HospitalInspections.org

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Based on observations, interview, and document review including medical records, hospital policy and procedures, meeting minutes, quality assessment and performance improvement documentation (QAPI), infection control data, and personnel file reviews, the governing body failed to assume full responsibility for the conduct of the hospital including the implementing and monitoring of the policies and procedures governing the total operation of the hospital.

1. The governing body failed to ensure a comprehensive, hospital wide Quality Assessment and Performance Improvement program was in place, which identified opportunities for improvement and change, that would lead to the improvement in patient care, including, ensuring the safe prescribing, dispensing and administration of medications, such as insulin infusion practices consistent with the use of the insulin protocol and the safe use of Fentanyl patches (Refer to A- 276, A-263); the governing body failed to ensure the QAPI program set priorities for performance improvement that focused on high risk and problem prone areas for all departments (Refer to A-266, A-276, A 285, A-385, A-618, A-620 and A-630 and A-749).

2. The governing body failed to ensure nursing services were consistently furnished to meet the needs of all patients in accordance with professional standards of care and facility policies and procedures; failed to ensure nursing staff consistently implemented facility policies and procedures for the safe administration of medications; (Refer to A-385, A- 395, A-397, A-404, A-405).

Failed to ensure insulin infusion orders were administered in accordance with physician's orders and the hospital's protocol, for three of four sampled patients.

These problems resulted in the hospital's inability to ensure the provision of the safe administration of intravenous insulin infusion. On 7/21/11 at 3 p.m., Administration was notified of the determination of an Immediate Jeopardy situation as the result of the above findings, which presented a condition that was likely to cause serious injury, harm, or impairment to patients.
The Immediately Jeopardy was abated on 7/21/11 at 4:45 p.m. after accepting the hospital's plan of correction and after verifying new guidelines for intravenous insulin infusion were developed to ensure safe use of insulin infusion for patients. (Refer to A-404).

3. The governing body failed to ensure a medical record service was maintained that ensured that adequate personnel to ensure prompt completion and filing of records were employed (Refer to A-431, A- 432); failed to ensure that medical records were accurately written, promptly completed, properly filed, and accessible; and that entries in medical records were complete, dated, timed, and authenticated (Refer to A- 438,A -450); failed to ensure that verbal/telephone orders were authenticated within 48 hours and that general consents for treatment/admission were complete and signed (Refer to A- 457, A-466); failed to ensure that medical records were completed within 14 days following discharge and that outside services were provided under current agreements (Refer to A-469, A-084); and failed to ensure that the medical staff bylaws contained a provision of oversight by the Medical Records Committee (Refer to A-353);

4. The governing body failed to ensure the provision of pharmaceutical care and services met the needs of the patients in accordance with professional standards of practice, this was evidenced by the failure to ensure an effective procedure was in place to ensure the safe use of Duragesic (fentanyl) patches (Refer to A- 500); failed to ensure a system was in place for the oversight and consistent monitoring of the use of the automated dispensing cabinet (Pyxis) override process, with Pyxis override review on a daily basis by the pharmacy staff, in accordance with accepted professional principles (see ASHP and ISMP guidelines). (Refer to A- 500); failed to ensure the temperatures for medication storage in the pharmacy and in 3 medication refrigerators were monitored, and consistently logged every day, according to the hospital policy and procedures, to ensure the integrity of medications were maintained. (Refer to A- 491); failed to ensure pharmacy services developed a comprehensive program that focused on the use and administration of the insulin infusion protocol, to identify problems and reduce medical errors. (Refer to A-404, A-285, A-266, A-276)

5. The governing body failed to ensure food and Dietary services were directed by a qualified employee who was dedicated full time, to the daily management of the operation of dietary services including: implementing training programs for dietary staff and assuring that established polices and procedures were maintained and consistently implemented that addressed safe and effective food production and food handling practices, adequacy of emergency food supplies, provide daily management and supervision of work performances, ensure patient diets were served as specified on the menu, menu planning, purchasing of food and supplies (Refer to A-618, A-620); failed to ensure QAPI activities were developed that reflected the scope and nature of the dietary and nutritional services. (Refer to A- 276, A- 285).

The cumulative effect of these systemic problems resulted in the hospitals inability to ensure the provision of quality health care in a safe environment.

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Based on document review, staff interview, and observation, the facility failed to ensure that a current agreement for the release of information company was in effect. This failure had the potential to jeopardize the confidentiality and security of medical records.

Findings:

1. During an interview with Staff J on the morning of 7/18/11, she stated that an outside company came to the hospital about 1 or 2 days a week to copy/scan medical records for outside requestors, primarily insurance companies. On the morning of 7/19/11, an agreement with a company with a different name was presented and reviewed. This agreement was with a former company, apparently purchased by the current company; and the agreement had expired as of 6/30/07, based on review of a purchase order.

During a tour of the Medical Records Department on the morning of 7/19/11, Staff J explained that the two file drawers full of records were waiting for the release of information company representatives to copy on their next visit later that week. Upon further research for a current agreement, on the afternoon of 7/21/11 Staff I said that this company was not a currently-used vendor, which was the reason why they were not on the master contract list. When this evaluator explained that according to Staff J, they were still being utilized, she said that they would have to get an agreement in place.

2. Four additional agreements with outside services were reviewed on the morning of 7/19/11. Three of these had expired on 6/30/11 and the amendments to extend the term had not been signed by both the facility and the outside service prior to the expiration (off-site storage of medical records, confidential data destruction, and temporary coder staffing).

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Based on document review the hospital failed to maintain a list of all contracted services that included the scope and nature of the services provided.

Findings:

Review of the list of contracts provided by the facility on 7/19/11 revealed the list did not include the scope and the nature of the services provided.

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Based on observation and interview, the hospital facility to protect each patient's right to personal privacy, by failing to limit the release or disclosure of confidential patient information in the Emergency Room (ER). A large dry erase board was observed behind the ER check in desk. The board was used by staff to track patient placement in the ER. The information written on the board included personal patient information such as, the patient's name, age and their chief medical complaint. The patient confidential information was visible to all patients, visitors, and family members who might stop at the desk.

Findings:

Observations made during a tour of the ER starting on 7/18/11 at 10:10 a.m., revealed a large white dry erase board, located inside the ER behind the check in/check out desk. The following information was recorded on the board and visible to all who would stop at the desk: the patient's name, age, physician, bay number, assigned RN, and the patient's complaint (reason for coming to the ER). Patients, visitors and family members were observed at the desk area receiving discharge instructions, and requesting information.

In an interview with the Nurse Manager of the ER (NMER) during the observation period, she indicated that the board is used by the staff to keep track of where patients are placed within the ER. She verified that the posted patient information was visible to both patients, and visitors to the ER.

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Based on observation, interview and document review the hospital failed to ensure there was an effective, ongoing, data driven, hospital wide quality assessment and performance improvement (QAPI) program in place as evidenced by:

1. The failure to develop a comprehensive program that focused on the use and administration of the insulin infusion protocol, to identify problems and reduce medical errors. (Refer to A-404, A-285, A- 276)

2. The failure to Identify opportunities for improvement and changes that would lead to improvement when the nursing staff failed to implement the insulin (to decrease blood sugar) infusion protocol, resulting medication administration errors. Medical record review of three of four patients who were administered intravenous (through the vein) infusion of insulin demonstrated nursing errors in making the required changes in the doses. Errors in dosage changes could lead to hyperglycemia (high blood sugar) and/or hypoglycemia (low blood sugar), which could further complicate patient's clinical status. (Refer to A- 276).

3. The failure to identify opportunities for improvement and changes that would lead to improvement when the hospital's prescribing and dispensing practices for Duragesic (fentanyl) patches did not conform to the Food and Drug Administration's Black Box Warnings. Two of five patients, who received orders for fentanyl patches, did not demonstrate opioid-tolerance before being administered the medication. The failure could lead to dangerous side-effects, such as respiratory depression, for patients. (Refer to A- 276)

3. The failure to identify high risk or problem prone area as evidenced by the failure of pharmacy services to conduct random checks or audits to evaluate the use of insulin infusion practices and implementation of the insulin protocols to detect errors, non-compliance, or issues related to insulin administration and errors. Failure to identify problem prone dietary/food issues such as a developing system to ensure safe cool down practices for food products were consistently implemented and documented. (Refer to A- 285, A-620)


The cumulative effect of these systemic problems resulted in the facility's inability to ensure the provision of a quality patient health care in a safe environment.

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Based on observation, interview and document review the Quality Assessment and Perfromace Improvement failed to develop a comprehensive program that focused on the use and administration of the insulin infusion protocol, to identify problems and reduce medical errors. (Refer to A-404, A-285, A-276)

Findings;

Although insulin was identified by the facility as a high risk medication, and an insulin infusion protocol was developed, there was no documentation to indicate further evaluation of this high risk problem prone area was implemented. There was no documentation to indicate the pharmacy conducted random checks or audits to evaluate the use of insulin infusion practices, and the insulin infusion protocol, to detect errors, non-compliance, or issues related to insulin infusion administration.

Medical record review of three of four patients reflected the following:
- Nursing staff did not follow the hospital's insulin protocol resulting administration errors, for three of four patients;
- An interview with an Intensive Care Unit (ICU) nurse revealed she adjusted the insulin doses based on her own judgment;
- The hospital staff failed to monitor blood sugar hourly when it was out of goal range according to protocol, for three of four patients;.
- There lacked documentation of nursing double checks when insulin infusion pump was set up, at infusion rate changes, and when insulin infusion was restarted, for three of four patients; and
- The Insulin protocol proved to be complicated and difficult to follow, evidenced by nursing staff not following it.

On 7/21/11 at approximately 10:30 a.m., an interview was conducted with the Pharmacy Manager (Pharm 1) and the Medication Safety Pharmacist (Pharm 2). Pharm 2 said, as the result of insulin-related medication errors reported from October 2010 to March 2011, the hospital launched a Insulin Administration Audit in June 2011 to get a "snapshot view of the subcutaneous insulin administration practices".

Pharm 2 said, however, that the hospital did not have audits/studies on the insulin infusion practices. The reported medication errors reflected "insulin ordered without using the order form", "Insulin drip adjusted without valid MD orders", "expired insulin drip hanging on patient", "wrong insulin dose", "Insulin gtt (drip) was not increased per protocol resulting in BS in the high 200s", "Insulin drip was entered with incorrect rate of administration", etc.

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Based on observation, staff interview, and document review, the hospital failed to identify opportunities for improvement and changes that would lead to improving patient care and services, as evidenced by;

1. The failure to identify nursing staffs' failure to consistently implement the insulin infusion protocol, resulting in medication administration errors. Medical record review of three of four patients who were administered intravenous (through the vein) infusion of insulin demonstrated nursing errors in making the required changes in the doses. Errors in dosage changes could lead to hyperglycemia (high blood sugar) and/or hypoglycemia (low blood sugar), which could further complicate patient's clinical status. (Refer to A-404, A-285).

2 The failure to identify the prescribing and dispensing practices that did not conform to the Food and Drug Administration's Black Box Warnings (FDA BBW) for Duragesic (fentanyl) patches. Two of five patients, who received orders for fentanyl patches, did not demonstrate opioid-tolerance before being administered the medication. The failure could lead to dangerous side-effects, such as respiratory depression, for patients. (See cross reference A- 500)

3. The failure to identify the Dietary department had no formal performance improvement program for the food service or for the clinical nutrition services. The supervision of the food services, which included monitoring of safe food preparation and storage and kitchen maintenance was designated to unqualified staff. (Refer to A- 265, A-618, A-620).

Findings:

1. Medical record review of three of four patients reflected the following:
- Nursing staff did not follow the hospital's insulin protocol resulting administration errors, for three of four patients;
- An interview with an Intensive Care Unit (ICU) nurse revealed she adjusted the insulin doses based on her own judgment;
- The hospital staff failed to monitor blood sugar hourly when it was out of goal range according to protocol, for three of four patients;.
- There lacked documentation of nursing double checks when insulin infusion pump was set up, at infusion rate changes, and when insulin infusion was restarted, for three of four patients; and
- The Insulin protocol proved to be complicated and difficult to follow, evidenced by nursing staff not following it.

The failure to follow protocol resulted in prolonged hyperglycemia for patients in some instances. The failure to carry out nursing double checks resulted in administration errors.

On 7/21/11 at 1 p.m., the ICU Clinical Nurse Manager (ICU CNM) and the Pharmacy Manager (Pharm 1) were asked if they had known about nursing staff not following the insulin infusion protocol, both staff said they had not.

2. On 7/18/11 at 10:35 a.m. during a pharmacy tour, the Pharmacy Manager (Pharm 1) and the Medication Safety Pharmacist (Pharm 2) were interviewed regarding the hospital's process for prescribing, dispensing, and administration of Duragesic (fentanyl) transdermal patches. Both pharmacy administrative staff said there was no specific policy and procedure for Duragesic patch usage, but the pharmacy staff's role was to ensure the FDA guidelines were met before they were released to the Pyxis for nursing staff to administer to patients. They said the pharmacists were the "gate keepers" of this process by ensuring prescribing criteria, such as chronic pain indication and for patients with demonstrated opioid-tolerance, as indicated by the FDA's Black Box Warning (BBW). They said "opioid tolerant" meant patients must have been on narcotics such as 60 milligrams (mg) of morphine, 30 mg of oxycodone, or 8 mg of Dilaudid for at least 7 days. They said pharmacists were educated about this process and the implementation had been in place since 2007.

During the same pharmacy visit, Pharm 1 also provided a Duragesic Medication Use Evaluation audit he had done in First Quarter 2011. The study showed 100 % compliance with the prescribing criteria: appropriate indication for use and opioid-tolerance requirement.

On 7/20/11 and 7/21/11, medical record review of Patients P-1 and P-20 indicated the patients did not demonstrate opioid-tolerance before being administered the medication. Patients who are considered opioid-tolerant are those who have been taking, for a week or longer, at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid (BBW, www.Duragesic.com).

The reviews also reflected the prescribers ordered Duragesic patches for pain in trauma patients (i.e. motor vehicle accident), indication that was not consistent with the FDA BBW: "DURAGESIC? is indicated for management of persistent, moderate to severe chronic pain that:
? Requires continuous, around-the-clock opioid administration for an extended period of time, and
? Cannot be managed by other means such as nonsteroidal analgesics, opioid combination products, or immediate-release opioids." (BBW, www.Duragesic.com)

On 7/21/11 at 5:30 p.m., Pharm 4 was interviewed about his evaluation for Patient P-1's fentanyl patch usage. He said he thought the patient was in a lot of pain and three-day Dilaudid usage would be appropriate for the fentanyl patch, therefore he did not intervene. He added, looking back, he said three-day would not be considered opioid-tolerant. Pharm 1 said he did not know that Pharm 4 did not know about the opioid-tolerant requirement.

During an interview with the pharmacy administrative staff on 7/22/11 at 9:30 a.m., Pharm 1 said he was surprised about the Duragesic findings during the survey and that his staff did not know about the opioid-tolerant requirement.

3. On 7/19/11 at 2:30 p.m., the Staff Services Manager stated that other than the patient satisfaction rounds and tray temperature monitoring the Food Service Department did not develop QAPI indicators relative to the scope of the food service that included; monitoring staff involved in recipe preparation, monitoring trayline accuracy, monitoring cool down procedures, and monitoring staff compliance to policies and procedures.

On 7/21/11 beginning at 10:00 a.m. an interview with RD III revealed there was no formal performance improvement program developed or implemented for the clinical nutrition services, nor was there any formal process to identify indicators relative to the scope of the nutrition services being provided.

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Based on staff interview and record review, the facility failed to set priorities for performance improvement that focused on high risk or problem prone area, that affect the health outcomes, patient safety and quality of care for pharmacy and dietary services. Although insulin was identified by the facility as a high risk medication, and an insulin infusion protocol was developed, there was no documentation to indicate further evaluation of this high risk problem prone, high risk area was implemented. There was no documentation to indicate the Dietary department, including clinical nutrition services, had assessed and identified high risk, problem prone areas, and developed and implemented actions aimed at performance improvement, and quality patient care. (Refer to A-276, A-404, A-630)

Findings:

1. The hospital identified insulin as one of its high-risk medications according to its "High Risk Medications" policy & procedure. The Institute for Safe Medications Practices (ISMP) defines high risk medications as those that bear a heightened risk of causing significant harm when they are used in error.

There was no documentation to indicate random checks or audits were conducted to evaluate the use of insulin infusion practices and the insulin infusion protocol, to detect errors, non-compliance, or issues related to insulin infusion administration.

On 7/21/11 at approximately 10:30 a.m., an interview was conducted with the Pharmacy Manager (Pharm 1) and the Medication Safety Pharmacist (Pharm 2). Pharm 2 said, as the result of insulin-related medication errors reported from October 2010 to March 2011, the hospital launched a Insulin Administration Audit in June 2011 to get a "snapshot view of the subcutaneous insulin administration practices".

Pharm 2 said, however, that the hospital did not have audits/studies on insulin infusion practices. The reported medication errors reflected "insulin ordered without using the order form", "Insulin drip adjusted without valid MD orders", "expired insulin drip hanging on patient", "wrong insulin dose", "Insulin gtt (drip) was not increased per protocol resulting in BS in the high 200s", "Insulin drip was entered with incorrect rate of administration", etc.

