HospitalInspections.org

Based on observation, the hospital failed to ensure patient privacy was protected. This could potentially result in a violation of the patients' rights.

Findings:

On 2/17/11 at 1000 hours, the Dialysis Unit was toured. The Dialysis Unit was the treatment area where patients with kidney disease were connected to machines to filter the waste products from the blood. Two patients were observed receiving dialysis treatment. A schedule board on the wall showed all the names of patients that were scheduled for dialysis from 2/14/11 to 2/17/11. By one of the patient's name was the word "clotted." The board was visible to anyone entering the room and one of the two patients in the unit.

5. On 2/16/11 at 1300 hours, inspection of the Primary Care Clinics (PCC) was conducted with RN 1 in accompaniment. A room labeled as CLEAN UTILITY was inspected. An unlocked refrigerator with a sign on the door showed FOOD ONLY, and when the door was opened there were two bottles of reagent control (solutions for testing efficacy) stored on the shelf of the refrigerator door. Labeling on the bottles showed the reagent was intended for urine dip-stick testing as HIGH and LOW controls for urine hemoglobin determination. On the bottom floor of the refrigerator were several unopened cartons of juice product.

Documentation from the manufacturer showed the Material Safety Data Sheets (MSDS) showed the solutions are toxic and not for human consumption and contain quality control materials (chemicals). The MSDS showed acute health effects or risks from exposure and lists the following: May be fatal if swallowed. Irritation of skin or eyes may be experienced. If swallowed, induce vomiting and call a physician or poison control center.

An interview with RN 1 showed she was not aware of the two bottles of reagent stored in the refrigerator and she removed them immediately. She stated the refrigerator was for the staff to provide juice or other food items to patients. She stated the reagents should not have been stored there.

6. On 2/16/11 at 1315 hours, inspection of the Primary Care Clinic (PCC) showed a sink located near medical supplies being used for patients. The handwashing sink was in close proximity to the supplies as the paper towel dispenser was located directly above the supplies. Evidence of water splash and water drops was observed on the supplies as a result of staff washing their hands. Supplies that were contaminated included an opened two by two gauze package, glucometer lancets, Q-tip swabs, and other packaged medical supplies.

7. On 2/14/11 at 1000 hours, a tour of the psychiatric unit was conducted. Observation and inspection of two, multiple occupancy patient rooms (four patients to each room) showed bathrooms that had a shelf below the mirror. In each bathroom, four tooth brushes were observed piled on top of each other. The toothbrushes were not labeled or protected from coming in contact with the other tooth brushes. Bristles of the individual tooth brushes were in contact with each other.

On 2/14/11 at 1030 hours, an interview with RN 13 was conducted. The nurse stated the patients are encouraged to keep their personal hygiene items in their bedside drawer. She stated staff should assist patients in promoting safe hygiene practices.


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8. On 2/16/11, per review of AORN 2010, it stated low humidity increases the risk of electrostatic charge which poses a fire hazard in an oxygen rich environment or when flammable agents are in use and increases the potential for dust. High humidity increases the risk of microbial growth (germs) in areas where sterile supplies are stored or procedures performed.

The use of free-standing humidifiers in the operating rooms was prohibited because they can harbor germs in fluid reservoirs and aerosolize these germs into the clean environment.

On 2/15/11 at 0940 hours, tours of ORs (operating rooms) 2, 8, and 10 and all four ORs in labor & delivery were conducted. Each room contained a portable humidifier. In OR 2, 8, and 10, the humidifier was dusty on its surface.

A review of the temperature and humidity logs for the four labor and delivery rooms and 10 operating rooms revealed the rooms were out of range for temperature and humidity. This placed patients at increased risks for infection or injury from fire. Cross reference A-951 #1.



22779


2. On 2/17/11 at 1030 hours, RN 30 demonstrated how water used for hemodialysis was checked for chloramines. Hemodialysis replaces a diseased kidney's ability to remove toxins from the blood. Chloramines in the water can cause hemolysis of the blood which is a breakdown of the blood cells and could cause patient death.

RN 30 filled two vials (Vials A and B) with purified and filtered water used for hemodialysis. In Vial B, RN 30 put powdered chloramines. The RN then tested the water in Vial A with a hand held machine which showed test results of 000. The RN stated this showed there were no chloramines in the water. The RN then tested Vial B which also showed 000. The RN then began to go to another test when the surveyor asked if Vial B shouldn't be showing some chloramines since she had added chloramines to the water. RN 30 then ran the test again, this time shaking the vial the chloramines were added to. This time the results were .01, showing there were chloramines in the water. The RN stated she should have shaken the vial the first time.

3. On 2/17/11 at 1100 hours, a review of the daily log for testing the water used in dialysis showed no documentation for 2/17/11. There were thirteen areas to be completed none of which were filled in. RN 30 stated she had done the testing that morning but had not yet filled in the form.

4. The ANSI/AAMI (American National Standard Institute/American Association for the Advancement of Medical Instrumentation RD52:2004) guidelines showed the dialysis unit should have plans to deal with sudden changes in municipal water quality for example, a water main break. This could affect the amount of chlorine/chloramines in source water.

On 2/17/11 at 1050 hours, during interview, MD 5 stated the dialysis unit did not have a procedure in place to have their source water utility notify the hospital if there was a major disruption in the water supply to the hospital. MD 5 stated the unit would expect the engineering department to notify the unit and the end testing of the water in the dialysis unit was sufficient. Review of the monitoring tool showed water was checked twice daily. However, ANSI/AAMI guidelines recommend for dialysis units if source water is highly chlorinated due to a water main break or flooding dialysis units should test more frequently for chlorine/chloramines.


25720

Based on interview and document review, the hospital failed to ensure the P&P (policies and procedures) for endotoxins and chloramine testing of dialysis water was followed. Endotoxins are byproducts of bacteria and chloramines are chemical toxins in dialysis water. Since hemodialysis replaces the non-functioning kidney's ability to filter the patient's blood of waste products, exposure of patients' blood to bacteria and/or endotoxins could result in infection. Presence of chloramines in hemodialysis water could cause breakdown of blood cells and possibly death.

The hospital failed to provide a safe and sanitary environment as evidenced by: a reagent solution used for urine testing was found stored with food in the Primary Care Clinic refrigerator. The urine reagent was classified by MSDS as fatal if swallowed. Sterile and clean medical supplies were stored beside the handwashing sink in the Primary Care Clinic; and in the Psychiatric Unit, four unlabeled, used, toothbrushes in a four-bed room were stored together. Contaminated medical supplies and toothbrushes was unsanitary and could cause infection.

Findings:

1. At 0950 hours on 2/17/11, a review of the log for endotoxin testing of the water used for hemodialysis showed a cover page stating endotoxin testing would be completed every six months. The endotoxin test results for the water showed tests were not done from 12/11/07 to 2/5/09. No testing was done from 2/5/09 to 12/16/09. Testing was not done from 12/16/09 to 8/11/10. There were no tests done from 8/11/10 to 2/17/11.

At 1000 hours on 2/17/11 the P&P for endotoxin testing of the hemodialysis water was requested for review. As of 1600 hours on 2/17/11, no P&P was presented for review.

At 1530 hours on 2/17/11, confidential staff interview revealed the endotoxin tests had been routinely submitted every six months but the results had not been reported because of the contracted laboratory's dispute with the hospital over payment issues.

Based on interview and medical record review, the hospital failed to ensure RN 17 evaluated Patient 29's care to notify MD 8 when blood glucose levels (the amount of sugar calculated in the blood) were greater than 400 milligrams/deciliter (mg/dL). Patient 29's blood glucose levels registered critically high or over 400 milligrams/deciliter (mg/dL). High blood glucose levels above 400 mg/dL have caused nausea, vomiting, vision problems, mood swings, stroke, and death in some if not treated promptly.

