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Based on observation, staff interview, and document review, the hospital failed to effectively govern the activities and conduct of the hospital staff to provide quality care in a safe environment for all patients as evidenced by:

A. The governing body failed to ensure that the medical staff is accountable to the governing body for the quality of care provided to patients. Refer to A 49.

B. The governing body failed to ensure that medical staff membership and professional privileges were only done after careful review of past clinical performance and not dependent solely upon certification, fellowship or membership in a special body or society.
Refer to A 51.

C. The governing body and hospital failed to ensure an effective system for monitoring and evaluating the services performed under contracts in order to verify that the services were of quality and were safe and effective. Refer to A 84 and 85.

D. The governing body failed to ensure patient rights were protected and promoted for a restrained patient. Refer to A 115.

E. The governing body failed to ensure that the hospital had developed, implemented, and maintained an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. Refer to A 263, 310, 312, and 315.

F. The governing body failed to ensure that nursing services were staffed and supervised to provide care consistent with nationally accepted standards of practice. Refer to A 385.

G. The governing body failed to ensure that the hospital had safe, effective pharmaceutical services that met the needs of the patients. Refer to A 490.

H. The governing body failed to ensure that the dietetic services met the needs of all patients. Refer to A 618.

I. The governing body failed to ensure that the hospital maintained a sanitary environment and minimized the risk of transmission of infections. Refer to A 747.

These failures resulted in a potential for increased infections, adverse medication episodes, and other adverse events for all patients. The cumulative effect of these systemic failures resulted in the inability of the hospital to comply with the statutorily-mandated Condition of Participation for Governing Body.




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Based on interview and document review, the governing body failed to ensure that the medical staff was following and enforcing their bylaws, in order to be responsible and accountable to the governing body, for the quality of care provided to patients. In so doing, the governing body and medical staff had not ensured that all medical staff members and other professionals had been demonstrated to be qualified and competent for the membership and privileges made available to them. This could lead to under-qualified practitioners providing poor quality of care to patients.

Findings:

On 9/24/12, the Medial Staff Bylaws and the Medical Staff Rules and Regulations charge the Medical Staff (MS) with several key assignments related to being accountable to the governing body for the quality of care provided to patients. Three of those assignments are to: 1.) Ensure that all applicants for medical staff membership and privileges are qualified as specified in the bylaws and rules; 2.) Ensure that all medical staff membership has periodic evaluation of their professional proficiencies based on objective data of past performance; 3.) Ensure that all new members of the Active, Active Ancillary, Courtesy, or Locum Tenens Staff be proctored as specified in the rules.

In order to identify the specific locations in the bylaws and rules, these assignments are stipulated, the following texts are from the Medial Staff Bylaws and Medical Staff Rules and Regulations as they were reviewed from 9/24/12 to 10/4/12:

"Medical Staff Bylaws (June 30, 2011)

"Article I PURPOSE" (page 4) states "the purposes of the Medical Staff are to: (in part) b. ... to promote good patient care. c. Screen and recommend applicants for Medical Staff Membership. d. Review Privileges of Members. e. Monitor, evaluate and assist in improving the work done by the Medical Staff. j. Ensure that quality of care delivered by those with privileges.

Article II, 2.3 - Effects of other affiliations - (page 5) 2.3-1 No individual is entitled to, nor can he or she be denied Membership and/or Clinical Privileges in the Medical Staff merely because of any of the following: a. Degree, b. Membership in professional organizations, c. Certification from a clinical board, d. Previous Medical Staff Membership, e. Current Staff Membership or Clinical Privileges at another health care facility

Article II, 2.7-1 - Active Staff (pages 7 & 8)
a. Qualifications, Active Staff Members: ... (2) Shall have at least 15 Patient Contacts annually.

c. Responsibilities, Active Staff Members: ... (5) Shall have at least 15 Patient Contacts annually such that patient care can be assessed and reviewed.

Article III, Procedure for Appointment, Reappointment, and determination of clinical privileges (page 13) 3.1 General Procedure - The Medial Staff through its designated Departments, committees, and Officers shall evaluate and consider each application for appointment ore reappointment to the Staff and each request for modifications of Staff Membership status or Privileges and shall adopt ant transmit recommendations thereon to the Board. The Medial Staff shall perform the same evaluation and recommendation functions in connection with any AHP (Allied Health Professionals) who seeks to exercise Privileges.

Medical Staff Rules and Regulations (May 2011)
Section H - Proctoring

H-1 Proctoring Requirements -- a. Each newly appointed Member of the Active, Active Ancillary, Courtesy, or Locum Tenens Staff shall be proctored for medical and surgical Privileges ...

H-2 Purposes of Proctoring --
a. Verify technical competence
b. Asses judgment
c. Evaluate pre- and post-procedure management
d. Evaluate medical record keeping and documentation
e. Determine compliance with Medical Staff bylaws, rules, regulations, and policies.

H-5 Determination of extent of proctoring
... The first proctoring review will occur no later than 12 months after the applicant has been granted full privileges."


On 10/1/12 from the provided roster, "All the Medical Staff Members (MSM) and Allied Health Professionals (AHP) currently on staff at the hospital," an initial 9 MSM and AHP were selected for credential file review. An additional physician (MSM 11), who was not listed on the Medical Staff Roster, was selected for review because of an irregular medication order that had been noted. During the afternoon of 10/2/12, the initial list of 10 practitioners was reviewed in the Medical Staff Office with Medical Staff Coordinator 1 (MSC-1), at which time it was learned that MSM 11 was a "Locum Tenens" physician (serving for a limited time to replace another physician) and the hospital currently had other Locum Tenens physicians providing services at the hospital. Two of the listed AHPs, both Clinical Cardiac Perfusionists (CCP: health care technician who operates a heart / lung machine during cardiac surgery to redirect blood flow allowing the surgeon to operate on the unbeating heart) were no longer considered AHP since a change in the AHP Manual (part of the MS Bylaws) that occurred in May 2011. At 3:25 pm on 10/2/12, MSC-1 stated, "that change had been made because the MS felt that since none of the physicians were perfusionists, they should not be doing 'peer review' on the CCPs. The CCPs were treated as hospital employees and their clinical proficiency evaluations were done by the Director of Perioperative Services."

During the afternoon of 10/2/12, the credential file of MSM-11 was reviewed. On 10/3/12, another list of MSMs and AHPs was selected and together with MSM-11 for a total of 13 credential files (MSM-1, MSM-2, MSM-3, MSM-4, MSM-5, MSM-6, AHP-7, MSM-8, MSM-10, MSM-11, MSM-12, MSM-13 & MSM-14) were reviewed in detail with MSC-1, beginning at 10:00 am on 10/3/12. With the following observations noted:

1. Three (3) of the physicians (MSM-11, MSM-12 & MSM-13) were locum tenens, and none of them had available documentation to show that they had been required to undergo proctoring. Proctoring reports were usually maintained in a separate folder (green folder - peer review) and most MSM had such a folder, but not the Locum Tenens physicians. None of the three had been given a specific effective period for their privileges.

2. MSM-12, a locum tenens physician with an advanced specialty, had requested very non-specific privileges and his privilege list had no signatures to indicate what may have been granted, or even if privileges had been granted. The effective date and ending date of privileges were left blank.

3. One (1) MSM-14, a PhD psychologist, was an Active staff member: His credential file and green folder showed that he had been reappointed in 1/12, but had at that time no patient contact data or other data to show his clinical performance of patient contacts over his prior appointment period. A report, dated 6/1/12, documented that from 6/1/10 through 6/1/12, he had only one patient contact. MSM-14's privilege request form documented he was not qualified for the requested core privileges and had hand written beside that fact, "Requesting waiver." However, there was no notation that a waiver had been officially entertained or granted. Although he had been reappointed to the Active Medical Staff, MSM-14's file had no evidence that MSM-14 had treated 15 patients in any one year during his prior medical staff appointment.

4 Of the 13 credential files reviewed, nine (9) (MSM-1, MSM-2, MSM-3, MSM-4, MSM-5, MSM-6, MSM-8, MSM-10 & MSM-14) had hand written modifications to the effective dates for their privilege lists, and review showed that the dates apparently approved by the Medical Executive Committee (MEC) & governing body (GB) had been altered by one of the Medical Staff Office staff members, but there was not notation that the alteration had been directed or approved by any MS officers or anyone with authority to act on behalf of the GB.

5. MSM-8 is a tele-radiologist (physician working from a distant site via computer, who assists with x-ray interpretations) whose file did not have any proctor reports or other peer review on file. When asked for the proctor reports of this individual and the other tele-medicine physicians, MSC-1 redirected the search to two other employees in the Medical Staff Office, MSC-2 and MSC-3 and several stacks of loose papers were provided.

6. The hospital utilized the services of 14 tele-neurologists (a physician working from a distant site via telephone and/or computer, who assists with nervous system evaluations of patients) and had given each Courtesy staff status (MSM-16 through MSM-29). Beginning on the afternoon of 10/3/12 until mid-morning of 10/4/12, a search for proctor reports on these 14 physicians yielded 2 incomplete reports. On 10/4/12 at 9:30 am, MSC-2 provided documentation that MSM-17 and MSM-16 had each been signed off as completing their proctor assignments on 3/18/10. MSC-2 reported each neurologist had submitted six neurological consults for proctoring, so there should have been six proctor reports for each physician. The data attached to each of the proctor completion letters clearly documented that only three proctor evaluations had been done; the other three proctor evaluation documents could not be completed because there was no neurological consult report found to review. The Medical Staff Office had no data to show that the other tele-neurologists (MSM-18 to MSM-29) had been proctored.

7. Similarly, the hospital uses the services of 28 tele-radiologists (MSM-8 and MSM-30 to MSM-56) who are Active medical staff members. On 10/3/12 until mid-morning 10/4/12, a search by the Medical Staff Office staff for evidence of proctoring of these 28 physicians yielded some evidence that they had been proctored or partially proctored. Six proctor reports were required of each physician. Evidence was provided to show that 12 physicians had six proctor reports each (MSM-8, MSM-31, MSM-33, MSM-34, MSM-37, MSM-39, MSM-41, MSM-45, MSM-54, MSM-55 & MSM-56), and two had only one proctor report (MSM-48 & MSM-52). The Medical Staff Office staff could not provide any proctor reports to show that the remaining 14 physicians had been proctored.

On 10/4/12 at 10:15 am, during an interview with the Director of Quality Management (DQM), she acknowledged that the hospital did not have an adequate system in place to collect, maintain, and analyze the critical data needed by the medical staff officers, the hospital administration, and the governing body to ensure that ongoing and periodic professional proficiency evaluations and proctoring were conducted, as required by the Medial Staff Bylaws and Rules. She explained that the hospital had relatively recently purchased a computerized software package that should in the future assist with this, but that had not yet been fully implemented and that the various computer systems of the hospital were not yet able to exchange data from system to system so as to facilitate the collection of the required data.

Based on interview and document review, the governing body failed to ensure that contracted services were performed in a safe and effective manner when changes were not made to assure there was an effective quality oversight system to objectively measure and evaluate the performance of contracted vendors. This failure put patients at risk for unsafe or ineffective care and services.

Findings:

In April 2012, the hospital had been cited for not having an effective oversight system to ensure contracted services were provided in a safe, effective manner. On 9/26/12 at 9:30 am, in an interview with the Chief Clinical Officer (CCO), the hospital's corrective actions to improve oversight of contracted services was discussed and the document titled, "Patient Services Contract Performance Measures (PM)," which had been provided on 9/25/12 as the list of contracted services was reviewed. This document, configured as a table, listed 20 contracts, each with between one to five performance measures (PM) and their associated performance goals and frequency of measurement. When questioned about the small number of listed contracts, the CCO acknowledged that there were quite a few more contracts, "between 125 and 130." The CCO stated he would supply the full list of contracts which could be obtained from a database located on a computer at the other hospital's campus.

CCO further explained that the itemized PMs for the 20 listed contracts had been developed in conjunction with the Board of Directors (Board) and that the available data was reported to the Board over the past months. He acknowledged that the list and the PMs were incomplete and said it was "a work in progress." Those contracts listed were chosen because they were "patient care services or clinical contracts."

A 109 page list of between 400 to 800 contracts was provided later that afternoon (9/26/12). This document did not have any performance measures and an unknown number in the list were expired contracts that were no longer utilized.

1. On the Patient Services Contract Performance Measures list/table was a contract written with a management firm (Man. Firm S) to provide one director and two managers; each of these individuals to be located at the hospital and to supervise the hospital employees that clean the hospital environment (EVS). For this contract the three PMs were listed as follows:

PM 1. "Adheres to regulatory & accreditation standards as evidenced by zero survey findings." To be measured/reviewed "Biannual(ly)" with a goal of 0 (zero), but with 3 deficiencies in the "1st 6 months of 2012" - The adjacent comment read, "Three findings in CMS validation survey. All findings have been corrected."

PM 2. "Improve patient satisfaction scores related to patient room and bathroom cleanliness on the 'named' survey." - "Biannual" - Goal of 80% - 1st 6 months 2012 = 64% - No comment."

PM 3. "Adheres to all current infection control practices." For this PM there was no listed interval of time between measurements, no listed goal, no data, and no comment.

On 9/26/12 at 10:19 am, an Immediate Jeopardy related to Infection Control (IC) deficiencies was declared. (Refer to A 749 for details.) Findings included an observation that some EVS employees that were assigned to clean the hospital environment were not knowledgeable of or following standard disinfection practices, and the directions for use of various disinfectants.

On 10/4/12 at 11:30 am, the CCO and the Director of Risk Management (DRM) were interviewed and they acknowledged that:

a. The performance measures for this contract with "Man. Firm S" for management of Environmental Services and for many of the other contracts, were not sufficient to assure that safe and effective quality services were provided in a manner that would permit the hospital to be compliant with requirements.

b. The statements that "All findings have been corrected" for Environmental Services and Nutritional Services were not factual as evidenced by the fact that some of the same deficiency findings had been pointed out during the current survey.

c. For seven contracts, (listed as: Pharmaceutical Supplier, Blood & Blood Products, Donor Services, Rental Specialty Beds, Radiation Safety, Reference Lab, Nursing) some or all of the listed PMs had not been evaluated.


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2. On 10/4/12, the contract for perfusion services (the use of a heart and lung machine during cardiac surgery to redirect blood flow allowing the surgeon to operate on the unbeating heart) was reviewed. This contract was not listed on the above short list of contracts that were "Patient care services or clinical contracts." The contract stated that perfusionists must be part of the allied health staff. The roster of allied health staff did not contain any perfusion staff.

On 10/4/12 at 8:35 am, Nurse Manager (NM) 4, the Director of the Perioperative Services, stated the perfusionists were under contract and were no longer part of the allied health staff. NM 4 was asked how the services of the perfusionists were evaluated. NM 4 stated that they were evaluated for competency using the same tools that were used for all the surgical staff. At 11:54 am, NM 4 provided six samples of surgical competency evaluation tools which were blank. When asked if the perfusionists had been assessed using these tools, NM 4 replied, "No." NM 4 was unable to produce any evaluation of perfusionist competency.

On 10/4/12 at 9 am, the CCO confirmed that competency of the staff contracted to perform perfusion services for the hospital had not been evaluated. CCO further confirmed that the contract required the perfusion staff to be part of the allied health staff and the perfusionists were not part of the allied health staff.



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Based on interview and record review, the facility failed to ensure that the hospital had a complete list of all the contracted services with accurate and current information about the scope and nature of those services.

This failure had the potential of allowing for some contracted services to be utilized without undergoing regular overview and quality / safety review by the hospital administration.

Findings:

On the morning of 9/24/12, the list of all contracted services utilized by the hospital was requested. A 6-page document titled, "Patient Services Contract Performance Measures" was provided, containing information about 20 contracts. On 9/26/12 at 9:30 am, the Chief Clinical Officer (CCO) acknowledged that the provided list was incomplete and did not include a full description of the scope and nature of each contract. CCO said, "The list of contracts is a work in progress." CCO said the hospital had about 125 to 130 contracts and stated he would provide a more complete list. That afternoon (9/26/12), a larger list the hospital's contracted services titled, "Existing & Expired Contract List" was provided. This second list had 109 pages and contained well over 400 different contracts.

This second list had varying amounts of information about the contracts, but neither list contained a full description of the scope and nature of the contracts. The larger list did not differentiate between those contracts that were currently being utilized and those that had expired and where no longer being utilized.



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Based on interview and record review, the facility failed to ensure that for one of 60 sampled patients (Patient 10), patient rights were protected and promoted as evidenced by:

1. Patient 10 was not free from restraints. Refer to A 154.

2. The least restrictive measures were not attempted, prior to physically and chemically restraining Patient 10. Refer to A 164.

3. Patient 10 was restrained without a physician's order. Refer to A 168.

These failures impacted Patient 10's right to be free from restraints, placing him at risk for harm from medication side effects, entrapment, or death. The cumulative effect of these systemic problems resulted in the inability of the hospital to comply with the statutorily-mandated Condition of Participation: Patient Rights.

Based on staff interview and record review, the facility failed to ensure that one of 60 sampled patients was free from restraints when Patient 10 was administered Haldol (an antipsychotic medication with increased risk of death in the elderly) by intramuscular injection (IM-injection into the muscle), and put in physical restraints (four side rails and a roll belt) with no documented evidence justifying such use or evidence that less restrictive measures were attempted before use of restraints. This failure impacted Patient 10's right to be free from restraints and could result in harm due to medication side effects, entrapment, or death.

Findings:

On 9/26/12 at 2:30 pm, Patient 10's record was reviewed with Registered Nurse (RN) 65. Patient 10, an 83 year old, was given Haldol by injection into the muscles on 9/17/12 at about 11:30 pm. The physician's telephone order was written at 2300 (11 pm) on 9/17/12, for Haldol IM for agitation and "restraints for patient protection."

The LexiComp Online Pharmaceutical Reference listed a warning regarding the use of Haldol in the elderly population, "Elderly patients with dementia-related psychosis treated with antipsychotics are at an increased risk of death compared to placebo."

The physician's order for both physical (mittens, belt, and side rails) and chemical (Haldol) restraints was written at the same time (2300 - 11 pm, on 9/17/12). There was no documented evidence that other interventions or less restrictive measures were attempted before resorting to using the restraints.

In a concurrent interview, RN 65 stated that the restraints were needed to prevent the patient from picking on his Permacath (a surgically placed catheter for dialysis.) However, there was no documentation of behaviors that necessitated the use of Haldol (chemical restraints) and the physical restraints (belt and side rails) both at the same time. It was not clear how using the belt or raising the side rails of the bed prevented Patient 10 from picking on the catheter. There was no documented evidence that less restrictive measures were attempted before using the restraints.

Based on staff interview and record review, the facility failed to ensure that less restrictive interventions were tried before using restraints for one of 60 sampled patients when Haldol (an antipsychotic medication which has a warning of increased chance of death when used in elderly patients for agitation) by injection into the muscle (IM) and physical restraints were used to restrain Patient 10. This failure had the potential for Patient 10 to be restrained unnecessarily and placed him at risk for medication side effects, entrapment, or death.

Findings:

Review of the facility's policy titled, "Restraints-Hospitalwide," approved on 8/8/12, indicated that the purpose of the policy was "limiting the use of restraints to clinically justified situations only..." The policy included that "Restraints will only be applied after all appropriate alternatives have proven ineffective in maintaining patient safety."

The LexiComp Online Pharmaceutical Reference listed a warning regarding the use of Haldol in the elderly population, "Elderly patients with dementia-related psychosis treated with antipsychotics are at an increased risk of death compared to placebo."

On 9/26/12 at 2:30 pm, review of the record with Registered Nurse (RN) 65, revealed that Patient 10, an 83 year old, was given Haldol IM on 9/17/12 at 11:30 pm. The telephone order written at 2300 (11 pm) on 9/17/12 was for Haldol IM "for agitation" and restraints "for patient protection." The orders for both physical (mittens, belt, and side rails) and chemical (Haldol) restraints were written on 9/17/12 at the same time 2300 (11 pm.) There was no documented evidence that other interventions or less restrictive measures were attempted before resorting to using restraints.


Further review of Patient 10's record, revealed nurses notes on 9/17/12 at 21:08 (9:08 pm), indicating that "(The) patient refusing meds." It was also documented that, when a staff member spoke to Patient 10 in his language, the staff member was "...able to get him to take his Remeron." Remeron is an antidepressant medication. This demonstrates that a less restrictive measure, speaking to Patient 10 in a language that he understood, was effective. However, there was no documented evidence that this less restrictive measure was attempted to prevent use of restraints.

Based on staff interview and document review, the facility failed to ensure that a physician's order was obtained, prior to restraining one of 60 sampled patients when (Patient 10). The order for restraints was written and signed on 9/19/12 at 1515 (3:15). The order for restraints was not written until 1730 (5:30 pm). Between 1515 and 1730 on 9/20/12, a period of 2.25 hours, the restraints were applied without an order. This failure had the potential for Patient 10 to be restrained unnecessarily and placed him at risk for harm from medication side effects, entrapment, or death.

