HospitalInspections.org

Based on observation, staff interview, document and policy and procedure review, the Critical Access Hospital (CAH), failed to ensure that the provision of services for Pharmaceutical, Infection Control, and Nutritional Services requirements were met as evidenced by:

1. The CAH failed to ensure that the Pharmacy and Therapeutics Committee developed and/or implemented polices and procedures that would ensure the safe use of the fentanyl transdermal system (also called the fentanyl patch which contains a fentanyl, a potent pain relieving narcotic) and the safe use of droperidol (used to treat nausea), both of which have black box warnings, which are the most serious warning the Food and Drug Administration requires a manufacturer to place in the product labeling. These failures could result in the potential for fatal respiratory events from fentanyl or the potential for fatal heart irregularities from droperidol (See C276).

2. The CAH failed to develop a system for identifying, reporting, investigating, and controlling infections and communicable diseases by failing to ensure:

a. The CAH failed to ensure that newly hired or contact personnel were screened for Mycobacterium tuberculosis (Staff WW, A, P and Q). (See C 278)

b. The CAH failed to ensure that all glucometers (devices used to test a patient's blood sugar) were cleaned after each patient and that lancet holders were disposable. ( see C 278)

c. The CAH failed to ensure that the housekeeping personnel received training and were competent to perform the daily cleaning of rooms of patients who were placed in transmission based precautions (isolation rooms of patients with infectious or communicable diseases), and perform terminal cleaning after the patients discharge (See C 278).

d. The CAH failed to ensure Surgical Services Policy and Procedures were established and implemented. (See C 278)

3. The CAH failed to ensure that the Nutrition Services Department provided safe and effective implementation of food services, and clinical care as evidenced by the following issues identified in food service, clinical nutrition care, and department organization:

a. Foodservice: Lack of effective cool down monitoring of potentially hazardous foods; no use of standardized recipes during food production; ineffective sanitation of work surfaces; lack of an effective plan for implementation of disaster meal planning; use of spoiled food in food production; unclean kitchen areas and equipment; issues surrounding food storage practices; retention of expired food items. (See C 279)

b. Clinical Nutrition Care: Lack of an effective system to ensure the nutritional needs for 4 of 6 patients (Patient 9, 10, 12, and 14) were met. (See C 279)

c. Organization: Lack of an effective organizational structure that ensured competency evaluation of dietary management and clinical nutrition staff; policies and procedures that did not meet standards of practice; lack of a current, approved therapeutic diet manual; lack of an effective training program for dietary staff relative to the scope of the department (See C279, C293).

The cumulative effects of these systemic problems resulted in a diminished ability of the hospital to provide:

1. Safe and effective use of drugs to meet the needs of the hospital patients and to minimize drug errors and adverse consequences.

2. Infection control measures to reduce the risk of surgical site infection and the transmission of communicable diseases.

3. Food services that were optimally safe and nutritious to hospitalized patients.

Based on observation, staff interview, and clinical record and document review, the hospital failed to ensure that the drug storage area was administered according to accepted professional principles and failed to ensure that expired medications (that were part of an emergency medication supply) were not available for patient use as evidenced by:

1. The failure of the hospital to ensure that one of five sampled patients (Pt 100), who had an order for a fentanyl patch, did not have a patch placed when the patient did not meet the definition of opioid tolerance, as documented in the approved fentanyl patch (a topical dosage form of the potent synthetic opioid pain reliever, fentanyl that releases the fentanyl at a constant rate. For example, the 25 mcg patch releases the fentanyl at a rate of 25 microgram (mcg)/hr over a 72 hour period) product labeling of the Food and Drug Administration (FDA: a Federal Agency which is the institution that regulates the approval, labeling, and all regulatory issues regarding medications in the United States). Opioid tolerance occurs when the patient receives a given level of a narcotic pain reliever related to opium for a defined time period. This potentially exposed Patient 100 to the risk of a significant and possibly fatal suppression of Patient 100's ability to breath spontaneously. (see finding #1)

2. The failure of the hospital to ensure that four out of four patients (Patients 101 through 104) who had received droperidol (used to treat nausea and vomiting in post-surgical patients) in the hospital had a 12 lead electrocardiogram (ECG: a graphic tracing in the variations in the electrical potential cause by the excitation of the heart muscle as detected by electrodes placed on the surface of the body) prior to use of the medication, that three out of four did not receive droperidol as first line drug (Patient 101, 103, and 104), and that two out of the four (Patient 101 and 104) had been monitored for a prolonged QT interval (an interval in the electrocardiogram of the heart) for 2 to 3 hours by ECG after receiving droperidol as stipulated by the hospital policy and procedure for droperidol and the FDA approved product labeling for droperidol. Patients with prolonged QT intervals can develop potentially lethal heart rhythms. (see finding # 2)

3. The failure of the hospital to ensure a pre-printed Post Anesthesia Care Unit (PACU: where patients are recovered immediately after a surgery) order set found in three out of three clinical records in which the patients underwent surgical procedures (Patient 101, 102, and 103) was in agreement with the hospital policy for droperidol with regard to need to monitor the use of droperidol via an ECG after the drug was administered and the failure to ensure this order set was in agreement with the policy to ensure that droperidol would be used as a second-line drug, i.e. after another antiemetic (anti-nausea/vomiting) drug had failed to prevent nausea and/or vomiting or had unacceptable side effects in a given patient (there were two versions of this order set: an earlier version was found in Patient 101's clinical record as opposed to Patient 102's and 103's clinical records; the later version added Phenergan to the antiemetics that could be ordered). This potentially could prevent staff from monitoring for an increase in the QT interval and use the use of droperidol as a first line drug exposed the patients to the risks of the use of droperidol before other drugs without such a warning had been tried firs. (see finding #3)

4. The failure of the hospital to ensure that procedures were developed that would prevent unlicensed non- pharmacy staff from having access to controlled drugs in the pharmacy which could increase the risk of drug diversion. (see finding #4)

5. The failure of the hospital to ensure that housekeepers did not have access to medications and syringes in the Emergency Department (ED) which could increase the risk of diversion. (see finding #5)

6. The failure of the hospital to ensure that a policy was developed that established who had access to medications in the hospital as stipulated in state regulation with the potential that non-licensed and non-designated staff could potentially have access to medications. (see finding #6)

7. The failure of the hospital to implement their policy regarding documentation of cleaning of the pharmacy department barrier isolator cabinets (sealed compartments used to combine intravenous [IV] solutions) resulting in the potential that staff may not have disinfected the cabinets before or after use. (see finding #7)

8. The failure of the pharmacist to develop a specific procedure for cleaning the barrier isolator cabinets and to ensure all staff did it properly to minimize the risk of bacterial contamination of solutions manufactured inside the isolator cabinets. (see finding #8)

9. The failure of the pharmacist to find out what the logs (posted on barrier isolator cabinets in the IV compounding area of the pharmacy) regarding changing sleeves and gloves meant, his failure to develop procedures setting guidelines and procedures establishing how to change the sleeves and gloves (through which staff could place their arms and hands in order to manipulate items inside the cabinet) attached the pharmacy barrier isolator cabinets, and how frequently they needed to be changed with the potential that the sleeves and gloves may not be changed if needed which could result in compromise of the clean environment inside the barrier isolator cabinet. (see finding #9)

10. The failure of the pharmacist to find out what tests the pharmacy technicians were performing when they tested the isolator cabinets for bacterial contamination, the failure of the pharmacist to be involved in designing the testing parameters to determine if there was bacterial contamination in the hood, and the failure of the pharmacist to request an update to Policy and Procedure IC 50-750 by the HP Committee if he felt that such testing should be done with the potential that such testing may not have been done properly such that hospital could be assured that bacterial contamination of the environment inside the isolator cabinets had not taken place. (see finding #12)

11. The failure of the hospital to ensure that the policies and procedures for restocking of the crash carts (emergency medications used during heart and respiratory failure) reflected the current practice of the hospital, the failure of the procedures to be in agreement with state regulations (Title 22, Section 70263(f)(2-3) for restocking the crash cart, and the failure of the pharmacist to be aware that these issues regarding the crash cart policies existed. (see findings #11-12)

12. The failure of the hospital to ensure that as expiration date on the content list of one out of two crash carts in the Emergency Department (ED) accurately reflected the actual expiration date of the listed medication with the potential that staff may not be alerted that the cart contained an expired medication which would be available for use in hospital patients, the failure of the hospital ensure staff stocked the medication tray with the procainamide (used to treat dangerous irregular heart rhythms) product documented on the content list, and the failure of the hospital to ensure that the content list specified the volume of a pediatric dosage unit of atropine (used to treat hearts that are beating too slowly) kept in the pediatric section of the medication tray with the potential that staff may stock the wrong volume of this drug in the pediatric section of the medication tray. (see finding #13)

13. The failure of the hospital to ensure that the Malignant Hyperthermia (MH: a rare but potentially lethal side effect of the use certain medications used in anesthesia which manifests as a rapid rise in body temperature over several minutes that can exceed 110 degrees Fahrenheit) emergency medication supply in the Surgery Department was in a portable container, the failure to ensure this emergency supply was sealed with a seal that needed to be broken to gain access to the supply (as opposed to being locked with a lock and key), the failure to ensure that the content list was posted outside this supply along with the expiration date of the first medication to expire within the supply, the failure to develop a policy and procedure that provided for procedures for use of all the medications in the supply, to provide procedures for restocking of the supply and the sealing of the supply by pharmacist, and a procedure ensuring a pharmacist, rather than a pharmacy technician inspected the supply at least every 30 days, not monthly, all as stipulated in state regulation [Title 22, Section 70263(f)(1-3)]. (see findings #14-16)

14. The hospital failed to ensure that the MH emergency medication supply stored in the Family Birthing Center had a content list posted on the outside the portable container and that the hospital considered all medications that were part of the supply including the refrigerated IV Normal Saline (NS: a 0.9% solution of sodium chloride) were considered when establishing the expiration date of the first drug to expire which was posted outside the emergency supply. As result, the two 1000 ml IV bags of NS stored in the refrigerator were found to be outdated by more than two months because staff had not been alerted to this fact by the posted expiration date. (see finding #17)

Findings:

1. The fentanyl transdermal system 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 the Food and Drug Administration requires be placed in the product labeling 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 and 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. The product labeling documents that the fentanyl concentration in the body gradually rises after the patch is applied and then levels off between 12 and 24 hours. It also documents that peak levels of fentanyl are achieved between 20 to 72 hours.

