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Based on observation, staff interviews, medical record and document reviews, the hospital failed to ensure that an effective governing body was legally responsible for the conduct of the hospital as evidenced by:

A. The governing body failed to ensure that the medical staff was accountable to the governing body for the quality of care provided to patients. (cross reference A 0049, A 338, and A 0347)

B. The governing body failed to ensure that criteria for renewing sedation/analgesia privileges included current demonstrated competence in accordance with medical staff bylaws and accepted standards of practice. (cross reference A 0050 and A 0363)

C. The governing body failed to ensure that services performed under a contract or agreement were provided in a safe and effective manner. (cross reference A 0084)

D. The governing body failed to ensure the medical staff operated in accordance with its bylaws. (cross reference A 0356 and A 0358)

E. The hospital failed to ensure the dietary services met the needs of all patients. (cross reference A 0618)

F. The hospital failed to ensure that an organized nursing service, supervised by a registered nurse, provided 24 hour nursing services. (cross reference A 0385)

G. The hospital failed to have pharmaceutical services that meet the needs of the patients. (cross reference A 0490)

H. The hospital failed to ensure that surgical services were provided in accordance with acceptable standards of practice. (cross reference A 0940)

I. The hospital failed to provide a sanitary environment to avoid sources and transmission of infections and communicable diseases. The hospital failed to ensure an active program for the prevention, control, and investigation of infections and communicable diseases. (cross reference A 0747)

J. The hospital failed to develop, implement and maintain an effective quality assurance and performance improvement (QAPI) program. (cross reference A 0263)

The cumulative effect of these systemic problems resulted in the inability of the hospital to comply with the statutorily-mandated Condition of Participation for Governing Body.

Based on observation, staff interviews, medical record and document reviews, the governing body failed to ensure that the medical staff was accountable to the governing body for the quality of care provided to patients when the medical staff did not adhere to medical staff rules and regulations, and permitted hospital staff to violate policies and procedures, which resulted 1 of 31 patients (Patient 34) experiencing a blood sugar of 37 mg/dl.(critically low, normal = 70-120mg/dl.) and required rescue interventions of orange juice and intravenous injection of a 50% sugar solution (D50) to stabilize her blood sugar. The event was identified during the survey and resulted in an immediate jeopardy to patient safety action by the survey team on 1/27/10.

Findings:

Review on 1/27/10 at 9:45 a.m. of the medical record for Patient 34 with RN 10 (a nursing administrative staff member) indicated that Patient 34 was 71 years old and was admitted to the hospital on 1/25/10 at approximately 5:15 p.m. from the emergency room (ED). Patient 34's diagnoses included leg pain and crush injury, congestive heart failure, insulin-dependent diabetes, and chronic kidney failure. Home insulin doses were not recorded or reconciled by physician, nursing, or pharmacy staff at the time of admission nor during the preceding ED care. An admission history and physical exam was not documented in the patient record within 24 hours of admission. A faxed medication order for insulin, written by the admitting physician on 1/25/10 at 3:30 p.m., documented that a combination rapid acting and intermediate acting insulin product was to be administered twice daily. The evening dose appeared to read as 46 units of 70/30 Novolin with dinner, and an illegible amount to be administered with breakfast. 70/30 Novolin insulin is an intermediate-acting combination insulin product containing both insulin regular and insulin NPH with a more rapid onset than that of insulin NPH alone; onset of action is 0.5 hours, peak effect 2-12 hours, duration of action 18-24 hours (according to Lexi-comp Online, a nationally recognized drug reference, retrieved at http://online.lexi.com/crlsql/servlet/crlonline on 2/3/10 at 5 p.m.)
According to concurrent interviews with RN 2 on 1/28/10 at 2:40 p.m. and Registered Pharmacist (RPh 2) on 1/26/10 at 12:25 p.m., the illegible morning insulin dose was not clarified by RN 2 or RPh 2 with the ordering physician. Instead, RN 2 asked the Patient 34 what her usual dose of insulin was at home, and transcribed the order as 60 units of 70/30 Novolin for the morning dose.
Patient 34's blood sugars were documented as 297 mg/dl and 364 mg/dl (the lab normal range was 70-120 mg/dl) in the emergency department on 1/25/10 with no documented insulin administration. The record documented that Patient 34 was admitted to the inpatient unit at 5:15 p.m. and consumed 80% of dinner at 6:52 p.m. At 9:05 p.m. a fingerstick blood sugar was recorded as 360 mg/dl. Ten units of rapid acting insulin was administered. At 9:30 p.m., the "dinner" dose of intermediate acting combination insulin, 46 units, was administered. No additional food intake was recorded and the nurse did not notify the physician of the late administration of insulin (per interview with RN 3 on 1/29/10 at 10 a.m.).

At 7 a.m. on 1/26/10, the diabetic flow sheet documented a blood sugar of 83 mg/dl. Breakfast consumption was recorded as 80% at 8:53 a.m. On 1/26/10 at 8:45 a.m. RN 1 was observed to administer 60 units of combination rapid and intermediate acting insulin to Patient 34. No meal tray or food was present in the room. RN 1 later stated that Patient 34 had just finished eating breakfast prior to the insulin administration. At 11:45 a.m. the diabetic flow sheet documented a blood sugar of 70 mg/dl. Lunch consumption was documented as 10% at 1:50 p.m. The diabetic flow sheet documented a blood sugar of 37 mg/dl (extremely low) at 1:45 p.m. Nursing notes described Patient 34 as "sweating, feeling faint, weakness. Patient mumbling and unable to keep eyes open. Fingerstick checked and is 37. OJ (orange juice) 240 mls (8 ounces) given."

Subsequent blood sugar measurements were documented between 2:15 p.m. and 2:35 p.m. as 57, 59, and 64 mg/dl. At 2:35 p.m. "D50 1/2 amp" (an intravenous sugar solution to rescue the patient from low blood sugar) was administered. At 2:50 p.m. the blood sugar was recorded as 184 mg/dl with the patient feeling better, no sweating, still some fatigue." A physician progress note dated 1/26/10 at 2:25 p.m. documented "70/30 Insulin. Hypoglycemia (low blood sugar) due to [upward pointing arrow] dose than patient normally takes."

The Institute of Safe Medication Practices listed insulin as a high risk high alert medication on its 2008 update [reference http://www.ismp.org/Newsletters/acutecare/articles/20031201.asp]. Lexi-Comp ONLINE, a nationally recognized drug reference retrieved on 1/29/10 at http://online.lexi.com/crlsql/servlet/crlonline, recommended close monitoring of blood sugars and warned of adverse effects from insulin: "Profound and prolonged episodes of hypoglycemia may result in convulsions, unconsciousness, temporary or permanent brain damage, or even death."

In an interview with Administrative Staff 2 on 1/28/10 at 11 a.m., AS 2 acknowledged that the admission insulin orders reflected assumptions of what had worked in the past for Patient 34, but confirmation of the doses, details of her previous care and course, and rationale for continuing high insulin doses in the context of Patient 34's unstable medical condition were not documented by physician, nursing, or pharmacy staff. AS 2 agreed that breakdowns in multiple systems had occurred.

Failures to deliver high quality patient care that were identified above, and addressed in detail elsewhere in the survey, included:

1. Reconciliation of insulin doses at home prior to admission, and most recent insulin administration. (cross reference A 0500)

2. Documentation of a complete history and physical exam by the admitting physician (to reflect the current condition of Patient 34 at the time of admission) as required by medical staff rules. (cross reference A 0358)

3. Clarification of illegible order for a high risk high alert medication (insulin). (cross reference A 0404)

4. Administration of insulin according to physician orders (with meal, rather than following or delayed). (cross reference A 0404)

5. Nursing assessments that did not include monitoring for when insulin blood levels would peak, or identifying blood sugar trends that reflected a risk for low blood sugar when insulin levels peak. (cross reference A 0395)

6. Inclusion of a nursing care plan to address the specific needs of a diabetic patient. (cross reference A 0396)

Review of the January 2007 Medical Staff Bylaws on 1/26/10 at 5 p.m. indicated in section 2.5(a) that a basic responsibility of the medical staff was to provide patients with the quality of care meeting the professional standard of the Medical Staff.

Review of the facility policy, "Medication Reconciliation," dated 9/1/05, indicated under Purpose, "To obtain, update and retain an accurate list of medications according to the physician's pre-hospital, admission, transfer, and/or discharge orders to increase patient safety and decrease potential and actual medication adverse drug events (ADEs)."

Review of the facility policy, "Medication Distribution - Inpatient," dated 5/03, revised 8/09, indicated under item 7a. Clarification of Unclear Orders, "Any prescriber's order that is not legible or clear in intent or rationality as applied to standard practices and literature will be clarified with the prescriber. The Physician will review any illegible orders with the Primary Nurse prior to leaving the nursing unit. Any clarifications will be written on the Physicians Order Sheet as 'Clarification of Order:..' and signed by the physician or the nurse transcribing the clarification. If the order is still unclear to the pharmacist, the pharmacist will contact the physician directly, or as applicable, will contact the transcriber of a verbal or telephone order for clarification."

Review of the facility policy, "Medication Administration Times," dated 3/17/03, revised 11/06, indicated under item C2, Administration Times, Medication Specific Exceptions, F. Oral Hypoglycemics, Insulin, and Carafate, BID, 0730 and 1730."

Review of the facility policy, "Medication Errors," dated 5/95, revised 1/09, indicated under item B1, "A medication error is defined as a dose administered differently than ordered by the physician as recorded on the patients medical record," and under item B1h, "Wrong time: Administration of a dose more than 60 minutes before or after the scheduled administration time. Additional parameters: Drugs ordered before meals or on an empty stomach should be given before food and within 30 minutes of the scheduled time; drugs ordered with food should be given within 30 minutes of the scheduled time."

Based on staff interviews and document reviews, the governing body failed to ensure that criteria for renewing sedation/analgesia privileges included current demonstrated competence in accordance with medical staff bylaws and accepted standards of practice for 1 of 1 credentials file reviewed (MD 5).

Findings:

On 1/29/10 at 10 a.m., Administrative Staff 11 was asked to determine the number of medical staff members outside of the anesthesia department who possessed privileges to administer and supervise sedation/analgesia. AS 11 offered the following information:

There were a total of 176 members of the medical staff.
Forty-two members of the medical staff had moderate sedation privileges.
The 42 members were from 9 different departments, including dentistry, radiology, orthopedics, obstetrics and gynecology, gastroenterology, family practice, internal medicine, plastic surgery, and emergency medicine.
Fifteen members had privileges for deep sedation, all from emergency medicine.

Review of credentials files on 1/26/10 at 9:40 a.m. with Administrative Staff 7 indicated that for Physician 5 (MD 5), privileges for moderate sedation were initially granted on 1/26/06 after completion of a sedation course. But at reappointment on 7/24/08, MD 5 signed an attestation that he was currently competent to perform all the privileges (including moderate sedation) listed on the privilege request. AS 7 confirmed that no updated knowledge test or demonstration of competency for moderate sedation was documented in the credentials file. AS 7 stated that non-anesthesiology providers who requested moderate sedation privileges were only required to complete the course once, and thereafter maintain advanced cardiac life support certification. No ongoing evaluations of competency were conducted by the medical staff leadership. Only emergency department staff were permitted to have deep sedation privileges. Those physicians performed annual skills testing to maintain their Board certification, which was considered adequate to demonstrate deep sedation competency.

In an interview with the Director of Anesthesia Services (MD 2) on 1/28/10 at 3 p.m., MD 2 indicated that he provided oversight of all anesthesia services in all locations of the hospital, including moderate and deep sedation. MD 2 stated that anesthesia policies were intended to reflect the practice standards and guidelines of the American Society for Anesthesiologists. For a medical staff member to be granted privileges for moderate sedation, the member had to show training in a recent residency program that included sedation skills, or attend a hospital-sponsored course in sedation that included a return demonstration for airway management and rescue from unintended deeper sedation. The member was required to pass the skills test with a score of 100%. But after initial privileges for moderate sedation were granted, the medical staff member was only required to maintain certification in advanced cardiac life support (ACLS) and attest that the member was familiar with the hospital sedation policy. No further evaluations of the member's competence for sedation privileges was conducted by the medical staff leadership. For example, MD 2 reviewed pharmacy reports on the utilization of rescue drugs for members of his department, but not for all members who performed sedation/analgesia. MD 2 expected privileged providers to know the dosing adjustments for elderly patients but did not verify that drugs were prescribed and administered correctly. MD 2 did not conduct random chart reviews to assess whether the doses of medications were within standard norms for age and medical risk, whether rescue measures were instituted but did not trigger a quality review, or whether nursing staff administered sedation/analgesia medications in accordance with the policy. After the initial two sedation procedures were proctored for initial privileging, no further observations were conducted of sedation competence. The performance improvement program captured self-reported incidents and adverse events, but no other process captured a way to verify ongoing competence for sedation skills.

Review on 1/28/10 at 3 p.m. of a hospital policy titled "Moderate and Deep Sedation," revised 8/09, under Policy item #6 documented that only credentialed licensed independent practitioners holding current privileges to administer moderate or deep sedation were authorized to order and supervise sedation tasks. Credentialing criteria included "verification of competency in both evaluating patients prior to performing moderate and deep sedation, and methods and techniques required to rescue those patients ..." In item #7 for Competency, "the physician and/or registered nurse responsible for managing the care of the patient receiving moderate sedation will hold current ACLS or PALS provider card and maintain moderate sedation competency in [six skills listed.]

Attachment D of the Sedation policy required all physicians holding sedation privileges to complete the Moderate Sedation Course. Thereafter, only ACLS certification must be maintained. Emergency Department physicians who maintained annual board certification were exempt from those requirements. The bottom of the form included an attestation that the signer was currently competent to perform Moderate Sedation.

In an interview with MD 2 on 1/28/10 at 3 p.m., MD 2 acknowledged that when some medical staff members completed the Moderate Sedation Course many years ago, some high risk medications and rescue techniques had not yet been developed. Without periodic testing or opportunity to demonstrate knowledge, MD 2 could not verify whether those staff members were current in knowledge or competence.

Definitions and standards of sedation-analgesia, procedural sedation, moderate sedation and conscious sedation have been addressed by a number of nationally recognized organizations including the American Society of Anesthesiologists (ASA), the Association for peri-Operative Nursing (AORN), American Association of Nurse Anesthetists (AANA), the California Board of Registered Nursing (BRN), and the California Society of Anesthesiologists (CSA). The organizations agree that professionals who administer or supervise the administration of moderate and deep sedation should have specialized and formal education, training, and demonstrated competency for the knowledge related to respiratory physiology, cardiac rhythms, medication pharmacology, airway management, and rescue from unintended oversedation or complications. (Refer to the ASA Statement on Granting Privileges for Administration of Moderate Sedation to Practitioners Who Are Not Anesthesia Professionals, 10/18/06) Under Performance Improvement, the ASA recommends assessing up-to-date knowledge as well as ongoing competence in the skills outlined in the education and training requirements, and to re-evaluate the practitioner's performance at regular intervals. Similar oversight guidelines are outlined by the CSA for non-anesthesiologists who administer deep sedation.

Section 5.2-2(b) of the January 2007 Medical Staff Bylaws, reviewed on 1/26/10 at 5 p.m., documented,"Requests for Clinical Privileges shall be evaluated on the basis of the Member's education, training, experience, demonstrated professional competence and judgment, clinical performance, health status, and the documented results of patient care and other quality review and monitoring."

The medical staff failed to evaluate the demonstrated professional competence of as many as 57 non-anestheologists to whom privileges for moderate and/or deep sedation were renewed, in accordancewith medicalstaff bylaws, hospital policy,and nationally recognized standards of practice.

Based on staff interviews and document reviews, the governing body failed to ensure that services performed under a contract or agreement were provided in a safe and effective manner for 10 of 10 agreements reviewed (food purchasing, vending services, dietary computer services, linen vendor, nuclear medicine vendor, and medical directors for pathology, radiology, rehabilitation, respiratory therapy, and outpatient ski clinic).

Findings:

During interviews on 1/26/10 at 4:30 p.m., contract oversight was discussed in general with Administrative Staff (AS) 12 who managed buildings and facilities. AS 12 stated that there was no quality assurance or performance improvement (QAPI) activities that evaluated the services of service vendors. In an interview with Administrative Staff (AS) 9 who directed the purchasing of supplies on 1/28/10 at 10:30 a.m., AS 9 also stated that supply vendor contracts were not formally evaluated for safety and effectiveness.

During interview with the Director of Dietary Services (DDS) on 1/27/10 at 2:30 p.m., contracts for food purchasing, vending services, and dietary computer services were reviewed. The DDS stated that she did not know how the contracted services were evaluated by the QAPI program. The DDS stated she did not provide any data or performance measurements related to the dietary contracted services to the governing body or other administrative leaders. The DDS did not collect or receive quality control reports from the vendors to verify the products passed food safety inspections.

