HospitalInspections.org

Based on observation, staff interviews, medical record and document reviews, the hospital failed to demonstrate an effective governing body responsible for the conduct of institutional operations in order to ensure safe and effective care for all patients as evidenced by:

A. The hospital failed to organize a system for the governing body to periodically evaluate the patient care services of all outside vendors with clear documentation of objective measures and evidence of the performance of each vendor to ensure the services were safe and effective (cross reference A 0084).

B. The hospital failed to maintain a list of all contracted services with scope and nature of services that clearly identified hospital-related services in order to organize its oversight separate from other non-hospital business operations (cross reference A 0085).

C. The hospital failed to develop, implement, and maintain an effective quality assessment and performance improvement program that addressed the complexity of services provided and that involved all hospital departments to prevent potential adverse events and improve patient outcomes (cross reference A 0263).

D. The hospital failed to ensure that a nursing service was well-organized to effectively meet the nursing needs of all patients (cross reference A 0385).

E. The hospital failed to maintain pharmaceutical services in accordance with acceptable standards of practice in order to ensure the safe storage and administration of medications to all patients which resulted in immediate jeopardy to patient safety on May 26, 2011 (cross reference A 0490).

F. The hospital failed to ensure that dietary services were directed in a manner to ensure food safety for all patients, including the preparation of food which resulted in immediate jeopardy to patient safety on May 24, 2011 (cross reference A 0618).

G. The hospital failed to develop and maintain an effective infection control program to ensure a sanitary environment, and to prevent, avoid and/or minimize sources of transmission of infectious and communicable diseases in accordance with nationally recognized infection control standards (cross reference A 0747).

H. The hospital failed to ensure that surgical services were organized in accordance with acceptable standards of practice, including preparedness for surgical emergencies which resulted in immediate jeopardy to patient safety on May 26, 2011 (cross reference A 0940).

The cumulative effect of these systemic problems resulted in the inability of the hospital to ensure the provision of quality health care in a safe environment.

Findings:

In an interview with the CEO (Chief Executive Officer), on May 25, 2011 at 1:40 p.m., the CEO indicated that the governing body (Board of Trustees) provided oversight of hospital operations. The Board of Trustees relied on hearing about the operations from the reports submitted by the CEO and medical staff committees at periodic meetings throughout the year. Although the Board of Trustees delegated specific management, quality measurement tasks, and monitoring duties to the CEO, medical staff leadership, department heads and managers, the CEO acknowledged that the Board of Trustees was ultimately responsible to ensure that the care and services to patients were safe, effective and of high quality.

Review on 5/25/11 at 8 p.m. of the 2/23/10 Amended and Restated Bylaws of the [hospital owner name, represented by the Board of Trustees], under Article V item 6, documented that the Board of Trustees "shall have ultimate responsibility for improving safety and the delivery of quality patient care provided by [hospital name]."

Based on staff interview and document review, the hospital failed to organize a system for the governing body to periodically evaluate the patient care services of all outside vendors with clear documentation of objective measures and evidence of the performance of each vendor to ensure the services were safe and effective.

Findings:

Review on 5/25/11 at 9 a.m. of a list of contractors, presented as the hospital ' s contracts list, indicated 85 vendors. Many vendor types were not typically associated with hospital services (such as home medication service, outpatient sleep evaluation services performed elsewhere).

Review on 5/25/11 at 9 a.m. of the governing body and medical staff leadership meeting minutes for 2010-2011 indicated only one specific discussion of annual review of contracted services. The minutes documented 5 vendors as being reviewed.

In an interview on 5/25/11 at 1:40 p.m. with the Chief Executive Officer (CEO) who was responsible for managing and evaluating contracted services, the CEO indicated that the Board of Trustees for the organization that owned the hospital also owned two other business entities. The CEO managed the contracted services for all three entities and reported contract-related issues to the Board of Trustees. The CEO presented a list (described above) of contract names that applied to all three entities (co-mingled). No discreet list that applied only to the hospital patient care services that were arranged with outside vendors was documented. The CEO indicated that the MEC (Medical Executive Committee selected only 5 vendors to review annually (described above). The CEO indicated that other vendors were not routinely discussed or reviewed by the Medical Staff (such as laundry/linen, outside laboratory or pathology vendors, equipment maintenance/servicing, ventilation maintenance/servicing, biomedical waste disposal, and medication purchasing), even though the safety and effectiveness of those services did directly impact the care outcomes for hospital patients.

In the 5/25/11 at 1:40 p.m. interview with the CEO, the CEO stated that evaluation of most contract vendors was delegated to department heads and managers, who reported to her. However, the CEO did not verify that the department heads and managers collected objective measures and analyzed the vendors to ensure they complied with federal regulations and standards of practice comparable to services rendered by the hospital. The CEO produced no reports to show that the vendors were currently licensed, certified, registered, or otherwise qualified, and performed positively by their own quality control reports.

The CEO and hospital administration representatives were asked if the hospital had a policy or procedure to define the patient care services that were performed by outside vendors, and a process through which to evaluate the vendors. No policies were produced.

Review on 5/26/11 at 8 a.m. of policy 25.01 titled Improving Organizational Performance Plan, last approved 5/2/11, documented on page 5, " When an outside source provides patient care services the medical staff is responsible for implementing the performance improvement process. "

However, review on 5/25/11 at 9 a.m. of the MEC and Quality Committee meeting minutes did not identify documented details of the qualifications of the 5 vendors (such as licenses, certifications, accreditations, registrations) under the annual contracted services review for 2010. No documentation with objective measures of the performance of those 5 vendors, or of other vendors who performed patient care services Staff (such as laundry/linen, outside laboratory or pathology vendors, equipment maintenance/servicing, ventilation maintenance/servicing, biomedical waste disposal, and medication purchasing), were documented as reviewed by the medical staff leadership or the governing body for 2010-2011.

Based on staff interview and document review, the hospital failed to maintain a list of all contracted services with scope and nature of services that clearly identified hospital-related services in order to organize its oversight separate from other non-hospital business operations.

Findings:

Review on 5/25/11 at 9 a.m. of a list of contractors, presented as the hospital ' s contracts list, indicated 85 vendors. Many vendor types were not typically associated with hospital services (such as home medication service, outpatient sleep evaluation services performed elsewhere).

Review on 5/25/11 at 9 a.m. of the governing body and medical staff leadership meeting minutes for 2010-2011 indicated only one specific discussion of annual review of contracted services. The minutes documented 5 vendors as being reviewed.

In an interview on 5/25/11 at 1:40 p.m. with the Chief Executive Officer (CEO) who was responsible for managing and evaluating contracted services, the CEO indicated that the Board of Trustees for the organization that owned the hospital also owned two other business entities. The CEO managed the contracted services for all three entities and reported contract-related issues to the Board of Trustees. The CEO presented a list (described above) of contract names that applied to all three entities (co-mingled). The CEO indicated that several of the vendors did not provide services to the hospital, however. No discreet list that applied only to the hospital patient care services that were arranged with outside vendors was documented. The CEO indicated that the Medical Executive Committee (MEC) selected only 5 vendors to review annually (described above). The CEO clarified that the hospital did arrange for more than 5 outside vendors to provide services to hospital patients, but no list to specifically identify only those vendors was documented.

Based on interview and document review, the hospital failed to implement an effective, on-going, hospital-wide quality assessment and performance improvement reflecting the complexity of the hospital's organization and services involving all hospital department and services including those services furnished under contract or arrangement as evidenced by:

A. The hospital failed to organize a system to periodically evaluate the patient care services of all outside vendors with clear documentation of objective measures and evidence of the performance of each vendor to ensure the services were safe and effective (cross reference A 0084).

B. The hospital failed to maintain a list of all contracted services with scope and nature of services that clearly identified hospital-related services in order to organize its oversight separate from other non-hospital business operations (cross reference A 0085).

C. The hospital failed to develop, implement, and maintain an effective quality assessment and performance improvement program to ensure the development of an effective program for the Food and Dietetic Services (Cross reference A264).

D. The hospital failed to ensure the development of an effective program for the Food and Dietetic Services (Cross reference A264).

E. The hospital failed to ensure that a nursing service was well-organized to effectively meet the nursing needs of all patients (cross reference A 0385).

F. The hospital failed to maintain pharmaceutical services in accordance with acceptable standards of practice in order to ensure the safe storage and administration of medications to all patients which resulted in immediate jeopardy to patient safety on May 26, 2011 (cross reference A 0490).


G. The hospital failed to ensure that dietary services were directed in a manner to ensure food safety for all patients, including the preparation of food which resulted in immediate jeopardy to patient safety on May 24, 2011 (cross reference A 0618).

H. The hospital failed to develop and maintain an effective infection control program to ensure a sanitary environment, and to prevent, avoid and/or minimize sources of transmission of infectious and communicable diseases in accordance with nationally recognized infection control standards (cross reference A 0747).

I. The hospital failed to ensure that surgical services were organized in accordance with acceptable standards of practice, including preparedness for surgical emergencies which resulted in immediate jeopardy to patient safety on May 26, 2011 (cross reference A 0940).

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

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

On 5/25/11 at 1:45 pm, quality appraisal and performance improvement (QAPI) activities for the dietary department were reviewed with DMS (Dietary Management Staff) J and AS (Administrative Staff) K. It was noted that while the department submitted performance improvement information, the submitted report focused on physician directed parameters such as glucose monitoring, timeliness of nutrition assessment for ventilator dependent patients, patients with renal issues and patients with a secondary diagnosis of renal failure. It was also noted that all of the reviewed parameters had a compliance rate of 100%, an indication that the reviewed topics met the expectation of the department.
In an interview on 5/25/11 at 1:45 pm, with Administrative Staff K, a member of the hospitals ' QAPI committee and the committee that reported to the governing body was asked how the hospital ensured development of departmental improvement programs. She stated that that the committee did not make decisions on the types of activities, rather would rely on departmental leaders to choose the activities. DMS J and AS K acknowledged that the reported activities were reflective of monitoring activities rather than activities for which there would be opportunities for improvement.
There was no documentation provided to ensure the QAPI program was developed for the scope of the hospital food service.

Based on observation, interview and record review, the facility failed to provide nursing service that met the needs of the patients when the RN failed to:

1. Assess the respiratory status and implement interventions to prevent the development pressure ulcers for one of 49 sampled patients (Patient 2) who was assessed at risk for pressure ulcer.(Refer to A 395).

2. Evaluate the effectiveness of the pain medication given to one of 49 sampled patients (Patient 6). (Refer to A 395).

3. Develop a care plan to prevent, assess and treat the pressure ulcers of one of 49 patients (Patient 2)(Refer to A396).

4. Administer medications according to physician's order for two of 49 patient samples (Patient 6 and 22) and follow manufacturer's instructions for one pt. (Patient 7) (Refer to A 404).

5. Administer blood transfusion to one patient of 49 patients (Patient 4) according to policy and procedure (Refer to A409).

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Based on observation, interview and record review, the RN failed to evaluate the nursing care provided to one of 49 sampled patients (Patient 2) when:

1. There was no documented evidence of oxygen saturation monitoring on 5/22/11 and 5/23/11 on day and night shift while Patient 2 was on oxygen at 10 L(liters)/min. to ensure patient maintained adequate oxygen levels.

2. The RN failed to do a comprehensive skin assessment and implement interventions to prevent Patient 2 from developing a Stage II and a Stage III pressure ulcer in the sacral area.

Stage II pressure ulcer- partial thickness loss of dermis presenting as a shallow open ulcer with a red-pink wound bed without slough. May also present as an intact or open/ruptured blister.

Stage III pressure ulcer- full thickness tissue loss. Subcutaneous fat may be visible but bone , tendon or muscle is not exposed.Slough may be present but does not obscure the depth of tissue loss.

3. The RN failed to evaluate the effectiveness of the pain medication given to one of 49 sampled patients (Patient 6).

Findings:

Patient 2 was admitted to the facility on 5/13/11 with diagnoses of fever, sepsis with hypotension and infected right arm wound.

1. Review of the dictated history and physical examination (H & P) by the physician dated 5/14/11 showed history of coronary artery disease and apparent congestive heart failure and probable chronic obstructive pulmonary disease.

Review of physician's orders showed a verbal order dated 5/20/11 at 8:00 AM that stated, O2 (Oxygen) at 7 L (liters) via oxymizer, titrate to keep saturation >(greater than) 92%.

An oxymizer is a disposable oxygen conserving device that concentrates oxygen delivery to allow for equivalent saturations at much lower flow rates.

Review of nursing Assessment Flowsheet on 5/22/11 showed from 12:00 AM to 7:00 AM (night shift) the respiratory assessment was, "lungs with rales, mild SOB (shortness of breath) on exertion. No cough, on O2 10L/min. per oxymizer." The assessment from 8:00 AM to 3:00 PM (day shift) was "lungs with rales, mild SOB on exertion, occasional cough with whitish sputum." There was no documented evidence of O2 saturation monitoring from 12AM to 3:00 PM to ensure patient maintained O2 saturation level greater than 92%.

Review of nursing Assessment Flowsheet on 5/23/11 showed from 12:00 AM to 7:00 AM (night shift) the respiratory assessment was, "lungs with rales, mild SOB (shortness of breath) on exertion. No cough, on O2 10L/min. per oxymizer." The assessment from 8:00 AM to 3:00 PM (day shift) was "lungs with rales, mild SOB on exertion, O2 at 10L oxymizer."

Review of Oxygen/Oximetry Monitoring Record written by the Respiratory Therapist on 5/22/11 at 8:15 AM showed oxygen setting at 10L/min. with no O2 satuation level recorded and 5/23/11 at 8:20 AM showed a range of O2 saturation from 90% to 100%.

Durning an interview with the Respiratory Therapist on 5/24/11 at 2:15 PM, he was asked why there was no O2 saturation level documented on 5/22/11. He said, "I assumed nurses were doing it." He could not explain if there were any interventions done when the O2 saturation was below 92%.

According to facility's Respiratory Protocol, revised 12/08, it sated, "Assess respiratory status every shift and prn (whenever necessary) ... Interventions: 6. Monitor arterial blood gases (ABG) or oximetry to maintain acid/base balance and /or adequate oxygen levels... 10. If respiratory condition changes, administer O2 PRN and notify physician to obtain orders."


2. Review of the Nursing Admission Database dated 5/14/11 at 2:00 AM, showed the Norton Pressure Ulcer Risk Assessment score for Patient 2 was as follows: (poor physical (2); alert (4); bed bound (1); very limited mobility (2) and not incontinent (4). The total score was "13." A total score of 14 or less indicated that a patient would be at risk for pressure ulcer.

