HospitalInspections.org

Based on interview and record review, the hospital's governing body failed to provide the necessary oversight and guidance for the safe and effective conduct of the hospital as an institution.

Findings:

1. The facility failed to document that its governing body had appointed the hospital chief executive officer (CEO). The deficient practice had the potential to allow the facility's parent organization to undermine the governing body's authority over the hospital. (A-0057).

2. The hospital failed to maintain written policies regarding how it would assess and refer medical emergencies other than a cardiac or respiratory arrest (code blue) at its off-campus locations other than occupational health. The deficient practice allowed operation of off-campus locations without identification of clinical staff qualified to assess a need for emergency care, and had the potential to create confusion regarding staff roles in emergencies which did not culminate in a code blue. (A-0094).

3. The facility failed to ensure implementation of its Prevention of Retained Surgical Items policy when there was no documentation that OR Nurse 1 (a contract operating room nurse) had a passing score of 85 % on the facility's "Sponge ACCOUNTing Competency Test." This policy was updated to include competency assessment for all operating room staff (including contract staff) as part of the facility's plan of correction following a Complaint Validation survey in February 2011 which found that the facility's failure to assess the competency of staff in sponge counting led to a retained surgical sponge. The patient had to have a second surgery to remove the retained sponge. The facility's failure to assess the competency of OR Nurse 1 indicates that the facility has not implemented it's plan of correction. The systems failure identified during the Complaint Validation survey had not been corrected and has the potential to allow unqualified personnel (including contract staff) to work in the facility's operating room and increases the risk of another adverse event involving a retained surgical item. (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 (as recommended by AORN-American Association of periOperative Nurses). (A-0951).

5. The facility's governing body, the legally responsible entity for the conduct of hospital operations, failed to ensure that the services provided by a contract operating room nurse (OR Nurse 1) were provided in a safe and effective manner. There was no documented performance appraisal of OR Nurse 1 after she completed her first shift per the facility's Agency Personnel Patient Care Policy and no documentation that OR Nurse 1 had a passing score of 85 % on the facility's "Sponge ACCOUNTing Competency Test" as required by the facility's Prevention of Retained Surgical Items policy. These deficient practices had the potential to allow unqualified contract personnel to work in the facility's operating room and increased the risk of a retained surgical item. The facility also failed to evaluate the services provided by two contracted vendors prior to the survey. The deficient practice had the potential to allow substandard services to escape scrutiny. (A-0084).

6. The hospital failed to implement and maintain an effective, on-going, hospital-wide data-driven quality assessment and performance improvement program reflecting the complexity of the hospital's organization and services; involving all hospital departments and services (including those services furnished under contract or arrangement); and focused on indicators related to improved health outcomes and the prevention and reduction of medical errors. (A-0263)

The cumulative effects of these systemic problems resulted in the facility's failure to maintain the effectiveness of its governing body.

Based on interview and record review, the facility failed to document that its governing body had appointed the hospital chief executive officer (CEO). The deficient practice had the potential to allow the facility's parent organization to undermine the governing body's authority over the hospital.

Findings:

Review of the hospital's bylaws dated 5/12/11 indicated, "The President shall be the Chief Executive Officer of the corporation. The President shall be appointed jointly by the Board and the CHW [Catholic Healthcare West] COO [Chief Operating Officer]."

Review of the CEO's employment offer dated 6/21/07 and effective 7/2/07 indicated that it was printed on the letterhead of a CHW corporate office in Southern California and that the offer was signed by the President of Group Operations of CHW.

Review of the facility's Board of Trustees Executive Committee minutes dated 7/12/07 indicated that the chair reported to the committee that the CEO had been appointed and congratulated him on his new role. There was no documentation that the board had approved the CEO's appointment.

In an interview on 5/13/11 at 1:42 p.m., Staff GG stated that CHW and the hospital jointly appointed the CEO. She agreed that the documentation was "not crisp" at reflecting that the hospital board had been one of the parties making that appointment.

Based on interview and record review, the facility's governing body, the legally responsible entity for the conduct of hospital operations, failed to ensure that the services provided by a contract operating room nurse (OR Nurse 1) were provided in a safe and effective manner. There was no documented performance appraisal of OR Nurse 1 after she completed her first shift per the facility's Agency Personnel Patient Care Policy and no documentation that OR Nurse 1 had a passing score of 85 % on the facility's "Sponge ACCOUNTing Competency Test" as required by the facility's Prevention of Retained Surgical Items policy. These deficient practices had the potential to allow unqualified contract personnel to work in the facility's operating room and increased the risk of a retained surgical item. The facility also failed to evaluate the services provided by two contracted vendors prior to the survey. The deficient practice had the potential to allow substandard services to escape scrutiny.

Findings:

1. OR Nurse 1's personnel file was reviewed on 5/16/11 at 10:17 a.m. and showed that she was contracted to work for the hospital from 4/12/11 to 7/22/11 in the operating room. OR Nurse 1's first shift in the operating room was on 4/26/11 from 7:00 AM to 5:30 PM, a total of ten hours.

The Perioperative Service Manager and Educator who was present during the review stated she did a performance appraisal of OR Nurse 1 regarding her first day of work. The manager stated the process involved herself, OR Nurse 1 and the surgical technician who worked with OR Nurse 1. The appraisal was done "after a couple of cases" that OR Nurse 1 was involved in. According to the Perioperative Service Manager, the appraisal included sponge accounting policy and procedures, attitude and behavior, especially in communication, and setting up for a surgical case. When the surveyor asked to review OR Nurse 1's appraisal, the manager stated the process was all done verbally and there was no written documentation of OR Nurse 1's appraisal. There was no evidence in OR Nurse 1's personnel file to demonstrate that her performance as an operating room nurse was safe and effective. When asked if a performance evaluation was done post contract, the manager responded, "No evaluation is done post contract. It's done only if there are problems."

There was a test in OR Nurse 1's personnel file titled, "Sponge ACCOUNTing - FY11 Competency Test." The written instructions for the nurse taking this test were: "There are two parts to the competency tests for each employee who works in surgery, labor and delivery, special procedures and/or cath lab. The first part consists of an "oral" set of questions for the manager, clinical specialist, clinical safety specialist or educator to ask each staff member. The second part is a written test of 10 questions, which is meant to follow Part 1. Upon completion, this competency is scored and retained in the employee's education file. Passing is 85%." Part 2 consisted of true or false questions, with the instruction that if "false", state why under the question.

A review of OR Nurse 1's Sponge ACCOUNTing competency test showed it was missing the following items:
a) A documented passing score of 85% or better on the test.
b) Part 1 did not contain written comments from the Perioperative Manager regarding OR Nurse 1's responses to the oral questions. The Perioperative Manager had documented the following on the test: " Reviewed each question with (name of OR Nurse 1)", and signed and dated the form 4/19/11. There was no documentation to show that OR Nurse 1's answers to the oral questions were correct.
c) OR Nurse 1 did not follow the instructions to "state why under the question" if the response was false. OR Nurse 1 responded false to 6 out of the 10 true and false questions in Part 2 of the test but did not document why the response was false.

The Perioperative Services Manager stated that OR Nurse 1's responses to the oral questions on the Sponge ACCOUNTing Competency Test were all correct. However she acknowledged that there was no documentation to support this, that OR Nurse 1 had not followed the instructions for completing part two of the test and a passing grade of 85 % was not documented for OR Nurse 1.

A review of the answer key to the Sponge ACCOUNTing competency test indicated detailed answers for both Part 1 and Part 2 of the test. Comparing the answer key and OR Nurse 1's test, there were no documented results to demonstrate and measure the nurse's competency and knowledge of the hospital's policy and procedures for sponge counting.

A review of the facility's Agency Personnel Patient Care Policy (approved 12/2010) indicated the following:

Policy:
1. All individuals from an agency must meet the basic job description/performance expectations of regular staff and employees in their respective classifications.

