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Based on observation, interview and record review, the facility's Governing Body/Board (GB) failed to ensure the facility's operation was conducted in an effective, safe, and organized manner by failing to:

1. Ensure there was documented evidence the Chief of Staff had hospital privileges granted by the Governing Body/Board. (Refer to A046);

2. Ensure the medical staff was accountable to the GB for the quality of patient care provided at the facility. (Refer to A049);

3. Ensure that granting of privileges (credentialing process) were granted based on current demonstrated competence, training and experience. (Refer to A050);

4. Ensure the organization and accountability of the Medical Staff to the Governing Body. (Refer to A338);

5. Ensure Surgical Services were provided in accordance with the facility policies and procedures and standards of practice. (Refer to A940);

6. Ensure the development, implementation, and maintenance of an effective, ongoing, hospital-wide, data-driven Quality Assessment and Performance Improvement (QAPI) program. (Refer to A263); and,

7. Ensure the development and implementation of a discharge process to provide for effective discharge planning. (Refer to A799).



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On March 12, 2013, at 12:18 p.m., the Interim Chief Nursing Officer (ICNO) and the Risk Manager (RM) were notified Immediate Jeopardy (IJ) was identified (an IJ is a situation in which the provider's noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a patient). The IJ was identified due to the facility's failure to have documented evidence the Chief of Staff had hospital privileges granted by the Governing Body/Board. This created an ongoing risk for both in-patients and out-patients if the physician was allowed to continue operating without designated privileges.

On March 14, 2013, at 8 a.m., the Acting Chief Executive Officer (ACEO) was notified that an additional IJ was identified and an addendum was made to include that the surgical tech's were being allowed to perform procedures in which they were not privileged.

The facility submitted an acceptable written plan of correction for the IJ's on March 14, 2013, at 8:50 a.m.

After the survey team validated the immediate correction, the ACEO was notified and the IJ was removed on March 14, 2013, at 9:10 a.m.

The cumulative effect of these systemic problems resulted in failure of the Governing Body/Board to ensure patients were receiving quality care in a safe and effective manner.

Based on interview and record review, the facility failed to ensure there was documented evidence the Chief of Staff, who was providing surgical services to patients, had hospital privileges granted by the Governing Body. This failure increased the risk of substandard quality of care for all hospital patients.

Findings:

A review of the Health Care District (governing body) Bylaws, dated January 29, 2009, under Quality Assurance, Medical Staff Membership and Clinical Privileges, indicated "Final action on all matters relating to Medical Staff quality assurance, membership status, clinical privileges and corrective actions shall be taken by the Board after considering Medical Staff recommendations."

During a review of the credential file for MD 1, on March 11, 2013, at 11:30 a.m., it was noted the General Surgery Delineation Form, dated June 6, 2012, on the last page, indicated, "Applicant may perform privileges and procedures as indicated," followed by three spaces for signatures approving MD 1's hospital privileges. Two of the three signature lines contained a signature: one by the reviewer and one by a representative of the Medical Executive Committee, dated July 18, 2012, as required. However, the space for the Board of Directors to sign, and thus granting final approval of MD 1's surgical privileges, was left blank. There was no documented evidence MD 1 had hospital privileges granted by the Governing Board. During a concurrent interview with Staff 16, while reviewing the files, she stated the Chairman of the Board refused to sign off on MD 1's hospital privileges.

During a review of the MEC (Medical Executive Committee) Credentialing Report to the Board, dated July 18, 2012, the Credentialing Committee Recommendation and Signatures portion of the form indicated a "Favorable Recommendation." However, the space left for the Chairman of the Board to sign did not contain an approval signature, but instead, the words "Mr. [X] refused to sign," dated November 28, 2012. MD 1's credential file did not contain a completed, approved application for hospital privileges. During a concurrent interview with Staff 16, while reviewing these files, she restated the Chairman of the Board refused to sign MD 1's hospital privileges.

During a review of the Regular Board of Directors Meeting Minutes for 2012 and 2013, there was no documented evidence of approval of MD 1's privileges. Further review of The Regular Board of Directors Meeting Minutes dated November 28, 2012 indicated two "closed sessions." There was no evidence that MD 1's privileges had been granted by the governing board.

On March 12, 2013, at 12:18 p.m., the Interim Chief Nursing Officer (ICNO) and the Risk Manager (RM) were notified Immediate Jeopardy (IJ) was identified (an IJ is a situation in which the provider's noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a patient). The IJ was identified due to the facility's failure to have documented evidence that the Chief of Staff had hospital privileges granted by the Governing Body/Board. This created an ongoing risk for both in-patients and out-patients if the physician was allowed to continue operating without designated privileges.

On March 14, 2013, at 8 a.m., the Acting Chief Executive Officer (ACEO) was notified that an additional IJ was identified and an addendum was made to include that the surgical tech's were being allowed to perform procedures in which they were not privileged.

The facility submitted an acceptable written plan of correction for the IJ's on March 14, 2013, at 8:50 a.m.

After the survey team validated the immediate correction, the ACEO was notified and the IJ was removed on March 14, 2013, at 9:10 a.m.

Based on interview and record review, the facility failed to ensure the medical staff was accountable to the Governing Body for the quality of patient care provided at the facility. This was evidenced by:
1. The lack of peer review information used at the time of reappointment;
2. The lack of Governing Body involvement in the Peer Review process; and,
3. The lack of privileges granted to the Chief of Staff by the Governing Body.

These failures increased the risk of poor quality healthcare for all facility patients.

Findings:

A review of the Health Care District (governing body) Bylaws, dated January 28, 2009, under Quality Assurance, Medical Staff Membership and Clinical Privileges, indicated, "The Board shall also require mechanisms to assure the provision of quality health care at the Hospital... The Board shall evaluate the performance of its officers and employees, and also its own performance... Quality Assurance, Medical Staff Membership and Clinical Privileges. Membership on the Medical Staff shall be restricted to Practitioners who are competent in their respective fields, worthy in character and in professional ethics."

1. A review of the credential files of three practicing physicians (MD 7, MD 1, and MD 4) on March 11, 2013, at 11:30 a.m., indicated a lack of documentation of current competencies for all three physicians. During a concurrent interview with Staff 16, she confirmed the lack of documentation and stated the current competencies and activity of the physicians were "not checked unless there are questions."

During further credential file review at 4:30 p.m., there was no documented evidence of peer review activity for two of two physician files reviewed (MD 7 and MD 1). During a concurrent interview, Staff 16 confirmed the lack of documentation. She added, more information was documented on the Ongoing Professional Practice Evaluation (OPPE) sheets. Review of the OPPE sheets revealed limited data and no documented evidence of information regarding physician behavior or peer review. During a concurrent interview with Staff 16, she confirmed these findings.

2. Inspection of three Medical Staff Peer Review Forms on March 13, 2013, indicated that three out of three adverse patient events reviewed by the facility peer review committee contained no documented evidence of follow up actions, recommendations for future changes or evidence that these cases were referred to the Quality Assurance (QA) Committee or Governing Board.

Peer Review of Case #1 indicated that the patient was admitted and expired on the same day in early 2012 and according to the peer review committee:
a. Something could have been done differently;
b. The occurrence was due to a possible error; and
c. The care differed from acceptable standards of practice.

Despite these comments, the incident was, "scored as 3- minor deviation from standard of care- no significant outcome." The follow up section was left blank and the recommendation section indicated, "no further action necessary (appropriate for score 1 case)." The box for "inform MD- trend and track (appropriate for score 3 cases) was not checked. There was no documented evidence of suggested policy changes due to this adverse event.

Peer Review of Case #2 indicated that the patient was admitted and expired on the same day in mid- 2012 and according to the peer review committee:
a. Something could have been done differently;
b. There was a delay in recognizing the occurrence; and
c. The care differed from acceptable standards of practice.

This case was, "scored as 5-Minor or major deviation from standard of care- major adverse outcome." The Recommendation section was left blank. There was no documented evidence of suggested policy changes due to this adverse event.

Peer Review of Case #3 indicated that the patient was admitted in late 2012, the discharge diagnosis was left blank. According to the peer review committee:
a. Something could have been done differently;
b. The occurrence was due to a possible error;
c. The intervention and treatment following the occurrence was inappropriate;
d. The care provided was different from acceptable standards of practice; and
e. The outcome was avoidable given the information available to the practitioner.

This case was "scored a 5-Minor or major deviation from standard of care-major adverse outcome." The recommendation section was left blank. There was no documented evidence of suggested policy changes due to this adverse event.

During the inspection of a Peer Reviewer Final Report, dated, November 25, 2012, written by an outside reviewer, it was noted the consultant reviewed three adverse patient events and concluded the following:

Case #4: 71 Esophagogastroduodenoscopy's (EGD's - operative scope to diagnose and treat upper intestinal disorders) was performed on one patient. The consultant indicated the procedures were not medically necessary, the standard of care was not met, and the reason for repeated procedures was not clearly documented.

Case #5: A 43 year old with a Trans oral Incision-less Fundoplication (TIF) procedure (operation to treat stomach acid reflux). The consultant indicated the procedure was not medically necessary and contraindicated (should not be done), the standard of care was not met, the procedure pre-requisites (tests before surgery) were not done, major complication of the procedure was perforation (a hole was made), sepsis (overwhelming infection), and the complication management was not appropriate.

Case #6: A 42 year old with inguinal hernia repair (operation to repair a tissue weakness which has allowed abdominal contents to come through the weakened area) that lasted twice as long as expected (four hours instead of two). The consultant indicated the procedure was not medically necessary, the standard of care was not met, there was no consent discussion regarding a portion of the procedure, the procedure was lengthy, and the added portion of the procedure was not appropriate. The consultant also indicated the history and physical was not appropriate, the authorization request was inconsistent, the length of the surgery was not explained in the documentation, the documentation was not timely and was inappropriate.

Despite the comments by the outside reviewer, regarding these three cases, there was no documented evidence of Governing Board review or recommendations found in the Governing Board Minutes of 2012 and 2013.

3. During a review of the credential file for MD 1, on March 11, 2013, at 11:30 a.m., it was noted the General Surgery Delineation Form, dated, June 6, 2012, on the last page, indicated, "Applicant may perform privileges and procedures as indicated," followed by three spaces for signatures approving MD 1's hospital privileges. Two of the three signature lines contained a signature: one by the reviewer and one by a representative of the Medical Executive Committee, dated, July 18, 2012, as required. However, the space for the Board of Directors to sign, and thus granting final approval of MD 1's surgical privileges, was left blank. There was no documented evidence MD 1 had hospital privileges granted by the Governing Board. During a concurrent interview with Staff 16, while reviewing the files, she stated the Chairman of the Board refused to sign off on MD 1's hospital privileges.

During a review of the MEC (Medical Executive Committee) Credentialing Report to the Board, dated, July 18, 2012, the Credentialing Committee Recommendation and Signatures portion of the form indicated a "Favorable Recommendation." However, the space left for the Chairman of the Board to sign did not contain an approval signature, but instead, the words "Mr. [X] refused to sign," dated, November 28, 2012. MD 1's credential file did not contain a completed, approved application for hospital privileges. During a concurrent interview with Staff 16, while reviewing these files, she restated the Chairman of the Board refused to sign MD 1's hospital privileges.

During a review of the Regular Board of Directors Meeting Minutes for 2012 and 2013, there was no documented evidence of approval of MD 1's privileges. Further review of The Regular Board of Directors Meeting Minutes dated November 28, 2012 indicated two "closed sessions." There was no evidence that MD 1's privileges had been granted by the governing board.

Based on interview and record review the facility Governing Board failed to ensure that the criteria for Medical Staff membership included current competency and training. This failure increased the risk of substandard quality of care for all facility patients.

Findings:

A review of the Health Care District Bylaws (Governing Body) dated January 28, 2009, Quality Assurance, Medical Staff Members and Clinical Privileges indicated, "Membership on the Medical Staff shall be restricted to Practitioners who are competent in their respective fields, worthy in character and in professional ethics, and who are currently licensed by the state of California."

A review of the Medical Staff By-Laws, dated, September 28, 2010, indicated, "Requests for clinical privileges shall be evaluated on the basis of the member's licensure, education, training, experience and current demonstrated professional competence and judgment, clinical performance... documented results of patient care and other quality review and monitoring which the medical staff deems appropriate."

A review of the credential files on March 11, 2013, at 11:05 a.m., and on March 13, 2013 at 8:30 a.m., for three physicians (MD 1, MD 4 and MD 7) indicated there was no documented evidence of current competencies or initial proctoring for three out of three physician files reviewed. Review also indicated, no documented evidence of qualifications, education and training for one of three physician credential files reviewed (MD 7). During a concurrent interview with Staff 16, she confirmed the above findings. She also added, that competencies were not reviewed, "unless there are questions."

During the inspection of a Peer Reviewer Final Report, dated, November 25, 2012, written by an outside reviewer, it was noted the consultant reviewed three adverse patient events and concluded the following:

Case #4: 71 Esophagogastroduodenoscopy's (EGD's - operative scope to diagnose and treat upper intestinal disorders) was performed on one patient. The consultant indicated the procedures were not medically necessary, the standard of care was not met, and the reason for repeated procedures was not clearly documented.

Case #5: A 43 year old with a Trans oral Incision-less Fundoplication (TIF) procedure (operation to treat stomach acid reflux). The consultant indicated the procedure was not medically necessary and contraindicated (should not be done), the standard of care was not met, the procedure pre-requisites (tests before surgery) were not done, major complication of the procedure was perforation (a hole was made), sepsis (overwhelming infection), and the complication management was not appropriate.

Case #6: A 42 year old with inguinal hernia repair (operation to repair a tissue weakness which has allowed abdominal contents to come through the weakened area) that lasted twice as long as expected (four hours instead of two). The consultant indicated the procedure was not medically necessary, the standard of care was not met, there was no consent discussion regarding a portion of the procedure, the procedure was lengthy, and the added portion of the procedure was not appropriate. The consultant also indicated the history and physical was not appropriate, the authorization request was inconsistent, the length of the surgery was not explained in the documentation, the documentation was not timely and was inappropriate.

There was no documented evidence that further action was initiated after the outside peer reviews were received and no documented evidence that any physicians were monitored or re-evaluated at time of reappointment due to these outside reviewer evaluations.

Based on interview and record review, the facility failed to ensure one patient's (Patient 22) right for an explanation of the risks versus benefits to remain in the facility, to be discharged to his home or to another facility for continued care, which had the potential to result in serious or potentially fatal consequences.

Findings:

On February 25, 2013, at 3:30 p.m., a visit was made to the facility for the purpose of investing a complaint. Patient 22 was a 65 year old male admitted through the facility's emergency department (ED) on January 27, 2013, with diagnoses that included bowel obstruction and colon cancer.

On January 30, 2013, at 3:25 p.m., Staff 29 documented in Patient 22's record, the patient was admitted from the ED. He had a history of two strokes that left him without peripheral vision and he lived in his RV (Recreational Vehicle) for a couple of months a year. The discharge plan stated, "Pt. [patient] will need a ride home. No other discharge needs at this time."

The record revealed Patient 22 was taken to surgery on February 1, 2013, and underwent a Laparotomy (a surgical incision into the abdominal cavity) with a bowel resection and colostomy (a surgical creation of an artificial anus on the abdominal wall by making an incision into the colon and bringing it out to the surface). A review of the operative note revealed, during the surgical procedure, the physician lacerated the patient's left ureter (a tube from the kidney to the urinary bladder).

On February 6, 2013, at 6:50 a.m., the physician wrote orders for social services to discuss nursing home admission and teach colostomy care to the patient. The physician's progress note, indicated the patient lived by himself.

On February 6, 2013, at 4:03 p.m., Staff 28 documented the patient's personal information, the patient's insurance, and the discharge plan, that the physician recommended nursing home care, but the patient did not want to go to a nursing home. The plan was to train Patient 22 in colostomy bag management, remove the urinary drainage bag and "discharge back to his trailer." There was no documented evidence that home health agency services was discussed with the patient.

On February 7, 2013, at 8 a.m., the nurse documented, "...Midline WD [wound] dry and redness MD [medical doctor] aware..." At 2:30 p.m., the same day, MD 1 wrote to discharge the patient. MD 1's progress note stated the wound was okay with positive redness in the lower end. MD 1 documented, "Will DC [discharge] and follow up with a urologist [a specialist in the practice of the urinary tract]. At 2:10 p.m., the nurse documented, "Pt [patient] be discharged home for doctors appointment. Ambulate to W/C [wheelchair] to private vehicle with his friend in stable condition. IV [intravenous catheter] off. Leave urinary catheter as ordered."

On March 7, 2013, at 4 p.m., Patient 22's record from Facility B was reviewed. The ED record revealed Patient 22 was sent to Facility B's ED on February 7, 2013, at 5:03 p.m., via taxi cab. The patient was diagnosed with acute urinary tract infection, abdominal incision infection which was positive for MRSA (methicillin resistant staphylococcus aureus), altered mental state, and retracted colostomy.

On March 7, 2013, at 4:50 p.m., a telephone interview with Patient 22 was conducted. Patient 22 stated, he was placed in a taxi cab and dropped off at Facility B's emergency room. "MD 1 was head of this whole mess." ...He didn't know quite what to do. So they placed me in a taxi without telling me where I was going. I was in the taxi by myself. I walked into the emergency room and was unable to explain to the receptionist why I was there. They never told me where I was going...That incision was infected.

On March 11, 2013, at 9:50 a.m., during an interview with MD 5, he stated, "I don't remember anything about that patient's discharge."

