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Based on observation, interview, and record review, the facility's governing body failed to exercise responsibility for and control over the hospital's conduct in a manner sufficient to ensure compliance with the Centers for Medicare & Medicaid Services (CMS) conditions of participation for hospitals. The governing body failed to provide a hospital wide infection control program to conduct effective surveillance that would prevent the transmission of food borne infections in the dietary department (A 264), failed to ensure that refrigerated meat was stored no longer than timeframes established by food safety standards (refer to A-749), failed to ensure that a laminar flow hood used for sterile compounding was maintained such that microbial counts were within acceptable levels (refer to A-500), failed to ensure dietary management staff provided effective oversight into food services as evidenced by 1) lack of effective system to ensure the safety of raw, thawed meats, poultry and fish; 2) lack of effective cool down monitoring of potentially hazardous foods (PHF); 3) lack of an air gap in food production sinks; 4) lack of an effective system to ensure time/temperature control for potentially hazardous foods in refrigeration; 5) failure to ensure ice machines were sanitized. (refer to 620),

The governing body also failed to ensure that surgical privileges were specific and granted based on each practitioner's documented current competence (refer to A-945), failed to ensure that malignant hyperthermia drills were conducted according to national guidelines (refer to A-951), and failed to ensure that a nurse in ambulatory surgery was knowledgeable regarding the facility's surgical count procedures (refer to A-951).

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.

Based on interview and record review, the facility failed to document that its governing body had approved the medical staff rules and regulations. The deficient practice had the potential to undermine the governing body's leadership.

Findings:

Review of the facility's medical staff rules and regulations indicated that they were dated 4/7/10 and had a notation on the cover sheet indicating "(IN PROCESS OF BEING REVISED)(JULY 2010)."

In an interview on 10/14/10 at 2:58 p.m., Staff B stated that the medical staff rules and regulations were being revised, but that the version presented to the surveyor was the version currently in effect.

Review of another cover sheet to the medical staff rules and regulations presented by Staff B indicated that they had been approved by the Executive Medical Board on 8/24/10 and by the Governance Advisory Council (GAC) on 8/31/10.

In an interview on 10/18/10 at 11:19 a.m., Staff C stated that the GAC was the governing body.

Review of the facility's medical staff bylaws indicated that the governing body was the regents of the university, but that governance of the facility had been delegated to the chancellor. Review of the facility's policy on administrative delegation clarified that the chancellor acted as the governing body of the facility but had convened a GAC, which she chaired, to advise her regarding decisions.

Review of the GAC minutes dated 8/31/10 indicated that the chair of the bylaws committee presented a summary of revisions to the bylaws which had been approved by the executive medical board (EMB) in August. The minutes stated that the GAC approved the bylaws committee report. Review of the bylaws committee report indicated that it had been presented to EMB on 8/24/10. It detailed revisions to the bylaws, including revisions to provisions in the bylaws regarding the medical staff rules and regulations. There was no mention in the bylaws committee report or the GAC minutes of the rules and regulations themselves or whether or not they had also been approved by the GAC.

Based on interview and record review, the facility failed to consider experience in each of the privileges requested for 6 of 13 sampled credentials files (Practitioners 4, 6, 7, 9, 12, and 13). The deficient practice reduced the facility's ability to determine the current competence of members of its medical staff to perform the requested privileges.

Findings:

Refer to A-945 regarding language in the facility's medical staff bylaws requiring that experience, and specifically the number of procedures performed each year, be considered in addition to training when assessing the competence of its medical staff.

Refer to A-945 regarding the documentation in the credentials files of the quantity of recent work experience for Practitioners 4, 6, 7, 12, and 13 being limited to the top billing codes and the resulting discrepancies between documented experience and the privileges requested.

Refer to A-341 regarding the facility's failure to document the privilege-specific experience of Practitioner 9.

Based on interview and record review, the facility failed to include details regarding anticipated sources of financing in its three-year prospective capital plan. The deficient practice had the potential to limit strategic planning regarding its capital projects.

Findings:

Review of the facility's capital budget dated 10/3/10 indicated that it included three fiscal years (2011 through 2013), and that planned projects over $600,000 were listed, but not the sources of funding for the projects.

Review of a memo responding to surveyor questions from Staff D (the Director of Finance) dated 10/20/10 indicated that for Fiscal Year 2011 there were 35 projects over $600,000, and that 33 of them would be funded by hospital reserves. The memo stated the remaining two projects would be funded by a combination of hospital reserves, departmental funds from the medical school, and donations. The memo indicated that details were available upon request. Review of an attachment to the memo labeled Appendix A indicated which projects for Fiscal Years 2011 and 2012 would be funded by hospital reserves and which would be funded by a combination of "hospital reserves and outside sources", but there was no detail present regarding which outside sources would be used for which projects and no information regarding projects planned for Fiscal Year (FY) 2013.

In an interview on 10/21/10 at 9:44 a.m., Staff D stated that the capital plan presented to the surveyors was a summary, and that details regarding the sources of funds were available in an online tool from which she could present additional documentation.

Review of the additional documents presented by the facility at the conclusion of the survey indicated that they were copies of slides from two presentations regarding the detailed sources of funds for perioperative services and "Intraoperative MR". Comparison of the slides to Appendix A of Staff D's memo indicated that the two projects presented were the two FY 2011 projects which would be funded by a combination of hospital reserves and outside sources. Comparison of the two sets of slides to the originally presented capital plan and Appendix A of Staff D's memo indicated that details regarding funding sources (a required component of the capital plan) had to be obtained from slides presented at meetings rather than from the capital plan itself. Comparison of the five documents further indicated that even when considered together, there was no information regarding anticipated sources of funds for projects more than two years in the future.

Based on interviews and document reviews the hospital physician failed to inform a patient of the consequences of refusal of medications which resulted in Patient 73's inability to make informed decisions regarding their health care.

Findings:

According to the hospital policy dated approved 05/06 entitled Patient Right to Refuse Treatment indicates "When a patient refuses to consent to treatment, the attending physician should make certain the patient has received all information necessary to make an informed decision to refuse treatment. The patient should understand the consequences of his/her refusal ...The physician should document the discussion and the patient's refusal in the medical record."

A review of the clinical record indicated Patient 73 was 89 years old and had a history of chronic obstructive pulmonary disease, hypertention, congestive heart failure, peripheral artery disease, Crohn's disease, hypothyroidism, and transient ischemic attacks. She had physician's orders for Norvasc, Plavix, Advair, Triamterene/Hydrochloriathize, Prednisone, Mesalamine, Paxil, and Senna to treat her conditions.

A review of the Medication Administration Record (MAR) indicated that from 10/08/10 through 10/13/10 the nurses documented that Patient 73 refused 15 of her medications.

A review of the inpatient progress notes indicated:
10/11/10 at 1:49 am "Pt has been refusing medication ...potassium remained low ...attempted to give PO KCL but she refused ...KCL IV was started but pt has been attempting to pull IV."
10/10/10 at 3:41 pm "Pt refused to take meds"
10/10/10 at 1:00 pm "Pt still refused to take PO meds"
10/10/10 at 9:30 am "Pt refused taking ...medications"

During an interview on 10/13/10 at 1:10 am Nurse 28 and Nurse 29 after reviewing the clinical record stated that there was no documentation that Patient 73 was informed of the consequences for refusing her medications.

The hospital did not provide documentation to indicate that Patient 73 received information necessary to make an informed decision to refuse her medications. The hospital did not provide documentation that Patient 73 understood the consequences of her refusal.

Based on record review and interview, the facility failed to implement is policy regarding abuse training for employees when 6 of 20 sampled employee files contained no evidence of training in abuse.

Findings:

During record review of twenty employee files on 10/19 and 10/20/10, while assisted by the Employment Manager (EM), six contained no evidence of training in abuse and no signed statement regarding mandated reporting, as was found in the other fourteen employee files.

When concurrently interviewed on 10/19/10 at approximately 4 PM, the EM said training in abuse occurred during the hospital orientation.

Review of the Hospital Orientation Agenda on 10/20/10 found no topic for abuse training
listed.

When interviewed on 10/20/10, the Director of Regulatory Affairs (Admin 1) said abuse training was provided for new employees but was not listed in the orientation agenda. She said mandated reporting was included in the facility handbook, and employees signed the mandated reporting statement when they received the handbook. The Admin 1 said the facility also conducted department specific trainings for nurses in abuse.

Based on interview and document review the hospital failed to ensure there was a hospital wide QAPI program as evidenced by:

1. The failure to ensure development of an effective program for the Food and Dietetic Service (A 264).



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2. The hospital quality assurance program failed to:

Identify and reduce medical error related to elevated bacterial and fungal colony forming units which resulted in intravenous medications being prepared for immunocompromised patients in a bacterial and fungal contaminated biological safety cabinet and a Laminar Air Flow hood,

Identify and reduce medication errors when Advair inhalers were not administered in accordance to physician's orders, and hospital policy which resulted in 5 medication errors (missed or extra doses administered) out of 6 patients on inhalers.

Identify and reduce medication errors when intravenous fluids were not administered in accordance to physician's orders which resulted in 2 medication errors (rates administered fast and slower) out of 3 patients in intravenous fluids. (A266)

The facility failed to recognize that food safety and sterile compounding had become problem-prone aspects of its operation and failed to include these areas in its priorities for performance improvement activities.

The cumulative effect of these systemic problems resulted in the facility's inability to ensure the provision of a quality health care in a safe environment and the facility's failure to meet statutorily mandated compliance with the Condition of Participation for Quality Assurance Performance Improvement.

Based on interview and document review, the hospital failed to have an ongoing quality appraisal and performance improvement program that addressed the complexity and scope of Food and Dietetic Services.

Findings:

On 10/14/10 at 10:30 am, the quality appraisal and performance improvement (QAPI) activities were reviewed. It was noted that while the department submitted performance improvement information, the submitted report focused on the hospital's customer satisfaction indicators and the implementation of room service for pediatric patients.

In an interview on 10/14/10 at 1:30 pm, with Administrative Staff (AS) L, a member of the hospital's QAPI committee as well as the committee that reported to the governing body was asked how the hospital ensured development of departmental improvement programs. She stated that the committee did not make decisions on the types of activities, rather would rely on departmental leaders to choose the activities. She further stated her expectation for activities would include key performance indicators and regulations. She also stated the department would have a requirement to monitor high risk, problem prone activities. She also stated that for the clinical departments there was a defined template related to patient safety and every department was obligated to report on their template as appropriate. She stated that for the dietary department there were no indicators that there were any issues related to patient safety. She also stated that the hospital currently utilized the food inspection report that was completed by a non-hospital university resource.

In an interview on 10/14/10 at 2:35 pm, with University Staff Q he stated that he completed an inspection of all food service areas within the hospital. He also stated that he used a pre-printed inspection sheet for the areas. He further stated that the inspection that was completed was done as a point-in-time based primarily on observations and food temperatures. He further stated that he did not evaluate food holding/production systems.

There was no documentation provided to ensure the QAPI program was developed for the scope of the hospital food service that included food safety indicators.

Based on observation, interviews and document reviews, the hospital failed to identify and implement actions to reduce medical errors:

1. The hospital quality assurance program failed to identify and reduce medical error related to elevated bacterial and fungal colony forming units which resulted in intravenous medications being prepared for immunocompromised patients in a bacterial and fungal contaminated biological safety cabinet and a Laminar Air Flow hood.

2. The hospital quality assurance program failed to identify and reduce medication errors when Advair inhalers were not administered in accordance to physician's orders and hospital policy which resulted in 5 medication errors (missed or extra doses administered) in 4 out of 6 patients on inhalers (patients 68, 72, 73 and 69).

3. The hospital quality assurance program failed to identify and reduce medication errors when intravenous fluids were not administered in accordance to physician's orders which resulted in 2 medication errors (rates administered fast and slower) in 2 out of 3 patients in intravenous fluids (Patients 79 and 75).

Findings:

1. It was observed on 10/13/10 at 4:30 pm at the Ida Friend Infusion Center Pharmacy a biological safety cabinet (BSC) and a Laminar Air Flow hood (LAFH). The BSC was primarily used for mixing and preparing chemotherapeutic intravenous medications. The LAFH was primarily used for mixing and preparing non-chemotherapeutic intravenous medications (i.e. antibiotics, steroids, etc).

A review of the bacterial air samples of the BSC and the LAFH for the Mount Zion Ida Friend Infusion Center indicated the following test results:
Date of Sampling 02/05/2010 Results:
BSC CFU (Colony Forming Units)-18
LAFH CFU-32
CFUs are number of colonies of bacteria or fungus that are observed after incubation at 35 degrees Celsius for 2-3 days. The results were bacterial air samples. The recommended bacterial CFU levels should not exceed 1 CFU for the BSC and LAFH.

A review of the fungal air samples of the biological safety cabinets (BSC) and the Laminar Air Flow hood (LAFH) for the Mt Zion Ida Friend Infusion Center indicated the following results:
Date of Sampling 02/05/2010 Results:
LAFH CFU-2
CFUs are number of colonies of bacteria or fungus that are observed after incubation at 35 degrees Celsius for 2-3 days. The results were fungal air samples. The recommended fungi CFU levels should not exceed 1 CFU for the LAFH.

During an interview on 10/19/10 at 3:30 pm the Director of Pharmacy (DOP) stated that they had not identified the cause for the elevated bacterial and fungal levels. She stated since February they had not resampled or had any qualified technicians or personnel evaluate the elevated bacterial and fungal levels. She said they had not reevaluated work practices, cleaning procedures, operation procedures, or investigated the source of the elevated bacterial and fungal levels.

Reviews of the Horizontal Flow Hood Product Preparation Logs indicated the LAFH in the Ida Friend Clinic an estimated five thousand compounded medications were prepared between 02/05/10 to 10/21/10.

Reviews of the Antineoplastic Preparation and Product Check Logs indicated the BSC in the Ida Friend Clinic an estimated seven thousand compounded medications were prepared between 02/05/10 to 10/21/10.

In total up to an estimated 12,000 medications over 253 day period were compounded in a bacterial and fungal contaminated environment for an immunocompromised patient population.

During an interview on 10/19/10 at 2:04 pm the Director of Performance Improvement stated that she was not aware of issues relating to compounding intravenous medications in a bacterial and fungal contaminated environment for immunocompromised patients at the Ida Friend Clinic. She also stated she had never seen any data or measurable indicators regarding the issue.

2. According to the hospital policy entitled Medication Error Reporting and Evaluation approved on July 2008 indicates "Medication Error: any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer."

a. A review of the clinical record indicated Patient 68 was a 60 years old and had a history of asthma and cardiac arrhythmias. She had physician's orders for Advair Diskus 250mcg/50mcg 1 puff twice daily for asthma. Patient 68's Advair had 2.5 days that were administered based on the Advair dose counter. The medication administration record (MAR) indicated that the Advair had been administered for 3.5 days.

The above indicated that 1 day (2 doses) of Advair (calculated as 3.5 days minus 2.5 days) were not administered over a 3.5 day period for Patient 68.

b. A review of the clinical record indicated Patient 72 was a 38 years old and had a history of asthma. She had physician's orders for Advair Diskus 150mcg/50mcg 1 puff twice daily for asthma. Patient 72's Advair had 2.5 days that were administered based on the Advair dose counter. The medication administration record (MAR) indicated that the Advair had been administered for 3 days

The above indicated that 0.5 day (1 dose) of Advair (calculated as 3 days minus 2.5 days) was not administered for Patient 72 over a 3 day period.

c. A review of the clinical record indicated Patient 73 was 89 years old and had a history of Chronic Obstructive Pulmonary Disease (COPD). She had physician's orders for Advair Diskus 500mcg/50mcg 1 puff twice daily for COPD. Patient 73's Advair had 6.5 days that were administered based on the Advair dose counter. The MAR indicated that Advair was administered for 3.5 days.

The above indicated that an extra 3 days (6 doses) of Advair (calculated as 6.5 days minus 3.5 days) were administered for Patient 73 over a 3.5 day period.

d. A review of the clinical record indicated Patient 69 was a 71 years old and had a history of severe COPD and had been admitted to the hospital multiple times for severe COPD exasperation. He had physician ' s orders for Advair Diskus 500mcg/50mcg 1 puff twice daily and Spiriva 18mcg daily for COPD. Patient 69's Advair had 7.5 days that were administered based on the Advair dose counter. The MAR indicated the Advair was administered for 7 days.

The above indicated that an extra 0.5 day (1 dose) of Advair (calculated as 7.5 days minus 7 days) was administered for Patient 69 over a 7 day period.

According to the hospital policy entitled Medication Management: Administration of Medication dated 04/08 indicates "Medications that are ordered as Routine are available for administration within 4 hours of being written ...Administration of the medication will follow ...The next Standard Administration time ...BID ...Standard Medication Adminstration Times 0900, 2100".

2e. A review of the clinical record indicated Patient 69 indicated was a 71 years old and had a history of severe COPD and had been admitted to the hospital multiple times for severe COPD exasperation. He had physician's orders for Advair Diskus 500mcg/50mcg 1 puff twice daily and Spiriva 18mcg daily for COPD. Patient 69's physician's orders was written on 10/06/10 at 12:15 am for Advair Diskus 500mcg/50mcg 1 puff twice daily for asthma. The pharmacy dispense record indicated that the pharmacy dispensed "stat" Advair on 10/06/10 at 9:08 am. The MAR indicated that the first dose was given at 10/06/10 at 9:45 pm.

Based on the policy Patient 69 should have been administered his first dose of Advair at 9:00 am. The dose was administered at 9:45 pm. The dose was late by over 12 hours.

In an interview on 10/19/10 at 12:40 pm Administrator 1 stated that the pharmacy had reviewed the last year of medication unit inspections and there were no documented cases of medication errors related to the use of Advair.

During an interview on 10/20/10 at 1:26 pm the Director of Pharmacy stated that the pharmacy quality programs to identify medication administration errors had not identified medication errors related to the use of Advair. She also stated there were no measurable indicators that identified the Advair medication errors.

An interview on 10/20/10 at 1:45 pm the Director of Performance Improvement that she was not aware of issues relating to Advair medication errors. She also stated she had never seen any data or measurable indicators regarding the issue.

3a. A review of a clinical record indicated Patient 74 was 40 years old and was admitted for procedure in the ambulatory surgery center. Patient 74 had physician's orders for Lactated Ringer at 30 ml/hour (KVO). The record indicated that Patient 74 received 100 ml/hour. The rate was more then three times the physician ordered rate.

b. A review of a clinical record indicated Patient 75 was 14 years old and was admitted for procedure in the ambulatory surgery center. Patient 75 had physician's orders for Lactated Ringer at 50 ml/hour. A review of the Post Anesthesia Care Unit Flowsheet documented that Patient 75 received 37 ml/hour. The rate administered to the patient was less then 50 ml/hour as ordered by the physician.

There were a total of 2 intravenous fluids medication errors out of 3 patients on intravenous solutions.

During an interview on 10/20/10 at 1:26 pm the Director of Pharmacy stated that the pharmacy quality programs to identify medication administration errors had not identified medication errors related to the use of intravenous fluids. She also stated there were no measurable indicators that identified the intravenous fluids medication errors.

An interview on 10/20/10 at 1:45 pm the Director of Performance Improvement that she was not aware of issues relating to intravenous fluids medication errors. She also stated she had never seen any data or measurable indicators regarding the issue.

Based on interview and record review, the facility failed to follow its bylaws and state licensing regulations when it allowed a cytogeneticist with a PhD rather than a medical degree to become a member of its medical staff (refer to A-353, Finding 1). The deficient practice reduced the importance of the criteria for medical staff membership.

Based on interview and record review, the facility failed to consider quantity of current work practice for the privileges requested at reappointment for 5 of 13 sampled credentials files (Practitioners 4, 6, 7, 12, and 13). Instead, analysis of the quantity of current work practice was limited to the top billing codes for each practitioner. The deficient practice reduced the facility's ability to determine the current competence of its medical staff to perform the privileges it granted.

Findings:

Review of Practitioner 4's credentials file indicated she was reappointed 1/28/10. Review of Practitioner 6's credentials file indicated she was reappointed 2/26/09. Review of Practitioner 7's credentials file indicated he was reappointed 8/26/09. Review of Practitioner 12's credentials file indicated he was reappointed 5/27/10. Review of Practitioner 13's credentials file indicated he was reappointed 9/30/10.

Refer to A-945 regarding the documentation in the credentials files of the quantity of recent work experience for Practitioners 4, 6, 7, 12, and 13 being limited to the top billing codes and the resulting discrepancies between documented experience and the privileges requested.

Based on interview and record review, the facility failed to consider experience in the privileges requested for a newly appointed member of the medical staff and failed to maintain records of proctoring in the credentials file for 1 of 13 sampled credentials files (Practitioner 9). The deficient practices mitigated regulatory and facility expectations that experience be considered in addition to training, and decreased the usability of the credentials files as a means of documenting and reviewing each practitioner's competence and standing at the facility.

Findings:

Refer to A-945 regarding language in the facility's medical staff bylaws requiring that experience, and specifically the number of procedures performed each year, be considered in addition to training when assessing the competence of its medical staff.

Review of Practitioner 9's credentials file on 10/19/10 indicated that he was newly appointed to the facility's medical staff on 12/19/08 after he had completed a nuclear medicine residency earlier that year. The credentials file included verification of Practitioner 9's residency, but did not include a case log from his residency or other verification of the quantity of nuclear medicine studies he had recently performed. The credentials file indicated that Practitioner 9 would need to complete proctoring within one year of his appointment. No report regarding Practitioner 9's proctoring was present in the credentials file.

In an interview on 10/18/10 at 3:11 p.m., Staff B stated that the facility did not ask for residency case logs but asked residency programs whether the applicant successfully completed the program and whether the privileges were appropriate. Staff B stated that there was no proctoring report in the file and that there should be a letter in the file indicating whether the proctoring was completed or the deadline was extended.

In an interview and record review on 10/19/10 at 10:49 a.m., Staff B stated that the proctoring report should have been in the file and that people were saving up their filing. He presented a report indicating that Practitioner 9's proctoring had been completed in 12/09.

Based on interview and record review, the facility failed to follow its medical staff bylaws regarding eligibility for medical staff membership. The facility's medical staff bylaws also contained inconsistent language regarding the term of appointment and a dead-end cross-reference regarding the categories of non-physicians who could be appointed to the facility as an advanced health practitioner (AHP). The deficient practices diminished the significance and usability of the medical staff bylaws.

Findings:

1. Review of Practitioner 2's credentials file indicated that she was reappointed to the facility's medical staff on 5/26/09 for two years. The file indicated that Practitioner 2 was a board-certified clinical cytogeneticist with a PhD rather than a physician. Practitioner 2 was licensed as a clinical cytogeneticist and not as a physician.

Review of the facility's medical staff bylaws indicated, "Membership on the Medical Staff and/or granting of clinical privileges shall be extended only to professionally competent physicians, dentists/oral surgeons, clinical psychologists, or podiatrists..."

In an interview on 10/15/10 at 12:59 p.m., Staff B stated that the facility had allowed Practitioner 2 on the medical staff as a PhD because she was board certified and was providing a clinical service.

Review of the California Code of Regulations, Title 22, section 70701(a)(1)(E) indicated that only physicians, dentists, podiatrists, and clinical psychologists were allowed to be members of the medical staff at a general acute care hospital in California.

2. Review of the facility's medical staff bylaws indicated, "Appointments shall be for no more than a two-year term unless terminated by other provisions of these Bylaws. Appointments shall be effective on approval by the GAC [Governance Advisory Council], and shall extend for a period of two (2) years."

Review of Practitioner 5's credentials file indicated that he was appointed for a one year term.

In an interview on 10/18/10 at 11:01 a.m., Staff C stated that the intent of the bylaws language was a term no more than two years, but she acknowledged that the language could be modified to avoid confusion over whether the term was two years or no more than two years.

3. Review of the facility's medical staff bylaws indicated, "Only AHPs in approved categories (see Credentialing Policy and Procedures in the Rules and Regulations)... are eligible to apply for Advanced Health Practitioner Staff." Review of the facility's medical staff rules and regulations revealed there was no listing of approved categories of AHP's.