Purpose:
To delineate a systematic process to ensure that agency personnel provide patient care services are competent.
Process:
B. Responsibility of Hospital
5. Oversees and monitors the files of agencies, agency staff, performance evaluations, orientations of agency staff in Staffing Services.
C. Responsibility of Staffing Services
3. Confirms staffs (sic) are competent to provide patient care services in accordance with department's established performance expectations.
6. Responsible to receive performance appraisals at the end of the first working shift....
6. Ensures that agency staff is in compliance with department policies and procedures.
( Incorrectly numbered in facility policy)
7. Retains all performance appraisals.
E. Responsibility of Assigned Resource Nurse (No letter D in facility policy).
4. Completes performance appraisals by the end of the first working shift.

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. 207,
"Retained objects are considered a preventable occurrence, and careful counting and documentation can significantly reduce, if not eliminate, these incidents."

Recommended Practices for Sponge, Sharp, and Instrument Counts.
Recommendation I (pg. 207 & 208).
Sponges should be counted on all procedures in which the possibility exists that a sponge could be retained.

3. Accurately accounting for sponges throughout a surgical procedure should be a priority of the surgical team to minimize the risks of a retained sponge.

8. Sponge counts should be conducted in the same sequence each time as defined by the facility. The counting sequence should be in a logical progression (e.g., from large to small or from proximal to distal). A standardized count procedure, following the same sequence, assists in achieving accuracy, efficiency, and continuity among perioperative team members. Studies in human error have shown that all errors involve some kind of deviation from routine practice.

Recommendation VI (pg. 213 & 214).
Policies and procedures for sponge, sharp, and instrument counts should be developed, reviewed periodically, revised as necessary, and readily available in the practice setting.

1. These policies and procedures should include, but not be limited to,
items to be counted,
directions for performing counts (e.g., sequence, item grouping),
...
competency validation.

Policies and procedures establish authority, responsibility, and accountability and serve as operational guidelines. Policies and procedures also assist in the development of patient safety, quality assessment, and quality improvement activities. Nurses should collaborate with all members of the healthcare team to develop policies that address surgical counts.

4. An introduction and review of policies and procedures should be included in orientation and ongoing education of perioperative personnel to assist them in obtaining knowledge and developing skills and attitudes that affect patient outcomes.

The facility's Prevention of Retained Surgical Items (approved 2/3/11) was reviewed and indicated the following:
I. Purpose:
A. To provide safety rules for perioperative registered nurse and scrub persons in the performance of sponge, sharp ,instrument and miscellaneous item counts.
G. Education and Training
1. Competency assessment:
b. At unit orientation, all new RN's and Surgical/Procedural personnel will complete the Learning Management System competency module (LMS) and test on Surgical Counts.

This policy was updated to include competency assessment for all operating room staff (including contract staff) as part of the facility's plan of correction following a Complaint Validation survey in February 2011 which found that the facility's failure to assess the competency of staff in sponge counting led to a retained surgical sponge. The patient had to have a second surgery to remove the retained sponge. The facility's failure to assess the competency of OR Nurse 1 indicates that the facility has not implemented it's plan of correction. The systems failure identified during the Complaint Validation survey has not been corrected and has the potential to allow unqualified personnel (including contract staff) to work in the facility's operating room and increases the risk of another adverse event involving a retained surgical item.


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2. In an interview on 5/13/11 at 1:52 p.m., Staff GG stated that the facility had not evaluated its contract for temporary staffing in the pharmacy. She stated that a contract with an imaging equipment manufacturer for preventive maintenance was a corporate-wide contract with the facility's parent organization and that she was having technical difficulties obtaining information regarding how the contract had been evaluated.

Review of documents provided by the facility on 5/16/11 regarding the preventive maintenance contract indicated that they included the contract itself as well as computations of uptime (the percentage of time a device is available for use, a commonly used evaluation of maintenance services). The uptime computations were for a one-year period ending 5/13/11, four days after the start of the survey. There was no documentation present indicating that an evaluation of the contracted service had been performed prior to the survey.

Based on interview and record review, the facility failed to maintain written policies regarding how it would assess and refer medical emergencies other than a cardiac or respiratory arrest (code blue) at its off-campus locations other than occupational health. The deficient practice allowed operation of off-campus locations without identification of clinical staff qualified to assess a need for emergency care, and had the potential to create confusion regarding staff roles in emergencies which did not culminate in a code blue.

Findings:

Review of the hospital's license indicated it had outpatient services in an adjacent medical office building, at a local baseball stadium, and sports medicine clinics in two adjacent counties.

In an interview and record review on 5/13/11 at 9:41 a.m., Staff II (the director of therapy services and occupational health) presented the surveyor the hospital's code blue policy approved 4/7/11, "Department-Specific Safety Response Guidelines" for occupational health and therapy services (both approved 4/23/10), and an "EMTALA [Emergency Medical Treatment and Labor Act] - EMERGENT CARE TRIAGING" policy for occupational health approved 4/21/11. Review of the policies indicated that the EMTALA policy for occupational health addressed medical emergencies other than a code blue. The code blue policy did not address assessment and referral of lesser medical emergencies at off-campus locations. Both "Department-Specific Safety Response Guidelines" addressed code blue, fires, and disasters, but not assessment and referral of medical emergencies other than code blue. Staff II stated, "Anything short of code blue is treated as code blue." She stated that a person had fainted at the hand clinic and the staff had called a code blue. She stated that at off-campus locations the staff would call 911. She stated that occupational health followed the EMTALA policy, but that the clinic in one of the adjacent counties did not.

In an interview on 5/13/11 at 1:42 p.m., Staff GG (the vice president of mission advocacy and community health) stated that the off-campus locations were not primary care settings, had limited capabilities, and either had no nurse or intermittent nurse staffing. She stated that the staff were certified in cardiopulmonary resuscitation (CPR) and use of an automated external defibrillator (AED), and that they would call 911 and deal with the emergency while waiting for 911 to arrive.

Based on interview and record review, the hospital failed to implement and maintain an effective, on-going, hospital-wide data-driven quality assessment and performance improvement program reflecting the complexity of the hospital's organization and services; involving all hospital departments and services (including those services furnished under contract or arrangement); and focused on indicators related to improved health outcomes and the prevention and reduction of medical errors.

1. The hospital failed to document that its governing body had approved the frequency and detail of data collection for its pathology performance indicators and its radiology "ticket to ride" project. The deficient practice reduced the governing body's leadership role regarding quality assessment and performance improvement (QAPI). (A-0277)

2. The facility failed to take actions aimed at performance improvement when it failed to ensure that the services provided by a contract operating room nurse (OR Nurse 1) were provided in a safe and effective manner. There was no documented performance appraisal of OR Nurse 1 after she completed her first shift per the facility's Agency Personnel Patient Care Policy and no documentation that OR Nurse 1 had a passing score of 85 % on the facility's Sponge ACCOUNTing Competency Test as required by the facility's Prevention of Retained Surgical Items policy. These deficient practices had the potential to allow unqualified contract personnel to work in the facility's operating room and increased the risk of a retained surgical item. (A-0289)

3. The facility failed to incorporate the radiation oncology service into its quality assessment and performance improvement (QAPI) program prior to the survey. The deficient practice sidestepped regulatory expectations that all hospital services be included in QAPI efforts and eliminated mechanisms by which the radiation oncology service could reach its maximum potential. (A-0298)

4. The facility failed to make an accurate determination of the number of distinct performance improvement (PI) projects it was conducting. The deficient practice eliminated a mechanism by which the facility leadership could know what projects were underway and prioritize its efforts. (A-0317)

5. The facility failed to incorporate into its QAPI program the monitoring and implementation and the facility's plan of correction for the complaint validation on February 2011 wherein the facility was found not in compliance with the Condition of Participation for Surgical Services due to a retained sponge and the patient had to undergo another surgery to remove the sponge that was retained. (Q 940, Q 951).

The cumulative effect of these system failures resulted in the failure of the hospital to maintain an effective quality assessment and performance improvement program.

Based on observation, interview, and record review, the facility failed to document that its governing body had approved the frequency and detail of data collection for its pathology performance indicators and its radiology "ticket to ride" project. The deficient practice reduced the governing body's leadership role regarding quality assessment and performance improvement (QAPI).