Review of the multidisciplinary continuing care plan did not identify the problem of potential risk for pressure ulcer based on the Norton Pressure Ulcer Risk Assessment score.

On 5/24/11 at 2:30 PM, Patient 2 was observed laying on the bed. The Nursing Supervisor 1was also present during the observation. Patient 2 was assisted by staff to turn to his side to examine his skin in the back and peri-area. His buttocks area was reddened with areas of excoriation and a small open area with yellowish slough tissue on the wound base was noted on the sacral area. The Nursing Supervisor acknowledged that the sacral wound appeared to be a Stage III pressure ulcer.

During a concurrent review of medical records and interview with the Nursing Supervisor 1 on 5/24/11 at 2:40 PM, she acknowledged that there was no care plan developed for potential risk for pressure ulcer and no evidence that the physician was notified about the pressure ulcer on the sacrum.

During observation on 5/31/11 at 11:30 AM with Nursing Supervisor 2, Patient 2 was seen laying on th bed and was assisted to turn to his right side by the nursing assistant. Patient 2's buttocks area was reddedned, with 2 open areas noted. One small superficial open wound with pinkish base on the left buttock was noted and the Stage III sacral ulcer was unchanged from the last observation on 5/24/11. Nursing Supervisor 2 agreed that the left buttock wound appeared to be a Stage II pressure ulcer.

Review of the Nursing Assessment Flowsheet showed the following documentation on the biophysical assessment section:

On 5/21/11 from 7AM to 3PM shift: " ...buttocks reddened-peri-area with opening."

On 5/22/11 from 7AM to 3PM shift: " ...sacral area with 2 cm. (centimeters) x 0.8 cm. skin abrasion."

On 5/23/11 from 12 AM to 7AM shift, "...sacral, perineal with redness and skin abrasion."

O 5/24/11 from 3PM to 11PM shift, "...perianal area 0.5 x 0.5 cm. redness with skin abrasion."

On 5/25/11 from 7AM to 3PM shift, "...Stage III sacral wound 0.5 cm. x 0.6 cm. no drainage zinc oxide applied."

On 5/30/11 from 7Am to 3PM shift, " ...sacral area with Stage II ulcer, wound bed slightly yellowish, open to air, wound size 1 cm. x 1 cm. Left buttock area with Stage II ulcer 1.8 cm. x 1 cm. wound bed pinkish, open to air."






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3. Patient 6 was admitted to the facility on 5/20/11 with a right hip fracture and had surgery on 5/22/11 to repair the fracture.

Patient 6 medical record was reviewed on 5/24/11 at 1:20 p.m. There was a physician's order dated 5/22/11 for Vicodin (narcotic pain medication) one tablet by mouth every four hours as needed for moderate/ break-through pain. A review of the MAR (medication administration record) indicated Patient 6 received Vicodin one tablet on 5/24/11 at 8:30 a.m. Patient 6 graphic record indicated his pain level was moderate (5 on a scale of 1 to 10) on 5/24/11 at 8 a.m. The graphic record indicated the following: "Any Pain Level-Refer to Clinical Flowsheet for intervention/outcome." A review of Patient 6 Assessment Flowsheet dated 5/24/11 showed an area titled "Pain Management Documentation". There were areas to document the time, location, pain level, intervention, time of reassessment and the outcome of the intervention. There was no documentation regarding the administration of Vicodin to Patient 6 on 5/14/11 at 8:30 a.m. and no documentation regarding the effectiveness of the medication.

During an interview on 5/24/11 at 2:35 p.m., RN 2 stated she gave Patient 6 one tablet of Vicodin for right hip pain. She said it was the facility's policy to recheck the effectiveness of pain medicine within one hour. She stated she was very busy and she "forgot to document" Patient 6 response to the medication.

A review of the facility's Pain Management Protocol (reviewed 6/08) indicated the following:
"Follow up: 10. reassess and evaluate response to interventions and document in chart timely, at least within 1 hour of PO medication and/or other alternative intervention. ..."

Based on observation, interview and record review, the facility failed to develop a care plan to prevent pressure ulcer for one of 49 sampled patients (Patient 2) who was assessed at risk for pressure ulcer based on the initial skin assessment.

Findings:

Patient 2 was admitted to the facility on 5/13/11 with diagnoses of fever, sepsis with hypotension and infected right arm wound.

Review of the dictated history and physical examination (H & P) by the physician dated 5/14/11 showed history of coronary artery disease and apparent congestive heart failure and probable chronic obstructive pulmonary disease.

Review of the nursing Admission Database dated 5/14/11 at 2:00 AM, showed the Norton Pressure Ulcer Risk Assessment score of "13" for Patient 2 based on the following factors: (poor physical condition (2); alert (4); bed bound (1); very limited mobility (2) and not incontinent (4). A total score of 14 or less indicated that a patient would be at risk for pressure ulcer.

Review of the multidisciplinary continuing care plan developed on admission did not include the problem of potential risk for pressure ulcer based on the Norton Pressure Ulcer Risk Assessment score.

On 5/24/11 at 2:30 PM, Patient 2 was observed laying on the bed. The nursing Supervisor was also present during the observation. Patient 2 was assisted by staff to turn to his side to examine his skin in the back and peri-area. His buttocks area was reddened with areas of excoriation and a small open area with yellowish slough tissue on the wound base was noted on the sacral area. The Nursing Supervisor acknowledged that the sacral wound appeared to be a stage III pressure ulcer.

During a concurrent review of medical records and interview with the Nursing Supervisor 1 on 5/24/11 at 2:40 PM, she acknowledged that there was no care plan developed for potential risk for pressure ulcer on admission and no evidence that the physician was notified about the pressure ulcer on the sacrum.

During observation on 5/31/11 at 11:30 AM with Nursing Supervisor 2, Patient 2 was seen laying on th bed and was assisted to turn to his right side by the nursing assistant. Patient 2's buttocks area was reddedned, with 2 open areas noted. One small superficial open wound with pinkish base on the left buttock was noted and the stage III sacral ulcer was unchanged from the last observation on 5/24/11. Nursing Supervisor 2 agreed that the left buttock wound appeared to be a stage II pressure ulcer. She also acknowledged that there was no care plan developed for care and treatment of the Stage II and Stage III pressure ulcers on the buttocks of Patient 2.

Review of the nursing Assessment Flowsheet showed the following documentation on the biophysical assessment section:

On 5/21/11 from 7AM to 3PM shift: " ...buttocks reddened-peri-area with opening."

On 5/22/11 from 7AM to 3PM shift: " ...sacral area with 2 cm. (centimeters) x 0.8 cm. skin abrasion."

On 5/23/11 from 12 AM to 7AM shift, "...sacral, perineal with redness and skin abrasion."

O 5/24/11 from 3PM to 11PM shift, "...perianal area 0.5 x 0.5 cm. redness with skin abrasion."

On 5/25/11 from 7AM to 3PM shift, "...stage III sacral wound 0.5 cm. x 0.6 cm. no drainage zinc oxide applied."

On 5/30/11 from 7AM to 3PM shift, " ...sacral area with stage II ulcer, wound bed slightly yellowish, open to air, wound size 1 cm. x 1 cm. Left buttock area with stage II ulcer 1.8 cm. x 1 cm. wound bed pinkish, open to air."

Based on interview and record review, the facility failed to administer medications according to physician's order and manufacturer's instructions when:

1. The insulin coverage ordered by the physician for one patient of 49 patients (Patient 22) was not administered as prescribed on 5/22, 5/23, and 5/24.

2. During a medication pass observation on 5/26/11, the RN administered Pepcid (anti-ulcer drug) 20 mgs. IV push over 5 seconds to one patient of 49 patients (Patient 7) instead of over 2 minutes according to manufacturer's instruction.

3. Nursing staff continued to administer morphine sulfate 2 mgs. IV every two hours (as needed for pain) to one of 49 patients (Patient 6) after the physician wrote a new order for morphine sulfate 2 mgs. every one hour as needed for pain.

Findings:

1. Review of Consultation Notes bt the physician dictated on 5/9/11 indicated that Patient 22 was admitted on 5/9/11 with pneumonia, acute kidney injury and chronic kidney disease and hyperglycemia.

Review of medical records showed a Blood Glucose Control Physician's Orders signed by the physician but was undated and untimed. This order was carried out on 5/21/11. It indicated the following order for subcutaneous correction doses of Humalog/Novolog insulin for low insulin use:

Blood AC (before meals)
Glucose (BG)
71-110 = 0 units
111-140 = 1 unit
141-200 = 2 units
201-250 = 3 units
251-300 = 4 units
301-350 = 5 units
351-400 = 6 units
>400 = 7 units
Bedtime: half of ac dose only starting with BG >140

Review of the Diabetes Record for documenting insulin administration showed the following:

Date Time FSBG Insulin
(fingerstick Dosage, Type)
blood glucose)
5/22/11 12:30PM 175 no insulin given
5/22/11 5:00PM 176 no insulin given
5/24/11 11:45AM 121 no insulin given


During interview with the Nurse Manager on 5/25/11 at 3:05 PM, he could acknowledged that there was no evidence that the physician was not notified when the insulin doses were not given on 5/22/11 as ordered by the physician.

2. During medication pass observation on 5/26/11at 9:25 AM, RN 1 administered Pepcid 20 mg. /2 ml (milligrams/milliliters) intravenously to Patient 7 over 5 seconds then flushed it with 10 ml. of sterile saline solution.

During interview with RN 1 on 5/26/11 at 9:35 AM, she was asked to show the facility's guidelines regarding IV medications that were administered on the unit. She found the information in the back of the medication administration binder from lexicomp Online that showed Pepcid to be given 10 mg. /min. RN 1 acknowledged that she should have given the Pepcid 20 mg. IV over 2 minutes.








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3. Patient 6 was admitted to the facility on 5/20/11 with a right hip fracture and had surgery on 5/22/11 to repair the fracture.

Patient 6 medical record was reviewed on 5/24/11 at 1:20 p.m. There was a physician's order dated 5/20/11 for morphine sulfate (pain medication) 2 mg (milligrams) IV (intravenous) every two hours as needed for pain. The physician wrote a post operative order on 5/22/11 at 10:33 a.m. for morphine sulfate 2 mg IV every one hour for severe pain (not to exceed 6 mg in 8 hours). There was a hand written MAR (medication administration record) dated 5/22/11 which showed the order for morphine sulfate 2 mg IV every one hour for severe pain. Patient 6 received 2 mg of morphine sulfate at 13:45, 15:45 and 20:30. The preprinted MAR dated 5/23/11 and 5/24/11 showed the physicians order from 5/20/11 for morphine sulfate 2 mg IV every two hours as needed for pain. Patient 6 received morphine sulfate 2 mg IV on 5/23/11 at 5 a.m., 8:30 a.m., 10:30 a.m., 14:00 and 16:00 and 2 mg on 5/24/11 at 5:30 a.m. The nursing staff continued to give Patient 6 2 mg of morphine sulfate IV for pain every two hours instead of every one hour as prescribed by the physician on 5/22/11.

The COO (chief operating officer) who was present during the review stated the nursing staff should not have continued to give Patient 6 morphine sulfate 2 mg IV every two hours after the physician wrote a new order on 5/22/11 for morphine sulfate 2 mg IV every one hour.

Based on interview and record review, the facility failed to administer blood transfusion to one of 49 sampled patients (Patient 4) according to policy and procedure when Patient 4 received Type O packed cells on 5/14/11 and 5/15/11 and there was no documented signature of a second RN who identified the units of blood prior to transfusion. This failed practice could potentially result to adverse transfusion reaction if blood was not properly crossmatched and administered to the patients.

Findings:

Patient 4 was admitted to the facility on 5/14/11 with diagnoses of acute gastro-intestinal bleed and hypovolemic (low blood volume) shock.

Review of facility's Blood Transfusion Form dated 5/14/11 at 1725 (5:25 PM) indicated that Patient 4 was given one unit of Type O positive cell mass. According to this form, 2 transfusionists signatures are required. to show that they have personally checked the following items:

1. Consent to blood products transfusion signed
2. Patient's identity confirmed by two identifiers
3. Blood Unit identity from label as to Number, Type, RH,. expiration date
4. Unit compatibility confirmed by crossmatch record
Only one Licensed Nurse signed the form as Transfusionist #2. Transfusionist's signature #1 was blank.

Review of Blood Transfusion Form dated 5/14/11 at 2240 indicated that Patient 4 was given another unit of Type O positive cell mass. RN 2 signed the form as Transfusionist #1 but there was no documented evidence that a second licensed nurse verified the consent to blood transfusion, patient's identity, blood unit identity and compatibility.

During an interview with the Nurse Manager on 5/25/11 at 3:30 PM, he confirmed that the above Blood Transfusion Forms were missing a second licensed nurse's signature.

According to facility's "Protocol For Blood/Blood Products Administration" review/revised on 8/10 indicated that: "Nursing Management...4. Two licensed nurses must check order for blood transfusion and proper informed consent obtained for blood/ blood products transfusion; patient name and hospital number against ID band and blood bank requisition, using two patient identifiers; donor unit number; expiration date of unit and crossmatch; and unit blood type and patient's blood type."

Based on interview and record review, the facility failed to maintain a complete medical record for one of 49 patients (Patient 6) whose medical records were reviewed. Patient 6 allergies were not consistently documented in the medical record and the pre-operative note was not completed by the physician. These deficient practices had the potential to lead to Patient 6 being prescribed medication he was allergic to and limited the physician's ability to detect any medical conditions that could affect Patient 6 surgical course.

Findings:

Patient 6 was admitted to the facility on 5/20/11 with a right hip fracture and had surgery on 5/22/11 to repair the fracture.

Patient 6's medical record was reviewed on 5/24/11 at 1:20 p.m. There was a physician's order sheet dated 5/20/11 which indicated that Patient 6 was allergic to penicillin (antibiotic). A review of all other physician order sheets and the hand written medication administration records showed no documentation of the patient's allergy to penicillin.

During an interview on 5/24/11 at 2:35 p.m., the COO (Chief Operating Officer) stated that the patient's allergies should be documented in all areas of the medical record to prevent errors.

There was a form titled "Physician's Pre and Post-Operative Note" dated 5/22/11. The form was divided into two parts, the "Pre-Operative Note and the "Post-Operative Note." The pre-operative note consisted of areas for the physician to document the proposed surgery, brief history of present illness, indications for surgery and check boxes to indicate there was a full history and physical in the chart, that there were no significant findings since the history and physical and that the physician had obtained informed consent. There was an area for the physician to sign, date and time when the pre-operative note was completed.