In an interview on 10/14/10 at 2:58 p.m., Staff B stated that he didn't think the rules and regulations included a listing of the categories of AHP's and that they needed to be revised. He stated he would bring a listing of the approved categories.

Review of the facility's "Advanced Health Practitioners (AHPs) Credentialing Policy & Procedure" provided by Staff B indicated there was a definition of AHP which listed categories of practitioners but concluded with the phrase "...and other categories as approved by the Governing Body." There was no clarification in the policy which categories had been approved by the governing body and which had not.

Based on interview and record review, the facility failed to include in its autopsy policy a mechanism for notifying the attending physician at one of its two main hospital campuses when an autopsy was being conducted. The deficient practice reduced the clarity of expectations for communication between the autopsy pathologists and the physicians who previously provided the decedent's medical care.

Findings:

Review of the facility's policy "Death of a Patient" indicated that it was last approved September 2007. The policy stated, "Autopsy pathology is integrated into one service for both Moffitt/Long and UCSF/Mount Zion patients. Autopsy facilities are centralized at the Moffitt/Long campus." Nevertheless, the policy contained a section labeled "Mount Zion Autopsy Procedures", which indicated, "Before beginning an autopsy, the pathology resident responsible for the case will contact the attending physicians or, in their absence, house staff." The policy contained no similar provisions for the Moffitt/Long campus.

In an interview on 10/19/10 at 3:49 p.m., Staff E stated that she could see the issue regarding undefined attending notification and that she would call the head of autopsy pathology to obtain clarification. In an interview on 10/20/10 at 11:50 a.m., Staff E stated that the practice at both campuses was the same and the policy needed to be changed.

Based on observation, interview and record review, the facility failed to:

1.Ensure nurses supervised specimen collection and receipt of specimens by the laboratory, when the specimen refrigerator on 7-long contained a syringe with unidentified straw-colored fluid that had no label and was dated 5/21/10, and a labeled ova and parasite specimen dated 6/9/10.

2. Ensure that a registered nurse supervised and evaluated the nursing care of three out of 11 sampled patients (Patient 63, 59 and Patient 61) as evidenced by:

a.For Patients 59 and 63: The lack of documented, accurate and timely assessments of pain and the effectiveness of pain medications, as required by hospital policy and procedures. This failure had the potential to expose Patients 59 and 63 to inadequate pain control and preventable adverse effects, thereby negatively affecting their disease states.

b.For Patient 61: The lack of documented assessments of the nature of the bowel movements and care needs for a patient with Clostridium difficile colitis (an infectious disease in the large intestine), in accordance hospital procedures. This failure had the potential to expose Patient 61 to inadequate treatment and disease complications, and to expose other patients and staff to infection.

3. Ensure nurses supervised specimen collection and receipt of specimens by the laboratory or investigational study, when the specimen refrigerator on the 13 th floor ICU contained undated specimens and blood samples that were dated 10/20/09 and 2/21/10.

Findings:

1. During a mid-day unit observation of 7-long on 10/12/10, while accompanied by the Unit Manager (RN 22), there was a specimen refrigerator in the dirty utility room. It contained a syringe with straw-colored fluid that was dated 5/21/10, and had no label identifying the source of the specimen or the patient from whom the specimen was obtained. In addition, there was an ova and parasite specimen that was labeled with the patient's name dated 6/9/10.

During concurrent interview with RN 22, he said he thought the laboratory (LAB) was responsible for the specimen refrigerator. He said the LAB picked up specimens that were not refrigerated every hour. RN 22 said he thought the straw-colored fluid in the syringe was obtained by a nurse who thought the physician would want it tested, but had not yet received an order to do so. He said the specimen should have been labeled with the patient name and specimen source. The patient whose name was on the ova and parasite specimen was no longer on the unit.


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2a. Patient 59: Record review on 10/19/10 showed that Patient 59 was 49 years old with a history of gastrointestinal disease and abdominal pain. The hospital admitted patient 59 on 10/13/10 for assessment of a two-week history of abdominal pain and vomiting. Patient 59 had orders, dated 10/13/10, for morphine 2 milligrams (mg) intravenously (IV) every two hours as needed for moderate to severe pain.

Review of Patient 59's medication administration records (MAR) and nursing documentation of pain assessment and reassessment in the hospital's electronic nursing documentation system (UCARE), on 10/19/10 at 1:30 p.m., with the unit's patient care manager (RN 17) and assistant patient care manager (RN 18), showed that hospital staff had administered morphine 2 mg IV, without documenting pain assessments and/or reassessment of response to pain medications, as follows:

10/14/10 7:10 a.m.: for a pain level of 6 (based on a pain rating scale of 0-10, where 0 is no pain, 5 is moderate pain and 10 is the worst possible pain); RN 17 said there was no documented reassessment of Patient 59's response to morphine 2 mg IV in UCARE.

10/14/10 9:25 p.m.: RN 17 said there was not documented assessment of Patient 59's pain to justify the administration of morphine 2 mg IV and there was no reassessment of the patient's response to the medication on UCARE.

10/15/10 4:00 p.m.: RN 17 said there was no documented assessment of Patient 59's pain to justify the administration of morphine 2 mg IV and there was no reassessment of the patient's response to the medication on UCARE.

10/15/10 6:45 p.m., for a pain level of 5: RN 17 said there was no documented reassessment of Patient 59's response to morphine 2 mg IV in UCARE.

RN 17 explained that the hospital's policy is to assess for pain every 4 hours, upon administration of pain medications and to reassess pain in response to intravenous pain medications in 15 to 30 minutes.

Further review of Patient 59's MAR's and UCARE documentation showed additional missing pain assessments and reassessments prior to and following morphine 2 mg IV administration, as follows:

10/16/10 11:20 p.m.: Morphine 2 mg; no assessment or reassessment
10/17/10 1:45 a.m.: Morphine 2 mg; no assessment or reassessment
10/17/10 7:20 a.m.: Morphine 2 mg; for pain level 5; no reassessment
10/18/10 2:30 a.m.: Morphine 2 mg; for pain level 5; no reassessment

Between 10/14/10 7:10: a.m. and 10/19/10 1:05 p.m., the hospital staff administered 28 doses of morphine 2 mg IV to Patient 59. This would have required 56 pain assessments, prior to and post morphine administration. The hospital did not have documented pain assessments for 12 out of 56 (21%) assessments, as required by hospital policy.

Review of the hospital's department of nursing policy and procedures titled, "Pain Assessment-(general)", reviewed and revised 1/10, indicated the following,

"Pain assessments occur on an ongoing basis while the documentation of assessments must occur at the minimum frequency ....with routine vital signs ....and after administration of interventions for pain."

"An assessment of the patient response to interventions is needed to determine the effectiveness of the pain management treatment plan. Pain intervention Re-assessment must be completed after the administration of all PRN (as needed) and one time (STAT or now) pharmacological interventions for pain."

2b. Patient 63: Record review on 10/13/10 showed that Patient 63 was 51 years old with multiple diagnosis including pancreatitis and chronic pain. Patient 63's as needed pain medication orders included the following,
Oxycodone 30-40 mg by mouth every two hours as needed for severe pain (order date 10/2/10)
Hydromorphone, nurse administered bolus dose (using the patient's PCA, patient controlled anesthesia pump), 0.6-1 mg IV every 2 hours as needed for pain (order date 10/2/10)

Further review of Patient 63's medical record, on 10/13/10 at 1:15 p.m., in the company of the educator nurse (RN 1), the director of pharmacy (DOP) and the unit's assistant patient care manager (RN 4), showed that according to the 10/13/10 MAR, a registered nurse had administered oxycodone 40 mg at 8:45 a.m. and 11:30 a.m. When asked how the nurse had assessed Patient 63's pain and determined to administer oxycodone 40 mg, RN 4 said the assessment for Patient 63's pain and response to pain medications should be documented in the electronic nursing charting system (UCARE). RN 4 reviewed Patient 63's UCARE records, in the presence of the surveyor, and stated that the assessments and reassessments for Patient 63's pain medication administration on 10/13/10 at 8:45 a.m. and 11:30 a.m., were not documented in UCARE. RN 4 said nurses assess patients' vital signs and pain status every four hours. RN 4 said the expectation is for nurses to document in "real time" or immediately, on UCARE, patients' pain assessments and response to interventions.

During interview on 10/13/10 at 1:30 p.m., in the presence of RN 1, RN 4 and DOP, Patient 63's primary care nurse (RN 3), stated that she had not yet documented Patient 63's pain assessment and reassessment in response to pain medications administered at 8:45 a.m. and 11:30 a.m. When asked how she had kept track of patient's pain level, RN 3 said she would write the information on a working document that contained her patients' names and other vital information. When asked to show the written documentation on the working document, RN 3 said she had not written down Patient 63's pain levels in this case. RN 3 said that she remembered Patient 63's pain levels and reassessments were as follow:

10/13/10 8:45 a.m.: Pain 7/10, gave oxycodone 40 mg; reassessment at 9:30 a.m., pain 5/10
10/13/10 11:30 a.m.: Pain 7/10, gave oxycodone 40 mg; reassessment at 12 p.m., pain 5/10

During the same interview, RN 3 said that she had four assigned patients to care for during her shift, two with pain medications. In the surveyor's presence, RN 4 instructed RN 3 to complete Patient 63's documentation.

On 10/20/10, the hospital provided a copy of Patient 63's pain assessment on UCARE from 10/13/10. The documented assessments were inconsistent with RN 3's interview as follows:

Assessment on 10/13/10 8:45 a.m.: Pain intensity 6, pain intervention was PCA Bolus (nurse administered bolus)
Reassessment on 10/13/10 9:15 a.m.: Pain intensity 5
10/13/10 11:30 a.m.: Assessment on Pain intensity 7, pain intervention was PCA Bolus (nurse administered bolus)
Reassessment on 10/13/10 11:58 a.m.: Pain intensity 5

During the same interview, RN 3 said she would reassess patients' response to Oxycodone within 30 to 90 minutes. Review of the hospital's department of nursing policy and procedures titled, "Opioid Medication-management of range orders (general)", reviewed and revised 3/07, indicated the following:

"Administer the lowest appropriate prescribed dose of opioid. Consider the length of time a bolus of the medication to take full effect, for example: Oral medication-time to full effect maybe 45-60 minutes or more."

Review of Appendix A attached to the policy indicated, "In general can monitor oral medications 60 minutes after dose administered." Appendix A indicated that for Oxycodone, the average time to peak effect was 30-60 minutes and the recommended time to monitor after dose given was 60 minutes.

Review of the hospital's department of nursing policy and procedures titled, "Pain Assessment-(general)", reviewed and revised 1/10, showed that pain intervention re-assessment, after the administration or oral pain medications, should occur 45-90 minutes after administration.

2c. Patient 61: Record review on 10/14/10 showed that Patient 61 was 69 years old with multiple diagnoses including pancreatitis (inflammation and/or infection of the pancreas), cellulitis (skin infection) and Clostridium difficile (C. diff.) colitis (an infection of the colon caused by C. diff.). C. diff. is a bacterial infection that causes diarrhea and other intestinal disease and is associated with the use of antibiotics. The hospital admitted Patient 61 to the intensive care unit (ICU) on 10/4/10 for sepsis (a severe illness in which the bloodstream is overwhelmed with bacteria) watch and the management of severe pancreatitis.

In the ICU, Patient 61 received antibiotics and was on contact precautions for C. diff. Contact precautions are work practices to reduce the risk of transmitting infectious agents such as C. diff. by direct or indirect contact with an infectious person. On 10/12/10 at 6:00 a.m., Patient 61 had orders to discontinue C. diff. Contact Precautions. On 10/12/10 at 3:30 p.m., Patient 61 had orders to transfer to the general surgery unit. On the same orders, the box indicating Contact Precautions was checked. Patient 61 continued on antibiotics for the management of C. diff.

During interview on 10/14/10 at 12:40 p.m., in the company of RN 1 and DOP, RN 4 said Patient 61 was no longer on contact precautions. RN 4 explained that according to the hospital's Diarrhea Decision Tree (revised 11/08), C. diff. Contact Precautions maybe discontinued when diarrhea resolves. According to the Diarrhea Decision tree, diarrhea is defined as three or more unformed stools in less than or equal to 24 hours.

According to RN 4, review of Patient 61's electronic nursing charting record (UCARE) on 10/14/10 at 12:40 p.m., showed that Patient 4 had three bowel movement in less than 24 hours, one loose and two without description, as follows,
10/13 at 6:59 a.m.: loose
10/13 at 10:59 p.m.: no description
10/14 at 2:50 a.m.: no description

RN 4 said that staff is required to document the character of patients' bowel movements in order to determine whether to reinstate C. diff. Contact Precautions. RN 4 said the hospital provided patients with a "hat" for bowel movements so staff can determine the bowel pattern, stool color and character.

3. During unit inspection, on the 13 th floor intensive care unit (ICU), on 10/12/10 at 3 p.m., in the company of the educator nurse (RN 1), 13th floor ICU assistant patient care manager 1 (RN 13) and ICU 13 th floor assistant patient care manager 2 (RN 14), the 13 th floor ICU specimen refrigerator contained the following:
1. Two undated specimen cups containing a patient's drainage fluid
2. Two undated, 1 liter each, urine collection containers, containing fluid
3. Two blood tubes, containing a patient's blood sample, dated 10/20/09
4. Two blood tubes, containing a patient's blood sample, dated 2/21/10

RN 14 could not provide an explanation for the presence of undated and old specimens in the refrigerator. RN 14 said that specimens and samples should be labeled with the patient's name and date. RN 14 added that specimens could have been collected for specific studies or clinical trials. RN 14 said the investigators should come and collect the samples. RN 14 could not say what the hospital's process was to ensure that samples were collected in a timely manner.

Based on interview and record review, the facility failed to implement the nursing care plan for one of 71 sampled patients when the RN in 4 East nursing unit failed to assess the amount of drainage from the Jackson -Pratt drain (Jackson- Pratt or JP drain is a surgical drainage device used to pull excess fluid from the body by constant suction) of Patient 33 who had a bilateral mastectomy on 10/11/10. (Bilateral mastectomy is a type of surgery to remove both breasts.) Failure to accurately record the volume of drainage could prevent early detection and monitoring for excessive bleeding after surgery.

Findings:

Patient 33 was admitted to 4 East nursing unit with diagnosis of breast cancer and had bilateral mastectomy on 10/11/10. Review of the copy of electronic record of the Intake and Output Record from 7PM on 10/11/10 thru 7AM on 10/12/10 showed Pt. 33 had one Jackson-Pratt drain from the left and one from the right side of the breast area. There was no documentation of the amount of drainage from the each drain during the 12-hour period following the patient's surgery.

Review of the nursing care plan initiated on 10/11/10 for impaired skin integrity related to the surgical manipulation of tissue and incisions indicated the following nursing interventions, "Assess incisions for edema, erythema, drainage and infection... Observe drainage and maintain intact/patient wound drains. Keep drains less than 1/3 full for adequate suction."

During an interview with RN 1 on 10/12/10 at 1:15PM, she confirmed that the previous shift (7PM- 7AM) failed to record the intake and output of the JP drains. She stated that on this day, at 8:30 AM, she emptied 40 cc from the right drain and 20 cc from the left drain of sero-sanguinous fluid (pinkish wound drainage). At 12:00PM, she drained out 60 cc from the right drain and 40 cc from the left drain. She acknowledged that she has not notified the physician about the 160 cc total fluid that she drained out from the JP drains.

Based on interviews and record reviews, the hospital failed to ensure that medications were prepared and administered in accordance with physician's orders and accepted standards of care, for seven patients (Patients 47, 48, 49, 59, 62, 58 and 57) out of 21sampled patients, as evidenced by:

1. For Patients 47 and 48, the hospital staff did not administer insulin (a medication that lowers blood sugar) as ordered. This failure had the potential to complicate Patient 47's and 48's treatment course.
2. For Patient 49, the hospital staff did not document the amount of administered pain medications, in accordance with hospital policy and procedures. This failure had the potential to expose Patient 49 to inadequate pain management and adverse reactions.
3. For Patient 59, the hospital staff did not notify the physician of the use of more than three doses of pain medications in less than eight hours as required by the physician ' s order. This failure had the potential to expose Patient 59 to inadequate pain management and adverse reactions.
4. For Patient 62, the hospital staff did not administer as needed pain medications consistently and in accordance with physicians orders. This failure had the potential to expose Patient 62 to ineffective and inconsistent pain management.
5. For Patient 58, the hospital staff did not administer six doses of intravenous antibiotics as prescribed. This failure had the potential to expose Patient 58 to an increased risk of infection after a major surgical procedure.
6. For Patient 57, The hospital failed to ensure that a syringe containing injectable medication was prepared and labeled in accordance with hospital policies and procedures and accepted standards of care, this failure had the potential to expose Patient 57 to expired or contaminated medications and medication errors.

Findings:

1a. Patient 47 came into the hospital with multiple medical conditions including diabetes. On 3/4/10, she had a physician order for 110 units of Lantus (a high dose of long-acting insulin for management of diabetes) to be given daily at dinner time.

On 10/15/10, review of Patient 47's medical record indicated her blood sugar levels were in the 200s and 300s (normal blood glucose is from 70 to 120) from 3/1/10 to 3/3/10. The 3/4/10 medication administration record (MAR) indicated the Lantus order was held (not given) with the documented reason of "held per MD order."

On 10/15/10 at 12:30 p.m., further review of Patient 47's medical record with a staff pharmacist (Pharm 5) and the unit manager (RN 19) reflected there was no physician order to hold the Lantus order on 3/4/10. Both staff agreed that the Lantus should have been given to the patient.

1b. On 10/20/10 at 10:30 a.m., review of Patient 48's medical record at the 14-Moffit Unit reflected he had an order to follow the "ADULT SUBCUTANEOUS INSULIN ORDER SHEET PATIENT NPO or on TPN, TUBE FEEDS" on 9/23/10 when the patient was at the 9 Intensive Care Unit. On 9/27/10 at 10 p.m., the patient blood glucose was 168, which required 4 units of nutritional insulin dose and 3 units of correctional dose of Aspart insulin (total 7 units). The patient's MAR indicated only 4 units of Aspart insulin was given.

At 10:55 a.m. on the same day, the Director of Clinical Operations (DIR 1) verified that 7 units of insulin should have been given to the patient according the the prescriber's order.

2. Patient 49 came into the hospital with diagnosis of breast cancer. On 10/13/10, her physician prescribed oxycodone (a potent narcotic for pain) 5 to 10 milligrams every 4 hours as needed for pain.

On 10/14/10, review of the patient MAR revealed oxycodone was given at 10/14/10 at 00:40 a.m. without indicating how much was given. The pain management flowsheet did not document how much Oxycodone was given at the said time.

On 10/14/10 at 11:30 a.m., DIR 1 said if the patient had a range order (i.e. 5 to 10 mg) then the patient's nurse needed to document the amount given on the MAR according to the hospital's policy.

The hospital's 3/07 policy on "Opioid Medication- Management of Range Orders (General)" indicated, "Administer the lowest appropriate prescribed dose of opioid...Ensure complete and timely documentation and communication of patient's response to dose and dosing interval. Document reassessment of pain after intervention..."

Documenting the amount of medication given helps clinicians evaluate and provide appropriate intervention(s) in the event of adverse drug reaction or side effects.



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3. Record review on 10/19/10 showed that Patient 59 was 49 years old with a history of gastrointestinal disease and abdominal pain. The hospital admitted patient 59 on 10/13/10 for assessment of a two-week history of abdominal pain and vomiting. Patient 59's as needed pain medications, dated 10/13/10 at 9:56 p.m., included the following for Moderate to severe pain:
? oxycodone 5-10 milligrams (mg) by mouth every 4 hours as needed for pain.
? Morphine intravenously (IV) 2 mg every 2 hours as needed for pain unresponsive to oral medications or if patient unable to take PO (by mouth), or as needed before procedures
Call HO (physician) if administered 3 or more times in any 8-hour period.

Review of Patient 59's medication administration record (MAR) on 10/19/10 at 1:30 p.m., with the unit's Patient Care Manager (RN 17) and Assistant Patient Care Manager (RN 18) showed the following IV Morphine administration times:

On 10/14/10, Patient 59 received IV Morphine five times at 7:10 a.m., 10:05 a.m., 2:15 p.m., 6:35 p.m. and 9: 25 p.m. Twice on 10/14/10, Patient 59 received three doses within an eight-hour period.

On 10/15/10, Patient 59 received Morphine IV four times at 9:15 a.m., 12:30 p.m., 4 p.m., and 6:45 p.m. Once on 10/15/10, Patient 59 received three doses within an eight-hour period.

On 10/16/10, Patient 59 received Morphine IV four times at 11:50 a.m., 2:10 p.m., 4:35 p.m. and 10:20 p.m. Once on 10/16/10, Patient 59 received three doses within an eight-hour period.

On 10/17/10, Patient 59 received Morphine IV six times at 1:45 a.m., 7:20 a.m., 10:00 a.m., 1:05 p.m., 4:45 p.m. and 9:30 p.m. Twice on 10/17/10, Patient 59 received three doses within an eight-hour period.

On 10/18/10, Patient 59 received Morphine IV five times at 2:30 a.m., 6:40 a.m., 10:00 a.m., 11:50 a.m. and 9 p.m. Twice on 10/18/10, Patient 59 received threes dose within an eight-hour period.

RN 17 could not find any documented evidence that nursing staff had notified a physician of the administration of three or more doses of pain medications within any given eight hour period. RN 17 could not provide an explanation for the lack of physician notification.

4. Record review on 10/18/10 showed that Patient 62 was 28 years old with complex medical problems secondary to a history of perinatal intracranial (inside the skull) hemorrhage and hydrocephalus (build up of fluid in the skull/water on the brain). The hospital admitted Patient 62 on 90/30/10 for revision of ventriculoperitoneal shunt, a surgical procedure to relieve intracranial pressure caused by hydrocephalus. Patient 62 had a long history of pain secondary to sharp and throbbing headaches.

Review of the hospital's policy titled, "Opioid medication-management of range orders (general)", reviewed and revised 3/07, showed the following:
"Pain is subjective. There is no objective way to measure the amount of pain a person is experiencing. Patient self-reporting is the cornerstone of pain assessment. At this hospital the tool that is most often used is the 0-10 scale where 0 is no pain and 10 is the worst pain imaginable."

Patient 62's, as needed, pain medication orders included the following:
Morphine Patient Controlled Anesthesia (PCA/used as needed by the patient) 2 mg every 15 minutes as needed for pain.
Nurse administered bolus dose: morphine 2-4 mg IV every 1 hour, as needed for pain (the orders did not contain clarification for what type or level of pain to use this order).
Fentanyl 50 micrograms (mcg) IV every 30 minutes as needed, used for severe pain.
Percocet (oxycodone 5 mg/acetaminophen 325 mg) 1-2 by mouth every 4 hours as needed, used for moderate pain.

Medication administration records and the neuro intensive care unit flow sheet for 10/17/10 showed that Patient 28 complained of pain and received the following medications:

8:35 a.m.: Patient "complaining of dull headache 10/10" (worst pain)
Treated with morphine IV 4 mg bolus

9:13 a.m.: Patient "crying and states he has headache dull 10/10" (worst pain)
Treated with Fentanyl IV 50 mcg and Percocet 2 tablets by mouth

9:30 a.m.: Patient "continue to complain of headache 8/10" (severe pain)
Treated with Morphine IV 4 mg bolus

12 p.m.: Patient "complaining headache dull 5/10" (moderate pain)
Treated with morphine IV 4 mg bolus

12:45 p.m.: Patient was given Fentanyl IV 50 mcg prior to a procedure

1:30 p.m.: Patient "complaining of dull headache 10/10" (worst pain)
Treated with Percocet 2 tablets by mouth

6 p.m.: Patient "complaining of throbbing neck pain 10/10" (worst pain)
Treated with morphine IV 4 mg bolus

During interview on 10/18/10 at 3:34 p.m., a neuro intensive care unit assistant patient care manager nurse (RN 6) explained that Patient 62 had a complex medical history. RN 6 said the unit was familiar with the patient's pain medication needs. When asked about the inconsistency of the treatment of 10/10 pain with three different medications (fentanyl, morphine and Percocet) during the same shift, RN 6 said the pain scale was not completely representative of the patient's pain status and the nurse had to determine the patient's pain level based on the nurse's assessment. When asked about the use of Percocet (a medication prescribed to treat moderate pain) for the treatment of severe 10/10 pain on 10/17 at 1:30 p.m., RN 6 said that the nurse opted to do this because the patient had received fentanyl IV 50 mcg, 45 minutes earlier, at 12:45 p.m.