Findings:

In an observation and record review during a tour of the clinical labs on 5/9/11 at 1:16 p.m., Staff CC (a pathologist) retrieved a document showing the performance indicators for the facility's anatomic pathology service. Review of the document indicated it had been reviewed and signed by Staff CC. There was no indication it had also been reviewed by other persons.

Review of the documents provided by the facility regarding performance indicators for its diagnostic radiology service indicated that they included "Ticket to Ride Compliance". Review of a document titled "Radiology Medical Record Review Action Plan" dated 2/11 explained that the project involved requiring a ticket to be filled out with information about the patient before the patient could be handed off or transported.

In an interview on 5/13/11 at 11:39 a.m., the surveyor requested Staff FF to provide documentation that the pathology performance indicators and radiology ticket to ride project had been approved by the hospital board. Staff FF stated that board minutes for April and later were not yet available. She then presented an undated page which she stated was from the quality committee of the board and pointed to a passage in the document which stated, "Medical Record Review activities are now being done in the QLC [Quality Leadership Council] group to ensure compliance with action planning." Staff FF also presented a memo she sent to members of the Quality Assessment and Improvement Committee dated 7/22/10 titled "Aggregated Documentation Review Year End Summary". The document discussed goal-setting by the medical record review committee and the number of audits done and planned. Staff FF also presented a table with performance measures for the hospital's national patient safety goals and pointed to the statistics labeled "Improve Effectiveness of Communication" and "Hand-off Communication". None of the documents presented by Staff FF addressed what data were being collected and how often for either the pathology performance indicators or the ticket to ride project. When the surveyor pointed out to Staff FF that the documents did not appear to demonstrate that the governing body had approved the details of either project, she replied, "This is how we did it", and stated that she did not have minutes with the documentation the surveyor was requesting.

Review of the Department of Special Services meeting minutes dated 2/2/11 indicated that the anatomic pathology performance indicators were discussed. Review of the Medical Executive Committee (MEC) minutes dated 2/17/11 indicated that the anatomic pathology performance indicators were included as part of the department's report and that the MEC approved the report and recommendations. Review of the hospital's board of trustees executive committee minutes dated 3/3/11 indicated that the committee approved the credentialing recommendations from the MEC meeting on 2/17/11, but that there was no mention that the board was approving other aspects of the 2/17 MEC meeting and no mention of departmental reports or pathology performance indicators. No board minutes subsequent to 3/3/11 were presented by the facility.

Review of the Survey Readiness Committee minutes dated 4/15/11 indicated that the radiology ticket to ride project was discussed along with a plan to measure compliance daily. No other documentation was present to indicate that the hospital board had approved this plan.

The facility failed to take actions aimed at performance improvement when it failed to ensure that the services provided by a contract operating room nurse (OR Nurse 1) were provided in a safe and effective manner. There was no documented performance appraisal of OR Nurse 1 after she completed her first shift per the facility's Agency Personnel Patient Care Policy and no documentation that OR Nurse 1 had a passing score of 85 % on the facility's Sponge ACCOUNTing Competency Test as required by the facility's Prevention of Retained Surgical Items policy. These deficient practices had the potential to allow unqualified contract personnel to work in the facility's operating room and increases the risk of a retained surgical item.

Findings:

OR Nurse 1's personnel file was reviewed on 5/16/11 at 10:17 a.m. and showed that she was contracted to work for the hospital from 4/12/11 to 7/22/11 in the operating room. OR Nurse 1's first shift in the operating room was on 4/26/11 from 7:00 AM to 5:30 PM, a total of ten hours.

The Perioperative Service Manager and Educator who was present during the review stated she did a performance appraisal of OR Nurse 1 regarding her first day of work. The manager stated the process involved herself, OR Nurse 1 and the surgical technician who worked with OR Nurse 1. The appraisal was done "after a couple of cases" that OR Nurse 1 was involved in. According to the Perioperative Service Manager, the appraisal included sponge accounting policy and procedures, attitude and behavior, especially in communication, and setting up for a surgical case. When the surveyor asked to review OR Nurse 1's appraisal, the manager stated the process was all done verbally and there was no written documentation of OR Nurse 1's appraisal. There was no evidence in OR Nurse 1's personnel file to demonstrate that her performance as an operating room nurse was safe and effective. When asked if a performance evaluation was done post contract, the manager responded, "No evaluation is done post contract. It's done only if there are problems."

There was a test in OR Nurse 1's personnel file titled, "Sponge ACCOUNTing - FY11 Competency Test." The written instructions for the nurse taking this test were: "There are two parts to the competency tests for each employee who works in surgery, labor and delivery, special procedures and/or cath lab. The first part consists of an "oral" set of questions for the manager, clinical specialist, clinical safety specialist or educator to ask each staff member. The second part is a written test of 10 questions, which is meant to follow Part 1. Upon completion, this competency is scored and retained in the employee's education file. Passing is 85%." Part 2 consisted of true or false questions, with the instruction that if "false", state why under the question.

A review of OR Nurse 1's Sponge ACCOUNTing competency test showed it was missing the following items:
a) A documented passing score of 85% or better on the test.
b) Part 1 did not contain written comments from the Perioperative Manager regarding OR Nurse 1's responses to the oral questions. The Perioperative Manager had documented the following on the test: " Reviewed each question with (name of OR Nurse 1)" and signed and dated the form 4/19/11. There was no documentation to show that OR Nurse 1's answers to the oral questions were correct.
c) OR Nurse 1 did not follow the instructions to "state why under the question" if the response was false. OR Nurse 1 responded false to 6 out of the 10 true and false questions in Part 2 of the test but did not document why the response was false.

The Perioperative Services Manager stated that OR Nurse 1's responses to the oral questions on the Sponge ACCOUNTing Competency Test were all correct. However she acknowledged that there was no documentation to support this, that OR Nurse 1 had not followed the instructions for completing part two of the test and a passing grade of 85 % was not documented for OR Nurse 1.

A review of the answer key to the Sponge ACCOUNTing competency test indicated detailed answers for both Part 1 and Part 2 of the test. Comparing the answer key and OR Nurse 1's test, there were no documented results to demonstrate and measure the nurse's competency and knowledge of the hospital's policy and procedures for sponge counting.

A review of the facility's Agency Personnel Patient Care Policy (approved 12/2010) indicated the following:

Policy:
1. All individuals from an agency must meet the basic job description/performance expectations of regular staff and employees in their respective classifications.

Purpose:
To delineate a systematic process to ensure that agency personnel provide patient care services are competent.
Process:
B. Responsibility of Hospital
5. Oversees and monitors the files of agencies, agency staff, performance evaluations, orientations of agency staff in Staffing Services.
C. Responsibility of Staffing Services
3. Confirms staffs (sic) are competent to provide patient care services in accordance with department's established performance expectations.
6. Responsible to receive performance appraisals at the end of the first working shift....
6. Ensures that agency staff is in compliance with department policies and procedures.
( Incorrectly numbered in facility policy)
7. Retains all performance appraisals.
E. Responsibility of Assigned Resource Nurse (No letter D in facility policy).
4. Completes performance appraisals by the end of the first working shift.

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. 207,
"Retained objects are considered a preventable occurrence, and careful counting and documentation can significantly reduce, if not eliminate, these incidents."

Recommended Practices for Sponge, Sharp, and Instrument Counts.
Recommendation I (pg. 207 & 208).
Sponges should be counted on all procedures in which the possibility exists that a sponge could be retained.

3. Accurately accounting for sponges throughout a surgical procedure should be a priority of the surgical team to minimize the risks of a retained sponge.

8. Sponge counts should be conducted in the same sequence each time as defined by the facility. The counting sequence should be in a logical progression (e.g., from large to small or from proximal to distal). A standardized count procedure, following the same sequence, assists in achieving accuracy, efficiency, and continuity among perioperative team members. Studies in human error have shown that all errors involve some kind of deviation from routine practice.

Recommendation VI (pg. 213 & 214).
Policies and procedures for sponge, sharp, and instrument counts should be developed, reviewed periodically, revised as necessary, and readily available in the practice setting.

