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Based on observation, interview, and record review, the facility's governing body, the legally responsible entity for the conduct of hospital operations, failed to assess and monitor Nursing services to prevent medication errors and failed to ensure that Quality Assurance and Performance Improvement (QAPI) Program was involved in collecting data to evaluate the quality of service provided by Nursing Services.

Findings:

1. The facility's governing body failed to ensure that an ongoing program for Quality Improvement was defined, implemented, and maintained when Nursing Services were not incorporated into the hospital wide QAPI program to evaluate the quality of services provided. (A263, A404, A405, A500).

2. The facility's governing body failed to meet the Condition of Participation of QAPI (A263) when the program was not involved in collecting data to monitor and evaluate the safe practices under Nursing Services to prevent medication errors. (A404, A405, A500).

3. The facility's governing body failed to meet the Condition of Participation of Nursing Services (A385) as identified under the following tags:

a. The facility failed to ensure the safe administration of medications when antibiotics, Morphine Sulfate, Advair (medication to treat obstructive airway disease) were not administered according to the Physician's orders which resulted in 2 medication errors for 2 out of 3 patients on inhalers (Patient 1 and 2). (A385, A404, A500).

b. The facility failed to ensure the safe administration of chemotherapeutic agents when the licensed nurse could not calculate and verify the accuracy of the chemotherapeutic dose as stated in the hospital's policy. (A385, A405).

The cumulative effect of these systemic problems resulted in the failure of the facility's governing body to ensure that Nursing Services was provided in a safe and effective manner, was monitored, evaluated, and incorporated into the hospital wide QAPI Program.

Based on interviews and document reviews the hospital physician failed to inform a patient of the consequences of refusal of medical treatment which resulted in a patient ' s inability to make informed consent decisions regarding health care.

Findings:

Document review and clinical record review was conducted on 11/15/10.

The hospital policy on entitled Patient Rights and Responsibilities indicated, " PATIENTS HAVE THE RIGHT TO ...Make decisions regarding medical care, and receive as much information about ...refuse a course of treatment ...this information shall include ...the medically significant risk involved, alternative courses of treatment or non-treatment and the risk involved in each. "

Patient 3, fifty three years old, had a history of chronic obstructive pulmonary disease, a recurrent obstruction of the lungs; congestive heart failure; sleep apnea, temporary stopping of breathing; hepatitis C, a virus - blood borne infection; cardiomypathy, muscle weakness of the heart; diabetes, and hypertension. She had physician ' s orders for DuoNeb (inhaler to treat patients with obstructive airway disease), Enoxaprin (anticoagulant), Advair (inhaler to treat obstructive airway disease), Lasix (diuretic) Insulin and Nystatin (antifungal) to treat her conditions.

The inpatient progress notes indicated:
11/15/10 3:39 pm " Refused RT [respiratory therapy] treatment today "
11/16/10 6:44 am " Refused to be weighted [sic] "
11/16/10 11:59 pm " Refused to have ...vital signs taken "
11/17/10 11:37 pm " refused Lovenox sq [subcutaneous] "
11/18/10 6:53 am " refused to have ...vital signs "

The Medication Administration Record (MAR) from 11/15/10 through 11/18/10 had nursing documentation that indicated Patient 3 refused over 20 of her medications or treatments.

During an interview on 11/17/10 at 3:29 pm Physician 1 stated that she was not aware of the refused medications and that she did not inform the patient of the consequences of refusing to take the medications.

The hospital did not provide documented evidence to indicate that Patient 3 received information necessary to make a decision to take or refuse the medications and treatments. The hospital did not provide documentation that Patient 3 understood the consequences of refusing to take the medications.

Based on observation, interview, and document review, the facility failed to secure patient confidentiality and privacy by displaying patient names on the census boards located on the facility's 7th and 8th floor units. These census boards were in public view, thus, not ensuring the patients' rights to privacy regarding their location while staying in the facility.

Findings:

On 11/15/10 between 9:52 AM to 10:20 AM, during a general tour of the facility's units on 8-West (telemetry), 8-East (oncology), and 7-West (orthopedic), the census boards posted the patients' last names and initials of their first names. Additionally, the room numbers were also placed alongside the patient names making it feasible to locate the whereabouts of the patients. These boards were located in the open at the central nursing stations where the public can also view these patient sensitive information.

During this same tour, the Risk Manager stated the facility had been unsure whether posting the patients' names was a violation of patient confidentiality and that it's been a debate with their corporate office.

Document review of the facility's policy and procedure titled, "Patient Rights and Responsibilities", number RI-10, revised date 11-09, stated: "The Patients Have the Right to...Confidential treatment of all communication and records pertaining to your care and stay in the hospital...Designate visitors of your choosing, if you have decision-making capacity, whether or not the visitor is related by blood or marriage..."

Further document review of the facility's policy and procedure titled, "Privacy for All Patients at ... (Hospital)", number RI-25, revised date 10-07, stated: "The privacy and confidentiality of all patient medical information shall be respected and practiced by the medical staff and all employees of ... (Hospital) in accordance with Federal and State laws, CHW HIPPA policies, and other hospital policies...all patients while hospitalized at ... (Hospital) shall have the right to privacy with respect to being seen by visitors..."

Based on observation, interview, and document review, the facility failed to implement and maintain an effective ongoing quality assessment and performance improvement program when medication errors were not incorporated into the hospital wide Quality Assurance and Improvement Program (QAPI) and there was no system in place to monitor and evaluate the quality of medication administration to ensure patient safety. The following medications were not administered according to the Physician's orders: Antibiotics, Morphine Sulfate (to control pain) Advair (inhaler) on 2 of 3 patients on inhalers. Chemotherapeutic agents for one patient were not administered according to the facility's policy when the medications were not witnessed or double checked prior to administration.