In an interview with Administrative Staff 1 on 1/28/10 at 4 p.m., AS 1 indicated that the hospital had approximately 400 contract/agreements in place. Oversight of hospital agreements was divided among three staff who reported to AS 1. There was no standardized approach for reviewing the agreements, or the services provided, by the staff assigned to the oversight responsibility. When asked if the contracted vendors routinely submitted quality control data or reports to objectively reflect how they maintained high quality of services, AS 1 indicated that vendors did not routinely submit such reports. For example, the linen vendor did not submit reports of the water temperatures for laundering the linen to ensure that the linen was sufficiently sanitized. The nuclear medicine vendor did not submit data to show how pure the materials were. AS 1 also indicated there were no objective measurements by hospital staff to rate specific expectations, such as timeliness or accuracy of the services provided by vendors. Instead, the evaluation process was informal by verbal queries of department managers to see if they were satisfied, or to see if managers reported problems with vendors. AS 1 did not produce documentation of such queries, or the results of any interventions in response to problems identified by the managers. AS 1 did not produce any objective measurements for the safety and effectiveness of contracted services.

In a review on 1/29/10 of the minutes of the governing board from January 2009 to December 2009, there were no documented entries related to evaluation and periodic review of contracted services.

Review of 5 medical director service agreements for Pathology, Radiology, Rehabilitation, Respiratory Therapy, and Outpatient Ski Clinic on 1/28/10 at 4 p.m. with AS 1 indicated that the last documented evaluation for the Radiology Director was in 2001 and the last documented evaluation for the Pathology Director was in 2006. AS 1 indicated that the Director reviews were not submitted to the Governing Board and he did not know why they were not maintained for these two directors. AS 1 stated that formal periodic reviews for the 5 medical director agreements listed above had not occurred. In fact, formal periodic reviews for safety and effectiveness of all contracted services by the governing board had not occurred since he began his administrative post 3 years ago.

Based on observation, staff and patient interviews, medical record and document reviews, the hospital failed to develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement (QAPI) program that reflected the complexity of the hospital's services, involved all hospital departments and services, and focused on indicators related to improved health outcomes and the prevention and reduction of medical errors as evidenced by:

A. The governing body, medical staff, and administrative staff failed to ensure effective systems of medication reconciliation, patient assessments by physician and nursing staff for safe insulin administration, clarifying illegible physician orders, and individualized nursing care plans that reflected the monitoring needs of diabetic patients receiving insulin. These failures resulted in an episode of dangerously low blood sugar for Patient 34 on 1/26/10 which required rescue interventions. An Immediate Jeopardy (IJ) situation was called by the survey team on 1/27/10. The IJ was abated on 1/29/10 when an acceptable plan of correction was provided and verified. (Cross reference to A 0049, A 0310, A 0395, and A 0500)

B. The governing body failed to periodically review the safety and effectiveness of services provided by contract or agreement. (Cross reference to A 0084, A 0267, and A 0310)

C. The medical staff failed to evaluate the competence and performance of practitioners administering or supervising sedation/analgesia (Cross-reference to A 0050, A 00363, A 0310 and A 0405) and practitioners performing surgical endoscopy procedures (Cross reference to A 0945).

D. Infection control standards were not applied throughout all hospital locations among all health care providers. Infection control policies were not evaluated for compliance and effectiveness. (Cross-reference to A 0310 and A 0747)

E. The hospital failed set priorities for its performance improvement activities that focused on high-risk, high-volume, or problem-prone areas. The hospital failed to monitor activities in the Surgical Services department related to the environment (humidity, and temperatures) and the use of flash sterilization for eye surgeries performed using supplies provided by contracted services. (Cross reference to A 0285)

The cumulative effect of these systemic problems resulted in the inability of the hospital to comply with the statutorily-mandated Condition of Participation for QAPI.

Based on interview and document review, the hospital failed to ensure that they measured, analyzed, and tracked the services provided by contractual agreement for 10 of 10 agreements reviewed (food purchasing, vending services, dietary computer services, linen vendor, nuclear medicine vendor, and medical directors for pathology, radiology, rehabilitation, respiratory therapy, and outpatient ski clinic).

Findings:

During interviews on 1/26/10 at 4:30 p.m., contract oversight was discussed in general with Administrative Staff (AS) 12 who managed buildings and facilities. AS 12 stated that there was no quality assurance or performance improvement (QAPI) activities that evaluated the services of service vendors. In an interview with Administrative Staff (AS) 9 who directed the purchasing of supplies on 1/28/10 at 10:30 a.m., AS 9 also stated that supply vendor contracts were not formally evaluated for safety and effectiveness, other than tracking for the renewal dates.

During interview with the Director of Dietary Services (DDS) on 1/27/10 at 2:30 p.m., contracts for food purchasing, vending services, and dietary computer services were reviewed. The DDS stated that she did not know how the contracted services were evaluated by the QAPI program. The DDS stated she did not provide any data or performance measurements related to the dietary contracted services to the governing body or other administrative leaders. The DDS did not collect or receive quality control reports from the vendors to verify the products passed food safety inspections.

In an interview with Administrative Staff 1 on 1/28/10 at 4 p.m., AS 1 indicated that there was no standardized approach for reviewing the nearly 400 contracts and service agreements in place. AS 1 indicated that contracted vendors did not routinely submit quality control data or accountability reports for the services they provided. Instead, the evaluation process was informal by verbal queries of department managers to see if they were satisfied, or to see if managers reported problems with vendors. AS 1 did not produce documentation of such queries, or the results of any interventions in response to problems identified by the managers. AS 1 did not produce any objective measurements for the safety and effectiveness of contracted services.

In a review on 1/29/10 of the minutes of the governing board from January 2009 to December 2009, there were no documented entries related to evaluation and periodic review of contracted services.

Review of 5 medical director service agreements for Pathology, Radiology, Rehabilitation, Respiratory Therapy, and Outpatient Ski Clinic on 1/28/10 at 4 p.m. with AS 1 indicated that the last documented evaluation for the Radiology Director was in 2001 and the last documented evaluation for the Pathology Director was in 2006. AS 1 indicated that the Director reviews were not submitted to the Governing Board and he did not know why they were not maintained for these two directors. AS 1 stated that formal periodic reviews for the 5 medical director agreements had not occurred. In fact, formal periodic reviews for safety and effectiveness of all contracted services by the governing board had not occurred since he began his administrative post 3 years ago.

Based on observations, staff interview and document review the hospital failed to set priorities for its performance improvement activities that focus on high-risk, high-volume, or problem-prone areas. The hospital failed to monitor activities in the Surgical Services department related to 1) the environment (humidity, and temperatures) for 11 of 11 days reviewed and 2) the use of flash sterilization for 23 of 24 eye surgeries performed on 10/22/09 using supplies provided by contracted services.

Findings:

1. During OR tour on 1/25/10 at 9:30 a.m. the Director of Surgical Services stated that staff in the OR did not keep logs or monitor of either humidity or temperatures. The monitoring was done remotely by engineering department and unless there was a problem identified and reported by the engineering she would not know if temperature and humidity were within any recommended ranges. The Director was not aware of any P&P pertaining to the acceptable ranges or monitoring or that anyone other than engineering was monitoring humidity and/or temperatures in the Surgery Departments.

The 2008 edition of Perioperative Standards and Recommended Practices published by the Association of periOperative Registered Nurses (AORN) made the following recommendations related to Safe Environment of Care: "V.b. Relative humidity should be maintained between 30% and 60% within the perioperative suite, including operating rooms, recovery area, cardiac catheterization rooms, endoscopy rooms, instrument processing areas, and sterilizing areas and be maintained below 70% in sterile storage areas. Low humidity increases the risk of electrostatic charges, which pose a fire hazard in an oxygen-enriched environment or when flammable agents are in use and increases the potential for dust. High humidity increases the risk of microbial growth in areas where sterile supplies are stored or procedures are performed."

Section V.b.2. indicated "Humidity should be monitored and recorded daily using a log format or documentation provided by the HVAC system. Section V.c. indicated "Temperature should be monitored and recorded daily using a log format or documentation provided by the HVAC system. V.c.1. Temperature should be maintained between 68 F to 73 F (20 C to 23 C) within the operating room suite and general work areas in sterile processing."

On 1/28/10 at 10:15 a.m. the Director of Engineering stated that OR temperatures were adjusted based on requests from surgeons and/or other surgical stuff to ensure their comfort and preference. There were no specific ranges that the facility maintained. There was no system in place for monitoring of the levels of humidity and/or temperatures in those areas on the days when surgeries were performed. There was no record or monitoring of humidity and temperatures in GI procedure rooms or the rooms where sterile equipment and supplies were maintained.

The 1/28/09 review of the temperature and humidity logs for the past 11 days printed and presented by Director of Engineering showed that the humidity and temperatures were not maintained in accordance with acceptable standards of practice. The humidity was below 30% ranges on all 11 days reviewed and reached below 20 for 4 of the 11 days reviewed. The logs showed the temperatures in the OR suites were below 68 F for all 11 days reviewed.

In an interview with the Director of Infection Control on 1/28/10 at 12:30 p.m., the Director stated that as to date, she was not involved in monitoring of environment and general operations in the Surgery Services other than monitoring of hand hygiene and surgical sites infections, which showed a slight increase. The Director stated that OR environment that would include monitoring of humidity and temperatures, were not monitored as a part of QAPI.

2. The 1/27/10 review of surgery logs showed that 24 eye surgeries were performed on 10/22/09 by one surgeon. Review of intraoperative records for the second case of the day (Patient 6) showed that on 10/22/09 the patient had left eye cataract extraction with intraocular implantation performed and that flash sterilization was used for the eye instruments used during the procedure. Review of additional 10 of 24 cases showed that flash sterilization was used to sterilize the eye instruments.

Review of the Facility's P&P titled "Sterilization of Instruments in the Operating Room Including Flash Sterilization and Implants" (rev 11/08) indicated "Flash Sterilization should be used only when time does not permit sterilization by the preferred wrapped method and there is an urgent need."

The 1/27/10 review of the Agreement Mobile Cataract and Specialty Services (signed by the facility on 1/25/10) indicated the contractor was responsible for providing two instrument sets (eye trays) to perform cataract surgery. Section 1.1.b. indicated that additional instruments, instrument sets were the responsibility of the facility directly, or through the contractor. Article 2.1.d section of the contract indicated that the facility was responsible for sterilization of reusable instrumentation between procedures.

Review of the Sterilization record with the Director of Surgery on 1/27/10 at 12 p.m. showed that on 10/21/09 two eye trays were sterilized, with one indicated as a backup tray. The Director explained that only one tray was used for all surgeries for the day. The first case was done with the tray sterilized by the routine sterilization process and wrapped. The subsequent cases were done with the same one eye tray, using flash sterilization, starting with the second case. She stated that on 10/22/09 all 23 cases, starting with case two at 8:35 a.m. and the last case starting at 3:11 p.m. (per the OR log), were performed with the same eye instruments, sterilized by flash sterilization. The second tray was retained as a back-up for emergencies. This practice was used routinely on the days that eye surgeries, scheduled in advance (non-urgent/emergent cases), were performed. This practice was not evaluated or identified as a problem through the facility's quality assurance program.

Based on staff interviews and document reviews, the hospital executive leadership failed to ensure that an ongoing program for quality improvement was defined, implemented, and maintained when:

1. The governing body, medical staff, and administrative staff failed to ensure effective systems of medication reconciliation, patient assessments by physician and nursing staff for safe insulin administration, clarifying illegible physician orders, and individualized nursing care plans that reflected the monitoring needs of diabetic patients receiving insulin. These failures resulted in 1 of 31 sampled patients (Patient 34) experiencing a blood sugar of 37 mg/dl.(critically low, normal = 70-120mg/dl.) and required rescue interventions of orange juice and intravenous injection of a 50% sugar solution (D50) to stabilize her blood sugar An Immediate Jeopardy (IJ) situation was called by the survey team on 1/27/10. The IJ was abated on 1/29/10 when an acceptable plan of correction was provided and verified. (Cross reference to A 0049, A 0395, A 0404, and A 0500)

2. The governing body failed to periodically review the safety and effectiveness of services provided by contract or agreement. (Cross reference to A 0084)

3. The medical staff failed to evaluate the competence of practitioners administering or supervising sedation/analgesia (Cross-reference to A 0050, A 0363, and A 0405) and practitioners performing surgical endoscopy procedures (Cross reference to A 0945).

4. Infection control standards were not applied throughout all hospital locations among all health care providers. Infection control policies were not evaluated for compliance and effectiveness. (Cross-reference to A 0747)

Findings:

1. Oversight of safe insulin administration resuling in low blood sugar requiring rescue for Patient 34

Review on 1/27/10 at 9:45 a.m. of the medical record for Patient 34 with RN 10 (a nursing administrative staff member) indicated that Patient 34 was 71 years old and was admitted to the hospital on 1/25/10 at approximately 5:15 p.m. from the emergency room (ED). Patient 34's diagnoses included leg pain and crush injury, congestive heart failure, insulin-dependent diabetes, and chronic kidney failure. Home insulin doses were not recorded or reconciled by physician, nursing, or pharmacy staff at the time of admission nor during the preceding ED care. An admission history and physical exam was not documented in the patient record within 24 hours of admission. A faxed medication order for insulin, written by the admitting physician on 1/25/10 at 3:30 p.m., documented that a combination rapid acting and intermediate acting insulin product was to be administered twice daily. The evening dose appeared to read as 46 units of 70/30 Novolin (an intermediate-acting combination insulin product containing both insulin regular and insulin NPH with a more rapid onset than that of insulin NPH alone; onset of action is 0.5 hours, peak effect 2-12 hours, duration of action 18-24 hours according to Lexi-comp Online, a nationally recognized drug reference, retrieved at http://online.lexi.com/crlsql/servlet/crlonline on 2/3/10 at 5 p.m.) with dinner, and an illegible amount to be administered with breakfast.
According to concurrent interviews with RN 2 on 1/28/10 at 2:40 p.m. and Registered Pharmacist (RPh 2) on 1/26/10 at 12:25 p.m., the illegible morning insulin dose was not clarified by RN 2 or RPh 2 with the ordering physician. Instead, RN 2 asked the Patient 34 what her usual dose of insulin was at home, and transcribed the order as 60 units of 70/30 Novolin for the morning dose.
Patient 34's blood sugars were documented as 297 mg/dl and 364 mg/dl (the lab normal range was 70-100 mg/dl) in the emergency department on 1/25/10 with no documented insulin administration. The record documented that Patient 34 was admitted to the inpatient unit at 5:15 p.m. and consumed 80% of dinner at 6:52 p.m. At 9:05 p.m. a fingerstick blood sugar was recorded as 360 mg/dl. Ten units of rapid acting insulin was administered. At 9:30 p.m., the "dinner" dose of intermediate acting combination insulin, 46 units, was administered. No additional food intake was recorded and the nurse did not notify the physician of the late administration of insulin (per interview with RN 3 on 1/29/10 at 10 a.m.).

At 7 a.m. on 1/26/10, the diabetic flow sheet documented a blood sugar of 83 mg/dl (low). Breakfast consumption was recorded as 80% at 8:53 a.m. On 1/26/10 at 8:45 a.m. RN 1 was observed to administer 60 units of combination rapid and intermediate acting insulin to Patient 34. No meal tray or food was present in the room. RN 1 later stated that Patient 34 had just finished eating breakfast prior to the insulin administration. At 11:45 a.m. the diabetic flow sheet documented a blood sugar of 70 mg/dl. Lunch consumption was documented as 10% at 1:50 p.m. The diabetic flow sheet documented a blood sugar of 37 mg/dl (extremely low) at 1:45 p.m. Nursing notes described Patient 34 as "sweating, feeling faint, weakness. Patient mumbling and unable to keep eyes open. Fingerstick checked and is 37. OJ (orange juice) 240 mls (8 ounces) given."

Subsequent blood sugar measurements were documented between 2:15 p.m. and 2:35 p.m. as 57, 59, and 64 mg/dl. At 2:35 p.m. "D50 1/2 amp" (an intravenous sugar solution to rescue the patient from low blood sugar) was administered. At 2:50 p.m. the blood sugar was recorded as 184 mg/dl with the patient feeling better, no sweating, still some fatigue." A physician progress note dated 1/26/10 at 2:25 p.m. documented "70/30 Insulin. Hypoglycemia (low blood sugar) due to [upward pointing arrow] dose than patient normally takes."