Findings:

On 9/26/12 at 2:30 pm, review of Patient 10's record with Registered Nurse 65, revealed that Patient 10 had orders for restraints. One order for restraints was written on 9/20/12 at 1515 (3:15 pm), the other order was written at 1730 (5:30 pm).

Review of the facility's policy titled, "Restraints-Hospitalwide," approved on 8/8/12, showed the following requirements for medical surgical restraints: "Initial LIP face to face evaluation of patient and written order in medication record. Within 24 hours of initiation."

The Director of Quality Management (DQM) reviewed Patient 10's record and confirmed that Patient 10 was in restraints from 9/20/12 at 1515 (3:15 pm) until 9/20/12 1730 (5:30), a 2.25 hour period, even though there was no order for restraints. DQM further confirmed the order for restraints was not obtained within 24 hours from the preceding order, which was not in accordance with the facility's policy.




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Based on observation, staff interview, and medical record and document review, the hospital failed to ensure an active, effective, ongoing data-driven surveillance of patient care practices (i.e. practices that carried high risk to patient safety), through its Quality Assessment and Performance Improvement (QAPI) program, reflecting the complexity of the hospital's organization and services, in all locations, in order to minimize those risks to all patients evidenced by:

1. The facility failed to provide documented evidence to show the following care processes were effectively evaluated when continued evidence of regulatory violations were identified:

a. Failure to conduct observations of food service trayline, review of clinical nutritional care, and menu planning and development to meet patients' nutritional needs. Refer to A 267 and A 630.

b. Failure to provide surveillance of high risk, problem prone medications to verify safe and standard dosages, safe frequency of administration, and safe monitoring of the effects of administration to avoid potential adverse events. Refer to A 285, A 404, and A 500.

c. Failure to provide observations and review of practices related to the prevention of cross contamination and disinfection practices throughout the hospital. Refer to A 267 and A 749.

d. Failure to have data collected for biomedical engineering processes. Refer to A 267.

e. Failure to perform a credible review of emergency resuscitations. Refer to A 267 and A 392.

f. Failure to incorporate key pressure ulcer indicators into the quality plan. Refer to A 392 and A 267.

2. The governing body, medical staff, and administrative staff failed to ensure that an effective quality improvement program was defined, implemented, and maintained. Refer to A 310.

3. The governing body failed to allocate adequate resources to measure, assess, improve, and sustain performance improvement. Refer to A 315.

4. The facility failed to conduct overview and performance assessments of all the contracted services provided to the hospital and its patients to assure they were quality services, delivered in a safe and effective manner. Refer to A 84 and A 85.

5. The facility failed to conduct ongoing professional proficiency evaluations of Medical Staff and other health care professionals in accordance with Medical Staff Bylaws, Rules, and related instructional manuals, and in accordance with the Governing Body Bylaws. Refer to A 49.

6. The facility failed to ensure that QAPI activities were evaluated for the effectiveness of their improvement activities. Refer to A 312.

These failures put patients at risk for substandard care, adverse events, infections, pressure ulcers, poor patient safety, compromised nutritional status, and foodborne illness. The cumulative effect of these systemic problems resulted in the inability of the hospital to comply with the statutorily-mandated Condition of Participation for Quality Assessment and Performance Improvement.



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Based on staff interview and document review, the hospital failed to ensure they measured, analyzed, and tracked quality indicators that assess processes of care, hospital services, and operation. The facility failed to:

1. Measure, analyze, and track quality indicators that addressed the complexity and scope of Food and Dietetic Services which resulted in the failure to identify issues in tray line. Departmental staff failed to recognize inadequacies in clinical nutrition care services and menu planning and development that could lead to unmet patient nutritional needs;

2. Analyze data collected to ensure Emergency Room processes were compliant with regulatory requirements and develop action plans to improve performance;

3. Analyze data collected to ensure infection control processes were compliant with current standards of practice and develop action plans to improve performance;

4. Collect data for biomedical engineering processes;

5. Measure, analyze, and track quality indicators for Code Blue (resuscitation) processes;

6. Measure, analyze, and track quality indicators for the prevention of pressure ulcers.

Failure to identify opportunities for improvement in operational processes may compromise the medical status of patients and result in adverse events and poor patient health outcomes.

Findings:

1. During the survey process specific issues related to food services and clinical nutrition care were identified (Refer to A 622, A 630).

On 9/27/12 at 2:35 pm, an interview with the interim Director of Food Services (DFS) and the interim Clinical Nutrition Manager (CNM) and review of performance indicators beginning in 5/2012 revealed that the dietary department was completing 1) weekly food safety audits; 2) plant safety audits; 3) weekly patient tray assessments and 4) diet order processing audits. It was noted that there was no benchmark noted on the diet order processing audits. The patient tray line audit for August 2012 indicated there was no benchmark or goal for any of the types of items they were tracking. In the column with accurate trays, there was an incorrect percentage that the surveyor pointed out to the CNM. The CNM stated the formula must have been entered incorrectly in the spreadsheet. There were "31.7%" of the trays that were accurate and 18% that were not accurate. The surveyor re-calculated the accurate trays which was 63% not 31.7%. It indicated that 36% were for a therapeutic error (diet order was not accurately followed). There was a summary, however, no action plan to correct any of these issues. The CNM stated this form did not go to the Patient Safety or Quality Committee. The DFS, an employee of the contracted food service, stated that she met with the Quality person when she came to the hospital and discussed what information would be provided, and at this time, she presents the sanitation quality monitoring, final internal cooking temperature monitoring, kitchen and cafe temperature compliance, and unit pantry temperature compliance. The DFS stated she had not had enough time to go through the last few months of the Fremont Campus data.

Similarly, review of clinical nutrition documentation, dated 8/12, revealed that the department completed peer review audits of the Registered Dietitian's (RD) clinical assessments, however, there was no real total score related to competency. The audits did not ask if the patient was classified in the appropriate risk level. The follow frequency was correct, however, did not assess whether they were following standards of practice for their estimated nutritional needs for the different disease states (e.g. wound healing). All of the audits showed 100% and with some assessments with "no" next to them. It was unclear what this means and this was not measured with a percentage, as a whole, how the different RD's are scored or what benchmark means they are competent.

On 10/2/12 at 4:55 pm, an interview was conducted with the CNM. The CNM stated they have not done any kind of performance improvement activities regarding wound care and nutrition.



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2. On 9/28/12, Emergency Room records were reviewed for Patients 15, 16, 17, and 18. All four records contained blank portions of the required certification for transfer, as required by the Emergency Medical Treatment and Labor Act (EMTALA).

On 10/9/12, Nurse Manager (NM) 2 was asked if there was a process to oversee this process. NM 2 indicated that the Emergency Department (ED) regularly measured their performance in this area. NM 2 presented indicators for the required certification of transfer elements. When asked what was done about non-compliance, NM 2 stated that they coach staff. NM 2 stated he did not have a record of an analysis or action plan for these data reports. NM 2 further stated that the reports stayed in the ED and were not reported into the quality plan or any other committee.



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3. On 10/2/12, quality management reports from 6/12 to 9/12 were reviewed. The Patient Safety Committee minutes, dated 8/28/12, indicated there was no infection control information reported. The Quality Council minutes, dated 9/18/12, indicated data collected on selected items from the previous survey such as hand hygiene, expiration of solutions, etc. were reported but no other infection control data was present.

During an interview with the Director of Quality Management (DQM) on 10/2/12 at 3 pm, she indicated quality management related to infection control had been negatively impacted when the hospital Infection Control Practitioner quit in June 2012. DQM stated, "Infection control data entry fell behind, and the ability to again pull together reports from collected hospital infection control data did not occur until a permanent ICP was hired late in 8/12." DQM acknowledged data collection and analysis were essential elements of quality management in order to identify patterns and trends that need to be addressed through interventions.

In a review of the surveillance infection control data that was collected since the last survey, the hospital had high rates of Clostridium Difficile (C-diff - a healthcare acquired infection which causes severe diarrhea) and ventilator-associated pneumonia (healthcare acquired infection caused by a breathing machine).



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4. During an interview on 9/25/12 at 8:50 am, the BioMed Engineering Manager (BEM) identified recurring problems with the intravenous (IV) pumps (a piece of equipment used to regulate the flow of fluid that enters a patient through a small tube placed in a patient's vein) and stated it was user error that was causing most of the problems. BEM stated that staff were forgetting to plug the pumps in to recharge them after they had been used. He stated this could become a patient safety issue if a pump or pumps were needed to transport a patient and they were not available because the batteries were dead.

BEM stated he had difficulty getting the safety information and goal percentages to the safety committee in a timely manner because his company (contracted to perform the BioMed activities) sent him the monthly statistics for their company nationwide. BEM stated it was very time consuming to separate the information needed just for this facility and he did not have adequate time or resources to complete all the work that was needed and provide the monthly reports.



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5. On 9/28/12 beginning at 9:50 am, an emergency response (code blue - cardiopulmonary resuscitation - CPR ) by nursing staff was observed in Room 379 in the Intensive Care Unit in which improper technique was used for chest compressions and the defibrillator was not charged, prior to use. Refer to A 392.

The written critique of the event did not evaluate the proper technique of cardiac compressions. There was a "yes and no" question of any defibrillation problems and no was marked. There was no signature of the person completing the CPR Critique.

A review of the Policy, "Cardiopulmonary Resuscitation (CPR) - Hospitalwide, dated 7/27/11, and Patient 65's critique form on 10/1/12 at 10:20 am was conducted with NM 5 and Nurse Educator (NE) 1. Both stated that a committee reviewed the procedure of "Code Blue" and that they were members themselves. Committee discussions were based on problems identified during the procedure "Code Blue," by the committee members without review of the CPR Critique Form. NM 5 stated that the critique form of the procedure was new to him and had not been reviewed in the committee since he had been participating in 6/12. NM 5 stated that NM 8 or he would be responsible to fill out the critique form, but was unfamiliar with the form. NE 1, who was familiar with the form, stated the committee would review the critique form when problems were identified by the committee members. She stated that the critique form officially goes to the Quality Assurance Department for review and was unable to identify any recent concerns. NE 1 stated that to her knowledge, no one had evaluated if the facility's policy had been implemented. Both stated that no one from the committee had been responsible to observe the procedure and evaluate the effectiveness of the team. The effectiveness was based on outcome, whether the patient survived or not. NM 5 stated that the CPR policy needed to be updated to reflect current practices.

The policy, "Cardiopulmonary Resuscitation (CPR) - Hospitalwide, dated 7/27/11, directed staff of the procedure, including the responsibilities of the Code Team and documentation. Pages 5 and 6 of the policy was a blank example of the Cardiopulmonary Resuscitation Record. The critique form was not included with the policy. The Code Team responsibilities, 2. C-Circulation b. read, "Do external cardiac compressions using proper technique." 6. Code Coordinator, read, "This role is filled by the Administrative Clinical Coordinator or Nursing Director on duty. a. Oversee functioning of Code Team and assess effectiveness " along with 9 other responsibilities including assisting any team member needing assistance, provide for needs of patient family and patient's roommate, oversee completion of CPR Record, Critique, and Charges.

During a review of Patient 65's code blue critique form with NM 8 on 10/3/12 at 11:15 am, NM 8 stated that he was familiar with the critique form and would be the designated Administrative Clinical Coordinator during the "Code Blue" event on 9/28/12 for Patient 65. NM 8 stated that he did not fill out the critique form and had no idea who would have filled out the form, even though he would be responsible to fill out the form. NM 8 confirmed that the critique form does not evaluate proper technique of cardiac compressions performed and that there was "no" defibrillation problems marked. NM 8 provided additional concerns related to the event, but the critique form did not reflect those concerns. The signature, date and time of the person completing the critique were left blank.

6. Nursing staff were noted to not be following the facility policy for turning patients to prevent skin breakdown and were not accurately scoring the patient's risk for skin breakdown using the Braden Scale (Refer to A 392).

On 10/4/12 at 10:40 am, NM 1 was interviewed regarding the hospital's pressure ulcer prevention quality improvement project. NM 1 stated the nurses had received a four hour class on pressure ulcer prevention in response to prior deficiencies. NM 1 stated the project did not involve the review of patient records for deficient practices. When NM 1 reviewed the patient records identified in A 392, NM 1 noted that the night shift had a majority of the above errors. NM 1 acknowledged that there was not a current plan to evaluate if nursing staff were implementing the skin care policies for repositioning patients from side to side and avoiding the back for high risk patients. NM 1 confirmed that accuracy of the Braden score for current patients had not been evaluated as part of the project.



22710

Based on staff interview and document, medical record, and policy review, the facility failed to prioritize its performance improvement activities with a focus on high-risk or problem-prone areas as evidenced by:

1. Orders for medications with cumulative side effects, orders with no dosing parameters, inadequate dosing or frequency were written by prescribers, processed by pharmacists, and administered by nurses with no evidence of intervention to ensure safety for Patients 31, 34, 35, and 64. Refer to A 500.

2. Lack of tracking and accountabilities of controlled substances to ensure patient safety. Refer to A 494.

3. Lack of meaningful monitoring for pain medications for Patient 32. Refer to A 500.
Findings:

1. Patient 34 had methadone (a very potent, long acting pain medication) and Roxanol (a strong, short acting pain medication) ordered when Patient 34 was not accustomed to strong pain medications. Patient 34's methadone was transcribed incorrectly as 25 milligrams (mg) instead of 2.5 mg, as ordered. The pharmacist and nurse reviewing Patient 34's order did not check the transcription against the order for accuracy. Patient 34 was administered methadone at ten times the ordered rate. Approximately two hours later, Roxanol 2.5 mg was administered to Patient 34 and the narcotic log did not demonstrate that the unused portion of the Roxanol was wasted, therefore, Patient 34 may have received all of the Roxanol in the vial (20 mg). Patient 34 was later found unresponsive and Narcan (a reversal agent for pain medications) was ordered in a dosage that was not consistent with the long acting methadone Patient 34 was prescribed. Additionally, the Narcan was not administered according to Patient 34's physician orders. Patient 34 died the next morning. Refer to A 500 findings 1-3 for detailed information.

2. On 9/27/12 in the afternoon, Patient 64 received two different types of benzodiazepines (sedatives); Xanax (one dose) and Ativan (two doses). Patient 64 became unresponsive and required the use of a rescue agent. Refer to A 500, finding 9.

3. Medication orders for Patients 31 and 35 were written with no guidelines for dosing or specific monitoring for safety of morphine and propofol (an anesthetic agent). There was no evidence of nursing or pharmacy staff clarifying the orders with the physicians. Refer to A 500, finding 4.

On 10/2/12 at 2 pm, in an interview and review of the facility's quality assurance and performance improvement (QAPI) system, the Director of Pharmacy (DP) confirmed that the facility's QAPI system failed to have performance measures related to high-risk or problem-prone areas such as opiates, anesthetic, or sedative use. Opiates are high alert medications. According to the Institute for Safe Medication Practices (ISMP), high-alert medications are, "Drugs that bear a heightened risk of causing significant patient harm when they are used in error. ... The consequences of an error are clearly more devastating to patients." ISMP has a list of potential high-alert, available online, that included narcotics/opioids and anesthetic agents (e.g., propofol).

The facility's QAPI system did not monitor prescribing patterns, pharmacy involvement for evaluating prescribers' orders and intervening when needed, and nursing practices related to safe medication administration, such as double checking of the transcribed orders to the original written order, and clarifying unclear orders.

Based on staff interview and document review, the governing body (GB) failed to ensure that the hospital had defined, implemented, and maintained an effective program for quality improvement and patient safety that did correct previously identified deficiencies in the Quality Assessment and Performance Improvement (QAPI) Plan program.

This failure hindered the hospital's ability to ensure that patients were treated safely and properly.

Findings:

On 9/24/12 and again on 10/1/12, the hospital's QAPI Plan was requested. On 10/1/12, the policy titled, "Quality Assessment/Performance Improvement Plan-Hospitalwide" was provided. This policy documented that it was "created" in 1990 and "last reviewed/approved" on 2/29/12.

On 10/1/12, the "Board Quality Council Reporting Calendar" was provided, showing that during the six months from 5/12 to 9/12, there had been no modification in the previous planned calendar. The overall "Plan & Annual Evaluation" had been presented once in May and would not again be reviewed until the following May. The "Environmental of Care Plans & Annual Evaluation," only listed topics that dealt with Infection Control issues, was reviewed once annually, had been presented in March, and was not planned again until the following March. The topic of "Environmental of Care" covered the issues of "safety, security, hazardous materials and waste, emergency management, life safety ..." The topic of "Medication Use," medication errors & significant adverse drug reactions ..., had been presented in June and was scheduled for review in September. The topic of "Regulatory Compliance Snapshot" was scheduled for June and December. On 10/2/12, the Director of Quality Management (DQM) verified that the Board Quality Council Reporting Calendar had not been modified to facilitate any corrections.

On 10/2/12, the minutes of monthly GB meetings from 4/12 to date were reviewed and there was no recording that a specific modification to the QAPI program/plan had been made. In the 5/12 meeting, there was a report referencing a 5/17/12 meeting of the Medical Executive Meeting (MEC) and results from the CMS survey in 4/12. Eleven specific anticipated deficiencies were listed and preliminary plans to correct them. The 5/12 meeting contained a copy of the "2011 Annual Report Performance Improvement." The last page of this report documented "Key Findings 2011" that included four surveys and very significant regulatory or accreditation findings for each. However, the report did not focus on any plans for improvement. Documented in the 5/12 minutes was, "Organizational Performance Improvement & Patient Safety Plan 2012 - 2013" without signatures or approval. The 7/12 meeting documented a presentation from the DQM reviewing the survey results. The presentation goes on to state a number of policies that were rewritten or being worked on for deep sedation, surgery services and others. However, QAPI was not referenced and there was no information about planned corrections for the QAPI plan.

On 10/2/12 at 5:25 pm, the DQM was asked for more information about the governing body's involvement and directions pertaining to any modification(s) of the QAPI plan/program after it had been cited as deficient in April 2012. Specifically requested was information about what the GB had done to assure that previously identified, high-risk, high-prevalence and/or problem-prone quality & safety issues were addressed. The DQM indicated that the hospital had been striving to target these areas in a number of administrative staff meetings, but that documentation of many of those meeting had not been recorded. Any indication of the governing body's involvement should be recorded in the minutes of the governing body's Quality Council.

On 10/3/12, the minutes of the Quality Council meetings for 2012 were reviewed and no specific information was apparent that the GB had changed the QAPI program plan or had instructed that corrective action be taken to improve the QAPI program.

On 10/4/12 at 10:15 am, the DQM was interviewed and verified the following:

GB oversight: There was no available documentation that the GB had specified corrective action for the deficient QAPI findings from prior CMS surveys.

Contracted Services: The Performance Measures for the contracted services was incomplete (only 20 of >400 contracts). The Performance Measures for the 20 listed contracts did not have specific objective quality indicators and had either not been measured in a meaningful way or had not been measured.

On 10/4/12, the Chief Clinical Officer (CCO) and Director of Risk Managment (DRM) were interviewed and verified that there was no documentation to substantiate that the GB had taken specific steps to correct the prior deficiencies cited on 4/30/12, for QAPI.

Based on interview and record review, the facility failed to ensure that quality assessment and performance improvement (QAPI) activities were evaluated for the effectiveness of the improvement actions. This failure had the potential for deficient practices to persist and adversely impact patients.

Findings:

On 9/25/12, the facility's Patient Safety, Quality Council, and Board of Directors committee minutes were reviewed for the previous three months. The minutes of these meetings demonstrated that data was collected for performance improvement projects and for regulatory compliance related to the facility's last survey in 4/12. The analysis of the data collected in the regulatory compliance studies documented only whether the indicator data had improved or not. The action plans were not documented or evaluated as to their effectiveness. The analysis of the systems involved or the staff knowledge of the systems were not documented.

On 9/26/12 at 7:30 am, the Director of Quality Management (DQM) was interviewed regarding how the facility planned to correct deficient practices identified in the previous 4/30/12 survey. DQM explained that indicators were developed and the staff were educated on the expectations and Department Managers and Directors were instructed to conduct random audits which were reported to the Quality Management department. The data from these reports were collated and presented to the above committees. DQM stated that actions plans were not documented, evaluated, nor reported to the Quality Council.

Based on interview, the facility failed to ensure that adequate resources for measuring, assessing, improving, and sustaining the hospital's performance were allocated in Quality Management. This failure resulted in the lack of performance improvement in areas previously identified as non-complaint, and could result in poor quality of care and adverse clinical outcomes to patients.