2. On 7/19/11 at 2:30 p.m., the Staff Services Manager stated that other than the patient satisfaction rounds and tray temperature monitoring the Food Service Department did not develop indicators relative to the scope of the food service that included; monitoring staff involved in recipe preparation, monitoring trayline accuracy, monitoring cool down procedures, and monitoring staff compliance to policies and procedures. There was no documentation the department had identified problems based on high-risk, high-volume, or problem-prone areas.

On 7/21/11 beginning at 10:00 a.m. an interview with RD III revealed there was no formal performance improvement program developed or implemented for the clinical nutrition services, nor was there any formal process to identify indicators relative to the scope of the nutrition services being provided, which focused on high -risk, high-volume or problem -prone areas.

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Based on document review and staff interview, the facility failed to ensure that the medical records oversight function was included in the Medical Staff Bylaws, Rules and Regulations in accordance with state regulation.

Findings:
The minutes of the 2011 meetings of the Medical Records Committee were reviewed on 7/18/11. On the morning of 7/20/11, Staff SS was asked if the Medical Records Committee was a medical staff committee, since there was no mention of it in the Medical Staff Bylaws, approved 5/16/11. She stated that the facility realized that this committee should have been included in the bylaws, but had inadvertently omitted the description, composition and duties of the committee.

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Based on observation, interview and record and document review, the facility failed to ensure nursing service were consistently furnished to meet the needs of the patients, and in accordance with facility policies and procedures and professional standards of care as evidenced by the failure to:

1. Ensure insulin infusion orders were administered in accordance with physician's orders and hospital protocol for three of four sampled patients (Patients P-12, P-16, and P-18). Medical record review of three of four patients, who were administered intravenous (through the vein) infusion of insulin (to decrease blood sugar), demonstrated nursing errors in making the required changes in the insulin doses as directed by the hospital protocol.

An interview with one nursing staff revealed she adjusted the insulin dose administered using her own judgment (discretion). Nursing staff failed to monitor hourly blood sugars when it was out of goal range. Nursing staff failed to document nursing double-checks when the infusion was first initiated, at infusion rate changes, and when the infusion was restarted, as required by facility policy and procedure and professional standards of practice for the safe use of insulin.

Errors in dosage changes could lead to hyperglycemia (high blood sugar) and/or hypoglycemia (low blood sugar). These conditions had the potential to adversely affect the patient's health and condition. Severe hypoglycemia or hyperglycemia could lead to loss of consciousness/coma.

These problems resulted in the hospital's inability to ensure the provision of the safe administration of intravenous insulin infusion. On 7/21/11 at 3 p.m., Administration was notified of the determination of an Immediate Jeopardy situation as the result of the above findings, which presented a condition that was likely to cause serious injury, harm, or impairment to patients.

The Immediately Jeopardy was abated on 7/21/11 at 4:45 p.m. after accepting the hospital's plan of correction and after verifying new guidelines for intravenous insulin infusion were developed to ensure safe use of insulin infusion for patients. (Refer to A-404, A-266, A-285).

2. Ensure nursing staff consistently completed and documented independent double-checks (to verify accuracy) for 2 of 2 patients (Patient -4 and P-11) who were on a narcotic PCA. Patient Controlled Analgesia (PCA) is an electronically controlled infusion pump that delivers an amount of intravenous pain medication that is controlled by the patient. Per facility policy and procedure nursing double-checks are to be completed and documented when there is a change in the PCA's administration rate, and/or at syringe change. PCA is considered one of the hospital's high risk medications. (See A- 405)

3. Ensure the amount of pain medication administered to one of two sampled patients on a PCA (Patient P-11) was documented. Documenting the amount of pain medication administered/required during a time period, identifies whether or not pain control was adequate. This failure had the potential to expose Patient P-11 to inadequate pain management. (See A- 405)

4. Ensure the licensed nurse (LN) documented a verbal order for Ativan (a controlled substance for treating agitation) in the medical record for Patient 3. The LN withdrew the Ativan by Pyxis override, and when the patient did not require the medication the the LN failed to return the Ativan to the Pyxis in a timely manner (4 hours later) as per facility policy and procedures. A licensed nurse in the Emergency Department (ED) failed to follow policy and procedures for the wasting of unused medication which was packaged for single use. The nurse saved the remaining dose of a Dilaudid Carpuject (a potent controlled drug for pain, packaged in a sealed device, similar to a syringe, and is meant for single use) to give to the patient Patient 13. The nurse failed to waste the remainder of another Dilaudid Carpuject in a timely manner (over 3 hours after withdrawn from Pyxis). The failure to return the controlled substance to the Pyxis in a timely manner increases the risk of loss, theft, or diversion of controlled drugs. The reusing of Dilaudid Carpuject presented an unsafe practice. (See A- 405)

5. Ensure safe medication administration policies and procedure were consistently implemented for two of two patients on Lovenox (a high risk medication to prevent blood clots). There was no documentation to verify nursing staff completed and documented a double check of the medication (Lovenox) when an odd-strength was prescribed for Patient P-4, as per hospital policy and procedure; and when Patient P-3 had two Lovenox orders which were not clarified (See A -405)

6. Ensure the safe use of medications for Patient 16 when nursing staff failed to record the amount of subcutaneous (under the skin) insulin administered to the patient on the medication administration record (MAR), did not document double checking was done at each administration, and did not re-write the medication order on the MAR when there were changes to the orders. These practices could lead to potential medication administration errors. (See A- 405)

The cumulative effect of these systemic problems resulted in the facility's inability to ensure the provision of quality health care in a safe environment.

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Based on observation, record review and staff interview the hospital failed to ensure the nursing care provided for Patient D1 was in accordance with professional standards of practice and facility policy and procedures. Patient D1 had orders to receive Pregestimil (infant formula) 24 calorie, 2 ounces every 2 hours by mouth. Regular infant formula provides 20 calories per ounce but the order required a higher calorie/concentration requiring special mixing. The infant formula was prepared by licensed staff in the pantry area of the unit, however, the preparation area was dirty, cluttered and unsanitary. The formula was not prepared in accordance with acceptable standards of practice and guidelines which state " a dedicated clean space with facilities for aseptic technique must be used for formula preparation," or in accordance with the facility's policy and procedure which specifies that "the preparation of special formula concentration requires guidelines for preparation from the dietician." This practice placed the patient at risk for potential infections (Refer to A- 630).

Finding:

1. Patient D1, a 2 month old infant, was admitted to the hospital on 7/5/11 with diagnoses including failure to thrive. The infant weighed 3.95 kilograms (8 pounds 9.6 ounces) upon admission, which reflects only a 2 ounce weight gain since birth. The patient's weight for his age and length were both under the 3rd percentile, indicating that the patient was severely underweight.

The plan upon admission (7/5/11) was to provide the infant with 20 calories per ounce (of formula) with a goal of 30 ounce per day. If the child's rate of weight gain was not satisfactory, the plan was to insert an NG (nasogastric tube, a feeding tube inserted through the nose into the stomach) to supplement what the patient did not take orally. The admission nutritional assessment conducted by the registered dietitian on 7/5/11 identified that the patient's nutritional needs could be met with the physician's order.

On 7/14/11 the patient's diet was changed to concentrated Pregestimil (infant formula) 24 calories, 2 ounces every 2 hours by mouth, and the rest by NG (feeding tube). Regular infant formula provides only 20 calories per ounce. The prescribed formula was a higher calorie/concentration which required special mixing.

The hospital policy titled "Formula Preparation and Feeding Guidelines" ( review date of 02/10) was reviewed on 7/18/11 at approximately 4:00 p.m.. According to this policy, "the preparation of special formula concentration requires a medical order with guidelines for preparation from the dietitian".

According to the American Dietetic Association "Guidelines for Preparation of Formula and Breastmilk in Health Care Facilities", "written formulations should be maintained in the infant formula preparation room for all infant formulas prepared. Formulations must be verified for accuracy and appropriateness, preferably by a registered dietitian trained in infant formula preparation."

Interview with LN 4 on 7/18/11 at approximately 11:00 a.m. revealed that the hospital was out of the 24 calorie formula, and was therefore using the powdered infant formula, which was prepared by licensed nursing staff in the pantry area on the pediatric unit. There was no documentation to indicate the special formula concentration recipe was verified and prepared under the guidance of a dietician as per policy and procedure.

2. On 7/18/11 at 11:00 a.m. a tour of the pediatric unit and the area where the infant formula was being prepared by licensed staff was observed. The counter space in the pantry area or " cocina " was dirty, and cluttered with staff drinks and used coffee cups, fruits, etc. A piece of brown paper towel was placed on the counter and on the paper towel was a can of powdered formula, a bottle of sterile water and a wet, inverted graduated measuring cup. The prep area was not a dedicated space and was unsanitary.

According to the guidelines of either the American Dietetic Association (ADA), or the World Health Organization (WHO) a separate infant formula room is strongly suggested. Where there is no formula room, " a dedicated clean space with facilities for aseptic technique must be used for formula preparation."

According to the WHO, poor hygiene has been reported to be the probable cause of some E.sakazakii (a bacteria) outbreaks. This is because harmful bacteria can be carried on the hands and on surfaces.

The nurse manager for the newborn intensive care unit (NICU) was interviewed on 7/19/11 at approximately 12:30 p.m. She indicated that she was not aware that there was infant formula being prepared on the pediatric unit. She acknowledged that the area as described above was not according to how it was prepared in the NICU. In response to a question on training, she further acknowledged that she had not trained the staff who prepared the formula and was not sure if they had been trained. She stated that the practice would cease and that formula preparation would only occur in the NICU.

The infection control nurse was interviewed on 7/20/11 at approximately 1:35 p.m. She acknowledged that the preparation area was not reflective of effective infection control practices.

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Based on personnel file review and interview, the facility failed to ensure two of six licensed nurses (RN) assigned to the emergency room (ER) were current in Pediatric Advanced Life Support Certification (PALS), a competency requirement for RN's who are assigned to work in the ER. ( Employee 3 and Employee 6).

Findings:

In an interview with the Nurse Manager of the ER (NMER) on 7/18/11 at 11:10 a.m., she indicated that all RN staff assigned to work in the ER are required to have Advanced Cardiac Life Support (ACLS)and PALS certification.

On 7/18/11 at 11:10 a.m. a review of the personnel files of 6 RN's assigned to work in the ER, revealed a job description which specified that ACLS and PALS are required certifications to work in the emergency department.

Two of 6 files reviewed (Employee 3 and 6) revealed the employee's PALS certification had expired, and there was no documentation to verify a renewal had been obtained.

Employee 6, who was a transfer from within the hospital to the ER, had no competency verification to work in the triage area. However a review of assignment sheets for the month of July 2011 revealed she had been assigned to work in the triage area of the ER two times.

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Based on staff interviews and record reviews, the hospital failed to ensure insulin infusion orders were administered in accordance with physician's orders and hospital's protocol, for three of four sampled patients (Patients P-12, P-16, and P-18), as evidenced by:

Medical record review of three of four patients who were administered intravenous (through the vein) infusion of insulin (to decrease blood sugar) demonstrated nursing errors in making the required changes in the doses. Errors in dosage changes could lead to hyperglycemia (high blood sugar) and/or hypoglycemia (low blood sugar). These conditions had the potential to adversely affect the patient's health and condition. Severe hypoglycemia or hyperglycemia could lead to loss of consciousness/coma.

? An interview with an Intensive Care Unit (ICU) nurse (LN 7) revealed she adjusted the insulin doses (infusion rate) based on her own judgment. This practice presented a risk for patients to suffer from hyperglycemia or hypoglycemia unnecessarily.

? The nursing staff failed to monitor the blood sugar according to protocol. This failure had the potential for insulin infusion adverse outcomes (hypoglycemia/hypoglycemia) in patients who needed intensive care to go undetected, and consequently, untreated.

? There lacked documentation of nursing double checks per hospital's policy and procedure when the insulin was first set-up (pump setting), at infusion rate change (running rate at X amount of units per hour based on the patient's blood sugar levels), and when insulin was restarted. This resulted in nursing errors in adjusting the doses/ infusion rate.

? Review of the ADULT INSULIN INFUSION ORDERs and its administration demonstrated a complicated process which was difficult to follow, as evidenced by nursing staff not following protocol in three of four sampled patients, at different units and two campuses of the hospital. There were instances that demonstrated the protocol would not work for the patients in keeping the blood sugar in range.

On 7/21/11 at 3 p.m., Administration was notified that an Immediate Jeopardy was called as the result of the above findings, which presented a condition that was likely to cause serious injury, harm, or impairment to patients.

On 7/21/11 at 4:45 p.m., the Immediate Jeopardy was abated after the survey team accepted the hospital's plan of correction by immediately suspending the current insulin drip protocol, and after verifying a new process in place for ordering and administration of insulin drip infusion, and ensuring nursing double-checks would be in place.

Findings:

The hospital identified insulin as one of its high-risk medications according to its "High Risk Medications" policy & procedure. The Institute for Safe Medications Practices (ISMP) defines high risk medications as those that bear a heightened risk of causing significant harm when they are used in error.

1. On 7/20/11 at 10:15 a.m., a visit SP ICU was conducted in the presence of the ICU (intensive care unit) clinical nurse manager (ICU CNM), the Medical/Surgical CNM, and the Pharmacy Manager (Pharm 1). Review of P-12's medical record revealed he was admitted to the hospital on 7/18/11. On 7/18/11 at 6:40 p.m., he had a physician order for "Insulin drip per protocol - Target BG (blood glucose) 120 - 200 [mg/dL]" (order was written on the physician's order form instead of the protocol). The 7/18/11 medication administration record (MAR) indicated it was carried out at 10 p.m. when blood glucose (BG) was 242. Based on the specified guidelines of the protocol, at BG of 242, the infusion rate was to be 3 units (of insulin) per hour (hr).

However, the documentation of the patient's medication administration record (MAR) stated the infusion rate was run at 2 units/hr. There was also no initials on the MAR indicating who started the infusion rate, and there was no documentation to verify that the set up and initiation of the insulin protocol was checked and verified by two nurses, as required by facility policy and procedures.

During this visit, the ICU CNM verified the nursing administration error and said there should have been two sets of nursing initials (as this was the initial infusion set-up). She said double checks by two licensed nurses were required at set-up and initiation of the infusion, at infusion rate change, and at insulin bag change. She said the nursing staff were to document the double checks on the MAR.

The ICU licensed nurse (LN AB) was interviewed at 7/20/11 at 10:30 a.m. She said when there was no protocol form ordered, the nursing staff would initiate the insulin infusion rate with Algorithm 1 on the protocol, and adjust the rates based on the patient's BG. The protocol indicated moving up and down based on the BG reading: "MOVING UP: Algorithm failure is defined as BG out of goal range and BG that has not decreased by at least 40 mg/dL in one hour" and "MOVING DOWN: When BG< 100 mg/dL or if BG decreases >40 mg/dL in an hour. Restart insulin drip when BG is greater than 100 mg/dL and move down an algorithm."

Review of the 7/19/11 MAR with LN AB during this visit reflected at 6 a.m., when the BG was 169, 1 unit/hr infusion rate was administered while the protocol called for 1.5 unit/hr. There was no indication who adjusted the infusion rate (no nursing initials by the entry) on the MAR. This failure lead to an increase in BG at the subsequent reading at 8 a.m. (BG 266).

At 8 a.m., the infusion rate was correct (5 units/hour per Algorithm 2). At 10 a.m., when the BG was 265, LN AB documented the infusion rate at 7 units/hr while the protocol called for 8 units/hr (per Algorithm 3; BG had not decreased by 40 mg/dL in an hour and BG out of goal range). When asked why she did not follow the protocol, LN AB said, "Because the patient just ate, so I used my own discretion to adjust the dose to keep the blood sugar in range." When asked if she had an order to deviate from the protocol, she said, "No. I just use my own discretion."

The MAR indicated at 12 p.m., the BG was 190, and the recorded infusion rate was 2 units/hr while the protocol called for 5 unit/hr. Further review of the MAR reflected the subsequent infusion rates were not corresponding to the protocol.

The protocol also called for patient monitoring: "BG every hour until it is within goal range for 4 hours. Then check every 2 hours for 4 hours. If BG remains stable, may decrease monitoring to every 4 hours. Resume hourly checks if BG falls out of goal range." There was no documented evidence the BG was monitored every hour when BG was out of goal range. For example, at initiation of the infusion rate on 7/18/11 at 10 p.m., the BG was 242 (out of goal range). The MAR indicated the next documented BG check was at 2 a.m. on 7/19/11, 4 hours later.

Review of Patient P-12's 7/19/11 MAR also revealed there were no nursing double checks documented when the infusion rates were changed, as per facility policy and procedure. The ICU CNM verified these findings.

2. On 7/20/11 at 12:10 p.m., a review of Patient 16's medical record with the ICU CNM and Pharm 1 at SP Medical/Surgical Unit revealed that the patient had a physician's order for "Insulin drip Titrate per protocol" on 7/17/11 at 12:45 p.m. The order was written on the physician's order sheet instead of on the protocol, and there was no specified BG goal range. The protocol indicated a goal BG range of "110-180 mg/dL.

The 7/17/11 MAR reflected the order was carried out at 12:50 p.m. without a nursing double check, as there was only one nurse's initials. At this time, the BG was 330 mg/dL and infusion rate was run at 4 unit/hr (correct, according to Algorithm 1 on protocol). At 2 p.m., when BS was 321, the infusion rate was run at 7 unit/hr (correct, according to Algorithm 2). At 4 p.m., when BG was 138 (BG decreased by 183 in two hours), the infusion rate was run at 1 unit/hr when the protocol indicated for 0.5 unit/hr (according Algorithm 1, after BG had decreased >40 mg/dL in one hour). Again at 6 p.m., when BG was at 138, the rate was run at 1 unit/hr when the protocol indicated for 0.5 unit/hr (Algorithm 1, BG was in goal range). At 9 p.m., when BG was 239, infusion rate was run at 3 unit/hr when the protocol indicated for 4 units/hr.

