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Based on interview and record review, the hospital failed to ensure that standards for licensing were met when:

1. Annual performance evaluations were not provided to one of 15 sampled employees, Environmental Services Worker (EVS) A. This failure had the potential for problems in employee performance to persist and negatively impact patient care.

2. Required education and competency assessments were not completed timely for four of 15 sampled employees, Registered Nurse (RN) T, RN U, EVS A, Central Processing Technician (CPT) A.

Findings:

1. On 5/14/14, EVS A's employee file was reviewed. EVS A's file indicated she was hired on 5/2/11 and contained annual performance evaluations for 2012 and 2013 which stated the employee was "unable to sign." (Refer to A 749, items 13 and 14 for performance concerns).

The California Code of Regulations, Title 22, Division 5, Chapter 1, Section 70719 (a) read, "Each hospital shall adopt written personnel policies concerning qualifications, responsibilities and conditions of employment for each type of personnel, which shall be available to all personnel. Such policies shall include but not be limited to:...(3) A plan for at least an annual evaluation of employee performance."

On 5/14/14, the hospital policy, titled, "Job Performance Evaluations," dated 6/13, read, "Overall the performance evaluation process should a) support employee development; b) set goals for individual performance; c) document employee performance; d) be flexible and user-friendly; and e) be collaborative with shared accountability and ownership and support the goals and values of the facility....Job performance evaluations will be completed by the employees immediate manager or designee..annually in October...Upon completion, the evaluator should have a performance discussion regarding the evaluation with the employee. The employee should sign the evaluation after the review. ...Employee who refuse to sign their evaluation or do not sign their evaluation, shall have "employee refused to sign" noted on the evaluation and the evaluation is submitted to Human Resources."

On 5/14/14 at 2:25 pm, the Director of Human Resources (DHR) stated that the managers complete the performance evaluation in a computer program and the employee is e-mailed a copy that they are to review and sign. DHR further stated that most managers will meet one to one with their employees to discuss their performance and create goals for future performance. DHR reviewed attendance records for EVS A and confirmed that EVS A was not on a leave of absence and was available to participate in an evaluation of her performance. DHR reviewed EVS A's employee record and acknowledged that there was no evidence that EVS A had ever had her performance evaluation discussion with her manager. DHR stated that the process should be more clean and not allow an employee to not be informed of their performance evaluation.

Review of a hospital document titled, "Master Service Agreement for Purchase of Environmental Services and Food and Nutrition Management Services DH-SS-132," effective date 6/17/13, revealed under Exhibit D that the contractor will provide an EVS manager to conduct service employee performance and progress evaluations.

On 5/15/14 at 11:20 am, the Director of Environmental Services (DEVS) stated he had started with the hospital in 12/2013 and he acknowledged that the performance evaluations should be discussed and signed by the employees.

2. On 5/14/14, employee competency and training records were reviewed. Four of 15 employees personnel records demonstrated that they had not completed required training in a timely manner, as follows:

a. RN T had not completed:
- Nursing Wound Education, due 2/28/14;
- (glucometer education was a requirement from a previous survey plan of correction), due 4/19/14;
- Wound Vac Nursing Education, due 4/30/14;
- Medication Pass algorithm (a requirement from a previous survey plan of correction), due 5/1/14;
b. RN U had not completed:
- Type and Screen & Glucometer Education, due 4/19/14;
- Wound Vac Nursing Education, due 4/30/14;
c. EVS A had not completed:
- Just Culture for Employees, due 1/31/14;
d. Central Processing Technician A had not completed:
- Just Culture for Employees, due 1/31/14.

The California Code of Regulations, Title 22, Division 5, Chapter 1, Section 70721(a) read, "The Hospital shall recruit qualified personnel and provide initial orientation of new employees, a continuing in-service training program and competent supervision to improve patient care and employee efficiency."

On 5/15/14, the hospital policy, titled, "Staff Competency and Education," dated 6/2013, read "In the event that an employee is unable to demonstrate proficiency, identify specific learning needs, implement training, and reassess the competency. If competency cannot be established, implement the performance management process (progressive discipline).

On 5/14/14 at 2:25 pm, DHR reviewed the above employee files and acknowledged that they were not compliant with completing their education and competency requirements. HR stated that department management was responsible for suspending employees who were not compliant.

Based on interview and document review, the hospital failed to ensure compliance with the California Code of Regulations as evidenced by:

1. Failure for dietary staff to possess required in-service training to be qualified under State law; and

2. Failure to maintain dietary staffing in accordance with regulatory requirements.

These failures may affect the quality of dietetic services provided by the hospital, further compromising the medical status of inpatients and result in the spread of infection.

Findings:

1a. California Code of Regulations, Title 22, Division 5, Chapter 1, Section 70271 defines Dietetic service as providing safe, satisfying and nutritionally adequate food for patients with appropriate staff, space, equipment and supplies.
California Code of Regulations, Title 22, Division 5, Chapter 1, Section 70275(a)(b) describes the requirements for dietetic services staffing. It requires that within dietetic services a registered dietitian shall be employed on a full-time, part-time or consulting basis and if a registered dietitian is not employed full-time, a full-time person who has completed an approved dietetic supervisor's training program shall be required. California Health and Safety Code, Section 1265.4 describes the required qualifications for this certification.
The dietetic services supervisor shall have completed at least one of the following educational requirements:
(1) A baccalaureate degree with major studies in food and nutrition, dietetics, or food management and has one year of experience in the dietetic service of a licensed health facility.
(2) A graduate of a dietetic technician training program approved by the American Dietetic Association, accredited by the Commission on Accreditation for Dietetics Education, or currently registered by the Commission on Dietetic Registration.
(3) A graduate of a dietetic assistant training program approved by the American Dietetic Association.
(4) Is a graduate of a dietetic services training program approved by the Dietary Managers Association and is a certified dietary manager credentialed by the Certifying Board of the Dietary Managers Association, maintains this certification, and has received at least six hours of in-service training on the specific California dietary service requirements contained in Title 22 of the California Code of Regulations prior to assuming full-time duties as a dietetic services supervisor at the health facility.
(5) Is a graduate of a college degree program with major studies in food and nutrition, dietetics, food management, culinary arts, or hotel and restaurant management and is a certified dietary manager credentialed by the Certifying Board of the Dietary Managers Association, maintains this certification, and has received at least six hours of in-service training on the specific California dietary service requirements contained in Title 22 of the California Code of Regulations prior to assuming full-time duties as a dietetic services supervisor at the health facility.
(6) A graduate of a state approved program that provides 90 or more hours of classroom instruction in dietetic service supervision, or 90 hours or more of combined classroom instruction and instructor led interactive Web-based instruction in dietetic service supervision.
(7) Received training experience in food service supervision and management in the military equivalent in content to paragraph (2), (3), or (6).

b. During initial tour on 5/12/14 beginning at 9:30 a.m., the Food Service Director (FSD) was introduced as the person hired by the contracted food service as responsible for dietetic services at the hospital. Review on 5/13/14 at 11:00 a.m. of the FSD's personnel file revealed that she did have a certified dietary manager credentialed by the Certifying Board of the Dietary Managers Association, however did not possess the necessary State training for this position.

In an interview on 5/13/14 at 11:50 a.m., the Area Director of Nutrition Services (ADNS) stated that she was the person responsible for the development of the organizational structure for food and nutrition services. The ADNS stated the FSD did not have any documentation of completing the 6 hours of in-service training on State requirements now or prior to becoming the FSD. The ADNS acknowledged she was not aware that needed to be completed.

Review of a hospital document titled, "Master Service Agreement for Purchase of Environmental Services and Food and Nutrition Management Services DH-SS-132," effective date 6/17/13, revealed that under Exhibit A that the contractor will provide a food manager however it did not state the qualifications that were needed for this position. Review of the job description for the FSD indicated qualifications, however, did not reference the State law.

2. The California Code of Regulations Title 22, Division 5, Chapter 1, Section 70275(a) reads, "A registered dietitian shall be employed on a full-time, part-time or consulting basis. Part-time or consultant services shall be provided on the premises at appropriate times on a regularly scheduled basis and of sufficient duration and frequency to provide continuing liaison with medical and nursing staffs, advice to the administrator, patient counseling, guidance to the supervisor and staff of the dietetic service, approval of all menus and participation in development or revision of dietetic policies and procedures and in planning and conducting in-service education programs."

On 5/13/14 at 10:50 a.m., an interview was conducted with the Area Director of Nutrition Services (ADNS) and the Clinical Nutrition Manager (CNM). The CNM stated she was the full-time Registered Dietitian (RD) responsible for oversight at this hospital.

On 5/13/14, the organizational chart, revised 3/14, for food and nutrition services was reviewed. It was noted that the Food and Nutrition Services Director, who was not a RD, was the position responsible for all aspects of the department, including supervision of the Clinical Nutrition Manager (CNM), the RD. The evaluation of the CNM, provided by the contracted food services vendor, did not reflect responsibilities for food service oversight, rather was limited to clinical nutrition care activities in addition to activities such as participating in the budget process, develops goals and objectives for Clinical Services to maintain high quality care, administers Clinical Services office activities including processing nutrition care orders, and menu correction. It indicated the RD would report to the FSD.

On 5/13/14 at 11:50 a.m., a concurrent interview was conducted with the ADNS and the CNM regarding the job descriptions and organization chart. The ADNS stated she was responsible for updating the organizational chart for the department. The ADNS stated the contractor was working on updating the job descriptions because they were aware they did not accurately reflect their job duties. When asked who would evaluate the competency of the CNM if it stated in the job description the CNM reports to the FSD, the CNM stated it would be a peer RD or the ADNS. The ADNS and CNM acknowledged the Director of Food and Nutrition Services was not qualified by education or experience to evaluate the competency of the RD.

Based on observation, staff and patient interviews, and medical record and document reviews, the hospital failed to effectively govern the activities and conduct of the hospital staff to provide safe and quality care to all patients as evidenced by:

1. Governing Body: The Governing Body failed to ensure that contract services were effectively evaluated. Refer to A 84 and A 273.

2. Nursing Services: The Governing Body failed to provide ordered nursing services in a safe and effective manner. Refer to A 385.

3. Infection Control: The Governing Body failed to ensure that the hospital provided a sanitary environment to avoid sources and transmission of infections and communicable diseases. Refer to A 747.

4. Food and Dietary Services: The Governing Body failed to ensure that dietary services met the needs of all patients. Refer to A 618.

These failures resulted in a potential for increased infections and 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: Governing Body.

Based on interview and record review, the medical staff failed to follow the hospital's policy for one of 41 sampled patients (Patient 6) when medical staff members had or should have detected an Adverse Event (AE- "Never Event," a preventable, unfavorable medical occurrence, which by law should never be allowed to happen; and if one should happen it is to be promptly reported to the licensing authority) and did not alert the hospital's administration of the potential AE when:

1. A radiologist and member of the medical staff detected an abnormal finding in a post-surgical (six days after surgery) Computerized Tomography scan (CT: an advanced technology, computer-assisted x-ray study), and did not alert the hospital administration of the abnormal finding, a potential AE. The surgeon who ordered the CT also did not report the potential AE when she reviewed the radiologist's CT reported findings.

