HospitalInspections.org

Based on the number and nature of deficiencies cited, the hospital failed to comply with the Condition of Participation of Governing Body. The governing body of the facility failed to ensure that nursing care provided to patients was provided in a safe and effective manner, in compliance with facility policies/procedures and met all standards of the Condition of Participation of Nursing Services. In addition, the governing body of the facility failed to ensure that the facility's performance improvement mechanism/activities adequately investigated medical errors/adverse events and instituted appropriate monitoring to prevent subsequent events. The governing body of the facility failed to ensure that the performance improvement activities related to adverse events met all standards of the Condition of Participation of Quality Assurance/Performance Improvement. In addition, the governing body failed to ensure that the surgical services provided by the facility met all standards of the Condition of Participation of Surgical Services. The governing body failed to ensure that all services, whether provided by the facility or as a contracted services were provided in a safe and effective manner and complied with Conditions of Participation and related Standards.

The facility failed to meet the following standards under the condition of Governing Body:

A 0083 Contracted Services Comply With Applicable Conditions of Participation
The governing body of the facility failed to ensure that all services furnished in the hospital, whether or not they were furnished under contract, permitted the hospital to comply with all applicable conditions of participation and standard for the services provided
Reference Tag A 0385 for the Condition of Participation of Nursing Services.

A 0084 Contracted Services Provided In A Safe And Effective
Manner
The governing body of the facility failed to ensure contracts for
leased space for outpatient services for the facility enforced requirements that the property managers conduct fire drills and inspections and provide written evidence of the drills and inspections conducted.

Based on review of medical records, meeting minutes, facility reports and staff interviews, the governing body of the facility failed to ensure that all services furnished in the hospital, whether or not they were furnished under contract, permitted the hospital to comply with all applicable conditions of participation and standards for the services provided. The failures created negative outcomes for some patients and the potential for a negative outcome for others.

The findings were:

Reference Tag A 0263 Condition of Participation: Quality Assurance/Performance Improvement (QAPI) and 2 standard tags.

Reference Tag A 0385 Condition of Participation: Nursing Services and 2 standard tags.

Reference Tag A 0940 Condition of Participation: Surgical Services and 1 standard tag.

Additional standard level tags were cited under the following Conditions of Participation:
- Compliance With Laws
- Governing Body
- Patient Rights
- Medical Staff
- Physical Environment
- Radiological Services
- Outpatient Services

Based on staff interviews and review of facility documents, the governing body of the facility failed to ensure contracts for
leased space for outpatient services for the facility enforced requirements that the property managers conduct fire drills and inspections and provide written evidence of the drills and inspections conducted. The failure created the potential for negative outcome for patients, visitors and staff.

The findings were:

Reference Tags A 0714 and A 0715 under the Condition of Participation of Physical Environment.

Due to the nature of the deficiency, the hospital failed to comply with the Condition of Patient Rights. The facility failed to ensure that the right of patients to refuse further treatment or leave the facility were protected.

The facility failed to meet the following standard under the Condition of Patient Rights:

A0131 Patient Rights - Informed Consent
The facility failed to ensure that a voluntary, non-impaired patient (Sample Patient #33) was allowed to leave the patient unit/facility, when s/he attempted to do so.

Based on review of medical records and facility documents, the facility failed to ensure that a voluntary, non-impaired patient (Sample Patient #33) was allowed to leave the patient unit/facility, when s/he attempted to do so. The patient was restrained by two security officers and forcibly returned to his/her room (on the step down unit for the intensive care unit -ICU), in violation of his/her right to refuse treatment and be free from restraint use. The failure created a negative patient outcome.

The findings were:

1. On 6/7/10 the log of patient complaints/grievances was reviewed and revealed the following findings, in pertinent parts regarding Sample patient #33:
"...Concern: 8/12/09 6:30 (a.m.) patient left SDU (step-down unit) to go (to) cafe to eat against unit safety policy. Security was notified that patient left unit. Security found patient in cafe. Security attempted to encourage patient back to unit when patient had an altercation with the security guard...I (pt rep.) explained that I was returning his call. S/he said s/he wanted to talk about his/her 'cracked ribs' when they took him/her down on the 1st floor. S/he was upset that we didn't let him/her leave the unit to go get breakfast. I tried to explain that s/he wasn't discharged and that s/he needed to stay on the unit. (Patient) stopped the conversation because s/he felt that we would just go 'around and around.'...
8/12/09 at 0730 (7:30 a.m.) patient made allegation of being touched in the private parts during a groin check at 0400 (4:00 a.m.) Allegation made to physician and oncoming nurse just prior to discharge."

2. On 6/10/10, the "Security Incident Report" for the incident with Sample Patient #33 was reviewed and revealed the following, in pertinent parts:
"...Description
On 8/12/09 at 0643 hrs (6:43 a.m.) Security officer #1 and security officer #2 were en route to ...(ICU). When they arrived in ICU, and Rn told them that the patient from room (Sample Patient #33) had just eloped. Both (security officers) began to search for the patient. They encountered him/her in the cafeteria area and asked him/her to return to his/her room. When both officers attempted to escort the patient, s/he threw a punch at security officer #2 and missed striking him/her because security officer #2 blocked the punch. The patient then called 911 (Denver Police) claiming that the officers assaulted him/her. Both officers escorted the patient around the corner toward the elevators and the patient punched security officer #1 in the mouth. Both the patient and security officer #1 stumbled into the elevator and security officer #1 grabbed the patient again in an attempt to stop him/her from fighting the officers. Security officer #2 then grabbed the patient's legs and both officers layed the patient down to the floor. I (security officer #3) responded to the scene and both officers had the patient on his/her back. Security officer #2 was restraining the patient's legs and security officer #1 was restraining the patient's arms. The 911 operator was on the phone (the patient's cell phone) the entire time during the incident until security officer #1 took the phone away from him/her and explained to the operator what was going on. I (security officer #3 assisted by taking the patient's right arm. A staff member (another hospital staff member), was assisting with the patient's right leg and the patient kicked him/her in the mouth. We kept the patient restrained until a Code Green was called and medical staff arrived. Medical personnel arrived with a cart and returned the patient to his/her room in ICU. Security officer #1 was not injured during the incident. Neither the other hospital staff member or security officer #1 wished to pursue charges against the patient. The other hospital staff member was injured though and checked into the ER. Denver Police responded and was advised of the incident and were told that neither party wished to pursue charges at this time..."

3. On 6/16/10, the medical record of Sample patient #33 was reviewed and revealed the following findings, in pertinent parts:
The patient was an adult admitted to the ER by ambulance for chest pain at 12:30 a.m. on 8/11/09. The patient had diagnostic testing and was given the diagnosis of unstable angina.

At 0026 (12:26 a.m.) the medication administration sheet reflected that "patient refused" injectable morphine.

At 0055 (12:55 a.m.) the nursing note stated "patient requested to have IV removed or s/he will remove it him/herself. Physician came in to talk to the patient and convinced patient to leave it in."

At 0108 (1:08 a.m.) the medication administration sheet reflected that "patient refused" nitroglycerine topical ointment.

At 0108 (1:08 a.m.) the nursing note stated "nurse went into room to take patient to css room. Patient stated he wanted to leave then. Nurse tried convincing patient he needs to stay for a stress test in the a.m. Will be in a more comfortable bed overnight, and that if he leaves AMA (against medical advice) his insurance may not pay for the ER visit. Patient became very upset, tried pulling IV out himself, and instructed the nurse to 'talk to the hand and not his face.' Physician came into room while talking with the patient. The patient interrupted physician looked at nurse and said 'would you get out of here now.' Nurse left room."

At 0151 (1:51 a.m.) the patient was placed on remote telemetry with ICU telemetry technician.

At 1505 (3:05 p.m.) the patient taken to cardiac catheterization lab.

On 8/12/09 at 0608 (6:08 a.m.) the nursing note stated: "patient removed all lead and is refusing to put them on. S/he states 'they are not working right' and that s/he 'wants to go home.' The importance of the leads was explained to the patient but s/he did still refuse to have them attached."