The hospital failed to ensure RN's evaluated three of 44 sampled patients. Patients 1 and 25 were not evaluated regarding pediatric parenteral nutrition as their daily weights were not obtained and documented per hospital policy. Also, an ICU patient (Patient 39) receiving enteral feedings (enteral - provide food through a tube placed in the stomach) was not evaluated per hospital policy. Exposure of the formula delivered to the patient held over 8 hours at room temperature had the potential of growing disease causing germs.

Findings:

1. On 2/15/11 at 1404 hours, Patient 29's medical record was reviewed. Patient 29 was started on insulin infusion on 2/15/11 at 0030 hours as written on the hospital's preprinted insulin order sheet by MD 8. The insulin order stated, "Call ICU physician for new orders if blood glucose levels are greater than 400 milligrams/deciliter (mg/dL)." The blood glucose levels for the morning of 2/15/11 revealed there were several levels above 400 mg/dL, i.e.
*0300 hours - blood glucose level registered "Critically high," too high for a numerical value.
*0400 hours - blood glucose level still registered "Critically high,"
*0500 hours - blood glucose level registered 487 mg/dL.
*0600 hours - blood glucose level registered 493 mg/dL.
*0700 hours - blood glucose level registered 483 mg/dL.
*0800 hours - blood glucose level registered 461 mg/dL.

There was no documentation in Patient 29's chart that RN 17 contacted the ICU physician for new orders when the blood glucose levels were above 400 mg/dL at 0300, 0400, 0500, 0600, 0700, and 0800 hours. Patient 29 continued on a dose of insulin that was not high enough to bring down his blood glucose; leaving his levels in dangerously high ranges.

On 2/16/11 at 0830 hours, RN 17 was interviewed. RN 17 was Patient 29's nurse during the hours of 0300-0800 on 2/15/11. RN 17 stated, "I notified MD 8 throughout the night and he gave orders to continue the same insulin dose. I assumed it was the highest dose on the protocol." RN 17 stated he did not document these physician contacts and orders in Patient 29's medical record.

On 2/16/11 at 1425 hours, MD 8 was interviewed. MD 8 stated he was called when the insulin infusion was started and when the level was critically high at 0200 hours but was not called by RN 17 at 0300, 0400, 0500, 0600, 0700 hours. MD 8 stated he had no contact with RN 17 after 0200 hours regarding blood glucose levels.

The patient's medical record showed on 2/16/11 the insulin infusion dose needed to be increased hourly from 0800 - 1100 hours to bring Patient 29's blood suger down.


2. On 2/15/11, the Procedural Parenteral Support policy stated, "Weigh patient daily or as ordered by the physician. Document weight." Review of Policy NO. 386 on Parenteral Nutrition, dated 06/07, revealed "Nursing staff weighs patients daily or as ordered for assessment of response to therapy."

Patient 25's medical record was reviewed on 2/15/11 at 1000 hours on the pediatric floor. Patient 25 was a 9-year old who had physician orders for parenteral nutrition. This is a liquid nutritional mixture given into the blood through an intravenous (IV) catheter bypassing the normal digestion in the stomach.

On 2/15/11 at 1030 hours, the Pediatric Nurse Manager and RN 16 were asked to provide documentation of the patient's weight. Both staff reviewed the chart but were unable to find documentation of Patient 25's daily weight. RN 16 added that it was difficult to obtain a patient's weight from the bed scale. RN 16 was unable to demonstrate how the bed scale operated. Another pediatric staff obtained the weight history from the bed scale.

Patient 25's weight by bed scale on 2/15/11 at 1030 hours, was 38.4 kilograms. History of weight obtained from the bed scale on 2/15/11 was recorded at 43.5 kilograms, on 2/6/11 at 45.8 kilograms, and on 2/8/11 at 45.8 kilograms. RN 16 and the Pediatric Nurse Manager were unable to show where these weights were documented in the patient's medical record.

3. On 2/16/11, review of the policy titled "Tube (enteral) feeding through nasogastric tube, gastrostomy tube and jejunostomy tube" dated 7/1/08, stated for open enteral feeding systems to limit the formula hang time to 8 hours. For open systems, flush the feeding bag/tubing with sterile water before filling with additional formula.

On 2/16/11 at 1420 hours, review of Patient 39's medical record revealed a physician order, dated 2/14/11, consisting of a 2 calorie tube feeding formula at 15 cc/hour. The rate of feeding was to be increased incrementally until the goal rate of 35 cc/hour was acheived.

On 2/16/11 at 1420 hours, Patient 39 was observed with an open enteral feeding system administering 2 calorie formula. The feeding pump was delivering formula at 35 cc/hour.

On 2/16/11 at 1420 hours, RN 31 was asked the procedure she used to refill the enteral feeding bag. She stated that she added one can of formula to the enteral feeding bag when the existing formula in the bag was at the bottom of the bag. She stated that she just poured in the additional formula. The Clinical Nutrition Services Manager stated on 2/16/11 at 1435 hours, the policy would be to ensure the enteral feeding bag was rinsed before adding additional formula to prevent cross contamination with the old formula and potential food borne illness.

On 2/16/11 at 1445 hours, the ICU Nurse Manager was asked to describe the procedure for adding additional formula to the enteral feeding bag. She stated two cans, equivalent to 500 cc were added to the feeding bag at 2300 hours and she had just added one can (250 cc) at 1300 hours. The 500 cc's of formula added to Patient 39's feeding bag at 2300 hours to infuse at the rate of 35 cc/hour would take 14.28 hours to deliver the 500 cc's of formula. The formula hung at room temperature for 14 hours; exceeding the policy for open systems on hanging formula for no more than 8 hours.


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4. On 2/14/11 at 1010 hours, Patient 1 was observed receiving a tube feeding via a nasal tube. Review of the medical record showed the patient was weighed last on 2/6/11. A nutritional consultant's recommendation dated 2/8/11, was to check the patient's weight every Monday and Thursday while the patient was receiving the tube feeding. There was no further weight documented.

A concurrent interview with RN 32 revealed the nursing staff was not aware of the recommendation nor was there a physician who evaluated the patient's weight.

Review of the hospital's procedure manual for Tube Feeding Through Nasogastric Tube, dated 7/08, revealed the patient's weight should be checked twice a week (Mondays and Thursdays).

Based on interview and medical record review, the hospital failed to ensure nursing staff followed medication orders for insulin infusion as prescribed for one of 48 sampled patients (Patient 29). When physician orders for insulin are not followed, blood glucose levels and the patients health could be adversely affected.

The hospital failed to ensure insulin infusion orders contained the name of the medication, dose, route of administration, and frequency of administration for one of 48 sampled patients (Patient 28). Medication orders that are not accurately written have the potential for causing a medication administration error that could place the patient at risk.

Findings:

1. On 2/15/11 at 1404 hours, Patient 29's medical record was reviewed. Patient 29 was started on an insulin infusion on 2/15/11 at 0030 hours as ordered on the hospital's preprinted insulin infusion order sheet by MD 8. The insulin order stated, "Call ICU (Intensive Care Unit) physician for new orders if blood glucose levels are greater than 400 milligrams/deciliter (mg/dL)." Reviewing the blood glucose levels for the morning of 2/15/11 there were several levels above 400 mg/dL;
*0300 hours - blood glucose level registered "Critically high," too high for a numerical value.
*0400 hours - blood glucose level still registered "Critically high"
*0500 hours - blood glucose level registered 487 mg/dL.
*0600 hours - blood glucose level registered 493 mg/dL.
*0700 hours - blood glucose level registered 483 mg/dL.
*0800 hours - blood glucose level registered 461 mg/dL.