Findings:

1. The Governing Body failed to ensure that an ongoing program for Quality Improvement was defined, implemented, and maintained when Nursing Services was not incorporated into the hospital wide QAPI program to evaluate the quality of nursing services provided. (A 500).

2. The facility failed to implement a system in place for QAPI to be involved in monitoring the licensed staff in administering medications according to the Physician's orders in order to prevent medication errors.

The cumulative effect of the the above deficient practices resulted in the inability of the hospital to ensure the delivery of safe and effective nursing services to meet the needs of the patients in accordance with the Condition of Participation for Quality Assurance and Performance Improvement.

Based on observation, interview and record review, the hospital failed to have an organized nursing service when there was lack of supervision by a Registered Nurse to ensure that pain medications, chemotherapeutic agents, and an antibiotic were administered according to the Physician's orders: Morphine Sulfate (for pain control) for 4 of 4 patients (Patients 9, 10, 11, 12), Vancomycin (antibiotic) for one of one patient (Patient 7), Advair (Inhaler) for 2 of 3 patients (Patients 1 and 2), and Chemotherapeutic agents for one (Patient 7) were not administered according to the Physician's orders. Cipro (antibiotic) was not given according to standards of practice for one patient on antibiotics. (Patient 8).

The facility did not provide evidence that these medication errors and concerns were integrated with the facility's Quality Assurance and Improvement Program (QAPI) to ensure patient safety.

Findings:

1. The facility failed to administer Morphine Sulfate in accordance with physicians' orders on Patients 9, 10, 11, and 12 to ensure proper pain control. (A 404).

2. The facility failed to administer Vancomycin for Patient 7 as ordered by the physician on 11/15/10 to avoid interruption of the antibiotic therapy. (A 404, A 405).

3. The facility failed to ensure the appropriate administration of Cipro in accordance with standard of practice when Cipro was given to Patient 8 as soon as the patient finished eating breakfast that included dairy products, that decreases the absorption of the medication. (A 404).

4. The facility failed to ensure that Advair inhalers were administered as ordered by the Physician. Extra doses of Advair were administered to Patient 1 and Patient 2 that caused a medication error. (A 404, A 500)

5. The facility failed to ensure that Nursing Service implemented the hospital's policy on Administration of Chemotherapeutic Agents. The licensed nurse failed to verify the appropriate dosage of the chemotherapeutic agents, failed to have a witness in administering chemotherapeutic agents to ensure patient's safety. (A 405).

The cumulative effect of the above deficient practice resulted in the inability of the hospital to ensure the delivery of safe and effective nursing services to meet the needs of the patients in accordance with the statutorily mandated Condition of Participation for Nursing Services.

Based on observation, interview and record review, the hospital failed to ensure that drugs were administered in accordance with physicians' orders and accepted standards of practice as evidenced by:

1. Failure to administer intravenous morphine in accordance with physicians' orders in 4 patients (Patient 9, 10, 11 and 12) who were on intravenous morphine for pain control.

2. Failure to administer Vancomycin (an antibiotics) as ordered by the physician on one of one patient (Patient 7).

3. Failure to administer Ciprofloxacin (an antibiotics) in accordance with standard of practice to ensure efficacy for one Patient 8 of 2 patients on antibiotics. (Patient 8).

4. Failure to ensure the safe use of medications when Advair inhalers (Inhaler to treat patients with obstructive airway disease) were not administered in accordance to physicians ' orders which resulted in 2 medication errors (extra doses administered) on 2 out of 3 patients on inhalers (Patients 1 and 2).

Findings:

A sample of 4 patients' clinical records were reviewed with Nursing Administrative Staff 11 at approximately 3:15 p.m. on 11/16/10. Four of 4 patients who were on intravenous morphine sulfate for pain control were administered the medication not in accordance with physicians' orders as follow:

1a. A review of Patient 9 ' s clinical record showed that the patient was admitted to the hospital on 11/10/10. On the date of admission, Patient 9 was ordered intravenous morphine for pain control as follows:

Morphine 2 to 6 mg IV (intravenously) push every 2 hours as needed for pain:

2mg for pain scale 1 to 3
4mg for pain scale 4 to 6
6mg for pain scale 7 to 10

Patient 9 ' s medication administration record (MAR) showed that the following doses of morphine were administered to the patient not in accordance with the physician ' s order:

11/11/10 at 4:43 a.m.: Morphine 2 mg was administered for pain intensity of 4 reported by the patient when 4 mg should have been given according to physician ' s order. Patient 9 ' s pain intensity was reported to be 3, fifteen minutes after the administration.

11/11/10 at 6:40 a.m.: Morphine 2 mg was administered for pain intensity of 5 reported by the patient when 4 mg should have been given according to physician ' s order.
Patient 9 ' s pain intensity was reported to be 3, fifteen minutes after the administration.

11/11/10 at 9:10 a.m.: Morphine 2 mg was administered for pain intensity of 7 reported by the patient when 6 mg should have been given according to physician ' s order. Patient 9 ' s pain intensity was reported to be 7, fifteen minutes after the administration.

11/11/10 at 2:18 p.m.: Morphine 2 mg was administered for pain intensity of 6 reported by the patient when 4 mg should have been given according to physician ' s order. Patient 9 ' s pain intensity was reported to be 7, fifteen minutes after the administration.