Findings:

On 10/4/12 at 2:40 pm, the Director of Quality Management (DQM) was interviewed regarding the repeated deficiencies in the areas of pharmacy and nursing, and the overall lack of evidence that a credible quality cycle of review (Plan, Do, Check, Act) was implemented. (Refer to A 267, 285, 392, 404, 500). DQM stated that the consultant (VPQM) hired to do the oversight of the quality program left in 5/12 and had not been replaced. DQM explained that the VPQM had proposed increasing the Quality Management staff, prior to her exit. DQM explained that she had added one staff person that was indicated on the plan, but that other positions recommended by the consultant were either not approved by administration or were on hold until a replacement VPQM arrived to hire additional staff. DQM stated that she was unable to do everything that needed to be done to oversee the quality cycle of review with her current staff.

Based on observation, interview, and record/policy review, the facility failed to ensure that nursing services were furnished or supervised by a registered nurse and consistent with nationally accepted standards of practice as evidenced by:

1. Failure to provide accurate nursing assessment to evaluate risk for pressure ulcer development, provide measures to prevent pressure ulcers, use speciality beds, and provide wound care in a manner consistent with nationally accepted standards of practice. Refer to A 392 and A 394.

2. Failure to provide emergency resuscitation measures in a manner consistent with nationally accepted standards of practice. Refer to A 392.

3. Failure to provide nursing services in a manner to prevent cross contamination. Refer to A 392 and A 749.

4. Failure to provide safe administration of medication, in accordance with physician orders, facility policy, and nationally accepted standards of practice. Refer to A 404.

5. Failure to provide conscious sedation, in accordance with nationally accepted standards of practice. Refer to A 392.

6. Failure to provide adequate nurse staffing for one of 60 sampled patients (Patient 2) and to have a comprehensive plan to meet patients nursing needs. Refer to A 392.

7. Failure to prevent an unlicensed nurse from providing assessment and care to patients. Refer to A 394.

8. Failure to document care provided to one of 60 sampled patients during a procedure. Refer to A 392.

These failures resulted in potential for delays in recognition of patient complications, and adverse outcomes such as excessive medication, pressure ulcers, cross contamination, spread of infection, and medical errors.

The cumulative effect of these systemic problems resulted in the inability of the hospital to comply with the statutorily-mandated Condition of Participation for Nursing Services.

Based on observation, interview, and record review, the facility failed to ensure that adequate numbers of licensed registered nurses were available to care for all patients and provide nursing care for two of 60 sampled patients (Patients 2 and 28) and three outside the sample (Patients 61, 62, and 63), as needed, evidenced by:

1. The facility failed to increase nursing staff to provide an increase in nursing care when Patient 2 had a significant change of condition, requiring intensive care.

The facility failed to have an effective, detailed, and comprehensive nursing services plan that outlined how patients' needs were to be met.

2. The facility failed to ensure that the nursing staff accurately identified risk for skin breakdown and provided accurate assessment and effective interventions to prevent pressure ulcers for Patients 28, 61, 62, and 70.

3. The facility failed to ensure that nursing staff was knowledgeable of and used techniques to prevent cross contamination.

4. The facility failed to ensure that the nursing staff used proper techniques for an emergency resuscitation, in accordance with facility policy and nationally recognized standards of practice, for Patient 61.

5. The facility failed to ensure that nursing staff monitored the effects of sedation during and after Patient 63's procedure.

6. The facility failed to ensure that medications administered to Patient 63 during a procedure were documented.

These failures put patients at risk for individual care needs not being met, unsuccessful resuscitation and death, skin breakdown and pressure ulcer development, infections, poor clinical outcomes and complications, and the facility's inability to effectively evaluate nursing staffing and services that meet the needs of all patients.

Findings:

1. On 9/27/12, Patient 2's record was reviewed. Patient 2 was admitted on 7/29/12 with a severe stroke with locked in syndrome (a condition in which a patient is aware and awake but cannot move or communicate verbally due to complete paralysis of nearly all voluntary muscles in the body except for the eyes). Patient 2 was fed through a gastric tube (a tube through the skin and into the stomach to provide nutrition for patients who cannot swallow safely).

On 9/19/12 at 2:35 pm, Registered Nurse (RN) 22 stated that on 8/15/12 at 7:30 am, she assumed care of Patient 2 on the medical surgical unit 3M. Patient 2 had a tracheostomy tube (a tube inserted through the neck into the airway which allows a person to breathe without the use of his or her nose or mouth) and had excessive secretions which required constant suctioning the previous shift (night) and increased nursing staff. RN 22 reported that suctioning occurred as often as every 2 minutes and that she had to "bag" (positive pressure respirations using a device called an Ambu-bag) Patient 2 every hour to ensure adequate oxygenation. RN 22 explained she was unable to keep up with the amount of suctioning and care for Patient 2, while also providing care for her other three patients. RN 22 further stated she had to station herself outside Patient 2's door to be able to monitor his respiratory status. RN 22 recalled Patient 2's physician examined Patient 2 at approximately 8:30 am and determined that Patient 2 should be in the intensive care unit (ICU), due to his unstable respiratory status and increased nursing needs. RN 22 further recalled that she was told that Patient 2 would not be transferring to the ICU because there were no beds available. RN 22 requested assistance with her patient load in order to care for Patient 2 and was told by her supervisor that there was no available RN staff to relieve her patient load. RN 22 explained that she was able to get help from her peers for specific patient care tasks, such as a dressing change, but remained responsible for the care of the other three patients. RN 22 indicated that by the late afternoon of 8/15/12, Patient 2 had stabilized and returned to a level of care that was appropriate for a medical surgical unit. RN 22 stated she reported her concerns regarding nurse staffing to the administration using the internal risk management reporting system, but had not received any response.

Patient 2's record contained a physician's order on 8/15/12 for transfer to the intensive care unit which had been crossed through (cancelled). Patient 2's physician recorded a progress note for 8/15/12, indicating that Patient 2 had excessive secretions and a presumed aspiration pneumonia (lung infection caused by inhaling secretions or fluids such as tube feeding).

The facility policy titled, "Patient Classification System - Nursing," dated 9/25/12, indicated the purpose of the policy was to:
- Determine staffing based on patient care needs;
- Identify workload and plan unit staffing;
- Enable Director, Administrative, Clinical Coordinator, Clinical Coordinator and/or the staffing office to make appropriate decisions related to staffing requirements and resource allocations...
- Assist Clinical Coordinators to make appropriate patient assignments on a given unit.
The policy further indicated, "Each patient classification system will have a mechanism for converting predicted patient care needs to required staff. From this, the supervisor will allocate staffing resources." The policy did not contain any objective measures of how the patient classification related to the staffing of a patient care unit.

On 10/4/12 at 11:25 am, Nurse Manager (NM) 3 reviewed Patient 2's record and recalled the events of 8/15/12. NM 3 confirmed that no ICU beds were available until later in the day by which time Patient 2 had stabilized. NM 3 further confirmed that RN 22 had requested a change in her patient care load, but that no staff were available and no adjustments were made to RN 22's patient care load. NM 3 stated she was the person who told Patient 2's physician that an ICU bed was not available. When asked how the facility planned to meet the nursing needs of patients when the acuity is high, like in the case of Patient 2, NM 3 stated, "We just ask for extra staff if we can get it, and we just help each other out." NM 3 stated that she, the clinical coordinator, and other RNs had assisted in the care of Patient 2 and the other patients assigned to RN 22 (Patients 3, 4, and 5) on 8/15/12, however, was unable to provide evidence in Patient 2, 3, 4, or 5's records of additional nursing care assistance being provided.

On 10/4/12, the facility policy titled, "Patient Concerns, Complaints, Grievances, and/or Service Recovery - Hospitalwide," dated 6/22/11, indicated the definition of a serious grievance was "A serious complaint related to a health care practitioner's practice or facility condition or system, which has a potential to cause or has actually caused patient harm or injury...Serious grievances require investigation and documentation by the Department Director and others (e.g. Director of Risk Management). The report is forwarded to Hospital Administration within 24 hours.... The Risk Management Director / Quality Director may respond to all grievances in writing by outlining steps taken to investigate the grievance, the results of the grievance process and the date of completion. This must occur within 7 days of the receipt of the grievance."

On 10/4/12 at 11:25 am, NM 3 was asked about the report made to risk management regarding RN 22's staffing concern. NM 3 was unaware of the report. NM 3 was able to produce a report from the risk management data base that indicated the concern had been sent to the Staffing Office supervisor and no action had been taken. NM 3 confirmed this was not consistent with the facility policy.

On 10/4/12 at 12 pm, the Chief Nursing Officer (CNO) was interviewed. CNO stated that if a patient was unable go to an ICU bed, the nurse staffing should be at the same level as if he was in the ICU.

On 10/3/12 at 4:10 pm, the facility policies regarding staffing were reviewed with NM 1. NM 1 confirmed that there was no tool or other objective means in use that would convert the patient classification scores each shift to the amount of staff needed on a nursing floor. NM 1 further confirmed that there was no mention in the policies of what to do in an event when ICU beds were unavailable, or if patients' change of condition occurred mid-shift.

On 10/4/12 at 12 pm, the CNO was interviewed regarding the above situation with Patient 2 and the facility policies regarding staffing. CNO confirmed that the current policies did not address how to maintain staffing levels consistent to meet the patients needs.




22707

2a. During record review on 10/1/12, the face sheet (contained demographic information) and a physician's progress note, dated 6/30/12, indicated that Patient 28 was admitted to the facility on 6/17/12 with diagnoses that included sepsis (severe infection) and multiorgan failure (kidney, liver, heart, respiratory). Patient 28 was admitted to the intensive care unit (ICU) and was unresponsive.

Photographs that were taken by facility staff indicated the progression of pressure ulcers to the back left side of Patient 28's head and his left ear that were not reported to the Department when they advanced to unstageable pressure ulcers.

The facility's "Wound Assessment Record" (revised 8/08) sheet under "Pressure Ulcer Staging" defined an unstageable ulcer as full thickness tissue loss in which the base of the ulcer is covered by slough (yellow, tan, gray, green or brown dead tissue) and/or eschar (dry scab - tan, brown, or black) in the wound bed.

Photographs, dated 6/26/12, visualized Patient 28's left ear as extremely red with an area approximately 1 centimeter (cm) by 1 cm at the center, outer rim of the ear that had visible eschar to the lower center edge. A photograph of the left side of the head (back) indicated an area of deep tissue injury (purple and maroon localized area of discolored intact skin due to damage of underlying soft tissue from pressure or shear) and was defined in the Wound Assessment Record sheet to be approximately 4 cm in circumference.

Patient 28's photographs, dated 7/5/12, indicated the progression of the eschar on the left ear to include a deeper center ridge in the center of the wound and change in color of the eschar from tan to brownish black. The photograph of the wound at the left side of the back of Patient 28's head localized to approximately 3 cm by 2 cm with eschar that had begun to develop over the top of the wound.

The photograph of Patient 28's left head (back), dated 7/17/12, indicated a definitive pattern of eschar approximately 3 cm by 2 cm.

During an interview on 10/1/12 at 3 pm, the manufacturer and supplier of specialty beds and other medical equipment representative (Rep) stated Patient 28 had been placed on a Triadyne bed (special air bed that can be adjusted to position the patient without pillows or wedges).

The Rep stated she arrived in the ICU to find air had leaked out of the head of Patient 28's air bed and that his head was slightly hyperextended (bent backwards) and that staff had placed a bath towel folded lengthwise under the back of his head and rolled the outer edges of the towel inward, toward each ear, to stabilize the head and prevent movement.

The Rep stated she instructed the staff member assigned to Patient 28 that a towel should never be placed under a patient when they are on an air bed because it prevents the flow of air to the skin and would cause pressure to the part of the body lying on the towel and could result in a pressure ulcer.

The Rep stated she emailed all members of the wound care team and cautioned them that staff in the ICU's had been using towels for positioning, causing the risk for pressure ulcers to develop. The Rep stated she had observed towels that were used under the heads of other patients on at least two other occasions.

The Rep stated when she instructed staff each time she came to the facility (weekly) she would instruct them that it was the manufacturer's recommendation that nothing external was to be used to prop a patient on the air beds including pillows and/or towels. She stated the air could be adjusted on any of the air beds to place the patient properly in any position that they had previously achieved with pillows and/or towels.

When the nurses in the ICU's would explain why they used the towels and/or pillows the Rep stated she instructed them that was their clinical judgment and choice, but not the recommended practice.









22456

2b. On 9/25/12, Patient 61's record was reviewed. On 6/30/12, Patient 61 was admitted for brief episodes of unconsciousness and a 2-3 day history of low grade fever and mild cough. Patient 61 had a history of heart disease, diabetes, high blood pressure, and kidney failure requiring hemodialysis (treatment to remove waste products from the body that are normally filtered by the kidneys).

On 9/25/12, the facility policy titled, "Skin Assessment - Nursing," dated 8/31/11, directed nursing staff to document daily their assessment for patient's level of risk for developing pressure ulcers using the Braden Score. Six areas of assessments include: sensory perception; moisture; activity; mobility; nutrition; and friction and shear. "For all patients with Braden score 14 or less or at high risk for skin breakdown due to other conditions, initiate wound and skin care protocol orders."

Patient 61's record contained the following information:

On 7/6/12 at 7:15 pm, Patient 61 was assessed to have a Braden Score of 14. The nutrition component was assessed "3" which meant adequate. Patient 61 had been receiving gastric tube feedings with Nepro (type of supplement for dialysis patients) at 28 milliliters/hour (Calculated 1344 calories if patient received for 24 hours without interruption). RN 12 positioned Patient 61 on her back at 10 pm for 2 hours;

On 7/18/12, Wound/Skin Care Orders were signed by the physician. The "Wound/Skin Care Orders" included, "1. Turn and reposition patient from side to side at least every 1-2 hours."

On 7/19/12, Wound Care Team Notes read, "Risk for further skin breakdown due to current pressure ulcer Stage 2 left heel, low Braden (score)."

On 7/24/12 at 11 pm, RN 19 assessed the Braden Score of 14, had an unstageable pressure ulcer to left heel, receiving pureed diet with assistance, and positioned her on her back at 11 pm and 6 am for 2 hours.

On 7/26/12 at 7:30 am, RN 17 assessed the Braden Score of 13 and positioned the patient on her back at 12 pm and 4 pm for 2 hours. At 7:25 pm, RN 18 assessed the Braden Score of 14 with adequate nutrition and positioned on back at 7:25 pm for 2 hours.

On 7/27/12, RN 16 assessed the Braden Score of 14, documented buttocks reddened and positioned her on her back at 8 am. There was no documentation of changes in position for Patient 61 during the 12 hour shift.

On 7/28/12, RN 15 assessed the Braden Score of 13 and was positioned on her back at 7 am for 2 hours and 31 minutes without justification.

On 7/30/12, RN 20 assessed the Braden Score as 13 and positioned her on her back at 8:19 am for 2 hours.

On 7/31/12, RN 13 documented Braden Score assessment was 13, and received Patient 61 on her back at 7:25 am and did not document that her position had been changed during the 12 hour shift. RN 13 documented that Patient 61 refused to be turned at 6:24 pm. First documentation of position change was at 10:38 pm, over 15 hours later.

On 8/1/12, RN 14 positioned Patient 61 on her back at 2 am for 2 hours and 47 minutes and at 6:03 am positioned Patient 61 on her back for 1 and half hours without justification. RN 15 assessed Braden Score of 12 and positioned the patient on her back at 12:37 pm for over 2 hours.

During a review of Patient 61's record with NM 1 on 10/4/12 at 10:40 am, NM 1 confirmed that the physician's order for side to side turning had not been followed and initiating side to side turning was not done when the Braden Score was 14 or below.

2c. On 10/1/12, Patient 62's record was reviewed. Patient 62 was admitted on 7/26/12 for lethargy (decrease in normal energy level) and had a history of poor intake due to nausea and vomiting, encephalopathy (brain dysfunction), high blood pressure, diabetes, and kidney failure requiring hemodialysis.

Patient 62's record contained the following information:

On 7/28/12, Patient 62 was transferred to the Intensive Care Unit (ICU) for septic shock (a life-threatening blood infection), and a low heart rate. The Braden Score (Predicting Pressure Sore Risk) was assessed to be 12 when he was transferred to the ICU and wound care consult was ordered. At 6 pm, Patient 62 was positioned on his back for 2 hours with documentation that his coccyx was purple by RN 10. The next nurse (night shift), RN 11 assessed his Braden Score at 13, documented that his coccyx (tailbone area) was purple and positioned Patient 62 on his back at 10 pm and 4 am the following morning, 7/29/12.

On 7/29/12, during day shift, RN 10 assessed the Braden Score as 13, documented purple coccyx, and positioned him on his back at 6:15 pm. During the night shift, RN 11 assessed the Braden Score as 12, documented sacrum (tailbone area) with deep tissue injury and skin tear and positioned him on his back at 11 pm and 3 pm for 2 hours each.

On 7/30/12, RN 10 assessed the Braden Score as 12, intubated on ventilator, documented sacrum purple with skin tear and positioned on back at 10 am for 2 hours without justification such as a procedure requiring patient to be on his back for that length of time. RN 11 assessed and documented that Patient 62's Braden Score as 14, there was no change in status, the patient was intubated, sacrum was purple and had skin breakdown, and Patient 62 was positioned on his back at 11 pm for 2 hours, without justification.

On 7/31/12 at 10:15 am, physician orders were "Turn and reposition patient from side to side at least every 1 - 2 hours. Not to be on back."

On 8/1/12 at 1:15 pm, Patient 62 was positioned on his back for 2 hours, and again at 5:15 pm.

On 8/2/12, Patient 62 was on his left side from 5:15 am to 8:15 am, three hours.

On 8/6/12, at midnight, Patient 62 was on his back until 4:15 am, 4.25 hours and then again on his back at 6:15 am for less than two hours. Patient 62 was on his right side from 12:15 pm to 8 pm, 7.75 hours.

On 8/7/12, Patient 62 remained on his left side from 4:15 am to 8:15 am, four hours. Patient 62 was noted to have a Stage 2 pressure ulcer on his sacrum at 8:15 am.

Patient 62's Braden Score remained below 14 for all of the above dates.

During a review of Patient 62's record with NM 1 on 10/4/12 at 10:40 am, NM 1 confirmed that nurses caring for Patient 62 were not following the facility's policy when Patient 62 was positioned on his back, but should not have been when he was assessed to have a Braden Score of 14 or less. NM 1 acknowledged that Patient 62 was positioned on his back more often during the night shift and was not turned every one to two hours, as indicated in the facility policy and physician's orders.

2d. On 10/1/12 at 2:30 pm, Patient 70 was observed in the ICU breathing with the assistance of a ventilator (mechanical respiratory machine), sedated with propofol (anesthesia) and fentanyl (strong narcotic) intravenous infusions, and receiving nutritional feeding via a gastric tube at 28 milliliters/hour.

In an interview on 10/1/12 at 3:30 pm, RN 4 stated that Patient 70 had a Braden Score of 14. After reviewing the elements of the Braden Score with RN 4, RN 4 concluded that Patient 70's Braden Score was actually 12. RN 4 had previously assessed Patient 70 demonstrating adequate sensation for movement and adequate nutrition. However, RN 4 stated she recognized that gastric tube feeding was not adequate for nutrition and two sedation infusions (propofol and fentanyl) would more accurately reflect Patient 70's Braden Score as 12.

2e. In an interview on 10/1/12 at 2:50 pm, RN 23 stated that for patients with a Braden Score of 14 and below, standing orders would be initiated and the patient would be turned every 1 - 2 hours from back to right side to left side to back. After reviewing the standing orders for wound and skin care, RN 23 stated that she was not aware the orders were "turning from side to side."

In an interview on 10/3/12 at 9:45 am, RN 24 stated he had been working for two weeks and had an extensive orientation that included skin assessment using the Braden Score. He stated that a Braden Score of 14 and below would initiate standing orders for the patient to be turned every 1 - 2 hours from back to right side to left side to back. After reviewing the standing orders for wound and skin care, RN 24 stated that he was not aware the orders were "turning from side to side."

3. On 10/1/12 at 9:55 am, RN 8 on 2 Central was observed in Room 222, wearing a gown and gloves for isolation precautions, adjusting the patients intravenous line on the patient's right arm. As RN 8 came around the bed to the left side, she bent down and picked up something off of the floor with her right hand, pushed her isolation gown away from the right side and front of her body, placed what she had picked up from the floor in her uniform pocket, and replaced the isolation gown back over her uniform.

During a concurrent interview, when asked what she had picked up from the floor and placed in her inner pocket RN 8 stated, "glucometer strips" (a plastic strip placed in a machine to measure blood sugar). RN 8 stated she realized after the fact what she had done and knew that it was not proper protocol. The Director of Risk Management (DRM, also an RN) instructed RN 8 to throw the bottle of glucometer strips away. The floor was a dirty surface and the nurse took a contaminated patient care item, the bottle of strips, and put it in her pocket for future use on other patients. This practice had the potential to expose other patients to pathogens from the patient in Room 222.