There was no documentation in Patient 29's medical record that RN 17 contacted the ICU physician for new orders when the blood glucose levels were above 400 mg/dL at 0300, 0400, 0500, 0600, 0700, and 0800 hours on 2/15/11. Patient 29 continued on a dose of insulin that was not high enough to bring down his blood glucose; leaving levels in dangerously high ranges.

On 2/16/11 at 0830 hours, RN 17 was interviewed. RN 17 was Patient 29's nurse during the hours of 0300-0800 on 2/15/11. RN 17 stated, "I notified MD 8 throughout the night and he gave orders to continue the same protocol dose. I assumed it was the highest dose on the protocol." RN 17 stated he did not document these physician contacts and verbal orders in Patient 29's medical record.

On 2/16/11 at 1425 hours, MD 8 was interviewed. MD 8 stated he was called when the insulin infusion was started and when the level was critically high at 0200 hours but was not called by RN 17 at 0300, 0400, 0500, 0600, 0700 hours. MD 8 stated he had no contact with RN 17 after 0200 hours regarding blood glucose levels.

The patient's medical record showed on 2/16/11 the insulin infusion dose needed to be increased hourly from 0800 - 1100 hours to bring Patient 29's blood suger down.

2. On 2/15/11 at 1339 hours, review of Patient 28's medical record revealed he was admitted to the hospital with the diagnosis of diabetic ketoacidosis (severely elevated blood sugar levels). On 2/15/11 at 0700 hours an order was written for insulin. The order read, "Insulin gtt (drop) 2 units/hour intravenously." The order form in the medical record had a specific box for the frequency. Under frequency, the physician wrote "gtt" which does not represent an appropriate response for frequency. RN 53 stated the order was for insulin intravenous infusion and "gtt" was interpreted by nursing staff to mean "drip." When asked if drip was an appropriate frequency, RN 53 said no. The hospital did not provide documentation the "gtt" was defined as anything other than its medical definition which means "drop."

Based on medical record review and interviews, the hospital failed to document clearly and accurately on a physician order sheet. Two of seven records reviewed in psychiatry showed physician order sheets with inaccurate order documentation for Patients 19 and 37. Inaccuracy in physician order documentation has the potential to delay treatment and other therapy regimens for patients admitted to the psychiatric service.

Findings:

On 2/15/11 at 0900 and 0915 hours, record review for Patients 19 and 37 was initiated. The physician admission order sheet showed the physicians documented on the hospital's pre-printed Psychiatric Admission Order Form. On the top of the order form were instructions for order entry. The instructions showed an "X" was to be placed in the box. The document showed physicians were to leave the box blank if the order was not requested.

Review of the admission orders for both Patient 19 and 37 showed the physicians drew lines. Some of the lines drawn were vertical and some lines were horizontal. The lines extended down the form covering entire sections of the form. The pre-printed form had the following domains: Activity, Precautions, Diet, Lab/Tests, and Medications. Each domain had lines drawn through the box instead of an "X" in the box.

On 2/16/11 at 1400 hours, an interview with the MD 7 was conducted. He reviewed the physician order entries for Patients 19 and 37. He was asked about the intent of the physician when a line was drawn through the order entry boxes. He stated the orders were not clear and the intention of the physician was not clear as well.

Based on interview and medical record review, the hospital failed to ensure there was documentation that RN 17 followed orders to notify MD 8 when blood glucose levels (the amount of sugar calculated in the blood) were greater than 400 milligrams/deciliter. Failure to document physician contact did not ensure accuracy of the care and medical decisions rendered.

Findings:

On 2/15/11 at 1404 hours, Patient 29's medical record was reviewed. Patient 29 was started on insulin infusion on 2/15/11 at 0030 hours as ordered on the hospital's preprinted insulin infusion order sheet by MD 8. The insulin order stated, "Call ICU (Intensive Care Unit) physician for new orders if blood glucose levels are greater than 400 milligrams/deciliter (mg/dL)."

There was no documentation in Patient 29's medical record that RN 17 contacted the ICU physician (MD 8) for new orders when the blood glucose levels were above 400 mg/dL at 0300, 0400, 0500, 0600, 0700, and 0800 hours on 2/15/11. Patient 29 continued on a dose of insulin that was not high enough to bring down his blood glucose; leaving levels in dangerously high ranges.

On 2/16/11 at 0830 hours, RN 17 stated he contacted the doctor during the hours of 0300-0800 hours on 2/15/11 but he did not document these physician contacts and orders in Patient 29's medical record.

2. On 2/16/11 at 1355 hours, a inspection of the Primary Care Clinics (PCC) was conducted with the RN 1. A room identified as the clean utility room was entered and showed a locked cabinet labeled 'MEDICATION'. The cabinet was opened and two, plastic, box-like bins containing a total of thirty cassettes were observed. Each cassette compartment was labeled with a name of a medication and the dosage strength for the individual medication in the compartment. Inspection of the individual cassettes found thirteen were empty. Additionally, one cassette was labeled Clonidine (blood pressure medication) but when inspected it contained a single tablet of hydrochlorothiazide (a water pill). One unlabelled cassette had a single bottle of nitroglycerin tablets.

On 2/16/11 at 1400 hours RN 1 was asked the reason for the empty cassettes. The nurse was not aware of why the cassettes were empty and could not explain why a medication was in the wrong cassette. She was asked for an inventory list of the medications and who was responsible for stocking the medications. She stated the pharmacy provides all medications to the clinic. The medication inventory list the nurse provided showed several medications not found labeled on the medication cassettes.

On 2/16/11 at 1430 hours, an interview with the DOP was conducted. He was asked about the medication bins and the systems in place for stocking, surveillance, and distribution of the medications from these cassettes. He stated the bins with the individual cassettes of medications did not belong in the PCC area. He stated he was not aware they were there. The DOP stated he did not know why the cassette labeled Clonidine contained hydrochlorothiazide.



25052

Based on observation and interview, the hospital failed to ensure medications were being sired in accordance with manufacturer's recommendations and expiration terms. Drugs and biologicals not stored in accordance with manufacturer's directions could potentially lead to unsafe administration of medications.

Findings:

1. On 2/15/11 at 0926 hours, during a tour of the ED (Emergency Department), the ADC (automated dispensing cabinet) contained injectable lorazepam (medication to treat anxiety). According to the manufacturer, lorazepam should be stored under refrigeration but may be stored at room temperature for no longer than three months before it would then expire. Lorazepam was found to be stored in the ADC at room temperature.

On 2/15/11 at 0928 hours, Pharmacist 2 stated lorazepam was stored in the ADC but given a 60 day expiration date from when it was removed from the refrigerator. "This is done by going back into the ADC's history of when the medication was last stocked to know when the expiration date should be." The DOP and Pharmacist 2 didn't know if there was a policy and procedure approved by the hospital that describes this procedure. Pharmacist 2 later commented that there was no approved policy and procedure. Without a policy and procedure for staff to follow or an expiration date visible on the medication, nurses and physicians who administer lorazepam injection would not know if the medication had expired or not.

7. A tour of the cath lab (cardiac catheterization laboratory) was performed at 1100 hours on 2/15/11. A metal storage box was seen in the laboratory. Interviews with the staff and the medical director of the cath lab revealed that this box a "loaner" and had been in the cath lab for 16 years. The storage device contained no biomedical inspection sticker. According to the Medical Director, this device had not been inspected by engineering since being loaned to the cath lab. The storage box was found to be a heating device to warm contrast agent being used for patient diagnostic angiographic studies. A paper strip in the heating device registered 37 degrees C (Centigrade), approximately 98 degrees F. The warming device contained 16 bottles of a contrast agent used for patient angiography. The bottles contained no written documentation as to when the bottles had been placed into the warmer. When interviewed, the cath lab staff and the Medical Director were unable to determine how long these bottles of contrast agent had been in the warmer. Inspection of the manufacturer's instructions revealed that the contrast agent should be stored at room temperature, 20-25 degrees C.