According to Lexi Comp Online, a nationally recognized drug reference source:

For fentanyl IV: average time to peak effect 5 minutes; duration of action up to one hour.

For morphine IV: average time to peak effect 5-15 minutes; duration of action varies maybe two to four hours.

For Percocet (oxycodone) PO: average time to peak effect 30-60 minutes; duration of action varies between three to six hours.

Additionally, fentanyl 50 mcg is roughly equivalent to morphine 5 mg. Both are roughly equivalent to four tablets of Percocet

The hospital staff used three different and not equivalent agents to treat Patient 62's severe pain, inconsistently with physicians orders and without clarifying physicians orders. According to the physician's orders, only fentanyl 50 mcg IV every 30 minutes was to be used for severe pain. The hospital staff used the same medication, morphine IV 4 mg nurse bolus, to treat both severe pain and moderate pain.

The hospital's policy titled, "Opioid medication-management of range orders (general)", reviewed and revised 3/07, indicated the following:
"When working with opioid analgesics base decisions about the implementation of range orders on a thorough pain assessment and knowledge of the drug to be administered. In addition, it is critical to carefully assess the patient's response to each dose change. The nurse is expected to be familiar with the anticipated time of onset, time to peak effect and duration of action .... "

The hospital's policy titled, "Medication Administration (General)/Part I Medication Order Processing), reviewed/revised 4/08, showed the following:
"When the order is unclear, questionable or incomplete, the RN or pharmacist must clarify the order with the prescribing physician/provider prior to administering the medication."

5. Record review on 10/20/10 showed the hospital had admitted Patient 58 on 10/5/10 for cardiac tumor removal surgery. Patient 58 had physicians orders, dated 10/5/10, for intravenous antibiotics (used to prevent infections), "Cefazolin 1 gram (g) every 8 hours x 6 times".

Review of Patient 58's MAR showed that the hospital had administered cefazolin 1g for five doses, starting 10/5/10 at 10 p.m. through 10/7/10 at 6:00 a.m. Patient 58's MAR showed that the hospital staff did not administer the sixth dose of cefazolin, scheduled for 10/7/10 at 2:00 p.m. The MAR did not contain any documentation to provide a reason for the lack of cefazolin administration.

Further record review on 10/20/10, with the Education Nurse (RN 1) and the Informatics Clinical Nurse (RN 2), showed that Patient 58's record did not contain any orders to discontinue the cefazolin or explanations for the lack of administration of the sixth dose of cefazolin. The hospital discharged Patient 5 on 10/9/10.

During interview on 10/20/10 at 10:05 a.m., RN 1 said that the MAR did not reflect that the hospital had administered the sixth cefazolin dose. The MAR did not contain a nurse's initials, administration time, if the dose had been given or a reason for why if the dose was not given, as required by hospital policy. RN 1 said, "If I was auditing this chart, I would think the dose was not given."

Review of the hospital's policy titled, "Medication Administration, Part IV-Medication Administration and Documentation", reviewed and revised on 4/08, indicated the following:
"After the medication had been administered to the patient, the following are clearly documented onto the designated medication administration record: drug, dosage, route and time of administration."
"Document the patient refusal or holding of an ordered medication by writing the dose and time the medication was to be given on the designated medication administration record with a circle around the time to indicated that the medication was not administered and the appropriate reason code and RN (nurse) initials."

6. Patient 57 was 7 months old and the hospital was treating him with chemotherapy and other supportive medications for cancer. During medication pass observation on 10/15/10 2:45 p.m., in the pediatric outpatient infusion center, in the company of Patient Care Director of Ambulatory Services, and a pediatric infusion registered nurse (RN 15), the medication tray in Patient 57's room contained a nurse prepare medication syringe for intravenous administration. The syringe had a handwritten label, which indicated that the contents were Kytril 70 mcg (micrograms)/0.7 milliliter (ml). The label also had the initials of the preparer but did not contain any other additional information such as date prepared, time, expiration, or any patient identifiers. Kytril is available as a 100 mcg/ml sterile (free from living germs and organisms) and preservative free (does not contain chemicals that prevent the growth of germs and organisms) injectable vial. It is used to treat nausea associated with chemotherapy. RN 15 said that another nurse (RN 16) had prepared the medication. During interview on 10/15/10 at 2:45 p.m., RN 15 said she did not observe RN 16 prepared the syringe.

During group interview on 10/15/10 at 2:55 p.m., the Patient Care Director of Ambulatory Services said it was not the infusion center's usual practice for one nurse to prepare syringes of medications for another nurse. The Patient Care Director of Ambulatory Services said the following information should be on the handwritten label if a nurse prepared medications that he/she will not administer: name of patient, date of birth, date and time the syringe was drawn, medication name and amount and the initials of the preparer. RN 16 stated that she had not completed labeled the syringe as expected.

Review of the hospital's policy titled, "Medication Administration (General); Part IV: Medication Administration and Documentation", reviewed and revised 4/08, indicated the following:
"If a medication is prepared outside the pharmacy, the RN who has prepared the medication must also administer the medication. Exception: The RN being asked to administer the medication, other than the RN preparing the medication, has observed preparation of the medication and can validate that it is the correct medication, correct dose, correct route, correct patient, and correct time."

According to the U.S. Pharmacopeia's (USP) Chapter <797> Pharmaceutical Compounding-Sterile Preparations, which sets practice standards to help ensure that compounded sterile preparations are of high quality, revised June 2008, preservative free medications must be used within one hour if prepared outside a clean compounding environment, such as room air in a nursing unit or a medication room. Additionally, USP 797 indicated the following:
"Unless immediately and completely administered by the person who prepared it or immediate and complete administration is witnesses by the preparer, the compounded sterile product (drugs that must be sterile when administered to a patient, such as intravenous Kytril) shall bear a label listing patient identification information, name or initials of the person who prepared it and the exact 1 hour BUD (Beyond Use Date or expiration) and time. If administration has not begun within 1 hour, the compounded sterile product shall be promptly, properly, and safely discarded."

During interview on 10/18/10 at 3:00 p.m., the director of pharmacy (DOP) said that if a nurse prepares a sterile injectable medication at the bedside, the nurse should label the syringe with the date and time prepared. DOP said the hospital's process was to discard nurse prepared sterile preparations by the end of the day.

Based on observation, interviews, and document reviews, the hospital failed to administer medications in accordance with hospital policy and procedures and professional standard of practice as evidence by:

1. The hospital nursing staff failed to ensure the safe use of medications when Advair inhalers were not administered in accordance to physician's orders which resulted in 5 medication errors (missed or extra doses administered) in 4 out of 6 patients on inhalers.(Patient 68, 72, 73, 69)
2. The hospital nursing staff failed to ensure the safe use of medications when Advair was not administered in accordance to hospital policy which resulted in a medication error for late administration time of greater then 12 hours (Patient 69).
3. The hospital nursing staff failed to ensure the safe use of medications when intravenous fluids were not administered in accordance to physician's orders which resulted in 2 medication errors (rates administered fast and slower) in 2 out of 3 patients on intravenous fluids (Patient 75, 74).
4. The hospital failed to ensure that all drugs and biologicals were administered in accordance with Federal and State laws and regulations, including applicable licensing requirements when a registered nurse in the preoperative area of the Ambulatory Suregry Center (ASC) administered intravenous fluids to Patient 72 without a physicians order.

Findings:

1a. A review of the clinical record indicated Patient 68 was a 60 years old and had a history of asthma. Asthma is a disease that affects a person's lungs. It causes repeated episodes of wheezing, breathlessness, chest tightness, and nighttime or early morning coughing. Patient 68 had physician's orders for Advair Diskus 250mcg/50mcg 1 puff twice daily for asthma.

It was observed on 10/12/10 at 3:41 pm Patient 68's Advair had 2.5 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 2.5 days). The dispense date on the label indicated Advair was dispensed on 10/08/10 which meant that 3-4 days of Advair should have been administered. A review of the Medication Administration Record (MAR) indicated that from 10/08/10 through 10/12/10 the nurses documented that they had administered 3.5 days of Advair.

The above indicated that 1 day (2 doses) of Advair (calculated as 3.5 days minus 2.5 days) were not administered over a 3.5 day period for Patient 68.

1b. A review of the clinical record indicated Patient 72 was a 38 years old and had a history of asthma. Patient 72 had physician's orders for Advair Diskus 150mcg/50mcg 1 puff twice daily for asthma.

It was observed on 10/13/10 at 12:20 pm, Patient 72's Advair had 2.5 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 2.5 days). The dispense date on the label indicated that Advair inhaler was dispensed on 10/10/10 which meant that 3 days of Advair should have been administered. A review of the Medication Administration Record (MAR) indicated that from 10/10/10 through 10/13/10 the nurses documented that they had administered 3 days of Advair.

The above indicated that 0.5 day (1 dose) of Advair (calculated as 3 days minus 2.5 days) was not administered for Patient 72 over a 3 day period.

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."

1c. A review of the clinical record indicated Patient 73 was 89 years old and had a history of Chronic Obstructive Pulmonary Disease (COPD). COPD is a progressive disease that makes it hard to breath She had physician's orders for Advair Diskus 500mcg/50mcg 1 puff twice daily for COPD.

It was observed on 10/13/10 at 1:10 pm Patient 73's Advair had 6.5 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 6.5 days). The dispense date on the label indicated that Advair was dispensed on 10/08/10 which meant that 3-4 days of Advair should have been administered. A review of the Medication Administration Record (MAR) indicated that from 10/08/10 through 10/13/10 the nurses documented that they had administered 3.5 days of Advair.

The above indicated that an extra 3 days (6 doses) of Advair (calculated as 6.5 days minus 3.5 days) were administered for Patient 73 over a 3.5 day period.

1d. A review of the clinical record indicated Patient 69 was a 71 years old and had a history of severe COPD and had been admitted to the hospital multiple times for severe COPD exasperation. He had physician's orders for Advair Diskus 500mcg/50mcg 1 puff twice daily and Spiriva 18mcg daily for COPD.

It was observed on 10/13/10 at 11:47 am, Patient 69's Advair had 7.5 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 7.5 days). The dispense date on the label indicated the Advair was dispensed on 10/06/10 and 10/12/10 which meant that 7 days of Advair should have been administered. A review of the Medication Administration Record (MAR) indicated that from 10/08/10 through 10/12/10 the nurses documented that they had administered 7 days of Advair.

The above indicated that an extra 0.5 day (1 dose) of Advair (calculated as 7.5 days minus 7 days) was administered for patient 69 over a 7 day period.

2. According to the hospital policy entitled Medication Management: Administration of Medication dated 04/08 indicates "Medications that are ordered as Routine are available for administration within 4 hours of being written ...Administration of the medication will follow ...The next Standard Administration time ...BID ...Standard Medication Adminstration Times 0900, 2100 "

A review of the clinical record indicated Patient 69 was a 71 years old and had a history of severe COPD and had been admitted to the hospital multiple times for severe COPD exasperation. He had physician ' s orders for Advair Diskus 500mcg/50mcg 1 puff twice daily and Spiriva 18mcg daily for COPD.

A review of Patient 69's physician's orders was written on 10/06/10 at 12:15 am for Advair Diskus 500mcg/50mcg 1 puff twice daily for asthma. The pharmacy dispense record indicated that the pharmacy dispensed "stat" (Immediately) Advair on 10/06/10 at 9:08 am. The Medication Administration Record (MAR) indicated that the first dose was given at 10/06/10 at 9:45 pm.

Based on the policy Patient 69 should have been administered his first dose of Advair at 9:00 am. The dose was administered at 9:45 pm. The dose was late by over 12 hours.

3a. According to the hospital nursing policy entitled Peripheral Intravenous Catheter Insertion and Maintenance, "The keep open rate (KVO) is 10ml/hour in pediatrics and 30ml/hour in adults unless otherwise ordered."

A review of a clinical record indicated Patient 74 was 40 years old and was admitted for procedure in the ambulatory surgery center. Patient 74 had physician's orders for Lactated Ringer at 30 ml/hour (KVO). The Surgery Center Post Anesthesia Care Unit (PACU) documented that Patient 74 received 100 ml/hour. The rate was more then three times the physician ordered rate.

3b. A review of a clinical record indicated Patient 75 was 14 years old and was admitted for procedure in the ambulatory surgery center. Patient 75 had physician's orders for Lactated Ringer at 50 ml/hour. The Post Anesthesia Care Unit Flowsheet documented that Patient 75 received 37 ml/hour. The rate was less then 50 ml/hour as ordered by the physician.

During an interview on 10/14/10 at 2:02 pm both Nurse 30 and Nurse 31 stated they did not count drops and did not use intravenous pumps to administer intravenous infusions. They both stated they estimate the rate of the intravenous infusions by "eye balling it." They acknowledged that estimating the rate was not accurate and may contribute to adverse outcomes (i.e. patients with edema, or antibiotic infusions such as Vancomycin).



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4. On 10/14/10 at 12:40 p.m., Patient 72's operative case record dated 10/14/10 was reviewed. The record showed that ASC RN 24 had inserted an intravenous catheter in Patient 72's right arm and started an intravenous infusion of lactated ringers in the preoperative area at 7 a.m. There was a set of preoperative orders which the physician had signed but had not indicated that he wanted an intravenous catheter inserted and intravenous fluids started.
On 10/14/10 at 1 p.m., ASC RN 24 was interviewed and stated she knew that the physician had not written any preoperative orders for Patient 72 but she reviewed the patient's history and decided which intravenous fluids she should start. She said "I should have gotten an order before starting the IV."

Based on observation, interview, and record review, the facility failed to maintain accurate medical records when a registered nurse in the Ambulatory Syrgery Center (ASC) documented that Patient 73 had an IV in her left foot instead of her left hand and a physician failed to document that he had notified the CTDN (California Transplant Donor Network) regarding Patient 74's death.

Findings:

1. On 10/14/10 at 3:12 p.m., Patient 73 was in the PACU (post anesthesia care unit) of the ASC. She had intravenous fluids infusing through a catheter in her left hand.

A review of Patient 73's record showed documentation that a registered nurse had started an intravenous catheter in the patient's left foot. The Patient Care Manager of the ASC stated the nurses select the IV site from a drop down menu and the nurse must have clicked on the wrong one.

2. Patient 74's record was reviewed on 10/19/10 at 11:25 a.m. There was a Postmortem and Death Information Form dated 9/6/09. The part of the form titled Donor Network Notification was not complete. There was no documentation that the physician notified the Donor Network of Patient 74's death.

During an interview on 10/19/10 at 1:15 p.m., the Director of Regulatory Affairs (Admin 1) stated the Donor Network was notified of Patient 74's death but there was "No explanation for why the form was not completed."

The facility's policy Medical Record - Content was reviewed and indicated the following:
III. Content of Medical Records
Medical record entries must be:
Accurate
Complete

Based on observation, interview, and record review, the facility failed to ensure the security of patient records when a computer in the ASC continued to display information one hour after the computer was accessed and the user walked away. This had the potential to allow unauthorized individuals access to patient records.

Findings:

During a tour of the ASC on 10/13/10 at 2:30 p.m., the Patient Care Manager used a computer to show the surveyor how the staff can check a physician's privileges. The computer was located on a wall at the end of a corridor which led to the post anesthesia care unit (PACU) on the left and the operating room on the right. Along the corridor there were rooms where preoperative patients and their families were waiting.

At 3:30 p.m., while passing the computer on the way to the PACU, the surveyor noted that the computer continued to display the physician information that the Patient Care Manager had accessed at 2:30 p.m. The Patient Care Manager said all ASC staff use the computer to check patient information. He stated the computer should be set to automatically log off after five minutes and he would follow up with the IT (information technology) department.

The facility's policy Workstation Use and Security Procedures was reviewed and indicated the following:

1.0 Purpose: The purpose of this document is to describe guidelines concerning appropriate use and security of workstations, peripheral devices, protection of confidential information, and securing unattended workstations to prevent unauthorized access.

3.2.5 Physical Security:Workstations that are located in open, common, or otherwise insecure areas must implement the following measures:

An inactivity timer or automatic logoff mechanism must be implemented.

Workstation monitors must be situated in a manner that prohibits unauthorized viewing. The use of a screen guard or privacy screen is recommended.

Users are required to log off of applications containing patient health or sensitive business information before leaving their workstations.
3.2.10 Auto Log Off: Workstations containing or accessing sensitive patient information or business information should enable auto log-off capabilities if available.

Based on medical record review and staff interview, the facility failed to ensure that entries were complete (with patient identifier), dated, timed and authenticated by the person who dictated the report in 5 of 11 closed records for (Patients 21, 22, 28, 24 and 25).

Findings:

1. Records for Patients 21, 22, and 28 were reviewed on 10/13 and 10/14/10. There were two transfer summaries and an operative report that were not authenticated by the person who dictated these reports. During an interview with the health Information Management Services Director (HIMS-1) on 10/14/10, she stated that the facility ' s practice is to require authentication only by the attending medical staff member, and not by the resident/allied health professional who actually dictated the report.

2. Patient 21's was reviewed on 10/13/10. The Anesthesia Record/Patient Information form was not dated nor timed in the space provided on the form, although it was signed by the anesthesiologist. This finding was confirmed by HIMS-2 during the record review.

3. Records for Patients 24 and 25 were reviewed on 10/13 and 10/14/10. These records contained forms that were fold-out flow sheets, such as the Neonatal note, Standardized Nursing Care Plan, and Adult Admission Assessment. The forma did not contain any patient identifier (such as name and medical record number) in every section of the form, including the front and back sides. Therefore, when the forms are photocopied/scanned, those sections of the forms could not be linked to a patient. This finding was confirmed by HIMS-2 during the record review.

Based on interview and record review, the hospital failed to have medication orders dated and/or timed by the practitioners responsible for patient care for two patients (Patients 50 & 51) in accordance with the hospital policy and procedures. Review of two medical records following medication pass observations revealed medication orders were not dated and timed for Patient 50. Review of two patients' medical records on the 12-Long Nursing Unit reflected eight pages of admit/transfer, patient controlled analgesia (PCA), and post-operative antimicrobial orders were not timed for Patient 51. The deficient practice demonstrated reduced accountability of medical staff for orders given.

Findings:

1. On 10/14/10 at 11:25 a.m., following the medication pass observation, review of Patient 50's medical record was conducted with the Director of Clinical Operations (DIR 1) at the 9-Long Nursing Unit. The record indicated two medication orders were not dated and timed when the patient was at 12-Long surgical floor on 10/7/10. DIR 1 acknowledged that the orders should have been dated and timed by the prescriber when he made the orders.

2. On 10/14/10 at 12 p.m., review of Patient 51's medical record on 12-Long Nursing Unit reflected five pages of admit/transfer orders, one page of adult PCA orders, one page of adult arthroplasty addendum orders, and one page of post-operative antimicrobial orders were dated but not timed by the prescriber. The nursing unit manager (RN 20) said all medication orders required to be dated and timed by the prescriber.

The hospital's 11/07 policy and procedures entitled "Medication Management: Ordering and Transcribing" stipulated that "date and time" are the required elements for all medication orders.

Based on interview and record review, the facility failed to complete the informed consent form for a procedure for one of 71 sampled patients when Patient 43 in the 9 Northeast Intensive Care Unit had a flexible sigmoidoscopy done without obtaining the signature of the responsible party on the consent form to indicate that the responsible party understood and agreed to the planned procedure.

Findings:

Patient 43 was admitted to the facility on 9/14/10 with diagnosis of end-stage liver disease. Review of the nurse's notes on the intensive care flow sheet dated 10/13/10 indicated that Patient 43 underwent endoscopy and that "all treatment and procedure explained" to the patient's wife who was at bedside.

Review of the document titled, "Authorization for Surgery or Special Diagnostic or Therapeutic Procedure" dated 10/13/10 indicated a consent for the following procedures: Upper endoscopy and flexible sigmoidoscopy with possible polypectomy, injection therapy and hemostatsis. (Upper endoscopy is the examination of the lining of the esophagus, stomach and upper duodenum with a flexible tube with a small camera at the end that is inserted down the throat. Sigmoidoscopy is the examination of the sigmoid colon or the lower part of the large intestines. Polypectomy is the removal of polyps.) The date, time and signature of the patient was blank. The date, time and the witness to the signature was signed by the RN 2.

During an interview on 10/19/10 at 11:20 AM with RN 2, she stated that she took care of Patient 43 on 10/13/10 when the patient had the endoscopy procedure. RN 2 indicated that the patient was not able to sign but patient's wife was present in the morning of the procedure. RN 2 acknowledged that she signed the consent form as the witness and stated that she did not know she had to obtain the wife's signature to show that she understood and consented to the procedure for Patient 43.

Review of the facility's policy and procedure entitled, "Informed Consent" dated Sept. 2009 stated the following:

"The medical center will ensure that the physician or provider has given the patient the information necessary to reach an informed consent by utilizing the appropriate consent form. Surgical (operative) consent forms must be completed prior to surgery unless an exception applies ... If the form has not been signed in the doctor's office (the preferred procedure) hospital personnel will have the patient sign the form. Hospital personnel will witness the patient's signature on the form."
"If an incompetent adult has not executed an Advance Health Care Directive, and lacks a conservator with the authority to make healthcare decisions, there is no one with clear-cut legal authority to grant consent for treatment. In general, the following individuals, in specified order of priority, may participate in the consent process: health care agent; legal guardian/ conservator; patient's spouse or registered domestic partner; adult child of the patient; adult sibling of the patient."

Based on observation, interviews, and document reviews, the hospital failed to ensure the provision of pharmaceutical services and care that meets the needs of the patients as evidenced by:

1. The pharmacy failed to develop and implement a plan to resolve elevated bacterial and fungal levels found in sterile compounding hoods which resulted in pharmacy staff compounding in contaminated hoods for an immunocompromised patient population for an estimated 12,000 medications over a 253 day period. (See A500, A749)
2. The pharmacy failed to evaluate the significance of the bacterial and fungal colonies sampled in sterile compounding areas when colony forming units were sampled and the bacteria and fungus were not further identified. (See A500, A749)
3. The pharmacy failed to ensure the safe use of medications when Advair inhalers were not administered in accordance to physician's orders and hospital policy which resulted in 5 medication errors impacting 4 out of 6 patients. (See A500, A405)
4. The pharmacy failed to ensure the safe use of medications when intravenous fluids were not administered in accordance to physicians' orders which resulted in 2 medication errors (rates administered fast and slower) in 2 out of 3 intravenous fluid patients. (See A500, A405)
5. The pharmacy failed to account for 79 medications, based on a one day audit, which could be attributed to medication errors such as administering extra doses, missing doses, and administering the wrong medications. (See A500)
6. The hospital failed to develop and implement written policies and procedures to ensure the safe and effective use of fentanyl patches. The hospital failed to follow manufacturer's instructions and FDA warnings when initiating fentanyl patch treatment for one patient (Patient 59) out of one sampled patients, initiated on fentanyl patches at the hospital. These failures had the potential to expose Patient 59 and other fentanyl patch patients to serious and life threatening adverse effects. (see A500)
7. The hospital failed to clarify orders for multiple as needed opiate pain medications for four patients (Patients 60, 61, 62 and 63) out of four sampled patients. This failure had the potential to expose Patients 60, 61, 62 and 63 to an increased risk of adverse events associated with opiate use such as respiratory depression and somnolence. (see A500)
8. The hospital failed to log refrigerator temperatures consistently for one of the inpatient medication refrigerators and the ninth Floor Satellite Pharmacy refrigerator in accordance with the hospital policy and procedure. (see A500)
9. The hospital failed to ensure that medications for internal use were segregated from medications for external use in the 8-Moffit Nursing Unit and the Urology Clinic to avoid inadvertent medication administration errors, in accordance with the hospital policy and procedures. (see A500)
10. The hospital failed to ensure that pharmacist unit inspections were completed, monthly for all units in the hospital for August and September 2010, in accordance with hospital policy and procedures. (see A500)
11. The hospital failed to ensure that patient's own home medications were stored away (to avoid potential for patient to self-administer own medications) in timely manner according to the hospital's policy and procedures. (see A500)
12. The hospital failed to ensure that outdated and mislabeled medications were not available for patient use, as evidenced by the presence of expired or mislabeled insulin (used to lower blood sugars) in one patient care unit. (see A505)

The cumulative effects of these systemic problems resulted in the pharmacy's inability to provide pharmaceutical services and care in a safe and effective manner in accordance with the statutorily-mandated Conditions of Participation for Pharmaceutical Services.

