate with a slot through which a ring attached to a door can pass. The plate is closed over the ring and the clasp of the padlock is placed through the ring which secures the door when the padlock is locked. The nursing station remained empty for nine minutes at which time two nurses entered the station. The above mentioned medications were not secured. During an interview of Licensed Staff OO at that time she stated she did not have a key to the padlock used to lock the refrigerator.

Based on inspection of the Surgery Department Warmers, the PACU Warmers, The Red Medication Cart and the Anesthesia Cart in Operating Room # 3 (the Heart Room) and staff interview, the hospital failed to ensure that medications were stored at temperatures stipulated by the manufacturer, that medications with shortened shelf lives at elevated temperatures were removed at the end of the stipulated storage period, or failed to ensure that they were dated per hospital procedure or tracked by another method so that they could be removed from active stock for patient use when the shortened shelf life was reached, and failed to ensure that all dates applied to medication containers were accurate which resulted in expired, mis-labeled or otherwise unusable drugs were available for patient use.

Findings:

1. On 10/5/2010 at 2:51 p.m., inspection of two warmers in the Surgery Department indicated that each had two compartments. An inspection of the lower compartment of one of these two warmers (the D compartment) indicated it contained 1000 ml IV bags of lactated ringers (used for electrolyte replenishment) and NS manufactured by Baxter. The temperature gauge for that compartment indicated the internal temperature was 105 degrees Fahrenheit. On 10/7/2010 at 2:13 p.m., Administrative Staff PP provided a letter from Baxter regarding storage of Baxter solutions at elevated temperatures. Baxter stipulated that one could store 1000 ml IV bags not to exceed 104 degrees Fahrenheit for 14 days. Baxter stipulated in the letter that "No extrapolation on temperatures and times can be supported by Baxter." As these bags were stored outside of manufacturer's guidelines, it was not possible to tell if they were still within the stated shelf life at elevated temperatures and therefore they would be considered unusable for patients in the hospital.

2. On 10/5/2010 at 2:51 p.m., inspection of two warmers in the Surgery Department indicated that each had two compartments. An inspection of the lower compartment of one of these two warmers (the D compartment) indicated it contained forty-five 50 ml vials of 25% Mannitol for injection manufactured by Hospira. Also, four vials of this same product were stored on a hot plate in Operating Room #3 and were hot to the touch. The label on the vials documented that the solution could be warmed to 80 degrees Centigrade to dissolve crystals that could form in the solution. The FDA approved product labeling for this product also documents that this product can be autoclaved at 121 degrees Centigrade for 20 minutes at a pressure of 15 pounds/square inch but provides no guidance for continuous storage at temperatures greater that 25 degrees Centigrade.

During an interview of Administrative Staff PP at that time, she stated she did not know if there was a limit to storage at elevated temperatures. By the end of the survey, no evidence was presented to support continuous storage of Mannitol at elevated temperatures. Therefore, these medications were unusable for the patients in the hospital.

3. On 10/25/2010 an inspection of the Red Medication Cart in Operating Room #3 (identified as the "Heart Room" by staff) indicated it contained five IVPB bags of milrinone 20 mg in 100 ml of 5% dextrose manufactured by Baxter. Four were sealed in a foil overwrap and one had been taken out of the overwrap. This cart also contained one 100 ml and one 250 ml Viaflex (Trademark) IVPB bag of NS outside of the plastic overwrap that the manufacturer provided to maintain stability of the solution until the expiration date printed on the IVPB bag. Administrative Staff PP and Licensed Staff GG could not say how long these medications were out of the overwrap containers. Baxter has documented that this milrinone product will remain stable for 30 days at a temperature of 77 degrees Fahrenheit when removed from the overwrap. Baxter has documented that the IVPBs in the Viaflex (Trademark) containers of 100 ml or greater are stable for 30 days outside the overwrap at a temperature not to exceed 75 degrees Fahrenheit. As there was no system available that staff could use to determine how long these medications had been out of the protective overwraps it was not possible to tell if they had exceeded the shortened shelf lives these products have been documented to have outside the overwrap. Therefore, these solutions were not usable for the patients in the hospital.

4. On 10/5/2010, an inspection of the single warmer in the PACU indicated the bottom compartment temperature was 105 degrees Fahrenheit and it contained the following solutions:

It contained sixteen 3000 ml Uromatic (Trademark) containers of 3% Sorbitol Urologic Irrigation Solution. None of these containers were dated.

It contained ten 3000 ml Uromatic (Trademark) containers of NS for irrigation. None of these containers were dated.

It contained nine 3000 ml Uromatic (Trademark) containers of sterile water for irrigation. None of these containers were dated.

It contained eight 3000 ml Uromatic (Trademark) containers of 3% Sorbitol Urologic Irrigation Solution dated 9/15/2010.

It contained two 3000 ml Uromatic (Trademark) containers of NS and one 3000ml Uromatic (Trademark) containers of 3% Sorbitol Urologic Irrigation Solution that were not in "overpouches" (plastic sleeves surrounding the solutions that limit evaporation of water from the container).

