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Based on observation, 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:

A. The Governing Body (GB) failed to responsibly ensure that contracts were in place to provide all of the necessary services, and failed to ensure that all contracted services are provided in a safe and effective manner. (Refer to A-83 and A-84)

B. The Governing Body failed to ensure that the hospital had established and maintained an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program that, at a minimum achieved and maintained regulatory compliance. (Refer to A-263.)

C. The Governing Body failed to ensure an effective infection control program was developed and functioning to ensure services were provided in a safe and sanitary manner (Refer to A-747 and A-749)

These failures (described in detail in Conditions of Participation A-263 and A-747) resulted in a potential for increased infections, insufficient services 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 for Governing Body.

Based on staff interview, document review, and medical record review, the hospital failed to ensure an active, effective, ongoing, hospital-wide, data-driven Quality Assessment and Performance Improvement (QAPI) program had been developed, implemented, and adjusted in order that the hospital could achieve sustainable regulatory compliance, quality care and safe standards of care, as evidenced by the following:

1. The hospital failed to ensure that processes of care and operations were measured, analyzed, and tracked as quality indicators to demonstrate implementation of corrective actions and sustaining safe care practices. (Refer to A-273)

2. The hospital failed to ensure that quality improvement activities were developed and performed to correct previously identified opportunities for improvement. (Refer to A-283)

3. The governing body failed to update the Quality Assessment and Performance Improvement plan written in 2006. (Refer to A-309)

4. The governing body failed to provide adequate resources to sustain a functioning QAPI program. (Refer to A-315)

These failures resulted in the hospital's inability to maintain an effective quality assessment and performance improvement program. The cumulative effect of these systemic failures resulted in the inability of the hospital to comply with the statutorily-mandated Condition of Participation for Quality Assessment and Performance Improvement.

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. Failure to supervise and evaluate nursing care for one of 32 sampled patients, when the heart rate alarms were disabled for 12 hours on his telemetry unit (portable box attached to patient that wirelessly displays their heart rate and rhythm at a central station) and the nurses were not monitoring it or aware the alarms were off (Patient 1). (Refer to A 395, finding 1).

2. Failure to follow the hospital policy to label intravenous (IV) dressings and tubing. (Refer to A 395, finding 2).

3. Failure to ensure development of care plans for diabetes mellitus type 2 (high blood sugar) for one of five patients (Patient 19) reviewed for nutrition. (Refer to A 396).

4. Failure to supervise contract nursing staff adequately for two of 32 sampled patients (Patients 1 and 11). (Refer to A 398).

5. Failure to identify one of 23 sampled patient's high risk discharge needs when the nurse did not complete the patient's initial nursing assessment. (Patient 3) (Refer to A 392).

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 document review, the hospital failed to ensure an effective, active system wide infection control program and surveillance for prevention, control, and investigation of infections and communicable diseases. The Infection Control, Condition of Participation is not met as evidenced by the facility's failure to have effective systems in place to provide and ensure:

1. Staff were trained and competent to ensure the operating suites' environment could be effectively cleaned and disinfected. (Refer to A-0749, item 1).

2. Safe and sanitary air handling systems in the perioperative and operative areas in accordance with nationally recognized infection control guidelines. (Refer to A 749, item 2).

3. Sterility of surgical instruments and sterile supplies. (Refer to A 749, items 3 a-c).

4. Physicians and staff were screened and offered immunization for vaccine preventable diseases in accordance with a facility policy that is based on nationally accepted infection control guidelines. (Refer to A 749, item 4).

5. A staff person was trained and competent to wash his hands in accordance with facility policy and nationally accepted infection control guidelines. (Refer to A 749, item 5).

6. Staff adhered to the standard for OR (operating room) infection control practices related to the use of OR attire in the surgical suites. (Refer to A 749, item 6).

7. The hospital failed to develop a system for identifying and maintaining sanitary environment when the kitchen bin ice machine was not maintained clean and free from scale deposits and the bin was not cleaned following manufacturer's directions. (Refer to A 748).

8. Clamps were present in the anesthesia drawer in operating room (OR) 308 that did not have an indication that they were clean or sterile, and they were avilable for use on the next patient. (Refer to A 749, item 7).

9. The emergency department contained a hopper (used to flush human waste) that did not have personal protective equipment readily avilable for use. (Refer to A 749, item 8).

The Condition of Participation for Infection Control is not met. The cumulative effects of these systemic problems resulted in the facilities inability to ensure an effective system-wide infection control program that failed to provide a safe environment free of transmission sources of infections and communicable disease.

Based on hospital staff interviews and review of the facility's pharmacy policy and procedures, the hospital failed to ensure that it had developed a contract to ensure that the hospital would have a pharmacist available when the facility's only pharmacist (DOP) was not available. This failure could have resulted in the hospital's inability to provide pharmaceutical services for their patients.

Findings:

Review of the hospital's pharmacy policy and procedure dated 4/21/08, entitled: "Pharmacy Staffing", read: "The Pharmacy shall be staffed at all times by a pharmacist who is a graduate of an accredited College of Pharmacy and licensed to practice in this state, who is responsible to the hospital administration .... During the hours the Pharmacy is closed, a pharmacist shall be "on call" through the use of a beeper or telephone ...illness/vacation relief: The following persons will provide relief coverage for vacations or illness (company name) ..."

Interview with the hospital's DOP (the hospital's only pharmacist), on 7/15/14 at 9:10 am, revealed the "company name" in the hospital's policy and procedure above did not have a current contract with this hospital. The hospital's DOP went on during the interview to state that the hospital did not have a contract with any Pharmacy company at the present time to provide the hospital a pharmacist in the event that the DOP was sick, on vacation, chosen for jury duty, etc. During the interview, the DOP went on to state, that a while back, he had been out of the hospital and unable to work because he had been chosen for jury duty.

During an interview with Administrative (Admin) Nurse A on 7/16/14 at 3:45 pm, Admin Nurse A confirmed that the hospital did not have a contract for a Pharmacist or with a Pharmacy provider, in the event that a hospital needed a Pharmacist to cover for the DOP while he was out of the hospital.

Based on staff interview and document review, the governing body failed to ensure that the services performed by outside vendors (contracted staff or arranged services) were provided in a safe and effective manner, and incorporated into the hospital's Quality Assessment and Performance Improvement Program (QAPI). This failure put patients and staff at risk for injury or adverse experience in the care environment.

Findings:

1. On 7/16/14 at 9:05 am, the facility's linen and bio-hazardous waste disposal contracts were reviewed. The linen contract was signed 2003. There was no evidence in either contract of objective performance indicators to measure the safety and quality of the services performed.

During a review of the linen and bio-hazardous contract and interview with Infection Control Nurse B on 7/16/14 at 9:30 am, he acknowledged the linen and bio-hazardous waste disposal contracts did not include any objective performance measures for safety and quality of services. Infection Control Nurse B stated "We should have something from them (referring to the vendors) on their quality assurance on a regular basis, including information related to the performance of any involved equipment/machinery." Infection Control Nurse B also indicated the contracts should include a contract review sheet as part of the contract. Infection Control Nurse B also indicated the contracts needed to be reviewed more frequently, as he acknowledged the linen contract's last review date was 2003.

Based on interview and record review, the hospital failed to ensure that processes of care and operations were measured, analyzed, and tracked as quality indicators to demonstrate implementation of corrective actions and sustaining safe care practices. Documented evidence was lacking to show the following care processes were effectively evaluated when continued evidence of regulatory violations were identified:

1. Emergency Department (ED) physician certifications for transfer were incomplete for the summary of risks and benefits of transfer and implementation of suicidal precautions when indicated.

2. Crash Cart (carts containing life saving equipment, medications, and supplies in the case of a medical emergency) checks (for complete supplies and operation) were not done each shift in the Emergency Department (ED) and the Intensive Care Unit (ICU).

3. Medical records were incomplete for a surgical patient which was not noted in the Medical Record Department review.

4. Nutrition care was not provided to patients who were at risk.

These failures resulted in continued care practices that jeopardized patient outcomes and safety.

Findings:

1. On 7/16/14, the quality assessment and performance improvement program (QAPI) was reviewed. The QAPI program contained no performance indicators regarding ED services including but not limited to the summary of risks and benefits of transfer on the physician transfer certification form, and for the proper supervision of patients requiring suicidal precautions.

On 7/16/14, the ED Manager was interviewed regarding the QAPI program. After reviewing deficient practices identified in ED services, ED Manager acknowledged that ED services did not monitor the completeness of the transfer certifications or the implementation of suicide precautions.

2. On 7/10/14, the crash carts in the ED and the ICU were evaluated. The ED crash cart was not checked each shift on 4/18, 4/28, and 6/16/14. The ICU crash cart was not checked each shift on 7/8/14.

On 7/16/14 at 9:52 am, the ED Manager stated the expectation is that all crash carts are checked for proper operation, complete medications, and supplies each shift at the beginning of the shift. ED Manager reported that there were no quality indicators following whether these checks were done each shift. (Refer to A 724, finding 2).

3. On 7/15/14, Patient 13's record was reviewed. Patient 13 was admitted on 7/7/14 for a colonoscopy (a procedure to view the inner lining of the large intestine or gut). Patient 13's record contained no evidence of a history and physical (H&P).

On 7/15/14 at 2 pm, the Medical Records Director (MRD) stated that the medical records staff was to review each record for completeness and the absence of a H&P should have been noted as part of the medical record quality program. MRD acknowledged that Patient 13's record review failed to identify the missing H&P. (Refer to A 458).


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4. Three of five patients (Patient 12, 17, and 19) reviewed for nutrition care, who were at nutritional risk, did not receive timely nutrition assessment, plan for nutrition care, and nutrition interventions appropriate for multiple nutrition related diagnoses.

During an interview with Food Service Director, a Registered Dietitian (RD), on 7/16/14 at 11 am, RD stated that the policy was to have nursing do the admission nursing screening within the first 24 hours of admission. RD stated that she would do a nutrition screen to determine the patient's risk within 72 hours of admission except for obstetric patients. The RD stated the policy was for the patient to then receive a nutritional assessment based on the level of nutrition risk based on the nutrition screening. The time frames to complete the nutrition assessment included high risk to be completed within three days and moderate risk within five days of admission.

The RD stated that last year she had monitored the policy to see that the time frames for the nutrition assessment were met. RD stated she discontinued the quality assessment and performance improvement plan (QAPI) when the benchmark was consistently met. RD stated the QAPI did not include evaluating the existing policies on nutrition screening, nutritional assessment and nursing admission screening to identify how the practice was working. RD stated she had not validated the nursing nutrition screening criteria to ensure it accurately identified nutritional risk specific to the hospital admissions. RD acknowledged that there was no QAPI identified to ensure nutrition care was met during the average patient length of stay of 3.1 days.

Based on interview and documents review, the hospital:

1. Failed to utilize data previously collected which identified opportunities for improvement; and to effectively take actions to correct previous deficiencies, when no alterations were made in infection control methods or other changes made to have an effective, active system wide infection control program and surveillance for prevention, control, and investigation of infections and communicable diseases. This failure had the potential to expose patients and staff to unsanitary conditions and the risk of infection. (Refer to A-747 and A-749)

2. Failed to have a quality program that contained mechanisms to ensure that there were actions taken to address indicators that did not meet the established performance thresholds. These failures had the potential for adverse patient outcomes due to persistent patient safety and quality of care performance issues.

This is evidenced by repeated deficient findings on survey despite a stated commitment to remedy deficient practices identified in previous surveys. This failure has the potential to expose patients and staff to unsanitary conditions and the risk infection. (Refer to A-747 and A-749)

Findings:

1. Findings of unsafe infection control practices during a health survey of the hospital, conducted by California Department of Public Health, completed on 3/19/14, included the discovery of failure to ensure a healthcare worker immunization program based on nationally accepted infection control guidelines, failure to identify and remove potentially compromised sterile supply items, and failure to maintain operating room equipment in a condition that permits disinfection. The hospital's written plan of correction indicated actions that promised to remedy these failures. On the survey ending 7/17/14, additional findings related to failure to ensure a healthcare worker immunization program based on nationally accepted infection control guidelines, failure to identify and remove potentially compromised sterile supply items, and failure to maintain operating room equipment in a condition that permits disinfection were found. (Refer to A-749)

On 7/15/14 at 11:35 am, a review of the hospital's plan of correction (POC) for the survey completed on 3/19/14 was conducted with Chief Nursing Officer (CNO), who was responsible for quality assessment and performance improvement (QAPI). In a concurrent interview, the CNO acknowledged the continued deficient practices and that the hospital had not addressed the deficiencies identified in the 3/19/14 survey in a systematic manner that would ensure sustained compliance with nationally accepted infection control practices. The CNO acknowledged the POC, had not addressed the need for the following systems: Staff training; review, update and/or development of policy; development of monitoring tools and training for their use; and a system of integrating monitoring findings into the facility's quality assurance and infection control processes.




