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101 CITY DRIVE SOUTH

ORANGE, CA 92868

PATIENT RIGHTS: CARE IN SAFE SETTING

Tag No.: A0144

4. On 2/23/12, a review of the hospital's P&P titled: Administrative Procedure with Regard to Treatment of Adults on an Adolescent Unit showed, no one 18 years or older, would be admitted to the Adolescent Unit. Consequently, the P&P showed minors under the age of 16 years were not admitted with adults receiving psychiatric treatment.

On 2/23/12, an interview with the Director of Neuropsychiatry (DNP) showed there was and still an ongoing practice of admitting 18-year-olds to the Adolescent unit. The DNP stated, with consultation and input of multiple mental health agencies, the decision was made to stop admitting 18-year-olds to the Adolescent Unit.

The DNP stated there was a corrective action taken with a directive to admitting physicians and nurse managers to immediately stop admission of 18-year-olds to the Adolescent unit. The DNP added revision of the existing Administrative Procedure with regard to Treatment of Adults on an Adolescent unit was in process.

Review of the list of 18-year-old patients showed two patients admitted to the Adolescent Unit.

Patient A was admitted to the Adolescent unit on 11/8/11. Patient A's date of birth was 9/5/93. Patient A would be 19 years old by 9/5/2012.

Patient B was admitted on 1/4/12. Patient B's date of birth was 3/30/93. Patient B would be 19 years old by 3/30/2012.

The attending psychiatrist notes were documented to admit Patient B to the Adolescent Unit for care and treatment.



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Based on observation, interview, the hospital failed to ensure one of eight patients (Patient 87) observed during the tour of ICU and Stepdown areas had received adequate oral care. This could potentially affect the patient's comfort as well as potentially result in the patient contracting a respiratory infection. The hospital failed to prevent the admission of 18-year-old patients to the Adolescent Unit which could possibly jeopardize physical and emotional health of the adolescent patients admitted there.

Findings:

1. In the CDC's GUIDELINES FOR PREVENTING HEALTH-CARE ASSOCIATED PNEUMONIA 2003, references were made to the role of bacterial growth in the oropharynx area as one of the potential sources for hospital acquired pneumonia. As a result of studies and the high mortality rate associated with hospital acquired pneumonias, the CDC recommended, as one component to reduce hospital acquired infections, that hospitals develop and implement a comprehensive oral-hygiene program for patients in acute-care settings (hospitals) who are at high risk of developing health-care-associated pneumonia.


On 2/22/12 at 0845 hours, the Surgical Stepdown Unit was toured. Patient 87 was observed in bed with a tracheostomy tube (a tube placed in an opening in the neck to assist with breathing) connected to oxygen. The surveyor requested the Charge Nurse, RN Gg, bring a flashlight to check the patient's mouth for oral care. The entire top of the patient's palate was covered with thick yellowish matter that was hardened. At 0915 hours, RN Hh, the RN caring for the patient, was interviewed. RN Hh stated the patient was able to receive oral care and from the appearance of the patient's mouth, according to RN Hh, the patient had not received oral care, at the least, over the past 24 hours.

2. On a bedside table in Patient 82's room there was a piston syringe in an irrigation container. There was no date on the syringe or container. When asked about the container and syringe, RN Ff stated it was to irrigate the patient's gastric feeding tube and contained tap water. When asked how often it was to be changed, RN Ff stated daily and added that the container should be dated.

3. Also in Patient 82's room, along the wall by the head of the bed, there were outlets for suction and oxygen. The suction tubing connected to the suction receptacle was on the floor and an oxygen mask was also on the floor.

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0166

Based on interview and record review, the hospital failed to ensure the assessments of the patients' need to continue medical restraints were documented in the medical record for two of 11 patients with restraints (Patients 121 and 122). This could potentially result in a patient being restrained unnecessarily.

Findings:

Review of the hospital's P&P for Patient Care Related: Seclusion and Restraints, effective 9/10, showed at the end of each day and each night for a patient who was medically restrained, the RN would evaluate the patient to determine if the patient met the indications for continued restraint.

A review of Patient 121's medical record showed the patient had the restraints initially applied on 2/1/12. There was no nursing evaluation documented regarding the need to continue restraints at the end of day shift for the dates 2/5/12, 2/8/12, 2/12/12 or 2/20/12. There was no documentation of a nursing evaluation on 2/5/12 for the night shift.

Review of Patient 122's medical record showed the patient initially had the restraints applied on 1/26/12. There was no nursing evaluation documented regarding the need to continue restraints at the end of day shift for the dates 2/7/12, 2/10/12 and 2/16/12. Additionally, there was no documentation of nursing evaluation on 2/10/12, 2/11/12, 2/17/12 and 2/22/12 for the night shift.

The findings for both patients were verified by Administrative RN III who assisted with the medical record review.

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0169

Based on interview and record review, the hospital failed to follow the P&P for restraints by failing to obtain physician orders for restraints prior to reapplication of the restraints for one of eleven patients with restraints (Patient 121). This could potentially affect the patient's rights to be restraint-free.

Findings:

Review of the hospital's P&P for Patient Care Related: Seclusion and Restraints, effective 9/10, showed each episode for restraint shall be initiated upon the order of a physician or house staff.

On 2/23/12, a review of Patient 121's medical record showed an initial physician order for restraints was written on 2/1/12. On 2/14/12 at 1500 hours, the medical record showed, in the patient restraint section, the patient's restraints were discontinued. On 2/15/12 the patient restraints were reapplied to Patient 121. There was no physician order to reapply the restraints. This was verified by Administrative RN III who assisted with the record review.

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0176

Based on interview and record review, the hospital failed to ensure one of one Licensed Independent Practitioner (LIP) interviewed was knowledgeable of restraint requirements as defined in the hospital's P&P for restraints. This could potentially lead to the LIP/Practitioner being unaware a patient was restrained.

Findings:

The hospital's P&P for Patient Care Related: Seclusion and Restraints, effective 9/10, showed physicians' orders for restraints not used for the management of violent or self-destructive behavior should remain in effect until the indications for restraints were no longer met.

On 2/23/12 at 0930 hours, Physician Assistant D (PA D) was interviewed. PA D stated one of his duties was to write physician orders. When asked about patient medical restraints, PA D stated an order for restraints was required every day or to discontinue the restraints. PA D was unaware of the 2010 Restraint P&P change involving the physician's order for restraints would remain in effect until the indications for restraint were no longer met.

MEDICAL STAFF ORGANIZATION & ACCOUNTABILITY

Tag No.: A0347

Based on interview and record review, the hospital failed to ensure triglyceride levels were ordered by the physician for two patients (Patients 91 and 92) prior to the initiation of total parenteral nutrition (intravenous feeding) in accordance with hospital policy. The failure had the potential to affect the patient's medical status by not knowing the initial and essential triglyceride guideline levels.

Findings:

According to the hospital's policy entitled ENTERAL NUTRITION SUPPORT, on page 5 of 7, physicians were responsible for the ordering of "comprehensive metabolic panel, hepatic function panel plus Magnesium, Phosphorus and Triglycerides prior to initiation of TPN (total parenteral nutrition)..."

1. On 2/22/12 at 1300 hours, Patient 91's medical record was reviewed. On 2/21/12, a physician ordered parenteral nutrition which included "fat emulsion 20% 250 mL infuse at: 16 mL/hour." On 2/21/12, the physician also requested a nutrition consult be completed for Patient 91.

On 2/22/12, a RD completed a nutrition consult per physician's order and included a recommendation to order a triglyceride level.

On 2/22/12 at 1310 hours, RD II reviewed Patient 91's electronic medical record (EMR). The RD stated there was no triglyceride lab value ordered for Patient 91.

2. On 2/22/12 at 1330 hours, Patient 92's medical record was reviewed. Patient 92 was admitted to the hospital on 1/24/12, due to small bowel obstruction per the physician's dictated history and physical examination.