Based on observation, interview, and document review, the hospital failed to deliver pharmaceutical services to meet the needs of the patients when medications where not controlled and distributed in accordance with standards of practice, federal and state laws as evidence by:

1. The pharmacy failed to develop and implement a plan to resolve elevated bacterial and fungal levels found in sterile compounding hoods which resulted in staff compounding intravenous medications in contaminated hoods for an immunocompromised patient population for an estimated 12,000 medications over a 253 day period.
2. The pharmacy failed to evaluate the significance of the bacterial and fungal colonies sampled in sterile compounding areas when colony forming units were sampled and the bacteria and fungus were not further identified.
3. The pharmacy failed to ensure the safe use of medications when Advair inhalers were not administered in accordance to physician's orders and hospital policy which resulted in 5 medication errors impacting 4 out of 6 patients.(Patient 68, 72, 73, 69)
4. The pharmacy failed to ensure the safe use of medications when intravenous fluids were not administered in accordance to physician's orders which resulted in 2 medication errors (rates administered fast and slower) for two of 3 patients on intravenous fluids(Patients 74 and 72).
5. The pharmacy failed to account for 79 medications, based on a one day audit, which could be attributed to medication errors such as administering extra doses, missing doses, and administering the wrong medications.
6. The facility failed to develop and implement written policies and procedures to ensure the safe and effective use of fentanyl patches. The hospital failed to follow manufacturer's instructions and FDA warnings when initiating fentanyl patch treatment for one patient (Patient 59) out of one sampled patient initiated one fentanyl patches at the hospital. These failures had the potential to expose Patient 59 and other fentanyl patch patients to serious and life threatening adverse effects.
7. The facility failed to clarify orders for multiple as needed opiate pain medications for four patients (Patient 60, 61, 62 and 63) out of four sampled patients. This failure had the potential to expose Patient 60, 61, 62 and 63 to an increased risk of adverse events associated with opiate use such as respiratory depression and somnolence.
8. The facility failed to log refrigerator temperatures consistently for one of the inpatient medication refrigerators and the ninth Floor Satellite Pharmacy refrigerator in accordance with the hospital policy and procedure.
9. The facility failed to ensure that medications for internal use were segregated from medications for external use in the 8-Moffit Nursing Unit and the Urology Clinic to avoid inadvertent medication administration errors, in accordance with the hospital policy and procedures.
10. The facility failed to ensure that pharmacist unit inspections were completed monthly for all units in the hospital for August and September 2010, in accordance with hospital policy and procedures
11. The failure to ensure that Patient 50's own home medications were stored away (to avoid potential for patient to self-administer own medications) in timely manner according to the hospital's policy and procedures.

Findings:

1. During an interview on 10/13/10 at 4:09 pm the Nurse Manager 1 stated that the Ida Friend Infusion Clinic patient population consisted of cancer patients primarily with solid tumors. The clinic had 23 infusion chairs and 4 beds. She also stated that patients would typically receive infusions anywhere from one to eight hours. The clinic would treat approximately 80 to 85 patients a day. The cancer patients would receive transfusions, chemotherapy and other intravenous solutions such as antibiotics.

It was observed on 10/13/10 at 4:30 pm at the Ida Friend Infusion Center Pharmacy a biological safety cabinet (BSC) and a Laminar Air Flow Hood (LAFH). The BSC was primarily used for mixing and preparing chemotherapeutic intravenous medications. The LAFH was primarily used for mixing and preparing non-chemotherapeutic intravenous medications (i.e. antibiotics, steroids, etc).

A review of the bacterial air samples of the BSC and the LAFH for the Mount Zion Ida Friend Infusion Center indicated the following test results:
Date of Sampling 02/05/2010 Results
BSC CFU-18
LAFH CFU-32
CFUs are number of colonies of bacteria or fungus that are observed after incubation at 35 degrees Celsius for 2-3 days. The results were bacterial air samples. The recommended bacterial CFU levels should not exceed 1 CFU for the BSC and LAFH.

A review of the fungal air samples of the biological safety cabinets (BSC) and the Laminar Air Flow hood (LAFH) for the Mt Zion Ida Friend Infusion Center indicated the following results:
Date of Sampling 02/05/2010 Results
LAFH CFU-2
CFUs are number of colonies of bacteria or fungus that are observed after incubation at 35 degrees Celsius for 2-3 days. The results were fungal air samples. The recommended fungi CFU levels should not exceed 1 CFU for the LAFH.

In an interview on 10/20/10 at 1:45 pm the Pharmacist 9 stated that since the last sampling in February elevated levels of bacteria and fungus the LAFH and BSC had not been retested. She also stated she did not know why the LAFH and BSC had not been retested.

An interview on 10/19/10 at 2:02 pm the Infection Control Hospital Epidemiologist stated cancer patients were often immunocompromised and at greatest risk for infections from bacteria and fungus. She said that these patients may not mount an immune response to ward off infections from bacteria and fungus. She also said that immunocompromised cancer patients were definitely more vulnerable to infections.

During an interview on 10/19/10 at 3:30 pm the Director of Pharmacy (DOP) stated that they had not identified the cause for the elevated bacterial and fungal levels. She stated they had not re-sampled or had any qualified technicians or personnel evaluate the elevated bacterial and fungal levels. The pharmacy had not reevaluated work practices, cleaning procedures, operation procedures, or investigated the source of the elevated bacterial and fungal levels.

According to the United States Pharmaceopedia 797 Pharmaceutical Compounding (USP 797) page 3713 under the entitled section Action Levels, Documentation, and Data Evaluation indicates " Action levels, documentation, and data evaluation ...Any cfu count that exceeds its respective action level ...should prompt a re-evaluation of the adequacy of personnel work practices, cleaning procedures, operational procedures, and air filtration efficiency within the aseptic compounding location. An investigation into the source of the contamination shall be conducted. Sources could include HVAC systems, damaged HEPA filters, and changes in personnel garbing or work practices. The source of the problem shall be eliminated, the affected area cleaned, and resampling performed."

An interview on 10/20/10 at 1:00 pm the Environmental Health and Safety Director stated in February the bacterial and fungal levels were significantly elevated in the BSC and LAFH. According to her it was very rare to see air sampled bacterial CFUs in the 30s. She also stated it was pharmacy's responsibility to correct the issue and then request a resample. She said that if the resample had been done they would have isolated and identified the type of bacteria in order to determine the significance. Pharmacy never requested a re-sampling or any other follow up with Environmental Health and Safety.

A review of the bacterial and fungal air samples of the BSC and the LAFH for the Mount Zion Ida Friend Infusion Center dated 02/05/2010 indicated "any colony forming units detected on a volumetric air plate ...must be identified to at least the genus level [identifying the type of bacteria]."

During an interview on 10/21/10 at 11:00 am the Infection Control Hospital Epidemiologist stated that bacteria were not commonly found in the air. She also stated that air flow would be needed in order for bacteria to be found in the air. According to her there were cases where Staphylococcus Aureus (a type of pathogenic bacteria) had been found in filters down stream from the air flow. She acknowledged the possibility that bacteria found in the BSC and LAFH in the Mt Zion Ida Friend Clinic could be in the filters. She said that infection control was never consulted and she was not aware of the elevated bacterial and fungal levels found in the BSC and LAFH at the clinic. She acknowledged that bacteria found in the air flow could blow onto medications being prepared in the BSC and LAFH.

Review of the Horizontal Flow Hood Product Preparation Logs indicated the LAFH in the Ida Friend Clinic an estimated five thousand compounded medications were prepared between 02/05/10 to 10/21/10.

Review of the Antineoplastic Preparation and Product Check Logs indicated the BSC in the Ida Friend Clinic an estimated seven thousand compounded medications were prepared between 02/05/10 to 10/21/10.

In total up to an estimated 12,000 medications over 253 day period were compounded in a bacterial and fungal contaminated environment for immunocompromised patient population.

2. According to the United States Pharmaceopedia 797 Pharmaceutical Compounding (USP 797) page 3713 under the entitled section Action Levels, Documentation, and Data Evaluation indicates "Regardless of the number of CFU identified in the pharmacy, further corrective actions will be dictated by the identification of microorganisms recovered (at least the genus level) by an appropriate credentialed laboratory of any microbial bioburden captured as a CFU using an impaction air sampler [referring to taking bacterial and fungal air samples]. Highly pathogenic microorganisms (e.g., Gram-negative rods, coagulase positive staphylococcus, molds and yeasts) can be potentially fatal to patients receiving CSPs [compounded sterile products] and must be immediately remedied, regardless of CFU count "

A review of the bacterial and fungal air samples documents for sterile compounding hoods indicated "any colony forming units detected on a volumetric air plate ...must be identified to at least the genus level [identifying the type of bacteria/fungus]. "

A review of the bacterial and fungal air sampling of the sterile compounding areas the documents indicated the date sampled, the area sampled, and the CFU counts. The following are the test results:
Date and Results of Bacterial Sampling
07/08/09
M39M hood South CFU-2
M39M work table CFU-1
M39M work counter CFU-5
12/09/09
By Mt. Z 5th E Hood CFU-12
By Mt Z. A002 NW hood CFU-3
IVAS Non Chemo S Table CFU-1
IVAS Non Chemo N Table CFU-1
IVAS Chemo by E hood CFU-1
02/03/10
L487 work counter by hood CFU-94
L487 work counter by door CFU-53
02/05/10
Mt Z H5310 east hood CFU-18
Mt Z H5310 west hood CFU-33
02/08/10
ACC515 by hood CFU-3
ACC515 by isolator CFU-14
02/09/10
Mt Z A002 work table West CFU-1
Mt Z A002 work table East CFU-1
M39J by East hood CFU-1
M39J by West hood CFU-6
Date and Results of Fungal Sampling
02/05/10
Mt Z H5310 east hood CFU-1
Mt Z H5310 west hood CFU-2
02/08/10
ACC515 by hood CFU-7
02/09/10
Mt Z A002 work table West CFU-2
Mt Z A002 work table East CFU-1

The hospital did not provide evidence that any of the sampled areas that had grown out bacterial or fungal colonies were identified at least to the genus level. The hospital failed to evaluate the significance of the bacterial and fungal colonies.

3. According to the hospital policy entitled Medication Error Reporting and Evaluation approved on July 2008 indicates "Medication Error: any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer."

According to the Centers for Disease Control and Prevention website, a nationally recognized health information resource indicates "Asthma is a disease that affects your lungs. It causes repeated episodes of wheezing, breathlessness, chest tightness, and nighttime or early morning coughing ...In 2004, approximately 255,000 people worldwide died of asthma ...In 2007 a CDC study showed 34 million people had been diagnosed with asthma during their lifetime, 12.3 million had experienced an asthma attack in the previous year."

3a. A review of the clinical record indicated Patient 68 was a 60 years old and had a history of asthma and cardiac arrhythmias. She had physician's orders for Advair Diskus 250mcg/50mcg 1 puff twice daily for asthma.

It was observed on 10/12/10 at 3:41 pm Patient 68's Advair had 2.5 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 2.5 days). The dispense date on the label indicated the Advair was dispensed on 10/08/10 which meant that 3-4 days of Advair should have been administered.

A review of the Medication Administration Record (MAR) indicated that from 10/08/10 through 10/12/10 the nurses documented that they had administered 3.5 days of Advair.

The above indicated that 1 day (2 doses) of Advair (calculated as 3.5 days minus 2.5 days) were not administered over a 3.5 day period for Patient 68.

3b. A review of the clinical record indicated Patient 72 was a 38 years old and had a history of asthma. She had physician's orders for Advair Diskus 150mcg/50mcg 1 puff twice daily for asthma.

It was observed on 10/13/10 at 12:20 pm Patient 72's Advair had 2.5 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 2.5 days). The dispense date on the label indicated that Advair inhaler was dispensed on 10/10/10 which meant that 3 days of Advair should have been administered.

A review of the Medication Administration Record (MAR) indicated that from 10/10/10 through 10/13/10 the nurses documented that they had administered 3 days of Advair.

The above indicated that 0.5 day (1 dose) of Advair (calculated as 3 days minus 2.5 days) was not administered for Patient 72 over a 3 day period.

According to the National Heart Lung and Blood Institute online, a nationally recognized health care resource, indicates "COPD [Chronic Obstructive Pulmonary Disease], 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."

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."

3c. A review of the clinical record indicated Patient 73 was 89 years old and had a history of COPD. She had physician's orders for Advair Diskus 500mcg/50mcg 1 puff twice daily for COPD.

It was observed on 10/13/10 at 1:10 pm Patient 73's Advair had 6.5 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 6.5 days). The dispense date on the label indicated that Advair was dispensed on 10/08/10 which meant that 3-4 days of Advair should have been administered.

A review of the Medication Administration Record (MAR) indicated that from 10/08/10 through 10/13/10 the nurses documented that they had administered 3.5 days of Advair.

The above indicated that an extra 3 days (6 doses) of Advair (calculated as 6.5 days minus 3.5 days) were administered for Patient 73 over a 3.5 day period.

3d. A review of the clinical record indicated Patient 69 was a 71 years old and had a history of severe COPD and had been admitted to the hospital multiple times for severe COPD exasperation. He had physician's orders for Advair Diskus 500mcg/50mcg 1 puff twice daily and Spiriva 18mcg daily for COPD.

It was observed on 10/13/10 at 11:47 am Patient 69's Advair had 7.5 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 7.5 days). The dispense date on the label indicated the Advair was dispensed on 10/06/10 which meant that 7 days of Advair should have been administered.

A review of the Medication Administration Record (MAR) indicated that from 10/08/10 through 10/12/10 the nurses documented that they had administered 7 days of Advair.

The above indicated that an extra 0.5 day (1 dose) of Advair (calculated as 7.5 days minus 7 days) was administered for patient 69 over a 7 day period.

3e. According to the hospital policy entitled Medication Management: Administration of Medication dated 04/08 indicates "Medications that are ordered as Routine are available for administration within 4 hours of being written ...Administration of the medication will follow ...The next Standard Administration time ...BID ...Standard Medication Administration Times 0900, 2100 "

A review of the clinical record indicated Patient 69 was a 71 years old and had a history of severe COPD and had been admitted to the hospital multiple times for severe COPD exasperation. He had physician's orders for Advair Diskus 500mcg/50mcg 1 puff twice daily and Spiriva 18mcg daily for COPD.

A review of Patient 69's physician's orders was written on 10/06/10 at 12:15 am for Advair Diskus 500mcg/50mcg 1 puff twice daily for asthma. The pharmacy dispense record indicated that the pharmacy dispensed "stat" Advair on 10/06/10 at 9:08 am. The Medication Administration Record (MAR) indicated that the first dose was given at 10/06/10 at 9:45 pm.

Based on the policy Patient 69 should have been administered his first dose of Advair at 9:00 am. The dose was administered at 9:45 pm. The dose was late by over 12 hours.

4. According to the hospital nursing policy entitled Peripheral Intravenous Catheter Insertion and Maintenance indicates "The keep open rate (KVO) is 10ml/hour in pediatrics and 30ml/hour in adults unless otherwise ordered."

A review of a clinical record indicated Patient 74 was 40 years old and was admitted for procedure in the ambulatory surgery center. Patient 74 had physician's orders for Lactated Ringer at 30 ml/hour (KVO).

A review of the Surgery Center Post Anesthesia Care Unit (PACU) documented that Patient 74 received 100 ml/hour. The rate was more then three times the physician ordered rate.

A review of a clinical record indicated Patient 75 was 14 years old and was admitted for procedure in the ambulatory surgery center. Patient 75 had physician's orders for Lactated Ringer at 50 ml/hour.

A review of the Post Anesthesia Care Unit Flowsheet documented that Patient 75 received 37 ml/hour. The rate was less then 50 ml/hour as ordered by the physician.

During an interview on 10/14/10 at 2:02 pm both Nurse 30 and Nurse 31 stated they did not count drops and did not use intravenous pumps to administer intravenous infusions. They both stated they estimate the rate of the intravenous infusions by "eye balling it " . They acknowledged that estimating the rate was not accurate and may contribute to adverse outcomes (i.e. patients with edema, or antibiotic infusions such as Vancomycin).

5. According to the American Society of Health Systems Pharmacists, a nationally recognized professional organization, in the entitled document ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals section Medication Distribution and Control indicates "The pharmacy shall be responsible for the procurement, distribution, and control of all drug products used in the hospital ...for inpatient and ambulatory patients."

During an interview on 10/14/10 at 11:59 am Pharmacist 9 stated that there were unaccounted medications in the automated dispensing cabinets (dispensing medication machine). She also stated the pharmacy did not always investigate or identify the causes for missing and extra medications found in the automated dispensing cabinets (ADC). She acknowledged that Pharmacy was responsible for control for all medications administered within the hospital.

A review of a discrepancy report for non-narcotic medications in the ADCs with matrix open drawers indicated a report of the quantity of unaccounted for medications (missing and extra doses) for a one day audit from 10/13/10 to 10/14/10. The total unaccounted number of doses for one day was 79 missing or extra doses of medications.

The interviewed Pharmacist 9 on 10/14/10 at 11:59 pm stated that the ADC drawers were matrix drawers (drawers with open pockets). The nurses could accidently take the wrong medication, give extra, or not give the medications which would cause medication errors. When patients are given too much medication, not administered medication or given the wrong medication these types of medication errors could cause significant harm and/or death. The Pharmacist 9 acknowledged that these unaccounted medications should be investigated.



26985


6. The fentanyl patch is a narcotic (opioid) pain medicine applied to the skin. It contains fentanyl, a very potent narcotic pain medicine. According to the FDA's required boxed warning on the labeling (the strongest warning that the FDA requires), fentanyl patches 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. Because serious or fatal respiratory depression could occur when used in patients who are not opiate tolerant.

According to the boxed warning, fentanyl patches should ONLY be used in patients who are already receiving opioid therapy, who have demonstrated opioid tolerance, and who require a total daily dose at least equivalent to fentanyl 25 microgram per hours (mcg/hr). 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 an equianalgesic dose of another opioid. Fentanyl patches are not indicated for the treatment of acute pain.

Due to numerous reports of adverse events with Fentanyl Patches, including fatalities, caused by inappropriate prescribing, dispensing, and administration of the drug, The Food and Drug Administration (FDA) issued a public advisory containing important safety information about using fentanyl transdermal patches, "Deaths and overdoses have occurred, and the directions for the use of this medication must be followed exactly to prevent death or serious side effects."

During interview on 10/15/10 at 1 p.m., the director of pharmacy (DOP) said the hospital did not have a specific, pharmacy and therapeutics (P&T) committee approved, policy and procedure for the use of fentanyl patches. DOP said the hospital followed the manufacturer's package insert regarding the use of fentanyl patches throughout the hospital.

Patient 59's record review on 10/19/10 at 12: 37 p.m., in the company of the director of pharmacy (DOP) and the unit's assistant patient care manager (RN 17) showed the following:

Patient was 59 years old with a history of gastrointestinal disease and abdominal pain. On 10/13/10 at 1:35 p.m., Patient 59 presented to the emergency department with complaints of worsening abdominal/flank pain for one week. The hospital admitted Patient 59 for assessment and management of pain and vomiting. Patient 59 was Cantonese speaking and required a translator for communication.

On 10/15/10, Patient 59 had orders for a fentanyl patch 12 (micrograms per hour) mcg/hr.
On 10/15/10, a physician's order clarified that patient was opioid tolerant and had tried patch in the past.

On 10/15/10 a pharmacist documented that the prescribing physician had indicated the following,"Verified that patient was on 12.5 mcg/hr patch prior to admission" or
"Verified that patient is opioid tolerant and receiving 30 mg of intravenous morphine of opioids daily"

An admission history and physical (H&P), dated 10/13/10, showed that Patient 59's only pain medication at home was Norco (hydrocodone 10 mg/acetaminophen 500 mg) every 4 hours as needed. The admissions History and Physical (H&P) did not indicate how much Norco patient 59 had been using.

Hospital records showed that Patient 59 had been discharged in August 2010 with orders for fentanyl patch.

During interview on 10/19/10 at 12:55 p.m., DOP stated that the pharmacists were to review the appropriateness of the fentanyl patch orders and dose, based on an evaluation of the patient's pain medications prior and during to admission. The pharmacists were expected to document their evaluation on the pharmacy's computer system. DOP said the pharmacists would normally rely on obtaining a current list of medications from patients' outpatient pharmacies in order to complete medication reconciliation. DOP said for Patient 59, the pharmacist was not able to obtain a list of Patient 59's outpatient medications, because his pharmacy had not faxed the list. DOP added, in cases where the pharmacists could not obtain a list of medications prior to admission from the patients' outpatient pharmacy, they would rely on the physicians or previous admission discharge medications to obtain the patient's medication history. DOP said the pharmacist had relied on Patient 59's discharge medication orders on 8/31/10, which included fentanyl patches. DOP and RN 17 could not provide an explanation for the discrepancy between the admissions H&P and the physician's clarification and the previous discharge orders.

During interview on 10/19/19 at 1:50 p.m., using an interpreter (Cantonese speaking clinical informatics nurse--RN 2) and in the presence of a staff pharmacist (Pharm 4), Patient 59 said he had not been using the fentanyl patch prior to admission for pain. Patient 59 said he had been taking one Norco per day to manage his pain for the past month and a half. Patient 59 said he had only used the patch once during his previous hospitalization in August, but not at home.

During interview on 10/19/10 at 2:00 p.m., Pharm 4 said it seemed that the pharmacy staff had not interviewed Patient 59 to clarify the history of narcotic pain medication use prior to admission.

During interview on 10/19/10 at 1 p.m., DOP said patients would have to meet the criteria for opiate tolerance, as defined in the manufacturer's instructions, the equivalent of 60 mg of oral morphine for seven day in order to be initiated on the fentanyl 12 mcg/hr patch. DOP said the hospital did not have a policy or procedure regarding initiating patients on fentanyl 12 mcg/hr patches.

Based on history of narcotic use over the seven days prior to the initiation of the fentanyl patch on 10/15/10, Patient 59 does not meet the criteria for opiate tolerance. Patient 59 was hospitalized for two days prior to initiation of the patch. On 10/13/10, Patient 59 received a total of morphine 8 mg intravenously (IV). On 10/14/10, Patient 59 received a total of morphine 10 mg IV. On 10/15/10, prior to initiation of the patch at 3:20 p.m., Patient 59 received a total of morphine 4 mg IV. His opiate usage prior to admission of one Norco tablet by mouth (contains 10 mg of hydrocodone which is equivalent to 10 mg of morphine) does not meet the definition of opiate tolerance of at least 60 mg of oral morphine or 10 mg of IV morphine daily for seven days.

According to the manufacturer's package insert, the efficacy of fentanyl patch 12 mcg/hr as an initiating dose has not been determined. In addition, patients who are not opioid-tolerant have experienced hypoventilation and death during use of fentanyl patches. Therefore, fentanyl patches should be used only in patients who are opioid-tolerant.

DOP provided a document dated 9/7/07 and titled "The Dose" (a staff newsletter). The document showed:
The following guidelines should be used when initiating a fentanyl patch: "Patient is opioid tolerant, for at least 1 week, of 60 mg morphine oral or equianalgesic dose of another oral or intravenous opioid. Every fentanyl patch order reviewed and processed will require proper documentation in the pharmacy computer system. Please document verification of review for all fentanyl patches in two locations 1. instructions field 2. note section."