During an interview on 10/1/12 at 10:30 am, RN 8 clarified that the bottle of glucometer strips contained up to 50 strips and were to be used for the isolated patient. When asked if she had thrown the bottle of contaminated glucometer strips away RN 8 stated, "No, they are in the room on the counter." When asked why she had not thrown them away when instructed to do so RN 8 stated, "I was already out of the room when DRM said to throw the bottle away and I was going to do it the next time I went into the room." RN 8 acknowledged that another nurse could have entered the patient's room to use the contaminated strips, posing a risk for cross contamination.

In a concurrent interview, the DRM acknowledged that RN 8's actions were not consistent with standards of nursing practice to prevent cross contamination.

4. On 9/28/12 at 9:50 am, an emergency response (code blue) by nursing staff was observed in Room 379 in the Intensive Care Unit (ICU). NM 8 was observed performing chest compressions on Patient 65, while standing at the middle of the bed and leaning forward. After a few minutes NM 8 announced to everyone, "Stand Clear." NM 8 discharged the defibrillator (apparatus used to produce a brief electroshock to the heart allowing the heart's natural pacemaker to regain control and regulation of the heart rate and rhythm) to find the defibrillator had not been charged. The Infection Control Practitioner (ICP) 1 was present during the code blue and acknowledged that NM 8 was not using proper position for high quality compressions.

The facility policy titled, "Cardiopulmonary Resuscitation (CPR) - Hospitalwide, dated 7/27/11, directed staff of the procedure, including the responsibilities of the Code Team. Under "The Code Team responsibilities," 2. C-Circulation b, reads, "Do external cardiac compressions using proper technique."

Proper technique for compressions during CPR as described by American Heart Association (AHA) includes positioning oneself directly over the patients chest to be able to compress the chest to a depth of 2 inches and allow the chest to recoil on its own. AHA's CPR videos online show improper methods of compressions, including the "Rocker" which was similar to the compressions given to Patient 65 by NM 8.

On 10/3/12 at 11:15 am, NM 8 was asked about his position while delivering compressions to Patient 65. NM 8 recalled that his position was not directly over Patient 65 when he was doing compressions. NM 8 acknowledged that he did not charge the defibrillator and there was a delay in delivering the shock to Patient 65.

5. On 9/27/12, Patient 63's record was reviewed. On 9/21/12, Patient 63 received Versed (sedation) and Morphine (narcotic) for a central line placement at 9:40 pm. This combination of drugs was used to provide conscious sedation (using pain and anxiety medications so patients can tolerate unpleasant or painful procedures) for Patient 63. Patient 63's record contained vital signs documented at 9:15 pm and 10:15 pm. There was no documented evidence that routine procedural vital signs were obtained during and after the procedure to monitor Patient 63's safety and recovery from the conscious sedation drugs.

On 9/27/12, the facility policy titled, "Procedural Anesthesia/Analgesia - Adult-Hospitalwide," dated 9/24/12, read, "Policy ... O. Intra-procedure Monitoring: Cardiac rhythm, vital signs (except temperature) including oxygen saturation, and End-tidal CO2 (when used for deep sedation), sedation level and pain level are to be monitored and recorded every 2 - 5 minutes throughout the duration of the procedure ...P. Immediate Post-procedure Monitoring: Post-procedure monitoring for both inpatient and outpatient will include vital signs (including SaO2, [oxygenation of blood] pain and sedation scale) will be assessed and documented every 5 minutes X 20 minutes either in the procedure area or PACU (Post Anesthesia Care Unit) of Critical Care Unit (prior to transport to the sending unit) ...S. Monitoring Post-Return to Sending Unit: For inpatients - upon return to the sending unit, heart rate, blood pressure, respirations, pain and sedation scale will be monitored every 15 minutes X 2, then every 30 minutes X 2."

In an interview on 9/27/12 at 10:45 am, NM 8 reviewed Patient 63's record and confirmed that intra-procedure and post-procedure monitoring should have been done, but there were no vital signs taken during or after the procedure per policy or nursing standards of care on 9/21/12 for Patient 63.

6. On 9/27/12 at 11:30 am, Patient 63 was observed to have an ultrasound guided thoracentesis (surgical puncture and drainage of the chest) procedure. Radiologist 59 injected medication to the identified area prior to the puncture and verbally informed RN 3 that he injected 10 milliliters. Sodium bicarbonate 8.4% (mixed with Lidocaine decreases the sting when medication is injected into the site) and 1% Lidocaine (numbing medication) were observed to be adminsitered by Radiologist 59.

A review of the documentation of the procedure for Patient 63 did not include the amount, mixture, and time of the medication given by Radiologist 59.

In an interview on 9/27/12 at 11:53 am, RN 3 stated that she did not document the amount and mixture of the medication given by Radiologist 59.

The facility's job description for "Registered Nurse," dated 1/91, indicated that the nurse must document all care given to the patient.

In an interview on 10/3/12 at 9:30 am, NM 17 confirmed there was no documentation that lidocaine and sodium bicarbonate was given, prior to the procedure.

Based on interview and record review, the facility failed to ensure that a contracted wound nurse consultant (WRN 3) had valid, current California State licensure, prior to having direct contact with a patient and performing a wound procedure. (The licensure investigative process would provide information for the issuance and/or denial of licensure in California. Until a nurse is licensed to practice in the State of California they may not have direct patient contact or involvement in the nursing process that would ultimately effect direct patient care).

This failure resulted in one of 60 sampled patients (Patient 26) receiving care that was not in accordance with nationally accepted standards of practice by an unlicensed individual, placing Patient 26 at risk for developing an infection and had the potential for the patient's wounds to worsen.

Findings:

During review of Patient 26's record, review of the emergency room physician's history and physical, dated 6/9/12, indicated that Patient 26 was originally admitted to the facility on 6/9/12 with diagnoses that included acute pneumonia with exacerbation of COPD (chronic obstructive pulmonary disease), MRSA (an antibiotic resistant bacterial infection), Hepatitis C (chronic infection effecting the liver), and a pseudoaneurysm (bulging of the artery caused by collection of blood in the weakened wall of the artery) in the left groin. Patient 26 was transferred to another facility on 6/11/12, for vascular surgery and readmitted to this facility on 6/17/12, with the wounds and blisters (as described above) and in contact isolation for MRSA and Hepatitis C. Patient 26's June 2012 wound treatement records were reviewed and documentation by WRN 3 was noted in the records.

On 9/26/12 at 4:45 pm, in an interview, WRN 3 stated that when she started work at this facility as a consultant wound nurse in early June of 2012, she was not licensed in the State of California to practice nursing and, until she became licensed, she was instructed by hospital Administration not to have any direct patient care contact. WRN 3 stated that she participated in the facility's performance improvement (PI) rounds that were conducted on 6/19/12 with a staff wound nurse (WRN 2) and licensed nurse wound treatment assistant (WTA). A patient (Patient 26) was presented that had an open wound to the left groin as a result of a non-healing wound post vascular surgery, severe edema to the left leg, and multiple fluid filled blisters on his left lower leg, ankle, and foot. WRN 3 stated she entered Patient 26's room to assess the wounds and blisters that Patient 26 had on his left groin, left leg, ankle and foot. WRN 3 stated that she did not have a temporary permit to practice nursing in the State of California on 6/19/12.

WRN 3 stated she did "pop" a blister on Patient 26's foot that "she thought" was on the top of the foot at the bend of the ankle when shown pictures of the blisters on Patient 26's left foot. WRN 3 stated she had put on a gown and gloves and squeezed the blister between her thumb and forefinger with her nails until the blister "popped." WRN 3 stated she then cleaned it and placed a 4 x 4 gauze dressing over it. (WRN 3 was not licensed in California at this time to perform the wound procedure).

When asked why she would pop the blister when she was instructed not to have patient contact, WRN 3 stated another wound nurse (WRN 2) had indicated the blister was an unstageable blood blister because it was dark colored around the edges. WRN 3 stated, "I wanted to prove to her that the blister was filled with clear liquid fluid and was not an unstageable blood blister."

When asked if she understood that standard protocol for wounds indicated that blisters were not to be broken unless for specific reasons, WRN 3 stated, "Yes." When asked if to prove to another nurse that the blister was clear fluid filled rather than blood filled was a valid reason to break the blister, WRN 3 stated, "It was an educational opportunity."

Review of the personnel records for WRN 3 indicated she was hired and began work at the facility on 6/4/12. No documentation of licensure was found until 8/2/12 at 2:03 pm, when a copy of an email from WRN 3 to the Chief Nursing Officer (CNO) read, "I now have a permanent license in CA."

An inquiry was sent to the Board of Registered Nursing (BRN) asking for the date of WRN 3's temporary permit issuance. According to the BRN, WRN 3 was issued a temporary license on 6/26/12 and "she was eligible to practice from that date."

During an interview on 10/1/12 at 2 pm, WRN 2 stated she and WRN 3 were in Patient 26's room on 6/19/12. WRN 2 stated that she left the room to get PolyMem (a soft absorbent foam dressing) to cover the intact blisters and when she returned to the room, WRN 3 was no longer there and WRN 2 noted that three of Patient 26's blisters were broken (no longer intact), wet with fluid leaking, and had no covering over them.

On 10/1/12 at 4:15 pm, an interview was conducted with WTA who stated she was in Patient 26's room when WRN 3 broke a blister on Patient 26's left medial ankle and peeled the skin away from another blister on the back of Patient 26's lower left leg. WTA stated WRN 2 had left the room to get PolyMem dressings, then while WRN 2 was gone, WRN 3 reached over onto the counter top near the bed and took an instrument from an opened wound care kit (she was unsure if it was the hemostat clamp or the tweezers). WTA stated that WRN 3 then grabbed the lower base of the blister on the medial (inner) ankle and pulled up quickly until it broke and "all this fluid just gushed out." WTA stated WRN 3 did not clean the blister area, but did place a 4 x 4 gauze over it. WTA stated that WRN 2 cleaned all the blistered areas when she returned and covered them with the PolyMem. WTA also stated that WRN 3 then went to a blistered area on the left leg behind the knee and peeled away all the loose skin that was over it. WTA stated that WRN 3 did not change her gloves between the wound procedures and did not clean either wound before or after touching them. When asked if WRN 3 cleaned or disinfected the instrument she used to break the blister, WTA stated, "No."

WRN 3 was functioning as a nurse within her specialty when she would enter a patient's room to assess a patient's wounds, evaluate the healing process with visualization of the wounds, and make recommendations for wound care treatments and/or changes to existing orders. The ability to perform these functions requires the skill and expertise of a nurse that was, by law, eligible to practice as a licensed nurse. WRN 3 was not licensed and not eligible to perform patient/wound care treatments on the date (6/19/12), she popped Patient 26's blisters and was not licensed to perform patient assessments, evaluations, and/or recommendations that would be within the nursing process and effect direct patient care until 6/26/12.

On 10/03/12 at 8:30 am, the above identified deficient practices of the facility failing to prevent WRN 3 from having direct contact with and performing a wound procedure on Patient 26, without a license to do so and not in accordance with nationally recognized standards of practice, were discussed with and verified by the Chief Executive Officer.

Based on staff interview and record review, the facility failed to ensure that medications were given, as ordered, for one of 60 sampled patients (Patient 34) when:

1. Patient 34 was given 10 times the ordered dose of Methadone;

2. Patient 34 was potentially given eight times the intended dose of morphine sulfate; and

3. Patient 34 was not administered Narcan, as ordered, to reverse the respiratory depressant effects of methadone and morphine.

Giving medications inconsistent with physician orders puts patients at risk for developing adverse effects related to excessive use, such as respiratory depression, unresponsiveness, and death. Patient 34 died on 9/15/12 at 7:30 am.

Findings:

On 9/26/12 at 5 pm, Patient 34's record was reviewed. Patient 34 was an 83 year old admitted to the hospital on 9/10/12 for diarrhea and abdominal cramping.

On 9/14/12 at 10:30 am, an order for "pain management" was written that included Methadone 2.5 milligrams (mg) to be given every 12 hours sublingually (under the tongue) and Roxanol (a potent morphine sulfate) 2.5 mg every hour for pain scale 0-3/SOB (shortness of breath); 5 mg every hour for pain 4-7/SOB; 10 mg every hour for pain 8-10/SOB.

1. Review of the medication administration record (MAR) revealed that 25 mg of methadone was given to Patient 34 (Ten times the dose that was prescribed).

On 9/27/12 at 10 am, review of the facility's pharmacy computer system revealed that the methadone order was entered erroneously for 25 mg instead of 2.5 mg (Ten times higher than what was intended).

On 9/27/12, review of the Accudose (automated dispensing cabinets, where medications are stored and electronically tracked) revealed that three syringes of methadone (10 mg each) were removed for Patient 34 on 9/14/12 at 12:02 pm.

2. Review of Patient 34's MAR revealed that on 9/14/12 at 1412 (2:14 pm), about 2 hours after the methadone dose, a morphine dose was administered and documented as 2.5 mg. However, review of the access record from the Accudose medication dispensing unit showed that one (1) milliliter was removed (one milliliter contains 20 mg of morphine). There was no documented evidence of the disposition of the remaining 17.5 mg.

The nurse that administered the medication was not available for interview.

On 9/27/12 at 10 am, Director of Pharmacy, was asked about the disposition of the 17.5 mg of morphine and stated that there was no electronic or manual documentation of wasting the 17.5 mg. Therefore, it could not be confirmed that Patient 34 was administered 2.5 mg of morphine. It was highly likely that 20 mg (1 milliliter) was administered.

3. On 9/14/12 at 2054 (8:54 pm,) Patient 34 had an order for Narcan 0.4 mg to be given now and repeat every half hour until responsive, times four doses. Narcan is a rescue agent for opiate/opioid type medication that reverses sedation and respiratory depression associated with excessive use of opiates, like morphine and methadone.

Review of the MAR revealed that two doses of Narcan were administered on 9/14/12 at 2115 (9:15 pm) and 2151 (9:51 pm). There was no documented evidence that the other two ordered doses were administered. Review of the Accudose medication dispensing unit Narcan usage report confirmed only two doses were removed on 9/14/12 at 2111 (9:11 pm) and 2152 (9:52 pm).

The first Narcan dose was administered about 20 minutes late. The second dose was not given within 30 minutes; it was given about 15 minutes late. Narcan is metabolized and eliminated from the body very fast, thus delay in administering the medication in minutes is very significant. Narcan is given in doses of 0.4 - 2.0 mg. Because of its fast clearance, it may need to be repeated every 2-3 minutes. Narcan is given in doses as high as 10 mg to achieve the desired reversal effect.

There was no documented evidence that Patient 34 was responsive to justify not administering the subsequent Narcan doses. Patient 34 died on 9/15/12 at 7:30 am.




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22710

Based on observation, interview, and record review, the facility failed to ensure that medical records were accurate for two of 60 sampled patients (Patients 32 and 34) and three patients outside the sample (Patients 61, 63, and 68).

1. Patient 32's pain assessment on the medication administration record (MAR) did not match the assessment in the electronically recorded nurses' notes.

2. Vancomycin (Vanco-an antibiotic) was not administered, as ordered, and there was no order for discontinuing the Vancomycin for Patient 34.

3. Patient 68's heart rhythm was not recorded during a procedure.

4. Patient 63 was administered medication which was not recorded.

Findings:

1. On 9/25/12 at 3:00 pm, Patient 32's record was reviewed with the Director of Pharmacy (DP.) Patient 32 was a 57 year old with multiple medical issues including chronic pain. Patient 32 had multiple pain medications orders. During the review, it was pointed out that pain re-evaluation may be documented in different areas in the record, such as the MAR and the HED (Horizon Expert Documentation-the electronic medical record).

On 9/26/12 at 11:30 am, during an interview, Registered Nurse (RN) 66 pointed out that the SAM (safe administration medication system), an electronic hand held device, requires an initial pain scale when pain medications are given. In order to proceed with administration of pain medication, a pain scale must be entered into SAM. RN 66 confirmed that the SAM alerts nurses to re-evaluate pain in one hour from medication administration. The information from the SAM is downloaded or is viewable on the MAR. RN 66 added that nursing assessments can be found in the HED, independent from the MARs, and that nurses actively chart notes, vital signs, and pain scales in the HED.

The DP and RN 66 confirmed that the data from the SAM is viewable on the MAR, but it is not communicated to the HED. The MAR did not match the nursing assessment for pain on 9/23/12 at 0826 (8:26 am), 1221(12:21 pm) and 1724 (17:24 pm). According to nursing notes documented in HED, the pain scale before medication administration was "9" and the pain scale after medication administration was "5." The MAR did not have re-evaluation for any of these times and instead of the pain scale, the following comment was entered, "Omitted-Dose Previously Given."

2. On 9/2712 at 9:30 am, review of the record for Patient 34 with the DP revealed the patient had an order for Vanco, a medication used to treat or prevent infections. Vanco was prescribed orally for C. Diff (Clostridium difficile), which is a bacteria that causes diarrhea. Review of the MAR revealed a note that on 9/12/12, Vanco was not given because it was discontinued. However, there was no prescriber's order indicating that it was discontinued. Review of the physician orders with DP revealed no discontinuation orders for Vanco.



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3. On 10/4/12 at 9:30 am, Patient 68's record was reviewed with NM 1. Patient 68 had a pericardial (area around the heart) window with drainage of an effusion (excess fluid) procedure on 10/2/12. The anesthesia record did not document the heart rhythm during the hour and a half procedure. The anesthesia record had an identified area for EKG (electrocardiogram, tracing represented the heart's electrical activity or heart rhythm) that was blank on the form.

In a concurrent interview, NM 1 stated that there was no documentation of heart rhythm on the anesthesia record.

4. On 9/27/12 at 11:30 am, Patient 63 was observed to have an ultrasound guided thoracentesis (surgical puncture and drainage of the thoracic cavity) procedure. Radiologist 59 injected medication to the procedure area, prior to the puncture, and verbally informed RN 3 that he injected 10 milliliters. Sodium bicarbonate (mixed with Lidocaine decreases the sting when medication is injected into the site) 8.4% and 1% Lidocaine (numbing medication) were observed administered by Radiologist 59.

A review of the documentation of the procedure for Patient 63 did not include the amount, mixture, and time of the medication given by Radiologist 59. The note by Radiologist 59 did not include information that medication was given to the patient.

In an interview on 10/3/12 at 9:30 am, NM 17 stated that after reviewing the dictation from Radiologist 59, Patient 68's record contained no documentation that Lidocaine and Bicarbonate was given, prior to the procedure.




26611

Based on interview and record review, the facility failed to ensure that patient records were legible, complete, and authenticated (verified/signed by the prescriber) within 48 hours for one of 60 sampled patients (Patient 1) and two outside the sample (Patients 61 and 76) when:

1. The post-procedure discharge sheet that verified that discharge instructions were understood was not signed by the patient or caregiver (Patient 1). Failure to obtain a patient's and/or caregiver's signature to verify that the patient discharge instructions were understood had the potential for the patient to not have essential information regarding limitations (such as participate in an activity that may interfere with the procedure performed or be dangerous to their health) or necessary follow up care.

2. The blood transfusion administration sheet was not signed by licensed staff who administered the blood (Patient 76). Failure to ensure licensed staffs signature upon administration of blood poses a risk that other health professionals may not know that the blood was administered, thereby potentially causing the patient to receive more than necessary and could result in complications.

3. Physician's orders for oxygen administration in the PACU (post anesthesia care unit) were not legible, resulting in the inability of licensed staff to accurately read/understand the orders and ensure that the intended order was followed (Patient 61).

Findings:

1. On 9/25/12, record review indicated that Patient 1 was admitted to the facility on 9/25/12 for outpatient surgery to remove a cataract from the right eye.

The pre-operative informed consent indicated that the State's language telephone line had been accessed for Patient 1, who was Spanish speaking only, to have his operative information explained to him in Spanish so he could understand what was being done and by whom.

The "Discharge Instructions Surgical/Post-Procedure" sheet and a "Post Sedation Discharge Instructions - Adult" sheet were both provided in English with written instructions for his next doctor appointment and to take his eye kit with him were also written in English. The line where the patient and/or caregiver were to sign that they received and understood the instructions was blank.

During an interview on 9/25/12 at 10:20 am, the Nurse Manager of the perioperative services (NM 4) stated that the discharge instruction sheet should have been signed by the Patient 1 or his caregiver.

2. Record review on 10/4/12 indicated that Patient 76 was admitted to the facility on 7/29/12 with diagnoses of drug overdose and facial trauma.

Lab records, dated 8/10/12, indicated that Patient 76 was anemic (low on red blood cells-necessary to carry oxygen to the brain and organs of the body) and Patient 76's physician wrote an order on 8/10/12 at 10:45 am, for 2 units of blood (one unit per bag) to be given to Patient 76.