On 8/12/09 at 0730 (7:30 a.m.) the nursing note stated: "At 0630
(6:30 a.m.) the patient got dressed in street clothes and walked out of his/her room and down the hall. When asked where s/he was going s/he stated 'to the cafeteria to get breakfast' when asked to return to his/her room and sign papers to leave s/he stated 'this isn't Nazi Germany.' The charge nurse was notified and security was called. A code green was announced on the 1st floor by the cafeteria elevator; the charge nurse and night nurse went to the call, apparently there was a physical altercation between the patient and security and upon arrival to the scene the patient was on the floor. The patient was put on a gurney and transported back to his/her room. (A physician) came to the bedside and discussed the situation with the patient. A phone call was made by the patient on his/her cell phone to the Denver Police Department. (The physician spoke with them and explained the situation. The physician agreed to the patient's discharge. The patient has remained agitated; threatening the staff; patient refused care from the night nurse requesting another nurse. Patient was escorted from the hospital by security; on the way out s/he stated s/he would file a ''sexual misconduct complaint' on the night nurse."

At 0700 (7:00 a.m.) the physician wrote an order for discontinuation of IV and "discharge to home." There was no indication that those orders were noted by the nurse.

At 0805 (8:05 a.m.) the nursing note stated: "Day nurse came onto shift when Code Green called on his/her patient on the first floor. Patient back in his/her room. Agitated and asking for the patient representative. Gave patient the number. Patient proceeded to pull out his/her IV. Physician at bedside getting discharge instructions. Security on floor and escorted patient out."

Based on the nature of deficiencies cited, the hospital failed to comply with the Condition of Participation of Quality Assurance/Performance Improvement (QAPI). The facility failed to ensure that the facility's performance improvement mechanism/activities adequately investigated adverse patient events, including misuse or malfunctioning equipment, staff failures to comply with facility policies/procedures and use of force with patients in "Code Green" (potential physical aggression)situations.

Furthermore, areas of concern identified as infractions of infection control such as improper scope cleaning in the GI (gastrointestinal) suite, absence of scrub sinks in the GI suite, and infrequent temperature and humidity recording in the Women's Surgery Center were not identified and addressed through the QAPI program.

The facility failed to meet the following standards under the condition of Quality Assurance/Performance Improvement:

A 0286 QAPI Tracking
The quality assurance/performance improvement (QAPI) function of the facility failed to implement the action of monitoring of physician and patient care staff activities after incidents of medical errors and adverse patient events.

A 0291 QAPI Sustained Improvement
The facility failed to complete performance improvement activities by not implementing all preventive actions and mechanisms that would reduce a same or similar adverse patient event in the future. The facility did not complete the process with appropriate tracking and monitoring of activities to ensure that improvements were sustained in two adverse surgical events.

Please refer to the Conditions of Surgical Services and Infection Control for additional information related to this Condition.

Based on review of meeting minutes, facility reports and staff interviews, the facility's governing body failed to ensure that performance improvement activities included monitoring medical errors and adverse events. Specifically, the quality assurance/performance improvement (QAPI) function of the facility failed to implement the action of monitoring of physician and patient care staff activities after incidents of medical errors and adverse patient events. The QAPI process treated medical errors and adverse events as isolated occurrences, rather than instituting monitoring to determine if errors/events were symptoms of more significant problems in areas such as widespread failure to follow policies/procedures, inadequate protocols, lack of training and system failures. The failures created the potential for additional negative patient outcomes when QAPI activities failed to adequately investigate the errors/events to prevent additional errors and adverse events.

The findings were:

1. Failure to Monitor for Compliance with the Blood Administration Policy/Procedure:

During a prior complaint investigation in January 2010, the Condition of Nursing was found to be out of compliance. One of the nursing standards that was out of compliance was Tag A 0409 Blood Transfusion and Intravenous Medication, partially due to the failure of at least one nurse to comply with the blood administration policy/procedure, which may have contributed to a negative outcome for the patient.

On 6/10/10 at approximately 10:25 AM, medical records for two patients (#31 and #32), who received blood transfusions, were reviewed. Both records revealed failure of the nurses involved to follow one or more elements of the blood administration policy/procedure. During a telephone interview with the director of quality improvement on 6/15/10 at approximately 2 p.m., s/he confirmed that the facility had instituted no routine monitoring of nursing compliance with the blood administration policy until after findings of evidence of continued non-compliance was identified on 6/10/10. S/he stated that the facility had instituted 100% auditing of all blood administration by a third party at the time of administration effective 6/11/10, the day after the surveyors left the facility.

2. Failure to Institute Monitoring as a QAPI Activity After Medical Errors/Adverse Events:

Review on 6/8/10 of a Report of Patient Safety Committee Cases (utilizing a new case review form) Corrective actions did not include monitoring or auditing.
from 1/1/10 through 5/31/10, revealed the following findings:
Case #1 "Fall with Injury (Major)," hip fracture. Corrective actions did not include monitoring or auditing.
Case #2 "Unintended Retained Foreign Object," sponge retained. Corrective actions did not include monitoring or auditing.
Case #3 "State Reportable: Misuse of Equipment," corneal abrasion due to re-use of single use electrode in eye surgery. Corrective actions include "monitor/audit," but the actions did not describe what was to be monitored, scope of auditing, time frames for auditing and reporting accountability to QAPI.
Case #4 "Inpatient Psych. Elopement" Corrective actions did not include monitoring or auditing.
Case #5 "Clinical Monitoring -Move to higher level of Care," Septic shock after outpatient laparoscopic surgery. Corrective actions did not include monitoring or auditing.
Case #6 "Medical Management/Communication/Rapid Response," respiratory distress. Corrective actions did not include monitoring or auditing.
Case #7 "Fall With Injury," humeral neck fracture. Corrective actions did not include monitoring or auditing.
Case #8 "Acute Liver Failure," after total knee arthroplasty/oversedation. Corrective actions did not include monitoring or auditing.
Case #9 "Red Rule Violation: 2 Pt Identifier," wrong x-ray performed on patient. Corrective actions did not include monitoring or auditing.
Case #10 "Retained Foreign Object (RFO)," false-negative x-ray to check for RFO. Corrective actions did not include monitoring or auditing.
Case #11 "Patient Behavior: Safety Concern," ED/domestic violence. Corrective actions did not include monitoring or auditing.
Case #12 "Tube feeding connected to common bile duct tube instead if G-Tube." Corrective actions did not include monitoring or auditing.
Case #13 "Telemetry Monitoring," telemetry left on "suspend mode"/Ventricular fibrillation arrest. Corrective actions did not include monitoring or auditing.
Case #14 "Fall with Injury," fell in ED parking lot after discharge, femur fracture that required surgical repair. Corrective actions did not include monitoring or auditing.
Case #15 "Two Patient Identification Violation," patient given another patient's antipsychotic medication. Corrective actions did not include monitoring or auditing.
Case #16 "Two Patient Identification," Bedside PT/INR test performed on wrong patient. Corrective actions did not include monitoring or auditing.
Case #17 "State Reportable: Diverted Drugs." Corrective actions include "monitor/audit," but the actions did not describe what was to be monitored, scope of auditing, time frames for auditing and reporting accountability to QAPI.
Case #18 "Patient fall with Injury (Moderate)," non-displaced clavicular fracture. Corrective actions did not include monitoring or auditing.
Case #19 "Medication Error = increased length of stay," incorrectly reduced dose of antipsychotic caused psychiatric decompensation (per notes on the 3/17/10 review, the medication error was not detected for 10 days.). Corrective actions did not include monitoring or auditing.
Case #20 "Fall With Injury," hip fracture. Corrective actions did not include monitoring or auditing.
Case #21 "IV extravasation during CT scan." Corrective actions include "monitor/audit," but the actions did not describe what was to be monitored, scope of auditing, time frames for auditing and reporting accountability to QAPI. A responsible individual was assigned to report back with a data collection plan within one month.
Case #22 "Attempted suicide," inpatient psychiatric unit. Corrective actions did not include monitoring or auditing.
Case #23 "Attempted suicide," inpatient psychiatric unit. Corrective actions did not include monitoring or auditing.
Case #24 "Red rule violation. Chest x-ray performed on wrong patient." Corrective actions did not include monitoring or auditing.