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2. On 7/16/14, the hospital quality program was reviewed. Each month of a calendar quarter was structured to present data to the Quality Council such that most departments reported each quarter. The minutes of the Quality Council did not contain actions taken in response to indicator of performance when measurements did not meet the threshold of performance.

On 7/16/14, the hospital policy, titled, "Performance Improvement Plan," dated 4/19/06, read, "Assess the care related to key aspects and key processes being monitored when benchmarks or thresholds are reached in order to identify opportunities to improve performance to resolve problem areas. Take action to correct identified problems or improve performance. Evaluate the effectiveness of the actions taken and document the improvement in care."

On the survey ending 3/19/14, the hospital had deficient practices noted in the areas of informed consent and patient care plans. On the survey ending 7/17/14, the hospital continued to have deficient practices noted with informed consent and care plans. (Refer to A 396 and A 955).

On 7/16/14 at 1:40 pm, the Chief Nursing Officer acknowledged that the quality program had been reviewing data, but was not active in the analysis of the data and the implementation of actions plans when opportunities for improvement were identified.

Based on interviews and document review the hospital's governing body failed to ensure that the Quality Assessment and Performance Improvement (QAPI) plan:
(1) had been updated since last approved in 2006;
(2) included clearly stated current expectations for quality improvement and patient safety;
(3) defined the current priority targets for improvement, as indicted by a hospital-wide quality assessment; and
(4) defined the current number of distinct improvement projects for the current year.
These failures potentially exposed patients and staff to unsafe conditions.

Findings:

On 7/14/14 the current Quality Assessment and Performance Improvement plan was requested. The document provided was Policy Statement (Administration # 8610-122-06) which had been approved on 4/19/06. On 7/15/14 and 7/16/14 the minutes of the Medical Executive Committee (MEC) and the Governing Body (aka: Board of Director, GB) for the past 12 months were requested and reviewed. In those meeting minutes there were no documented actions taken by either the GB or MEC with regard to the hospital's QAPI program. On 7/16/14 at 2:40 pm the Medical Staff Coordinator (MSC) stated that the most recent QAPI plan was Policy Statement # 8610-122-06 approved on 4/1/06.

On 7/17/14 the Chief Executive Officer (CEO), the Chief Nursing Officer (CNO) and MSC were each asked to provide any available documentation, dated within the past 12 months that documented the GB or MEC had reviewed and approved an update of the QAPI plan; no such documents were available.

On 7/17/14, at 1:30 pm, in a joint interview and concurrent review of the GB minutes, the CEO, CNO and MSC acknowledged that during the past 12 months the GB and MEC had not:
* documented actions taken pertaining to Quality Improvement;
* issued any written statements or directions that updated the 2006 QAPI plan;
* documented review of a hospital-wide quality assessment and/or prioritized improvement objectives;
* defined the current number of distinct improvement projects for the current year; or
* issued a clear statement of the expectation for the QAPI program.

Based on interviews and document review the hospital's governing body failed to take action to provide adequate resources for an effective Quality Assessment and Performance Improvement (QAPI) program. This failure potentially exposed patients and staff to unsafe conditions.

Findings:

On 7/15/14 and 7/16/14 review of the minutes of the Governing Body (GB) and Medical Executive Body (MEC) showed that there were no documentation of actions taken to allocate resources for the QAPI program.

On 7/16/14 at 1:15 pm in a joint interview with the Chief Executive Officer (CEO), Chief Nursing Officer (CNO), Chief Medical Officer (CMO) and Medical Staff Chief (Physician A) they acknowledged than none of the hospital staff or medical staff leadership had received training in the methods used to promote QAPI. They stated that the CMO was scheduled to receive some Medical Staff Leadership training in the near future, however no other QAPI training was currently planned for Medical Staff members or other hospital staff members.

On 7/17/14 in an interview at 10:10 am the Chief Executive Officer (CEO) stated that the members of the Governing Body (GB) had not received any training related to QAPI, and acknowledged he had no documentation to demonstrate the GB had allocated resources for QAPI.

Based on interview and document review, the Medical Staff (MS) and the Governing Body (GB) had not ensured that the Medical Staff Bylaws included a statement of the duties and privileges for each category of Medical Staff membership, and the hospital utilized a significant number of Telemedicine (over the telephone) and Interim (short term) physicians to provide healthcare services in the hospital. These practitioners had been granted privileges without the safeguard of following the requirements in the Medical Staff Bylaws. This failure to follow the bylaws could potentially allow unqualified practitioners to provide medical care.

Findings:

On 7/14/14, the Medical Staff roster (a complete list of physician and other providers) and the Medical Staff Bylaws was requested. The 6-page MS roster that was provided contained lists of seven (7) categories of medical staff members: Active Staff, Provisional Active, Courtesy, Consulting Staff, Provisional Consulting, Allied Health Professionals, and Locum Tenens (temporary). The MS Bylaws, approved 6/18/14, defined these categories and listed the duties and privileges for each.

The bylaws stated the following, beginning on page 10:
"3.7 Locum Tenens Physicians
3.7-1 Qualifications Locum Tenens physician shall consist of member who:
(a) meet the general qualification set forth in Section 2.2.
(b) attends only those patients of the member(s) for whom that person in providing coverage, for a period not to exceed 90 days in any one calendar year ...
(c) are members in good standing of the Active or associate Medical Staff of another California licensed Hospital ..."

The bylaws did not define or provide any information about two categories of physicians and allied health professionals that were contracted or hired to be provide services in the hospital:
1) Telemedicine physicians members (e.g.: radiologists, aka, tele-radiologists) that provide services via a telephone or computer hookup with the hospital, and
2) Interim physicians or Interim allied health professionals, who were not "providing coverage" for an identified MS member, but were hired or contracted to provide services to any patient coming to the hospital.

On 7/16/14 beginning at 10:40 am, in an interview with the Medical Staff Coordinator (MSC), the MS roster and 11 selected credential files were concurrently reviewed. The MSC acknowledged the following:

1) On the MS roster none of the 33 practitioners (physicians and allied health professionals) listed as "Locum Tenens" were providing coverage for any specific MS member, but this category was used because the bylaws did not have a category for these interim practitioners. Therefore they had not been properly categorized and their clinical privileges were not granted as specified in the bylaws.

2) Since March the hospital began using the services of approximately 150 tele-medicine physicians, who were not listed on the roster, and for whom no category currently existed in the MS Bylaws. These physicians had not been assigned a category and they had been granted clinical privileges outside of the specifications in the bylaws.

Based on interview and record review, the hospital failed to identify one of 23 sampled patients' (Patient 3) high risk discharge needs when they did not complete her initial nursing assessment. This failure had the potential for Patient 3's psychosocial needs to not be met.

Findings:

Patient 3 was admitted to the hospital on 7/8/14 with diagnoses that included chest pain, amphetamine (meth) use, and alcohol abuse.

On 7/15/14, the hospital's Discharge Planning policy, dated 9/18/13, read, "The following high risk triggers, when identified during initial screening, will prompt a full discharge planning evaluation:...5. Patients needing counseling or community resources in regard to to substance abuse...12. Disease/diagnosis in which inadequate coping is demonstrated..."

Patient 3's Admission History and Physical (H&P), dated 7/9/14, showed that "Until recently she was homeless, jobless (less than a month)...Patient has a hx (history) of significant alcohol use for the past 20+ years. She also had a significant hx of heavy amphetamine use for more than 25 years...she gets DT's (delirium tremens, alcohol withdrawal that can include seizures, confusion, rapid heart rate) sometimes as soon as 24 hrs (hours) after the last drink." The H&P also showed Patient 3's urine tested positive on 7/8/14 at 3:16 pm for amphetamines and her blood alcohol level was high at 233, indicating she had consumed approximately 8 drinks.

Patient 3's H&P, dated 7/9/14, included documentation that stressed "The importance of 'staying away from friends that do drugs' as patient is on probation and she gets drug tested monthly and could potentially loose her job and freedom."

Patient 3's Discharge Summary, dated 7/10/14, included instructions to "Stay away from drinking alcohol, smoking weed or cigarettes and especially stay away from methamphetamines."

Patient 3's Nursing Admission History-Assessment, dated 7/8/14, included a Suicide Risk Assessment section was checked "Yes" for excessive alcohol or drug use and checked "No" for no social support of friends or family. There was a High Risk Triggers for Discharge Planning section that was not completed. It included the questions, "Need for counseling or community resources in regard to substance abuse" and "Disease diagnosis in which inadequate coping is demonstrated" which were both left blank.

On 7/15/14 at 2:50 pm, Administrative (Admin) Nurse A stated that the admitting nurse should have completed Patient 3's Nursing Admission History Assessment that included the high risk questions. Admin Nurse A stated that had those questions been answered, it would have triggered discharge planning for Patient 3. Admin Nurse A confirmed that discharge planning did not occur for Patient 3.

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

1. Supervise and evaluate nursing care for one of 32 sampled patients, when the heart rate alarms were disabled for 12 hours on his telemetry unit (portable box attached to patient that wirelessly displays their heart rate and rhythm at a central station) and the nurses were not monitoring it or aware the alarms were off (Patient 1). Nursing being unaware of this created the potential for Patient 1's heart rate to becoming dangerously high, low or stop (cardiac arrest-death) and go undetected/treated.

2. Follow the hospital policy to label intravenous (IV) dressings and tubing. This failure had the potential to result in a blood infection from a IV staying in longer than recommended.

Findings:

1. Patient 1 was admitted on 7/9/14 with diagnoses that included a drug overdose, diabetes (high blood sugar), high blood pressure, and chronic atrial fibrillation (very fast, irregular heartbeat).

On 7/10/14, Patient 1's record included a physician's order, dated 7/9/14 at 11:15 pm, to admit the patient to telemetry (to have heart rate and rhythm monitored).

On 7/10/14 at 10 am, the Intensive Care Unit (ICU) was initially toured with
Administrative (Admin) Nurse A and the telemetry monitors were observed. Patient 1's telemetry was observed on standby mode with a small red alarm icon that had a slash through it. ICU Registered Nurse (RN) 2 stated that she was orienting ICU RN 1 to the unit. After opening Patient 1's alarm settings page on his telemetry screen, ICU RN 1 and ICU RN 2 were not able to explain what the slashed red alarm icon signified. They did not know how to correct/fix it and stated they would find out what was wrong. ICU RN 2 stated that she understood Patient 1's telemetry was on standby mode because his telemetry unit was detached while he was being showered. When asked how they kept track of patients whose telemetry units were on standby, ICU RN 2 stated that if it was off for too long they would call down to the Medical Surgical unit and have nursing staff place it back on the patient.

On 7/10/14 at 11:35 am, the Medical Surgical unit was toured with Admin Nurse A and Patient 1 was observed sleeping heavily and snoring loudly. His telemetry unit was observed to be disconnected and on his bedside table. This was one hour and thirty five minutes after his telemetry unit was observed in the ICU on standby mode (not on patient). Admin Nurse A confirmed Patient 1's telemetry was not attached and should have been on him, while his heart rate and rhythm was being currently monitored remotely by the ICU RNs.

On 7/10/14 at 11:36 am, Admin Nurse A was asked to call the ICU to look through Patient 1's telemetry history to identify when his telemetry unit was placed on standby, at which time it was discovered that the telemetry monitor clocks were malfunctioning. Admin Nurse A stated that the correct times were not documented on the history and the time frames could not be extracted from the telemetry record, because of the clock malfunction.

On 7/10/14 at 1:45 pm, Patient 1's telemetry monitor was observed and did not display the slashed red alarm icon. ICU RN 2 concurrently stated that ICU RN 1 had figured out that Patient 1's heart rate alarm on the monitor was off. ICU RN 2 stated the alarm should not have been turned off and that they should, "never be turned off." She stated that the alarm was off when she got there at 7 am and that she did not know who had turned it off.