During an interview of Licensed Staff GG at this time she stated that the dates on the dated bags were the dates the bags were put into the warmer.

On 10/7/2010 at 2:13 p.m. Administrative Staff PP provided a letter from Baxter regarding storage of Baxter solutions at elevated temperatures. Baxter stipulated that one could store Uromatic (Trademark) irrigation solutions at 113 degrees Fahrenheit for 14 days. It stipulated that the guidelines applied to solutions in the "overpouches".

It was not possible to tell how long the undated bags had been in the warmer and therefore they were not usable for the patients in the hospital. The bags dated 9/15/2010 were 6 days past the 14 day limit set by the manufacturer and therefore were expired. There were no guidelines provided by the manufacturer for storage of Uromatic (Trademark) solutions outside the "overpouches" so these were unusable for the patients in the hospital.

5. On 10/7/2010 at 2:56 p.m., during an inspection of the single warmer in the Pre-Op and Post-0p Area of the Pavilion Surgery Department the surveyor observed two 1000 ml IV bags of lactated ringers manufactured by Baxter stored in the upper compartment of this warmer. The temperature gauge for that compartment indicated the internal temperature was 105 degrees Fahrenheit. On 10/7/2010 at 2:13 p.m. Administrative Staff PP provided a letter from Baxter regarding storage of Baxter solutions at elevated temperatures. Baxter stipulated that one could store 1000 ml IV bags not to exceed 104 degrees Fahrenheit for 14 days. Baxter stipulated in the letter that "No extrapolation on temperatures and times can be supported by Baxter." As these bags were stored outside of manufacturer's guidelines, it was not possible to tell if they were still within the stated shelf life at elevated temperatures and therefore they would be considered unusable for patients in the hospital.

6. On 10/5/2010 an inspection of the Operating Room #3 Anesthesia Cart indicated it contained one open vial of Quelicin (Hospira brand of succinylcholine) dated "10/6" and one syringe labeled "succinylcholine 20 mg/ml" dated "10/6". During an interview of Licensed Staff GG at this time, she stated that the vial was supposed to be dated with the date it was opened and for the syringe it was supposed to be dated with the date it was drawn up. Both items were mis-labeled with respect to the dates.

Based on review of a policy and procedure and interview of two staff members, the hospital failed to develop a system that would ensure that medications would be discontinued after a reasonable time established by the medical staff and the policy did not apply to all classes of drugs with the potential for a medication regimen to be continued longer than necessary for the benefit of the patient and potentially with a harmful outcome secondary to the prolonged use of a medication.

Findings:

On 10/6/2010 at 2:43 p.m., a review of Policy and Procedure PCM VI.A.8 entitled "Stop Orders/Dates" (written 1/1986 and revised 2/2001) indicated it did not provide a process to contact the physician when the stop date approached except for the placement of a written report (that was automatically generated by the pharmacy computerized patient profile system) in the clinical record requesting that he renew or discontinue the listed orders. Furthermore it did not provide for all classes of medications. It only provided stop dates for antibiotics, hypnotics (sleeping medications), narcotics, oncology drugs (for treatment of cancer), and anticoagulants (blood thinners).

During an interview of Pharmacy Staff HH at that time he stated that the stop orders were generated automatically 24 hours before the medications were to be stopped. He stated each report was patient specific and listed medications that were due to be renewed for that patient and the reports provided prompts for the physician to renew or discontinue the medication or to continue it for a period of time specified by the physician. He stated that these were "soft stops" in that the order would not automatically stop in the computer without staff intervention based upon receipt of a returned report filled out by the physician. Administrative Staff PP stated at this time that there was no way to track these reports after they left the pharmacy and if the physician did not respond, under the present system in place in the pharmacy, the pharmacy staff would not know if these stop orders were still outstanding.

On 10/7/2010 at 1:04 p.m., during an interview of Administrative Staff PP in the pharmacy, she stated that the "soft-stops" would continue until the patient was discharged or until staff entered a "hard stop" into the computerized patient profile.

Based on observation, interview and document review the hospital failed to ensure that dietary services met the needs of all patients as evidenced by failure to:

1. Provide organized dietetic services as evidenced by findings of unsafe food handling practices and supervision of the dietary department (Cross Reference A620).

2. Ensure the availability of organized dietary services that are directed and staffed by adequate qualified personnel (Cross Reference A622).

3. Ensure comprehensive disaster planning (Cross Reference A701)


4. Develop performance improvement activities that reflected the scope and nature of the services (Cross Reference A264).

5. Ensure safe and effective food production practices (Cross Reference A749)

6. Ensure the development of comprehensive policies and procedures that reflected the scope and nature of services (Cross Reference A749)

The cumulative effect of these systemic problems resulted in the hospitals inability to ensure that the nutritional needs of the patients are met in accordance with the Condition of Participation for Food and Dietetic Services.