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5. On 2/16/11 at 1300 hours, inspection of the Primary Care Clinics (PCC) was conducted with RN 1. When the clean utility room was inspected, two bottles of reagent control (biological) stored in an unlocked refrigerator intended for FOOD ONLY, as indicated by a posted sign. RN 1 stated the refrigerator contained food for the patients. Labeling on the bottles showed the reagent was intended for urine dip-stick testing.

Documentation from the manufacturer showed the Material Safety Data Sheets (MSDS) showed the solutions are toxic and not for human consumption. The MSDS showed acute health effects or risks from exposure and lists the following: May be fatal if swallowed. Irritation of skin or eyes may be experienced. If swallowed, induce vomiting and call a physician or poison control center.

6. On 2/16/11 at 1340 hours review of the hospital's policy and procedure titled: Medication Regulations and Administrations, Drug storage showed the following: All medications delivered by the pharmacy are placed in the unit's assigned drug storage location. This P&P was not implemented in the Primary Care Clinics as follows:

On 2/16/11 at 1355 hours, an inspection of the Primary Care Clinics (PCC) was conducted with RN 1. A room identified as the clean utility room was entered and showed a locked cabinet labeled "MEDICATION." The cabinet was opened and two, plastic, box-like bins containing a total of thirty cassettes were observed. Each cassette compartment was labeled with a name of a medication and the dosage strength for the individual medication in the compartment. Inspection of the individual cassettes found thirteen were empty. Additionally, one cassette was labeled Clonidine (blood pressure medication) but when inspected it contained a single tablet of hydrochlorothiazide (a water pill). One unlabelled cassette had a single bottle of nitroglycerin tablets. On 2/16/11 at 1400 hours RN 1 stated the pharmacy provides all medications to the clinic.

On 2/16/11 at 1430 hours, an interview with the DOP was conducted. He stated the bins with the individual cassettes of medications did not belong in the PCC area.


25052

Based on observation, interview, and document review, the hospital failed to:

*Ensure two of two pharmacy staff received yearly sterile product competency exams and the exam questions were changed from year to year to assess staffs' ability to answer correctly to questions never seen before (Pharmacy Tech 1 and Pharmacist 2).

*Ensure removal of Phenergan? (promethazine) injection (medication to treat nausea and vomiting) by intravenous administration from their pre-printed order sheet entitled, "Craniotomy for Aneurysm Clipping (Post Op) - ICU." Phenergan was not to be administered intravenously according to the hospital's policy and procedure.

Phenergan administered intravenously has a Black Box Warning (BBW) associated with its use to ensure it is used safely. Adverse events reported by the use of Phenergan include tissue necrosis, abscesses, and paralysis. Surgical intervention including skin graft, and/or amputation have been necessary in some cases.

*Ensure a list describing the contents of the emergency medications stored inside and the first medication to expire was posted on the outside of the emergency medication carts and the medication carts were sealed by a pharmacist in accordance with state law.

*Ensure medications, with their quantities, listed on the outside of the emergency medication cart were accurate.

*Ensure the PCCs (Primary Care Clinics) had medications correctly labeled and appropriate to the clinic where it is stored.

*Ensure storage for contrast agents, used in the cardiac catheterization laboratory (cath lab) and/or the clinic, was safe and consistent with standards of practice and manufacturer's guidelines. The failure could lead to impaired contrast agent being used for patients' diagnostic studies. The urine dye for urine testing could potentially contaminate other food items stored in the same area.

Findings:

1. On 2/14/11 at 1137 hours, during a tour of the main pharmacy, Pharmacy Tech 1 was compounding chemotherapy medications (medications administered intravenously to treat cancer and other life threatening diseases), and Pharmacist 2 was checking the products compounded by Pharmacy Tech 1. On 2/15/11 at 1250 hours, the DOP provided the last two sterile product competency exams for these two employees. The DOP stated, the two employees are required to take these competency exams yearly. Review of the exams revealed that Pharmacy Tech 1 and Pharmacist 2 took an exam in 2010 and 2008 but were missing exams for 2009. The exams for 2008 and 2010 were identical with the same questions for both years. The DOP stated, "The exam questions are not changed." The pharmacy staff takes the same exam each year with the same questions and answers. Leaving the questions the same from year to year does not ensure pharmacy staff were competent in the most recent techniques, procedures, and calculations to ensure the medications were safely compounded before they were administered to patients.

On 2/16/11 at 1300 hours, during an interview the HR Manager stated competency exams are required annually. According to the HR Manager, "Annually, means each calendar year."

2. On 2/14/11 at 1350 hours, review of the hospital's pre-printed order sheets that contain medications revealed Phenergan, as a medication available to be ordered by intravenous (IV) administration. On 2/15/11 at 1318 hours, the DOP stated, "I am not familiar with Phenergan use IV." Phenergan (promethazine) administered intravenously has a BBW which means medical studies indicate the drug carries significant risks of serious or even life-threatening adverse effects. It is the FDA's strongest drug labeling message. The BBW for Phenergan (promethazine) states, "Promethazine injection can cause severe tissue injury (including gangrene) regardless of the route of administration. In addition to gangrene, adverse events reported include tissue necrosis, abscesses, burning, and paralysis. Surgical intervention including skin graft, and/or amputation have been necessary in some cases. The preferred route of administration is by deep intramuscular (I.M.) injection."

The hospital's own P&P entitled, "Black Box Warning Guidelines" states not to give Phenergan intravenously in the hospital.

3. On 2/15/11 at 0945 hours, during a tour of the ED, the medication list that contained the contents of what was stored in the emergency cart was located in a binder that was docked in a holder on the wall. An expiration date for the first drug to expire in the drug box was not listed on the outside of the cart. On 2/15/11 at 0947 hours, the DOP stated there was a list of the drugs stored in the emergency cart located inside the binder.

On 2/15/11 at 0957 hours, the Malignant Hyperthermia Cart (emergency cart containing medications to treat Malignant Hyperthermia) was found not to have a list of medications posted to the outside of the cart. The medication list was located in a binder on top of the cart. The first drug to expire was not listed on the outside cover of the cart.

According to the California Code of Regulations, Title 22, 70263(f)(2) "The emergency drug supply shall be stored in a clearly marked portable container which is sealed by a pharmacist in such a manner that a seal must be broken to gain access to the drugs. The contents of the container shall be listed on the outside cover and shall include the earliest expiration date of any drugs within."

An All Facilities Letter (AFL) was issued by the Department of Public Health (formerly the Department of Health Services) in 2/2005 which clarified in detail the requirements for the emergency medication cart. The AFL was distributed to all hospitals in California. The AFL states, "The expiration date of the first medication to expire must be posted on the outside of the moveable cart. A content list must be posted on the outside of the portable container containing emergency medications and equipment."

4. On 2/17/11 at 0954 hours, while touring the Family Medicine Clinic, RN 29, stated she checks the emergency medication cart and documents the first drug that expires in the binder. She replaces medications that need to be replaced and locks the cart. RN 29 stated, "If a drug expires, she obtains another from the main pharmacy and places it in the drug box and then locks the cart."

According to the California Code of Regulations, Title 22, 70263(f)(2) "The emergency drug supply shall be stored in a clearly marked portable container which is sealed by a pharmacist in such a manner that a seal must be broken to gain access to the drugs. The contents of the container shall be listed on the outside cover and shall include the earliest expiration date of any drugs within."