Patient 6 pre-operative note was signed by the physician on 5/22/11 at 8:45 a.m. There was no documentation regarding Patient 6 proposed surgery, history of present illness and indications for surgery. The check boxes to indicate there was a full history and physical in the chart and that there were no significant changes since the history and physical were blank.

The COO who was present during the review acknowledged the finding and stated Patient 6 pre-operative note was not complete.

Based on interview and record review, the facility failed to authenticate verbal orders within 48 hours for 2 of 49 sampled patients (Patient 3 and 22).

Findings:

1. Patient 3 was admitted to the facility on 5/21/11 with diagnoses of pneumonia and congestive heart failure.

Review of physician orders indicated a verbal order on 5/21/11 at 1500 (3:00PM) received by the RN that stated, " DC (discontinue) Prilosec Prevacid (anti-ulcer drugs). Dulcolax (laxative) 1 PR (per rectum) prn (as necessary). This verbal order was not signed and dated by the ordering physician.

During an interview with the Nursing Supervisor 1 on 5/24/11at 10:30 AM, she acknowledged that verbal orders should be signed by the physician within 48 hours.

2. Patient 22 was admitted on 5/9/11 with diagnoses of pneumonia and hyperglycemia.

Review on 5/24/11 of physician orders showed an undated and untimed verbal order received by the licensed nurse and written on the pre-printed Blood Glucose Control Physician's Orders Form. The physician signed the order but failed to write the date and time when order was signed.

During an interview with the Nursing Supervisor 2 on 5/31/11 at 1045 AM, she acknowledged that the pre-printed Blood Glucose Control Physician's Orders Form did not have a section for the date and time of physician's order.

According to facility's policy and procedures titled, "Administration and Monitoring of Medications revised/reviewed on 5/08, it stated, " Medications are administered only upon the order of a member of the medical staff or other individual who are lawfully authorized to write such orders and have been granted clinical privileges...
a. The order should be written, signed, timed and dated by the member of the medical staff or other individual who are lawfully authorized to write such orders...
b. Phone or verbal orders must be taken by an authorized healthcare professional and countersigned by the member of the medical staff or other individual who are lawfully authorized to write such orders and have been granted clinical privileges by the hospital within 48 hours."

Based on observation, interview and record review, the facility failed to have pharmaceutical services that met the needs of the patients when:

1. The drug storage area was not administered according to accepted professional principles that resulted in immediate jeopardy to the health and safety of the patients (Refer to A 491).

2. The facility failed to maintain current and accurate records for the disposition od scheduled drugs (Refer to A494).

3. The facility failed to ensure that there were no expired and outdated medications found in the drug storage area (refer to A505).

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure provision of quality health care in a safe environment.

Based on observation, interview and record review, the drug storage area was not administered according to accepted professional principles and manufacturer's recommendations to ensure stability, potency and safety of refrigerated medications when:

1. The refrigerator in the Treatment Center was not in the proper temperature range and the alarm was turned off during observation on 5/25/11. There was no documented evidence of temperature monitoring to ensure that temperature range was within 35-46 degrees Fahrenheit from 4/22/11 to 5/24/11 that could adversely affect the integrity of the medications.

2. There were 22 patients who were admitted in the Treatment Center between 4/25/11 to 5/25/11 who may have potentially received ineffective tetanus vaccine because the vaccines were stored below the acceptable range.

3. The freezer in the Pharmacy was below the acceptable range on 5/22/11 and there was no evidence of action taken to correct the situation per facility policy. The freezer was also out of range on 4 occasions during the month of April. Two of the times when the temperature was above the desired range at 8 AM, the temperature was not checked until around 2 PM, that is 6 hours after it was identified.

4. There was no documented evidence of temperature monitoring in the Intensive Care Unit to ensure that temperature range was within 35-46 degrees Fahrenheit from 5/24/11 to 5/26/11 to maintain proper storage and quality of the medications.

5. Phenylephrine Hydrochloride Ophthalmic solution was not stored in the refrigerator per manufacturer's recommendation.

Findings:

1. During observation of the Treatment Center on 5/25/11 at 1:30 PM, the medication refrigerator in the medication room showed a temperature of 29 degrees Fahrenheit. There was ice build-up about one inch (in.) to 1.5 in. all around the freezer compartment of the medication refrigerator. The temperature alarm was set at a range of 35-46 degrees. Nursing Supervisor 2 who accompanied the surveyor was asked why the alarm did not go off when the temperature was below the desired range. She looked at the thermometer gauge and said, "The alarm was turned off."

During an interview with RN 3 from the Treatment Center on 5/25/11 at 1:35 PM, she acknowledged that she was not aware that the temperature was below 35 degrees. She depended on the thermometer alarm to go off if the temperature goes out of range. She also said that they did not keep a log for monitoring the refrigerator temperature.

According to an All Facilities Letter dated 09-56 released on 12/10/09, regarding Medication Safety: Storage of Medications Requiring Refrigeration, it indicated the following principles of proper medication storage as follows:

"An alerting system to quickly identify situations where high and low refrigerator temperature limits are exceeded.... For refrigerators used to store vaccines, the temperature should be monitored and recorded twice a day."

The following medications were found stored in the Treatment Center's refrigerator:

1. 4 Bicillin L-A 4 syringes
2. 12 Acephen 120 mgs. suppository
3. One box of Alteplase and Activase 100 mg.
4. 10 5cc. syringes of Lat. Gel
5. 8 vials of Infuvite adult multivitamins for infusion
6. 3 vials of Acetylcysteine solution 20%
7. One vial of Novolog 10 ml. 100 units/ml
8. One roll of Nitratest paper
9. One bottle of Tropicamide ophthalmic solution 0.5%
10. One bottle Tetracaine of hydrochloride ophthalmic solution 5%
11. One vial of Succinylcholine injection 20mg./ml.
12. 2 vials of Amidate 20 mg/10ml
13. One vial of Anectine 200 mg/10ml
14. One vial Octreotide Acetate 200 mcg. /ml. 5 cc vial
15. One bottle of Proparacaine Hydrochloride ophthalmic solution 0.5%
16. 2 bottles of Phenylephrine hydrochloride ophthalmic solution 2.5% 5 ml
17. One bottle of Gonak Hypromellose ophthalmic solution 2.5%
18. One bottle of A-K Dilate (Phenylephrine HCL. ophthalmic solution 10%)
19. One bottle of Pilocarpine HCL ophthalmic solution 1%
20. One vial of Humulin R 100 units /ml
21. 9 vials of Famotidine 20 mg/2 ml
22. One box of Cathflo Activase
23. 10 vials of Diltiazem HCL 25 mg/5 ml

2. The following vaccines were found stored in the refrigerator when the temperature gauge showed 29 degrees Fahrenheit on 5/25/11 at 1:35 PM:

a. 12 vials of Tetanus and Diphtheria Toxoid (Decavac 1 ml/vial) (Td) (vaccine to prevent tetanus and diphtheria infection)
b. 10 vials of Tetanus Toxoid adsorbed (preservative-free) 0.5 ml/vial (vaccine to prevent tetanus)
c. 2 syringes of Tetanus immune globulin (human) Hyperptet 250 units (TIG)
d. 9 vials Tetanus Toxoid Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (adsorbed (T-Dap) for adolescent and adult use 0.5 ml/vial (vaccine to prevent tetanus, diphtheria and whooping cough)

Review of monthly Pharmacy Inspection Record of the Treatment Center from December 2010- May 2011 showed the following temperature readings:

1. 12/28/10- 35 degrees F (Fahrenheit)
2. 1/20/11- 37 degrees F
3. 2/25/11- 37 degrees F
4. 3/24/11- 40 degrees F
5. 4/22/11- 36 degrees F
5. 5/24/11- 33 degrees F

During interview with Pharmacist 1 on 5/25/11 at 2:00 PM, she acknowledged the importance of maintaining the correct temperature of the medication storage area because it could affect the integrity of the stored medications and vaccines.

Review of the Treatment Center's patient admission log showed there were 22 patients admitted in the Treatment Center who have received the Tetanus vaccine from 4/25/11 to 5/25/11. The refrigerator temperature was possibly out of the acceptable range during this time period.

The following 22 patients may have potentially received ineffective Tetanus vaccines from 4/25/11 to 5/25/11:

Patient Date Vaccine
Taken

Pt. 30 5/25/11 T-Dap
Pt. 31 5/25/11 T-Dap
Pt. 32 5/25/11 T-Dap
Pt. 33 5/25/11 T-Dap
Pt. 34 5/24/11 T-Dap
Pt. 35 5/20/11 T-Dap
Pt. 36 5/17/11 Td
Pt. 37 5/14/11 T-Dap
Pt. 38 5/13/11 T-Dap
Pt. 39 5/12/11 Td
Pt. 40 5/11/11 T-Dap
Pt. 41 5/9/11 TIG/T-Dap
Pt. 42 5/7/11 T-Dap
Pt. 43 5/6/11 T-Dap
Pt. 44 5/6/11 T-Dap
Pt. 45 5/4/11 T-Dap
Pt. 46 5/4/11 T-Dap
Pt. 47 5/2/11 T-Dap
Pt. 48 4/27/11 T-Dap
Pt. 49 4/27/11 T-Dap
Pt. 50 4/25/11 T-Dap
Pt. 51 4/25/11 T-Dap

According to the World Health Organization (WHO), an internationally recognized health organization in the document titled, "Temperature Sensitivities of Vaccines" indicated, "More than two million deaths were averted by immunization, as well as an additional 600,000 hepatitis B related death that would otherwise have occurred in adulthood...However, despite this, more deaths could be prevented and illnesses avoided, if vaccines which are sensitive both to excessive heat and excessive cold, were transported and stored correctly...Liquid formulations of vaccines containing diphtheria, pertussis, tetanus, hepatitis B, Hemophilus influenzae type b, IPV and their combinations should not be frozen...When a vaccine containing an antigen absorbed to an aluminum adjuvant (e.g. hepatitis B, tetanus toxoid,..) is damaged by freezing, the loss of potency can never be restored; the damage is permanent...Freezing affects the adsorbed vaccines through changing their physical form...Freezing brings changes in the structure and morphology of the adsorbed vaccines...ice crystals formed during freezing force aluminum particles to overcome repulsion, thereby producing strong interparticle attraction resulting in aluminum particle coagulation/agglomeration.... The size of the granules seems to increase on repeated freezing and thawing cycles."


According to the Morbidity and Mortality Weekly Report, Dec. 8, 2006 indicated the following medication storage recommendations:*Diphtheria tetanus: Do not freeze (Aluminum adjuvant -- irreversible loss of potency with exposure to freezing temperature)

3. During observation in the Pharmacy Department's medication freezer on 5/26/11 at 10:30 AM, the following medications were found:

1. Four vials of Zoster Vaccine Live 0.65 ml/vial
2. 13 syringes of Mitomycin injection 0.5 mg/ml
3. 17 syringes of Mitomycin injection 0.4 mg/ml
4. Three syringes of Mitomycin injection 0.3 mg/ml

The Pharmacy Department's Temperature log for vaccines for the last 6 months from Dec. 2010 to May, 2011 was reviewed. It indicated that the acceptable range for the freezer temperature was negative 15 to 17 degrees C ( Celsius). It also stated, "Take immediate action if temperature is in the shaded section (when freezer temperature is too warm from negative 14 to equal or greater than 12 degrees C). The following temperature readings of the medication freezer were recorded and found to be out of range:

Date Temperature

4/3/11 8 AM negative 13 degrees C rechecked at 4:00 PM
4/7/11 8 AM negative 13 degrees C rechecked at 11:00 AM
4/8/11 8 AM negative 14 degrees C rechecked at 2:00 PM
4/11/11 8 AM negative 14 degrees C rechecked at 1:55 PM
5/22/11 9 AM negative 35 degrees C
5/23/11 8 AM negative 35 degrees C

According to facility's policy and procedure titled, "Drug Storage" reviewed on 4/10, it stated, "...9. If the recorded temperature is in the shaded zone, observe the thermometer within 4 hours to ensure temperature is within the appropriate range (the freezer could be in the autodefrosting period.)."

According to theTemperature Log for vaccines, it stated, " If the recorded temperature is in the shaded zone, this represents an unacceptable temperature range. Follow these steps:

1. Store the vaccine under proper conditions as quickly as possible.
2. Call the vaccine manufacturer(s) to determine whether the potency of the vaccine(s) has been affected.
3. Call the immunization program at your local health department for further assistance.
4. Document the action taken on the reverse side of this log."

During an interview with Pharmacist 2 on 5/25/11 at 11:45 AM, he could not explain why the the freezer temperature was negative 35 degrees C on 5/22/11. He noted the temperature on 5/23/11 was still at negative 35 degrees C and notified the Director of Pharmacy. There was no evidence that the steps described above were implemented on 5/22/11 and 5/23/11 when the Zoster vaccines were exposed to unacceptable temperature range.

4. During inspection of the drug storage area of the Intensive Care Unit with Nursing Supervisor 2 on 5/25/11 at 2:00 PM, the refrigerator thermometer showed a temperature of 40 degree Fahrenheit. The thermometer alarm was in the "off " position. This was brought to the ICU staff's attention.

During an interview with ICU Nurse 1 on 5/25/11 at 2:10 PM, she stated that there was no temperature log for the medication refrigerator. She relied on the thermometer to alarm when the temperature was out of range.

5. On 5/25/11 at 11:10 a.m., there were five bottles of Phenylephrine Hydrochloride Ophthalmic solution 2.5% (eye drops) stored in a drawer in OR (operating room) 1. The SSUC (Surgical Suite Unit Coordinator) who was present stated that the medication was used during eye surgery. A review of the manufacturer's recommendations indicated the following:
"Storage: Store in a refrigerator at 2-8 C(36-46 F)."

The SSUC also stated that she was not aware that the medication had to be stored in the refrigerator and removed the medication from the operating room.

An Immediate Jeopardy was called on 5/26/11 at 4:25 PM because of the temperature of the medication refrigerator that was below the acceptable range that would compromise the integrity of the medications, particularly the vaccines that were stored in the Treatment Center. Present were the Chief Operating officer and the Medical Staff Coordinator.
The Immediate Jeopardy was abated on 5/26/11 at 6:06 PM with Chief Operating Officer, the Medical Staff Coordinator, and the Nurse Manager present. The facility submitted an acceptable plan of correction and implemented actions to remove the immediate jeopardy situation as follows:

1. Policy and procedure for temperature monitoring of the medication refrigerators was revised to reflect recording of temperatures each shift including corrective action steps when the temperature was out of range.