Review of the physician's orders dated 1/26/12, there was an order for parenteral nutrition which included fat emulsion 20% 250 mL Infuse at: 16 mL/hour.

According to the EMR, triglycerides were ordered for Patient 92 on 2/1/12. RN Gg reviewed Patient 92's medical record and verified a triglyceride lab value was not obtained prior to 2/1/12.

RN SUPERVISION OF NURSING CARE

Tag No.: A0395

Based on observation, interview and record review, the hospital failed to ensure one of two patients (Patient 76) reviewed for tube feedings received formula in accordance with the physician's orders. This had the potential to compromise the patient's medical status. In addition, the hospital failed to ensure RNs followed physician orders for the administration of intravenous (IV) insulin for three of five patients (Patients 81, 99 and 100) reviewed for IV insulin. As a result, the patients' blood sugars were not maintained between 100 and 150, a goal established in the hospital's IV Insulin Guideline (IIG).

Findings:

1. On 2/22/12 at 0905 hours, a medical record review was conducted for Patient 76. On 2/17/12 at 2107 hour, according to the EMR (electronic medical record), a physician ordered "Jevity 1.2 cal via nasogastric feeding tube; continuous feeding start rate 30 mL per hour; rate increase 10 mL every 6 hours; goal rate 70 mL per hour; water flush volume 25 ml every 6 hours."

According to Patient 76's flow sheet, Patient 76 began to receive the tube feeding on 2/18/12. According to Patient 76's flow sheet dated 2/19, 2/20, and 2/21/12, the patient received "Twocal" formula, and not the physician's order for Jevity 1.2.

Patient 76's medical record indicated that a nutrition assessment was completed by a RD on 2/21/12. According to the nutrition assessment, the RD observed that "Twocal @ 70 ml/hour" was provided to the patient. The RD documented Patient 76 had received 3,360 calories and 140 grams of protein from the twocal formula that had been provided at 70 ml/hour. The RD initially assessed Patient 76's estimated nutritional needs, on 2/16/12, to be between 1, 710-2, 140 calories per day, and between 61-92 grams of protein per day. The RD assessment completed on 2/21/12 remained at the same estimated calorie and protein needs per day, as determined on 2/16/12.

According to Patient 76's lab report located in the EMR, dated 2/18/12, the patient's BUN (blood urea nitrogen - a protein waste product), was 20 (normal range used by the hospital - 8-26 MG/DL). On 2/18/12, Patient 76 began to receive tube feeding. On 2/19/12, Patient 76's BUN level was 26. By 2/20/12, Patient 76's BUN level was 28.

On 2/21/12, a recommendation provided by the RD as indicated on the nutritional assessment was to provide the physician's order of Jevity 1.2 @ 70 ml per hour x 24 hours per day which would provide 2,016 calories and 93 grams of protein per day, 47 grams of protein less a day than the patient had received.

On 2/22/12 at 0952 hours, RN Cc reviewed Patient 76's medical record and verified that there had never been a physician's order to provide twocal formula, and that Jevity 1.2 should have been provided. RN Cc stated that the food and nutrition department provided the formula to the nursing unit with the patient's name individually attached to the formula.

RN Ee acknowledged that the nurses should have ensured that the formula provided to Patient 76 was in accordance with the physician's order.



27873

2. For Patient 81, blood sugar (BS) levels were not measured according to physician orders. As a result, IV Insulin rates were administered incorrectly on 4 occasions. Further, the IV insulin was discontinued by an RN without a physician's order.

Incorrect doses of IV Insulin could result in unmanageable high and low spikes in patients' BS. This could result in being unable to properly treat a patient's Diabetes. Cross Reference A405 #3.

3. For Patient 99, IV Insulin rates were administered incorrectly on 6 occasions. Further, the BS was not measured as ordered at 2400 hours on 2/16/12. Cross Reference A405 #1.

For Patient 100, the BS was not measured as ordered on 3 occasions. The IV Insulin rate was administered incorrectly on 6 occasions. Cross Reference A405 #2.

SUPERVISION OF CONTRACT STAFF

Tag No.: A0398

Based on interview, medical record review, and administrative document review, the hospital failed to show documentation one non-employee traveler RN (RN Ii) had passed the hospital's medication administration competency exam to ensure the RN followed the hospital's P&P for the administration of medications prior to being allowed to administer medications to patients independently. This resulted in RN administering a medication Patient 123 that was ordered for her roommate. The medication, methadone 10 milligrams was a potent painkiller for the relief of moderate to severe pain. Patient 123 became drowsy and unarousable, and required mechanical assistance in breathing and transfer to the ICU. Patients who receive potent narcotic medications with no history of taking them in the past, such as Patient 123, were at increased risk of serious side-effects or even death.

Findings:
The hospital's Maintenance and Administration of Medications Policy required staff under Administration #10: "Identifies correct patient by checking two sources of information in accordance with the Patient Identification Policy." Also, under #14: "Just prior to administration, compares the medication to the order and adheres to the rules of right: right patient, right drug, right dose, right time, right route, right indication, and follows with the right documentation."

On 2/22/12, review of Patient 123's medical record showed on the morning of 1/17/12, Patient 123 was found drowsy, unarousable, and not her normal self. Patient 123 stated she began to feel very drowsy after being given a medication by her nurse at 0300 hours. The patient's respiration rate (number of breaths per minute) slowed from 16 (normal) to six (dangerously low). The patient's SP02 (measure of oxygen in the blood - normal =95) fell to the low 90's. Patient 123 required emergency intubation (a procedure performed when a patient cannot breathe on their own and a tube is inserted through the mouth into the trachea, the airway from the mouth to the lungs) for airway protection and oxygenation. The patient was subsequently transferred to the ICU. Patient 123 had no previous history of taking pain killers. The patient remained in the ICU for over 48 hours.

Review of hospital documents showed on 1/19/12, RN Ii was contacted by the Chief Nursing Officer (CNO) and was interviewed on 1/20/12. There was no documentation in the MAR (Medication Administration Record) to show methadone was administered to Patient 123 or her roommate on 1/17/12 at 0300 hours.

During an interview on 2/22/12 at 1312 hours, the CNO stated RN Ii did not follow the hospital's medication pass protocol to verify the identity of the patient before administering the medication. The ADC record (medication storage cabinet that retains information on who retrieved what medication, for what patient, including the date and time the transaction was completed) showed RN Ii removed a methadone 10 milligram tablet for the correct patient, Patient 123's roommate; however, the medication was given to Patient 123 by mistake.

On 2/22/12 at 1317 hours, the CNO stated all nurses including RN Ii, who was a traveler nurse, underwent standard administration competency exams; however this exam was missing from RN Ii's competency file. The CNO stated, "it must be in a file somewhere, I will get back to you."

On 2/23/12 at 0918 hours, the CNO stated she was unable to find the competency exam form signed off to show RN Ii completed and passed the medication administration competency requirements prior to being allowed to administer medications to patients independently.

No Description Available

Tag No.: A0404

Based on medical record review, the hospital failed to show documented evidence that a second RN double checked expressed breast milk prior to administration to an infant in the NICU as per hospital P&P. The failure could potentially expose newborn infants to infectious diseases from an unknown source in the event an infant was administered breast milk from another mother not his own. In addition, the hospital failed to follow their policy and procedure for the labeling of IV solution for one of eight patient's observed (Patient 82). Failure to properly identify and label drugs/biologicals could potentially compromise patients' medical status such as severe allergies and infection.

Findings:

1. On 2/21/12, review of the hospital's P&P titled Expressed Breast Milk Collection, Storage and Utilization, revised on 4/10, showed prior to transfer of breast milk to any other feeding container and before administration, the breast milk would be verified with a scanner machine. The P&P showed that in the absence of a scanner machine, all breastmilk must be double checked by another RN.