On 2/17/11 at 0958 hours, while reviewing the list of medications in the binder located on top of the emergency cart showed the medication box should have 10 epinephrine (medication to treat heart attacks) 1/10,000 injections stored inside. On inspection of the medication box, only five doses were stored inside. Also on the list was naloxone (medication to reverse narcotic overdoses) 0.4 milligrams/milliliter - 10 milliliter vial as stored in the cart. On observation, there were only four milliliters of 0.4 milligrams/milliliter stored in the cart (instead of 10 milliliters). Having less than the number of required doses available in the emergency cart could potentially cause serious harm to the patient if they required higher doses.

Based on observation and interview, the hospital failed to properly dispose of a liter of normal saline so as to prevent it from being used for patient care and treatment. Intravenous fluids not stored properly have the potential for degradation of the fluid, decreasing the effectiveness of the intravenous therapy; and increasing the risk for contamination and infection.

Findings:

1. On 2/16/11, review of the hospital's policy and procedure titled: Medication Regulations and Administrations, Drug storage showed the following: All medications delivered by the pharmacy are placed in the unit's assigned drug storage location. Non-refrigerated I.V. medications are placed directly into bins that are labeled "non-refrigerated I.V. medications," on the medication room counter or the unit's assigned medication storage location.

On 2/16/11 at 1300 hours, a inspection of the Primary Care Clinics (PCC) was conducted with RN 1. Located in a clean utility room was a single, intravenous (IV), one-liter bag of normal saline solution stored in a cabinet, on a shelf above a counter in the room. The cabinet was not labeled as a medication storage location. The IV solution was without its outer-wrapping and was stored on a shelf that was dusty and dirty. Additionally, the bag of normal saline was stored on a shelf with a box of opened cookies. On the cabinet door there was no sign that showed the IV solution was there and no sign the IV solution should not be used.

On 2/16/11 at 1315 hours, an interview with the Nurse Manager was conducted and showed she had no awareness the IV solution was stored in such a manner and removed the solution immediately.



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2. On 2/15/11 at 1025 hours, the OR 2 anesthesia cart was inspected after a pediatric surgical case. The medication drawer revealed two syringes with liquid drugs. One syringe had 5 ml of medication in a 10 ml syringe. The syringe was labeled propofol 8 mg/ml, 2/15/11, 0710 hours. The second syringe was a 1 ml syringe labeled glycopyprolate 0.2 mg/ml.



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3. The hospital's P&P Warming Cabinet for Solutions, dated 8/4/07, was reviewed on 2/14/11. The purpose of the policy was to safely provide warmed solutions to patients. The policy showed irrigation solutions were to be stored at a maximum temperature of 104 to 110 degrees F. The maximum length of time irrigation solutions were to be stored at those temperatures was 72 hours. Irrigation solutions warmed to temperatures not exceeding 104 degrees F may remain in the warmer no longer than 30 days.

The L&D OR suites were toured with RN 1 and Scrub Tech 1 on 2/14/11 at 0945 hours. Observation of the warming unit used for irrigation solutions in surgical cases showed the temperature inside the unit was 108 degrees F. Stored in the unit were approximately 15 one-liter bottles of sterile water. Two bottles were dated 1/20/11, two bottles were dated 1/23/11, and three bottles were dated 2/6/11. Scrub Tech 1 was asked how long the sterile water bottles could be stored in a warming unit. The Scrub Tech stated she thought fluids could be stored three days unless the temperature of the unit was 104 degrees or less. Observation of the temperature log for February 2011 showed temperatures of 108 to 110 degrees F were recorded for each day. RN 1 and Scrub Tech 1 were unable to explain the reason irrigation solution stored over three days at these temperatures were available to use for surgical procedures.

Based on observation, document review and interviews the hospital failed to ensure an acceptable level of cleanliness and safety for the physical environment was implemented and maintained. This could lead to the spread of infection, increased risk of fire and improperly functioning equipment.

Findings:

1. A review of the temperature and humidity logs for 4 labor and delivery rooms and 10 operating rooms showed these rooms were out of range for temperature and humidity. OR Room 3 logs dated 5/5/10 to 5/18/10, showed the temperature and humidity logs of these rooms were out of range. On 5/5/10 and 5/16/10, the relative humidity was 102.79. (The AORN guidelines for 2010 and 2011 specify that the relative humidity should be maintained in the range, 20-60%). Review of the temperature and humidity logs for 2/11 revealed all 10 operating rooms and all 4 labor and delivery rooms were out of range, with a relative humidity less than 20%. The AORN guidelines state this increases the risk of fire in an environment with a high concentration of oxygen. Interviews with the medical director of the department of surgery revealed he was unaware portable humidifiers were being used in the operating rooms. The AORN guidelines for 2010 and 2011 recommends no use of portable humidifiers in the operating rooms due to aerosolization of harmful germs into the sterile environment..

A tour of the four gastroenterology procedure rooms and three cardiac catheterization labs was conducted on 2/16/2011. A review of the temperature and humidity logs for this date revealed no written documentation the temperature and humidity was being monitored.


2. On 2/15/11 at 0930 hours, a tour of ORs 2, 8 and 10 revealed penetrations in the ceiling of these rooms. In OR 2, 8, and 10 x-ray view boxes were broken with a gap between the viewing boxes and the wall with visibly accumulated dust and dirt. The baseboard in all three operating rooms had pulled away from the wall, with visibly accumulated dust and dirt. OR 2 contained an exhaust vent that was blocked by an instrument and supply cart. The OR contained stored binders and surgeons' chairs and a clean supply cart that was seen in one corner of the OR.

3. On 2/15/11 at 1400 hours observation of the cardiac cath lab found it contained a large air vent that was blocked by a medication dispensing machine. The vent was covered with visible dust and dirt. The cath lab patient monitoring equipment was covered by visible dust and dirt. The radiology biplane arm contained spots of dried blood.

4. On 2/15/11 at 1140 hours, a soiled chest piece (used by anesthesiologists for monitoring patient's breath sounds and heart rates) was found stored in the anesthesia cart in a hallway of the surgical services area. Anesthesia Tech 1 revealed the technicians were responsible to clean it.

5. On 2/15/11 at 1140 hours, an anesthesia tech was observed diluting an enzymatic product for the cleaning of laryngoscopes in a manner inconsistent with manufacturer's guidelines, resulting in a highly concentrated solution.

6.. On 2/16/11 at 1300 hours, OR room 10 was revealed as being used for surgical procedures and pain management procedures as well as GI procedures. The room was observed to contain a scrub sink and an open drain on the floor. Interviews with the OR manager and the director of surgical services revealed the room had formerly been used for cystoscopy. The floor drain had not been removed. No evaluation for a change of use for this room with regard to fire safety or infection control was provided.


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7. The outpatient Family Health Clinic (FHC) was located off of the main hospital campus. On 2/17/11 at 0900 hours, during a tour of the outpatient clinic with MD 10 and the Outpatient Manager, a digital thermometer was found in Station A with no biomedical maintenance service date to show it had been inspected for accuracy.

Further tour of the FHC clinic revealed a brown medication refrigerator by Station A which was past due for its annual biomedical inspection since 11/06. The white refrigerator used to store laboratory specimens in the utility room had no biomedical service/approval sticker. Another white refrigerator in Treatment Room 4 had no inspection sticker to prove the equipment was inspected for safety and accurate performance by the Biomedical Engineering Department. All three refrigerators needed defrosting to ensure acceptable temperature control.

On 2/17/11 at 0940 hours, RN 34 was asked with regard to biomedical maintenance inspection of the equipment. She made no comment but acknowledged the need for the equipment to be inspected to ensure safety and acceptable performance.