The MAR reflected three errors in one day's administration of insulin infusion. There were no nursing double checks at the initiation of the infusion and when there were infusion rate changes. The BG was checked (as documented on the MAR) every 2 hours, instead of hourly, when the BG was out of goal range (i.e. BG 321 at initiation). The ICU CNM confirmed these findings.

3. On 7/21/11 at 9 a.m., a review of Patient 18's medical record on the direct observation unit (DOU) with the ICU CNM, Pharm 1, and Pharm 2 was conducted. The record indicated that Patient 18 was admitted with medical conditions including diabetes. The insulin drip protocol was ordered to start with Algorithm 2 , and the BG goal range was 110-180 mg/dL, on 7/19/11 at 4:10 p.m.

Review of the MAR revealed the insulin infusion was started at 9:30 p.m. at 1 unit/hr (BG 165), however the protocol indicated 2 unit/hr (according to Algorithm 2). There were no nursing double checks documented on the MARs. At 10:30 p.m., the infusion was turned off when BG was 93 (according to protocol).

On 7/20/11 at 2 a.m., when the BG was 200, the infusion rate was restarted at 1 unit/hr when protocol called for 2 unit/hr (Algorithm 1, move down an algorithm when insulin drip restarted). There were no nursing double check when the insulin infusion was restarted. As a result the patient's BG increased, and was 232 at the next BG reading at 4 a.m. (BG 232). At 4 a.m. the rate was at 2 unit/hr when protocol called for 4 unit/hr (Algorithm 2, BG out of goal range and had not decreased by at least 40 in one hour). At 6 a.m. the BG was 210, and the protocol stated to follow Algorithm 3, to run at 6 unit/hr, but infusion was actually run at 2 unit/hr.

Because the initial infusion rates were incorrect, the subsequent rates were thrown off. Review of a 24-hour insulin infusion administration for Patient 18 revealed six administration errors when the protocol was not followed. Both Pharm 1 and ICU CNM verified the calculations and the infusion rate administration errors.

Patient 18's BG was not checked (monitored) hourly when BG was out of goal range, as per the protocol, and there was no documented nursing double checks when the infusion rates were changed.

On 7/21/11 at 12:48 p.m., ICU CNM was asked if the double checking and rationale were documented as to why the nursing staff variated from the hospital protocol. At 1 p.m., she said there were no documented reasons in the electronic or paper medical records. There was no documented evidence that there was physician's order to variate from the protocol.

An interview with the DOU licensed nurse (LN CC) on 7/21/11 at 1:05 p.m. She verified that nursing double checks were to be done at the initiation of the insulin infusion, at rate changes, and when the insulin infusion was restarted. the double checks were to be documented on the MAR.

The hospital's 6/08 policy and procedure entitled "High Risk Medications" indicated the following for insulin: "Two independent checks on the dose being administered including pumps and bolus doses."

Review of the " facility's name ADULT INSULIN INFUSION ORDERS (not for DKA)" protocol reflected it was to difficult to follow, as evidenced by nursing staff not following it for three of four patients. Also, there were instances if the algorithms on the protocol had been followed, an increase/decrease in the BG might have resulted. For example, for Patient 16, when the BG was 138 at 6 p.m., the nurse ran the dose at 1 unit per hour instead of 0.5 unit/hr by protocol. At 9 p.m., the BG was 239 (high and out of range). If the nurse had run at 0.5 unit/hr according to protocol, the 9 p.m. the BG would have been higher than 239.

For patient 18, at 12 p.m. the BG was 149, the LN ran the dose at 3 unit/hr (Algorithm 3, according to protocol.) At 2 p.m., the BG was 247 (high, out of goal range), the LN stayed at Algorithm 3 and gave 8 unit/hr dose instead of jumping to Algorithm 4 (16 unit/hr) according to the protocol (moving up algorithm if BG out of goal range and BG has not decreased by at least 40 mg/dL in one hour). The 8 unit/hr infusion rate yielded the subsequent BG of 152 (in range) at 4 p.m. Had the nurse followed the 16 unit/hr per protocol, the BG would have gone down much lower than 152. These demonstrated that the protocol was not working for these patients.

27000

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Based on observation, interviews, and document and record reviews, the facility failed to ensure that all drugs were administered in accordance with approved policies and procedures and accepted standard of practice for 5 of 21 sampled patients. (Patients P-3, P-4, P-11, P-13, P-16)

1. Nursing staff failed to implement the facility's policy and procedure to ensure the safe use of medication. Nursing staff failed to document independent double-checking (method to verify accuracy) was done at set-up, when there was an administration rate change, and at syringe change, for 2 of 2 patients (P-4 and P 11) who were on narcotic PCA.

2. Nursing staff failed to document the amount of pain medication administered, for one of two patients (P-11)on a PCA. Documenting the amount of pain administered/required during a time period help indicate whether or not pain control was adequate. This failure had the potential to expose Patient P-11 to inadequate pain management.

3. Nursing staff failed to document a verbal order for Ativan (a controlled substance for treating agitation) in Patient 3's medical record. The ICU licensed nurse withdrew the medication by Pyxis override. The LN , however, failed to return the Ativan in a timely manner (4 hours later) when the patient did not require it. Facility policy requires the unused medication be returned in 1 hour.
An Emergency Department licensed nurse(LN) failed to implement the facility policy and procedure that requires that doses not administered must be wasted. Patient 13 had an order for Dilaudid Carpuject (a potent controlled drug for pain) 0.5mg for pain. Carpuject is a sealed device that is meant for single use and is supplied in a 1 mg. dose. The LN administered the 0.5mg dose of the Dilaudid, as ordered, but did not waste the remaining 0.5mg as per policy. A second order for Dilaudid 0.5 mg. was received for the patient two minutes later. The LN administered the remaining Dilaudid 0.5mg that was left from the first Carpuject. She also failed to waste the remainder of another of Dilaudid Carpuject in a timely manner (3 hours after withdrawn from Pyxis). The failure to return CS to the Pyxis in a timely manner increases the risk of loss or diversion of controlled drugs.

4. Nursing staff failed to ensure the safe use of medications for two of two patients (P-3 and P-4) on Lovenox (a high risk medication to prevent blood clots) when there was a lack of nursing double check for an odd-strength Lovenox administration for Patient P-4; and when Patient P-3 had two Lovenox orders without nursing clarification. A nursing double-check is required per facility policy and procedure,

5. Nursing staff failed to implement facility policies and procedures to ensure the safe use of medications for Patient 16. Nursing staff failed to document the amount of subcutaneous (under the skin) insulin administered on the MAR, failed to document double checking was done at each administration, and failed to re-write the order on the MAR when there were changes to the orders. These failures could lead to confusion and administration errors.

Findings;

The hospital's policy and procedure entitled "PATIENT CONTROLLED ANALGESIA (PCA)", revised 11/09, indicated:
"10. Obtain 2nd RN's presence at bedside to verify all PCA settings prior to proceeding.
"11. Verify all PCA settings to MD orders (both RNs must check MD orders and PCA settings).
"13. Before he/she leaves the bedside, ensure 2nd RN is aware he/she must co-initial and sign PCA entry on MAR."

1a. On 7/18/11 at 3 p.m., a review of Patient P-4's medical record at the DOU (Definitive Observation Unit) was conducted with Pharm 1 and the ICU clinical nurse manager (ICU CNM). The ICU CNM indicated that PCAs were considered high risk according to the hospital policy and nursing double checks (two nurses checking for correct physician's order, medication, the running rate, etc.) were required at PCA set-up (pump settings), at setting change, and at syringe change (refill of medication). She said two nurses' initials were required on the medication administration records (MAR) for these changes. The MAR had allotted times for nursing staff to document the PCA setting verification every 4 hours (at 2 a.m., 6 a.m., 10 a.m., 2 p.m., 6 p.m., and 10 p.m.)

Patient Controlled Analgesia (PCA) is the use of an electronically controlled infusion pump that delivers an amount of intravenous pain medication that is controlled by the patient. PCA is considered one of the hospital's high risk medications - those that bear a heightened risk of causing significant harm when they are used in error, according to the Institute for Safe Medications Practices (ISMP).

Patient P-4 was prescribed Dilaudid (a potent narcotic) PCA to control pain on 7/7/11 at 3:35 p.m. Review of the MAR (where the PCA administration was documented) with ICU CNM revealed when the PCA was carried out at 4:30 p.m., however, there was only one nurse's initials on the MAR. On 7/9/11 at 12 p.m., the physician order was changed to "add continuous infusion 0.2 mg/hour" to the running rate, which required pump setting change. The 7/9/11 MAR indicated the order was carried out at 6 p.m. (2 p.m. administration was circled indicating the PCA was not run at the time); there was only one nurse's initials on the MAR. However, there was only one nurse's initials when there was a PCA refill (syringe change) on 7/11/11 at 7:45 a.m., and again, on 7/12/11 at 1:45 p.m. ICU CNM verified that there should have been two nurses' initials on the MAR for these entries and acknowledged that nursing staff were not following the hospital's policy and procedures.

Patient Controlled Analgesia (PCA) is the use of an electronically controlled infusion pump that delivers an amount of intravenous pain medication that is controlled by the patient. PCA is considered one of the hospital's high risk medications - those that bear a heightened risk of causing significant harm when they are used in error, according to the Institute for Safe Medications Practices (ISMP).

1b. On 7/19/11 at 3 p.m., a review of Patient P-11's medical record was conducted at the 2 West Nursing Unit with the Medical/Surgical CNM (MS CNM). The record reflected Patient P-11 had an order for Dilaudid PCA on 7/17/11. The MAR indicated the PCA was "initiated" at 1:50 a.m. However, there was only one nurse's initials on the MAR.

At 5:20 p.m., a "new syringe" was written on the MAR, again there was only one nurse's initials. On 7/18/11 at 10:45 p.m., there was a change from "morphine PCA to Dilaudid PCA" with specific PCA settings (i.e. lockout period, patient administered dose, and maximum 1-hour dose) indicated. The order was carried out and documented on the MAR on 7/19/11 at 2 a.m. Again, there was only one nurse's initials on the MAR at this time.

2. The hospital's policy on "Medication Management", dated 3/09, indicated, "6. Certain high risk meds MUST be double checked and initialed by two licensed personnel.
a. PCA settings and amount administered (in mg) are to be checked every 4 hours by the nurse and noted on the MAR."

On 7/20/11 at 3 p.m., a review of Patient P-11's MAR from 7/17/11 to 7/19/11 revealed the amount administered (amount of pain medication administered/delivered by the pump on patient demand) were not documented every 4 hours, according the the hospital's policy and procedure.

There were eight documented "4-hour PCA checks" during this period and the amount administered was not documented 5 out of 8 times. The amount administered gives an a history of use for the last 4 hours, which helps indicate unrelieved pain or over usage. It also helps clinicians evaluate and provide appropriate intervention(s) in the event of adverse drug reaction or side effects. MS CNM acknowledged that nursing staff failed to document the amount of medication administered every 4 hours on the MAR.

3. On 7/18/11 at 10:35 a.m., a review of the Pyxis override (medication obtained by nursing staff before the order was reviewed and entered by the pharmacist) revealed an ICU nurse obtained Ativan 4 mg through the Pyxis override at 2:46 p.m. on 7/17/11. She returned the medication to the Pyxis at 6:41 p.m. (4 hours lapse between Pyxis withdrawal and return) for Patient P-3.

On 7/18/11 at 1:45 p.m. at the ICU, a review of Patient P-3's medical record with Pharm 1 and the ICU CNM reflected no documentation of an Ativan order in the record. The ICU CNM explained that she had placed a call to the said nurse, who explained that she had a verbal order for Ativan for the patient, but due to the circumstances at the time, she forgot to document the order in the medical record, and did not have time to return the medication to the Pyxis until four hours later. ICU CNM said the nurse failed to document the order in the record and should have returned the Ativan to the Pyxis within one hour, per hospital policy.

4. The hospital's policy's on "CONTROLLED SUBSTANCES", revised 7/06, indicated, "Doses that are refused, contaminated, and dosage other than what was ordered for administration to patients will be considered doses not administered and must be documented as wasted."

The 7/11 "Medication Management" policy and procedures indicated, "Medication will not be transported in clothing pockets or in otherwise, inappropriate or unsecured means unless urgent patient care needs necessitate temporary alternatives."

A review of Patient 13's medical record was conducted at the site #2 Emergency Department (ED) on 7/20/11 at 11 a.m. with Pharm 1 and ED nurse (LN CH). According to the record the patient came into the ED on 7/20/11 for abdominal pain and an order for Dilaudid 0.5 mg was received at 1:50 a.m. The Pyxis report and the ED record indicated an ED nurse (LN CB) obtained a Dilaudid Carpuject 1 mg (prefilled syringe meant for single use) single dose and administered the prescribed 0.5 mg at 1:52 a.m. Shortly after 2 a.m., the patient had another order for 0.5 mg Dilaudid, which was also administered by the ED nurse.

The Pyxis report indicated there was no withdraw for the second dose of Dilaudid. At 3 p.m., the patient had another 0.5 mg Dilaudid order and the medication was withdrawn for the third dose at 3:11 p.m. The patient had two subsequent Dilaudid 1 mg orders at 4:23 a.m. and 6 a.m. The total Dilaudid order was 3.5 mg. Pyxis report showed 4 withdraws of 1 mg (4 mg) for Patient 13. The record showed the remainder of 0.5 mg was wasted at 6:38 a.m.

When asked to explain why the remainder (0.5 mg) was not wasted after the 1:52 a.m. administration, LN CH reasoned that the nurse (LN CB) must have kept the remainder and gave to the patient after she got the second 0.5 mg Dilaudid order. LN CH explained it was not "normal practice" for nursing staff to do so. Pharm 1 said the Carpue were to be used as single doses; unused portion should be wasted as soon as possible or within an hour.

LN CB was not available for interview. The CNM was interviewed on the phone on 7/22/11 at 9:05 a.m. She said, through a conversation, LN CB told her she used a syringe to withdraw 0.5 mg Dilaudid from the Carpue for the first Dilaudid administration and saved the remaining 0.5 mg for the second administration.

When she got the third 0.5 mg Dilaudid order, she withdrew a new Dilaudid Carpuject from the Pyxis (at 3:11 a.m.), withdrew 0.5 mg from it and saved the remaining portion in her pocket. After that, the patient did not have 0.5 mg orders anymore.

CNM said LN CB told her she got busy and did not waste the remainder of Dilaudid until 6:38 (over 3 hours later). The CNM said LN CB did not follow the hospital's policy and procedure by reusing single dose Dilaudid Carpuject and by not wasting the medication in a timely manner. She said controlled substance wastage should occur right away as soon as obtained from Pyxis or as soon as possible; three hours was not acceptable.

5. On 7/18/11 at 1:45 p.m., a review of Patient 3's medical record at the ICU with the ICU CNM revealed that the patient had two concurrent orders for once-daily subcutaneous Lovenox: 40 mg written on 7/17/11 at 2 p.m. and 30 mg written on 7/17/11 at 3 p.m. (one hour apart). The 7/17/11 MAR was first written with 40 mg, then was crossed out and replaced with 30 mg. The pharmacy record indicated Lovenox 30 mg was dispensed. There was no documented evidence that the nursing staff clarified the orders with the physician. The ICU CNM acknowledged the orders should have been clarified to prevent administration error.

6. The hospital's policy and procedure on "Medication Management- High Risk Medications", revised 6/08, reflected the following under Lovenox: "Doses that are not commercially available must be double checked by another person. (i.e. Lovenox 85 mg)."

During an interview with Pharm 1 on 7/18/11 at 2 p.m., he said any Lovenox doses that were not commercially available (in other words, odd strength, which required manipulation before administration) needed to be double checked by two licensed staff before administration and MAR documentation.

Review of Patient P-4's medical record on 7/18/11 reflected he had Lovenox 70 mg (commercially available in 80 mg; to give 70 mg, 10 mg needed to be discarded before administration) to be administered twice daily on 7/11/11. The MAR indicated there was only one nurse's initials on 7/12/11 at the 10 p.m. administration. Pharm 1 confirmed the finding.

7. The hospital's policy and procedure on "Medication Management", dated 7/11, Under "Documentation of New Orders, Changes, Discontinuations and Renewals, it indicated: "When a new order supersedes an existing order, it is documented by discontinuing the first order on the MAR and writing entry in the next available space on the MAR. Do not make written corrections or changes on the old order"; and under "Medication Administration and Documentation", it indicated: "Medications ordered to be given on a sliding scale are documented in the same manner as other medications, except that the dose given (e.g., units, mg, etc.) will be written in below the time."

Review of Patient 16's medical record with Pharm 1 and ICU CNM on 7/20/11 at 12:10 p.m. reflected a low dose sliding scale order for insulin started on 7/16/11 at 6:50 p.m. At 9:38 a.m. the next day, 7/17/11, there was an order to increase the insulin dose to "medium dose", and at 11:20 a.m. (same day) to increase insulin sliding scale to "high dose". Each insulin sliding scale had a separate set of dosing breakdowns. For example, if blood glucose was between 200 - 249, give 2 unit of insulin for low dose sliding scale. For medium and high dose sliding scale, the amount of insulin would be 3 units and 4 units respectively.