2. Hospital policy defines criteria for certain surgical cases that must be carefully reviewed, in detail for medical occurrences that may indicate an opportunity for improvement. This case met several of those criteria, when it was noted that Patient 6 was (1) readmitted to the hospital shortly after her first hospitalization, and (2) had a second surgical procedure due to complications from the first surgery. The first review of this case, triggered by the re-admission: (a) did not include all of the pertinent case information; (b) did not include the CT study; and (c) was not sufficiently detailed to recognize the potential AE.

3. The second review of this case was triggered by a complaint about the surgery. This review did include the CT scan, but not all other pertinent case information, and as a result, the hospital administration was not alerted to the possibility of an AE in a timely manner.

These failures on the part of Medical Staff (MS) members and committees reporting to the Medical Executive Committee (MEC) to consider all pertinent case information and to carefully review this case, in accordance with the MS rules and hospital policy and procedure, resulted in the Governing Body's (GB) failure to ensure that the MS was accountable for the quality of patient care. This failure resulted in the hospital's non-compliance with the statutory requirement to report AE's in timely manner to the State Agency within five days. This ongoing failure also leaves in place the potential for other patients to have similar unrecognized adverse events and poor surgical or medical outcomes.

Findings:

A hospital policy, dated 1/13/11, titled, "Adverse Event Reporting to the California Department of Public Health" instructed, "It shall be the policy of the hospital to report an event as defined within Health and Safety Code 1279.1, to the California Department of Public Health (CDPH) no later than 5 days after the event has been detected. It is our policy to investigate the source of the event, ..." The section titled, Procedure, "Adverse event" included: "Surgery performed on a wrong body part that is inconsistent with the documented informed consent for that patient."

The section of the policy titled, "Investigation" instructed, "An investigation into the cause of the event shall be undertaken, using root cause analysis (RCA), intensified review or other approved investigative process. It shall be the responsibility of the Risk Manager, in collaboration with Quality Management staff, to coordinate the initial investigation and support the RCA or other approved investigative process within the framework of the Medical Staff Executive Committee."

The section of the policy titled, "Report of Finding of Investigation and Follow-up" instructed, "Any error or issues associated with either personnel or system performance discovered during the course of the investigation, shall be referred to Risk Management for referral to the appropriate medical staff or departmental committee for review and follow-up."

A policy dated, 7/2012, titled, "Event Reporting and Management" indicated, "... consistent and prompt reporting and follow-up of events and integration with the quality activities of the medical staff. Timely and consistent reporting of events provides a mechanism to improve quality of care by preventing future similar events and identifying opportunities to improve internal processes."

The section of the policy titled, "Policy" instructed, "Timely event reporting through the development and implementation of non-punitive reporting which support the analyses of healthcare errors by establishing a "just culture" throughout the organization . . . "Evaluation of events and development of corrective action plans to prevent future or similar events from occurring."

The section of the policy titled, "Procedure" instructed, "If the event results in bodily injury to the patient, the department manager or supervisor on duty will notified immediately of the event. Notify the patient's treating physician as soon as appropriate."

On 4/29/14, the hospital faxed "A Report of Adverse Event ... " to the California Department of Public Health (CDPH). The document indicated a "surgery performed on the wrong body part" had occurred for Patient 6. The report section titled, "Adverse Event Information: 1. Date of Event Occurrence/Detection: 11/21/2012 2. Date of Report: April 29, 2014.

On 5/13/14 at 9 am, the Risk Manager (RM) stated the hospital had received a "notice of complaint" on 10/31/13 which involved Patient 6. RM stated the notice did not indicate a specific reason for the notice and she requested a medical review of Patient 6's record. RM stated this review, performed on 11/21/12, indicated there was a discrepancy in the CT scan report and further evaluation of the CT scan was recommended. RM stated she received another complaint which indicated Patient 6 had suffered a wrong site surgery on 11/15/12. RM stated it was with the second complant that she became aware there was a potential AE concerning Patient 6 involving wrong site surgery. RM stated she then notified CDPH of the AE, as required, on 4/29/14.

On 5/14/14 at 3 pm, RM stated it was the responsibility of all medical staff to immediately notify risk management whenever they became aware of a potential or actual AE when identified during Peer Review process. RM stated it was difficult for physicians to understand the necessity to report to risk management as soon as a potential or actual AE was detected.

On 5/14/14, Patient 6's record documented that on 11/7/12, Patient 6 signed a consent for surgery for "Bilateral Foraminotomies at Cervical 6 - 7" (a surgical procedure to widen the bone opening where the spinal nerve roots in the neck exit the spinal canal). Patient 6 was admitted to the hospital for the first surgical procedure on 11/15/12. The operative report, dated 11/15/12, indicated the operative procedure was "Microscopic, fluoroscopically-guided (use of a microscope and x-ray) bilateral C6 -7 foraminotomies."

The records further indicated Patient 6 was re-admitted to the hospital on 11/17/12, and required another surgery on 11/17/12. The 11/17/12 operative report indicated Patient 6 had a "Postoperative posterior cervical wound hematoma" (a collection of blood after surgery) and underwent a "Wound incision and drainage with evacuation of hematoma," (opening and draining of the hematoma). Patient 6 was discharged from the hospital on 11/17/12. That discharge record, dated 11/19/12, brief history indicated "... was admitted for foraminal stenosis (narrowing) for foraminotomy on the 15th. Surgery was uncomplicated. ... then presented ... with increasing neck pain and arm pain, burning numbness and tingling. She had a lot of incisional (at the surgery site) swelling and was taken to surgery for evacuation (removal) of the hematoma."

A report, dated 11/21/12, titled, "OP (Outpatient) CT Cervical Spine without contrast" (no dye was used), indicated the patient "History" as "Post OP (operative) Swelling." The "Findings" section of the report included: "... on the right side at C (cervical) 6 - 7 there has been a foraminotomy decompressing the right neuroforamen (opening where the nerve exits). On the left side at C7 - T1 (thoracic spine, below the last cervical spine) there is a foraminotomy decompressing (relieve) the C7 - T1 neuroforamen. The report "Impression" was "Bilateral foraminotomies as described. Moderate to severe degenerative disc disease at C6 - 7.

On 5/14/14 at 1:38 pm, an interview was conducted with the Vice President of Medical Affairs and the Chief of Staff (CS). VPMA stated that a review of this case, triggered by the re-admission to the hospital: (a) did not include all of the pertinent case information; (b) did not include the CT study; and (c) was not sufficiently detailed to recognize the potential AE. The VPMA further stated the second review of this case was triggered by a complaint about the surgery. This review did include the CT scan, but not all other pertinent case information and as a result the hospital administration was not alerted to the possibility of an AE in a timely manner. The VPMA and CS expressed it was difficult for medical staff members to understand the necessity to report to Risk Management as soon as a potential or actual AE had been identified. They acknowledged Risk Management was not notified, according to hospital policy, and further education of the policies were necessary to ensure compliance.

Based on document review and staff interview, the governing body failed to be responsible for all services furnished in the hospital when it failed to ensure that each contractor of services was furnishing services that did permit the hospital to comply with all applicable conditions of participation and standards for the contracted services, as evidenced by:

1. The hospital contracted with a vendor to provide nutritional care services, but had not put in place an effective means of ensuring the safety and efficacy of those services. Refer to A-23, A-84, A-273, and A-618.

2. The hospital contracted with a vendor to provide pharmaceutical services, but had not put in place an effective means of ensuring the safety and efficacy of medications provided through this contract. Refer to A-84, A-467 and A-494.

These failures had the potential to expose patients and/or staff to unsafe conditions related to un-monitored services.

Findings:

1. On 5/15/14 at 8:50 a.m. during an interview was conducted with the COO regarding contracted nutritional services and concerns regarding various aspects of the services provided since a recent change in the vendor, the COO acknowledged that the hospital had no evidence to show evaluations or measures taken to ensure the contracted services were effectively meeting their contractual obligations. (Cross Reference A-23, A-84, A-273 and A-618).

2. On 5/13/14 at 2:30 p.m. during a tour of the pharmacy, a preparation of succinylcholine was found at room temperature, marked with an expiration date that exceeded the 48 hours maximum durations specified in the hospital ' s policies and procedures. On 5/15/14 at 11:45 a.m., the Director of Pharmacy (DP) acknowledged that the succinylcholine had been compounded by Pharmacy 1 (a contractor providing pharmaceutical services) and that it had not been evaluated for sterility to support the medication was safe and effective for patient use during the extended duration indicated by the written expiration date.

Based on observation, interview, and administrative record review, the Governing Body failed to ensure contracted services were provided in a safe and effective manner, and therefore met the needs of the patients, when:

1. The hospital did not implement a quality assessment and performance program (QAPI), to ensure that nutrition care met the needs of the patients in a timely manner, furnished under contract, were reviewed on a routine basis to identify quality and performance problems, implement appropriate corrective or improvement activities, and to ensure the monitoring and sustainability of those corrective or improvement activities.

2. The hospital did not have a program in place to check the safety and efficacy of medications provided by a contract pharmacy.

The failure to monitor contract services for safety and efficacy had the potential for negative patient health outcomes including infection and malnutrition.

Findings:

1. During the course of the survey from 5/12 through 5/14/14, two of five patients (Patients 34 and 35) reviewed for clinical nutrition care had a delayed nutrition assessment by the RD. (Cross Reference A 630).

On 5/15/14 at 10:30 a.m., in an interview and document review of the quality appraisal and performance improvement (QAPI) data for food and nutrition services with the Area Director of Nutrition Services (ADNS) and Clinical Nutrition Manager, the 2013 PI (performance improvement) data related to food service was reviewed. The data pertained to tray accuracy, diet order checks, test tray evaluations, cleanliness rounds, temperature and sanitation monitoring, and hand hygiene compliance. The data included dietary departmental checklists which consisted of hospital safety rounds, and kitchen inspections. The data had started to be measured since December 2013 after the ADNS started in November. There was no data for clinical nutrition care that had been monitored. ADNS and the CNM acknowledged that there were no identified opportunities for clinical nutrition care. There was no indication that the hospital developed a QAPI program that identified opportunities for patient outcome in relationship to clinical nutrition care.

Review of a hospital document titled, "Master Service Agreement for Purchase of Environmental Services and Food and Nutrition Management Services DH-SS-132," effective date 6/17/13, revealed under Exhibit A that the contractor will provide Clinical Dietitians (RD) and their duties included to evaluate the effectiveness of medical nutrition therapy interventions; to provide appropriate and timely documentation that summarizes the nutrition care plan in the patient's medical record including nutrition assessment, diagnosis, plan, implementation, and progress to goals; and to identify and collect performance improvement data, monitor outcomes, and initiate corrective actions.