The hospital's 2008 P&T approved guidelines for the initiation and titration of the fentanyl transdermal patch in hospitalized patients indicated that the fentanyl transdermal patch should only be ordered for patients with prolonged pain and a total daily doses of oral morphine 60 mg daily for greater than 1 week before initiating therapy.

During interview on 10/12/10 at 11:40 a.m., a staff pharmacist (Pharm 8) said she would follow the hospital's fentanyl patch policy to make sure patients met the criteria. When asked if patients did not meet the criteria and the prescriber was adamant about using the fentanyl patch, she said she would document that she communicated to the prescriber and tell him/her to best start with a low dose.

During interview on 10/13/10 at 2:30, a staff pharmacist (Pharm 1) could not say what the definition of opiate tolerance was and could not easily locate hospital guidance.

During interview on 10/15/10 at 12:40 p.m., the pain management pharmacist (Pharm 5) said she would ensure the appropriate use of fentanyl patches by making sure patients are opiate tolerant. Pharm 5 said, the procedure at the hospital was to use the last 24 hours of narcotic utilization to determine the appropriate fentanyl dose conversion.

During interview on 10/19/10 at 12:40 p.m., Pharm 4 could not say for how long a patient had to be on the equivalent of 60 mg of oral morphine prior to meeting the criteria for opiate tolerance, as defined in the fentanyl patch manufacturer's package insert.

During interview on 10/20/10, the second year medical resident (MD 1) who had prescribed the fentanyl patch for Patient 59 said she determined opiate tolerance based on a patient's response to opiates during the "last couple of days of therapy", patient's response to pain and side effects. MD 1 was not familiar with the fentanyl patch manufacturer's criteria for opiate tolerance and initiation of fentanyl patches. MD 1 said she was not familiar with the FDA's boxed warning regarding fentanyl patches. MD 1 said she relied on the pharmacists to provide information and guidance regarding boxed warnings.

DOP provided a document titled "Medication Use Evaluation/Fentanyl Transdermal Patch" and dated 5/27/10. Review of the document on 10/21/10 showed the following conclusions:
"There is room for improvement of appropriate patient selection ..."
"Use of an order form may help facilitate prescribing for the fentanyl patch"

According to the Institute for Safe Medication Practice (WWW.ISMP.ORG), "Despite warnings from the FDA, manufacturers, and various patient safety agencies, fentanyl transdermal patches continue to be prescribed inappropriately to treat acute pain in opiate-naive patients... Unfortunately, pharmacists have often filled these prescriptions without question, and nurses caring for patients have applied the patches without recognizing the prescribing error."

ISMP's Fentanyl Patch safe practice recommendations include the following:"Creating specific prescribing and dispensing guidelines"

"Determining the indication: Pharmacists should determine the indication and ensure that the patient is opiate-tolerant and suffering from chronic pain before dispensing the medication.. Verification of the indication and any conversations with the prescriber regarding the patient and the prescribed medication should be documented in a consistent place."

7. Review of the hospital's policy titled, "Medication Administration (General)/Part I Medication Order Processing)", reviewed/revised 4/08, showed the following,
"When the order is unclear, questionable or incomplete, the RN or pharmacist must
clarify the order with the prescribing physician/provider prior to administering the medication." The policy also indicated that orders must contain an indication for as needed orders.

Review of the hospital's policy titled, "Opioid Mediation-management of range orders (general)", reviewed/revised 3/07, showed that the hospital allowed for

Based on observations and interviews the hospital failed to ensure that outdated and mislabeled medications were not available for patient use, as evidenced by the presence of expired or mislabeled insulin (used to lower blood sugars) in one patient care unit. This failure had the potential to expose patients to expired and ineffective insulin, thereby exacerbating their disease states.

Findings:

During medication storage inspection in the tenth floor cardiovascular thoracic unit medication room, on 10/12/10 at 4:30 p.m., in the company of the educator nurse (RN 1), the unit's assistant patient care manager (RN 10) and the unit's charge nurse (RN 11), the unit's un-refrigerated pharmacy delivery box contained a patient specific vial of Lantus Insulin. Lantus Insulin is a once a day, long acting insulin that works for 24 hours to lower blood sugars. The vial had a dispense date of 10/12/10 and an expiration date of 12/9/10, 60 days expiration.

During interview on 10/12/10 at 4:30 p.m., RN 11 said the pharmacy had delivered the Lantus Insulin and it would be stored at room temperature in the patient's medication cassette. When asked, RN 11 could not say whether 60 days expiration was accurate for Lantus Insulin at room temperature.

According to the manufacturer's package insert, un-refrigerated Lantus Insulin vials expire 28 days after removal from the refrigerator. ()

During interview on 10/14/10 at 10:15 a.m., the director of pharmacy (DOP) said that according to hospital policy, all insulin vials expire 28 days after removal from the refrigerator. DOP said the mislabeled, 60-day expiration date, on the Lantus Insulin was an oversight on the part of the pharmacist who had checked and released the Lantus Insulin.

During interview on 10/12/10 at 4:35 p.m., RN 10 said the unit stores all insulin at room temperature, either in patient specific medication cassettes or in the unit's automated dispensing cabinet. During inspection, the unit's automated dispensing cabinet contained three vials of Humulin Regular Insulin. Regular insulin is a fast acting insulin used to quickly lower blood sugars during urgent situations. One vial did not have any dates indicating when it had been removed from the refrigerator or when it would expire. The two other vials had a sticker with two dates 9/15 (on top of the sticker) and 9/13 (on the bottom of the sticker). RN 10 and RN 11 could not provide an explanation for the dates on the sticker or determine whether the vials had expired.

During interview on 10/12/10 at 4:45 p.m., a staff pharmacist (Pharm 2) said the top date indicated the date removed from the refrigerator and the bottom date would indicate the expiration date. Pharm 2 explained that upon removing vials of insulin from the pharmacy refrigerators for distribution to patient care units, pharmacy staff would apply a sticker on each vial of insulin to indicate the date removed from the refrigerator and the expiration date. Pharm 2 said, most types of insulin would expire 28 days after removal from the refrigerators. Pharm 2 said the three vials should not be used, since their expiration could not be determined.

During interview on 10/14/10 at 10:15 a.m., DOP explained that upon removing insulin vials from pharmacy refrigerators for distribution to the units, a sticker should be placed on the vials indicating the removal date from the refrigerator and the expiration date. DOP explained that pharmacy staff use a date stamper to generate the dated stickers. She added that at times the dates set on the stamper are accidentally changed or the stickers fall off. DOP added that pharmacists are required to check the vials and stickers to ensure the presence and accuracy of the dates prior to distribution to the units.

Based on observation, interview, and record review, the facility failed to ensure that its staff were knowledgeable regarding appropriate locations to stand during intraoperative radiation therapy (IORT). The deficient practice had the potential to increase staff members' exposure to radiation.

Findings:

Review of the Radiation Protection Survey Report for Operating Room 11 (OR11) dated 2/7/98 indicated that during IORT at one setting of the portable linear accelerator, the door between the scrub room L491 and OR11 was a controlled location because the expected dosage of leaking X-rays from OR11 at the door would exceed 2 millirem (millirem is a unit of measurement of radiation doses) per hour and 100 millirem per year. The report concluded, "Prior to treatment the surgical team will move from OR-11 to the scrub room. People will be prohibited from standing near the Scrub room door."

In an observation and interview on 10/19/10 at 1:39 p.m., scrub room L491 had a door with a window leading to OR11. A scrub sink was located to the right of the door between L491 and OR11. A glass window above the scrub sink was obstructed with boxes of surgical masks. Once the boxes of masks were moved, OR11 could be seen through the window above the scrub sink. Staff F stated that the anesthesiologist could stand at the door between scrub room L491 and OR11 and look through the window to monitor the patient during IORT. Staff G stated that it was "OK to stand by the door " between the scrub room and OR11.

Based on observation, interview, and record review, the facility failed to provide adequate radiation shielding to staff when they allowed a lead apron that was worn and frayed to remain in use in the ambulatory surgery center.

Findings:

During a tour of the ASC (ambulatory surgery center) on 10/13/10 at 3:25 p.m., there was a lead apron (Number AS15) that was torn and frayed on the right shoulder and hanging by a few threads. The Patient Care Manager of the ASC (RN 25) who was present stated that the radiology department checks the aprons on an annual basis and the last check was in August or September of this year. The Patient Care Manager looked at the apron and said "It's well worn at the shoulder".

A review of the radiology inspection log on 10/20/10 at 10:05 a.m., showed the apron was last inspected on 9/22/10. The names of six radiology staff members were printed on the inspection log but the area for staff signature was blank. There was no signature to indicate which staff member had inspected the apron.

On 10/20/10 at 1:53 p.m., the chief technologist of diagnostic radiology was interviewed and stated all the lead aprons are inspected on an annual basis by two radiology technologists who sign the inspection log. He stated the annual inspection consists of a visual and physical inspection, any apron that fails that inspection is sent for a fluoroscopy inspection. When asked about the apron that was frayed and torn on the right shoulder, he said the technologists should have noticed it was torn and sent the apron for repair.

Based on observation, interview, and record review, the facility failed to do a periodic inspection of equipment when Radiology Services did not do the annual preventive maintenance check that was due on Sept. 2010 on 3 C-arm and 3 video monitors in the operating room. A C-arm machine is an imaging device which uses X-rays and produces a live image feed which is displayed on a TV screen.

Findings:

During a tour of the Operating Room at Mt. Zion Hospital on 10/15/10 at 11:10 AM, 3 C-arm X-ray machines and 3 video monitors were found in one of the rooms used as a storage area. The three video monitors and one of the C-arm machines had a green clinical engineering sticker that said maintenance was due on Sept. 2010. The green sticker on the other two C-arms could not be found.

During an interview with the Patient Care Manager of Perioperative Services on 10/15/10 at 11:20 AM, she stated that each video monitor was used for each C-arm machine so all C-arm machines were probably due for maintenance check on Sept. 2010 also.

During an interview with the Clinical Engineering staff on 10/15/10 at 11:30 AM, he acknowledged that the C-arms and video monitors were due for maintenance check and that Radiology Department was responsible for maintenance of the radiology equipment.

Review of facility policy and procedure titled, "Radiology Equipment Management Program" revised on 8/2008 indicated that, "It is the policy of the Department of Radiology to conduct inspections of all x-ray equipment to evaluate mechanical and electrical safety factors; and to monitor the same equipment to insure that the patients and employees are appropriately protected from unnecessary exposure to radiation and injury...

All x-ray equipment is also inspected at least once a year for radiation safety integrity by a radiation safety inspector..."

Based on interview and record review, the facility failed to ensure that its agreement with an outside blood collecting agency require that the blood collecting establishment notify the hospital when the following occurs:
1. Within three calendar days if the blood collecting establishment supplied blood and blood components collected from a donor who tested negative at the time of donation but tests reactive for evidence of HIV or HCV infection on a later donation or who is determined to be at increased risk for transmitting HIV or HCV infection;
2. Within 45 days of the test, of the results of the supplemental (additional, more specific) test for HIV or HCV infection;
3. Within three calendar days after the blood collecting establishment supplied blood and blood components collected from an infectious donor, whenever records are available, as set forth at 21 CFR 610.48(b)(3).

Findings:

On 10/20/10, the facility's agreement with an outside blood collecting agency was reviewed with the Licensure and Certification Coordinator (Admin 2). The agreement indicated the following under Supplements to Agreement:

(Name of blood collecting agency), shall notify Hospitals immediately upon discovery that (name of blood collecting agency), has delivered potentially infectious blood or blood product units.

The agreement did not specify the timelines and circumstances for when the outside blood collecting agency would notify the hospital in the event it supplied blood and blood components collected from an infectious donor to the hospital.

The Licensure and Certification Coordinator acknowledged the agreement did not meet the regulatory requirement and stated "I don't see it there."

Based on observation, interview, and document review the hospital failed to ensure that dietary services met the needs of all patients as evidenced by failure to:
1. Provide organized dietetic services as evidenced by findings of unsafe food handling practices and supervision of the dietary department (A620).
2. Ensure the availability of organized dietary services that are directed and staffed by adequate qualified personnel (A622).
3. Ensure comprehensive disaster planning (A701)
4. Develop performance improvement activities that reflected the scope and nature of the services (A264).
5. Ensure safe and effective food storage/production practices (A749)
6. Ensure the development of comprehensive policies and procedures that reflected the scope and nature of services (A 619, A620, A749)

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

Based on dietetic services observations, dietary management staff (DMS)interview, and dietary document review, the hospital failed to ensure the department was organized in a manner that would ensure safe food handling practices. Failure to implement safe food handling practices may result in food borne illness, further compromising patient's medical status.

Findings:

1. During comprehensive review of the hospital's food service systems it was noted that dietary management staff failed to ensure an organized food and nutrition department that included safe food handling practices as evidenced by observed deficient practices related to unsafe storage of refrigerated uncooked and raw meats, poultry and fish in various forms (whole muscle or ground) foods; time/temperature control of potentially hazardous foods; effective sanitation of food production equipment (Cross Reference 749); and implementation of an effective system to monitor the expiration of beverages (Cross Reference 620).

Review of hospital document titled "Departmental Policy & Procedure Manual-Nutrition & Food Services" dated 9/24/10 revealed that while the department had policies and procedures related to purchasing and storeroom, the food production, dish machine operation and catering policies were addressed in general terms. It did not reflect the scope and complexity of departmental operations and did not adequately guide staff on procedures according to standards of practice. It was also noted that the table of contents of the policy and procedure manual listed specific policies related to safe food handling practices. However, the policies were not cross-referenced in the manual as listed.

During an interview on 10/12/10 at 3:30 p.m. DMS A acknowledged that although the manual had been revised and the table of contents renumbered, the corresponding update of cross-references within individual policies were incorrect. DMS A was asked to find policies and procedures related to infection control through safe refrigerated storage times of various forms (whole muscle such as roasts, whole birds, or ground) of meats, poultry and fish once they were taken out of the freezer, or if delivered fresh. He stated the manual had just recently been approved and was complete. After reviewing the manual, he acknowledged that the policies and procedures addressing this topic were not present. When asked if the safe food storage guidance might be anywhere else, DMS A responded "No, it would be here if we had it."

Based on food production observations, dietary staff interview, and dietary document review, the hospital failed to ensure the Dietary Management Staff (DMS) provided effective oversight into food services as evidenced by 1) lack of effective system to ensure the safety of raw, thawed meats, poultry and fish; 2) lack of effective cool down monitoring of potentially hazardous foods (PHF); 3) lack of an air gap in food production sinks; 4) lack of an effective system to ensure time/temperature control for potentially hazardous foods in refrigeration; 5) failure to ensure ice machines were sanitized.

Findings:

1. At 12:00 p.m. on 10/12/10 during an interview regarding preventive maintenance (including cleaning and sanitizing) of the new Manitowoc ice maker and existing Manitowoc ice bin in the kitchen, Refrigeration Specialist K provided the product "Nu Calgon liquid ice machine cleaner as the product he use to clean the ice machine bin with. He stated the sanitizer he used is "somewhere in the shop" and on 10/14/10 hospital administrative staff provided the powder product "Follet ice machine cleaner".

Review of the Manitowoc bin cleaning and sanitizing directions revealed the manufacturer required 3 ounces of Manitowoc ice machine cleaner diluted in one gallon of warm water, then rinsed with fresh water and sanitized with Manitowoc sanitizer one ounce in four gallons of water. Information provided on the package of Follet ice machine cleaner revealed it is not a sanitizer.

2. During general food storage observation and dietary staff interview on 10/12/10 beginning at 11:30 am, it was noted that the hospital did not have an effective system to ensure that all Potetiallt Hazardous Foods (PHFs) that were cooked and held for later use were monitored for time/temperature control during cool down (Cross Reference 749). PHFs are defined as those foods requiring time/temperature control for food safety to limit pathogenic growth of microorganisms or toxin formation. PHFs are described as " ...a plant or animal food that is heat treated ... " (Food Code, 2009).

In an interview on 10/12/10 at 11:45 am, the surveyor asked DMS H to describe the items that dietary staff typically monitored for cool down. He stated that the staffs' "main focus was protein foods" such as meats. He also stated that dietary staff did not monitor the cool down of pastas because staff ran cold water over it after it was drained.

Review of hospital document titled "Departmental Policy & Procedure Manual-Nutrition and Food Services", dated 9/24/10 revealed there were no policies guiding staff on procedures for ensuring safe food handling practices for potentially hazardous foods (PHFs). Review on 10/15/10 of hospital document dated 8/2007 and titled "Leftover Food" revealed the goal of the policy was to "identify the proper use of leftover foods"; however, there was no guidance on the types of foods that would fall into this category or ensuring time/temperature control during the cool down process of PHFs.

3. During food storage observations on 10/13/10 at 4 pm, in the cafeteria, it was noted that the hospital did not have a system to effectively measure time/temperature control of refrigerated PHFs in the cafeteria (Cross Reference 749). Also noted were multiple packages of sushi in a refrigerator dated 10/12 with a use by date of 10/13. The internal temperature of the sushi was noted to be 47?F. The surveyor asked Dieatary Staff (DS) E to describe how the hospital ensured the food remained under time/temperature control. She stated that on a daily basis hospital staff recorded the temperature of the unit. The surveyor asked DS E if the hospital evaluated the food temperatures for any of the cold items. She stated that they only monitored temperatures of hot foods at the time they were put on the steam table. She acknowledged there was no temperature monitoring of cold food items.

Review of hospital document titled "Departmental Policy & Procedure Manual-Nutrition and Food Services", dated 9/24/10 revealed there were no policies guiding staff on procedures for ensuring safe food handling practices for potentially hazardous foods (PHFs). Hospital document titled "Food Temperatures" dated 8/07 guided staff that food temperatures were to be taken prior to the start of cafeteria service by the cafe supervisor. It was also noted the policy addressed only the temperatures of hot food items. The policy did not address holding temperature of cold food items.

4. During general food production observations and concurrent dietary staff interview on 10/12/10 at 12:50 pm, it was noted that dietary staff were not following an effective sanitation method of large steam kettles (Cross Reference 749).

Review of hospital document titled "Departmental Policy & Procedure Manual-Nutrition and Food Services", dated 9/24/10 revealed there were no policies guiding staff on the proper methods for ware washing of in-place equipment.

The Food and Drug Administration, Food Code-2009 notes that sanitation of equipment would "include the application of sanitizing chemicals by ...manual swabbing ... " The guidance does not include rinsing the sanitizer off with water.

5 During tray line observation on 10/12/10 at 12:30 pm, it was noted that there were greater than 50, four-ounce cartons of apple, cranberry and orange juice that were not dated with an expiration date. In a concurrent interview with DS U she was asked how the facility ensured that these products were not expired. She stated that the hospital went through the products quickly enough that they didn't need to be labeled. She additionally stated that the product expiration date was 14 days after it was pulled from the freezer.

In a follow up interview on 12/10/10 with DS I at 12:30 pm, he stated that the facility ordered multiple cases each week. He also stated that he monitored the usage of all food products while concurrently attempting to demonstrate that there were only about 3 cases of the product that were in use. He further stated that these items went out only on patient trays during meal times and that if they were not consumed they were discarded. He further stated that none of these items would be stored on the nursing units for patients.

In an observation on 10/13/10 in the transitional care unit on 14North/South it was noted that there were cartons of undated, 4-ounce juice cartons in the patient refrigerator.

Review of the position description titled "Procurement Manager" revealed that it was the responsibility of DMS I to develop "all ...standards ...related to ...storage, issuing of food ...supplies ...supervises the functions ...of storage. "

6. During initial tour on 10/12/10 beginning at 10:30 am, the following was noted. In the produce refrigerator there were tomatoes with no delivery date as well as salad that was opened and exposed to air. In the freezer there was frozen lasagna that was undated and opened to air; and mixed vegetables that were opened and undated. In the cold prep refrigerator there was a product identified by Dietary Management Staff B as pesto, with no date or label and buttermilk dressing with use by date of 10/3 (8 days prior). On the shelf above the cold prep area there was a bag of peanuts with no open date. In refrigerator R-24 there were hamburger patties, opened and undated.

7. On10/12/10 during three separate observations of the refrigerators used for the Room Service food delivery to the pediatrics unit at 11:30 a.m., 12:30 p.m. and 4:40 p.m. the temperatures of the units and the foods in them were observed to be unsafe for refrigerated potentially hazardous foods. (Cross reference to A749)

On 10/14/10 beginning at 3:30 p.m. during an interview regarding Room Service, DMS B stated the service was relatively new and had been implemented to increase patient satisfaction. DMS B stated the policies and procedures for the service were in "draft" form and provided the documents. Time/temperature monitoring of refrigerated potentially hazardous foods during the meal service times 7:00 a.m.- 7:00 p.m. had not been identified as a critical control point for food safety. DMS B stated "it's a good idea to develop such a policy, we didn't think about that." She stated they relied on the routine refrigerator temperature monitoring at 6 a.m and 8 p.m. as indicators rather than the actual temperature of foods throughout the day. DMS B acknowledged the reach-in refrigerators used for Room Service were constantly being opened and closed between 7:00 a.m.-7:00 p.m.

Based on observation, interview, and document review, the hospital failed to ensure that the dietary staff was trained in safe food thawing methods.

Findings:

1. During the initial tour on 10/12/10 at 10:45 am, it was noted that Dietry Staff (DS) P was utilizing the 2 compartment sink area to place raw salmon on baking sheets. In a concurrent interview the surveyor asked DS P to describe how he would use the sink. He stated that he would use it to rinse vegetables as well as using the area to prepare meats for cooking. He additionally stated that he would use the sink to thaw meat prior to placing it on the baking trays.

In a follow up observation on 10/12/10 at 11:15 am, there was approximately 20 pounds of chicken breasts, immersed in standing water while a small stream of water was running into the sink. While it would be acceptable to thaw or rinse meat utilizing water, the acceptable method as described in the USDA Food Code 2009, Chapter 3.501.13 is "completely submerged under running water ...with sufficient water velocity to agitate and float off loose particles in an overflow ... "

Review on 12/15/10 at 9 am, of "Departmental Policy & Procedure Manual" approved 9/24/10 revealed there was no policy/procedure that guided dietary staff on the proper methodology for thawing meat products. Review on 10/14/10 of dietary departments' training records failed to document any training on proper thawing/rinsing of meats in water.

Based on observation, nursing staff interview, and medical record review, the hospital failed to ensure that two patient (Patient 70 and Patient 68) in a sample of 7 patients reviewed for nutrition care received their physician ordered nutritional intervention. Failure to provide for identified nutritional needs may further compromise patients' medical status.

Findings:

1. Patient 70 was admitted with diagnoses including persistent nausea and vomiting. Medical record review was conducted on 10/13/10 beginning at 2:30 pm. Admission diet order, dated 10/4/10, was NPO (nothing by mouth). A pharmacy document dated 10/7/10, for total parenteral nutrition (TPN-nutrition through a vein) noted the implementation of feeding at a rate of 15 cc/hour for 24 hours, increasing the rate by 20 cc every 24 hours to a goal rate of 65 cc.

Observation of Patient 70 on 10/13/10 at 3 pm, in the presence of RN 28 noted that a new TPN bag was hung on 10/12/10 at midnight, running at a rate of 65 cc/oer hour. The bag was observed to have 900 cc left. In a concurrent interview with RN 28 stated the initial volume of the bag was 1500 cc's. The surveyor asked her to describe the process how nursing staff monitored the volume of feeding. She stated that the feeding was hung at midnight the previous evening and as she checked the feeding she would make sure the rate of the feeding matched the physician's order, which was then recorded on the patient's flowsheet. She also stated that the pump being used did not have the ability to record a cumulative amount of feeding; only the current rate of flow. RN 28 was unable to explain the difference in observed feeding and recorded feedings.