The Institute of Safe Medication Practices listed insulin as a high risk high alert medication on its 2008 update [reference http://www.ismp.org/Newsletters/acutecare/articles/20031201.asp]. Lexi-Comp ONLINE, a nationally recognized drug reference retrieved on 1/29/10 at http://online.lexi.com/crlsql/servlet/crlonline, recommended close monitoring of blood sugars and warned of adverse effects from insulin: "Profound and prolonged episodes of hypoglycemia may result in convulsions, unconsciousness, temporary or permanent brain damage, or even death."

During a follow-up interview on 1/27/10 at 9 a.m. the DOP confirmed that Patient 34's Insulin 70/30 was administered after breakfast on 1/25/10 (at 8:50 a.m.), not with breakfast as per the Physician's Order, and therefore was a medication error. The DOP further indicated that Patient 34 had a hypoglycemic episode on 1/26/10 at approximately 2 p.m. requiring the administration of a reversal agent (50% dextrose, a sugar solution) intravenously. The DOP indicated that an adverse drug reaction report was being generated by RN 10.

In an interview with Administrative Staff 2 (who also served as Medical Director) on 1/28/10 at 11 a.m., AS 2 acknowledged that the admission insulin orders reflected assumptions of what had worked in the past for Patient 34, but confirmation of the doses, details of her previous care and course, and rationale for continuing high insulin doses in the context of Patient 34's unstable medical condition were not documented by physician, nursing, or pharmacy staff. AS 2 agreed that breakdowns in multiple systems had occurred.

In an interview with AS 4 (who also served as director of quality services) on 1/28/10 at 12 noon, AS 4 acknowledged that policies and procedures were not followed and breakdowns in care systems had occurred. "We have become too complacent."

In a review of the July 2007 Medical Staff Bylaws on 1/28/10 at 6 p.m., Section 10.3-2 listed the duties of the Medical Executive Committee to include:
(b) coordinating and implementing the professional and organizational activities and policies of the Medical Staff; and
(f) evaluating the quality and appropriateness of medical care rendered to patients in the Hospital.

2. Oversight of contracted services' effectiveness

During interviews on 1/26/10 at 4:30 p.m., contract oversight was discussed in general with Administrative Staff (AS) 12 who managed buildings and facilities. AS 12 stated that there was no quality assurance or performance improvement (QAPI) activities that evaluated the services of service vendors. In an interview with Administrative Staff (AS) 9 who directed the purchasing of supplies on 1/28/10 at 10:30 a.m., AS 9 also stated that supply vendor contracts were not formally evaluated for safety and effectiveness.

During interview with the Director of Dietary Services (DDS) on 1/27/10 at 2:30 p.m., contracts for food purchasing, vending services, and dietary computer services were reviewed. The DDS stated that she did not know how the contracted services were evaluated by the QAPI program. The DDS stated she did not provide any data or performance measurements related to the dietary contracted services to the governing body or other administrative leaders. The DDS did not collect or receive quality control reports from the vendors to verify the products passed food safety inspections.

In an interview with Administrative Staff 1 on 1/28/10 at 4 p.m., AS 1 indicated that there was no standardized approach for reviewing the nearly 400 contracts and service agreements in place. AS 1 indicated that contracted vendors did not routinely submit quality control data or accountability reports for the services they provided. Instead, the evaluation process was informal by verbal queries of department managers to see if they were satisfied, or to see if managers reported problems with vendors. AS 1 did not produce documentation of such queries, or the results of any interventions in response to problems identified by the managers. AS 1 did not produce any objective measurements for the safety and effectiveness of contracted services.

In a review on 1/29/10 of the minutes of the governing board from January 2009 to December 2009, there were no documented entries related to evaluation and periodic review of contracted services.

Review of 5 medical director service agreements for Pathology, Radiology, Rehabilitation, Respiratory Therapy, and Outpatient Ski Clinic on 1/28/10 at 4 p.m. with AS 1 indicated that the last documented evaluation for the Radiology Director was in 2001 and the last documented evaluation for the Pathology Director was in 2006. AS 1 indicated that the Director reviews were not submitted to the Governing Board and he did not know why they were not maintained for these two directors. AS 1 stated that formal periodic reviews for the 5 medical director agreements had not occurred. In fact, formal periodic reviews for safety and effectiveness of all contracted services by the governing board had not occurred since he began his administrative post 3 years ago.

In a review of the January 2007 Medical Staff Bylaws on 1/28/10 at 8 p.m., Section 9.5-5 listed as duties of each Department Chair:
(m) assure the maintenance of quality control programs as may be necessary; and
(n) recommend and supervise the use of outside services used by the Hospital.

3. Oversight of staff competence and performance

a. Review of credentials files on 1/26/10 at 9:40 a.m. with Administrative Staff 7 indicated that for Physician 5 (MD 5), privileges for moderate sedation were initially granted on 1/26/06 after completion of a sedation course. But at reappointment on 7/24/08, MD 5 signed an attestation that he was currently competent to perform all the privileges (including moderate sedation) listed on the privilege request. AS 7 confirmed that no updated knowledge test or demonstration of competency for moderate sedation was documented in the credentials file. AS 7 stated that non-anesthesiology providers who requested moderate sedation privileges were only required to complete the course once, and thereafter maintain advanced cardiac life support certification. No ongoing evaluations of competency were conducted by the medical staff leadership. Only emergency department staff were permitted to have deep sedation privileges. Those physicians performed annual skills testing to maintain their Board certification, which was considered adequate to demonstrate deep sedation competency.

In an interview with the Director of Anesthesia Services (MD 2) on 1/28/10 at 3 p.m., MD 2 indicated that he provided oversight of all anesthesia services in all locations of the hospital, including moderate and deep sedation. MD 2 stated that anesthesia policies were intended to reflect the practice standards and guidelines of the American Society for Anesthesiologists. For a medical staff member to be granted privileges for moderate sedation, the member had to show training in a recent residency program that included sedation skills, or attend a hospital-sponsored course in sedation that included a return demonstration for airway management and rescue from unintended deeper sedation. The member was required to pass the skills test with a score of 100%. But after initial privileges for moderate sedation were granted, the medical staff member was only required to maintain certification in advanced cardiac life support (ACLS) and attest that the member was familiar with the hospital sedation policy. No further evaluations of the member's competence for sedation privileges was conducted by the medical staff leadership. For example, MD 2 reviewed pharmacy reports on the utilization of rescue drugs for members of his department, but not for all members who performed sedation/analgesia. MD 2 expected privileged providers to know the dosing adjustments for elderly patients but did not verify that drugs were prescribed and administered correctly. MD 2 did not conduct random chart reviews to assess whether the doses of medications were within standard norms for age and medical risk, whether rescue measures were instituted but did not trigger a quality review, or whether nursing staff administered sedation/analgesia medications in accordance with the policy. After the initial two sedation procedures were proctored for initial privileging, no further observations were conducted of sedation competence. The performance improvement program captured self-reported incidents and adverse events, but no other process captured a way to verify ongoing competence for sedation skills.

In an interview with MD 2 on 1/28/10 at 3 p.m., MD 2 acknowledged that when some medical staff members completed the Moderate Sedation Course many years ago, some high risk medications and rescue techniques had not yet been developed. Without periodic testing or opportunity to demonstrate knowledge, MD 2 could not verify whether those staff members were current in knowledge or competence.

In a review of the January 2007 Medical Staff Bylaws on 1/28/10 at 8 p.m., Section 9.6-4 listed the duties of each Department Chairperson. Item (c) read, "continued surveillance of the professional performance of all individuals who have delineated Clinical Privileges in the department."

Similarly for nursing staff, review of the employee files for two nurses who performed conscious sedation (RN 4 and RN 5) on 1/29/10 indicated no documented evidence of demonstrated competency for sedation/analgesia administration, rescue, and monitoring.

The position statement titled Conscious Sedation by the California Board of Registered Nursing (BRN) retrieved at www.rn.ca.gov, in part, indicated: In administering medications to induce conscious sedation, the RN is required to have the same knowledge and skills as for any other medication the nurse administers ... National guidelines for administering conscious sedation should be consulted in establishing agency policies and procedures ...The institution should have in place a process for evaluating and documenting the RNs demonstration of the knowledge, skills, and abilities for the management of clients receiving agents to render conscious sedation. Evaluation and documentation of competency should occur on a periodic basis ..."

Review of the facility's P&P titled "Moderate and Deep sedation" (rev 08/09) in part indicated in section 5. Personnel Requirements: "c. A qualified registered nurse or qualified physician must have the responsibility for medication administration and monitoring the patient's vital signs and level of consciousness during moderate sedation ...e. The registered nurse administering medications, monitoring and recovering the moderate sedation patient must demonstrate current competence in moderate sedation and advanced cardiac life support (ACLS or PALS, as appropriate)."

b. In an interview with the Surgical Services Director, the Director stated that no privileging or competencies were completed for endoscopy (GI) techs for technical tasks (handling and maintaining equipment) and there were no annual or ongoing competency assessments for GI techs who performed cutting and clamping of tissue under the direction of a physician during endoscopy procedures.

Personnel files reviewed on 1/27/10 at 4 p.m. with the HR personnel showed that GI Tech C and D had no competencies formally evaluated for the GI duties that included surgical assist. The surgical technicians had not been granted any surgical tasks privileges. Surgical technicians had no documented state licensure, certifications, or primary verification of education and training to indicate any qualifications to perform the surgical procedures which they performed.

Review of the Bylaws of Medical Staff (revised January 2007) indicated in Article V, titled "Clinical Privileges," section 5.1: A practitioner shall be entitled to exercise only those Clinical Privileges or Practice Prerogatives must be location (i.e., Hospital and/or clinic) specific and within the scope of the person's license, certificate or other legal credential authorizing practice in the appropriate State ..." Section 5.2-2 indicated: "Requests for Clinical Privileges shall be evaluated on the basis of the Member's education, training, experience, demonstrated professional competence and judgment, clinical performance, health status, and the documented results of patient care and other quality review and monitoring which the Medical Staff deems appropriate."

4. Evaluation and oversight of Infection Control policies and effectiveness

In an interview with Administrative Staff (AS) 8 (the medical staff coordinator), AS 2 (the medical director) and AS 3 (the chief of the medical staff) on 1/26/10 at 9:40 a.m., all leadership representatives agreed that members of the medical staff were not required to attend or participate in infection control trainings. Formal verifications or certifications of infection control training was not collected or filed in the staff credentials or occupational health files for medical staff members. Medical staff members were not included in hand hygiene observations for quality data analysis to evaluate the effectiveness of the infection control program. Influenza vaccine and tuberculosis immunity status was tracked by an occupational health department, but there was no required screening for immunity to hepatitis B, hepatitis C, or other communicable diseases. The leadership representatives acknowledged that medical staff members performed procedures and were exposed to blood-borne pathogens similar to other healthcare workers (direct care staff).

Review of the hospital online infection control course, presented as the current hospital infection control plan, on 1/27/10 at 6 p.m. indicated that the course objective was to identify and reduce risks of healthcare-associated infections. Page 4 of 35 documented, "Transmissible infections are a major concern among healthcare workers ... that can affect patient safety." Page 6 of 35 documented, "This facility monitors infections among staff and patients." Page 34 of 35 listed references to support the training. The most current reference was dated 2004.

In a review of the Association of Practitioners for Infection Control (APIC) Position Paper: Safe Injection, Infusion and Medication Vial Practices in Healthcare, dated 7/30/09, the following infection control standards and practices for healthcare workers (including medical staff exposed to blood and body fluids) to prevent outbreaks of serious infections in health facilities were outlined:

Provide the hepatitis B vaccination series to all previously-unvaccinated healthcare personnel.
Ensure staff preparing or administering injections or other parenteral medications are competent to aseptically perform these tasks.
Periodically assess compliance with safe injection practices by observing and evaluating personnel performing these procedures.

The APIC position paper concluded that "healthcare workers and their managers must understand, practice, and promote safe injection, infusion and medication vial practices." Administrators of medical facilities must support safe injection practices and provide resources for training and equipment. The role of the "Infection Preventionist" is to assess procedures for safety, develop programs, train, and implement safe practices. "The health and safety of our patients require adherence to infection prevention practices by all healthcare workers."

To address safe practices related to the use of blood sugar devices and percutaneous procedures that were performed by healthcare workers, the Center for Disease Control (CDC) issued standards similar to APIC in the March 11, 2005 / Vol. 54 / No. 9 edition of the CDC Morbidity and Mortality Weekly Report. Some of the practice standards to minimize the risk for cross-contamination of potentially contagious infections included:

a. Provide a full hepatitis B vaccination series to all previously unvaccinated staff members with exposure to blood or body fluids. Check and document postvaccination titers 1-2 months after completion of the vaccination series. Require staff members to know standard precautions and demonstrate proficiency in taking these precautions with procedures involving potential blood or body fluid exposures.

b. Provide staff members who perform percutaneous procedures with infection-control training that includes practical demonstration of aseptic techniques and instruction regarding reporting exposures or breaches. Conduct annual retraining of all staff members who perform procedures with exposure to blood or body fluids.

c. Assess compliance with infection-control recommendations (e.g., hand hygiene or glove changes) by periodic observation of staff and tracking use of supplies.

In a review of the January 2007 Medical Staff Bylaws on 1/28/10 at 8 p.m., Section 9.6-4 described the duties of the Service Directors to include collection and analysis of data with recommendations being made to the organized Medical Staff. Subsection (c) documented that the Service Director was to review and evaluate adherence of Medical Staff Members to the bylaws, rules, regulations, and policies. The Service Director was expected to report the compliance results to the Department Chairperson, appropriate Medical Staff committee, and/or Medical Executive Committee. Section 9.6-2 documented that medical staff members were expected to be involved in service performance improvement activities.

Based on observation, staff interviews, medical record and document reviews, the medical staff failed to operate in accordance with its bylaws, and failed to be responsible for the quality of medical care provided to patients by the hospital as evidenced by:

A. The medical staff failed to be accountable to the governing body for the quality of care provided to patients when it did not adhere to medical staff rules and regulations, and permitted hospital staff to violate policies and procedures, which put 1 of 31 patients reviewed (Patient 34) in harm's way (low blood sugar requiring rescue interventions). The event was identified during the survey and resulted in an immediate jeopardy to patient safety action by the survey team on 1/27/10. (cross reference A 0347)

B. The medical staff failed to adhere to the organizational structure by way of its rules and regulations when Registered Dietitians (RDs) were permitted to write and accept medication treatment orders (a practice outside the State scope for RDs) for 2 of 31 patient records reviewed. (cross reference A 0356)

C. The medical staff failed to comply with their bylaws (rules and regulations) requirement to document a medical history and physical examination performed no more than 30 days before or 24 hours after admission for 2 of 31 patient records reviewed. (cross reference A 0358)

D. The medical staff failed to evaluate the qualifications for administering and supervising sedation/analgesia when renewing clinical privileges for sedation/analgesia in accordance with hospital policy and national standards of practice for 1 of 1 credentials file reviewed. (cross reference A 0363)

The cumulative effect of these systemic problems resulted in the inability of the hospital to comply with the statutorily-mandated Condition of Participation for Medical Staff.

Based on staff interviews, medical record and document reviews, the medical staff failed to be accountable to the governing body for the quality of care provided to patients when it did not adhere to medical staff rules and regulations, and permitted hospital staff to violate policies and procedures. These failures resulted in 1 of 31 sampled patients (Patient 34) experiencing a blood sugar of 37 mg/dl.(critically low, normal = 70-120mg/dl.) and required rescue interventions of orange juice and intravenous injection of a 50% sugar solution (D50) to stabilize her blood sugar. The event was identified during the survey and resulted in an immediate jeopardy to patient safety action by the survey team on 1/27/10.