The contract did not contain evidence of a quality program report or specific quality indicators that would be used to evaluate the effectiveness of the contract services for the food and dietetic services.

On 5/15/14 at 8:50 a.m., an interview was conducted with the COO (Chief Operating Officer) regarding contracted services. The following items were discussed: RD oversight for the food and dietetics services and the Food Service Director qualifications (Refer to A 23); Food substitutions on the patient menu due to the change in vendors Refer to A 620); and how the hospital was evaluating the contract for food and dietetic services. The COO stated they had been having regular calls and meetings with the contractor since November to discuss concerns during the transition to the contractor. Although regular calls were being made with the contractor there was no evaluation by the hospital to ensure the contractor was meeting their contract or if it was effective. (Refer to A 283).


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2. During a concurrent tour, interview, and record review, on 5/13/14 at 2:20 pm, in the pharmacy, Director of Pharmacy (DP) identified a rapid intubation (medications and supplies used to place a breathing tube) kit (box 2). The kit was stored at room temperature. Inspection of the kit showed that it contained succinylcholine (medication used to relax muscles) liquid injectable medication. Inspection of the succinylcholine label showed succinylcholine, 20 mg (milligram) /ml (milliliter), 200 mg/10 ml, exp (expiration date) 6/25/2014 (44 days), NDC 61553-364-72, and lot # 14086128m. The hospital was requested to provide data showing the succinylcholine was safe and effective for patient use at the expiration date. The hospital did not provide sterility data for lot #14086128m, prior to the end of the survey.

During a concurrent interview and administrative record review on 5/15/14 at 10:10 am, Pharmacy Supervisor (Pharm Sup) identified the hospital policy and procedure for Definition of Risk level for Compounding (mixing) Sterile (germ free) Products. Pharm Sup acknowledged the policy defines the beyond use (expiration) date of 48 hours when low risk level (low risk of contamination) compounded medications are stored at room temperature. Pharm Sup further stated the beyond use date is based on USP<797> (USP (United States Pharmacopeial) <797>, a nationally recognized compounding information source).

During a concurrent interview and administrative record review on 5/15/14 at 11:45 am, DP identified the hospital policy and procedure for Outside Patient Care Services. DP acknowledged that B. 8 "Outside Services Provided to Mercy Redding (and patients)" applies to Pharmacy 1. DP reviewed section C and acknowledged it required Pharmacy 1's services to be evaluated for quality and safety. DP acknowledged that Pharmacy 1's succinylcholine, lot # 14086128m, was not evaluated for sterility to support the medication was safe and effective for patient use at the expiration date.

An administrative record review, of the U.S. Food and Drug Administration, National Drug Code Query-Package Code website at http://www.accessdata.fda.gov/scripts/cder/ndc/packagecode.cfm, for NDC 61553-364-72, returned results of "No matching records found."

An administrative record review, of the U.S. Food and Drug Administration, For Consumers website at showed, FDA does not approve compounded drugs. "Pharmacy compounding is an age-old practice in which pharmacists combine, mix, or alter ingredients to create unique medications that meet specific needs of individual patients. The FDA has not verified their safety and effectiveness. Poor practices on the part of drug compounders can result in contamination or in products that don't possess the strength, quality, and purity required."

During an administrative record review, of the hospital's policy and procedure for Definition of Risk level for Compounding Sterile Products (Procedure No.: 08.003B, Date Issued: 5/09) showed, Low Risk, Description, "Beyond Use Date maximum of 48 hours at room temperature ..."

During an administrative record review, of the USP (United States Pharmacopeial) <797>, a nationally recognized compounding information source, Guidebook to Pharmaceutical Compounding-Sterile Preparations (2008, pg 32) showed, Low-Risk Level CSPs, 4. " For a low-risk level preparation, in the absence of passing a sterility test (see Sterility Tests <71>), the storage periods cannot exceed the following time periods: before administration, the CSPs are properly stored and are exposed for not more than 48 hours at controlled room temperature (see General Notices and Requirements), for not more than 14 days at a cold temperature (see General notices and Requirements, and for 45 days in solid frozen state between -25 degrees and -10 degrees.

During an administrative record review, of Pharmacy 1's, LLC, Services Agreement, Amendment (11/2/12) showed, 5. Pharmacy 1 Performance: Operations, Stability: "Pharmacy 1 will provide current stability which is reasonable for services, utilizing standards and methods meeting or exceeding USP requirements." Further review showed, 6. Customer Responsibilities, "Customer shall be responsible for determining whether any compounded solution provided under this Pharmacy 1's Services Agreement is clinically correct, appropriate or accurate for prescribing to any particular patient and for any particular disease or condition, and for determining and recording the individual patients that receive the medications."

During an administrative record review, of the Pharmacy 1's invoice for (Invoice # A1014409, Date 3/31/2014) showed, Shipped "6", UM per QTY "CA5", NDC # "61553-364-72", Description/Shipping Method "20 mg/mL Succinylcholine Chloride Injection (Preserved)." Invoice is for succinylcholine lot # 14086128m.

During an administrative record review, the hospital's policy and procedure for Outside Patient Care Services (Approval: 8/2010) showed, B. "In order for Mercy Medical Center to provide services to meet the needs of all patients served, the following services are provided through contractual arrangements. The services must be provided at the same standard of care as Mercy Medical Center including meeting applicable regulatory standards ...8. Outside Services Provided to Mercy Redding (and patients)." Continued review showed, "C. "Clinical leaders and medical staff provide advice about the sources of clinical services to be provided by contractual agreement. All contracted services are evaluated for quality and safety of services provided using evidence-based information in the decision-making process, when possible. The organized medical staff recommends implementation or renewal of all contracted services to the Board of Directors for final approval annually."

Based on interview and record review, the hospital failed to ensure that quality assessment and performance improvement (QAPI) program was comprehensive to address all aspects of care, service, and operations in the following areas:

The QAPI program did not contain evidence of quality indicators for Environmental Services (EVS), Cardiac Rehabilitation, and Clinical Nutrition Departments.

The QAPI program did not address the processes of performance evaluations, and staff competency/ education.

The failure to identify and correct deficient practices jeopardizes patient health and safety.

Findings:

1. On 5/15/14, the QAPI Committee minutes from 11/2013 to 4/2014 were reviewed. These minutes did not contain any evidence that the Environmental Services Department, a contracted service, submitted QAPI reports to the QAPI Committee. (Refer to A 022 for further information)

On 5/15/14, the hospital policy, titled, "Performance Improvement Plan," dated 1/12/12, read, "The organizational PI Plan, established by the medical staff and an interdisciplinary performance improvement committee with the support and approval from the governing body, has as its scope the monitoring of every aspect of patient care and service, including contracted services.... Monitoring is undertaken in order to identify and resolve any breakdowns that may result in suboptimal patient care and safety, while striving to continuously improve and facilitate positive patient outcomes."

Review of a hospital document, titled, "Master Service Agreement for Purchase of Environmental Services and Food and Nutrition Management Services DH-SS-132," effective date 6/17/13, revealed under Exhibit D that the contractor will perform weekly audits of the quality of work and perform corrective actions as needed documented on checklists and submit these checklist to the designated representative of the hospital.

On 5/15/14 at 11:20 am, the Director of EVS acknowledged that there was not a QAPI plan for the EVS Department.

2. On 5/15/14, the QAPI Committee minutes from 11/2013 to 4/2014 were reviewed. These minutes did not contain any evidence that the committee received any reports regarding the performance evaluation process.

On 5/15/14 at 9:45 am, the Director of Human Resources confirmed that the performance evaluation process was not measured as part of the QAPI program.

3. On 5/15/14, the QAPI Committee minutes from 11/2013 to 4/2014 were reviewed. These minutes did not contain any evidence that the committee received any reports regarding the competency of staff or completion of required education was measured as part of the QAPI program. (Refer to A 022 for further information).

On 5/15/14 at 9:45 am, the Chief Nursing Executive confirmed that the completion of required education and competencies were not tracked and reported in the QAPI program.


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4. During an interview with the Director of Cardiac Rehabilitation (DCR) on 5/14/14 at 10 am, the DCR was asked about the outpatient cardiac rehabilitation (Cardiac Rehab) quality assurance program. DCR stated Cardiac Rehab did not participate with the hospital's Quality Assessment and Performance Improvement (QAPI) program and did not have quality measures and/or indicators in place to improve the health outcomes for patients seen in the outpatient Cardiac Rehab program. DCR stated all hospital departments, which included Cardiac Rehab, are required to participate in the hospital's QAPI program.


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5. On 5/15/14 at 10:30 a.m., an interview and document review of the quality appraisal and performance improvement (QAPI) data for food and nutrition services was conducted with the Area Director of Nutrition Services (ADNS) and Clinical Nutrition Manager. The 2013 PI data related to food service pertained to tray accuracy, diet order checks, test tray evaluations, cleanliness rounds, temperature and sanitation monitoring, and hand hygiene compliance. The data included dietary departmental checklists which consisted of hospital safety rounds, and kitchen inspections. The data had started to be measured since December 2013 after the ADNS started in November. There was no data for clinical nutrition care that had been monitored. ADNS and the CNM acknowledged that there were no identified opportunities for clinical nutrition care. The ADNS stated she actively participated in the hospitals' performance improvement program since December 2013. They stated they were to present at the QA committee in May and the last two meetings had been canceled. They stated they could only speak to what they had done since they had started at the hospital. There was no indication that the hospital developed a QAPI program that identified opportunities for patient outcome in relationship to clinical nutrition care.

Review of the QA & Improvement Committee meeting minutes, indicated in July 2013 was the last time Nutrition Services had presented to the QA committee with data from January through May 2013 on Tube Feeding starts within 24-48 hours, 50-65% of caloric goal for ICU patients by Day 7, and permissive underfeeding of obese ICU patients. The quarter summary was 98%, 98%, and 96% respectively. There was no data collected from June until December 2013 for Food and Dietetic Services.

Review on 5/15/14, of the hospital document titled, "Performance Improvement Plan" approval date 1/12/12, noted that the purpose of the plan was "to continually and systematically plan, design, measure, assess, and improve performance of priority focus areas." The scope of the plan was to encompass organization wide activities related to quality control, quality assessment and performance improvement.

Review of a hospital document titled, "Master Service Agreement for Purchase of Environmental Services and Food and Nutrition Management Services DH-SS-132," effective date 6/17/13, revealed under Exhibit A that the contractor will provide Clinical Dietitians (RD) and their duties included to evaluate the effectiveness of medical nutrition therapy interventions; to provide appropriate and timely documentation that summarizes the nutrition care plan in the patient's medical record including nutrition assessment, diagnosis, plan, implementation, and progress to goals; and to identify and collect performance improvement data, monitor outcomes, and initiate corrective actions. (Refer to A 84).