The transfusion administration sheet for the 2 units of blood showed that the nurse that started the second unit of blood was supposed to sign their name on the line provided, demonstrating that the blood was given, but the nurse did not sign the sheet.

During an interview on 10/4/12 at 2 pm, NM 1 stated that all of the documentation needed for a blood transfusion is completed on the transfusion administration sheet and that the nurse that started the second unit of blood should have signed her name in the appropriate space.



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3. On 10/4/12 at 10:45 am, a concurrent interview and review of Patient 61's record was conducted with NM 1.

Physician's orders, dated 7/20/12, for oxygen administration in the PACU (post anesthesia care unit) were not legible. NM 1 confirmed that the oxygen administration orders were not legible.




11389

Based on staff interview and record review, the facility failed to ensure that physicians' verbal/telephone orders were authenticated (verified/signed by the prescriber who gave the order) and/or signed within 48 hours for one of 60 sampled patients (Patient 32) and one outside the sample (Patient 61). This failure resulted in delayed authentication posing a risk for medication errors and related adverse outcomes.

Findings:

1. On 9/24/12 at 3 pm, review of Patient 32's record with the Director of Pharmacy (DP) and Nurse Manager (NM) 15 revealed telephone and verbal orders that were either not authenticated (by the physician), or were cosigned later than 48 hours, which was not consistent with hospital policy.

a. The following orders were not authenticated:

An order for a fentanyl patch (potent pain medication delivered through the skin), dated 9/16/12, was not signed.

An order clarification to discontinue Tylenol, written on 9/22/12, was not cosigned.

An order for Morphine (a potent pain medication) to be given by injection was written on 9/16/12, but was not authenticated.

A clarification order for pain medications (Tylenol, Vicodin, and morphine) was written on 9/15/12, but was not authenticated.

b. The following orders were authenticated later than 48 hours from the time written:

An order to transfer Patient 32 to a critical care area was written on 9/15/12 and cosigned on 9/18/12.

Two orders to change a fentanyl patch were written about 1.5 hours apart on 9/18/12, but were cosigned on 9/21/12.

Review of the the verbal order form showed that the form had specific directions to physicians to "Please authenticate within 48 hours..."

The DP and NM 15 did not find any documented evidence that these orders were authenticated electronically or on paper.

According to the facility's policy titled, "Orders, Transcription and Requisition- Nursing," approved 8/24/12, indicated, "According to FRHG Medical Staff By-laws, verbal/telephone orders must be verified and signed (by hand with date/ time or electronically) by the physician who gave the order within 48 hours."


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2. A record review for Patient 61 with NM 1 was conducted on 10/4/12 at 10:45 am. The following was identified in the record:

On 7/9/12, verbal orders for Insulin Standing Orders were not authenticated by Medical Staff Member (MSM) 59 until 8/4/12, 27 days later.

On 7/11/12, verbal orders for medication changes were not authenticated by MSM 60 until 7/16/12, five days later.

On 7/17/12, verbal orders for speech therapy were not authenticated by MSM 58 until 8/6/12, 20 days later.

On 7/27/12, verbal orders for speech therapy were not authenticated by MSM 57 until 8/4/12, eight days later.

In a concurrent interview, NM 1 stated that several verbal orders were not authenticated by the physician within 48 hours, according to facility policy.

Based on staff interview and record review, the facility failed to properly execute informed consent for one of 60 sampled patients (Patient 31) by obtaining the patient's signature for blood transfusion, when the patient did not have the capacity to participate in health care decisions. This failure put the patient at risk for agreeing to and receiving procedures without understanding the risks associated with such procedures.

Findings:

On 9/25/12 at 8 am, Patient 31 was observed receiving morning medications. Review of Patient 31's record with Nurse Manager (NM) 5 and the Director of Pharmacy (DP), documented, "Assessment of Capacity and Resuscitation Orders," that Patient 31 "does not have the capacity to participate in health care decisions. Decisions will be made with surrogate(s) as described in progress notes." NM 5 and the DP explained that Patient 31 had a durable power of attorney, which means that the patient legally appointed someone to act on her behalf to handle health related decisions. However, the record contained two documents signed by Patient 31 on 9/20/12: 1) The Consent to Blood Transfusion, and 2) The Patient Teaching Handout - Blood Transfusion.

NM 5 and the DP did not provide any justification or documented rational for having Patient 31 sign both consents considering the evidence that she was not able to consent.


26611

Based on observation, staff interview, and record/policy review, the facility failed to ensure that pharmaceutical services met the needs of patients by failing to develop and implement policies and procedures to provide safe, effective use of drugs evidenced by:

1. Medications were not prescribed, controlled, and administered in a manner that ensures patient safety. Refer to A 500.

2. Controlled substance was not evaluated to prevent or timely detect abuse or diversion, to ensure patient safety. Refer to A 494.

3. Medications were not administered in accordance with policy, acceptable standards of practice, or the order of the physician. Refer to A 404.

Due to the pattern of deficient practices to ensure medication safety, an Immediate Jeopardy was declared on 9/27/12 at 6:48 pm with the Chief Executive Officer (CEO), Chief Clinical Officer (CCO), Chief Nursing Officer (CNO), the Director of Quality Management (DQM), Director of Risk Management (DRM), and the Director of Pharmacy (DP). The Immediate Jeopardy was abated on 10/3/12 at 2:30 pm after onsite monitoring of the facility's corrective action plan, including weekend monitoring on 9/29 and 9/30/12, demonstrated compliance and safe medication practices. Refer to A 500, findings 1-3.

The cumulative effect of these systemic problems resulted in the hospitals inability to ensure the provision of quality pharmaceutical services safely and effectively.

Based on staff interview and record and policy review, the facility failed to ensure accurate accountability of all controlled substances when they failed to have a surveillance to detect and identify potential misuse, abuse, or theft. There was no system in place for evaluation of frequent discrepancies. Lack of accountability can facilitate misuse or abuse of controlled substance, and subsequently put patients at risk of harm by being cared for by intoxicated persons, or suffer in pain when the medications intended to treat them are diverted.
Findings:

1. On 10/3/12 at 1 pm in an interview, the Director of Pharmacy (DP) stated, related to controlled substance accountability, that Pharmacy Technician (Pharm Tech) 2 evaluated open (unresolved) discrepancies. However, there were no systems in place to evaluate activities such as the frequently returned controlled substances and frequent reports of miscounting, specifically in resolved discrepancies. These reports were not evaluated to trend or track users or discrepancy rates. The DP said that only non-reconciled discrepancies were reviewed. Non-reconciled discrepancies are potentially nonexistent because staff is expected to resolve discrepancies by the end of the shift.

There was no documented evidence that the pharmacy department evaluated how discrepancies were resolved or their patterns. For evaluation of the unresolved discrepancy, Pharm Tech 2 generated a report for 9/30/12 from midnight until 9:10 am on 10/3/12. There were no open (unresolved) discrepancies on the report. However, when a report for resolved discrepancies was generated for the same time frame, the report was 13 pages long. For 26 out of 45 discrepancies, the reason for discrepancies and resolution was documented as "Error in counting, no discrepancy."

There was no evidence that the resolved discrepancy reports were evaluated for trends or that the information was validated. The facility policy titled, "Controlled Substance-Hospitalwide," dated 2/20/2012, read, "Controlled substances ... will be inventoried during each pocket access ...." However, a 58% (26 out of 45) error rate in counting should be a cause for concern and an indicator for further evaluation.

2. On 9/26/12 at 5 pm, the record for Patient 34 was reviewed. The record revealed that on 9/14/12 at 10:30 am, an order for "pain management" was written for Roxanol (a potent morphine) as follows:
2.5 milligrams (mg) every hour for pain scale 0-3/SOB (shortness of breath);
5 mg every hour for pain 4-7/SOB; and 10 mg every hour for pain 8-10/SOB.

Patient 34's medication administration record revealed documentation that a 2.5 mg morphine dose was administered on 9/14/12 at 1412 (2:12 pm). Morphine comes as 20 mg per milliliter. Review of the access record from the Accudose medication dispensing unit showed that 1 milliliter was removed. But there was no documentation of the disposition of the remaining 17.5 mg if Patient 34 was administered 2.5 mg.

On 9/27/12 at 10 am, when asked about the disposition of the 17.5 mg of morphine, DP stated that there was no electronic or manual documentation of it.

Based on observation, staff interview, and clinical record and document review, the facility failed to ensure patient safety by administering medications safely to four of 60 sampled patients (Patients 31, 32, 34, and 35) and one outside the sample (Patient 64) evidenced by:

1. A long-acting narcotic pain medication was ordered for a patient who had no history of taking any narcotics. The order was not questioned or clarified in relation to the patient history by pharmacy or nursing staff. The narcotic was transcribed incorrectly to the medication system as 25 milligrams (mg) instead of 2.5 mg, as ordered. (Patient 34).

2. A duplicate short-acting narcotic was ordered in addition to the long-acting narcotic for Patient 34 without questioning or clarification by pharmacy or nursing staff.

3. A drug to reverse the effects of a narcotic overdose was ordered in inappropriate dosing and was not questioned or clarified by the pharmacist and the nurse did not administer the drug, according to the physician's order. (Patient 34)

4. Medications were ordered for two patients without specific dosage guidelines and monitoring for safety and pharmacy staff did not question or clarify the orders. (Patients 31 and 35)

5. Orders to discontinue medications for Patient 31 were unclear and were not clarified by the pharmacy or nursing staff.

6. Patient 32's pain was not reassessed in a timely manner to evaluate the effectiveness of pain medications.

7. A name band was placed on Patient 31 without verifying the patient's identification.

8. The facility policy for the flushing of intravenous (IV) lines was not followed.

9. Duplicate doses of anxiety medications which lead to an overdose were administered to Patient 64. The pharmacy and nursing staff did not review or question the order. The wrong rescue agent was prescribed for Patient 64's overdose.

Due to the pattern of deficient practices to ensure medication safety, an Immediate Jeopardy was declared on 9/27/12 at 6:48 pm with the Chief Executive Officer (CEO), Chief Clinical Officer (CCO), Chief Nursing Officer (CNO), Director of Quality management (DQM), Director of Risk Management (DRM), and Director of Pharmacy (DP). The Immediate Jeopardy was abated on 10/3/12 at 2:30 pm after monitoring of the facility's corrective action plan demonstrated compliance with safe medication practices with the above facility staff present. Refer to findings 1-3.

These failures can lead to medication errors which can result in patient harm and death. Patient 34 died on 9/15/12 at 7:30 am.

Findings:

1. On 9/26/12 at 5 pm, Patient 34's record was reviewed. Patient 34 was an 83 year old, admitted to the hospital on 9/10/12 for diarrhea and abdominal cramping and had a history of heart failure, chronic kidney disease, and pulmonary hypertension. (A condition in which high blood pressure in the lungs makes the heart work harder.)

On 9/14/12 at 10:15 am, a physician's note was written indicating there had been a discussion regarding Patient 34's DNR/DNI (do not resuscitate, do not intubate) and that a form was signed. The same note documented that the patient's gastric tube (a feeding tube inserted into the stomach) was discontinued, other medications were stopped, and pain medications were increased.

On 9/14/12 at 10:30 am, an order for "pain management" was written that included Methadone 2.5 milligram (mg) to be given every 12 hours (hrs) sublingually (under the tongue).

According to LexiComp Online, a pharmaceutical reference, Methadone is a long acting pain medication that has a long half-life, which means it stays in the body for a long time. In a young healthy adult, it can take about 200 hrs (approximately eight days) to eliminate the medication from the body. According the drug labeling information, it is directed to use methadone with caution in debilitated patients as there is a greater potential for critical respiratory depression, even at therapeutic dosages. Another concern is using methadone in an elderly person as the elderly may be more sensitive to adverse effects.

Methadone has a boxed warning, which is the strongest warning that certain contraindications or serious warnings, particularly those that may lead to death or serious injury, may be required by the FDA to be added to the labeling of the drug.

The warning indicates that severe respiratory depression has occurred with administration of methadone. It also directs to use extreme caution during treatment initiation, dose titration and conversion from other opioid agonists to methadone.

According to the medication history, Patient 34 had acetaminophen (Tylenol) and gabapentin (non-narcotic medication for nerve pain) ordered for pain.

In an interview, the Director of Pharmacy (DP) confirmed on 9/27/12 at 10 am, that there was no methadone, no morphine, or other opiates (narcotics) on the medication reconciliation for Patient 34. DP further confirmed Patient 34's record contained no documented justification for ordering Methadone for pain considering the history of medication use for Patient 34.

Patient 34 was 83 years old with multiple medical problems and no current medication history of taking narcotics. There was no clinical justification to prescribe methadone, a strong opiate with a long half-life as a first step. The practitioner who wrote the order, was not available for interview during the survey.

There was no documented evidence that the pharmacist evaluated the drug for appropriateness considering the patient condition and history of previous medication use. The DP confirmed the medication system did not contain evidence of the pharmacist questioning the order.

On 9/27/12 at 10 am, review of the pharmacy computer system revealed that the methadone order was entered erroneously for 25 instead of 2.5 mg (ten times higher than what was intended) into the medication system.

2. On 9/14/12 at 10:30 am, in addition to the above Methadone order, Patient 34's physician ordered Roxanol (oral morphine sulfate, a short acting pain medication) as follows:

2.5 mg every hr for pain scale 0-3/SOB (shortness of breath); 5 mg every hr for pain scale 4-7/SOB; 10 mg every hr for pain 8-10/SOB.

During an interview and record review, the DP confirmed there was no clinical justification for ordering duplicate pain medications (Methadone and Morphine) as Patient 34 was previously only taking acetaminophen and gabapentin, and there was no evidence of prior narcotic use. The DP confirmed that there was no documented evidence that the pharmacist that processed the order questioned or clarified the need for duplicate therapy.

3. On 9/14/12 at 2054 (8:54 pm), Patient 34 had an order for Narcan 0.4 mg to be given now and repeat every half hr until responsive, times four doses.

According to LexiComp Online, Narcan is a rescue agent for opiate/opioid type medication that reverses sedation and respiratory depression associated with excessive use of opiate, like morphine. Narcan is metabolized and eliminated from the body very fast; therefore, is it usually given in frequent dosing, every few minutes. According the drug labeling information, Narcan is given as follows:

"Initial: 0.4-2 mg; may need to repeat doses every 2-3 minutes; after reversal, may need to readminister dose(s) at a later interval (i.e., 20-60 minutes) depending on type/duration of opioid. If no response is observed after 10 mg total, consider other causes of respiratory depression. ...Continuous infusion (should be considered )... For use with exposures to long-acting opioids (e.g., methadone), sustained release product ..."

The practitioner who wrote the order was not available for interview during the survey. During a concurrent interview, the DP confirmed there was no documented evidence that the pharmacist that processed the Narcan order questioned the dose or the frequency of the order.

The nurse did not administer Narcan according to the physician order, giving Narcan twice instead of the four times ordered. Refer to A 404, finding 3.

Patient 34's record revealed that he had became unresponsive after he was administered 25 mg of methadone, at 10 times the intended dose, and potentially 20 mg of morphine about two hrs later. Refer to A 404, finding 2. Patient 34 was prescribed Narcan, a rescue agent, in inadequate doses and inadequate frequencies for reversal of Methadone.

On 9/15/12 at 7:30 am, Patient 34 died.

The facility failed to have systems in place to protect patients from receiving medications that put them at risk for respiratory depression, and involved medical staff, pharmacists and nursing as follows:

a. Medications were prescribed in a manner that was not consistent with standard pharmaceutical standards. Methadone was prescribed without regard to recommendations for extreme caution in elderly, debilitated, and opiate naive patients such as Patient 34. Narcan was not prescribed in dosages appropriate for reversing the life threatening side effects of a long acting narcotic, such as methadone.

b. Orders were processed without evidence of evaluation or clarification with the prescriber regarding the appropriateness of medication, dose or frequencies.

c. Medications were processed in error.

d. Medications were administrated in error without verifying that what is being administered matched the physician's order.

e. Medications to reverse life threatening side effects were not administered, according to physicians orders.

On 9/27/12 at 3:40 pm, DQM was asked if the facility was aware of the above errors and if any action had been taken. DQM stated they were aware of the error but had not taken any action yet, due to the current survey. DQM confirmed that the facility was aware of deficient practices in the medication prescription, dispensing, and administration from previous surveys and medication incidents.

Because of the above pattern of systems failures, an Immediate Jeopardy (IJ) was declared on 9/27/12 at 6:48 pm with the CEO, CCO, CNO, DQM, DRM, and DP present.

Hospital management staff presented a plan of corrective action on 9/27/12 at 7:25 pm, to ensure safe use of medications. The plan included the following elements:
1. Two registered nurses would review all current orders for duplication of opiates/opioid medications and accuracy of orders. Nurses would verify that the orders input into the pharmacy computer system matched the orders in the patient record. The nurses will call the physician for any questionable orders.

2. Because there was not enough pharmacy staff, a registered nurse would work with pharmacists to serve as a second reviewer until pharmacists were hired to do the double review. The review will ensure/evaluate accuracy of orders and detection of duplicate therapy. The DP will provide specific guidelines for what to look for.

3. Physicians will evaluate onsite any patients that need a reversal /rescue agents.

Other elements including education were added to the action plan. Modifications were also made to address concerns identified during monitoring from 9/28/12 through 10/2/12.

Between 9/28/12 and 10/2/12, during review of the facility's action plan implementation, the following concerns were identified:
1. Inconsistent with the immediate action plan, pharmacy technicians were reviewing orders for accuracy and duplication instead of registered nurses.

2. Confidential interviews with registered nurses that were reviewing orders revealed that staff were comfortable identifying duplicate therapy if it involved the same medication or "obvious" large doses. They expressed concerns that they were not very familiar with other aspects of the pharmacist's job, such as identifying medications with duplicate effects (medications in the same class), duplicated side effects (medications from different drug classes that cause sedation and respiratory depressions (opiates and benzodiazepines - anxiety), drug-drug or drug disease interaction, appropriate dosing for compromised renal or liver functions.

3. Unclear orders were not clarified, as an order for a morphine sulfate infusion to be given for "comfort care" was not clarified by the nurse or the pharmacist. Although the reviewing nurse indicated that this order was discussed with the DP, there was no documented evidence that it was clarified through the double review process. Refer to A 500, finding 4.

4. Patient 64 was administered duplicate anxiety drugs which resulted in an overdose. Pharmacy and nursing staff did not question or clarify the order. Patient 64 had the wrong rescue agent prescribed to treat the overdose. Refer to A 500, finding 9.

On 10/2/12, additional steps to be implemented by medical staff to ensure competency of mid-level practitioners and patient safety were added to the action plan, such as increased peer review related to these events and when reversal agents for narcotics were used, mandatory education for physicians and mid-level practitioners regarding the use of reversal agents for long acting narcotics, evaluating activities of midlevel practitioners through peer review, reviewing and revising protocols, and restricting the list of medications (formulary) to be utilized by mid-levels in the absence of the supervising physicians. It was also added that medical staff will be expected to review the patient's pharmacy profile and narcotic/sedative dosing history, prior to prescribing sedatives and narcotics. The modified plan of action was unanimously approved by the Medical Executive Committee Staff. The plan was signed by Chief of Staff, Chief Medical Officer, and Chief Clinical Officer and the Chief Nursing Officer.

Onsite monitoring of the corrective actions was continued, including during the weekend of 9/29/12 and 9/30/12. On 10/3/12 at 1:30 pm, after verification of various steps taken to ensure medication safety, and 24 hours without observed deficient practices, hospital management staff (CEO, CCO, CNO, DQM, DRM, and DP) were informed that the Immediate Jeopardy was abated.

4. Medication orders for Patients 31 and 35 were written with no guidelines for dosing or specific monitoring for safety, and there was no evidence of clarifications by nursing or pharmacy staff.

a. On 10/1/12 at approximately 5:00 pm, the record for Patient 35 was reviewed with the DP and Registered Nurse (RN) 67. Patient 35, a 75 year old with multiple medical conditions, that was brought to the hospital by ambulance, after 3-day episodes of chest pain at home and history of collapse on 9/29/12. On 10/01/12 at 1620, Patient 35 had a physician order for " ...continue morphine drip, titrate up to comfort, no lab draws." RN 67 was not sure how to implement an order with no parameters and searched for a protocol for "comfort care." RN 67 confirmed after research and checking with other staff, that the facility did not have a policy for comfort care.

The order did not have a starting rate, increments by which to increase the rate, there was no maximum rate, or directions as to when to stop the infusion. The order did not include any safety measures, such as monitoring for respiratory depression or low blood pressure.