11/12/10 at 9:15 a.m.: Morphine 2 mg was administered for pain intensity of 7 reported by the patient when 6 mg should have been given according to physician ' s order.

The administration of morphine doses less than Patient 9 ' s prescribed dose had caused the patient to experience inadequate pain control.

1b. A review of Patient 10 ' s clinical record showed that the patient was admitted to the hospital on 11/11/10. On the date of admission, Patient 10 was ordered intravenous morphine for pain control as follows:

Morphine 2 to 6 mg IV (intravenously) push every 2 hours as needed for pain:

2mg for pain scale 1 to 3
4mg for pain scale 4 to 6
6mg for pain scale 7 to 10

Patient 10 ' s medication administration record (MAR) showed that the following doses of morphine were administered to the patient not in accordance with the physician ' s order:

11/11/10 at 8:27 p.m.: Morphine 3 mg was administered for pain intensity of 7 reported by the patient when 6 mg should have been given according to physician ' s order. Patient 10 ' s pain intensity was reported to be 2, fifteen minutes after the administration.

11/11/10 at 10:25 p.m.: Morphine 3 mg was administered for pain intensity of 9 reported by the patient when 6 mg should have been given according to physician ' s order. Patient 10 ' s pain intensity was reported to be 6, thirty five minutes after the administration.

11/12/10 at 2:03 a.m.: Morphine 4 mg was administered for pain intensity of 8 reported by the patient when 6 mg should have been given according to physician ' s order. Patient 10 ' s pain intensity was reported to be 4, twenty eight minutes after the administration.

11/12/10 at 9:28 a.m.: Morphine 2 mg was administered for pain intensity of 8 reported by the patient when 6 mg should have been given according to physician ' s order. Patient 10 ' s pain intensity was reported to be 4 fifteen minutes after the administration.

The administration of morphine doses less that Patient 10 ' s prescribed dose had caused the patient to experience inadequate pain control.

1c. A review of Patient 11 ' s clinical record showed that the patient was admitted to the hospital on 11/11/10. On the date of admission, Patient 11 was ordered intravenous morphine for pain control as follows:

Morphine 2 to 8 mg IV (intravenously) push every 2 hours as needed for pain:

2mg for pain scale 1 to 3
4mg for pain scale 4 to 6
8mg for pain scale 7 to 10

Patient 11 ' s medication administration record (MAR) showed that the following doses of morphine were administered to the patient not in accordance with the physician ' s order:

11/11/10 at 1:04 p.m.: Morphine 4 mg was administered for pain intensity of 7 reported by the patient when 8 mg should have been given according to physician ' s order. Patient 11 ' s pain intensity was reported to be 7, fifteen minutes after the administration.

11/12/10 at 12:39 p.m.: Morphine 2 mg was administered for pain intensity of 7 reported by the patient when 8 mg should have been given according to physician ' s order. Patient 11 ' s pain intensity was reported to be 3, fifteen minutes after the administration.

11/12/10 at 8:56 p.m.: Morphine 2 mg was administered for pain intensity of 6 reported by the patient when 8 mg should have been given according to physician ' s order. Patient 11 ' s pain intensity was reported to be 6, fifteen minutes after the administration.

11/13/10 at 4:20 a.m.: Morphine 2 mg was administered for pain intensity of 6 reported by the patient when 4 mg should have been given according to physician ' s order. Patient 11 ' s pain intensity was reported to be 3, fifteen minutes after the administration.

11/12/10 at 10:35 a.m.: Morphine 2 mg was administered for pain intensity of 6 reported by the patient when 4 mg should have been given according to physician ' s order. Patient 11 ' s pain intensity was reported to be 3, fifteen minutes after the administration.

11/13/10 at 3:25 p.m.: Morphine 2 mg was administered for pain intensity of 7 reported by the patient when 8 mg should have been given according to physician ' s order. Patient 11 ' s pain intensity was reported to be 5, fifteen minutes after the administration.

11/13/10 at 6:18 p.m.: Morphine 2 mg was administered for pain intensity of 6 reported by the patient when 4 mg should have been given according to physician ' s order. Patient 11 ' s pain intensity was reported to be 6, fifteen minutes after the administration.

11/13/10 at 9:30 p.m.: Morphine 2 mg was administered for pain intensity of 5 reported by the patient when 4 mg should have been given according to physician ' s order. Patient 11 ' s pain intensity was reported to be 5, fifteen minutes after the administration.

11/14/10 at 10:05 a.m.: Morphine 2 mg was administered for pain intensity of 7 reported by the patient when 8 mg should have been given according to physician ' s order. Patient 11 ' s pain intensity was reported to be 3, fifteen minutes after the administration.

The administration of morphine doses less that Patient 11 ' s prescribed dose had caused the patient to experience inadequate pain control.

1d. A review of Patient 12 ' s clinical record showed that the patient was admitted to the hospital on 11/08/10. On 11/10/10, Patient 12 was ordered intravenous morphine for pain control as follows:

Morphine 1 to 4 mg IV (intravenously) push every 1 hour as needed for pain:

1-2mg for pain scale 1 to 5
3-4mg for pain scale 6 to 10

Patient 12 ' s medication administration record (MAR) showed that the following doses of morphine were administered to the patient not consistent with the physician ' s order:

11/10/10 at 5:01 p.m.: Morphine 2 mg was administered for pain intensity of 10 reported by the patient when 3 to 4 mg should have been given according to physician ' s order.