6. During the course of the survey from 5/12 - 5/14/14, 2 of 4 ice machines in the nourishment rooms throughout the hospital, the ice machine in the hospital kitchen, and the ice machine in the cafeteria dining room were observed to have either white or black substance and 2 of 2 ice machines in the cafeteria were not cleaned or sanitized by the soft drink vendor or the hospital. (Refer to A 749).

On 5/15/14 at 10:10 a.m., an interview was conducted with the Infection Control Preventionist (ICP) regarding her role at the hospital. The ICP stated she does environmental care rounds, two times a year for each department. The ICP stated she does look at and monitor the ice machines. There was no formal QAPI regarding the ice machines in the hospital. The ICP stated they had identified some ice machines with white substances on the drain pans and that is why the Maint Staff B said they had ordered a few recently.

Based on observation, interview, and record and 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. Nursing care to prevent blood clots was not provided for two of 41 sampled patients (Patients 15 and 19) Refer to A 396.

2. Nursing care was not provided to one of 41 sampled patients (Patient 15) following a significant change in cardiovascular condition. Refer to A 397.

3. Pain medication was given to one of 41 sampled patients (Patient 11) outside of the ordered parameters on three different occasions. Refer to A 405.

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 hospital failed to implement the plan of care for two of 41 sampled patients (Patients 15 and 19) when their Sequential Compression Device (SCD, limits development of potentially fatal blood clots, known as Deep Vein Thrombosis [DVTs], while patients are inactive by creating circulation) were not applied, as ordered by the physician, and failed to clarify SCD orders written by the physician. This failure had the potential for patients to experience life threatening blood clots.

Findings:

1. A review of Patient 15's record disclosed he was admitted to the hospital on 5/5/14 with diagnoses that included low blood sodium and a fall. The record included a physician's order for bedrest, dated 5/8/14 and a physician's order, dated 5/5/14, to wear the SCDs BID (twice daily).

On 5/12/14 at 1:25 pm, Patient 15 was observed with his SCDs laying across the foot of his bed. The SCD pump was not running and the SCDs were not on Patient 15's legs. During a concurrent interview with Registered Nurse (RN) G, she confirmed that Patient 15 SCD's had not been on since 10 am that morning. RN G confirmed that Patient 15's record included a physician's order, dated 5/5/14, to wear the SCDs and that they were for the prevention of DVTs.

2. A review of Patient 19's record disclosed he was admitted to the hospital on 3/2/14 with diagnoses that included a fractured hip, dementia and altered level of consciousness. SCDs BID had been ordered by his physician on 3/3/14.

On 5/12/14 at 1:45 pm, Patient 19 was observed in his bed without his SCDs on. His SCDs were laying across the foot of the bed and the pump was not running. In a concurrent interview, Administrative (Admin) Nurse C confirmed that Patient 19's SCDs were not on although his physician had ordered them to be on. In a concurrent interview, RN G confirmed that Patient 19's SCDs had been ordered by his physician on 3/3/14.

On 5/12/14 at 1:50 pm, RN E was asked what Patient 15 and 19's SCDs ordered BID (twice daily) meant. She stated that she interpreted the BID frequency to mean 9 am and 9 pm and that their SCDs were to be on some time during those shifts.

On 5/12/14 at 1:53 pm, RN F stated that SCDs BID meant that they were to be on at night and off when being bathed or when patients were agitated.

On 5/12/14 at at 1:55 pm, RN G stated that SCDs ordered BID meant they were to be on first thing in the morning and at night time, depending on the patient's activities.

On 5/12/14, the hospital's Antiembolic Stockings and Sequential Compression Devices policy (Mosby, 2014) was reviewed. The Monitoring and Care section, #7 read, "Remove...SCDs periodically, at least once per shift...SCDs are removed long enough to perform assessment and hygiene measures and replaced as soon as possible..."

On 5/14/14 at 11:55 am, Admin Nurse C stated the "SCDs BID" orders needed parameters of when to have them on and when to have them off. Admin Nurse C confirmed the orders were unclear and open to misinterpretation. Admin Nurse C stated she had been unaware of this problem until brought to her attention during the survey.

Based on observation, interview and record review, the hospital failed to provide nursing care that met the needs of one of 41 sampled patients (Patient 15). Staff delayed the implementation of physician's orders that included telemetry monitoring (portable box with electrodes attached to the chest that remotely transmit patient's heart rhythm for continuous monitoring by specialty trained nurses and technicians). This had the potential for a significant delay by staff in responding to any heart arrhythmias (abnormal heart rhythms that can lead to death) Patient 15 could experience.

Findings:

A review of Patient 15's record disclosed he was admitted to the hospital on 5/5/14 with diagnoses that included low blood sodium and a fall.

On 5/12/14 at 1:45 pm, Patient 15 was observed in his bed on the Medical unit. During a concurrent interview with Registered Nurse (RN) G, she stated that at 12:03 pm, Patient 15's physician had ordered his transfer to the Intermediate Care Unit (IMCU, higher level of care) with telemetry. RN G stated Patient 15 had not been transferred because there was no bed available on IMCU and that he was not currently being monitored by telemetry, as ordered by his physician. RN G stated that a "Rapid Response" was called at 10 am that morning and that Patient 15's heart rate had gone up to 138 beats per minute (normal less than 100).

A review of the hospital's Rapid Response Team (RRT) Responder Interventions for Adults Standardized Procedure, dated 9/2010, read, "RRT is called to provide early intervention in order to promote better outcomes such as reduced cardiac and/or respiratory arrests (heart attacks/stops breathing) in the hospital..."

Patient 15's Critical Care Consultation written by the physician, dated 5/12/14, read, "...he has had multiple rapid responses for elevated heart rate...currently in the 100-130 range...Cardiac monitoring at this time shows atrial flutter with rapid ventricular response (unstable abnormal rhythm)..."

A memo from CNE to all Nursing Staff and Supervisors, dated 5/12/14, was reviewed and read, "Please be aware that if you receive a physician's order for a patient to receive a higher level of care, i.e. (in other words) medical floor patient has a telemetry order, or telemetry patient has an ICU (Intensive Care Unit) order, that patient MUST start receiving that level of care at the TIME of the order."

On 5/12/14 at 1:55 pm, Administrative (Admin) Nurse C stated that they were not able to utilize telemetry from Patient 15's current room on the Medical unit and that RN G was not trained in telemetry monitoring.

On 5/13/14 at 8:15 am, Chief Nursing Executive (CNE) stated that the Rapid Response Nurse was supposed to stay with the patient until the transfer to the higher level of care unit.

On 5/13/14 at 2:19 pm, Admin Nurse C confirmed that Patient 15 was transferred to IMCU and telemetry monitoring was started at 2:15 pm (4 hours after the orders were received).

Based on interview and record review, the hospital failed to administer a medication as ordered by the physician, when hydromorphone (a narcotic pain medication) was given to one of 41 sampled patients (Patient 11) outside the ordered parameters on three different occasions.

This had the potential for the medication to be ineffective and not in accordance with the physician's plan of care.

Findings:

Patient 11 was admitted to the facility on 5/9/14 with diagnoses that included hip fracture and respiratory failure.

In an interview on 5/12/14 at 10:30 am, Patient 11 stated that the nurses were working to help relieve her pain, without much success. "I hurt from my toes to my chin."

A review of Patient 11's medical record showed that her pain level was assessed using a numerical rating system, with "0" representing no pain, and "10" representing unbearable pain. A physician's order, dated 5/10/14, read: "Hydromorphone 0.5 - 1 mg (milligram) IV (intravenous-given through a small tube into a vein) every four hours PRN (as needed). Give per pain scale (1-6): 0.5 mg, (7-10): 1 mg." The order further specified, "Contact physician for new order if patient requires doses different from the scale."

Patient 11's Medication Administration Record showed the following:
a) On 5/10/14 at 3:23 pm, hydromorphone 0.5 mg was given for pain scale of 8.
b) On 5/11/14 at 1:51 am, hydromorphone 0.5 mg was given for pain scale of 7.
c) On 5/13/14 at 7:05 am, hydromorphone 0.5 mg was given for pain scale of 9.

During an interview and concurrent record review on 5/13/14 at 11:20 am, Registered Nurse (RN) J confirmed that the hydromorphone had been given to Patient 11 outside the ordered parameters. RN J stated that there was no documentation indicating that the physician had been notified, despite the order to do so.

Based on interview and record review, the facility failed to ensure physicians authenticated (verified with signature) verbal orders promptly for four of 41 sampled patients (Patients 15, 18, 19, and 20). This had the potential for an error in the transcription of the verbal order to not be discovered in a timely manner, which could lead to adverse clinical outcomes to patients.

Findings:

a. Patient 15 was admitted to the hospital on 5/5/14 with diagnoses that included low blood sodium and a fall.

On 5/12/14, Patient 15's record included a physician's telephone order for an electrocardiogram (EKG, recording of the heart's electrical activity), dated 5/12/14 at 10:01 am.

On 5/14/14 at 11:27 am, Patient 15's EKG order, dated 5/12/14 at 10:01 am, included a notification that read, "This order is yet to be cosigned by the ordering physician." Patient 15's EKG order was concurrently reviewed with Administrative (Admin) Nurse C who confirmed it had not by cosigned within 48 hours of being given.

b. Patient 18 was admitted to the hospital on 5/9/14 with diagnoses that included fainting and a urinary tract infection.

On 5/14/14 at 3 pm, Patient 18's record included a physician's telephone order, dated 5/11/14 at 5:53 am, for Sodium Chloride (intravenous solution) that was not signed. A second physicians telephone order, dated 5/11/13 at 5:51 am, for 2 units of packed red blood cells was not signed. Both included notations that read, "This order is yet to be cosigned by the ordering physician." Admin Nurse J concurrently confirmed that there was no evidence the order had been signed within 48 hours.

c. Patient 19 was admitted to the hospital on 3/2/14 with diagnoses that included a fractured hip, dementia and altered level of consciousness.

On 5/14/14 at 4 pm, Patient 19's record included physician's telephone order, dated 5/12/14 at 11:14 am for bilateral soft wrist restraints. Admin Nurse J concurrently confirmed the orders were not signed within 48 hours.

d. Patient 20 was admitted to the hospital on 5/10/14 with diagnoses that included a skin infection.

On 5/15/14 at 11:37 am, Patient 20's record included physician's telephone order, dated 5/10/14 at 2:43 am, for Tylenol. Director of Risk Management (DRM) concurrently confirmed Patient 20's orders for Tylenol was not signed by the physician within 48 hours.

On 5/14/14, the hospital's Rules & Regulations of the Medical Staff, May/2013 Edition, included a section titled, "Countersignatures" read, "Telephone/verbal orders shall be authenticated by the prescriber, or another physician if the prescriber is not available, within forty-eight (48) hours."

Based on interview and medical record review, the hospital failed to document in the medical record the date and time a fentanyl (scheduled (narcotic) pain medication) patch (topical, on the skin) was administered to one of 41 sampled patients (Patient 39). This failure resulted in the potential for patients to be exposed to preventable medication errors which could lead to adverse clinical outcomes.