At 11:15 a.m., on March 11, 2013, an interview was conducted with MD 1. He stated in regards to Patient 22's discharge to Facility B's ED by taxi cab, 108 miles away, "That was a mistake. I made arrangements for the patient to see a urologist after discharge by way of a charity car run by MD 5's mission. He is a missionary. The patient was to have gone to the urologist's office and another patient to the ED, but the driver made a mistake and took both patients to the ED."

On March 11, 2013, at 3:10 p.m., in an interview with Staff 28, she stated, "When the patient was getting into the taxi I asked where he was going and he stated he didn't know. I asked MD 3 the reason the patient was in the taxi and MD 3 said that MD 1 was getting a specialist. I saw Patient 22 as he was being wheeled out to the taxi."

On March 12, 2013, at 8:30 a.m., in an interview with Staff 29, she stated, "I tried to talk to the patient about SNF [skilled nursing facility/nursing home] and the physician about home health agency visits. I wasn't expecting the patient to be gone when I came back to work. He wasn't ready...This wasn't the first time MD 1 had an unsafe discharge."

On March 13, 2013, at 4:30 p.m., an interview was conducted with Staff 3. She stated, "Colostomy care instructions were given to the patient's friend over the phone. I was going to send the patient home with written instructions." There was no documented evidence Staff 3 gave colostomy care instructions to Patient 22 or his friend.

Based on interview and record review, the facility failed to provide care in a safe setting, by failing to conduct an investigation or causal analysis for two patient deaths. Patient 20, a patient with a known history of esophageal varices (enlarged veins in the walls of the lower part of the esophagus, the tube that connects throat to stomach), was placed on a contraindicated noninvasive positive pressure device. Patient 19's surgery was delayed while non urgent surgeries were being conducted. This delay had the potential to contribute to the patient's pain and death. The failure to conduct investigations or causal analysis into poor patient outcome had the potential to result in patient harm or death .

Findings:

The facility "Quality Improvement (QI) Plan 2012" revealed "... Goals: To reduce and prevent medical and/or health care errors. ... Actions: Incorporate performance improvement throughout the facility. ... Continuously improve clinical and operational processes ... The QI Plan, established by an interdisciplinary Quality Council with the recommendation of the Medical Executive Committee (MEC) and approval of the Governing Board, has as its scope the monitoring of every aspect of patient care and service, including contracted services. ..."

In addition, "the scope of the organizational quality improvement program includes the monitoring, assessment, and evaluation for the dimensions of performance of patient care and the clinical performance of all individuals with clinical privileges."

a. The medical record for Patient 20 was reviewed. Initial admission orders dated, May 18, 2012, at 6:10 a.m., indicated the patient was admitted with diagnoses that included hepatic encephalopathy (a worsening of brain function that occurs when the liver is no longer able to remove toxic substances in the blood), alcoholic cirrhosis (damage to the liver due to alcohol abuse) and anemia (low blood count).

According to the "Death Summary," Patient 20 was initially admitted to the medical/surgical unit, then "patient's condition crashed on May 20, 2012, he was transferred to the intensive care unit for more aggressive care."

A "Consultation Report," dated, May 20, 2012, indicated the patient had "probable upper gastrointestinal bleed; massive hemorrhage," and the plan was a Esophagogastroduodenoscopy (EGD) to identify and the source of the patient's bleeding. EGD is a test to examine the esophagus, stomach, and first part of the small intestine. It is done with a small camera [flexible endoscope] that is inserted down the throat.) The "Consultation Report," indicated the patient "already had four units of packed red bloods cells..."

An "Operative Notes," dated, May 20, 2013, at 12 noon, indicated Patient 20 underwent EGD and esophageal banding (place a rubber band around the bleeding veins).

A review of the "E-Record Flowsheets," indicated on May 21, 2012, the patient had labored breathing and was incoherent. Breathing treatments with a hand held nebulizer were started. On May 22, 2012, at 8 p.m., in the ICU Assessment, the nurse documented the patient's quality of respiration was "Labored: Deep Accessory Muscle Use." On May 23, 2012, at 1:47 a.m., the nurse documented the patient's quality of respiration was "Deep Tachypnic [rapid] Accessory Muscle Use." On May 23, 2012, at 2 p.m., the nurse documented the patient was "Stuperous [unresponsive]," with a Glasgow Coma Scale score of 8.

(Glasgow Coma Scale The Glasgow Coma Scale or GCS was a neurological scale that aimed to give a reliable, objective way of recording the conscious state of a person for initial as well as subsequent assessment. A patient is assessed against the criteria of the scale, and the resulting points give a patient score between 3 (indicating deep unconsciousness) and 15 (fully awake).

On May 23, 2012, at 4:10 p.m., MD 4 wrote an order for "BIPAP with settings 10/5."

(BIPAP- Bi level positive airway pressure machine is a breathing apparatus that helps get more air into the patient's lungs. BIPAP uses variable levels of air pressure and is used to help patients with breathing difficulties, particularly obstructive sleep apnea. BIPAP is a form of non-invasive positive pressure ventilation. Mask is used instead of a tube inserted into the patient's trachea (breathing tube). Contraindications for the use of BIPAP, according to the Cleveland Clinic Journal of Medicine, included: encephalopathy with inability to protect airways and a high risk of aspiration; increased risk of aspiration: copious secretions, vomiting, or severe gastrointestinal bleeding; and recent airway or gastrointestinal surgery.)

A second physician's order written on May 23, 2012, at 4:30 p.m., indicated the BIPAP was to start "ASAP [as soon as possible]."

On May 23, 2012, at 5:25 p.m., documentation revealed the patient was on BIPAP with a full face mask, a set inspiratory pressure of 10 and an expiratory pressure of five.

On May 23, 2012, at 7:35 p.m., the nurse documented "...mask is full of blood I pulled his face mask off as quickly as possible and called to the HUC [unit secretary] for a stat code blue for intubation, and also called to MD 6 for rupture of esophageal varices as a possibility. MD came from ER and intubated Pt. [Patient] MD 6 came from OR to evaluate."

The "Code Blue," form dated, May 23, 2012, indicated at 7:30 p.m., hospital wide resuscitation response was activated. The following was documented "CODE BLUE CALLED FOR Airway 2° to Acute GI Bleed/Esophageal varices ruptured with a BIPAP MASK in use."

Further documentation in the "Death Summary," indicated "Since he was wheezing so badly, we offered a trial of BIPAP... he did not tolerate the BIPAP well. He began to hemorrhage orally...clips that had banded his previous varices were found to be falling off."

On March 14, 2013, at 9:30 a.m., Staff 13 was interviewed. Staff 13 stated he recalled the incident with Patient 20. Staff 13 stated BIPAP was contraindicated due to the patient's condition, his history of esophageal banding and his poor cognition. Staff 13 stated he spoke with the ICU (Intensive Care Unit) Manager, who agreed the patient was not a candidate for BIPAP. Staff 13 stated the patient was eventually placed on BIPAP and bled out a short time later. Staff 13 stated there had been no review or investigation into the incident.

On March 14, 2013, at 9:45 a.m., Staff 14 was interviewed. Staff 14 stated he remembered the patient and the situation. Staff 14 stated he and Staff 13 went to the ICU Manager to express their concerns about placing Patient 20 on BIPAP due to the patient's history of esophageal varices and recent banding. Staff 14 stated he was not contacted about the incident or included in an investigation or causal analysis of Patient 20's death.

b. Patient 19's record was reviewed and the following noted:

According to the Emergency Department (ED) Record, Patient 19 presented to the ED on November 25, 2012, at 3:21 p.m., with the chief complaint "Constipation." Initial "Clinical Impression," was documented as "Colitis, query C.Difficile [inflammation of the large bowel, possibly due to c.difficile- a bacteria that causes severe diarrhea]." The patient was admitted to the facility on November 26, 2013, at 3:31 a.m.

A dictated "Operative Report," with a date of surgery of November 28, 2012, indicated Patient 19's preoperative diagnosis was "Colitis on CT scan (computerized tomography)." According to the report, Patient 19 underwent a colonoscopy (insertion of tube through the rectum to visualize the bowel) and four biopsies (removal of bowel tissue for examination under microscope).

Patient 19's Anesthesia Record, indicated the patient underwent the colonoscopy on November 28, 2012, between 2:15 p.m., and 2:50 p.m.

On November 29, 2012, at 2 a.m., the following was documented in the progress notes: "Addendum increasing pain p [after] scope...very tender increased guarding...recheck x-ray ...r/o [rule out] free air."

On November 29, 2012, at 3:31 a.m., an abdominal x-ray was ordered. The indication for the x-ray was "Abdominal distention after colonoscopy." Findings: "...Suspect free intraperitoneal air on the upright view. There is prominent gaseous dilatation of the colon and small bowel." Impression: "free intraperitoneal air is suspected...Prominent gaseous dilation of the colon and small bowel."

The "Clinical Documentation Report," for "Patient Care Activities," contained the following documentation:

On November 29, 2012, at 8:30 a.m., "Received patient from m/s [medical surgical unit] after given report by Staff 5. Head to toe assessment done. sbp [systolic blood pressure] wnl [within normal limits] in 100's skin clammy/cool, afebrile...c/o pain in lower abdomen...very little urine output. Comfort measure given..."

On November 29, 2012, at 10:33 a.m., "still c/o [complain of] left abdominal pain -2/10 pain..monitoring closely..."

On November 29, 2012, at 12 p.m., "c/o increasing pain, MD 5 informed of update, sbp 80's ...abdomen pain over 9/10 noted dilaudid 1 mg given."

The "Clinical Documentation Report," under "NSG-(Nursing) Pain Assessment," contained the following documentation:

On November 29, 2012, at 12:21 a.m., patient was having acute pain.

On November 29, 2012, at 7:35 a.m., patient was having acute pain, sharp and continuous.

The following Physician's orders were written on November 29, 2012, at 8:05 a.m.:
Transfer to ICU;
Dopamine (medication used to support/ increase blood pressure) if needed, start 5 mcg (micrograms)/kg (kilograms)/min (minute); and
Consent for Laparotomy and Colectomy (surgical opening of abdomen and bowel repair).

The record contained a consent signed by Patient 19, dated, November 29, 2012 at 8:15 a.m.

On November 29, 2012, an untimed note indicated the following:

"Surg note
S: Pt [patient] developed pain and has free air in x-ray.
O: tender abd [abdomen] BP [blood pressure] 70 systolic
A: Perforation- probably ischemic colon site
P Laparotomy, poss resection of colon Transfer ICU fluid bolus, dopamine [medication used to increase blood pressure]."

On March 13, 2013, during a confidential interview with facility staff, the staff stated, Patient 19's surgery was delayed due to the elective surgeries scheduled in the operating room on November 29, 2013. The staff member stated, elective surgeries continued as scheduled, while Patient 19's surgery was on hold.

A review of the surgery schedule for November 29, 2013, indicated a repeat cesarean section (Patient 23), under spinal anesthesia, was scheduled for 7:30 a.m. Patient 24 was assigned to undergo EGD and Colonoscopy in OR 2 at 11:30 a.m. by MD 5. This procedure was scheduled to be conducted under monitored anesthesia care (MAC). The facility's one anesthesiologist was assigned to both of these cases.

Patient 23's record was reviewed. Patient 23 presented to the facility at 6:05 a.m., for elective repeat cesarean section. According to the intraoperative record Patient 23 left the operative suite at 10:30 a.m., on November 29, 2012.

Patient 24's record was reviewed. Patient 24's procedure was "elective," according to documentation on the "Intraoperative Record." Patient 24 was brought to OR 2 on November 29, 2012, at 12:50 p.m.

The facility policy titled "Scope of Service of the Surgical Services Department," was reviewed. The policy indicated the Surgical Services Department provided services for operative and other invasive procedures and immediate postoperative care on a 24 hour basis. The Department was staffed to operate 2 (two) OR (operating room) suites. An on call staff was available.

From an article titled "Management of Colonoscopic Perforations," in order to minimize morbidity and mortality, prompt operative intervention was the best strategy in most patients. Non-operative management is warranted in carefully selected patients without peritoneal irritation.

A review of the facility QRR (Quality Record Review) Log indicated Patient 19 expired in the ICU. The information was routed to QRD (Quality Review Department) and no further actions required. It was also documented in the log "proper procedure followed," and status was listed as closed. In the comment section it was documented "RCA [Root Cause Analysis] was to be conducted."

In an interview with Staff 16, on March 14, 2013, at 11:30 a.m., Staff 16 stated the peer review and the RCA for Patient 20 were still going through the process. Staff 16 stated a review was conducted in the month following the patient's death. Staff 16 indicated, she did not know about a RCA or peer review for Patient 19's case. No evidence of the investigation into these patients' death was provided prior to the end of the survey.

During a group interview with the Quality Assurance Performance Improvement (QAPI) staff and QAPI Committee Members, on March 12, 2013, at 4:15 p.m., when asked about adverse patient events and sentinel events reviews, Staff 2 replied "Sentinel events are never discussed in quality. That is done behind closed doors." When asked where they get the information regarding adverse patient events, Staff 2 replied "we don't get any." Staff 2 then asked "where is the information supposed to come from?" She further replied that in the past, the staff had been afraid to report incidents and concerns regarding quality of care secondary to fear of retaliation.

There was no evidence the facility conducted an internal investigation, peer review or causal analysis of these two death cases.

Based on interview and record review, the facility failed to develop, implement, and maintain an effective, ongoing, hospital-wide, data-driven Quality Assessment and Performance (QAPI) program, in which the Governing Body/Board (GB) ensured the program focused on indicators that would improve health outcomes by failing to:

1. Identify adverse patient events and sentinel events to include analysis and review in order to improve the quality of care, reduce medical errors, and change facility policies and procedures as needed. (Refer to A266);
2. Provide care in a safe setting, by failing to conduct an investigation or casual analysis for two patient deaths. (Refer to A144);
3. Track and trend adverse patient events in order to improve patient safety and to have an effective peer review process. (Refer to A049);
4. Identify opportunities for improvement that would ensure care provided to patients was consistent with facility policies and procedures and standards of practice. (Refer to A273);

5. Identify opportunities for improvement that were proportional to the scope and complexity of the hospital's services and operations and that if a project was chosen, measurable progress was achieved on these projects. (Refer to A297); and
6. Have an ongoing quality appraisal and performance improvement program that addressed and monitored the complexity and scope of a written effective discharge planning process that applied to all patients. (Refer to A117, A799, A800, and A806).



25937

On March 12, 2013, at 5:18 p.m., the Acting Chief Executive Officer (ACEO), Interim Chief Nursing Officer (ICNO), two board members, and a consultant were notified an Immediate Jeopardy (IJ) was identified. (An IJ is a situation in which the provider's noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a patient). The IJ was identified due to the facility's failure to track adverse/sentinel events. There was no effective program in place to improve the quality of care, because causal analysis was not being done on adverse and/or sentinel events.

The facility submitted an acceptable written plan of correction for this IJ on March 14, 2013, at 8:50 a.m.

After the survey team validated the immediate correction, the ACEO was notified and the IJ was removed on March 14, 2013, at 9:10 a.m.

The cumulative effect of these systemic problems resulted in the failure for the facility quality assurance, performance improvement program to ensure high quality healthcare and a safe environment for all patients.



31467

Based on interview and record review, the facility failed to ensure the Quality Assessment and Performance Improvement (QAPI) program tracked, trended and analyzed adverse patient events including post-operative management of surgical complications and patient deaths. These failures increased the risk of future patient morbidity and mortality.

Findings:

A review of the Medical Staff By-Laws, dated September 28, 2010, indicated "The Quality Council shall measure, assess, and improve quality control and performance improvement processes related to the following functions: Patient safety and error reduction... The Quality Council shall also oversee issues related to compliance with JCAHO standards, Title 22 regulations and CMS conditions of participation."

During a group interview with the QAPI staff and QAPI Committee Members, on March 12, 2013, at 4:15 p.m., they were asked about quality indicators for each hospital department. For example, did Labor and Delivery have a quality indicator that was followed, such as the cesarean section rate? There was no answer. When asked: why is the cesarean section rate (67%), so much higher than in the community, and what is the plan to find out? No answer was given. When asked if Quality Staff analyzed the data collected for the cesarean section rate, Staff 4 stated "No, we should have."

In regards to Quality-Medical Errors:
During a group interview with the QAPI staff and QAPI Committee Members, on March 12, 2013, at 4:15 p.m., when asked about adverse patient events and sentinel events reviews, Staff 2 replied "Sentinel events are never discussed in quality. That is done behind closed doors." When asked where they get the information regarding adverse patient events, Staff 2 replied "we don't get any." Staff 2 then asked "where is the information supposed to come from?" She further replied that in the past, the staff had been afraid to report incidents and concerns regarding quality of care secondary to fear of retaliation.

On March 12, 2013, at 5:18 p.m., the Acting Chief Executive Officer (ACEO), Interim Chief Nursing Officer (ICNO), two board members, and a consultant were notified that an Immediate Jeopardy (IJ) was identified. (An IJ is a situation in which the provider's noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a patient). The IJ was identified due to the facility's failure to track adverse/sentinel events. There was no effective program in place to improve the quality of care, because causal analysis was not being done on adverse and/or sentinel events.


The facility submitted an acceptable written plan of correction for this IJ on March 14, 2013, at 8:50 a.m.


After the survey team validated the immediate correction, the ACEO was notified and the IJ was removed on March 14, 2013, at 9:10 a.m.

Based on interview and record review, the facility failed to identify opportunities for improvement that would ensure care provided to patients was consistent with facility policies and procedures and standards of practice. This failure had the potential to result in unsafe practices being allowed to continue without being immediately detected.

Findings:

The services provided were not consistent with facility policies and procedures and standards of practice (Refer to A144, A800).