Findings:

Review on 1/27/10 at 9:45 a.m. of the medical record for Patient 34 with RN 10 (a nursing administrative staff member) indicated that Patient 34 was 71 years old and was admitted to the hospital on 1/25/10 at approximately 5:15 p.m. from the emergency room (ED). Patient 34's diagnoses included leg pain and crush injury, congestive heart failure, insulin-dependent diabetes, and chronic kidney failure. Home insulin doses were not recorded or reconciled by physician, nursing, or pharmacy staff at the time of admission nor during the preceding ED care. An admission history and physical exam was not documented in the patient record within 24 hours of admission. A faxed medication order for insulin, written by the admitting physician on 1/25/10 at 3:30 p.m., documented that a combination rapid acting and intermediate acting insulin product was to be administered twice daily. The evening dose appeared to read as 46 units of 70/30 Novolin (an intermediate-acting combination insulin product containing both insulin regular and insulin NPH with a more rapid onset than that of insulin NPH alone; onset of action is 0.5 hours, peak effect 2-12 hours, duration of action 18-24 hours according to Lexi-comp Online, a nationally recognized drug reference, retrieved at http://online.lexi.com/crlsql/servlet/crlonline on 2/3/10 at 5 p.m.) with dinner, and an illegible amount to be administered with breakfast.
According to concurrent interviews with RN 2 on 1/28/10 at 2:40 p.m. and Registered Pharmacist (RPh 2) on 1/26/10 at 12:25 p.m., the illegible morning insulin dose was not clarified by RN 2 or RPh 2 with the ordering physician. Instead, RN 2 asked the Patient 34 what her usual dose of insulin was at home, and transcribed the order as 60 units of 70/30 Novolin for the morning dose.
Patient 34's blood sugars were documented as 297 mg/dl and 364 mg/dl (the lab normal range was 70-120 mg/dl) in the emergency department on 1/25/10 with no documented insulin administration. The record documented that Patient 34 was admitted to the inpatient unit at 5:15 p.m. and consumed 80% of dinner at 6:52 p.m. At 9:05 p.m. a fingerstick blood sugar was recorded as 360 mg/dl. Ten units of rapid acting insulin was administered. At 9:30 p.m., the "dinner" dose of intermediate acting combination insulin, 46 units, was administered. No additional food intake was recorded and the nurse did not notify the physician of the late administration of insulin (per interview with RN 3 on 1/29/10 at 10 a.m.).

At 7 a.m. on 1/26/10, the diabetic flow sheet documented a blood sugar of 83 mg/dl. Breakfast consumption was recorded as 80% at 8:53 a.m. On 1/26/10 at 8:45 a.m. RN 1 was observed to administer 60 units of combination rapid and intermediate acting insulin to Patient 34. No meal tray or food was present in the room. RN 1 stated that Patient 34 had just finished eating breakfast prior to the insulin administration. At 11:45 a.m. the diabetic flow sheet documented a blood sugar of 70 mg/dl. Lunch consumption was documented as 10% at 1:50 p.m. The diabetic flow sheet documented a blood sugar of 37 mg/dl (extremely low) at 1:45 p.m. Nursing notes described Patient 34 as "sweating, feeling faint, weakness. Patient mumbling and unable to keep eyes open. Fingerstick checked and is 37. OJ (orange juice) 240 mls (8 ounces) given."

Subsequent blood sugar measurements were documented between 2:15 p.m. and 2:35 p.m. as 57, 59, and 64 mg/dl. At 2:35 p.m. "D50 1/2 amp" (an intravenous sugar solution to rescue the patient from low blood sugar) was administered. At 2:50 p.m. the blood sugar was recorded as 184 mg/dl with the patient feeling better, no sweating, still some fatigue." A physician progress note dated 1/26/10 at 2:25 p.m. documented "70/30 Insulin. Hypoglycemia (low blood sugar) due to [upward pointing arrow] dose than patient normally takes."

The Institute of Safe Medication Practices listed insulin as a high risk high alert medication on its 2008 update [reference http://www.ismp.org/Newsletters/acutecare/articles/20031201.asp]. Lexi-Comp ONLINE, a nationally recognized drug reference retrieved on 1/29/10 at http://online.lexi.com/crlsql/servlet/crlonline, recommended close monitoring of blood sugars and warned of adverse effects from insulin: "Profound and prolonged episodes of hypoglycemia may result in convulsions, unconsciousness, temporary or permanent brain damage, or even death."

In an interview with Administrative Staff 2 on 1/28/10 at 11 a.m., AS 2 acknowledged that the admission insulin orders reflected assumptions of what had worked in the past for Patient 34, but confirmation of the doses, details of her previous care and course, and rationale for continuing high insulin doses in the context of Patient 34's unstable medical condition were not documented by physician, nursing, or pharmacy staff. AS 2 agreed that breakdowns in multiple systems had occurred.

Failures to deliver high quality patient care that were identified above, and addressed in detail elsewhere in the survey, included:

1. Reconciliation of insulin doses at home prior to admission, and most recent insulin administration. (cross reference A 0500)

2. Documentation of a complete history and physical exam by the admitting physician (to reflect the current condition of Patient 34 at the time of admission) as required by medical staff rules. (cross reference A 0358)

3. Clarification of illegible order for a high risk high alert medication (insulin). (cross reference A 0404)

4. Administration of insulin according to physician orders (with meal, rather than following or delayed). (cross reference A 0404)

Review of the January 2007 Medical Staff Bylaws on 1/26/10 at 5 p.m. indicated in section 2.5(a) that a basic responsibility of the medical staff was to provide patients with the quality of care meeting the professional standard of the Medical Staff.

Review of the facility policy, "Medication Reconciliation," dated 9/1/05, indicated under Purpose, "To obtain, update and retain and accurate list of medications according to the physician's pre-hospital, admission, transfer, and/or discharge orders to increase patient safety and decrease potential and actual medication adverse drug events (ADEs)."

Review of the facility policy, "Medication Distribution - Inpatient," dated 5/03, revised 8/09, indicated under item 7a. Clarification of Unclear Orders, "Any prescriber's order that is not legible or clear in intent or rationality as applied to standard practices and literature will be clarified with the prescriber. The Physician will review any illegible orders with the Primary Nurse prior to leaving the nursing unit. Any clarifications will be written on the Physicians Order Sheet as 'Clarification of Order:..' and signed by the physician or the nurse transcribing the clarification. If the order is still unclear to the pharmacist, the pharmacist will contact the physician directly, or as applicable, will contact the transcriber of a verbal or telephone order for clarification."

Review of the facility policy, "Medication Administration Times," dated 3/17/03, revised 11/06, indicated under item C2, Administration Times, Medication Specific Exceptions, F. Oral Hypoglycemics (diabectic medication), Insulin, and Carafate, BID, 0730 and 1730."

Review of the facility policy, "Medication Errors," dated 5/95, revised 1/09, indicated under item B1, "A medication error is defined as a dose administered differently than ordered by the physician as recorded on the patients medical record," and under item B1h, "Wrong time: Administration of a dose more than 60 minutes before or after the scheduled administration time. Additional parameters: Drugs ordered before meals or on an empty stomach should be given before food and within 30 minutes of the scheduled time; drugs ordered with food should be given within 30 minutes of the scheduled time."

Based on staff interviews, medical record and document reviews, the medical staff failed to adhere to the organizational structure by way of its rules and regulations when Registered Dietitians (RDs) were permitted to write and accept medication treatment orders (a practice outside the State scope for RDs) for 2 of 31 patient records reviewed (Patients 41 and 42).

Findings:

Review on 1/25/10 at 3:30 p.m. of the medical record for Patient 41 indicated that Patient 41 was 71 years old and was admitted on 1/8/10 and readmitted to the hospital on 1/16/10 for complications of a diverting loop colostomy (bowel procedure that diverted the anatomical flow of stool to the front of the belly). On 1/10/10 orders were documented to administer total parenteral nutrition (TPN), an intravenous mixture of biochemical products intended to sustain bodily functions. The two-page preprinted order set resembled a treatment protocol for TPN. The orders included choices of mixtures with varying amounts of proteins (amino acids), sugar (dextrose), fats (lipids), salt chemicals (electrolytes), vitamins, trace elements, and medications (insulin). The orders also included lab test orders, chest x-ray, specialized intravenous catheter equipment selections, nursing assessment and monitoring parameters, blood sugar testing, and alternative intravenous solutions if needed. The order set was documented by a registered dietician (who was not a registered nurse) as a telephone order from a physician on 1/10/10 at 1:50 p.m. A registered nurse "noted" the orders on 1/10/10 at 2:10 p.m. and a physician cosigned the orders on 1/11/10 at 11 a.m.

Review on 1/25/10 at 2:15 p.m. of the medical record for Patient 42 indicated that Patient 42 was 24 years old and was admitted to the hospital on 1/16/10 for a small bowel obstruction (blocked intestines). A TPN order set was documented by a physician on 1/19/10. The order set contained similar items as for Patient 41. An additional telephone order was accepted by a registered dietician on 1/24/10 at 1:20 p.m. to alter the chemical composition (specific ingredients) of the TPN solution and the rate of administration. The order was noted by a registered nurse on 1/24/10 at 1:35 p.m. and cosigned by a physician on 1/25/10 at 8:50 a.m.

In an interview with the Director of Nutrition Services (DNS) on 1/25/10 at 3:30 p.m., the DNS stated that the hospital dieticians can order the TPN and actually do this by documenting as a telephone order which the physician eventually approves with a cosignature.

In an interview with the Director of Pharmacy (DOP) on 1/26/10 at 1:45 p.m., the DOP was asked who had the authority to prescribe TPN. The DOP indicated that the Registered Dietician (RD) was responsible to select the macronutrients (proteins, fats, sugar concentrations) portion of the TPN, and the pharmacist (RPh) selected other additives (electrolytes, insulin, etc.). He said that there is a protocol and a hospital policy regarding who can take verbal orders which must be countersigned by a physician. The DOP indicated that he was very comfortable with the RD ordering macronutrients, stating "They are very good at it." He further indicated that the RD should not be selecting electrolytes/additives, as "Pharmacy does that part." He then stated, "The form is not that good; we are working on it." The DOP did not produce what he considered to be a TPN protocol during the survey.

In a review of the 2/22/07 Medical Staff Rules and Regulations on 1/26/10, Section B(1)(m) listed the requirements for treatment/medication orders: "a verbal order shall be considered to be in writing if dictated to a fully authorized person functioning within his/her sphere of competence." The Rules further documented, "Duly authorized persons who may receive verbal orders for treatments/medications are licensed vocational and registered nurses, physician's assistants, nurse practitioners, lab technicians, respiratory care practitioners, physical therapists, occupational therapists, medical imaging technicians and pharmacists." The Rules did not list registered dieticians as duly authorized persons who may accept verbal orders for treatments/medications.

According to a policy titled "Verbal & Telephone Orders," revised 9/05, under section II(B), "orders given verbally or by telephone shall only be given by a qualified physician, surgeon, dentist, podiatrist or other person duly licensed or authorized to prescribe by the State." Section C documented that such orders should only be "received and recorded by licensed, registered, or nationally certified health professionals provided that the orders received relate to the licensed, certified, or registered area of competence of the individual receiving the orders."

However, in a policy titled "Nutrition Support - TF/TPN," revised 11/6/08, the policy documented that "tube feedings (TF) and TPN (total parenteral nutrition) are ordered by the physician or by the registered dietitian (RD) by written, telephone or verbal order from the physician." The procedure documented, "the physician or RD under direction from the physician writes the nutrition support order in the medical record using the approved formulary."

Review on 1/26/10 of the California State Business & Professions Code (B&P) section 2586 (a) documented that the RD scope of practice was "on referral by a health care provider authorized to prescribe dietary treatment, provide nutritional and dietary counseling, conduct nutritional and dietary assessments, and develop nutritional and dietary treatments, including therapeutic diets. The services described in this subdivision may be termed 'medical nutritional therapy.'" The B&P Code did not list nursing assessment and monitoring, administration of intravenous biochemical compounds and medications, or care and management of intravenous catheters as part of the RD scope of practice.

B&P Section 2586 (b) documented, "A registered dietitian, or other nutritional professional meeting the qualifications set forth in subdivision (e) of section 2585, may accept or transmit verbal orders consistent with an established protocol to implement medical nutritional therapy."

B&P in section 2068 outlined what was meant by nutrition services as distinguished from the practice of medicine in this manner. "This chapter shall not be construed to prohibit any person from providing nutritional advice or giving advice concerning proper nutrition. However, this section confers no authority to practice medicine or surgery or to undertake the prevention, treatment, or cure of disease, pain, injury, deformity, or physical or mental conditions or to state that any product might cure any disease, disorder, or condition in violation of any provision of law. For purposes of this section the terms 'providing nutritional advice or giving advice concerning proper nutrition' means the giving of information as to the use and role of food and food ingredients, including dietary supplements."

In a review on 2/4/10 at 10 a.m. of the American Dietetic Association (ADA) website at url
a registered dietician was defined as a food and nutrition expert who has met academic and professional requirements including a bachelor's degree with course work in food and nutrition sciences, foodservice systems management, business, economics, computer science, sociology, biochemistry, physiology, microbiology and chemistry. Pharmacology, anatomy, pathophysiology, and medicine were not included in the requirements for a registered dietician. Although the ADA listed diseases and conditions including "parenteral" nutritional support as situations that benefit by RD services, the ADA defined "Medical Nutrition Therapy" as 1. performing a comprehensive nutrition assessment determining the nutrition diagnosis, 2. planning and implementing a nutrition intervention using evidence-based nutrition practice guidelines, and 3. monitoring and evaluating an individual's progress over subsequent visits with the RD. "During an MNT intervention, RDs counsel clients on behavioral and lifestyle changes required to impact long-term eating habits and health." The ADA did not include the management or prescribing of total parenteral nutrition as a task within the scope of an RD. The ADA list of position papers included no position for RDs to prescribe, adjust, or select the composition of TPN. A position paper dated October 2003 and titled "Integration of Medical Nutrition Therapy and Pharmacotherapy" discussed the interactions of RDs with other members of the health care team for patients with chronic health conditions amenable to lifestyle changes to minimize the need for prescription medications. The paper did not address any role for an RD to manage intravenous treatments and medications. A position paper dated December 2009 and titled "Nutrient Supplmentation" identified RDs as knowledgeable about nutrient supplements but referred only to oral vitamin and mineral products, not intravenous treatments and medications.

The State of California Business and Professions Code limits authority to prescribe treatments and medications to licensed physicians, physician assistants, and nurse practitioners (B&P 2053). Prescribers are required to carry medical malpractice insurance and obtain patient care privileges at the hospital. A registered dietician is not accountable to any California state licensure board (there is none).

In a review of Lexi-Comp ONLINE, a nationally recognized pharmaceutical reference, on 2/4/10 at 10 a.m. at url http://online.lexi.com/crlsql/servlet/crlonline, the citation for Total Parenteral Nutrition documented, "The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drugs which have a heightened risk of causing significant patient harm when used in error." Indications for use included "Infusion of nutrient solutions into the bloodstream to support nutritional needs during a time when patient is unable to absorb nutrients via the gastrointestinal tract, cannot take adequate nutrition orally or enterally, or have had (or are expected to have) inadequate oral intake for 7-14 days." Under Dosage Forms, "TPN is usually compounded from optimal combinations of macronutrients (water, protein, dextrose, and lipids) and micronutrients (electrolytes, trace elements, and vitamins) to meet the specific nutritional requirements of a patient." Thus, although TPN can be a form of nutrition, nutrition supplement, or nutrition treatment, TPN is considered a high risk medication available only by prescription.
Documented in a policy titled "Clinical Consultation Services," issued 3/5/08, was authorization for a number of dependent care practitioners, some licensed and some not, to "write orders pursuant to their specialty for the individualized care of patients. Clinicians performing consultation services at the request of a physician will enter the new order in the physician order section pursuant to their specific scope of practice."

In an interview with Administrative Staff 2 on 1/28/10 at 11:30 a.m., AS 2 indicated that treatment and medication orders were to be written and authorized only by members of the medical staff (physicians, physician assistants, nurse practitioners). AS 2 understood that certain licensed staff were permitted to accept verbal orders, such as licensed nurses, for treatments and medications. AS 2 was not aware that registered dieticians were authorized by the medical staff to write and accept medication orders, per the Nutrition Support and Clinical Consultation policies described above. AS 2 acknowledged that a registered dietician did not possess the education and training to understand the pathophysiology or various disease states that affect body biochemistry, or the interactions of various medications with TPN solutions, to order or reconcile TPN orders for an individual patient with a variety of unstable medical conditions.

In an interview on 1/26/10 at 9:40 a.m. with Administrative Staff 7, AS 7 indicated that clinical privileges were granted by the governing body and medical staff only to those practitioners listed on the medical staff roster. No registered dieticians were listed on the roster presented by AS 7 on 1/26/10. AS 7 also indicated that the patient record reviews for medical staff members under the ongoing performance improvement process (OPPE) did not specifically capture the performance (or competency) of non-medical staff providers. Therefore, no process to capture the competency or accuracy of the RD writing TPN orders would be linked to patient record reviews for performance improvement as one reflection of oversight by the medical staff and accountability to the governing body for clinical care to all patients.

Based on staff interview, patient record and document reviews, the medical staff failed to comply with their bylaws (rules and regulations) requirement to document a medical history and physical examination performed no more than 30 days before or 24 hours after admission for 2 of 31 patient records reviewed (Patients 34 and 27). Staff did not have an accurate medication history for Patient 34 and in the first 24 hours of admission Patient 34 experienced a blood sugar of 37 mg/dl.(critically low, normal = 70-120mg/dl.) and required rescue interventions of orange juice and intravenous injection of a 50% sugar solution (D50) to stabilize her blood sugar.