2. Procedure to regularly monitor temperatures was implemented starting on PM shift on May 26,2011 by the nursing supervisors. This includes education of the staff on documenting the temperatures, corrective actions and specific instruction to not turn the alarm off.

3. Secondary thermometers will be added to each medication refrigerator by June 3, 2011 by the Engineering Dept.

4. Temperature logs will be reviewed by Pharmacy manager on a monthly basis to ensure medications are stored in a manner that maintains their integrity.

5. All medications at risk in the Emergency Dept. (Treatment Center) medication refrigerator have been discarded.

Based on observation and interview and record review, the facility failed to maintain current and accurate records for the disposition of scheduled drugs when RN 4 drew up a syringe of Fentanyl and a syringe of Versed but did not record it on the narcotics log. This limited the facility's ability to identify or limit the diversion of controlled substances.


Findings:

During a tour of a procedure room in the SDS (same day surgery) unit on 5/25/11 at 1:30 p.m., there were two syringes in the the narcotics cabinet. There was no name, date or time on one of the syringes. The other syringe was labeled "Versed 1 mg" but had no date or time. RN 4 who was present stated the syringes contained Fentanyl and Versed which he had drawn up in advance for a procedure that was scheduled for 11 a.m. However, he said the procedure was cancelled and he "forgot" to dispose of it. The narcotics log was reviewed with RN 4 and he acknowledged he had not signed out the Versed and Fentanyl when he drew it up for the 11 a.m. procedure. He said he should have signed out the medication on the log when he drew it up, as the amount of medication listed on the narcotics log did not correspond to what was in the narcotics cabinet.

Based on observation, interview and record review, the facility failed to ensure that there were no expired medications found in the following drug storage areas:

1. One bottle of Cetacaine spray that expired on 4/20/11 was stored in the ICU crash cart.

2. One bottle of Children's Ibuprofen was opened and undated in the Treatment Center medication refrigerator.

3. There were numerous expired medications in the operating room area.

Findings:

Several expired medications were found during inspection of the following medication storage areas:

1. On 5/25/11 at 10:40 AM, in the Intensive Care Unit, the crash cart contained one bottles of Cetacaine Spray with expiration date of 04/11.

2. On 5/25/11 at 1:30 PM, in the Treatment Center, the medication refrigerator contained one 4 ounce bottle of Children's Ibuprofen that was opened and undated. During a concurrent interview with the Treatment Center Nurse 1, she acknowledged that the bottle should be dated when it was opened.

Review of facility's policy and procedures entitled, "Drug Storage" revised/ reviewed on 04/10 indicated that, "4. During the Nursing Unit inspection, the Pharmacist should make sure that all medications on the floor are in conformity with the established guidelines on storage.5. Outdated drugs are stored separately in designated boxes to be returned to the manufacturers for credit or for disposal."





23107

3. On 5/25/11 at 10:40 a.m., the following expired patient care items and medications were found in the operating room area:

- Isopropyl Alcohol 99 % (1 bottle), expiration date 12/2010.
- Isopropyl Alcohol 70 % (1 bottle), expiration date 11/09.
-5 % Dextrose & 0.49 % Sodium Chloride 500 ml IV solution (5 bags), expiration date Dec. 2010.
- Bupivacaine 30 ml (1 bottle), expiration date April 01, 2010.
- Xylocaine 2 % 20 mg/ml (2 bottles), expiration date 10/09.
- 0.9 % Sodium Chloride Injection 10 ml (1 bottle), expiration date 2010-01.

The SSUC who was present stated the nurses were supposed to check for expired patient care items and medications. When asked if she assigns the nurses to do this on a regular basis, she responded "No, whoever has time is supposed to do it."

Based on interview and record review, the hospital failed to ensure that its agreement with an outside blood collecting agency require that the blood collecting establishment notify them when the following occurs:

1. Within three calendar days if the blood collecting establishment supplied blood and blood components collected from a donor who tested negative at the time of donation but tests reactive for evidence of HIV or HCV infection on a later donation or who is determined to be at increased risk for transmitting HIV or HCV infection;

2. Within 45 days of the test, of the results of the supplemental (additional, more specific) test for HIV or HCV infection;

3. Within three calendar days after the blood collecting establishment supplied blood and blood components collected from an infectious donor,whenever records are available, as set forth at 21 CFR 610.48(b)(3).

Findings:

On 5/31/11 at 1:40 p.m., the hospital's 2010-2011 agreement with their outside blood collecting agency was reviewed with Administrative Staff I, who was the Laboratory Manager. The agreement noted the following, under (Name of blood collecting agency) Responsibilities:

"(Name of blood collecting agency) agrees to meet the Hospital's need for whole blood, red blood cells, platelets, frozen plasma and cryoprecipitate, during the term of this agreement, together with such other blood services and products described in this agreement or regularly offered by the (Name of blood collecting agency), at the prices set forth in Attachment C to this agreement. (Name of blood collecting agency) agree that such services and products shall be provided in accordance with the regulations and requirements of the Food and Drug Administration ("FDA"), the laws and regulations of the state of California, Standards of the AABB, all requirements of the Joint Commission on Hospital Accreditation (JCAHO) and the Clinical Laboratory Improvement Act (CLIA)."

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

1. Within three calendar days if the blood collecting establishment supplied blood and blood components collected from a donor who tested negative at the time of donation but tests reactive for evidence of HIV or HCV infection on a later donation or who is determined to be at increased risk for transmitting HIV or HCV infection;

2. Within 45 days of the test, of the results of the supplemental (additional, more specific) test for HIV or HCV infection;

3. Within three calendar days after the blood collecting establishment supplied blood and blood components collected from an infectious donor,whenever records are available, as set forth at 21 CFR 610.48(b)(3).


In a concomitant interview, the Laboratory Manager acknowledged that the hospital's agreement language did not meet the CMS requirement.

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

1. Provide organized dietetic services as evidenced by findings of unsafe food handling practices and supervision of the dietary department (Cross Reference A620).

2. Obtain physician ' s orders for the diet served to 4 of 49 patients (Patients 8, 10, 6 and 11). Failure to obtain a physician ' s diet order may compromise the medical condition of the patient who potentially receives the incorrect therapeutic diet (Cross-reference A 629).

3. Ensure comprehensive disaster planning (Cross Reference A701)

4. Develop performance improvement activities that reflected the scope and nature of the services (Cross Reference A264).

5. Ensure safe and effective food storage/production practices (Cross Reference A749)

6. Ensure the development of comprehensive policies and procedures that reflected the scope and nature of services (Cross Reference A 619, A620, A749)


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

Based on dietetic services observations, dietary staff interview and dietary document review the hospital failed to ensure effective organization of the department as evidenced by lack of operating policies and procedures that met the depth and breadth of the departments functions as evidenced by:

1) the development of procedures to allow nursing staff to modify physician ordered diets and

2) a produce policy that did not reflect safe food handling practices. Lack of safe and effective policies may result in clinical compromise of inpatients and food handling practices which may result in food borne illness.

Findings:

1. During medical record review on 5/24 and 5/25/11 it was noted that nursing staff changed physician ordered diets in 4 of 6 patient records (Pt. 8, 10, 6 and 11) reviewed for nutrition care (Cross Reference 629). In an interview on 5/24/11 at 1:55 pm, with RN F she was asked to describe the system that allowed RN's to change physician ordered diets. She stated that the physicians' usually ordered a regular diet. She further stated that nursing staff tried the regular diet first and may then change the texture of the diet as nursing staff thought appropriate. In an interview with RN G she stated that it was within the scope of the registered nurse to downgrade diet orders as appropriate.

Undated hospital policy titled "Diet Orders and Diet Changes" noted that "1. All diet orders and diet changes should be prescribed and recorded in the patient's medical record by a physician ..." It was also noted that the hospital had a conflicting policy titled "Diet Texture" dated 4/11. It was noted that the policy outlined a procedure to allowed nursing staff to either upgrade the diet, in particular "when no specific diet texture is prescribed by the physician, nursing staff should make the best judgment on the appropriate diet texture ..." Similarly, when downgrading patient diet it noted " ...nursing staff may downgrade the diet texture of a patient to match changes in the patient's condition ..."

California Nursing Practice Act dated 11/2010 noted that the practice of nursing is defined as " ...(b)(2) Direct and indirect patient care services ...ordered by and within the scope of licensure of a physician ..." There was no indication that the California Nursing Practice Act allowed RN's to operate as independent practitioners.

2. During general food production observations on 5/25/11 beginning at 11:05 am, DS A was observed taking several heads of lettuce out of the walk in refrigerator. He was observed cutting of the bottom stem of the lettuce and removing several of the outer leaves. In a follow up observation on 5/25/11 at 11:35 DS C was also observed cutting the lettuce. In a concurrent interview with DS C she stated that DS A washed the lettuce.

On 5/25/11 beginning at 11:30 am, DS B was observed preparing Taro. It was noted that the item was removed from the walk-in refrigerator and was cut without washing prior to cutting.

While the hospital had a policy titled "Food Preparation" dated 6/10 guided staff to fill the sink with cold water and place produce in the sink, this policy did not meet the standard of practice. The standard of practice would be to thoroughly wash vegetables under running water prior to cutting (Food Code, 2009).

Based on dietary services observations, dietary and administrative staff interview and dietary document review the hospital failed to ensure oversight of daily activities of dietetic services as evidenced by:

1) the lack of comprehensive systems for food handing practices to minimize bacterial growth associated with foodborne illness;

2) improper thawing techniques;

3) lack of a system to monitor length of time staple foods were stored;

4) observed cross contamination during food production and ware washing activities. Failure to handle foods in a safe/effective manner may result nausea, vomiting, further compromise of clinical status and in severe instances may result in death. (Cross-reference A749).

Findings:

1. During review of dietetic services from 5/23-5/25/11 it was noted that there were multiple breaches in safe food handling practices.

During general food storage/production observations on 5/23/11 beginning at 1:35 pm, it was noted that in the walk-in produce refrigerator there was undated rice with a temperature of 125?F and 3-one gallon containers of pork broth dated 5/23/11 with a temperature of 80?F and a two gallon container of pork broth with a temperature of 88?F. The observed foods were identified as potentially hazardous foods (PHF's). PHF's are capable of supporting bacterial growth associated with foodborne illness (Food Code, 2009).

A follow up observation on 5/23/11 at 4 pm, noted that the temperature of the items were as follows: rice-75?F, 1-gallon broth-60?F, 2-gallon broth-69?F. It was also noted that there was a container identified by DMS as red bean paste with a temperature of 90?F. In an interview on 5/24/11 at 9:30 am, with DMS she confirmed the process for holding leftover PHF's was to place them in the refrigerator, date them and to reheat them to a temperature of 165?F prior to using them.

Dietary department policy titled "Handling Leftover Food" dated 5/11 guided staff that "C. Left over foods ...can be saved if immediately cooled and chilled in shallow pans ...Potentially hazardous foods must be stirred frequently and allow to cool: From 140?F to 70?F within 2 hours From 70?F to 40?F within 4 hours." While the hospital had a policy guiding staff on the proper handing of cooked PHF's there was no evidence that the policy was followed and that an effective system was implemented.

An immediate jeopardy was called on 5/24/11 at 10:15 am, related to the lack of an effective cool down monitoring system for potentially hazardous foods. The immediate jeopardy was abated on 5/25/11 at 4:40 pm, after the facility a) developed a policy titled "Food Cooling", b) identified all PHF's in the hospitals' menu cycle that required cooldown monitoring, c) implemented and demonstrated an effective system to monitor the cooldown of PHF's and d) demonstrated training and competency evaluation of all dietary staff with a plan to train one staff member prior to the next work shift.

2. During general food production observations on 5/23/11 beginning at 1:25 pm, it was noted that dietary staff was thawing raw chicken pieces in the sink by placing it in a shallow pan that was leaning against the side of the sink at an angle with a small stream of water running over the unpackaged, frozen meat. It was noted that the meat was not submersed in the running water.
Hospital policy titled "Defrosting Food" dated 2/11 guided staff that when thawing under cold water the food should be submerged under running potable water.

During continual food production observation on 5/23/11 at 2 pm, it was noted that DS A removed the thawing, raw chicken from the food production sink. On 5/23/11 at 2:15 pm, DS C was observed soaking dried bok choy that would later be used in soup in the same sink where raw chicken was previously thawed.

In a concurrent interview with DS C the surveyor asked her to describe the method for soaking the dried item. She stated that she would usually clean the sink prior to use by using a sanitizer. She further stated that the sanitizer was stored in the chemical closet in the hallway, outside of the kitchen. There was no observation of sink sanitation prior to the soaking of the bok choy. Hospital policy titled "Food Preparation" dated 6/10 guided staff to "1. Make sure vegetable sink is clean ...8. Wash and sanitize ...sink." There was no observed cleaning/sanitation of the sink prior soaking the bok choy.

Review of the hospital document titled "Dietary Department Organizational Chart" dated 5/10 reviewed that the DMS was responsible for the activities in the dietary department. Similarly hospital document titled "Annual Managerial Evaluation-Dietary Manager" dated 4/11 indicated that this position supervised food production and services.

3. During food storage observations on 5/23/11 beginning at 1:35 pm in the cooks preparation area it was noted there were multiple items that were opened, unlabeled, undated and/or stored in a manner that promoted cross contamination.

In an interview on 5/23/11at 2:25 pm, with DMS she stated that she could not demonstrate when the items were opened. She further stated that there was no policy for labeling/dating opened items or the length of time that self stable items would be stored. Review of the Food & Nutrition Services Departmental policy and procedure manual, reviewed 2/11 revealed that while the department had policies related to food production activities they were limited to food preparation, defrosting food and handling of left over foods.

4. During observations on 5/23/11 beginning at 1:55 pm, DS B was observed washing dishes using the dish machine. She was observed putting latex gloves on her hands, then placing yellow dishwashing gloves over the latex gloves. DS B was then observed handling several loads of soiled dishes, removing the yellow gloves and then handling cleaned/sanitized dishes with the latex gloves. There was no observation of hand washing. In a concurrent interview with DS B she stated this was her usual method of dishwashing.

Dietary Department policy titled "Dishwashing and Ware Washing" dated 4/11 guided staff that "4. All dietary personnel must thoroughly wash hands before handling clean dishes to prevent recontamination."

Based on observations, interview and document review, the hospital failed to obtain physician ' s orders for the diet served to 4 of 49 patients (Patients 8, 10, 6, and 11). Failure to obtain a physician ' s diet order may compromise the medical condition of the patient who potentially receives the incorrect therapeutic diet.