Review on 10/14/10 at 9 am, of patients flowsheets for 10/12 and 10/13/10 confirmed that the bag of the TPN solution was hung 10/12/10 at midnight (2400 hours) as indicated by a small triangle written in the box labeled "TPN." It was also noted that nursing staff consistently recorded that the patient was receiving 65 cc/hour with no interruption. A feeding that was hung at midnight on 12/10 at a rate of 65 cc/hour with no interruption should have delivered a volume of 975 cc over a 15 hour period, rather than the observed 600 cc. Nursing staff was unable to explain the difference in observed feeding and recorded feedings. Registered dietitian nutrition assessment dated 10/7/10 revealed that the ordered feeding provided 1.2 calories/cc, resulting in a shortage of 450 calories during the observed 15 hour period.

2. Patient 68 was admitted with diagnoses including pancreatic cancer. Medical record review was conducted in the presence of RN 29 and RD W on 10/13/10 beginning at 12:30 pm. The admission diet order dated 10/12/10 was a cardiac, 2 gram sodium diet. Concurrent review of the hospitals diet list for 10/13/10 noted that the diet was entered as a cardiac diet rather than the physician ordered 2 gram diet.

In an interview on 10/13/10 at 12:45 pm, RN 29 and RD W were asked to describe the process for entering physician ordered diets into the electronic medical record. RN 29 proceeded to demonstrate the screen that would be used to enter the diets. It was noted that the screen had eight of the most commonly used hospital diets. She stated that nursing staff would select the diet from the list. The surveyor also asked her to demonstrate how a combination diet would be entered. RN 29 attempted to enter a 2-gram, cardiac diet. It was noted that the electronic medical record would allow the entry of only one of the diet restrictions. RD W stated that there was an empty field in the diet section of the electronic medical record that allowed staff to enter multiple diet orders. RD W also stated that the cardiac diet was a 3 gram sodium, low fat diet. RN 29 also acknowledged that Patient 68 did not get the physician ordered diet and that she was unaware of the limitations of the diet order screen.

Based on interview and document review, the hospital failed to ensure a detailed written menu with food inventory that could be implemented during a disaster that required the hospital to be self sufficient.

Findings:

On 10/14/10 beginning at 12:30 p.m. Dietary Management Staff (DMS) A and DMS B discussed the disaster menu and plan and provided Policy 09.100.01 Emergency Management Plan, revised December 2009. Review of the plan revealed "planning considerations" for a menu; however, there was no detailed written menu that included foods/corresponding inventory for patients on therapeutic diets and tube feedings. Ready-to-eat meals were included in the plan, but location at the two campuses did not reflect an implementation plan. DMS A and DMS B acknowledged a detailed written menu and corresponding inventory to provide for patients and staff had not been developed.

Based on observation and interview, the facility failed to maintain adequate facilities for its services when there was no hand washing sink and eye wash station in the decontamination area of the ASC and no hand washing sink in the decontamination area of the orthopedic institute. This had the potential to expose staff and patients to an unsafe environment that could be a source of infection and cross contamination and could cause serious injury to the eyes of staff members who worked in the decontamination areas.

Findings:

1. During an observation on 10/14/10 at 11:20 a.m., there were two sinks in the decontamination area of the ASC. SPDT 1(sterile processing department technician) was asked which sink was used as a hand washing sink. SPDT 1 stated there was no hand washing sink as both of the sinks were used to wash instruments. He stated staff used hand sanitizer after removing PPE (personal protective equipment). Prior to leaving the decontamination area, SPDT 1 removed his gloves and washed his hands in the sink used to wash soiled instruments.

SPDT 1 was asked if there was an eye wash station in the decontamination area and responded there was not. When asked what he would do if chemicals used to clean the instruments splashed in his eye, he said "That's a good question; there is no eye wash station in the unit." The Patient Care Manager who was present told SPDT 1 he could rinse his eyes at the scrub sink in the corridor outside the decontamination area.

2.During a tour of the OI (orthopedic institute) on 10/18/10 at 8:45 a.m., OI RN 26 was asked which of the two sinks in the decontamination area was the hand washing sink. She responded there was no hand washing sink, that both of the sinks were used to wash soiled instruments and staff used hand sanitizer after removing their PPE or they could wash their hands outside at the scrub sinks.

The Association of periOperative Registered Nurses, or AORN, is an organization with input and liaisons including CDC (Centers for disease Control), Association for Professionals in Infection Control and Epidemiology, American College of Surgeons, American Society of Anesthesiologists and the American Association of Ambulatory Surgery Centers. The AORN position papers, standards and recommended practices are widely used not only in the perioperative clinical setting but as an authoritative guide to clarify regulatory requirements.

According to 2008 AORN Perioperative Standards and Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment, pg 421,
"These recommended practices are intended as achievable recommendations, representing what is believed to be an optimal level of practice."
Recommendation VII (pg.425)
Instruments should be decontaminated in an area separated from locations where clean activities are performed.
VII.a. Instruments should not be decontaminated in scrub or hand sinks.
Cleaning soiled instruments in a scrub or hand sink can contaminate the sink and faucet, which may also be used for clean activities (e.g. hand washing, surgical hand antisepsis).
VII.b. The decontamination area should be physically separate from clean areas and include a door. This area should contain, but not be limited to, the following equipment:
- hand washing facilities.
- eye wash station.
Hand-washing facilities are required by OSHA for use after removal of personal protective equipment (PPE).
An eye wash station is required by OSHA when chemicals such as those used to clean instruments are used.
The facility's policy Cleaning and Decontamination of Instruments was reviewed and indicated the following:
Purpose
To control potential spread of cross infection all instruments used during patient care, diagnostic or surgical procedures are considered contaminated and require decontamination in the reprocessing cycle for reuse. Both staff and patients must be protected from these unknown and invisible pathogens. All contaminated items and instruments are conducted under recommended guidelines and standards.
Procedure
A. Decontam Dress Code
1. f. Note: On leaving the "dirty" area for any reason, gloves and waterproof gown are removed. Hands must be washed thoroughly using antibacterial hand soap before leaving, and the hair cover should be discarded.

Based on observation, interview, and record review, the facility failed to:
1. Ensure therapy equipment received routine preventative maintenance in the pediatric gym and the pediatric outpatient therapies departments.

2. Follow their policy and procedure for cleaning autoclaves when during inspection of the operating room on 10/15/10, there were no documented evidence of monthly cleaning of the chambers of 7 of 7 sterilizers (A sterilizer or an autoclave is a device to sterilize equipment and supplies by subjecting them to high pressure saturated steam at 121 degrees centigrade or more, typically for 15-20 minutes depending on the size of the load). The facility had 5 gallons containers of chamber cleaning solutions that were expired and the facility did not have any chamber solutions in stock for use to replace the expired cleaning solutions.


Findings:

1a. During observation of the pediatric gym on 10/14/10 at 1:30 PM, while accompanied by the Assistant Director of Therapies (ADT), there were two high-low mats and an electric parallel bars with maintenance due stickers dated 6/2010.

In concurrent interview, the ADT said that the clinical engineering department was responsible for routine maintenance of the equipment.

1b. During observation of the pediatric outpatient therapies department on 10/15/10 at approximately 11 AM, while accompanied by the ADT, there was a high-low mat and an examination table with maintenance due stickers dated 9/2010.

In concurrent interview, the ADT said that the clinical engineering department had put the maintenance dates in their database tracking system and were responsible for follow-up. This was a change from their previous system, in which the therapies department notified the clinical engineering department when maintenance of the equipment was due.


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2. During a tour with concurrent interview on 10/15/10 at 11:40 AM in the OR (Operating Room) storage area Room B332, there were several plastic gallon containers of cleaning solutions stored on a shelf under the table. One container was a disinfectant solution, another container was a glass and hard surface cleaner, and a third container was a citrus-based degreaser for floor cleaning. There were also 5 one gallon containers of partially used chamber cleaning solutions used for cleaning the chambers of the sterilizers. One of the chamber cleaning solutions had an expiration date of 12/18/05. The expiration dates on the other 4 chamber cleaning solutions were smudged over and no longer readable. The Manager of the Peri-operative Services stated that she would remove all 5 chamber cleaning solutions that were outdated and unreadable expiration dates.

During an interview with the Assistant Manager of the Sterile Processing Department on 10/15/10 at 1:20 PM, the surveyor asked who was responsible for cleaning the autoclaves. He stated that Sterile Processing staff brings the chamber cleaning solution to the Operating Room but the OR staff was responsible for periodic cleaning the chambers of the sterilizers. He acknowledged that the facility was currently out of stock of the chamber cleaning solutions so that there was no supply to replace the expired solutions in the Operating Room.

On 10/15/10 at 2:15PM, The Patient Care Manager of the Perioperative Services was interviewed again. She stated that the sterile processing staff was responsible for cleaning the chamber of the autoclaves, not the OR staff. She acknowledged that there was a misunderstanding of whose responsibility it was to clean the sterilizer and how often it was suppose to be cleaned. She did not know when was the last time the chambers were cleaned. She confirmed that there was no tracking log for maintenance and cleaning of the 7 sterilizers in the Operating Room.

Review of the facility policy and procedure titled SPD (Sterile Processing Department) Procedures Manual: Sterilizer Cleaning dated 3/07 indicated that, "The following equipment is cleaned monthly to ensure proper function and prevent buildup of contaminants: 1. high vacuum steam sterilizers 2. washer/decontaminators 3. Pass through washers 4. steris sterilizers 5. sterrad low plasma sterilizer. Ensure cleaning of all sterilizers by SPD Employees in the following locations: sterile processing department, substerile rooms in the operating rooms and the ambulatory surgery centers. ... Thoroughly scrub the entire inside surface (walls, rear panel, the floor and the inside of the door) with the chamber cleaning solution. Stubborn stains or marks on stainless steel can be cleaned using a non-abrasive cleaning paste..."

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

1. Develop and implement safe food storage and food preparation systems to avoid sources and transmission of infections as evidenced by:

a. Failure to provide safe/effective dietetic services as evidenced by findings of unsafe food storage and handling practices that resulted in immediate jeopardy to the health and safety of the patients (A749).

b. Failure to provide a hospital wide infection control program to conduct effective surveillance that would prevent the transmission of food borne infections in the dietary department (Cross Reference A 749)


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2a. Contain hazardous pharmaceutical waste within a closed biohazard receptacle on unit 6-long.

During unit observation of 6-long on 10/12/10 at 11:30 AM, while accompanied by the Clinical Nurse Specialist (RN 23), there was a black hazardous waste bin that was overflowing with used intravenous (IV) medication bags and tubing hanging over the edge and down the side. The lid that was designed to snap in place on the bin was propped open by the IV medications bags and tubing. Next to it was a blue bin that was also overflowing with IV bags and tubing that propped the lid open. Behind the black bin was an empty blue bin.

Posted nearby on the wall were guidelines to the use of the bins. It identified waste to be placed in the blue bins as non-hazardous pharmaceutical waste as including syringes, insulin pens, IV bags, vials, tablets and pills. Designated to be placed in the black bin was hazardous pharmaceutical waste that included: anesthetics, bulk/partial chemotherapy medications, hormones/steroids, immunosuppressants, and anticoagulation medications. There were phone numbers to be called for disposal listed at the bottom of the posted guidelines.

When concurrently interviewed, RN 23 said the bins were routinely changed once a day and observed there was an extra empty blue bin available.

2b. Ensure cleanliness of a patient food freezer on unit 7-long.

During observation of unit 7-long mid-day on 10/12/10, while accompanied by the Unit Manager (RN 22), there was a side by side refrigerator freezer in the storage room that was used for patient food. The inner door of the freezer had a red spill that was refrozen from the top of the door to a midway shelf and on to a plastic bag of frozen waffles. The bottom shelf of the freezer was coated in a pinkish-red frozen spill. There was no thermometer in the freezer.

When concurrently interviewed, RN 22 identified the red substance as popsicle, and said the freezer should have been cleaned. He said temperatures of the refrigerator were monitored by probe to a hospital wide system, but acknowledged there was no thermometer or probe in the freezer.


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3a. Ensure the cleanliness of the ice machine and one of two food refrigerators on the 13 th floor ICU, in accordance with hospital policies

During unit inspection, on the 13 th floor intensive care unit (ICU), on 10/12/10 between 2:30 and 3:30 p.m.., in the company of the educator nurse (RN 1), 13 th floor ICU assistant patient care manager 1 (RN 13) and ICU 13 th floor assistant patient care manager 2 (RN 14), the 13 th floor ICU North patient food refrigerator (a dorm style refrigerator) had a dry, beige colored, crusted spill across the bottom grill. An ice machine located on the counter above the refrigerator was dripping steadily into the ice machine's drain. The drain had multiple black spots and accumulated water. During interview on 10/13/10 at 3:25 p.m., RN 14 said the ice machine and the refrigerator should be cleaned daily by the housekeeping staff.

Inspection of the 13 th floor ICU North food refrigerator and ice machine on 10/19/10 at 3 p.m., in the company of RN 13, RN 14 and an ICU clinical nurse III (RN 12) showed that the ICU North patient food refrigerator had the same dry, beige colored, crusted spill across the bottom grill. The ice machine was dripping steadily into the ice machine's drain. The drain had multiple black spots and accumulated water. During interview on 10/19/10 at 3 p.m., when asked about what the black spots, RN 12 said, "If this was at my house, I would think it's mold." RN 14 said that they had requested repair of the dripping ice machine many times.

A cleaning log attached to the refrigerator showed the following instructions, "Twice daily the refrigerator is to be cleaned by FSA (Food Service Assistant), as assigned in each nursing unit." The log showed daily (except for weekends) staff initial entries for morning and evening shifts, and check marks in the comments column. The log had initials for morning and evening shifts on 10/12, 10/13, 10/18. The log initials for 10/19 morning shift indicating that the refrigerator had been cleaned. The log had a revised date of 8/25/10.

During interview on 10/19/10 at 3:15 p.m., a patient support assistant (PSA) responsible for ICU 13 north, said she had initialed the log in the mornings. PSA said that she does not clean the refrigerator. PSA said the refrigerator cleaning has to occur at night due the busy morning schedule. PSA said that she would clean the ice machine if she had time. PSA said most of the time it is too busy in the morning to clean the ice machine.

Review of the hospital's policy titled, "Temperature Monitoring of Refrigerators, Freezers, and Blanket/Fluid Warmers", Policy 6.06.13/last approved in 12/2007, indicated the following,
"Patient Support Assistants (PSA) on each nursing unit are responsible for cleaning refrigerators in their assigned area once each week or more frequently if there are spills"

Review of the hospital's policy titled, "Hospitality Services Cleaning Procedures Ice Machine", issued 9/2009, indicated that daily and as needed the hospitality staff would clean the grill, other surfaces and top of the ice machines with disinfectant.

3b. Ensure that the temperature of two out of two patient food refrigerators on the 13 th floor ICU was recorded and maintained in accordance with hospital policies


During unit inspection, on the 13 th floor intensive care unit (ICU), on 10/12/10 between 2:30 and 3:30 P.M.., in the company of the educator nurse (RN 1), and two 13 th floor ICU assistant patient care managers (RN 13 and RN 14), the East patient food refrigerator (a dorm style refrigerator) temperature was 22.5 degrees Celsius ( C ), according to the thermometer display attached to the outside of the refrigerator. The thermometer had a probe that was located inside the refrigerator.

Review of the hospital's policy titled, "Temperature Monitoring of Refrigerators, Freezers, and Blanket/Fluid Warmers", Policy 6.06.13/last approved in 12/2007, showed that food refrigerator temperatures should be maintained between 35-41 Fahrenheit (F) or 2-5 Celsius ( C ).

Review of the 13 th floor ICU East patient food refrigerator temperature log showed the following,
October 2010: temperature range 19.1 to 21 (no units recorded on the log)
September 2010: temperature range 19.1 to 25.6 (no units recorded on the log)
August 2010: temperature range 19.6 to 40.1 (no units recorded on the log)

The logs did not contain any explanations or documentation of actions taken regarding the out of range temperatures. The temperature log indicated the following for out of range temperatures: "notify supervisor, document action taken and hospital building management and Nutrition and Food Services."

During interview on 10/12/10, at 2:45 p.m., the hospital's refrigeration supervisor examined the thermometer and the refrigerator in the surveyor's presence and stated that the thermometer was set to read the ambient room temperature rather than the temperature of the refrigerator. Upon resetting the thermometer to read the temperature inside the refrigerator, the thermometer displayed a refrigerator temperature of 5.8 C.

On 10/12/10 at 3:23 p.m., the 13 th floor ICU North patient food refrigerator thermometer indicated that the temperature was 21 C. When the hospital's refrigeration supervisor reset the thermometer to read the temperature inside the refrigerator, the thermometer displayed a refrigerator temperature of 7.2 C.

Review of the 13 th floor ICU North patient food refrigerator temperature log showed the following,
October 2010: temperature range 19.7 to 21.4 (no units recorded on the log)
September 2010: temperature range 19.9 to 21.6 (no units recorded on the log)
August 2010: temperature range 19.5 to 23.6 (no units recorded on the log)

The logs did not contain any explanations or documentation of actions taken regarding the out of range temperatures.

During interview on 10/12/10 at 3:00 p.m., RN 14 said the Patient Care Assistants are responsible for recording refrigerator temperatures and the unit managers and assistant managers are responsible for reviewing the logs. RN 13 and RN 14 could not provide any explanation for the lack of action regarding the ongoing out of range food refrigerator temperatures.

On 10/19/10 at 3:00 p.m., in the company of RN 13 and RN 14, the 13 th floor ICU North patient food refrigerator thermometer, showed a temperature of 20.4 C. RN 13 said the thermometer was set to read the ambient temperature instead of the refrigerator temperature. Review of the refrigerator log showed recorded temperatures for 10/13 and 10/18 to range between 20.1 and 40.4 (no units recorded on the log). The log contained the following entries, "Food refrigerator out of range". The log did not provide any explanations or documentation of actions taken regarding the out of range temperatures. .

Review of the hospital's policy titled, "Temperature Monitoring of Refrigerators, Freezers, and Blanket/Fluid Warmers", Policy 6.06.13/last approved in 12/2007 indicated that temperatures must be checked and logged daily and must fall within appropriate ranges. Additionally, if temperatures fall outside the acceptable range, a supervisor must be notified at the earliest opportunity should be reset to the appropriate level. Furthermore, the policy indicated the following, "Indicated on temperature record who was called and by whom."

During interview on 10/19/10 at 3:15 p.m., RN 14 said it was the responsibility of the unit's assistant managers to review refrigerator temperatures and to take appropriate action if the temperatures are out of range. During the same interview, a registered dietician with the hospital's dietary management (Staff A) stated that the food refrigerator temperatures were recorded wirelessly (Aware Point). Staff A stated that the system was to go live in November. Staff A provided a graph of the temperatures of the 13 th floor ICU north patient food refrigerator showing that the average temperature was within range between 10/4 and 10/18. The hospital did not provide a policy regarding wireless monitoring of refrigerator temperatures. The hospital's policy titled, "Temperature Monitoring of Refrigerators, Freezers, and Blanket/Fluid Warmers " , Policy 6.06.13/last approved in 12/2007, did not address wireless temperature monitoring.

3c. Ensure the cleanliness of the specimen refrigerator on the 13 th floor ICU.

During unit inspection, on the 13 th floor intensive care unit (ICU), on 10/12/10 at 3 p.m., in the company of the educator nurse (RN 1), 13 th floor ICU assistant patient care manager 1 (RN 13) and ICU 13 th floor assistant patient care manager 2 (RN 14), the 13 th floor ICU specimen refrigerator had multiple blotches and splashes of dry brown stains on the bottom shelf. During interview on 10/12/10 at 3 p.m., RN 14 said the refrigerator should be cleaned. RN 14 did not know which department would be responsible for cleaning the specimen refrigerator.

These failures had the potential to expose critically ill, intensive care unit patients to an unnecessary risk for infections.

The cumulative effect of these systemic problems resulted in the hospital's failure to meet statutorily mandated compliance with the Condition of Participation for Infection Control.

1. Based on refrigerated food storage observations for various forms (whole muscle and ground) of raw meats, poultry and fish, dietary staff interview, and dietary document review, the hospital failed to ensure comprehensive systems to minimize the risk of food borne illness as evidenced by the lack of an effective system to store refrigerated meats, poultry and fish.

The inability of the hospital to provide safe/effective dietetic services as evidenced by findings of unsafe food handling practices from receipt to production resulted in an immediate jeopardy to the health and safety of the patients.

This resulted in the notification of hospital administrative staff of an Immediate Jeopardy (IJ) situation on 10/13/10 at 11:00 a.m. Administrative staff was notified that the IJ was abated at 2:50 p.m. on 10/18/10.

Additionally, based on observation, interview, and record review, the hospital failed to:

2.Sanitize ice machines, and failed to follow safe cool down of potentially hazardous foods, and failed to monitor time temperature of refrigerated foods held for cafeteria and room service menus, and failed to develop and implement safe and sanitary food handling methods.

3a. Implement its Hand Hygiene policy when an operating room technician was observed wiping down a table he had removed from the operating room while wearing gloves, removing his gloves and not washing or sanitizing his hands and when a physician wearing gloves was observed positioning a patient and equipment and then using the telephone while wearing the same gloves.
3b. Develop a policy for the transportation of contaminated surgical instruments in the ASC which resulted in an operating room technician transporting uncovered contaminated surgical instruments from the operating room to the decontamination area.
3c. Provide a hand washing sink in the decontamination area of the ASC and the Orthopedic Institute

4. Implement its policies for infection control testing and immunization of physicians and staff when:
? 7 of 11 sampled physician files had no evidence of hepatitis B vaccination or immunity and there was no declination statement;
? 2 of 11 sampled physician files had no evidence of a skin test (PPD) to identify exposure to tuberculosis (a highly contagious disease);
? 1 of 20 sampled employee files had no evidence of hepatitis B vaccination or immunity, and there was no declination statement.

5. Develop a system for identifying, investigating, and controlling infections as evidence by:

a. The hospital infection control failed to develop and implement a plan to resolve elevated bacterial and fungal levels found in sterile compounding hoods which resulted in staff compounding in contaminated hoods for an immunocompromised patient population for an estimated 12,000 medications over a 253 day period.
b. The hospital infection control failed to evaluate the significance of the bacterial and fungal colonies sampled in sterile compounding areas when colony forming units were sampled and the bacteria and fungus were not further identified.