1. These policies and procedures should include, but not be limited to,
items to be counted,
directions for performing counts (e.g., sequence, item grouping),
...
competency validation.

Policies and procedures establish authority, responsibility, and accountability and serve as operational guidelines. Policies and procedures also assist in the development of patient safety, quality assessment, and quality improvement activities. Nurses should collaborate with all members of the healthcare team to develop policies that address surgical counts.

4. An introduction and review of policies and procedures should be included in orientation and ongoing education of perioperative personnel to assist them in obtaining knowledge and developing skills and attitudes that affect patient outcomes.

The facility's Prevention of Retained Surgical Items (approved 2/3/11) was reviewed and indicated the following:
I. Purpose:
A. To provide safety rules for perioperative registered nurse and scrub persons in the performance of sponge, sharp ,instrument and miscellaneous item counts.
G. Education and Training
1. Competency assessment:
b. At unit orientation, all new RN's and Surgical/Procedural personnel will complete the Learning Management System competency module (LMS) and test on Surgical Counts.

This policy was updated to include competency assessment for all operating room staff (including contract staff) as part of the facility's plan of correction following a Complaint Validation survey in February 2011 which found that the facility's failure to assess the competency of staff in sponge counting led to a retained surgical sponge. The patient had to have a second surgery to remove the retained sponge. The facility's failure to assess the competency of OR Nurse 1 indicates that the facility has not implemented it's plan of correction. The systems failure identified during the Complaint Validation survey has not been corrected and has the potential to allow unqualified personnel (including contract staff) to work in the facility's operating room and increases the risk of another adverse event involving a retained surgical item.

Based on interview and record review, the facility failed to incorporate the radiation oncology service into its quality assessment and performance improvement (QAPI) program prior to the survey. The deficient practice sidestepped regulatory expectations that all hospital services be included in QAPI efforts and eliminated mechanisms by which the radiation oncology service could reach its maximum potential.

Findings:

In an interview during the tour of the radiation oncology clinic on 5/9/11 at 11:27 a.m., the surveyor requested Staff DD (the manager of radiation oncology) and EE (the chief therapist) to provide documentation of how the radiation oncology service was integrated into the hospital's QAPI program. Staff DD requested clarification of what the surveyor's request meant, then agreed to provide performance indicators and examples of quality improvement projects as a follow-up item.

In an interview and record review on 5/10/11 at 2:21 p.m., Staff GG (the vice president for mission advocacy and community health) presented documents with an adhesive memo attached stating that they contained information about quality assurance in radiation oncology. Review of the documents indicated that they included minutes of the hospital safety committee dated 4/6/11, with an item highlighted indicating that the annual lead apron checks had been completed. The documents also included the "Radiation Protection Committee" minutes dated 3/15/11; the section on radiation oncology indicated that the radiation oncologist no longer wanted to be the radiation safety officer. Neither document included a discussion of metrics used to measure the performance of the radiation oncology service or projects to improve that performance. Staff FF (the senior clinical quality analyst) stated that she would check for performance indicators and performance improvement projects in radiation oncology.

In an interview on 5/11/11 at 10:20 a.m., the surveyor requested Staff GG to provide the promised performance indicators for radiation oncology.

In an interview and record review on 5/11/11 at 3:49 p.m., Staff EE presented performance measurements regarding treatment plan review by the physicist within three days and discharge summaries sent to referring physicians within 7 days. Both documents presented a graph with a baseline measurement and no follow-up measurements. Both documents contained analysis and action plans dated 5/11/11, 2 days after the start of the survey and the same day the documents were presented to the surveyor. Both documents had reports attached used to compute the performance measurements which were also dated 5/11/11. Staff GG stated that although the department did not have previously dated results in the customary format, they had been doing tremendous amounts of quality assurance (QA). Staff EE presented a "QA Indicators Flowsheet" listing the indicators checked during the course of treating a patient. The flowsheet indicated that the therapist would log any "parameters out of spec", listed "Weekly QA Indicators" which would be reported if missing, specified that "QA Checklist Results" would be reported to a "QCI Meeting" and that a "QCI Summary Report" would be brought to the Special Services Department meeting. When the surveyor asked to see the "QA Checklist Results" and "QCI Summary Report", Staff EE replied that the system had lockouts so treatments could not proceed if any of the required items were missing, but that any exceptions were reported to the "CQI Committee".

Review of the "Radiation Oncology CQI Meeting Minutes" indicated the committee had met on 11/8/10 and 12/13/10. Neither meeting discussed exceptions to the QA indicators listed on the flowsheet, "QA Checklist Results" or a "QCI Summary Report". The 11/8/10 meeting discussed a problem with difficulties seeing fiducial rods (markers placed as a reference point) and a plan to address the issue, but there was no data quantifying the problem or follow-up at the next meeting measuring the efficacy of the planned improvement.

Review of the minutes from the Department of Special Services for the 12 months preceding the survey indicated there had been no discussion of quality indicators or quality improvement for the radiation oncology service.

Review of the hospital's "Prioritization Grid: Performance Improvement Initiatives 2011" dated 5/12/11 indicated there were no projects listed which were specific to radiation oncology. Review of the hospital's "Performance Improvement Monitoring Summary Sheet" dated 5/10/11 indicated none of the 136 items being monitored involved the radiation oncology service.

Based on interview and record review, the facility failed to make an accurate determination of the number of distinct performance improvement (PI) projects it was conducting. The deficient practice eliminated a mechanism by which the facility leadership could know what projects were underway and prioritize its efforts.

Findings:

In an interview on 5/13/11 at 10:04 a.m., the surveyor requested a summary of the hospital's performance indicators. Staff FF presented the surveyor with a 17 page document titled "Care Management/Patient Safety MOR Performance as of Mar 2011" which detailed the facility's performance on 48 indicators. In an interview on 5/13/11 at 10:55 a.m., Staff FF stated that the facility was conducting 13 PI projects. When the surveyor expressed surprise at the discrepancy between the the number of performance indicators and the number of PI projects, Staff FF stated that there were actually 13 groupings of projects and presented a document titled "Prioritization Grid: Performance Improvement Initiatives 2011" which was dated 5/12/11. She stated that there was another list which further broke out the projects, but that there were also additional projects that were not included on that list either and that there was no single document listing every project in the hospital or enumerating them.

Review of the prioritization grid provided by Staff FF indicated that it included thirteen categories such as "Patient safety initiatives", "NPSG [National Patient Safety Goals] initiatives", and "Core measures". For nine of the thirteen categories, the grid included subheadings; four of the thirteen categories had neither subheadings nor a further description or enumeration of the projects included in the category. There was no tally of the total number of projects included in each category.

Review of the facility's "Performance Improvement Monitoring Summary Sheet" dated 5/10/11 indicated that the hospital was monitoring its performance on 138 parameters. The document did not indicate which parameters had PI projects associated with them.

Review of a packet labeled "National Patient Safety Goals" indicated that it included a document titled "SFMH [initials of the facility] Sustainability Plan FY11" which was undated. The sustainability plan indicated that the "NPSG initiatives" included as one of the thirteen categories on the prioritization grid included 88 goals in 10 categories for which the hospital was measuring its performance. 52 of the 88 goals had comments written in a column labeled "Facility Identified Vulnerabilities and Improvement or Sustainment Strategies". Review of the 52 comments indicated that 25 of them identified plans for improvement.

Based on interview and record review, the facility failed to consider relevant information during its periodic appraisals of medical staff. For 5 of 10 sampled credentials files (Practitioners 4, 6, 7, 9, and 10), the facility did not document the outcomes of its peer review activities. For 1 of 10 sampled credentials files (Practitioner 9), the facility had not updated the information regarding the quality of the physician's work since 2007. For 1 of 10 sampled credentials files (Practitioner 4), the facility had not noticed that the physician's malpractice coverage was not appropriate for the scope of his privileges. The deficient practices limited the efficacy of the medical staff reappointment process.

Findings:

1. Review of the credentials files for Practitioners 4, 6, 7, 9, and 10 indicated that none had information regarding what the outcomes were of cases that had been sent to peer review, if any.