On 10/2/12 at 11:30 am, a review of Patient 35's record revealed a telephone order, dated 10/2/12 and timed 1720 (5:20 pm) that read, "Titrate morphine drip by 2 mg/hr as needed for respiratory gasping. No Max (maximum) dose."
"As needed for respiratory gasping. No max." was entered into the pharmacy computer system and consequently printed on the MAR. There was no evidence of intervention to clarify the order. The pharmacist said on interview, that respiration monitoring is a nursing responsibility. No justifications were offered to explain the rational for the no maximum dosing that was included in the order.

Morphine is used to alter perception of and response to pain. It also produces generalized central nervous system depression (sedation) which would include slowing the respirations of the patient.

On 10/2/12, interviews of staff pharmacists that processed the order and nursing (RN) staff that conducted the second review revealed no documented evidence for clarification of the order, its intended use, or the goal of therapy, especially when "No Max dose" was specified on the order.

Review of the dispensing record from the pharmacy revealed that three morphine infusions were signed out to Patient 35. That provided additional opportunities for interventions. The pharmacists who signed out the morphine from the controlled substance cabinet and the pharmacists that double checked the morphine infusion for dispensing had additional chances to evaluate, identify, question, or intervene, but no documentation was done to this effect.

Similarly, the nurses who noted the morphine orders, started any of the morphine infusions or increased the rate, had additional opportunities to evaluate, identify, question, or intervene.

b. On 9/25/12 at 8 am, Patient 31 was observed receiving morning medications. Review of Patient 31's record with NM 8 and the DP revealed an order for Propofol drip for sedation. Propofol is a medication used intravenously in intubated and mechanically ventilated adult patients undergoing treatment in a critical care setting. The order did not have any guideline on what dose to start at, how to titrate, the maximum dose, or the goal of treatment. In a concurrent interview, the DP confirmed there was no documented evidence that pharmacy staff clarified the order for the starting rate or titration rate.

According to Lexi-Comp Online, propofol infusion is associated with a serious side effect with a high mortality rate, called Propofol-related infusion syndrome. Risk factors for developing this syndrome include administration of high doses.

5. On 9/25/12 at 8 am, Patient 31 was observed receiving morning medications. Review of the record with NM 8 and the DP revealed four orders for respiratory treatments written on 9/23/12 at 9:56 pm. On the following page, an order for Solu-Medrol (used as an anti-inflammatory or immunosuppressant agent in the treatment of respiratory conditions such as asthma or COPD) 125 mg to be given now and every 6 hrs, was dated 9/23/12 and timed 10:06 pm. Shortly after the Solu-Medrol order, another order was written to "discontinue above respiratory orders of tonight." It was not clear if Solu-Medrol was to be discontinued with the respiratory orders or to be administered to Patient 31. There was no documented evidence that the order was clarified by nursing or pharmacy staff.

6. On 9/25/12 at 3 pm, Patient 32's record was reviewed with the DP. Patient 32 was a 57 year old and had multiple medical conditions including chronic pain. Patient 32 had multiple orders for pain medications. Evaluation of the medication administration record (MAR) revealed information that did not represent a true assessment of Patient 32's pain. The pain reassessment after treatment was either too soon after the dose, or too late to give accurate assessment if the treatment was effective.

According to the facility policy titled, "Pain Management- Hospitalwide," approved 8/24/12, "The patient's pain will be re-assessed within 60 minutes of administration of a PRN medication."

The pain reassessment was not completed within 60 minutes, as directed by policy. The time for re-assessment ranged from 10 to 16 hours after the medication was administered, as follows:

a. According to the MAR, Patient 32 was administered morphine sulfate on 9/23/12 at 8:26 am; the reassessment for pain was documented at 7 minutes after midnight on 9/24/12, about 16 hours after the dose.

b. A morphine dose was administered at 6:06 am, on 9/19/12; the reevaluation was documented at 16:57, about 11 hours later.

c. Similarly, on 9/18/12 at 20:30 (8:30 pm), a dose of morphine was administered; the assessment was documented at 5:51 am on 9/19/12, about 10 hours after the dose.

Evaluating the pain assessment for Patient 32 revealed documentation of either "accept" or "sleeping" from 9/21 until 9/24. These documentations did not give a clear assessment of the patient's condition. It was not known if Patient 32 was "sleeping" because he was overmedicated or his pain was truly controlled.

According to the California Board of Registered Nursing for Pain Management Policy, proper management of patient's pain is a nursing function. Pain management includes assessing pain and evaluating response to pain management interventions, documenting pain assessment, intervention, and evaluation activities in a clear and concise manner; and intervening to minimize drug side effects.

In a concurrent interview, DP acknowledged the above findings.

7. On 9/25/12 at 8 am, RN 64 was observed administering medications to Patient 31. In the room, the nurse indicated that Patient 31 did not have an identification (ID) band. RN 64 took an ID band that was on the sink and tried to fasten it to the patient's right ankle. RN 64 was asked about the facility's procedures for identifying patients that can not identify self; she said that she would call the family, and then clarified that the family would have to be on site to be able to positively identify the patient. RN 64 continued administering the medication without confirming the identity of the patient.
Review of the facility's policy titled, "Patient Identification Precautions- Hospitalwide," approved 6/29/211, revealed, "Two forms of patient identification are always used to assure correct patient identification ... If the patient is unable to respond, a photo identification will be utilized to identify the patient."

8. On 9/25/12 at 8 am, Patient 31 was observed receiving morning medications. During the medication pass, a 250 milliliter (ml) bag of normal saline (salt solution for injection) was observed hanging on the IV (intravenous) pole, but it was not infusing at that time. Review of the record with NM 8 and the DP revealed no orders for normal saline.

In a concurrent interview, the DP stated that the bag of saline was used to flush the IV line.

On 9/25/12, a concurrent interview and review of the facility's policy titled, "Flushing: Saline Lock & Central Venous Catheter- Hospitalwide," approved 6/10, with the DP revealed the following: "When administering intermittent medication thought a peripheral catheter, a flush bag may be used with the following parameters: Flush bag will be 50 ml of Normal Saline." The DP confirmed the policy was not implemented when a 250 ml bag was used for flushing the IV lines instead of 50 ml bag, as required in the policy. The importance of using a small volume for IV flushing is to prevent unintended fluid overload which can cause harm to a patient.




22456


9. On 9/28/12, Patient 64's record was reviewed. Patient 64 was scheduled for an MRI (magnetic resonance image - scan that occurs in a tube) of the brain on 9/27/12. At 3:40 pm, Patient 64's physician ordered "Xanax (class: benzodiazepine - sedative) 0.5 mg (milligram) now" and "Give prior to MRI Ativan (class: benzodiazepine - sedative) 1 mg IV x 1, if not working give another 1 mg of Ativan - monitor patient while having MRI."

Patient 64's MAR indicated that the Xanax was administered at 3:53 pm.

According to LexiComp Online, a pharmaceutical reference, oral Xanax has an onset of action within one hour and reaches its peak in the blood at two hours. Xanax has a duration of 5-7 hours.

On 9/27/12, Patient 64's MAR indicated that Ativan was given at 4:40 pm (less than one hour later and before the full onset of the Xanax). Patient 64 received a second dose of Ativan at 5:48 pm (less than 2 hours after the Xanax and 68 minutes after the first Ativan.)

According to LexiComp, Ativan IV has an onset of action from 5-20 minutes and has a duration of 6-8 hours.

9/27/12 nurses notes indicated Patient 64 was found unresponsive at 7:55 pm (approximately four hours after the Xanax and two hours after the second Ativan dose when all these drugs were at their peak blood concentration). Patient 64's physician ordered Narcan (a drug used to reverse narcotic overdose)which was given at 8:22 pm. Patient 64 revived somewhat but was unable to state his name or where he was. Patient 64 was transferred to the ICU and later received a dose of Romazicon (a drug used to reverse benzodiazepine overdose). The nurses notes indicated Patient 64 became more alert and appropriately responsive after receiving the dose of Romazicon.

In an interview with RN 25 on 10/3/12 at 8:53 am, RN 25 stated he gave the Xanax as ordered and communicated to the MRI RN 21 who took Patient 64 for the MRI. RN 25 said the hand off communication was done verbally and there was no written record of the exchange.

In an interview with RN 21 on 10/1/12 at 1:50 pm, RN 21 stated that RN 25 informed her of the orders for the Ativan that could be repeated but denies being told of the Xanax. RN 21 stated she gave the first Ativan dose, as ordered, and the second dose because Patient 64 wasn't able to lay down for the MRI. RN 21 stated that Ativan was frequently used to sedate patients so they could tolerate the MRI. RN 21 stated Patient 64 was sleepy during the procedure and was able to walk to the wheelchair after the procedure. RN 21 stated she was unaware of the Xanax being given (it was charted on Patient 64's MAR and in the physician's orders). RN 21 stated she was confused why Patient 64 was given Narcan when she was told Patient 64 had not received any narcotics.

During the time of these events, an Immediate Jeopardy was called regarding concern of unsafe medication ordering and administration practices related to duplicate drugs and drugs within the class such as this case with Patient 64. Refer to A 500, findings 1-3.



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28773

Based on observation, interview, and document review, the hospital failed to ensure that dietetic services met the needs of all patients as evidenced by failure to:

1. Develop comprehensive organizational structure to ensure the nutritional needs of patients were met. Refer to A 630 and A392.
2. Develop, track, measure and analyze performance improvement activities that accurately reflected the scope and nature of the services. Refer to A 267.
3. Ensure the dietetic service staff was competent in their respective duties. Refer to A 622.

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

Based on tray line observations, staff interviews, and hospital document review, the hospital failed to ensure the competency of the staff member responsible for taking food temperatures as evidenced by the inability to accurately calibrate food thermometers and take food temperatures. Failure to ensure staff competency in this task may result in foods being cooked and/or held at temperatures that support the bacterial growth associated with foodborne illness. Foodborne illness may result in nausea, vomiting, and in severe instances, death.

Findings:

On 9/25/12 at 11:40 am, Cook B was observed taking food temperatures in preparation of the noon tray line. It was noted there was a 30°F difference between the hospital's and surveyor's thermometers. Upon completion of the task, the surveyor requested Cook B demonstrate the procedure for thermometer calibration. Cook B stated she had already calibrated her own thermometer earlier. Cook B obtained a small silver pan of water and ice. It was noted the pan contained approximately 1/2 ice and the remainder was water. At this time, Cook B realized she was not using her own thermometer that had been calibrated. Upon thermometer stabilization, Cook B adjusted the thermometer to 32°F. At this time, the interim Clinical Nutrition Manager (CNM) instructed Cook B to pour out water and add more ice since the surveyor's digital thermometer was higher than 32°F. Once ice was added Cook B adjusted the thermometer to 32°F. Cook B then went to retake the temperatures of the food on tray line. It was still noted to have 30°F differences between the hospital's and surveyor's thermometers. The CNM informed Cook B to leave the thermometer in the food until the needle stops moving then to wait 15 seconds and record that temperature.

The standard of practice would be to ensure the ice/water mixture had enough ice to ensure a slushy mixture.

On 9/25/12, in a concurrent interview with the interim CNM, interim Director of Food Service, and the interim Patient Services Manager, the CNM stated that Cook B was confusing the procedure on how to take temperatures of the food items. The CNM stated the thermometer needed to stay in the food until the needle stops moving then hold for 15 seconds.

Review of the in-services for 2012-2011, did not show any in-services to Dietetic Service staff regarding thermometer calibration or how to accurately take temperatures of the food.
Review of the hospital's in-service on thermometer calibration and accurate measurement of the food dated 9/26/12, indicated thermometers must be accurate to at least +/- 2°F from 32°F. It showed steps to calibrate a bi-metallic thermometer ice bath method and to fill with 60% cubed ice and to add just enough cold water to cover the ice (40%). Place thermometer in ice water bath at least 3 inches deep for two minutes. If the thermometer does not read 32°F, adjust accordingly. It indicated how to accurately take the temperature of food. It indicated to remove the item from the heating source. Probe the item of food in the middle of the food, making sure the tip does not touch the bottom or sides of the container. It indicated to keep the probe in the item until the needle stops moving then hold for 15 seconds then record the temperature of the item in the log and clean the thermometer.

28773

Based on observation, staff interviews, nutrition care review, and review of hospital documents, the hospital failed to ensure:

1) An effective system, based on standards of practice, for evaluation of medical nutrition therapy interventions for four of eight patients reviewed for nutrition care (Patient 24, 26, 27, and 74);

2) The menu was being followed; and

3) The pureed menu was analyzed for the nutritional components to meet the current national standards including the RDA (Recommended Dietary Allowances) and the DRI (Dietary Reference Intake) of the Food and Nutrition Board of the National Research Council. Failure to implement timely and effective systems for evaluation of medical nutrition therapy may result in further compromising nutritional and medical status for at risk patients. Failure to have a nutrient analysis of the pureed menu and to follow the planned menu has the potential for the patients in the hospital to receive inadequate nutrition. Refer to A 392, finding 3.

Findings:

Nutrition Care

Rideout Campus

1. Patient 24 was admitted with left shoulder septic arthritis on 9/16/12. Medical record review was conducted on 9/26/12. Review of the history and physical, dated 9/16/12, indicated Patient 24 has a past medical history of diabetes and chronic pressure ulcer (localized injury to the skin and/or underlying tissue usually over a bony prominence, as a result of pressure, or pressure in combination with shear and/or friction).

Review of the physician's orders, dated 9/16/12 and timed 4:15 pm, indicated a diabetic cardiac diet. Review of the physician's orders, dated 9/17/12 and timed 8:30 am, indicated wound care orders with a dietitian referral for consult if patient has a stage 3 or 4 pressure ulcer. A wound care team assessment, dated 9/17/12, noted that Patient 24 had an unstageable pressure ulcer (localized area of tissue damage). The standard of practice for an unstageable pressure ulcer would be to classify it as a Stage 4. Hospital policy titled, "Clinical CVS -Adult Nutrition Risk Level Criteria," dated 5/3/12, noted that patients with Stage 3 and 4 pressure ulcers would be considered to be at high nutritional risk.

A comprehensive nutrition assessment, dated 9/18/12, noted that Patient 24 was 5 feet 3 inches and weighed 170 pounds. The Registered Dietitian (RD) noted the patients' ideal body weight was 115 pounds. It was also noted that Patient 24's body mass index was 30. Patients whose body mass index is 30 or greater are considered to be obese (National Institutes of Health, 2012). The RD estimated Patient 24's nutritional needs to be 1755-2048 calories (30-35 calories per kilogram (kg) of adjusted body weight) and 88-105 grams (g) of protein (1.5-1.8 g per kg). The RD recommended the implementation of a sugar free health shake, three times/day with meals, as well as a 250 milligrams (mg) Vitamin C twice a day by mouth, 220 mg Zinc once a day by mouth, Neprovite once a day by mouth, and a consistent carbohydrate standard diet with ground meats. The nutritional goal for Patient 24 was documented as a dietary intake of greater than 75% of meals and supplements and to meet micronutrient needs to promote wound healing. It was also noted that the recorded meal intake for the last two meals at the time of assessment was 53%. The RD classified Patient 24 as being at high nutritional risk and would be re-evaluated at 2-4 days.

A nutrition reassessment, dated 9/20/12, noted that Patient 24's weight was 141 pounds. The RD questioned the accuracy of the admit weight of 170 pounds and the patient reported her usual body weight was 145 pounds. It was also noted the patients' BMI was now 25. Patients whose BMI is 25 are considered to be overweight (National Institutes of Health, 2012). The RD re-estimated Patient 24's nutritional needs to be 1923-2244 calories (30-35 calories per kg) and 64-77 g of protein (1-1.2 g per kg). The nutritional goal for Patient 24 was documented as a dietary intake of 50% or greater for meals and supplements and to promote wound healing. The RD classified the patient as being at moderate nutritional risk with the reason being low oral intake and would be re-evaluated at 4-6 days.

Review of the nutrient analysis for the consistent carbohydrate standard diet indicated it provides approximately 1610 calories and 96 g of protein as a weekly average.

On 9/26/12 at 9:55 am an interview was conducted with the interim Clinical Nutrition Manager (CNM). The CNM stated that Patient 24 should have stayed as a high nutrition risk especially since the patient had low oral intake. The CNM stated the protein needs were too low for the wound healing needs. The CNM stated they do not have a policy for the nutritional assessment of wounds, however, she has a reference that is the standard of practice that should be followed. The CNM stated they started doing clinical peer reviews in August after the last survey. The CNM stated she had not tied any kind of competency into the RD's evaluations at this time but she would definitely need to do a coaching with the RD after seeing these concerns.

Review of the hospital's standard of practice for Stage 4 pressure ulcers indicated: 35-40 calories per kg, 1.5-2 g of protein, multivitamin with minerals, 250-500 mg Vitamin C per day plus 25-50 mg Zinc per day for up to 8 weeks. This standard of practice was based on the reference: Malnutrition in the Institutional Elderly: Effects on Wound Healing, Ostomy Wound Management, 2004; Vol. 50, Issue 10.

Review of the hospital policy titled, "Adult Nutrition Risk Level Criteria," dated 5/3/12, noted that patients with Stage 3 and 4 pressure ulcers would be considered to be at high nutritional risk and would receive re-assessment every 2-4 days. Patient 24 was not classified at high nutritional risk at the reassessment period nor was there a timely evaluation of the effectiveness of implemented medical nutritional therapy, and the standard of practice for wound healing was not followed. It would be the standard of practice for nutrition practitioners to assess and evaluate the effectiveness of nutrition care, according to each person's individual medical condition and needs (Academy of Nutrition and Dietetics, 2010).

2. Patient 74 was admitted on 9/12/12 with diagnoses that include acute upper gastrointestinal bleed, acute/recurrent aspiration pneumonia on the right side possibly due to poor dentition, and dehydration. Medical record review was conducted on 9/27/12. Review of the physician's orders, dated 9/13/12 and timed 1:02 am, indicated a Total Parenteral Nutrition (feeding a person intravenously, bypassing the usual process of eating and digestion)/Nutrition consult in the morning. Review of a wound care team assessment, dated 9/13/12, noted that the patient had an unstageable pressure ulcer (localized area of tissue damage). The standard of practice for an unstageable pressure ulcer would be to classify it as a Stage 4.

A comprehensive nutrition assessment, dated 9/13/12, noted that Patient 74 was 5 feet 6 inches and weighed 126 pounds. The Registered Dietitian (RD) noted the patients' ideal body weight was 142 pounds. It was also noted that Patient 74's body mass index was 20.3. Patients whose body mass index is 18.5 to 24.9 are considered to be normal weight (National Institutes of Health, 2012). The RD estimated Patient 74's nutritional needs to be 1719-2006 calories (30-35 calories per kg and 57-67 grams (g) of protein (1-1.2 g per kg). The RD recommended the implementation of a health shake, three times/day with meals, as well as a 250 milligrams (mg) Vitamin C twice a day by mouth, multivitamin with minerals once a day by mouth. The RD stated Patient 74 had a functional gastrointestinal track, therefore, Total Parenteral Nutrition was not recommended at this time. The RD indicated she spoke with the speech therapist and the swallow evaluation was performed and they were recommending a Dysphagia 1 diet (puree diet with nectar thick liquids). The nutritional goal for Patient 74 was documented as a oral tolerance of diet advancement. The RD classified the patient as being at high nutritional risk and would be re-evaluated at 2-4 days.

A nutrition reassessment, dated 9/17/12, noted that the patient's weight was 148.8 pounds. The RD questioned the accuracy of the admit weight of 126 pounds. The RD did no re-estimate of Patient 74's nutritional needs after the new weight was noted. The RD indicated the patient was not meeting estimated nutrient needs for wound healing with current oral intake. The RD indicated she spoke with Patient 74 and he is not eating well because of the puree texture. The RD indicated she explained the need for the texture and that the speech therapist would have to update the diet order. The RD indicated the patient likes ice cream and health shakes. The nutritional goal for Patient 74 was documented as a dietary intake of 75% or greater for meals and to promote wound healing. It was also noted that the recorded average meal intake at the time of reassessment was 36%. The RD recommended magic cup (4 oz frozen supplement that provides 290 calories and 9 grams of protein) twice a day with lunch and dinner. The RD classified the patient as being at high nutritional risk and would be re-evaluated at 2-4 days.

Review of the physician's orders, dated 9/17/12 and timed 10:56 am, indicated the RD recommendations for physician approval for the magic cup twice a day with lunch and dinner. There was no signature from the physician.