Based on dietetic services observations, dietary staff interview and dietary document review the hospital failed to ensure that dietary management staff effectively managed the day to day operations of the department as evidenced by; 1. lack of implementation of an effective system to monitor the cool down of potentially hazardous foods; 2. lack of training for dietary with respect to proper procedure for taking food temperatures; 3. lack of an effective system to ensure proper labeling/dating of stored foods; 4. storage of expired foods and 5. unclean food production equipment and kitchen areas. Failure of the department to develop, implement and maintain safe food handling practices may result in further compromising patients' medical status.

Findings:

1. During general kitchen observation on 10/4/10 beginning at 11:15 am, it was noted that in the blast chiller (a refrigeration unit) there was an unlabeled/undated pan, covered with plastic wrap. The item was identified by Dietary Staff JJJ as polenta. In a concurrent interview Dietary Staff JJJ stated that the item was cooked earlier in the day. He further stated that the item would be used for the evening meal as part of cafeteria food services. Polenta is considered to be a potentially hazardous food (PHF). PHF's are foods that are capable of supporting the growth of bacteria associated with foodborne illness (Food Code, 2009). The surveyor asked him to describe how he ensured the foods were safe to be used at a later time. He responded that after a "few hours" in the chiller, he would label and date the item and move it into the walk-in refrigerator. The surveyor asked if there were any other steps that would be taken. He replied "no."

On 10/4/10 at 1:30 p.m., the surveyor attempted to take another temperature. It was noted that the item was missing from the chiller. In a concurrent interview with Dietary Management Staff J she stated that the item was tossed because dietary staff took the temperature at 1 pm, and noted that the temperature was 80°F, which was out of the desired temperature range. Dietary Management Staff J also acknowledged the department did not have a system to monitor the cool down of potentially hazardous foods. The standard of practice for cooling PHF's would be to cool to 70°F within 2 hours and to 41°F, or below within an additional 4 hours (Food Code, 2009).

In an interview on 10/4/10 at 1:45 p.m., Dietary Management Staff I confirmed that the chiller was put back into service during the last 2-3 months.

Review on 10/5/10 at 3 p.m., of dietary staff meeting dated 9/17/10, revealed that while department management staff discussed utilization of the chiller the minutes also noted that supervisory staff "will do an in-service regarding the chiller in near future." It was also noted that while cafeteria staff were provided guidance for checking cafeteria foods, there was no training provided on the handling of PHF foods which were cooked and held for service at a later time. Additionally, It was also noted that while dietary staff were provided training on safe food temperatures, Dietary Staff JJJ was not in attendance.

2. During general food production observations on 10/4/10 at 11:30 a.m., Dietary Staff III was observed removing cooked chicken from the oven. The surveyor asked how she knew the meat was done. She stated the chicken would be done when it reached 165°F. Dietary Staff III was observed taking temperatures with a dial thermometer on single chicken breast which was approximately ½" thick. The temperature was noted to be 120°F. In a concurrent interview with DS III she stated this was her usual temperature taking method.

Dial thermometers have an indentation or a "dimple" on the stem of the thermometer, which designates the end location of the sensing device. In order to obtain an accurate reading the thermometer must penetrate the food 2-3 inches, significantly more than the observed ½" depth of the chicken breast (foodsafety.com, 2010).

Dietary department in-service record dated 9/17/10, revealed that while Dietary Staff III received training on checking food temperatures, the training did not discuss the limitations of a dial thermometer.

3. During initial tour on 10/4/10 beginning at 10:15 am, the following was noted: In the dry storage area there was pasta and spaghetti noodles that were unsealed and goldfish crackers that were opened, undated. In the walk-in freezer there were mixed vegetables, green beans and carrots that were opened and undated. It was also noted there were ice crystals on the green beans. In the walk-in refrigerator there was mozzarella cheese, opened and undated. It was also noted that dietary staff was storing the chemical sanitizer on food production work surfaces.

In a concurrent interview with Dietary Management Staff I he stated that it would be the standard of practice within the department to label/date items that were opened. He also acknowledged that the chemical sanitizer should have been stored away from food production areas.



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4. On 10/4/10 beginning at 10:15 a.m., in the reach-in refrigerator #014 there were 8 individual potato salads with "use by" date 10/3. Facility policy "Dating Refrigerated/Frozen Foods" revised 01/01, specified freshly prepared salads would be discarded after three days.

On 10/4/10 at 10:20 a.m., the reach-in cafeteria refrigerator had 2.5 pounds opened, original container of Dr. Smoothie Doctor's Garden Nutritional supplement, dated 7/6 and one pitcher hand-labeled "Dr. Smoothie Northwest Berry Smoothie Concentrate," dated 6/19. The Garden supplement did not have manufacturer's expiration date. Dietary Management Staff J stated "I don't know how long those last." Facility policy "Dating Refrigerated/Frozen Foods" revealed "If manufacturer's "Use By" date is not visible on the carton, the written instructions will be kept on file in the department." Facility was unable to provide instructions for product use.

5. On 10/4/10 at 10:25 a.m., in the 4-door refrigerator, the door gasket was observed to have approximately 1/8 inch of fluffy gray material that coated the top of the gasket and food debris/slimy wet deposits coated the sides of the gasket at the open door end, and the shelving in the cooks area was observed to be coated with gray debris and black slimy flecks and sticky to touch.