Findings:


1. Patient 8 was admitted with diagnoses of a failed left femur nail fixation. Admission height was 5 feet 2 inches and weight was 104 pounds. Admission diet order dated 5/13/11 was a regular diet. A nutrition assessment dated 5/14/11 noted that the patients' therapeutic diet was regular-chopped diet. The assessment also noted that the patients' intake was "pending." The assessment also noted a recommendation to "continue the current diet until further notice." Follow up nutrition assessments dated 5/17, 5/20 and 5/22 all noted that the patient was receiving a chopped diet; however there was no physicians' order for this therapeutic diet.

In an interview on 5/24/11 at 1:55 pm, with RN F she was asked to describe the origin of the chopped diet order. She stated that the physicians' ordered a regular diet. She further stated that nursing staff tried the regular diet first and may then change the texture of the diet as nursing staff thought appropriate. In an interview with RN G she stated that it was within the scope of the registered nurse to downgrade diet orders as appropriate.

2. Patient 10 was admitted with diagnoses cancer of the pancreas. Admission diet order dated 5/19/11 was " Diet as Tolerated. " Diet provided by the dietary department was chopped. During a concurrent interview, Registered Dietitian H stated " nursing decides the diet texture if the doctor doesn ' t.

3. Patient 6 was admitted with diagnoses included right femur fracture. 5/22/11diet ordered by the physician was " Clear Liquid Advance as Tolerated. " Diet sent by the kitchen on 5/24/11 was chopped. During concurrent interview RD H reported " the doctor doesn ' t dictate the texture; the nurse does. "

4. Patient 11 was admitted with diagnoses including leukocytosis and hypoxia. On 5/22/11 the physician ordered a " Diet as Tolerated " and the kitchen sent a puree diet. During concurrent interview RD H reported " the doctor doesn ' t dictate the texture; the nurse does. "

Undated hospital policy titled "Diet Orders and Diet Changes" noted that "1. All diet orders and diet changes should be prescribed and recorded in the patient's medical record by a physician ..." California Nursing Practice Act dated 11/2010 noted that the practice of nursing is defined as " ...(b)(2) Direct and indirect patient care services ...ordered by and within the scope of licensure of a physician ..."

Based on dietary staff interview and dietary document review the hospital failed to ensure a disaster meal plan that was readily implementable as evidenced by a meal plan that would include guidance and supplies for patients who were on therapeutic diets. This would put the health and safety of patients requiring therapeutic diets at risk in the event of a disaster that required the hospital to shelter in place.

Findings:

During food storage observations, dietary document review, and interview with Dietary Management Staff J on 5/26/11 beginning at 1:45 p.m., it was noted that the hospital disaster menu failed to provide guidance and regarding foods to serve to patients on therapeutic diets. During concurrent interview, Dietary Management Staff J acknowledged therapeutic diets had not been included in the menu, only regular diets. DMS J acknowledged not all patients would be able to eat regular diets and therapeutic diets should be planned prior to a disaster and the related food items available.

Based on observation, interview, and record review, the hospital failed to maintain adequate facilities for its Central Supply Room when the eye wash station was located in the employee locker/dressing room area instead of in the contaminated instrument processing area.

Findings:

On 5/26/11 at 10:30 a.m., during an inspection of the Central Supply Room, the eyewash station was noted to be not in the instrument decontamination area, but through a door into the employee dressing room. There was a warning sign above the station that indicated that the water was 140 degrees Fahrenheit. The eyewash station contained two taps, connected to a hose, which was curled and partly hanging on the floor. When the taps were turned on, water that was brown in color was released.

In an interview on the same date and time, Central Supply Room Technician 1 told surveyors that they don't test the station and never actually use it. She said that if decontamination chemicals splashed in her eyes she would use the sink where she was decontaminating instruments, or else go to the treatment room (on another floor of the hospital) right away. There was no policy developed for the use of an eyewash station.

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

According to 2008 AORN PeriOperative Standards and Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment, p 421, "These recommended practices are intended as achievable recommendations, representing what is believed to be an optimal level of practice."

Recommendation VII (pg.425)
Instruments should be decontaminated in an area separated from locations where clean activities are performed.
VII.b. The decontamination area should be physcially separate from clean areas and include a door. This area should contain, but not be limited to, the following equipment:
? eye wash station.

An eye wash station is required by OSHA when chemicals such as those used to clean instruments are used.

Based on observation interview, the facility failed to maintain the quality of supplies to ensure an acceptable level of safety when the following expired supplies were found in the storage area:

1. There were 5 gauge 20 AutoGuard angiocath needles and 5 gauge 22 angiocath needles that were expired and found stored in the ICU crash cart.

2. There were expired patient care items in the operating room area.

3. There were five packets of expired Kendall Heavy Drainage Packs in the Central Supply Area.

Findings:

1. During observation on 5/25/11 at 9:50 AM, in the medical surgical unit, the crash cart contained 5 gauge 20 Insyte autoguard angiocath with expirationdate of 04/11; there were 5 gauge 22 Insyte autoguard angiocath with expiration date of 02/10.

During an interview on 5/25/11 at 9:55 AM with Material Management Manager, he acknowledged that the angiocaths were expired and should be discarded.

2. On 5/25/11 at 10:40 a.m., the following expired patient care items were found in the operating room area:

- AutoSuture TA 60 4.8.m (1 box), expiration date 2009/05.
- Tuohy Stimulation Needle, expiration date 2010-10.

The SSUC who was present stated the nurses were supposed to check for expired patient care items. When asked if she assigns the nurses to do this on a regular basis, she responded "No, whoever has time is supposed to do it."

3. On 5/26/11 at 11 a.m., the following expired patient care items were found in the central supply area:

- Kendall Heavy Drainage Packs (5), expiration date 2009-10.

CSS M who was present acknowledged the items were expired and removed them from the supply area.

Based on observation, interviews, and record reviews, the hospital failed to
develop, implement, and maintain an active hospital-wide program for the prevention, control, and investigation of infections and communicable diseases and failed to provide a sanitary environment to avoid sources and transmission of infections as evidenced by:

1. Failure to designate a qualified infection control officer to develop and implement policies governing the control of infectious and communicable diseases. (A-748);

2. Failure to maintain a system to evaluate the hospital staff's immunization status for designated infectious diseases, as recommended by the nationally recognized infection control guidelines (Refer to A749);

3. Failure to ensure personnel were periodically trained in infection control practices (Refer to A 749);

4. Failure to provide safe/effective dietetic services as evidenced by findings of unsafe food handling practices and lack of effective monitoring of potentially hazardous foods that resulted in immediate jeopardy to the health and safety of the patients (Refer to A 749);

5. Failure to provide a hospital wide infection control program to conduct surveillance and prevent the transmission of infections in the dietary department (Cross Reference A 264);

6. Failure to clean and sanitize the glucometer following manufacturer ' s guidance (Refer to A 749);

A glucometer is a medical device for determining the approximate concentration of glucose in the blood;

7. Failure to perform terminal room cleaning following approved infection control guidelines (Refer to A 749);

8. Failure to sterilize re-usable surgical equipment following approved infection control guidelines (Refer to A 749);

9. Failure to follow manufacturer's instructions for proper cleaning of endoscope reprocessors (Refer to A 749).

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Based on interview and record review, the hospital failed to designate a qualified Infection Control Practitioner (ICP)to develop and implement policies governing the control of infectious and communicable diseases.

Findings:

Document review showed the ICP was hired as the coordinator of the hospital's infection control program in 2001. His background included completion of medical school but did not obtain a license to practice medicine. The coordinator's educational background included a Bachelor's of Art degree in psychology in 1983 and completion of medical school in Dominica, West Indies in 1993.

During an interview on 5/31/11 at 2:55 PM, the ICPstated that he did not further pursue taking the medical boards. When this surveyor asked about ongoing training or certification, the Infection Control Officer stated he did not have certification such as that offered by the CBIC (Certification Board of Infection Control and Epidemiology Inc.)nor did he maintain all the records from past infection control meetings from local or national meetings organized by recognized professional agencies such as APIC (Association for Professionals in Infection Control and Epidemiology)or SHEA (Society for Healthcare Epidemiology of America). The ICP presented proof of meetings and continuing education courses he had done in the past from membership meetings with the San Francisco Infection Control Work Group in 2010 and 2011 and inservices in infection control given by Chinese Hospital in October 2002, May 2005, and January 2011.

During an interview on 5/31/11 at 3:45 PM, this surveyor asked the Chief Operating Officer (COO)what qualifications did the ICP have and she stated his background in medical school gave him the ability.

The CDC (Centers for Disease Control and Prevention) has defined "infection control professional" as "a person whose primary training is in either nursing, medical technology, microbiology, or epidemiology and who has acquired specialized training in infection control."

The hospital's job description for the Infection Control/Employment Health Coordinator, last reviewed/revised was 1/09, documented the following: "Qualifications: 1)Bachelor's Degree in Nursing or equivalency required, 2)Two years clinical experience, within past four years preferred, 3)BLS certificate, 4)Meets screening criteria of Human Resources and Occupational Health, 5)Certification Board for Infection Control preferred".

Based on staff interview and document review, the infection control officer failed to develop systems for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel in accordance with medical staff bylaws and nationally recognized infection control guidelines as evidenced by:

1. The hospital failed to ensure all personnel were consistently screened for infectious diseases.

2. The hospital failed to ensure all personnel were periodically trained in infection control practices.

3. Failure to provide safe/effective dietetic services as evidenced by findings of unsafe food handling practices and lack of effective monitoring of potentially hazardous foods that resulted in immediate jeopardy to the health and safety of the patients (Cross Reference A 620).

4. Failure to clean and sanitize the glucometer following manufacturer ' s guidance.

5. Failure to sterilize re-usable surgical equipment following approved infection control guidelines.

6. Failure to perform terminal room cleaning following approved infection control guidelines.

7. Failure to follow manufacturer's instructions for proper cleaning of endoscope reprocessors.


Findings:

1a. In collaborative reviews of medical staff files on 5/25/11 and 5/26/11 with the medical staff coordinator, the coordinator indicated that the process for communicable disease screening for medical staff members (200+) included a written request for "TB (tuberculosis) status" at the initial appointment time, and every 2 years for reappointment applicants. The coordinator collected the written responses and submitted them with the application packets to the credentials committee, but did not submit the responses to the hospital's infection control officer for review. Verifications of the TB skin tests on an annual basis were not documented. Symptom screening for skin test reactors was not documented on an annual basis. Two-step TB skin testing was not required for new medical staff applicants. No specific medical staff policy documented the health screening requirements for medical staff members, although the hospital did have employee health screening policies for other people who worked directly with hospital patients.

On 5/26/11 the medical staff coordinator presented 4 large binders of TB screening documents. Review of the binders indicated that annual TB screening in accordance with nationally recognized standards was not documented for all medical staff members.

According to the Centers for Communicable Diseases (CDC) Guidelines for Preventing the Transmission of Mycobacterium tuberculosis (in a Health-Care Setting, 2005, page 10, "the classification of medium risk should be applied to settings in which the risk assessment has determined that health care workers (HCW) will or will possibly be exposed to persons with TB disease or to clinical specimens that might contain M. tuberculosis. The recommendations for medium risk included, "All HCWs should receive baseline TB screening (checked to identify presence of the disease) upon hire, using two-step TST (skin test) or a single BAMT (alternate test) to test for infection," and "After baseline testing for infection, HCWs should receive TB screening annually."

Review of 8 of 8 medical staff files (Physicians 1-8) on 5/25/11 and 5/26/11 with the medical staff coordinator also indicated no documentation of hepatitis B, varicella, measles, mumps, rubella, or influenza screening or immunity. The coordinator indicated that verification of immunity or screening for bloodborne pathogens and other communicable diseases was not part of the medical staff application and credentialing process. The coordinator was not aware of any communicable screening process in place through the hospital's infection control program that included medical staff members.

Review on 2/25/10 at 8 p.m. of the 7/30/09 Association for Professionals in Infection Control and Epidemiology (APIC) Position Paper: Safe Injection, Infusion and Medication Vial Practices in Healthcare indicated that healthcare workers whose activities involved contact with blood or body fluids be offered hepatitis B vaccination. The national guideline also recommended that compliance with safe injection practices be periodically assessed "by observing and evaluating personnel performing these procedures."

Review on 5/31/11 at 2 p.m. of the CDC Morbidity and Mortality World Report (MMWR Volume 46, Number RR-18, December 26, 1997) documented on page 24: Persons who work within medical facilities should be immune to measles and rubella. Immunity to mumps is highly desirable for all HCWs. Because any HCW (i.e., medical or nonmedical, paid or volunteer, full time or part time, student or nonstudent, with or without patient-care responsibilities) who is susceptible can, if exposed, contract and transmit measles or rubella, all medical institutions (e.g., inpatient and outpatient, public and private) should ensure that those who work within their facilities* are immune to measles and rubella. Likewise, HCWs have a responsibility to avoid causing harm to patients by preventing transmission of these diseases. On page 25, the MMWR documented: All HCWs should ensure that they are immune to varicella.

Review on 5/31/11 at 2 p.m. of the CDC MMWR Early Release Volume 55, dated February 9, 2006, recommended annual vaccination for influenza for all health care workers.

Review on 5/31/11 at 2 p.m. of the 2011 Association for peri-Operative Registered Nurses Recommended Practices for Prevention of Transmissible Infections in the Perioperative Practice Setting (page 295), Recommendation VIII.1. addressed the immunization and/or screening of health care workers for hepatitis B virus. Recommendation VIII.2. read, "Health care workers should be immunized against other communicable and infectious agents," with a footnote reference to the CDC MMWRs above.

Review on 5/31/11 at 2 p.m. of a revised California Department of Public Health (CDPH) All Facilities Letter to general acute care hospitals (AFL 10-29), dated 9/16/10, indicated that licensed hospitals were required to report to CDPH the status of influenza vaccination of all health care workers annually (each influenza season). The hospital presented no evidence of the influenza vaccination status for the 200+ medical staff members discussed with the medical staff coordinator.