On 2/21/12 at 1422 hours, during interview, the NICU Nurse Specialist stated the nurse double checked the label breast milk container with another RN prior to administering to an infant. When asked to show how the double check procedure was documented, the Nurse Specialist showed a check mark made in the "MOM (mothers own milk) double check" column on an infant's flowsheet. When asked how the second RN that checked the breast milk could be identified, the Nurse Specialist was unable to state.

On 2/22/12 at 0928 hours, when asked the double check procedure to ensure the right breast milk was administered to the right patient, RN U stated the scanner was preferable. The RN stated however, the scanner had not been functioning. RN U stated the nurse would ask another nurse to double check the breast milk label matched the infant's identification band at the bedside. When asked how the nurse who did the double check was documented, RN U stated it was not documented. When asked who documented the check mark for the breast milk double check, RN U stated the nurse who fed the baby.

On 2/22/12 at 1102 hours, during an interview, the Director of Women and Children's Services stated staff had not used the scanner for two months as the scanner printer could not print the documentation of the scanning result.



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2. The hospital's P&P for Intravenous Therapy, effective 12/11, showed IV solutions would be labeled with the date when it was initially hung.

On 2/21/12, during a tour of the Surgical Intensive Care Unit, Patient 82's room was randomly observed. One IV bag failed to have the date indicating when it was hung. RN Ff stated the date and time should be on the IV bags.

ADMINISTRATION OF DRUGS

Tag No.: A0405

Based on interviews and record reviews, the hospital failed to ensure that nurses (RN ' s) followed physician orders for 3 of 5 sampled patients on intravenous (IV) Insulin. (Patients 81, 99 and 100). RN ' s failed to:
* For Patient 99:
a) Measure blood sugar (BS) levels as ordered.
b) Administer Insulin as ordered.
*For Patient 100:
a) Measure BS levels as ordered.
b) Administer Insulin as ordered.
*For Patient 81:
a) Measure BS levels as ordered.
b) Administer Insulin as ordered.



Findings:

1. Patient 99 ' s record was reviewed on 2/21/12 starting at 1430 hours with the CNO, the SICU Manager and RN Aa. Patient 99 was admitted to the Emergency Department (ED) on 1/25/12 and was diagnosed (among others conditions) with Congestive Heart Failure, Chronic Obstructive Pulmonary Disease (difficulty in breathing), high blood pressure, End Stage Renal Disease (failing kidneys) and Diabetes. He was transferred to the Surgical Intensive Care Unit (SICU) on 1/25/12.

IV Insulin was ordered on 2/14/12 using the Insulin Infusion Guideline (IIG). The IIG also required a BS level to be measured every hour. The IIG was not implemented for Patient 99 in the following instances:
a) At 1100 hours on 2/15/12 his BS was 321. According to the IIG he received a bolus (a dose given all at once) of 12 units of Insulin and an IV rate of 6.5 units of Insulin per hour as ordered by the IIG.
b) From noon through 1500 hours the dose remained at 6.5 units per hour according to the IIG.
c) At 1600 hours Patient 99 ' s BS measured 136 which was 33 points below the BS measured at 1500 hours. According to the IIG the Insulin dose should have been reduced by 50% (to 3.25 units per hours) and to recheck the BS in 30 minutes. Instead, the IV Insulin was discontinued (the pump was turned off). This was confirmed by the CNO, the SICU Manager and RN Aa.
d) At 1630 hours Patient 99 ' s BS was 158, 22 points higher than at 1600 hours. According to the IIG, the Insulin rate should have been changed to 4.25 units per hour. Instead, the RN restarted the IV Insulin at 3.25 units per hour.
e) At 1700 hours Patient 99 BS was 141, 17 points lower than at 1630 hours. According to the IIG, the Insulin rate should be lowered by 0.5 to 3.75 units per hour. Instead the RN changed the dose to 2.75 units per hour.
f) A chest X-Ray was ordered at 1800 hours so the patient went down to Radiology and the IV Insulin was stopped for the procedure. The IV Insulin was started at 2100 hours correctly at 2 units per hour.
g) All subsequent rates were administered as ordered until 240 hours on 2/15/12. Patient 99 ' s BS measured 129 at that time, 46 points below the BS at 2300 hours. According to the IIG, the IV Insulin should have been stopped and the BS rechecked in 30 minutes. Instead, the RN continued the IV Insulin at 2 units per hour and did not recheck the BS until 0100 hours.
h) At 0100 hours Patient 99 BS was 151. According to the IIG, if the BS rose above 130, the IV Insulin was to be started at 50% of the previous rate. The previous BS measurement and rate used should have been at 2300 hours (since the Insulin should have been stopped at 2400 hours.) At 2300 the BS was 175 and the IV Insulin rate was at 4 units per hour. Thus, the rate at 0100 hours should have been 2 units per hour (50% of the 4 units per hour at 2300. hours). Instead, the RN started the Insulin rate at 3 units per hour.
i) At 0200 hours the BS was 144 and according to the IIG, the Insulin should have remained at 2 units per hour. Instead the Insulin rate remained at 3 units per hour. All the following Insulin rates were also contrary to the IIG orders as they were based upon an incorrect starting rate.
At no time was there any evidence of a discussion with a physician to provide notification of Insulin rates which were contrary to the IIG or to request a new order. This was confirmed by the CNO and the SICU Manager.

2. Patient 100 ' s record was reviewed starting at 0950 hours on 2/22/12 with a Clinical Specialist and Pharm II who provided the following information:

Patient 100 was admitted to the ED at 2047 hours on 2/11/12 and diagnosed with an Intracranial Hemorrhage (bleeding in the brain). A surgical procedure was performed and the patient was sent to the Neurosurgery Unit.
a) At 0435 hours Patient 100 ' s BS was measured at 356.
b) At 0557 hours IV Insulin was ordered using the IIG. A 12 unit bolus of Insulin and 6.5 units per hour was administered which complied with the IIG.
c) At 0803 hours Patient 100 ' s BS was 248, 108 points below the BS at 0435 hours. (There was no BS documented at 0700 as required by the IIG.) The IV Insulin rate was continued at 6.5 units per hour. However, the IIG indicated that the IV Insulin rate should have been lowered by 50% to 3.25 units per hour.
d) At 0940 hours (which should have been at 0900 hours according to the IIG) the BS was 175, 73 points below the BS at 0803. The Insulin rate was lowered to 3.25 units per hours. According to the IIG, the IV Insulin should have been stopped, to recheck the BS in 30 minutes and to restart the Insulin at 50% of the previous rate if the BS was greater than 150.
e) At 1000 hours the BS was 194, 19 points higher than at 0940 hours. The Insulin rate was lowered to 3.25 units per hour. However, according to the IIG, the Insulin rate should now be at 1.625 units per hour.
f) At 1206 hours (the next BS should have been at 1100 hours), the BS was 150, 44 points lower than at 1000 hours. The Insulin was stopped correctly. Also, according to the IIG, the BS must be rechecked in 30 minutes and the Insulin restarted at 50% the previous rate (which was 1.625 units per hour) if the BS was greater than 130.
g) At 1237 hours the BS was 162, 12 points higher than at 1206 hours. The Insulin rate was restarted at 3.12 units per hour. According to the IIG the Insulin rate should have been restarted at 0.812 units per hours (50% of 1.625).

Patient 100 ' s record showed that his BS never remained stable between 100 and 150 which is identified as a goal in the IIG. Once an error is made in the Insulin rate, the incorrect rate continues on unless the RN speaks with the physician to write a new order. There was no evidence in Patient 100 ' s record that the physician was contacted or a new order was written. This was confirmed by the Clinical Specialist and Pharm II.