On 7/10/14 at 1:50 pm, ICU RN 1 confirmed that after going through the alarm settings for Patient 1's telemetry, he discovered that the red alarm icon with the slash through it was displayed because the heart rate alarms were disabled.

On 7/10/14 at 1:52 pm, ICU RN 1 stated that Patient 1's heart rate had been up to 180 beats per minutes (bpm, normal less than or equal to 100 bpm) that morning when he was up out of bed. ICU RN 1 and ICU RN 2 confirmed that Patient 1's telemetry unit should have been placed back on him right after his shower. ICU RN 2 stated there was no log to show when telemetry units were taken off of patients, for nursing to keep track of how long they were off and call to have nursing place them back on. She stated they should be writing it down somewhere in a log.

On 7/10/14 at 1:55 pm, ICU RN 1 stated that all of Patient 1's heart rate alarms had been shut off on the monitor (displayed by the slashed red alarm icon). ICU RN 1 stated that the high rate alarm and low rate alarm had been shut off. ICU RN 1 stated that if Patient 1's heart had stopped, they would not have known it.

On 7/10/14 at 2 pm, ICU RN 2 stated that ICU RN 3 had shut Patient 1's heart rate alarm off during the night shift. Admin Nurse A concurrently stated that ICU RN 3 worked in the ICU the previous night shift (7/9/14 evening until morning of 7/10/14). Admin Nurse A stated that ICU RN 3 had just been oriented to the unit and was a "registry nurse (contracted temporary staff called in on an as needed basis)." Admin Nurse A stated that last night was ICU RN 3's second shift in the ICU on his own.

On 7/11/14, Patient 1's telemetry records showed that at 11:30 pm on 7/9/14, his heart rate was high at 176 bpm. His telemetry records showed that on 7/9/14, the alarms were on at 8 pm, then off at 11:30 pm, off on 7/10/14 at 12:40 am, off at 4:10 am, off at 7 am, and off at 12:30 pm.

On 7/14/14, the hospital's "Policy Statement" on Clinical Alarm Systems and Patient Safety policy, dated 9/18/13, indicated its purpose was to ensure effective alarm coverage, appropriate alarm use, adequate annunciation of alarms, and safe operation of alarms on medical equipment and monitoring systems in patient care areas. The policy read, "2. All alarm systems incorporated into medical equipment and into patient monitoring systems must be activated whenever the piece of equipment is in use. Alarms will not be disabled or inactivated at any time..."

The hospital's "Procedure" on Clinical Alarms and Patient Safety showed its purpose was "To improve the effectiveness of critical alarm systems." The procedures for effective use were: Clinical Staff using the device must be thoroughly familiar with its operation including equipment self-check procedures for verifying the alarms operation before and during use; Verifying all active medical device alarms at the start of each shift; Alarms may be suspended for brief periods only when the staff member is monitoring, evaluating and/or treating the patient; and "Before turning attention away from the patient, the alarm must be reactivated."

On 7/14/14 at 10:40 am, Admin Nurse A stated that alarm verification was obviously not done at the start of each shift and that Patient 1 was not adequately supervised by nursing. He stated that "Registry Nurse Staff" does not always get orientation and was not specifically oriented to the telemetry monitors on ICU during their initial tour of the unit.

On 7/17/14 at 1:50 pm, Admin Nurse A stated that ICU RN 3 was not trained to the telemetry monitors except on how to admit a patient to telemetry.

2. During initial tour of the Obstetrics (birthing) unit on 7/10/14 at 10:30 am, the patient in Room 26 had an IV catheter in her right hand. There was no label on the IV dressing or the IV tubing.

During initial tour of the Medical/Surgical unit on 7/10/14 at 11:23 am, Patient 2 in Room 14 had an IV with the dressing unlabeled. Unit B Registered Nurse (RN) 3 concurrently confirmed that IV dressings and tubing were to be labeled with the date and time they are initiated and signed by the nurse that did it.

At 11:27 am, Patient 3 in Room 15 had an IV line with no label. Admin Nurse A confirmed that the hospital's expectation and policy was that the IV line should be labeled.

At 11:28 am, the patient in Room 18 had an IV in his left hand. The dressing was not labeled and was concurrently confirmed with Admin Nurse A.

Based on staff interview and record review, the hospital failed to ensure development of care plans for diabetes mellitus (high blood sugar) for one of five patients (Patient 19) reviewed for nutrition. Failure to develop comprehensive, multidisciplinary care plans puts patients at risk for compromised medical care.

Findings:

Resident 19's clinical record was reviewed on 7/16/14. Patient 19 was admitted on 6/19/14 and discharged on 6/24/14. Patient 19 was admitted for chief complaint of chronic obstructive asthma with acute exacerbation (increase in severity). Medical history from discharge summary, dated 6/24/14, included recent diagnosis of bladder cancer, diabetes mellitus, generalized weakness with loss of ambulation and failure to thrive at home, gastroesophageal reflux disease (reflux of the stomach and duodenal contents into the esophagus), hypertension (elevated blood pressure), and iron deficiency anemia (low iron level).

Review of a care plan created on 6/20/14 and updated on 6/22/14 did not have planning for type 2 diabetes mellitus, Gastroesophageal reflux disease and iron deficiency anemia.
The hospital policy and procedure titled "Interdisciplinary Care-Planning Acute and Sub-Acute Care" reviewed 9/4/13 stated "an interdisciplinary nutrition care plan with measurable goal is developed and periodically updated for patients at nutritional risk. The development of a plan of care treatment and services is individualized and appropriate to the patient's needs, strengths, limitations and goals."

Based on observation, interview, and record review, the hospital failed to provide adequate supervision and evaluation for registry (non-employee) nursing personnel caring for two of 32 sampled patients (Patients 1 and 11), when:

1. Heart rate monitor alarms were turned off for Patient 1's telemetry unit (portable box attached to patient that wirelessly displays their heart rate and rhythm at a central station). The oncoming nurses were unaware of this, which created the potential for Patient 1's heart rate to become dangerously high, low, or stop (cardiac arrest- death) and go unrecognized/untreated.

2. Registry nursing personnel failed to follow the hospital's policy and procedure for recording the hospital's correct expiration date on an intravenous (IV) compounded (combined) drug for one of 32 sampled patients.

Findings:

1. On 7/10/14, the hospital's Clinical Alarms and Patient Safety policy, dated 9/18/13, showed, "Clinical Staff using the device must be thoroughly familiar with its operation...;" that all medical equipment alarms on patient monitoring systems must be activated and not be disabled or inactivated at any time; and that "Nurse Managers are responsible for assessing staff competency and for providing training...to include the use of alarm systems..."

Patient 1 was admitted on 7/9/14 with diagnoses that included a drug overdose, diabetes (high blood sugar), high blood pressure, and chronic atrial fibrillation (very fast, irregular heartbeat).

On 7/10/14, Patient 1's record included a physician's order, dated 7/9/14 at 11:15 pm, to admit the patient to telemetry (to have heart rate/rhythm monitored).

On 7/10/14 at 10 am, the Intensive Care Unit (ICU) was initially toured with Administrative Nurse (Admin Nurse) A. Patient 1's telemetry box had a small red alarm icon with a slash through it. ICU Registered Nurse (RN) 2 and ICU RN 1 (new orientee) were not able to explain what the slashed red alarm icon signified and did not know how to correct/fix it.

On 7/10/14 at 1:45 pm, Patient 1's telemetry monitor was observed and did not display the slashed red alarm icon. ICU RN 2 concurrently stated the alarm should "never be turned off," that Patient 1's alarm was off when she got there at 7 am and that she did not know who had turned it off.

On 7/10/14 at 1:50 pm, ICU RN 1 confirmed that he had discovered the slashed red alarm icon displayed on Patient 1's telemetry because the heart rate alarms were disabled (turned off).

On 7/10/14 at 1:55 pm, ICU RN 1 stated that all of Patient 1's heart rate alarms had been shut off on the monitor (displayed by the slashed red alarm icon). ICU RN 1 stated that the high rate alarm and low rate alarm had been shut off. ICU RN 1 stated that if Patient 1's heart had stopped, they would not have known it.

On 7/10/14 at 2 pm, ICU RN 2 stated that ICU RN 3 had shut Patient 1's heart rate alarm off during the night shift. Admin Nurse A concurrently confirmed that ICU RN 3 worked in the ICU the previous night shift (7/9/14 evening until morning of 7/10/14). Admin Nurse A stated that ICU RN 3 had just been oriented to the unit and was a "registry nurse (contracted temporary staff called in on an as needed basis)." Admin Nurse A stated that last night was ICU RN 3's second shift in the ICU on his own.

On 7/11/14, Patient 1's telemetry records showed that the alarms were off from 11:30 pm on 7/9/14 to 12:30 pm on 7/10/14.

On 7/14/14 at 10:40 am, Admin Nurse A stated, "Registry Nurse Staff" does not always get orientation and was not specifically oriented to the telemetry monitors on ICU during their initial tour of the unit.

On 7/14/14, a review of the hospital's Orientation For Registry Personnel and Registry Personnel Orientation/Tour of Unit documents did not include orientation to the telemetry units.

On 7/17/14 at 1:50 pm, Admin Nurse A stated that ICU RN 3 was not trained to the telemetry monitors except on how to admit a patient to telemetry, according to hospital policy.

On 7/10/14 at 2:15 pm, Admin Nurse B confirmed he was the ICU Manager where ICU RN 3 had worked the night shift of 7/9 to 7/10/14 and was not aware ICU RN 3 had turned off the alarms on Patient 1's heart rate monitor. Admin Nurse B confirmed ICU RN 3 had not followed hospital policy when he turned Patient 1's heart rate alarms off and that it was inappropriate.


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2. Observation of Unit B Registered Nurse (RN) 1 (a registry nurse), on 7/16/14 at 11:50 am, revealed that this registry Nurse was making a dose of Clindamycin (antibiotic) 600 milligrams (mg) in 50 ml (milliliters) of normal saline (salt solution) to be administered by IV piggyback (a small IV bag that is attached to an existing IV line) to Patient 11. Unit B RN 1 made the IV piggyback and placed a date on the finished IV piggyback of 6/15 indicating that this piggyback would expire in June of 2015, (11 months later). As Unit B RN 1 was writing the expiration date on the IV piggyback, Unit B RN 1 showed the surveyor that she was taking the manufacturer's date off of the Clindamycin vial and applying this expiration date onto the piggyback.

Interview with the hospital's Director of Pharmacy (DOP) on 7/15/14 at 9:10 am, revealed that it was the hospital's policy that any IV which is compounded by the hospital's staff, be given a one hour expiration date after the drug has been made.

During an interview with Administrative (Admin) Nurse A on 7/16/14 at 12:10 pm, Admin Nurse A confirmed that it was the hospital's policy that all IV medications which were compounded in the hospital, be given a one hour expiration date from the time at which they are made.

During an interview with Unit B Nurse 1 on 7/16/14 at 11:56 am, she was asked if she was aware of the hospital's policy which required the nursing staff to apply a one hour expiration date to all IV compounded medications. Unit B RN 1 indicated that she was not aware of the hospital's IV compounding process which required a one hour expiration date for these IV compounded medications. Review of the hospital's pharmacy policy and procedure dated 6/5/14, on 7/16/14 at 12 pm entitled: "Intravenous Drug Guidelines", reads: "The number of units prepared at one time should be for immediate use."

Based on interview and record review, the facility failed to maintain three of six sampled surgical patients records per accepted standards. (Patients 6, 9 and 22)

1a. Patient 6's interval history and physical (a form indicating changes from the previous history and physical) was not timed.

1b. Patient 6's immediate post (after) procedure note was not timed.

2. Patient 9's history and physical listed her blood type incorrectly.

3. Patient 22's emergency department (ED) record did not contain the time the patient was triaged (priority determined) and roomed (placed in a room).

These failures has the potential to create an inaccurate medical record and negatively impact care.

Finding:

1. Patient 6's record was reviewed on 7/16/14. Patient 6 was admitted for surgery on 5/16/14 for a Dilation and Curettage (D&C, which refers to the dilation or widening of the cervix and surgical removal of part of the lining of the uterus or womb).

Patient 6's record contained a document titled, "Interval History and Physical," in which the surgeon had indicated that there had been no significant changes since the time the first history and physical had been performed. This document was signed and dated by the physician, but had not been timed.