On 12/10/10 a review of Patient 100's clinical record indicated that Resident 100 was admitted to the hospital at 4:54 p.m. on 10/29/10 from another hospital. A review of the History and Physical dictated 10/29/10 at 5:15 p.m. indicated that Patient 100 had a history of a previous stroke with right-sided paralysis, that she had been treated at another hospital for pneumonia, and now was re-admitted to this hospital with new onset left-sided paralysis and with aphasia (a speech disorder).

On 10/31/10 at 3:30 a.m., a nurse took a telephone order from a physician for morphine 1 to 2 milligrams (mg) IV every hour as needed for pain or respiratory distress with 1 mg for moderate pain/distress and 2 mg for severe pain/distress. On 10/31/10 at 6:50 a.m. all medications were discontinued except comfort care medications which included morphine. On 10/31/10 at 11:40 a.m. a physician ordered Roxanol (a concentrated oral solution of morphine) 20 mg/milliliter (ml) and also the placement of a Duragesic 25 mcg/hr patch (a brand name for a fentanyl transdermal system) every 3 days.

There was no history of prior opioid medication usage documented in the History and Physical. There was no history of opioid medication use at home. Therefore, the first documented order for an opioid medication, morphine, was taken at 3:30 a.m. on 10/31/10 and the Duragesic Patch was ordered eight hours later at 11:40 a.m.

A review of the medication administration record (MAR: used by nurses to accurately medicate their patients and document the date, time, and dose that a given medication was administered to a given patient) indicated that Patient 100 received 1 mg of IV morphine at 7:44 a.m. on 10/31/10 (equivalent to 6 mg of oral morphine as documented in Table D of the product labeling for fentanyl patch) and that the fentanyl patch was placed on Patient 100 on 10/31/10 at 1:51 p.m.

On 10/31/10 at 1:40 p.m., the patient was transferred to the Extended Care Service/Skilled Nursing Facility with admission orders that continued the intravenous morphine, Roxanol, and the Duragesic Patch. A Transfer Summary dictated on 10/31/10 at 1:45 p.m. Indicated that the patient had had "...progressive respiratory failure here at the hospital and (Patient 100's) lungs are clearly not clear and has never really completely resolved from the pneumonia that she had at (the other hospital) ...make (Patient 100) comfort care."

On 10/31/10 a review of the Interdisciplinary Record indicated staff had documented that on 11/1/10 at 4 a.m. (14 hours after the patch was placed) the patient started "gasping" and it documented that at 6 a.m. the patient was still "gasping." Finally at 6:10 a.m. staff documented that Patient 100 had stopped breathing.

A physician's progress note written at 6:25 a.m. on 11/1/10, documented the cause of death was cardiopulmonary arrest secondary to stroke. A copy of the Certificate of Death in the clinical record documented, on Line (A) that the "Immediate Cause" of death was "cardiopulmonary arrest" and it "sequentially (listed) conditions, if any, leading to cause on Line (A)." The first entry was "Pseudomonas pneumonia" (Pseudomonas is a bacteria which can cause pneumonia) on Line (B) and "New Right Cerebral vascular Accident (a stroke) with Left Hemipersis (sic) with Aphasia" on Line (C). Hemiparesis (spelled as hemipersis on the document) is paralysis on one side of the body.

On 12/10/10 a review of Policy and Procedure MM 50-710-1 entitled "High Risk/High Alert Medications" (effective 9/2004, current revision 6/2008) indicated the hospital "...shall employ specific precautions to minimize adverse drug events associated with high risk/high alert medications" and appended to this policy was a list of "High risk/High-alert Medications including BBWs" (black box warnings). "Fentanyl Patch" appeared in this table. It documented that, "This dose form may result in respiratory depression in opiate naive patients" ("opiate naive"is not defined in the product labeling for fentanyl patches). The documented intervention was to, "Determine if patient has a history of opiate tolerance, "and, "Contact MD for alternative dose form of medication: Opiate naive patients." This policy did not document what constituted opioid tolerance as described in the boxed warning found in the fentanyl patch product labeling.

On 12/10/10 at 12:22 p.m. during an interview Administrative Staff R stated that this was the only policy that the hospital had regarding the use of a fentanyl patch.

2. Droperidol (brand name Inapsine) is a medication used to treat nausea and vomiting. This medication has a "black box" warning. Boxed warnings document potential problems that can lead to serious injury or death. The prescriber would be expected to consider alternative treatments in arriving at a decision to use this product. In the case of preprinted orders for droperidol (Inapsine) the hospital would be expected to provide procedures to the nursing staff for the safe administration for this drug. The boxed warning documents that use of droperidol has been associated with prolongation of the QT interval (a part of the electrocardiogram) and/or torsades de pointes (an uncommon but potentially fatal irregular heartbeat).

The QT interval is seen on the ECG of the heart and is the period the heart is, "recharging," so to speak. If this period is extended too long, abnormal heart beats may occur including torsades de pointes which can lead to more serious arrhythmias. The boxed warning makes the following points:

Cases of QT interval prolongation and/or torsades de points can occur at recommended or below recommended doses.

This has occurred in patients without known risk factors for QT interval prolongation and some cases have been fatal.

This drug is not intended for use as a first line agent for treatment of nausea.

All patients should be screened using a 12-lead ECG to check for pre-existing QT prolongation and if present, droperidol should NOT be used (emphasis is in the boxed warning and defined as a QTc more than 440 milliseconds in males or 450 milliseconds in females).

Patients who receive the medication should be monitored via an ECG (i.e. telemetry) prior to and after receiving the drug.

It lists potential risk factors for developing torsades de pointes including the use of benzodiazepines (minor tranquilizers), volatile anesthetics (gases used to induce anesthesia), and IV opiates.

On 12/7/10 a review of facility Policy and Procedure MM-50-710-3 entitled, "Droperidol Usage" (revised 10/2004) indicated the policy of the hospital stipulated that, "Droperidol will be utilized in accordance with the Food and Drug Administration (FDA) warnings of December 2001." It documented that the patient criteria for use of the drug were failure of other antiemetics (anti-vomiting), availability of monitoring equipment, that it was contraindicated in patients with known or suspected to have QT prolongation, and to use it with extreme caution in patients at risk for development of QT prolongation. It stipulated that staff would perform a 12 lead ECG prior to initiation of therapy and that it was not to be administered to males whose QTc interval was greater than 440 milliseconds and to females whose QTc interval was greater than 450 milliseconds.

On 12/9/10 a review of Patient 101's clinical record indicated that he was admitted to the hospital for a surgical procedure. A set of pre-printed orders in Patient 101's clinical record entitled, "Anesthesia PACU Standing Orders," revised 9/2007, included pre-printed orders for droperidol, Reglan (used to treat nausea and vomiting), and Zofran (used to treat nausea and vomiting). While there was no printed indication on the record as to which one was to be used first, the ordering physician had circled Zofran and droperidol and put a numeral "1" in front of the Zofran order and a numeral "2" before the droperidol order. The physician ordered droperidol 0.25 mg IV every 5 minutes times four doses as needed for nausea and vomiting.

A review of the "PACU Record" indicated that Patient 101 received 0.25 mg of IV droperidol at 10:35 a.m. and at 11:05 a. m. on 1/21/10. There was no indication that staff had given Patient 101 a dose of Zofran. A review of the nursing notes indicated that Patient 100 was discharged home at 11:30 a.m. on 1/21/10.

On 12/9/10 at 12:47 p.m., during an interview of Licensed Staff S, she reviewed the "Anesthesia PACU Orders" and then stated that, as the order was written, she would have given the Zofran first and if that did not control the nausea she would have given the droperidol second. She could find no evidence in the clinical record that staff had given Patient 101 the Zofran or that a 12 lead ECG had been ordered.

On 12/9/10 at 12:58 p.m., during an interview of Licensed Staff T, she reviewed the "Anesthesia PACU Orders" and then stated that, as the order was written, she would have given the Zofran first and then the droperidol. But she said she could see that one might interpret the orders as giving a nurse two equal choices. She could find no evidence that the Zofran had been given.

There was no evidence that the Zofran was given first before the droperidol was given. There was no evidence that a 12 lead ECG was done prior to using the droperidol. There was no evidence that Patient 101's ECG was monitored for two to three hours after he received the droperidol.

On 12/9/10 a review of Patient 102's clinical record indicated that Patient 102 underwent a surgical procedure in the hospital. A review of the intraoperative record indicated that Patient 102 received 1.25 mg of droperidol IV during surgery. The clinical record had a preoperative check list that included an ECG but the ECG choice was not checked. There was no evidence that Patient 102 had a 12 lead ECG before she received droperidol.

On 12/9/10 a review of Patient 103's clinical record indicated that Patient 102 underwent a surgical procedure in the hospital. A review of the intraoperative record indicated that Patient 103 received 0.625 mg of droperidol IV during the surgery. There was no record that another antiemetic such as Zofran or Reglan was given to Patient 103 before the droperidol was given. There was no evidence that Patient 103 had a 12 lead ECG before she received droperidol.

On 12/9/10 a review of Patient 104's clinical record indicated Patient 104 was seen in the Emergency Department (ED) on 1/30/10. A review of the "Emergency Department Order Sheet" dated 1/30/10, indicated that a physician was to, "circle or write in," initial orders on this sheet. A 12 lead ECG was one printed choice on this sheet but it was not circled.

At 6:48 p.m. a physician ordered staff to give Patient 104 a 2.5 mg dose of IV droperidol. The "Medication Therapy Flow Sheet" documented that Patient 104 received 2.5 mg of droperidol IV push (no time indicated but the nurses notes documented that medications were given as ordered at 6:50 p.m.). The "Medication Therapy Flow Sheet" also documented that Patient 104 received Zofran 4 mg IV push at 10:48 p.m. and Reglan 10 mg IV push at 11:05 p.m. (All three medications are used to control nausea and vomiting). A review of the "Emergency Department Physician Record" indicated that the physician had pre-printed options to order an ECG, a rhythm strip, a monitor, and an interpretation (of the ECG) by an ED physician. None of these choices were checked. There was no mention of an ECG in the Emergency Department Continuation Record.