3. Patient 81 ' s record was reviewed starting at 1430 hours on 2/22/12 with RN Bb, Pharm IV and the SICU Manager. All provided the following information:

Patient 81 was admitted to the ED on 2/20/12 at 0113 hours with a gunshot wound to the head. Insulin was ordered to titrate according to the IIG.
a) At 1300 hours on 2/20/12, Patient 81 ' s BS was 143. 1 unit of insulin per hour and a 1 unit bolus was administered as ordered by the IIG. An hourly BS was measured and the appropriate Insulin rates were administered until 2000 hours. The Insulin was stopped correctly at 2000 hours at a BS of 95 since the previous BS at 1900 hours was 132.
b) At 2240 hours the BS was 163. While the dose actually administered was 0.6 units per hour, it should have started at 2030 hours not 2240 hours.
c) At 0032 hours on 2/21/12 the BS was 128, 35 points lower than at 2240 hours. However, this was measured almost 2 hours later rather than at 2340 hours according to the IIG. The IIG also indicated that the Insulin rate should be decreased by 50% (to 0.3 units per hours) and the BS rechecked in 30 minutes. Instead the Insulin was stopped and held for the next 2 hours until 0200 hours when the Insulin was discontinued. There was no evidence of a physician ' s order that the Insulin should be stopped, contrary to the IIG. There was no evidence of a physician ' s order to discontinue the IV Insulin. This was confirmed by the SICU Manager.
Thus, not only were Insulin rates and times incorrect, but the RN discontinued the Insulin without a physician ' s order.

PHARMACY ADMINISTRATION

Tag No.: A0491

Based on observation and document review, the hospital failed to ensure the Airway Emergency Box located in the Emergency Department contained accurate documentation on the outside of the box of the first medication to expire. In addition, the hospital failed to ensure there was a list of the medications contained in the Emergency Transport box on the outside of the box. These failures were not consistent with professional principles by not providing easy access to the list of contained medications and which among the listed medications were the first ones to expire.
Findings:
1. On 2/21/12 at 0927 hours, during a tour of the Emergency Department, the Airway Emergency Box was observed. Documentation on the outside of the box showed the date of the first drug in the box to expire. The date listed was 3/15/12; however, located inside the box was a 10 milliliter vial of succinylcholine 20 milligrams/milliliter (a medication that induces muscle relaxation so airway tubes would be inserted) with an expiration date of 3/5/12.
On 2/21/12 at 0930 hours, Pharm 1 (Chief Pharmacy Officer) stated, "The date on the outside of the box was the date of the first drug to expire. The pharmacist was responsible for restocking the medications in the box and writing the expiration date on the outside."

2. On 2/21/12 at 0938 hours, observation of the Transport Box in the ED which contained emergency medications did not show a list of all medications stored inside. Observation of the contents of the box showed the medications not listed included: Atropine 1 milligram syringe, Epinephrine 1:10,000 syringes, and sodium chloride syringe.

DELIVERY OF DRUGS

Tag No.: A0500

Based on interviews and document reviews, pharmacists failed to provide supervision for the distribution and use of medications stored throughout the hospital. As a result, patients could have received the wrong drug or dose and floor drugs could have been taken from the hospital fraudulently.

Findings:

A pharmacist failed to ensure that:
1. Hospital policy was followed for the use of overrides and medications removed from the Automated Dispensing Machines (ADCs) as overrides, were correct and appropriate (proper for why the physician ordered the medication and accurate for its intended purpose).
2. Medications removed from the Emergency Department ADCs were appropriate.
3. Standard of professional practice was followed for medications removed from the ADCs.
4. Requested medications refilled for the Interventional Radiology Lab (IRL) were used for patients.
5. Requested refills for medications located in the Emergency Department (ED) cabinets above the sink were used for patients.

The ADC permits quick access to medications by a nurse. The ADC is to be filled by pharmacy with medications approved by the Pharmacy & Therapeutics Committee. When properly programmed (profiled), the ADC electronically permits a nurse to remove a medication only after a pharmacist had reviewed and entered the new physician's order into the correct patient profile in the pharmacy computer. This releases the medication dose for that patient. This release is authorized because the computer located in the pharmacy is electronically connected to the ADC.

If a nurse (RN) wishes to remove a medication before a pharmacist has reviewed and entered the order into the pharmacy computer, the RN must use an override. An override usually occurs when a pharmacist is not present in the hospital to review the order or in an emergency. Use of an override generates a medication order override report which should include:
a. The name of the patient.
b. The name and dosage of the medication.
c. The number of doses removed.
d. The reason the dose(s) were removed.
e. The nurse who removed the dose.

Findings:

1. G.2. of the hospital ADC policy and procedure read: "Override medications are needed on an urgent or emergent basis. These items can be removed prior to pharmacist review and verification of the physician's order." G.3. read: "A designated pharmacist regularly reviews overrides on all profile med stations for each nursing unit." On 2/21/12, at approximately 1100 hours, Pharm 1 stated that the regular review occurs once a month.

On 2/23/12 at approximately 0900 hours, Pharm 1 provided an override analysis (OA) for 2011. The analysis identified that overrides occurred most frequently in Labor & Delivery (L&D) and Post Anesthesia Recovery (PACU) also provided an actual override report for 12 nursing areas in the hospital, including L&D, the Pre-Op area, PACU and NICU). The report covered 2 weeks, from 2/9/12 through 2/22/12, and identified that L&D had 85 overrides, PACU had 43 but the Neonatal Intensive Care (NICU) had 49. Thus the OA did not provide accurate information as it excluded an analysis of the NICU. In addition, the OA revealed that the pharmacy focuses on controlled substances (Controlled substances are considered to be potentially addicting.) This is evident by the lack of attention given to other medications as identified by the following data:
a) For L&D:
(1) 14 doses removed were for oral medications. Oral medications are not used in emergencies as their effect takes too long.
(2) Three of the oral medications removed were Acetaminophen (aka Tylenol) 325mg. The reason indicated was for acute pain. According to Lexicomp (a nationally recognized drug information source) Tylenol is indicated only for mild to moderate pain. In any event, an oral dose takes too long to be effective in an acute situation.
(3) There were 6 instances where there was no reason the dose was removed from the ADC via an override. So, it is not known whether or not those doses were needed in an emergency.
(4) Propofol 1% 20ml (a potent agent used for sedation) was removed from the ADC on 2/15/12 at 1436 hours. A review of the Pharmacy & Therapeutics (P&T) approved override list showed that Propofol is not approved for L&D. The American Society of Anesthesiologists statement on the safe use of Propofol reads: " The Society believes that the involvement of an anesthesiologist in the care of every patient undergoing anesthesia is optimal. However, when this is not possible, non-anesthesia personnel who administer Propofol should be qualified to rescue patients whose level of sedation becomes deeper than initially intended ....The physician responsible for the use of sedation/anesthesia should have the education and training to manage the potential medical complications of sedation/anesthesia. The physician should be proficient in airway management, have advanced life support skills appropriate for the patient population, and understand the pharmacology of the drugs used." Thus, Propofol should not be readily available to anyone, no less where hospital policy indicates it should not be present.
It also seems that Tylenol and other non-emergency drugs were removed using an override for convenience rather than necessity.

b) For the NICU:
(1) As identified above, NICU RN's removed 49 doses of medication from the ADC's without a review by a Pharmacist. A review of the P&T approved override list does not include the NICU. That is, according to hospital policy, RN's in the NICU should not be able to remove any medication from an ADC without a pharmacist first reviewing the physician's order.

c) In Pre-Op (an area where patients are prepared for surgical procedures):
(1) 10 doses of medication were removed during the 2 week period. The Pre-Op area is not included on the P&T approved override list. Thus, RN's in Pre-Op should not be able to remove ny medication from an ADC without a pharmacist first reviewing the physician's order.
(2) One of the medications removed was Propofol. (See the American Society of Anesthesiologists statement on the safe use of Propofol above.) Permitting access to this drug without proper oversight creates an unsafe environment for patients.