Patient 6's record contained a document titled, "Immediate Post Procedure Note," dated 5/16/14. This document was signed and dated by the physician, but had not been timed.

During an interview and concurrent record review, on 7/16/14 at 9:05 am with Administrative (Admin) Nurse A, it was acknowledged that Patient 6's interval history and physical and immediate post procedure note, had not been timed by the surgeon. Admin Nurse A stated that these documents needed to have been signed, dated and timed by the surgeon.

2. Patient 9's record was reviewed on 7/16/14. Patient 9 was admitted on 5/6/14 with the diagnoses of Oligohydramnios (problems associated with the fluid in which a fetus is suspended in).

Patient 9's record contained a document titled, "Admission History and Physical," dated 5/6/14, which indicated that Patient 9's blood type was O positive.

According to laboratory studies taken on; 5/23/11, 10/7/13 and 5/7/14, Patient 9's blood type was B positive.

Patient 9's record contained a document titled, "Discharge Summary," dated 5/10/14, which read, "Prenatal lab unremarkable. Blood Type B positive per written prenatal records, however is recorded as O positive in the Admission History and Physical."

During an interview and concurrent record review, on 7/16/14 at 9:05 am with Administrative (Admin) Nurse A, it was acknowledged that Patient 9's blood type had been incorrectly recorded in her admit history and physical. Admin Nurse A stated that although there was a notation in the discharge summary, the original record had not been corrected or amended.

The facility's policy statement, titled, "Entries into & Completion of the Medical Record," dated 6/20/13, indicated that if an entry into the patient's medical record needed to be amended, it must be done in a manner that clearly shows that an amendment has occurred. All entries into the medical record must be authenticated (signed), dated, and timed by the individual who made the entry. The date and time should reflect when the actual entry was made.


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3. On 7/14/14, Patient 22's record was reviewed. Patient 22 presented to the ED with complaints of groin pain. Patient 22's ED record did not contain a triage (priority determination) time or a time that Patient 22 was roomed.

On 7/16/14 at 9:52 am, the ED Manager reviewed Patient 22's record and acknowledged that the triage and room times were not recorded.

Based on interview and record review, the hospital failed to ensure that two of six sampled surgical patients had a history and physical examination documented and/or complete. (Patients 6 and 13) These failures had the potential for adverse outcomes due to undetected patient conditions/or changes in condition.

Findings:

1. On 7/15/14, Patient 13's record was reviewed. Patient 13 was admitted on 7/7/14 for a colonoscopy (a procedure to view the inner lining of the large intestine or gut). Patient 13's record contained no evidence of a history and physical.

On 7/16/14, the Rules and Regulations of the Medical Saff Bylaws read, "A History and Physical (H&P) must be performed and documented in the medical record for all patients admitted for inpatient care within 24 hours as well as prior to operative and complex invasive procedures, and/or administration of moderate or deep sedation or anesthesia in either the inpatient or outpatient setting."

On 7/15/14 at 2 pm, Medical Records Director (MRD) reviewed Patient 13's record and acknowledged that the H&P was not present in Patient 13's record.


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2. Patient 6's record was reviewed on 7/16/14. Patient 6 was admitted for surgery on 5/16/14 for a Dilation and Curettage (D&C, which refers to the dilation or widening of the cervix and surgical removal of part of the lining of the uterus or womb).

Patient 6's record contained a document titled, "Interval History and Physical," in which the surgeon had indicated that there had been no significant changes since the time the first history and physical had been performed. This document was signed and dated by the physician, but had not been timed.

During an interview and concurrent record review, on 7/16/14 at 9:05 am with Administrative (Admin) Nurse A, it was acknowledged that Patient 6's interval history and physical had not been timed by the surgeon. Admin Nurse A stated that this document needed to have been signed, dated and timed by the surgeon.

The facility's policy statement, titled, "Entries into & Completion of the Medical Record," dated 6/20/13, indicated that all entries into the medical record must be authenticated (signed), dated, and timed by the individual who made the entry. The date and time should reflect when the actual entry was made.

Based on interview and record review, the hospital failed to ensure the informed consent process followed hospital policy for one of six surgical patients reviewed. This failure had the potential for the patient to be misinformed regarding their surgery and result in an unwanted surgical procedure. (Patient 6)

Findings:

Patient 6's record was reviewed on 7/16/14. Patient 6 was admitted for surgery on 5/16/14 for a Dilation and Curettage (D&C, which refers to the dilation or widening of the cervix and surgical removal of part of the lining of the uterus or womb).

Patient 6's record contained a document titled, "Consent to Surgery or Special Procedure," signed by Patient 6 on 5/16/14, which read, "Your doctors have recommended the following operation or procedure: D/C of Uterus."

Patient 6's record contained a history and physical document which contained evidence that the risks, benefits, and alternatives to surgery had been discussed with the patient prior to surgery.

The hospital's policy, titled, "Consent/Informed Consent," reviewed 3/18/13, indicated, that it is the responsibility of the physician performing the procedure to give the patient or surrogate decision-maker all necessary information concerning the procedure and to obtain the informed consent. The consent form must state the name of the attending physician and/or treating or operating surgeon and the name of the proposed procedures and describe the nature of the treatment.

During an interview and concurrent record review, on 7/16/14 at 9:05 am with Administrative (Admin) Nurse A, it was acknowledged that Patient 6's surgical consent had not been properly executed. Admin Nurse A explained that the full name of the procedure should be spelled out and then explained in simple terms on the consent form.

Based on observation, interview, and document review, the hospital failed to ensure the pharmacist was responsible for coordinating all activities of the pharmacy services when:

1. The emergency department (ED) "Secondary Code Box" (box of back up emergency supplies) was not stocked according to policy.

2. The hospital's emergency drug supplies stored in crash carts (carts containing emergency supplies) did not match the contents described in the hospital policy.

This failure could have resulted in the hospital's inability to treat hospitalized patients during a code (emergency).

Findings:

1. The hospital's "Secondary Code Box" (stored in the hospital's ED and is taken to the nursing unit every time an emergency code is called in the hospital) was inspected on 7/17/14 at 10:30 am. The inspection in the hospital's ED revealed that the list of contents on the outside of this box, did not match the list of drugs which was found in the pharmacy's policy and procedure manual. The list of contents for this box which was found in the hospital's pharmacy policy and procedure manual indicated that two 1 gram per 10 ml (milliliter) vials of procainamide (a drug to treat heart beat irregularities) should have been inside this "Secondary Code Box", however the list on the outside did not include any procainamide vials.

Interview with the hospital's Director of Pharmacy (DOP), on 7/15/14 at 11:45 am, revealed that procainamide had been removed from the hospital's drug formulary several years ago, but the procainamide had not been removed from the hospital's pharmacy policy and procedure list.

Further inspection of this box revealed that two vials of vasopressin (a hormone used to treat heart beat irregularities) 20 units per ml were present in this box. The vasopressin vials were not a part of the box's list of contents which had been taped to the outside of this "Secondary Code Box". Review of the hospital's pharmacy policy and procedure, titled, "Emergency Crash Cart Medications", dated 4/16/08 read, "The Pharmacy has responsibility for all drugs included in the drug trays on the Cardiac Arrest Cart and Emergency Tackle Boxes. Items cannot be deleted or added to the list of drugs and supplies without approval of the Medical Staff through the Pharmacy and Therapeutics Committee, Department of Pharmacy Services, and Department of Nursing ...".

2. Inspection of the hospital's Emergency Crash Cart in the Intensive Care Unit (ICU) on 7/15/14 at 2:35 pm revealed that the hospital's list of drug contents on the outside of the crash cart, was labeled as: "Contents of Crash Cart - Monthly Checklist". This checklist indicated that the following drugs should have been present inside this crash cart:

a. One vial Flumazenil (a reversal drug) 0.5 mg (milligram) but two vials of flumazenil were found inside the cart.

b. One vasopressin 20 units/ml vial should have been present in this crash cart, but two vials of vasopressin 20 units/ml were found inside the cart.

c. One bottle of sterile water 1000 ml should have been present on the cart but two bottles of sterile water 1000 ml were found inside the cart.

During an interview with the hospital's DOP at 2:45 pm on 7/15/14, the DOP stated that he was never consulted during the development of this crash cart checklist for any of the hospital's crash carts. He also stated that he was not even aware that nursing had even developed this crash cart checklist.

Based on observation and interview, the hospital's registry nurse failed to follow the hospital's policy and procedure for recording the hospital's correct expiration date on an intravenous (IV) compounded (combined) drug for one of 32 sampled patients. (Patient 11) This failure could have resulted in reduced benefits from this medication for this patient.

Findings:

Observation of Unit B Registered Nurse (RN) 1, a registry nurse, on 7/16/14 at 11:50 am, revealed that she was making a dose of Clindamycin (antibiotic) 600 milligrams (mg) in 50 ml of Normal Saline to be administered by IV piggyback (a small IV bag that is attached to an existing IV line) to Patient 11. Unit B RN 1 made the IV piggyback and placed a date on the finished IV piggyback of 6/15 indicating that this piggyback would expire in June of 2015, (11 months later). As Unit B RN 1 was writing the expiration date on the IV piggyback, she showed the surveyor that she was taking the manufacturer's date off of the Clindamycin vial and applying this expiration date onto the piggyback.

Interview with the hospital's Direcotr of Pharmacy (DOP), on 7/15/14 at 9:10 am, revealed that it was the hospital's policy that any IV which is compounded by the hospital's staff be given a one hour expiration date after the drug has been made.

During an interview with Administrative (Admin) Nurse A on 7/16/14 at 12:10 pm, Admin Nurse A confirmed that it was the hospital's policy that all IV medications which are compounded in the hospital, be given a one hour expiration date from the time at which they are made.

During an interview with Unit B Nurse 1 on 7/16/14 at 11:56 am, Unit B RN 1 was asked if she was aware of the hospitals policy which required the nursing staff to apply a one hour expiration date to all IV compounded medications. Unit B RN 1 indicated that she was not aware of the hospital's IV compounding which required a one hour expiration date for these IV compounded medications.

Review of the hospital's pharmacy policy and procedure, dated 6/5/14, on 7/16/14 at 12 pm, titled, "Intravenous Drug Guidelines", reads: "...The number of units prepared at one time should be for immediate use."

Based on observation and interview, the hospital failed to ensure that expired medication were not available for use on the Station B medication room and the medical surgical unit night locker. This failure could have resulted in patients receiving medications which may have been harmful.

Findings:

1. Inspection of the Station B medication room on 7/15/14 at 10:35 am revealed that there were three 2000 milliliter (ml) bags of Clinimax E 4.25 amino acid with electrolytes in 25% (percent) dextrose with calcium for injection. These 2000 ml bags are given to patients who require Total Parenteral Nutrition (TPN). TPN is usually reserved for patients who are unable to consume their own food or nutrition. All three of the Clinimax bags had expired on 5/14.

Further inspection of the Station B medication room on 7/15/14 at 11 am revealed five 500 ml bags of normal saline (salt solution) with 5 ml of potassium phosphate (antacid) vials attached to them and ready to be mixed. The pharmacy had prepared these bags on 6/14/14 and given the bags a 30 day expiration date after preparing them. Further inspection of the five - 500 ml bags revealed that the 500 ml bags of normal saline had a manufacturer's expiration date of 6/14. This meant that these bags and the potassium phosphate vials which had been attached expired on 7/1/14.

One vial of insulin (Humalin Regular-used to control blood sugar) was found on 7/16/14 at 11 am on Station B inside the hospital's medication refrigerator. The bag that the insulin was found in had been labeled for Patient 12. This insulin vial had been opened by the hospital's nursing staff, but the label on the vial (indicating when to discard this vial), had only been marked with "10".

During an interview with the hospital's Director of Pharmacy (DOP) on 7/16/14 at 11:10 am, the DOP indicated that the hospital's policy and procedure was to discard any open vials of insulin within 28 days of opening the vial. The DOP indicated that he did not know what the number "10" stood for even though it had been written on the label's discard line.


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2. During a tour of the medical/surgical unit on 7/10/14 at 11:40 am, the "Night Locker (storage cabinet containing prescribed medications for nursing access when the pharmacy is closed)" was observed and a partial sample of medications were checked for expiration (exp) dates. The following expired medications were observed:

Avodart (for treatment of enlarged prostate), exp 6/14
Chlorthalidone (for treatment of high blood pressure), exp 6/14
Abilify (for treatment of mental disorders), exp 3/14
Cymbalta (for treatment of depression), exp 5/14
Neomycin (an antibiotic), exp 6/14

Administrative (Admin) Nurse A concurrently confirmed these medications were expired and should not have been available for use.