On 12/9/10 Administrative Staff U reviewed Patient 104's clinical record to see if she had been monitored via an ECG while in the ED. He could find no evidence that a 12 lead ECG had been done in the ED. He could find no evidence that ED staff were monitoring the QT interval via an ECG while Patient 104 was in the ED.

3. On 12/7/10 a review of Policy and Procedure MM-50-710-3 entitled "Droperidol Usage" (effective 11/1/04, current revision 10/2004) indicated the policy of the hospital stipulated that, "Droperidol will be utilized in accordance with the Food and Drug Administration (FDA) warnings of December 2001." It documented that the patient criteria for use of the drug were failure of other antiemetics (anti-vomiting), availability of monitoring equipment, that it was contraindicated in patients with known or suspected to have QT prolongation, and to use it with extreme caution in patients at risk for development of QT prolongation. It stipulated that staff would perform a 12 lead ECG prior to initiation of therapy and that it was not to be administered to males whose QTc interval was greater than 440 milliseconds and to females whose QTc interval was greater than 450 milliseconds. It made no provision for a dosage threshold that needed to be breached in order to institute monitoring.

On 12/9/10 a review of three clinical records for patients who underwent surgical procedures of the hospital (Patient 101, 102, and 103) indicated Patient 101's record contained a pre-printed "Anesthesia PACU Standing Orders" (revised 9/2007), while Patient 102's and 103's clinical records contained a pre-printed" Anesthesia PACU Orders" (revised 3/2009). Order set "(6) PRN (as needed) Antiemetics" included preprinted choices for droperidol, Reglan, Zofran, Phenergan, and "Other" (Patient 101's earlier order set did not include a choice for Phenergan). Droperidol, Reglan, Zofran, and Phenergan can be used to treat nausea and vomiting. Both versions of the order set included order "(6)" that included the printed instructions:" If Droperidol dose is greater than 1.25 mgs, must implement monitoring per policy and procedure." There was no indication on this sheet that another antiemetic should be used first and if it failed to work that droperidol could then be used. It established a dosage threshold that had to be breached before monitoring would be performed by staff. This order was not in agreement with the hospital policy and procedure or the boxed warning found in the droperidol product labeling.

4. On 12/7/10 at 11:15 a.m. during an inspection of the pharmacy there were drawers in which the controlled substances were stored (drugs subject to abuse such as morphine) and the cabinet in which the expired controlled drugs were stored until they handed over to a reverse hauler for destruction were unlocked. A pharmacist and a technician in the room at that time had their backs turned away from these drawers and the cabinet while they were working.

During a concurrent interview Administrative Staff R stated that the drawers were left unlocked during the pharmacy business hours and locked when the pharmacy was closed down for the evening. During an interview at this time, Staff V stated that when a housekeeper was cleaning the pharmacy, they would not be under direct (in-line of site) supervision by the pharmacy staff. Therefore, the housekeepers potentially had access to the controlled drug supply in the pharmacy.

5. On 12/8/10 at 10:14 a.m. during an inspection of the medication storage area behind the nursing station in the ED, the surveyor noted that twenty-five 10 ml vials of normal saline (NS: 0.9% solution of sodium chloride used to flush IV lines and dissolve certain medications prior to injection) and twenty-two 10 ml pre-filled syringes (PFS) of NS for injection (used to flush IV lines) were not locked up and could potentially be accessible by housekeepers.

An "Eye Tray" in an unlocked cabinet in this area contained a 4 ounce bottle of Eye Stream Eye Wash solution, five 10 ml PFS of NS, one 12 ml syringe and three 6 ml syringes (syringes are considered to be dangerous devices).

An "Emergency Dept. E.N.T. (ear, nose, throat) Tray" in this unlocked cabinet contained lidocaine 4% topical solution (a local anesthetic), one 3 ml vial of Adrenalin 1:1000 for topical application (used to stop bleeding), one 2 ounce container of Hurricaine Topical Anesthetic Spray (20% oral benzocaine: a local anesthetic), and one container of Arzol Sliver Nitrate Applicators (use to stop minor bleeding).

This unlocked cabinet also contained two IV trays that contained a 10 ml PFS of NS and 12 ml syringes.

During a concurrent interview, Administrative Staff U stated that all medications were locked up in this area, therefore, he was comfortable with housekeeping coming in and cleaning the ED drug area without direct nursing supervision of the housekeeping staff.

6. On 12/8/10 at 9:09 a.m. during interview, Administrative Staff R was asked who was designated to have access to medications in the hospital. Staff R provided a copy of Policy and Procedure MM 50-210-3 entitled, "Hospital Drug Distribution" (revised 7/2008). A review of that policy at that time indicated that procedure I(A) stipulated that only a pharmacist or a pharmacy technician could dispense medications in the pharmacy.

Administrative Staff R also provided a copy of Policy and Procedure MM 50-220-1 (effective 10/2001, current revision 5/2008) entitled, "Pyxis Authorized Access." (Pyxis is a computerized automated dispensing system where the computer control is maintained in the pharmacy and dispensing cabinets are located in various nursing stations). Procedure 3 documented who had access to medications in the Pyxis.

These were the only procedures provided by Administrative Staff R with regard to the question as to who could have access to medications in the hospital and neither clearly designated who could have access to medications in general. Title 22, Section 70263(q)(8) stipulates that, "Drugs shall be accessible only to responsible personnel designated by the hospital ..."

7. On 12/7/10 a review of Policy and Procedure IC 50-750 entitled, "Infection Control & Pharmacy IV Admixtures," (revised 9/2007) indicated that procedure I (I) stipulated that the, "barrier isolator cabinet shall be cleaned periodically during the day with an antiseptic solution, e.g. first thing in the morning, before closing at night, after spillage, etc. The I.V. Technician will document cleaning by signing the log next to the hood." (Barrier isolator cabinets are sealed chambers with flexible sleeves which protrude into the cabinet and to which staff attach rubber gloves. The cabinets contain filtered air and are used to mix IV solutions with minimal risk of contamination. Staff place items into the hood via a secondary chamber attached to the side of the isolator cabinet then put their arms into the sleeves and pull the items into the main hood from the secondary chamber so that they can mix IV solutions.)

On 12/7/10 at 11:34 a.m., during an inspection of the pharmacy, the IV room in which staff compounded IV solutions contained three barrier isolator cabinets, one which stood alone and two that were joined together. During an interview at that time, Administrative Staff R stated that the stand alone cabinet and the left cabinet of the joined pair were used to make regular IV solutions while the right cabinet of the joined pair was used to make chemotherapeutic IV solutions (medication solutions used to treat cancer). Staff R stated this last cabinet was currently not in use as the hospital did not compound chemotherapeutic agents at that time.

An inspection of a log entitled, "MIC Daily Cleaning Log" (the "MIC" was the barrier isolator cabinet) attached to the stand alone cabinet revealed it had columns labeled for the months of July through December 2010 and numbered rows which corresponded to the days of the month in the column. Staff would initial the square formed by the intersection of the row and the column to document they had cleaned the hood on a given day of a given month. A review of the log indicated that 11 days were not initialed in July, 12 days were not initialed in August, 11 days were not initialed in September, 4 days were not initialed in November, and 1 day was not initialed in December (through 12/7/10). A review of the log from the left cabinet of the dual pair indicated that 14 days were not initialed in July, 13 days were not initialed in August, 16 days were not initialed in September, 7 days were not initialed in October, 9 days were not initialed in November, and 1 day was not initialed in December (through 12/7/10).

8. On 12/7/10 a review of Policy and Procedure IC 50-750 entitled "Infection Control & Pharmacy IV Admixture "(effective 1/1/92, current revision 9/2007) indicated that procedure I (I) stipulated that the, "barrier isolator cabinet shall be cleaned periodically during the day with an antiseptic solution, e.g. first thing in the morning, before closing at night, after spillage, etc." It contained no procedure as to how the isolator cabinet would be cleaned by staff.

On 12/9/10 at 10:34 during an interview Staff Y stated that the current barrier isolator cabinets were installed in late 2004. Staff Y stated that blank copies of the current cleaning log sheets were in use from the time of a former Director of Pharmacy (DOP) who left the hospital about a year before the cabinets were installed in the pharmacy. That DOP was followed by a series of temporary DOPs until Administrative Staff R came about 3 years ago. Staff R did not get any guid

Based on observation, staff interview, and document review, the hospital failed to develop a system for identifying, reporting, investigating, and controlling infections and communicable diseases as evidenced by the failure to ensure:

2. a. That 4 of 4 newly hired or contact personnel were screened for Mycobacterium tuberculosis (Staff WW, A, P and Q).

b. That glucometers (devices used to test a patient's blood sugar) were cleaned after each patient and that lancet holders (devices that hold the lancets), were disposable for 3 of 4 nursing units (Intensive Care Unit, Birthing Center, and Emergency Department).

c. That housekeeping personnel received training and were competent to perform the daily cleaning of the rooms of patients who were placed in transmission based precautions (isolation rooms of patients with infectious or communicable diseases), and to perform terminal cleaning after the patients discharge.

d. That the policies and procedures directing traffic patterns in the semi-restricted and restricted areas of Surgical Services are developed and implemented.
That staff wear proper surgical attire.
That the temperature and humidity in the surgical services areas are monitored and maintained.

Findings:

2 a. On 12/8/10 at 4 p.m., the personnel files of the following staff (Staff WW, A, P, and Q) were reviewed and the following was revealed:

The file indicated that Staff WW was hired 10/29/10.
The health file showed that the first skin test for screening for Mycobacterium tuberculosis (TST) was performed 10/6/10. The file lacked documented evidence that Staff W returned to have the TST read. In addition, the file indicated that a second TST was administered 10/27/10, which was read on 10/29/10. The file contained no evidence that a second TST was performed and read.