3. Review on 6/8/10 of Patient Safety Committee minutes revealed that on 4/14/10, the committee referred Cases #22 and
#23 and a third case from 2009 (that all involved suicide attempts on the inpatient psychiatric unit) to the inpatient psychiatric team for review as part of QAPI activities.
The report of the inpatient psychiatric team review was requested for review. Review of the report on 6/9/10 revealed the following findings: The report was a one page hand written document titled "Psych Section 5-5-10"
The names of ten staff members were listed next on the document. The last part of the document appeared to be the content of the meeting. That section stated the following:
"Discussed case similarities of 2 similar attempted suicides
- Marital (next word not legible)
- Change of shift alertness
- BPD (Borderline personality disorders)"

The report was later reviewed with the manager of the psychiatric unit on 6/9/10 at approximately 9:30 a.m.. S/he stated that the minutes did not reflect all of the discussion that occurred during the meeting. S/he stated that the cases were reviewed to determine if all policies and procedures were followed. S/he stated that only the two most recent suicide attempts were reviewed, rather than the three indicated in the Patient Safety Committee minutes. S/he stated that the review did determine that they needed to change their procedures related to laptop computers, since one of the attempts involved an attempted hanging with the cords from the laptop computer. S/he stated that they would no longer allow the patients to take the laptop cords into their rooms, regardless of their level of privileges/precautions. S/he stated that laptops would have to be charged in a secure area and the patient could then use only the laptop, not the cords. S/he stated that s/he sent a brief e-mail of the review findings to the patient safety officer.

The e-mail dated 5/18/10 was provided and reviewed on 6/9/10. The e-mail stated the following, in pertinent parts:
"We had our psych section meeting and discussed the two cases (the two patient names). Some of the similarities were: both diagnosed with Borderline Personality Disorder, both had received a phone call with disturbing news from family. Info was received to the patients right before change of day/evening shift. Neither had stated they were feeling suicidal or wanting to do self harm. So essentially both had similar diagnosis and lack of coping skills. We have determined we can place patients of this type on high alert and monitor their calls more closely to observe for disturbing news they might receive. If you need more info please let me know."

The e-mail contained no information about whether policies/procedures were followed, what the implications were related to the information being received at change of shift, and whether any policies/procedures changed or modified.

Review of the Patient Safety Committee report for these cases indicated that the contents of the e-mail had been "cut & pasted" into the report. No additional questions were raised as a part of the
QAPI process. There was no evidence that the report findings were reviewed by the committee to determine if further action was needed.

4. On 6/10/10 a review of a "Code Green" (potential physical aggression) Data report for 2009 and 2010 revealed the following findings:
The total number of "Code Green" events for 2009 was 113.
The "Code Green" events for 2010 were:
January 2010: 18
February 2010: 9
March 2010: 7
April 2010: 7
May 2010: 3

On 6/10/10 at approximately 8:30 a.m., the director of safety and security was interviewed about physical environment issues. Because s/he also had oversight over security activities, s/he was also questioned about the review process for "Code Green" events. S/he acknowledged that no debriefings or reviews were conducted after "Code Green" events. Initially the director of quality stated that "Code Green" events were reviewed by the Safety Committee, but stated at the onsite wrap-up meeting at 3 p.m. on 6/19/10, that s/he had mis-spoken and that "Code Green" events were not reviewed by that committee.

In summary, the facility failed to conduct reviews of "Code Green" events to determine if uses of force were warranted, and to review and improve the staff judgement and interventions regarding use of force.

Based on a tour, observations, staff interviews, medical record review, and policy and procedure review, the facility failed to complete performance improvement activities by not implementing all preventive actions and mechanisms that would reduce a same or similar adverse patient event in the future. The facility did not complete the process with appropriate tracking and monitoring of activities to ensure that improvements were sustained in two adverse patient events. Specifically, there was one incident of a foreign body retained requiring additional surgery and one incident of neglect with injury to a patient caused by operator error of a robotic machine during surgery.

The findings were:

The medical record of sample patient #34 was reviewed. The patient was a 22 year-old adult admitted May 2010 for an elective kidney donation. The patient sustained a trocar injury to the aorta necessitating emergent surgery to repair the aorta. No sponge count was completed when the case became emergent. A radiograph taken after the procedure while the patient was still in the operating room (OR) was read by a radiologist as negative for a retained foreign body. However, the film was of poor quality. A subsequent radiograph in the intensive care unit (ICU) revealed a foreign body in the abdomen. The patient was returned to surgery for removal of a sponge. The kidney was not donated and the patient remained hospitalized for 7 days with residual pain and weakness of the right lower extremity at the time of discharge. A consultation by neurology noted that there was an expectation the residual symptoms would resolve, but this was not determined to be conclusive.

A review of OR Unit Meeting minutes for 5/28/2010 on 6/10/2010 and an interview with the Director of Peri-Operative Services at approximately 1:30 p.m. revealed that the department is reviewing their current sponge count process and policy to determine what changes, if any, need to be made based on review of best practices, staff input and research. In the meantime, a protocol for the Radiology Technician to ask the OR team whether the X-ray is of sufficient quality or not before the patient leaves the OR was initiated.

A review of the current policy, dated 4/13/2010, "Sponge, Sharps and Instrument Counts" on 6/10/2010 revealed the following, in pertinent parts:
"A. There will be an X-ray taken prior to extubation and/or transfer of the patient from the OR suite for the following situations:
1. For an emergent case, where pre-surgical counts are not timely for efficient patient care.
2. Incorrect counts..."

An interview with the Director of Quality, Patient Safety Coordinator, and Chief Medical Officer on 6/10/2010 at approximately 3:00 p.m. revealed the following: the facility completes investigations of all adverse patient events. The injury to the aorta created an emergent situation such that there was no time to perform a sponge count in order to save the patient's life. The X-ray taken in the OR was of poor quality in part because there was a piece of equipment in the way and positioning the patient was difficult at the time. A repeat film should have been requested. Other issues pending investigation include communication between the surgeon and radiologist with questionable films and a policy revision for counts with emergent procedures. There had not been any tracking or monitoring of similar or same OR events since the incident. Although a protocol had been initiated whereby the Radiology Technician will question whether a film is sufficient or not, no final policy regarding counts and/or film adequacy had been completed. Facility internal review of the case is in progress.

The medical record of sample patient #35 was reviewed. The patient was a 86 year-old adult admitted December 2009 for elective excision of a left adrenal gland, pancreas and spleen secondary to metastatic carcinoma. During the surgery a Davinci robotic machine was erroneously moved before all connections to the patient were undocked and the patient sustained a tear to the aorta. Emergent repair was initiated but the patient sustained intraoperative hemorrhage with an estimated blood loss of 2000 ml, respiratory failure, and acute renal failure requiring dialysis. The patient eventually regained sufficient mental capacity to refuse further treatment and elected to proceed with hospice care. The prognosis was grave.

An interview with the Director of Quality and Director of Peri-Operative Services on 6/08/2010 at approximately 4:00 p.m. revealed that the facility had initiated a protocol but no policy had been implemented. Staff had received training, however, to perform a timeout when removing the Davinci robot on December 3, 2009. A sign-in sheet with 19 signatures for the training was received on 6/10/2010 along with a new policy dated 6/10/2010 requiring a timeout when removing the Davinci robot during a procedure.

An interview with the Director of Quality, Patient Safety Coordinator, and Chief Medical Officer on 6/10/2010 at approximately 3:00 p.m. revealed the following: the circulating nurse had misunderstood what s/he thought was an order to remove the Davinci robot. Although a protocol had been determined and staff received training about this, there was no formal policy created until one was suggested by the surveyor. There had not been any tracking or monitoring for adherence to the protocol and the performance of actual timeouts.

A review of the documentation provided by the facility on 6/17/2010 demonstrated that there were 59 times in which the Davinci robot was used since the incident. Monitoring for policy compliance was initiated on 6/14/2010, six months after the adverse patient event, with weekly submissions to the Quality and Patient Safety department.

Based on staff interview, review of medical records and the facility's Medical Staff Rules and Regulations, the facility failed to enforce the rules and regulations regarding medical records in nine (#1, #2, #5, #7, #8, #11, #15, #23 an #28) of 33 medical records reviewed. Specifically, the facility failed to ensure that physician orders were consistently timed.

The findings were:

The facility's Medical Staff Rules and Regulations stated, in pertinent part: "All orders, including verbal orders, must be legible, dated, timed, and authenticated promptly by the ordering practitioner or another practitioner who is responsible for the care of the patient and authorized to write orders by hospital policy in accordance with State law..."