Findings:

During a concurrent interview and medical record review, on 5/13/14 at 11:35 am, Administrative Nurse (Admin Nurse E) identified that Patient 39 was admitted to the hospital on 5/2/14. Review of the medical record showed a physician's order, dated 5/2/14 at 23:36 (11:36 pm), for fentanyl (Duragesic-a topical, potent narcotic medication that is applied to and absorbed via the skin) every 72 hr (hours). Admin Nurse E, Pharmacy Supervisor (Pharm Sup), and Pharmacist (Pharm A), reviewed the medical records and stated the pharmacy dispensed the first fentanyl patch on 5/4/14 at 1600 (4 pm). Admin Nurse E, Pharm Sup, and Pharm A stated the medical records, dated 5/4/14, document Patient 39 was wearing the first hospital dispensed fentanyl patch. Admin Nurse E, Pharm Sup, and Pharm A further stated that the medication administration record (MAR, record of medication administration) does not show the date and time the first fentanyl patch was applied.

During an administrative record review, of the hospital's policy and procedure for Management of Controlled Substances (Original: April 2014) showed, IV. Procedure, F. Administration of Controlled Substances, 2) "The administering nurse must document each dose of controlled substances administered on the Medication Administration Record or as otherwise appropriate in the medical record." The nurse did not document the first fentanyl (controlled substance) patch that was administered on 5/4/14 in the MAR.

Based on observation, interview, and administrative record review, the hospital failed to ensure all scheduled (potential for abuse) medications are accounted for from purchase to administration or wastage. The hospital did not have a process to ensure that all scheduled medications dispensed from an automated dispensing cabinet (ADC, device to dispense medications) are accurately documented as administered or wasted. This failure resulted in the potential for diversion of scheduled medications and preventable medication errors.

Findings:

During an interview, on 5/13/14 at 2:30 pm, Director Pharmacy (DP) was asked to describe the process that is used to ensure all scheduled medications are accurately documented from purchase to administration or wastage. DP described a process for several patient care areas. In these areas the pharmacy audits 100% of the scheduled medications dispensed from an ADC for accurate documentation in the medical record. DP further described a process for specific scheduled medications. The pharmacy audits specific scheduled medications dispensed from an ADC for accurate documentation in the medical record. DP did not describe a process to ensure that all scheduled medications dispensed from an ADC are accurately documented in the medical record.

During an administrative record review, of the hospital's policy and procedure for Management of Controlled Substances (Original: April 2014) showed, I. Purpose: "To establish guidelines for the procurement, receiving, dispensing, security and record keeping of all controlled substances and reduce the potential for drug diversion at Mercy Medical Center Redding."

Based on interview and record review, the hospital failed to ensure that a pain medication was ordered, in accordance with standards of practice, when Percocet (a narcotic pain medication) was ordered for one of 41 sampled patients (Patient 11) without pain scale parameters.

This had the potential for duplication of medication and adverse drug reaction, such as oversedation or ineffectiveness.

Findings:

Patient 11 was admitted to the facility on 5/9/14 with diagnoses that included hip fracture and respiratory failure.

In an interview on 5/12/14 at 10:30 am, Patient 11 stated that the nurses were working to help relieve her pain, without success. "I hurt from my toes to my chin."

Review of Patient 11's medical record showed that her pain level was assessed using a numerical rating system, with "0" representing no pain, and "10" representing unbearable pain. The record contained orders for three different medications for pain management (ibuprofen, Percocet and Dilaudid).

One physician's order, dated 5/10/14, called for "Oxycodone/acetaminophen (Percocet) 10/325 mg (milligrams) tab. One PO (by mouth) every six hours PRN (as needed for) pain."

In an interview and concurrent record review on 5/14/14 at 8:25 am, the Director of Pharmacy (DP) confirmed that Patient 11's Percocet order lacked pain scale parameters. He stated that including pain scale parameters on PRN pain medication orders is considered "routine practice."

In an interview on 5/14/14 at 9:10 am, Pharmacist B stated that he had reviewed and approved the original order for the Percocet on 5/10/14. He stated that he should have clarified the order with the physician, and that "standard procedure" would be to define pain scale parameters any time there is more than one pain medication to be given by the same route, as was the case with Patient 11 to ensure effective pain management.

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

1. Ensure the implementation of dietetic services in an effective and organized manner. Refer to A 619, A 620.

2. Provide a comprehensive therapeutic diet manual that reflected the diets offered in the hospital. Refer to A 631.

3. Ensure the nutritional needs of patients were met for two of five patients (Patients 35 and 34) reviewed for clinical nutrition care. Refer to A 630.

4. Ensure there was adequate food supplies for the disaster menu. Refer to A 701.

5. Ensure that performance improvement activities demonstrated opportunities for improvement of services and fully reflected the depth and scope of the department. Refer to A 273.

6. Ensure staffing of dietetic services, in accordance with State regulatory requirements. Refer to A 23.

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 dietetic services staff interview and document review, the hospital failed to ensure that the organizational structure of dietetic services met State regulatory requirements as evidenced by the organizational chart and job descriptions were not reflective of the Food Service Director and Clinical Nutrition Managers job responsibilities.

Findings:

During initial tour on 5/12/14 beginning at 9:30 am, the Food Service Director (FSD) was introduced as the person hired by the contracted food service as responsible for dietetic services at the hospital.

A review of the organizational structure of dietetic services beginning on 5/13/14, revealed that the department was not organized in a manner consistent with State regulatory requirements. Refer to A23.

On 5/13/14 at 10:50 am, an interview was conducted with the Area Director of Nutrition Services (ADNS) and the Clinical Nutrition Manager (CNM). The CNM stated she was the full-time Registered Dietitian responsible for oversight at this hospital.

On 5/13/14 at 11:50 am, a interview was conducted with the ADNS and the CNM regarding the job descriptions and organization chart. The ADNS stated she was responsible for updating the organizational chart for the department. The ADNS stated the contractor was working on updating the job descriptions because they were aware they did not accurately reflect their job duties for both the CNM and the FSD.

Based on observation, staff interviews, and review of hospital documents, the Food Service Director (FSD) failed to:
1) Ensure the food supplies were adequate to meet the disaster menu, and
2) Ensure the hospital menu was being followed as approved by the Registered Dietitian when multiple food substitutions were being made.

These failures can result in patients not receiving adequate nutrition.

Findings:

1. On 5/12/14 beginning at 10:40 am, food service for disaster preparedness was reviewed with the Area Director of Nutrition Services (ADNS), Food Service Director (FSD), and Food Service Staff A. A concurrent review of the hospitals' disaster menu noted the plan included the provision to provide meals for 1,315 patients and staff, three times a day for four days. A random comparison of the hospital developed inventory and available food supplies revealed there was inadequate supplies of items such as instant cream of wheat (3 cases short), nonfat dried milk (50 pounds short), cheerios (2 cases short), and granola cereal (13 cases short).

In a concurrent interview with Food Service Staff (FSS) A, she stated some of their stock was out dated and that is why they are currently short some supplies. Refer to A701.

2. On 5/13/14 at 1:30 pm, an interview and review of the substitution log was conducted with the FSD. The FSD stated they had to change vendors to be consistent with the contractor and the new food vendor did not have all the products for them. The FSD stated they are still having to make some substitutions at this time.

Review of the Menu Item Substitution Log from 2/1/14 through 5/14/14 indicated there was 68 days out of 103 days when substitutions were made for the menu; 66% of the time substitutions were made with anywhere from one to 13 substitutions, per day.

On 5/14/14 at 9:20 am, an interview was conducted with FSS A in the presence of ADNS regarding ordering. The FSS A stated the vendor changed in December and at first had issues with getting in some products but things were better now.

On 5/14/14 at 9:25 am, an interview was conducted with the ADNS, who stated substitutions have been made for a variety of reasons. The ADNS stated they did not have much warning about the change of vendors so at first there was lack of availability of some products. She stated at times they run out of something during tray line with an increase of patients or guest trays. The ADNS stated they worked on the managed order guide to ensure FSS A had all the items in there to order. The ADNS stated they had not monitored this for any kind of quality assurance plan. She stated they plan to change over their computer system this summer and have learned from this and will make sure they have all of the ingredients and products in the system before the change over.

Review of the hospital policy and procedure titled, "Menus; Planning, Approval and Meet and Greet Process" revised 8/09, indicated the Director of Nutrition, Supervisor, and the Chief Clinical Dietitian are responsible for the planning, preparation and selection of menus.

Based on clinical nutrition care review, clinical nutrition manager interview and dietary department document review, the hospital failed to ensure nutritional needs were met for two of five patients reviewed for nutrition care (Patient 34 and 35). 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.

Findings:

1. Patient 35 was admitted on 5/6/14 with a right hip fracture. Medical record review was conducted on 5/14/14. A review of the physician's orders, dated 5/6/14, indicated a "NPO" diet order (nothing by mouth). A review of the physician's orders, dated 5/7/14, indicated a clear liquid diet. A review of the physician's orders, dated 5/8/14, indicated a regular diet. A review of the physician's progress notes, dated 5/10/14, indicated Patient 35's problem list included moderate protein calorie malnutrition.

Review of the meal percentage records for Patient 35 indicated the following:

On 5/8/14, indicated Patient 35 ate 25% (percent) for breakfast. There was no documentation recorded on the lunch and dinner meal intakes;
On 5/9/14, 25% was recorded for breakfast and lunch. There was no meal intakes recorded for dinner;
On 5/10/14 indicated 50% for lunch and dinner. There was no meal intake recorded for breakfast;
On 5/11/14, Patient 35 ate 45% for breakfast, 0% for lunch. There was no meal intake recorded for dinner;
On 5/12/14 Patient 35 ate 65% for breakfast. There was no meal intake recorded for lunch or dinner;
On 5/13/14 Patient 35 ate 70% for breakfast. There was no meal intake recorded for lunch or dinner; and
On 5/14/14 indicated 50% for breakfast.

On 5/14/14 at 3:30 pm, an interview was conducted with Registered Nurse (RN) V regarding meal percentages. RN V stated nursing staff picks up trays and documents percentages in the electronic medical record. RN V stated there was no policy and procedure on this but it was part of nursing practice at the hospital.

Review of the Nutrition Assessment for Patient 35, dated 5/13/14, the RD indicated a current clinical issue was moderate protein calorie malnutrition. The RD indicated the patient reports oral intake less than 50% of meals, likely not meeting nutrition needs and the patient reports she believes she has had some weight loss, due to nausea which makes her afraid to consume any food. The RD indicated Patient 35's estimated nutritional needs were 1650-1980 calories, 66-79 grams of protein per day. The RD indicated the nutrition diagnosis was inadequate oral food/beverage intake related to nausea as evidenced by consuming less than 50% of meals. The RD recommendations were to continue with the regular diet, as ordered, and to honor patient food preferences. The RD goal was for Patient 35 to consume at least 50% of meals and to have a bowel movement every 1-3 days. The RD indicated Patient 35 was at a normal risk level and to follow up in 7 days. The Nutrition Assessment was completed on the 7th day of admission.