By focusing on controlled substances, the pharmacy failed to identify other ADC use contrary to hospital policy.

According to Pharm 1, pharmaceutical services are available 24 hours a day each day of the week. Thus, a Pharmacist is always available to review a physician ' s order. A review of overrides once a month which focuses on controlled substances does not provide adequate monitoring for the inappropriate use of overrides. This is clearly evident in L&D, the Pre-Op area and in the NICU.

2. The ED was visited on 2/21/12 starting at 0925 hours. The ED Supervisor stated that about 100 patients are seen each day of which 48% are admitted to the hospital. An ED transaction report was provided by. There were a total of 2,511 transactions for 2 weeks between 2/7/12 and 2/21/12 or about 60,000 doses removed from the ED ADCs per year. Since the ED ADCs are not profiled, RN's have access to all the medications in the ADC at any time. The removal of a dose yields a transaction rather than an override.
a) Of 155 randomly selected transactions, 41 or 26% were for oral medications. As described above, oral medications are not usually used in emergencies as their effect takes too long.
b) There is no reason shown anywhere on the transaction list as to why the medication was removed from the ADC. So there is no way to determine whether or not a dose was removed for an emergency.
c) During an interview with the ED Supervisor, on 2/21/12 starting at 0935 hours, she stated that not all medications removed from the ADCs are for emergencies.

3. During an interview with, on 2/23/12 at approximately 0910 hours, he stated that pharmacy does not review ED transactions.
The American Society of Health-Systems Pharmacists, (ASHP - the internationally recognized organization which establishes professional practice standards for pharmacists in hospitals), under Standard III, Medication Orders, reads: "All prescribers' medication orders (except in emergency situations) must be reviewed for appropriateness by a pharmacist before the first dose is dispensed."
Non-emergency medications dispensed from the ED ADCs by RN's are not reviewed by a pharmacist before the dose is administered contrary to the standards for professional practice as established by the ASHP. In fact, according to Pharm 1, all medications dispensed from the ED ADCs and administered to patients (approximately 60,000 per year) are never reviewed by a pharmacist for appropriateness contrary to standards for professional practice and contrary to safe patient care.

5. The Interventional Radiology unit (IR) was visited with Pharm II on 2/21/12 starting at 1100 hours. 29 medications were observed to be in a cabinet above the ADC. The IR Charge RN stated these medications are replenished by the pharmacy when ordered by IR. The 29 medications included Heparin and Plavix (both potent anticoagulants). According to Lexicomp, both drugs have FDA Black Box Warnings which means that serious harm can occur if any of these drugs are administered in error.
Pharm II stated that the drugs requested by IR are refilled and there is no medication reconciliation performed to determine how the drug was used. Thus, pharmacists do not check to verify what is refilled as compared to what has been administered to patients. So, pharmacists are unaware of whether or not drugs on IR floor stock are used for patients.

6. The ED was visited as identified above with. The ED Supervisor provided a Request for Medication form which she uses to replenish floor stock medication which has been used. This form contained a total of 37 medications which were stored in the cabinets above the sink and were observed to be present. According to the ED Supervisor, ED sends the request to refill medication to pharmacy. The pharmacy then sends the requested medication back to the ED. According toPharm 1, pharmacy does not check to verify that what is refilled is compared to what has been administered to patients. So, pharmacists are unaware of whether or not the drugs on floor stock in the cabinets are used for patients.

PHARMACIST SUPERVISION OF SERVICES

Tag No.: A0501

Based on interview and document review, the pharmacy failed to ensure that the compounding of intravenous solutions in the Operating Room (OR) and Emergency Department (ED) was supervised. As a result a patient could receive the wrong drug or wrong dose.

Findings:

Page 2 of the hospital policy and procedure entitled "High Risk Medication" reveals a page with an Appendix labeled "Risk Reduction Strategies for High Risk Medications." This Appendix shows that intravenous (IV) Insulin, which has been identified by the hospital as a High Risk drug, may be prepared in the OR and ED. On 2/21/12 at approximately 0930 hours, Pharm 1 stated there is no pharmacist present in the ED or in the OR. Since a pharmacist is not present and therefore cannot supervise the compounding of IV Insulin which may be prepared in the ED or in the OR, the policy and procedure and practice in the hospital are contrary to Federal regulation.

UNUSABLE DRUGS NOT USED

Tag No.: A0505

Based on observation, the hospital failed to ensure outdated biologicals were not available for patient use. Expired biologicals/drugs could compensate patients' medical status.

Findings:

On 2/21/12 at 0915 hours, during a tour of the Labor and Delivery Unit, four expired intravenous bags were found in the bed side cart in one patient room. Two bags of dextrose 5 % in normal saline and one bag of dextrose 5 % in a half normal saline showed expiration dates of September, 2011. One bag of dextrose 5 % in a half normal saline had an expiration date of October, 2011.

PHARMACY: REPORTING ADVERSE EVENTS

Tag No.: A0508

Based on interviews and record reviews, pharmacists failed to identify that blood sugar (BS) measurements and the administration of intravenous (IV) Insulin were in error for 3 of 5 sampled patients (Patients 81, 99 and 100).
As a result, the patient's blood sugars were not maintained between 100 and 150, a goal established in the hospital's IV Insulin Guideline
* For Patient 99:
a) Blood sugar (BS) levels were not measured as ordered.
b) Insulin was not administered as ordered.
*For Patient 100:
a) Blood sugar (BS) levels were not measured as ordered.
b) Insulin was not administered as ordered.
*For Patient 81:
a) Blood sugar (BS) levels were not measured as ordered.
b) Insulin was not administered as ordered.

Findings:

1. For Patient 81, blood sugar (BS) levels were not measured according to physician orders. As a result, IV Insulin rates were administered incorrectly on 4 occasions. Further, the IV insulin was discontinued by an RN without a physician's order.
Incorrect doses of IV Insulin can result in unmanageable high and low spikes in a patient's BS. This could result in being unable to properly treat a patient's Diabetes. Cross Reference A405 #3.

2. For Patient 99, IV Insulin rates were administered incorrectly on 6 occasions. Further, the BS was not measured as ordered on 2/15/12 at 2400 hours. Cross Reference A405 #1.

3. For Patient 100, the BS was not measured as ordered on 3 occasions. The IV Insulin rate was administered incorrectly on 6 occasions. Cross Reference A405 #2.

There is no evidence in any of the above referenced patient records that a pharmacist reported the errors to the appropriate physicians, notified nursing administration, or reported the errors to the hospital quality assurance program.

DIRECTOR OF DIETARY SERVICES

Tag No.: A0620

Based on observation, interview and record review, the hospital failed to ensure an expired enteral nutrition supplement located in one of three nourishment rooms inspected was discarded. Expired nutritional supplement could potentially compromise patients' medical status especially when made available in nourishment rooms.

Findings:

The hospital's policy and procedure, Policy 313, entitled Nourishment Rooms indicated, "Nourishment Rooms are provided for inpatients and can be found in each patient care area. The purpose was "To provide food to all inpatients while food services is closed." Per the guidelines, responsible staff were; "Food Service Worker...Dates, rotates and discards all items supplied by food services as appropriate."

On 2/22/12 at 1040 hours, in nourishment room #5647, one unopened can of an oral nutrition supplement with a manufacturer's expiration date of 12/16/11, was found. RN Ee, and RD II noted the expired can of NutriHep (a nutrition supplement for patients with liver condition) and acknowledged it should not have been available for patient use.

DIETS

Tag No.: A0630

Based on observation, interview and record review, the hospital failed to ensure one of two patients (Patient 76) reviewed for tube feedings received formula in accordance with the physician's orders. The hospital also failed to ensure the nutritional needs of the patients were met in accordance with recognized dietary practices. Menus were not analyzed to ensure they met Recommended Dietary Allowances or the Dietary Reference Intakes (DRIs) of the Food and Nutrition Board or the National Research Council. These failures could potentially place patients at risk of not receiving required nutrients thereby compromising medical care.