The following sample medical records were reviewed on 6/7/10 and 6/9/10. Many of the sample medical records that are cited below were documented on forms that prompted the physicians to both date and time the orders.

1. The patient in sample medical record #1 was admitted to the facility on 3/3/10 for a total knee replacement and discharged on 3/5/10. The epidural order written on 3/3/10 was not timed. There was a space provided on the form for the documentation of time.

2. The patient in sample medical record #2 was admitted to the facility on 3/3/10 with post operative vaginal prolapse and discharged on 3/5/10. The anesthesia pre-operative orders written on 3/3/10 were not timed. There was a space provided on the form for the documentation of time.

3. The patient in sample medical record #5 was admitted to the facility on 3/4/10 for a total knee replacement and discharged on 3/6/10. The post operative orders and anesthesia pre-operative orders were not timed. There was a space provided on both forms for the documentation of time.

4. The patient in sample medical record #7 was admitted to the facility on 4/15/10 for the removal of a pacemaker and discharged on 4/17/10. Three physician orders written on 4/15/10 were not timed. Two physician progress notes written on 4/16/10 were not timed. Two physician progress notes and two physician orders written on 4/17/10 were not timed.

5. The patient in sample medical record #8 was admitted on 4/15/10 with abdominal pain and discharged on 4/19/10. A physician order written on 4/17/10 was not timed. A physician order written on 4/18/10 was not timed.

6. The patient in sample medical record #11 was admitted on 4/17/10 with vomiting and discharged on 4/19/10. A physician order dated 4/19/10 was not timed. An EGD (esophagogastroduodenoscopy) pre, during, post procedure form was not timed. The time printed on the form was highlighted to draw attention to the need to be completed by the physician when the order was written.

7. The patient in sample medical record #15 was admitted on 5/24/10 with chest pain, hypoxia and atrial fibrillation and discharged on 5/26/10. Physician progress notes written on 5/24/10, 5/25/10 and 5/26/10 were not timed.

8. The patient in sample medical record #23 was admitted on 5/28/10 for S/P (status post) respiratory failure. The patient has not been discharged as of 6/7/10. There were several physician orders noted in the medical record that were not timed.

9. The patient in sample medical record #28 was admitted on 6/8/10 with prostate cancer. The patient has not been discharged as of 6/9/10. A physician order written on 6/8/10 was not timed.

An interview was conducted with the Clinical Outcomes Coordinator on 6/9/10 at approximately 10:45 a.m. The Coordinator stated that physician orders are entered into the electronic medical record and at that time, the time of the entry is electronically recorded. However, it is still the expectation of the facility that physicians time the orders when they are written.

Based on review of medical records, medical staff bylaws/rules and regulations and other facility documents, the facility failed to ensure that a History and Physical Examination (H & P) for Sample Patient #25 was completed, documented and placed in the patient medical record within 24 hours of admission, as required. The failure created the potential for a negative patient outcome.

The findings were:

1. Review, on 6/7/10, of the medical record of Sample Patient #25 revealed that the patient was admitted to the facility for inpatient psychiatric treatment on 5/28/10. Review of the H & P revealed that the patient was examined by the physician on 5/29/10, but the report was not dictated by the physician or transcribed for placement in the patient medical record until 6/1/10.

2. Review, on 6/7/10, of the "Rules and Regulations of the Medical Staff," as amended 5/27/10, "Addendum A - Medical Record Directives," revealed the following, in pertinent parts:
"...2.0 A medical history and physical examination should be completed and documented for each patient no more than 30 days prior to or 24 hours after admission or registration..."

Based on the nature of deficiencies cited, the hospital failed to comply with the Condition of Participation of Nursing Services. The facility failed to ensure that nursing care included routine monitoring of bowel movements for abnormal bowel function, including constipation, which is a common side-effect of many psychotropic medications, for acute psychiatric inpatients. In addition, the department of nursing services failed to ensure that nursing staff on the inpatient psychiatric unit documented detailed information, including types and amounts of food and fluids and record of instances of urination and bowel movements for acute inpatient psychiatric patients while they were in seclusion and/or restraints. In addition the facility failed to monitor nursing staff compliance with the various elements of the blood administration policy/procedure, including insuring that consents were in place, that two nurses checked the blood, that vital signs were taken before, during and after the procedure and that a physician was notified when a patient's vitals signs changed, indicating a possible transfusion reaction.

The facility failed to meet the following standards under the condition of Nursing Services:

Tag A 0386 Organization of Nursing
The department of nursing failed to ensure that nursing care met standards of practice for monitoring acute psychiatric patients for food, fluids and elimination during seclusion/restraint use on the inpatient psychiatric unit. In addition, the department failed to ensure that routine monitoring of bowel function was in place for acute psychiatric patients, who were psychotropic medications that frequently cause constipation and put them at risk for development of a bowel obstruction.

Tag A 0409 Blood Transfusions and Intravenous Medications
The department of nursing failed to monitor care to ensure that nursing staff were complying with all aspects of blood administration policies/procedures including consent, two-nurse checks for blood prior to administration, monitoring/documenting of vital signs and recognizing and notifying the physician of vital sign changes indicating a possible transfusion reaction.

Based on medical record review and staff interviews, the facility's department of nursing services failed to ensure that nursing care included routine monitoring of bowel movements for abnormal bowel function, including constipation, which is a common side-effect of many psychotropic medications, for acute psychiatric inpatients. In addition, the department of nursing services failed to ensure that nursing staff on the inpatient psychiatric unit documented detailed information, including types and amounts of food and fluids and record of instances of urination and bowel movements for acute inpatient psychiatric patients while they were in seclusion and/or restraints. The patients in seclusion and/or restraints required a closer level of monitoring, since they were totally dependent on staff to provide food, fluids and toileting opportunities. These patients were likely to be receiving additional doses of psychotropic medication that had the potential to interfere with normal elimination. In addition, patients requiring seclusion and/or restraints were more likely to be disorganized and unable to attend to, or articulate, their basic needs for food, fluids and elimination. The failures created the potential for a negative patient outcome.

The findings were:

1. On 6/7/10, at approximately 2:30 p.m., during a tour of the inpatient psychiatric unit, sample record #25, an open record, the following findings, in pertinent parts:
The patient was an adult patient with a diagnosis of major depressive disorder and history of a traumatic brain injury. The patient was admitted on 5/28/10. At the time of admission, the nursing assessment stated that the patient's last bowel movement was 5/27/10, the day prior to admission. The abdominal assessment, including bowel sounds, was blank in the electronic medical record. The patient was receiving psychotropic medications. At the time of record review, the patient was in his/her 11th hospital day. The record contained no documentation of any bowel movements since admission. When interviewed about these findings, the nursing manager on the unit stated that the unit had no standard for documenting routine bowel activity. S/he stated that the nursing might be asking general questions of patients about "how they were doing" when they came up to the window line to get their medications at medication passing times. S/he stated that the standard was to "chart by exception," so routine bowel activity would not be recorded.

The unit manager was asked about documentation of food, fluid intake and elimination for patient in seclusion/restraints on the unit.
The "Seclusion And Restraint Flowsheet" form was examined while interviewing the manager. The sheet contained a section "food/fluids/bathroom." The heading stated "check (check mark) if offered every 2 hours." The associated boxes on the form only had room for a check mark. There was no area to document food or fluid intake amounts/estimates or descriptors of what was consumed. In addition, there was no area to document urination and bowel movements. The manager reiterated that the expectation was to only use the form as it was designed and only additional charting of information about intake and elimination "by exception only."

Based on medical record review, staff interviews, review of facility documents and policies and procedures, the facility failed to ensure that personnel who administered blood transfusions had special training for that duty.

The facility failed to ensure that the nurse (Sample Nurse #3) administering blood to a patient (Sample Patient #31) on the medical/surgical floor followed the facility's policy of having another RN independently document the required check prior to blood product transfusion. The facility failed to ensure that the nurses (Sample Nurses #1, #2 and #3) administering blood to a patient (Sample Patient #31) on the medical/surgical floor followed the facility's policy to confirm informed consent was signed by the physician and patient appropriately prior to transfusion of blood products. The failure created the potential for a negative patient outcome and a violation of patients' rights.