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1b. Record reviews on 5/25/11 and 5/31/11 revealed the following 15 out of 22 employee health files had missing TB annual screenings:
1) Registered Nurse (RN)-1: no records for 2009 and 2010
2)RN-2: no records from 2002 to 2010
3)RN-3: no records for 2009 and 2010
4)RN-4: no records from 2004 to 2010
5)RN-5: no record for 2010
6)RN-6: no records from 2004 to 2010
7)RN-7: no records from 2003 to 2010
8)RN-8: no records before 2008
9)RN-9: no records from 2003 to 2007, and no records for 2009 and 2010
10)Dietary Staff-1: no records for 2004 and 2009
11)Dietary Staff-2: no records from 2003 to 2010
12)Dietary Staff-3: no records from 2003 to 2010
13)Respiratory Staff-1: no records from 2003 to 2010
14)Respiratory Staff-2: no records from 2010
15)Respiratory Staff-3: no records from 2003 to 2010

During an interview on 5/31/11 at 2:55 PM, the Infection Control Coordinator stated he had been reorganizing the employee health files but he does not know where the missing files could be.

The hospital's guidelines titled, "Infection Control Guidelines, Employee Health, Tuberculosis Screening - Pre-Employment/Annual", (undated), stated the following on page 105: "Employees shall be screened for tuberculosis infection during the pre-employment physical and annually thereafter (if previous PPD tuberculosis skin test is <10 mm in duration). Employees who work in designated high-risk areas such as Respiratory Therapy shall be screened for tuberculosis infection semi-annually".

The hospital's policy #45.02 titled, "Employee Health", date last revised/reviewed 4/08, stated, "In order to reduce the potential for transmission of infection to or from employees, Chinese Hospital provides an Employee Health Program developed under the guidelines of the Hospital Safety and Hospital Liaison Committees...Each employee shall be screened for tuberculosis annually".

The hospital's job description for the Infection Control/Employee Health Coordinator stated the following: "The Infection Control/Employee Heakth Coordinator is responsible for the management of the Infection Control and Employee Health Program. He/She manages the planning, development, implementation, evaluation, prevention and control services/programs that meet or exceed established standards/performance measures for infection control and employee health. In partnership with department managers, he/she develops, monitors and modifies infection prevention and control program and department specific goals/objectives as appropriate. The Infection Control/Employee Health Coordinator provides services/programs which meet identified needs of departments; assure compliance with applicable regulatory requirements through interpretation of regulatory standards, investigation of disease outbreaks and exposures, surveillance and reporting communicable diseases to the Department of Health Services as required; reduce potential employee injury and transmission of infection; provide resources and/or counseling to employees who may have had...tuberculosis exposure..."

2. In collaborative reviews of medical staff files on 5/25/11 and 5/26/11 with the medical staff coordinator, the coordinator indicated that there was no requirement or policy for medical staff members to attend periodic infection control training or participate in infection control activities conducted at the hospital. Therefore, the medical staff files would not contain consistent documented evidence of ongoing infection control training and knowledge by medical staff members as a whole.

Review on 5/31/11 at 2 p.m. of the 2011 AORN Recommended Practices for Prevention of Transmissible Infections in the Perioperative Practice Setting (page 297), Recommendation XIV directed that health care personnel should be knowledgeable and educated on the underlying principles of infection control in order to minimize risks for infections to patients and staff, and take appropriate actions if exposed. The Recommendation referred to an Occupational Safety and Health Administration requirement: Instruction on the proper use of personal protective equipment and other disease transmission prevention should take place within 90 days of new hire and updated at least annually.

Review of the Medical Staff Constitution and Bylaws, last approved 11/30/10, under Section 10.2-7(c), documented that the Patient Care Committee was responsible for infection control functions including "preventing and reducing infections and exposures to pathogens (germs) ... and maintaining surveillance" over the hospital-wide infection control program.









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3a. During general kitchen tour on 5/23/11 on beginning at 10:35 am, it was observed there was a large wok on the stove where Dietary Staff was boiling chunks of meat approximately 5 inches x 5 inches x 2 inches thick. As the pieces were taken out, the dietary staff stacked them one on top of another in a 6 inch full steam table pan. It was observed red could be seen in the striations of the meat whereas the outside was grayish color.

During kitchen observations on 5/23/11 beginning at 1;20 p.m., a full steam table pan of meat was observed in the walk-in refrigerator with approximately 20 chunks of grayish meat. During a concurrent interview Dietary Management Staff I (DMS I) stated the meat was the same meat that had been observed earlier during the 10:35 a.m. tour, and was used to prepare soups. At 1:23 p.m. during an interview Dietary Staff E, the a.m. cook, stated the meat was pork and had been blanched only (cooking briefly in boiling water), but that it was not fully cooked. She further stated the meat would be used over approximately four days to make broth for the daily soups. The surveyor requested DS E take the temperature of some of the meat chunks and the temperatures were observed to range from 90?-97?F. DS E stated the meat had been put in the refrigerator soon after the survey team had been on tour, approximately 10:45 a.m. DS E stated no one had not taken the temperature of the pork when it was cooked or while in the refrigerator cooling; DS E stated no one was supposed to take food temperatures during cooking or cooling. Pork was identified as a potentially hazardous food capable of supporting bacterial growth and needing time-temperature monitoring during cool-down to prevent food-borne illness.
At 3:55 p.m. on 5/23/11 Dietary Staff I was observed making soup for patient dinner meal. DS I pulled up two pieces of meat from the boiling cauldron, and stated "here is some of the pork cooked earlier (observed at 10:30 a.m. during the tour."

3b. On 5/23/11 further observations in the walk in refrigerator at 1:55 p.m. revealed several pots of jook (rice porridge) as well as broth and gravy. DS E stated she had just put them in the walk-in refrigerator at "about 12:00 p.m." after lunch trayline where they had been used for patient meal service. DS E stated they would remain in the refrigerator until about 4:00 p.m. when they would be reheated to 165? F for patient dinner meal. The surveyor requested DS E take the temperature of the items, and they were as follows: 1) 1 gallon pot of plain jook 162?F; 1 quart plain jook #1 148?F, 1 quart meat jook #2 160?F, 1 quart regular gravy 152?F, 1 quart low sodium gravy 131? and 1 quart broth 137?F.
At 3:59 p.m. on 5/23/11, at the request of the surveyor, DS J took temperatures of the various containers of jook which revealed the 1 quart plain jook was 109? and the meat jook was 127?. The regular gravy was 82?F, the broth was 81?, low salt gravy was 106?. DS J stated it was not the procedure to take the temperature of the foods when they were cooked nor were they monitored during cooldown. The jook , broth and the gravy were identified as potentially hazardous foods, capable of supporting bacterial growth associated with foodborne illness. Concurrently, the surveyor requested DS I calibrate the thermometers with an ice water bath, which revealed the thermometers were accurate.

3c. During general food storage observations on 5/23/11 beginning at 1:35 pm, it was noted that in the walk-in produce refrigerator there was undated rice with a temperature of 125?F and 3-one gallon containers of pork broth dated 5/23/11 with a temperature of 80?F and a two gallon container of pork broth with a temperature of 88?F. The observed foods were identified as potentially hazardous foods (PHF's). PHF's are capable of supporting bacterial growth associated with foodborne illness (Food Code, 2009).

In an interview on 5/23/11 at 1:50 pm, with DS C she stated the broth was cooked at approximately 10:30 am, and the rice was left over from the noon trayline. She also stated that each of the items were covered and put in the refrigerator to use either later in the afternoon or the following day.
In an interview on 5/23/11 at 2:15 pm, with DS D, who was responsible for the preparation of the items, stated that the broth was placed in the walk in on 5/23 at approximately 9 am and the rice was placed in the refrigerator on 5/23 at approximately 1 pm. The surveyor also asked DS how she ensured that leftover foods were safe to use at a later time, she replied that the items would be reheated to an internal temperature of 165?F. The surveyor also asked if there was any temperature monitoring while the food was in the refrigerator, she replied there was not.

A follow up observation on 5/23/11 at 4 pm, noted that the temperature of the items were as follows: rice-75?F, 1-gallon broth-60?F, 2-gallon broth-69?F. It was also noted that there was a container identified by DMS as red bean paste with a temperature of 90?F. In an interview on 5/24/11 at 9 am, DS D confirmed that she was responsible for the preparation of the red bean paste. She stated the item was prepared shortly after lunch and placed in the refrigerator at 1 pm, on 5/23/11. She also stated that there was no temperature monitoring of the item on 5/23/11 but that the item would be reheated to 165?F on 5/24/11 for the noon meal. In an interview on 5/24/11 at 9:30 am, with DMS she confirmed the process for holding leftover PHF's was to place them in the refrigerator, date them and to reheat them to a temperature of 165?F prior to using them.

Dietary department policy titled "Handling Leftover Food" dated 5/11 guided staff that "C. Left over foods ...can be saved if immediately cooled and chilled in shallow pans ...Potentially hazardous foods must be stirred frequently and allow to cool: From 140?F to 70?F within 2 hours From 70?F to 40?F within 4 hours." While the hospital had a policy guiding staff on the proper handing of cooked PHF's there was no evidence that the policy was followed and that an effective system was implemented.

An immediate jeopardy was called on 5/24/11 at 10:15 am, related to the lack of an effective cool down monitoring system for potentially hazardous foods. The immediate jeopardy was abated on 5/25/11 at 4:40 pm, after the facility a) developed a policy titled "Food Cooling", b) identified all PHF's in the hospitals' menu cycle that required cooldown monitoring, c) implemented and demonstrated an effective system to monitor the cooldown of PHF's and d) demonstrated training and competency evaluation of all dietary staff with a plan to train one staff member prior to the next work shift.

3d. During general food production observations on 5/23/11 beginning at 1:25 pm, it was noted that dietary staff was thawing raw chicken pieces in the sink by placing it in a shallow pan that was leaning against the side of the sink at an angle with a small stream of water running over the unpackaged, frozen meat. It was noted that the meat was not submersed in the running water. In an interview on 5/23/11 at 1:50 pm, with DS A he stated he placed the raw chicken in the sink approximately 1 hour prior. He further stated that this was an "OK" method for thawing the meat.

Hospital policy titled "Defrosting Food" dated 2/11 guided staff that when thawing under cold water the food should be submerged under running potable water.

During continual food production observation on 5/23/11 beginning at 2 pm, it was noted that DS A removed the thawing, raw chicken from the food production sink. On 5/23/11 at 2:15 pm, DS C was observed soaking dried bok choy in the same sink where raw chicken was previously thawed.

In a concurrent interview with DS C the surveyor asked her to describe the method for soaking the dried item. She stated that she would usually clean the sink prior to use by using a sanitizer. She further stated that the sanitizer was stored in the chemical closet in the hallway, outside of the kitchen. There was no observation of sink sanitation prior to the soaking of the bok choy. Hospital policy titled "Food Preparation" dated 6/10 guided staff to "1. Make sure vegetable sink is clean ...8. Wash and sanitize ...sink." There was no observed cleaning/sanitation of the sink prior soaking the bok choy.

3e. During food storage observations on 5/23/11 beginning at 1:35 pm in the cooks preparation area it was noted there was baking soda with a spoon in the container; garlic powder that was opened and undated stored in a container labeled lemon pepper; ground rosemary, opened, undated; dill dated 5/10; black pepper, opened, undated; vanilla dated 3/09; red and yellow food coloring, opened, undated and bay leaves dated 5/27/10. In a follow up observation on 5/23/11 at 2:15 pm, it was noted there was a powder, identified by DS D as a combination of salt and pepper in a container that was labeled as thickener.

In an interview on 5/23/11at 2:25 pm, with DMS she stated that she could not demonstrate when the items were opened. She also stated that dietary staff was instructed to label items when they arrived. She further stated that there was no policy for labeling/dating opened items or the length of time that self stable items would be stored. Review of the Food & Nutrition Services Departmental policy and procedure manual, reviewed 2/11 revealed that while the department had policies related to food production activities they were limited to food preparation, defrosting food and handling of left over foods.

3f. During observations on 5/23/11 beginning at 1:55 pm, DS B was observed washing dishes using the dish machine. She was observed putting latex gloves on her hands, then placing yellow dishwashing gloves over the latex gloves. DS B was then observed handling several loads of soiled dishes, removing the yellow gloves and then handling cleaned/sanitized dishes with the latex gloves. There was no observation of hand washing. In a concurrent interview with DS B she stated this was her usual method of dishwashing.

Dietary Department policy titled "Dishwashing and Ware Washing" dated 4/11 guided staff that "4. All dietary personnel must thoroughly wash hands before handling clean dishes to prevent recontamination."

3g. During general food production observations on 5/25/11 beginning at 11:05 am, DS A was observed taking several heads of lettuce out of the walk in refrigerator. He was observed cutting of the bottom stem of the lettuce and removing several of the outer leaves.

On 5/25/11 beginning at 11:30 am, DS B was observed preparing Taro. It was noted that the item was removed from the walk-in refrigerator and was cut without washing prior to cutting. In a concurrent interview with DS B she confirmed that the observed process or cutting prior to washing was her normal process.

In a follow up observation on 5/25/11 at 11:35 DS C was also observed cutting the lettuce. In a concurrent interview with DS C she stated that DS A washed the lettuce. There was no observation of either the lettuce or Taro being washed prior to cutting. The standard of practice would be to thoroughly wash vegetables prior to cutting (Food Code, 2009).

3h. During review of sanitation processes on 5/25/11 at 9 am, DS E was asked to describe how food contact surfaces were cleaned. DS E described a process that included the use of a sanitizer. DS E stated that the sanitizer was obtained from a spray bottle. The surveyor asked how the department ensured there was an adequate amount of chemical in the bottle. She demonstrated the use of quaternary ammonia testing strips. She proceeded to dip the test strip in the bottle. It was noted that the chemical concentration of the sanitizer was greater than the manufacturer's upper limit of 400 parts per million (ppm).

Review on 5/31/11 at 8 am, of the Quality Food Protection Act of 1996 and the Antimicrobial Regulation Technical Correction Act of 1998 noted that the use of quaternary ammonia products above the level of 200 ppm is not recommended.

3i. On 5/25/11 at 11:30 a.m. during interview with Stationary Engineer P regarding process he followed providing preventive maintenance (PM) for the hospital ice machines in the 3rd floor medical surgical unit, SE P stated he "ran Scotsman ice machine cleaner through the machine, then cleaned the tubing with hand soap and a bottle brush." S P stated he had worked in the position for 6 years and regularly did preventive maintenance on all the hospital ice machines, which were all the same. When asked if any other product was used in the PM, he stated "no". Review of the ice machine manufacturer's cleaning specifications provided by the hospital revealed cleaning of all parts was to be done with the ice machine cleaner, and then the machine was to be sanitized with an approved sanitizer such as sodium hypochlorite. SE P acknowledged he did not clean and sanitize the ice machines following manufacturer ' s guidance and when completing preventive maintenance on the ice machines.