On March 12, 2013, at 4:15 p.m., facility staff responsible for the Quality Assessment and Performance Improvement (QAPI) program were interviewed. Staff 17 stated the committee met monthly and took the cumulative data presented by the departments for the meeting minutes. Staff 17 stated, each department was assigned a quarter to report their data, some departments have never developed a performance improvement plan/project, and some department have never presented any data. Staff 2 and Staff 4 stated data was collected, not analyzed, and interventions to improve the quality of care were never considered. Staff 2, 4, and 17, stated departments just gave numbers or percentages.

In addition, Staff 2, 4, and 17, stated the QAPI program had never reviewed, discussed patient care/quality cases, sentinel events, adverse events, or near misses.

Staff 2 stated formal quality rounds were done but the departments response to problems identified was often not returned.

Staff 2, 4, and 17, stated they knew of no sentinel events or adverse events that had occurred in 2012 or 2013 to date but had heard rumors.

Based on interview and record review, the facility failed to identify opportunities for improvement that were proportional to the scope and complexity of the hospital's services and operations and that if a project was chosen, measurable progress was achieved on these projects. These failures resulted in not all services having a performance improvement program and the facility could not demonstrate where implemented interventions had produced measurable achievement on projects.

Findings:

The quality assessment performance improvement (QAPI) minutes dated, January 26, 2012, indicated Human Resources, Business Office, Materials Management, Accounting, Emergency Department, and OB/Labor & Delivery had no performance improvement plan and no performance improvement projects.

The QAPI minutes for the year 2012, indicated Business Office, Information Technology, Medical Staff and Plant Operations did not present data/projects to the QAPI program.

On March 12, 2013, at 4:15 p.m., facility staff responsible for the QAPI program were interviewed. Staff 17 stated the committee met monthly and took the cumulative data presented by the departments for the meeting minutes. Staff 17 stated, each department was assigned a quarter to report their data, some departments have never developed a performance improvement plan/project, and some departments have never presented any data. Staff 2 and Staff 4 stated data was collected, not analyzed, and interventions to improve the quality of care were never considered. Staff 2, 4, and 17, stated departments just gave numbers or percentages.

Staff 4 stated Labor & Delivery presented data on their monthly cesarean section (abdominal birth of an infant) rates which were determined to be higher than the national standard but the data was not analyzed and no interventions were put in place to try and decrease the number of cesarean sections performed at the facility.

The facility "Quality Improvement Plan 2012" revealed "... Goals: To reduce and prevent medical and/or health care errors. ... Actions: Incorporate performance improvement throughout the facility. ... Continuously improve clinical and operational processes ... The QI Plan, established by an interdisciplinary Quality Council with the recommendation of the Medical Executive Committee and approval of the Governing Board, has as its scope the monitoring of every aspect of patient care and service, including contracted services. ..."

In addition, "the scope of the organizational quality improvement program includes the monitoring, assessment, and evaluation for the dimensions of performance of patient care and the clinical performance of all individuals with clinical privileges."

Based on interview and record review, the facility failed to ensure the Medical Staff was organized and accountable to the Governing Body/Board by failing to:

1. Ensure members of the medical staff followed the medical staff bylaws, and Rules and Regulations. (Refer to A353 and A358);

2. Ensure there were complete appraisals on three of three physicians reviewed. (Refer to A340);

3. Ensure an effective peer review process was in place. (Refer to A347);

4. Ensure there was documented evidence the Chief of Staff had privileges granted by the Governing Body/Board. (A363);

5. Ensure OR scrub technicians were not allowed to participate in surgical procedures without privileges and beyond their scope of practice. (Refer to A339);

6. Ensure there was documented evidence of current competencies and initial proctoring for three of three physician files reviewed. (Refer to A341); and,

7. Ensure there was documented evidence of the qualifications, education and training for one of three physician credential files reviewed. (Refer to A341)



25937

On March 12, 2013, at 12:18 p.m., the Interim Chief Nursing Officer (ICNO) and Risk Manager (RM) were notified Immediate Jeopardy (IJ) was identified (an IJ is a situation in which the provider's noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a patient). The IJ was identified due to the facility's failure to have an effective peer review process. The Medical Staff failed to act upon their own determinations, and made no recommendations when deficiencies were identified.

On March 14, 2013, at 8 a.m., the Acting Chief Executive Officer (ACEO) was notified that an additional IJ was identified and an addendum was made to include that Medical Staff allowed the surgical technicians to perform procedures in which they were not privileged.

The facility submitted an acceptable written plan of correction for the IJ's on March 14, 2013, at 8:50 a.m.

After the survey team validated the immediate correction, the ACEO was notified and the IJ was removed on March 14, 2013, at 9:10 p.m.

The cumulative effect of these systemic problems resulted in the failure for the facility Medical Staff to ensure high quality healthcare and a safe environment for all patients.

Based interview and record review, the facility failed to prevent unprivileged, unlicensed Operating Room (OR) scrub technicians (techs) from assisting in surgery. This practice increased the risk of substandard quality of care for all facility surgical patients.

Findings:

Review of the facility Medical Staff By-Laws dated, September 28, 2010, indicated "no person shall exercise clinical privileges in the hospital unless and until that person applies for and received appointment to the Medical Staff is granted privileges... by applying for appointment to the medical staff each applicant: pledges ... refraining from delegating patient care responsibility to non-qualified or inadequately supervised practitioners."

According to the American College of Surgeons, 2011, Assistant at Surgery Consensus study, "The first assistant during a surgical operation should be a trained individual who is able to participate in and actively assist the surgeon in completing the operation safely and expeditiously by helping to provide exposure, maintain hemostasis, and serve other technical functions." In addition, "The American College of Surgeons supports the concept that, ideally, the first assistant at the operating table should be a qualified surgeon or resident... It may be necessary to utilize non-physicians as first assistants. Surgeon's Assistants (SAs) or physician's assistants (PAs) with additional surgical training should meet national standards and be credentialed by the appropriate local authority."

On March 11, 2013, at 8:50 a.m., Staff 12 was interviewed. Staff 12 described the surgery scheduling process. Staff 12 stated she verified physician's privileges before scheduling a surgery. Staff 12 stated the physician would let her know if there was going to be an assistant.

On March 11, 2013, at 9 a.m., during a tour of the Surgical Services Department, Staff 15 was interviewed. Staff 15 stated the department did not have a list of surgeries that required an assistant. Staff 15 had discussed the issue with supervisory and medical staff, but had not received an answer.

During a review of a letter dated March 12, 2013, from the most recent former OR Manager, the letter indicated, "There were issues with assistant surgeons being needed and a great deal of resistance being met specifically from [Surgeon Name]. There were incidents when he would have all three of my OR techs scrubbed in with him until he could find someone else to assist, knowing it was outside their scope of practice to assist him. It was at his insistence the ER physician was called to scrub leaving the ER unattended." The letter continued, "[Surgeon Name] has a habit of intimidating the OR techs into inserting and advancing the colonoscopies (which I was trying my best to stop the practice) when a colon was perforated. I cannot say for sure if the colon was perforated because of the scope or because of the tissue, nonetheless, the patient expired later that day in the ICU."

On March 13, 2013, at 2:30 p.m., Staff 9 was interviewed. Staff 9 stated he was a surgical scrub technician. Staff 9 stated he had assisted surgeons in manipulating scopes, during colonoscopies and upper gastrointestinal endoscopies. Staff 9 stated he had not received training in this procedure. Staff 9 stated he informed the managers that he was performing this procedure, and that it was not part of his core responsibilities in the operating room.

During an interview on March 13, 2013, at 3:05 p.m., MD 1 was asked, "while performing esophagogastroduodenoscopy (EGD - test to examine the lining of the esophagus [throat] with a scope) and colonoscopy (test to exam the lining of the bowels with a scope), does the scrub tech ever assist you in any way, and if so, in what way?"

MD 1 answered, "the scrub tech pushes and advances the scope, under my direction, because I prefer to keep two hands on the scope controls." He stated that it was safer for him to keep two hands on the scope controls and have the scrub tech move the scope. MD 1 further added that "during an EGD the scrub tech would advance the scope, and he has frequently told the scrub tech not to advance the scope unless he (the scrub tech) can see the lumen." In addition, MD 1 stated "during a colonoscopy the scrub tech may take the scope out. I make sure the tech takes the scope out slowly so I can see everything on the way out." He added that the scrub tech removes the scope on his orders only.

When MD 1 was asked about a past surgical case in which the patient's esophagus (throat) was perforated by a scope, MD 1 was asked if he used a scrub tech on that case. He stated that he did not remember if a scrub tech assisted him with that procedure or not.

When asked if he (MD 1) considered advancing and moving the scope was within the scope of practice for a scrub tech, he replied, "The OR manager advised me that I should use a scrub tech as an assistant, because they are not licensed and therefore do not have a scope of practice. A Registered Nurse (RN), is licensed and has to follow the RNs scope of practice." When asked "do you think it is safe to allow an unlicensed scrub tech to advance and remove scopes?" MD 1 replied, he had "never had a perforation while performing surgery with a scrub tech." He added that he only had a problem, a perforation, when he was not having the scrub tech move the scope. Thus, it was safer to use the scrub tech.

Based on interview and record review, the facility failed to ensure periodic appraisals were completed on the medical staff in order to ensure quality of patient care. Incomplete appraisals, including a lack of documentation of current competencies, were found in three of three sampled physician credential files reviewed. This increased the risk of substandard care for all facility patients.

Findings:

A review of the Medical Staff By-Laws dated September 28, 2010, indicated "Requests for clinical privileges shall be evaluated on the basis of the member's licensure, education, training, experience and current demonstrated professional competence and judgment, clinical performance... documented results of patient care and other quality review and monitoring which the medical staff deems appropriate."

A review of the credential files of three practicing physicians (MD 7, MD 1, and MD 4) on March 11, 2013, at 11:30 a.m., indicated a lack of documentation of current competencies for all three physicians. During a concurrent interview with Staff 16, she confirmed the lack of documentation and stated that the current competencies and activity of the physicians were "not checked unless there are questions."

During further credential files review on March 11, 2013, at 4:30 p.m., indicated no documented evidence of peer review activity for two of two physician files reviewed (MD 7 and MD 1). This lack of documentation was confirmed by Staff 16. She added that more information was documented on the Ongoing Professional Practice Evaluation (OPPE) sheets. Review of the OPPE sheets indicated limited data and no documented evidence of information regarding physician behavior or peer review. This was also confirmed by Staff 16.

During review of archived credential file material on March 13, 2013, at 8:30 a.m., it was noted that there was no documented evidence of proctoring for three out of three physician credential files reviewed (MD 1, MD 7, and MD 4). Also, there was a lack of documented evidence of training for one of three physicians (MD 7).

Based on interview and record review, the facility failed to ensure:
1. Three of three physicians had documented evidence of current competencies or proctoring at initial appointment; and,
2. One of three physicians had documented evidence of his qualifications, education and training.

This failed practice increased the risk of substandard quality of care for all facility patients.

Findings:

A review of the Medical Staff By-Laws dated, September 28, 2012, indicated, "Requests for clinical privileges shall be evaluated on the basis of the member's licensure, education, training, experience and current demonstrated professional competence and judgment, clinical performance... documented results of patient care and other quality review and monitoring which the medical staff deems appropriate."

Review of the credential files on March 11, 2013, at 11:05 a.m., and on March 13, 2013, at 8:30 a.m., revealed no documented evidence of current competencies or initial proctoring for three of three physician files reviewed (MD 1, MD 4, and MD 7). The review also revealed no documented evidence of qualifications, education, and training for one of three physician credential files reviewed (MD 7).

During a concurrent interview with Staff 16, she confirmed the above findings. She also added, competencies are not reviewed "unless there are questions."

Based on interview and record review, the facility failed to ensure there was an effective Medical Staff peer review process and failed to ensure the Medical Staff was accountable to the Governing Body/Board (GB) for quality of patient care. This increased the risk of poor health and safety outcomes for all facility patients.

Findings:

A review of the Medical Staff By-Laws, dated September 28, 2012, revealed, under the Peer Review Committee Duties, "The duties and responsibilities of the peer review committee shall be to evaluate and improve the quality of care provided to hospital patients; to conduct patient care reviews for the purpose of analyzing and evaluating the quality and appropriateness of care and treatment provided by members of the medical staff holding clinical privileges and any allied health practitioners; to perform peer review and/or practitioner-specific intensified assessments when indicated, to identify system problems requiring process improvement activities and refer such concerns to the performance improvement committee. "

Inspection of three Medical Staff Peer Review Forms on March 13, 2013, indicated that three out of three adverse patient events reviewed by the facility peer review committee contained no documented evidence of follow up actions, recommendations for future changes or evidence that these cases were referred to the Quality Assurance (QA) Committee or Governing Board.

Peer Review of Case #1 indicated that the patient was admitted and expired on the same day in early 2012 and according to the peer review committee:
a. Something could have been done differently;
b. The occurrence was due to a possible error; and
c. The care differed from acceptable standards of practice.

Despite these comments, the incident was, "scored as 3- minor deviation from standard of care- no significant outcome." The follow up section was left blank and the recommendation section indicated, "no further action necessary (appropriate for score 1 case)." The box for "inform MD- trend and track (appropriate for score 3 cases) was not checked. There was no documented evidence of suggested policy changes due to this adverse event.

Peer Review of Case #2 indicated that the patient was admitted and expired on the same day in mid- 2012 and according to the peer review committee:
a. Something could have been done differently;
b. There was a delay in recognizing the occurrence; and
c. The care differed from acceptable standards of practice.

This case was, "scored as 5-Minor or major deviation from standard of care- major adverse outcome." The Recommendation section was left blank. There was no documented evidence of suggested policy changes due to this adverse event.

Peer Review of Case #3 indicated that the patient was admitted in late 2012, the discharge diagnosis was left blank. According to the peer review committee:
a. Something could have been done differently;
b. The occurrence was due to a possible error;
c. The intervention and treatment following the occurrence was inappropriate;
d. The care provided was different from acceptable standards of practice; and
e. The outcome was avoidable given the information available to the practitioner.

This case was "scored a 5-Minor or major deviation from standard of care-major adverse outcome." The recommendation section was left blank. There was no documented evidence of suggested policy changes due to this adverse event.

During the inspection of a Peer Reviewer Final Report, dated, November 25, 2012, written by an outside reviewer, it was noted the consultant reviewed three adverse patient events and concluded the following:

Case #4: 71 Esophagogastroduodenoscopy (EGD) - (operative scope to diagnose and treat upper intestinal disorders) was performed on one patient. The consultant indicated the procedures were not medically necessary, the standard of care was not met, and the reason for repeated procedures was not clearly documented.

Case #5: A 43 year old with a Trans oral Incision-less Fundoplication (TIF) procedure (operation to treat stomach acid reflux). The consultant indicated the procedure was not medically necessary and contraindicated (should not be done), the standard of care was not met, the procedure pre-requisites (tests before surgery) were not done, major complication of the procedure was perforation (a hole was made), sepsis (overwhelming infection), and the complication management was not appropriate.

Case #6: A 42 year old with inguinal hernia repair (operation to repair a tissue weakness which has allowed abdominal contents to come through the weakened area) that lasted twice as long as expected (four hours instead of two). The consultant indicated the procedure was not medically necessary, the standard of care was not met, there was no consent discussion regarding a portion of the procedure, the procedure was lengthy, and the added portion of the procedure was not appropriate. The consultant also indicated the history and physical was not appropriate, the authorization request was inconsistent, the length of the surgery was not explained in the documentation, the documentation was not timely and was inappropriate.

Despite the comments by the outside reviewer, regarding these three cases, there was no documented evidence of Governing Board review or recommendations found in the Governing Board Minutes of 2012 and 2013.

Based on interview and record review, the facility failed to ensure a physician's (MD) daily progress note was written for one sampled Intensive Care Unit (ICU) patient (Patient 2). This had the potential to result in a lack of care and treatment for Patient 2.

Findings:

On March 11, 2013, the record for Patient 2 was reviewed. Patient 2 was admitted to the facility on March 4, 2013, with diagnoses including vomiting and hematuria (blood in the urine), and was transferred to the ICU on March 8, 2013, at 4 p.m., due to an altered level of consciousness.

The "Progress Notes Physician" dated, March 8, 2013, at 10 a.m., indicated Patient 2 was seen and evaluated by MD 5.

The "Code Blue (an emergency event involving respiratory distress and/or cardiac arrest)" dated March 10, 2013, at 8:26 a.m., indicated Patient 2 experienced respiratory distress and a slow heart rate, was intubated and placed on a ventilator by the Emergency Department MD.

The "Progress Notes Physician" dated, March 10, 2013, at 5 p.m., indicated a "Transfer Note" was written by MD 5.

There was no MD progress note from March 8, 2013, at 10 a.m., until March 10, 2013, at 5 p.m., (55 hours later) and no MD progress note on March 9, 2013.

Patient 2 was transferred to a higher level of care on March 11, 2013, at 9:52 a.m.

During an interview with Staff 6, on March 11, 2013, at 11 a.m., he reviewed the record and was unable to find documentation of a MD progress note on March 9, 2013. Staff 6 stated there should be a daily physician's progress note.

During an interview with the Interim Chief Nursing Officer (ICNO), on March 14, 2013, at 8:30 a.m., she reviewed the record and was unable to find documentation of a MD progress note on March 9, 2013. The ICNO stated there should be at least a daily MD progress note and more often if needed based on the patient's condition.

The facility Medical Staff "Rules and Regulations" undated, revealed "Progress Notes: Daily hospital visits and pertinent progress notes must reflect the condition of the patient and course of therapy, as the patient's condition warrants and such notes must provide continuity of care and transferability. ... Progress notes shall be written at least daily, or more often on critically ill patients and those where there is difficulty in diagnosis or management...."