The facility failed to ensure that the nurses (Sample Nurse #4 and #5) administering blood to a patient (Sample Patient #32) in the ICU recognized the signs and symptoms of a potential febrile transfusion reaction and took the appropriate actions as outlined in the blood administration policy/procedure. Specifically, the nurses failed to document the notification of the Licensed Independent Practitioner as required in the policy/procedure, when the patient exhibited an increased temperature following the administration of three units of blood. The facility also failed to ensure that the nurses followed facility's policies regarding the documentation of patient vital signs during blood transfusions. Specifically, the nurses failed to follow the facility's policy of documentation of pre and post vital signs during the transfusion of blood products. The failure created the potential for a negative patient outcome.

The findings were:

1. Medical Record Review:

On 6/10/10 at approximately 10:25 AM, medical records for two patients (#31 and #32), who received blood transfusions, were reviewed.

Sample patient #31 was an adult patient on a medical/surgical floor. On 6/8/10, an order for the transfusion of two units of packed red blood cells (PRBCs) was written. A consent for blood transfusion was dated 6/8/10 and timed at 6:30 PM. The signature of the patient was on the line that read "Sign here if refusing blood transfusion". An entry on the consent was made on 6/10/10 at 10:00 AM that stated, "Verbally explained to patient that his/her signature is on the refusal line, s/he stated that s/he is too ill to re-sign but verbally consented for change in signature space" which was made by the Clinical Manager of the patient care unit. On 6/8/10, at 6:55 PM, the first unit of PRBCs was started; the computer documentation reflected that two Registered Nurses (RNs) (Sample Nurse #1 and #2) verified the blood consent and that all other steps in the verification of blood products were completed. On 6/8/10, at 10:45 PM, the second unit of PRBCs was started, the computer documentation reflected only one RN (Sample Nurse #3) verified the blood consent. There was no documentation of the unique unit number assigned to the second unit of PRBCs that was transfused on the computer documentation.

Sample patient #32 was an adult patient in the Intensive Care Unit (ICU). On 6/9/10, an order for the transfusion of three units of PRBCs was written. On 6/9/10, at 9:35 PM, the first unit of PRBCs was started. A review of vital sign documentation reflected an initial core temperature of 37.1 degrees Celsius at 9:30 PM; this accompanied a full set of vital signs recorded according to the facility's blood transfusion policy. The first unit of PRBCs was completed at 9:52 PM and the second unit of PRBCs was started at 9:53 PM. A full set of vital signs was recorded at 10:00 PM and indicated a core temperature of 37.2 degrees Celsius. The second unit of PRBCs was completed at 10:20 PM and the third unit of PRBCs was started at 10:34 PM. A full set of vital signs was recorded at 11:00 PM. The third unit of PRBCs was completed at 11:30 PM. A full set of vital signs was recorded on 6/10/10, at 12:00 AM, and reflected a core temperature of 38.6 degrees Celsius. The patient received Tylenol at 12:25 AM as a PRN (as needed) medication for temperature greater than 38.5 degrees Celsius that had been written by the physician upon admission to the ICU. There was no documentation of the nurse contacting the physician or licensed independent practitioner during or after the blood transfusion.

2. Policy/Procedure Review:

On 6/10/10, the policy/procedure "Blood and Blood Product," dated and approved 12/15/2009 was reviewed and revealed the following, in pertinent parts:
"...Procedure:...
...II. Preparation for Transfusion of Blood Products:...
...B. Confirm informed consent is signed by physician and patient...
...E. Obtain pre-transfusion vital signs within 1 hour of administering blood products and notify physician of any temperature elevation (greater than 37.5 degrees C) before blood is obtained from blood bank...
...G. Two RNs or RN/MD/CCP must identify patient by confirming name, MR# or DOB and BBA#. This must be done with the patient at the bedside. One of the two RNs/MD/CCP must administer blood product.
H. Verification at Bedside
1. Two RNs or an RN/MD/CCP check the following on Blood Bank label, BBA, and independently document. RNs to use the clinical documentation system:
a. Patient name
b. MR# or DOB (if MR# not available)
c. Blood Bank armband number
d. Patient's blood type
e. Unit blood type and product
f. Bag unit number
g. Product expiration date...
...III. Administration of Blood Products:
A. General Information:...
...2. Obtain vital signs 15 min after starting transfusion of each unit and then post-transfusion (within an hour). Products infused within 30 minutes - may obtain pre and post vital signs...

...IV. Transfusion Reactions:...
Febrile Reactions:
Commonly occur in 1-3% of all transfusions

Manifestations:
Fever > 1 C rise

Associated signs/symptoms (S&S):
Chills
Feeling cold
Discomfort
Headache
Rigors
Nausea/vomiting
Dyspnea
Severe lower back ache

(usually toward the end of the transfusion, present up to two hours after the transfusion)

Treatment:
Stop Transfusion
Keep IV open with N/S
Obtain vital signs and assess patient for stability
Recheck blood unit/patient for agreement in name, numbers, Blood Bank armband
Notify Licensed Independent Practitioner (LIP)
Give antipyretics as ordered
Re-check temperature at least 1/2 hour after chill
Notify Blood Bank of reaction and complete transfusion reaction documentation.
Consider collecting a urine specimen if the S&S significantly suggest a hemolytic reaction. The lab will request urine if needed.
Send entire blood administration setup and blood bag to blood bank in a biohazard bag..."

3. Staff Interview:

On 6/10/10 at approximately 10:25 AM, an interview was conducted with the Clinical Manager of the medical surgical unit that treated Sample Patient #31. The interview revealed the following:
The Clinical Manager had reviewed the transfusion documentation on 6/10/10 and noted that the patient had signed the blood transfusion consent form on the line that indicated she had refused blood products. The Clinical Manager stated that she had spoken on 6/10/10 at approximately 10:00 AM with Sample patient #31 in regards to the consent. S/he indicated that the patient told him/her that s/he did consent to receive blood but had written on the wrong line and felt too ill to re-sign the consent.

On 6/10/10 at approximately 10:35 AM, an interview was conducted with the Director of Quality Improvement. The interview revealed the following:
The Director of Quality Improvement reviewed the documentation of the blood transfusions performed on Sample Patient #31 with the surveyor on 6/10/10. S/he confirmed that there was no documentation that the second unit of blood was checked by anyone other than the nurse that administered the blood. S/he also confirmed that there was no documentation on the transfusion documentation of the unique unit number assigned to the second unit of blood that was administered to the patient.

On 6/10/10, at approximately 11:35 AM, an interview was conducted with the Clinical Manager of the Intensive Care Unit that treated Sample Patient #32. The interview revealed the following:
The Clinical Manager reviewed the documentation of the blood transfusions performed on Sample Patient #32 and the documented vital signs with the surveyor on 6/10/10. S/he stated that the ICU utilized the same policy on blood transfusions that the hospital had and provided a copy of the policy to the surveyor. S/he indicated that the patient was cared for by two RNs (Sample Nurses #4 and #5) as one of the nurses was being oriented to the unit by the other RN. S/he stated that since the blood being transfused had been infused within thirty minutes, the nurses would have documented the patient's vital signs before and after each unit of blood as the policy stated. S/he confirmed that the documentation reflected that the post-transfusion vital signs for the first unit of blood and the pre-transfusion vital signs for the second unit of blood was performed eight minutes after the completion of the transfusion of the first unit of blood and seven minutes after the initiation of the transfusion of the second unit of blood. S/he also confirmed that the next documented full set of vital signs was not until forty minutes after the completion of the transfusion of the second unit of blood and twenty six minutes after the initiation of the transfusion of the third unit of blood. S/he then also confirmed that the next documented full set of vital signs was not until thirty minutes after the completion of the transfusion of the third and final unit of blood. The Clinical Manager confirmed that there was a documented increase in patient temperature of 1.5 degrees Celsius. S/he confirmed that there was no documentation of the nurse contacting the Licensed Independent Practitioner or Blood Bank or completion of the transfusion reaction documentation as the facility's policy indicated should have occurred. The Clinical Manager stated that since the patient had undergone an open heart surgery, the increase in temperature was not a transfusion reaction. The Clinical Manager confirmed that the patient was given Tylenol on 6/10/10 at 12:25 AM in response to the elevated temperature documented at 12:00 AM.

In summary, the facility failed to ensure that nurses in the facility followed the facility's policies/procedures for the transfusion of blood products. There was no evidence in the patient record of Sample Patient #32 if the increase in the patient's temperature was due to a transfusion reaction or another factor (such as post-operative warming) and no evidence that the patient's nurse considered the former.