Review of the hospital undated policy titled, "Nutrition Screening," indicated patients not at risk on admission will be screened or assessed by the dietitian by day 5 of admit.

On 5/14/14 at 3:20 pm, an interview was conducted with the Clinical Nutrition Manager (CNM). The CNM stated they are short RD's so she has been covering on the floors, however, she was out of the office last week so they were short and this was why the assessment was late. The CNM stated her expectation is for all patients to have an assessment on day 5 of admission, if nothing else brings the RD in sooner, since the RD's already screen all the patients daily. The CNM stated that often, many meals are not documented in the electronic medical record. The CNM acknowledged the assessment was late and the RD should not have put the patient at normal risk due to oral intake, weight loss, and the diagnosis of protein calorie malnutrition.

2. Patient 34 was admitted on 5/6/14 with congestive heart failure, status post right big toe amputation, due to peripheral vascular disease (blood vessel obstruction) with a history of Chronic Kidney disease, coronary artery disease, and diabetes. Medical record review was conducted on 5/14/14. Review of the Operating Room notes, dated 5/14/14, indicated Patient 34 received a right below the knee amputation. Review of the physician's orders, dated 5/6/14, indicated consistent carbohydrate diet. Review of the physician's orders, dated on 5/13/14, indicated a NPO diet (nothing by mouth) after midnight. Review of the physician's orders, dated 5/14/14, indicated a consistent carbohydrate diet.

Review of the Nutrition Assessment for Patient 35, dated 5/12/14, indicated the Nutrition Diagnosis was increased nutrient needs related to wounds as evidenced by estimated calories/protein needs higher to promote wound healing. The CNM indicated the intervention is to have the patient consume at least 75% of estimated needs. The CNM indicated the estimated needs were 1900-2230 calories, 51-83 grams of protein, and to adjust protein for kidney function. The CNM indicated Patient 34 was at moderate nutrition risk. The Nutrition Assessment was completed on day 6 of admission.

Based on dietary staff interview, and dietary document review, the hospital failed to ensure the hospital's approved diet manual was consistently utilized to develop the hospitals' diets. Lack of a current and comprehensive diet manual that reflected hospital developed diets may result in inaccurate guidance to dietary and hospital staff when following physician ordered diets and meeting the nutritional needs of patients, further compromising medical status.

Findings:

A review of the hospital's diet manual revealed there were physicians guidelines for ordering diets, however, it did not encompass how to order all of the diets in the manual. It was noted under certain types of diets for specific diseases (e.g., diet for renal disease) there would be further information on how to order the diet. It noted that the diet would limit sodium, potassium, and phosphorus.

On 5/13/14 at 10:07 am, a concurrent interview with the Area Director of Nutrition Services (ADNS) and the Clinical Nutrition Manager (CNM) was conducted. The ADNS stated the hospital's renal diet's parameters were 60 grams of protein, 2 grams of sodium, and 2 grams of potassium unless specified for dialysis then they would provide 80 grams of protein. This was not reflected in the diet manual. The Consistent Carbohydrate diet parameters set by the hospital are 60 grams of carbohydrate for males and 45 grams for females, however, this is not indicated in the diet manual. The ADNS acknowledged they did not address how these diets were in accordance with the current national standards.

Further review of the diet manual indicated that there was no reference to show the adequacy of the diets in accordance with the current national standards, such as the Recommended Dietary Allowances (RDA) or Dietary Reference Intakes (DRI's) for any of the diets the hospital provides.

Further review of the diet manual, indicated there was a high protein, high calorie diet modifier, however, the diet manual did not explain how many calories or grams of protein would be provided for this diet.

The Diet Manual should encompass: the diets ordered at the hospital, the parameters of the diet, in accordance with the current national standards, such as RDA or DRI, and how to order the diet.

Review of the hospital's policy and procedure titled, "Diet Manual," revised 6/09, indicated the American Dietetic Association's Nutrition Care Manual is the diet manual. The hospital has the Nutrition Care Manual however it is not specific for the hospital ordered diets. The hospital has developed another document regarding the diet ordered in the hospital, however, that is not referenced in their policy and procedure.

Based on interview and document review, the hospital failed to ensure that the Utilization Review (UR) Committee reviewed professional services. The UR Committee did not review the hospital's use of necessary services, such as laboratory, pharmacy and diagnostic imaging for underuse, overuse or appropriate use.

This failure had the potential for professional services and therapeutic procedures to be used inefficiently, which could result in increased costs or inappropriate use of the available services.

Findings:

During a concurrent interview and document review on 5/15/14 at 8:40 am, the UR meeting minutes were reviewed for the past year. There was no indication that the UR Committee had reviewed professional services. The Director of Case Management (DCM) confirmed that the UR Committee had not been reviewing professional services except for monitoring timeliness of services.

In an interview on 5/15/14 at 9:40 am, the Vice President of Medical Affairs, a member of the UR Committee, confirmed the UR Committee had not been reviewing professional services for underuse, overuse or appropriate use.

Based on dietetic services observations, staff interviews of emergency preparedness and document review, the hospital failed to ensure food supplies were adequate to meet the hospital developed plan. Failure to ensure adequate food supplies were located within the hospital may result in unavailability of the supplies in the event of a disaster.

Findings:

On 5/12/14, beginning at 10:40 am, food service for disaster preparedness was reviewed with the Area Director of Nutrition, Food Service Director and Food Service Staff A. Concurrent review of the hospitals' disaster menu noted the plan included the provision to provide meals for 1,315 patients and staff, three times a day for four days. A random comparison of the hospital developed inventory and available food supplies revealed there was inadequate supplies of items such as instant cream of wheat (3 cases short), nonfat dried milk (50 pounds short), cheerios (2 cases short), and granola cereal (13 cases short). In a concurrent interview with Food Service Staff A, she stated some of their stock was out dated and that is why they are currently short some supplies.

Based on observation, interview, and medical record reviews, the hospital failed to provide an environment to avoid sources and transmission of infections and communicable disease and to have effective systems in place as evidenced by:

1. Temperatures in the operating room (OR) were not maintained in accordance with facility policy and procedure or facility-adopted, nationally recognized infection control guidelines. Refer to A 749, item 1.

2. The Central Processing environment was not kept in a sanitary manner. Refer to A 749, item 2.

3. Staff was not knowledgeable of proper disinfection processes for glucometers (a device used to obtain blood to test blood sugar levels). Refer to A 749, item 3.

4. During a surgical procedure, staff failed to perform hand hygiene in accordance with facility policy and procedure or facility-adopted, nationally recognized infection control guidelines. Refer to A 749, item 4.

5. There were no protective masks or gowns readily available for staff disposing of patient waste in the patient rooms in the Intensive Care Unit (ICU) North and ICU South. The rooms in ICU West and the on-site Outpatient Chemotherapy department lacked a method for rinsing contaminated patient waste containers, such as urinals and bedpans, and also did not have protective masks or gowns available. Refer to A 749, item 5.

6. A sharps container (a container used for the disposal of contaminated, used needles and other sharp objects) was overfull and overflowing on ICU West. Refer to A 749, item 6.

7. The outpatient Oncology Center environment was not disinfected, according to manufacturer recommendations. Refer to A 749, item 7.

8. Sixteen of 16 ice machines were not maintained in a sanitary manner, in accordance with manufacturer's recommendations. Refer to A 749, item 8.


9. Intravenous (IV) dressings were not labeled for one of 41 sampled patients and one patient outside the sample, Patients 20 and 42. Refer to A 749, item 9.

10. Two IV clamps and a patient gown were left contaminated with blood for one of 41 sampled patients, Patient 18. Refer to A 749, item 10.

11. Patient personal care items were stored in the patient refrigerator/freezer on the Post Operative Care unit 2 Central. Refer to A 749, item 11.

12. The Clean Supply room on the Medical unit 2 South was not maintained in a clean, sanitary manner. Refer to A 749, item 12.

13. Surgical attire was not observed in the interventional radiology (IR) suite when an Environmental Services Staff (EVS) member was noted to have hair uncovered. Refer to A 749, item 13.

14. An EVS staff member used contaminated, gloved hands to make a phone call after cleaning an IR suite. Refer to A 749, item 14.

15. Pudding cups were not stored in a refrigerator in the Oncology Unit, under proper temperature to prevent spoiling. Refer to A 749, item 15.

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 Participation: Infection Control Services

Based on observation, staff interview, and document review, the hospital failed to maintain a system for controlling sources of infections, in accordance with internal policies and procedures, nationally recognized infection control practices and guidelines, and regulations, when:

1. Temperatures in the operating room (OR) were not maintained in accordance with facility policy and procedure or facility-adopted nationally recognized infection control guidelines.

2. The floor adjacent to a washer in Central Processing was observed to be soiled underneath and surrounding containers of detergent.

3. Registered Nurses (RN) incorrectly described the disinfection process for glucometers (a device used to obtain blood to check blood sugar levels) and glucometers were not effectively disinfected, in accordance with facility policy and procedure and disinfectant product use guidelines.

4. During a surgical procedure, staff failed to perform hand hygiene, in accordance with facility policy and procedure or facility-adopted, nationally recognized infection control guidelines.

5. There were no protective masks or gowns readily available for staff disposing of patient waste in the patient rooms in the Intensive Care Unit (ICU) North and ICU South. The rooms in ICU West and the on-site Outpatient Chemotherapy department lacked a method for rinsing contaminated patient waste containers, such as urinals and bedpans, and did not have protective masks or gowns available.

6. A sharps container (a container used for the disposal of used, contaminated needles and other sharp objects) was overfull and overflowing on ICU West.

7. A laboratory technician in the off-campus Oncology Center did not use a disinfecting wipe (Sani-Cloth Bleach), in accordance with the manufacturer's instructions.

8. Sixteen of 16 ice machines located throughout the hospital were not maintained in a sanitary manner, in accordance with manufacturer's recommendations.

9. Patients' intravenous (IV) dressings were not labeled for one of 41 sampled patients and one patient outside the sample, Patients 20 and 42.

10. Two IV clamps and a patient gown were left contaminated with blood for one of 41 sampled patients, Patient 18.

11. Patient personal care items were stored in the patient refrigerator/freezer on the Post Operative Care unit 2 Central.

12. The Clean Supply room on the Medical unit 2 South was not maintained in a clean, sanitary manner.

13. Surgical attire was not observed in the interventional radiology (IR) suite when an Environmental Services Staff (EVS) member was noted to have hair uncovered.

14. An EVS staff member used contamiated, gloved hands to make a phone call after cleaning an IR suite.

15. Pudding cups were not stored in a refrigerator, under proper temperature, in the Oncology Unit.

These failures exposed patients to the potential for the growth and spread of microorganisms, infectious disease, and food borne illness.