Findings:

1. According to the hospital's policy and procedure entitled Enteral Nutrition Formula, Policy 318; (last reviewed 11/10), "RN/MD enters the enteral feeding order into QUEST system, specifying the formula product, strength, rate, and duration of feeding, Diet Operator; ...For ready to feed formulas, a meal ticket will accompany the formula to the floor. For prepared formulas, a sticker is placed on the bottle that indicates the patients name, room number, formula recipe, and volume."

On 2/22/12 at 0905 hours, a medical record review was conducted for Patient 76. On 2/17/12 at 2107 hour, according to the EMR (electronic medical record), a physician ordered "Jevity 1.2 cal via nasogastric feeding tube, continuous feeding; start rate 30 mL per hour; rate increase 10 mL every 6 hours; goal rate 70 mL per hour; water flush volume 25 ml every 6 hours."

According to Patient 76's flow sheet, Patient 76 began to receive the tube feeding on 2/18/12. According to Patient 76's flow sheet dated 2/19, 2/20, and 2/21/12, the patient received "Twocal" formula, and not the physician's order for Jevity 1.2.

Patient 76's medical record indicated that a nutrition assessment was completed by a RD on 2/21/12. According to the nutrition assessment, the RD observed that "Twocal @ 70 ml/hour" was provided to the patient. The RD documented Patient 76 had received 3,360 calories and 140 grams of protein from the twocal formula that had been provided at 70 ml/hour. The RD initially assessed Patient 76's estimated nutritional needs, on 2/16/12, to be between 1, 710-2, 140 calories per day, and between 61-92 grams of protein per day. The RD assessment completed on 2/21/12 remained at the same estimated caloric and protein needs per day, as determined on 2/16/12.

According to Patient 76's lab report located in the EMR, dated 2/18/12, the patient's BUN (blood urea nitrogen - a protein waste product), was 20 (normal range used by the hospital - 8-26 MG/DL). On 2/18/12, Patient 76 began to receive tube feeding. On 2/19/12, Patient 76's BUN was 26. By 2/20/12, Patient 76's BUN was 28.

On 2/21/12, a recommendation provided by the RD as indicated on the nutrition assessment was to provide the physician's order of Jevity 1.2 @ 70 ml per hour x 24 hours per day which would provide 2,016 calories and 93 grams of protein per day, 47 grams of protein less a day than the patient had received.

On 2/22/12 at 0952 hours, RN Cc reviewed Patient 76's medical record and verified that there had never been a physician's order to provide twocal formula, and that Jevity 1.2 should have been provided. RN Cc stated that the food and nutrition department provided the formula to the nursing unit with the patient's name individually attached to the formula.

On 2/22/12 at 1536 hours, RD I verified that FSW 1 had sent "TwoCal HN" to the nursing unit for Patient 76. TwoCal HN [HN = High Nitrogen] formula was a calorie and protein dense formula.



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2. RD I was asked for the nutrient analysis of the menus. On 2/22/12 at 0930 hours, an interview was conducted with the RD I regarding the nutrient analysis. When asked, RD I stated they had to enter their recipes into the computer software system and the nutrients were calculated by day, meal, and type of diet. RD I stated she then had to calculate each day for the macronutrients and total for each of the diets. RD I stated she did not analyze all the different micronutrients and vitamins for the menus.

Review of the nutrient analysis for the non-select meals was reviewed. This showed the moderate consistent carbohydrate, high consistent carbohydrate, low consistent carbohydrate, 40 gram protein renal, 60 gram protein renal, 80 gram protein renal, dysphagia 1 pureed regular, 2 gram low sodium, dysphagia 2 ground, dysphagia 3 chopped, full liquid, and soft/low residue/GI soft menus were analyzed for calories, carbohydrate, fat, protein, sodium and potassium. The low fat/low cholesterol and cardiac were analyzed for calories, carbohydrate, fat, protein, sodium, potassium, and cholesterol.

There was no complete analysis to ensure the quantifiable amounts of all nutrients, such as vitamins and minerals were provided for the therapeutic diets.

THERAPEUTIC DIET MANUAL

Tag No.: A0631

Based on observation, interview and record review, the hospital failed to customize their on-line diet manual to be hospital specific to include the hospital's approved therapeutic diet orders for two of two patients reviewed (Patients 78 and 94). A non-customized diet manual which did not reflect how the hospital prepared and implemented physician's diet orders had the potential for miscommunication from multidisciplinary team members to the patient and had the potential for misinterpretations by staff of a physician's diet order.

Findings:

1. On 2/22/12 at 1300 hours, Patient 78's medical record was reviewed. According to Patient 78's electronic medical record the physician prescribed a "Consistent Carb (Diabetic), Mod [moderate] 180-225 gm (1600-1900 cal) Carb Amount" diet.

RD II was asked to utilize the hospital's approved diet manual to demonstrate how the diet manual was used to communicate the hospital's defined therapeutic diet orders to multidisciplinary team members. RD II was unable to utilize the hospital's approved on-line ADA [American Dietetic Association] diet manual to demonstrate the physician prescribed diet order for Patient 78, which was a routinely prescribed diet order at the hospital.

2. On 2/22/12 at 1426 hours, Patient 94's medical record was reviewed with RD III. RD III stated Patient 94 was on a cardiac diet. RD III stated the hospital's cardiac diet was defined as low fat, low cholesterol and low sodium. When RD III was asked the acceptable parameters for the amounts of fat, cholesterol and sodium per day to be provided to a patient on a physician's prescribed cardiac diet. The RD stated, "I believe it is limited to 50 grams of fat a day, less than 300 mg of cholesterol a day, and less than 2 grams of sodium." RD III then accessed the hospital's approved on-line ADA diet manual. The RD stated the on-line manual defined a cardiac diet as less than 200 mg of cholesterol per day. RD III stated she would not be able to use the hospital's approved on-line diet manual to verify the hospital's approved definition of a cardiac diet because the diet manual belonged to the ADA. RD III stated she would need to go into the kitchen and obtain a meal ticket to reflect how the diet order was defined.

On 2/22/12 at 1515 hours, RD I was asked to use the hospital's diet manual to demonstrate how the hospital defined and implemented a cardiac diet. RD I accessed the approved on-line diet manual and stated there were general principles listed. The RD stated, "Let me grab the supplement." RD I returned with a binder that was labeled as "Explanation of Diets and Sample Menus." The supplemental information included definitions of routinely prescribed therapeutic diet orders and various meal patterns for various therapeutic diets, to reflect how the supplement was used as a guide for preparing patient meal trays. RD I stated the "Explanation of Diets and Sample Menus" was confined to the food and nutrition services department only and was not available to all medical and nursing personnel.

RD I acknowledged the purchased on-line ADA diet manual had not been customized to reflect the different types of therapeutic diet orders routinely ordered at the hospital and therefore was not able to be used as guidance for ordering and preparing diets at the hospital.

According to the hospital's policy and procedure, Policy 300, The Food and Nutrition Services Department used Nutrition Care Manual from the American Dietetic Association as reference manual. Therapeutic diets were ordered by physicians only. The stated purpose of the policy was to provide guidance and clarification on therapeutic diets with listings of foods allowed and not allowed.

MAINTENANCE OF PHYSICAL PLANT

Tag No.: A0701

Based on observation, staff interviews, and document review the hospital failed to ensure the required food supplies planned for use in a disaster were stored within the certified areas of the hospital. The failure could potentiate inaccessibility to needed food supplies during a disaster.

Findings:

On 2/21/12 the disaster food and water supply was observed in an offsite warehouse. Review of the disaster menu and food supply was adequate; however, it was located approximately five miles away from the hospital. There was part of the water supply observed in this location.