Based on policy and procedure review, staff interviews, and tour/observations, the Radiology department failed to ensure appropriate storage of personal radiation monitoring devices and sufficient training of personnel to policies and procedures.

On 6/08/2010 at approximately 10:00 a.m. a tour of the Radiology department was conducted by one state surveyor. During the tour several employees were identified wearing their personal radiation badges. When asked by the surveyor about storage of the badges at the end of their respective shifts, two nuclear medical technicians, one CT (computerized tomography) technician, and one interventional radiology technician responded that they take their badges home with them at the end of their shifts.

A review of the ALARA (As Low As Reasonably Allowed) Guidelines policy on 6/08/2010 revealed the following: no mention of badge maintenance in the policy. The radiation safety officer reviews the occupational radiation exposure reports and communicates with management via the Radiation Safety Committee about elevated exposure limits.

A review of the Radiation Safety Committee reports for the last quarter revealed one employee with an elevated exposure report for the previous month. Prior reports also listed employee exposures above the acceptable limit.

A review of the Department Orientation on 6/08/2010 revealed no mention regarding badge storage and maintenance.

An interview with the department manager on 6/08/2010 at approximately 11:00 a.m. revealed that s/he was aware badges should not be removed from the facility as they can be affected by heat and light sources when exposed to the sun and the interior of vehicles on hot days. By the end of the survey day the manager had sent out via email a Talking Points bulletin to all staff alerting them of the above and to store badges at the facility at the end of their shifts.

A tour of the offsite location on 6/07/2010 at approximately 4:30 p.m. was conducted by one state surveyor. When asked by the surveyor about policies and procedures, the technician responded that s/he was trained at the main campus and had only been at this location for about 4 months. After a search through the policy and procedure manual for an ALARA (As Low as Reasonably Allowed) policy, s/he could not locate one. The manual onsite contained approximately 10 old policies and procedures dated 3/30/2007. The technician stated that most likely all the policies and procedures were online, but s/he did not know how to access these.

In summary, the facility failed to appropriately track and monitor the personal radiation safety badges designed to alert staff members when exposure limits were reached. Badges were potentially exposed to both heat and light while stored in employee cars and removed from the facility. Although the reports of overexposure erred on the side of safety for the individuals noted, they may not have been accurate or provided quality information supportive of proper safety requirements. In addition, training for one technician at the offsite location was inadequate with a lack of knowledge about policies and procedures and how to access these. Failure to ensure all staff were adequately trained regarding proper safety measures and policies and procedures created the potential for negative patient and staff harm.

Based on a tour, observations, and staff interview, the offsite outpatient department failed to ensure film copies and reports were properly stored and secured.

A tour of the offsite department on 6/07/2010 at approximately 4:30 p.m. revealed the following: three film jackets with films inside and several reports lying in a bin on a counter. When asked by the surveyor about film storage, the technician on duty replied that the courier comes three times a week to pick up films. The counter was the designated spot so the courier would know where to obtain them. Completed reports remained in the bin until the technician had time to disperse to the urgent care clinic or private practices located in the same building. Reports for the private practices could remain overnight in the bin and until the offices opened in the morning Monday through Friday. Any reports received after close of business on Friday remained in the bin until Monday morning. The department was accessible from three doorways to urgent care personnel as well as office personnel from the physician practices in the building and housekeeping at night. In addition, there were offices of the urgent care practice with a common hallway into the Radiology department.

Upon further exploration it was determined that the department had locked storage space available, but that no one had considered the current situation to be a HIPAA violation.

A review of the Radiology policies and procedures on 6/08/2010 revealed no specific policy for film storage and security designated for the offsite location. According to the Film Handling policy guideline, in pertinent parts:
"Procedure:
1. Storage of Patient Films
Individual patient films will be stored according to the Centura Corporate Policy...".

In summary, the facility failed to provide specific guidelines for the proper storage and security of patient radiology films which are part of patient medical records at the offsite location. Unsecured medical records created the potential for negative patient harm by not ensuring the privacy of the patients involved.

Based on staff interviews and review of facility documents, the facility failed to monitor fire control plan activities, including records of fire drills, conducted by contracted property managers at leased properties where outpatient services were provided. The failure created the potential for a negative outcome for patients, visitors and staff.

The findings were:

1. On 6/10/10 at approximately 8:30 a.m., the director of safety and security was interviewed about physical environment issues. When asked about dates for the most recent fire drills and fire safety inspections at several outpatient clinic locations, s/he stated that the two property managers for those locations were not reliably providing current information about fire drills and inspections conducted at those properties. S/he, as well as the director of facilities management and the plant operations coordinator, who were also present at the interview, were not able to provide information about the most recent drills/inspections, because of what they characterized as a lack of cooperation/follow-through by the contract property managers. S/he acknowledged that this lapse related to ensuring that fire drills and inspections were actually being conducted by the contract property managers was a problem s/he had identified several weeks prior to the survey. S/he stated that they were attempting to address the problem.

2. On 6/10/10, subsequent to the interview, the director of safety and security provided a newly generated document titled "Outpatient Fire Drill Schedule on 2010." S/he stated that this information was being provided to address the lapse in monitoring fire drills and inspections at the outpatient clinic locations. Review of the document revealed that there were 5 separate properties being managed by the property managers, which contained one or more outpatient clinics/services. Fire drills were scheduled for the week of 6/21 for 4 of the locations and the week of 6/28 for the 5th location.

A note at the bottom of the document stated the following:
"Please note: (The property management company) has agreed to work on a process for training office fire wardens for each tenant as well as to conduct routine fire drills for the buildings that are managed for (the facility). (The director of safety and security) will continue to work (the property management company) to formalize this process as well as obtain data from departments located in those buildings upon drill completion."

Based on staff interviews and review of facility documents, the facility failed to maintain current written evidence of regular inspection and approval by local fire control agencies coordinated by contracted property managers at leased properties where outpatient services were provided. The failure created the potential for a negative outcome for patients, visitors and staff.

The findings were:

Refer to the findings for Tag A 0714 regarding failure to maintain written evidence of regular inspections and approval by local fire control agencies.

Due to the nature and number of deficiencies, the hospital failed to comply with the Condition of Infection Control. Specifically, there were no scrub sinks available in the GI (gastrointestinal) suite, improper scope cleaning method, and inconsistent and infrequent temperature and humidity recordings in the Women's Surgery Center. Acceptable standards of practice were not met.

The facility failed to meet the following standard under the Condition of Infection Control:

A0749 Infection Control Officer
The infection control officer failed to identify, assess and track unsafe practices in both the GI Suite and Women's Surgery Center which had the potential to contribute to communicable and nosocomial infections.

Please refer to the Conditions of Surgical Services and QAPI for additional pertinent information related to this Condition.

Based on observations during tour, staff interviews and facility documentation, the infection control officer failed to mitigate risks contributing to healthcare-associated infections including the presence of scrub sinks for proper handwashing before procedures in the GI suite, monitoring compliance with policies and procedures, requiring the proper use of detergents and/or germicides used in endoscopy high-level disinfection in accordance with manufacturer's guidelines, and consistent temperature and humidity monitoring in the Women's Surgery Center.

The findings were:

1. On 6/09/2010 a tour/observations of the GI Suite and staff interviews were conducted by two state surveyors. The suite had 4 procedure rooms in which each had a single sink. There were no scrub sinks observed outside of the procedure rooms. When asked by the surveyor about physician handwashing, the clinical coordinator explained that the physicians either use an alcohol-based foam located in each room or the sink in the employee lounge located at the end of the hall of the procedure rooms and separated by a door.

2. Further tour of the GI Suite and a cleaning room where endoscopy scopes are cleaned and sterilized revealed the presence of 2 sinks. When asked by the surveyor about cleaning procedures for scopes in the sink, the clinical coordinator explained that staff use 1-2 squirts of detergent in the water. The amount of water used was enough to cover the scopes. When asked about the manufacturer's guidelines and whether an exact amount of water was required per a specific amount of detergent, the nurse referred to the manufacturer's guidelines on the bottle of Medline Enzymatic detergent. The instructions stated to presoak equipment using 1-2 ounces per gallon of warm water. The nurse stated that staff do not measure the amount of water. The surveyor suggested to the clinical coordinator to mark the measured level of water on the sink so staff would not have to "guess" to determine proper strength of detergent, and to follow up with training for staff.