Based on interview and record review, the facility failed to ensure the record contained a history of the patient's prenatal course for one sampled patient (Patient 6). This resulted in an incomplete history of Patient 6's prenatal course/care and had the potential to result in laboratory tests needing to be redrawn, unnecessary treatment being administered, and a delay in care and treatment.

Findings:

On March 11, 2013, the record for Patient 6 was reviewed. Patient 6 was admitted to the facility on February 26, 2013, with diagnosis of pregnancy at 38 weeks gestation (term pregnancy 40 weeks gestation) in active labor.

The Labor and Delivery (L&D) assessment dated February 27, 2013, at 1:55 a.m., indicated "Maternal Blood Type and RH; Maternal Antibody Screen; Maternal Rubella (measles); Maternal HBSAg (a blood test screening for hepatitis); Maternal HIV [a blood test screening for human immunodeficiency virus that causes acquired immunodeficiency syndrome (AIDS)]; Maternal GBS (Group B Streptococcus - a severe vaginal infection that affects newborn infants); Maternal GC (gonorrhea - sexually transmitted infection); and Maternal Chlamydia (sexually transmitted bacterial infection)" were all "unknown."

In addition, when the question "Prenatal care began when?" was asked, the documentation indicated "unknown, no prenatal record on file."

There was no prenatal history in Patient 6's record.

Patient 6 had a vaginal delivery of a baby girl on February 27, 2013, at 2:53 a.m.

During an interview with Staff 18, on March 11, at 9:55 a.m., she reviewed the record and was unable to find documentation of a physician's prenatal history for Patient 6. Staff 6 stated L&D used to get a list of the patients who were going to deliver along with their prenatal records but that stopped. She stated the L&D staff were unable to obtain information on the patients if the MD's office was closed or on the weekends.

During an interview with Interim Chief Nursing Officer (ICNO) on March 14, 2013, at 8:30 a.m., she reviewed the record for Patient 6 and was unable to find documentation of a prenatal history. The ICNO stated the L&D staff should have access to the patients' prenatal records, and the patient's prenatal history should be in each patient's record.

The facility Medical Staff "Rules and Regulations" undated, revealed "... History and Physical: A complete admission history and physical examination shall be recorded by the attending physician with twenty-four (24) hours of admission. ..."

Based on interview and record review, there was no documented evidence the Chief of Staff, who was providing surgical services to patients, had privileges granted by the Governing Body. This failure increased the risk of substandard quality of care for all hospital patients.

Findings:

A review of the Medical Staff By-Laws dated, September 28, 2010, Appointment and Reappointment revealed, "no person shall exercise clinical privileges in the hospital unless and until that person applies for and receives appointment to the Medical Staff, is granted privileges as set forth in these bylaws."

A review of the Health Care District (governing body) Bylaws dated January 29, 2009, Quality Assurance, Medical Staff Membership and Clinical Privileges, revealed, "Final action on all matters relating to Medical Staff quality assurance, membership status, clinical privileges and corrective actions shall be taken by the Board after considering Medical Staff recommendations."

During a review of the credential file for MD 1, on March 11, 2013, at 11:30 a.m., it was noted the General Surgery Delineation Form, dated, June 6, 2012, on the last page, indicated, "Applicant may perform privileges and procedures as indicated," followed by three spaces for signatures approving MD 1's hospital privileges. Two of the three signature lines contained a signature: one by the reviewer and one by a representative of the Medical Executive Committee, dated July 18, 2012, as required. However, the space for the Board of Directors to sign, and thus granting final approval of MD 1's surgical privileges, was left blank. There was no documented evidence MD 1 had hospital privileges granted by the Governing Board. During a concurrent interview with Staff 16, while reviewing the files, she stated the Chairman of the Board refused to sign off on MD 1's hospital privileges.

During a review of the MEC (Medical Executive Committee) Credentialing Report to the Board, dated, July 18, 2012, the Credentialing Committee Recommendation and Signatures portion of the form indicated a "Favorable Recommendation." However, the space left for the Chairman of the Board to sign did not contain an approval signature, but instead, the words "Mr. [X] refused to sign," dated, November 28, 2012. MD 1's credential file did not contain a completed, approved application for hospital privileges. During a concurrent interview with Staff 16, while reviewing these files, she restated the Chairman of the Board refused to sign MD 1's hospital privileges.

During a review of the Regular Board of Directors Meeting Minutes for 2012 and 2013, there was no documented evidence of approval of MD 1's privileges. Further review of The Regular Board of Directors Meeting Minutes dated November 28, 2012 indicated two "closed sessions." There was no evidence that MD 1's privileges had been granted by the governing board.

Based on observation, interview, and record review, the facility failed to ensure it provided an organized nursing service to all patients by failing:

1. To ensure the facility provided around the clock nursing supervision. There was no House Supervisor from 7 a.m. to 8 a.m., on March 11, 2013. (Refer to A386);

2. To ensure there was documented evidence as to when and why the Registered Nurse (RN) increased the Nitroprusside drip (medication used to treat congestive heart failure and life threatening high blood pressure) from 10.1 milligrams (mg) per hour (hr) to 13.1 mg/hr on March 11, 2013, for one sampled patient (Patient 2). (Refer to A395);

3. To ensure there was documented evidence nursing personnel were competent to perform their assigned duties for six of seven employee files reviewed. (Refer to A397);

4. To ensure there were at least two qualified and competent nursing staff in the Intensive Care Unit (ICU) caring for three patients on March 9, 2013, for the 7 a.m. to 7:30 p.m. shift. (Refer to A397);

5. To ensure physician's order for Propofol (a medication used for sedation) was clarified and/or administered as ordered for Patients 13 and 14. (Refer to A405);

6. To ensure physicians' orders for analgesic medications where complete and specified the circumstances under which the drug was to be administered for Patients 10 and 12. (Refer to A405);

7. To ensure physicians' orders for intravenous cardiac and vasoactive medications were complete and included the dose and specific instructions including the maximum infusion rate parameter and incremental change rate. (Refer to A405);

8. To ensure the physician's (MD) order for Nitroprusside (medication used to treat congestive heart failure and life threatening high blood pressure) and Versed (medication used for sedation) were complete and correct for one sampled patient (Patient 2). (Refer to A405); and,

9. To ensure physician's order for Regular Insulin was administered as ordered for Patient 15, and failed to document the exact dosage of insulin administered. (Refer to A405);

The cumulative effects of these systemic problems resulted in the failure of the nursing department to ensure care was being provided in a safe and effective manner.

Based on interview and record review, the facility failed to provide around the clock nursing supervision. There was no House Supervisor from 7 a.m. to 8 a.m., on March 11, 2013.

Findings:

On March 11, 2013, at 7:45 a.m., the survey team arrived at the facility. A request was made to speak with the Chief Executive Officer (CEO), the Chief Nursing Officer (CNO), the House Supervisor (HS), or whoever was currently in charge of the hospital. The staff member stated the CEO and CNO were not in the facility at this time, and she was not sure who was on duty for the HS.

On March 11, 2013, at 8 a.m., Staff 1 was observed arriving to the facility. Staff 1 stated she was the day shift HS, and had just arrived. She stated that she did not know who she was relieving.

On March 11, 2013, at 10:30 a.m., Staff 1 stated the night shift HS had left the facility prior to her arrival, but had given report to Staff 19 and left him in charge.

On March 11, 2013, at 10:45 a.m., Staff 19 was interviewed. Staff 19 stated his shift started at 7 a.m., and he talked with the night shift HS before she left at 7 a.m., but only about staffing. Staff 19 stated that he was not told that he would be in charge until Staff 1 arrived.

A Memorandum, dated, March 6, 2013, regarding "House Supervisor Weekday Hours," was reviewed. The memo indicated, Staff 1 would act as day HS from 7 a.m. to 5 p.m.

Based on interview and record review, the facility failed to ensure there was documented evidence as to when and why the Registered Nurse (RN) increased the Nitroprusside drip (medication used to treat congestive heart failure and life threatening high blood pressure) from 10.1 milligrams (mg) per hour (hr) to 13.1 mg/hr on March 11, 2013, for one sampled patient (Patient 2). This had the potential to result in an over medication of the patient without an indication.

Findings:

On March 11, 2013, the record for Patient 2 was reviewed. Patient 2 was admitted to the facility on March 4, 2013, with diagnoses including vomiting and hematuria (blood in the urine), and was transferred to the Intensive Care Unit (ICU) on March 8, 2013, at 4 p.m., due to an altered level of consciousness.

The "Physician's Orders" dated March 10, 2013, at 1:40 p.m., indicated "Nitroprusside gtt (drops) titrate (adjust) to keep SBP (systolic blood pressure) > (greater than) 100 (millimeters of mercury) and < (less than) 150 (millimeters of mercury)."

The "Flow Sheet" dated March 11, 2013, indicated the Nitroprusside was infusing at 10.1 mg/hr at 6 a.m., and at 7:22 a.m., when Staff 6 received report from the night shift RN, the Nitroprusside was infusing at 13.1 mg/hr.

The "Vital Sign" dated March 11, 2013, indicated Patient 2's blood pressure was 148/68 mmHg (millimeters of mercury) at 6 a.m., 148/66 mmHg at 6:28 a.m., and 141/68 mmHg at 7:39 a.m.

There was no indication in the record as to when and why the Nitroprusside was increased from 10.1 mg/hr to 13.1 mg/hr, on March 11, 2013, between 6 a.m., and 7:22 a.m.

During an interview with Staff 2 and Staff 6, on March 11, 2013, at 2:20 p.m., they reviewed the record and were unable to find documentation of when and why the Nitroprusside was increased from 10.1 mg/hr to 13.1 mg/hr, on March 11, 2013, between 6 a.m. and 7:22 a.m. Staff 6 stated when he received report from the night shift nurse at 7:22 a.m., the Nitroprusside was infusing at 13.1 mg/hr. In addition, Staff 2 and Staff 6 stated the nurse should have documented when and why she increased the Nitroprusside to 13.1 mg/hr.

During an interview with the Interim Chief Nursing Officer (ICNO) on March 14, 2013, at 8:30 a.m., she stated the facility had no order sets or protocols for the administration of Nitroprusside. The ICNO stated the nurse should have documented why and when she increased and/or decreased the Nitroprusside.

Based on interview and record review, the facility failed to:

1. Ensure there was documented evidence nursing personnel were competent to perform their assigned duties for six of seven employee files reviewed. This resulted in the facility not knowing if the staff assigned to care for patients were clinically competent.

2. Ensure there were at least two qualified and competent nursing staff in the Intensive Care Unit (ICU) caring for three patients on March 9, 2013, for the 7 a.m. to 7:30 p.m. shift. This had the potential to result in inappropriate care and treatment for the ICU patient.

Findings:

1a. The employee file for Staff 22 was reviewed on March 13, 2013. Staff 22 had a hire date of October 22, 2012, and was assigned to the ICU.

There were no initial clinical skills competencies or a 90-day performance evaluation in Staff 22's employee file.

b. The employee file for Staff 23 was reviewed on March 13, 2013. Staff 23 had a hire date of April 22, 2010, was assigned to the Medical/Surgical Unit, was promoted to Charge Nurse on May 19, 2011, and was assigned to care for patients in the Obstetrical Unit as needed.

There were no initial clinical skills competencies or annual clinical skills competencies in Staff 23's employee file.

c. The employee file for Staff 24 was reviewed on March 13, 2013. Staff 24 had a hire date of December 28, 2010, was assigned to the Medical/Surgical Unit, and was assigned to care for patients in the Obstetrical Unit as needed.

There were no initial clinical skills competencies or annual clinical skills competencies in Staff 24's employee file.

d. The employee file for Staff 18 was reviewed on March 13, 2013. Staff 18 had a hire date of June 13, 2011, and was assigned to the Labor & Delivery/Obstetrical/Newborn Nursery Units.

There were no initial clinical skills competencies or annual clinical skills competencies in Staff 18's employee file.

e. The traveler registry file for Staff 6 was reviewed on March 13, 2013. Staff 6 started at the facility on October 22, 2012, was assigned to the Emergency Department, and was assigned to care for patients in the Intensive Care Unit (ICU) and the Medical/Surgical Unit as needed.

There were no initial clinical skills competencies in Staff 6's file.

f. The employee file for Staff 7 was reviewed on March 13, 2013. Staff 7 had a hire date of May 30, 2012, was assigned to the Surgical Services Department, and was assigned to care for patients in surgery and the post anesthesia care unit.

There were no initial clinical skills competencies in Staff 7's employee file.

During an interview with the Human Resources Manager on March 13, 2013, at 1:50 p.m., she reviewed the employee/traveler registry files and was unable to find documentation of initial and annual clinical skills competencies. The Human Resources Manager stated there should be orientation and annual competencies for all staff based on their position within the facility.

During an interview with the Interim Chief Nursing Officer (ICNO), on March 14, 2013, at 8:50 a.m., she reviewed the employee/traveler registry files and was unable to find documentation of initial clinical skills competencies or annual clinical skills competencies to the units the personnel were assigned or floated to. The ICNO stated the employees/travel registry staff should have had documentation of orientation clinical competencies and annual clinical competencies in their files.

The facility policy and procedure titled "Performance Evaluations - Competency" reviewed/revised March 24, 2010, revealed "... Unit specific orientation conducted by the Department Director/designee is carried out for all new employees, including employees being cross-trained. The unit preceptor or the department director will assess the individual's unit specific proficiency as outlined on the unit-specific skills checklist. ... Documentation of mastery of unit specific skills will be recorded on the Unit-Specific Skills checklist. At the conclusion of the 90-day introductory period, the Department Director/Supervisor will conduct a performance evaluation of the new employee. ... Documentation of satisfactory performance for current competencies will be placed in the employee's file. ... The Department Director/Supervisor assures all required competencies have been satisfactorily completed within the allowed time frame. ... Required employee documentation: Clinical Initial skills competency, due the first 90 days of employment, if an employee works multiple units there must be a competency for each unit. ..."

2. On March 11, 2013, at 10 a.m., a tour of the Intensive Care Unit (ICU) was conducted.

During a concurrent interview with Staff 25, she stated there had been a lot of changes in personnel and currently the only fulltime employee for the 7 a.m. to 7 p.m., shift in the ICU was Staff 22 and she was currently orienting to the ICU.

On March 11, 2013, the staffing for the ICU was reviewed.

The "Intensive Care Unit Schedule" dated March 3, 2013, through April 3, 2013, revealed Staff 22 was the only Registered Nurse (RN) assigned to the ICU on March 9, 2013, for the 7 a.m. to 7:30 p.m., shift.

The "ICU Daily Assignment Sheet" for March 9, 2013, for the 7 a.m. to 7:30 p.m., shift, revealed Staff 6 was assigned to care for two patients in the ICU and Staff 22 was assigned to care for one patient in the ICU.

During an interview with Staff 6, on March 11, 2013, at 2 p.m., he stated he and Staff 22 were the personnel assigned to care for the patients in the ICU on March 9, 2013, for the 7 a.m. to 7:30 p.m., shift. Staff 6 stated Staff 22 was orienting to the ICU but was given a patient care assignment with his oversight due to no other staff being available. In addition, Staff 6 stated "they tried to give me a fourth ICU patient but I said no."

During an interview with the Interim Chief Nursing Officer (ICNO) and Staff 1, on March 11, 2013, at 2:15 p.m., they stated Staff 22 was a new graduate RN and was orienting to the ICU. They stated Staff 22 had started at the facility on October 22, 2012, and her orientation to the ICU would take six months.

The employee file for Staff 22 was reviewed on March 13, 2013. Staff 22 had a hire date of October 22, 2012, and was assigned to the ICU.

There were no initial clinical skills competencies or a 90-day performance evaluation in Staff 22's employee file.

During a subsequent interview with the ICNO, on March 14, 2013, at 8:50 a.m., she reviewed the staffing for the ICU on March 9, 2013, for the 7 a.m. to 7:30 p.m., shift and verified Staff 22 was the second RN in the ICU, there were three patients in the ICU, and Staff 22 was assigned to care for one of the ICU patients. The ICNO stated Staff 22 was on orientation and should not have been counted as staff because she was on orientation.

The facility policy and procedure titled "Staffing Responsibilities of the ICU Nursing Personnel" revised March 2010, revealed "Upon completion of the orientation program, when competent performance has been documented per completion of skills inventory, nursing personnel will be responsible for the following: ..."

The facility policy and procedure titled "Staffing - Nursing Services Plan With Patient Classification System" revised/reviewed April 2010, revealed "... Registered Nurses, with demonstrated competency in patient care, are accountable for all patient assignments ... Intensive Care: The department will be staffed by RNs with training and competencies in critical care nursing. ..."

Based on observation, interview, and record review, the facility failed to administer medications in accordance with acceptable standards and the facility's policy and procedure by failing to:

1. Ensure physician's order for propofol (a medication used for sedation) was clarified and/or administered as ordered for Patients 13 and 14. This had the potential to result in over or under medication;

2. Ensure physicians' orders for analgesic medications where complete and specified the circumstances under which the drug was to be administered to Patients 10 and 12. This had the potential to result in inadequate pain control or over medication;

3. Ensure physicians' orders for intravenous cardiac and vasoactive medications were complete and included the dose and specific instructions including the maximum infusion rate parameter, and incremental change rate. The failure lead to Registered Nurses (RNs) practicing outside of their scope of practice, by determining the infusion rate of the medications given to the patients, and the potential for poor patient outcome;

4. Ensure the physician's (MD) order for Nitroprusside (medication used to treat congestive heart failure and life threatening high blood pressure) and Versed (medication used for sedation) were complete and correct for one sampled patient (Patient 2). This resulted in RNs practicing outside of their scope of practice, and had the potential to result in an over or under dosing of the medications; and

5. Ensure physician's order for Regular Insulin was administered as ordered for Patient 15, and failed to document the exact dosage of insulin administered. As a result, Patient 15 did not receive the correct dose of insulin, or the dose given could not be determined.