On 7/10/14 at 2 pm, Admin Nurse B stated the hospital did not have a policy for taking inventory of the night locker to check for expired medications.

Based on interview and record review, the hospital failed to ensure the pharmacy stop order policy was consistent with the hospital's rules and regulations of the medical staff. This failure could have resulted in hospital patients receiving medications beyond the medical staff's designated stop times.

Findings:

Review of the hospital's pharmacy policy and procedure, dated 4/21/08, on 7/16/14 at 3 pm, titled, "Automatic Stop Orders" read: "....Anticoagulants (blood thinners) Heparin/LMWH -three days, Warfarin (Coumadin) till dose is stabilized by lab value- one day.

Review of the "Rules and Regulations of the Medical Staff", dated 2/14 stated: "...Heparin/ Low Molecular Heparin- 5 days, Warfarin until stable- 7 days ...".

During an interview with the hospital's Director of Pharmacy (DOP) on 7/16/14 at 3:10 pm, he stated that the pharmacy policies and procedures may have been out of date and that they were in need of revision, since they were from 2008. The stop orders for the pharmacy and the hospital's medical staff rules and regulations should have matched and both policies should have reflected the same length of time for consistency and optimal patient care

Based on observation, interview, and record review, the Food Service Director failed to ensure direct oversight of the daily operations of foodservice to ensure safe food handling and disaster food supply as evidenced by: 1) maintaining emergency food supply per hospital plan, 2) maintaining a system to ensure bread and tortillas used from freezer followed manufacturer's direction for use. The potential of not maintaining emergency disaster food supplies put patient, staff and visitors at risk of inadequate food in the event of an emergency. The potential for not following manufacturer's directions can put patient at risk of food borne illness.

Findings:

1. During an observation on 7/14/14 starting at 8:35 am, there was a rack of bread in the kitchen containing several loaves of sliced bread, rolls, and buns, with no open dates or use by dates on the packaging. There was one bin full of flour tortillas stored in the refrigerator. One tortilla package was dated 6/5/14. The Food Service Manager (FSM) stated concurrently this bread was received frozen and then thawed in the refrigerator and then put on the bread rack and left in the kitchen. FSM stated that the thawed bread was left in the refrigerator of two weeks. There were approximately 12 loaves of bread in the walk in refrigerator. FSM stated the bread rack was returned to the refrigerator at the end of the day for storage. FSM stated that he did not know how long the bread or tortilla products could be held at room temperature or thawed in the refrigerator. FSM stated that he would contact the manufacturer for directions on the bread products.

On 7/15/14, review of the "Food Supply and Supply Storage" policy 1900.028, reviewed 12/31/13, did not address the storage and thawing and holding of bread and tortillas provided from frozen or stored in refrigerator or at room temperature.

2. An observation of the emergency/disaster food plan on 7/15/14 at 10:20 am, showed a plan for 100 patients, staff and visitors for four days. The disaster menu included canned chicken to be used for lunch on two days. The FSM stated that the canned chicken had been discontinued and there was none in their disaster stock. Food Service Worker stated they planned to use canned tuna but they had not ordered the additional two cases required to meet the plan.

Review of the Food Service Director's job description (dated 7/14/14) stated the position was responsible to direct and provide oversight of all foods service and nutrition activities in accordance with the hospital or skilled nursing accreditation standards.

Based on observation, interview, and document review, the hospital failed to have a system in place which would have identified three of five patients (Patient 19, 17, and 12) reviewed for nutrition care, who were at nutritional risk to ensure timely nutrition assessment and plan for nutrition care and nutrition interventions appropriate for multiple nutrition related diagnoses. Failure to identify and provide complete nutrition assessment in a timely manner and based on average length of stay puts all patient at risk of not meeting nutritional needs.

Findings:

During an interview on 7/16/14 at 9 am, Administrative Staff B stated the current patient's average length of stay was 3.1 days.

1. The clinical record for Patient 19 was reviewed on 7/16/14. Patient 19 was admitted on 6/19/14 and discharged on 6/24/14. Patient 19 was admitted for chief complaint of chronic obstructive asthma with acute exacerbation (increase in severity). Medical history from discharge summary dated 6/24/14, included recent diagnosis of bladder cancer, type 2 diabetes mellitus (high blood sugar), generalized weakness with loss of ambulation and failure to thrive at home, gastroesophageal reflux disease (reflux of the stomach and duodenal contents into the esophagus), hypertension (elevated blood pressure), and iron deficiency anemia (low iron level).

Nutrition screening by Registered Dietitian, dated 6/23/14, determined Patient 19 was at moderate nutritional risk. The nutrition screening noted a mild depletion of albumin (blood protein can be indicative of poor nutritional state) 3.3 g/dl (gram per deciliter - normal at 3.5 -5.0 g/dl). Patient 19's diet was diabetic with variable intake of 1 to 70 percent of meals.

Review of the Patient 19's intakes/outputs for meals showed 12 meals recorded from 6/20 to 6/24/14 with an average meal intake of 34 percent.

There was no comprehensive nutrition assessment to include the appropriateness of the diet order or the consistent poor meal intake. There was no nutritional assessment of the nutritional related diagnoses of gastroesophageal reflux disease, hypertension, or iron deficiency anemia.

2. The clinical record for Patient 17 was reviewed on 7/15/14. Patient 17 was admitted on 7/13/14 with acute diverticulitis (inflammation or infection of small sacks of the colon that is marked by abdominal pain or tenderness often accompanied by fever, chills, and cramping).

Patient 17's history and physical, dated 7/14/14, stated diagnoses include sigmoid diverticulitis (out pocket in the lining of the intestine), hyperglycemia (low blood sugar)- possibly secondary to undiagnosed diabetes, elevated transaminase (possible indicator of liver damage) with fatty liver.

Review of admission nursing screen, dated 7/13/14, based on the criteria for nutritional related risk assessed for nausea, vomiting, weight loss, poor dentition, or special diet, did not indicate any nutrition notification.

Patient 17 did not have a nutrition screening or nutrition assessment as of day three of his hospital stay.

3. The clinical record for Patient 12 was reviewed on 7/15/14. Patient 12 was admitted from 7/10/14 to 7/15/14 with diagnoses of urinary tract infection, hypertension (high blood pressure), diabetes mellitus (high blood sugar), and hyperlipidemia (high fat levels in blood). Diet order on admission was 1500 diabetic heart healthy.

Patient 12's lab work on 7/11/14 showed low albumin (blood protein can be indicative of poor nutritional state) of 2.9g/dl and 2.8 g/dl on 7/12/14.

Patient 12's nutrition screening, dated 7/13/14, indicated moderate nutrition risk.

Patient 12's nutrition assessment was completed on 7/15/14 (day five) of his hospital stay. The nutrition risk was stated as moderate.

During an interview with Food Service Director, a Registered Dietitian (RD), on 7/16/14 at 1:30 pm, stated that the policy was to have nursing do the nutritional related screening for first 24 hours of admission. The RD stated the patient received a nutritional assessment based on the level of nutrition risk. The time frames to complete the nutrition assessment are high risk to be completed within three days and moderate risk within 5 days. RD stated that she would do a nutrition screen to determine the patient's risk within 72 hours of admission except for obstetric (pregnant and birthing) patients.

During an interview 7/16/14 at 1:30 p.m., the RD confirmed that the time for nursing admission screening for first 24 hours and the nutrition screening a 72 hours (or three days) exceeded the average length of stay for most patients. RD acknowledged that Patient 19 should have a complete nutrition assessment earlier to ensure timely nutrition interventions. RD acknowledged with this system, Patient 17 would have been identified as high risk but not until day 3 of the hospital stay. RD stated that based on the average length of stay of 3.1 days the hospital did not have a system to ensure the patients who needed nutrition interventions would be assessed in a timely manner and within their length of stay. RD was not able to explain how the system for the nutrition screening to prioritize assessment in 72 hours (three days) and the nutrition assessment for high risk patient in three days of admissions ensured patients received appropriate nutrition care from admission.

On 7/16/14, the hospital policy, titled, "Nutrition Screening- Acute Care," dated 11/14/12, confirmed the screening time frames. The policy stated the purpose was to identify patients at nutritional risk so that nutritional intervention may be provided in a timely manner: to allocate nutrition to patients at nutritional risk and to initiate interventions to reduce length of stay.

The hospital policy, titled, "Nutrition Assessment - Acute Care," dated 9/4/13 confirmed the time frames for nutrition assessment as 3 day of admission for high risk and five days for moderate risk patients.

On 7/16/14, review of the Food Service Director Job Description, a Registered Dietitian position, dated 7/14/14, indicated the specific duties were to monitor nutritional care of patients, including assessments and education.

Based on observation, staff interview, and document review, the facility failed to maintain garbage containers in a sanitary condition to prevent the harborage (place providing shelter) and feeding of pests (an insect or other small animal that harms or destroys).

Findings:

Per the FDA Food Code 2013, waste stored, located and disposed will not permit the transmission of communicable disease or odor, creates a nuisance or provides a breeding place for, or food source for insects, rodents and vermin (various small animals or insects, such as rats or cockroaches, that are destructive, and injurious to health). Outside receptacles must be constructed with tight fitting lids and maintained closed to prevent the scattering of the garbage and refuse by birds, the breeding of flies, or the entry of rodents.

During an observation of the outdoor trash area on 7/15/14 at 10:10 a.m., with the Food Services Manager (FSM) the following were observed:

1. Two of four dumpsters were not securely covered. One dumpster was overfull and the lid did not close and one dumpster had a large box causing the lid to not close securely. FSM stated that all departments loaded the dumpsters and he did not know who was responsible for maintaining the dumpsters. FSM did not have a policy regarding the trash area.

2. Trash bags from the kitchen were stored and transported from the back dock to the dumpsters on the far side of the lot using an open mesh cart. The FSM concurrently stated the food service staff put the black bags in the open cart and then transported the trash to the dumpsters when this cart was full. The FSM stated he did not have a closed, covered cart to store and transport the kitchen trash. The FSM stated there was no specific policy for kitchen trash being stored and transported outside that specified the closed cleanable container.

Based on observation and staff interview, the hospital failed to ensure supplies and equipment was maintained to ensure patient safety as follows:

1. The low temperature dishwashing machine which used a chlorine concentration of 50 ppm (parts per million) to ensure sanitation of patient dishware maintained the sanitizer concentration when washing dishes. Failure to maintain the required chlorine concentration through the entire washing period puts patient at risk of food borne illness (A disease caused by consuming food or drink contaminated with pathogenic [causing harm] bacteria.

2. Crash Cart (carts containing life saving equipment, medications, and supplies in the case of a medical emergency) checks were not done each shift in the Emergency Department (ED) and the Intensive Care Unit (ICU).

3. The telemetry (used to monitor heart rate and rhythm) was not maintained with an accurate clock.

4. Infant formula and bottle nipples were expired and available for use.

These failures had the potential for adverse patient events, food borne illnesses, and infection to occur.

Findings:

During an observation on 7/15/14 starting at 9:40 am with the Food Services Manager (FSM) and Food Services Director, Food Service Worker (FSW) 1 was loading patient dishware to run through the low temperature dish machine. FSW 1 checked the chlorine concentration in the machine with a chemical strip which read 10 ppm (parts per million). After two more racks of dishes were run through the machine the concentration of the chlorine was retested by the Food Service Manager. Two separate test strips read 10 parts per million and FSM stated this was not adequate concentration. FSM stated concurrently the required concentration should be a minimum of 50 ppm. FSM instructed the food service staff to temporarily manually adjust the chlorine until the technician could come into the facility to fix the machine.

During an interview on 7/15/14 starting at 9:40 am with the FSM, FSM stated the dish machine technician checked the machine monthly and the food service staff recorded the wash temperature and the chlorine concentration at the beginning of each meal. FSM acknowledged that there was no system in place to recheck the chlorine concentration during the washing procedure especially when they identified the low concentration at the beginning of the observation.

Observation on 7/16/14 at 10:15 am, with the FSM and dish machine technician, showed tubing in the chlorine delivery system had been replaced. The technician stated this happens. Retesting of the machine showed a chlorine concentration of 50 ppm.