Findings:

1. On 5/12/14 at 10:30 am, during observation and interview in Operating Room #8, the thermometer was observed to read 62.1° F (degrees Fahrenheit) and humidity of 29% (percent). The Infection Control Preventionist (ICP) verified the observation.

During an interview with Administrative (Admin) Nurses B, G and H, on 5/12/14 at 9:55 am, they stated that hospital followed the American Association of periOperative Nurses (AORN) Standards and Recommended Practices as national guidelines for practice. The Perioperative Standards and Recommended Practices, 2014 Edition, stated, at a minimum, the temperature of the operating room should be maintained at 68-73°F.

During a document review on 5/12/14 at 4:30 pm, the policy titled, "Humidity and Temperature Monitoring of Operating Suites and Procedural Areas," with an approval date of June 2013, included the language "The air temperature in procedural areas is recommended to range from 68°F to 75°F (AORN, California Mechanical Code). The policy included: "The temperature and humidity levels of operating suites ...should be monitored, recorded and addressed via TempTrak® during regular business hours by each department."

In an interview and document review with Admin Nurses B, G and H, the fourteen day (4/28 - 5/13/14) TempTrak® (wireless temperature monitoring system) Sensor History for Operating Room (OR) #8 provided documentation that the temperature did not return to policy ranges of 68°F to 75°F at any time on 5/12/14. The average temperature for OR #8 was 64°F for the entire fourteen day period. The alarm parameters that were set in the TempTrak® program were a lower range of 55°F and an upper range of 73°F. Admin Nurses B, G, and H stated, "The temperature, depending on certain surgical conditions, could be adjusted to be cooler"; no policy was provided to describe these conditions. They further stated that Plant Operations is responsible for setting the parameters in the TempTrak® system and responsible for maintaining ranges within established parameters.

In an interview on 5/15/14 at 8:30 am with Director of Plant Operations (DPO), he stated that the monitoring of the TempTrak® was done by the laboratory department and the surgical department leadership is notified of any temperatures outside the alarm parameters that are entered into the TempTrak® program. He stated that the temperatures are controlled by the perioperative staff in the department.

In an interview on 5/15/14 at 9 am with Laboratory Director and Laboratory Information Services Coordinator (LIS), they stated that the surgery department is responsible for choosing the alarm parameters for the TempTrak® system and communicating those settings to the laboratory staff. The laboratory's responsibility is limited to entering the alarm settings into the program.

2. On 5/12/14 at 11:35 am, during observation of the decontamination area of central processing with Admin Nurses B, G, H, ICP and CPT, the floor was observed to be soiled underneath and around the containers of detergent adjacent to washer # D942846*02. This was validated by a concurrent interview with Admin B and CPT.

The American Association of periOperative Nurses (AORN) Standards and Recommended Practices, 2014 Edition, states that sterile processing areas should be terminally cleaned (process to ensure sterility). Sterile processing areas where decontamination occurs have some of the highest risks for environmental contamination of all perioperative areas. Environmental cleaning in sterile processing areas is critical for reducing the risk of disease transmission from reservoirs of bloodborne pathogens and microorganisms in the decontamination environment.

During a document review on 5/14/14 at 4:30 pm, the policy, titled, "Perioperative Services Unit Specific Infection Control: Cleaning Processes for Perioperative Service," with approval date 10/10/2011, under section IV letter C indicated, "Cleaning of ancillary rooms such as sub-sterile rooms will be done as needed."

On 5/12/14 at 3:45 pm in an interview with the ICP, she acknowledged the environmental cleaning needed to be done.

3. On 5/12/14 at 2:15 pm during an interview and observation, RN B could not correctly describe the two step process for disinfecting the glucometer if it was visibly soiled with blood. RN B stated that she "would wipe the surfaces of the glucometer with the Super Sani Cloth and wait for a wet time of 2 minutes."

On 5/12/14 at 2:35 pm during an interview and observation, RN C could not correctly describe the two step process for disinfecting the glucometer if it was visibly soiled with blood. She stated that she "would wipe the surfaces of the glucometer with a paper towel to clean the blood, then she would wipe the glucometer with the Super Sani Cloth and wait for a wet time of 2 minutes."

A review conducted on 5/13/14 at 8:00 am of the hospital policy titled, "Cleaning and Disinfecting Point Of Care Testing Devices," with approval date 11/08/12, indicated, "Step One consists of physically wiping away any visible organic matter (blood or body fluids) from the exterior surface with the Super Sani Cloth germicidal wipe once the patients point of care laboratory procedure is completed." Step 2 specified that "When all visible signs of organic soil have been cleaned form the exterior of the point of care device a fresh, clean germicidal wipe must be obtained and used to wipe the exterior surface of the device for the final disinfection process to occur...and allow the wipe's germicidal agent to air dry on the exterior surface of the point of care device for the recommended kill time of two minutes ...use additional wipes if needed to maintain the wet kill time."

According to the manufacturer's recommendation for the glucometer Accu-CHEK Inform II device, page 124, "The cleaning and disinfection of the exterior surface of the meters used with multiple patients may require more frequent cleaning and disinfecting. Follow recommendations from the FDA, CDC, and CMC and your facility's policy and procedures for infection control."

According to Super Sani Cloth manufacturer's information, this product is an EPA Reg. No. 9480-4 and is a pre-moistened nonwoven durable wipe containing a quaternary/alcohol based solution. Recommended for use in hospitals for use on hard non-porous surfaces and equipment made of stainless steel, plastic, and glass. Some organisms are removed from the surface by thoroughly wiping the surface with the wipe. Most remaining organisms are killed within two (2) minutes by exposure to the liquid in the wipe. It is recommended to use a two-step process if there is visible organic matter.

4. On 5/13/14 at 10:15 am, during the observation of a Caesarian Section (C-Section - surgery to deliver a baby by an abdominal incision) in the Labor and Delivery surgical suite, RN R failed to sanitize her hands after removing her gloves on three different occasions: after assisting with positioning of the patient during spinal anesthesia, after performing a urinary catheterization, and after application of a surgical prep.

On 5/13/14 at 10:40 am, in an interview, Admin Nurse I (who observed the C-section procedure from outside the surgical suite) stated, "She (RN R) did not have time for hand hygiene when changing gloves due to the emergent nature of the procedure."

On 5/13/14 at 1 pm, review of the hospital infection control policy titled, "Hand Hygiene and Surgical Hand Antisepsis" with an approval date of 4/17/13, the "Guidelines," section A.6. indicated, "All personnel shall cleanse hands ...before and after patient care ...and after removal of gloves."

According to the American Association of periOperative Nurses (AORN) Standards and Recommended Practices (2014), Section II: Recommended Practices for Perioperative Nursing, Recommendation II.a. "A hand wash should be performed ...before and after every patient contact...and before putting gloves on and after removing gloves or other personal protective equipment." It further states under section II.c. that "Hand washing may be performed using an alcohol-based antiseptic hand rub when soil is not present on hands." Furthermore, AORN recommendations state that "Contamination of hands may occur as a result of holes or tears in gloves that are not visible," and "When gloves are removed."


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5. During observations on 5/12 and 5/13/14, the following was noted:

a. The patient rooms in ICU North were noted to have hoppers (flushing sinks used for the disposal of patient waste such as urine and feces) with attached spray wands for rinsing soiled items in each room. There were no protective masks or gowns available to protect staff from potential splashing of patient waste.

b. In ICU South, each patient room had a toilet which served as a means for staff to dispose of patient waste. Spray wands were located next to the toilets. There were no protective masks or gowns in the rooms.

c. The patient rooms in ICU West had toilets, but no spray wands, masks or gowns.

In an interview on ICU South on 5/12/14 at 1:40 pm, Registered Nurse (RN) A demonstrated her process for disposal of patient waste, such as urine or feces. She stated that after dumping the waste into the toilet, she would then use the water from the sink faucet to rinse out bedpans or urinals. RN A confirmed that the same faucet was used for providing drinking water for the patients. She was unaware that there was a spray wand in a cabinet adjacent to the toilet.

During an interview with RN D on 5/12/14 at 2:05 pm on ICU West, when describing his process for disposing of patient waste such as urine or feces, he stated he would dump or pour the waste into the toilet, then rinse the bedpan or urinal under the sink faucet. He stated that the faucet was the only water available in the room for this purpose. RN D confirmed that the same faucet was used to provide drinking water for the patients. He further stated that he would probably use protective equipment, such as a face shield, if it was available near the toilet.

On 5/12/14 at 11:30 am, Administrative Nurse (AN) A confirmed that there were no protective masks or gowns in the patient rooms on ICU North, ICU South or ICU West, and stated that there should be.

On 5/13/14 at 9:45 am, the Director of Environmental Services (DEVS) confirmed that there should be masks and gowns in the in the ICU North, ICU South and ICU West patient rooms. The DEVS further stated that there should be spray wands adjacent to the toilets in ICU West.

d. During an observation on 5/14/14 at 12:15 pm, in the Outpatient Chemotherapy department with RN O and Infection Preventionist (ICP), it was noted that there was no dirty utility room. There was one bathroom containing a toilet and a sink. RN O stated that patient waste, such as urine and feces, is emptied into the bathroom toilet. She further stated that the arrangement "is a problem," as there was no spray wand available to rinse out urinals or portable commodes, and the only source of water was the sink faucet. She stated that there was no protective equipment available, and stated that she would use it if there was. The ICP confirmed that the Outpatient Chemotherapy department should have an alternative means of rinsing out patient waste containers and that protective masks and gowns should be available.

6. During an observation and interview with Administrative Nurse (AN) A on 5/12/14 at 10:45 am, a large, blue sharps container was noted to be overfull, with used intravenous tubing hanging over the side of the container. AN A confirmed that the sharps container should have been closed and sealed, prior to becoming overfull.

According to the facility's Infection Control Manual, dated 3/11, "Sharps containers, when full, are to be closed and taken by the Contract Company or Environmental Services personnel to the designated area for disposal."

7. During an observation and interview on 5/14/14 at 4:15 pm, with Laboratory Technician (LT) A and ICP at the off-site outpatient Oncology Center, LT A stated that he routinely used Sani-Cloth Bleach wipes to disinfect the laboratory area counters and surfaces. He stated that he allowed the disinfectant to stay wet for two minutes. In a review of the manufacturer's instructions printed on the Sani-Cloth Bleach container, LT A stated that the instructions called for a wet contact time of four minutes, in order to effectively sanitize surfaces. The ICP stated that proper use of the Sani-Cloth Bleach wipes called for a wet contact time of four minutes. A staff instruction sheet provided by the ICP for using Sani-Cloth Bleach, undated, called for "4 Minute Contact Time."