Review of the MAR, during the same visit, reflected the MAR on 7/17/11 had one print-out entry of insulin for three sliding scale orders. The nursing staff crossed out the low sliding scale breakdowns, and replaced them with hand-written "medium dose" sliding scales. When the "high dose" sliding scale was ordered, they crossed out the hand-written "medium-dose" sliding scale breakdowns and replaced them with that of the high-dose sliding scale.

The MAR also reflected there were four documented administrations of insulin on 7/17/11. Three of four administrations lacked nursing double checks. Three of four did not document the amount of units given. It was undeterminable if the insulin sliding scale was carried out corresponding to the timing of the changes of the sliding scale orders.

During the same visit, ICU CNM said the nursing staff should have yellowed out the old order and re-write with a new one. She also said the amount of insulin should be documented on the MAR.

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Based on record review and interview, the hospital failed to ensure all medication orders were complete and written in compliance with standards of practice to ensure safe preparation and administration. Review of two of two surgical records (P-3 and P-4) revealed that the post anesthesia care unit (PACU) physician's orders for medications were incomplete. The orders were not timed by the physician when written, and the duration and doses of medications were not specified. This practice created a potential for medication errors and a potential for harm to the patient.

Findings:

The facility policy and procedure titled "Initiation, Review and Acceptance of Pre-printed Orders" dated 3/10, indicated, "All existing pre-printed orders will be reviewed annually by department specific committee and either accepted as is or modified by department committee."

According to current standards of practice, elements that must be present in orders for all drugs and biologicals, to ensure safe preparation and administration include;
name of the patient, age and weight of patient,when applicable, date and time of the order, drug name, exact strength or concentration when applicable, dose, frequency and route, quantity and/or duration,when applicable. specific instructions for use, when applicable, and name of prescriber

1. Review of Patient 3's medical record beginning on 7/20/11 at 11:00 a.m. revealed pre-printed Post-Anesthesia/Recovery Room orders including; "Dilaudid mild pain .2 mg (milligrams) IV Q (every) 5 min (minutes). Moderate pain .4 mg IV Q 5 min. Maximum dose of 2 mg PRN (as needed) pain.
Metoclopramide (Reglan) 10 mg IV PRN nausea.
Ondansetron (Zofran) (blank dosage) IV PRN nausea. Ketorolac (Toradol)(blank dosage) IV PRN, pain"

The order for the Dilaudid for the mild or moderate pain was incomplete, it failed to specify a duration time. The orders for the Ondansetron and Ketorolac failed to specify doses, and none of the orders were timed by the physician when written.

2. Review of Patient 4's medical record beginning on 7/20/11 at 11:10 a.m. revealed pre-printed Post-Anesthesia/Recovery Room orders including; "Morphine mild pain 2 mg IV Q 10 min, Moderate pain 4 mg IV Q 10 min, Severe pain 4 mg IV Q 10 min. Maximum dose of 20 mg PRN pain.
If ineffective, Dilaudid, Mild pain .2 mg IV Q 10 min, Moderate pain .4 mg IV Q 10 min, Severe pain .4 mg IV Q 10 min. Maximum dose of 2 mg PRN pain. Metoclopramide (Reglan) 10 mg IV PRN nausea.
Ondansetron (Zofran) 2 mg IV PRN nausea."

The orders for the Morphine and the orders for the Dilaudid did not specify a duration time for the use of the drug(s).
The orders for the Metoclopramide and the Ondansetron failed to specify a dose, and the orders were not timed when written by physician.

This information was shared with the CNE on 7/21/11 at 6:15 p.m..

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Based on medical record and document review, observation, and staff interview, the facility failed to maintain a medical record service that was in compliance with 42 CFR 482.24 as evidenced by:

1. Failure to ensure that adequate personnel to ensure prompt completion and filing of records were employed. (Refer to A- 432)
2. Failure to ensure that medical records were accurately written, promptly completed, properly filed, and accessible. (Refer to A- 438)
3. Failure to ensure that entries in medical records were complete, dated, timed, and authenticated. (Refer to A -450)
4. Failure to ensure that verbal/telephone orders were authenticated within 48 hours. (Refer to A 457)
5. Failure to ensure that general consents for treatment/admission were complete and signed. (Refer to A -466)
6. Failure to ensure that medical records were completed within 14 days following discharge. (Refer to A-469)
7. Failure to ensure that outside services were provided under current agreements. (Refer to A- 084)
8. Failure to ensure that the medical staff bylaws contained a provision of oversight by the Medical Records Committee. (Refer to A-353)

The cumulative effect of these systemic problems resulted in the hospitals inability to provide a medical record service that ensured an accurate medical record was maintained for every individual, both inpatient and outpatient evaluated or teated in the hospital.

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Based on document review, observation and staff interview, the facility failed to ensure that adequate personnel were employed in the SP medical records office to ensure prompt filing of records, including loose paper filing. This failure had the potential to cause delays in obtaining information on patients' care and treatment. Also the facility failed to ensure that employees received annual performance appraisals for 2 of 5 employees; and documentation of these employee's qualifications were not included.

Findings:
1. During an interview on 7/19/11 at 2:30 p.m. with Staff J, she explained that she is in the final steps of hiring a second Record Tech I for the SP location to help with filing duties. Currently there are 3 full-time staff (a Record Tech III, a Record Tech I, and a coder). On the morning of 7/21/11, a tour of the SP medical records office was made with Staff C. The following backlogs in records processing were observed, measured and verified by Staff C:
- 104 inpatient records awaiting assembly and analysis dating back to 6/29/11 (plus 6/23 and 6/27 discharges)
- 97 same day surgery records awaiting assembly and analysis dating back to 6/10/11
- approximately 58-inches of physical therapy records awaiting filing
- 10 stacks of emergency department records awaiting filing
- approximately 9 banker's boxes of loose reports awaiting filing (each box holds about 12 inches of papers)

2. On the afternoon of 7/21/11, the Human Resources files of 5 medical record department employees were reviewed. Two employees had not received a performance appraisal since 2009. The same two employees were required to possess a specific credential per their job descriptions. The files did not contain evidence of their credential verification prior to hiring or validation of continuing education maintenance. One of these two files contained an unsigned confidentiality agreement, dated 4/17/09 This employee is a coder and reviews medical records daily. Upon further research by Staff I, she located evidence that the employee completed an on-line confidentiality training on 7/21/10. .At 3:50 p.m., Staff I confirmed that appraisals are to be done on an annual basis and that they had not been done; and she also verified the lack of credential verification.

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Based on observation, document review and staff interview, the facility failed to ensure that medical records were accurately written, promptly completed, and accessible. This failure is evidenced by records awaiting assembly and analysis dating back to 5/31/11. When there are backlogs of processing recently discharged records, they may already be delinquent (more than 14 days after discharge) when made available to the physicians for their final completion. Records were stored directly on the basement floor, which had the potential for records to be damaged by water. Also, due to the lack of an approved abbreviation list, medical records may not be accurately written.

Findings:

1. On 7/19/11 beginning at 10:35 a.m., a tour of the Medical Records Department at VC was made with Staff J. A backlog of recently discharged records was observed. A count revealed that there were 370 inpatient records awaiting assembly and analysis, dating back to 7/8/11; and 386 same-day surgery records awaiting assembly and analysis, dating back to 5/31/11. While touring the basement chart room accompanied also by Staff C, it was observed that there was not enough available shelving space to accommodate all the records, as evidenced by records being stacked directly on the floor, partially sticking out of the shelves and additional volumes of records filed in various places, out of numeric order. Boxes of loose paper filing and clinic records stacked around the file room directly on the floor. On 7/21/11 at 10 a.m., Staff C provided a document with the tally of 140 boxes of unfiled loose papers, dating back to 2010. Each box may contain up to 12-inches of papers.

2. The Administrative Policy #107.005, Medical Abbreviations, last revised 4/08, was reviewed of the afternoon of 7/18/11. It was noted that the "Approved by" section was blank. Upon research, Staff SS explained that the list had been updated and approved by the Medical Records Committee on 3/14/11 and had been posted on the facility's on-line reference site. However, she stated that since there were additions to the list it should have been routed through the Medical Executive Committee for final approval and this was an oversight.

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Based on medical record and document review and staff interview, the facility failed to ensure that entries were legible, complete, dated, timed and authenticated in 13 of 17 records.

Findings:

Medical records were reviewed on 7/20-21/11. The following findings were discussed with and confirmed by Staff N on 7/20/11 and Staff C on 7/21/11:

1. Entries were not timed in multiple forms , such as pre- and post-anesthesia notes, physician orders, delivery record, obstetrical discharge form, home care instructions, and sedation records (Records R-3, 9, 10, 14)

2. 3 of 3 obstetrical discharge forms were not fully completed, lacking the summary of care section (Records R-2, 3, 15)

3. Emergency department forms were not fully completed, the plan of care, disposition and condition sections were left blank (Records R-8, 10)

4. Records contained forms that were in a double-sided/fold-out format, but not all sections contained patient identification, such as name and medical record number. Since forms are photocopied or scanned as 8-1/2 by 11-inch pages, every page must stand alone and be identifiable to the patient (Records R-4, 5, 8, 10, 11, 14, 15)

5. Entries were not signed, nor was the author identified (an Alcohol Withdrawal Protocol in Record R-7 and nursing notes in Record R-10)

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Based on medical record and document review and staff interview, the facility failed to ensure that all verbal orders were authenticated within 48 hours in 4 of 24 records (R-3,R-4, R-5 and M3).

Findings:
The Medical Staff Bylaws, Rules and Regulations, approved 5/16/11, were reviewed on the morning of 7/20/11. Rule 10, Medical Records, section 10.1-8 states that the covering or attending physician shall authenticate such orders (telephone/verbal) within 48 hours.

In an interview with Staff J on 7/19/11 at 1:45 p.m., she stated that it has been the facility's practice not to obtain a physician's authentication on telephone/verbal orders after a patient's discharge. This has been the practice for more that two years.

During review of medical records of discharged patients, the following records contained telephone/verbal orders that were never signed (Records R-3, 4, 5, M3). These findings were verified by Staff N on the afternoon of 7/20.






16739

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Based on record review and interview, the hospital failed to ensure that an updated examination of the patient, including any changes in the patient's condition, was completed within 24 hours prior to the planned surgery for 4 of 6 sampled surgical patients. (P-2, P-4, P-5, and P-9).

Findings:

Record review on 7/20/11 beginning at 11:00 a.m., with the Chief Nurse Executive (CNE) revealed the following;

1. Review of Patient 2' record revealed the facility utilizes a stamp for all surgical patients for the pre-surgical evaluation which states "I have reviewed the H & P and there are no changes unless otherwise noted." Three lines are available; one for the physician's signature, one to document the time, and one to document the date.

According to the documentation on Patient 2's record this stamped area was signed by the physician, indicating that the patient's history and physical was reviewed on 7/5/11 and at 11:30 a.m.. However, a review of the patient's Perioperative Nursing Record dated 7/5/11 indicated that the patient's surgery had actually started at 10:34 a.m. and ended at 11:44 a.m..

Interview with the CNE revealed that the patient is not to go to the OR until the 24 hour update is completed. She had no explanation as to how the patient was permitted to go to the operating room without the update being completed. She verified that the documentation reflected that the H & P update was completed after the surgical procedure was completed.

2. Review of Patient's 4 and Patient 5's medical records revealed that the patients' pre-surgery update examinations were not timed to verify when it was completed. There was no documentation in the record to indicate when the 24 hour update was completed.

3. Review of Patient 9's medical record revealed no documented evidence that an updated examination of the patient was completed prior to the patient's surgical procedure.

All of the findings were verified with the CNE at this time. She stated that the patient(s) should not have been permitted to go to the operating room without the updated examination being completed.

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Based on medical record review and staff interview, the facility failed to ensure that records documented a completed general consent for treatment /conditions of admission (COA) form in 8 of 17 records. This failure had the potential for the facility being liable for treating a person without written consent. (Patients R-2, R-4, R-5, R- 7, R- 8, R-10, R-13, R-14.

Findings:

Medical records were reviewed on 7/20-21/11. Following are findings which were confirmed by Staff N on 7/20/11 and Staff C on 7/21/1:
- the COA was not fully completed; missing items were the patient's right acknowledgement and advance directive check-boxes (Records R-2, 5, 8, 14)
- someone other than the patient signed the form, but there was no documentation explaining who that person was and their relationship to the patient (Records R-4, 7, 8)
- no consent form was in record R-13 (a newborn) and it could not be located in the pending filing or in the mother's record
- the consent was not signed (Record R-10, 13)

On 7/20/11 at 3:30 p.m., Staff N was asked for a policy and procedure which might explain the process for completing the COA form, especially when a person presents to the emergency department, is unable to sign a consent, and is later admitted; however nothing was provided to this surveyor by the end of the survey.

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Based on document review and staff interview, the facility failed to ensure that medical records were completed within the time period specified in the Medical Staff Bylaws, Rules and Regulations and in accordance with state regulations. This failure had the potential to result in records lacking vital information for continuity of care.

Findings:

The Medical Staff Bylaws, Rules and Regulations, approved 5/16/11, were reviewed on 7/20/11. Section 13.3-4, Medical Records, states that medical staff members are required to complete medical records within the time prescribed by the Medical Executive Committee and that failure to do so within fourteen (14) days after the patient is discharged shall result in suspension of clinical privileges, 10 days after written notification. Further, Rule 9.1-1, Discharges, states: "....All records must be completed within fourteen (14) days following the patient's discharge from the hospital."

During an interview with Staff J on 7/19/11, she stated that currently there were no practitioners whose privileges had been suspended, although there were records that had not been completed within fourteen days following the patient's discharge. The facility's practice is to issue suspensions only once a month; and residents, who prepare the majority of discharge summaries, are not be suspended.

The Medical Record Committee minutes were reviewed on 7/18/11. As of 5/511, there were 361 delinquent records (still incomplete more than fourteen days following the patient's discharge). A separate count prepared by Staff J on 7/19/11 revealed that there were 44 delinquent discharge summaries, with the oldest dating back to 1/30/11; and 15 delinquent operative reports, with the oldest dating back to 4/24/11.

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Based on observation, interview, and document and record review, the hospital failed to ensure the provision of safe pharmaceutical services that met the needs of the patients as evidenced by;

1. Failed to ensure drugs and biologicals were safely controlled and distributed in accordance with acceptable standards of practice, and hospital policies and procedures; failed to ensure the safe use of Duragesic (fentanyl) patches. Two of five patients (Patients P-1 and P-20), who received orders for fentanyl patches, did not demonstrate opioid-tolerance before being administered the medication. The failure could lead to dangerous side-effects, such as respiratory depression (severe trouble breathing or very slow or shallow breathing) for patients; failed to ensure a system was in place for the oversight and consistent monitoring of the use of the automated dispensing cabinet (Pyxis) override process. There was no procedure for Pyxis override review on a daily basis by the pharmacy staff, in accordance with accepted professional principles (see ASHP and ISMP guidelines). There was no process to ensure for review of override appropriateness (i.e. overridden medications met hospital's policy and overrides did not take place after the pharmacist already reviewed the orders). Overridden medications did not match the approved override medications. This failure had the potential to increase patient risk to the adverse effects of medication errors. (Refer to A- 500)

3. Ensure the temperature of the medication storage areas (refrigerator/freezer) in the pharmacy,and the temperatures of 3 medication refrigerators were monitored and consistently logged every day, according to the hospital policy and procedures. The temperature wheels, which kept track of the weekly temperature readings were not changed weekly, as required, these failures could result in out-of-range temperatures to go undetected during the period it was not monitored. Storing medications out of the required range (36 - 46 degrees Fahrenheit) could render medications unsafe and/or ineffective for patients. (Refer to A- 491)

4. Ensure the provision of safe pharmaceutical services was provided to meet the needs of patient who received intravenous insulin administration, by promoting safe medication use process that reduced adverse drug events oversight and monitoring of the safe administration of intravenous insulin (Refer to A-276, A- 404)

5. Failed to set priorities for performance improvement that focused on high risk or problem prone area as evidenced by the failure to conduct random checks or audits to evaluate the use of insulin infusion practices to detect errors, non-compliance, or issues related to insulin infusion administration (Refer to A 285).

6. Failed to ensure outdated, mislabeled or otherwise unusable drugs and biologicals were not available for patient use (Refer to A-505).

The cumulative effects of these systemic problems resulted in the hospitals inability to ensure pharmaceutical services and care were provided in a safe and effective manner to meet the needs of the patients.

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Based on observations, staff interviews, and record review, the hospital failed to ensure drug storage refrigerator temperatures were maintained within the acceptable range to ensure the integrity of the stored medications. The temperature of the main medication storage refrigerator in the pharmacy, and the temperatures of three medication refrigerators ( 3 west, and 1 in surgery area and 1 in Central processing ) were not consistently monitored, and logged, according to hospital policy and procedures. The facility utilizes a temperature wheel to track and record refrigerator temperatures for a week at a time. However, the weekly recording disc's were not consistently changed, making it difficult to verify that the daily temperatures were maintained within the acceptable range. These failures could result in out-of-range temperatures to go undetected during the period it was not monitored. Refrigerated medication that is not stored with the required established range (36 - 46 degrees Fahrenheit) could render the medications unsafe and/or ineffective for patients.