A nutrition reassessment, dated 9/21/12, noted that Patient 74 was NPO (nothing by mouth), there was a speech therapy swallow evaluation pending, and that the patient's weight was 144.9 pounds. The RD re-estimated Patient 74's nutritional needs to be 1600 calories (24 calories per kg) and 65-80 g of protein (1-1.2 g protein per kg). The RD indicated the patient's average meal intake was 15% from 9/17/12-9/19/12 and it was unclear if the patient was drinking the health shakes. The RD noted the 9/17/12 recommendations were not signed or implemented. The nutritional goal for Patient 74 was to have oral intake of 75% or greater once the diet is resumed versus if alternate nutrition support is indicated by speech therapy. The RD recommended if alternate nutrition support is indicated then to start Jevity 1 calorie at 65 milliliters (ml) per hour to provide 1654 calories and 69 g of protein. The RD classified the patient as being at high nutritional risk and would be re-evaluated at 2-4 days.

On 9/27/12 at 11:05 am, an interview was conducted with the CNM. The CNM stated they only will follow up with their recommendations at the next scheduled follow up. The CNM stated if the patient is in the intensive care unit they would follow up with those recommendations daily. On 9/27/12 at 11:27 am, an interview was conducted with the CNM. The CNM stated if recommendations are not implemented or signed then they would re-recommend if it is still appropriate. The CNM stated that interventions would not be followed up on until the next scheduled follow up, for high risk that would be 2-4 days later. The CNM acknowledged they should check on if the RD recommendations are implemented sooner.

Review of the hospital's standard of practice for Stage 4 pressure ulcers indicated: 35-40 calories per kg, 1.5-2 g of protein, multivitamin with minerals, 250-500 mg Vitamin C per day plus 25-50 mg Zinc per day for up to 8 weeks. This standard of practice was based on the reference: Malnutrition in the Institutional Elderly: Effects on Wound Healing, Ostomy Wound Management, 2004; Vol. 50, Issue 10.

Review of hospital policy titled, "Adult Nutrition Risk Level Criteria," dated 5/3/12, noted that patients with Stage 3 and 4 pressure ulcers would be considered to be at high nutritional risk and would receive re-assessment every 2-4 days. Patient 74 was not followed up timely per the policy classified nor was there a timely evaluation of the effectiveness of implemented medical nutritional therapy and the standard of practice for wound healing was not followed. It would be the standard of practice for nutrition practitioners to assess and evaluate the effectiveness of nutrition care according to each person's individual medical condition and needs (Academy of Nutrition and Dietetics, 2010).

3. Patient 27 was admitted with chest pain on 5/12/12. Medical record review was conducted on 10/2/12. Review of the history and physical dated 9/16/12, indicated Patient 27 has a past medical history of diabetes. Review of the physician's orders, dated 5/12/12 and timed 11:00 pm, indicated a 1800 calorie diabetic, no coffee, no caffeine diet. Hospital policy titled, "Clinical CVS -Adult Nutrition Risk Level Criteria," dated 5/3/12, noted that admission assessment reports for RD consult, significant unintended weight loss, skin breakdown or others, per RD discretions, are to have an initial assessment in 1 day. It also indicated high nutrition risk assessments to be completed in 2-3 days, moderate nutrition risk assessments to be completed in 4-5 days, and low nutrition risk to be completed in 7-8 days.

A nutrition note, dated 5/13/12, indicated RD consult per admit assessment report secondary to patient requesting a special diet. The special diet was a diabetic diet. The RD indicated the physician ordered a diabetic diet and they would assess per protocol.

A comprehensive nutrition assessment, dated 5/22/12, indicated it was due to a physician consult for tube feeding. The RD noted the patient was on a ventilator and skin was intact. The RD noted that the patient was 5 feet 10 inches and weighed 175 pounds. The Registered Dietitian (RD) noted the patients' desirable body weight was 166 pounds. It was also noted that the patients' body mass index was 25. Patients whose body mass index is 25-29.9 are considered to be overweight (National Institutes of Health, 2012). The RD estimated Patient 27's nutritional needs to be 1840-2160 calories (23-27 calories per kilogram (kg)) and 88-104 grams (g) of protein (1.1-1.3 g per kg). The RD recommended to start Pulmocare (high-calorie, low-carbohydrate nutritional product designed to help reduce carbon dioxide production) at 20 ml per hour times 8 hours, then advance to 40 ml per hour times 8 hours, then advance to Goal rate of 60 ml per hour to provide a total of 2160 calories and 90 g of protein. The nutritional goal for Patient 27 was documented to monitor tube feeding. The RD classified the patient as being at high nutritional risk and would be re-evaluated at 2-4 days.

On 10/2/12 at 2:42 pm, an interview was conducted with the CNM. The CNM stated there were not any triggers to come in before the low nutritional risk, however, the assessment was late according to their policy.

Hospital policy titled, "Clinical CVS -Adult Nutrition Risk Level Criteria," dated 5/3/12, noted that admission assessment reports for RD consult, significant unintended weight loss, skin breakdown or others per RD discretions are to have an initial assessment in 1 day. It also indicates high nutrition risk assessments to be completed in 2-3 days, moderate nutrition risk assessments to be completed in 4-5 days, and low nutrition risk to be completed in 7-8 days. Patient 74 was not assessed timely per the policy. The policy states that if admission assessment reports for RD consult then an assessment would be completed within one day. It does not state to delay assessment according to protocol for another time frame. The assessment was not timely for the low nutrition risk time frames. It would be the standard of practice for nutrition practitioners to assess and evaluate the effectiveness of nutrition care according to each person's individual medical condition and needs (Academy of Nutrition and Dietetics, 2010).

4. Patient 26 was admitted with left femoral artery repair on 6/17/12. Medical record review was conducted on 10/2/12. Review of the physician's orders, dated 6/17/12, indicated a regular 2 g sodium diet and a wound care consult. A wound care team assessment, dated 6/22/12, noted that the patient had redness on buttocks, right heel with redness, left upper posterior thigh with scattered open areas, wounds (wound beds) pink, right posterior leg with an open wound, left lateral ankle with open wound and left mid medial foot with open wound. It also indicated the patient is at very high risk for pressure ulcers.

A comprehensive nutrition assessment, dated 6/18/12, noted that the assessment was a consult because of skin breakdown. The RD noted Patient 26 was 5 feet 8 inches and weighed 233 pounds. The Registered Dietitian (RD) noted Patient 26's desirable body weight was 154 pounds. It was also noted that Patient 26's body mass index was 35.4. Patients whose body mass index is 30 or greater are considered to be obese (National Institutes of Health, 2012). The RD estimated Patient 26's nutritional needs to be 1950-2340 calories (25-30 calories per kilogram (kg) of adjusted body weight) and 78-93 grams (g) of protein (1-1.2 g per kg adjusted body weight). The RD recommended the implementation of a multivitamin with minerals once daily, as well as a 250 milligrams (mg) Vitamin C twice a day orally. The nutritional goal for Patient 26 was documented as a dietary intake of greater than 50% of meals and beverages. It was also noted that there was no recorded meal intake at the time of assessment, but it indicated the RD spoke with the nurse and the majority of the breakfast was gone, however, the patient spilled a lot on himself so it was hard to gauge the amount he actually consumed. The RD classified Patient 26 as being at moderate nutritional risk and would be re-evaluated at 4-6 days.

A nutrition reassessment, dated 6/22/12, noted that the patient was consuming 100% of his meals, and he was receiving the multivitamin with minerals and Vitamin C. The nutritional goal for Patient 26 was documented as a dietary intake of greater than 75% of meals to meet needs for wound healing. The RD classified the patient as being at moderate nutritional risk and would be re-evaluated at 4-6 days.

Review of the nutrient analysis for the 2 g sodium menu indicated it provided an average of 2369 calories and 109 g of protein.

A nutrition reassessment, dated 6/28/12, noted that Patient 26 was consuming 100% of his meals, and he was receiving the multivitamin with minerals and Vitamin C. The prealbumin (important marker for assessing protein deficiency) level, dated 6/25/12, was 17 milligrams (mg) per deciliter (dl) (reference range 20-40). The nutritional goal for Patient 26 was documented as a dietary intake of greater than 75% of meals to meet needs for wound healing. The RD classified the patient as being at moderate nutritional risk and would be re-evaluated at 4-6 days.

A nutrition reassessment, dated 7/6/12, noted that the patient was consuming 50-100% of his meals, and he was receiving the multivitamin with minerals and Vitamin C and noted with wounds. The nutritional goal for Patient 26 was documented as a dietary intake of greater than 75% of meals to meet needs for wound healing. The RD classified the patient as being at low nutritional risk and would be re-evaluated at 7-10 days.

Review of the prealbumin level, dated 6/30/12, indicated 7 mg / dl (which had dropped 10 mg from the last lab level).

On 10/2/12 at 2:30 pm, an interview was conducted with the CNM. The CNM stated Patient 26 should not have been at a low nutritional risk with the prealbumin level that dropped to 9. The CNM stated the RD should have put the patient at a moderate risk and addressed the lab level.

Patient 26 was not reassessed accurately, per the policy. The policy stated that if admission assessment reports for RD consult then an assessment would be completed within 1 day. It does not state to delay assessment according to protocol for another time frame. The assessment was not timely for the low nutrition risk time frames. It would be the standard of practice for nutrition practitioners to assess and evaluate the effectiveness of nutrition care according to each person's individual medical condition and needs (Academy of Nutrition and Dietetics, 2010).

Food Service

Rideout Campus

1. On 9/24/12 starting at 11:45 am, an observation of the lunch tray line was conducted. The following observations were made: white dinner rolls were served for all diets; there was no pureed fruit on the six observed puree trays made during lunch tray line; a #10 scoop (2/5 cup) was used for the pureed zucchini on the six observed puree trays.

Review of the lunch menu for 9/24/12 indicated the regular, consistent carbohydrate, cardiac and 2 gram sodium diets were to receive a wheat dinner roll. The menu also indicated the puree diet food items were: 1/2 cup (four ounces) pureed carrot soup, 1/2 cup pureed fruit cocktail, #8 scoop (1/2 cup) pureed turkey tetrazzini, #8 scoop puree zucchini.

On 9/24/12 at 12:55 pm, an interview was conducted with Cook A. Cook A stated they make fresh dinner rolls daily. Cook A stated she used white dinner rolls because the wheat came in today and there was not enough time for them to rise before the lunch tray line.

On 9/24/12 at 1:00 pm, an interview was conducted with Food Service Worker (FSW C). FSW C stated there was not any pureed fruit cocktail for her to give the patients. FSW C stated the lunch cold food items are made the day before. FSW C stated she had not worked since Thursday and there had been many changes on the menu.

On 9/24/12 at 2:15 pm, an interview was conducted with the interim Director of Food Services (DFS). The DFS stated the menus were revised late last week after the nutrient analysis was completed. On 9/24/12 at 2:30 pm, an interview was conducted with the interim Clinical Nutrition Manager (CNM). The CNM stated one of the changes was having wheat rolls for a lot of the diets.

On 9/27/12 at 2:35 pm, an interview was conducted with the DFS and the CNM. The CNM stated the new menu was started on Friday (9/21/12). The DFS stated this was discussed with the executive chef and all of the Registered Dietitians. The CNM stated she informed the diet aides and diet office supervisor of the changes, but did not really in-service thoroughly all of the tray line staff. The DFS was not present in the hospital over the weekend to assist the staff. The CNM stated she worked on Sunday, but was primarily doing clinical work. The CNM acknowledged it was her responsibility to have the oversight of the new menu being implemented and looking back she realizes it could have been implemented better. The CNM stated she has only been in the interim role of clinical nutrition manager for approximately three to four weeks.

On 10/1/12 at 1:33 pm, a telephone interview was conducted with the Contracted Services' District Manager (DM). The DM stated according to his schedule, the DFS worked for 10 days then had four days off. The DM stated the chef was working on those four days when the DFS was off. The DM stated that after an official offer is given to the CNM position they will get training. The DM acknowledged the interim CNM should have been provided more training in her interim role and they should have done a better job with that.

2. On 9/27/12 at 4:00 pm, an interview was conducted with the CNM regarding the nutrient analysis of the menus. The CNM stated after the last survey they completed the nutrient analysis of the menus. The CNM stated she thought it only needed to be done for the main diets, therefore, she had not done it on the pureed diet. The CNM stated it is like the mechanical soft diet except that the pureed diet does not have any bread. The CNM stated she was not sure why the puree diet did not get pureed bread. The CNM acknowledged that if there were changes to the mechanical soft diet with the pureed diet then they would not be the same food items and then the analysis would be different.

Based on observation, interview, and document review, the facility failed to ensure that personal electrical equipment was not present in the operating rooms. Personal electrical equipment in the operating rooms that were not checked for safety by bio-med and/ or maintenance had the potential to spark and/or short out causing a fire from the flammable gases used in the operating room and could cause serious injury and/or death to the patient.

Findings:

During a tour of the operating rooms (OR) at the Fremont campus on 9/25/12 at 8:15 am, a portable stereo speaker and/or player was found on top of the anesthesia machines in each OR.

During a concurrent interview, the Biomedical Engineering Manager (BEM) stated that no outside, private electrical items were allowed to be brought into the OR's or the hospital. BEM stated the speakers found in the OR's at the Fremont campus should not have been there.

During document review on 9/25/12, a policy titled, "Electrical Safety - Safety/Security" was reviewed. Under section IV. Policies - letter I, it indicated the use of personal electrical equipment by patients and staff will be prohibited "unless approved in writing as safe and after inspection by the BioMed Department.

When asked if he had inspected the stereo speakers BEM stated, "No."




17065



22705

Based on observation, interview, and document review, the facility failed to provide a safe, sanitary environment to avoid sources and transmission of infections and communicable disease as evidenced by the hospital's failure to have effective systems in place to ensure:

1 a. Staff were trained and competent to effectively clean and disinfect the hospital environment and shared patient care equipment, and prevent cross contamination in patient care environments.

b. Disposed trash and infectious wastes (including large blood spills) were handled safely.

c. Patient care equipment such as glucometers (a device used to check blood sugar levels), thermometers, and blood pressure cuffs, were cleaned and disinfected before and after patient use.

d. Clean/sterile patient care supplies (such as intravenous (IV) tubing, needles, syringes, unused urinals, and dialysis supplies) were stored in a sanitary environment, and separate from dirty/contaminated items/areas.

e. Staff donned personnel protective equipment to prevent cross-contamination.

f. Clean/disinfected surgical equipment was stored in a sanitary environment, away from a sink that was in use.

g. Endoscopes were high level disinfected in a sanitary environment, away from an area located in close proximity to where contaminated surgical instruments were cleaned.

h. Contracted staff working on construction projects were trained and competent in basic work related infection control practices.

i. Single use antiseptic solution was not used for multiple patients.

Refer to A 749.

2. Conduct quality assessment and improvement activities to ensure an effective Infection Control system to provide a safe, sanitary patient care environment. Refer to A 749.

On 9/26/12 at 10:19 am, an Immediate Jeopardy was declared for the widespread pattern of ineffective disinfection of shared equipment and environmental surfaces, and the failure to implement practices to prevent cross contamination. Continued observations and interviews identified ongoing deficient practices in disinfection and prevention of cross contamination. The State provided onsite monitoring over the weekend of 9/29-30/12. On 10/3/12 at 1:30 pm, the Immediate Jeopardy was abated, after 24 hours of compliant practices in disinfection and prevention of cross contamination were observed. Refer to A 749.

The cumulative effects of these systemic problems resulted in the hospital's inability to provide infection control services and care in a safe and effective manner, in accordance with the statutorily-mandated Condition for Coverage for Infection Control Services.




22456

Based on observation, staff interview, and document review, the hospital failed to ensure the development and implementation of effective systems for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel, in accordance with facility policy, nationally recognized infection control guidelines, and manufacturer's recommendations, evidenced by:

1 a. The facility failed to ensure that staff were trained and competent to effectively clean and disinfect the hospital environment and shared patient care equipment, and prevent cross contamination in patient care areas.

b. The facility failed to ensure that disposed trash and infectious wastes (including large blood spills) were handled safely.

c. The facility failed to ensure that patient care equipment such as glucometers (a device used to check blood sugar levels), thermometers, and blood pressure cuffs, were cleaned and disinfected before and after patient use.

d. The facility failed to ensure that clean/sterile patient care supplies (such as intravenous (IV) tubing, needles, syringes, unused urinals, and dialysis supplies) were stored in a sanitary environment, and separate from dirty/contaminated items and areas.

e. The facility failed to ensure that staff donned personnel protective equipment to prevent cross-contamination.

f. The facility failed to ensure that clean/disinfected surgical equipment was stored in a sanitary environment, away from a sink that was in use.

g. The facility failed to ensure that endoscopes were high level disinfected in a sanitary environment, away from an area located in close proximity to where contaminated surgical instruments were cleaned.

h. The facility failed to ensure that contracted staff working on construction projects were trained and competent in basic work related infection control practices.

i. The facility failed to ensure that single use antiseptic solution was not used for multiple patients.

2. The facility failed to conduct quality assessment and improvement activities to ensure an effective Infection Control system to provide a safe, sanitary patient care environment.

These failures placed patients, staff, and visitors at risk for infections. As a result of widespread deficient practices regarding disinfection and prevention of cross contamination, an Immediate Jeopardy to patient safety was declared on 9/26/12 at 10:19 am in the presence of the Chief Clinical Officer (CCO), Chief Nursing Officer (CNO), and Director of Quality Management (DQM).

Findings:

1. During the initial tour at the Rideout Campus on 9/24/12 from 9:15 am to 11 am, cross contamination concerns were observed: overflowing trash cans in Isolations Rooms 110 and 310, linen on the floor in Room 310, and trash on the floor in Rooms 108, 303, and the intravenous (IV) fluid storage locker 3W Unit,

During concurrent interviews, Nurse Manager (NM) 1 and the Chief Nursing Officer (CNO) acknowledged that the above findings were cross contamination risks and did not meet their expectations for cleanliness.

2. During a tour of the labor and delivery surgical suites at the Fremont Campus on 9/24/12 at 10:30 am, the overhead surgical lights in operating room (OR) 1 had recessed edges bordering the top of both movable light sources that had clumps of lint, a moderate amount of collected dust, and loose white particles inside the edging. Both movable, overhead surgical lights in OR 2 had a light to moderate buildup of dust inside the edging. The dust, lint, and particles on the lights had the potential to fall out into the sterile surgical field and contaminate the surgical filed, instruments, and/or an open wound. This would increase the risk for infection to the patient and/or newborn baby.

NM 6 observed the findings concurrently during the tour and stated the top of the surgical lights was a daily part of the cleaning for the OR rooms and should have been completed with the routine cleaning by environmental services.

3. On 9/24/12 at 11:30 am, Environmental Services Staff (EVS) 2 was observed cleaning patient Room 372, a room located in the intensive care unit. EVS 2 was observed to use one cloth to clean a straight back chair, a recliner, and four pillows in the room. These items were observed to begin to dry within one minute. In a concurrent interview, EVS 2 stated she used a cleaning solution called "456 II" to clean the chairs and pillows. When asked what the kill time (the amount of disinfectant surface time necessary to effectively disinfect) for 456 II, she responded that it was 10 minutes. When asked what that meant, EVS 2 indicated that it took 10 minutes for the product to dry. When asked what she should do if the furniture articles dried before 10 minutes, EVS 2 indicated she did not know.

Review of the manufacturers' specifications for the product used by EVS 2, Virex 256®, revealed that the product should be used as follows, "Thoroughly wet surfaces with the recommended solution for at least 10 minutes."

4. During an interview on 9/24/12 at 1:00 pm in the perioperative area, EVS 5 was asked how she would clean up a large blood spill. EVS 5 indicated she would soak up the blood with mops and dispose of the bloody mops in the bags designated for soiled linens. In a concurrent observation, EVS 5 pointed out the yellow bag labeled "soiled linen' where she would dispose of the bloody mops.

During an interview on 9/25/12 at 11:30 am, in the labor and delivery area of the Fremont Campus, EVS 6 was asked how she would clean up a large blood spill. EVS 6 stated she would use a mop to clean up the blood, and use more than one mop if necessary. When asked where she would dispose of the bloody mop heads, EVS 6 stated she would put them in the regular trash. EVS 6 indicated she received training on cleaning up large blood spills at orientation and at monthly meetings where cleaning information was obtained by watching videos.

Review of the hospital's policy and procedure titled, "Cleaning Procedures for all Areas-Blood and Body Fluid Spills," reviewed/approved 04/12, stipulated, "When cleaning spills of blood or ...personal protective equipment (this includes the use of gloves and may include gown, mask, and eye protection), cover the spill with additional cloths or paper towels to absorb the spilled fluid and to facilitate removal. Prevent the spill from spreading with cloths, paper towels, or disposable materials. Place material soaked with blood or body fluid into a red infectious waste liner and tie closed. Using germicidal solution wet mop the spill area and allow it to air dry. Take the red liners to the nearest infectious waste disposal area ..."