In an interview on 5/11/11 at 3:18 p.m., Staff JJ agreed that the credentials files did not contain peer review data. She stated that the medical staff office recorded minutes at the meetings where peer review cases were discussed, and the data were kept by the quality department. She stated the medical staff office did not have access to cumulative results by practitioner, only the minutes recording the discussion of individual cases. In an interview on 5/11/11 at 2:43 p.m., Staff JJ stated that she was not able to locate physician-specific peer review results for the radiology service.

2. Review of Practitioner 9's credentials file indicated that the quality data in the file was for calendar year 2007 and that more recent quality indicators were missing.

In an interview on 5/11/11 at 2:08 p.m., Staff JJ agreed that more recent quality data regarding Practitioner 9 wasn't present.

3. Review of Practitioner 4's credentials file indicated that he was a pulmonologist whose privileges included invasive procedures. Practitioner 4's malpractice insurance certificate (dated 10/30/10) indicated it was for "Internal Medicine (Non-Invasive)".

Review of the facility's medical staff bylaws dated 8/5/10 indicated that professional liability insurance was a basic responsibility of medical staff membership.

In an interview on 5/11/11 at 3:18 p.m., Staff JJ stated that the facility had not caught the discrepancy between Practitioner 4's privileges and his malpractice insurance.

Based on interview and record review, the facility failed to enforce its bylaws for 2 of 10 sampled credentials files (Practitioners 1 and 2). For Practitioner 1, the facility failed to enforce provisions regarding the term of provisional appointments. For Practitioner 2, the facility failed to verify details surrounding discipline by the licensing board and failed to obtain the department chair's recommendation regarding proposed privileges. The deficient practices reduced the accountability of the medical and allied health staff.

Findings:

1. Review of Practitioner 1's credentials file indicated he was appointed to provisional status of the facility's medical staff on 8/6/09. A letter from the facility to Practitioner 1 dated 6/3/10 stated that the governing body had approved Practitioner 1's reappointment for an additional year, but that he would be dropped from the medical staff if he did not have sufficient clinical activity for evaluation during the final provisional year. A letter from the facility to Practitioner 1 dated 4/7/11 stated that the governing body had once again approved Practitioner 1 for reappointment for another year, but that he would dropped from the medical staff if he did not have sufficient activity during the final provisional year.

Review of the facility's medical staff bylaws dated 8/5/10 indicated, "Appointment to the provisional staff will expire twelve months from the date of appointment. Provisional staff appointment may be extended an additional twelve months at the discretion of the department chair. The purpose of this provisional category is to provide for the close observation and evaluation... of the new staff member... If at the end of two years there is insufficient clinical activity for appropriate evaluation, the member may be dropped from the medical staff without prejudice."

In an interview on 5/11/11 at 11:16 a.m., Staff JJ stated that Practitioner 1 had not had any activity at the facility and that the discrepancy was because the wrong dates had been put on the credentialing roster which was sent to the medical executive committee and on to the board.

2. Review of Practitioner 2's credentials file indicated he was reappointed to the allied health staff on 5/5/11 as a physician assistant. The primary source verification of his physician assistant's license indicated he had completed probation, but the details regarding the disciplinary action were from the board of registered nursing rather than the physician assistant committee of the medical board (the agency responsible for licensing physician assistants in California). Practitioner 2's privilege request form indicated that the first page did not indicate which of the requested privileges had been approved. The second page indicated treatment of specific age groups had been approved, but the field for the department chair's signature was blank.

Review of the facility's medical staff bylaws dated 8/5/10 indicated that applications from allied health professionals "must be processed and specific privileges granted by the governing body in the same manner as for members of the medical staff." The medical staff bylaws also indicated that the reappointment process was to include a review of all pertinent information available, that "The practitioner shall supply any information regarding... challenges to licensure...", and that "Proposed delineations of privileges shall be recommended to the medical executive committee by the applicable department."

In an interview on 5/11/11 at 11:16 a.m., Staff JJ stated that she suspected the physician assistant committee had taken "reciprocal action" on Practitioner 2's license because of the discipline by the board of registered nursing. In an interview on 5/11/11 at 1:32 p.m., Staff JJ stated that she had brought the records of the disciplinary action by the physician assistant committee and would add it to Practitioner 2's file.

Based on interview and record review, the facility failed to implement it's Medical Staff Rules and Regulations regarding verbal orders when there were four pages of telephone orders in Patient 28's record that had not been authenticated by the ordering physician within 48 hours. Failure to authenticate verbal orders has the potential to cause medication errors.

Findings:

During a review of Patient 28's record on 5/10/11 at 11:10 a.m., there were four pages of telephone orders dated 2/4/11. The part of the order sheet for the physician's signature and date indicated the following: t.o (telephone order), name of the physician, name of the nurse taking the order and the date. All four order sheets were the same except for page three which was not dated.

On 5/10/11 at 3:35 p.m., Patient 28's telephone orders were reviewed with the Director of Pharmacy who stated it was the facility's policy that all telephone orders be signed by the ordering physician within 48 hours. He said it was "not acceptable" that Patient 28's telephone orders had not been signed, dated and timed by the ordering physician.

A review of the facility's Medical Staff Rules and Regulations (dated April 2011) indicated the following:

Orders
62. All orders dictated over the telephone shall be signed by the authorized licensed person to whom dictated and shall include the name of the practitioner who gave the order, the date and time. All such entries shall be authenticated by the ordering or attending practitioner within forty-eight (48) hours.

4. Patient 27 was seen in the emergency room on 5/2/11 and admitted to the facility as an inpatient. A review of Patient 27's Emergency Department Record on 5/11/11 at 1:20 p.m. indicated there was no physician's signature and no date and time to indicate when Patient 27 was transferred to the inpatient unit.

During an interview on 5/11/11 at 1:57 p.m., the Director of the Emergency Department stated the physician should have signed, dated and timed Patient 27's Emergency Department Record.






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Based on interview and record review the facility failed to ensure that all patient medical record entries were dated, timed, and signed when one physician's written order did not have the date and time it was written (Patient 25), two Emergency Department Records did not have the date and time the patient was seen (Patient 24 & 26), two Emergency Department Records did not have the date and time the patient was transferred to the inpatient unit (Patient 24 & 26), and one Emergency Department Record was not dated, timed or signed by the physician (Patient 27). Failure to date and time all entries in the medical record could create confusion for other staff caring for the patient and can negatively affect patient safety and quality of care.

Findings:

1. Patient 25 was admitted to the facility on 7/24/10 due to burns from a house fire.

Review of the medical record indicated there were 2 physician's orders for Patient 25 with no date and time the orders were written.

In an interview on 5/10/11 at 2:30 PM, the Director of Burn Unit stated that the two physician orders were written by Dr. X. She said she could not tell if the two orders were written the same day or on separate days because there were no date and time.

2. Patient 26 was admitted to the facility on 4/26/11 with diagnoses including acute altered mental status and acute respiratory failure.

Review of the Emergency Department (ED) Record did not indicate the date and time the patient was seen and examined by the physician in the ED. It also was missing the date and time the patient was transferred to the inpatient unit.

3. Patient 24 was admitted to the facility on 12/11/10 with diagnosis of psychosis.

Review of the Emergency Department (ED) Record showed there was no date the patient was seen and examined by the physician in the ED and no date and time the patient was transferred to the inpatient unit.

Based on observation, interview, and record review, the facility failed to conduct preventive maintenance at the usual interval on a bone densitometer at its outpatient radiology service. The deficient practice had the potential to allow the use of poorly functioning equipment.

Findings:

In an observation on 5/9/11 at 12:49 p.m., the equipment at the outpatient radiology service included a bone densitometer. There were no markings on the equipment indicating it had received preventive maintenance within the past 12 months.

Review of the facility's maintenance log for the bone densitometer indicated the equipment was planned to receive annual preventive maintenance. The log and an attached report from the manufacturer indicated the preventive maintenance was last performed on 8/12/09, that the equipment had a repair for a specific problem on 12/20/10, and that another preventive maintenance had been requested on 5/10/11, the day after the surveyor had requested the preventive maintenance records.