The administration of morphine doses less that Patient 12 ' s prescribed dose had caused the patient to experience inadequate pain control.

During an interview at approximately 11:00 a.m. on 11/17/10, Nursing Administrative Staff 11 and Pharmacy Administrative Staff 4 stated that Patient 9, 10, 11 and 12 were administered morphine not according to the physicians' orders. Pharmacy Administrative Staff 4 also stated that it was the hospital policy that medications be administered as ordered by the physicians.

2. A review of Patient 7 ' s clinical record showed that the patient was ordered Vancomycin (an antibiotics) 1500mg (milligrams) intravenously every 12 hours at 4:30 a.m. and 4:30 p.m. for osteomyelitis (infection of bone) on 11/12/10. Patient 7 ' s MAR showed that the patient did not receive the 4:30 p.m. dose of Vancomycin on 11/15/10.

During an interview with Nursing Administrative Staff 11 at 2:30 p.m. on 11/17/10, Administrative Staff 11 stated that Patient 7 was in a surgical procedure at the time of scheduled Vancomycin dose on 11/15/10. Nursing Administrative Staff 11 further stated that Patient 7 was returned to his room at about 5:20 p.m. after the surgical procedure and the Vancomycin dose should have been administered at that time to ensure no interruption in the patient ' s antibiotics therapy.

The omission of the Vancomycin dose on 11/15/10 had the potential to cause the patient ' s blood vanocomycin level to drop below an effective level to inhibit the growth of bacteria in the infection site.

3. During medication administration observation at 9:00 a.m. on 11/16/10, Patient 8 was observed resting on her bed after finishing her breakfast which included milk and yogurt. Ciprofloxacin (an antibiotics) 500 mg tablet was administered to Patient 8 at 9:02 a.m. Patient 8 stated that she had just finished her breakfast.

Lexi-Comp, a drug information provider for health care professionals, indicated that oral Ciprofloxacin should be administered 2 hours before or 6 hours after antacids or other products containing calcium, iron, or zinc including dairy products or calcium-fortified juices to avoid decrease in absorption of the drug.

A review of Patient 8 ' s clinical record on 11/16/10 showed that the patient was prescribed Ciprofloxacin 500 mg by mouth every 12 hours on 11/14/10. Patient 8 was administered Cipro after breakfast at 9:00 a.m. on 11/15/10 and 11/16/10.

During an interview at 11:00 a.m. on 11/16/10, the Director of Pharmacy (DOP) stated that Ciprofloxacin should not be administered to patients immediately after breakfast due to decrease in absorption from food-drug interaction with dairy products.

A review of Patient 8 ' s MAR on 11/18/10 showed that the patient continued to receive Ciprofloxaxin after breakfast at 9:00 a.m. on 11/17/10 and 11/18/10.


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4. Clinical record and document review was conducted on 11/15/10.

The clinical record indicated Patient 1 was 55 years old and had a history of asthma. Asthma is a disease that affects the lungs. It causes repeated episodes of wheezing, breathlessness, chest tightness, and nighttime or early morning coughing. Patient 1 had a physician order for Advair (inhaler) 250mcg/50mcg 1 puff twice daily for asthma.

According to Lexi-comp Online, a nationally recognized medication information resource, indicates for Advair " Concerns related to adverse effects ...suppression of hypothalamic-pituitary-adrenal (HPA) axis ...receiving high doses of prolonged periods ...may lead to adrenal crisis ...do not exceed recommended dose; serious adverse events; including fatalities, have been associated with excessive use. "

It was observed on 11/17/10 at 2:51 pm that Patient 1 ' s Advair had 7 days that were administered based on the Advair dose counter. The Advair dose counter would display the actual doses administered from the inhaler (in this case 7 days). The dispense date on the label indicated that Advair was dispensed on 11/15/10 which meant that 1.5 days of Advair should have been administered.

A review of the Medication Administration Record (MAR) indicated that from 11/15/10 through 11/17/10 the nurses documented that they had administered 1.5 days of Advair.

The above indicated that an extra 5.5 days (11 doses) of Advair (calculated as 7 days minus 1.5 days) were administered for Patient 1 over a 1.5 day period.

5. A review of the clinical record indicated Patient 2 was 78 years old and had a history of COPD and asthma. COPD (Chronic Obstructive Pulmonary Disease - recurrent obstruction of the lungs) is a progressive disease that makes it hard to breath. COPD is a major cause of disability, and it ' s the fourth leading cause of death in the United States. Patient 2 was on Advair 500mcg/50mcg 1 puff twice daily for COPD.

It was observed on 11/17/10 at 10:40 pm Patient 2 ' s Advair had 7 days that were administered based on the Advair dose counter. The Advair dose counter would display the actual doses administered from the inhaler (in this case 7 days). The dispense date on the label indicated that Advair was dispensed on 11/11/10 which meant that 6.5 days of Advair should have been administered.

A review of the Medication Administration Record (MAR) indicated that from 11/11/10 through 11/17/10 the nurses documented that they had administered 6.5 days of Advair.

The above indicated that an extra 0.5 days (1 doses) of Advair (calculated as 7 days minus 6.5 days) was administered for Patient 2 over a 6.5 day period.

Based on interview and document review the hospital failed to ensure the safe administration of chemotherapeutic agents as evidenced by:
1. The hospital nurse could not calculate and verify accuracy of chemotherapeutic doses as required by hospital policy.
2. The hospital nurses were not independently double checking high alert medications (chemotherapy) as required by hospital policy.