The personnel file for Staff A contained documentation showing the environmental services staff was hired 3/30/09. Documentation in the health file showed the employee had a TST 3/30/09. The health file contained no evidence that a second TST was performed after the initial TST. In addition, there was no documentation showing that Staff WW had an annual TST in 3/10.

The personnel file of Staff P contained documentation showing the dietary aide was hired 11/17/10. Documentation in the health file showed the employee had a TST performed 11/10/10 which was read 11/12/10. The health file contained no evidence that a second TST was performed after the initial TST.

The personnel file of Staff Q contained documentation showing the registered nurse was hired 11/19/10. Documentation in the health file showed that a TST was performed on 11/17/10 and was read on 11/19/10. The health file contained no evidence that a second TST was preformed after the initial TST.

On 12/9/10 at 9 a.m., Employee Health Staff YY was interviewed. Employee Health Staff YY stated that her department was responsible for ensuring that employees were screened for Mycobacterium tuberculosis (TB). Staff YY also stated that the hospital did not have a policy and procedure directing employee health on how employees were to be screened for TB. In addition, Employee Health Staff YY, stated that the hospital did not perform a 2-step TST for newly hired employees. When asked about the process for ensuring that all employees were screened annually for (TB), Staff YY stated that the individual managers and directors were notified of when employees were due for their annual TB screening, but it was an informal process since the hospital did not have a policy and procedure to ensure that employees were annually screened for TB.

On 12/9/10 at 10 a.m., Centers for Disease Control and Prevention (CDC), Guidelines for Preventing the Transmission of Mycobacterium tuberculosis (M. tuberculosis) in Health-Care Settings, published in 2005, was reviewed. Direction in the document was that: Baseline testing for M. tuberculosis infection is recommended for all newly hired HCWs (health care workers), regardless of the risk classification of the setting and can be conducted with the TST or BAMT (blood assay for Mycobacterium tuberculosis). Baseline test results 1) provide a basis for comparison in the event of a potential or known exposure to M. tuberculosis and 2) facilitate the detection and treatment of LTBI (latent TB infection) or TB disease in an HCW before employment begins and reduces the risk to patients and other HCWs. If TST is used for baseline testing, two-step testing is recommended for HCWs whose initial TST results are negative. (39,224). If the first-step TST result is negative, the second-step TST should be administered 1-3 weeks after the first TST result was read. If either 1) the baseline first-step TST result is positive or 2) the first-step TST result is negative but the second-step TST result is positive, TB disease should be excluded, and if it is excluded, then the HCW should be evaluated for treatment of LTBI. If the first and second-step TST results are both negative, the person is classified as not infected with M. tuberculosis. If the second test result of a two-step TST is not read within 48-72 hours, administer a TST as soon as possible (even if several months have elapsed) and ensure that the result is read within 48-72 hours (39). Certain studies indicate that positive TST reactions might still be measurable from 4-7 days after testing (225,226). However, if a patient fails to return within 72 hours and has a negative test result, the TST should be repeated.

The hospital failed to develop and implement an employee TB screening policy and procedure consistent with current CDC recommendations.

2 b. On 12/7/10 beginning at 9:05 a.m., an initial tour of the hospital was conducted. During the tour nursing staff were asked to explain the process for cleaning the glucometer.

In the Intensive Care Unit:
Staff QQ, stated that the glucometer was cleaned once a shift using a bleach wipe. Staff QQ also stated the reusable lancet (device with a sharp point that pricks the skin), holders (device for holding the lancet), were cleaned once a shift.

In the Birthing Center:
Staff UU stated that the glucometer and the reusable lancet holders were cleaned once a day.

In the Emergency Department:
Staff U stated that the glucometer, reusable lancet holders were cleaned once a day using Sani-Cloth Plus wipes.

On 12/7/10 at 11 am, a request was made to review the hospital's glucometer cleaning policy and procedure.

During a concurrent interview, the Administrative Staff K stated that the policy and procedure was not approved by the governing board. Administrative Staff K also stated that once the governing board approved the policy and procedure, nursing staff would be trained on the process for cleaning the glucometer. During the interview Administrative Staff K and Staff ZZ stated that the training would include the cleaning process to follow for the reusable lancet holders.

On 12/9/10 at 10 a.m., an article published by the Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved. (Am J Infect Control 2010;38:167-72.), titled, " Safe injection, infusion, and medication vial practices in health care" was reviewed. Direction in the article was that: The transmission of bloodborne viruses and other microbial pathogens to patients during routine health care procedures continues to occur because of the use of unsafe and improper injection, infusion, and medication vial practices by health care professionals in various clinical settings throughout the United States.

Additional direction in the article specific to blood glucose monitoring devices was to:
Assign a glucometer to each individual patient if possible.
Clean and disinfect glucometers if they must be shared between multiple patients.
Restrict the use of finger stick capillary blood sampling devices to individual patients.
Maintain supplies and equipment, such as finger stick devices and glucometers, within individual inpatient rooms, if possible.
Use single-use lancets that permanently retract after puncture.
Never reuse finger stick devices and lancets. Dispose of them at the point of use in an approved sharps container. Lancets in a pen should be removed by mechanical means (hemostat) to avoid finger contact.
Thoroughly clean all visible soil or organic material (eg, blood) from the glucometer before disinfection.
Disinfect the exterior surfaces of the glucometer after each use following the manufacturer ' s directions.
Use an Environmental Protection Agency-registered disinfectant effective against HBV, HCV, and HIV or a 1:10 bleach solution (1 part bleach to 9 parts water).

Failure to develop and implement a policy and procedure for the cleaning of glucometers including the safe use of blood glucose supplies placed patients and staff at risk of exposure to bloodborne pathogens (viruses that causes Hepatitis B, Hepatitis C, and HIV).

2 c. On 12/7/10 at 10 a.m., a request was made to review the infection control classes and in-services provided for hospital staff for the past 12 months.

On 12/8/10 at 9 a.m., a list of infection control in-services was provided and reviewed. It was noted that the in-service list covered the time frame of 12/8/09 - 12/7/10. Documentation in the list disclosed that the housekeeping staff received training on aerosol transmitted disease (use of personal protective equipment for patients with TB, meningitis), and regulatory compliance, which included a segment on infection control.

On 12/8/10 at 10 a.m., the Administrative Staff A was asked to clarify what infection issues were covered during the regulatory compliance in-service. The Admin Staff A stated that the in-service covered hand hygiene and use of gloves. When asked if any in-services were provided for housekeeping staff covering the cleaning of room for patients in transmission based precautions (isolation), Admin Staff A stated that he had held an in-service for housekeeping staff a couple of months earlier. A request was made to review the content of the additional training.

On 12/9/10, at 10:30 a.m., copies of the flyer detailing the housekeeper training were provided and reviewed. According to the in-service flyers the topics included in the training were: mopping and wiping; making beds; handling linen; carts and dusting; trash; and environmental services cart and inventory, and steps for cleaning. The in-service flyers contained no evidence that housekeeping staff received training on the daily process used to clean the rooms of patients who were placed in transmission based precautions.

During a concurrent interview, Administrative Staff A was asked if the housekeeping staff received training on how to clean the rooms of patients in transmission based precautions including terminal cleaning after the patient was discharged? Staff A stated that he had no documentation showing that housekeeping staff received training on the daily cleaning process or the terminal cleaning process of rooms of patients who had been placed on transmission based precautions.

Failure to ensure that housekeeping staff were trained in the process of daily cleaning of rooms, and the terminal cleaning process of rooms where patients were placed in transmission based precautions, placed other patients and staff at risk of being exposed to infectious and communicable diseases.

2 d. On 12/8/10 at 2:30 p.m., an initial tour was conducted of the surgical services area. During the tour it was noted that operating room (OR) Room 1 was not included in the semi and restricted areas of the surgical services area. During the initial tour it was noted that some of the surgical services staff were wearing reusable cloth hair covering. It was also noted that the reusable cloth hair covering was not covered by single use disposable hair coverings.

During a concurrent interview, Administrative Staff Z stated that primarily endoscopic procedures were performed in OR Room 1. Staff Z stated that OR Room 1, was not consistently included in the surgical services semi and restricted areas and that some of the staff working in OR Room 1, wore hospital provided surgical attire, and some staff including physicians, did not wear hospital provided surgical attire.

Staff Z also stated that pain management staff who assisted with endoscopic procedures, in OR Room 1, did not change into hospital provided surgical attire when assisting with endoscopic procedures. When asked about the use of cloth hair coverings, Staff Z stated that the reusable cloth hair coverings were owned by the staff wearing them, and that the staff were responsible for laundering them. When asked if staff were required to wear a disposable covering over the reusable hair cover, she replied, "No, they are not."

During the initial tour it was noted that plant operations staff entered OR Room 1, without wearing hospital provided surgical attire or attire covering their street clothes.

During the concurrent interview, Staff Z was asked to review the hospital's policy and procedure directing traffic patterns in the surgical services area. Staff Z stated that the hospital did not have a policy and procedure directing traffic patterns in the surgical services area.

On 12/8/10 at 5 p.m., the hospital's 11/2010, policy and procedure titled, "Operating room attire regulations" was reviewed. Under the section titled, "Policy" direction was that, "All persons who enter the semi-restricted and restricted area of the surgical suite should be in surgical attire intended for use only within surgical suites. Surgical attire is worn to promote a high level of cleanliness and hygiene within the surgical environment." Under the, "Procedure" section, item A, direction was that, "Clothing - Sanitized scrubs provided by the hospital shall be worn within the restricted area of the surgical suite." Under item 1, additional direction was that, "Street garb is never worn in the restricted area."

On 12/8/10 at 5 p.m., the 2010, Perioperative Standards and Recommended Practices, published by Association of preOperative Registered Nurses (AORN) was reviewed.
Documentation on page 67, under Recommendation I, AORN recommended that, "All individual who enter the semi-restricted and restricted areas of the surgical suite should wear freshly laundered surgical attire intended for use only within the surgical suite." On page 69, under Recommendation II, item 2, AORN recommended that, "Disposable bouffant and hood-style covers are preferred ..."

The hospital failed to develop and implement a policy and procedure defining the semi-restricted and restricted areas within the surgical services area, and failed to implement their policy and procedure directing attire in the surgical services area.