Findings:

1. On 7/18/11 at 10:20 a.m., during a pharmacy tour, observation of the temperature logs for the main medication refrigerator revealed the temperatures had not been consistently logged twice daily from February to July 2011. The pharmacy manager (Pharm 1) said the temperatures were supposed to be logged twice a day since the refrigerator contained vaccines. He said he realized that the pharmacy staff had not been consistently logging the temperatures twice daily. The July 2011 log showed there was no temperature logging for 7/16/11 during p.m. shift, 7/17/11 both shifts, and 7/18/11 the a.m. shift. Review of February to June 2011 logs reflected there were several days each month that were without temperature logging.

The pharmacy refrigerators had a temperature reading tracking system - the temperature wheel (the circular monitor graph)- which recorded the weekly temperature readings. A complete circle on the graph reflect one week's worth of readings. Observation of the temperature wheel on the main refrigerator reflected it had a thick circular red line (overlapping red lines), indicating that the tracking wheels had not been changed out weekly (there were supposed to be a thin red line if changed weekly).

During the same pharmacy tour at 11:45 a.m., observation of the medication freezer with Pharm 1 revealed it contained many frozen medications (i.e. antibiotics and varicella vaccine). Review of the freezer temperature logs reflected they were not logged consistently every day. For example, there were eight days in May 2011 and 12 days in June 2011 when temperatures were not recorded. The temperature wheel on the freezer also had a thick circular red line (indicating the tracking wheel had not been replaced timely). Pharm 1 confirmed that the logs had not been filled out every day and that the temperature wheels had not been replaced weekly.

2. The facility policy and procedure titled "Storage of Medications" dated 4/23/08, states... "Drugs are stored under proper conditions according to manufacturer recommendation." In addition, "Refrigerator temperature shall be between 2.2 degree to 7.7 degree Celsius (36 degree to 46 degree Fahrenheit)". "A temperature log must be maintained for each medication refrigerator and temperature is monitored daily."

Observations on 7/19/11 at 9 a.m., during a visit to 3 west nursing unit, revealed that the temperature for the medication refrigerator was not recorded for 7 days on the July 2011 log. The refrigerator contained several antibiotics and tuberculin testing solution. The unit licensed nurse (LN 6) said the temperatures were to be logged once daily. She also said the refrigerator would not alarm if it went out of range.

On 7/19/11 at 10:00 a.m., during a visit to the Surgical Department (SSD) observations revealed that a medication refrigerator temperature was monitored with the use of a temperature wheel. At the time of the observation, the digital thermometer on the refrigerator read 3.2 degrees Celsius. The device did not continuously mark the temperature of the refrigerator. The monitoring temperature wheels for the previous six months were requested to review. Only three temperature wheels for the department dated 6/8, 6/22, and 6/29 could be located. Upon inspection of the temperature wheels, it appeared that the monitoring wheel, which is to be used for a week at a time, had not been replaced timely and had been used to monitor the temperature for multiple weeks at a time. This was verified with Staff N.

An observation on 7/22/11 starting at 11:30 a.m., while in the Central Surgical Processing (CSP) area of the facility, revealed a refrigerator marked "No Food." The temperature of the refrigerator was monitored with the use of a weekly temperature wheel. Upon inspection of the monitoring device, one could not ascertain when the last time the weekly tracking wheel was changed. The marks of the wheel were 7/16 of an inch in height. The refrigerator is used to store temperature sensitive testing materials. These findings were verified with the CNE.


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Based on observations, interviews and record reviews, the hospital failed to ensure drugs and biologicals were safely controlled and distributed in accordance with acceptable standards of practice, and hospital policies and procedures, as evidenced by:

1. Failed to ensure there was an effective procedure to ensure the safe use of Duragesic (fentanyl) patches (narcotic used for pain management). Two of five patients (Patients P-1 and P-20) who received orders for fentanyl patches, did not demonstrate opioid-tolerance, as required, before being administered the medication.

2. Failed to ensure oversight for the automated dispensing cabinet (Pyxis) override process (override is a function by which an authorized user obtains the medication before the pharmacist has entered the medication into the Pyxis profile for the patient). There was no process in place for Pyxis override review, on a daily basis, by the pharmacy staff, in accordance with accepted professional principles (see ASHP (American Society of Health-System Pharmacists) and ISMP (Institute for Safe Medical Practices guidelines). There was no process in place per professional standards to ensure a review of override appropriateness (i.e. overridden medications met hospital's policy and overrides did not take place after the pharmacist had already reviewed the orders). Review of Pyxis override reports indicated there were overridden medications that were not on the approved list of override medications.

3. Failed to ensure the sleeves of the intravenous flow hood were changed every 6 months, to conform with the manufacturer's instruction.

These failures resulted in potentially unsafe systems for the distribution and use of medications in the hospital which could result in unnecessary adverse patient outcomes.

Findings:

1. On 7/18/11 at 10:35 a.m. during a pharmacy tour, the Pharmacy Manager (Pharm 1) and the Medication Safety Pharmacist (Pharm 2) were interviewed regarding the hospital's process for prescribing, dispensing, and administration of Duragesic (fentanyl) transdermal patches. Both pharmacy staff said there was no specific policy and procedure for Duragesic patch usage, but the pharmacy staff's role was to ensure the FDA guidelines were met before they were released to the Pyxis for nursing staff to administer to patients. They said the pharmacists were the "gate keepers" of this process by ensuring prescribing criteria, such as chronic pain indication and for patients with demonstrated opioid-tolerance, as indicated by the FDA's (federal drug administration) Black Box Warning (BBW). They said "opioid tolerant" meant patients must have been on narcotics such as 60 milligrams (mg) of morphine, 30 mg of oxycodone, or 8 mg of Dilaudid for at least 7 days. They said pharmacists were educated about this process and the implementation had been in place since 2007.

Fentanyl transdermal patch is a potent narcotic (opioid) pain medicine applied to the skin, which are only intended for treating persistent, moderate to severe pain in patients who are opioid-tolerant, meaning those patients who take a regular, daily, around-the-clock narcotic pain medicine. For patients who are not opioid-tolerant, the amount of fentanyl in one fentanyl patch of the lowest strength is large enough to cause dangerous side effects, such as respiratory depression (severe trouble breathing or very slow or shallow breathing) and death (FDA Public Health Advisory, www.fda.gov). The FDA requires pharmaceutical companies who manufacture fentanyl patches to place a BBW on the labeling. A boxed warning provides a brief, concise summary of the information that is critical for a prescriber to be aware of, including any restriction on distribution or use.

DURAGESIC? is indicated for management of persistent, moderate to severe chronic pain that:
? Requires continuous, around-the-clock opioid administration for an extended period of time, and
? Cannot be managed by other means such as nonsteroidal analgesics, opioid combination products, or immediate-release opioids

Due to risk of serious or life-threatening respiratory depression, the contraindications to use of fentanyl patches in the BBW include:
I. Patients who are not opioid tolerant (opioid tolerant = patient has been taking another opioid at a dose comparable to a transdermal fentanyl patch for at least 7 days).
II. Management of post-operative pain
III. Management of mild or intermittent pain
IV. Management of acute pain or if opioid analgesia is only needed for a short period of time. (www.Duragesic.com)

On 7/20/11 at 3:10 p.m., review of Patient P-1's closed medical record with Pharm 1, Pharm 2, and the ICU( intensive care unit) clinical nurse manager (CNM) revealed the patient was admitted to the hospital for a motorcycle accident on 6/28/11. The medication reconciliation document indicated the patient had only been on Keppra and Lamictal (medications for seizure disorder) prior to admission; no history of opioid use prior to admission.
Three days after admission, 7/1/11, the physician prescribed Fentanyl 100 mcg/hr (micrograms/hour) patch to be applied every 3 days. During the period between admission and 7/1/11 (three days), the patient had been on Dilaudid (an opioid drug used for pain) PCA (patient controlled analgesia) for pain.

Because the patient had not been opioid from home and only been on an opioid (Dilaudid PCA) for 3 days prior to fentanyl patch initiation, the patient did not meet the "opioid-tolerant" requirement/criteria prior to the initiation of the fentanyl patch. On 7/20/11 at 3:30 p.m., Pharm 1 and Pharm 2 agreed that Patient P-1 did not meet the FDA's BBW guidelines. They agreed he did not qualify for fentanyl patch usage.

On 7/21/11 at 9 a.m., Pharm 1 said a staff pharmacist (Pharm 4) reviewed and entered the fentanyl patch for Patient P-1. There was no documented pharmacy intervention in the computer indicating Pharm 4 had intervened when the patient did not meet the requirements/prescribing criteria for fentanyl patch usage.

1a. On 7/21/11 at 3:40 p.m., review of Patient P-20's closed medical record with Pharm 1 and Pharm 2 revealed the patient was admitted to the hospital for a head-on collision from which he suffered neck pain and fractures on 6/17/11. On 6/18/11, the physician prescribed Fentanyl 25 mcg/hr patch to be applied every 3 days. His home medications revealed the usage of Vicodin (a short acting narcotic pain medication) without indication of last dose, or how long he had been on it. He had one-day use of morphine PCA prior to the fentanyl patch administration. The 6/17/11 blood tests revealed positive for opiates (opioid). Both pharmacy staff agreed Patient 20 did not meet the criteria for fentanyl patch usage. He did not have the chronic pain indication and did not demonstrate opioid tolerance (usage equivalent to fentanyl patch for at least 7 days) prior to fentanyl patch administration. Pharm 1 confirmed there was no documented intervention in the system by the staff pharmacist who reviewed and entered the order for the patient.

Both Patients, P-1 and P-20, did not meet the prescribing criteria - indications for use and opioid-tolerant requirement - for fentanyl patch usage.

On 7/21/11 at 5:30 p.m., Pharm 4 was interviewed about his evaluation for Patient P-1's fentanyl patch usage. He said he thought the patient was in a lot of pain and three-day Dilaudid usage would be appropriate for the fentanyl patch. He added, looking back, he said three-day would not be considered opioid-tolerant. Pharm 1 said he did not know that Pharm 4 did not know about the opioid tolerant requirement.

2. Pyxis override is a function by which an authorized user obtains the medication before the pharmacist has entered the medication into the Pyxis profile for the patient. Pyxis override bypasses the pharmacist verification for order appropriateness and accuracy. The hospital's policy allowed overrides in emergent situations when a delay could result in patient harm.

On 7/18/11 at 10:35 a.m., during an interview in the pharmacy, Pharm 1 said he reviewed the Pyxis overrides twice per week and reviewed controlled substance (CS) overrides only; the non-CS overrides were not reviewed. He said he looked to ensure each CS override had a matching order; he said he did not review for override appropriateness (such as, if the override met the hospital policy or if it took place after the pharmacist had already reviewed and entered the medication into the Pyxis profile).

On 7/18/11, during the same visit as above, review of the previous day's override report reflected an ICU (intensive care unit) nurse obtained Ativan 4 milligrams (a controlled substance medication for treating agitation) through the Pyxis override at 2:46 p.m. and returned the medication to the Pyxis at 6:41 p.m. (4 hours lapse between Pyxis withdrawal and return) for Patient P-3.

On 7/18/11 at 1:45 p.m. at the ICU, review of Patient P-3's medical record with Pharm 1 and the ICU CNM reflected there was no matching Ativan order in the record. Pharm 1 said the override was not appropriate - no matching order and the Ativan should have been returned to the Pyxis within one hour per hospital policy.

On 7/19/11, the medication safety pharmacist (Pharm 2) provided 10 day's worth of Pyxis override reports, from 7/11/11 to 7/18/11. There were 69 pages of overrides which included both CS and non-CS medications. The "Pyxis Override Medication Policy" which included the approved override medications was also provided.

On 7/20/11 at 2:40 p.m., review of the Pyxis override reports with Pharm 1 reflected medications not on the approved override list were also overridden. These included docusate sodium 100 mg capsules (a stool softener, not an emergent medication), short-acting insulin (Humalog), long-acting insulin (Lantus), and Zyprexa (an antipsychotic). When asked why non-approved medications were also overridden, Pharm 1 stated, "It was an oversight."

During a meeting on 7/22/11 starting at 9:30 a.m., the pharmacy administrative staff including Pharm 1 and Pharm 2 presented an override report for pharmacy performance improvement project for First Quarter 2011. It showed 67% override rate at the Santa Paula Obstetrics (SPOB)- indicating 67% of Pyxis withdraws were through the override function.

In the Medication Safety Alert of July 2000, the Institute for Safe Medication Practices (ISMP) identified the following regarding automated dispensing cabinet overrides: "Administering a drug before a pharmacist has reviewed the order and screened it for safety increases the risk of a medication error, most notably administering drug to which patients are allergic, at unsafe doses, or with unrecognized food or drug interactions." As a safe practice safeguard, the institute recommended, "The order should be reviewed before subsequent doses are administered (or immediately after the pharmacy reopens)."

In the "Guidelines on the Safe Use of Automated Dispensing Devices" 2010, the American Society of Health-System Pharmacists (ASHP- a nationally recognized organization) wrote the following in regards to overrides: "Override access to medications should be limited to cases in which the drug product has been approved by a multidisciplinary committee of physicians, pharmacists, and nurses as having a clinically urgent need for the medication that outweighs the potential risk of medication error."

The hospital's policy and procedure entitled "Medication override from Automated Dispensing Cabinets", revised 9/08, indicated, "The purpose of the override function is to allow for quick administration of medication emergency and STAT situations" and "Medications removed using the override function shall be reviewed by the pharmacy department on a regular basis."

3. On 7/18/11 at 10 a.m., a tour of the pharmacy was conducted with Pharm 1. The pharmacy had a biosafety cabinet (Iso Tech Design glovebox) where admixing and sterile compounding of medications and solutions were conducted. Gaining entry to the glovebox in order to compound/admix products was through the two attached sleeves (made with durable PVC). When asked how often the sleeves were changed, Pharm 1 said, "Only when they ripped." He said he thought the sleeves were 3 years old. He said pharmacy staff only replaced the outer ring (used to secure the sleeves in place) when they get worn out but not the sleeves.

Review of the Iso Tech Design website (www.isotechdesign.com) indicated the sleeves to the cabinet "should be replaced every 3 months for chemotherapy and cytotoxic applications, and every 6 months for sterile applications."

On 7/19/11 at 8:45 a.m., Pharm 1 confirmed the biosafety cabinet's sleeves should be changed every 6 months.

27000

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Based on observation, staff interview, and document review, the hospital failed to ensure outdated, mislabeled or otherwise unusable drugs and biologicals were not available for patient use. The facility facility failed to ensure

1. Medications for a discharged patient were removed from the medication cassette cart and not available for patient use. This had the potential for the medications to be administered in error to a newly admitted patient occupying the room/bed as the discharged patient.

2. Only approved emergency medications were included in the Pediatric Emergency Cart (crash cart). Inspection of the Pediatric Crash Cart at the Santa Paula Intensive Care Unit (SPICU) found two vials of vecuronium (a high risk medication, used in general anesthesia, to provide muscle relaxation during surgery or mechanical ventilation), which were not part of the emergency drug content. This created a potential for a medication error during an emergency situation.

3. The facility failed to ensure their policies and procedures related to multi-dose and single dose vials of medications; and the recording of medication refrigerator temperature logs were consistently implemented.

Findings:

1. On 7/20/11 at 11:30 a.m., during a visit to the SP Medical/Surgical Unit, three medications, Lovenox (a high risk medication to prevent blood clots), Lisinopril and Atenolol (medications for high blood pressure), were found in one medication cassette drawer. Further review with unit staff and SP CNM (chief nurse manager) reflected that the medications were withdrawn on 7/18/11 for a patient who had been discharged on the same day as the medications were withdrawn. The SP CNM said they should have been returned to the pharmacy or the Pyxis (the medication automated dispensing cabinet) when the patient was discharged. She agreed that having the medications available had the potential for them to be administered to a new patient admitted to the same room and bed as the discharged patient.

The hospital's policy and procedure entitled "Medication: Administration, Ordering and Documentation", revised 7/11, indicated: "When a patient is discharged, expires or leaves the hospital Against Medical Advice (AMA), the medications remaining the cassette are sent to the Pharmacy."

2. On 7/20/11 at 9:45 a.m., an inspection of the Pediatric Crash Cart at the SPICU with Pharm 1 and SP CNM reflected the medication tray was unsealed. In it, there were two vials of the medication vecuronium, which was not listed as a part of the tray's
contents. Pharm 1 agreed the vecuronium did not belong on the pediatric crash cart.

3. The facility policy and procedure titled "Storage of Medications" dated 4/23/08, states... "Drugs are stored under proper conditions according to manufacturer recommendation." In addition, "Refrigerator temperature shall be between 2.2 degree to 7.7 degree Celsius (36 degree to 46 degree Fahrenheit)". "A temperature log must be maintained for each medication refrigerator and temperature is monitored daily." The policy also stated.."Single dose vials will be discarded after one use since they do not contain preservatives. Multi-dose vials with preservative shall be treated as single-dose vials and used once and discard."

During a tour of the surgical services on 7/19/11 beginning at 10:00 a.m., included an inspection of the medication refrigerator revealed;
One open, undated, multidose vial of Novolin (insulin).
One container of Mastisol (a liquid adhesive). Per manufacturers directions for use, Store at controlled room temperature between 59-86 degrees Fahrenheit (15-30 degrees Celsius). The temperature of the refrigerator at the time of discovery was 3.2 degrees Celsius. The manufacturer directions for use indicate the fluids are to be stored at a mean temperature of 77 degrees Fahrenheit.
One opened hematology control dated 6/7/11 and identified as good for 30 days.