In an interview with Dietary Management Staff I on 10/5/10 at 9 a.m., he was asked to describe the system to ensure that kitchen areas and equipment remained clean he stated that the department gave guidance to cooks on which equipment to clean when they had the opportunity. He further stated that on 9/3/10, he assigned different pieces of equipment to each of the cooks after conducting a kitchen tour with Dietary Management Staff J. Concurrent review of the departmental document dated 9/23/10, and titled "Cooks cleaning list to be done by 9/23/10" revealed that the only areas listed included the steam kettles, shelf under the spices, counter tops, tool drawers, splash wall behind stove and ovens. There were no other areas/equipment listed.

Facility policy Food Contamination, Avoiding, specified "All employees are to follow a "clean as you go" work policy.

Based on food service observations, dietary staff interview and dietary document review, the hospital failed to ensure staff competency as evidenced by 1) lack of staff training on the principles of monitoring of potentially hazardous foods during the cool down process, and 2) effective training and competency evaluation on the effective use of the blast chiller (refrigeration unit) and food measuring devices.

Findings:

1. During general kitchen observation on 10/4/10 beginning at 11:15 am, it was noted that in the blast chiller there was an unlabeled/undated pan, covered with plastic wrap. The item was identified by Dietary Staff JJJ as polenta. In a concurrent interview Dietary Staff JJJ stated that the item was cooked earlier in the day, he further stated that the item would be used for the evening meal as part of cafeteria food services. Polenta is considered to be a potentially hazardous food (PHF). PHF ' s are foods that are capable of supporting the growth of bacteria associated with foodborne illness (Food Code, 2009). The surveyor also asked him to describe how he ensured the foods were safe to be used at a later time. He responded that after a "few hours " in the blast chiller, he would label and date the item and move it into the walk-in refrigerator. The surveyor asked if there were any other steps that would be taken. He replied there were not.

On 10/4/10 at 1:30 pm, the surveyor attempted to take another temperature. It was noted that the item was missing from the blast chiller. In a concurrent interview with Dietary Management Staff J she stated that the item was discarded. She further stated that dietary staff took the temperature at 1 pm, and noted that the temperature of the item was 80°F which was out of the desired temperature range. Dietary Management Staff J also acknowledged the department did not have a system to monitor the cool down of potentially hazardous foods.

In an interview on 10/4/10 at 1:45 pm, Dietary Management Staff I stated that the blast chiller was recently put back into service.

Review on 10/5/10 at 10 am, of the Nutritional Services departmental manuals, dated July 2010, revealed that there were no policies or procedures related to the cool down of PHF ' s.

Review on 10/5/10 at 3 pm, of hospital training document for the 9/17/10 departmental meeting revealed that while department management staff noted the implementation of the blast chiller the minutes also noted that supervisory staff " Will do an in-service regarding the chiller in near future. " It was also noted that while cafeteria staff were provided guidance for checking cafeteria foods, there was no training provided for PHF foods which were cooked and held for service at a later time. It was also noted that while dietary staff were provided some training, Dietary Management Staff JJJ was not in attendance.

2. During general food production observations on 10/4/10 at 11:30 am, Dietary Staff III was observed removing chicken form the oven. The surveyor asked how she knew the meat was done. She stated the chicken would be done when it reached 165°F. Dietary Staff III was observed taking temperatures with a dial thermometer on single chicken breast which was approximately ½ " thick. The temperature was noted to be 120°F. In a concurrent interview with Dietary Staff III she stated this was her usual temperature taking method.

Dial thermometers have an indentation or a "dimple" on the stem of the thermometer which designates the end location of the sensing device. In order for an accurate reading the thermometer must penetrate 2-3 inches of the food, significantly more than the observed ½ " depth of the chicken breast (foodsafety.com, 2010).

Dietary department in-service record dated 9/17/10 revealed that while Dietary Staff III received training on checking food temperatures there was no training on limitations of a dial thermometer.

Based on observation, interview and document review, the hospital failed to develop a system to accurately transmit physician diet orders to the dietary department to ensure patients receive the therapeutic diet ordered.

Findings:

Patient 300 had diagnoses including kidney dialysis. On 10/4/10, Patient 300's physician ordered a "renal" diet and a protein supplement three times a day. During review on 10/5/10 at 2 pm, of the physician ordered diets, Patient 300's diet was listed as a 50 gram protein, limited carbohydrate, cardiac diet. Dietary Management Staff JJ stated the diet, which was being provided to the patient, did not accurately reflect the physician's order. Dietary Management Staff JJ stated the diet was ordered by the nurse and needed to be clarified in order to provide the therapeutic diet as ordered by the physician. Dietary Management Staff JJ stated the diet orders were entered into the dietary system manually by nursing and that "sometimes the nurse writes the wrong order."

Based on observation, staff interviews, review of facility documentation, the hospital failed to be arranged and maintained to ensure the safety of patients as evidenced by Life Safety Code violations.