Findings:

1. A review of the clinical record indicated Patient 1 was 55 years old and had a history of parotid adenocarcinoma (cancer of the parotid gland) and was admitted to the hospital for chemotherapy. Patient 1 ' s physician orders for chemotherapy included Epirubicin (antineoplastic to repair or restore a body part), Cisplatin (antineoplastic), and 5FU (antineoplastic).

According to the hospital policy entitled Administration of Chemotherapy Agents indicated " Prior to drug administration ...compare and verify ...the physician ' s written orders with the prepared drugs for accuracy of patient ' s ...appropriate dose based on the patient ' s body surface area...Recalculation of the dose and double check against the order "

During an interview on 11/15/10 at 11:36 pm Nurse 1 stated that she was a chemotherapy certified nurse and she was responsible for administering chemotherapy. She also stated that she did not know how to calculate Patient 1 ' s chemotherapy orders and could not verify if the doses were appropriate. She acknowledged the reason why it is important to verify chemotherapy orders was because incorrect administration of chemotherapeutic agents could be fatal.

According to the hospital policy entitled High-Alert Medications indicated " Medications considered to be High-Alert include ...Chemotherapy drugs ...Independent, verified documented double checking by 2 nurses are required in administration of the following High-Alert Medications ...Chemotherapy drugs ...Drug, dosage, rate and I.V. pump setting are independently double checked and documented. "

In an interview on 11/15/10 at 11:25 am, Nurse 2 stated that the nurses would not do independent double checks when administering chemotherapy. She also stated that the nurses would have a witness when administering chemotherapy but the double check was not independent.

During an interview on 11/18/10 at 2:52 pm Nurse 3 stated that he had been working in the hospital for 15 years. He stated it was not the nursing practice to do independent double checks when administering chemotherapy.

According to the Institute for Safe Medication Practices (ISMP), a nationally recognized drug information resource, in the entitled document ISMP ' s List of High-Alert Medications indicates " High-alert medications are drugs that bear a heightened risk for causing significant patient harm when they are used in error. Although mistakes may or may not be more common with these drugs, the consequences of an error are clearly more devastating to patients ...Classes/Categories of Medications ...Chemotherapeutic agents. "

Independent double checks can reduce medication errors when administering chemotherapy. The incorrect administration of chemotherapeutic agents could cause significant harm to the patient.

Based on interview and record review, the hospital failed to provide safe and effective pharmaceutical services to ensure patient safety as evidenced by:

1. Patient 7 was not monitored for Vancomycin (an antibiotics) level in accordance with the hospital protcol to ensure appropriate dosing which had the potential to cause kidney toxicity or ineffective therapy.

2. Failure to ensure that crash cart (emergency drug supply cart) was sealed by a pharmacist as required by state regulation.

3. The pharmacy failed to ensure the safe use of medications when Advair inhalers were not administered in accordance to physicians' orders which resulted in 2 medication errors (extra doses administered) for 2 out of 3 patients on inhalers (Patients 1 and 2).

4. The pharmacy failed to surface sample test sterile compounding areas where intravenous (IV) medications were compounded in order to ensure sterility of IV preparations.

Findings:

1. A review of Patient 7 ' s clinical record on 11/19/10 showed that the patient was admitted to the hospital with multiple medical conditions including osteomyelitis (an infection of the bone). Vancomycin 1500mg (milligrams) IV (intravenously) every 12 hours was ordered by the physician on 11/12/10. One vancomycin tough level of 13.7mcg/ml (micrograms per millimeter) was reported on 11/14/10. There was no record of vancomycin level drawn since 11/14/10.
Vancomycin is an antibiotics for the treatment of infection. The trough level is monitored to facilitate dosage adjustment and to reduce the risk of nephrotoxicity (kidney toxicity). A trough level is the lowest level that a medicine is present in the body. The trough level should be measured just before the administration of the next dose.
The hospital vancomycin protocol for pharmacy monitoring approved by the Pharmacy and Therapeutics Committee in November 2009 was reviewed on 11/19/10 which stated that patients on vancomycin for osteomyelitis should be maintained a vancomycin trough level of 15 to 20mcg/ml and vancomycin trough level should be ordered before the fourth dose and then every 3 days.

During an interview at approximately 1:50 p.m. on 11/19/10, Pharmacy Administrative Staff 5 stated that according to the monitoring protocol, Patient 7 was on vancomycin for osteomyelitis with a vancomycin trough level goal of 15 to 20 mcg/ml. Pharmacy Administrative Staff 5 also stated that there was no documentation in the patient ' s clinical record indicating that the physician ordered a different vancomycin monitoring schedule.

The failure of the hospital to monitor Patient 7' s vancomycin trough level had the potential to cause kidney toxicity from overdosing or treatment failure from underdosing of the medication.

2. During an interview at approximately 2:30 p.m. on 11/17/10 in the outpatient clinic at the San Francisco Airport, Clinic Staff 7 stated that the crash cart (emergency drug supply cart) was not sealed by a pharmacist after supplies were removed from the crash cart. Clinic Staff 7 further stated that the outpatient clinic staff would replenish the crash cart from a back up supply in the clinic.

California Code of Regulations, Title 22, 70263 (f) (2) stipulates that emergency drug supplies shall be sealed by the pharmacist in such a manner that a seal must be broken to gain access to the drugs.


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3. The pharmacy failed to ensure the safe use of medications when Advair inhalers were not administered in accordance to physicians ' orders which resulted in 2 medication errors (extra doses administered) for 2 out of 3 patients on inhalers (Patients 1 and 2).