Findings:

1a. On March 12, 2013, at 7:50 a.m., Patient 13 was observed in bed 4 in the ICU. Patient 13 was orally intubated (tube placed in the patients throat to facilitate breathing) and undergoing mechanical ventilation.

A review of Patient 13's record indicated the patient was admitted from the emergency room on March 11, 2013, with hepatic (liver) failure. On March 11, 2013, the following order was written: "Propofol Infusion, titrate for patient comfort." There was no evidence in the record the order was clarified by the pharmacy or the nursing staff.

b. Patient 14's record was reviewed on March 12, 2013. Patient 14 presented to the facility, and was admitted to the facility on February 24, 2013. On March 3, 2013, there was a physician's order for: "May start Propofol IV titrate [adjust] for sedation while intubated 5-50 mcg/kg/min [micrograms per kilograms per minute] if BP [blood pressure] tolerates." There was no evidence in the record that the order was clarified and a level of sedation was described.

The facility policy titled "Propofol (Diprivan) Sedation Guidelines in ICU [Intensive Care Unit]," dated March 2010, was reviewed. The policy indicated its purpose was to ensure safe practices in the administration of propofol in the ICU. The policy indicated propofol was an intravenous sedative hypnotic agent for the use in the induction and maintenance of anesthesia or conscious sedation. According to the policy the physician's order must identify the patient, drug and prescribed level of sedation using the Modified Ramsey Sedation Scale (indicates level of sedation between level 1- anxious, irritated ore restless and level 7- no response to firm nail pressure).

In an interview with the Interim Chief Nursing Officer (ICNO), on March 14, 2013, at 8:30 a.m., the ICNO stated she had identified a problem with the order for Patient 13, yesterday. The ICNO stated the propofol order needed a sedation level to be a complete order.

2a. Patient 12's record was reviewed on March 11, 2013. Patient 12 was admitted to the facility on March 9, 2013, with diagnoses that included blunt chest trauma and pneumothorax (an abnormal collection of air or gas in the area that separates the lung from the chest wall and may interfere with normal breathing). On March 9, 2013, the following physician's order was noted: "Dilaudid [a narcotic pain medication, with a side effect of respiratory depression] 1 [one] to 2 [two] milligrams IV [intravenous] Q [every] 4 hours PRN [as needed] pain. Titrate [increase] up to 3 [three] milligrams every 4 [four] hours. There was no evidence this order was clarified by pharmacy or nursing staff.

On March 11, 2013, at 2:50 p.m., the Pharmacy Manager was interviewed. The Pharmacy Manager reviewed the order for Patient 12's Dilaudid and stated the order was not complete. The Pharmacy Manager stated the order should specify at what pain level which dose was administered. The Pharmacy Manager stated the order as written, allows nursing personnel to determine the dose.

b. Patient 10's record was reviewed on March 12, 2013. Patient 10 had undergone incision and drainage of his left arm abscess on March 11, 2013. Physician's orders included an order for Norco 5/325 (an oral analgesic) one to two tablets orally every four hours as needed for pain. There was no evidence this order was clarified by pharmacy or nursing staff.

On March 12, 2013, a pain management policy/protocol was requested. This policy was not received prior to the end of the survey.

On March 14, 2013, at 7:30 a.m., Staff 1 was asked about Patient 10 and 12's written orders for pain. Staff 1 stated the orders were not written correctly, as dosage should not be left up to the nurse. Staff 1 stated the orders needed to be clarified.

On March 14, 2013, at 8:30 a.m., the Interim Chief Nursing Officer (ICNO) was interviewed. The ICNO stated analgesic orders needed to be clarified.

The facility policy and procedure titled "Medication Orders/Pre-Printed Order" reviewed March 2010, revealed "Pharmacist shall check for: Completeness of the drug order; Correctness of the drug order; Appropriate dosage, route, frequency, and indications. Any questions or clarifications regarding the physician drug order shall be directed to the physician by the Pharmacist. ... Verbal orders shall be written in the patient's chart if any drug orders are changed. ... Drugs shall be dispensed only after review of the product and/or the physician order by the Pharmacist."

3. According to the California Nursing Practice Act § 2725.1, "...Notwithstanding any other provision of law, a registered nurse may dispense drugs or devices upon an order by a licensed physician and surgeon if the nurse is functioning within a licensed clinic..."

According to the California Code of Regulations, Title 22, Division 5, § 70263(g), "No drugs shall be administered except by licensed personnel authorized to administer drugs and upon the order of a person lawfully authorized to prescribe or furnish..."

a. On March 12, 2013, at 7:50 a.m., Patient 13 was observed in bed 4 in the ICU. Patient 13 was orally intubated (tube placed in the patients throat to facilitate breathing) and undergoing mechanical ventilation.

A review of Patient 13's record indicated the patient was admitted from the emergency room on March 11, 2013, with hepatic (liver) failure. On March 12, 2013, the following order was written: "Start Cardizem gtt [drip] titrate [adjust] to keep HR [heart rate] < [less than] 120." There was no evidence in the record the order was clarified by the pharmacist or the nursing staff.

(Cardizem is a calcium channel blocker that works by relaxing the muscles of the heart and blood vessels. Cardizem is used to treat hypertension [high blood pressure], angina [chest pain], and certain heart rhythm disorders.)

b. Patient 14's record was reviewed on March 12, 2013. Patient 14 presented to and was admitted to the facility on February 24, 2013. On March 7, 2013, there was a physician's order for: "Levophed Drip Titrate to SBP [Systolic Blood Pressure] greater than 90." There was no evidence the order was clarified as to medication concentration, starting rate, incremental dose changes, and maximum rate.

On March 12, 2013, the facility policy for intravenous cardiac medications (including vasoactive medications-used to maintain blood pressure) was requested.

On March 14, 2013, at 8:30 a.m., the Interim Chief Nursing Officer (ICNO) was interviewed. The ICNO stated she had identified a problem with these types of orders.

The facility policy and procedure titled "Medication Orders/Pre-Printed Order" reviewed March 2010, revealed "... Pharmacist shall check for: Completeness of the drug order; Correctness of the drug order; Appropriate dosage, route, frequency, and indications. Any questions or clarifications regarding the physician drug order shall be directed to the physician by the Pharmacist. ... Verbal orders shall be written in the patient's chart if any drug orders are changed. ... Drugs shall be dispensed only after review of the product and/or the physician order by the Pharmacist. ..."



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4. On March 11, 2013, the record for Patient 2 was reviewed. Patient 2 was admitted to the facility on March 4, 2013, with diagnoses including vomiting and hematuria (blood in the urine), and was transferred to the Intensive Care Unit (ICU) on March 8, 2013, at 4 p.m., due to an altered level of consciousness.

The "Physician's Orders" dated March 10, 2013, at 10:10 a.m., indicated "Versed gtt (drops) 20-100 mcg/kg/hr (micrograms per kilogram per hour) titrate to affect."

The Physician's order for Versed did not have a starting dose, a maximum dose, define what was meant by "affect," or how often the rate could be changed.

The "Physician's Orders" dated March 10, 2013, at 1:40 p.m., indicated "Nitroprusside gtt titrate (adjust) to keep SBP (systolic blood pressure) > (greater than) 100 (millimeters of mercury) and < (less than) 150 (millimeters of mercury)."

The Physician's order for Nitroprusside did not have a starting dose, a maximum dose, or how often the rate could be changed.

During an interview with the Pharmacy Manager (PM) on March 11, 2013, at 2:10 p.m., he stated he was "not used to seeing these kind of orders" from a physician. The PM stated the Physician (MD) should write the Versed order with parameters such as the Modified Ramsey Sedation Scale (used to assess the level of sedation - Levels 1 through 7) to keep the patient sedated at the level the MD wants. The PM stated the MD should have been called for a clarification of the orders to include starting doses, maximum doses, and how often the rate could be changed. In addition, the PM stated once the orders were clarified with the MD, the orders should have been re-written by the MD or as a telephone order from the MD.

During an interview with the Interim Chief Nursing Officer (ICNO), on March 14, 2013, at 8:30 a.m., she reviewed the record and stated the orders for Versed and Nitroprusside were incomplete and should have been clarified with the physician by the nurse or the pharmacist prior to being administered. The ICNO stated as the orders are currently written, the nurse could do whatever they wanted to do and thus would be "practicing medicine." In addition, the ICNO stated "correct" orders should have been written.

The facility policy and procedure titled "Medication Orders/Pre-Printed Order" reviewed March 2010, revealed "... Pharmacist shall check for: Completeness of the drug order; Correctness of the drug order; Appropriate dosage, route, frequency, and indications. Any questions or clarifications regarding the physician drug order shall be directed to the physician by the Pharmacist. ... Verbal orders shall be written in the patient's chart if any drug orders are changed. ... Drugs shall be dispensed only after review of the product and/or the physician order by the Pharmacist. ..."



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5. The medical record for Patient 15 was reviewed. Patient 15 was admitted to the facility on March 7, 2013, with diagnoses that included abdominal pain, flank pain, UTI (Urinary Tract Infection), and a history of uncontrolled diabetes.

The physician orders, dated March 7, 2013, indicated to perform Blood Glucose Accu-check before each meal and at bedtime (7 a.m., 11 a.m., 5 p.m., and 9 p.m.). The dosage scale (sliding scale), based on the results of the blood glucose, indicated to give Regular insulin as follows:
61-150 = 0 units;
151-200 = 2 units;
201-250 = 3 units;
251-300 = 4 units;
301-350 = 8 units;
351-400 = 10 units; and
Greater than 400 = 12 units.

A review of the electronic MAR (medication administration record) revealed the following:
a. On March 7, 2013, at 6:25 a.m., Regular insulin was given, however there was no documentation of the amount of insulin given. Based on physician order and a blood glucose of 220 at that time, 3 units of Regular insulin should have been given;
b. On March 8, 2013, at 5 p.m., no insulin was given. Based on physician order and a blood glucose of 152 at that time, 2 units of Regular insulin should have been given;
c. On March 9, 2013, at 5:29 p.m., 8 units of Regular insulin was given. Based on physician order and a blood glucose level of 369 at that time, 10 units of regular insulin should have been given;
d. On March 9, 2013, at 9 p.m, there was no documentation if the blood glucose was checked, or if any Regular insulin was given;
e. On March 10, 2013, at 6:58 a.m., Regular insulin was given, however there was no documentation of the amount of insulin given. Based on physician order and a blood glucose of 197 at that time, 2 units of Regular insulin should have been given;
f. On March 10, 2013, at 5:30 p.m., 3 units of Regular insulin was given. Based on physician order and a blood glucose level of 289 at that time, 4 units of regular insulin should have been given;
g. On March 10, 2013, at 9 p.m., 4 units of Regular insulin was given. Based on physician order and a blood glucose level of 303 at that time, 8 units of regular insulin should have been given; and
h. On March 11, 2013, at 7:02 a.m., 3 units of Regular insulin was given. Based on physician order and a blood glucose level of 251 at that time, 4 units of regular insulin should have been given;

On March 11, 2013, at 10:15 a.m., Staff 2 was interviewed. Staff 2 stated that because the vial of Regular insulin was a multi-dose vial, the nurse administering the insulin should have documented the exact dose that was given. Staff 2 was unable to find the documentation of the insulin that was given. In addition, Staff 2 stated that two nurses were to verify all insulin doses prior to administration, and could not explain why the wrong doses were given.

Based on observation, interview and record review, the facility failed to ensure entries into Patient 12's progress notes were legible. This failure had the potential to impact and delay care and treatment provided to Patient 12 by other providers.

Findings:

On March 11, 2013, the medical record for Patient 12 was reviewed. According to the dictated "Discharge Summary," in the patient's record, Patient 12's "chest tube [tube placed in chest to remove air or fluid] was taken out. Patient tolerated the procedure and patient will be discharged home." Date of discharge was documented as March 11, 2013.

On March 11, 2013, at 2:10 p.m., Patient 12 was interviewed. Patient 12 stated he had not been told he was being discharged today. Patient 12 stated he still had a chest tube and Foley catheter (tube placed in the bladder to drain urine).

In an interview with Staff 20, on March 11, 2013, at 2:25 p.m., Staff 20 stated the discharge summary was a plan and not necessarily a summary of the patient's stay.

Due to the discrepancy in the patient's physical assessment and the dictated Discharge Summary, the patient's progress notes were reviewed.

The progress notes in Patient 12's record were reviewed with Staff 20 and Staff 21. Neither staff was able to read the progress notes written by MD (physician) 3, on March 10, or 11, 2013. Staff 21 stated she was able to read his orders but could not read the progress notes.

The "Medical Staff Rules and Regulations," were reviewed on March 13, 2013. The rules indicated in the section for progress notes: "Daily hospital visit and pertinent progress notes must reflect the condition of the patient and course of therapy, as the patient's condition warrants and such notes must provide continuity of care and transferability."

Based on observation and interview, the facility failed failed to ensure a Discharge Summary was completed after the patient was discharged instead of prior to the patient being discharged. As a result, there was an inaccurate accounting of two patient's hospital course, when the patients had not been discharged. (Patient 21 and Patient 12)

Findings:

1. During a tour of the Medical/Surgical Unit on March 11, 2013, at 8:45 a.m., Patient 21 was observed sleeping in his room.

On March 11, 2013, the record for Patient 21 was reviewed. Patient 21 was admitted to the facility on March 8, 2013, with diagnoses that included bronchitis, hypoxia (a condition in which the body is deprived of adequate oxygen), and chronic obstructive pulmonary disease (COPD- a disease involving constriction of the airways and difficulty or discomfort in breathing).

Patient 21's medical record contained a "Discharge Summary," that detailed, among other things, the hospital course of Patient 21. The "Discharge Summary" was dictated on March 10, 2013, at 2:21 p.m., and indicated, "Patient was started on IV Solu-Medrol, breathing treatment, IV antibiotics. Patient did well. Her Solu-Medrol was weaned off and changed to oral prednisone. Patient did better..."

The physician order for Prednisone 20 mg, by mouth, every day, was entered into the computer on March 10, 2013, at 2:59 p.m. The first dose of Prednisone was administered to Patient 21 on March 11, 2013, at 8:32 a.m. (more than 18 hours after the "Discharge Summary" was dictated and revealed Patient 21 had been started on the Prednisone and was doing better).

2. On March 11, 2013, the medical record for Patient 12 was reviewed. According to the dictated "Discharge Summary," in the patient's record, Patient 12's "chest tube [tube placed in chest to remove air or fluid] was taken out. Patient tolerated the procedure and patient will be discharged home." Date of discharge was documented as March 11, 2013. According to documentation on the form, this summary was dictated and typed on March 10, 2013.

On March 11, 2013, at 2:10 p.m., Patient 12 was interviewed. Patient 12 stated he had not been told he was being discharged today. Patient 12 stated he still had a chest tube and Foley catheter (tube placed in the bladder to drain urine).

Patient 12 was observed walking in the medical surgical unit hallway on March 13, 2013.

The "Medical Staff Rules and Regulations," were reviewed on March 13, 2013. The rules indicated in the section for progress notes: "Daily hospital visit and pertinent progress notes must reflect the condition of the patient and course of therapy, as the patient's condition warrants and such notes must provide continuity of care and transferability."

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

1. Ensure the physician's orders for propofol (medication used as a sedative) were complete and accurate prior to the administration of the medication for two sampled patients (Patients 13 and 14). This had the potential to result in the patients becoming over sedated.

2. Ensure pain medication orders were not written with dose ranges and/or pain medications were given based on the patient's severity of pain for two sampled patients (Patients 12 and 10). This resulted in the nurse determining the amount of pain medication the patient would receive and had the potential to result in patients being under or over medicated for their pain.

3. Ensure the physician's orders for calcium channel blockers and/or intravenous cardiac medications were complete and accurate prior to the administration of the medication for two sampled patients (Patients 13 and 14). This resulted in the nurse administering medications with no medication concentration, no starting dose, no identification as to when incremental dose changes should occur, and no maximum dose.

4. Ensure the physician's orders for Nitroprusside (medication used to treat congestive heart failure and life threatening high blood pressure) and Versed (medication used as an anesthetic or sedative) were complete and accurate prior to the administration of the medication for one sampled patient (Patient 2). This resulted in no starting dose, no maximum dose and no specific parameters for titration of the Versed.

Findings:

1a. On March 12, 2013, at 7:50 a.m., Patient 13 was observed in bed 4 in the ICU. Patient 13 was orally intubated (tube placed in the patients throat to facilitate breathing) and undergoing mechanical ventilation.

A review of Patient 13's record indicated the patient was admitted from the emergency room on March 11, 2013, with hepatic (liver) failure. On March 11, 2013, the following order was written: "Propofol Infusion, titrate for patient comfort." There was no evidence in the record the order was clarified by the pharmacy or the nursing staff.

b. Patient 14's record was reviewed on March 12, 2013. Patient 14 presented to the facility, and was admitted to the facility on February 24, 2013. On March 3, 2013, there was a physician's order for: "May start Propofol IV titrate [adjust] for sedation while intubated 5-50 mcg/kg/min [micrograms per kilograms per minute] if BP [blood pressure] tolerates." There was no evidence in the record that the order was clarified and a level of sedation was described.

The facility policy titled "Propofol (Diprivan) Sedation Guidelines in ICU [Intensive Care Unit]," dated March 2010, was reviewed. The policy indicated its purpose was to ensure safe practices in the administration of propofol in the ICU. The policy indicated propofol was an intravenous sedative hypnotic agent for the use in the induction and maintenance of anesthesia or conscious sedation. According to the policy the physician's order must identify the patient, drug and prescribed level of sedation using the Modified Ramsey Sedation Scale (indicates level of sedation between level 1- anxious, irritated ore restless and level 7- no response to firm nail pressure).