Findings:

1. On 1/27/10 at 9:45 a.m. the medical record for Patient 34 was reviewed with RN 10. Patient 34 was admitted to the hospital on 1/25/10 with diagnoses of congestive heart failure, leg pain, insulin-dependent diabetes and chronic kidney failure. RN 10 confirmed that a comprehensive medical history and physical examination (H&P) was not documented in the patient record. Efforts by the unit clerk to locate a H&P for the current hospital admission were unsuccessful. A H&P dated 11/23/09 (previous admission) was presented as the most recent H&P dictated in the electronic system. That 11/23/09 H&P was not filed in the patient record and did not list the discharge medications. There was no documentation in Patient 34's record of recent insulin dosages for the 1/25/10 admission. No hemoglobin A1C test (objective measure of blood sugar control over the previous 3 months) was not documented. An order for insulin was not written legibly by the admitting physician or clarified by nursing or pharmacy staff. The attending physician documented on 1/26/10 that the insulin ordered on admission was higher than the usual amount the patient was used to taking (following an episode on 1/26/10 of dangerously low blood sugar on the very high insulin dose ordered). Thus, an opportunity to evaluate the overall insulin needs for Patient 34 was missed when the complete H&P was not available to all providers of care.

2. On 1/29/10 at 9:40 a.m., the medical record for Patient 27 was reviewed with RN 10. Patient 27 was admitted to the hospital on 1/28/10 at 3:28 a.m. for a multiple sclerosis exacerbation. Treatment was rendered and discharge was planned on the morning of 1/29/10. RN 10 confirmed that the dictated H&P dated 1/28/10 at 9:57 a.m. for Patient 27 did not document an admission physical examination. Neither did the brief progress note by the admitting physician on 1/28/10 at 9:45 a.m. document a H&P. A neurologist had consulted on 1/28/10 at 8:40 a.m., but neither the progress note entry nor the dictated consultation described a complete physical examination.

Review (on 1/29/10 at 1 p.m.) of the 2/22/07 Medical Staff Rules and Regulations documented under section B(1)(a) that "The attending practitioner shall be responsible for the preparation of a complete and legible medical record for each patient. Its contents shall be pertinent and current. This record shall include identification data, complaint, personal history, family history, history of present illness, review of systems, physical examination, special reports ...summary of discharge note ..." Section B(1)(b) documented, "A History & Physical must be dictated no more than 24 hours before or by midnight the following day of the admission for each patient (unless completed within 30 days prior to admission and updated) ... The History and Physical will have ... complete physical exam." Section B(1)(b) further added, "For all patients admitted to an inpatient status, a dictated H&P must be performed within 24 hours of admission."

Review (on 1/29/10 at 1 p.m.) of the January 2007 Medical Staff Bylaws documented the responsibilities of the medical staff under section 2.5(B)(b) to abide by the medical staff rules and regulations, and hospital policies. Under section 2.5(B)(d), medical staff members were required to prepare and complete in timely fashion, medical and other required records for all patients to whom the member provided care.

Based on staff interviews and document reviews, the medical staff failed to evaluate the qualifications for administering and supervising sedation/analgesia when renewing clinical privileges for sedation/analgesia in accordance with hospital policy and national standards of practice for 1 of 1 credentials file reviewed (MD 5).

Findings:

On 1/29/10 at 10 a.m., Administrative Staff 11 was asked to determine the number of medical staff members outside of the anesthesia department who possessed privileges to administer and supervise sedation/analgesia. AS 11 offered the following information:

There were a total of 176 members of the medical staff.
Forty-two members of the medical staff had moderate sedation privileges.
The 42 members were from 9 different departments, including dentistry, radiology, orthopedics, obstetrics and gynecology, gastroenterology, family practice, internal medicine, plastic surgery, and emergency medicine.
Fifteen members had privileges for deep sedation, all from emergency medicine.

Review of credentials files on 1/26/10 at 9:40 a.m. with Administrative Staff 7 indicated that for Physician 5 (MD 5), privileges for moderate sedation were initially granted on 1/26/06 after completion of a sedation course. But at reappointment on 7/24/08, MD 5 signed an attestation that he was currently competent to perform all the privileges (including moderate sedation) listed on the privilege request. AS 7 confirmed that no updated knowledge test or demonstration of competency for moderate sedation was documented in the credentials file. AS 7 stated that non-anesthesiology providers who requested moderate sedation privileges were only required to complete the course once, and thereafter maintain advanced cardiac life support certification. No ongoing evaluations of competency were conducted by the medical staff leadership. Only emergency department staff were permitted to have deep sedation privileges. Those physicians performed annual skills testing to maintain their Board certification, which was considered adequate to demonstrate deep sedation competency.

In an interview with the Director of Anesthesia Services (MD 2) on 1/28/10 at 3 p.m., MD 2 indicated that he provided oversight of all anesthesia services in all locations of the hospital, including moderate and deep sedation. MD 2 stated that anesthesia policies were intended to reflect the practice standards and guidelines of the American Society for Anesthesiologists. For a medical staff member to be granted privileges for moderate sedation, the member had to show training in a recent residency program that included sedation skills, or attend a hospital-sponsored course in sedation that included a return demonstration for airway management and rescue from unintended deeper sedation. The member was required to pass the skills test with a score of 100%. But after initial privileges for moderate sedation were granted, the medical staff member was only required to maintain certification in advanced cardiac life support (ACLS) and attest that the member was familiar with the hospital sedation policy. No further evaluations of the member's competence for sedation privileges was conducted by the medical staff leadership. For example, MD 2 reviewed pharmacy reports on the utilization of rescue drugs for members of his department, but not for all members who performed sedation/analgesia. MD 2 expected privileged providers to know the dosing adjustments for elderly patients but did not verify that drugs were prescribed and administered correctly. MD 2 did not conduct random chart reviews to assess whether the doses of medications were within standard norms for age and medical risk, whether rescue measures were instituted but did not trigger a quality review, or whether nursing staff administered sedation/analgesia medications in accordance with the policy. After the initial two sedation procedures were proctored for initial privileging, no further observations were conducted of sedation competence. The performance improvement program captured self-reported incidents and adverse events, but no other process captured a way to verify ongoing competence for sedation skills.

Review on 1/28/10 at 3 p.m. of a hospital policy titled "Moderate and Deep Sedation," revised 8/09, under Policy item #6 documented that only credentialed licensed independent practitioners holding current privileges to administer moderate or deep sedation were authorized to order and supervise sedation tasks. Credentialing criteria included "verification of competency in both evalating patients prior to performing moderate and deep sedation, and methods and techniques required to rescue those patients ..." In item #7 for Competency, "the physician and/or registered nurse responsible for managing the care of the patient receiving moderate sedation will hold current ACLS or PALS provider card and maintain moderate sedation competency in [six skills listed.]

Attachment D of the Sedation policy required all physicians holding sedation privileges to complete the Moderate Sedation Course. Thereafter, only ACLS certification must be maintained. Emergency Department physicians who maintained annual board certification were exempt from those requirements. The bottom of the form included an attestation that the signer was currently competent to perform Moderate Sedation.

In an interview with MD 2 on 1/28/10 at 3 p.m., MD 2 acknowledged that when some medical staff members completed the Moderate Sedation Course many years ago, some high risk medications and rescue techniques had not yet been developed. Without periodic testing or opportunity to demonstrate knowledge, MD 2 could not verify whether those staff members were current in knowledge or competence.

Definitions and standards of sedation-analgesia, procedural sedation, moderate sedation and conscious sedation have been addressed by a number of nationally recognized organizations including the American Society of Anesthesiologists (ASA), the Association for peri-Operative Nursing (AORN), American Association of Nurse Anesthetists (AANA), the California Board of Registered Nursing (BRN), and the California Society of Anesthesiologists (CSA). The organizations agree that professionals who administer or supervise the administration of moderate and deep sedation should have specialized and formal education, training, and demonstrated competency for the knowledge related to respiratory physiology, cardiac rhythms, medication pharmacology, airway management, and rescue from unintended oversedation or complications. (Refer to the ASA Statement on Granting Privileges for Administration of Moderate Sedation to Practitioners Who Are Not Anesthesia Professionals, 10/18/06) Under Performance Improvement, the ASA recommends assessing up-to-date knowledge as well as ongoing competence in the skills outlined in the education and training requirements, and to re-evaluate the practitioner's performance at regular intervals. Similar oversight guidelines are outlined by the CSA for non-anesthesiologists who administer deep sedation.

Section 5.2-2(b) of the January 2007 Medical Staff Bylaws, reviewed on 1/26/10 at 5 p.m., documented,"Requests for Clinical Privileges shall be evaluated on the basis of the Member's education, training, experience, demonstrated professional competence and judgment, clinical performance, health status, and the documented results of patient care and other quality review and monitoring."

Based on observation, staff interviews, medical record and document reviews, the hospital failed to have organized nursing services furnished or supervised by a registered nurse as evidenced by:

A. The hospital failed to ensure that a registered nurse supervised the care of a patient with diabetes (Patient 34, 1 of 31 patient records reviewed) through ongoing assessments and evaluations in order to administer insulin safely. As a result, Patient 34 experienced an episode of dangerously low blood sugar that required rescue interventions.(Cross-reference to A0395)

The practice constituted an Immediate Jeopardy by placing patients and others at risk for harm. The Immediate Jeopardy was called on 1/27/10 at 2:30 p.m. with the CEO and other administrative staff members present. The IJ was abated on 1/29/10 at 2:30 p.m., prior to the exit conference, with VP of Nursing, VP of Operations and other administrative staff present, after the facility presented and implemented a written acceptable plan of correction, confirmed by the surveyors' interviews with staff and document review.

B. The hospital failed to ensure that nursing staff developed and kept current a nursing care plan for diabetic patients on insulin for 1 of 31 patient records reviewed (Patient 34).(Cross-reference to A0396)

C. The hospital failed to administer medications in accordance with physician orders and facility policy for two of 31 sampled patients (Patients 33 and 34). This failure contributed to an adverse drug reaction (hypoglycemia) for Patient 34 and potential adverse drug reaction for Patient 33.
1. Patient 34's insulin was not administered as ordered by the physician on two separate occasions.
2. Patient 33's Norco 10/325 (a narcotic-containing pain medication) was not administered according to facility policy.).(Cross-reference to A0404)

D. The hospital failed to ensure that Registered Nurses administering moderate sedation had demonstrated competencies documented specific to the nursing management of patients receiving conscious sedation in accordance with P&Ps and acceptable standards of practice. (Cross-reference to A0405)

E. The hospital failed to ensure that verbal orders were accepted only by authorized personnel and in accordance with hospital policy and procedures for 3 of 31 patient records reviewed (Patients 24, 26, 41 and 42).(Cross-reference to A0408).

The cumulative effect of these systemic problems resulted in the nursing services not provided in compliance with the statutorily mandated Condition of Participation for Nursing Services.

Based on observation, staff interviews, medical record and document reviews, the hospital failed to ensure that a registered nurse supervised the care of a patient with diabetes (Patient 34, 1 of 31 patient records reviewed) through ongoing assessments and evaluations in order to administer insulin safely. Nursing and pharmacy staff did not clarify and evaluate a physician's order for insulin, thereby exposing Patient 34 to an adverse drug reaction. The P&Ps for medication reconciliation, clarifying of illegible medication orders, and medication administration were not followed. The hospital failed to develop and/or implement policies and procedures regarding dietary considerations for diabetic patients and monitoring of patients receiving hypoglycemic agents care planning and dietary considerations. As a result, on 1/26/10, Patient 34 experienced episodes of dangerously low blood sugars of 37, 57, 59 & 64 mg/dl (normal non-fasting level is 70-120mg/dl.) between 1:35 p.m. and 2:35 p.m., that required rescue interventions of 8 oz of orange juice followed with 1/2 amp of D50 (50% sugar solution administered intravenously).

The above failures constituted an Immediate Jeopardy by placing patients and others at risk for harm. The Immediate Jeopardy was called on 1/27/10 at 2:30 p.m. with the CEO and other administrative staff members present. The facility presented an acceptable POC and the IJ was abated on 1/29/10 at 2:30 p.m., prior to the exit conference, with the VP of Nursing, the VP of Operations and other administrative staff present.

Findings:

On 1/26/10, at 8:45 a.m., during an observation of medication pass observation, RN 1 was observed to draw up 60 units of Novolin 70/30 insulin into an insulin syringe and verify the dose with another licensed nurse. Novolin 70/30 insulin is a mixture of 70% NPH insulin (an intermediate-acting insulin, indicated for the treatment of diabetes mellitus, which peaks in 6 to 12 hours) and 30% regular insulin (a short-acting insulin, indicated for the treatment of diabetes mellitus, which peaks in 0.8 to 2 hours). At 8:50 a.m., RN 1 injected the 60 units of Novolin 70/30 insulin subcutaneously (beneath the skin) into Patient 34's upper right arm. RN 1 then administered the remainder of Patient 34's morning (oral) medications with a cup of water and charted all medications administered on the MAR (Medication Administration Record). When asked when Patient 34 had eaten breakfast, RN 1 indicated that Patient 34 had just finished breakfast. There was no breakfast tray present in Patient 34's room.

According to Institute of Safe Medication Practices (ISMP), a nationally recognized organization that promotes the safe use of medication in healthcare facilities, insulin is considered a high-risk, high alert medication due to the heightened potential for significant patient harm. ISMP recommends healthcare facilities utilize special safeguards to reduce the risk of insulin adverse effects.

Lexi-Comp ONLINE, a nationally recognized drug reference, indicates that insulin should be used with caution in patients with renal impairment/insufficiency, and recommends close monitoring of blood sugars. The most common adverse effect of insulin is hypoglycemia. Profound and prolonged episodes of hypoglycemia may result in convulsions, unconsciousness, temporary or permanent brain damage, or even death.

The 70/30 Novolin insulin has a more rapid onset than that of insulin NPH alone; onset of action is 0.5 hours, peak effect 2-12 hours, duration of action 18-24 hours according to Lexi-comp Online, a nationally recognized drug reference, retrieved at http://online.lexi.com/crlsql/servlet/crlonline on 2/3/10 at 5 p.m.

Review of Patient 34's 1/26/10 printed MAR revealed that the morning dose of Insulin 70/30 indicated 60 units at breakfast, with an administration time of 7:30 a.m. (per observation the dose was actually administered at 8:50 a.m.)

On 1/26/10 at 9:30 a.m., a reconciliation (comparison for accuracy) of observations made during the medication pass with Patient 34's current Physician Orders revealed a faxed admission order (handwritten by Patient 34's physician), dated 1/25/09 (and timed 3:25 p.m.), for Insulin 70/30 [illegible] units at breakfast and 46 units at dinner.

Review of the facility policy, "Medication Distribution - Inpatient," revised 8/09, indicated under item 7a. Clarification of Unclear Orders, "Any prescriber's order that is not legible or clear in intent or rationality as applied to standard practices and literature will be clarified with the prescriber. The Physician will review any illegible orders with the Primary Nurse prior to leaving the nursing unit. Any clarifications will be written on the Physicians Order Sheet as 'Clarification of Order:..' and signed by the physician or the nurse transcribing the clarification. If the order is still unclear to the pharmacist, the pharmacist will contact the physician directly, or as applicable, will contact the transcriber of a verbal or telephone order for clarification."

Review on 1/27/10 at 9:45 a.m. of the medical record for Patient 34 with RN 10 (a nursing administrative staff member) indicated that Patient 34 was 71 years old and was admitted to the hospital on 1/25/10 at approximately 5:15 p.m. from the emergency room (ED). Patient 34's diagnoses included leg pain and crush injury, congestive heart failure, insulin-dependent diabetes, and chronic kidney failure. Home insulin doses were not recorded or reconciled by physician, nursing, or pharmacy staff at the time of admission nor during the preceding ED care. An admission history and physical exam was not documented in the patient record within 24 hours of admission.

During an interview on 1/26/10 at 9:45 a.m. RN 10 confirmed that the morning dose of Insulin 70/30 on Patient 34's faxed admission Physician Orders was not legible, and that her Medication Form and emergency room Nurse's Notes and Physician Documentation did not specify the insulin doses that Patient 34 received at home. RN 10 further confirmed that Patient 34's nursing assessment notes on admission did not indicate that her physician had been contacted to clarify the intended morning dose of Insulin 70/30, but that the admitting nurse (RN 2) had obtained the information from Patient 34. RN 10 confirmed that Patient 34's admission medication orders had been scanned to the inpatient pharmacy on 1/25/10 at 5:20 p.m.