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2. On 7/10/14 at 10 am and 11:20 am respectively, the crash carts in the ED and the ICU were evaluated. The ED crash cart was not checked each shift on 4/18, 4/28, and 6/16/14. The ICU crash cart was not checked each shift on 7/8/14.

On 7/16/14 at 9:52 am, the ED/ICU Manager stated the expectation is that all crash carts are checked for proper operation, complete medications, and supplies each shift at the beginning of the shift. No policy was received from the hospital outlining the nurses responsibilities in regards to checking the crash carts.


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3. On 7/10/14 at 11:36 am, Administrative (Admin) Nurse A was asked to call the Intensive Care Unit (ICU) to look through Patient 1's telemetry history, at which time it was discovered that the telemetry monitor clocks were malfunctioning. Admin Nurse A stated that the correct times were not documented on the history from the telemetry record because of the clock malfunction.

On 7/10/14 at 2 pm, the ICU manager stated he was not aware that the telemetry monitor's clock was broken.

On 7/11/14, Patient 1's telemetry records for 7/9 and 7/10/14 showed that the times and dates recorded were inaccurate due to the clock malfunction from 12:35 pm on 7/9 to 7/11/14 at 7:30 am.

A review of Patient 10's telemetry records showed the telemetry clock was inaccurate on 6/26 from 12 noon to 6/27/14 at 12:30 pm. There were hand written notations by the ICU nurse that read, "Time needs to be reset on monitor," indicating ICU nurses were aware of the problem the previous month.

On 7/14/14 at 3:30 pm, Admin Nurse B stated there was no technical support available for the telemetry monitors because the hospital did not have a contract with the manufacturer.

On 7/14/14 at 2:05 pm, Maintenance Supervisor stated that no one ever told them there was a problem with the clock on the telemetry monitors

On 7/14/14 at 2:30 pm, Information Technology Supervisor (ITS) confirmed they had no log of equipment malfunction calls to show the hospital had followed their policy. ITS stated that IT would set the clocks on the telemetry monitors and they would keep correct time for a while. ITS stated there was some kind of a "glitch" and they had thought it was a software problem. ITS stated that on 7/3/14, they reset the clock and it was fixed for a while, then went back to the wrong times. ITS stated they called the manufacturer on 7/10/14 (when the surveyor brought the clock malfunction to their attention) and were told it needed a new battery.

The hospital's Clinical Alarms and Patient Safety policy, dated 9/18/13, Responsibilities section read, "3. Maintenance is responsible for the preventative maintenance and for the repair of all medical devices in the Hospital and for documentation of such inspections and repairs."

4. During a tour of the Obstetrics Unit on 7/10/14 at 10:30 am with Obstetrics Nurse Manager (OB RN) 1, seven cases of expired infant formula were observed with an expiration date of 7/1/14. A second supply of a different brand of infant formula was discovered with expiration dates of 7/1/14. Three containers of expired neonatal (newborn baby) nipples were observed with expiration dates of 1/1/14. A second supply of a different brand of infant nipples were observed to be expired with an expiration date of 5/2013. OB RN 1 concurrently confirmed the formula and nipples were expired.

On 7/17/14 at 10:35 am, Food Services Director was interviewed about the risks of the expired infant formulas to newborn babies. She stated that the expired infant formulas contained proteins, soy, and milk sugars that created food safety issues. Food Services Director stated these factors could create gastrointestinal (stomach) upset to the babies.

On 7/17/14 at 1:45 pm, the hospital's "Formula Preparation and Storage" policy, dated 1/2/04, showed its purpose was to safeguard its sterility and nutritional value. The formula and nipple expiration dates were to be checked monthly and formula was to be discarded on the expiration date. Food Services Director concurrently confirmed that the monthly checks were not being done adequately.

Based on observation, staff interview, and document review, the hospital failed to develop a system for identifying and maintaining a sanitary environment when the kitchen bin ice machine was not maintained clean and free from scale deposits and the bin was not cleaned following manufacturer's directions. Failure to maintain ice-machines' in a sanitary manner could potentially place medically compromised patients at risk of food borne illness.

Findings:

Review of Center for Disease Control Guidelines (CDC June 6, 2003) stated mold and slime build up inside ice machines allows bacteria growth and slime buildup inside commercial ice-making machines which can contain pathogenic (causing harm) microorganism (organism, especially a bacterium, virus, or fungus).

During an observation of the kitchen ice machine on 7/14/14 at approximately 9 am, the following were observed:

1. The Food Services Manager (FSM) stated concurrently, the bin (ice storage area) of the kitchen ice machine was cleaned monthly by food service staff using either a bleach solution or a kitchen quaternary cleaner.

Review of the manufacturer's directions for the brand of ice machine showed that the bin was to be cleaned using "Only Manitowoc approved ice Machine Cleaner and Sanitizer."

2. There was buildup of yellow brown colored stains and scale substance on the water trough and the ledge below the ice making cells that are part of the foodzone (surfaces that in direct contact with food/ice) surfaces.

Maintenance Supervisor (MS) stated concurrently the ice machine was cleaned every three months and the brown/yellow scale does not come off. MS confirmed that these areas needed to be cleaned.

During an interview with the Infection Control Nurse B (ICNB) on 7/14/14 at 10:45 am, acknowledged he had not inspected the interior of the kitchen ice machine during kitchen environmental rounds. ICNB acknowledged the ice machine needed to be maintained clean and sanitized to prevent potential of food borne illness.

Based on observation, staff interview, and document review the infection control officer failed to develop effective systems for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel in accordance with facility policy and nationally recognized infection control guidelines as evidenced by failure to have effective systems in place to ensure:

1. The sanitary condition of the Operating Suites environment when the facility failed to provide for and monitor the cleaning and disinfection of the operating room (OR); which was not maintained in a condition that would permit some OR equipment to be disinfected.

2. Safe and sanitary air handling systems in the preoperative and operative areas when the facility failed to maintain air temperature and humidity levels in the Perioperative (surgical) suite areas in accordance with nationally recognized infection control guidelines.

3. The sterility of surgical instruments and sterile supplies when the facility failed to ensure:

3.a. Effective monitoring and training to ensure staff was trained and competent to effectively pack sterilized surgical instruments in rigid containers in a manner that ensured sterilization to all instrument surfaces.

3.b. Potentially compromised patient sterile supply items were removed from circulation.

3.c. Training and monitoring systems to ensure staff was trained and competent to effectively monitor, identify, and pull from circulation; surgical instruments which were in a condition that would not allow them to effectively sterilized.

4. Physicians and staff were screened and offered immunization for vaccine preventable diseases in accordance with a facility policy that is based on nationally accepted infection control guidelines.

5. A staff person was trained and competent to wash his hands in accordance with facility policy and nationally accepted infection control guidelines.

6. Staff adhered to the standard for OR (operating room) infection control practices related to the use of OR attire in the surgical suites.

7. That clamps available for use were sterilized.

8. That personal protective equipment was readily available for use.


Findings:

1. During initial tour of the perioperative surgical suite on 7/14/14 at 11:20 am two blue Velcro and cloth arm restraints were observed hanging from an IV pole in operating room (OR) 308. In a concurrent interview, RN C, indicated the restraints were being cleaned between patients with Super Sani-cloth wipes. After review of the Sani-cloth manufacturer's instructions for use, RN C acknowledged the instructions stated the product was for use on hard non-porous surfaces and therefore, the product would not disinfect (kill the germs) on the soft cloth/Velcro arm restraints. RN C acknowledged there was a potential for transmission of blood borne pathogens if the restraints were not cleaned and disinfected between patient uses. When asked, RN C acknowledged she was uncertain if the manufacturer approved the restraints for use among multiple patients.

During initial tour of the perioperative surgical suite on 7/14/14 at 11:10 am, a reddish/brown substance was observed coating the wheel covers of a metal cart located in operating room (OR) 308. In a concurrent interview when the OR supervisor was asked if the cart wheel covers could be disinfected (germs killed), he responded "The wheels probably can't be disinfected in that condition. I'm going to have to get another cart."

Failure to effectively clean and disinfect OR equipment placed the hospitals patients at potential risk for transmission and infection from infectious agents, including blood borne pathogens, such as hepatitis B, C, and HIV, in the case of the arm restraints.

2. Review of the perioperative temperature and humidity logs revealed the humidity level exceeded the hospital set parameter of 20-60% on 6 out of 30 documented days in June and 11 out of 16 documented days in July in operating room (OR) 308. The humidity was documented exceeding the 60% parameter on 18 of 30 days in June 2014 and 9 out of 16 days in July 2014 in OR 310. The humidity exceeded the 60% established parameter in Central supply on 17 out of 30 days in June 2014 and 11 out of 30 days in July 2014.

The temperature was outside the facility established parameter on 1 out of 30 days in June 2014 and 3 out of 16 days in July 2014 in OR room 308. The temperature was outside of parameter 1 out of 30 days in June 2014. In both OR 308 and 310 the temperature and humidity was not monitored for 9 out of 10 days in June 2014 and 4 out of 16 days in July 2014.

In Central Supply, where sterile patient supplies are stored, the temperature was outside of facility parameter 13 out of 30 days in July 2014 and 9 out of 16 days in July 2014. In Central Supply, the humidity exceeded 60% 17 out of 30 days in June 2014 and 12 out of 16 days in July 2014. Temperature and humidity were not monitored in Central Supply for 10 out of 30 days In June 2014 and 4 out of 16 days in July 2014. Humidity in Central Supply was recorded above 75, 2 days out of 30 in June 2014 and 1 out of 16 days in July 2014.

During an interview with Environmental Services Manager (EVSM) on 7/16/14 at 3 pm, he indicated the facility had been trying to get a handle on the humidity levels in the perioperative area. EVSM stated that the accuracy of the humidity monitoring devices was being evaluated. EVSM acknowledged the facility had experienced trouble keeping the temperatures and humidity in the desired ranges in the operating rooms and sterile supply areas since January 2014. EVSM confirmed operating room staff persons made documented calls to environmental services when temperatures or humidity was not in range of the desired parameters, but there was no system currently in place to document if the problem was fixed, and temperature and humidity was returned to desired parameters.

A policy/procedure was requested for monitoring temperature and humidity in the perioperative areas and the facility indicated it did not have a policy or procedure.

Review of the 2013 edition of AORN's Perioperative Standards and Recommended Practices reflected, "Sterilization Recommended Practice XV.b. Sterile packages should be stored under environmentally controlled conditions...Controlled conditions reduce the risk of contamination of sterile items. XV.b.1 Room temperature, humidity, and ventilation should be controlled in accordance with local, state, and federal policies and regulations. Regulatory agencies may enforce American Society for Healthcare Engineering (ASHE) or AAMI (Association for the Advancement of Medical Instrumentation) recommendations...These parameters are intended to be used for the design of the heating, ventilation, and air-conditioning systems and there may be daily fluctuations based on the environmental conditions. Recommendations from AAMI include that temperature in sterile storage areas not exceed 75 degrees F (Fahrenheit)...that there be a minimum of 4 air exchanges per hour, and that relative humidity is between 20% and 60%...The ASHE recommends temperatures in the sterile storage area of between 72 degrees F to 78 degrees F and that humidity not exceed 60%."

According to the Association of periOperative Registered Nurses (AORN) Perioperative standards and Recommended Practices Recommendation information accessed online at the following web site: http://www.aorn.org/Clinical_Practice/Clinical_FAQs/Environment_of_Care.aspx#b
The recommended temperature range in an operating room is between 68°F and 73°F (20°C to 23°C). Collaborate with infection prevention, and facility engineers when determining temperature ranges. Each facility should determine acceptable ranges for temperature in accordance with regulatory and accrediting agencies. The temperature should be monitored and recorded daily using a log or electronic documentation of the heating, ventilation, and air conditioning (HVAC) system.

The recommended humidity range in an operating room is 20% to 60% based upon addendum d to ANSI/ASHRAE/ASHE Standard 170-2008. Each facility should determine acceptable ranges for humidity in accordance with regulatory and accrediting agencies and local regulations. The center for Medicaid and Medicare systems has modified their requirements to allow for the 20% lower limit effective June 2013. Temperature and humidity should be monitored and recorded daily using a log or electronic documentation of the heating, ventilation, and air conditioning (HVAC) system.