4. On 5/24/11 at 2:30 pm, it was noted that Patient 25 had a physicians' order for bedside glucose testing. In a concurrent interview with RN H the surveyor asked her to describe the cleaning of bedside blood glucose testing equipment. She stated that once she completed the blood test she wiped down the exterior of the machine with an alcohol pad. In an interview with Administrative Staff I, who was responsible for lab services, he confirmed that nursing staff was guided to use alcohol wipes to clean bedside blood glucose testing equipment. In an interview on 5/25/11 at 2:45 pm, with AS I, the position responsible for infection control practices within the hospital acknowledged that the use of alcohol would not effectively clean all potential hospital organisms.

In 4/10 the American Journal of Infection Control published an article written by the Association of Professionals in Infection Control and Epidemiology, on page 171 under the section titled, "Blood Glucose Monitoring Devices," direction was given, "Assign a glucometer to each individual if possible. Clean and disinfect glucometers if they must be shared between glucometers ... Disinfect the exterior of the glucometer after each use following manufacturers' guidance. Use an Environmental Protection Agency registered disinfectant Hepatitis B, Hepatitis C, HIV or a 1:10 bleach solution (1 part bleach:9 parts water)."

On 5/25/11 at 2 pm, the hospital policy titled "Policy and Procedure for Quality Control Testing of the Blood Glucose Meter" dated 7/07 was reviewed. It was noted that the policy did not address proper cleaning of the device.

In an interview on 5/31/11 at 9 am, with the manufacturers' representative he stated that the recommended solution for cleaning the exterior of the machine was the use of Super-Sani Cloth?, a wide spectrum disinfectant/germicide.

5. On 5/25/11 at 11:15 am, central sterilization was toured. During the tour, staff working in the sterile processing area, were interviewed about the process for sterilizing instruments. Central Sterilization Staff (CSS) M stated that the instruments were brought from the operating room to the sterilization area, where they were inspected for particles of tissue as well as functionality. She further demonstrated that the instruments were then closed and stacked on edge, next to one another, in a closed position, in an instrument tray (a metal tray with holes on the bottom and sides). The tray was then placed in the washer. Once the instruments were washed they were then placed in a steam sterilizer.

On 5/25/11 at 2 pm, the hospital policy titled "Procedure for Sterilization" dated 4/08 was reviewed. The policy directed that "1. Procedure for Steam sterilization ...c. All items are placed in the sterilizer in an open position." The 2011 Perioperative Standards and Recommended Practices, page 438 noted that "Recommendation XII. Cleaned instruments should be organized ...in a manner to allow sterilant to contact all exposed surfaces ...XIIc. Sterilization occurs only on surfaces that have direct contact with the sterilant ...XIIc1. Instruments should be kept in the open and unlocked position ..."

6. On 5/25/11 beginning at 12 pm, terminal cleaning of patient rooms was reviewed. In a concurrent interview with Environmental Services Staff N (ES) he was asked to describe the process for cleaning of isolation rooms. He demonstrated that once patients leave he would spray a mixture of bleach and water into the air after which he would leave the room closed for 10 minutes. The surveyors also asked him to demonstrate the amount of bleach he would use. He demonstrated that he would put approximately 2 ounces of bleach into a spray bottle which held 12-16 ounces of fluid. He also stated that he would use Virex 256?, a disinfectant cleaner, by spraying the product onto a terry towel which would be used to wipe all equipment and surfaces in the patient rooms. ES N also stated he would use a similar process, with the exception of the bleach, for cleaning non-isolation patient rooms.

In an interview on 5/25/11 at 2:45 pm, with ES O he stated that for isolation rooms staff was guided to spray bleach into the air and to close the room for 20 minutes after which the equipment and the room's surfaces would be wiped clean with a germicidal disposable cloth. He further stated that the hospital changed the cleaning procedure from the use of Virex 256? to a disposable disinfectant cloth in 2010. In an interview on 5/25/11 at 3 pm, with Infection Control Practitioner (ICP) P the surveyor asked him to describe the reference for spraying bleach into the room. He stated that he was unaware that this was the hospital practice. He further stated that he had not reviewed the hospitals' procedures for terminal room cleaning.

Review on 5/25/11 at 3 pm, of the manufacturers' specifications for Virex 256? revealed that the product should be used as follows "Thoroughly wet surfaces with the recommended solution for at least 10 minutes."

Review on 5/25/11 at 3:30 pm, of hospital policy titled "Environmental Services Patient Room/Cleaning (3rd & 4th Floors) dated 2/11 noted that the cleaning procedure continued to specify the use of a disinfectant "using a spray bottle ..." It was also noted that the procedure did not mention the length of exposure time that would be necessary for product effectiveness. Review on 5/25/11 at 3 pm, of hospital policy titled "Environmental Services Terminal Cleaning of Isolation Room ..." dated 9/08 revealed that the procedure guided staff to "spray the room with bleach solution. Leave for 30 minutes ..."





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7. On 5/26/11 at 11:25 a.m., the two Olympus scope processors were noted to have yellow satins on the covers and the basins. The Infection Control Practitioner stated the machines were wiped down everyday with alcohol. He showed the surveyor Sani-Cloth wipes with a manufacturers date of 2011-02. When asked when the wipes would expire, he said he didn't know but he would find out.

A review of "Medivators Reprocessing Systems Service Bulletin" (dated 10/19/05) indicated the following:
"End of day practices should include surface decontamination of the AER (automated endoscope reprocessor), including all external surfaces that may be contacted by staff and/or endoscopes. This will minimize potential cross contamination and ensure that equipment is maintained to a high standard.... All surfaces should be wiped with a lint free non-woven cloth wetted with either 70% isopropyl or ethyl alcohol, or a 1:10 dilution of sodium hypochlorite (regular bleach 2.5 %) with water."

A review of the ingredients of the Sani-Cloth wipes indicated it did not contain the necessary chemical components required to clean the external surfaces and basins of the AERs.

On 5/26/11 at 1:40 p.m., the Infection Control Practitioner stated the Sani-Cloth was the "wrong thing" to use to clean the external surfaces and basin of the AERs. He said he would order a wipe with bleach. He also said that per the manufacturer, the Sani-Cloth was good for two years from the manufacturers date.

Based on observation, interview and record review, the facility failed to provide surgical services that were well organized and in accordance with nationally recognized standards of practice in order to ensure safe and high quality surgical care to all patients as evidenced by:

1.The hospital failed to ensure that moderate sedation privileges for surgical procedures were granted by verifying the demonstration of current competence for all practitioners given these privileges in accordance with standards of practice and medical staff bylaws (A 945)


2. The facility failed to develop and implement a malignant hyperthermia policy based on MHAUS guidelines and failed to train their staff how to respond during a malignant hyperthermia crisis. (A-0951).

3. The facility failed to develop and implement a policy that requires a designated perioperative nurse continually monitor a patient during the administration of moderate sedation (as recommended by AORN-American Association of periOperative Nurses). (A 0951).

4. The facility failed to develop and implement a policy regarding terminal cleaning of the operating room which included the use of a wet vacuum and the cleaning and disinfection of scrub sink faucet aerators on a weekly basis (as recommended by AORN-American Association of periOperative Nurses). (A-0951).

5. The facility failed to implement their policy regarding the cleaning of autoclaves in the operating room and central supply department. (A-0951).

6. The facility failed to store sterile items separately from non-sterile items in the operating room and central supply department and date intravenous fluids placed in the warmer in the operating room. (A-0951).

The cumulative effects of these system failures resulted in the facility's inability to provide safe and effective surgical services to its patients.

Based on staff interview and document review, the hospital failed to ensure that moderate sedation privileges for surgical procedures were granted by verifying the demonstration of current competence for all practitioners given these privileges in accordance with standards of practice and medical staff bylaws.

Findings:

Review on 5/25/11 at 10 a.m. of the medical staff file for Physician 1 with the medical staff coordinator indicated that Physician 1 was granted bowel surgery privileges and moderate sedation privileges by the governing body at a reappointment review on 2/23/10. Moderate sedation is the administration of drugs to render a minimally depressed level of consciousness that allows a surgical patient to retain the ability to independently and continuously maintain a patent airway and respond appropriately to verbal commands and physical stimulation; also known as moderate sedation/analgesia, conscious sedation and intravenous sedation. The file contained documentation of a successfully completed moderate sedation knowledge test dated in 2009, and a successful airway management demonstration dated in 2002. No current advanced cardiac life support certification or direct observations of airway management skills were documented since 2002.

In an interview on 5/26/11 at 10 a.m. with the medical staff coordinator, the coordinator indicated that the requirements for initial moderate sedation privileges by a non-anesthesiologist included completion of a knowledge test and an airway management demonstration, but both requirements were not documented in medical staff policies. When practitioners requested renewal of moderate sedation privileges, the coordinator collected only the knowledge test for the reappointment cycle documentation. The coordinator was aware of at least 4-5 non-anesthesiology practitioners who routinely performed bowel surgery procedures using moderate sedation on a weekly basis. The coordinator acknowledged that many medical staff members (a specific number among the 200+ total membership was not given) did not have current demonstrated competency for airway management when their moderate sedation privileges were renewed at the reappointment cycles.

Definitions and standards of sedation/analgesia, procedural sedation, moderate sedation and conscious sedation have been addressed by a number of nationally recognized organizations including the American Society of Anesthesiologists (ASA), the Association for peri-Operative Nursing (AORN), and the California Board of Registered Nursing (BRN). The organizations have agreed that professionals who administer, or supervise the administration of, moderate sedation, as well as the "supervised sedation professionals," should have specialized and formal education, training, and current demonstrated competency for the knowledge related to respiratory physiology, cardiac rhythms, medication pharmacology, airway management, and rescue from unintended oversedation or complications. (Refer to the ASA Statement on Granting Privileges for Administration of Moderate Sedation to Practitioners Who Are Not Anesthesia Professionals, 10/18/06) The ASA recommended privileging all practitioners given this patient care authority with ongoing performance improvement oversight by the facility governing body.

Review on 5/25/11 at 8 p.m. of American College of Surgery standard ST-46 titled " Statement on patient safety principles for office-based surgery utilizing moderate sedation/analgesia, deep sedation/analgesia, or general anesthesia " documented under Core Principle #10, " Physicians administering or supervising moderate sedation/analgesia, deep sedation/analgesia, or general anesthesia should have appropriate education and training.

Review on 5/25/11 at 8 p.m. of the Medical Staff Constitution and Bylaws, last approved 11/30/10, under Section 7.1-3(b) documented that the basis for granting clinical privileges in the reappointment cycle included demonstrated professional competence and clinical performance.

Based on observation, interview and record review the facility failed to develop and implement surgical services policies in accordance with acceptable standards of practice when they failed to:

1. Develop and implement a malignant hyperthermia policy based on MHAUS guidelines and failed to train their staff how to respond during a malignant hyperthermia crisis.

MHAUS (Malignant Hyperthermia Association of the United States) is a nonprofit organization dedicated to assisting in the diagnosis and treatment of MH (malignant hyperthermia).

Malignant hyperthermia (MH) is a rare, life threatening condition triggered by exposure to certain drugs used in general anesthesia. In susceptible individuals, these drugs can induce a drastic metabolic response which overwhelms the body's capacity to supply oxygen, remove carbon dioxide and regulate body temperature, eventually leading to circulatory collapse and death, if not treated quickly by giving IV dantrolene (the only known antidote), correcting acidosis and organ disfunction, and rapidly cooling the patient.

2. Develop and implement a policy that requires a designated perioperative nurse continually monitor a patient during the administration of moderate sedation (as recommended by AORN-American Association of periOperative Nurses).

3. Develop and implement a policy regarding terminal cleaning of the operating room which included the use of a wet vacuum and the cleaning and disinfection of scrub sink faucet aerators on a weekly basis (as recommended by AORN-American Association of periOperative Nurses).

4. Implement their policy regarding the cleaning of autoclaves in the operating room and central supply department.

5. Store sterile items separately from non-sterile items in the operating room and central supply department and date intravenous fluids placed in the warmer in the operating room.

Findings:

1. During a tour of the operating room on 5/25/11 at 10:40 a.m., the SSUC (Surgical Suite Unit Coordinator) was asked to show the surveyor the supplies for responding to an MH crisis. She opened an unlabelled drawer of the crash cart which contained six vials of dantrolene (dantrolene is used to treat MH), six 50 ml (milliliter) vials of sterile water and one 35 cc syringe. When asked how she would mix the dantrolene, she said she would mix each vial of dantrolene with 50 ml of sterile water. She stated "It's one to one, I think." When the surveyor pointed out she only had one 35 ml syringe, she said "I need to find a 60 cc syringe." After searching through the crash cart she found one 60 cc syringe.

The SSUC stated 30 more vials of dantrolene was kept in a cupboard. After obtaining the key from the PACU (post anesthesia care unit) nurse, she opened the cupboard and told the surveyor the dantrolene was stored on the top shelf. The SSUC had to stand on a step ladder to reach the dantrolene. When asked how staff responding to an MH crisis would access the cupboard, she said "Someone would have to come and get the key from her (the PACU nurse)."

When asked about the availability of ice to cool a patient during a MH crisis, the SSUC stated she would get ice from the fourth floor. There was no cold 0.9 % saline solution for irrigation and intravenous infusion available in the operating room.

MHAUS, an organization dedicated to the control of MH by improving medical care related to MH, providing patient support, and improving understanding of MH through research recommends that a full supply of dantrolene (36) vials be available onsite. The MHAUS guidelines indicates the following: "36 vials of dantrolene will allow for initial stabilization and treatment while more vials are being acquired to continue treatment, as needed" and "the full 36 vials of dantrolene should be available within five minutes of the diagnosis of MH." The guideline also indicates the following regarding mixing dantrolene: " Dissolve the 20 mg in each vial with at least 60 ml sterile, preservative-free water for injection. MHAUS also recommends that open body cavities, i.e. bladder be irrigated with cold saline, that cold saline be given intravenously and ice applied to the patient in a MH crisis. This helps lower the high temperature that often occurs in a patient in a MH crisis.

On 5/25/11 at 1 p.m., OR Nurse 1 was asked how she would mix dantrolene during an MH crisis. She stated "I don't know, I've never had to do that, there's a packet insert, I would look at that. I've never used it so I don't know what to mix it with."

The SSUC who was present during the interview stated "We've never had a drill or training for that (MH crisis) because we've never had that (MH crisis) happen here."

The facility's "Policy/Procedure for Management of Malignant Hyperthermia" (policy # 7420-3026, revision/review date 12/08) was reviewed on 5/25/11 at 3 p.m. and indicated the following:

I. Policy

A. Any patient showing signs and symptoms of suspected malignant hyperthermia shall be started on an emergency treatment regimen in accordance with physician's orders.