Refer to Life Safety Code violations: K012 - failure to ensure penetrations in walls and ceilings were sealed with fire rated material, K018 - failure to maintain corridor doors free from obstructions to closing and latching in 16 doorways, K021 - failure to provide hold open devices for cross-corridor doors and maintain doors that automatically close upon activation of the fire alarm system, K025- failure to maintain the smoke barrier walls with a one half hour fire resistance rating in accordance with Section 8.3, K027- failure to maintain that cross corridor doors closed and latched during an event of spread of smoke or fire from one compartment to another,K038 - failure to maintain the exit access readily accessible at all times, K046 - failure to provide documentation of the monthly inspections, annual testing of the battery operated emergency lights in the operating and the cysto room, K048 - failure to conduct semi-annual disaster drills in preparation for the evacuation in the event of an emergency, K050 - failure to ensure staff is knowledgeable with procedures and aware of drills in the event of an emergency, K051 - failure to ensure all fire alarm systems were functioning properly and failure to maintain, inspect and certify all fire alarm system devices, K052 - failure to ensure all fire alarm devices were tested annually, K054 - failure to ensure smoke detectors were maintained and not obstructed by storage of items, K062 - failure to maintain sprinkler system in reliable operating condition, K064 - failure to maintain the portable fire extinguishers, K067 - failure to ensure duct work for the heating, ventilation and air conditioning system was maintained in accordance with Section 9.2 and the manufacturer's specifications, K069 - failure to maintain the kitchen hood system, K070 failure to ensure that portable space heaters used in staff offices did not exceed 212 degrees Farenheit, K072 - failure to ensure corridors were maintained and free from obstruction, K076 - failure to ensure oxygen cylinders were stored and maintained in accordance with NFPA 99, K078 - failure to ensure humidity levels that were not maintained equal or greater than 35%, K144 - failure to provide complete records for weekly inspections for the emergency generator, K147 - failure to maintain the electrical utilities and connections in accordance with NFPA 70, NFPA 99 and the National Electrical Code (NEC),

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision for safe care in a physically safe setting and further to deliver statutorily mandated compliance with the Condition of Participation for Physical Environment.

Based on dietary staff interview and dietary document review, the hospital failed to ensure a disaster meal plan that was readily implementable as evidenced by a meal plan that would require extensive food production at levels that were greater than current production activities.

Findings:

During food storage observations on 10/4/10 beginning at 11:15 am, it was noted that in a walk-in freezer in the basement of the hospital there were supplies intended to be used in the event of a disaster. In a concurrent interview with Dietary Management Staff I he stated that there were several hundred pounds of beans, rice, turkey slices and bread.

In a follow up interview and concurrent document review on 10/5/10 at 1:20 pm with Dietary Management Staff I and Dietary Management Staff O the disaster meal planning was reviewed. It was noted that the plan included food production for 800 people, which would be significantly more than the current level of food production. Dietary Management Staff I and Dietary Management Staff O presented a quarterly inventory dated 7/2010. It was noted that the inventory relied heavily on items that would require cooking such as eggs, meat, polenta, rice, spaghetti, oats, and legumes. It was also noted that while the hospital had a menu that guided staff to use the most perishable items first, the frozen items second and the shelf stable items last, there was no detailed plan on how staff would accomplish food preparation for the cooked items if utilities were unavailable.

Dietary Management Staff I and Dietary Management Staff O were asked to describe the types of equipment that was available in the event of a disaster. They stated that the only electrical items available were a convection oven, a household microwave and kettles that were heated with steam. It was also noted that they were unsure of which items would continue to be supplied through the hospitals emergency generator. It was also noted that the July 2010 inventory was missing par levels of items such as oats, peanut butter and dried fruit.

Dietary Management Staff I and Dietary Management Staff O acknowledged that while the hospital planned to feed 800 people, implementation of the plan may be difficult since the plan was to include significantly more meals than the hospital was currently cooking. They also acknowledged that currently the hospital did not serve anywhere near 2400 meals/day and in order to implement this menu the department would need more staff, space and equipment.

Based on observation, staff interview, document review the facility failed to provide a sanitary environment to avoid sources and transmission of infections as evidenced by:

1. Failure to provide safe/effective dietetic services as evidenced by findings of unsafe food handling practices and lack of effective monitoring of potentially hazardous foods that resulted in immediate jeopardy to the health and safety of the patients (Cross Reference A 620 and A 749).

2. Failure to provide a hospital wide infection control program to conduct surveillance and prevent the transmission of infections in the dietary department (Cross Reference A 264 and A 749).

The cumulative effect of this systemic problem resulted in the hospital failure to identify and implement dietary systems and procedures that are necessary to prevent food-borne illness and failed to meet statutorily mandated compliance with the Condition of Participation for Infection Control.

8. On 10/04/10 at 2:00 pm, review of ten physician credentials files, including five initial appointment files and five reappointment files, demonstrated that the files were all absent evidence of tuberculin testing results. Review of the medical staff bylaws, rules and regulations on 10/05/10 at 9:30 am indicated that the application form submitted by the medical staff requires information about physical and mental health status with reference to the specific clinical privileges requested.