On 12/7/10 at 3 p.m., a request was made to review the temperature and humidity logs for the surgical services area.

On 12/8/10 at 2 p.m., Administrative Staff Z stated that prior to August of 2010, she had not collected or maintained information on the temperature and humidity in the surgical services area.

On 12/8/10 at 3 p.m., the table of content for the surgical services policy and procedure manual was reviewed. A review of the hospital's infection control plan was also reviewed. There was no direction in either the surgical services manual or the infection control plan that the temperature and humidity was to be monitored and maintained in the surgical services area.

On 12/8/10 at 5 p.m, the 2010, Perioperative Standards and Recommended Practices, published by Association of preOperative Registered Nurses (AORN) was reviewed. AORN recommended on page 221 under item V.b., the relative humidity should be maintained between 30 and 60 percent within the surgical suites, recovery area, and the endoscopy rooms, and sterilizing areas. AORN also recommended that the humidity should be maintained below 70 percent in the sterile storage area. AORN rationale was that high humidity increases the risk of microbial growth. Under V.c., AORN recommended that the temperature should be monitored and recorded daily using a log format or documentation provided by the HVAC (heating, ventilation and air conditioning) system.

Failure to monitor and maintain the humidity and temperature in the surgical service area placed surgical patients at risk of developing post operative infections.

Based on dietary services observations, dietary and administrative staff interview, dietary and administrative document review, policy and procedure review, and record review, the hospital failed to ensure safe and effective implementation of the Nutrition Services Department as evidenced by the following identified in food service, clinical nutrition care, and the organization:

3 a. Foodservice:

Lack of effective cool down monitoring of potentially hazardous foods.

No use of standardized recipes during food production.

Ineffective sanitation of work surfaces.

Lack of an effective plan for implementation of disaster meal planning.

Use of spoiled food in food production.

Unclean kitchen areas and equipment.

Issues surrounding food storage practices.

Retention of expired food items.

Lack of systems to ensure effective implementation of dietetic services may result in putting patients at risk of foodborne illness, cross contamination of prepared foods and compromised nutritional content of food. These systems failures may further compromise the medical status of patients, extend hospital stays and in severe instances may result in death as a result of hospital acquired infections.

3 b. Clinical Nutrition Care:

Lack of an effective system to ensure the nutritional needs for 4 of 6 patients were met (Patient 9, 10, 12, and 14).

Lack of accurate and effective clinical nutrition care may result in a complete lack of, or delay in medical nutrition therapy. Lack of timely and effective nutrition interventions may result poor dietary intake, weight loss and malnutrition, further compromising patients' medical status.

3 c. Organization:

Lack of an effective organizational structure that ensured competency evaluation of dietary management and clinical nutrition staff.

Policies and procedures that did not meet standards of practice.

Lack of a current, approved therapeutic diet manual.

Lack of an effective training program for dietary staff relative to the scope of the department.

Lack of an effective organizational structure for dietetic services and clinical nutrition care may result in practices that do not meet professional standards resulting in compromising patients' nutritional and medical status.

Findings:

3 a. Foodservice:

During initial tour on 12/7/10 at 9:05 a.m., it was observed that there was tuna salad and black bean and rice salad in the glass door refrigerator. During a concurrent interview, Dietary Staff (DS C) stated that both of the salads were prepared the previous day. DS C was asked to describe how the hospital ensured the food was safe to serve the following day. She stated that once the items were prepared they would be labeled and dated for expiration in three days and would be placed in the refrigerator. In addition, she stated that items such as the rice would be prepared by the cooks and items such as tuna salads would be prepared by the diet aids.

During an interview on 12/7/10 at 11:30 a.m., Dietary Staff (DS F) was asked to describe how the tuna salad was prepared. He stated the tuna and mayonnaise would be combined after which he covered, labeled and dated the item and placed it in the refrigerator. In addition, he stated there was no temperature monitoring of the item.

During an interview on 12/8/10 at 3:30 p.m., Dietary Staff (DS D) was asked to describe how he ensured that an item, such as rice in the salad, was safe to be used the following day. He stated that while he was not the cook that prepared the item, once cooked it would be placed in the walk-in refrigerator. In addition, he was asked if anything else would be done, he stated that if it were items such as meats there would be monitoring of the cool down; however he didn't believe items such as rice would be monitored.

During a concurrent review of the temperature log for 12/7/10, the date the rice was prepared, lacked documented evidence of the monitoring of the cool down of the rice. In addition, the temperature log lacked documented evidence that the tuna salad was monitored for cool down.

Previously prepared protein items such as tuna salad and previously cooked items such as rice are considered to be potentially hazardous foods (PHF's). PHF's are capable of supporting bacterial growth associated with food borne illness. It would be the expectation that hot foods are monitored to ensure that cool down temperatures reach 70 ?F within 2 hours and 41 ?F within an additional 4 hours. Similarly it would be the expectation that cold foods reach a temperature of 41 ?F or lower within 4 hours (Food Code, 2009).

During general food production observations on 12/7/10 at 11 a.m., revealed that DS D was preparing a stir fry item for the noon meal. It was observed that he placed an unmeasured amount of steamed beef and a steam pan of mixed Asian vegetables as well as a 5 pound bag of frozen broccoli on the grill. On 12/7/10 at 12:30 p.m., Dietary Staff (DS E) was observed making a sandwich for the noon trayline. During a concurrent interview DS E was asked to describe the guidance that was used to prepare the patient sandwiches. He stated that to his knowledge there was no guidance and that he placed 2 slices of deli meat on the sandwich. He also acknowledged he did not know how much each of the slices weighed.

During an interview on 12/7/10 at 3:30 p.m., Dietary Management Staff A (DM A) was unable to explain the lack of recipe standardization used in food production. He also acknowledged that lack of standardization of recipes may affect the nutritional intake of inpatients.

Review of the recipe titled "Stir Fried Beef..." indicated that 24 servings of the entree should have included 4.5 pounds of beef, as well as measured amounts of Asian vegetables. In addition to spices; such as garlic, ginger, and green onions, none of which were included in the preparation of the entree. As of 12/9/10, the hospital was unable to provide a recipe guiding the preparation of deli sandwiches.

Review of the policy and procedure titled "Meal Preparation," dated 10/09, indicated that the purpose of utilizing standardized recipes was to determine appropriateness of menu items for specific patients. In addition changes to a recipe potentially alter the impact of the food on patients.

During a review of sanitation procedures on 12/7/10 at 11:30 a.m., Dietary Staff (DS B) was observed cleaning work surfaces in the food production area. It was also observed that the solution in the bucket was cloudy. During a concurrent interview, DS B was asked to describe how surfaces were cleaned. She stated that she used a sanitizer solution. DS B was asked how she ensured that the sanitizer was effective. She stated that she would obtain the sanitizer from the 3-compartment sink in the dish room. DS B was asked to demonstrate the effectiveness of the sanitizer in the bucket that was used. DS B tested the bucket with a chemical testing strip, which revealed the level of sanitizer was not effective.

During an interview on 12/7/10 at 11:35 a.m., DS E he stated that every, "few hours" he would fill the sink with sanitizer. DS E was asked to test the effectiveness of the sanitizer in the recently filled sink. DS E tested the sanitizer and the result indicated that there was a minimal reaction on the test strip, however, it did not meet the specified 200 parts-per-million (ppm) strength for the use of quaternary sanitizer (Food Code, 2009).

Review of disaster planning on 12/7/10 at 3 p.m. indicated that while the hospital had a disaster supply of food, DMS A was unfamiliar with the location and implementation of the plan. During a concurrent interview, DMS A stated that he assumed responsibility for the department in May 2010. He also stated he knew the previous manager had a plan, but he did not know where the plan was located. He also acknowledged he was not familiar with basic implementation elements of the plan, such as the inventory of the food supply, the number of days for the disaster food supply, plan for preparation of the menu, plan for therapeutic diets and the amount of water required for the implementation of the plan.

During a follow up interview on 12/8/10 at 9:30 a.m., DMS A stated that he had dietary staff count the amount of food in the designated disaster supply area; however he acknowledged he was unsure whether the designated inventory would meet the needs of the plan. He also acknowledged that while the hospital had a food supply, there was the absence of a well-developed, comprehensive plan for dietetic services that would be implemented in the event of a widespread disaster. He also acknowledged he was not familiar with the expectations of dietetic services in the event of a disaster.

Review of policy and procedure titled "Disaster Plan-EC 61-903," (not dated) indicated that it was the responsibility of the Manager or the Dietitian to direct the activity, be the charge person, and make decisions regarding dietetic services.

During general food production observations on 12/7/10 at 10:35 a.m., revealed that Dietary Staff (DS C) and DS E were cutting eggplant. It was also noted that the eggplant had a large brown spot in the flesh, which were being included with the remainder of the pieces that were being cut. During a concurrent interview with DS C and DS E, they stated that the item would be used in a recipe later that day.

During an interview on 12/8/10 at 2:30 p.m., DMS A was asked to describe how he provided oversight into dietetic services. He stated that he was responsible for both dietetic and environmental services. He also stated that he usually spent time "walking through the kitchen" on a daily basis. In addition, DMS A was asked how he evaluated whether the operational processes such as food storage and preparation were implemented in accordance with hospital procedures and standards of practice. He stated that on a quarterly basis the contracted food service asked him to complete a "safety check." A copy of the evaluation was requested.

On 12/9/10 at 9:30 a.m., DMS A stated he was unable to find copies of the evaluation.

During general kitchen observations on 12/7/10 at 10:30 a.m., revealed that DMS A was not wearing a hair covering while in the food production area. On 12/7/10 at 11:55 a.m., observation revealed that the bread vendor was delivering items in the food production areas. During a concurrent interview with the bread vendor, he was asked if the hospital had ever asked him to wear a hair net in the area. He stated that he had never been asked to wear a hair covering when delivering supplies. At 1:30 p.m., observation revealed that DMS A was again not wearing a hair net. In a concurrent interview with DMS A he acknowledged he was not wearing a hairnet as he was "not used to wearing one" because he used to have a shaved head.