B. The following guidelines for treatment are included to be used only as a guide and it is the responsibility of the physician to plan medical intervention based on individualized assessment of the patient.

II. Procedure

A. For additional information, call the Malignant Hyperthermia Hot Line: (209) 634-4917 (Meid Alert Foundation International).

D. Suggested guidelines for treatment during acute phase:

4. Administer Dantrium IV (mixed with distilled water). Starting dose of 1 mg/kg up to mg/kg.
***** Procure 10 additional boxes of Dantrium and more distilled water from Pharmacy if necessary.
5. Initiate cooling to decrease patient's body temperature.
a. IV iced saline solution 1000 ml/10 min for 30 minutes.
b. If applicable, lavage stomach, bladder, rectum, peritoneal and thoracic cavities with
iced saline (3-6 liters).
c. Surface cool with ice:
Obtain hose from porter's closet (by OR plaster room and emergency exit) and connect hose to faucet outlet in porter's closet. Fill plastic boat with cold water and buckets of ice obtained from ice machine near back elevator and kitchen.
8. Hyperkalemia is common in the acute phase and should be treated with glucose and insulin.

A review of the MHAUS guidelines indicated that Dantrolene 2.5 mg/kg is to be administered IV during the acute phase of a MH crisis, not 1 mg/kg as indicated by the facility's policy. The guidelines also indicated that regular insulin should be available and given IV to treat hyperkalemia.

A review of the facility's "Nursing Department Annual Competency Assessment" indicated that MH crisis was not included in the annual competencies for operating room and post anesthesia care unit nurses.

The number listed on the facility's policy as the "Malignant Hyperthermia Hot Line" was called by the surveyor. The person who answered the phone stated this number was for the Medical Alert Foundation (an emergency medical information service that relays members medical conditions, allergies, medications and dosages to emergency responders). The number listed on the facility's policy was not the correct number to be called during an MH crisis.

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

According to 2010 AORN Perioperative Standards and Recommended Practices, pg. 572,
" In 1981, MHAUS was formed to provide a central clearinghouse to collect data and to provide education and information to the public on MH. One of the most important features of MHAUS is an emergency hotline, (800) 644-9737 (in US and Canada) or 001-1-315-464-7079 (outside the US), that is available for expert help with the diagnosis and treatment of an ongoing MH episode." ...

According to 2010 AORN Perioperative Standards and Recommended Practices, pg. 584,
" Every facility should include MH training in the orientation plan for new members of the perioperative team and other teams involved in responding to the crisis. On going periodic reviews should be scheduled. The MHAUS recommendations suggest that the perioperative team initiate mock MH drills at least twice a year to improve staff efficiency in treating a patient during an MH crisis. Because dantrolene sodium is hard to mix, some institutions reconstitute the outdated medication in staff member education sessions to give hands-on training during the mock drills. For perioperative nurses, it may also be helpful to include a review of electrolyte imbalances and the shifts in ABGs that occur with respiratory and metabolic acidosis during an MH crisis. Facilities should identify specific tasks assigned to each member of the response team to effectively manage a MH crisis.

During an observation in the operating room on 5/26/11 at 9:40 a.m., there were six vials of dantrolene, six vials of sterile water (50 ml) and seven 60 cc syringes in a drawer of the crash cart labelled "Yankauer Suction Suction Kit". The SSUC who was present stated "I didn't do anything after you left. I didn't change the sterile water because we have to order it. We are going to order, I must ask pharmacy."

When asked if insulin was available to be given IV during a MH crisis, the SSUC responded "We might have some, usually we don't keep it, we call Pharmacy." After looking through the refrigerator she said "If it's not here, we don't have it."

An Immediate Jeopardy was called on 5/26/11 at 2 p.m. for the facility's failure to have the necessary medications and supplies on hand to deal with a MH crisis, for failing to train staff on responding to a MH crisis and for having the wrong information (amount of dantrolene to be administered and telephone number for Medical Alert Foundation instead of MHAUS) as part of their "Policy/Procedure for Management of Malignant Hyperthermia." The COO (chief operating officer), the NM (nurse manager), the SSUC (surgical suite unit coordinator) and the MRS (manager of risk and safety) were present. On 5/31/11 at 12:22 p.m., the Immediate Jeopardy was abated. The facility placed medications and supplies required during a MH crisis in a dedicated Malignant Hyperthermia Cart in the operating room. Insulin was placed in the operating room refrigerator and a refrigerator dedicated to maintaining supplies of chilled 0.9 % saline for irrigation and IV infusion was installed in the PACU. The facility planned to install an ice machine in the Same Day Surgery Unit by 6/30/11 (a chest cooler containing sufficient quantities of ice to cool a patient was placed in the PACU and will be used in the interim). All surgical suite staff and nursing supervisors received mandatory training on Malignant Hyperthermia on 5/27/11. The training was based on AORN and MHAUS guidelines and included a mock Malignant Hyperthermia drill. Staff were required to complete a competency and exam and this will be part of surgical suite staff and nursing supervisors annual competency. The facility will hold a mock Malignant Hyperthermia drill at least once a year using expired dantrolene for staff to practice mixing and drawing up the medication. The facility will use it's Anesthesia policy and procedure: Management of Malignant Hyperthermia (# 7450) which contains the correct dosage information regarding dantrolene and the correct contact number for MHAUS. Arrangements were made to transfer all patients requiring general anesthesia to another facility until the Immediate Jeopardy was abated.

2. On 5/25/11 at 1:20 p.m., RN 4 was interviewed in the SDS (same day surgery) unit. He showed the surveyor two procedure rooms where endoscopy and colonoscopy exams are performed. He said these procedures are done with the patient under "conscious sedation". He said the nurse is responsible for administering conscious sedation under the direction of the physician. He stated the doctor and a nurse are the only staff in the room during the procedure. When asked who assists the physician with obtaining a biopsy, he said " I assist with that." He also said that he helps press on the patient's stomach to prevent the scope "looping" during the procedure.

During an observation on 5/26/11 at 11:15 a.m., both rooms in the SDS unit were occupied by patients having procedures under conscious (moderate) sedation. There was a physician and one registered nurse in each procedure room.

The NM (nurse manager) was interviewed on 5/26/11 at 11:45 a.m. When asked if it was the facility's policy to have a physician and one registered nurse in the room when a patient is having a procedure under conscious sedation, he responded "Correct."

According to 2010 AORN Perioperative Standards and Recommended Practices, pg. 315,
"Moderate sedation/analgesia is a drug-induced mild depression of consciousness achieved by the administration of sedatives or the combination of sedatives and analgesic medications, most often administered intravenously, and titrated to achieve a desired effect."

Recommended Practices for Managing the Patient Receiving Moderate Sedation/Analgesia, pg. 317 & 318.

Recommendation IV
The perioperative registered nurse monitoring the patient receiving moderate sedation/analgesia should have no other responsibilities that would require leaving the patient unattended or would compromise continuous monitoring during the procedure.

Continuos monitoring of the patient's physiological and psychological status by the perioperative nurse leads to early detection of potential complications.

IV.a. A designated perioperative registered nurse should continually monitor the patient during administration of moderate sedation/analgesia.

IV.b. An additional perioperative registered nurse should be assigned to the circulating role during the administration of moderate sedation.

IV.c. When moderate sedation is administered, the supervising licensed independent practitioner should remain immediately available during the procedure and recovery period.

The facility's policy titled "Sedation policy" (revised/reviewed 8/08) was reviewed and indicated the following:

Procedure:
Intra-procedure
4. Monitoring of the patient is to be continuos throughout the procedure ...

The policy did not specify that a designated perioperative registered nurse should continually monitor the patient during administration of moderate sedation/analgesia and should have no other responsibilities that would require leaving the patient unattended.

The facility's policy titled "Staffing Guidelines For Same day Surgery Unit (SDSU) and Endoscopy Suite (ENDO) (revised/reviewed 11/08) was reviewed on 5/26/11 at 11:50 a.m. The endoscopy suite staffing guidelines indicated that one registered nurse would be on duty if one procedure room was open and the census was four or below. If two procedure rooms were open and the census was five to six, two registered nurse would be on duty. Based on the facility's guidelines, there was no designated registered nurse available to continually monitor the patient during the procedure as the nurse also had to be available to assist the physician as needed.

During an interview on 5/31/11 at 11:30 a.m., the NM again stated that only one nurse and a physician are present when a patient is having an endoscopy or colonoscopy under moderate sedation. He acknowledged that a designated registered nurse is not available to continuously monitor a patient during conscious sedation and that the facility's practice does not meet AORN standards of practice.

3. During an observation in the operating room on 5/25/11 at 10:50 a.m., the aerators on the scrub sink faucets were coated with a brown and white colored material. The SSUC who was present stated the housekeeping department took care of cleaning the scrub sinks.

HKS 1 (housekeeping staff ) was interviewed on 5/25/11 at 12:45 p.m. He stated he cleaned the scrub sinks after every case but that he never cleaned the aerators. He said "Nobody told me about cleaning those." When asked how he does the terminal cleaning of the operating room floor he said he used a mop to apply Expose 256 ( EPA registered disinfectant). He said the facility did not use a wet vacuum for the terminal cleaning of the operating room floor. The ICP (infection control practitioner) who was present stated he was not aware of the need to clean the aerators on the scrub sink faucets or that AORN recommended the use of a wet vacuum for the terminal cleaning of the operating room floor.

According to 2010 AORN Perioperative Standards and Recommended Practices, pg. 241,
"These recommended practices provide guidance for environmental cleaning and disinfection in the surgical practice setting. Conscientious application of these recommended practices should result in a clean environment for surgical patients and minimize the exposure risk of health care personnel and patients to potentially infectious microorganisms. ...

Recommended Practices for Environmental Cleaning in the Perioperative Setting, pg. 245 & 246.

Recommendation IV
Surgical and invasive procedure rooms and scrub/utility areas should be terminally cleaned daily.

Terminal cleaning and disinfection of the perioperative environment decreases the number of pathogens, dust, and debris that is created during the day.

IV.a.2. Floors should be wet-vacuumed with an EPA-registered disinfectant after scheduled cases are completed.

Recommendation V
All areas and equipment in the surgical practice setting should be cleaned according to an established schedule.

A clean environment will reduce the numbers of microorganisms present.

V.d.1. Aerators on faucets should be cleaned and disinfected weekly by removing the aerator, scrubbing it with a detergent and a brush reserved for this purpose, and immersing it in a disinfectant.

The facility's "Housekeeping Policy/Procedure For Duties In The O.R." (revised/reviewed 11/10) was reviewed on 5/25/11 at 4:35 p.m. The policy did not address the issue of terminal cleaning of the operating rooms or that the aerators on the scrub sink faucets needed to be disinfected on a weekly basis.

The facility failed to develop and implement a policy regarding terminal cleaning of the operating rooms which included the use of a wet vacuum as recommended by AORN (American Association of periOperative Nurses). The policy also contained no mention of the scrub sink faucet aerator cleaning, also recommended by AORN. This had the potential to cause infection in patients having surgery at the facility.

4. During an interview on 5/25/11 at 12:45 p.m., the SSUC stated the autoclave in the operating room was cleaned by the housekeeping staff once a month. HKS 1 who was present stated he worked Monday to Friday and he didn't have time to clean the autoclave. He stated "The housekeeper on the weekends should clean it." The SSUC stated there was no log regarding the cleaning of the autoclave and she was not monitoring the housekeeping staff to ensure they were cleaning the autoclave.

On 5/26/11 at 11:48 a.m., the inside of the autoclave was coated with a brown reddish material.

During an interview on 5/26/11, CSRT (central supply requisition tech) 1 stated the autoclaves in the instrument processing area were cleaned "once in a while, maybe once a month." She said the outside of the autoclave was wiped with a solution of soap and water and the inside was sprayed with FACTS (foaming autoclave cleaning treatment system). When asked how staff are assigned to clean the autoclaves, she responded "Whoever is working the first weekend of the month should do it." CSRT 1 stated there was no log to document that the autoclaves were being cleaned.

The facility's policy "Procedure For Cleaning Autoclave" (revised/reviewed 12/08) was reviewed and indicated the following:

Purpose: To establish guideline for effective cleaning of the autoclave.

Procedure:
1. The Autoclave must be cleaned weekly.

AORN 2010 Recommended Practices for Sterilization in the Perioperative Practice Setting, pg. 471 indicates the following:

Recommendation XV

Policies and Procedures
Policies and procedures for sterilization processes should be developed, reviewed periodically, and readily available in the practice setting.

Policies and procedures establish authority, responsibility, and accountability and serve as operational guidelines. Policies and procedures also assist in the development of continuous quality improvement activities.

XV.a. Policies and procedures for routine cleaning of sterilizer chambers, carts, and exterior surfaces should be developed and implemented.

XV.b. These recommended practices for sterilization should be used to guide the development of policies and procedures within individual perioperative practice settings.

XV.c. The sterilizer manufacturer's written instructions for cleaning should be reviewed and followed.

5. During a tour of the perioperative area on 5/25/11 at 10:40 a.m., there was a sterilized cement gun stored in a cupboard with unsterile items and a pink plastic wash basin stored on top of sterilized items. In OR 1 there were multiple sterile eye sets stored with unsterile pink plastic wash basins. The SSUC who was present stated that sterile items should not be stored with unsterile items as this compromised the sterility of the items. There was several bags of 0.9 % normal saline (IV fluid) in the OR warmer. There was no date on the bags to show when they had been placed in the warmer. The SSUC said she was sure the fluids had been placed in the warmer last week but it was not the facility's policy to date the bags when they were placed in the warmer.

On 5/26/11 at 10:30 a.m., there were packages of sterilized towels stored with a white cardboard box. CRST 1 stated sterile items should not be stored with unsterile items and removed the box. She said the towels would have to be re-sterilized.

AORN 2010 Recommended Practices for Sterilization in the Perioperative Practice Setting, (pg. 469) indicates the following:

Recommendation XI

Sterilized materials should be packaged, labeled, and stored in a manner to ensure sterility, and each item should be marked with the sterilization date.

Limiting exposure to moisture, dust, excessive light or handling, and temperature and humidity extremes decreases potential contamination of sterilized items.

AORN 2010 Recommended Practices for a safe Environment of Care (pg. 224) indicates the following:

VIII.b.1. Fluids kept in fluid warmers should be labeled with the date they should be removed or the date when they were placed in the warmer.

VIII. b.2. Solutions should be rotated on a first-in, first-out basis.