During an interview on 1/26/10 at 12:25 p.m. the Director of Pharmacy (DOP) and RPh 1 confirmed that the morning dose of Insulin 70/30 on Patient 34's faxed admission Physician Orders was not legible. The DOP indicated that Patient 34's admission medication orders were entered into the pharmacy computer by the technician on 1/25/10 at 5:27 p.m. and verified by RPh 2 at 5:37 p.m. During a concurrent interview, RPh 2 stated that, on 1/25/10, she did question the legibility of Patient 34's morning Insulin 70/30 order, and called the nurse, who had verified the insulin dose with the patient. RPh 2 acknowledged that she did not call Patient 34's physician to verify the morning dose of Insulin 70/30.

According to interviews with RN 2 on 1/28/10 at 2:40 p.m., the illegible morning insulin dose was not clarified by RN 2 with the ordering physician. Instead, RN 2 asked the Patient 34 what her usual dose of insulin was at home, and transcribed the order as 60 units of 70/30 Novolin for the morning dose.

Review of the facility policy, "Medication Reconciliation," dated 9/1/05, indicated under Purpose, "To obtain, update and retain an accurate list of medications according to the physician's pre-hospital, admission, transfer, and/or discharge orders to increase patient safety and decrease potential and actual medication adverse drug events (ADEs)." Under Hospital Procedure, item 1 indicated "The medication history may be obtained from the patient and/or family members who are present at the time of admission. The nurse should determine if they are reliable historians. If the patient or family is able to provide accurate data, no additional source of information is required." Under item 1a., "In those cases when a patient and family are not considered to be a reliable source of information alternative sources must be located."

During an interview on 1/26/10 at 10 a.m. RN 1 indicated that Patient 34 was "probably not a good historian" regarding the insulin doses that she had received at home.

In an interview with AS 2 on 12/28/10 at 11 a.m., AS 2 agreed that Patient 34 was quite ill and medically unstable when she was admitted to the hospital on 1/25/10 with low blood oxygen, congestive heart failure, kidney failure and a leg injury that kept her from ambulating for the three previous days. AS 2 acknowledged that Patient 34 may not have been a reliable historian regarding her home insulin doses and a safer practice would be to verify those doses from reliable sources such as outpatient records, pharmacy records, treating physician, or her medication diary.

During an interview at 10:55 a.m. on 1/27/10, Patient 34 indicated that she usually self-administered her insulin twice daily at home according to her blood sugar readings, and kept a book at her home. She further indicated that if her blood sugar readings were "OK," she did not administer any insulin. Some days, she did not take insulin at all. She was very familiar with recognizing symptoms of low blood sugar at levels of 20-30, which caused her to get "shaky." For those moments, which had occurred in recent months, she would drink juice. After about 20 minutes, she would feel better. Her blood sugar readings varied considerably but she considered her diabetes to be "well-controlled." She could not state what a typical dose of insulin was in the week prior to admission.

Continued record review revealed that Patient 34's Patient Medication Form (which reflected her medications taken at home, was dated 1/25/10, and had not yet been dated or signed by her physician) did not specify the dose of Insulin 70/30 to be administered. Review of Patient 34's Nurse's Notes and Physician Documentation (from her emergency room assessment date of 1/25/10), under "Home Meds," revealed that the dose of Insulin 70/30 was not specified, nor did the document indicate the last dose received.

Review of Patient 34's 1/25/10 admission nursing assessment indicated that no signs or symptoms of high or low blood sugar levels were described. No nursing care plans specifically addressed the management of diabetes or insulin monitoring to include ongoing assessment of high and low blood sugar levels, given the significant doses of long-acting insulin transcribed from the admitting orders.

The review showed that in addition to the faxed admission order dated 1/25/09 (timed 3:25 p.m.) for Insulin 70/30 [illegible] units at breakfast and 46 units at dinner, Patient 34 also had a Physician Order (written 1/25/10 at 6:25 p.m.) for fingerstick blood sugar assessments (FSBS) before meals and at bedtime and Moderate Sliding Scale (regular subcutaneous insulin) based on blood sugar results (for a FSBS 70 - 149 mg/dL = give 0 units; for FSBS 150 - 199 mg/dL = give 2 units; for FSBS 200 - 249 mg/dL = give 4 units; for FSBS 250 - 299 mg/dL = give 6 units; for FSBS 300 - 349 mg/dL = give 8 units; for FSBS 350 - 399 mg/dL = give 10 units; for FSBS above 400 mg/dL = give 12 units and call the physician).

Patient 34's blood sugars were documented as 297 mg/dl and 364 mg/dl (the lab normal range was 70-120 mg/dl) in the emergency department on 1/25/10 with no documented insulin administration. The record documented that Patient 34 was admitted to the inpatient unit at 5:15 p.m. and consumed 80% of dinner at 6:52 p.m. At 9:05 p.m. a fingerstick blood sugar was recorded as 360 mg/dl. Ten units of regular insulin (a rapid acting insulin) was administered. At 9:30 p.m., the "dinner" dose of intermediate acting combination Insulin 70/30, 46 units was administered subcutaneously by RN 3. No additional food intake was recorded and no documentation that the nurse notified the physician of the late administration of insulin (confirmed by interview with RN 3 on 1/29/10 at 10 a.m.).

During an interview on 1/28/10 at 2:40 p.m. RN 2 (who had processed Patient 34's admission the afternoon of 1/25/10) confirmed RPh 2 had contacted her via telephone regarding the illegibility of Patient 34's morning Insulin 70/30 dosage on the Physician Orders. RN 2 further confirmed that she had asked Patient 34 regarding her current insulin doses, but did not verify this information when the physician was called that evening. RN 2 indicated that she did not administer Patient 34's dose of insulin at dinner at 6 p.m. because she did not have a current fasting FSBS assessment and did not note that the insulin was to be given at dinner.

During an interview on 1/29/10 at 10 a.m. RN 3 (who was working the night shift following RN 2's 1/25/10 shift) indicated that Patient 34 ate well during the dinner meal of 1/25/10 and also consumed a snack at bedtime (not documented). RN 3 confirmed the administration of 10 units of regular insulin at 9:05 p.m. and further indicated since Patient 34's bedtime FSBS (of 360 mg/dL at 9:05 p.m. on 1/25/10) was elevated, that the additional dose of Insulin 70/30 (46 units) intended to be given at dinner (administered by RN 3 at 9:30 p.m.) would be acceptable. RN 3 indicated that she did not contact Patient 34's physician regarding the late administration of the Insulin 70/30, nor to seek additional guidance regarding Patient 34's insulin regimen.

Review of the facility policy, "Medication Errors," dated 5/95, revised 1/09, indicated under item B1, "A medication error is defined as a dose administered differently than ordered by the physician as recorded on the patients medical record," and under item B1h, "Wrong time: Administration of a dose more than 60 minutes before or after the scheduled administration time. Additional parameters: Drugs ordered before meals or on an empty stomach should be given before food and within 30 minutes of the scheduled time; drugs ordered with food should be given within 30 minutes of the scheduled time."

Review of Patient 34's "Diabetic Flow Sheet" revealed that her fasting FSBS (assessed on 1/26/10 at 7 a.m.) was 83 mg/dL (milligrams per deciliter); normal fasting range is 70 - 100 mg/dL.

A review of Patient 34's meal intake record revealed that on 1/26/10, she consumed 80% of her breakfast, documented at 8:53 a.m., and 10% of lunch, documented at 1:50 p.m. Patient 34's prescribed diet was not documented in nursing notes. No dietary consultation was ordered or documented in the record.

At 7 a.m. on 1/26/10, the diabetic flow sheet documented a blood sugar of 83 mg/dl (low). Breakfast consumption was recorded as 80% at 8:53 a.m. On 1/26/10 at 8:45 a.m. RN 1 was observed to administer 60 units of combination rapid and intermediate acting insulin to Patient 34. No meal tray or food was present in the room. RN 1 later stated that Patient 34 had just finished eating breakfast prior to the insulin administration. At 11:45 a.m. the diabetic flow sheet documented a blood sugar of 70 mg/dl. Lunch consumption was documented as 10% at 1:50 p.m. The diabetic flow sheet documented a blood sugar of 37 mg/dl (extremely low) at 1:45 p.m. Nursing notes described Patient 34 as "sweating, feeling faint, weakness. Patient mumbling and unable to keep eyes open. Fingerstick checked and is 37. OJ (orange juice) 240 mls (8 ounces) given."

Subsequent blood sugar measurements were documented between 2:15 p.m. and 2:35 p.m. as 57, 59, and 64 mg/dl. At 2:35 p.m. "D50 1/2 amp" (an intravenous sugar solution to rescue the patient from low blood sugar) was administered. At 2:50 p.m. the blood sugar was recorded as 184 mg/dl with the patient feeling better, no sweating, still some fatigue." A physician progress note dated 1/26/10 at 2:25 p.m. documented "70/30 Insulin. Hypoglycemia (low blood sugar) due to [upward pointing arrow] dose than patient normally takes."

Review of a policy titled "Diabetes Management," issued 1/09, guided staff for treatment interventions for low blood sugar (Hypoglycemia Treatment Protocol). The protocol defined hypoglycemia as a blood sugar less than 70 mg/dl. It considered reasons why hypoglycemia occurred, such as reduction in oral intake or insulin given and meal not ingested, only after a low blood sugar had occurred. The policy did not direct staff to anticipate triggers of hypoglycemia and to intervene with additional monitoring to prevent a fall in blood sugar to a dangerous level.

During an interview on 1/27/10 at 9:55 a.m., RN 10 confirmed the hypoglycemic episode that had occurred on 1/26/10 at 1:45 p.m.

During a follow-up interview on 1/27/10 at 9 a.m. the DOP confirmed that Patient 34's Insulin 70/30 was administered after breakfast on 1/25/10 (at 8:50 a.m.), not with breakfast as per the Physician's Order, and therefore was a medication error. The DOP further indicated that Patient 34 had a hypoglycemic episode on 1/26/10 at approximately 2 p.m. requiring the administration of a reversal agent (50% dextrose, a sugar solution) intravenously.

The above failures constituted an Immediate Jeopardy by placing patients and others at risk for harm. The Immediate Jeopardy was called on 1/27/10 at 2:30 p.m. with the CEO and other administrative staff members present. The facility presented an acceptable POC and the IJ was abated on 1/29/10 at 2:30 p.m., prior to the exit conference, with the VP of Nursing, the VP of Operations and other administrative staff present.

Based on observation, staff interviews, patient record and document reviews, the hospital failed to ensure that nursing staff developed and kept current a nursing care plan for diabetic patients on insulin for 1 of 31 sampled patient (Patient 34). Staff administered insulin without clarifying an illegible physician order and did not administered insulin per physician's order. This resulted Patient 34 experiencing a blood sugar of 37 mg/dl.(critically low, normal = 70-120mg/dl.) and required rescue interventions of orange juice and intravenous injection of a 50% sugar solution (D50) to stabilize her blood sugar.

Findings:

Review on 1/27/10 at 9:45 a.m. of the medical record for Patient 34 with RN 10 (a nursing administrative staff member) indicated that Patient 34 was 71 years old and was admitted to the hospital on 1/25/10 at approximately 5:15 p.m. from the emergency room (ED). Patient 34's diagnoses included leg pain and crush injury, congestive heart failure, insulin-dependent diabetes, and chronic kidney failure. Home insulin doses were not recorded or reconciled by physician, nursing, or pharmacy staff at the time of admission nor during the preceding ED care. An admission history and physical exam was not documented in the patient record within 24 hours of admission. A faxed medication order for insulin, written by the admitting physician on 1/25/10 at 3:30 p.m., documented that a combination rapid acting and intermediate acting insulin product was to be administered twice daily. The evening dose appeared to read as 46 units of 70/30 Novolin (an intermediate-acting combination insulin product containing both insulin regular and insulin NPH with a more rapid onset than that of insulin NPH alone; onset of action is 0.5 hours, peak effect 2-12 hours, duration of action 18-24 hours according to Lexi-comp Online, a nationally recognized drug reference, retrieved at http://online.lexi.com/crlsql/servlet/crlonline on 2/3/10 at 5 p.m.) with dinner, and an illegible amount to be administered with breakfast.
According to concurrent interviews with RN 2 on 1/28/10 at 2:40 p.m. and Registered Pharmacist (RPh 2) on 1/26/10 at 12:25 p.m., the illegible morning insulin dose was not clarified by RN 2 or RPh 2 with the ordering physician. Instead, RN 2 asked the Patient 34 what her usual dose of insulin was at home, and transcribed the order as 60 units of 70/30 Novolin for the morning dose.
Patient 34's blood sugars were documented as 297 mg/dl and 364 mg/dl (the lab normal range was 70-100 mg/dl) in the emergency department on 1/25/10 with no documented insulin administration. The record documented that Patient 34 was admitted to the inpatient unit at 5:15 p.m. and consumed 80% of dinner at 6:52 p.m. At 9:05 p.m. a fingerstick blood sugar was recorded as 360 mg/dl. Ten units of rapid acting insulin was administered. At 9:30 p.m., the "dinner" dose of intermediate acting combination insulin, 46 units, was administered. No additional food intake was recorded and the nurse did not notify the physician of the late administration of insulin (per interview with RN 3 on 1/29/10 at 10 a.m.).

At 7 a.m. on 1/26/10, the diabetic flow sheet documented a blood sugar of 83 mg/dl (low). Breakfast consumption was recorded as 80% at 8:53 a.m. On 1/26/10 at 8:45 a.m. RN 1 was observed to administer 60 units of combination rapid and intermediate acting insulin to Patient 34. No meal tray or food was present in the room. RN 1 later stated that Patient 34 had just finished eating breakfast prior to the insulin administration. At 11:45 a.m. the diabetic flow sheet documented a blood sugar of 70 mg/dl. Lunch consumption was documented as 10% at 1:50 p.m. The diabetic flow sheet documented a blood sugar of 37 mg/dl (extremely low) at 1:45 p.m. Nursing notes described Patient 34 as "sweating, feeling faint, weakness. Patient mumbling and unable to keep eyes open. Fingerstick checked and is 37. OJ (orange juice) 240 mls (8 ounces) given."

Subsequent blood sugar measurements were documented between 2:15 p.m. and 2:35 p.m. as 57, 59, and 64 mg/dl. At 2:35 p.m. "D50 1/2 amp" (an intravenous sugar solution to rescue the patient from low blood sugar) was administered. At 2:50 p.m. the blood sugar was recorded as 184 mg/dl with the patient feeling better, no sweating, still some fatigue." A physician progress note dated 1/26/10 at 2:25 p.m. documented "70/30 Insulin. Hypoglycemia (low blood sugar) due to [upward pointing arrow] dose than patient normally takes."

The Institute of Safe Medication Practices listed insulin as a high risk high alert medication on its 2008 update [reference http://www.ismp.org/Newsletters/acutecare/articles/20031201.asp]. Lexi-Comp ONLINE, a nationally recognized drug reference retrieved on 1/29/10 at http://online.lexi.com/crlsql/servlet/crlonline, recommended close monitoring of blood sugars and warned of adverse effects from insulin: "Profound and prolonged episodes of hypoglycemia may result in convulsions, unconsciousness, temporary or permanent brain damage, or even death."

Review on 1/27/10 at 9:45 a.m. of the medical record for Patient 34 with RN 10 indicated that Patient 34 was 71 years old and was admitted to the hospital on 1/25/10 at approximately 5:15 p.m. from the emergency room (ED). Patient 34's diagnoses included leg pain and crush injury, congestive heart failure, insulin-dependent diabetes, and chronic kidney failure. Insulin doses were not recorded or reconciled by physician, nursing, or pharmacy staff at the time of admission and through the preceding ED care. A faxed admission order for insulin written by the admitting physician on 1/25/10 at 3:30 p.m. documented a combination short and long-acting insulin product to be administered twice daily. The evening dose appeared to read as 60 units of 70/30 Novolin (combination insulin) with dinner, and an illegible amount to be administered with breakfast. The illegible morning insulin dose was not clarified by the nurse or pharmacist with the ordering physician. Instead, the admitting nurse asked the patient what her usual dose of insulin was, and transcribed the order as 46 units for the morning dose. Patient 34's blood sugars were documented as 297 mg/dl and 364 mg/dl in the ED on 1/25/10 with no documented insulin administration. (Lab normal range was 70-120 mg/dl) The record documented that Patient 34 was admitted to the inpatient unit at 5:15 p.m. and consumed 80% of dinner at 6:52 p.m. At 9:05 p.m. a fingerstick blood sugar was recorded as 360 mg/dl. Ten units of short acting insulin was administered. At 9:30 p.m., the "dinner" dose of combination insulin, 46 units, was administered. No additional food intake was recorded and the nurse did not notify the physician of the late administration of insulin.