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8. On 2/14/11, the ED (Emergency Department) was toured and in the storage closet and the clean/dirty utility room there were cardboard boxes on the floor prohibiting the housekeeper from cleaning the floor.

9. An observation was conducted on 6W with RN 23 on 2/16/11 at 1110 hours. A room was noted to contain the laundry chute and was also used to store paper chart forms. One of the two metal bookcases in the room was positioned next to the laundry chute, approximately six inches from the bin opening. Some of the paper stacked on the shelves were encased in plastic for protection/preservation, however the majority of the paper was uncovered. In addition, boxes of chart forms were stacked directly in contact with the floor, two to three boxes high in front of the bookshelves. RN 23 stated the room contained the only laundry chute for the unit and it was used by nursing staff and EVS staff to deposit dirty laundry, as well as store clean chart forms.

10. An automatic blood pressure machine was observed plugged in for charging on 2/17/11 at 1015 hours. The machine was located in a utility room located across the hallway from the Infusion Unit on the 5W unit. The blood pressure machine was covered in a layer of dust and drip stains were noted on the side of the machine.

RN 20 was interviewed on 2/17/11 at 1020 hours. The RN confirmed the blood pressure machine in the utility room was used by staff for patients in the Infusion Unit. When asked, the RN confirmed 90% of the patients in the Infusion Unit received chemotherapy medications and were at high risk for infections.

RN 20 and the Associate Nursing Director observed the blood pressure machine with the surveyor on 2/17/11 at 1025 hours. The RN and the Director confirmed the machine was not clean. When asked, the RN stated this type of equipment was cleaned weekly by nursing staff.

During a follow up interview with the Associate Nursing Director on 2/17/11 at 1330 hours, the Director stated EVS was responsible for the cleaning of patient care equipment, such as a blood pressure machine. Review of the P&P Environmental Services, last review date 5/04, with the Director showed patient care equipment not attached to the patient was to be cleaned daily.

11. On 2/17/11, while the surveyor was in the elevator, portable x-ray machine #17 was observed. The machine was visibly soiled with an 8" by 11" torn and stained piece of paper taped to the back of the machine.

Based on interviews, observation and a tour of the hospital, the hospital failed to implement and maintain an active, hospital-wide, surveillance program to be able to identify possible sources of transmission of infection and communicable diseases. The deficient practices could lead to spread of infections in the hospital.

Findings:

1. The hospital failed to ensure that all 10 operating rooms and all four labor and delivery rooms were within recommended humidity range. Cross-reference A-951.

2. The hospital infection control committee was not aware portable humidifiers were being used in the surgical and labor and delivery suites in the hospital which could potentially spread microorganisms to the clean and sterile environment. Cross-reference A-749.

3. The hospital failed to observe the accumulated dust and dirt in the surgical suites, labor and delivery and the cardiac cath laboratory. Cross-reference A-749.

4. The hospital failed to ensure staff in Pediatric and Medical-Surgical Units followed the hospital's droplet isolation protocol. Cross reference A-749 #6.

5. The hospital failed to ensure the staff in the intensive care unit follow the hospital's protocol on catheter dressing changes and labeling of intravenous tubing to indicate when applied and when to be changed. Cross reference A-749 #7.

The Infection Control Officer failed to provide oversight to ensure the staff followed the hospital's P&P on replenishing tube feeding and hand hygiene. Cross-reference A-395 #3.

5. During interviews with the infection control committee at 1000 hours on 2/16/11, infection control concerns regarding the surgical suites' humidity, hand hygiene, isolation precautions, housekeeping techniques, and general sanitary measures were discussed with the representatives of the Infection Control Committee. MD 13, stated there were only 2 physicians and a nurse who were designated as infection control officers. The committee included one member from each of the following departments: Medicine, Surgery, OB/GYN, Pediatrics and Pathology. It was stated enviromental rounds were being executed every week. However, in order for the committee to cover all areas in the hospital, each area was inspected only three times a year, except for ED and OR, which were inspected monthly. It was stated the hospital had been without major negative infection outcomes; possibly due to major efforts of the committee members to cover the size of the census and the complexities of the patients' cases which included the clinics, inside and outside of the campus.

MD 13 stated multiple requests had been sent to the governing body for an increased number of staff to deal with such a huge campus and patient population, and new state laws and standards, but no changes had been made.


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6. On 2/15/11, the Urgent Care Unit was toured. In Exam Rooms 4, 5, 7 and 8, the pads covering the exam tables had tears in vinyl type material prohibiting thorough cleaning of the surfaces. The tears varied from three inches to as large as six inches in length and were from 1/2 -1 and 1/2 inches in width. The tears limited the effectiveness of the disinfection between patient use.



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Based on observation, record review and staff interview, the infection control officer(s) failed to show that infection control policies and practices were continuously being developed and implemented throughout the hospital. The size of the campus, the patient census, and characteristics and complexities of the population, could potentially limit the officers' ability to do surveillance of the environment and staff practices for adherance to P&Ps.

Findings:

1. Review of the AORN 2010, Perioperative Standards and Recommended Practices showed free-standing humidifiers should not be used because they can harbor microorganisms in the fluid reservoirs and aerosolize these microorganisms into the surgical environment.

The L&D OR suites were toured with RN 2 and Srub Tech 1 on 2/15/11 at 0910 hours. The RN stated four OR suites were located on the unit, three of which were in active use.

During an observation of OR 4, a digital readout of the room's temperature and humidity was observed on the wall. When asked regarding the monitoring of the humidity and temperature levels, the RN stated, if the air was too dry, each OR room had a portable humidifier set to go on automatically.

A plastic portable humidifier was observed in ORs 2, 3, and 4. Standing water was observed in the interior of each machine. When asked, Srub Tech 1 stated the engineering staff came often to clean the humidifiers. The Srub Tech stated a special type of water was used in the machine. See A749 #1.

2. The hospital failed to ensure the P&P (policies and procedures) for endotoxin testing of the water used for hemodialysis was followed. Endotoxins are byproducts of bacteria. Hemodialysis replaces a non functioning kidney's ability to clear the blood of waste products. Exposure of a patient's blood to bacteria and/or endotoxins could result in serious complications of infection. See A144 #1.

3. RN 19 was observed in the ED on 2/17/11 at 1020 hours. The RN appeared to be triaging (assessing the order patients will be seen) patients arriving by ambulance. The RN was observed to cough into his hand on three separate occasions. After coughing into his hand, the RN walked over to the nurses station, picked up a medical record and then proceeded to move to the grease board which listed the ED patients and the staff assigned to each patient. The RN picked up a grease pen and an eraser and wrote on the board. During the approximately five-minute observation, the RN walked back and forth through the unit looking for staff and physicians. RN 19 was not observed to wash his hands or use the hand gel provided on the wall in this area for hand hygiene.

4. An automatic blood pressure machine was observed plugged in for charging on 2/17/11 at 1015 hours. The machine was located in a utility room located across the hallway from the Infusion Unit on the 5W unit. The blood pressure machine was covered in a layer of dust and drip stains were noted on the side of the machine.

RN 20 was interviewed on 2/17/11 at 1020 hours. The RN confirmed the blood pressure machine in the utility room was used by staff for the patients in the Infusion Unit. When asked, the RN confirmed 90% of the patients in the Infusion Unit received chemotherapy medications and were at high risk for infections.

RN 20 and the Associate Nursing Director observed the blood pressure machine with the surveyor on 2/17/11 at 1025 hours. The RN and the Director confirmed the machine was not clean. When asked, the RN stated this type of equipment was cleaned weekly by nursing staff.

During a follow up interview with the Associate Nursing Director on 2/17/11 at 1330 hours, the Director stated EVS was responsible for the cleaning of patient care equipment, such as a blood pressure machine. Review of the P&P Environmental Services, last review date 5/04, with the Director showed patient care equipment not attached to the patient was cleaned daily.