In Operating Room (OR) 2, a single-use, opened vial of Diprivan, and a multi-dose vial of glycopyrrolate (used to reverse neuromuscular blockade) were observed on an anesthesiology cart. Both medications should have been discarded after patient use, per facility policy and procedures.

In the Central surgical processing area on 7/22/11 starting at 11:30 a.m., was a refrigerator labeled "No Food." The temperature of the refrigerator was monitored with the use of a weekly tracking wheel. Upon inspection of the monitoring device, one could not ascertain when the last time the weekly tracking wheel was changed. The marks of the wheel were 7/16 of an inch in height. The refrigerator is used to store temperature sensitive testing materials. without adequate monitoring of the temperatures there was no system in place to ensure the integrity of contents of the refrigerator.

All of these findings were verified with the facility staff who were accompanying the surveyor


4. During a tour of the emergency department on 7/18/11 at 9:45 a.m. two opened bottles of ophthalmic topical anesthetic were observed in the eye room refrigerator. In an interview at that time a nurse stated the hospital policy was to discard the bottles after a single use.

Review to the hospital policy titled " Storage of Medications " revealed that multi-dose vials were to be treated as single-dose vials and used once then discarded. In an interview on 7/20/11 at 2:30 p.m. the director of pharmacy stated bottles of eyedrops were to be treated as multi-dose vials and discarded after a single use.

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Based on review of the hospital's policy and procedure related to infectious blood or blood components revealed the policy did not accurately reflect the requirement that the hospital must make reasonable attempts to give notification over a period of 12 weeks.

Findings:

Review of the facility's policy and procedure titled "Look-back Protocol" on 7/22/11 at 10:00 a.m. revealed the Look-back process is a means of dealing with a blood donation that has been screened and identified for transfusion transmissible diseases. If the blood donation has been identified as contaminated and the blood has been transfused, the facility has a responsibility to notify the recipient who has received the potentially infectious blood. If the physician is unavailable or declines to notify the recipient, the pathologist will notify the recipient and inform the recipient of the need for follow-up testing and counseling. The policy and procedure erroneously stated that the notification is to be completed within a maximum of 8 weeks, not 12 weeks as required.

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Based on observation and document review, the hospital failed to ensure dietary services were provided to meet the needs of patients as evidenced by the failure to:

1. Ensure the food and dietary services were directed by a qualified employee who was dedicated full time, to the daily management of the operation of dietary services including:
implementing training programs for dietary staff and assuring that established polices and procedures were maintained and consistently implemented that addressed safe and effective food production and food handling practices, adequacy of emergency food supplies, provide daily management and supervision of work performances, ensure patient diets were served as specified on the menu, menu planning, purchasing of food and supplies, and retention of essential records including QAPI reports with adequate data collection.
(Refer to A-620)

2. Ensure that the nutritional needs of Patient (D1) was met in accordance with recognized dietary practices and in accordance with the order of the physician. (Refer to A-630, A- 726).

3. Ensure performance improvement activities were developed that reflected the scope and nature of the services. (Refer to A- 265, A- 276)

The cumulative effect of these systemic problems resulted in the inability of the hospital's food and nutrition services to direct and staff in such a manner to ensure that the nutritional needs of the patients were met in accordance with practitioner's orders and acceptable standards of practice.

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Based on observation, dietary staff interviews, and document review the hospital failed to ensure the food and dietary services were directed by a qualified employee who was dedicated full time to the daily management of the operation of dietary services including:
implementing training programs for dietary staff, and assuring that establish polices and procedures were maintained and consistently implemented that addressed safe food handling practices, adequacy of emergency food supplies, provide daily management and supervision of work performances, menu planning, purchasing of food and supplies, and
retention of essential records including QAPI reports with adequate data collection. This failure was evidenced by;
1. Failure to ensure an effective system was in place to ensure proper cool down of left over food was consistently implemented as required to ensure food safety.
2. Failure to ensure the disaster food plan met quantity and therapeutic diet requirements.
3. Failure to ensure adequate supervision of staff was provided including the monitoring of entree production and recipe implementation to ensure entrees provided met protein specifications, and supervision of staff to ensure the facility's policy and procedure regarding the use of aprons outside of the kitchen areas was consistently implemented.
4. Failure to ensure safe food storage practices were consistently implemented
5. Failure to maintain establish policies and procedures that reflect the practices of the service
6. Failure to identify, develop, and maintain an ongoing Quality Assurance Performance Improvement (QAPI) program in dietary services.
All of these placed patients at risk of developing a food borne illness. (Refer to A-749)

Findings:

1. Review of the hospital's organizational chart revealed the Staff Services Manager(SSM) is responsible for the management of three different departments, Dietary, Laundry and Housekeeping, at both campuses. According to the facility's job description for the Food Service Manager, the position held by the SSM, responsibilities included "plans, directs and coordinates activities of Food Service Department to provide dietetic services for patients, hospital staff and medical staff which meets the goals of the hospital and medical staff." The SSM's designation of multiple managerial duties does not meet the intent of the regulation, which requires that the hospital have a qualified, director of food and dietetic services, who is dedicated to, and responsible for, on a full-time basis, the daily management of the dietary services.

A review of the personnel file of the Food Service Manager (SSM) revealed the SSM is qualified to serve as the Director of food and dietetic services, but currently does not function in that role on a full time basis, as required.

Interview with the SSM on 7/18/11 at 2:30 p.m. verified that his assigned duties does include two other departments, in addition, to Dietary services. He added that the duties of the daily management of the dietary services, including menus, food inventory, supplies, and supervision of dietary services, is delegated to the Assistant Food Services Supervisor (AFSS).

A review of the job description of the AFSS revealed the AFSS is to "assist" with the "supervision of the department in the absence of the Food Service Director." The duties listed included; supervision of staff and food served and prepared, review of menus, determination of food qualities, food inventories, ordering supplies, etc. A review of the personnel file of the AFSS revealed the AFSS does not meet the qualifications to be assigned the responsibilities of the daily management and supervision of the dietary services, assuring that established policies and procedures are maintained, these are the required responsibilities of the Food and Dietetic services Director.

2. Observations at SP on 7/20/11 beginning at 8:00 a.m. revealed products in the walk- in refrigerator identified by staff as leftover from the day before; spaghetti sauce in a !/2 pan, chili beans in a 1/2 pan, and chicken soup. The soup was dated as prepared on 7/18, with an expiration date of 7/21. The Food Service Shift Supervisor was asked how their leftover products were stored to maintain safe food practices. She stated that the products were put in the walk- in refrigerator after service. She stated that there was no log kept to ensure the cool down temperatures of the left over items were taken, to ensure safe cool down temperature requirements were met. within the required time frames.. She confirmed that after the dinner meal the food was put in the refrigerator and that staff went home at 7:15 p.m..

Review of the hospital's policy titled Purchasing and Storage of Food D.61 B.5. stated .. "cooked foods (to be utilized later) and leftovers should be put in shallow pans and immediately refrigerated to expedite cooling. Foods must reach a temperature of 70 degrees Fahrenheit (F) or below in less than two hours. Food must be cooled to 41 degrees F or lower in less than four hours total after cooking or hot holding."

The hospital's cool down policy did not reflect the FDA (Food and Drug Administration) Food Code 2009 correctly. The Food Code 2009 specifies that the food be cooled from 135 degrees F to 70 degrees F in 2 hours, and from 70 degrees F to 41 degrees F in 4 hours. This is a total of 6 hours of cooling, not 4 hours total.

The policy failed to specify the separation of the specific time temperature requirements from the Food code 2009. The first cooling is required in 2 hours, and the total time for the second cooling is 4 hours. The facility's policy failed to identify a monitoring system to ensure the cooling time and temperatures followed the Food Code 2009 requirements, and safe food practices were maintained.

3. Observations on 7/21/11 starting at 9:30 a.m. at VC included a review of facility's cool down log with the Assistant Food Services Supervisor. The time frame of 6/3/11 to 7/11/11 was reviewed. Documentation of 6/3/11 stated "roast beef "; start temperature and time was 165 degrees F at 11:30 a..m.; the 2 hours temperature and time was 90 degrees F at 1:00 p.m.. The 2 hour cool down temperature of the product did not reach the required 70 degrees.

Documentation of 6/4/11 stated "roast turkey." The start temp/time was 165 degrees F at 10:00 a.m.; the 2 hour temp/time was 80 degrees F at 12:00 p.m.. Again the 2 hour cool down temperature of the product did not reach the required 70 degrees

There was no documentation to indicate what steps were taken regarding the failure to cool the two product(s) to the specific temperature of 70 degrees in the specified time of two hours, as required. The Assistant Food Services Supervisor stated he was not aware of any interventional steps that were taken.

The subsequent documentation on the cool down monitoring log revealed 21 entries for the dates of 6/10/11 though 7/16/11. All 21 entries were completed by two cooks, and all of entries reflected the same information. The two hour temperature was always documented as "70 degrees F", and the 4 hour temperature was always documented as "40 degrees F." The Assistant Food Services Supervisor stated that he did not monitor the "cool down monitoring chart" or the staff's accuracy in documenting the cool down temperatures. He acknowledged that the document may not be accurate.

On 7/19/11 at 2:30 p.m. a dietary "Staff Meeting Report" dated May 31 2001, was reviewed. The report stated " Please do not throw food away. We need to utilize leftovers with the intent of increasing revenues and reducing food costs. This includes food leftover from the tray-line. Please be sure it is handled properly." There was no documentation at either hospital to indicate a monitoring system was in place to ensure the proper cooling of leftovers foods was being completed.

4. On 7/18/11 beginning at 3:00 p.m. the Disaster Plan (reviewed 4/10) for both sites was reviewed. The facility's disaster food and water storage was observed at each hospital campus site. The following are the results of these observations and document review.

The Diaster plan specified menus for perishable food to bee used first and then nonperishable food. The lunch and dinner specified sandwiches of tuna or chicken. There was also a supply of canned entree products like chili beans and peanut butter. There was no direction on the plan, or a menu, for the use of the canned entree products or their location. There was no plan for modified consistency or therapeutic diets including renal, sodium restricted or carbohydrate modified diets that were served in the hospitals.

Review of the quantity of the canned entrees showed approximately 140 portions of chili beans. The Staff Services Manager stated the plan was for approximately 300 staff and patients. He acknowledged there was not an adequate amount of canned entree products to meet the required number of serving.

The Staff Services Manager or Clinical RD III were unable to identify why these restrictions were not addressed in the hospital's disaster plan..

On 7/20/11 beginning at 8:00 a.m. the diaster food supply of nonperishable canned foods items at SP was observed in a small shed located in the back of the facility service area. The shed was not monitored for temperature. The cases of canned product- like chili beans- specified " store in cool dry place. "

Review of the facility's policy titled Purchasing and Storage of Food (revised 4/10), stated "#3. Storage temperatures should be of dry goods and canned goods at 65 to 70 degrees F.

The Staff Services Manager acknowledged these products were not stores in accordance with the manufacturer's directions, and would relocate them.

5. On 7/18/11 beginning at 11:45 a.m. the VC patient lunch meal service was observed. The regular diet entree was beef stew and the recipe specified an 8 ounce portion to include 3 ounces protein. The therapeutic cardiac diet specified a 4 ounce portion low sodium beef stew to include 2 ounces of protein. The regular beef stew and the low salt beef stew appeared watery, and did not appear to contain a sufficient amount of meat, vegetables and potatoes.

At 12:00 p.m. the Assistant Food Services Supervisor took an 8 ounce portion of the regular beef stew from the trayline. The meat (protein) was separated out and weighed. The protein serving weighed 1 1/2 ounces, when it should have weighted 3 ounces per the recipe. The 4 ounce serving of low sodium beef stew contained 1 ounce of meat (protein), it should have weighted 2 ounces, per the recipe.

The entree was being served to patients before dietary supervisory staff intervened to assess the protein content. There was no supervisory staff monitoring the quality and quantity of the entree to ensure the correct protein portion was served. On 7/19/11 at 12:00 p.m. the Staff Services Manager stated that he would follow up with the cook who prepared the beef stew recipe. He stated that the cook told him that he had added too much water to the recipe.

6. On 7/18/11 at 08:00 a.m., one food service staff was observed in the parking lot wearing her apron. On 7/18/11 9:00 a.m., two food service staff were observed outside the kitchen with apron on in front lobby of the hospital. The Assistant Food Services Supervisor stated on 8/18/11 at 12:30 p.m., that he expects his staff to know what to do, he added that the dietary staff was responsible for washing their own aprons. The practice of staff home laundering their kitchen aprons, does not ensure that the aprons are not cross contaminated with other home laundry items. There is no system in place to ensure the aprons are properly cleaned and sanitized effectively.

Review of the policy titled Employee Health and personal hygiene D.70 dated reviewed 4/10 stated " 8. Remove aprons before leaving the kitchen and replace aprons as they become soiled. "

Interview with the infection control nurse on 7/19/11 at 1:30 p.m., stated she was not aware of the dietary policy and stated " of course the hospital should launder the food service aprons

7. Food storage practices and dietary environment were observed at VC on 7/18/11 beginning at 9:00 a.m., and at SP on 7/20/11 beginning at 8:00 a.m.. The following are the results of these observations.

Review of the policy titled Purchasing and Storage of Food D.61( revised 4/10) stated "If product has not been opened, it must be returned or discarded by the expiration date. "

a. VC kitchen:
Walk in Freezer #7
One brown bag opened and not resealed; identified by staff as " French fries " with no date when opened or product identification.
One bag of breaded chicken pieces opened, not dated and not resealed.
One bag French toast not dated when opened.
One box of lemon cookies not dated when opened.
One bag of unidentified product not dated when opened or identified.
One tray of muffins open and exposed to cross contamination, not dated when opened.

Walk in refrigerator #8
Six approximately 10 pound packages ground beef, and two 10 pound packages of ground turkey thawing with no date when the items were placed in refrigerator to thaw.
One box of chicken pieces with no date when placed in the refrigerator to thaw.

Walk in refrigerator #10
Three flats of shell eggs removed from case, with no expiration date.
Five 4 ounce containers of yogurt with an expiration date of 7/17.

Reach in tray line refrigerator #6
Two 4 ounce yogurts expired 7/17. Staff stated " Just took from refrigerator for service to patient lunch today. "

A review of the facility's policy on 7/20/11 at 2:00 p.m., titled D.61 Purchasing and Storage of Food stated " 4. All foods in refrigerators are covered, labeled, and dated. "

SP site;
Three door reach- in freezer
A large quantity of frozen beef stew meat, chicken pieces or the frozen meat in unmarked plastic bags. These meat products had been removed from the original package and were not dated when received. Staff confirmed that there was no way to tell how long the products were being held and maintaining quality.
Floor was dirty with pink colored refrozen ice. Shift supervisor stated the freezer was cleaned one time per month
Gaskets on two of the freezer doors had black substance in the gasket grooves.

A review of the facility's policy on 7/20/11 at 2:00 p.m., titled D.61 Purchasing and Storage of Food stated " 4. All foods in refrigerators are covered, labeled, and dated. "

8. Observations of staff and facility practices, that failed to ensure established safe food safety policies and procedures were consistently maintained;

a. VC observation on 7/18/11 beginning at 9:00 a.m.
The Food service staff (FS1) was observed preparing fresh fruit, including cantaloupe. When she was asked how she prepared the cantaloupe she stated that she washed the rind under running water like any other fruit. Assistant Food Services Supervisor stated the rind of cantaloupe should be scrubbed. To remove exterior dirt that can cause cross contamination.

FDA Food Code 2009 specifies that raw fruit and vegetables that are intended for washing before consumption, raw fruit and vegetables, shall be washed in water to remove soil and other contaminants before being cut ....Scrubbing with a clean brush is only recommended for produce with a tough rind or peel.

A review of the facility's policy on 7/20/11 at 2:00 p.m., titled Purchasing and Storage of Food stated " 6. Fruits and vegetables are thoroughly washed before using. " The policy did not reference how fruits and vegetables are to be washed with emphasis on fruits with membrane skin that can contain dirt or insecticides and require attention to thorough cleaning.

b. SP observation on 7/20/11 beginning at 8:00 a.m.
One rack of bread was observed stored in the hall outside the kitchen. The Shift supervisor stated that the supply of bread is stored in the hallway as there is no room in the kitchen. Observations revealed the hallway is a main hallway used by staff to get to the back of the building and is heavily used. There were 2 housekeeping staff present in the hall at the time of the observation. The Assistant Food Service Supervisor acknowledged the bread stored outside kitchen and in an area exposed to cross contamination.

The inside shelves ( 6 ) of the two door refrigerator were rusted, and the exterior surface was corroded and pitted. Shift Supervisor stated the shelves were washed monthly. The FDA Food Code 2009 specifies food contact surfaces must be smooth free from breaks, and cracks.

9.. On 7/19/11 beginning at 2:30 p.m., the Quality Assessment and Performance Improvement Program (QAPI) plan for the dietary department was reviewed with the Staff Services Manager and the Assistant Food Services Supervisor. Both stated that they monitored customer service rounds, test trays for food temperatures and the environmental of care rounds ( focuses on fire and safety issues). There was no documentation to indicate high risk problem prone areas were identified to monitor to improve care and services

In an interview on 7/21/11 at 10:00 a.m., RD III described a data gathering procedure for congestive heart patient and readmission reduction. RD III stated this was the only quality program tool, but acknowledged upon review, it was only data collection and there was no analysis of the data collected to develop into a formal performance improvement program.