Review on 1/27/10 at 9:45 a.m. of the care plans for Patient 34 on admission on 1/25/10 indicated no nursing care plan for diabetic management, blood sugar measurement monitoring, tracking of meal consumption, nutrition, or monitoring for signs and symptoms of high or low blood sugars.

In an interview with RN 10 on 1/29/10 at 3:30 p.m., RN 10 indicated that nursing staff chose care plans from an electronic menu following the admission assessment, and updated the selections as care needs arose. On 1/25/10, the menu included a selection titled "Endocrine" (adjective for glands that secrete directly into the blood system) which included some aspects of diabetes (a disease) care (but not monitoring for signs and symptoms of high or low blood sugar). RN 10 confirmed that Patient 34's care plans did not include "Endocrine" or any specific plan to address diabetic care or insulin administration. After the low blood sugar episode for Patient 34, the electronic menu was amended to "Diabetes/Endocrine" and added a provision for monitoring signs and symptoms of high or low blood sugar.

Review on 1/29/10 at 3 p.m. of a policy titled "Admission Nursing Assessment and Data Base," revised 8/03 indicated that "the Standard of Care will be individualized to the specific patient by selecting appropriate Nursing Diagnosis and/or diagnosis related components."

Elements of a care plan were addressed in a policy titled "Clinical Decision Making," issued 10/05, which emphasized "the importance of individualizing each patient's plan of care." The plan of care "is reassessed on a continual basis as indicated by changes in patient condition, diagnostic test results, assessment, and patient input."

Based on observation, interview, clinical record and facility document review, the hospital failed to administer medications in accordance with physician orders and facility policy for 2 of 31 sampled patients (Patients 33 and 34). This failure contributed to an adverse drug reaction (critically low blood sugar of 37 mg/dl. requiring intravenous dextrose rescue interventions to stablize her blood sugar) for Patient 34 and potential adverse drug reaction (sedation, low blood oxygen) for Patient 33.

1. Patient 34's insulin was not administered as ordered by the physician on two separate occasions.
2. Patient 33's Norco 10/325 (a narcotic-containing pain medication) was not administered according to facility policy.

Findings:

1. On 1/26/10, at 8:45 a.m., during an observation of medication administration, RN 1 was observed to draw up 60 units of Novolin 70/30 insulin into an insulin syringe and verify the dose with another licensed nurse. Novolin 70/30 insulin (also known as Insulin 70/30) is a mixture of 70% NPH insulin (an intermediate-acting insulin, indicated for the treatment of diabetes mellitus, which peaks in 6 to 12 hours) and 30% regular insulin (a short-acting insulin, indicated for the treatment of diabetes mellitus, which peaks in 0.8 to 2 hours). At 8:50 a.m., RN 1 injected the 60 units of Novolin 70/30 insulin subcutaneously (beneath the skin) into Patient 34's upper right arm. RN 1 then administered the remainder of Patient 34's morning (oral) medications with a cup of water and charted all medications administered on the MAR (Medication Administration Record). When asked when Patient 34 had eaten breakfast, RN 1 indicated that Patient 34 had just finished breakfast. There was no breakfast tray present in Patient 34's room.

At 9:30 a.m., a reconciliation (to confirm physician orders were followed) of observations made during the medication pass with Patient 34's current Physician Orders revealed a FAX'd admission order (handwritten by Patient 34's physician), dated 1/25/09 (and timed 3:25 p.m.), for Insulin 70/30 [illegible] units at breakfast and 46 units at dinner.

Review of Patient 34's 1/26/10 printed MAR revealed that the morning dose of Insulin 70/30 indicated 60 units at breakfast, with an administration time of 7:30 a.m.

During an interview on 1/26/10 at 9:45 a.m. RN 10 confirmed that the morning dose of Insulin 70/30 on Patient 34's FAX'd admission Physician Orders was not legible, and that her Medication Form and emergency room Nurse's Notes and Physician Documentation did not specify the insulin doses that Patient 34 received at home. RN 10 further confirmed that Patient 34's nursing assessment notes on admission did not indicate that her physician had been contacted to clarify the intended morning dose of Insulin 70/30, but that the admitting nurse (RN 2) had obtained the information from Patient 34. RN 10 confirmed that Patient 34's admission medication orders had been scanned to the inpatient pharmacy on 1/25/10 at 5:20 p.m.

According to Institute of Safe Medication Practices (ISMP), a nationally recognized organization that promotes the safe use of medication in healthcare facilities, insulin is considered a high-risk, high alert medication in its 2008 comprehensive list due to the heightened potential for significant patient harm. ISMP recommends healthcare facilities utilize special safeguards to reduce the risk of insulin adverse effects.

During an interview on 1/26/10 at 12:25 p.m. the Director of Pharmacy (DOP) and RPh 1 confirmed that the morning dose of Insulin 70/30 on Patient 34's FAX'd admission Physician Orders was not legible. The DOP indicated that Patient 34's admission medication orders were entered into the pharmacy computer by the technician on 1/25/10 at 5:27 p.m. and verified by RPh 2 at 5:37 p.m. During a concurrent interview, RPh 2 stated that, on 1/25/10, she did question the legibility of Patient 34's morning Insulin 70/30 order, and called the nurse, who had verified the insulin dose with the patient. RPh 2 acknowledged that she did not call Patient 34's physician to verify the morning dose of Insulin 70/30.

Review of the facility policy, "Medication Distribution - Inpatient," dated 5/03, revised 8/09, indicated under item 7a. Clarification of Unclear Orders, "Any prescriber's order that is not legible or clear in intent or rationality as applied to standard practices and literature will be clarified with the prescriber. The Physician will review any illegible orders with the Primary Nurse prior to leaving the nursing unit. Any clarifications will be written on the Physicians Order Sheet as 'Clarification of Order:..' and signed by the physician or the nurse transcribing the clarification. If the order is still unclear to the pharmacist, the pharmacist will contact the physician directly, or as applicable, will contact the transcriber of a verbal or telephone order for clarification."

During a follow-up interview on 1/27/10 at 9 a.m. the DOP confirmed that Patient 34's Insulin 70/30 was administered after breakfast on 1/25/10 (at 8:50 a.m.), not with breakfast as per the Physician's Order, and therefore was a medication error.

Review of the facility policy, "Medication Administration Times," dated 3/17/03, revised 11/06, indicated under item C2, Administration Times, Medication Specific Exceptions, F. Oral Hypoglycemics, Insulin, and Carafate, BID, 0730 and 1730."

Review of the facility policy, "Medication Errors," dated 5/95, revised 1/09, indicated under item B1, "A medication error is defined as a dose administered differently than ordered by the physician as recorded on the patients medical record," and under item B1h, "Wrong time: Administration of a dose more than 60 minutes before or after the scheduled administration time. Additional parameters: Drugs ordered before meals or on an empty stomach should be given before food and within 30 minutes of the scheduled time; drugs ordered with food should be given within 30 minutes of the scheduled time."

a. On 1/27/10, further review of Patient 34's clinical record revealed that, on 1/25/10 (the evening of her admission), the night shift nurse (RN 3) had assessed a fingerstick blood sugar of 360 mg/dL and had administered 10 units of regular insulin (according to the moderate sliding scale prescribed). At 9:30 p.m., RN 3 administered 46 units of Insulin 70/30 subcutaneously (the dose that had been prescribed at dinner).

During an interview on 1/28/10 at 2:40 p.m. RN 2 (who had processed Patient 34's admission the afternoon of 1/25/10) confirmed RPh 2 had contacted her via telephone regarding the illegibility of Patient 34's morning Insulin 70/30 dosage on the Physician Orders. RN 2 further confirmed that she had asked Patient 34 regarding her current insulin doses, but did not verify this information when the physician was called that evening. RN 2 indicated that she did not administer Patient 34's dose of insulin at dinner at 6 p.m. because she did not have a current fasting FSBS assessment and did not note that the insulin was to be given at dinner.

During an interview on 1/29/10 at 10 a.m. RN 3 (who was working the night shift following RN 2's 1/25/10 shift) indicated that Patient 34 ate well during the dinner meal of 1/25/10 and also consumed a snack at bedtime. RN 3 confirmed the administration of 10 units of regular insulin at 9:05 p.m. and further indicated since Patient 34's bedtime FSBS (of 360 mg/dL at 9:05 p.m. on 1/25/10) was elevated, that the additional dose of Insulin 70/30 46 units intended to be given at dinner (administered by RN 3 at 9:30 p.m.) would be acceptable. RN 3 acknowledged that she did not contact Patient 34's physician regarding the late administration of the Insulin 70/30 and she confirmed that the insulin was not given in accordance with the physician's order or facility policy.

2. Record review on 1/26/10 at 10:15 a.m. revealed that Patient 33 was a 70 year-old admitted to the facility on 1/25/10 with diagnoses including degenerative joint disease (right knee), gout (increased uric acid in the blood which may deposit in the bony joints and result in pain) and a history of hypoxia. Patient 33 had a surgical procedure on 1/25/10.

Review of Patient 33's "Patient Medication List," dated 1/25/10, revealed no opiate-type medications, indicating that Patient 33 was opiate naive (minimal to no history of receiving narcotic medications, has not built up a tolerance to narcotics).

Review of Patient 33's Physician Orders revealed an order (dated 1/26/10 at 7:25 a.m.) for hydrocodone 10 mg with acetaminophen 325 mg (an opiate containing pain medication indicated for moderate to severe pain), one to two tablets every 4 to 6 hours as needed for pain.

During a concurrent interview, RN 10 indicated that the nursing staff would select the administration of one tablet (containing 10 mg hydrocodone) or two tablets (containing 20 mg hydrocodone) based on whether or not a patient is opiate naive.

According to Institute of Safe Medication Practices (ISMP), a nationally recognized organization that promotes the safe use of medication in healthcare facilities, hydrocodone is considered a high-risk, high alert medication in its 2008 comprehensive list due to the heightened potential for significant patient harm.

Lexi-Comp ONLINE, a nationally recognized drug reference, indicated in its monograph regarding hydrocodone with acetaminophen, under "Geriatric Considerations," that the elderly may be particularly sensitive to the sedating effects of the medication. Under "Dosing: Geriatric" it recommends dosing of 2.5 to 5 mg hydrocodone every 4 hours. Under "Disease-related Concerns," it recommends using hydrocodone with extreme caution in patients with pre-existing respiratory compromise such as hypoxia, as critical respiratory depression may occur.

Review of Patient 33's 1/26/10 MAR revealed that RN 4 administered two hydrocodone 10 mg with acetaminophen 325 mg tablets at 9:40 a.m. (a total of 20 mg hydrocodone, four to eight times that recommended by Lexi-Comp) for a documented pain level of 5.

During an interview on 1/26/10 at 10:30 a.m. RN 4 indicated that Patient 33 had surgery (with a pain level of 5). RN 4 stated "were those 5 mg hydrocodone? No, 10 mg - well, he requested it after I informed him of the strength of the medication."

Review of the facility policy, "Medication, 'As Needed,' or PRN Range Orders," dated 10/05, under Procedure item 5: "Assess patient for need of PRN medication. When initiating new PRN range order, RN will start with the lowest dose in range to establish patient response to medication. Further dosing will be based on individual patient response."

During an interview on 1/28/10 at 4:40 p.m. the DOP acknowledged RN 4's non-adherence to the facility policy with regard to Patient 33's new PRN pain medication order for hydrocodone 10 mg with acetaminophen 325 mg.

Based on observations, staff interview, P&P and medical record review, the hospital failed to ensure that 2 of 2 registered nurses observed administering moderate sedation had demonstrated competencies documented specific to the nursing management of patients receiving conscious sedation in accordance with P&Ps and acceptable standards of practice (California Board of Nursing position statement on Consicious Sedation).

Findings:

On 1/25/10 at 2:10 p.m. RN 4 was observed in the OR room administering conscious sedation medications and providing monitoring for Patient 1, while a physician performed a pain procedure.

On 1/26/10 at 1:30 p.m. RN 5 was observed performing conscious sedation monitoring for Patient 3, while the physician performed endoscopic procedure in the Gastrointestinal procedure room.

The 1/29/10 personnel files reviewed for RN 4 and RN 5 showed no record of demonstrated competencies for moderate (conscious) sedation administration, rescue and monitoring.

The position statement titled Conscious Sedation by the California Board of Registered Nursing (BRN) retrieved at www.rn.ca.gov, in part, indicated: In administering medications to induce conscious sedation, the RN is required to have the same knowledge and skills as for any other medication the nurse administers ... National guidelines for administering conscious sedation should be consulted in establishing agency policies and procedures ...The institution should have in place a process for evaluating and documenting the RNs demonstration of the knowledge, skills, and abilities for the management of clients receiving agents to render conscious sedation. Evaluation and documentation of competency should occur on a periodic basis ..."

Review of the facility's P&P titled "Moderate and Deep sedation" (rev 08/09) indicated in section 5. Personnel Requirements, under item c., that "A qualified registered nurse or qualified physician must have the responsibility for medication administration and monitoring the patient's vital signs and level of consciousness during moderate sedation ...e. The registered nurse administering medications, monitoring and recovering the moderate sedation patient must demonstrate current competence in moderate sedation and advanced cardiac life support (ACLS or PALS, as appropriate)."

In a 1/29/10, 10:00 a.m. interview, the CNO stated that P&P for implementation of competencies in conscious sedation was under revision. Currently, there was no formal process to evaluate RNs competencies for medication administration that included moderate sedation administration, rescue and monitoring.

Based on staff interviews, medical record and document reviews, the hospital failed to ensure that verbal orders were accepted only by authorized personnel and in accordance with hospital policy and procedures for 4 of 31 patient records reviewed (Patients 24, 26, 41 and 42). For Patients 41 & 42, verbal orders were written by unqualified persons (RDs). For Patients 24 & 26, verbal orders were not signed by RNs as signatures were not legible or the "noted" and "read back & verified" boxes were blank .

Findings:

1. Patients 41 and 42

Review on 1/25/10 at 2:15 p.m. of the medical record for Patient 42 indicated that Patient 42 was 24 years old and was admitted to the hospital on 1/16/10 for a small bowel obstruction (blockage of small intestines). A TPN order set was documented by a physician on 1/19/10. The order set contained similar items as for Patient 41. An additional telephone order was accepted by a registered dietician on 1/24/10 at 1:20 p.m. to alter the chemical composition of the TPN solution and the rate of administration. The order was noted by a registered nurse on 1/24/10 at 1:35 p.m. and cosigned by a physician on 1/25/10 at 8:50 a.m.

Review on 1/25/10 at 3:30 p.m. of the medical record for Patient 41 indicated that Patient 41 was 71 years old and was admitted on 1/8/10 and readmitted to the hospital on 1/16/10 for complications of a diverting loop colostomy (bowel procedure that diverted the anatomical flow of stool to the front of the belly). On 1/10/10 orders were documented to administer total parenteral nutrition (TPN), an intravenous mixture of biochemical products intended to sustain bodily functions. The two-page preprinted order set resembled a treatment protocol for TPN. The orders included choices of mixtures with varying amounts of proteins (amino acids), sugar (dextrose), fats (lipids), salt chemicals (electrolytes), vitamins, trace elements, and medications (insulin). The orders also included lab test orders, chest x-ray, specialized intravenous catheter equipment selections, nursing assessment and monitoring parameters, blood sugar testing, and alternative intravenous solutions if needed. The order set was documented by a registered dietician (who was not a registered nurse) as a telephone order from a physician on 1/10/10 at 1:50 p.m. A registered nurse "noted" the orders on 1/10/10 at 2:10 p.m. and a physician cosigned the orders on 1/11/10 at 11 a.m.

In an interview with the Director of Nutrition Services (DNS) on 1/25/10 at 3:30 p.m., the DNS stated that the hospital dieticians can order the TPN and actually do this by documenting as a telephone order which the physician eventually approves with a cosignature.

In an interview with the Director of Pharmacy (DOP) on 1/26/10 at 1:45 p.m., the DOP was asked who had the authority to prescribe TPN. The DOP indicated that the Registered Dietician (RD) was responsible to select the macronutrients (proteins, fats, sugar concentrations) portion of the TPN, and the pharmacist (RPh) selected other additives (electrolytes, insulin, etc.). He said that there is a protocol and a hospital policy regarding who can take verbal orders which must be countersigned by a physician. The DOP indicated that he was very comfortable with the RD ordering macronutrients, stating "They are very good at it." He further indicated that the RD should not be selecting electrolytes/additives, as "Pharmacy does that part." He then stated, "The form is not that good; we are working on it." The DOP did not produce what he considered to be a TPN protocol during the survey.