Based on observation and interviews, the hospital failed to ensure the infection control officer(s) developed or implemented a plan to evaluate measures regarding environmental sanitation issues. The hospital failed to show there was active monitoring of hospital staffs' compliance with the infection control policies, procedures, protocols and other infection control program requirements. Failure to adhere to infection control requirements and P&Ps could lead to an unsanitary environment and the possible spread of infection.

Findings:

1. Interviews with the infection control committee at 1000 hours on 2/16/11, revealed the committee was unaware portable humidifiers were being used in the surgical and labor and delivery suites in the hospital. The members of the infection control committee stated that environmental rounds were made in the hospital on a monthly basis.

The AORN 2010 recommends not to use free-standing humidifiers in the operating rooms because they could harbor microorganisms in fluid reservoirs and aerosolize these microorganisms into the clean environment.

2. A tour of the medical surgical unit revealed a four bed room with four patients in the room. One patient was found to have contact isolation precautions for preventing the spread of infection. However, the isolation sign was not visible to the public before entering the four bed room. A review of the hospital P&P dated 2009, showed posting of contact isolation precautions on the door of the room is required. Personal belongings of two registered nurses were observed in the room with the contact isolation patient.

3. Observation of OR 2 on 2/15/11 at 1030 hours, showed the OR microscope was covered prior to being cleaned after a surgical procedure.

4. The CDC recommends IV sites and tubing, should be changed no less frequently than every 72 hours. The hospital's P&P for changing IV sites was every three days.

On 2/14/2011, Patient 1 was observed to have two IV sites. One was dated 2/7/11 and the second 2/9/11. These IV sites had not been changed per hospital policy.

5. A tour of the GI lab on 2/16/11 at 1400 hours revealed colonoscopes were being transported uncovered from the GI lab, through a patient care area, to the processing area. The soiled suction container used during a colonoscopy was placed into the handwashing sink following the procedure. The sink was not disinfected.


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8. On 2/14/11 at 1000 hours, a tour of the psychiatric unit was conducted. Observation and inspection of two, multiple occupancy patient rooms (four patients to each room) showed bathrooms that had a shelf below the mirror. In each bathroom, four tooth brushes were observed piled on top of each other. The toothbrushes were not labeled or protected from coming in contact with the other tooth brushes.

On 2/14/11 at 1030 hours, an interview with RN 13 was conducted. The nurse stated the patients are encouraged to keep their personal hygiene items in their bedside drawer. She stated staff should assist patients in promoting safe hygiene practices.






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6. On 2/17/11, the hospital's isolation policy, effective date 6/23/08, described
three types of transmission-based isolation precautions which were airborne, droplet and contact. These might be combined for diseases that had multiple routes of transmission.

Contact precautions were applied to patients known or suspected to be colonized by microorganisms that could be transmitted by direct or indirect contact (e.g., infected wound with drainage, infected urine and stools). Standard PPE requirements were required which included gown, gloves and handwashing. Gowns were required for all interactions that might involve contact with the patient. Gloves were to be worn when having contact with infective material, followed by washing hands immediately with soap and water or the use of an alcohol based hand rub.

Droplet precautions were applied to any patient known or suspected to have infectious diseases spread by droplet, such as the influenza virus, parvovirus and Neisseria meningitis. The droplet transmission involves contact with mucous membranes of the infectious patient (nose and/or mouth). The droplets are generated from the infected person during coughing, sneezing, talking and/or during suctioning and bronchoscopy. Transmission of these large particle droplets requires close contact of usually less than 3 feet. This requires the precaution of donning a mask in addition to gloves and a gown.

Airborne precautions were applied to patients known or suspected to be infected with microorganisms that could be transmitted by the airborne route, such as measles and chickenpox, of which small particles remain suspended in the air for long periods of time. This precaution requires wearing a fit-tested N-95 mask or higher level respirator, in addition to wearing gloves and a gown. Staff failed to implement these procedures as follows:

a) On 2/15/11 at 0900 hours, the initial tour of the Pediatric Ward was conducted with MD 10, Associate Nursing Director RN 33, and the Nurse Manager of Pediatrics.

In room 5, Bed-A was empty. The pediatric patient in Bed-B was noted to have a "Droplet Precaution" sign posted on the bed. Yellow isolation gowns, a box of masks and a box of gloves were laid on the overhead table. However, the patient's guardian and the primary nurse, RN 37, who examined the patient, were noted not wearing any gowns, masks or gloves. RN 37 was noted to leave the room without hand washing. There was no isolation cart or isolation sign by the door to alert individuals to the isolation precautions to follow when entering the room.

On 2/15/11 at 0930 hours, the patient's guardian, while holding the pediatric patient, was asked why she was not wearing a gown, mask or gloves. She responded she did not need to wear any. The protective gear on the overhead table was for the nurses to wear to be able to follow the hospital protocol.

The Nurse Manager of Pediatrics, who was standing beside the surveyor, heard the guardian's response. She stated she expected the visitors were educated by nurses regarding isolation techniques. She added, isolation precaution signs were to be placed at the infected patient's bedside per policy. However, signs were only noted to be attached by the door entering the two bed room.

b) On 2/15/11, while the surveyor was standing at the pediatric nurse station, MD 12, was observed in room 6. There was an isolation cart and a droplet isolation sign at the door. MD 12 was noted to take off the isolation gown, mask and gloves. MD 12 walked out of the room and went directly to nurse's station, grabbed a medical record and started charting without washing her hands.

On 2/15/11 at 0935 hours, the observation was shared with the Nurse Manager of Pediatrics. The Nurse Manager of Pediatrics identified the doctor as an attending physician.

c) On 2/15/11, in room-19 of the Pediatric unit the patient in Bed-A was being held by the mother who was wearing a yellow isolation gown but no gloves. The mother wore a mask that covered only the mouth but not the nose. The sign on the crib said contact and droplet isolation precautions.

On 2/15/11 at 0945 hours, the Nurse Manager of Pediatrics was asked regarding the manner the PPE was worn by the mother. It was stated the mother of the patient had been educated several times but had been non-compliant per nursing documentation. The Manager had already spoken to the mother but it was not effective. There were no further steps taken to educate the mother.

d) On 2/15/11, while speaking to the Nurse Manager of Pediatrics by Bed-A in room 19, who was on droplet and contact isolation precautions, the dividing curtain was pulled open by a resident physician, MD 11, who was observed touching the patient in Bed-A without wearing PPE.

On 2/15/11 at 0915 hours, MD 11 was asked if he was supposed to wear PPE. MD 11 looked at the sign but made no comment. MD 11 did not wash his hands when he left the room.

e) On 2/15/11 at 0950 hours, Bed-B in room 19 of the Pediatric Unit had a sign stating the patient was on "droplets and contact isolation." The mother of the patient, who was a yard away from RN 8, was noted to be wearing a mask only. RN 8 was not wearing PPE.

7. On 2/15/11 at 1625 hours, the hospital's P&P on Care of Central Venous Catheters -Dressing Change, effective 8/9/07, stated, the transparent dressing should be changed every five days if using a chlorhexidine gluconate patch followed by a transparent dressing, or every 72-96 hours if using a gauze dressing. All dressings should be clearly labeled and positioned in such a way as to permit easy site inspection. This policy to prevent infection was not implemented as follows:

a) On 2/15/11 at 1325 hours, the initial tour of the surgical intensive care units (SICU) was conducted with the Associate Nursing Director and the ICU Nurse Manager.

The ICU Nurse Manager showed the central venous catheter site of the patient in Bed-1. The site was covered by a transparent dressing.