2. The pharmacy failed to surface sample test sterile compounding areas where intravenous (IV) medications were compounded in order to ensure sterility of IV preparations.

Findings:

Document review and clinical record review was conducted on 11/15/10.

1. A review of the clinical record indicated Patient 1 was 55 years old and had a history of asthma. Asthma is a disease that affects your lungs. Patient 1 had a physician order for Advair 250mcg/50mcg 1 puff twice daily for asthma.

According to Lexi-comp Online, a nationally recognized medication information resource, indicates for Advair " Concerns related to adverse effects ...suppression of hypothalamic-pituitary-adrenal (HPA) axis ...receiving high doses of prolonged periods ...may lead to adrenal crisis ...do not exceed recommended dose; serious adverse events; including fatalities, have been associated with excessive use. "

It was observed on 11/17/10 at 2:51 pm Patient 1 ' s Advair had 7 days that were administered based on the Advair dose counter. The Advair dose counter would display the actual doses administered from the inhaler (in this case 7 days). The dispense date on the label indicated that Advair was dispensed on 11/15/10 which meant that 1.5 days of Advair should have been administered. The Medication Administration Record (MAR) indicated that from 11/15/10 through 11/17/10 the nurses documented that they had administered 1.5 days of Advair.

The above indicated that an extra 5.5 days (11 doses) of Advair (calculated as 7 days minus 1.5 days) were administered for Patient 1 over a 1.5 day period.

2. A review of the clinical record on 11/15/10 indicated Patient 2 was 78 years old and had a history of COPD and asthma. COPD (Chronic Obstructive Pulmonary Disease) is a progressive disease that makes it hard to breath. Patient 2 was on Advair 500mcg/50mcg 1 puff twice daily for COPD.

It was observed on 11/17/10 at 10:40 pm Patient 2 ' s Advair had 7 days that were administered based on the Advair dose counter. The Advair dose counter would display the actual doses administered from the inhaler (in this case 7 days). The dispense date on the label indicated that Advair was dispensed on 11/11/10 which meant that 6.5 days of Advair should have been administered. The Medication Administration Record (MAR) indicated that from 11/11/10 through 11/17/10 the nurses documented that they had administered 6.5 days of Advair.

The above indicated that an extra 0.5 days (1 doses) of Advair (calculated as 7 days minus 6.5 days) were administered for Patient 2 over a 6.5 day period.

During in interview on 11/19/10 at 9:23 am the Director of Pharmacy (DOP) stated that pharmacy does have responsibility in reducing administration medication errors. She also stated that pharmacy does medication pass observations in order to ensure that medications were being administered appropriately and accurately. She said that there were not enough medication pass observations being done in order to ensure accurate and appropriate medication administration.

In an interview on 11/19/10 at 9:30 am the DOP stated that the monthly nursing medication unit audits done by pharmacists never identified over the last year any issues with Advair discrepancies (i.e. missing or extra doses administered). She also stated that the pharmacists did not look for Advair discrepancies. She acknowledged that the pharmacist should look for medication errors related to medication storage during the monthly audits.

According to the United States Pharmaceopedia 797 Pharmaceutical Compounding (USP 797) page 3730 under the entitled section Appendix I. Principal Competencies, Conditions, Practices, and Quality Assurances That Are Required and Recommended in USP Chapter 797 indicates " Surface sampling shall be performed in all ISO classified areas [referring to sterile compounding hood] on a periodic basis and can be accomplished using contact plates and/or swabs and shall be done at the conclusion of compounding ...Environmental sampling data shall be collected and reviewed on a routine basis as a means of evaluating the overall control of the compounding environment. "

The hospital did not provide any documentation that surface sample testing was done for any of their sterile compounding hoods in which IV medications were being prepared.

During an interview on 11/16/10 at 1:00 pm the DOP stated that surface sample testing for the sterile compounding hoods were not being done. She also stated that she could not review the data from the routine surface sample testing because the testing was not being done.

Based on interview and document review the hospital failed to provide radiologic services according to the needs of the patients when the radiology department could not ensure accuracy of radiologists ' evaluation of studies (X-Ray, CT, MRI). There was no quality data or statistically significant quality data to determine radiologists ' accuracy in evaluation of studies (X-Ray, CT, MRI).

Findings:

During an interview on 11/17/10 at 2:30 pm the Radiologist 1 stated that there have been egregious discrepancies with radiologists ' evaluations. He also stated that some discrepancies were missed pathologies. The radiologists ' reviews of studies (X-Ray, CT, MRI) were not always accurate.

According to the American College of Radiology, a nationally recognized professional organization, in the entitled document New Accreditation Physician Peer-Review Requirements indicated " Examinations [referring to results of X-radiation (X-ray), Computer tomography (CT), Magnetic resonance imaging (MRI)] should be systematically reviewed and evaluated as part of the overall quality improvement program ...Monitoring should include evaluation of the accuracy of interpretation as well as the appropriateness of the examination ...An acceptable ...physician peer review program must include ...A peer review process that includes a double reading two MDs interpreting the same study assessment ...summary statistics and comparisons generated for each physician by modality[referring to X-ray, CT, MRI] "

The hospital did not provide any summary data statistics and comparisons generated for each physician by modality.

In an interview on 11/17/10 at 2:26 pm the Imaging Director stated he did not have any summary statistics and comparisons generated for physicians by modality for X-ray, CT, and MRI. He also stated that he had never seen any summary statistics and comparisons for each radiologist. He said that they did not review that type of data but there was summary data for the entire hospital.