5. During an interview with Registered Nurse (RN) 5 on 9/24/12 at 3:25 pm, he indicated he cleaned the shared patient glucometer (a device used to check blood sugar levels) before and after patient use. The RN stated he cleaned the glucometers with a Super Sani-wipe (indicating the Sani-wipes located in the purple top container labeled, "Super Sani-wipes"). When asked what the Sani-wipe product kill time was, RN 5 responded it was two minutes. When asked what he would do if the glucometer began to dry before two (2) minutes, RN 5 stated, "I would just wait."

During an interview with RN 6 on 9/25/12 at 12 pm, she indicated she cleaned shared patient equipment, and that included glucometers, thermometers, and blood pressure machines both before and after use. When asked what she disinfected the shared items with, RN 6 indicated she used a product called Super Sani-wipes (in the purple top container). When asked how long the disinfectant had to remain wet on the item to kill germs, she stated, "I am not sure how long. I can look it up. I think it was one (1) minute."

Review of the Super Sani-wipe label (purple top container) stipulated treated surfaces must remain visibly wet for two minutes. Label directions indicated, "Treated surfaces must remain wet for the stated contact time on the product label. Use additional wipe(s) if needed to assure continuous contact time stated on label."

Review of the hospital's policy titled, "Cleaning and Disinfection of Reusable Patient Equipment-Infection Control," dated 10/1998, listed as its purpose: To prevent cross-contamination between patients. Under procedure this policy stipulated, "Put on appropriate personal protective equipment. Using soap and water thoroughly remove any drainage or crusted exudates from the items to be cleaned. Wipe item completely with the approved germicide / bleach solution. Let the item dry completely (the drying time is part of the destruction of the organisms). If there is any question on the proper cleaning method needed to clean patient items contact the Central Supply Supervisor ..."

The ONLINE Centers for Disease Control and Prevention communication titled, "Infection Prevention during Blood Glucose Monitoring and Insulin Administration" was accessed on 10/4/12. The article stated, "The Centers for Disease Control and Prevention (CDC) has become increasingly concerned about the risks for transmitting hepatitis B virus (HBV) and other infectious diseases during assisted blood glucose (blood sugar) monitoring and insulin administration. CDC is alerting all persons who assist others with blood glucose monitoring and/or insulin administration of the following infection control requirements: Fingerstick devices should never be used for more than one person. Whenever possible, blood glucose meters should not be shared. If they must be shared, the device should be cleaned and disinfected after every use, per manufacturer's instructions. If the manufacturer does not specify how the device should be cleaned and disinfected then it should not be shared."

An article published in volume 38, number 3 (April 2010), of the American Journal of Infection Control, by the Association for Professionals in Infection Control and Epidemiology (APIC), provided the following guidance: "Assign a glucometer to each patient if possible. Clean and disinfect glucometers if they must be shared between multiple patients. Thoroughly clean all visible soil or organic material (e.g., blood) from the glucometer before disinfection. Disinfect the exterior surfaces of the glucometer after each use following the manufacturer's directions. Use an E.P.A. (Environmental Protection Agency) registered disinfectant effective against HBV, HCV, and HIV (bloodborne pathogens) or a 1:10 bleach solution (1 part bleach to 9 parts water)."

6. On 9/24/12 at 3:40 pm, a supply cart containing dialysis supplies was observed in a locked supply room in the environmental services area on the second floor. The cart supplies housed blood lines, syringes, needles and other items, and it was located immediately adjacent to a large sink discolored with pink orange stains. A mop was leaning against the sink. During an interview with the Director of Risk Management (DRM), he acknowledged storing clean/sterile supplies in close location to a large sink could result in splash and contamination of the nearby stored patient dialysis supplies from fluids discarded in the sink.

During an interview on 9/25/12 at 2:00 pm, RN 7 stated the sink in the dialysis supply room was used to dispose of acid and bicarbonate solutions. RN 7 stated no human waste products were disposed of in the sink. RN 7 stated that although the door was supposed to be locked he had found it open on 9/25/12 when he arrived at the hospital and inspected the supply room. RN 7 acknowledged hospital environmental staff persons had supplies and offices nearby and could access the dialysis room and sink when the door was not locked. RN 7 stated it was very common to have sinks in dialysis supply areas and acknowledged that clean and sterile supplies, if splashed with liquid, could contaminate the supplies.

The 6/03 Recommendations of CDC and the Healthcare Infection Control Practices Advisory Committee (HICPAC) for Environmental Infection Control in Health-Care Facilities were reviewed and provided the following information, "The most common point-of-use fixtures for water in patient-care areas are sinks, faucets, aerators, showers, and toilets. The potential for these fixtures to serve as a reservoir for pathogenic microorganisms has long been recognized. Wet surfaces and the production of aerosols facilitate the multiplication and dispersion of microbes."

7. On 9/25/12 at 9:15 am, EVS 7 was observed emptying trash in the hospital's second floor intensive care unit (ICU). EVS 7 was wearing scrubs (uniform), but she was not wearing gloves or a gown over her scrubs. EVS 7 was observed leaning over the large trash bin, contacting the front of her scrubs with the bin, as she emptied bags of trash into the bin. EVS 7 then walked over to the nurse's station hand-washing sink and leaned against the sink with the front of her scrubs as she washed her hands.

During an interview with EVS 7 on 9/25/12 at 9:23 am, she indicated she had worked for the hospital for four (4) days and had been told to go to the second floor ICU and empty trash in the patient rooms. When asked if she had received any other instructions, as there were patients on contact isolation precautions which required the individual to wash their hands and wear a gown and gloves when entering the room, EVS 7 indicated she was told to wear gloves when entering the patient rooms to empty trash.

On 9/25/12 at 9:30 am, during an interview with NM 5, he acknowledged EVS 7 had contaminated her scrubs and then walked over to the nurses station sink, contaminating the sink. NM 5 acknowledged EVS 7 should have worn gloves and a gown over her scrubs when she emptied the trash. When asked if NM 5 was comfortable with EVS 7 continuing to work in the ICU, he stated, "I'm not comfortable, she needs more training."


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8. During a tour of the Emergency Room (ER) on 9/26/12 at 8:30 am, an environmental staff member (EVS 4) was asked what product she used to clean the gurneys and cubicles after a patient was discharged from the ER. EVS 4 stated she used a cleaning solution called "456 II" to clean a non-isolation room and that the solution had to remain wet on the surfaces for 2 minutes.

Review of the manufacturer's specifications for the amount of time that the solution must remain on the surfaces when cleaned was at least 10 minutes.

9. On 9/26/12 at 9:40 am, EVS 1 was observed cleaning a gurney with a damp blue towel after patient use in Bed 8, in the Post Anesthesia Care Unit. The gurney was observed to dry after 5 minutes.

In an interview on 9/26/12 at 10:05 am, EVS 1 stated that the gurney was washed with the solution "4-5-6" and the gurney should remain wet for 10 minutes for appropriate disinfection.
According to the manufacturer's directions, the disinfection of hard non-porous surfaces was to remain wet for at least 10 minutes.

10. During an interview on 9/26/12 at 10 am, a RN 9 was asked how long the Super (purple color-coded) Sani-Wipe (a pre-packaged disinfectant cloth) would need to remain on the surface of a piece of equipment before it would be considered disinfected (the kill time). RN 9 stated the solution should be left on until it dried which would take about 15 to 20 seconds.

Review of the Super Sani-Wipes container specifications indicated that the actual kill time was 2 minutes.

When asked what would be used to clean an object in an isolation room for clostridium difficile spores (C-diff, a highly contagious bowel infection causing diarrhea), RN 9 stated she would use the Clorox wipes. RN 9 stated the Clorox solution is also left on until it dries, but she was unsure of the kill time for the Clorox wipes when used for C-diff. RN 9 stated she did not know the surface of an object being disinfected needed to remain wet during the entire kill time.

Review of the Clorox specification for use indicated that the kill time for the Clorox wipes when used for C-diff was 3 minutes.

The above deficient practices in disinfection and prevention of cross contamination occurred in many locations throughout the facility and among a wide variety of staff. The widespread pattern of deficient practices for disinfection and prevention of cross contamination put patient(s) and staff persons at immediate risk for possible exposure to infectious microorganisms and placed them at risk for serious illness. Similar findings were found on the previous survey ending on 4/30/12 and a plan of correction was submitted by the facility to address those deficient practices. DQM was interviewed on 9/26/12 at 7:30 am regarding the facility's monitoring of the plan of correction from the last survey. Results of the monitoring showed that compliance had not been achieved. DQM was asked about the analysis and action plans for their monitoring and replied that there were no records of the analysis and action plans. Facility administrative staff accompanied all surveyors during the observation of the above practices from 9/24-26/12, and were knowledgeable of the widespread nature of the deficient practices in disinfection of environmental surfaces and shared equipment, and the prevention of cross contamination. DQM provided an e-mail memo from the ICP (Infection Control Practitioner) 1 sent to the facility nursing management staff on 9/25/12 at 7:51 pm, titled, "Infection Prevention Items." This memo contained reminders regarding Universal Precautions (to prevent cross contamination), cleaning a grossly bloody spill, and disinfection. No action plan or direction was provided in the memo. DQM confirmed this was the only action that she was aware of that the facility took to address the deficient practices in disinfection and prevention of cross contamination.

As a result of widespread deficient practices regarding disinfection and prevention of cross contamination, an Immediate Jeopardy to patient safety was declared on 9/26/12 at 10:19 am in the presence of the CCO, CNO, and DQM. Survey activities continued.

11. On 9/26/12 at 10:45 am, EVS 1 was observed cleaning the room, Prep 5, in the preoperative area. EVS 1 was wiping down the mattress, rails, and then the frame underneath the gurney. With the same blue towel EVS 1 then began wiping the foot of the mattress to the head of the mattress, and then wiped down the pillow. In a concurrent interview, NM 7 stated that she observed EVS 1 cleaning from the area underneath the gurney to the top of the mattress, which was not correct procedure.
On 9/26/12 at 10:50 am, EVS 1 was observed wiping the wires/cords from the cardiac monitor. The wires and cords from the monitor were tangled and lying on the floor. EVS 1 wiped the tangled cords, but did not separate the wires while cleaning them. In a concurrent interview, NM 7 stated that she observed the wires/cords on the floor by EVS 1 during the cleaning of the room, which was not correct procedure.

12. During a tour on 9/26/12 at 10:50 am, EVS 7 stated when a patient that was on isolation for C-diff was discharged, she cleaned the bed, furnishings, and all equipment with a bleach solution of 1 part bleach to 10 parts water and cleaned the walls and floors with the 456 II cleaning solution.

During a concurrent interview,NM 1 verified that all surfaces in a C-diff isolation room were to be cleaned with the bleach solution and confirmed that the 456 II cleaning solution does not kill the C-diff spores.

13. On 9/26/12 at 10:55 am, a portable x-ray machine was observed in the Post Anesthesia Care Unit (PACU) at Bed 6. Radiation Technologist (RT) 1 was observed to wear gloves as he was removing the portable x-ray machine from the bedside of a patient. RT 1 was observed wiping down the x-ray film and handle bar with a purple Sani-wipe. RT 1 removed his gloves and proceeded to leave the unit without washing the area of the equipment that came in contact with the patient.

14. On 9/26/12 at 11:25 am, the towel dispenser was observed after washing hands at the PACU sink. The counter under the dispenser was approximately 6 inches. The towel did not release until the hand hit the counter. The towel had difficulty releasing when pulled at an angle. In a concurrent interview, NM 10 stated that cross contamination occurred at the PACU sink when staff used the towel from the dispenser.

15. On 9/26/12 at 3:10 pm, EVS 2 was observed cleaning a patient room and equipment in Room 376. While cleaning machine cords and wires, EVS 2 placed one end of the cords and wires on the floor and began wiping from the machine connection down the tangled cords and wires. In a concurrent interview, NM 8 stated that the wires and cords should not be laid on the floor when cleaned. NM 8 did not recognize that the wires and cords were tangled and cleaned as a bunch by EVS 2, rather than separately.
On 9/26/12 at 3:20 pm, two small holes perforating the bed mattress were observed in Room 376 after being cleaned by EVS 2.
On 10/2/12 at 3:35 pm, a patient was observed in the bed, in Room 376. Two holes were observed on the mattress just under the patient's right shoulder. In a concurrent interview, Respiratory Manager (RM) 1 stated that the mattress should have been replaced.

On 9/26/12 at 5:40 pm, the facility submitted an acceptable plan of correction to correct the threats to patient and staff safety. The survey team continued to monitor and observe the implementation of the plan of correction, including on-site monitoring over the weekend of 9/29-30/12. Onsite monitoring from 9/26/12 to 10/2/12 identified continued deficient practices in disinfection and prevention of cross contamination. The Immediate Jeopardy remained unabated.


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16. During a tour with the Lab Manager (LM) on 9/27/12 at 9:25 am, two large grey bins used to store the new plastic male urinals were observed to be overflowing with four urinals on the floor at the base of the bins. When the urinals on the floor were brought to the attention of a Central Supply Technician (CST 1), he picked them up and placed them on a rack in the aisle.

During a concurrent interview CST 1, he stated that there were so many of the urinals in the delivery bags that he did not have enough room to store all of them in the bins without the overflow. CST 1 stated he would obtain another grey bin to contain the overflow. When asked what CST 1 was going to do with the urinals he picked up off the floor CST 1 stated, "I guess I ought to throw them away, huh?"

LM stated that the storage bins for the urinals should not have been stacked higher than the top edge of the bins and should not have been overflowing. LM instructed CST 1 to throw the contaminated urinals away. The urinals removed from the floor had the potential for cross contamination of bacteria on the floor of the Central Supply room to be transferred to a patient causing infection.

17. On 9/27/12 at 9:45 am, an environmental services staff member (EVS 8) was observed cleaning a contact isolation room in Bay 4 of the emergency department (ED) with the ED Manager (NM 2) also observing. EVS 8 cleaned the surfaces of the Bay with Neutral cleaning solution which had a kill time of 10 minutes.

EVS 8 removed the disposable blood pressure cuff and oxygen saturation probe from the wires to the monitor and dropped the EKG (heart beat tracing) wires, the blood pressure cuff wire, and the oxygen saturation probe wire to the floor. When EVS 8 cleaned the wires they were cleaned as one complete unit instead of individually wiping each wire to disinfect. EVS then cleaned the top of the gurney and went to the top base of the gurney and down to the wheels. With the same cloth EVS 8 went to the other side of the gurney cleaned the top base of the gurney and back to the wheels again.

The cleaning of the wheels contaminated the cleaning cloth by touching the floor and then contaminated the base of the gurney by using the same cloth on the other side. NM 2 stated EVS 2 should have more than one cloth to clean the different areas of the room to avoid cross contamination. This could introduce the bacteria of the contact isolation measures to the next patient that was placed in that room.

18. During an observation on 9/27/12 at 11:15 am, the isolation trash receptacle in Room 388 was next to the open door and the arms and base of a disposed gown were noted to be overflowing in the trash.

During a concurrent interview with the DRM, he stated that the nurses were to be aware of the overflowing trash containers and they should have contacted housekeeping because it needed to be emptied.

19. On 9/27/12 at 12:20 pm, RT 1 was observed wiping down a portable x-ray machine in the Intensive Care Unit after patient use. RT 1 wiped the equipment from top to bottom with purple Sani-wipes. RT 1 laid out the used Sani-wipes on the ground to run the wheels of the machine over the wipes. He touched the handlebar with his dirty gloves to be able to maneuver the machine over the Sani-wipes. He then removed the gloves, washed his hands, and while holding onto the handlebar to drive the machine, he proceeded to exit the unit. In an concurrent interview, RT 1 stated that he did not wipe the handlebar after touching with dirty gloves until it was brought to his attention.

20. On 10/1/12 at 9:55 am, RN 8 was observed in Room 222 on the 2 Central Unit wearing a gown and gloves, adjusting the patient's intravenous line on their right arm. As RN 8 came around the bed to the left side, she bent down and picked something up off of the floor in her right hand, pushed her isolation gown away from the right side and front of her body, placed what she had picked up from the floor in her uniform pocket, and replaced the isolation gown back over her uniform.

During a concurrent interview, when asked what she had picked up from the floor and placed in her inner pocket, RN 8 stated, "glucometer strips" (a plastic strip placed in a machine to measure blood sugar). RN 8 stated she realized after the fact what she had done and knew that it was not proper protocol. DRM, also present during the observation, instructed RN 8 to throw the bottle of glucometer strips away.

During an interview on 10/1/12 at 10:30 am, RN 8 clarified that the bottle of glucometer strips could contain up to 50 strips and were to be used for the patient. When asked if she had thrown the bottle of contaminated glucometer strips away as directed by the DRM, RN 8 stated, "No, they are in the room on the counter." When asked why she had not thrown them away when instructed to do so RN 8 stated, "I was already out of the room when DRM said to throw the bottle away and I was going to do it the next time I went into the room."

The bottle of glucometer strips was contaminated by other dirt and bacteria that may have been on the floor before RN 8 picked up the bottle. Placing the bottle on the counter contaminated the counter and had the potential to contaminate anyone else who touched the bottle, if RN 8 was not the next nurse to enter the room and use the glucometer strips. This had the potential of introduction of new bacteria to the patient that was already ill and in isolation.

21. Review of the infection control risk assessment (ICRA) documentation for hospital construction, occurring from 2010 to present showed an ICRA, dated 10/5/2010, had not been completed for a construction project located at the Rideout Campus 1 West location. On the form, the level/class of construction with corresponding infection control precautions and directions was blank and the ICRA did not designate a contractor. In a concurrent interview with Clinical Engineering Manager (CEM), he verified after checking past documents, that the project was initiated and completed and he acknowledged an ICRA should have been completed and signed by the contractor.

Review of infection control construction compliance survey documents showed compliance monitoring for infection control practices at hospital construction sites for the period of time 2010 to present and only two (2) compliance survey documents were conducted by the ICP 1 for the cardiac catheterization lab in 9/12. The surveys included evaluating: 1) barriers protecting patient from construction by- products, 2) air handling, 3) site clean- up /trash disposal, 4) traffic control, and 5) dress code (wearing appropriate protective clothing). At the time of survey, the hospital was conducting a large construction project almost immediately adjacent to the main hospital (known as "the towers"). No infection control compliance surveys were produced/found for the towers project. During a concurrent interview with the CEM, he indicated the ICP 2 had used a form titled, "daily intermediate life safety measures (ILSM)" to document his infection control evaluations of construction site projects until the new ICP 1 was hired late in 8/12. Review of an IDSL, dated 10/10, showed the ICP 2 assessment was limited to assessment for fire safety and undefined hazards. CEM acknowledged the form lacked essential infection control elements necessary for a comprehensive infection control evaluation of a construction site.

During an interview with CEM on 10/1/12 at 12:45 pm, he indicated that all contractors and their staff were provided training, prior to being allowed to work on hospital construction projects. CEM acknowledged this training was very limited in infection control information and practices, and instead training was focused around topics such as maintaining patient confidentiality, knowing when to call a nurse for help with a patient, and on life safety measures (i.e. fire safety).

Review of the hospital's policy titled, "Infection Control during Construction," effective date 6/13/12 and presented as current, stipulated, "Before a construction on site begins, a preconstruction meeting will include expectations, and requirements regarding infection control in the construction area within the hospital. The infection control department or designee will make periodic visits to work site to ensure compliance with policy (referring to infection control during construction policy).

22. On 10/2/12 at 10:55 am, EVS 2 was observed cleaning Pre Op Room 2 at the outpatient surgery department. EVS 2 was placing one end of the tangled wires and cords on the floor and began wiping them down from the connection of the machine. In a concurrent interview, NM 1 instructed EVS 2 not to place the wires and cords on the floor while cleaning.

23. On 10/2/12 at 11:25 am, a half filled "single use" 8 ounce bottle of Betadine solution (sterile product to clean the surgical site to reduce microorganisms) was observed to be poured into a container for a surgical prep. The solution on the 4 X 4's (gauze) was observed to be used to prep the surgical site. In a concurrent interview, NM 1 stated that the Betadine had been opened and used, prior to the current patient in the surgical suite, and acknowledged it posed a risk for cross contamination.

24. On 10/2/12 at 1:00 pm, during a tour of the hospital's outpatient surgery center, an automatic endoscope reprocessor (AER) machine (a machine that processes endoscopes to achieve high level disinfection) was observed approximately 2.5 feet across from a sink in the decontamination room.

On 10/2/12 at 1:05 pm, an interview was conducted in the outpatient surgery decontamination room with Infection Control Practitioner (ICP) 1. The ICP 1 indicated the hospital followed The Association of periOperative Registered Nurses (AORN) guidelines for instrument cleaning and disinfection in the perioperative areas. The ICP 1, after being told staff persons occasionally cleaned surgical instruments in the sink during the same time other staff worked with an endoscope (i.e. removing it from the AER), acknowledged that the potential for disinfected endoscopes to come in contact with contaminants generated from cleaning instruments in the nearby sink existed.

Review of the 2012 edition of AORN guidelines was conducted. 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