Findings:

1. On 10/12/10 at 10:15 a.m. at the commencement of the initial tour of the kitchen with surveyor and Dietary Management Staff (DMS) A, DMS A revealed the hospital policy was to label all refrigerated foods with a "Use by" date. During general kitchen observations between 10:15 a.m. to 11:15 a.m., the following was observed:

In refrigerator #3

a. Two 10-pound boxes of thawed, cooked Chicken Breast Strips, manufacturer's label "Keep Frozen." Shipping date from vender was 10/8/10. Facility label added "Use by 10/19/10." Dietary Management Staff (DMS) A stated he did not know when the product had been thawed.
b. Harbor Banks brand fishes, 150 pounds of: catfish filets, tilapia filets, and Koho salmon fillets, all thawed fully. Vendor shipping dates on the boxes were 9/30/10, 10/4/10, and 10/8/10, and all boxes with manufacturer's label "Keep Frozen." Facility label added "Use by 10/18/10." DMS A stated he did not know when the product had been thawed.
c. Three cases 20 pounds each of thawed diced beef. One case with a sticker "10/5" and all three with facility label "Use by 10/19/10." DMS A stated the product had been received on 10/5. He stated he did not know when the product had been thawed.
d. Ground grayish meat, unlabeled, in plastic sealed wrap, with dark reddish liquid in bottom of bag, with facility label: "Use by 10/19/10." During concurrent interview, DMS A stated the food was ground pork. During an interview at 2:00 p.m. DMS A stated the ground item was actually beef, when he observed the contents of a box on a lower shelf which had same packaging and was reddish color. DMS A stated he did not know when the grayish meat had been thawed.
e. Two boxes of thawed Ground beef, each with four five-pound pieces of meat in sealed plastic. Delivery date of 9/29. Facility label "Use by 10/19/10." DMS A stated he did not know how long the meat had been thawed. DMS A stated he did not know when the product had been thawed.
f. 40 pounds Jones Sausage in 10-pound boxes, delivered 10/4. No use by date.
g. 17 raw turkey breasts, approximately 19 pounds each, thawed, undated with facility label "Use by 10/19." DMS A stated he did not know when the product had been thawed.
h. Tyson raw chicken thigh meat 160 pounds, delivered 9/30, Manufacturer's label "Keep Frozen", facility label "Use by 10/19." DMS A stated he did not know when the product had been thawed.
i. Tyson Boneless raw thighs delivery date 10/4/10, manufacturer's label "Keep Frozen" and facility label "Use by 10/18." DMS A stated he did not know when the product had been thawed.
j. Three 20 pound brown boxes of thawed, raw ground turkey, manufacturer's label "Keep Frozen" and facility label "Use by 10/19." DMS A stated he did not know when the product had been thawed.
k. Two undated, unlabeled approximately 20 pound pieces of raw, thawed beef roast with facility label "Use by 10/19." DMS A stated he did not know when the product had been thawed.
l. Approximately 70 pounds raw, unlabeled, undated fish with what appeared to be assorted dry herbs on it which DMS A stated was "seasoned salmon" with facility label "Use by 10/19." The fish was in plain brown boxes with no vendor labeling. DMS A stated he did not know how long the product had been thawed.
m. Koch brand cooked chicken breast strips "Keep Frozen" facility label "Use by 10/19."
n. Three approximately 10-pound pieces unlabeled whole muscle beef, raw, thawed, with facility label "Use by 10/19." DMS A stated he did not know when the product had been thawed.
During an interview at 3:30 p.m. DMS A stated the facility followed "HACCP" (Hazard Analysis Critical Control Points) for food storage procedures. When asked by the surveyor how the facility "Use by" dates were determined for the meats, poultry and fish items observed, DMS A referred to the hospital Food and Nutrition policies and procedures. Review of Food Preparation, Storage policy 05.530.11 revealed the facility had not: a) developed a comprehensive food labeling policy to encompass the wide array of foods on the menus, b) provided guidance to staff regarding labeling protein foods that were required by manufacturer's to be frozen, c) determined thaw times for the foods once taken out of the freezer, and d) did not know length of time to safely store meats, poultry, and fish in various forms (ground or whole muscle) once thawed. The United States Department of Agriculture guidelines for thawed ground meats and ground poultry and fish are 1-2 days under refrigeration, and 3-5 days for whole cuts of meat and poultry. When asked if any storage guidelines would be anywhere else for department staff to use, DMS A replied "No." The United States department of Agriculture (USDA) guidelines for thawed ground meats and ground poultry and fish are 1-2 days under refrigeration, and 3-4 days for whole cuts of meat and poultry.

This resulted in the notification of the facility administrative team including the Chief Nursing Officer, Chief Administrative Officer, Assistant Director of Patient Food Services and Associate Director of Nutrition Services, of an Immediate Jeopardy (IJ) situation on 10/13/10 at 11 AM.

The facility submitted an acceptable plan of correction on 10/18/10 at 2:50 PM. The POC included: 1. a policy and procedure with specific guidance as to how meats, fish, and poultry in various forms was to be dated ahen received, taken out of the freezer to thaw, and use by date based on USDA guidelines, 2. a kitchen staff in-service plan to train staff in the new labeling system, 3. an inventory system of removing protein foods from the freezer storage based on the menu, and storing the needed foods in separate locations based on date needed, and 4. testing of staff competencies and procedures.

The Chief Administrative Officer was informed that the IJ was lifted on 10/18/10 at 2:50 PM.

2a. At 11:30 a.m. on 10/12/10, meal preparation activities were observed in the "Blue Room," where during a concurrent interview, DMS A stated "We serve all the pediatric units all day room service from here. 7 a.m.- 7 p.m.: We don't stop".

Refrigerator 1 temperature was observed to be 44 degrees F (Fahrenheit) and contained assorted, undated Ardmore Farms 4 ounce juices: orange juice, apple, and cranberry, milk and yogurt. DMS A stated "I can't tell you when they (the juices) were thawed." Manufacturer's guidelines for this product revealed they are to be stored frozen, and have a 14 day refrigerated shelf life.

Refrigerator 2 temperature was 57 degrees F. and contained sandwiches, including labeled as turkey, peanut butter, as well as salads and desserts. No food items had preparation times listed. An interview with Dietary Management Staff (DMS)B revealed the refrigerators were in constant use and re-stocked as needed throughout the day.

At 11:40 a.m. Dietary Staff (DS) R stated she made sandwiches for the blue room as they were needed, but did not note the time they were prepared as part of the label. DS R provided the production document "Cold Food" dated 10/12/10 that revealed TK (turkey) Sandwich prepared at "5:55" was 38 degrees. Time of lunch meal preparation was not noted.

At 12:35 p.m. the temperature in Refrigerator 1 was observed to be 46 degrees and Refrigerator 2 was 61 degrees F. Dietary Staff S was asked to take the temperature of foods in each of the refrigerators. Refrigerator 1 had milk that was 46 degrees F and Crystal low fat yogurt was 45 degrees F. Refrigerator 2 turkey sandwich was 61 degrees F and chocolate mousse was 58 degrees. DS S calibrated his thermometer at that time and insured the temperature taken was accurate.

!t 12:40 p.m. DS S stated all refrigerator temperatures were monitored twice a day: at 6 am and 8 p.m. He provided the document PFS Refrigeration Temperature Log that indicated Refrigerator 1 was noted be at 40 degrees at 6:00 a.m. that morning and refrigerator 2 was 38 degrees at 6:00 a.m.

At 4:20 p.m. observations of refrigerators 1 and 2 were again made. Refrigerator 1 was 53 degrees and contained milk that was 45 degrees, a turkey sandwich that was 53 degrees and a cottage cheese and fruit plate that was 50 degrees. Refrigerator 2 was "not in use because it's not working" per DS S.

On 10/13/10 during review of hospital policy, Food Preparation, Storage, last revises August 2007, directed "Perishable foods are stored in the appropriate refrigerators and maintained at safe temperatures. Dairy, meat and all other refrigeration temperatures are 41 degrees F or lower."

2b. At 12:00 p.m. on 10/12/10 during an interview regarding the new ice maker and existing ice bin in the kitchen, the refrigerator man provided the product Nu Calgon liquid ice machine cleaner as the product he cleans the ice machine bin with. He stated the sanitizer is "somewhere in the shop" and on 10/14/10 hospital administrative staff provided the powder product "Follet ice machine cleaner". Review of the bin cleaning and sanitizing directions revealed the manufacturer required 3 ounces of Manitowoc ice machine cleaner diluted in one gallon of warm water, then rinsed with fresh water and sanitized with Manitowoc sanitizer one ounce in four gallons of water. Follet ice machine cleaner is not a sanitizer.

2c. At 12:14 a.m. DS T was observed making salads. The sink in the room where he was working had the drain disconnected. DS stated "they just did that." When asked where he would wash produce, DS took the surveyor to the cook's prep sink adjacent to the room where he worked. He stated "I would wash it here unless it's dirty and then I would go there (DS T walked over and pointed to the hand wash sink in the deli area). Hand wash sinks may only be used for handwashing per the 2009 Food Code.

2d. During the initial tour on 10/12/10 at 10:45 am, it was noted that there was no air gap in the 2-compartment sink adjacent to the cold production food area, rather the sink drained directly into the waste water system. In a concurrent interview with DS D, he was asked to describe the use of the sink. He stated that he would use it if he needed to rinse items such as tomatoes prior to cutting them. In a follow up observation DS P he was observed utilizing the sink area to place raw salmon on baking sheets. In a concurrent interview the surveyor asked DS P to describe how he would use the sink. He stated that he would use it to rinse vegetables as well as using the area to prepare meats for cooking. He additionally stated that he would use the sink to thaw meat prior to placing it on the baking trays

In a follow up observation on 10/12/10 at 11:15 am, there was approximately 20 pounds of chicken breasts, immersed in standing water in the sink. Food that is to be thawed in water must be immersed in cold running water according to the 2009 Food Code.

The purpose of an air gap is to prevent waster water back flow into food production sinks (Food Code, 2009).

2e. During general food production observations on 10/12/10 beginning at 11:20 am, DS X was preparing cooked vegetables. He was observed placing a steam pan on top of a colander that was placed on the floor, above a trough-like drain that was covered with a metal grate. After placing the pan in the colander he was observed running hot water from the steam kettle over the vegetables. It was also noted that water was splashing back onto the vegetables. In a concurrent interview with DS X he stated that this was his usual practice. He also stated that the purpose of placing them on the floor was to run hot water over the frozen vegetables to get the ice crystals off of them prior to steaming them. It was also noted that DMS B and DMS H observed this practice; however neither intervened. A follow up observation on 10/12/10 beginning at 11:50 am, revealed that DS Q followed the same process.

In a follow up interview with DMS B she acknowledged that this likely was not a method that would ensure sanitation food preparation. She also stated that recipes the hospitals ' recipes would guide staff on preparation methods.

Review on 10/14/10 of undated dietary department recipe titled "P-Vegetable, Mix, Malibu, Fzn" did not guide staff to run hot water from the steam kettle over them prior to cooking. Review of hospital document titled "Departmental Policy & Procedure Manual-Nutrition and Food Services", dated 9/24/10 revealed there were no policies guiding staff on procedures for preparing vegetables.

2f. During general food storage observations on 10/12/10 at 11:30 am, in refrigerator R-10 it was noted that there was a piece of cooked roast beef measuring 7-8 pounds dated 10/10. In a concurrent interview with DMS H he stated the hospital practice was to cook larger cuts of meats that would be utilized over the ensuing three days for patient meal service. It was also noted there were an additional 2 pans of various types of pasta that were cooked on 10/8 for a use by date of 10/11, all of which would be considered to be potentially hazardous foods (PHFs). PHFs are defined as those foods requiring time/temperature control for food safety to limit pathogenic growth of microorganisms or toxin formation. PHFs are described as " ...a plant food that is heat treated ... " (Food Code, 2009).

In an interview on 10/12/10 at 11:45 am, with Dietary Staff Q he was asked to describe how the facility ensured the food was safe to use at ensuing meals. He stated that when he cooked items he would place them in the blast chiller and monitor the temperature of the foods which would be documented on a cool down log. Concurrent review of the cool down log revealed that there was no temperature monitoring for the observed pastas or the cooked roast beef.

In an interview on 10/12/10 at 11:45 am, the surveyor asked DMS H to describe the items that dietary staff typically monitored for cool down. He stated that the staffs "main focus was protein foods" such as meats. He also stated that dietary staff did not monitor the cool down of pastas because staff ran cold water over it after it was drained.

In a follow up observation on 10/12/10 at 12:50 pm it was noted that DS P was placing sliced beef in a metal holding pan. In a concurrent interview the surveyor asked him where the meat came from. DS P stated that he got the meat from the cook's refrigerator which was designated by DMS H as R-10. He further stated the meat was for the evening patient meals. There was no indication that DMS H removed the observed meat that was not monitored for time/temperature control during the cool down process.

Review of hospital document titled "Departmental Policy & Procedure Manual-Nutrition and Food Services", dated 9/24/10 revealed there were no policies guiding staff on procedures for ensuring safe food handling practices for potentially hazardous foods (PHFs). Review on 10/15/10 of hospital document dated 8/2007 and titled "Leftover Food" revealed the goal of the policy was to "identify the proper use of leftover foods"; however there was no guidance on ensuring time/temperature control during the cool down process of PHFs.

Review of position description titled "Executive Chef" and dated March 2003 revealed that it was the responsibility of this position to "Develop, enforce and maintain operational standards for ...production procedures."

2g. During food storage observations on 10/13/10 at 4 pm, in the cafeteria, it was noted that there were multiple packages of sushi in a refrigerator dated 10/12 with a use by date of 10/13. The internal temperature of the sushi was noted to be 47?F. The internal thermometer of the refrigerator was noted to be 40?F. In a concurrent interview with DMS C and DS E they stated that the items dated 10/12 were obtained from an outside vendor the day before directly into the cafeteria refrigerator. They also stated that the vendor delivered the product on a daily basis and would remove the items that were expired. The surveyor asked DS E to describe how the hospital ensured the food remained under time/temperature control. She stated that on a daily basis hospital staff recorded the temperature of the unit. The surveyor asked DS E if the hospital evaluated the food temperatures for any of the cold items. She stated that they only monitored temperatures of hot foods at the time they were put on the steam table. She acknowledged there was temperature monitoring of cold food items.

Review of hospital document titled "Departmental Policy & Procedure Manual-Nutrition and Food Services" , dated 9/24/10 revealed there were no policies guiding staff on procedures for ensuring safe food handling practices for potentially hazardous foods (PHFs). Hospital document titled "Food Temperatures" dated 8/07 guided staff that food temperatures were to be taken prior to the start of cafeteria service by the cafe supervisor. It was also noted the policy addressed only the temperatures of hot food items. The policy did not address holding temperature of cold food items.

2h. During food storage observations on 10/12/10 at 11:45 am, in refrigerator-10 it was noted that dietary staff was storing raw bacon above cooked deli meats. It was also noted that staff was storing raw chicken next to cooked roast beef. In a concurrent interview with DMS H he acknowledged that this was not the proper storage method. He further stated that staff was expected to store cooked foods above raw foods and that all raw foods should be stored on the bottom shelf.

2i. During general food production observations on 10/12/10 at 12:50 pm, it was noted that dietary staff was cooking foods in large, non-removable steam kettles. In a concurrent interview with DS J he stated these kettles were used to cook items such as soups and pastas. The surveyor asked him to describe how the kettles would be cleaned. He stated that after food was cooked he would wash, rinse then sanitize the equipment by wiping a surface sanitizer on the equipment. He also stated that his final step would be to rinse the sanitizer off.

The Food and Drug Administration, Food Code-2009 notes that sanitation of equipment would "include the application of sanitizing chemicals by ...manual swabbing ..." The guidance does not include rinsing the sanitizer off with water.

Review of hospital document titled "Departmental Policy & Procedure Manual-Nutrition and Food Services", dated 9/24/10 revealed there were no policies guiding staff on the proper methods for ware washing of in-place equipment.

2j. During general unit observation on 10/12/10 at 2:30 pm in the 13th floor intensive care unit it was noted that the ice machine had a black, slime like substance in the drain area resembling mold. During general unit observation on 10/13/10 at 3:50 pm in the pantry area of unit 9L it was noted that the ice machine was completely enclosed behind sheet metal plating and was not observable.

In an observation and concurrent interview on 10/14/10 at 11:50 am, with RS K he was asked open up the fully enclosed unit on 9L and describe the process for cleaning the ice machines. It was noted that there was a build up of grey particles resembling dust on the condenser of the enclosed unit. RS K stated that he inspects the machines every 3 months. He further stated the inspection included a visual inspection of the filter and the condenser. He also stated he would clean the machine if he thought it needed it. The surveyor asked him to describe the parameters that would be used to determine if the machine required cleaning. He stated that it would evaluate whether or not it needed cleaning based on how it was producing ice, "if it's slow." He also stated that the ice machine would be removed from the unit for the cleaning process 1 or 2 times/year. The surveyor also asked him to describe the cleaning process. He stated that he would pour an ice machine cleaner (an ice machine cleaning powder mixed with water) into the pump of the machine and allow it to circulate. The surveyor also asked if he ever cleaned the ice holding bin. He stated that he would usually wash it out with hot water. RS K stated that there were 2 or 3 different brands of ice machines on the hospital campus and all of them operated in a similar fashion. He further stated that there were a total of 40-50 ice machines.

Review of the undated hospital document titled "Ice Machine Semi-Annual PM-Refrig. Mech." guided staff to disinfect per manufacturers specification using calgon ice machine cleaner. Review of manufacturer's specifications provided the following guidance. With respect the dispenser grill and drain pain the manufacturer recommended to clean and sanitize these areas on a weekly basis using a manufacturer recommended solution as well as bleach followed by a hot water flush. With respect to the internal components the manufacturer recommended a monthly condenser cleaning using a vacuum cleaner or stiff brush. Additionally the preventive maintenance instructions recommended a quarterly cleaning of the ice making components followed by a sanitation step. Additionally the instructions recommended a sanitation step of the ice storage hopper utilizing a sanitizing solution. While the hospital was utilizing an ice machine cleaner on an as needed basis, there was no sanitation of the ice producing mechanism or the ice storage hopper.

2k. During general unit observation on 10/13/10 at 3:50 pm in the pantry area of unit 9L it was noted that the ice machine was completely enclosed behind sheet metal plating and was not observable.

In an observation and concurrent interview on 10/14/10 at 11:50 am, with RS K he was asked open up the fully enclosed unit on 9L. Once the unit was opened it was noted there was no observed air gap for the condensation line associated with the ice machine. RS K was asked to describe the installation of the machine. He stated that to his knowledge the condensation line was installed in the space between the walls and drained into a small pipe in the floor and acknowledged that visualization or verification of the installation process was not possible as it was fully enclosed. RS K also stated that he estimated there were 5 additional ice machines in the hospital units that were installed in a similar fashion.

Proper installation of an ice machine would include an air gap to protect from cross contamination from a non-potable water supply such as the waste water system (Food Code, 2009).

On 10/13/10 beginning at 4:05 p.m. Infection Control Practitioner O was interviewed regarding how food and nutrition services were monitored as part of the hospital wide infection control program. ICP O stated "We don't do that because we don't have any expertise. We defer to the University and they have an environmentalist that does monitoring twice a year. We haven't had any problems." ICP O provided minutes of the infection control committee from that included a 5/27/10 report from Food and Nutrition Services on "Food Safety Inspection Report Summary." The report included a single page checklist of an inspection of the Moffitt Cafeteria that had been completed in 30 minutes.


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3a. In the ASC on 10/13/10 at 2:55 p.m., ORT 1 (operating room technician) was observed pushing a wheeled table down a corridor from the operating room to the decontamination area. There was a tray of uncovered soiled surgical instruments on top of the table. While wearing gloves, ORT 1 carried the tray of instruments into the decontamination area and proceeded to wipe down the table he had used to transport the instruments. He removed his gloves and wheeled the table back to the operating room without washing or sanitizing his hands.

The Patient Care Manager of the ASC (RN 25) who was present stated he would expect to see ORT 1 wash or sanitize his hands after he removed his gloves. He also stated that staff usually covers soiled instruments with a drape before transporting them from the operating room to the decontamination area.

On 10/14/10 at 11:50 a.m., MD 3 was observed helping to position a patient and equipment in the operating room of the ASC while wearing gloves. MD 3 then proceeded to use the telephone while wearing the same gloves.
The facility's hand Hygiene policy was reviewed and indicated the following:

I. Purpose
Effective hand hygiene removes transient microorganisms, dirt and organic material from hands and decreases the risk of cross contamination from patients, patient care equipment and the environment.
Hand hygiene is the single most important strategy to reduce the risk of transmitting organisms from one person to another or from one site to another on the same patient. Cleaning hands promptly and thoroughly between patient contact and after contact with blood, body fluids, secretions, excretions, equipment and potentially contaminated surfaces is an important strategy for preventing healthcare-associated infections.

III. Procedures

When to clean hands: All students, staff and faculty having direct patient care will clean hands at the following times:

Before and after patient contact, including dry skin contact.

After removing gloves.

8) After handling equipment, supplies, or linen contaminated with body substances.

3b. On 10/19/10 at 1:30 p.m., the facility's policy Cleaning and Decontamination of Instruments was reviewed with RN 25 and Admin.1. The policy indicated the following under Soiled Surgical Instrumentation:

1. End of Surgical Procedure

a. Surgical team member transports the soiled instrument case cart to OR decontamination area as soon as possible to begin the cleaning process.

RN 25 stated this was a hospital wide policy but did not apply to the ASC as they did not use case carts to transport soiled instruments from the operating room to the decontamination area. He said staff in the ASC usually covered the instruments with the drape from the back table in the operating room and wheeled the instruments to the decontamination area. Admin.1 acknowledged the policy did not address the transport of soiled surgical instruments in the ASC and stated the policy would be updated.

According to 2008 AORN Perioperative Standards and Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment: (pg 424)

Recommendation VI

Contaminated instruments must be contained during transport and should be transported in a timely manner to a location designed for decontamination.

Proper containment of instruments decreases the potential for injury to personnel or their exposure to infectious organisms and prevents damage to the instruments during transport.

VI a. During transport to a decontamination area, soiled instruments must be contained in a manner to prevent exposure of patients or personnel to bloodborne pathogens and other potentially infectious organisms. OSHA requires that contaminated instruments be contained in a leak-proof container to minimize the risk of exposing personnel to contaminants during transport.

VI.a.3. Items placed on top of a transport cart must be contained (e.g., plastic bag).

3c. During an observation on 10/14/10 at 11:20 a.m., there were two sinks in the decontamination area of the ASC. SPDT 1(sterile processing department technician) was asked which sink was used as a hand washing sink. SPDT 1 stated there was no hand washing sink as both of the sinks were used to wash instruments. He stated staff used hand sanitizer after removing PPE (personal protective equipment). Prior to leaving the decontamination area, SPDT 1 removed his gloves and washed his hands in the sink used to wash soiled instruments.

During a tour of the OI (orthopedic institute) on 10/18/10 at 8:45 a.m., OI RN 26 was asked which of the two sinks in the decontamination area was the hand washing sink. She responded there was no hand washing sink, that both of the sinks were used to wash soiled instruments and staff used hand sanitizer after removing their PPE or they could wash their hands outside at the scrub sinks.

According to 2008 AORN Perioperative Standards and Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment, pg 421,

"These recommended practices are intended as achievable recommendations, representing what is believed to be an optimal level of practice."

Recommendation VII (pg.425)

Instruments should be decontaminated in an area separated from locations where clean activities are performed.

VII.a. Instruments should not be decontaminated in scrub or hand sinks.

Cleaning soiled instruments in a scrub or hand sink can contaminate the sink and faucet, which may also be used for clean activities (e.g. hand washing, surgical hand antisepsis).

VII.b. The decontamination area should be physically separate from clean areas and include a door. This area should contain, but not be limited to, the following equipment: hand washing facilities.

Hand-washing facilities are required by OSHA for use after removal of personal protective equipment (PPE).

The facility's policy Cleaning and Decontamination of Instruments was reviewed and indicated the following:

Purpose

To control potential spread of cross infection all instruments used during patient care, diagnostic or surgical procedures are considered contaminated and require decontamination in the reprocessing cycle for reuse. Both staff and patients must be protected from these unknown and invisible pathogens. All contaminated items and instruments are conducted u

Based on interview and record review, the facility failed to grant specific surgical privileges based on each practitioner's documented current competence (refer to A-945), failed to conduct malignant hyperthermia drills according to national guidelines (refer to A-951), and failed to ensure that a nurse in ambulatory surgery was knowledgeable regarding the facility's surgical count procedures (refer to A-951).

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.

Based on interview and record review, the facility failed to grant specific surgical privileges for 3 of 13 sampled credentials files (Practitioners 7, 12, and 13) and failed to document each practitioner's recent experience in each of the surgical privileges granted for 5 of 13 sampled credentials files (Practitioners 4, 6, 7, 12, 13). The deficient practices created surgical privileges which were either vague or without documentation of current competence, and had the potential to allow members of the medical staff to perform procedures in which they had not had recent experience.

Findings:

Review of the facility's medical staff bylaws indicated, "The prerogatives and purposes of the Medical Staff Organization shall be ... To ensure that all Medical Staff members maintain quality in their performance of professional duties through the appropriate delineation of clinical privileges ... The applicant for appointment, reappointment, and/or clinical privileges shall have the burden of producing adequate information for a proper evaluation of his/her qualifications for membership or clinical privileges, including documentation of their general competencies regarding their experience, background, training ... Each application for appointment and reappointment to the Medical Staff must contain a request for the specific privileges desired by the applicant ... Basis for Medical Staff Member or AHP [Advanced Health Practitioner, the facility's term for mid-level practitioners] Privilege Determination: Requests shall be evaluated on the basis of the medical staff member or AHP's current clinical competence. This evaluation shall include, but is not limited to: ...Assessing the medical staff member or AHP's education, training, experience, demonstrated professional competence ... and evidence of physical ability to perform requested privileges ... performance of a sufficient number of procedures each year to develop and maintain the member or AHP's skills and knowledge ..."