On 10/05/10 at 10:00 am, review of the hospital's appointment application form demonstrated that the applicants are asked to attest whether they are suffering from any communicable health condition that could pose any significant health and safety risk to their patients. In interview on 10/06/10 at 10:30 am, Administrative Staff SS stated that the attestation statement is the only requirement with which physician applicants for appointment or reappointment must comply with respect to tuberculosis testing.

Center for Disease Control (CDC) Recommendations and Reports dated December 30, 2005, article titled "Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, 2005" indicated "HCWs [health care workers] refer to all paid and unpaid persons working in health-care settings who have the potential for exposure to M. tuberculosis through air space shared with persons with infectious TB disease. Part time, temporary, contract, and full-time HCWs should be included in TB screening programs. All HCWs who have duties that involve face to face contact with patients with suspected or confirmed TB disease (including transport staff) should be included in a TB screening program." The article lists 46 position titles who should be included in the TB screening program and Physicians (assistant, fellow, resident, or intern) are included in the list.



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6. Beginning on 10/04/10 at 11 a.m., tours of the emergency department (ED) and inpatient units of the hospital was conducted. During the unit tours, nursing staff were asked to describe the hospitals' frequency for disinfecting the glucometers (equipment used to measure patients' blood sugar level). The following responses were noted:

Licensed Staff E, working in the ED stated that the glucometer was cleaned once daily by the night shift and as needed when it was visibly soiled.

Licensed Staff F, working in the Cardio Vascular Unit, stated that the glucometer was cleaned one time each day as a scheduled maintenance by "Bio Med" and in between if it was "too soiled".

Licensed Staff G, working in the Psychiatric Unit stated that the glucometer was cleaned once daily by the night shift and as needed when it was visibly soiled.

Licensed Staff H, working in the Medical/Surgical & Oncology Unit stated that glucometer was cleaned once daily by the night shift.

On 10/06/10 at 2:30 p.m., Infection Control Staff I was interviewed about his training and certification as the hospital's Infection Control Practitioner (ICP). He stated that he was a member of the Association for Professionals in Infection Control and Epidemiology (APIC) and that he kept current with the standards of practice and updates in the area of his expertise. He stated during an earlier interview, on 10/05/10 at 1:45 p.m., that he was not aware of a standard which required the disinfection of glucometers after each patient use.

Review of an article titled, "APIC position paper: Safe injection, infusion, and medication vial practices in health care", published 4/10, in the American Journal Infection Control. On page 171, under the section titled, "Blood glucose monitoring devices" direction was given that: " Assign a glucometer to each individual patient if possible. Clean and disinfect glucometers if they must be shared between multiple patients.... Thoroughly clean all visible soil or organic material (e.g., blood) from the glucometer before disinfection. Disinfect the exterior surfaces of the glucometer after each use following the manufacturer's direction."

On 10/05/10 at 2 p.m., the hospital's 11/09, policy and procedure titled, "Infection Control, Supplies & Equipment, Section E - Glucometers", page 2 was reviewed and revealed steps on how to clean and disinfect glucometers when they were visibly soiled but did not indicate frequency of routine disinfection of the devices.

7. Infection Control Staff I stated during an interview, on 10/06/10 at 1:20 p.m., that the hospital did not conduct periodic monitoring visits to ensure infection control practices were done in accordance with current standards of practice. He stated that he had confirmed this information with the previous ICP (Staff K), who told him that the hospital did not have a previous program which monitored the Positron Emission Tomography (PET) Scan, (an imaging test) mobile unit for potential infection control issues.

Infection Control Staff I said that the hospital did not have a policy which addressed the issue of having an infection control monitoring process for the PET scan unit and produced a policy which referred to Radiology Corporation of America (RCOA), the contracted service that provided the mobile unit, as being responsible for conducting the monitoring infection control practices.

Staff J stated during an interview, on 10/06/10 at 1:40 p.m., that the PET scan mobile service had provided services to the hospital for three years and was utilized for approximately 12 patients each month.



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9. On 10/7/10 at 9:15 a.m., during a medication pass in room number 262, bed 1, Patient 100's intravenous line had two additional access ports which were observed to be on the floor and next to the patient's bed. Upon inquiry, regarding whether or not the ports were supposed to be on the floor, Licensed Staff A stated that the ports were only used when there were no other available ports and maybe the ports should not be on the floor, however he stated the ports are made of a hard substance and stated that staff clean them before they are used.

On 10/7/10 at 11:05 a.m., Licensed Staff M was questioned whether or not intravenous access ports could be resting on the floor. She stated that they should not be on the floor and the nurses should hook them over the pole to prevent contamination from touching the floor.

On 10/7/10, at 12:55 p.m., Infection Control Staff I acknowledged that an intravenous access port should not be touching the floor by shaking his head from side to side. He stated he was not aware of any monitoring of infection control issues, on patient floors, since he had been hired two months ago. The facility's policy and procedure regarding intravenous therapy did not include any information regarding the maintenance of intravenous tubing, while in use.