During general kitchen observations on 12/7 and 12/8/10 intermittently between 8 a.m. and 5 p.m., observations revealed that there were multiple kitchen areas that were not clean: 1. There were food particles in the crevices on the front part of the stove, 2. Unidentified food particles splattered on the sides of the steamer, 3. Dried food particles was on the meat slicer, 4. The dry storage bins under the food production counter were also covered with unidentified food particles. In addition, observation revealed that all of the handles of the refrigeration units were covered with a clear grease-like substance. In the cafeteria there was a build up of dust on top of the equipment, such as; 1. The soda vending machine and coffee machine. In addition, observation revealed that there was a bucket of coffee grounds in the cabinet underneath the beverage area.

During an interview on 12/8/10 at 3:30 p.m., DMS A acknowledged the unclean areas. DMS A was asked how he ensured that kitchen areas and equipment remained clean. He stated that cleaning responsibilities were incorporated into position descriptions and was done primarily on weekends.

Review of the document titled "Hazard Surveillance Department Report," dated 3/17/10, on 12/8/10, indicated that the hospital identified issues surrounding the cleanliness of the department. The department indicted that on 3/29/10, the issues were resolved. While the documentation indicated that follow up surveillance noted that the areas were clean, there was no indication that an effective system was implemented to ensure that the department remained clean.

Review of the department's cleaning schedule for 12/4/10 and 12/5/10, on 12/9/10, indicated that it was the shared responsibilities of the porter, pantry, and cooks positions to maintain the cleanliness of dietetic services areas and equipment.

Review of the policy and procedure titled "Hazard Analysis Critical Control Points," (included sanitation issues) dated 10/09, on 12/9/10, indicated that it was the responsibility of the dietary department to develop action plans with documented follow up for any areas not meeting standards. There was no documentation that an action plan was developed for the identified cleanliness issues.

During initial kitchen tour on 12/7/10 at 9:05 a.m., observation revealed that there were greater than 20 containers of various opened spices, none of which were dated. Many of the spices had invoice delivery stickers on them, one of which noted the delivery date of the allspice was 3/1997.

During an interview on 12/7/10 at 2:30 p.m., DMS A was asked to determine the delivery date of the spices with invoice stickers on them. He stated he did not know how to read the coding on the stickers, but would contact the vendor.

As of 12/9/10 at 10 a.m., DMS A did not provide additional information with respect to the delivery dates of the spices.

Review of an untitled dietetic guideline document, (not dated) for timeframe's for keeping dried goods, indicated that spices would be held no longer than 6 months once opened.

During general kitchen observation on 12/7/10, at 10:30 a.m., revealed that none of the waste receptacles in the kitchen area had lids. It was also observed that the dietary staff regularly used the receptacles to discard foods and supplies, used in food production activities. During an interview on 12/7/10 at 2:30 p.m., DMS A stated he did not know where the lids were and acknowledged that he had not identified this as an area of concern.

The standard of practice in food handling would ensure that all waste receptacles were covered to minimize the risk of cross contamination of by flies and/or rodents (Food Code, 2009).

During initial tour on 12/7/10 at 9:05 a.m. the following was observed:

In the cooks refrigerator there were multiple items, including 7 packages of opened cheese that were unlabeled and/or undated; an undated/unlabeled container identified by DS B as garlic/butter mixture; undated, thawed hamburger patties. During a concurrent interview DS B was asked to describe the amount of time that the thawed meat would be used. She stated that she would discard it if changed colors and it was, "kind of black." During a concurrent interview DMS A acknowledged that the policy was to label and date all opened items.

In the cooks freezer the following was observed; there were plastic zip lock bags of; waffles, peas, corn, carrots, mixed vegetables, onion rings and veggie burgers, that were opened and undated. There was also salami, fish filets, and French fries that were opened to air and undated.

In the glass door refrigerator, there was a carton of cream with an expiration date of 12/6 (one day prior); vegetable and clam bases, pesto, opened no date. It observed that the dietary staff was storing personal food in dietetic services refrigerators.

During a concurrent interview with DMS A he stated that the hospital provided a separate break room for hospital staff to use. He corroborated that dietary staff used the kitchen refrigerators.

In the dry storage area in the kitchen the following was observed: a container of brown rice, labeled as bread crumbs. In the main dry storage area there was a clear plastic container resembling a water jug that contained bulgur. During a concurrent interview, DMS A stated that this container was likely not intended for food storage purposes.

During review of cafeteria food storage practices and concurrent interview with DMS A on 12/7/10 at 10 a.m., DMS A was asked to describe how the hospital ensured food safety in the vending machines. DMS A stated that the items were produced in the hospital and that food safety was evaluated based on the preparation dates. In a concurrent observation there was ham and cheese sandwich with an expiration date of 12/6/10 (one day prior).

3 b. Clinical Nutrition

Review of Patient 9's record indicated that Patient 9 was admitted with diagnosis with altered mental status, cardiac problems and elevated potassium. Admission diet order was a soft cardiac diet. An admission history and physical dated 12/1/10 indicated that the patient was cachectic (muscle wasting and weight loss). The physical also noted that the patients' condition was critical and his prognosis was fair. A nursing admission assessment dated 12/1/10, documented that Patient 9 experienced a weight loss of 10 pounds in previous 1-2 months.

A comprehensive nutrition assessment, completed by the Registered Dietitian (RD), dated 12/2/10, indicated that Patient 9's height was 5 feet 7 inches and his weight was 100 pounds. The assessment also indicated that the patient's ideal weight was 148 pounds. The patient was 68% of his ideal body weight. His body mass index of 15.7 (A measurement of weight in relationship to height - Centers for Disease Control, 2010) and he had a poor intake prior to admission. The RD also classified the patient as severely underweight. The assessment also classified the patient as being at "low" nutritional risk, despite his low body weight, report of recent weight loss, and classification of being "severely" underweight. The assessment also indicated that since the patient was classified at "low" risk, a follow up visit would be completed 3-5 days later.

During an interview on 12/8/10 at 10:30 a.m., the RD was asked to describe how she determined that Patient 9 was at "low" nutritional risk. She stated that she reviewed his lab values, in particular his albumin (a measure of protein stores), which was 3.9 milligrams per deciliter (mg/dl). She stated that since she felt the lab values were adequate, he was not considered to be at nutritional risk despite other indicators of nutritional compromise, such as, appetite and weight. She also stated she followed the hospital policy and since she felt he did not fall into the "high" risk criteria per the policy, he would be "low" risk. The record lacked documented evidence of any nutritional recommendations, despite poor intake prior to admission and his severe underweight status. Indicators such as low weight and body mass index values of less than 19 are related to increased morbidity and mortality rates in the elderly population (National Institutes of Health, 2009).

Review of the policy and procedure titled "Nutrition Assessment & Reassessment," dated 10/09, indicated that patients who were less that 80% of their ideal body weight would be classified as high nutrition risk.

Patient 10 was admitted with diagnoses of hip fracture and esophageal cancer with severe dysphasia and weight loss. The admission diet order was for parenteral nutrition (nutrition through the vein) per pharmacy protocol. A comprehensive nursing admission assessment, dated 12/6/10, indicated that the patient had food allergies, experienced a significant weight loss, had chewing/swallowing difficulties, and had a high risk diagnosis of esophageal cancer.

Review of the comprehensive nutrition assessment, dated 12/6/10, which was completed by the RD, documented that the patient's height was 5 feet 2 inches; the admission weight was 100 pounds, 91% of her ideal body weight. Her albumin level was 3.2 gm/dl, and her body mass index was 18.3. The assessment also indicated that the patient's home diet was limited to liquids and that she was underweight. The RD classified the patient at "low" nutritional risk with the recommendation for a swallow evaluation.

The record contained an assessment of estimated caloric needs, however there was no assessment in relationship to the physician's order for parenteral nutritional or the high risk diagnosis. The record revealed documentation that the RD would not follow up for 3-5 days.

Review of the policy and procedure titled "Nutrition Assessment & Reassessment," dated 10/09, indicated that patients who were less that 80% of their ideal body weight would be classified as high nutrition risk.

Review of Patient 10's record indicated that Patient 10 was admitted with diagnoses of hip fracture and esophageal cancer with severe dysphasia and weight loss. The admission diet order was for parenteral nutrition (nutrition through the vein) per pharmacy protocol. A comprehensive nursing admission assessment, dated 12/6/10, indicated that the patient had food allergies, experienced a significant weight loss, had chewing/swallowing difficulties, and had a high risk diagnosis of esophageal cancer.

Review of the comprehensive nutrition assessment, dated 12/6/10, which was completed by the RD, documented that the patient's height was 5 feet 2 inches; the admission weight was 100 pounds, 91% of her ideal body weight. Her albumin level was 3.2 gm/dl, and her body mass index was 18.3. The assessment also indicated that the patient's home diet was limited to liquids and that she was underweight. The RD classified the patient at "low" nutritional risk with the recommendation for a swallow evaluation.

The record contained an assessment of estimated caloric needs, however there was no assessment in relationship to the physician's order for parenteral nutritional or the high risk diagnosis. The record revealed documentation that the RD would not follow up for 3-5 days.

Review of the policy and procedure titled, "Nutrition Assessment & Reassessment," dated 10/09, indicated that patients who had a diagnoses of the head/or neck, dysphasia, and received parenteral feeding would be classified as high risk.

During an interview on 12/8/10 at 11:30 a.m., the RD was asked how she was notified of lab values that had nutritional implications. She stated that there was no system to notify her when nutritionally related labs such as albumin were abnormal. She also stated she would likely not know until the next time she completed a follow-up with the patient, which in this case would be 3-5 days, after the initial assessment, as the patient was incorrectly classified as "low" risk.