In an interview on 5/11/11 at 11:07 a.m., Staff HH stated that the preventive maintenance on the bone densitometer had last been done in 2009, that it was due in 2010 but no action had been taken, and that the machine was on the schedule to have its preventive maintenance done the following week.

Based on observation, the facility failed to ensure that one radiologic technologist was wearing her dosimetry badge while she was working in the vicinity of a computed tomography (CT) scanner. The deficient practice reduced the facility's ability to measure its employees exposure to radiation.

Findings:

In an observation on 5/9/11 at approximately 10:30 a.m., Staff AA was sitting in the control room of the CT scanner and was not wearing a dosimetry badge. When questioned by the surveyor, she located her badge and put it on.

Based on interview and record review, the facility failed to have its medical executive committee (MEC) approve the policy delineating the tissue specimens that could be subject to gross examination only. The deficient practice had the potential to bypass consensus-building on a possible point of controversy.

Findings:

Review of the facility's policy "GROSS ONLY SPECIMENS" indicated that it was approved by the pathologist on 7/23/09, adopted by a non-physician on 9/15/09, and reviewed by the pathologist on 10/2/10. The policy listed the types of specimens which would be subject to gross examination only. The policy did not indicate that it had been approved by the MEC or other members of the medical staff aside from the pathologist.

In an interview on 5/10/11 at 11:07 a.m., Staff BB and CC stated that they would have the policy sent to the MEC for approval.

Based on food service observations, dietary staff interview, and dietary document review the Director of the department failed to ensure effective food production systems as evidenced by 1) the retention of spoiled and/or expired food items and 2) lack of development/implementation of a cooldown policy that ensured time/temperature control for potentially hazardous foods. Lack of effective food safety systems may put patients at risk for foodborne illness, further compromising medical status.

Findings:

*1. During initial tour on 5/11/11 beginning at 10 am the following was noted:

*a. In the produce refrigerator there was a bag of shredded carrots and diced celery dated 5/3. In a concurrent interview with Dietary Management Staff A , she stated that the hold time of produce was 3 days once opened. It was also noted that there was a bag of sweet potatoes, dated 5/10, of which several were covered with a white fuzzy material resembling mold.

*b. In the spice storage area there were expired spices that included ground chili powder (expired 2/11), mustard seed (expired 3/11), caraway seeds (delivered 4/07), basil leaves (expired 1/11) and bay spice (expired 3/11). In a concurrent interview with DMS A she stated that the expiration of spices, once opened was 12 months.

*2. During initial tour on 5/11/11 beginning at 10:30 am, it was noted that there were issues surrounding cooldown monitoring of potentially hazardous foods (PHF's-Cross Reference 749). PHF's are capable of supporting bacterial growth associated with foodborne illness if not handled correctly (Food Code 2009).

Undated dietary department policy titled "HACCP Standards" guided staff to cool food down rapidly to 70 degrees and to 41 degrees or below within 4 hours. It was also noted that the policy identified PHF's as including meats, eggs, vegetables and stuffed pasta. The policy did not include previously cooked starches such as potatoes, rice and unstuffed pasta. It was also noted that the policy guided staff that if the food did not reach 70 degrees within 2 hours the corrective measure would be to move the item to the freezer, finish the cooling and check the temperature after 4 hours.

The standard of practice for foods that do not reach 70 degrees within 4 hours would be to reheat the item to 165 degrees and begin the cooling/monitoring process again (Food Code, 200).

Based on observation, interview, and document review, the hospital failed to ensure that the diet manual provided comprehensive guidance on foods to serve to patients with physician's orders for therapeutic diets including mechanical soft and consistent carbohydrate. Failure to accurately provide foods on the consistent carbohydrate diet could lead to poor control of diabetes mellitus, and failure to provide mechanical soft foods could lead to food swallowing difficulties.

Findings:

1. Patient 1 had diet order Consistent Carbohydrate. On 5/12/11 at 2:30 p.m. the menu selected by Patient 1 for the dinner meal that night was reviewed with Dietary Staff H. DS H stated her job was to count the servings of carbohydrates and ensure no more than 3-5 per meal were served. Dietary Staff H stated Patient 1 had selected 3 or 4 carbohydrates. She stated she was unsure of the composition of soy milk selected by the patient, and did not have a food list to refer to, and consequently did not know whether the soy milk selected by Patient 1 should be counted as a carbohydrate. DS H stated the menu had changed, and there was no longer a list of carbohydrate foods. During review of the Diet Manual, it was revealed the diet specific to the hospital did not provide comprehensive guidance for foods to count as carbohydrates for the consistent carbohydrate diet.

2. During trayline observation on 5/11/11 at 12:15 pm, it was noted that random Patient 2 had a physician ordered mechanical soft, chopped diet. It was also noted that on her tray was the chopped stir fry entree as well as mashed potatoes in place of the rice. In a concurrent interview with DS I she stated that Patient 2 was likely a new admission and would not have had the opportunity to select her own food; rather the diet clerk would have selected the mashed potatoes instead of the rice.

In an interview on 5/12/11 at 2:30 pm, with DS H she stated that the department did not have a list of foods that would be allowed/not allowed for the different diets. In an interview with DMS A on 5/12/11 at 3:30 pm, she acknowledged there were no lists of foods that would be allowed or restricted for the various diets the hospital offered.

Based on observation, interview and document review, the hospital failed to ensure that 1.) potentially hazardous foods were monitored for time/temperature during cool-down and following hospital policy, 2) outdated foods were discarded and unavailable for use in patient food service, 3) ice machines were cleaned and sanitized following manufacturer's specifications, 4) frozen yogurt machine was cleaned and sanitized following manufacturer's recommendations, 5) food being prepared were protected from contamination by handwash water, 6) correct hand sanitizing precautions when delivering meal trays to patients was observed, and that 7) ice machines and food preparation sinks were attached to the wastewater system by air gaps that could prevent contamination of ice/foods in the event of a water back up. Failure to ensure foods are prepared using safe and sanitary methods may result in foodborne illness.

Findings:

1. During initial tour on 5/11/11 beginning at 10:30 a.m., it was noted that there was an unlabeled container, identified by Dietary Management Staff A (DMS A) as egg salad that was dated 5/10/11. In a concurrent interview with DMS A she stated that the cooks boiled the eggs for use in the sandwiches. In an interview on 5/11/11 with Dietary Staff B (DS B) he confirmed that the cooks boiled the eggs after which they peeled them; chopped them and put them in the refrigerator. He also stated that the cooks would monitor the temperature and record it on the cool down log. Concurrent review of dietary document titled "St Francis-Cooling Log" for 5/10/11 revealed that there was no entry of boiled eggs. DS B stated "they must have forgotten". DS B also stated that eggs were prepared every few days. Additional review of the department's cool down logs beginning 1/4/11 revealed there were no temperature entries that monitored the cool down of boiled eggs. Boiled eggs are considered a potentially hazardous food (PHF). PHF's are capable of supporting bacterial growth associated with foodborne illness if not handled correctly (Food Code 2009).

Additional observation in the walk-in refrigerator revealed that there was previously cooked pasta dated 5/9; orzo dated 5/10 and jook dated 5/10. None of these items were documented on the cool down log. Similarly in the walk-in freezer there was a pan of pork strips dated 5/7 and vegetarian chili dated 3/30 which were also not documented on the cool down log. In an interview on 5/12/11 at 9:15 a.m., with DMS A she stated that dietary staff were instructed to monitor all previously cooked foods for cool down and acknowledged they were not following the department's policy.

Undated dietary department policy titled "HACCP Standards" guided staff to cool food down rapidly to 70 degrees and to 41 degrees or below within 4 hours. It was also noted that the policy identified PHF's as including meats, eggs, vegetables and stuffed pasta. The policy did not include previously cooked starches such as potatoes, rice and unstuffed pasta. The Food Code 2009 defines starches, rice, and plain pasta as potentially hazardous foods that could support bacterial growth during cooldown.