3.a. On 7/16/2014 at 1:45 pm, during a concurrent observation and interview in the Central Supply area with CS Tech B, OR supervisor and ICNB, a hysterectomy tray (instruments used for surgery to remove female reproductive organs) which was ready for transport to the OR, was opened by CS Tech B. Packed in the tray a stringer (typically, approximately a foot long 3 rod type device to assist with the positioning of instruments for sterilizing) was noted to be packed with, twenty-three (23) sterile hinged instruments packed in a tight group. Ten (10) out of twenty-three (23) hinged instruments blades closed and tips layered on the bottom of the tray. Wrapped in a blue towel was 10 instruments spaced apart, wrapped in a roll and placed on top of the stringer. Additionally, two (2) heavy sterile instruments were stacked on top of the stringer with metal to metal contact. Another stringer was packed lawyered on top with hinged instruments in the same condition. The largest of the hinged instruments were packed in the middle of the stringer tightly.

CS Tech B, OR Supervisor and ICNB acknowledge they were not aware of the facility's policy and procedure for packing surgical Instruments for sterilization. In addition, OR Supervisor stated, Policy and Procedures were not readily available to staff. Policy and procedures were requested and not received by exit date.

According to the Association of periOperative Registered Nurses (AORN) Perioperative standards and Recommended Practices Recommendation IV, Items to be sterilized should be packaged in a manner that facilitates sterilization and provides for an aseptic presentation of the package contents. ...Incorrect packaging may prevent sterilization from occurring. Inappropriate handling can lead to loss of package integrity. Incorrect packaging can make aseptic delivery of the contents to the sterile field difficult or impossible. Items to be sterilized should be positioned within packages to allow sterilant contact with all surfaces. Sterilant contact is necessary for sterilization to be achieved. Instruments composed of more than one part that can be disassembled should be disassembled unless the manufacturer's written and validated instructions for use specifies that disassembly is not required. Sterilization of assembled instruments can prevent exposure of some areas of the device to the sterilant. Items to be sterilized that have concave or convex surfaces that create potential for water retention should be positioned within packages in a manner that prevents those surfaces from retaining water. Preventing water retention can help avoid the occurrence of wet packs and sterilization failure. Towels placed within instrument sets should be lint-free, freshly laundered, and thoroughly rinsed by a health care-accredited laundry facility. Adequate rinsing reduces the risk of leaving chemical residues that could be transferred from the towels to instruments. Lint left on sterile instruments may be transferred to the surgical wound and may cause a foreign-body reaction. Items to be sterilized should be placed in the package or tray in an open or unlocked position.

3.b. On 7/14/14 at 11:15 am a package of Magill forceps (An instrument resembling a pair of pincers or tongs, used for grasping, manipulating, or extracting) was observed in the first drawer of the anesthesia cart located in operating room (OR) 308. The package was observed to be yellow and folded in half. Two packages of Salem Sump tubing (nasogastric tube with an air vent, used to drain gastric or refluxed intestinal secretions) were also observed to be in packages that were discolored yellow. A clear package containing a sterile vent adaptor elbow was observed to have a hole in the package.

On 7/14/14 at 11:20 am the supplies were shown to the OR Supervisor and an interview was conducted. When asked if the supplies with the discolored packaging should be considered sterile, The OR Supervisor stated, "As long as the package is intact it should be considered sterile." The OR Supervisor acknowledged the vent adaptor packaging was torn and the item should not be used. When asked what standards the hospital followed for storage of event-related (package is compromised) sterile supplies, the OR Supervisor indicated the hospital followed the Association of periOperative Registered Nurses (AORN) Perioperative standards and Recommended Practices.

On 7/14/14 at 1:55 pm an interview was conducted with Infection Control Nurse B about event-related sterility. Infection Control Nurse B although she stated she was not familiar with the term "event-related sterility", stated these packages would need to be inspected for water damage, such as ink runs, and water spots, and tears. Infection Control Nurse B indicated packaging that was discolored yellow could indicate age or heat damage and the contents of such a package should not be trusted for patient use. Infection Control Nurse B stated packages should not be stored folded.

Review of the facility's policy titled "Event Related Sterility", dated and signed 3/19/14, was reviewed. The policy stipulated in part, "All hospital-sterilized items are deemed sterile as long as the integrity of the package is not compromised. If the package is torn, wet, damaged, or otherwise suspected of being contaminated, the items are returned to Central Sterile to be reprocessed and re-sterilized. If sterile items remain on the shelf for a period of 24 months, the need for those items should be evaluated. Items deemed needed will be reprocessed and re-sterilized every 24 months."

The 2014 AORN standards section "Recommended Practices for Selection and Use of Packaging Systems for Sterilization " indicated, under "Recommendation III d. " The shelf life of a packaged sterile item should be considered event-related. The sterility of an item does not change with the passage of time, but may be affected by particular events (e.g. amount of handling) or environmental conditions ... "
Failure of the facility to monitor, identify, and remove potentially compromised sterile supplies from storage areas where they are available for patient use places patients at potential risk for transmission of and infection from infectious organisms.

3.c. On 7/16/2014 at 1:45 pm, during a concurrent observation and interview in the Central Supply area with CS Tech B, OR Supervisor and ICNB, a hysterectomy tray (instruments used for surgery to remove female reproductive organs) which was ready for transport to the OR, was opened by CS Tech B. Instruments were packed in the tray along with three instruments with reddish color substance on the instruments. The reddish color substance was identified by staff as "rust" or oxidation (interaction between oxygen and other substances). CS Tech B, OR Supervisor agreed the reddish color substance was the typical state for some of the instruments and they were not surprised to find the instruments in this shape.

According to Surgical instrument, Herbert J. Kaiser, PhD; Patrick Schwab, MBA; Jason F. Tirey, MA. (October 1, 2000). Spotting, Staining, and Corrosion of Surgical Instruments. Infection Control Today. Retrieved from: Spotting, staining, and corrosion are serious problems in many healthcare facilities ... Spotting, staining, and corrosion of surgical instruments can impair their function ... Spotting, staining, and corrosion also interfere with sterilization. Spores can be protected from destruction by the layers of iron oxide (rust). Corrosion can result in a shortened instrument life, which results in increased cost.

According to the Association of periOperative Registered Nurses (AORN) Perioperative standards and Recommended Practices Recommendation IV, "Instruments should be kept free of gross soil during surgical procedures. Blood and body fluids can cause pitting of instruments and, if left to dry, can be difficult to remove. If blood and body fluids are not removed, they can prevent adequate sterilization, which could be an avenue for transmission of other potentially infectious materials. Instruments should be wiped as needed with sterile surgical sponges moistened with sterile water during the procedure to remove gross soil. Blood and body fluids, as well as saline, are highly corrosive. Corrosion, rusting, and pitting occur when saline, blood, and debris are allowed to dry in or on surgical instruments. Dried blood and debris can be difficult, if not impossible, to remove from all surfaces during the decontamination process; therefore, subsequent disinfection or sterilization may not be achieved."

According to AORN, Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment, 2013: "Instruments should be inspected for ...corrosion, pitting, burrs, nicks, and cracks ...wear and chipping of ...plated surfaces damage[d] protective surfaces of instruments, contribute to corrosion, impede sterilization surface corrosion damage ...can inhibit sterilization."

4. On 7/16/14, five (5) health records of facility health care workers (HCW) were reviewed. There was missing documentation of titer (level) status or immunization provided for one or more of the following vaccines: measles, mumps, rubella (German Measles), and varicella (Chicken Pox) in four out of five records Employee Health Records [EHR] ICN B, CS Tech B, EHR 4 and Medical Staff Health Records (MSHR) COS. There was no documentation of (Tdap) Diphtheria (a serious bacterial infection), Tetanus (a serious illness caused by bacteria that can enter the body through a deep cut) and Pertussis (commonly known as Whooping Cough, is an infectious bacterial disease that causes uncontrollable coughing) immunization status in four out of five records (ICN B, CS Tech B, COS, and Physician A). There was no documentation of follow-up for offer of or discussion related to second series of Hepatitis B when ICN B was determined to be non-immune after receiving the Hepatitis B series.

During an interview on 7/16/14 at 11am, with Employee Health RN B, she stated that the facility follows CDC (Centers for Disease Control and Prevention) guidelines for employee health services. RN B stated they "currently did not require employees be offered the Tdap vaccine. RN B indicated the facility did not yet have an approved policy/procedure for screening employees according to CDC guidelines.

The facility employee/contract staff person immunization health practices, did not follow the facility adopted, nationally recognized current 2014 CDC guidelines for healthcare worker (HCP) immunizations that stated:
Hepatitis B: Give a 3 dose series. Obtain anti-HBS serologic (blood) testing (indicates if individual is now immune) to Hepatitis B.
MMR: For HCP born in 1957 or later without serologic evidence of immunity or prior vaccinations, give two doses of MMR. Although HCP born before 1957 are generally considered immune to MMR, healthcare facilities should consider recommending 2 doses of MMR vaccine routinely to unvaccinated HCP born before 1957 who do not have laboratory evidence of disease or immunity to measles and or mumps and should consider 1 dose of MMR for HCP with no laboratory evidence of disease or immunity to rubella ...

Varicella (chicken-pox): For HCP who have no serologic proof of immunity, prior vaccination, or history of varicella disease, give 2 doses of varicella vaccine.

Tetanus/Diptheria/Pertussis (Tdap): All HCP's who have not or who are unsure if they previously received a dose of Tdap should receive a dose of Tdap as soon as feasible. Pregnant HCPs need to get repeat doses during each pregnancy. All HCPs should then receive Td boosters every 10 years thereafter.

5. On 7/15/14 OR Supervisor was observed acting as circulating nurse in an operating room. Between 1:30 and 2 pm he was observed exiting the OR touching the OR door latch with his gloved hand and re-entering the OR again touching the door latch with his gloved hand with no hand washing or changing of his gloves after leaving or upon reentering the OR and resuming his duties.

During an interview with OR Supervisor and Infection Control Nurse B on 7/16/14 at 10:20 am, OR Supervisor acknowledged he hadn't changed his gloves, and elaborated by stating he also didn't wash his hands between glove changes. He stated this included when he handled bloody items, such as gauze squares that had blood on them. When asked, Infection Control Nurse B stated hand washing when exiting and re-entering the OR should be the same for entering and exiting any patient room, "Gel in and Gel Out." Infection Control Nurse B stated hands should be washed between glove changes. Infection Control Nurse B stated the Facility followed AORN for handwashing standards in the perioperative suite.

The facility's unsigned policy titled, "Hand Hygiene", dated June 1 2014, was reviewed. The policy stipulated, in part, "Careful hand hygiene must be performed before leaving unit and upon return: "Gel in" and "Gel out" . Before and after gloves are used ..."

A Review of the Association of periOperative Registered Nurses (AORN) Perioperative standards and Recommended Practices, 2014 edition was conducted. Under Reccommended Practices for Hand Hygiene in the Perioperative Setting the guidelines stipulated in part, "A hand wash should be performed upon arrival at the health care facility, before and after every patient contact, before putting gloves on and after removing gloves or other personal protective equipment, any time there is a possibility that there has been contact with blood or other potentially infectious materials or surfaces ...Hand washing remains one of the most important measures in maintaining patient and health care personnel safety. Following these hand washing practices will prevent transmission of infection and reduce health care-associated infections for the patient and health care personnel. Contamination of hands may occur as a result of holes or tears in gloves that are not visible; when gloves are removed; and when continuing to wear gloves following the care of a patient, which may lead to transmission of microorganisms from patient to patient. Wearing gloves will not replace hand hygiene. One study found a 15% rate of colonization from methicillin-resistant Staphylococcus aureus (MRSA)-positive patients to health care personnel's hands after removal of gloves. Another study found a 17% rate of colonization from MRSA-colonized patients to gloves of health care personnel."

Review of OR Supervisor's In-service and Continuing Education Profile log was conducted. The log was a record of educational courses OR Supervisor had attended. The log showed no evidence in any courses related to infection control, hand washing, or blood borne pathogens.

6. On 7/16/14 at 10:05 pm, RN C was observed in the semi-restricted hallway of the of perioperative suite with a cloth hat covering her hair. In a concurrent interview, RN C acknowledged she had forgotten to cover her home-laundered cloth cap with a disposable hospital bouffant cap.