Review of Patient 12's record indicated that Patient 12 was admitted with diagnoses including heart failure. The admission diet order, dated 12/4/10, was for a 2 gram sodium diet. A nursing admission assessment dated 12/4/10, indicated that the patient had difficulty chewing and swallowing. A comprehensive nutrition assessment dated 12/6/10, indicated that the patient was moderately underweight and classified the patient at high nutritional risk. It was also noted that the RD recommended the implementation of a nutritional supplement three times/day; however there was no physicians order for the supplement. In addition, there was documentation for the recommendation to implement a daily multi-vitamin; however there was no response from the physician regarding this recommendation

During an interview on 12/8/10 at 10:30 a.m., the RD was asked to describe the process for implementing nutritional recommendations. She stated that the physicians allowed the RDs to provide nutritional supplements as needed for whatever reason. She also stated that the medical staff and governing body approved the RD to provide supplements without physician ' s orders. The hospital was asked for documentation for approval related to the supplements. The RD was also asked how nutritional recommendations were processed. She stated that if she made a recommendation she would write it on a note and place it in the medical record. She also stated that if there was no follow-up order written for the recommended nutrition intervention, she would assume the physician did not agree. The RD was asked if she contacted physicians directly as a follow-up, if there was no order written, she replied that she did not.

Review of a document titled "Diet Orders & Alterations in Diet Orders or Diet, " dated 10/09, indicated that all Changes in diet orders must be initiated by physicians. There was no indication that the physicians allowed the RD to order nutrition supplementation without a physicians order.

During an observation on 12/7/10 at 11:45 a.m., of patient meal orders, revealed that DS C was taking a diet order for Patient 14. DS C stated that the new order for Patient 14 included encouragement of high sodium foods. She also stated that she would include special diet instructions for patients in the notes section. In a follow-up observation on 12/7/10 at 12:30 p.m., during the trayline, observation of the preparation of 14's meal tray revealed that dietary staff plated a regular meal tray. Observation revealed that there was no indication of the physician's instructions to encourage high sodium foods.

During an interview on 12/9/10 at 9:30 a.m., the RD was asked to define the diet order. She stated that foods with high sodium content would include items such as French fries. She was asked if there was guidance for dietary staff to follow these physicians ' instructions, she stated she was unsure.

As of 12/10/10 at 12 p.m., the hospital failed to provide any guidance associated with this physicians' order.

During the administrative document review on 12/8/10 at 10:30 a.m., The RD was asked to demonstrate the location of the diet manual. Observation revealed that there was no diet manuals located at either of the nurses stations.

In a follow-up interview and concurrent review on 12/8/10 at 2 p.m., with the RD, revealed that the only copy of the diet manual was in the dietary department. The diet manual was revised in 1996, with the most recent approval date of 2001.

Review of the policy and procedure titled "Diet Manual," dated 10/09, indicated that the American Diabetic Association (ADA) diet manual was the standard for nutrition care and that the manual was approved every three years. In addition, the policy indicated that the diet manuals should be located in the dietary department, the dietitian ' s office, and in the nurse ' s stations.

3 c. Organization

During administrative review of dietary processes, there were multiple issues surrounding delivery of dietetic services (Cross Reference C279, Examples 1-11).

During an interview on 12/8/10 at 11 a.m., RD was asked to describe her responsibilities in relationship to dietetic services. She stated that she had no oversight in food services, rather was hired only to provide clinical nutrition care and provide guidance to diet office staff.

During an interview on 12/8/10 at 3 p.m., DMS A was asked to describe his education and experience pertinent to serving as the director of food and dietetic services. He stated that he joined the hospital as the director of environmental services; however had a history of working in food service earlier in his career. He stated that he took a safe food handling course. DMS A was asked to provide documentation of his qualifications.

As of 12/9/10 at 10 a.m., DMS A failed to provide documentation related to his qualifications. DMS A was unable to provide verification that he possessed any of the hospital required educational certifications/registrations

During an interview on 12/8/10 at 11:40 a.m., Administrative Staff J was asked to describe the current organizational structure of the contracted dietary department. She stated that earlier in 2010, the hospital had a full time Director of Nutritional Services, as well as a full time Director of Environmental Services. She stated that in March 2010, the responsibilities were combined with the Director of Environmental services assuming responsibility for both departments.

Review of the position description titled, "Director, Nutrition and Environmental Services," (position description) dated 9/12/07, on 12/8/10 at 4 p.m., indicated that the educational requirements for the position included certification as a dietary manager or a Registered Dietitian. In addition, the position description indicated that the employee must maintain/demonstrate competencies designated in Competence Assessment Checklist, per position and policy requirements. There was no documentation that the hospital completed any competency assessment as per the position description for DMS A. During a concurrent interview, hospital personnel staff corroborated that there was no competency assessment of the contracted staff member fulfilling the responsibilities of this position.

Review of the position description titled, "Dietitian," on 12/8/10 at 4 p.m., indicated that the position summary included the responsibility to act as a liaison between the food service departments for the provision of nutritional care. The position description indicated that one of the principal accountabilities included "sanitation and regulatory responsibilities." The RD acknowledged and accepted the responsibilities on 7/29/10 by signing the position description.

During clinical nutrition review there were issues surrounding the accurate classification of patients at nutritional risk per hospital policy (Cross Reference C279 Examples 12-15).

During an interview on 12/8/10 at 4:15 p.m., Human Resources Staff O was asked to demonstrate performance evaluation, training/competency assessment of the RD. Concurrent review of the personnel file, lacked documented evidence of a competency assessment related to the functions of clinical nutrition care. Review of the continuing education coursework for the RD, indicated that the activities for the period of 2008 through 2010, were limited to coursework related to maintaining certification as a certified diabetes educator. There was no documentation of continuing education related to Foodservice or other clinical nutrition care.

Review of Patient 12 ' s record indicated that Patient 12 was admitted with diagnoses including heart failure. A nutrition assessment dated 12/6/10, indicated that the patient was moderately underweight and classified the patient at "high" nutritional risk. Documentation indicated that the RD recommended the implementation of a nutritional supplement three times/day; however there was no physician's order for the supplement.

During document review on 12/8/10 at 3:30 p.m., the hospital presented a policy and procedure titled "Diet Orders & Alterations in Diet Orders or Diet, " dated 10/09. Documentation indicated that the hospital allowed nursing and registered dietitians to change consistency to diets. The implementation of this policy did not ensure that all therapeutic diets be prescribed by the practitioner responsible for the care of the patient.

Review of the training program of dietary staff was evaluated on 12/9/10 at 8 a.m. During a concurrent interview, DMS A was asked to provide the educational programs for dietary staff. He stated that he did not have a program; however any training that was completed would be in each employees personnel file.

Review of the documents provided by the human resources on 12/9/10 at 8:30 a.m., indicated that while the hospital had a training program for general hospital topics such as sexual harassment in the workplace, workplace violence and corporate compliance, there was no documentation that there was a training program for dietary staff related to the scope and activities within the department.

Based on administrative and dietary staff interview, and dietary document review, the hospital failed to ensure comprehensive evaluation of the contracted vendor responsible for the operations of the Nutrition Services Department. The lack of evaluation of contracted services may result in operations that would not meet the nutritional needs of inpatients and further compromising the inpatients medical status.

Findings:

During review of dietetic and clinical nutrition services from 12/7/10 - 12/9/10 surrounding clinical nutrition services and dietetic services that were provided through a contracted vendor were identified (Cross Reference 279).

During an interview on 12/8/10 at 11 a.m., Administrative Staff K was asked to describe how the hospital ensured the effectiveness of contracted services. She stated that contracts were evaluated by the manager of the department.

During an interview on 12/8/10 at 3:30 p.m., DMS A (The representative of the contracted vendor), was asked to describe how he evaluated the effectiveness of the contract that he represented. He stated that in the past he provided administrative staff with accomplishments of the department.

Review of a document titled, "2009 Accomplishments Food & Nutrition Services," on 12/9/10 at 9 a.m., indicated that the accomplishments outlined were financial, community, technology, people, patient satisfaction and service. In addition, the document was primarily a list and did not evaluate the effectiveness of the accomplishments. This document was provided by the contracted vendor, rather than an evaluation by hospital administrative staff.

In a follow up interview on 12/8/10 at 12 p.m., with Administrative Staff K she acknowledged that the hospital had not fully evaluated the effectiveness of the nutrition services contract.

Based on staff interview, document review, policy and procedure review, and record review, the hospital failed to comply with the requirement that records are legible in 6 of 21 records reviewed.

Findings:

Review of the records of Patient 51, 52, 54, 60, 65, and 71, on 12/7/10 and 12/8/10, indicated that they contained one or more illegible notes entered by physicians, and the record of Patient 60 also contained one illegible order entered by a physician.

During an interview on 12/8/10 at 11:45 a.m., Licensed Staff H acknowledged that she could not decipher the physician's handwriting entered on the preoperative history and physical (H&P) examination reports for Patient 51 and Patient 52. On 12/8/10 at 11:55 a.m., Licensed Staff I acknowledged that she could not read the physician's handwriting entered on the H&P report for Patient 71.

Review of the hospital rules and regulations, page 12, on 12/8/10, indicated that the requirement is that progress notes shall be legible.

Review of policy and procedure titled "Legibility of Medical Record Entries," indicated that all healthcare documentation in the medical record must be legible to hospital staff and medical staff.

Based on staff interview, record review, and document review, the hospital failed to ensure: 1. That there is compliance with the requirement for documentation of a complete medical history and physical assessment, performed by a physician within 30 days prior to surgery in 4 of 21 records reviewed. This failure had the potential of affecting patient care in cases when conditions that might preclude surgery were not recognized, and 2. That patient records accurately reflected the patients allergies. This failure had the potential to cause a patient to be given a medication the patient was allergic to and develop a severe adverse reaction.

Findings:

Review of the records of Patient 51, 52, 65, and 71, on 12/7/10 and 12/8/10, revealed that the preoperative history and physical (H&P) examination reports were absent one or more of the required components for a complete assessment: history of present illness (required to verify the need for surgery), past medical history, allergies, medications, and review of systems (all to facilitate the provision of optimal care), and appropriate physical examination (to rule out physical conditions that could place the patient at increased surgical risk).

During an interview on 12/8/10 at 12 p.m., Administrative Staff Z pointed out that a preoperative nurse documents each patient's diagnosis, planned procedure, allergies, medications, review of systems, prior surgery, medical history, and vital signs, and the anesthesiologist performs and documents an appropriate physical exam before the patient enters the operating room.