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Based on observation, review of clinical records, staff interviews and hospital documents, the hospital failed to ensure that the nutritional needs of Patient (D1) was met in accordance with recognized dietary practices and in accordance with the order of the physician. (Refer to A- 726).

Finding:

Patient D1 was a 2 month old infant who was admitted to the pediatric unit on 7/5/11 with diagnoses including failure to thrive. The patient's admission weight was 3.95 kilograms (8 pounds 9.6 ounces), which represented a 2 ounce weight gain since birth. The patient's weight for age and length were both under the 3rd percentile, indicating that the patient was severely underweight.

The plan upon admission was to provide the patient with 20 calories per ounce of formula with a goal of 30 ounces per day. If the child's rate of weight gain was not satisfactory, the plan was to insert an NG (nasogastric tube, a tube inserted through the nose into the stomach) feeding tube to supplement what the patient did not take orally. The admission nutrition assessment conducted by the registered dietitian on 7/5/11 identified that the patient/s nutritional needs could be met with the physician's order.

Patient D1 continued to have problems with feeding and the infant formula and did not meet the goal rate for weight gain. The formula orders were changed and NG tube (feeding tube) was inserted.

On 7/14/11 the formula orders were changed to concentrated Pregestimil (infant formula) 24 calories, 2 ounces every 2 hours by mouth, give the rest via the feeding tube. Regular infant formula provides 20 calories per ounce; therefore the higher calorie/concentration required special mixing.

On 7/18/11 at approximately 11:00 a.m., LN 4 indicated in an interview that the hospital was out of the premixed 24 calorie formula and was therefore staff were using the powdered infant formula. The infant preparation area was observed in the pantry and the recipe or instructions for the preparation for this formula was requested. The clinical nurse manager of the pediatric unit who was present stated that the requested "recipe" would be provided before the end of the day. RD 1 was interviewed at approximately 11:00 a.m. and stated that she had not provided any instructions on special formula preparation, as required by policy and procedures..

The hospital policy titled "Formula Preparation and Feeding Guidelines" (review date of 02/10) was reviewed on 7/18/11 at approximately 4:00 p.m.. According to this policy, "the preparation of special formula concentration requires a medical order with guideline for preparation from the dietitian".

On 7/19/11 at 12:30 p.m. the clinical manager for the newborn intensive care unit, provided a copy of the instructions on the preparation of the 24 calorie infant formula. She stated that she had not provided the instructions to the pediatric unit because she was not aware that they prepared powdered infant formula, since the usual practice was to provide the ready to feed formula.

On 7/20/11 at approximately 8:57 a.m., LN 4 stated in a telephone interview that she followed the instruction on the Pregestimil can to mix the formula for the patient. Following the instructions on the can, the preparation would provide only 20 calories per ounce. Patient D1 received less calories than was ordered by his physician, the order was for 24 calories per ounce.

According to the American Dietetic Association "Guidelines for Preparation of Formula and Breastmilk in Health Care Facilities", "written formulations should be maintained in the infant formula preparation room for all infant formulas prepared. Formulations must be verified for accuracy and appropriateness, preferably by a registered dietitian trained in infant formula preparation."

There was no documentation to indicate a registered dietician was involved in the preparation of the special formula prescribed for the patient to ensure the nutritional needs of the patient were being met, as per facility policy and procedures.

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Based on observation, review of hosptial documents and staff interview the hospital failed to ensure the condition of the physcial plant and hospital environment was maintained in such a manner that the safety and well-being of patients was assured.

Findings:

At 8:30 a.m. on 7/20/11 cracks and potholes were observed in the asphalt surface of the patient parking lot at SP. The deterioration of the surface was severe enough to cause difficulty for anyone attempting to cross it using a wheeled mobility aid such as a front wheel walker.




26615

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Based on observation, staff interview, and document review the hospital failed to ensure facilities, supplies and equipment were maintained to ensure an acceptable level of safety and quality. Patient refrigerators were not maintained in a sanitary manner and hazardous chemicals were not stored in a secured, safe manner to ensure an acceptable level of safety for patients, staff and visitors

Findings:

1. Observations made during a tour of VC 7/19/11 beginning at 1:50 p.m. revealed the following:

a. The patient refrigerator on the pediatric wing was observed to be dirty with food spills, and a build-up of dirt and grime. A Styrofoam container that contained leftover food was labeled with a patient's name, but was not dated. Other food items like jello, and fruit, were labeled with the same patient's name, none of which were dated when place in the refrigerator.

b. The interior of the patient refrigerator on 3N, located in the pantry, had a build- up of dirt, grime and food spills. The charge nurse of the unit who was present during the observation stated that the refrigerator was cleaned monthly and as needed by the nursing staff.

The refrigerator temperature log which includes the date and signature of the staff who cleaned the refrigerator was reviewed. It indicated that the refrigerator was last cleaned on 6/21/11. Further interview with the charge nurse for the unit on 7/19/11 at approximately 2:10 p.m. revealed that there were no set instructions on the cleaning of the refrigerators.

c. The patient refrigerator in the ICU unit was observed on 7/19/11 at approximately 3:00 p.m.. The refrigerator had a cabinet enclosure around it. The space in between the cabinet and the refrigerator was dusty and dirty. Also in the same room, there was a sink. The cupboard underneath the sink had dark brown colored debris, which the hospital staff present described as " rust " possibly from the old sink that was removed. It was unclear how long the debris had been there.

The ICU manager, who was present during the observation, stated that the nursing staff was responsible for maintaining the cleanliness of the pantry area. She acknowledged that there were no set instructions or policies on how the area was to be cleaned.


2. Observations made on 7/20/11 beginning at 8:00 a.m. at SP revealed thirteen, 5 gallon bottles of chemicals, were stored outside the hospital's back entrance. The chemicals were marked: WC510, WC 670, and WC 220.

ME 1 stated that the chemicals were delivered the day before and that they were used for the maintenance of the boiler. There were two yellow locked cabinets behind the 13 containers. The ME 1 stated these chemicals were OK here but they could be put into the yellow storage cabinets.

On 7/20/11 at 12:00 p.m. hazardous material inventory information was requested. On 7/21/11 at approximately 9:00 a.m., the hospital provided inventory lists of hazardous materials, but none of the lists contained the chemicals observed earlier stored outside the hospital back entrance.

MSDS( Material Safety Data Sheet) sheets were faxed from the hospital, as they were not readily available when requested after discovery of the chemicals on 7/20/00. The safety data sheets were reviewed on 7/21/11 at 1:00 p.m.

A review of the MSDS information on the WC 220 chemical stated .. " Sodium Hydroxide" symptoms of exposure were " acute irritation to burns resulting in deep ulceration. "
A review of the MSDS information on the WC 510 stated the chemical was moderately irritating to the eyes and skin, and low toxicity if ingested. A review of the MSDS information on WC 670 stated it may cause nausea, vomiting, and diarrhea if ingested.

There was no word designating degree of hazard or danger or warning poison on the labels. There was not precautionary measures to be taken or action to avoid or instructions in care of contact or exposure on the label.

Review of the policy titled Hazardous Materials Handling/Storage/Disposal 6.0 and revised 8/25/09 stated " The Facilities Manager/Chief Engineer is responsible for ensuring that the correct procedures for labeling, handling, using and storing hazardous materials is strictly adhered to by all hospital personnel. " Storage and Handling Section stated " Hazardous materials must be stored in clearly marked and strictly controlled safety storage areas. All containers of hazardous materials must be labeled properly and include the following: Product name, word designating degree of hazard ...Precautionary measures to be taken or action to be avoided ...Instructions in care of contact or exposure. "

2. Observations made during a tour of VC 7/19/11 beginning at 1:50 p.m. revealed the following:

a. The patient refrigerator on the pediatric wing was observed to be dirty with food spills, and a build-up of dirt and grime. A Styrofoam container that contained leftover food was labeled with a patient's name, but was not dated. Other food items like jello, and fruit, were labeled with the same patient's name, none of which were dated when place in the refrigerator.

b. The interior of the patient refrigerator on 3N, located in the pantry, had a build- up of dirt, grime and food spills. The charge nurse of the unit who was present during the observation stated that the refrigerator was cleaned monthly and as needed by the nursing staff.

The refrigerator temperature log which includes the date and signature of the staff who cleaned the refrigerator was reviewed. It indicated that the refrigerator was last cleaned on 6/21/11. Further interview with the charge nurse for the unit on 7/19/11 at approximately 2:10 p.m. revealed that there were no set instructions on the cleaning of the refrigerators.

c. The patient refrigerator in the ICU unit was observed on 7/19/11 at approximately 3:00 p.m.. The refrigerator had a cabinet enclosure around it. The space in between the cabinet and the refrigerator was dusty and dirty. Also in the same room, there was a sink. The cupboard underneath the sink had dark brown colored debris, which the hospital staff present described as " rust " possibly from the old sink that was removed. It was unclear how long the debris had been there.

The ICU manager, who was present during the observation, stated that the nursing staff was responsible for maintaining the cleanliness of the pantry area. She acknowledged that there were no set instructions or policies on how the area was to be cleaned.

3. Observations made in the emergency room at VC on 7/18/11 at 10:10 a.m., revealed the covering of a stool in the treatment area was torn, exposing the stuffing of the stool. This created a surface that could not be cleaned or sanitized.

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Based on observation, review of facility policies and procedures and interview, the infection control officer failed to successfully develop, implement and evaluate measures of a hospital wide infection prevention and control program for the identifying reporting and investigating infections. Observations made during tours of the two sites revealed infection control policies and procedures were not consistently implemented by all staff and departments including;
1. A sanitary hospital environment was not consistently maintained; patient refrigerators were not maintained in a clean and sanitary manner. (Refer to A-724, A- 951);
2. Staff failed failure to implement the facility's infection control policies and procedures, and professional standards of practice, including effective handwashing, use of personal protective equipment, and the use of appropriate surgical attire (Refer to A-951);
3. Failed to ensure surgical suites, including surgical equipment, was effectively cleaned, sanitized and disinfected per facility policies and procedure (Refer to A-951);
4. Failed to ensure housekeeping staff assigned to the surgical department/area were trained and verified as competent to work in this speciality area (Refer to A-951);
5. Failed to ensure surgical instruments were properly prepared for adequate sterilization as per facility policies and procedures (Refer to A-951);
6. Failed to ensure safe food practices for the preparation and storage of food items, including left over products, were consistently implemented and monitored, failed to ensure effective infection control practices were consistently implemented by dietary staff. (Refer to A-620, A-630)
7. Failed to ensure infant formula was prepared according to professional standards, infection control guidelines, and facility policy and procedures (Refer to A-620, A-395)

Findings:

1. Review of the facility's policy and procedure for all departments "Hand Hygiene" dated 11/10 indicated, "Hand hygiene is the single most important strategy to reduce the risks of transmitting organisms from one person to another or from one site to another on the same patient. Following the Guidelines for the World Health Organization (WHO) and cleaning hands promptly and thoroughly between patient contact and after, before performing an aseptic task, after contact with blood and body fluids, and after contact with patient surroundings and equipment is an important strategy for preventing health-care associated infections." Additionally the policy and procedure indicated, "Clean hands with either alcohol based hand sanitizer or soap and water at minimum during the 5 WHO identified moments for hand hygiene: 1. Before patient contact. 2. Before aseptic task. 3. After body fluid exposure risk. 4. After patient contact. 5. After contact with patient surroundings and equipment."

Review of facility document, policy and procedure titled, "Standard Precautions" dated 11/07,indicated, "Perform hand hygiene immediately after gloves are removed, before and after patient contact, and after contact with contaminated items, whether or not gloves are worn. It may be necessary to change gloves/and perform hand hygiene between tasks and procedures on the same patient to prevent cross-contamination of different body sites." This policy affects all departments in the hospital.

Observations made during a facility tour, accompanied by facility staff on 7/18/11 beginning at 10:10 a.m., revealed staff failed to implement effective infection control practices. In the Emergency Room (ER) triage area at VC , RN 1 was observed assessing an ER patient, which included the taking of the patients vital signs and blood pressure. The nurse did not sanitize or wash her hands after providing the patient care, and before proceeding to another task. When RN 1 was asked if there was something else that she was suppose to do, she replied "Wash my hands."

Observations of the Nuclear Medicine (NM) area at VC on 7/18/11 at 2:30 p.m., accompanied by facility staff, revealed the area was equipped with a handwashing sink. However, there were no handwashing supplies including soap and paper towels available for use. A cannister of foam hand sanitizer was located on a metal rack next to the sink, but when the nuclear medicine technician attempted to activate the hand sanitizer, he found the cannister to be empty.

Observations made at SP site on 7/20/11, beginning at 10:15 a.m., while in the surgical services area, revealed an Instrument Technician (IT) handling a basin of soiled water. The IT removed his gloves and walked into the sterile instrument room of the Operating Room, and began picking up prepackaged sterile supplies. The IT was not observed to wash or sanitize his hands after he removed his contaminated gloves and prior to handling the sterile supplies.

Observations of an employee working in the surgical services department on 7/22/11 at 11:00 a.m. revealed the staff was cleaning soiled surgical instruments. The employee was wearing personal protective equipment (PPE), including gloves, gown, face shield, and a surgical mask, however the mask was not worn properly to to be effective. The mask did not cover the staff's nose, and the bottom strings of the mask were hanging down, in front of the employee.

All of these observations were made while accompanied by facility staff. All of the observations were shared with the Infection Control Preventionalist (ICP) who verified that staff were not implementing effective infection control practices or facility policies and procedures.

2. Review of facility document titled, "Re-use of Disposable Items" dated 11/09, indicated, "(Name of facility) and (Name of facility) do not reprocess disposable, single-use items."

Review of the facility document titled, Infection Control Plan" dated 10/10, revealed, "Equipment and Product Evaluation: Single use intended items are not reprocessed or reused."

Review of facility document titled, "Standard Precautions" dated 11/07, indicated, "Ensure that single-use items are discarded properly."

Observation made on 7/18/11 beginning at 10:10 a.m., while in the triage area of the Emergency Room at VC (ER) revealed RN 1, who was assessing a patient, was taking the patient's blood pressure. The facility utilizes disposable blood pressure cuffs in the ER area. The RN obtained the patient's blood pressure, then placed the disposable, contaminated cuff into the basket which contained clean unused cuffs. The blood pressure cuff was marked as "disposable, single use."

The two facility tour guides, the manager of ER and manager of OB concurred with the findings. When LN 1 was asked about placing the contaminated blood pressure cuff back into the basket with the clean cuffs, she indicated that she just forgot. She stated that she knew that the blood pressure cuffs were disposable and to used for only one patient. The manufacturer's literature described the blood pressure cuffs as "Disposable."

During a tour of the surgical services department at VC on 7/19/11 stylets (used to help guide an endotracheal (breathing) tube into the trachea of a patient) were observed stored in various areas including; an anesthesia supply room, individual anesthesia carts, and a pediatric supply cart. The stylets were labeled "Do Not Reuse". RN 2 indicated that the facility does clean, process, and re-use the stylets.

3. Observations beginning on 7/19/11 and 7/20/11 while touring the surgical services departments (SSD) of both hospital sites revealed that staff did not consistently implement effective infection control practices, as per facility policies and procedures and protocols. Surgical suites that were identified as "clean" and ready for the next patient's case were not adequately cleaned and sanitized. Equipment was dirty and in disrepair, not allowing for adequate sanitization. Staff failed to implement policies and procedures to ensure surgical instruments were properly prepared to ensure effective sterilization. Housekeeping staff assigned to the surgical services had no site specific competencies, to ensure adequate cleaning, disinfecting and sanitizing of these specialized areas as recommended by professional standards of care. Surgical staff failed to implement professional standards and facility policies for acceptable operating room attire, use of PPE and handwashing. Tissue samples were not stored in a manner to ensure adequate protection from cross-contamination.

4. Infant formula was prepared by licensed staff in the pantry area of the pediatric unit.. The preparation area was cluttered and unsanitary. According to the guidelines of either the American Dietetic Association (ADA), or the World Health Organization (WHO) a separate infant formula room is strongly suggested. Where there is no formula room, " a dedicated clean space with facilities for aseptic technique must be used for formula preparation." According to the WHO, poor hygiene has been reported to be the probable cause of some E.sakazakii (a bacteria) outbreaks. This is because harmful bacteria can be carried on the hands and on surfaces.

The formula was not prepared in accordance with acceptable standards of practice and guidelines. This practice placed the patient at risk for potential infections.

5. On 7/18/11 at 8:00 a.m., a food service staff was observed in the parking lot wearing her apron. On 7/18/11 9:00 a.m., two food service staff were observed outside the kitchen, in the front lobby of the hospital, still wearing their aprons. The Assistant Food Services Supervisor stated on 8/18/11 at 12:30 p.m., that he expects his staff to know what to do and that dietary staff were responsible for washing their own aprons. The practice of staff home laundering their kitchen aprons, does not ensure that the aprons are not cross contaminated with other home laundry items. There is no system in place to ensure the aprons are properly cleaned and sanitized effectively.

Review of the facility policy titled " Employee Health and personal hygiene" D.70 ( reviewed 4/10) stated " 8. Remove aprons before leaving the kitchen and replace aprons as they become soiled. "

Interview with the infection control nurse on 7/19/11 at 1:30 p.m., stated she was not aware of the dietary policy and stated " of course the hospital should launder the food service aprons."