When asked what policy and procedure staff follow to perform endoscope cleaning and sterilization, the clinical coordinator produced a checklist provided by the company of the HLD sterilizer, Olympus, dated 7/02/2003. A notation on the document stated, in pertinent parts: "Olympus does not guarantee or otherwise represent to the customer or to any third party that any level of disinfection or any other results will be achieved through the completion of the following checklist procedures."

One surveyor returned to the GI Suite on 6/10/2010 at approximately 11:30 a.m. to verify staff training/understanding of procedures. It was observed that the sink had not been marked and that no container had been obtained to accurately measure the amount of water to be placed in the sink. No training had been completed per the manager.

On 6/09/2010 a review of the policy, "Disinfection - High Level Chemical", revealed the following, in pertinent parts:
POLICY
"I. General Information
A. Items to be disinfected should be categorized as to one of the following:
2. Semi-critical items: A device that comes into contact with intact mucous membranes and does not ordinarily penetrate sterile tissue. These items should receive a minimum of high-level disinfection immediately before use...
E. Instruments and scopes are thoroughly cleaned with a low-foaming detergent, rinsed thoroughly, and dried prior to immersion in the HLD...

PROCEDURE
I. Meticulously clean the instrument or scope to remove all organic material.
A. Soak scope/instrument in an enzymatic pre-soak for a minimum of 10 minutes and no longer than 1 hour (if approved by manufacturer).
B. Manually scrub instruments, cords, lens as needed using a mild, low-foaming detergent.
1. Open all stopcocks and scrub all channels and lumens with brush.
2. Use a syringe to flush ports..."

3. On 6/10/2010 a review of the temperature and humidity log for the Women's Surgery Center for the months of March to current date revealed the following: there were 12 days of recorded humidity for the months of March 2010 and April 2010 and no temperature recordings; 3 days of recorded humidity and no temperature recordings for May 2010, and 1 day of humidity and temperature recordings for June 10. Twenty-two (22) dates fell out of range (March 16, 17, 18, 19, 22, 23, 24, 25, 26, 29, 30, 31, April 1, 2, 5, 6, 8, 9, 12, 19, May 13 and June 10, 2010) with no corrective action noted.

On 6/09/2010 a review of the policy, "Operating Rooms/Same Day Surgery/OPMS Infection Control", revealed the following, in pertinent parts:
"D. General Environmental Considerations
5. Temperature, humidity and air exchanges are automatic and monitored by Plant Operations..."

During the survey there were no policies and procedures provided separately for the WSC. In an interview with the Director of Perioperative Services on 6/10/2010 at approximately 11:00 a.m. it was revealed that the Women's Surgery Center was under the auspices of Perioperative Services. Staff in this area must follow the same policies and procedures as the main perioperative services area.

An interview with the Director of Facilities on 6/10/2010 at approximately 1:30 p.m. revealed that temperature and humidity in the Women's Surgery Center cannot be centrally monitored. Staff in that area must physically look at the thermostats and record daily. No one person had been assigned to record and monitor the levels.

In summary, the facility failed to ensure services were provided within acceptable standards of practice and guidelines governing infection control. Proper equipment such as a scrub sink to perform basic handwashing to prevent the spread of germs was not present near the procedure rooms in the GI Suite. Appropriate procedure to wash endoscopy scopes was not followed. There was no policy with the exact steps required to clean and sterilize endoscopy scopes available for all staff to utilize. Temperature and humidity were not monitored and maintained within accepted standards of practice in the WSC.

Based on the number and nature of deficiencies cited, the hospital failed to comply with the Condition of Participation of Surgical Services. The hospital failed to ensure surgical services and policies achieved and maintained high standards of medical practice and patient care with resultant harm to four patients and the potential for negative patient harm to all patients.

The facility failed to meet the following standard under the Condition of Surgical Services:

A 0951 Operating Room Policies
The department of Surgical Services failed to provide staff with policies governing endoscope cleaning and disinfection that included best practices in the prevention of infections. Furthermore, with a lack of scrub sinks and appropriate alternative method for handwashing in the GI Suite, the facility failed to provide personnel with proper handwashing instructions. There was no policy and procedure in the Women's Surgery Center delineating responsibility and best practice for monitoring and tracking temperature and humidity levels such that surgical services would be provided in an appropriate environment.

Please refer to the Conditions of Infection Control and QAPI for additional information related to this Condition.

Based on a tour, observations, staff interviews, medical record review, and policy and procedure review, the facility failed to provide surgical services in accordance with acceptable standards of practice. Specifically, there were two incidents of foreign bodies (sponges) retained requiring additional surgery, one incident of neglect with injury to a patient caused by operator error of a robotic machine during surgery, and one incident of wrong site surgery requiring additional surgery on the correct side. Furthermore, there were inconsistent and infrequent temperature and humidity checks in the Women's Surgery Center (WSC) and no scrub sinks available for the physicians and staff in the GI Suite. In addition, scope cleaning procedures in the GI Suite did not meet standard of practice according to the manufacturer's guidelines and best infection control practices.

The findings were:

1. The medical record of sample patient #30 was reviewed. The patient was a 37 year-old adult admitted June 2010 for a right L5/S1 microdiscectomy. A timeout procedure was conducted by personnel in the operating room. However, the operation was performed on the wrong side of the spine. Before the patient was fully awakened from anesthesia, the surgeon determined that the procedure should have been completed on the other side. The patient was repositioned and the incision was re-opened to perform the operation on the correct side. The surgeon noted in the operative report that there was disc bulging on both sides of the spine.

An interview with the Director of Quality on 6/07/2010 at approximately 9:00 a.m. revealed that the facility was conducting an investigation and there were no definitive findings at this time. The survey team was made aware of the incident on this date.

2. The medical record of sample patient #34 was reviewed. The patient was a 22 year-old adult admitted May 2010 for an elective kidney donation. The patient sustained a trocar injury to the aorta necessitating emergent surgery to repair the aorta. No sponge count was completed when the case became emergent. A radiograph taken after the procedure while the patient was still in the operating room (OR) was read by a radiologist as negative for a retained foreign body. However, the film was of poor quality. A subsequent radiograph in the intensive care unit (ICU) revealed a foreign body in the abdomen. The patient was returned to surgery for removal of a sponge. The kidney was not donated and the patient remained hospitalized for 7 days with residual pain and weakness of the right lower extremity at the time of discharge. A consultation by neurology noted that there was an expectation the residual symptoms would resolve, but this was not determined to be conclusive.

A review of OR Unit Meeting minutes for 5/28/2010 on 6/10/2010 and an interview with the Director of Peri-Operative Services at approximately 1:30 p.m. revealed that the department is reviewing their current sponge count process and policy to determine what changes, if any, need to be made based on review of best practices, staff input and research. In the meantime, a protocol for the Radiology Technician to ask the OR team whether the X-ray is of sufficient quality or not was initiated.

A review of the current policy, "Sponge, Sharps and Instrument Counts" on 6/10/2010 revealed the following, in pertinent parts:
"A. There will be an X-ray taken prior to extubation and/or transfer of the patient from the OR suite for the following situations:
1. For an emergent case, where pre-surgical counts are not timely for efficient patient care.
2. Incorrect counts..."

An interview with the Director of Quality, Patient Safety Coordinator, and Chief Medical Officer on 6/10/2010 at approximately 3:00 p.m. revealed that tracking and monitoring for adherence to the new protocol was not being done. The investigation continues with regard to any policy changes. The case is currently under facility internal review.

3. The medical record of sample patient #35 was reviewed. The patient was a 86 year-old adult admitted December 2009 for elective excision of a left adrenal gland, pancreas and spleen secondary to metastatic carcinoma. During the surgery a Davinci robotic machine was erroneously moved before all connections to the patient were undocked and the patient sustained a tear to the aorta. Emergent repair was initiated but the patient sustained intraoperative hemorrhage with an estimated blood loss of 2000 ml, respiratory failure, and acute renal failure requiring dialysis. The patient eventually regained sufficient mental capacity to refuse further treatment and elected to proceed with hospice care. The prognosis was grave.