2. During initial tour on 5/11/11 beginning at 10:30 a.m., it was noted that in the walk-in refrigerator there was a tub of fully frozen chicken breasts dated 5/10/11. It was also noted that a separate tub was filled with bags of chicken breasts, each weighing approximately 3 pounds, dated 5/10 which were fully thawed. In a concurrent interview with DS B he was asked to describe why one tub was fully thawed and the other fully frozen, both with the same thaw date. He stated that he thawed the chicken breasts in the bags on 5/10 under running water and did not need them so he placed them in the refrigerator.

While it would be possible to utilize running water as a mechanism to thaw meats this process would require a system to ensure specific time/temperature controls for food safety (Food Code, 2009).

3. On 5/11/11 during the initial tour of the kitchen between 10:00 a.m.-12:30 p.m., one case of sun-cup orange juice dated 4/28 was observed in the three-door reach-in trayline refrigerator. During a concurrent interview with Dietary Staff D (DS D), stated the foods in this refrigerator were dated with the date the case was opened. Product information provided by the hospital on 5/12/11 revealed the product had a ten day refrigerated shelf life. During an interview at 10:30 a.m. on 5/12/11, DS D acknowledged the juice should have been discarded two days earlier.

4. On 5/10/11 at 10:45 a.m. during discussions of the cleaning procedures for the two ice machines located in the kitchen, Engineer Staff E (ES E) stated he cleaned them semi-annually (twice a year). He stated he put ? cup (6 ounces) of "bleach" in a gallon of water and put that in the reservoir and let it circulate through the ice maker. Additionally the ice bin was cleaned by removing the ice and using the same concentration of bleach solution. ES E stated he did not need to de-scale the machine because the water used in the hospital is "great." A clean paper towel wiped across the bottom of the ice deflector in the bin revealed an orange debris

Review of the manufacturer's cleaning specifications provided by the hospital revealed the large cube ice machine should be de-scaled and then sanitized with 5.25 per cent sodium hypochlorite solution 1.5 ounces in one gallon of water. The frequency was annual. The second small cube ice machine specifications were to annually de-scale and then sanitize with a solution of 1.5 ounces sodium hypochlorite in 2 gallons of water. On 4/12/11 at 2:30 p.m., during review and discussion of the manufacturer's specifications, ES E acknowledged the ice machines had not been cleaned and sanitized following manufacturer's guidance.

5. At 11:10 a.m. on 5/11/11 in the cafe, the frozen yogurt machine manufacturer's cleaning specifications was reviewed and revealed the machine required sanitizing with 100 ppm chlorine strength sanitizer. Dietary Staff D stated the sanitizer used by the hospital was a broad range quaternary ammonia sanitizer. During a concurrent interview Dietary Management Staff C acknowledged the food machine was not sanitized following manufacturer's specifications.

6. On 5/11/11 during the initial tour of the kitchen between 10:00 a.m.-12:30 p.m., the hand wash sink in the food preparation area was observed to be immediately adjacent to a cold food preparation area where raw vegetables were being washed by dietary staff. Water from the hand wash sink could splash onto the raw ready-to-eat vegetables being cleaned. During a concurrent interview, DS D acknowledged the hand sink should have a splash guard on the side adjacent to the food preparation area.

7. During food distribution observation on 5/11/11 beginning at 12:15 p.m., CNA F was observed delivering meals in the rehab unit. CNA F took the patient's meal tray out of the cart, placed it on the over-bed table, proceeded to have direct patient contact after which she proceeded to handle the dishes on the patient's meal tray. It was also noted that she used an alcohol based hand sanitizer as she exited the room.

In an interview on 5/12/11 at 3:10 p.m., with CNA G the surveyor asked her to describe the meal delivery process. She described a process that would include using an alcohol based hand sanitizer prior to entering a patient room, after every direct patient contact and upon leaving the room. Hospital policy titled "Hand Hygiene Policy" dated 3/10 guided staff to utilize a waterless antiseptic agent or wash their hands with an antimicrobial soap before and after contact with a patient.


8. During general observations on 5/11/11 at 12:15 a.m., in the clean utility room on the 7th floor it was noted that the ice machine condensation line was directly connected to the waste water system. In an interview on 12:35 p.m., with ES E he confirmed that the ice machine was directly connected without the benefit of an air gap. He also stated there were other ice machines in the hospital that were connected the same way. In a follow up interview on 5/11/11 at 3:15 p.m., with ES E he stated that 8 of 25 hospital ice machines were directly connected to the waste water system.

Review of manufacturer's guidance for installation of the ice machine model DCM-500BAF, dated 5/24/99 guided staff to "keep more than a 2" air gap between drain pipe ends or hose ends and a floor drain."

9. During food production observations on 5/11/11 beginning at 10:45 a.m., it was noted that all of the food production sinks were plumbed directly into the wastewater system. It was also noted that there were food stuffs each of the food production sinks indicating that they were used for food production activities. In a follow up interview on 5/12/11 at 2:50 p.m., with DMS A she acknowledged there was no air gap in the departments' food production sinks.

The standard of practice in the food production industry is to ensure installation of an air gap between the water supply inlet and the flood level rim of the food production non-food equipment (Food Code, 2009).

Based on interview and record review, the facility failed to provide surgical services in accordance with nationally recognized standards of practice when :

1. The facility failed to implement its Prevention of Retained Surgical Items policy when there was no documentation that OR Nurse 1 (a contract operating room nurse) had a passing score of 85 % on the facility's "Sponge ACCOUNTing Competency Test." This policy was updated to include competency assessment for all operating room staff (including contract staff) as part of the facility's plan of correction following a Complaint Validation survey in February 2011 which found that the facility's failure to assess the competency of staff in sponge counting led to a retained surgical sponge. The patient had to have a second surgery to remove the retained sponge. The facility's failure to assess the competency of OR Nurse 1 indicates that the facility has not implemented it's plan of correction. The systems failure identified during the Complaint Validation survey has not been corrected and has the potential to allow unqualified personnel (including contract staff) to work in the facility's operating room and increases the risk of another adverse event involving a retained surgical item. (A-0951).

2. The facility failed to develop and implement a policy regarding terminal cleaning of the operating room which included the use of a wet vacuum (as recommended by AORN-American Association of periOperative Nurses). (A-0951).

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

2. On 5/12 /11 at 10:35 a.m. the Director of Perioperative Services was interviewed regarding the terminal cleaning of the facility's operating rooms. She stated,"We don't have a wet vacuum. We believe AORN guidelines are just that (guidelines). We do thoroughly clean with a mop". The surveyor reminded her that if the OR based their policies and process on AORN recommendations and standards they needed to be followed. She denied that scrub sink aerators are removed and cleaned and did not know what cleaning solution was being used for the OR floor cleaning. The OR staff educator told the surveyors that HB quat 25H was used for the floors and the scrub sinks.

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. 241,
"These recommended practices provide guidelines 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. ...

Recommendation IV (pg. 245).
Surgical and invasive procedure rooms and scrub/utility areas should be terminally cleaned daily.

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

Recommendation V (pg.245-246)
All areas and equipment in the surgical practice setting should be cleaned according to an established schedule.

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 Surgical Services Environmental Cleaning in The Perioperative Setting policy(approved 4/7/11) was reviewed and indicated the following:

Purpose:
2. To provide, through established practices, policies and schedules, relevant cleaning measures for the control and prevention of infection in the surgical suite.

Policy:
C. Surgical and invasive procedure room and scrub/utility areas will be terminally cleaned daily.
2. Floor must be wet mopped with and (sic) EPA-registered disinfectant after scheduled cases are completed.

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 as recommended by AORN. This had the potential to cause infection in patients having surgery at the facility.







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Based on interview and document review, the facility failed to implement its Prevention of Retained Surgical Items policy cited in their plan of correction for the complaint validation survey on 2/24/11, when there was no documentation that OR Nurse 1 (a contract operating room nurse) completed the Learning Management System competency module and test on surgical counts and had a passing score of 85 % on the facility's "Sponge ACCOUNTing Competency Test".

In addition, the facility failed to develop and implement a policy regarding terminal cleaning of the operating room which included the use of a wet vacuum (as recommended by AORN-American Association of periOperative Nurses).