In an interview with the Interim Chief Nursing Officer (ICNO), on March 14, 2013, at 8:30 a.m., the ICNO stated she had identified a problem with the order for Patient 13, yesterday. The ICNO stated the propofol order needed a sedation level to be a complete order.

2a. Patient 12's record was reviewed on March 11, 2013. Patient 12 was admitted to the facility on March 9, 2013, with diagnoses that included blunt chest trauma and pneumothorax (an abnormal collection of air or gas in the area that separates the lung from the chest wall and may interfere with normal breathing). On March 9, 2013, the following physician's order was noted: "Dilaudid [a narcotic pain medication, with a side effect of respiratory depression] 1 [one] to 2 [two] milligrams IV [intravenous] Q [every] 4 hours PRN [as needed] pain. Titrate [increase] up to 3 [three] milligrams every 4 [four] hours. There was no evidence this order was clarified by pharmacy or nursing staff.

On March 11, 2013, at 2:50 p.m., the Pharmacy Manager was interviewed. The Pharmacy Manager reviewed the order for Patient 12's Dilaudid and stated the order was not complete. The Pharmacy Manager stated the order should specify at what pain level which dose was administered. The Pharmacy Manager stated the order as written, allows nursing personnel to determine the dose.

b. Patient 10's record was reviewed on March 12, 2013. Patient 10 had undergone incision and drainage of his left arm abscess on March 11, 2013. Physician's orders included an order for Norco 5/325 (an oral analgesic) one to two tablets orally every four hours as needed for pain. There was no evidence this order was clarified by pharmacy or nursing staff.

On March 12, 2013, a pain management policy/protocol was requested. This policy was not received prior to the end of the survey.

On March 14, 2013, at 7:30 a.m., Staff 1 was asked about Patient 10 and 12's written orders for pain. Staff 1 stated the orders were not written correctly, as dosage should not be left up to the nurse. Staff 1 stated the orders needed to be clarified.

On March 14, 2013, at 8:30 a.m., the Interim Chief Nursing Officer (ICNO) was interviewed. The ICNO stated analgesic orders needed to be clarified.

The facility policy and procedure titled "Medication Orders/Pre-Printed Order" reviewed March 2010, revealed "Pharmacist shall check for: Completeness of the drug order; Correctness of the drug order; Appropriate dosage, route, frequency, and indications. Any questions or clarifications regarding the physician drug order shall be directed to the physician by the Pharmacist. ... Verbal orders shall be written in the patient's chart if any drug orders are changed. ... Drugs shall be dispensed only after review of the product and/or the physician order by the Pharmacist."

3. According to the California Nursing Practice Act § 2725.1, "...Notwithstanding any other provision of law, a registered nurse may dispense drugs or devices upon an order by a licensed physician and surgeon if the nurse is functioning within a licensed clinic..."

According to the California Code of Regulations, Title 22, Division 5, § 70263(g), "No drugs shall be administered except by licensed personnel authorized to administer drugs and upon the order of a person lawfully authorized to prescribe or furnish..."

a. On March 12, 2013, at 7:50 a.m., Patient 13 was observed in bed 4 in the ICU. Patient 13 was orally intubated (tube placed in the patients throat to facilitate breathing) and undergoing mechanical ventilation.

A review of Patient 13's record indicated the patient was admitted from the emergency room on March 11, 2013, with hepatic (liver) failure. On March 12, 2013, the following order was written: "Start Cardizem gtt [drip] titrate [adjust] to keep HR [heart rate] < [less than] 120." There was no evidence in the record the order was clarified by the pharmacist or the nursing staff.

(Cardizem is a calcium channel blocker that works by relaxing the muscles of the heart and blood vessels. Cardizem is used to treat hypertension [high blood pressure], angina [chest pain], and certain heart rhythm disorders.)

b. Patient 14's record was reviewed on March 12, 2013. Patient 14 presented to and was admitted to the facility on February 24, 2013. On March 7, 2013, there was a physician's order for: "Levophed Drip Titrate to SBP [Systolic Blood Pressure] greater than 90." There was no evidence the order was clarified as to medication concentration, starting rate, incremental dose changes, and maximum rate.

On March 12, 2013, the facility policy for intravenous cardiac medications (including vasoactive medications-used to maintain blood pressure) was requested.

On March 14, 2013, at 8:30 a.m., the Interim Chief Nursing Officer (ICNO) was interviewed. The ICNO stated she had identified a problem with these types of orders. The ICNO stated additional information, such as starting dose, and change rate needed to be included in the orders.

The facility policy and procedure titled "Medication Orders/Pre-Printed Order" reviewed March 2010, revealed "... Pharmacist shall check for: Completeness of the drug order; Correctness of the drug order; Appropriate dosage, route, frequency, and indications. Any questions or clarifications regarding the physician drug order shall be directed to the physician by the Pharmacist. ... Verbal orders shall be written in the patient's chart if any drug orders are changed. ... Drugs shall be dispensed only after review of the product and/or the physician order by the Pharmacist."



28294

4. On March 11, 2013, the record for Patient 2 was reviewed. Patient 2 was admitted to the facility on March 4, 2013, with diagnoses including vomiting and hematuria (blood in the urine), and was transferred to the ICU on March 8, 2013, at 4 p.m., due to an altered level of consciousness.

The "Physician's Orders" dated March 10, 2013, at 10:10 a.m., indicated "Versed gtt (drops) 20-100 mcg/kg/hr (micrograms per kilogram per hour) titrate to affect."

The Physician's order for Versed did not have a starting dose, a maximum dose, define what was meant by "affect," or how often the rate could be changed.

The "Physician's Orders" dated March 10, 2013, at 1:40 p.m., indicated "Nitroprusside gtt titrate (adjust) to keep SBP (systolic blood pressure) > (greater than) 100 (millimeters of mercury) and < (less than) 150 (millimeters of mercury)."

The Physician's order for Nitroprusside did not have a starting dose, a maximum dose, or how often the rate could be changed.

During an interview with the Pharmacy Manager (PM) on March 11, 2013, at 2:10 p.m., he stated he was "not used to seeing these kind of orders" from a physician. The PM stated the Physician (MD) should write the Versed order with parameters such as the Modified Ramsey Sedation Scale (used to assess the level of sedation - Levels 1 through 7) to keep the patient sedated at the level the MD wants. The PM stated the MD should have been called for a clarification of the orders to include starting doses, maximum doses, and how often the rate could be changed. In addition, the PM stated once the orders were clarified with the MD, the orders should have been re-written by the MD or as a telephone order from the MD.

During an interview with the Interim Chief Nursing Officer (ICNO), on March 14, 2013, at 8:30 a.m., she reviewed the record and stated the orders for Versed and Nitroprusside were incomplete and should have been clarified with the physician by the nurse or the pharmacist prior to being administered. The ICNO stated as the orders are currently written, the nurse could do whatever they wanted to do and thus would be "practicing medicine." In addition, the ICNO stated "correct" orders should have been written.

The facility policy and procedure titled "Medication Orders/Pre-Printed Order" reviewed March 2010, revealed "... Pharmacist shall check for: Completeness of the drug order; Correctness of the drug order; Appropriate dosage, route, frequency, and indications. Any questions or clarifications regarding the physician drug order shall be directed to the physician by the Pharmacist. ... Verbal orders shall be written in the patient's chart if any drug orders are changed. ... Drugs shall be dispensed only after review of the product and/or the physician order by the Pharmacist. ..."

Based on observation, interview, and record review, the facility failed to ensure the medications and biologicals in the Labor & Delivery (L&D) anesthesia epidural and the Operating Room (OR) anesthesia cart were secure and locked. This had the potential to result in the unauthorized access to drugs and biologicals.

Findings:

On March 11, 2013, at 8:30 a.m., a tour of L&D was conducted. The doors to the L&D unit were unlocked, and no one was in the unit. The door to Labor, Delivery, Recovery (LDR) 3 was open.
Staff 18 was located in the Newborn Nursery and proceeded to L&D to conduct the tour with the Heath Facilities Evaluator Nurse.

An anesthesia epidural cart was located in LDR 3 at the entrance to the room. The anesthesia epidural cart was unlocked and the drawers contained needles, syringes, epidural tray kits, intravenous start kits, and medications to include multiple vials of xylocaine 2%.

During a concurrent interview with Staff 18, she verified the anesthesia epidural cart was unlocked and stated the cart was left open most of the time.

During the initial tour of the OR area, on March 11, 2013, at 9:45 a.m., after the operative case in OR 1 was completed, MD 2 left the anesthesia medication cart open and unlocked. Staff 10 was brought into OR 1, which was empty of all personnel, and was shown the medication cart. Staff 10 confirmed the medication cart was open and unlocked. When asked if it was "OK" to leave the medication cart open and unattended, he stated he was uncertain if that was OK. He further stated that he "doesn't mess with it (anesthesia cart)."
During an interview with MD 2, on March 11, 2013, at 10:05 a.m., when he was shown the open anesthesia medication cart, he confirmed the cart was open and unlocked. He stated that he "locks it at the end of the day." MD 2 confirmed that Propofol (anesthetic agent) was stored in the cart and was accessible to other OR staff and cleaning personnel during the day while the anesthesia cart was left open and unattended. MD 2 also confirmed that the Propofol was not locked and was a drug which could be potentially abused by individuals.

During an interview with the Pharmacy Manager (PM) on March 11, 2013, at 2:10 p.m., a request was made to obtain the facility policy and procedure for the securing of drugs and biologicals located in the L&D anesthesia epidural cart. The facility provided the policy and procedure titled "Pyxis Automated Medstation Use" reviewed March 2010, which addresses securing medications in the automated dispensing cabinet system.

The facility did not provide a policy and procedure addressing the securing of drugs and biologicals that were located outside the automated dispensing cabinet system such as drugs and biologicals located in the L&D anesthesia cart.

Based on observation, interview and record review, the facility failed to ensure drugs and biologicals were properly stored, maintained and not expired per facility policies and procedures. This resulted in expired laboratory tubes and solutions, supplies, infant formula, medications, and biologicals being available for patient care use.

Findings:

a. On March 11, 2013, at 8:50 a.m., the pediatric crash cart in the medical/surgical unit was inspected. The crash cart contained two syringes of Dextrose 2.5 grams, with an expiration date of March 1, 2013.

In a concurrent interview with Staff 27, he stated the crash cart was checked daily by each shift, and monthly by the pharmacy, and items replaced as needed. Staff 27 stated the Dextrose should have been removed and replaced prior to the expiration date.

The facility policy titled, "Emergency Drugs," and dated March 2010, was reviewed. The policy indicated, "The Pharmacy shall replace missing, expired, and unusable drugs as soon as possible."



28294

b. On March 11, 2013, at 8:30 a.m., a tour of Labor & Delivery (L&D), Obstetrics, and the Newborn Nursery was conducted with Staff 18.

The following was observed:
- One box of 2-0 Vicryl suture with an expiration date of January 2013.
- In an unlocked, unsecured anesthesia cart, two open, not dated vials of Xylocaine 2%,
- An opened bottle of Hydrogen Peroxide dated August 8, 2012.
- Two "IV (intravenous - fluid/medications given directly into a vein) Start Kits," one with an expiration date of July 2012, and one with an expiration date of December 2012.
- Five green top laboratory specimen tubes with an expiration date of January 2013.
- Ten vials of solution for MRSA (Methicillin-resistant Staphylococcus Aureus - a bacteria resistant to certain antibiotics) testing, six with an expiration date of September 21, 2010, and four with an expiration date of September 27, 2010.
- Four "Quick A.B.G. (arterial blood gas) Kits," one with an expiration date of March 2011, and three with an expiration date of September 2011.
- Eight boxes (six bottles per box) of infant formula with an expiration date of March 1, 2013.

During a concurrent interview with Staff 18, she verified the products were expired and should have been returned to Pharmacy, Laboratory or Materials Management for credit, or discarded. Staff 18 stated multiple dose vials of medications/solutions should be dated when opened and discarded 28 days after being opened. In addition, Staff 18 stated Materials Management personnel checked for outdated products, and the Obstetrical staff should use or give away the formula before it becomes outdated.

The facility policy and procedure titled "Infection Control, Multi-Use Sterile Drugs" reviewed March 2010, revealed "... Multiple-use containers of sterile drugs shall be dated and initialed or signed when first opened and entered. A 'Vial Opened' label should be applies to each opened multi-use vial. ... After the initial entry, multiple-dose use sterile drugs in vials may be used up to 28 days after the date first opened or entered provided they are in date, ..."

The facility policy and procedure titled "Sterile Manufactured Supplies Expiration Process" reviewed May 5, 2009, revealed "... All sterile items throughout the hospital must be checked for expiration dates on a routine basis. This is the responsibility of each department; however the Materials Management Department retains oversight responsibility. Items that have reached the marked expiration date will be immediately removed from patient care areas and returned to the Materials Management Department. ... Each department must have a method of regularly checking their sterile supplies for outdates and documenting it..."

Based on observation, interview, and record review, the facility failed to ensure expired supplies were not available for patient care use. This had the potential to result in expired products being used for patient care.

Findings:

On March 11, 2013, at 8:30 a.m., a tour of Labor & Delivery (L&D), Obstetrics, and the Newborn Nursery was conducted with Staff 18.

The following was observed:
- One box of 2-0 Vicryl suture with an expiration date of January 2013.
- Two "IV (intravenous - fluid/medications given directly into a vein) Start Kits," one with an expiration date of July 2012, and one with an expiration date of December 2012.
- Five green top laboratory specimen tubes with an expiration date of January 2013.
- Ten vials of solution for MRSA (Methicillin-resistant Staphylococcus Aureus - a bacteria resistant to certain antibiotics) testing, six with an expiration date of September 21, 2010, and four with an expiration date of September 27, 2010.
- Four "Quick A.B.G. (arterial blood gas) Kits," one with an expiration date of March 2011, and three with an expiration date of September 2011.
- Eight boxes (six bottles per box) of infant formula with an expiration date of March 1, 2013.

During a concurrent interview with Staff 18, she verified the products were expired and should have been returned to Laboratory or Materials Management for credit, or discarded. Staff 18 stated Materials Management personnel checked for outdated products, and the Obstetrical staff should use or give away the formula before it becomes outdated.

During an interview with Staff 26, on March 13, 2013, at 9:20 a.m., he stated the unit was responsible to check for outdated laboratory products, and should not have expired laboratory tubes or specimen containers available for patient care use. In addition, Staff 26 stated the facility did not have a policy and procedure that addressed expired laboratory products.

During an interview with Materials Management Manager, on March 13, 2013, at 9:25 a.m., he stated both the unit and Materials Management were responsible to check for outdated products. The Materials Management Manager stated there should not be expired products on the units available for patient care use.

The facility policy and procedure titled "Sterile Manufactured Supplies Expiration Process" reviewed May 5, 2009, revealed "... All sterile items throughout the hospital must be checked for expiration dates on a routine basis. This is the responsibility of each department; however the Materials Management Department retains oversight responsibility. Items that have reached the marked expiration date will be immediately removed from patient care areas and returned to the Materials Management Department. ... Each department must have a method of regularly checking their sterile supplies for outdates and documenting it. ..."



18918

On March 11, 2013, at 10:30 a.m., the Post Anesthesia Care Unit (PACU) emergency cart was observed. There were packages of Kendall 510 Resting ECG (electrocardiography) Electrodes with an expiration date of April 2012, on the cart and available for use. In a concurrent interview, Staff 8 stated those electrodes were used for 12 lead EKGs, "we don't use them."

A review of the policy titled "Crash Cart-Standardized Arrangements," dated June 2006, was conducted. The list indicated the cart should have two packages of "Diaphoretic Electrodes," on the "top of crash cart/right side bin."

Based on observation, interview, and record review, the facility failed to ensure the terminal cleaning process and the manufacturer's recommendation for contact time were followed during the cleaning of Operating Room 2 on March 11, 2013. This failure had the potential for cross contamination due to inadequate disinfection of hard surfaces in the operating room.

Findings:

On March 11, 2013, at 9:25 a.m., Staff 7 was observed in Operating Room (OR) 2, caring for a patient. Staff 7 was monitoring the patient's vital signs and inputting information into a computer on wheels.

In a concurrent interview, Staff 7 stated she was recovering Patient 10 in the operating room as the surgery was "dirty," and they did not want to contaminate the post anesthesia recovery room. Staff 7 stated the room would need terminal cleaning. At the conclusion of the recovery period Staff 7 took Patient 10 to his room via his bed.

On March 11, 2013, at 9:35 a.m., Staff 11 entered the room and began cleaning. Staff 11 sprayed flat, hard surfaces and tray and table legs, with Virex Tb solution. Staff 11 then began wiping the surfaces. The Virex Tb solution contact (wet) time was less than two minutes.

In a concurrent interview with Staff 11, on March 11, 2013, at 9:40 a.m., Staff 11 stated she would leave the Virex Tb on the surface for one minute, and then remove.

On March 11, 2013, at 9:45 a.m., Staff 7 returned to the room and indicated to Staff 11 the room would need terminal cleaning due to the previous surgery. Staff 11 left the room and returned with a bucket containing solution "499." Staff 11 was observed using this solution on the walls, trays, tables and trash containers. The solution was applied to the walls using a long handled mop. The walls were dry within a minute of the solution being applied.

In a concurrent interview, Staff 11 stated she did not need to reapply solution to walls or table tops, she just needed to let it air dry.

On March 11, 2013, at 9:55 a.m., Staff 11 explained the process for obtaining cleaning solution. Staff 11 indicated "Oasis 499 Cleaner," was used in the operating room she had just cleaned.