On 2/21/12 at 1350 hours, an interview was conducted with the Director of General Services. He stated half of the water supply was stored in a container on the hospital campus and they were planning to move the other half of the water supply at some point.

INFECTION CONTROL PROFESSIONAL

Tag No.: A0748

9. On 2/22/12 at 0928 hours, observation showed a soiled diaper and used gloves had been left on the floor of one patient room in the NICU, instead of disposing these items direct to he trash bin to avoid contaminating the floor.




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Based on observation, staff interview and record review, the hospital failed to determine the proper dilution of enzymatic cleanser to clean the instruments used in Interventional Radiology. Too little amount of the enzymatic cleanser as a result of improper dilution could potentially be ineffective in its purpose. Too much cleanser for the same reason could potentially cause allergies. In addition, the hospital failed to maintain a safe and sanitary environment as evidenced by:
* Clean linens stored in two of two linen rooms were stored adjacent to dusty blanket warmers and dirt was observed on the floors under the linen carts.
* Hand hygiene was not performed during observations in three operating rooms.
* A procedure room was observed not terminally cleaned between procedures.
* Patient care infusion pumps were not labeled clearly after disinfection and were not stored separately.
*A CNA was observed to answer her cell phone while wearing contaminated gloves inside an isolation room.
* A soiled diaper and used gloves were left on the floor in one of the NICU rooms thereby contaminating the floor.
These failures could potentially spread further infection throughout the hospital.

Findings:

1. Review of the CDC guidelines for disinfection and sterilization of instruments 2008 showed, "As with all chemicals, enzymes must be rinsed from the equipment or adverse reactions could result (e.g., fever and skin reactions). Enzyme solutions should be used in accordance with manufacturer's instructions which include proper dilution of the enzymatic detergent and contact with equipment for the amount of time specified on the label. Detergent enzyme can result in asthma or other allergic effects in users. Alkaline-based cleaning agents are used for processing medical devices because they efficiently dissolve protein and fat residues, however they can be corrosive."

On 2/21/12 at 1445 hours, during tour of Interventional Radiology conducted with RN T and Rad Tech-CL, used instruments from the latest procedure were noted in the sink. When RN T was asked regarding how long the instruments needed to soak to be disinfected, she pointed to Rad Tech-CL who was in charge of cleansing the used instruments. When Rad Tech-CL was asked regarding the procedure, he stated the correct amount of enzymatic solution was to use "enough" water to make the appropriate dilution. When asked specifically the proper ratio of water to make the appropriate dilution per the manufacturer's recommendation, including the contact time, Rad Tech-CL stated he did not know and would have to verify with the hospital's P&P.

2. On 2/22/12 at 1030 hours, a tour of the fifth floor was conducted with the Floor Manager and the CNO.

Inspection of two linen rooms, rooms 5659 and 5859, revealed two portable blanket warmers on the second deck of the linen cart. Both blanket warmers were located on the left hand side of the linen cart. Dry linens were placed directly above and below the warmer. The dust deposits on the top of the blanket warmers was acknowledged by the CNO and the fifth floor RN Manager.



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3. According to CDC Recommendations and Reports October 25, 2002, Hand Hygiene in Healthcare Settings, Hand Hygiene Basics:
"Healthcare providers should practice hand hygiene at key points in time to disrupt the transmission of microorganisms to patients including: before patient contact; after contact with blood, body fluids, or contaminated surfaces (even if gloves are worn); before invasive procedures; and after removing gloves (wearing gloves is not enough to prevent the transmission of pathogens in healthcare settings)."
According to AORN, the Recommended Practices for Environmental Cleaning in the Perioperative Setting, 2010, Recommendation VI showed all personnel should take precautionary measures to limit transmission of microorganisms when performing routine environmental cleaning and disinfection activities. Hand hygiene should be performed when gloves are removed and as soon as possible.
a. On 2/21/12 at 1009 hours, a surgical procedure was observed in Douglas OR (Operating Room) accompanied by MD J and the OR Director.
MD O was observed providing anesthesia services in OR 15. MD O, while wearing gloves, began an intubation (insertion of a breathing tube into a patient's throat), inserted an intravenous catheter (IV), documented on the electronic medical record, removed medications from the anesthesia cart, and administered medication via the IV port. MD O then placed two patches on the patient's forehead and connected the patient's nasogastric tube to suction. MD O wore the same gloves as he moved from task to task. No hand hygiene was observed.
b. MD M was observed assisting MD O for intubation, also wearing gloves. MD M reached in the anesthesia cart drawer, removed medications, administered the medications intravenously, and then touched a computer keyboard. MD M then removed the gloves. There was no hand hygiene observed.
c. On 2/21/12 at 1330 hours, the Outpatient Surgical Services (OSS) was toured with MD J and OR Director. Three EVS staff (EVS 5, 6,and 7) were observed cleaning the OR room between cases in OR 1. EVS 5, wearing gloves, wiped the OR surfaces with a Sani wipe, walked out of the room and trashed the wipe in a trash bag, and closed the trash bag. EVS 5 then walked back into OR 1, took another clean Sani wipe from the container and continued to clean the room without changing gloves.
d. On 2/21/12 at 1451 hours, EVS 6 was observed in the OR 1 cleaning the room between cases. EVS 6, wearing gloves, was observed to take a used contaminated towel from EVS 7. EVS 6 walked out of the room, opened a trash bag, and placed the cloth towel in the bag. EVS 6 then entered OR 1 and removed the gloves and placed the gloves in his pocket. EVS 6 then moved on to mopping the floor.
4. On 2/21/12 at 1009 hours, during a tour of the Douglas Hospital Operating Rooms (OR) accompanied by MD J and the OR Director, OR 15 was observed during a surgical procedure. The following were noted:
a. The monitoring tower that was suspended from the ceiling had three levels. The top level had a piece of unknown particle and dust approximately 0.3 cm in size. The surface of the second level of the tower was to have multiple black marks. According to the OR Director, those marks were from the monitor corner pads. The OR Director was not able to determine how long the marks had been there.
b. An infusion pump holder (infuses fluids/medications into a patient's circulatory system) was observed with multiple white to light brown chemical residuals. A concurrent interview with the OR Director revealed the residuals could be attributed to the approved disinfection agents used in the ORs.

c. A padded positioning device (Stirrup) used by patients was observed. The left stirrup was noted to have a cracked line where the inner padding was visible from a distance.

d. A Neptune suction device (a unit used to collect fluid waste and small debris from the surgical site) surface was observed with approximately 0.1 cm light red unknown particle.