These deficient practices had the potential to allow unqualified contract personnel to work in the facility's operating room, increase the risk of a retained surgical item and increase the risk of infection for all patients having surgery at the facility.

Findings:

During the complaint validation survey on 2/24/11, the facility failed to meet the Condition of Participation for Surgical Services. A Raytec sponge had been retained in the back of a patient who had undergone a complex spinal surgery. The circulating nurse and scrub technician were both contract employees. The hospital had no system in place to assess the sponge counting competency of any of its surgery staff, including travelling contract employees.

1. OR Nurse 1's personnel file was reviewed on 5/16/11 at 10:17 a.m. and showed that she was contracted to work for the hospital from 4/12/11 to 7/22/11 in the operating room. OR Nurse 1's first shift in the operating room was on 4/26/11 from 7:00 AM to 5:30 PM, a total of ten hours.

The Perioperative Service Manager and Educator who was present during the review stated she did a performance appraisal of OR Nurse 1 regarding her first day of work. The manager stated the process involved herself, OR Nurse 1 and the surgical technician who worked with OR Nurse 1. The appraisal was done "after a couple of cases" that OR Nurse 1 was involved in. According to the Perioperative Service Manager, the appraisal included sponge accounting policy and procedures, attitude and behavior, especially in communication, and setting up for a surgical case. When the surveyor asked to review OR Nurse 1's appraisal, the manager stated the process was all done verbally and there was no written documentation of OR Nurse 1's appraisal. There was no evidence in OR Nurse 1's personnel file to demonstrate that her performance as an operating room nurse was safe and effective. When asked if a performance evaluation was done post contract, the manager responded, "No evaluation is done post contract. It's done only if there are problems."

There was a test in OR Nurse 1's personnel file titled, "Sponge ACCOUNTing - FY11 Competency Test." The written instructions for the nurse taking this test were: "There are two parts to the competency tests for each employee who works in surgery, labor and delivery, special procedures and/or cath lab. The first part consists of an "oral" set of questions for the manager, clinical specialist, clinical safety specialist or educator to ask each staff member. The second part is a written test of 10 questions, which is meant to follow Part 1. Upon completion, this competency is scored and retained in the employee's education file. Passing is 85%." Part 2 consisted of true or false questions, with the instruction that if "false", state why under the question.

A review of OR Nurse 1's Sponge ACCOUNTing competency test showed it was missing the following items:
a) A documented passing score of 85% or better on the test.
b) Part 1 did not contain written comments from the Perioperative Manager regarding OR Nurse 1's responses to the oral questions. The Perioperative Manager had documented the following on the test: " Reviewed each question with (name of OR Nurse 1)" and signed and dated the form 4/19/11. There was no documentation to show that OR Nurse 1's answers to the oral questions were correct.
c) OR Nurse 1 did not follow the instructions to "state why under the question" if the response was false. OR Nurse 1 responded false to 6 out of the 10 true and false questions in Part 2 of the test but did not document why the response was false.

The Perioperative Services Manager stated that OR Nurse 1's responses to the oral questions on the Sponge ACCOUNTing Competency Test were all correct. However she acknowledged that there was no documentation to support this, that OR Nurse 1 had not followed the instructions for completing part two of the test and a passing grade of 85 % was not documented for OR Nurse 1.

A review of the answer key to the Sponge ACCOUNTing competency test indicated detailed answers for both Part 1 and Part 2 of the test. Comparing the answer key and OR Nurse 1's test, there were no documented results to demonstrate and measure the nurse's competency and knowledge of the hospital's policy and procedures for sponge counting.

A review of the facility's Agency Personnel Patient Care Policy (approved 12/2010) indicated the following:

Policy:
1. All individuals from an agency must meet the basic job description/performance expectations of regular staff and employees in their respective classifications.

Purpose:
To delineate a systematic process to ensure that agency personnel provide patient care services are competent.
Process:
B. Responsibility of Hospital
5. Oversees and monitors the files of agencies, agency staff, performance evaluations, orientations of agency staff in Staffing Services.
C. Responsibility of Staffing Services
3. Confirms staffs (sic) are competent to provide patient care services in accordance with department's established performance expectations.
6. Responsible to receive performance appraisals at the end of the first working shift....
6. Ensures that agency staff is in compliance with department policies and procedures.
( Incorrectly numbered in facility policy)
7. Retains all performance appraisals.
E. Responsibility of Assigned Resource Nurse (No letter D in facility policy).
4. Completes performance appraisals by the end of the first working shift.

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. 207,
"Retained objects are considered a preventable occurrence, and careful counting and documentation can significantly reduce, if not eliminate, these incidents."

Recommended Practices for Sponge, Sharp, and Instrument Counts.
Recommendation I (pg. 207 & 208).
Sponges should be counted on all procedures in which the possibility exists that a sponge could be retained.

3. Accurately accounting for sponges throughout a surgical procedure should be a priority of the surgical team to minimize the risks of a retained sponge.

8. Sponge counts should be conducted in the same sequence each time as defined by the facility. The counting sequence should be in a logical progression (e.g., from large to small or from proximal to distal). A standardized count procedure, following the same sequence, assists in achieving accuracy, efficiency, and continuity among perioperative team members. Studies in human error have shown that all errors involve some kind of deviation from routine practice.

Recommendation VI (pg. 213 & 214).
Policies and procedures for sponge, sharp, and instrument counts should be developed, reviewed periodically, revised as necessary, and readily available in the practice setting.

1. These policies and procedures should include, but not be limited to,
items to be counted,
directions for performing counts (e.g., sequence, item grouping),
...
competency validation.

Policies and procedures establish authority, responsibility, and accountability and serve as operational guidelines. Policies and procedures also assist in the development of patient safety, quality assessment, and quality improvement activities. Nurses should collaborate with all members of the healthcare team to develop policies that address surgical counts.

4. An introduction and review of policies and procedures should be included in orientation and ongoing education of perioperative personnel to assist them in obtaining knowledge and developing skills and attitudes that affect patient outcomes.

The facility's Prevention of Retained Surgical Items (approved 2/3/11) referred to in their plan of correction was reviewed and indicated the following:
I. Purpose:
A. To provide safety rules for perioperative registered nurse and scrub persons in the performance of sponge, sharp ,instrument and miscellaneous item counts.
G. Education and Training
1. Competency assessment:
b. At unit orientation, all new RN's and Surgical/Procedural personnel will complete the Learning Management System competency module (LMS) and test on Surgical Counts.

This policy included competency assessment for all operating room staff (including contract staff) as part of the facility's plan of correction following a Complaint Validation survey in February 2011 which found that the facility's failure to assess the competency of staff in sponge counting led to a retained surgical sponge. The patient had to have a second surgery to remove the retained sponge. The facility's failure to assess the competency of OR Nurse 1 indicates that the facility has not implemented its plan of correction. The systems failure identified during the Complaint Validation survey has not been corrected and has the potential to allow unqualified personnel (including contract staff) to work in the facility's operating room and increases the risk of another adverse event involving a retained surgical item.

Based on interview and record review, the facility failed to document that the medical director of the nuclear medicine service (Practitioner 9) had recent experience in nuclear medicine to demonstrate that he had current qualifications in the field. The deficient practice had the potential to deprive the nuclear medicine service of appropriate leadership.

Findings:

In an interview during the survey team meeting on 5/10/11 at 9:31 a.m., the surveyor assigned to nuclear medicine stated that Practitioner 9 was the chief of both the radiology service and the nuclear medicine service.

Review of Practitioner 9's credentials file indicated he was an interventional radiologist and that he did not have privileges in nuclear medicine. The file indicated Practitioner 9 had completed a diagnostic radiology residency in 2000 and a vascular/interventional radiology fellowship in 2001. Practitioner 9 was board certified in general diagnostic radiology in 2000, and became board certified in vascular and interventional radiology in 2004. The credentials file did not indicate what recent experience, if any, Practitioner 9 had in nuclear medicine.

In an interview on 5/12/11 at 2:43 p.m., Staff JJ stated that Practitioner 9 did not have privileges in nuclear medicine.