Review of Infection Control Today article entitled "Preventing Intravenous Catheter-Associated Infections: An UPdate," dated 6/1/2001 indicated "Airborne contaminates settle on injection ports. Intravenous tubing may be inadvertently contaminated when allowed to drape onto the floor or placed next to the patient in bed where urine and fecal incontinence could contaminate access ports or tubing exterior."




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Based on food production observations, dietary staff interview and dietary document review the hospital failed to ensure comprehensive systems to minimize the risk of food borne illness as evidenced by 1) lack of monitoring the cool down of potentially hazardous foods; 2) lack of effective cleaning/sanitation of food production equipment, 3) lack of effective cleaning/sanitation of the ice machine; 4) bare hand contact with ready-to-eat food, and 5) the absence of air gaps in food production equipment.

The inability of the hospital to provide safe/effective dietetic services as evidenced by findings of unsafe food handling practices and lack of effective monitoring of potentially hazardous foods resulted in an immediate jeopardy to the health and safety of the patients (Cross Reference A620 and A749).

The hospital also failed to develop a system for controlling infections by failing to: 6) ensure devices that have potential contact with blood were cleaned and disinfected after each patient use, 7) ensure the Positron Emission Tomography Scan (nuclear medicine imaging technique which produces three dimensional image of functional processes in the body) mobile unit was evaluated on a regular basis, 8) require that medical staff undergo periodic tuberculin testing (Tuberculosis, TB) as evidenced by review of 10 out of 10 physician credential files, none of which had evidence of tuberculin skin testing results, and 9) ensure that an intravenous access port was kept sanitary and off the floor. Facility failures 6),7), and 9) had potential for patient contamination from medical equipment and facility failure 8) had potential for medical staff to acquire tuberculosis and expose patients and staff in the facility.

Findings:

1. During general kitchen observation on 10/4/10 beginning at 11:15 am, it was noted that there was a pan, covered with plastic wrap and identified by Dietary Staff JJJ as polenta in the blast chiller (a type of holding refrigerator which provides critical temperature control.) In a concurrent interview Dietary Staff JJJ stated that the item was cooked earlier in the day, he further stated that the item would be used for the evening meal as part of cafeteria food services. The surveyor also asked him to describe how he ensured the foods were safe to be used at a later time. He responded that after a "few hours" in the blast chiller, he would label and date the item and move it into the walk-in refrigerator. The surveyor asked if there were any other steps that would be taken. He replied there were not.

In an interview on 10/4/10 at 11:20 am, with Dietary Management Staff J the surveyor asked him if patients had access to cafeteria foods. She stated that while patients were discouraged from coming to the cafeteria they may use cafeteria foods to feed patients, in particular if there was a patient that had an extended length of stay and desired variety in their meal choices. The surveyor took the temperature of the item on 10/4/10 at 11:30 am, and noted it to be 150°F.

On 10/4/10 at 1:30 p.m., the surveyor attempted to take another temperature. It was noted that the item was missing from the blast chiller. In a concurrent interview with Dietary Management Staff J she stated that the item was discarded. She further stated that dietary staff took the temperature at 1 pm, and noted that the temperature of the item was 80°F which was out of the desired temperature range. Dietary Management Staff J stated that she assumed responsibility of the department in June 2010 and she identified that the lack of monitoring the cool down of PHF's along with other issues. She also stated she developed a plan of work to address the identified problems. The surveyor asked her to describe the current problems being addressed. She stated the issues were prioritized and the first to be addressed was the holding temperature of hot foods in the cafeteria because there were complaints that the hot foods were not hot enough. She also acknowledged that choosing to implement cafeteria food temperature logs was likely not the most important issue, in terms of food safety. Dietary Management Staff J also acknowledged the department did not have a system to monitor the cool down of potentially hazardous foods. The standard of practice for cooling potentially hazardous foods would be to cool to 70 degrees Farenheit within 2 hours and to 41 degrees Farenheit, or below within an additional 4 hours (Food Code, 2009).

In an interview on 10/4/10 at 1:45 pm, the surveyor asked Dietary Management Staff I if it was the routine of the department to take temperatures of items as they were cooling or if it was taken because they observed the surveyor taking a temperature earlier. He acknowledged that monitoring temperatures during the cool down process was not a standard practice and also stated that he checked the temperature after several hours because he observed the surveyor taking temperatures. The surveyor asked him to describe other menu items that might require cool down monitoring. He stated there were 2-3 items/day such as soups, rice, stews and casseroles that would also require monitoring.

In a follow up interview on 10/4/10 at 1:45 pm, Dietary Management Staff I stated that the blast chiller was put back into service a few months ago. The surveyor asked if the department requested engineering to evaluate the effectiveness of the equipment prior to putting it into service, he replied "no."

In an interview on 10/5/10 at 2 pm, with Dietary Staff JJJ besides polenta he identified an additional 3-6 PHF's each week that would require cool down monitoring.