e. Patient intubation equipment was observed covered with a blue towel. Underneath the towel, multiple green and light brown spots were noted. This was found both in OR 15 and OR 16. According to MD J, those spots were the residuals from an approved cleaning product used in cleaning the ORs. A follow- up interview with OR Director on 2/23/12 at 1300 hours, revealed all the spots had been removed by the cleaning crew.
5. On 2/22/12 at 0800 hours, the Pain Management Service in the Gottschalk Plaza was toured. Inspection of the procedure room revealed heavy dust on the procedure table. The pad and the table had multiple black and brown spots. During a concurrent interview, Rad Tech 1 stated he was responsible for cleaning. Rad Tech 1 stated he was not aware of the dust. Rad Tech 1 added he never removed the linen on the table and checked the back of the pad.
According to AORN, the Recommended Practices for Environmental Cleaning in the Perioperative Setting, 2010, Recommendation I, showed the exogenous sources for pathogens that may cause a surgical site infection included surgical personnel; the operating room environment and all tools, instruments and supplies. Exogenous flora are mainly aerobes. The risk of infection from pathogenic organisms on environmental surfaces is due not only to their presence, but to their ability to survive on and be transferred to many surfaces.
Recommendation II showed a safe, clean environment should be reestablished after each surgical procedure. Routine cleaning and disinfection reduces the amount of dust, organic debris, and microbial load in the environment.
Recommendation II.b. Mattress and padding positioning device surfaces (e.g., OR beds, arm boards) should be moisture-resistant and intact.
Recommendation IV showed surgical and invasive procedure rooms should be terminally cleaned daily. The terminal cleaning and disinfection of the perioperative environment decreases the number of pathogens, dust, and debris that is created during the day.
6. On 2/21/12 at 0940 hours, the Pre-op and PACU area at OSS (Outpatient Surgical Services) were inspected. The clean pump area was noted in the lowest level of a cabinet. Below the cabinet was a hand washing sink and a space for storage. Observation of the clean area showed one intravenous infusion pump with a green sign, indicating the pump was clean and ready to use. Two other pumps did not show a label. One PCA pump (Patient Controlled Analgesia) and one small IV pump were stored in the same location.
During a concurrent interview with Pre-operative RN Z the RN revealed the contaminated dirty pumps could be disinfected by the hospital's central services or by the OSS staff. The used pumps were kept on the countertop next to the sink. The RN stated if central service staff completed the cleaning of pumps, they attached a green tape. The pumps cleaned by the OSS staff could not be identified. When questioned as to how one would know if the pump was clean or used, RN Z could not answer.
On 2/22/12 at 0945 hours, the Infection Control Practitioner for Surgical Services was interviewed. The ICP stated the hospital standard of practices was to keep the dirty infusion pumps in the soiled utility room. Cleaned pumps should be kept in the clean utility room, but not in the patient direct care areas.
7. According to Centers for Disease Control and Prevention (known as CDC) 2007 Guideline for isolation precautions: preventing transmission of infectious agents in healthcare settings that since facemasks have been shown to limit spread of droplets arising from the oral flora, the CDC has recommended their use by healthcare providers when performing spinal injection procedures. Anyone performing a spinal injection procedure should review the following CDC recommendations to ensure that they are not placing their patients at risk for infections such as bacterial meningitis. The facemasks should always be used when injecting material or inserting a catheter into the epidural or subdural space.

According to AORN (Association of periOperative Registered Nurses) periOperative Standard and Recommended Practices 2011, the recommended Practices for Surgical Attire, Recommendation III showed a mask should fully cover both mouth and nose and be secured in a manner that prevents venting.

On 2/22/12 at 1010 hours, a spinal injection procedure was observed. MD L was performing the injection in the Pain Management Service in the Gottschalk Plaza OSS. MD L wore a surgical mask that did not cover the nose.



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8. Patient 59 was interviewed on 2/21/12 at 1405 hours. Outside of the patient's room was a sign suggesting the patient was on contact isolation. Gown and gloves must be worn upon entering the room. Observation of the patient during the interview showed the patient had a urinary drainage catheter draining dark amber urine. Patient 59 stated she had VRE infection in her urine (vancomycin-resistant enterococci, a type of bacteria that have developed resistance to many antibiotics).

During the interview, CNA A entered the room and stated she needed to empty the patient's urinary drainage bag. The CNA was wearing a gown and gloves. The urine was emptied into a measuring container. As the CNA entered the bathroom to dispose the urine, her telephone rang. The CNA was observed to reach into her uniform pocket with her gloved hand and answered the phone call. The CNA then replaced the telephone into her uniform pocket and finished emptying Patient 59's urine bag. The CNA then removed her gown and gloves and exited the room. The CNA was not observed to sanitize the telephone.

INFECTION CONTROL PROGRAM

Tag No.: A0749

2. According to the hospital's P&P entitled Nourishment Rooms, Policy 313, "POLICY; Nourishment Rooms are provided for inpatients and can be found in each patient care area. PURPOSE; To provide food to all inpatients while food services is closed. GUIDELINES; Responsible; "EVS [environmental services]; Cleans nourishment rooms including the exterior of refrigerators."

On 2/22/12 at 1035 hours, a microwave was observed in nourishment room #5647. When the microwave was opened a build-up of a yellow colored substance that was dry and hard was noted. RN Hh stated the microwave was used "mostly for patients." The unclean microwave was verified by RN Ee.

RN Hh stated nursing was responsible to ensure the internal part of the microwave was kept clean. She added, "mainly by the CNAs [certified nursing assistant]." RN Ee confirmed that the microwave was not specifically assigned on a cleaning schedule but it was a nursing responsibility to ensure it was kept clean.



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Based on observation, staff interviews, and document review, the hospital failed to ensure ice machines located in three of three nourishment rooms inspected were maintained in a sanitary manner. In addition, the hospital failed to ensure a microwave used for patients, located in one of the three nourishment rooms inspected, was clean. Failure to do so could potentially spread infection throughout the hospital.

Findings:

1. On 2/22/12 at 1035 hours, in nourishment room #5647, a joint observation of the ice machine was made with RD II. The chute of the ice machine had a white colored substance surrounding the lower end of the chute where the ice was dispensed.

On 2/23/12 at 0840 hours, in nourishment room #4444, a joint observation of the ice machine was made with RD I. The chute of the ice machine had a white colored substance surrounding the lower end of the chute where the ice was dispensed. On the rim of the chute, a dark brown substance was observed. The surveyor wiped the chute with a paper towel and showed it to RD I.

On 2/23/12 at 1010 hours, an observation was made of the ice machine in the nourishment room on the Mother Baby unit. The chute of the ice machine had a white colored substance surrounding the lower end of the chute where the ice was dispensed. At approximately 1030 hours, staff was observed to give a patient a pitcher of ice water from the nourishment room.

An interview was conducted with Contracted Staff 1 on 2/23/12 at 1440 hours, regarding the cleaning of ice machines in the nourishment rooms. Contracted Staff 1 stated he did the preventative maintenance of the ice machines in the hospital on a quarterly basis. He stated he cleaned and sanitized the ice machines quarterly which included the ice chutes. Contracted Staff 1 stated the environmental service workers cleaned the outside of the ice machines in the nourishment rooms more frequently. Contracted Staff 1 stated the next cleaning was due next month.

Review of the hospital policy titled Ice Machine Preventative Maintenance, dated 3/03 and revised 4/11, showed weekly cleaning of the drain pan, grill, and a wipe down of external surfaces was to be done by environmental services. A quarterly inspection of the unit, clean sensor, dispenser hopper and chutes would be done by facilities.

Further review of the nourishment room ice machine's manufacturer's guidelines, showed the above recommended cleaning procedures should be performed at least as frequently as needed, and more often if environmental conditions dictate.

DESIGNATED REQUESTOR

Tag No.: A0889

Based on interview and record review, the hospital failed to ensure one of seven hospital staff interviewed (RN Ff) was aware of the hospital's Organ and Tissue Donation P&P that showed the OPO (Organ Procurement Organization) requestors were solely responsible to approach families regarding organ/tissue donation. This could potentially result in the failure to achieve family consent for organ/tissue donation.

Findings:

The UNOS (United Network for Organ Sharing) currently had a waiting list of over 100,000 candidates awaiting organ transplantation. An OPO requestor was a person with special education in approaching families for possible organ and tissue donation. According to One Legacy's website (an organ procurement agency), untrained staff requests for donation could lead to confusion and misunderstanding by the family, leading to anger, mistrust, perception of conflict of interest, and a decline to donate. Alternatively, untimely request for donation could lead to hope created for the family that something positive could come out their loss when the patient might not be suitable for donation. Therefore the use of a trained requestor was required by The Joint Commission (an accrediting agency) and CMS (Centers for Medicare and Medicaid).

The hospital's P&P titled Organ and Tissue Donation, revised 2/10, showed the OPO Coordinator (Requestor) was solely responsible for approaching the family regarding the option of donation.

On 2/21/12, an interview was conducted with RN Ff. When asked about organ donation, RN Ff, not a trained requestor, stated he would let the family know about donation as an option.