The ICU Nurse Manager was asked when the catheter dressing was due for a dressing change. It was stated that it was impossible to tell because the dressing was not dated and contained no initial of the person who applied it. She stated the usual protocol was to change the catheter dressing every 72 hours and the dressing should be dated and timed.

b) On 2/15/11, the patient in Bed-5 of the Medical Intensive Care Unit (MICU) was noticed to have a central venous catheter with an intravenous medication (Levophed) infusing continuously.

On 2/15/11 at 1400 hours, RN 35 was asked when the catheter was inserted. RN 35 checked the patient's record and replied the catheter was inserted on 2/11/11. When asked when the catheter dressing was last changed, RN 35 was unable to tell because the dressing was not dated and there was no initial of the staff who applied it.

The IV tubing of the Levophed drip was also noted to be dated 2/11/11. RN 35 stated the IV tubing should have been changed on 2/14/11.

The CDC recommends IV tubing be changed no less frequently than every 72 hours.

c) On 2/15/11, further tour of the MICU Bed-3 showed a patient having continuous hemodialysis treatment. Tracing the dialysis tubing led to an undated dressing of the central venous dialysis catheter of the patient. In addition, the arterial line tubing (a catheter in the artery allowing continuous blood pressure monitoring and blood sampling) for flushing the line was also undated.

The ICU Manager at the bedside made no comment. RN 36 apologized regarding the undated arterial line tubing and undated hemodialysis catheter dressing. RN 36 verbalized she needed to change and date the tubing of the arterial line for flushing and the catheter dressing every 72 hours.

Based on interview and record review, the hospital failed to ensure the hospital's policy for organ and tissue donation was followed for two of 10 records (Patients 23 and 48) reviewed for organ donation and to ensure a staff member knew the referral process for organ donation. This could potentially result in a missed opportunity for organ donation.

Findings:

Review of the hospital's policy and procedure "Tissue and Organ Donations," revised 11/10, showed the OPO (Organ Procurement Organization) was to be notified of all patient deaths in a timely manner. The notification was to be documented in the patient's medical record. In the case of cardiac death, the OPO was to approach the next of kin for donation opportunity and consent.

On 2/15/11 at 1010 hours, RN 24 was interviewed regarding what procedures were to be implemented in the event of a patient death. The RN stated the physician would approach the family about organ donation.

Ten medical records of patients who died at the hospital were reviewed for documentation whether the OPO was notified of the patients' death. The following was found:

a. In Patient 48's medical record, on the Certificate of Death form dated 2/8/11, the section for notification of the OPO was left blank. The Associate Director of Nursing was unable to find documentation anywhere else in the patient's medical record whether the OPO was notified .

b. In Patient 23's medical record, on the Certificate of Death form dated 2/12/11, there was no section for notification of the OPO but instead there was a section "WAS ORGAN DONATION DISCUSSED WITH THE FAMILY?" This section was left blank. The Associate Nursing Director stated the Certificate of Death form used for Patient 23 was wrong because it was outdated.

Based on observation, document review and interviews, the hospital failed to ensure that an acceptable level of safety for the environment of surgical services was implemented and maintained. This could lead to the spread of infection.

Findings:

1. The hospital failed to ensure all 10 operating rooms and all four labor and delivery rooms were maintained with a relative humidity no less than 30% or higher than 60% per AORN guidelines. Cross reference A951 #1.

2. The hospital failed to ensure the surgical service department was aware that portable humidifiers were being used in the operating rooms. Cross reference A951 #1.

3. The hospital failed to ensure the operating rooms were dust free and cleaned. Cross reference A724.

4. The hospital failed to ensure the operating rooms were hazard free and environmentally safe. The OR exhaust vent was blocked. The operating room contained stored binders, surgeon's chairs and a supply cart. Cross reference A951 #3.

5. The hospital failed to evaluate and/or change utility function of an OR room with regard to fire safety or infection control. Cross reference A951 #4.

The cummulative effects of these systemic practices resulted in the hospital's inability to ensure quality care in a safe environment.

Based on observation and a review of policies and procedures, the hospital failed to maintain a sanitary environment for the provision of surgical services. This could lead to contaminated surfaces in the operating room and the spread of infection.

Findings:

1. According to AORN 2010 - Perioperative Standards and Recommended Practices, the recommended practice for a safe environment revealed the temperature in the OR should be maintained between 68 and 73 degrees F. The relative humidity should be maintained between 30-60% in the ORs, recovery rooms, cardiac catheterization labs, endoscopy rooms, instrument workrooms and sterilization areas. A low humidity increases the risk of fire from electrostatic charge in this oxygen rich environment or when flammable liquids agents were in use and increased the risk for dust. A high humidity increased the risk germs growing where sterile supplies were stored or procedures performed. Freestanding humidifiers were recommended to be prohibited in the surgical environment because the moist environment in the humidifier could harbor germs and be spread into the air of the sterile environment.

The L&D OR suites were toured with the L&D Nurse Manager, RN 2 and Scrub Tech 1 on 2/15/11 at 0910 hours. The RN stated there were four OR suites located on the unit, three of which were in active use. During an observation of OR 4, the RN stated, if the air was too dry, each OR room had a portable humidifier set to go on automatically.

Plastic portable humidifiers was observed in ORs 2, 3, and 4. Standing water was observed in the interior of each machine.

Interviews with the infection control committee at 1000 hours on 2/16/2011 revealed that the committee was unaware that portable humidifiers were being used in the OR and Labor and Delivery rooms. The members of the infection control committee stated that environmental rounds were made in the hospital on a monthly basis. However, they failed to observe the portable humidifiers in the OR and Labor and Delivery rooms.

Interviews with the Assistant Director of Facilities and the Assistant Administrator of Operations on 2/16/11 at 1000 hours revealed the responsibility for monitoring the use of the humidifiers was unclear.

2. In OR 2, on 2/15/11, the operating room microscope was covered after use in a surgical procedure, without being cleaned.

3. The AORN Perioperative Standard and Recommended Practice, 2010, for Safe Environment of Care recommended that air flow patterns should be controlled and uninterrupted. Equipment and supplies should be located away from exhaust ducts to allow directed air flow out of the room. Air exchanges per hour should be monitored per the hospital's policy.

At 0930 hours on 2/15/11 and inspection of OR 2 showed the room contained an exhaust vent that was blocked by an instrument and supply cart. The OR contained stored binders for papers. Surgeons' chairs and a supply cart were observed stored in the corner of the OR.

4. On 2/15/11 at 0950 hours, OR 2 was observed for cleaning. The EVS staff was observed cleaning OR surfaces from the top of the surface to the floor, and then back up to the top. This is in violation of the hospital's policy and procedure dated 2009 that required cleaning from the top to the bottom. The armboard and mattress on the OR table had cracks in the material with visible soiling after cleaning.

5. Observation of the anesthesia staff revealed failure to wash or disinfect hands after removing gloves. There was no hand sanitizer on the anesthesia carts for this purpose.

6. A tour of OR 2 on 2/15/11 and a tour of ORs 8 and 10 on on 2/16/11 revealed penetrations in the ceiling of these rooms. In ORs 2,8, and 10, x-ray view boxes were broken with a gap between the boxes and the wall. There was visible accumulated dust and dirt.

7. On 2/16/11 at 1300 hours, observation of OR 10 revealed the room was being used for minor surgical procedures requiring a sterile environment, pain management procedures and GI endoscopy procedures. The room was observed to contain a scrub sink and an open drain on the floor. Interviews with the Surgical Department Chair and the Surgical Services Nurse Manager revealed the room had formerly been used for urinary cystoscopy procedures. The floor drain had not been removed. There had been no evaluation of the infection control safety of the change in use for the room.


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