Review of the hospital's rules and regulations (page 16) on 12/8/10 at 2:00 p.m., indicated that the requirement is that the attending physician who must place a history and physical examination (H&P) report that has been completed within 30 days preoperatively in the patient's chart before the patient is taken to surgery. The H&P shall contain the following elements (page 11): chief complaint, present illness, relevant past history to include relevant social and family history, list of current medications, inventory of body systems relevant to diagnosis and procedure, conclusions/diagnostic impressions, and statement of course of action planned for the patient. According to the rules and regulations, it is the responsibility of the attending physician to perform the H&P and the responsibility should not be delegated to the preoperative nurse and/or the anesthesiologist.



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Review of Patient 1's record on 12/7/10 at 10:17 a.m., indicated an Allergy sticker on the front of the record. Written on the sticker was "NKDA" which indicates that the patient does not have any known drug allergies. This indicated that the patient was not aware of any allergies she had. Review of the Patient Medical Re-order Form dated 12/5/10, indicated that the patient had drug allergies to the following medications: Codeine and Darvon (both are for controlling pain.).

During an interview on 12/8/10 at 10:25 a.m., Licensed Staff (LS G) was asked about "NKDA" on the cover of Patient 1's record and on the Patient Medical Re-order Form dated 12/5/10, inside of the record that documented that the patient had allergies to Codeine and Darvon. LS G stated that usually the unit secretary reviews the emergency department's notes and then writes the information on the source of medication list, in the record. LS G stated that the documentation should be consistent in the patient's record and the "allergy" sticker on the outside of the patients records should not only be consistent with what was in the record but also accurate. He stated, "its wrong, it shouldn't have been written like that."

Review of Patient 2's record on 12/7/10 at 11:05 a.m., indicated an Allergy sticker on the front of the record, which documented that the patient was allergic to the medications: morphine (an opioid analgesic) and Vicodin (a pain medication that contains acetaminophen (Tylenol) and hydrocodone). Review of the Patient Medication Re-order Form, indicated a physician's written order for Tylenol 650 milligrams, every 4 hours as needed to control pain, not to exceed 4 grams in 24 hours.

During an interview on 12/8/10 at 10:20 a.m., LS G was asked about the physician's written order for the Tylenol and Vicodin, LS G stated he remembered that the patient was allergic to the chemical "hydrocodone" the second ingredient in Vicodin. LS G said that the patient had told him that.

Continued review of the record lacked documentation that indicated that the patient was allergic to hydrocodone. During a concurrent interview, LS G was asked to provide documentation that the patient was allergic to hydrocodone and not the Tylenol. LS G was unable to locate it. He stated he thought he had written it down but apparently didn't.

Review of Patient 3's record on 12/8/10 at 8:40 a.m., indicated that there was an Allergy sticker on the cover. The Allergy sticker indicated that the patient was allergic to sulfa. Review of the Patient Medication Re-order Form, in the record, indicated that the patient had allergies too two medications: Haloperidol (an antipsychotic) and sulfa.

Review of the policy and procedure titled, "Administration of Medications," dated 12/10, on 12/8/10, indicated that the licensed nurse on admission will ask the patient and/or family about medication allergies. The drug and their reaction are recorded in the assessment and the information is forwarded to the pharmacist via the computer.

Review of the, "American Journal of Nursing," July 2007, Volume 107 Number 7, pages 58 - 60; Documentation Part 1, indicated under the heading of preserving the Medical Record that regardless of the practice setting, nurses must preserve the integrity of the medical record in the following ways. Accurate and complete patient information must be entered on all paper and electronic documents."

Based on staff interview, record review, and document review, the hospital failed to comply with the requirement that all entries in the medical record be dated and timed in 7 of 21 records reviewed. This had the potential for affecting patient care that might depend on timeliness of response to entries.

Findings:

Review of records on 12/7/10 and 12/8/10, revealed the following:

1. Patient 52's record contained 2 untimed physician orders and 2 untimed physician entries.

2. Patient 54's record contained 5 untimed physician entries.

3. Patient 60's record contained 7 untimed physician orders and 3 untimed physician entries.

4. Patient 61's record contained 5 untimed physician orders and 3 untimed physician entries.

5. Patient 65's record contained 1 untimed physician order and 1 untimed physician entry.

6. Patient 66's record contained 2 untimed physician entries.

7. Patient 71's record contained 1 untimed physician entry.

Review of hospital rules and regulations dated 8/10 on 12/7/10, page 12, indicated that the requirement is that the progress notes shall be legible, signed, dated, and timed and on page 17, that signed, dated, timed progress notes shall be entered at least daily. In addition, on page 27, is the requirement that each drug order shall be dated and timed.

Review of the 7/6/10 medical executive committee on 12/8/10, indicated that the committee recommended that all handwritten physician entries be required to include date, time, and legible signature.

During an interview on 12/7/10, Administrative Staff TT stated that during medical record review for completion 15 days after discharge, if the only issue with the record is that orders are not timed, the record is not considered delinquent.

Based on dietary management staff interview, and administrative 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 12/8/10 at 9:30 a.m., the quality appraisal and performance improvement (QAPI) activities were reviewed. In a concurrent interview with DMS A he stated that the only performance improvement activity was related to customer service activities.
During an interview on 12/8/10 at 11 a.m., Administrative Staff K, a member of the hospital's Quality Assurance Performance Improvement (QAPI) committee, was asked how the hospital ensured the development of departmental improvement programs. 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 also stated that departments would choose their own project and the committee would have the expectation that the projects chosen reflect the scope of the department.
Review of the dietary department's QAPI activities for 2010, on 12/8/10 at 5 p.m., indicated that the single activity presented was the delivery time of patient meal trays revealing that the department was consistently meeting departmental parameters. There was no documentation that the hospital was addressing any opportunities for performance improvement. In addition, documentation revealed that there were no clinical nutrition performance improvement activities. There was no program provided to ensure the QAPI program was developed for the scope of the hospital food and clinical nutrition areas.
Review of the document titled, "Dietary Department Performance Improvement," dated 10/09, indicated that while the department had a policy intended to identify activities and develop processes for potential areas of improvement there was no documentation that the presented project was deemed to be a problem rather than monitoring of delivery timeframes.

Based on observation, patient and staff interview, record review, and policy and procedure review, the hospital failed to ensure that 1 of 6 patients (Patient 2), was free from physical restraints as evidenced by a physician order for all four side rails to be placed in the upward position, at all times, when the patient was in his bed. This had the potential for the patient to injure himself in attempts to escape the restraints.

Findings:

During an observation on the Medical/Surgical nursing care unit on 12/7/10 at 11:35 a.m., observations revealed that Patient 2 was in his room in his bed. The bed had all four side rails in the upward position. All four side rails were up during the remainder of the survey, 12/8/10, and 12/9/10.

Review of Patient 2's record on 12/7/10 at 11:45 a.m., indicated that the patient was readmitted to the hospital on 11/26/10, as an extended care service patient (patient's that require longer period of stay after acute care). The patient's record indicated that the patient's diagnosis was abscess of the cervical spine. The Interdisciplinary (IDT) notes indicated that the patient was fidgety and at times agitated. Review of the Shift Assessment Record dated 11/26/10, indicated that the patient could not bear weight on both legs. The history and physical (H&P) exam dated 11/20/10 indicated that the patient had loss of balance and required physical therapy.

The IDT notes indicated that on 12/1/10 at 11:35 a.m., the patient was calling for help and was found on the floor. The attending physician was notified and the following order was received at 11:45 a.m., "Keep pads on all four side rails and keep all four side rails up." The order failed to provide a reason for the side rails and there was no documentation in record to indicate justification for the physician's order for all side rails to be in an upward position. The record also indicated that on 12/4/10 at 11:45 p.m., the patient had multiple attempts to get out of bed in the evening.

On 12/8/10 at 10:15 a.m., Student Nurse B was observed providing care to Patient 2, at 11: 58, on the same day, the student nurse was questioned why Patient 2 had his side rails up. She stated that the patient got agitated at times and would "scoot" out of the bed.

During an interview on 12/8/10 at 4:30 p.m., Charge Nurse G was asked about Patient 2's record and the policy and procedure. Charge Nurse G was asked about whether or not the hospital had followed a systematic process of evaluation and care planning prior to the use of the side rails as restraints for Patient 2. She was asked if the patient was informed and had signed consent for the use of the side rail. She was asked to locate any documentation which provided justification for the physician's order for side rails. Charge Nurse G reviewed Patient 2's record and did not locate that information. Charge Nurse G was asked if a care plan had been developed specifically for the use of the side rails. The nurse stated there was no care plan for the use of the side rails. When asked if the hospital had followed a process, which involved less restrictive measures, such as lowering the bed and placing a pad on the floor next to the bed. She stated that a bed alarm and personal alarm was applied and the patient continued to use it. There was no documentation located in Patient 2's record to show that monitoring of the patient was done while the patient was restrained.

During an interview on 12/9/10 at 8:55 a.m., Administrative Staff M stated that staff was not aware the side rails were considered restraints.

During an interview on 12/9/10 at 10:25 a.m., Patient 2 (with staff present) was asked he knew why he had all four side rails up in his bed. The patient stated, "They told me it was for safety."

During an interview on 12/9/10 at 10:40 a.m., Physical Therapist (PT N) was asked why Patient 2 had all four side rails up at all times. The PT N stated that the patient had rolled himself out of bed one day. When asked if the patient had a diagnosis that would warrant the use of the side rails restraints, he stated that the patient had no physical diagnosis to warrant the use of the restraints and stated he believed the patient could have a behavioral problem that would warrant the use of the side rail restraints but did not elaborate on this. PT N stated that a few days ago, the patient had asked when the side rails would be removed and he said he reminded him of the time he (Patient 2) hit his knee.

Review of the policy and procedure titled "Restraints & Seclusion," dated 6/2009, on 12/9/10, indicated that whenever staff must use restraints they will use the least restrictive device and explore all possible causes for patient behavior and cognitive state. In addition, the rationale that a patient should be restrained because he/she "might" fall is an inadequate basis for using four side rails. When assessing the care planning for the patient, consider whether he/she has a history of falling or a medical condition or symptom that indicates a need for a protective intervention.