A review of the summary hospital data report indicated the total number of peer reviews, double reading two MDs interpreting the same study, from 10/15/10 to 11/16/10 indicated:
CT 1
MRI 2
X-ray 12

A review of the summary hospital data report indicating total number of exams separated by modality from 10/15/10 to 11/16/10 indicated:
CT 581
MRI 303
X-ray 2349

The above indicated the percent based on total number of peer reviews and total number of exams from 10/15/10 to 11/16/10:
CT 0.2 % peer reviewed
MRI 0.7% peer reviewed
X-ray 0.5% peer reviewed

During an interview on 11/17/10 at 2:30 pm the Radiologist 1 stated that at least 1% of the total evaluations peer reviewed would be an adequate sample size in order to determine accuracy in evaluation for X-ray, CT, and MRI. The data, as indicated above, was less then 1%.

An interview on 11/17/10 at 2:30 pm the Imaging Director stated that he could not ensure that the Radiologist were accurately evaluating examinations. The radiology department did not have data or did not have statistically significant data indicating that X-ray, CT and MRIs were accurately evaluated by the radiologists.

Based on observation, interview and document review, the hospital failed to ensure the dietary department was organized administratively to ensure systems were in place to monitor food preparation and food service activities to minimize potential for food-borne illness. (Cross reference A 749)

Findings:

1. On 11/15/10 at 2:25 p.m. during kitchen observations with DMS A (Dietary Management A), the temperature on cooked potentially hazardous foods were as follows:
One full pan of Beef Stew: 70°F
Two Pork Roasts: 50°F
One full pan of Chicken breasts: 55°F
Beef Juice: 70°F
The food items were all dated 11/15/10

2. On 11/15/10 at 2:50 p.m. a cart was observed with covered undated hot foods with temperature as follows:
Rice: 110°F
Macaroni and Cheese: 124°F
Vegetables: 110°F
The pans of food had no date or time. DMS B (Dietary Management B) stated the foods had been left there by the cafeteria cook before he left, and identified DSE (Dietary Staff E) as responsible for monitoring the foods as they would be refrigerated and given to the shelter. Surveyor asked DSE what he would now do with the food? DSE stated, "I don't know anything about this food." DSE left the cart and returned to his other activities.

3. On 11/16/10 at 10:55 a.m., four large soup pots of Jook soup were observed in the walk in refrigerator with temperatures of 110°F (two pots) and 80°F (two pots). During a concurrent interview, Dietary Staff E stated he had prepared the soup earlier, but did not record temperature as it cooled down.

During an interview on 11/16/10 at 11:00 a.m., DMS B acknowledged there were no procedures for cooks to record cool-down of food items. Hospital provided the policy NS 25 which listed the goal "To ensure food safety standards used in Nutrition Services meets or exceeds those established by the Food Code, U.S. Public Health Service FDA 1997. The Food Code identifies proper monitoring of time and temperature during cool down as a critical control point that can prevent food borne illness." On 11/18/10 DMS A acknowledged the monitoring procedures to implement the policy had been overlooked.

Based on observation, interview, and document review, the hospital failed to implement a system to maintain and control infections and communicable diseases in patients and personnel by not ensuring systems for a safe, sanitary food service operation in the storage, preparation and distribution and service of food. Unsafe, unsanitary food preparation methods can cause food borne illness.

Findings:

During kitchen observations on 11/15/10 commencing at 1:30 p.m., the following was observed:
1a. In the walk-in produce refrigerator there was an undated five gallon tub of peeled, sliced potatoes. DMS A during a concurrent interview stated, "It should be dated when it was opened."
1b. In the reach-in refrigerator there were two undated, opened, thawed, and partially used cakes in boxes with manufacturer's labels "Keep Frozen." Additionally, there was a one-pound undated, thawed container of guacamole, with manufacturer's labeling: "Keep Frozen until Used."

On 11/16/10 when asked by the surveyor how long the cakes and guacamole were safe to use after thawing, DMS B stated there was not a specific comprehensive food storage policy to determine the shelf life of the foods used by the hospital.
The facility provided hospital policy NS-23, reviewed 7/10, that directed "All foods held in refrigerator will be covered, labeled and dated," and NS-10 that directed "highly perishable foods are discarded after 72 hours." DMS A acknowledged during a concurrent interview that without date, it was not possible to know when to discard the food item.

2. At 2:25 p.m. in the meat walk-in the following were found:
a. One full steam table (approximately 12 inches by 20 inches) pan of beef stew dated 11/15 and the temperature taken concurrently by DMS B was observed to be at 70° Fahrenheit (F).
b. One steam table pan containing two pork roasts about 10 pounds each, dated 11/15 and the concurrent temperature taken by DMS B were observed to be at 50° F,
c. One steam table pan of cooked chicken breasts dated 11/15, and concurrent temperature by DMS B determined to be at 55°F, and
d. One 15 inch deep pot of Consommé beef juice dated 11/15 with temperature at 70°F.
DMS B was asked to calibrate the thermometer used, and confirmed the temperatures of the observed foods were accurate. DMS B stated "That food was all prepared today and the morning cook put it in here just before he left."

3a. At 2:50 p.m. a rolling cart was observed to have covered hot foods. DMS B stated, "Those are leftover from the cafeteria and are going to be put back in the refrigerator." DMS B took the temperatures of the foods on the cart: a full pan of rice was at 110°F, a pan of macaroni and cheese was at 124°F, and a pan of vegetables was at 110°F. DMS B then stated the café cook put the foods there before going home, and said Dietary Staff D (DS D) should record the time and temperature because the foods were to be put into the walk-in refrigerator. DS D was called over to the cart and asked what he was supposed to do with it, and stated "I don ' t know anything about this food" and left the area. The food was left there on the cart at room temperature.