An interview with the Director of Quality and Director of Peri-Operative Services on 6/08/2010 at approximately 4:00 p.m. revealed that the facility had initiated a protocol but no policy had been implemented. Staff had received training, however, to perform a timeout when removing the Davinci robot on December 3, 2009. A sign-in sheet with 19 signatures for the training was received on 6/10/2010 along with a new policy dated 6/10/2010 requiring a timeout when removing the Davinci robot during a procedure.

An interview with the Director of Quality, Patient Safety Coordinator, and Chief Medical Officer on 6/10/2010 at approximately 3:00 p.m. revealed that tracking and monitoring for adherence to the protocol and the performance of actual timeouts was not being done.

A review of the documentation provided by the facility on 6/17/2010 demonstrated that there were 59 times in which the Davinci robot was used since the incident. Monitoring for policy compliance was initiated on 6/14/2010, six months after the adverse patient event, with weekly submissions to the Quality and Patient Safety department.

4. The medical record of sample #36 was reviewed. The patient was a 37 year-old adult who had a Mediport placed in the interventional radiology (IR) department February 2010. The patient was followed for port evaluation and function in the IR department on three occasions over the next 4 weeks. On the 4th visit due to persistent leakage of fluid, the port and a 4x4 sponge that had been left in at the time of the original procedure were removed. A drain was placed. Three days after this the patient was seen in the emergency room complaining of a fever. S/he was given a course of antibiotics. The patient was seen in clinic on two more occasions at which time the drain was removed. Six weeks later a new port was placed.

Documentation received from the facility was reviewed. A new policy was initiated in March 2010 requiring the use of radiopaque sponges in the placement of all ports in the future. An X-ray will be taken to check the position of the chest port and to determine whether any foreign objects are retained prior to closure of the opening. Monitoring for use of radiopaque sponges with these cases is ongoing with no deficient practice noted.

5. On 6/10/2010 a review of the temperature and humidity log for the Women's Surgery Center for the months of March to current date revealed the following: there were 12 days of recorded humidity for the months of March 2010 and April 2010 and no temperature recordings; 3 days of recorded humidity and no temperature recordings for May 2010, and 1 day of humidity and temperature recordings for June 10. Twenty-two (22) dates fell out of range (March 16, 17, 18, 19, 22, 23, 24, 25, 26, 29, 30, 31, April 1, 2, 5, 6, 8, 9, 12, 19, May 13 and June 10, 2010) with no corrective action noted.

On 6/09/2010 a review of the policy, "Operating Rooms/Same Day Surgery/OPMS Infection Control", revealed the following, in pertinent parts:
"D. General Environmental Considerations
5. Temperature, humidity and air exchanges are automatic and monitored by Plant Operations..."

During the survey there were no policies and procedures provided separately for the WSC. In an interview with the Director of Perioperative Services on 6/10/2010 at approximately 11:00 a.m. it was revealed that the Women's Surgery Center was under the auspices of Perioperative Services. Staff in this area must follow the same policies and procedures as the main perioperative services area.

An interview with the Director of Facilities on 6/10/2010 at approximately 1:30 p.m. revealed that temperature and humidity in the Women's Surgery Center cannot be centrally monitored. Staff in that area must physically look at the thermostats and record daily. No one person had been assigned to record and monitor the levels.

6. On 6/09/2010 a tour/observations of the GI Suite and staff interviews were conducted by two state surveyors. The suite had 4 procedure rooms in which each had a single sink. There were no scrub sinks observed outside of the procedure rooms. When asked by the surveyor about physician handwashing, the clinical coordinator explained that the physicians either use an alcohol-based foam located in each room or the sink in the employee lounge located at the end of the hall of the procedure rooms and separated by a door.

7. Further tour of the GI Suite and a cleaning room where endoscopy scopes are cleaned and sterilized revealed the presence of 2 sinks. When asked by the surveyor about cleaning procedures for scopes in the sink, the clinical coordinator explained that staff use 1-2 squirts of detergent in the water. The amount of water used was enough to cover the scopes. When asked about the manufacturer's guidelines and whether an exact amount of water was required per a specific amount of detergent, the nurse referred to the manufacturer's guidelines on the bottle of Medline Enzymatic detergent. The instructions stated to presoak equipment using 1-2 ounces per gallon of warm water. The nurse stated that staff do not measure the amount of water. The surveyor suggested to the clinical coordinator to mark the measured level of water on the sink so staff would not have to "guess" to determine proper strength of detergent, and to follow up with training for staff.

When asked what policy and procedure staff follow to perform endoscope cleaning and sterilization, the clinical coordinator produced a checklist provided by the company of the HLD sterilizer, Olympus, dated 7/02/2003. A notation on the document stated, in pertinent parts: "Olympus does not guarantee or otherwise represent to the customer or to any third party that any level of disinfection or any other results will be achieved through the completion of the following checklist procedures."

One surveyor returned to the GI Suite on 6/10/2010 at approximately 11:30 a.m. to verify staff training/understanding of procedures. It was observed that the sink had not been marked and that no container had been obtained to accurately measure the amount of water to be placed in the sink.

On 6/09/2010 a review of the policy, "Disinfection - High Level Chemical", revealed the following, in pertinent parts:
POLICY
"I. General Information
A. Items to be disinfected should be categorized as to one of the following:
2. Semi-critical items: A device that comes into contact with intact mucous membranes and does not ordinarily penetrate sterile tissue. These items should receive a minimum of high-level disinfection immediately before use...
E. Instruments and scopes are thoroughly cleaned with a low-foaming detergent, rinsed thoroughly, and dried prior to immersion in the HLD...

PROCEDURE
I. Meticulously clean the instrument or scope to remove all organic material.
A. Soak scope/instrument in an enzymatic pre-soak for a minimum of 10 minutes and no longer than 1 hour (if approved by manufacturer).
B. Manually scrub instruments, cords, lens as needed using a mild, low-foaming detergent.
1. Open all stopcocks and scrub all channels and lumens with brush.
2. Use a syringe to flush ports..."

In summary, the facility failed to ensure services were provided within acceptable standards of practice and guidelines governing surgical services. There was no tracking and monitoring for adherence to new policies and procedures for occurrences that are considered "never" events in the first place. One patient had wrong site surgery performed despite a timeout in the OR. Two patients required additional procedures to remove retained sponges. As a result of an emergent situation with no sponge count and a subsequent poor film read incorrectly by a specialist, a patient had to return to the OR for removal of a retained sponge and was not able to provide a kidney to a family member due to the injuries. Another patient was seen multiple times with complaints and required removal of a chest port and retained sponge only to have a new port placed three months later. Another patient sustained a severe aortic injury with resultant hemorraghic shock and renal failure when a robotic instrument was moved while still attached to the patient.

Temperature and humidity were not monitored and maintained within accepted standards of practice in the WSC.

Proper equipment such as a scrub sink to perform basic handwashing to prevent the spread of germs was not present near the procedure rooms in the GI Suite. Appropriate procedure to wash endoscopy scopes was not followed. There was no policy with the exact steps required to clean and sterilize endoscopy scopes available for all staff to utilize.

Failure to provide and ensure services were provided in accordance with acceptable standards of practice contributed to negative patient harm and created the potential for future negative patient harm.

Based on staff interviews and tours/observation at the outpatient clinics locations, the facility failed to ensure that outpatient services were appropriately organized and integrated with inpatient services. During tours and staff interviews conducted at outpatient clinics from 6/7/10-6/10/10, findings demonstrated a lack of oversight and policy/procedure support in the areas of fire drill and safety inspection, medical records management, radiological services and outpatient surgical services. Failures created the potential for negative outcomes for patients, visitors and staff.

The findings were:

Reference Tag A 0553 regarding improper storage of medical records in an outpatient radiology clinic.

Reference Tag A 0536 regarding improper storage of personal radiation monitoring devices and sufficient training of personnel to policies and procedures at a second outpatient radiology clinic.

Reference Tag A 0714 regarding failure to monitor fire control plan activities, including records of fire drills, conducted by contracted property managers at leased properties where outpatient services were provided.

Reference Tag A 0715 regarding failure to maintain current written evidence of regular inspection and approval by local fire control agencies coordinated by contracted property managers at leased properties where outpatient services were provided.

Reference Tag A 0951 regarding failure to have appropriate scrub sinks and diagnostic equipment cleaning procedures in place in the gastrointestinal (GI) suite, which provided outpatient services to patients.