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8. a. On 5/13/14 at 1:35 p.m., in the hospital kitchen during a joint observation of the ice-machine and interview with Maintenance Staff A and the Area Director of Nutrition Services (ADNS), the trough and ice shield contained a speckled black colored substance. The top of the ice machine bin contained a white colored substance. Maintenance Staff A verified the substances and stated they clean and sanitize the ice machines every three months and they are responsible for cleaning and sanitizing all ice machines in the hospital except the two in the cafeteria that are done by the soft drink vendor.

b. On 5/13/14 at 1:55 p.m., in the hospital cafeteria, two ice machines were observed. A concurrent interview was conducted with the ADNS. The ADNS verified these ice machines were the ones from the soft drink vendor and they would contact them.

c. On 5/13/14 at 2:00 p.m., in the hospital cafeteria dining area, a joint observation was made of the ice-machine with the ADNS, in which the chute of the ice machine had a white colored substance throughout. The ADNS verified the white substance in the ice machine chute.

d. On 5/14/14 at 10:15 a.m., in the nourishment room in 2 Central, a joint observation was made of the ice-machine with the ADNS, in which the drain pan and grille of the ice-machine had a large amount of a white colored substance throughout the drain pan and grille. ADNS acknowledged the white substance on the ice machine. A concurrent interview was conducted with the ADNS regarding the cleaning of the ice machine. She stated housekeeping cleans the outside of the ice machine.

On 5/14/14 at 10:50 a.m., an interview was conducted with EVS C regarding the cleaning of the ice-machines in the nourishment rooms. EVS C stated she wipes off the outside of the ice machine daily with the 25 sanitizer (HB Quat Disinfectant). She stated she takes the grille off the drain pan and wipes it down, however, the white substance will not come off.

e. On 5/14/14 at 3:55 p.m., in the soiled utility room on 2 East, a joint observation was made of the ice machine with the ADNS and the Clinical Nutrition Manager (CNM), in which the chute of the ice machine had a white colored substance throughout the chute from where the ice and water were dispensed. The ADNS and CNM verified the white substance on the ice machine.

On 5/15/14 at 8:30 a.m. an interview was conducted with Maintenance (Maint)Staff B. Maint Staff B stated they use all the different brands approved cleaner and sanitizer. He stated they clean all the ice machines in the hospital except the ones in the cafeteria. He stated they had recently purchased new drain pans for some of the ice machines that they were unable to clean off all of the white substances. Maint Staff B stated the black substance on the kitchen ice machine has not been able to come off since he has worked here for over a year. He stated he would need to replace it.

On 5/15/14 at 10:10 a.m., an interview was conducted with the Infection Control Preventionist (ICP) regarding her role at the hospital. The ICP stated she does environmental care rounds, two times a year for each department. The ICP stated she does look at and monitor the ice machines. The ICP stated they had identified some ice machines with white substances on the drain pans and that is why the Maint Staff B said they had ordered a few recently.

On 5/15/14 at 12:40 p.m., an interview was conducted with the soft drink vendor regarding the cleaning of the two ice machines in the cafeteria in the hospital. The soft drink vendor stated he is not responsible for cleaning and sanitizing the ice machines in the hospital cafeteria. He stated the ice machines are owned by the hospital, therefore, are the responsibility of the hospital.

Ice Machines in the cafeteria dining room, 2 Central and 2 East were the same brand of ice machines. Review of a list of ice machines revealed there were 16 of these ice machines located throughout the hospital. Review of this ice machine manufacturer's directions, indicated cleaning should be performed at least every 6 months, and more often if local water conditions dictate. It indicated the dispenser grille and drain pan to be cleaned at weekly intervals. It indicated to remove grille and wash with a cleaning solution (200 ppm of available chlorine content of Ecolab Mikro-chlor Cleaner or equal chlorinated detergent with a solution temperature of 75-125 degrees Fahrenheit) and then rinse thoroughly. Pour one cup of household bleach into drain pan, followed by one gallon of hot tap water to flush drains. This weekly cleaning of the drain pan and grille was not being done by either the EVS or engineering staff.

The ice machine in the kitchen and cafeteria were the same brand of ice machine. Review of this ice machine manufacturer's directions, indicated to clean and sanitize the ice machine every six months for efficient operation. It indicated if the ice machine requires more frequent cleaning and sanitizing, consult a qualified service company to test the water quality and recommend appropriate water treatment. It indicated to use only the brand's approved Ice Machine cleaner and sanitizer for the cleaning and sanitizing procedures. Neither the hospital or the soft drink vendor had been cleaning or sanitizing the two ice machines in the hospital cafeteria.


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9. During an initial tour of the Intermediate Care Unit (IMCU) on 5/12/14 at 11 am, Patient 42's IV dressing was observed to not have been labeled with the date, time, or initials of who placed the IV. Registered Nurse H concurrently observed and confirmed that Patient 42's IV site dressing should have been labeled and dated, but was not.

On 5/12/14 at 1:55 pm, Patient 20's IV site dressing was observed without having a date on the label. Administrative (Admin) Nurse C concurrently confirmed that Patient 20's IV dressing was unlabeled.

10. During an initial tour of the IMCU on 5/12/14 at 9:45 am with the Director of Case Management (DCN), Patient 18's IV site was observed. Patient 18's gown (underneath the IV site) and the two plastic clamps attached to her IV line, were observed to have dried red substance on them. DCN concurrently confirmed there was dried blood on Patient 18's gown and IV clamps that should have been cleaned off.

On 5/15/14, the hospital's Blood and Body Fluid Exposure Plan, dated 4/17/13, included a section titled, "Methods of Compliance" that read, "A. STANDARD PRECAUTIONS SHALL BE OBSERVED TO PREVENT CONTACT WITH BLOOD OR OTHER POTENTIALLY INFECTIOUS MATERIAL. ALL FLUIDS ARE CONSIDERED TO BE CONTAMINATED..." and "J. Equipment that may become contaminated with blood or other potentially infectious material will be decontaminated prior to reuse..."

11. During an initial tour on 5/12/14 at 11:17 am, the patient food refrigerator, located adjacent to the nursing station, was observed at Post Operative Care (2 Central). A personal reusable cold compress was observed stored in the freezer section of the patient food refrigerator, along side food items. Admin Nurse C confirmed that the compress was a personal care item and should not be stored with patient foods.

On 5/14/14, the hospital's Foods Supplied to Patients Other Than Nutrition Services policy, dated 8/4/10, read, "4. Items that have been in a patient's room may not be placed in the refrigerator."

12. During initial tour on 5/12/14 at 2:05 pm with Admin Nurse C, the clean supply room (where nursing and patient care items are stored) on the Medical Patient Care unit (2 South) was observed. The floor of the room was noted to be covered with gray/black spots and areas of yellowing discoloration. Admin Nurse C concurrently confirmed the floor was not clean and was able to demonstrate that the spots and discolorations were removable with scrubbing.



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13. On 5/12/14 at 11 am, Environmental Services Staff (EVS) A was observed cleaning an interventional radiology (IR) room, following a procedure, wearing a blue bonnet with six wisps of hair hanging out from the bonnet.

On 5/12/14 at 11:10 am, EVS A was asked about the hair outside her bonnet and she responded that all her hair should be covered by the bonnet.

In a concurrent interview, the Manager of Imaging Services (MIS) acknowledged that hair should be completely covered in the IR suites.

According to AORN, Perioperative Standards and Recommended Practices, Recommended Practices for Surgical Attire, 2013: "All personnel should cover head and facial hair, including sideburns and the nape of the neck, when in the semirestricted (peripheral support areas of the surgical suite: storage areas for clean and sterile supplies, work areas for storage and processing of instruments, scrub sink areas, and corridors leading to the restricted areas) and restricted areas (operating rooms, procedure rooms and the clean core area). A clean, low-lint surgical head cover or hood that confines all hair and covers scalp skin should be worn. The head cover or hood should be designed to minimize microbial dispersal. Hair acts as a filter when it is uncovered and collects bacteria in proportion to its length, waviness, and oiliness. Studies have shown that Staphylococcus aureus and Staphylococcus epidermidis have a tendency to colonize hair ...Head coverings designed to contain hair and scalp skin will minimize microbial dispersal. Skull caps may fail to contain the side hair above and in front of the ears and hair at the nape of the neck. Head coverings contain skin squames (flakes) and hair shed from the scalp. It is important to prevent shed skin squames from falling onto the sterile field ...Human hair can be a site of pathogenic bacteria such as MRSA (a treatment resistant bacteria)."

14. On 5/12/14 at 11 am, Environmental Services Staff (EVS) A was observed leaving the IR room, following the cleaning of the room after a procedure, and using a telephone with her gloved hands.

At 11:10 am, EVS A was asked about the procedure for using gloves while cleaning. EVS A responded that she should remove the gloves and wash her hands. EVS A acknowledged that she should not have used the phone with her gloved hands.

In a concurrent interview, the Manager of Imaging Services (MIS) acknowledged that gloves should be removed after cleaning a IR room and hands washed prior to using a phone.


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15. During a concurrent tour, interview, and administrative record review on 5/4/14 at 12 pm, in the outpatient infusion center, Registered Nurse (RN O) identified a closed cabinet. Inspection of the cabinet showed that it contained pudding cups. Inspection of the pudding cups showed, [Brand name] chocolate pudding, "Perishable (food that will go bad quickly if left out of the refrigerator)," and "Keep Refrigerated." RN O inspected the pudding cups and acknowledged they were labeled, "perishable and keep refrigerated." RN O acknowledged that the pudding cups were not stored in a refrigerator.

During an administrative record review, of the hospital's policy and procedure for Food Receiving and Storage (Reference # 11-002, Revised 7/11) showed, Procedure, 9. "Refrigerated food shall be maintained at 41 degrees Fahrenheit or less ..." The hospital did not maintain the pudding at 41 degrees Fahrenheit or less.

Based on interview and record review, the hospital failed to ensure that one of seven sampled surgical/procedural patient's pre-anesthesia evaluation included the identification of potential anesthesia problems, particularly those that may suggest potential complications or contraindications to the planned procedure. (Patient 5). This failure had the potential for an adverse reaction to anesthesia that could have been prevented.

Findings:

On 5/15/14 at 1:50 pm, Patient 5's record was reviewed. Patient 5 was admitted for a cardiac catheterization following recurring episodes of chest pain. Patient 5's record contained a cardiac catheterization progress note, dated 5/13/14, which contained blank check off boxes for yes and no responses to the following items:

- Past adverse reaction to anesthesia/sedation;
- Airway WNL (within normal limits);
- Family adverse reaction to anesthesia/sedation; and
- Level of consciousness WNL.

On 5/15/14, the hospital's policy, titled, "Anesthesia Services/Anesthesia and Procedural Sedation," dated 8/11, read "A pre-anesthesia evaluation must be completed and documented by the anesthesiologist, or individual qualified to administer anesthesia, within 48-hours prior to any inpatient or outpatient surgery or procedure requiring anesthesia services. At a minimum, the pre-operative anesthetic evaluation of the patient should include:...Review of medical history, including anesthesia, drug and allergy history. Identification of any potential anesthesia problems..Patient's condition prior to induction of anesthesia."

On 5/15/14 at 1:50 pm, Administrative Nurse B reviewed Patient 5's record and acknowledged the record did not contain evidence of a complete pre-anesthesia evaluation.