During an interview on 11/15/10 at 3:45 p.m., DMS A stated all the foods observed without time/temperature monitoring would be discarded.

3b. On 11/16/10 at 10:55 a.m. Dietary Staff E, the morning cook, was interviewed regarding the cooked chicken, consommé beef, beef stew, and pork roasts observed the day before. DS E stated "I wasn't here yesterday. That was some other guy. I don't know that cook. I cook for the day. I never cook foods ahead." During concurrent observations in the walk-in refrigerator, multiple deep soup pots of Jook (a thick rice soup) were observed and the temperatures taken by DMS B were observed to be: Two pots were at 110° F, and two pots were at 80° F. During a concurrent interview, DSE acknowledged he did prepare Jook ahead of time because it was needed for residents for all meals. DS E stated he did not record the temperature of the soup as it cooled."

The facility provided Nutrition Services Policy 25, revised and reviewed 10/10 that specified food was to be cooled from 135°-70° within two hours, and then from 70° to 41° within four hours. During an interview on DMS B acknowledged the hospital had not developed procedures to implement the cool down policy, and there was no system to record temperature over time to ensure safe food cool down for foods to be served at a later time.

4. On 11/15/10 at 2:25 p.m. a large food warming oven was observed to be set for 180° F. It held several steam table pans of cooked beef, chicken, mash potatoes and gravy. Dietary Staff D stated he had put the foods in the warmer "about 35 minutes ago" for dinner tray line. Dinner was observed to begin at 4:45 p.m.

The hospital provided Policy NS-9 reviewed and revised 7/10, that revealed "Hot food preparation is to occur that all products will be completed no sooner than 30 minutes prior to tray-line to assure quality and maintain nutrients." On 11/16/10 at 11:30 a.m., DMS B acknowledged the food was prepared too early, contrary to hospital policy.

5. On 11/15/`0 during kitchen observations at 2:55 p.m., a produce preparation sink was observed in the dietary department with food in it in a colander. There was no air gap between the sink drain and the sewer. According to the 2009 Federal Food Code,
a direct connection may not exist between the sewage system and a drain originating from equipment in which food, portable equipment, or utensils are placed. During an interview at 3:20 p.m. Hospital Engineering Staff G acknowledged there was no air gap between the sink drain and the sewer.

On 11/18/10 at 1:20 p.m. during observation of the ice machine at station 7, HES G acknowledged the ice machine was directly plumbed to the sewer and there was no air gap.

6. Dietary staff C was observed on 11/15/10 at 2:45 p.m. as he manually washed pots and pans in a three compartment sink. He was observed. to remove wet pots and pans from the sanitizing rinse and stack them tightly together and placed on the rack to be used by cooks and dietary staff and without air-drying.
On 11/16/10 at 10:00 a.m. two cooks were observed removing pots and pans that were dripping with water where stacked overnight, and proceeding to use them for food preparation. During a concurrent interview, DMS B acknowledged the pots and pans needed to be air-dried to prevent an environment for growth of potentially harmful microorganisms. The hospital was unable to provide a policy and procedure that directed air-drying of kitchenware after washing and sanitizing.

7a. On 11/15/10 at 3:20 p.m. (Hospital Engineering Staff G) HES G was interviewed regarding his responsibilities in doing preventive maintenance (pm) on the ice machine in the kitchen. He stated the ice maker at that location was new, and did not require any PM yet, but that he cleaned the ice bin with "Simple Green."
The facility provided product information that did not indicate this product met machine manufacturer's cleaning guidelines.

7b. On 11/18/10 at 1:20 p.m. HES G was interviewed about the ice dispensing machines located at the nursing station. HES stated the machine had "quarterly PM" that consisted of cleaning with a descaler, and then sanitizing with "Fruit and Vegetable Wash." The ice machine manufacturer sanitizing guidelines were to use Calgon sanitizer or an equivalent. Fruit and Vegetable Wash product information on the label did not identify it to sanitize ice making equipment. HES acknowledged the product used was not in the manufacturer's guidelines.

8. Infection Control Practitioner F (ICP) was interviewed on 11/16/10 regarding the hospital wide infection control program to ensure prevention of hospital based infections including food borne illness. ICP F provided information that a tour of the kitchen twice a year by the environment of care team provided the total of the inclusion of the dietary activities and provided copies of the environment of care rounds check list completed 3/10 and 9/10.
The EOC checklist included 10 elements related to food service infection control concerns: such as no staff food in patient refrigerators, and whether staff were observed washing hands. None of the 10 elements identified time/temperature control processes for potentially hazardous foods, chemicals used to clean and sanitizing the ice machine when not followed could potentially lead to food borne illness. ICP E stated all staff received annual training in blood-borne pathogens, food brought in from the outside, and hand hygiene."

During an interview on 11/17/10 at 1:45 p.m. ICP E stated these three elements were "all the policies that are important to me about dietary."

During an interview on 11/17/10 at 2"00 p.m. DMS A stated she also completed a kitchen checklist and provided the document "Continuous Readiness/EOC Departmental Self-Inspection Checklist 2010 completed March and September of 2010. The checklist did not include cool down or procedures/chemicals used for cleaning and sanitizing the ice machines, or kitchen ware washing.