6. On 7/19/11 at 2:30 p.m. a dietary "Staff Meeting Report" dated May 31 2001, was reviewed. The report stated " Please do not throw food away. We need to utilize leftovers with the intent of increasing revenues and reducing food costs. This includes food leftover from the tray-line. Please be sure it is handled properly." There was no documentation at either hospital to indicate a monitoring system was in place to ensure the proper cooling of leftovers foods was being completed, creating a potential for possible food borne illness.

All of these infection control concerns were shared with the Infection Control Preventionalist (ICP) on 7/22/11 at 2:00 p.m..

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Based on observation, interview, record review, facility document review, the hospital failed to ensure their policies and procedures were consistently implemented to ensure surgical services were provided in a safe and sanitary manner and in accordance with professional standards of practice. The hospital
1. Failed to ensure the surgical services environmental cleaning, sanitization and disinfection procedures were consistently implemented between surgical cases and when preparing instruments for sterile processing, per facility policies and procedures and per professional standards of practice to decrease the potential for infections. Failed to ensure the surgical room environment was maintained free from extraneous items that could not be cleaned or sanitized per professional standards of practice.
2. Failed to ensure mattress and padded positioning device surfaces were moisture resistant and in-tact to ensure the items could be effectively cleaned and sanitized.
3. Failed to ensure tissue specimens were stored in a clean and sanitary manner.
4. Failed to ensure staff consistently implemented effective hand washing practices to prevent the spread of infections per policy .
5. Failed to ensure staff implemented the use of personal protective equipment (PPE0 in an effective manner per policy
6. Failed to ensure their policy and procedure related to the preparation of instruments to be properly cleaned and sanitized was consistently implemented.
7. Failed to ensure staff consistently wore acceptable operating room attire per hospital policy, and recommended professional standards of practice
7. Failed to ensure the malignant hypothermia kits were monitored according to facility policy and procedure.
8. Failed to ensure the hospital policy and procedure related to one- time use items was consistently implemented.

Findings:

1. According to Perioperative Standards and Recommended Practices by the Association of Perioperative Nurses, 2008 Edition, Copyright 2008, page 377, Environmental Cleaning indicates: "A safe, clean environment should be reestablished after each surgical procedure." In addition the standard indicates, "Mattresses and padded positioning device surfaces (e.g. OR beds, arm boards, patient transport carts) should be moisture-resistant and intact." Additionally the standard indicates, "All receptacles (e.g. bins, kick buckets, pails), work surfaces, and tables should be cleaned and disinfected." Page 384 Competency indicates, "Personnel should receive initial education, training, and competency validation on proper environmental cleaning and disinfection methods, agent selection, and safety precautions."

A review of the facility's policy and procedure titled " Operating Room Sanitation" dated 3/10, indicated, "Daily cleaning: # 4. Between-case cleaning shall include, but is not limited to: a. Removal of all waste biohazardous, ordinary trash, and linen. 2. Cleaning organic debris from hampers, kick buckets, and foot stools, IV poles, Mayo stand, back table, and spot cleaning walls, lights, anesthesia machine, etc."

The following are observation made at VC on 7/19/11 beginning at 10:00 a.m. while touring the surgical department including two surgical suite areas, the Intervention Room (IR) (a procedure room where patients have invasive radiologic procedures performed) and operating room (OR) #3. LN 2, who accompanied the evaluator on the tour, confirmed that both of the surgical rooms toured were clean and ready for the next patient. LN 2 verified that the surgical service department (SSD) follows the recommended practices issued by the Association of Perioperative Nurses (AORN).

Observations made during a tour of the surgical Intervention Room;
a. Wooden fibers were found under the operating room surgical table.
b. A remote control for a C-arm (a device used to take see real time x-ray) was taped to the unit. The top of the C-arm was dirty and stained with dried brown stains, approximately one-half inch in length. Interview with x-ray technician 1, present at the time, confirmed that the tape was used to secure the remote control to the c-arm. The technician verified the condition of the C-arm.
c. The mattress on top of the procedure table was torn, exposing the inner contents of the mattress, rendering the mattress non moisture resistant, and unable to be adequately cleaned.

Observations made during a tour of OR #3;
a. The metal head section of the operating room table was dirty and stained with dried brown stains. The foot pedal of the OR table, utilized by a surgeon during a surgical procedure, was dirty and stained with dried brown stains. Pieces of dirty tape were still adhered to the pedal.
b. The four wheels of the OR back table (used to place sterilized equipment to be used during surgery) had remnants of blue material approximately two inches in length and light colored suture material, approximately two inches in length, wound around the four wheels.
c. Suture and fibers were entwined in the wheels of two kick buckets (utilized for surgeons and staff to place trash or discarded items during a surgical procedure).
d. A padded armboard (which attaches to the OR table) was stored on the floor and had remnants of hair and tape on it.
e. The mattress on the surgical table in OR 3 was torn, exposing the inner contents of the mattress. The covering of rolling stools were torn. The condition of the these surfaces rendered then as not moisture resistant and unable to be adequately cleaned.

All of these findings were verified with LN 2 and the manager of OB who were present during the tour.

Staff interview at this time revealed that the cleaning of the surgical/treatment rooms in between cases was the responsibility of housekeeping staff. Housekeeping staff competencies for staff assigned to the surgical areas were requested. Interview with the Chief Nurse Executive (CNE) on 7/22/11 at 2:00 p.m. revealed that she had spoken to the Housekeeping Department manager who informed her that the facility does not have specific competencies for the housekeeping staff assigned to cleaning and disinfecting the operating rooms after each surgical case.


2. Observations made during a tour of the surgical services at S.P. on 7/20/11 starting at 9:45 a.m. revealed a bag containing a tissue specimen was stored on the top of a medication refrigerator. The Nurse Manager of Surgical Services (NMSS) verified that the surgical specimen was from an earlier surgical case. The NMSS indicated that surgical staff place the container that holds the specimen in a plastic bag, and then they place the bagged item on top of the medication refrigerator. A sign above the medication refrigerator indicated, "Please put all specimens in biohazard bag." There was no system in place to ensure that the tissue specimens were being stored in an effective manner to prevent contamination of the environment, and staff's potential exposure to infectious items.

The three facility tour guides, the NMSS, the Director of Nursing for (name of facility) and the manager of OC concurred with the findings.

3. According to Perioperative Standards and Recommended Practices by the Association of Perioperative Nurses, 2008 Edition, Copyright 2008, page 285, Recommended Practices for Surgical Attire state.."Home laundering of surgical attire is not recommended. Reusable surgical attire, including cover jackets and cloth hats, should be laundered by a designated facility-approved and monitored commercial laundry after daily use. Suggested criteria relating to home laundering of soiled surgical attire are prescriptive relating to chemicals, water temperatures, and care of the home appliances."

This standard also states..."Nonscrubbed personnel should wear long-sleeved jackets that are buttoned or snapped closed during use. Long-sleeved attire is advocated to prevent bacterial shedding from bare arms and is included in the Occupational Safety and Health Administration (OSHA) regulation for the use of personal protective equipment (PPE)."

The purpose of the long-sleeve attire is to prevent the spreading of scurf which is a shedding from the skin. When staff does not cover their arms, scurf can shed from the uncovered arms of surgical staff, contaminating the patient or a sterile area, increasing the potential for cross contamination and possible infection.


A review of the facility's policy and procedure titled "Attire - OR and PACU" dated 2/10, stated.. "Disposable hats or hoods which confine hair shall be worn." There were no provisions in the policy and procedure that addressed the use of personal, cloth, head coverings, or the home laundering of such items.

Observations made at VC on 7/19/11 starting at 10:00 a.m., and on 7/20/11 starting at 9:45 a.m. at SP revealed SSD staff wearing personal, cloth head coverings. without the benefit of a disposable bouffant covering over the cloth head covering. LN 2, acting of the behalf of the Surgery Manager and Surgery Director, indicated the staff take their personal, cloth head coverings home and launder them, bringing them back into the department. This practice does not reflect the facility's policy and procedure, or the recommended standards of practice.

Staff assigned to the task of circulating were observed performing their duties, and not wearing long-sleeved jackets, creating a potential for bacterial shedding from their bare arms. This practice does not reflect the recommended standards of practice.

4. According to Perioperative Standards and Recommended Practices by the Association of Perioperative Nurses, 2008 Edition, Copyright 2008, page 546, Patient Skin Antisepsis states, "Hand hygiene should be performed before initiating the surgical prep. Hand hygiene prevents contamination of the prepped area in the event of a glove failure. Antiseptic agents used for skin preparation should be applied using sterile supplies. Sterile gloves should be worn unless the antiseptic prep applicator is of sufficient length to prevent the antiseptic and patient's skin from contact with the nonsterile glove."

Review of facility document, policy and procedure titled, "Standard Precautions" dated 11/07,indicated, "Perform hand hygiene immediately after gloves are removed, before and after patient contact, and after contact with contaminated items, whether or not gloves are worn. It may be necessary to change gloves/and perform hand hygiene between tasks and procedures on the same patient to prevent cross-contamination of different body sites." This policy affects all departments in the hospital.

During OR observations at SP on 7/20/11 starting at 9:45 a.m. LN 3 was observed applying the prepping/cleaning solution to the abdomen of a patient in OR #1. LN 3 did not perform hand hygiene before beginning the prepping, she was not wearing a long-sleeved jacket, nor was she wearing gloves when applying the prepping solution. The Manager of the OR (MOR) verified the observational findings.

Later the same day (7/20/11) at SP beginning at 10:15 a.m., an Instrument Technician (IT) was observed handling a basin with soiled water. The IT removed his gloves, but did not sanitize his hands, even though there were supplies available to wash his hands, or use a hand sanitizer. He removed the gloves and walked into the sterile instrument room of the Operating Room, and began to pick up prepackaged sterile supplies. These observations were verified with the Director of Nurses, the OR manager, and the manager of OB.

5. According to Perioperative Standards and Recommended Practices by the Association of Perioperative Nurses, 2008 Edition, Copyright 2008, page 440, under the Care of Instruments states.. "Personal protective equipment (PPE) consistent with the anticipated exposure must be worn. The appropriate PPE for these types of exposure include, but are not limited to: a fluid-resistant gown, heavy duty gloves, a mask, and face protection."

An employee working in the soiled processing area of the Central Sterile Processing (CSP) at VC on 7/22/11 beginning at 11:00 a.m., was observed performing an initial cleaning of soiled surgical instruments to prepare the instruments for processing. The employee was wearing gloves, a gown, a face shield, and a surgical mask. However, the mask was not properly applied or secured in place to ensure effective protection. The mask was placed so it did not cover her nose, and the bottom strings of the mask, used to secure the mask, were untied and hanging down in front of the employee.

In an interview with the Infection Control Preventionalist (ICP) on 7/22/11 at 11:00 a.m. she verified that to be effective the mask should cover the employees nose and that the bottom strings of the mask should be secured around the staff members neck or the bottom of her head. The tying of the mask strings ensures the person wearing the mask has maximum protection from air-bourne contaminants. The Infection Control Preventionalist, the Hospital Administrator, and the manager of OB, who were present when the observations were made concurred with the findings.

6. According to Perioperative Standards and Recommended Practices by the Association of Perioperative Nurses, 2008 Edition, Copyright 2008, page 424, Care of Instruments states: "Instrument (box locks) [a mechanism which prevents an instrument from opening] be fully open and the instrument secured to prevent closing by using stringers, racks, or instrument pegs designed to contain instruments." (Instrument stringers, racks, or instrument pegs when used ensure instruments remain open).

Opening of the instruments ensure that the instrument is totally cleaned during the mechanical cleaning process.

Review of the facility' policy and procedure titled "Care of Instruments" dated 1/10, revealed,"All instruments should be arranged in mesh-bottom trays so all surfaces are exposed to the action of the washer. Box-locks wide open."

Observation made in the CSP area at VC on 7/22/11 beginning at 11:00 a.m., of the cleaning and decontamination process of surgical instruments revealed the instruments were processed with the box locks closed. This practice does not ensure proper cleaning and disinfecting of the surgical instruments. There was no evidence that the instruments had been placed on stringers, racks or pegs during the cleaning process. Two facility tour guides, the manager of OB and the Infection Control Preventionalist concurred with the findings.

7. The facility policy and procedure "Malignant Hyperthermia Cart" dated 2/10 indicated, "The cart will be checked daily to insure its integrity; that it is locked and ready for usage." (Malignant Hyperthermia (MH) is a genetic condition where patients undergoing anesthesia may suffer from fever, high heart rate, lack of oxygen in the blood stream, low blood pressure, and possibility of death. Items that might trigger malignant hyperthermia include some anesthetic agents used during anesthesia.)

Observation and review of the MH cart in SSD at VC on 7/19/11 starting at 10:00 a.m. revealed the MH cart was not checked on 6/24/11 and 6/25/11. LN 2, indicated that the MH cart is to be checked daily, if there are surgical cases scheduled. LN 2 checked the OR schedule and verified that surgical cases were performed on 6/24/11 and 6/25/11. This information was verified with LN 2.

Observations and review of the MH cart in the surgical services at SP on 7/20/11 starting at 9:45 a.m. revealed the MH cart was not checked on 6/4/11 and 6/19/11. The OR manager indicated that the MH cart is to be checked daily if there are surgical cases scheduled. The OR manager checked the OR schedule and verified that surgical cases were performed on 6/4/11 and 6/19/11. This information was verified with the OR manager, the Director of Nurses, and the manager of OB.

8. Review of facility document titled, "Re-use of Disposable Items" dated 11/09, indicated, "(Name of facility) and (Name of facility) do not reprocess disposable, single-use items."

Review of the facility document titled, Infection Control Plan" dated 10/10, indicated, "Equipment and Product Evaluation: Single use intended items are not reprocessed or reused."

Review of the facility document titled, "Standard Precautions" dated 11/07, indicated, "Ensure that single-use items are discarded properly."

Observation beginning on 7/19/11 at 10:00 a.m., in the Surgical Suite Department (SSD) at VC revealed that stylets (used to help guide an endotracheal (breathing) tube into the trachea of a patient) were observed stored in various areas including the anesthesia supply room, individual anesthesia carts, and a pediatric supply cart. The stylets are labeled, "Do Not Reuse". This practice does not reflect the facility's policy and procedure related to single use items.

RN 2 indicated that the facility does clean, process, and reuse the stylets even though the item is labeled "Do Not Use". In an interview with the Infection Control Preventionalist (ICP) on 7/22/11 at 2:00 p.m., she indicated that items labeled as "do not reuse" are not to be reused.

9. According to Perioperative Standards and Recommended Practices by the Association of Perioperative Nurses, 2008 Edition, Copyright 2008, page 375. Recommended practices for Environmental Cleaning in the periopertive setting; Recommendation 1. The patient should be provided a clean, safe environment...Exogenous sources or pathogens that may cause a surgical site infection include surgical personnel; the operating room environment ( including the air); and all tools, instruments, and supplies brought to the sterile field during the procedure. Exogenous flora are mainly aerobes. Health care associated infections have been linked to external sources,which can include environmental surfaces."

Observations made on 7/19/11 beginning at 10:00 a.m., in the surgical services department revealed three commercial magazines stored in the shelving above the anesthesia cart in OR 3. In OR 1, during the procedure the anesthesiologist was observed sitting, leaning back in a chair, reading a newspaper. A wooden door stop was found in the surgical suite the Intervention Room. Wooden clip boards were found through out the surgical services department, including the Intervention Room. A wooden box was found in OR 3. The purpose of the box is to temporarily store patient x-ray films. Wood can not be adequately disinfected between patient use.

On 7/22/11 starting at 11:00 a.m., while in the Central Surgical Processing (CSP) area of the surgical services, a cork board was observed in the immediate area of the CSP area. The infection control practitioner (ICP) indicated that the cork board material could not be adequately disinfected and should be removed from the area.

All of these infection control concerns were shared with the Infection Control Preventionalist (ICP) on 7/22/11 at 2:00 p.m..

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Based on observation and interview, the hospital failed to ensure the operating room register contained all of the required components.

Findings:

Observation starting on 7/19/11 at 10:00 a.m., in the Surgical Suite Department (SSD), of a paper copy of the computerized Operating Room Register for the month of 6/11, the printed copy did not contain the type of anesthesia. Interview with the Secretarial Support Staff, she indicated that she inputs the information into a computer program. At the end of month she prints out a computerized report detailing the information. The two facility tour guides, Manager of OB and LN 2, an operating room nurse concurred with the findings.

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Based on review of documents the facility failed to ensure that a post-anesthesia evaluation was documented in the medical record of each patient within 48 hours of surgery. One of seven closed medical records did not contain documentation of a post-anesthesia evaluation.(M-6)

Findings:

Review of the medical record of patient M6 on 7/20/11 at 9:30 a.m. revealed it did not contain documentation of a post-anesthesia evaluation. Patient M6 had undergone a cesarean section (delivery of her baby through an incision) with an epidural block (an anesthetic agent is injected into the spinal canal) on 6/26/11.

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Based on review of documents the facility failed to ensure that the equipment used for nuclear medicine services was inspected, tested, and calibrated at least annually by qualified personnel.

Findings:

The service records for the gamma cameras (a device used to image gamma radiation emitting radioisotopes) used in nuclear medicine were reviewed on 7/21/11 at 4:30 p.m. The most recent date for preventative maintenance for one camera was April 2010 while the other had no documentation of preventative maintenance being performed since October 2009. In an interview on 7/22/11 at 1:30 p.m. the director of radiologic services stated there was no documentation of more recent preventative maintenance having been performed. Federal regulations require an annual inspection of the cameras.