A review of the facility policy, "Surgery Cleaning Procedure," with a last revised date of January 2009, was conducted. The purpose indicated, "To ensure an aseptically clean environment for staff and for the processing through strict adherence to post case cleaning and terminal cleaning procedures and schedules." The policy had instructions for cleaning "Surgery suites following isolation case," and "Terminal cleaning of Surgery Suites." Both sets of instructions indicated "Germicide Solution," was to be used.

Operating Room 2 was not cleaned according to either of the above instructions.

A review of the "Virex Tb," reference material indicated "when used as directed Virex Tb ...highly effective against a wide variety of pathogenic microorganisms including bacteria, antibiotic resistant bacteria, viruses, fungi, mold and mildew." Contact time for this solution goes from 30 seconds for the "Norwalk Virus," to ten minutes for Hepatitis A. To kill staphylococcus aureus on hard non-porous inanimate environmental surfaces, the solution required a three minute contact time.

A review of the product information for "Oasis 499 HBV Disinfectant," indicated it was a one-step disinfectant. According to the product description "Cross-contamination is of major housekeeping concern." Directions for use indicated the solution was applied "thoroughly wetting surfaces...Treated surface must remain wet for 10 minutes."

Patient 10's record was reviewed on March 12, 2013. Patient 10 had undergone incision and drainage of his left arm abscess on March 11, 2013. The "Operative Notes," indicated the findings were "deep abscess (MRSA) [Methicillin Resistant Staphylococcus Aureus]."

The facility policy and procedure titled "Management of Patients with Methicillin Resistant Staphylococcus Aureus (MRSA)," with a revised date of March 2010, was reviewed. The policy indicated: "The most likely method of transmission of methicillin-resistant Staphylococcus within the hospital appears to be patient to patient transmission via the hands of healthcare personnel." Section VI Procedure indicated the following: "Environmental terminal cleaning protocols shall be followed for the OR and all equipment used for the patient."

Based on interviews and record reviews, the facility failed to develop and implement policies and procedures to provide patients with effective discharge planning, that would include a case manager, nursing services, the physician and a patient representative to coordinate discharges, transfers to other facilities, or referrals to outside services (Refer A800, A806).



25937

On March 12, 2013, at 12:18 p.m., the Interim Chief Nursing officer (ICNO) and Risk Manager (RM)were notified Immediate Jeopardy (IJ) was identified (an IJ is a situation in which the provider's noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a patient). The IJ was identified due to the facility's inappropriate discharge of a patient. The patient was placed in a taxi and sent to another facility 108 miles away. The facility was aware of the incident, however no investigation was done. There was no system in place to prevent this from happening again.

The facility submitted an acceptable written plan of correction for the IJ on March 14, 2013, at 8:50 a.m.

After the survey team validated the immediate correction, the Acting Chief Executive Officer (ACEO) was notified and the IJ was removed on March 14, 2013, at 9:10 p.m.

The cumulative effect of these systemic problems resulted in the failure for the facility to deliver statutory mandated compliance with the Federal regulations for the Condition of Participation: Discharge Planning.

Based on interviews and record reviews, the facility failed to ensure medically safe discharge planning was implemented, to provide a safe discharge plan, which had the potential to result in serious or potentially fatal consequences.

Findings:

On February 25, 2013, at 3:30 p.m., a visit was made to the facility for the purpose of investigating a complaint. Patient 22 was a 65 year old male admitted through the facility's emergency department (ED) on January 27, 2013, with diagnoses that included bowel obstruction and colon cancer.

On January 30, 2013, at 3:25 p.m., Staff 29 documented in Patient 22's record, the patient was admitted from the ED. He had a history of two strokes that left him without peripheral vision. Staff 29 documented the patient lives in his RV (Recreational Vehicle) for a couple of months a year. The discharge plan stated, "Pt. [Patient] will need a ride home. No other discharge needs at this time."

The record revealed that Patient 22 was taken to surgery on February 1, 2013, and underwent a Laparotomy (a surgical incision into the abdominal cavity) with a bowel resection and colostomy (a surgical creation of an artificial anus on the abdominal wall by making an incision into the colon and bringing it out to the surface). A review of the operative note revealed, during the surgical procedure, the physician lacerated the patient's left ureter (a tube from the kidney to the urinary bladder).

On February 6, 2013, at 6:50 a.m., the physician wrote orders for social services to discuss nursing home admission and teach colostomy care with the patient . The physician's progress note, indicated the patient lived by himself.

On February 6, 2013, at 10 a.m., MD 1 documented, "...Abd (abdomen) soft,...wound OK, ostomy OK..."

On February 6, 2013, at 4:03 p.m., Staff 28 documented the patient's personal information, the patient's insurance, and the discharge plan, that stated physician recommended nursing home care after discharge, but the patient did not want to go to a nursing home. The plan was to train Patient 22 in colostomy bag management, remove the urinary drainage bag and discharge back to his trailer.

On February 7, 2013, at 4:43 a.m., the nurse documented, "Skin around abdominal surgical incision is red, 4 cm [centimeters] round hard area on each side mid incision, 3 cm round hard area at top of surgical incision. Staples intact edges well approximated no drainage noted."

On February 7, 2013, at 8 a.m., the nurse documented, "...Midline WD [wound] dry and redness MD [medical doctor] aware..." At 2:30 p.m., the same day, MD 1 wrote orders to discharge the patient. MD 1's progress note stated the wound was okay with positive redness at the lower end. MD 1 documented, "Will DC [discharge] and follow up with a urologist [a specialist in the practice of the urinary tract]. At 2:10 p.m., the nurse documented, "Pt [patient] be discharged home for doctors appointment. Ambulate to W/C [wheelchair] to private vehicle with his friend in stable condition. IV [intravenous catheter] off. Leave urinary catheter as ordered."

On March 7, 2013, at 4 p.m., a review of Patient 22's record from Facility B was conducted. The ED record revealed Patient 22 arrived to Facility B's ED on February 7, 2013, at 5:03 p.m. via taxi cab. The patient was diagnosed with acute urinary tract infection, abdominal incision infection which was positive for MRSA (methicillin resistant staphylococcus aureus), altered mental state, and retracted colostomy. The records indicated that Patient 22 required further surgery to debride (remove damaged tissue) the surgical incision and to revise the colostomy.

At 4:50 p.m., that same day a telephone interview was conducted with Patient 22 stated, he was placed in a taxi cab and dropped off at Facility B's emergency room. "MD 1 was head of this whole mess." ...He didn't know quite what to do. So, they placed me in a taxi without telling me where I was going. I was in the taxi by myself. I walked into the emergency room and was unable to explain to the receptionist why I was there. They never told me where I was going...That incision was infected.

On March 11, 2013, at 9:50 a.m., during an interview with MD 5, he stated, "I don't remember anything about that patient's discharge."

At 11:15 a.m., that same morning, an interview was conducted with MD 1 regarding Patient 22 being sent to Facility B. "That was a mistake. I made arrangements for the patient to see a urologist after discharge by way of a charity car run by MD 5's mission. He is a missionary. The patient was to have gone to the urologist's office and another patient to the ED, but the driver made a mistake and took both patients to the ED."

At 3:10 p.m., the same day, in an interview with Staff 28, she stated, "When the patient was getting into the taxi I asked where he was going and he stated he didn't know. I discussed with MD 3 and Staff 3 the patient's arms were edematous and he was retaining fluids. I asked the physician the reason the patient was in the taxi and said that MD 1 was getting a specialist. I saw the patient wheeled out to the taxi."

On March 12, 2013, at 8:30 a.m., in an interview with Staff 29, she stated, "I tried to talk to the patient about SNF [skilled nursing facility/nursing home] and the physician about home health agency visits. I wasn't expecting the patient to be gone when I came back to work. He wasn't ready. This wasn't the first time MD 1 had an unsafe discharge."

On March 13, 2013 at 4:30 p.m., an interview was conducted with Staff 3. She stated, "Colostomy care instructions was given to the patient's friend over the phone. I was going to send the patient home with written instructions." There was no documented evidence that Staff 3 gave colostomy care instructions to Patient 22 or to the patient's friend.

Based on interviews and record reviews, the facility failed to ensure a patient (Patient 22) was provided an effective and safe discharge plan that identified the patient's complex conditions, with continued evaluation and the coordination of services this had the potential to result in serious or potentially fatal consequences.

Findings:

On February 25, 2013, at 3:30 p.m., a visit was made to the facility for the purpose of investigating a complaint. Patient 22 was a 65 year old male admitted through the facility's emergency department (ED) on January 27, 2013, with diagnoses that included bowel obstruction and colon cancer.

On January 30, 2013, at 3:25 p.m., Staff 29 documented, in Patient 22's record, that the patient was admitted from the ED. He had a history of two strokes that left the patient without peripheral vision. Staff 29 documented the patient lives in his RV (Recreational Vehicle) for a couple of months a year. The discharge plan stated, "Pt. will need a ride home. No other discharge needs at this time."

The medical record revealed that Patient 22 was taken to surgery on February 1, 2013, and underwent a Laparotomy (a surgical incision into the abdominal cavity) with a bowel resection and colostomy (a surgical creation of an artificial anus on the abdominal wall by making an incision into the colon and bringing it out to the surface). A review of the operative note revealed, during the surgical procedure, the physician lacerated the patient's left ureter (a tube from the kidney to the urinary bladder.

On February 6, 2013, at 6:50 a.m., the physician wrote orders for social services to discuss with the patient regarding nursing home admission and teach colostomy care. In the the progress note, the physician documented that the patient lived by himself.

On February 6, 2013, at 4:03 p.m., Staff 28 documented the patient's personal information, the patient's insurance, and the discharge plan, that the physician recommended nursing home care, but the patient did not want to go to a nursing home. The plan was to train the Patient 22 in colostomy bag management, remove the urinary drainage bag and discharge the patient back to his trailer.

On March 7, 2013, at 4 p.m., a review of Patient 22's records from Facility B was conducted. The ED record revealed Patient 22 arrived at Facility B's ED on February 7, 2013, at 5:03 p.m. via taxi cab. The patient was diagnosed with acute urinary tract infection, abdominal incision infection which was positive for MRSA (methicillin resistant staphylococcus aureus), altered mental state, and retracted colostomy.

At 4:50 p.m., that same day a telephone interview was conducted with Patient 22. He stated he was placed in a taxi cab and dropped off at Facility B's emergency room. "MD 1 was head of this whole mess". ...He didn't know quite what to do. So they placed me in a taxi without telling me where I was going. I walked into the emergency room and was unable to explain to the receptionist why I was there. They never told me where I was going...That incision was infected.

On March 11, 2013, at 9:50 a.m., during an interview with MD 5, he stated, "I don't remember anything about that patient's discharge."

At 11:15 a.m., that same morning, an interview was conducted with MD 1. He stated regarding to Patient 22 being sent to Facility B, 108 miles away, "That was a mistake. I made arrangements for the patient to see a urologist after discharge by way of a charity car run by MD 5's mission. He is a missionary. The patient was to have gone to the urologist's office and another patient to the ED, but the driver made a mistake and took both patients to the ED."

At 3:10 p.m., in an interview with Staff 28, she stated, "When the patient was getting into the taxi I asked where he was going and he stated he didn't know. I asked MD 3 the reason the patient was in the taxi and he said that MD 1 was getting a specialist. I saw Patient 22 wheeled out to the taxi."

On March 12, 2013, at 8:30 a.m., in an interview with Staff 29, she stated, "I tried to talk to the patient about SNF [skilled nursing facility/nursing home] and the physician about home health agency visits. I wasn't expecting the patient to be gone when I came back to work. He wasn't ready...This wasn't the first time MD 1 had an unsafe discharge."

On March 13, 2013, at 4:30 p.m., an interview was conducted with Staff 3. She stated, "Colostomy care instructions was given to the patient's friend over the phone. I was going to send the patient home with written instructions." There was no documented evidence that Staff 3 gave colostomy care instructions to Patient 22 or the patient's friend.

On March 12, 2013, at 12:18 p.m., the Interim Chief Nursing officer (ICNO) and Risk Manager (RM)were notified Immediate Jeopardy (IJ) was identified (an IJ is a situation in which the provider's noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a patient). The IJ was identified due to the facility's inappropriate discharge of a patient. The patient was placed in a taxi and sent to another facility 108 miles away. The facility was aware of the incident, however no investigation was done. There was no system in place to prevent this from happening again.

The facility submitted an acceptable written plan of correction for the IJ on March 14, 2013, at 8:50 a.m.

After the survey team validated the immediate correction, the Acting Chief Executive Officer (ACEO) was notified and the IJ was removed on March 14, 2013, at 9:10 p.m.

Based on observation, interview, and record review, the facility failed to ensure it provided an organized surgical service to all patients by failing:

1. To prevent unprivileged, unlicensed Operating Room (OR) scrub technicians from assisting in surgery. (Refer to A339);

2. To ensure the surgical privileges roster was updated when MD (Physician) 1's privileges were not renewed by the governing body. (Refer to A 945);

3. To ensure all staff performing procedures were competent and privileged to perform procedures. (Refer to A 945);

4. To maintain the Relative Humidity (RH) in the operating room within those specified in facility policy and in accordance with the AORN (Association of Perioperative Registered Nurses) standards and NFPA requirements. In addition, the facility failed to ensure facility staff acted upon out of range temperature and relative humidity (RH) readings in the operating rooms. The facility policy and procedure indicated Surgical Services staff would contact the Plant Operations if the temperature and/or humidity were out of range. (Refer to A 951);

5. To ensure evaluation of staff competency was conducted per facility policy and procedure. The facility failed to ensure annual clinical competency of surgical services staff was conducted for two department staff. (Refer to A 951);

6. The facility failed to determine which operative procedures require an assistant surgeon or assistants to the surgeon. (Refer to A 951);

7. The facility failed to ensure the terminal cleaning process and the policy and procedure for contact time were followed during the cleaning of Operating Room 2 on March 11, 2013. (Refer to A 749 and A 951)

The cumulative effects of these systemic problems resulted in the failure of surgical services to ensure care was being provided in a safe and effective manner.

Based on interview and record review, the facility failed to ensure:

1. The surgical privileges roster was not updated when MD (Physician) 1's privileges were not renewed by the governing body. This had the potential for unprivileged personnel performing surgery, patient injury and death; and

2. All staff performing procedures were competent and privileged to perform procedures. This lead to surgical scrub technicians manipulating scopes during colonoscopies and upper gastrointestinal endoscopies. This had the potential for unprivileged personnel performing surgery, patient injury and death.

Findings:

1. On March 11, 2013, at 8:50 a.m., Staff 12 was interviewed. Staff 12's duties included scheduling surgeries. According to Staff 12, a physician would fax over or call with information to schedule a surgery. Staff 12 stated she verified physician's privileges in the privileging book before the surgery was scheduled. Staff 12 stated the surgery privileging book was updated "frequently."

A review of the Health Care District (governing body) Bylaws dated January 29, 2009, under Quality Assurance, Medical Staff Membership and Clinical Privileges, indicated "Final action on all matters relating to Medical Staff quality assurance, membership status, clinical privileges and corrective actions shall be taken by the Board after considering Medical Staff recommendations."

During a review of the credential file for MD 1, on March 11, 2013 at 11:30 a.m., it was noted that the General Surgery Delineation Form dated June 6, 2012, on the last page, indicated "Applicant may perform privileges and procedures as indicated," followed by three spaces for signatures approving MD 1's hospital privileges. Two of the three signature lines contained a signature: one by the reviewer and one by a representative of the Medical Executive Committee, dated July 18, 2012, as required. However, the space for the Board of Directors to sign, and thus granting final approval of MD 1's surgical privileges, was left blank.

There was no documented evidence that MD 1 had hospital privileges granted by the Governing Board. During a concurrent interview with Staff 16, while reviewing the files, she stated the Chairman of the Board refused to sign off on MD 1's hospital privileges.

During a review of the MEC (Medical Executive Committee) Credentialing Report to the Board, dated July 12, 2012, the Credentialing Committee Recommendation and Signatures portion of the form indicated a "Favorable Recommendation." However, the space left for the Chairman of the Board to sign did not contain an approval signature, but instead, the words "Mr. [X] refused to sign," dated November 28, 2012. This means MD 1's credential file did not contain a completed, approved application for hospital privileges. During a concurrent interview with Staff 16 while reviewing these files, she restated that the Chairman of the Board refused to sign MD 1's hospital privileges.

During a review of the Regular Board of Directors Meeting Minutes for 2012 and 2013, there was no documented evidence of approval of MD 1's privileges. Further review of The Regular Board of Directors Meeting Minutes dated November 28, 2012 indicated two "closed sessions." There was no evidence that MD 1's privileges had been granted by the governing board.

On March 12, 2013, at 12:18 p.m., the Interim Chief Nursing Officer (ICNO) and the Risk Manager (RM) were notified Immediate Jeopardy (IJ) was identified (an IJ is a situation in which the provider's noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a patient). The IJ was identified due to the facility's failure to have documented evidence the Chief of Staff had hospital privileges granted by the Governing Body/Board. This created an ongoing risk for both in-patients and out-patients if the physician was allowed to continue operating without designated privileges.

On March 13, 2013, at 8:30 a.m., Staff 8 was observed in the medical/surgical unit asking if Patient 30 was ready for surgery. Staff 8 was asked what physician was scheduled to perform the surgery and stated MD 1.

On March 13, 2013, at 9 a.m., Staff 12 stated MD 1 notified her yesterday that Patient 30's surgery was rescheduled for today. Staff 12 denied she had been informed about a change in MD 1's hospital privileges.