The 2014 AORN Perioperative Standards and Recommended Practices, under Surgical Attire stipulates that, "Clean surgical attire, including shoes, head covering, masks, jackets, and identification badges should be worn in the semi-restricted and restricted areas of the surgical or invasive procedure setting. Clean attire minimizes the introduction of microorganisms and lint from health care personnel to clean items and the environment. Facility-approved, clean, and freshly laundered or disposable surgical attire should be donned daily in a designated dressing area before entry or reentry into the semi-restricted and restricted areas. Changing from street apparel into facility-approved, clean, and freshly laundered or disposable surgical attire in a designated area decreases the possibility of cross-contamination and assists with traffic control. All personnel should cover head and facial hair, including sideburns and the nape of the neck, when in the semi-restricted and restricted areas. 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. All individuals who enter the semi-restricted and restricted areas should wear freshly laundered surgical attire that is laundered at a health care-accredited laundry facility or disposable surgical attire provided by the facility and intended for use within the perioperative setting. Home laundering is not monitored for quality, consistency, or safety. Exposure of health care personnel and their family members to blood and other potentially infectious materials may result from improper handling and decontamination of surgical attire. Home washers may have a lower temperature (i.e., < 160° F [71.1° C]) or washing parameters and temperatures may not be adjustable. Home washers may have limited capacity for chemical additives and may not have directions for using alkalis and acids. Home laundering may not meet the specified measures necessary to achieve a reduction in microbial levels in soiled surgical attire.



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7. On 7/14/14 at 11:40 am, during a tour of Operating Room (OR) 308, the anesthesia cart contained a set of curved Kelly clamps outside of a sterile package that did not have any evidence that they were cleaned between patients.

In a concurrent interview, the OR Supervisor acknowledged that the clamp should not be in the anesthesia drawer and should be processed with other patient care equipment at the end of the case.

8. On 7/10/14 at 10 am, during a tour of the Emergency Department (ED), the hopper (used to flush the contents of bedpans and other body fluids) had no personal protective equipment (PPE) such as gowns and face shields, available for use.

In a concurrent interview, the ED Manager stated supplies were kept in a room across the hall and behind a biohazardous trash bin that had to be moved to access the supplies. The ED Manager acknowledged that the PPE was not readily available to staff to protect themselves from exposure to blood borne pathogens and other infectious agents.

Based on interview and record review, the hospital failed to identify Patient 3's high risk discharge needs when they did not complete her initial nursing assessment. This had the potential for Patient 3's psychosocial needs to not be met.

Findings:

Patient 3 was admitted to the hospital on 7/8/14 with diagnoses that included chest pain, amphetamine (meth) use, and alcohol abuse.

On 7/15/14, the hospital's Discharge Planning policy, dated 9/18/13, read, "The following high risk triggers, when identified during initial screening, will prompt a full discharge planning evaluation:...5. Patients needing counseling or community resources in regard to to substance abuse...12. Disease/diagnosis in which inadequate coping is demonstrated..."

Patient 3's Admission History and Physical (H&P), dated 7/9/14, showed that "Until recently she was homeless, jobless (less than a month)...Patient has a hx (history) of significant alcohol use for the past 20+ years. She also had a significant hx of heavy amphetamine use for more than 25 years...she gets DT's (delirium tremens, alcohol withdrawal that can include seizures, confusion, rapid heart rate) sometimes as soon as 24 hrs (hours) after the last drink." The H&P also showed Patient 3's urine tested positive on 7/8/14 at 3:16 pm for amphetamines and her blood alcohol level was high at 233, indicating she had consumed approximately 8 drinks.

Patient 3's H&P, dated 7/9/14, contained documentation that stressed "the importance of 'staying away from friends that do drugs' as patient is on probation and she gets drug tested monthly and could potentially loose her job and freedom."

Patient 3's Discharge H&P, dated 7/10/14, included instructions to "stay away from drinking alcohol, smoking weed or cigarettes and especially stay away from methamphetamines."

Patient 3's Nursing Admission History-Assessment, dated 7/8/14, included a Suicide Risk Assessment section was checked "Yes" for excessive alcohol or drug use and checked "No" for no social support of friends or family. There was a High Risk Triggers for Discharge Planning section that was not completed. It included the questions, "Need for counseling or community resources in regard to substance abuse" and "Disease diagnosis in which inadequate coping is demonstrated" which were both left blank.

On 7/15/14 at 2:50 pm, Administrative (Admin) Nurse A stated that the admitting nurse should have completed Patient 3's Nursing Admission History Assessment that included the high risk questions. Admin Nurse A stated that had those questions been answered, it would have triggered discharge planning for Patient 3. Admin Nurse A confirmed that discharge planning did not occur for Patient 3.

Based on interview and record review, the hospital failed to do a discharge evaluation, arrange implementation of a discharge plan, or counsel Patient 3 to prepare her for discharge. This had the potential for Patient 3's psychosocial needs to not be met.

Findings:

Patient 3 was admitted to the hospital on 7/8/14 with diagnoses that included chest pain, amphetamine (meth) use, and alcohol abuse.

On 7/15/14, Patient 3's Admission History and Physical (H&P), dated 7/9814, showed that "Until recently she was homeless, jobless (less than a month)...Patient has a hx (history) of significant alcohol use for the past 20+ years. She also had a significant hx of heavy amphetamine use for more than 25 years...she gets DT's (delirium tremens, alcohol withdrawal that can include seizures, confusion, rapid heart rate) sometimes as soon as 24 hrs (hours) after the last drink." The H&P also showed Patient 3's urine tested positive on 7/8/14 at 3:16 pm for amphetamines and her blood alcohol level was high at 233, indicating she had consumed approximately eight drinks.

The physician's H&P for Patient 3, dated 7/9/14, stressed, "Patient is on probation and she gets drug tested monthly and could potentially loose her job and freedom."

The physician's Discharge H&P for Patient 3, dated 7/10/14, included instructions to "stay away from drinking alcohol, smoking weed or cigarettes and especially stay away from methamphetamines."

Patient 3's Nursing Admission History-Assessment, dated 7/8/14, included a High Risk Triggers for Discharge Planning section with the questions, "Need for counseling or community resources in regard to substance abuse" and "Disease diagnosis in which inadequate coping is demonstrated," which were both left blank. The Suicide Risk Assessment section was checked "Yes" for excessive alcohol or drug use and checked "No" for no social support of friends or family.

There was no indication in Patient 3's record to show she had been provided any information on referrals to any type of substance abuse resources or counseling in the community.

The hospital's Discharge Planning policy, dated 5/31/13, read, "In the process of discharge planning, there are two elements which must be managed: the patient's physical needs and the patient's psychosocial needs. High Risk Criteria include patients needing counseling or community resources in regard to to substance abuse and patients with disease/diagnosis in which inadequate coping is demonstrated

On 7/15/14 at 2:50 pm, Administrative Nurse A stated that because Patient 3's Nursing Admission History Assessment was not completed, the hospital had not provided discharge planning for her substance abuse issues, per the hospital's policy.

Based on staff interview and record review, the hospital failed to develop and implement written protocols or procedures which encouraged hospital staff to show discretion and sensitivity with respect to the circumstances, views, and beliefs of the families of potential donors. The lack of these specific written protocols for training of hospital staff created the possibility that hospital staff could unknowingly offend or cause added anguish for families of patients nearing death.

Findings:

On 7/15/14, a request for the hospital's written policies, procedures, protocols and staff training logs or other documents pertaining to organ, tissue and eye procurement was requested. The single written document provided was the Administrative Policy Statement (8610-34-04) titled "Organ and Tissue Donation." This document recorded that it had been approved and distributed on 4/21/04.

On 7/16/14 at 1:40 pm in an interview with the Chief Nursing Officer (CNO) this document was concurrently reviewed. This document has one sentence that states, "(names of two organ procurement organizations) coordinators will use discretion and sensitivity with respect to the circumstances, views, and beliefs of the families of potential donors." The CNO acknowledged that this policy statement does not address the training or encouragement of the hospital staff members. The CNO also stated that the hospital did not have any other written protocols concerning this subject and that there were no documents to show that hospital staff had been trained in the manner of approaching these families.

Based on interview and record review, the hospital failed to ensure that two of six sampled surgical patients had a history and physical examination documented and/or complete. (Patients 6 and 13) These failures had the potential for adverse outcomes due to undetected patient conditions/or changes in condition.

Findings:

1. On 7/15/14, Patient 13's record was reviewed. Patient 13 was admitted on 7/7/14 for a colonoscopy (a procedure to view the inner lining of the large intestine or gut). Patient 13's record contained no evidence of a history and physical.

On 7/16/14, the Rules and Regulations of the Medical Staff Bylaws read, "A History and Physical (H&P) must be performed and documented in the medical record for all patients admitted for inpatient care within 24 hours as well as prior to operative and complex invasive procedures, and/or administration of moderate or deep sedation or anesthesia in either the inpatient or outpatient setting."

On 7/15/14 at 2 pm, Medical Records Director (MRD) reviewed Patient 13's record and acknowledged that the H&P was not present in Patient 13's record.



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2. Patient 6's record was reviewed on 7/16/14. Patient 6 was admitted for surgery on 5/16/14 for a Dilation and Curettage (D&C, which refers to the dilation or widening of the cervix and surgical removal of part of the lining of the uterus or womb).

Patient 6's record contained a document titled, "Interval History and Physical," in which the surgeon had indicated that there had been no significant changes since the time the first history and physical had been performed. This document was signed and dated by the physician, but had not been timed.

During an interview and concurrent record review, on 7/16/14 at 9:05 am with Administrative (Admin) Nurse A, it was acknowledged that Patient 6's interval history and physical had not been timed by the surgeon. Admin Nurse A stated that this document needed to have been signed, dated and timed by the surgeon.

The facility's policy statement, titled, "Entries into & Completion of the Medical Record," dated 6/20/13, indicated that all entries into the medical record must be authenticated (signed), dated, and timed by the individual who made the entry. The date and time should reflect when the actual entry was made.

Based on interview and record review, the hospital failed to ensure the informed consent process followed hospital policy for one of six surgical patients reviewed. This failure had the potential for the patient to be misinformed regarding their surgery and result in an unwanted surgical procedure. (Patient 6)

Findings:

Patient 6's record was reviewed on 7/16/14. Patient 6 was admitted for surgery on 5/16/14 for a Dilation and Curettage (D&C, which refers to the dilation or widening of the cervix and surgical removal of part of the lining of the uterus or womb).

Patient 6's record contained a document titled, "Consent to Surgery or Special Procedure," signed by Patient 6 on 5/16/14, which read, "Your doctors have recommended the following operation or procedure: D/C of Uterus."

Patient 6's record contained a history and physical document which contained evidence that the risks, benefits, and alternatives to surgery had been discussed with the patient prior to surgery.

The hospital's policy, titled, "Consent/Informed Consent," reviewed 3/18/13, indicates, that it is the responsibility of the physician performing the procedure to give the patient or surrogate decision-maker all necessary information concerning the procedure and to obtain the informed consent. The consent form must state the name of the attending physician and/or treating or operating surgeon and the name of the proposed procedures and describe the nature of the treatment.

During an interview and concurrent record review, on 7/16/14 at 9:05 am with Administrative (Admin) Nurse A, it was acknowledged that Patient 6's surgical consent had not been properly executed. Admin Nurse A explained that the full name of the procedure should be spelled out and then explained in simple terms on the consent form.

Based on interview and record review, the hospital failed to ensure the immediate post procedure note process followed hospital policy for one of six surgical patients reviewed. This failure had the potential to create an inaccurate surgical record. (Patient 6)

Findings:

Patient 6's record was reviewed on 7/16/14. Patient 6 was admitted for surgery on 5/16/14 for a Dilation and Curettage (D&C, which refers to the dilation or widening of the cervix and surgical removal of part of the lining of the uterus or womb).

Patient 6's record contained a document titled, "Immediate Post Procedure Note," dated 5/16/14. This document was signed and dated by the physician, but had not been timed.

During an interview and concurrent record review, on 7/16/14 at 9:05 am with Administrative (Admin) Nurse A, it was acknowledged that Patient 6's immediate post procedure note, had not been timed by the surgeon. Admin Nurse A stated that this document needed to have been signed, dated and timed by the surgeon.

The facility's policy statement, titled, "Entries into & Completion of the Medical Record," dated 6/20/13, indicates that all entries into the medical record must be authenticated (signed), dated, and timed by the individual who made the entry. The date and time should reflect when the actual entry was made.