Review of Practitioner 4's credentials file indicated that she was a transplant hepatologist who was board certified in her subspecialty in 2006. Practitioner 4's privileges included bone marrow aspiration, bone marrow biopsy, esophageal dilation, colonoscopy with biopsy, and endoscopic polypectomy as well as several other procedures. Practitioner 4's credentials file included an OPPE (ongoing professional practice evaluation) profile which listed Practitioner 4's top 10 inpatient and outpatient billing codes. Comparison of Practitioner 4's privileges to the top billing codes on the OPPE revealed that there was no data regarding how frequently Practitioner 4 had recently performed bone marrow aspirations, bone marrow biopsies, esophageal dilations, colonoscopies, and endoscopic polypectomies.

Review of Practitioner 6's credentials file indicated that she was a podiatrist who had been granted privileges to perform 21 surgical procedures. Practitioner 6's credentials file contained a provider utilization summary indicating her top five billing codes for 4/06 through 3/08. Two of the codes were for surgical procedures, one was for anesthesia, and the remaining two were for x-ray exams. There was no data in the credentials file regarding how many of the other surgical procedures on her privileges Practitioner 6 had performed recently.

In an interview on 10/18/10 at approximately 2:30 p.m., Staff B (the director of medical staff services) stated that it was difficult to get the volumes of each specific procedure, and that this difficulty was compounded in a teaching hospital where the medical staff might not be able to bill for procedures performed by the residents under their supervision.

Review of Practitioner 7's credentials file indicated that he was a radiation oncologist who was board certified in his specialty in 1987. Practitioner 7's privileges included "Biopsy" and "Endoscopy" but did not specify what types of biopsies and endoscopies were included. The credentials file contained Practitioner 7's top 4 billing codes for 1/07 through 12/08, but none of them were for biopsies or endoscopies. Review of Practitioner 7's credentials file further indicated that his privileges included "Cyberknife" (robotic radiosurgery). Beneath the privilege for "Cyberknife" was a statement that "Recertification will be necessary following any 12 month period during which the practitioner did not directly participate and was responsible for at least 5 cases. Recertification would require additional proctoring of at least 3 additional cases." Review of Practitioner 7's top 4 billing codes in the credentials file indicated that they included radiation therapy planning, radiation therapy dose plan, and radiation therapy treatment management, but there was no documentation regarding whether or not the cases involved use of the cyberknife.

In an interview on 10/18/10 at 2:40 p.m., Staff B stated that he could not find the number of cyberknife cases that Practitioner 7 had performed. In an interview on 10/18/10 at 2:44 p.m., Staff B stated that he didn ' t think the credentials file included any additional data regarding the volume and types of endoscopies and biopsies recently performed by Practitioner 7.

Review of Practitioner 12's credentials file indicated that his privileges included "Patient management, including ... diagnostic and therapeutic treatments, procedures and interventions encompassing the areas described under the heading checked below. Requiring a level of training generally associated with persons who have completed the residency program prescribed by the certifying board or boards checked below, and a level of skill and ability generally associated with persons who are diplomates of that board... American Board of Orthopaedic Surgery ... " No delineation was present regarding which aspects of orthopedic surgery were included in Practitioner 12's privileges and which were not. Review of Practitioner 12's OPPE data indicated that his top 10 billing codes for inpatient procedures were listed and that they included various surgical procedures of the spine, administration of antibiotics, and prophylaxis against blood clots. The OPPE also listed Practitioner 12's top 10 outpatient billing codes, which were all for office visits. The OPPE did not include data indicating whether or not Practitioner 12 had recent experience in orthopedic surgery not involving the spine such as total joint replacements or hand surgery.

In an interview on 10/19/10 at approximately 11:30 a.m., Staff B stated that the chair of orthopedic surgery was insistent that the physicians in his department had been trained in the specialty and therefore were competent to do any procedure in the specialty. Staff B did not explain how the department chair's views reconciled with apparently contradictory terms in the facility's bylaws requiring specific privileges determined by criteria including performance of a sufficient number of procedures each year and requiring that experience be considered in addition to training.

Review of Practitioner 13's credentials file indicated that his privileges included "Vascular and Interventional radiology" but did not specify which specific interventional radiology procedures were included. Review of Practitioner 13's OPPE data detailed his top 10 inpatient and outpatient billing codes, but there was no data regarding Practitioner 13's recent experience in other procedures included in the specialty of interventional radiology.

Based on interview and record review, the facility failed to:

1. Apply national standards regarding surgical counts to its interventional radiology (IR) service during Patient 4s procedure. The deficient practice resulted in a missed opportunity to prevent retained foreign objects.
2. Ensure that all nursing staff at the ASC knew how to reconstitute Dantrolene in a MH (malignant hyperthermia) crisis, failed to develop a policy that specified the duties of ASC staff during a malignant hyperthermia emergency.
Malignant hyperthermia is a rare, life-threatening condition triggered by exposure to certain drugs used in general anesthesia. In susceptible individuals, these drugs can induce a drastic metabolic response which overwhelms the body's capacity to supply oxygen, remove carbon dioxide and regulate body temperature, eventually leading to circulatory collapse and death if not treated quickly by giving IV dantrolene (the only known antidote), correcting acidosis and organ dysfunction, and rapidly cooling the patient.
3.Ensure all nursing staff knew the procedure for doing a manual entry into the Surgicount Scanner (used to count surgical sponges).
4. Implement its policy on transporting specimens to the pathology laboratory.
5. Develop a policy for the transportation of contaminated surgical instruments in the ASC.
6. Follow their Time-out policy and procedure when the one Scrub Tech (Scrub Tech 1) failed to suspend all activities during time out by continuing to set up instruments while time out procedure was in progress during the surgery of one patient observed during surgery. Patient 43 had a radical cystoprostatectomy (surgical removal of the bladder, prostate and pelvic lymph nodes for treatment usually for treatment of bladder cancer) on 10/15/10. Time out procedure is a universal protocol performed immediately before starting a surgical or invasive procedure to confirm the correct patient, procedure, and site using active communication techniques.
7. Ensure that one RN from 10 CVT (Cardiovascular Transitional Care) nursing unit complete a pre-operative (before surgery) checklist for one of 85 sampled patients (Patient 44) before the patient had a right and left heart catheterization on 10/11/10 (heart catheterization is the insertion of a catheter into a chamber or a vessel of the heart to treat or diagnose certain heart conditions).
8. Follow the policy and procedure for handling specimens in the operating room when several entries in the specimen log showed incomplete documentation of the date, time or signature of the person who obtained the specimen or the person who picked up the specimen from the operating room to the laboratory.
These deficient practices limited the facilities ability to provide surgical services in accordance with acceptable standards of medical practice and surgical patient care.

Findings:

1. Review of Patient 4's medical record indicated that he had an IR procedure performed on his bile ducts on 10/12/10. No information regarding surgical counts was present in the record.

In an interview on 10/12/10 at 11:10 a.m., Staff A stated that no surgical counts were done in IR, that the radiologist was responsible for tracking the items used, and that the guidelines from the American College of Radiology did not mention the need for surgical counts.

Review of the Centers for Medicare & Medicaid Services (CMS) interpretive guidelines for hospitals indicated that for CMS purposes, alteration or transposition of human tissue with probes and needles as well as injection of diagnostic substances (other than injections by nursing ordered by a physician) were considered surgery and that recommendations promoted by surgical organizations therefore applied and were considered standards of practice.

Review of the Association of periOperative Registered Nurses (AORN) "Recommended Practices for Prevention of Retained Surgical Items" indicated that the recommendations were "intended as guidelines adaptable to various practice settings. These practice settings include... radiology departments..." The recommended practices further indicated that there should be a multidisciplinary approach to preventing retained surgical items in any invasive procedure, that radio opaque soft goods "should be accounted for during all procedures for which soft goods are used", that non-radio opaque soft goods should be isolated from the surgical field until a final count is conducted, that sharps and miscellaneous items opened onto a sterile field should be accounted for during all procedures in which they are used, that "Instruments should be accounted for in all procedures in which the likelihood exists that an instrument could be retained", that the organization's policy should clearly define any circumstances in which instrument counts are waived because they are not achievable or practical, and that efforts to prevent retained surgical items should be documented in the patient's medical record.

Review of the facility's own nursing policy "Counts: Instruments, Sponges, Needles and Small Items" dated 2009 indicated, "UCSF Medical Center maintains a policy of counting all sponges, sharps, instruments, and/or other countable items on all procedures in which the likelihood exists that they could be retained... Keeping track of the location of items used in and around the sterile field is a shared responsibility between surgeons and nursing personnel." The section of the policy regarding instrument counts indicated that instrument counts were required "on all procedures in which the likelihood exists that an instrument may be retained when: A cavity is entered... Any procedure where size of patient or incision creates the possibility of lost instruments... Any laparoscopic procedure..." No provisions defining circumstances in which instrument counts were waived were present in the policy.

Review of the article "Preventing the Retention of Foreign Objects during Interventional Radiology Procedures" (Pennsylvania Patient Safety Advisory, Vol. 5, No. 1 - March 2008, pp. 24-27, accessed at http://patientsafetyauthority.org/ADVISORIES/AdvisoryLibrary/2008/Mar5(1)/Pages/24.aspx) revealed that the Pennsylvania Patient Safety Authority had received reports of retained gauze in venous port pockets as well as a retained guidewire following lower extremity angiography. The article stated that retained surgical items were possible in IR and that surgical counts should therefore be done in IR.



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2. During an interview on 10/13/10 at 2:30 p.m., the Patient Care Manager of the ASC (RN 25) stated no "hands on" malignant hyperthermia drills were held with ASC staff. He said all staff had an annual paper review of malignant hyperthermia procedures.

On 10/14/10 at 3 p.m., RN 27 was asked what she would do if a MH crisis happened in the ASC operating room. She stated she would press the emergency button and bring the MH cart to the room. When asked what she would do next, she said she would follow the anesthesiologist orders. RN 27 was asked how she would mix the dantrolene and responded "I've never had to do that, I would have to follow the anesthesiologist's orders." RN 27 did not know the amount or name of the solution she would use to reconstitute the dantrolene.

The facility's Malignant Hyperthermia Response Policy was reviewed and indicated the following:

Treatment of Acute MH
Call the anesthesiologist on call
Call for the Malignant Hyperthermia Cart
Call for the code cart
Call for additional help. Anesthesia Providers, Nurses, Anesthesia Technicians, Service Coordinators and scrub Technicians should be mobilized to help.
Give 2.5 mg/kg of Dantrolene sodium for injection. If possible designate one team member (a nurse, CRNA, anesthesia resident or anesthesia attending) solely to reconstitute the dantrolene as this process is time intensive.

The policy did not specify which staff member would be responsible for carrying out these actions.

According to 2008 AORN Perioperative Standards and Recommended Practices Malignant Hyperthermia Guideline (pg 116):

Every facility should include MH training in the orientation plan for new members of the perioperative team and other teams involved in responding to the crisis. Ongoing periodic reviews should be scheduled. The MHAUS (malignant hyperthermia association of the United States) recommendations suggest that the perioperative team initiate mock MH drills a least twice a year to improve staff member efficiency in treating a patient during a MH crisis. Because dantrolene sodium is difficult to mix, some institutions reconstitute the outdated medication in staff member education sessions to give hands-on training during the mock drills.

Facilities should identify specific tasks assigned to each member of the response team to effectively manage a MH crisis.

3. The facility's plan of correction for a survey on 6/1/10 through 6/3/10 included training all surgical staff on the new procedure for making a manual entry into the Surgicount scanner in order to prevent retained sponges during surgery. Staff were trained that a two person (circulator and scrub) check of the correct sponge number was required before any manual entry into the Surgicount scanner).

On 10/14/10 at 3 p.m., RN 27 was asked to explain the procedure for making a manual entry into the Surgicount scanner. She stated "There is a new procedure but I don't know what it is. I've never had to do a manual entry." She said "I would have to ask (name of RN 25)."

4. During an interview on 10/13/10 at 3:15 p.m., RN 25 stated that pathology specimens from the ASC are taken to the pathology lab by the PCA (patient care assistant). He said the PCA takes the specimen and the log book to the pathology lab and the pathology lab staff member initials the log to indicate receipt of the specimen.

The pathology specimen log consisted of an area for the date, patient label, RN initials, number of specimens and pathology lab. initials. From 9/21/10 through 10/12/10 there were 22 occasions when there was no pathology laboratory staff member initials to indicate receipt of the specimens.

RN 25 stated the log was not complete and staff were not following the facility's policy.

A review of the facility's policy Care of Specimens indicated the following:

I. Purpose
A. Provide appropriate methods for caring for and handling specimens used in establishing or confirming diagnosis.

V. Procedures
B. All specimen containers will be placed in plastic bags and sealed prior to transport to Pathology
1. The specimen is taken to the designated specimen location and logged into the Specimen Log Book with the following information
a. date and time
b. Patient's addressograph label
c. Number of specimens
d. Initials of the person entering the information.
3. A representative from the pathology department signs the Specimen Log Book for each specimen delivered, verifying the specimen has been taken to the pathology department.

According to 2008 AORN Perioperative Standards and Recommended Practices for the Care and Handling of Specimens in the Perioperative Environment (pg 560)

Recommendation VIII

Transfer and transport methods and processes should be established by the health care organization according to the specimen type and diagnostic requirements.
1) Procedures should be established to prevent mishandling of specimens by verifying patient and specimen information before transfer, and by transport personnel at each point of exchange. Proper documentation allows tracking of the specimen from its source to its final disposition. A logbook should be used to record specimen, date, time, and the name of each person involved in each transfer process.
8) Documentation should be completed to establish the chain of custody from the point of removal until examination. Chain of custody is requires for tissue specimens as well as materials removed for forensic examination.
5. In the ASC on 10/13/10 at 2:55 p.m., ORT 1 (operating room technician) was observed pushing a wheeled table down a corridor from the operating room to the decontamination area. There was a tray of uncovered soiled surgical instruments on top of the table.

The Patient Care Manager of the ASC (RN 25) who was present stated staff usually cover soiled instruments with a drape before transporting them from the operating room to the decontamination area.

On 10/19/10 at 1:30 p.m., the facility's policy Cleaning and Decontamination of Instruments was reviewed with RN 25 and Admin.1. The policy indicated the following under Soiled Surgical Instrumentation:
1. End of Surgical Procedure
a. Surgical team member transports the soiled instrument case cart to OR decontamination area as soon as possible to begin the cleaning process.

In a concurrent interview RN 25 stated this was a hospital wide policy but did not apply to the ASC as they did not use case carts to transport soiled instruments from the operating room to the decontamination area. He said staff in the ASC usually covered the instruments with the drape from the back table in the operating room and wheeled the instruments to the decontamination area. Admin.1 acknowledged the policy did not address the transport of soiled surgical instruments in the ASC and stated the policy would be updated.

According to 2008 AORN Perioperative Standards and Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment: (pg 424)

Recommendation VI
Contaminated instruments must be contained during transport and should be transported in a timely manner to a location designed for decontamination.
Proper containment of instruments decreases the potential for injury to personnel or their exposure to infectious organisms and prevents damage to the instruments during transport.

VI a. During transport to a decontamination area, soiled instruments must be contained in a manner to prevent exposure of patients or personnel to bloodborne pathogens and other potentially infectious organisms. OSHA requires that contaminated instruments be contained in a leak-proof container to minimize the risk of exposing personnel to contaminants during transport.

VI.a.3. Items placed on top of a transport cart must be contained (e.g., plastic bag).



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6. The operating room suite was observed on 10/15/10 at 12:15 PM during Patient 43's surgery for a radical cystoprostatectomy. The Patient Care Manager for Perioperative Services was also present during the observation. The surgical team included the Surgeon 1, Anesthesiologist 1, the Circulating Nurse 1, Anesthesia Resident 1, Surgical Resident 1 and Scrub Technician 1. The The surgeon began the time out procedure at 12:20 PM. He began by verifying patient identity, announcing the patient's name, medical record number, date of birth, allergies and verified the type of surgical procedure to be performed. All of the members of the surgical team stopped and listened during the verification process except Scrub Technician 1. She did not focus on the verifying information about the patient but continued to set up the surgical instruments on the table during the time out procedure.

During an interview with the Patient Care Manager of the Perioperative Services at 12:25 PM, she stated that she acknowledged that Scrub Technician 1 should have stopped what she was doing and paid attention to what was being said during the time out process.

Review of the facility policy and procedure entitled, "Universal Protocol, Perioperative/Pre-Procedure Verification" dated April, 2010 indicated the following:

The final verification (time out) is initiated by the proceduralist, the person privileged or permitted by the hospital to perform the intended procedure. In the operation room the proceduralist is the attending surgeon. The time out involves all the members of the procedure team, including the proceduralist, attending anesthesiologist, other anesthesia providers, circulating nurse, OR scrub tech/nurse, and others as appropriate who will be participating in the procedure.

The time out will have the following characteristics: During the time out, other activities are suspended, consistent with patient safety, so that all relevant members of the procedure team are focused on the active confirmation of the time out elements.. It involves interactive verbal communication between all procedure team members..."

7. Patient 44 was admitted to the 10th floor CVT (cardiovascular transitional care) unit on 10/9/10 with diagnosis of pulmonary hypertension. Review of the Pre-Sedation/procedure Nursing Assessment Record dated 10/11/10 showed Patient 44 arrived in the procedure room at 10:40 AM for a right heart catheterization.

There was no documented evidence that a Patient Pre-Operative / Pre-Invasive Procedure Checklist was completed on 10/11/10 prior to sending Patient 44 from 10 CVT unit to the procedural area for the right heart catheterization.

During an interview with RN 3 and the Assistant manager of 10 CVT on 10/19/10 at 1:00 PM, they confirmed that the Patient Pre-Operative/Pre-invasive Procedure Checklist was missing in the clinical records.

Review of facility policy and procedure entitled, "Universal Protocol, Perioperative/ Pre-Procedure Verification" dated April, 2010 indicated the following:

"Verification of the correct person, site and procedure should take place, when possible, with the active involvement of the patient. The Pre-procedure verification process will occur at the following points in time: At the time the procedure is scheduled; At the pre-admission testing and assessment; At the time of admission or entry into the facility for a procedure; Anytime the responsibility for care of the patient is transferred to another member of the procedure team.

A checklist (Universal Protocol Verification Form #602-820 or a paper or electronic equivalent) is used to verify and document that all relevant information and supplies are available and matched to the patient... The checklist includes : Verification of patient safety; verification of proposed procedure and site; history and physical that has been conducted within 30 days; Interval update if the History and Physical is more than 24 hours old; Consent(s) that are completed, signed, dated and witnessed; Results of laboratory, pathology and radiology studies are present and matched to patient; Required blood products, implants, devices and equipment are present and functioning;; required specimens for blood bank have been obtained and sent."

8. On 10/15/10 at 12:30 PM in the operating room, the Pathology Specimen Log Book for 2009 -2010 was reviewed with the Pt. Care Manager of Perioperative Services present. She stated that the circulating nurse usually obtains the specimen, signs the log book then the staff from the laboratory comes to pick up the specimen. She acknowledged that there were multiple entries in the log with incomplete information. Several entries from 10/4/10 to 10/14/10 were either missing the date, time or signature of the person who obtained the specimen and/or the signature of the person who picked up the specimen from the operating room to the laboratory.

Review of the facility's policy and procedure entitled, "Care of Specimens" dated Feb. 2002 indicated that:

"All tissue, foreign bodies or any material that is removed from a patient must be sent to the Department of Pathology for examination ....The circulating nurse places the specimen into a container of the appropriate size with preservative unless otherwise instructed by the surgeon of pathologist ... The specimen is taken to the designated specimen location and logged into the Specimen Log Book with the following information: a. Date and time b. Patient's addressograph label c. Number of specimens d. Initials of the person entering the information ... A representative from the Pathology department signs the Specimen Log Book for each specimen delivered , verifying the specimen has been taken to the Pathology Department.. "

Based on record review, the facility failed to require a complete medical history and physical examination (H&P) on every patient having surgery. The deficient practice sidestepped an opportunity to identify relevant health information prior to invasive procedures.

Findings:

Review of Patient 5's medical record on 10/14/10 indicated that he was undergoing gamma knife radiosurgery. The paper record contained a hand-written H&P dated 10/13/10 for which the physical examination included vital signs, general appearance, extraocular movements, neurologic exam, and mental status. No physical exam findings were recorded in spaces marked "Ears/Nose/Mouth & Throat", "Cardiovascular", "Respiratory/Chest", "Gastrointestinal/Abdomen", "Genitourinary", "Musculoskeletal/Back/Extremities", "Skin/Breast", "Hematologic/Immunologic", or "Lymphatic".

Review of dictations regarding Patient 5 dated 9/15/10 and 10/13/10 indicated that neither included additional components of the physical examination.

Review of the facility's medical staff bylaws indicated, "As more fully described in the Rules and Regulations, a complete history and physical examination requires compliance with either of the following: 3.5.7.1 The entire history and physical examination is completed within 24 hours after admission or registration and within 24 hours prior to surgery or a procedure requiring anesthesia services; or 3.5.7.2 A complete history and physical examination is completed within the 30 days prior to admission or registration, and an update for changes is performed within 24 hours after admission or registration and within 24 hours prior to surgery or a procedure requiring anesthesia services."

Review of the facility's medical staff rules and regulations indicated that contrary to bylaws provisions calling for an "entire" or "complete" H&P, there were four categories of requirements for H&P's and that two of the four did not require a complete physical examination. Category 3 indicated that procedures under moderate sedation required a directed H&P which "includes, but is not limited to... Cardiovascular and respiratory assessment and... An assessment of the system or body part undergoing intervention". Category 4 indicated that "Procedures where minimal sedation and/or local anesthetic are used require... An assessment of the system or body part undergoing intervention." A subsequent provision in the medical staff rules and regulations had yet another definition of the scope of the H&P; it required the physical examination to include general appearance, vital signs, and "Examination of at least 9 elements from the 7 Body Areas or 13 Organ Systems".

Based on interview, and record review, the facility failed to have the job descriptions of its nuclear medicine technologists approved by the medical staff. The deficient practice circumvented expectations for physician leadership of the service.

Findings:

Review of the job description for the associate chief of nuclear medicine dated 4/1/01 and updated 4/4/01 indicated that the position was for a nuclear medicine technologist who would supervise the other staff in nuclear medicine. The job description was approved by the Radiology Operations Director, who was not a physician. There was no evidence that the job description had been approved by the medical staff.

Review of the job description for the "Sr. Nuclear Medicine Technologist" dated 9/1/99 and updated 4/1/00 indicated that it was approved by the Radiology Operations Director, who was not a physician. There was no evidence that the job description had been approved by the medical staff.

In an interview on 10/14/10 at 4:36 p.m., Staff E stated that the facility did not have nuclear medicine job descriptions which had been approved by the medical director of the service.

Based on observation, interview, and record review, the facility failed to make a description of the laboratory services performed in its nuclear medicine department available to the medical staff. The deficient practice had the potential to limit the medical staff's understanding of the services available.

Findings:

Review of Title 42, Code of Federal Regulations, section 482.27(a)(2) indicated that a written description of the laboratory services provided must be available to the medical staff.

In an interview on 10/12/10 at 2:33 p.m., Staff I stated that the nuclear medicine department had a laboratory which offered red blood cell volume assays and plasma volume assays.

Review of the facility ' s protocol for in-vitro red blood cell (RBC) volume assays indicated that it was a paper document last revised on 2/3/07 which included a description of the service.

In an observation and interview on 10/14/10 at 1:46 p.m., Staff J accessed the facility ' s online lab manual. The lab manual did not include entries for RBC volume or for plasma volume. Staff J made several further attempts to locate descriptions of the red blood cell volume and plasma volume assays online but was unsuccessful. She stated that she was unable to locate the nuclear medicine protocols for in-vitro assays online.

In an interview on 10/15/10 at 11:22 a.m., Staff K stated that the written policies regarding the RBC volume and plasma volume assays were not available to the entire medical staff, but that she would get a description of the services posted on the department's website.