2. Endoscopy is a nonsurgical procedure used to examine a person's digestive tract. Using an endoscope, a flexible tube with a light and camera attached to it, the doctor can view pictures of the patient's digestive tract on a color TV monitor. During an upper endoscopy, an endoscope is passed through the mouth and throat and into the esophagus allowing the doctor to view the esophagus, stomach, and upper part of the small intestine.

Similarly, endoscopes can be passed into the large intestine (colon) through the rectum to examine this area of the intestine. This procedure is called sigmoidoscopy or colonoscopy, depending on how far up the colon is examined. Potential complications may include: perforation (tear in the gut wall), sedation reaction, infection and bleeding.

On March 13, 2013, at 2:30 p.m., Staff 9 was interviewed. Staff 9 stated he was a surgical scrub technician. Staff 9 stated he had assisted surgeons in manipulating scopes, during colonoscopies and upper gastrointestinal endoscopies. Staff 9 stated he had not received training in this procedure. Staff 9 stated he instructed the managers that he was performing this procedure, and that it was not part of his core responsibilities in the operating room.

On March 13, 2013, at 3:30 p.m., MD 1 was interviewed. MD 1 stated he performed both colonoscopies and upper gastrointestinal endoscopies, here in the facility's OR. MD 1 stated once the physician had inserted the scope, the scrub technician can manipulate it. MD 1 stated he was instructed the scrub technicians "If you don't see the lumen, you don't push it in." MD 1 stated they must be qualified to help with the procedure, if they were unqualified they would not be assisting.

On March 14, 2013, the employee files for the OR Scrub Technicians (ORST) (Staff 9 and Staff 10) were reviewed. The facility Scrub Techs, had job descriptions and competency assessments in their files.

Each of the ORSTs' "Job Description," was reviewed and the following noted:

"Under the Direct supervision of the OR RN, the ORST assist during operative and invasive procedures."

"Consistently reports to manager any safety issues or concern..."

There was no documentation in the job description that indicated the ORST would manipulate scopes during surgery.

On March 14, 2013, the employee files for the ORSTs were reviewed. There was no evaluation of Staff 9 or Staff 10's competency related to manipulating scopes during surgery.

Based on observation, interview and record review, the facility failed to ensure Surgical Services' policies and procedures were implemented and enforced in accordance with acceptable standards of medical practice and surgical patient care:

1. The facility failed to maintain the relative humidity (RH) in the operating room within those specified in facility policy and in accordance with the AORN (Association of Perioperative Registered Nurses) standards and NFPA (National Fire Protection Association) requirements. In addition, the facility failed to ensure facility staff acted upon out of range temperature and relative humidity (RH) readings in the operating rooms. The facility policy and procedure indicated Surgical Services staff would contact the Plant Operations if the temperature and/or humidity were out of range. This had the potential to result in out of range temperature and/or relative humidity to go uncorrected;

2. The facility failed to ensure evaluation of staff competency was conducted per facility policy and procedure. The facility failed to ensure annual clinical competency of surgical services staff was conducted for two department staff. This had the potential to impact the quality of care in the surgical services department;

3. The facility failed to determine which operative procedures require an assistant surgeon or assistants to the surgeon. This had the potential for surgeons performing unassisted surgery, which could lead to patient harm and death; and

4. The facility failed to ensure the terminal cleaning process and the policy and procedure for contact time were followed during the cleaning of Operating Room 2 on March 11, 2013. This failure had the potential for cross contamination due to inadequate disinfection of hard surfaces in the operating room.


Findings:

1. On March 11, 2013, at 8:35 a.m., Operating Room 1 was observed with Staff 10. The room contained a wall mounted device to monitor the room's temperature and relative humidity (RH). The current readings indicated the room's temperature was 69.7 ° F (Fahrenheit) and the relative humidity was 25 %.

In a concurrent interview with Staff 10, he stated the temperature and relative humidity were checked by nursing staff on days the department was open and in use.

In an interview with Staff 15, on March 11, 2013, at 9 a.m., Staff 15 stated the facility used AORN (Association of Perioperative Registered Nurses) as a reference or resource in the operating room.

AORN (Association of Perioperative Registered Nurses) standards and recommendations for a safe operating environment indicated potential hazards associated with Heating Ventilation and Air Conditioning (HVAC) system should be identified and safe practices established.

The Operating Room Temperature Logs for January, February and March 2013, were reviewed. Instructions on the log indicated operating room temperature range should be between 68 °- 72° F and relative humidity should be between 35 % - 60 %. The following instructions indicated "Any deviation from the temperature ranges above must be corrected immediately. Attempt to bring temperature and/or humidity into acceptable range by adjusting the thermostat. If there is no thermostat, contact Environmental Services immediately. Recheck the temperature and/or humidity within one hour to see if temperatures are within the acceptable range. If not, notify the Surgical Services Manager. Please document all corrective actions taken, persons notified, and resolution."

The values recorded on the logs indicated the following:

a. In January 2013, for 20 of 22 days in which relative humidity was recorded; the humidity was recorded as below 35%. Documented corrective actions were "Stated Fire Safety or Verbalized Fire Safety each case." On nine of the 20 out of range days, there was no documentation the RH was rechecked and on 11 of the 20 days the rechecked RH was below 35 %.

b. In February 2013, for 18 of 18 days in which the RH was recorded, the RH was recorded as below 35%. Documented corrective actions included "Verbalized fire safety each case." RH was rechecked and remained less than 35 % for all 18 days.

c. In March 2013, RH was below 35 % on three of three days where it was documented. (There was no documentation of temperature and relative humidity monitoring on March 1, (Friday), March 7 (Thursday), March 8 (Friday) and March 11 (Monday), 2013. Documented corrective action included "Verbalized fire safety each case OR1 /OR2." RH rechecks indicated the rooms RH remained below 35%.

On March 11, 2013, at 9:45 a.m., a tour of Operating Room two was conducted with Staff 7. The room had wall mounted temperature and relative humidity monitors. The relative humidity in Operating Room 2 read 26 %.

In a concurrent interview with Staff 7, she stated Operating Room staff checked the temperature and relative humidity daily. Staff 7 stated RH should be above 35 %. Staff 7 stated if RH was below 35 % staff "verbalize fire safety before each case in the room." Staff 7 stated if the RH was low, there was an increased "safety risk." Staff 7 stated they look for pooling liquids and wet prep towels, prior to each surgical case. Staff 7 stated "we also contact the engineering department if temperatures or RH were out of range."

On March 11, 2013, at 10:25 a.m., Chloraprep (an alcohol based skin antiseptic used prior to surgery) was observed in the cupboard in OR 1.

The facility policy titled, "Temperature and Humidity in the Operating Rooms," with an effective date of July 2010, was reviewed. The purpose was to "Provide environment temperature and humidity recording/documentation guideline for the Surgical Services Department." The facility policy indicated the humidity of the Operating Rooms "shall be maintained between 35 % and 60 %." In addition, the policy indicated staff will contact "Plant operations department if the temperature and/or humidly are out of range and cannot be controlled by actions made by the surgical services staff."

The facility policy and procedure titled "Fire Safety in an Oxygen Rich Environment-Operating Room," with a revised date of March 2010, was reviewed. The policy indicated its purpose was to identify and define guidelines for fire safety in an oxygen rich environment. The policy indicated fuel found in the OR included alcohol used for prepping and Dura prep (an alcohol and iodine based cleanser). Specific safety rules for the OR included keeping the relative humidity at "30 to 60 percent (American Institute of Architects, 1996, 2001)."

According to the NFPA recommendations, relative humidity should be maintained between 35% and 60% in the operating rooms, recovery area, endoscopy rooms, and instrument processing areas, as low humidity increases the risk of electrostatic charges (fire hazard) in the oxygen rich surgical environment and high humidity increases the risk of microbial growth in areas where sterile supplies are stored or procedures are performed.

2. On March 11, 2013, at 8:35 a.m., a tour of the Surgical Services Department was conducted. Staff 7 was observed in OR (Operating Room) 2 where she was monitoring a patient.

In an interview with Staff 15, on March 11, 2013, at 9 a.m., Staff 15 stated he was the Interim OR Manager.

a. The employee file for Staff 7 was reviewed on March 13, 2013. Staff 7 had a hire date of May 30, 2012, and was assigned to the Surgery Department. Staff 7 had undergone facility orientation, but there were no initial clinical skills competencies or a 90-day performance evaluation in Staff 7's employee file.

b. The employee file for Staff 15 was reviewed on March 13, 2013. Staff 15 had a hire date of June 15, 2009. Staff 15 was assigned to the Surgery Department. Staff 15 underwent OR Department orientation on June 15, 2009 and initial competencies were completed on September 8, 2010. There was no evidence annual competencies had been conducted since 2010.

During an interview with the Human Resources Manager on March 13, 2013, at 1:50 p.m., the Human Resources Manager stated there should be orientation and annual competencies for all staff based on their position within the facility.

During an interview with the Interim Chief Nursing Officer (ICNO), on March 14, 2013, at 8:50 a.m., the ICNO stated the employees ' staff should have had documentation of orientation clinical competencies and annual clinical competencies in their files.

The facility policy and procedure titled "Performance Evaluations - Competency" reviewed/revised March 24, 2010, revealed "... Unit specific orientation conducted by the Department Director/designee is carried out for all new employees, including employees being cross-trained. The unit preceptor or the department director will assess the individual's unit specific proficiency as outlined on the unit-specific skills checklist. ... Documentation of mastery of unit specific skills will be recorded on the Unit-Specific Skills checklist. At the conclusion of the 90-day introductory period, the Department Director/Supervisor will conduct a performance evaluation of the new employee. ... Documentation of satisfactory performance for current competencies will be placed in the employee's file. ... The Department Director/Supervisor assures all required competencies have been satisfactorily completed within the allowed time frame. ... Required employee documentation: Clinical Initial skills competency, due the first 90 days of employment, if an employee works multiple units there must be a competency for each unit."

The facility policy titled "Scope of Services of the Surgical Services Department," with a revised date of March 2010, was reviewed. The policy indicated the "Surgical Services Department provides quality-conscious, competent and cost-effective care with respect for life and dignity." Qualifications of staff include current BCLS and "...periodic clinical skills evaluation for all staff members is maintained to ensure that the quality of care provided is kept current with the developments in the medical, nursing, anesthesia and infection control fields."


3. The American College of Surgeons, a scientific and educational association of surgeons that was founded in 1913 to improve the quality of care for the surgical patient by setting high standards for surgical education and practice.

In cooperation with the surgical specialty societies, the College has compiled a report titled Use of Physicians as Assistants at Surgery. For each surgical service listed in the American Medical Association's Physicians' Current Procedural Terminology, (CPT (Trademark)) 2011, the College report indicated whether a physician as an assistant at surgery was required "almost always," "some of the time," or "almost never."

The American College of Surgeons supports the concept that, ideally, the first assistant at the operating table should be a qualified surgeon or a resident in an approved surgical education program. If such assistants were not available, other physicians who were experienced in assisting may participate.


According to the California Code of Regulations, Title 22, Division 5, § 70223(b) (4), " A committee of the medical staff shall be assigned responsibility for: (4) Determining which operative procedures require an assistant surgeon or assistant to the surgeons."


On March 11, 2013, at 8:50 a.m., Staff 12 was interviewed. Staff 12 described surgery scheduling process. Staff 12 stated she verified physician's privileges before scheduling a surgery. Staff 12 stated the physician would let her know if there was going to be an assistant.


On March 11, 2013, at 9 a.m., during a tour of the Surgical Services Department, Staff 15 was interviewed. Staff 15 stated the department did not have a list of surgeries that required an assistant. Staff 15 had discussed the issue with supervisory and medical staff, but had not received an answer.


On March 13, 2013, at 3:30 p.m., MD (Physician) 1 was interviewed. MD 1 stated he thought the facility had a list of procedures that required an assistant but the staff was unable to find it. MD 1 stated a prior OR Manager suggested an assistant was required for a colectomy, and then told him he could perform the surgery without an assistant. MD 1 stated "we do not follow the American College of Surgeons, but we will comply with CMS (Centers for Medicare/Medicaid Services) and state regulations in regard to a list of surgeries that require an assistant." MD 1 stated there were "about 10 surgeries," that required an assistant.

4. On March 11, 2013, at 9:25 a.m., Staff 7 was observed in Operating Room (OR) 2, caring for a patient. Staff 7 was monitoring the patient's vital signs and inputting information into a computer on wheels.

In a concurrent interview, Staff 7 stated she was recovering Patient 10 in the operating room as the surgery was "dirty," and they did not want to contaminate the post anesthesia recovery room. Staff 7 stated the room would need terminal cleaning. At the conclusion of the recovery period Staff 7 took Patient 10 to his room via his bed.

On March 11, 2013, at 9:35 a.m., Staff 11 entered the room and began cleaning. Staff 11 sprayed flat, hard surfaces and tray and table legs, with Virex Tb solution. Staff 11 then began wiping the surfaces. The Virex Tb solution contact (wet) time was less than two minutes.

In a concurrent interview with Staff 11, on March 11, 2013, at 9:40 a.m., Staff 11 stated she would leave the Virex Tb on the surface for one minute, and then remove.

On March 11, 2013, at 9:45 a.m., Staff 7 returned to the room and indicated to Staff 11 the room would need terminal cleaning due to the previous surgery. Staff 11 left the room and returned with a bucket containing solution "499." Staff 11 was observed using this solution on the walls, trays, tables and trash containers. The solution was applied to the walls using a long handled mop. The walls were dry within a minute of the solution being applied.

In a concurrent interview, Staff 11 stated she did not need to reapply solution to walls or table tops, she just needed to let it air dry.

On March 11, 2013, at 9:55 a.m., Staff 11 explained the process for obtaining cleaning solution. Staff 11 indicated "Oasis 499 Cleaner," was used in the operating room she had just cleaned.

A review of the facility policy, "Surgery Cleaning Procedure," with a last revised date of January 2009, was conducted. The purpose indicated, "To ensure an aseptically clean environment for staff and for the processing through strict adherence to post case cleaning and terminal cleaning procedures and schedules." The policy had instructions for cleaning "Surgery suites following isolation case," and "Terminal cleaning of Surgery Suites." Both sets of instructions indicated "Germicide Solution," was to be used.

Operating Room 2 was not cleaned according to either of the above instructions.

A review of the "Virex Tb," reference material indicated "when used as directed Virex Tb ...highly effective against a wide variety of pathogenic microorganisms including bacteria, antibiotic resistant bacteria, viruses, fungi, mold and mildew." Contact time for this solution goes from 30 seconds for the "Norwalk Virus," to ten minutes for Hepatitis A. To kill staphylococcus aureus on hard non-porous inanimate environmental surfaces, the solution required a three minute contact time.

A review of the product information for "Oasis 499 HBV Disinfectant," indicated it was a one-step disinfectant. According to the product description "Cross-contamination is of major housekeeping concern." Directions for use indicated the solution was applied "thoroughly wetting surfaces...Treated surface must remain wet for 10 minutes."

Patient 10's record was reviewed on March 12, 2013. Patient 10 had undergone incision and drainage of his left arm abscess on March 11, 2013. The "Operative Notes," indicated the findings were "deep abscess (MRSA) [Methicillin Resistant Staphylococcus Aureus]."

The facility policy and procedure titled "Management of Patients with Methicillin Resistant Staphylococcus Aureus (MRSA)," with a revised date of March 2010, was reviewed. The policy indicated: "The most likely method of transmission of methicillin-resistant Staphylococcus within the hospital appears to be patient to patient transmission via the hands of healthcare personnel." Section VI Procedure indicated the following: "Environmental terminal cleaning protocols shall be followed for the OR and all equipment used for the patient."

Based on observation, interview and record review, the facility failed to ensure the pediatric crash cart, located in the operating room, contained all the equipment required in the case of a pediatric emergency. This failure had the potential to result in a delay in administering emergency medications to a pediatric patients.

Findings:

On March 11, 2013, at 8:50 a.m., Staff 10 stated they were setting up Operating Room 1 for a twelve year old patient (Patient 11).

On March 11, 2013, at 10:30 a.m., during a tour of the facility Surgical Department, the pediatric crash cart was observed. The crash cart was a color coded nine drawer cabinet on wheels, based on the Broselow Method for pediatric emergency care. Medications and supplies in each of the color coded drawers corresponded to a color on a Broselow Tape. There was no Broselow Tape on or near the crash cart.

A Broselow Tape is divided into color-coded segments that estimate a child's weight based on length. The Broselow Tape provides corresponding doses of emergency medications, sizes of commonly used equipment, and IV fluids. The cart, when used in conjunction with the Broselow tape, allowed the staff to open the drawer corresponding to the color and obtain items needed for a patient in that weight category. The Broselow Tape is used for children up to 12 years of age and 80 pounds.

In an interview with Staff 8, on March 11, 2013, at 10:30 a.m., Staff 8 stated he did not know where the Broselow Tape for the Pediatric Crash cart was.

A review of the "Crash Cart Checklist-Surgery," for March 11, 2013, indicated the cart had been checked. There was a check mark in the section for "Broselow Tape on clip board."

In an interview with Staff 15, on March 11, 2013, at 11 a.m., Staff 15 reported he had removed the Broselow Tape from the Pediatric Crash Cart on Friday.

The facility policy and procedure titled "Crash Cart-Standard Arrangement QC-Nursing Units: Adults, Special Patient Populations," dated June 2006 was reviewed. The policy indicated in the section for "Special Patient Populations:"

"Pediatric Patients and Nursery Patients will arrange their crash carts according to the patient's population special units' needs and will check their crash carts, defibrillator and related equipment every 24 hours."

On March 12, 2013, Patient 11's record was reviewed. Patient 11 was a twelve year old female, and there was no evidence of a documented height or weight in her record.