Review on 10/4/10 at 1:30 pm, of hospital document titled "Nutritional Services Plan of Work" dated 8/30/10, confirmed that the lack of cooling logs was identified. It was also noted that the plan documented an implementation date for all identified problems. The implementation of the cooling logs was to have been completed by 9/3/10.

Review on 10/5/10 at 10 am, of the Nutritional Services departmental manuals, dated July 2010, revealed that there were no policies or procedures related to the cool down of PHF's.

Review on 10/5/10 at 3 pm, of hospital training document for the 9/17/10 departmental meeting revealed that while department management staff noted the implementation of the blast chiller the minutes also noted that supervisory staff "Will do an in-service regarding the chiller in near future."

This resulted in the notification of administrative staff of an Immediate Jeopardy (IJ) situation on 10/4/10 at 4:35 p.m.. The Quality Control Director, Regional Vice President of Patient Care Services and Nutrition Services Director attended this meeting. Administrative staff were notified that the IJ was abated on 10/7/10 at 1:40 p.m. after the hospital removed all previously cooked PHF's from service; began monitoring time/temperature control of PHF's, trained all dietary staff on proper handling of PHF's; implemented and completed competency evaluation of all dietary staff handling PHF's.

2. During initial tour on 10/4/10 beginning at 10:15 am, it was noted that the dietary department had several large kettles that required cleaning in place. In an interview on 10/4/10 at 11:15 a.m., Dietary Staff JJJ was interviewed regarding the cleaning of the kettles. He stated that in between cooked items they would be washed with soap and water and would be rinsed out using the water supply above the kettle. He further stated that on a weekly basis, usually on weekends, the kettles would be washed with soap and water and rinsed with hot water from the steam kettle "if they needed it." The surveyor asked Dietary Staff JJJ how he would determine if the kettles needed it, he replied that rinsing with hot water was usually done on weekends because staff had more time.

Review on 10/5/10 at 10 am, of the Nutritional Services departmental manuals, dated July 2010, revealed that there were no policies or procedures related to cleaning equipment that was too large to be put in the dishwasher or the pot and pan sink.

3. At 11:10 a.m. the facility ice machine was observed to have black debris on the ice bin dispenser chute. Dietary Staff KK stated it was his job to clean the ice machine bin, and "it didn't look clean." He demonstrated he cleaned the ice bin with a scrubber with green back, rinsed with water from a blue hose that was lying with the end on the floor, then dried with a clean towel. He removed the front of the ice cube maker and demonstrated where he cleaned an open area with the scrubber. The area was observed to have a pink residue that could be removed when rubbed with a clean paper towel. He stated facility engineering also did cleaning of the ice machine.

At 11:42 a.m., during an interview, Maintenance Staff III stated he took the ice machine up to the roof and cleaned and sanitized the ice maker bi-annually. He stated he used nickel safe ice machine cleaner to clean the ice maker, and a bleach solution of 10 cc (approximately 1/3 ounce) bleach in a gallon of water to sanitize it.


Review of the facility's ice maker manufacturer's guidance revealed 16 ounces of "Scale Away" or "Lime-Away" was to be diluted in 3 gallons of water and this solution used to de-scale the dish machine. The directions further revealed 1.5 ounces of scale away be diluted in three gallons of water to sanitize. The maintenance man did not follow manufacturer's cleaning and sanitizing guidelines. Additionally the ice machine filters had signage "Clean twice a month". The filters were coated with approximately ¼ inch of gray fluffy dust. Maintenance Staff III stated he cleaned the filters "every time I walk by." He was unable to state how frequently that was.


4. At 11:20 a.m. Dietary Staff KKK was observed preparing a salad of fresh grapes and raw spinach salad and had direct bare hand contact with the grapes and the spinach which she stated were served raw, not cooked. At 11:35, Dietary Staff KKK was again observed cutting raw papaya and slicing the fruit with bare hand contact with the ready to eat food. Facility provided policy "Food Contamination, Avoiding" revised 1/01 which directed "Use equipment or gloves to handle foods, not bare hands."


5. During general kitchen observation on 10/4/10 beginning at 11:40 a.m., it was noted that the sink directly adjacent to the stove did not have an air gap (a separation between the water supply inlet and the flood level rim of the plumbing fixture, preventing backflow of sewage) and was directly connected to the waste water system. In a concurrent interview with Dietary Staff JJJ, the surveyor asked him to describe the types of food production activities the sink was used for. He stated that he used this sink to wash food items prior to cooking. The standard of practice would be to ensure an air gap between the plumbing fixture and food and/or non-food equipment (Food Code, 2009).

On 10/5/10 during an interview at 10:30 a.m., Infection Control Staff I stated the dietary department was invited to attend quarterly infection control meetings and a dietary staff designee had last attended on 12/07/09. Infection Control Staff I stated the dietary department was not monitored in any way by the infection control committee, and was not included in the environment of care rounds. He stated any department could bring up "concerns" at those meetings. Additionally Infection Control Staff I stated he thought "touring dietary would be a good idea" to add to environmental rounds of the committee to ensure prevention of hospital-acquired food-borne illness.