In a review of the 2/22/07 Medical Staff Rules and Regulations on 1/26/10, Section B(1)(m) listed the requirements for treatment/medication orders: "a verbal order shall be considered to be in writing if dictated to a fully authorized person functioning within his/her sphere of competence." The Rules further documented, "Duly authorized persons who may receive verbal orders for treatments/medications are licensed vocational and registered nurses, physician's assistants, nurse practitioners, lab technicians, respiratory care practitioners, physical therapists, occupational therapists, medical imaging technicians and pharmacists." The Rules did not list registered dieticians as duly authorized persons who may accept verbal orders for treatments/medications.

According to a policy titled "Verbal & Telephone Orders," revised 9/05, under section II(B), "orders given verbally or by telephone shall only be given by a qualified physician, surgeon, dentist, podiatrist or other person duly licensed or authorized to prescribe by the State." Section C documented that such orders should only be "received and recorded by licensed, registered, or nationally certified health professionals provided that the orders received relate to the licensed, certified, or registered area of competence of the individual receiving the orders."

However, in a policy titled "Nutrition Support - TF/TPN," revised 11/6/08, the policy documented that "tube feedings (TF) and TPN (total parenteral nutrition) are ordered by the physician or by the registered dietitian (RD) by written, telephone or verbal order from the physician." The procedure documented, "the physician or RD under direction from the physician writes the nutrition support order in the medical record using the approved formulary."

Review on 1/26/10 of the California State Business & Professions Code (B&P) section 2586 (a) documented that the RD scope of practice was "on referral by a health care provider authorized to prescribe dietary treatment, provide nutritional and dietary counseling, conduct nutritional and dietary assessments, and develop nutritional and dietary treatments, including therapeutic diets. The services described in this subdivision may be termed 'medical nutritional therapy.'" The B&P Code did not list nursing assessment and monitoring, administration of intravenous biochemical compounds and medications, or care and management of intravenous catheters as part of the RD scope of practice.

B&P Section 2586 (b) documented, "A registered dietitian, or other nutritional professional meeting the qualifications set forth in subdivision (e) of section 2585, may accept or transmit verbal orders consistent with an established protocol to implement medical nutritional therapy."

B&P in section 2068 outlined what was meant by nutrition services as distinguished from the practice of medicine in this manner. "This chapter shall not be construed to prohibit any person from providing nutritional advice or giving advice concerning proper nutrition. However, this section confers no authority to practice medicine or surgery or to undertake the prevention, treatment, or cure of disease, pain, injury, deformity, or physical or mental conditions or to state that any product might cure any disease, disorder, or condition in violation of any provision of law. For purposes of this section the terms 'providing nutritional advice or giving advice concerning proper nutrition' means the giving of information as to the use and role of food and food ingredients, including dietary supplements."

In a review on 2/4/10 at 10 a.m. of the American Dietetic Association (ADA) website at url
a registered dietician was defined as a food and nutrition expert who has met academic and professional requirements including a bachelor's degree with course work in food and nutrition sciences, foodservice systems management, business, economics, computer science, sociology, biochemistry, physiology, microbiology and chemistry. Pharmacology, anatomy, pathophysiology, and medicine were not included in the requirements for a registered dietician. Although the ADA listed diseases and conditions including "parenteral" nutritional support as situations that benefit by RD services, the ADA defined "Medical Nutrition Therapy" as 1. performing a comprehensive nutrition assessment determining the nutrition diagnosis, 2. planning and implementing a nutrition intervention using evidence-based nutrition practice guidelines, and 3. monitoring and evaluating an individual's progress over subsequent visits with the RD. "During an MNT intervention, RDs counsel clients on behavioral and lifestyle changes required to impact long-term eating habits and health." The ADA did not include the management or prescribing of total parenteral nutrition as a task within the scope of an RD. The ADA list of position papers included no position for RDs to prescribe, adjust, or select the composition of TPN. A position paper dated October 2009 and titled "Integration of Medical Nutrition Therapy and Pharmacotherapy" discussed the interactions of RDs with other members of the health care team for patients with chronic health conditions amenable to lifestyle changes to minimize the need for prescription medications. The paper did not address any role for an RD to manage intravenous treatments and medications. A position paper dated December 2009 and titled "Nutrient Supplmentation" identified RDs as knowledgeable about nutrient supplements but referred only to oral vitamin and mineral products, not intravenous treatments and medications.

The State of California Business and Professions Code limits authority to prescribe treatments and medications to licensed physicians, physician assistants, and nurse practitioners (B&P 2053). Prescribers are required to carry medical malpractice insurance and obtain patient care privileges at the hospital. A registered dietician is not accountable to any California state licensure board (there is none).

In a review of Lexi-Comp ONLINE, a nationally recognized pharmaceutical reference, on 2/4/10 at 10 a.m. at url http://online.lexi.com/crlsql/servlet/crlonline, the citation for Total Parenteral Nutrition documented, "The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drugs which have a heightened risk of causing significant patient harm when used in error." Indications for use included "Infusion of nutrient solutions into the bloodstream to support nutritional needs during a time when patient is unable to absorb nutrients via the gastrointestinal tract, cannot take adequate nutrition orally or enterally, or have had (or are expected to have) inadequate oral intake for 7-14 days." Under Dosage Forms, "TPN is usually compounded from optimal combinations of macronutrients (water, protein, dextrose, and lipids) and micronutrients (electrolytes, trace elements, and vitamins) to meet the specific nutritional requirements of a patient." Thus, although TPN can be a form of nutrition, nutrition supplement, or nutrition treatment, TPN is considered a high risk medication available only by prescription.
Documented in a policy titled "Clinical Consultation Services," issued 3/5/08, was authorization for a number of dependent care practitioners, some licensed and some not, to "write orders pursuant to their specialty for the individualized care of patients. Clinicians performing consultation services at the request of a physician will enter the new order in the physician order section pursuant to their specific scope of practice."

In an interview with Administrative Staff 2 on 1/28/10 at 11:30 a.m., AS 2 indicated that treatment and medication orders were to be written and authorized only by members of the medical staff (physicians, physician assistants, nurse practitioners). AS 2 understood that certain licensed staff were permitted to accept verbal orders, such as licensed nurses, for treatments and medications. AS 2 was not aware that registered dieticians were authorized by the medical staff to write and accept medication orders, per the Nutrition Support and Clinical Consultation policies described above. AS 2 acknowledged that a registered dietician did not possess the education and training to understand the pathophysiology or various disease states that affect body biochemistry, or the interactions of various medications with TPN solutions, to order or reconcile TPN orders for an individual patient with a variety of unstable medical conditions.

In an interview on 1/26/10 at 9:40 a.m. with Administrative Staff 7, AS 7 indicated that clinical privileges were granted by the governing body and medical staff only to those practitioners listed on the medical staff roster. No registered dieticians were listed on the roster presented by AS 7 on 1/26/10.

2. Patients 24 and 26

Review of the medical record for Patient 24 on 1/27/10 at 5 p.m. indicated that Patient 24 was 50 years old and admitted to the hospital on 1/7/09 for liver failure and low blood sugar. On 1/8/09 at 11 a.m. a verbal order for intravenous solutions and oxygen monitoring was documented. Two registered nurse (RN) signatures appeared close to the order but not in the designated location for the authorized party to accept orders to document. The "Read Back & Verified" portion of the order was not checked.

Review of the medical record for Patient 26 on 1/27/10 at 5 p.m. indicated that Patient 26 was 28 years old and was admitted to the hospital on 11/11/09 and transferred on 11/16/09. Diagnoses included pneumonia, pandemic (nationwide) virus infection, ventilator (breathing machine) care, kidney failure, low and high blood pressure. On 11/14/09 at 5:30 a.m. a telephone order was documented by an illegible signature. The order included a medication for fungal infection, fungal culture, lab testing for a virus, tuberculosis skin test, blood gas test, and transfer to the intensive care unit. The "Read Back & Verified" portion of the order was not checked.

The patient record entries described above were confirmed by RN 10 in an interview on 1/28/10 at 5:15 p.m.

Review of a policy titled "Verbal & Telephone Orders," revised 9/05, under section III Procedure, documented, "The receiver of the verbal/telephone order must repeat the entire order to the prescriber (READ BACK)." Section IIIA7 directed staff to "indicate the order was verified (read back)."

Based on staff interview, medical record and document review, the hospital failed to ensure that all patient medical record entries were legible and complete for 5 of 31 patient records reviewed (Patients 23, 25, 26, 27, and 31).

Findings:

Review of the following patient records on 1/27/10 identified these problems:

1. Patient 31 was 71 years old and admitted to the hospital on 1/25/10 with diagnoses of congestive heart failure, leg pain and injury, insulin-dependent diabetes, and kidney failure. Medication reconciliation entries did not list Patient 31's previous insulin doses or last dose given (in either physician or nursing notes) in both the Emergency Department and Inpatient Unit. A History and Physical was not documented in the record within 24 hours of admission. An admission insulin order for combination short and long-acting insulin was not legible. The order was not clarified with the physician by nursing or pharmacy staff. A medication error related to this order resulted in the patient experiencing a dangerously low blood sugar requiring rescue interventions.

2. Patient 25 was 20 months old and admitted to the hospital on 12/16/09 for respiratory distress and pneumonia. The dictated history and physical exam report was not signed. The discharge summary was not signed.

3. Patient 26 was 28 years old and admitted to the hospital on 11/11/09 and transferred on 11/16/09. Diagnoses included pneumonia, pandemic virus infection, ventilator care, kidney failure, low and high blood pressure. A dictated procedure note for right arterial line placement dated 11/15/09 was not signed. A dictated procedure note by a different provider for intubation dated 11/15/09 was not signed.

4. Patient 27 was 60 years old and admitted to the hospital on 1/28/10 for dizziness related to multiple sclerosis. The physical examination portion of the admission History and Physical was not documented.

5. Patient 23 was 56 years old and admitted to the hospital on 6/29/09 with diagnoses of weakness, alcoholic liver disease, low blood pressure, and kidney failure. Patient 23 expired on 7/8/09. A summary of hospital care by a physician (including the death) was not documented in the record.

The incomplete and illegible patient record entries described above were confirmed by RN 10 in an interview on 1/28/10 at 5:15 p.m.

Review of the 2/22/07 Medical Staff Rules and Regulations on 1/26/10 at 5 p.m. indicated the following requirements:

Section B(1)(a) The attending practitioner shall be responsible for the preparation of a complete and legible medical record for each patient. Components included summary of discharge note.

Section B(1)(b)(2) The History and Physical must include a complete physical exam.

Section B(1)(b)(3) For all patients admitted to an inpatient status, a dictated H&P must be performed within 24 hours of admission.

Section B(1)(k) A discharge summary shall be written or dictated on all medical records of patients hospitalized over 24 hours.

Section B(1)(o) The practitioner's orders and progress notes must be written clearly, legibly and completely. Orders which are illegible or improperly written will not be carried out until re-written or understood by the nurse.

Section B(1)(r) The patient's medical record shall be complete at the time of discharge ... [subject to actions at 7 and 14 days including suspension].

Based on staff interview, medical record and document review, the hospital failed to ensure a medical history and physical examination was completed and documented within 30 days prior to admission, or within 24 hours after admission, for 2 of 31 patient records reviewed (Patients 27 and 31).

Findings:

Review of patient records on 1/27/10 identified the following:

1. Patient 31 was 71 years old and admitted to the hospital on 1/25/10 with diagnoses of congestive heart failure, leg pain and injury, insulin-dependent diabetes, and kidney failure. A History and Physical was not documented in the record within 24 hours of admission.

2. Patient 27 was 60 years old and admitted to the hospital on 1/28/10 for dizziness related to multiple sclerosis. The physical examination portion of the admission History and Physical was not documented.

The patient record entries described above were confirmed by RN 10 in an interview on 1/28/10 at 5:15 p.m.

Review of the 2/22/07 Medical Staff Rules and Regulations on 1/26/10 at 5 p.m. indicated the following requirements:

Section B(1)(a) The attending practitioner shall be responsible for the preparation of a complete and legible medical record for each patient.

Section B(1)(b)(2) The History and Physical must include a complete physical exam.

Section B(1)(b)(3) For all patients admitted to an inpatient status, a dictated H&P must be performed within 24 hours of admission.

Based on staff interview, medical record and document review, the hospital failed to ensure that a discharge summary with outcome of hospitalization was documented in 1 of 31 patient records reviewed (Patient 23).

Findings:

Review on 1/27/10 at 6 p.m. of Patient 23's medical record indicated that Patient 23 was 56 years old and admitted to the hospital on 6/29/09 with diagnoses of weakness, alcoholic liver disease, low blood pressure, and kidney failure. Patient 23 developed infections and did not respond well to treatment. Patient 23 was found with tube feeding formula in her mouth and airway on 7/8/09 but did not respond to treatment and expired. A summary of hospital care by a physician (including the death) was not documented in the record.

In an interview with RN 10 on 1/28/10 at 5:15 p.m., RN 10 confirmed the lack of a documented discharge or death summary in the record for Patient 23.

Review of the 2/22/07 Medical Staff Rules and Regulations on 1/26/10 at 5 p.m. indicated in Section B(1)(k), "A discharge summary shall be written or dictated on all medical records of patients hospitalized over 24 hours."

Based on observation, interview, record and facility document review, the facility failed to ensure that pharmaceutical services met the needs of the patients as policies and procedures to provide safe and effective use of drugs were not implemented as evidenced by the following:

A. Medications were administered in accordance with the order of the practitioner and facility policy (refer to A-0404).

B. Annual clinical and job-related competencies were updated for pharmacists and pharmacy technicians (refer to A-0492).

C. The facility had accountability procedures in place to ensure control of the use and disposition of scheduled drugs (refer to A-0494).

D. Medications were controlled distributed and administered to provide patient safety as evidenced by: not having a system in place to identify real or potential medication therapy issues, not following their policies and procedures for medication reconciliation, clarification of physician orders, care planning, medication and narcotic administration, and readily available diluent for malignant hyperthermia treatment according to standard of practice (refer to A-0500).

E. The facility developed effective reporting systems for the identification of medication errors and adverse drug reactions (refer to A-0508).

The practice constituted an Immediate Jeopardy by placing patients and others at risk for harm. The Immediate Jeopardy was called on 1/27/10 at 2:30 p.m. with the CEO and other administrative staff members present. The IJ was abated on 1/29/10 at 2:30 p.m., prior to the exit conference, with VP of Nursing, VP of Operations and other administrative staff present, after the facility presented and implemented a written acceptable plan of correction, confirmed by the surveyors' interviews with staff and document review.

The cumulative effect of these systemic problems resulted in the hospital's inability to comply with the statutorily-mandated Condition of Participation for Pharmaceutical Services to ensure the provision of quality health care in a safe environment.

Based on interview and document review the facility failed to ensure annual clinical and job-related competencies were updated for 4 of 4 pharmacists and 2 of 7 pharmacy technicians files reviewed.

Findings:

On 1/28/10, beginning at 10:55 a.m., a review of pharmacist and pharmacy technician competencies was performed with the DOP (Director of Pharmacy) and RPh 1.

RPh 1 explained that, for pharmacists and technicians, a Direct Observation Checklist was performed annually with regard to Operations, I.V. Admixture Aseptic Technique (technique to prevent contamination) and TPN Preparation/Aseptic Technique. In addition, pharmacists and technicians take separate annual exams consisting of Competency Testing Questions. RPh 1 explained that the answers to the exam questions are reviewed as a group, but not scored.

Review of the facility policy, "Performance Evaluations and Competency Assessments," dated 10/00, revealed under Performance Evaluations: "The Director of Pharmacy or a designee shall evaluate the performance of each individual periodically (preferably annually). Under Requirements for Competency Assessment: The department shall define specific tasks needed to perform a job function and identify qualifications of staff who perform these functions. Competency requirements shall be updated when work processes change as a result of performance improvement activities, new developments in health care and changing patient care needs."

Review of the pharmacy technicians' competency files revealed that, of the seven reviewed, two of the files did not have Direct Observation Checklists completed; the Competency Testing Questions (not dated) were completed.

Review of the pharmacists' competency files revealed that, of the four reviewed, none had completed Direct Observation Checklists (for Operations, I.V. Admixture Aseptic Technique, or TPN Preparation/Aseptic Technique) completed (but not dated) the Competency Testing Questions.

Based on observation, interview and record review the facility failed to have accountability procedures in place to ensure control of the use and disposition of a scheduled drug for 1 of 31 sampled patients (Patient 32).

Findings:

On 1/25/10 1:55 p.m. a review of the 2009 fentanyl (an opiate medication classified as a Schedule II controlled substance under the Federal Comprehensive Drug Abuse Prevention and Control Act of 1970) transdermal (applied to the skin) patch usage with the DOP (Director of Pharmacy) revealed that a licensed nurse removed three fentanyl 50 mcg patches from the medication automated dispensing cabinet (ADC, a computer controlled robotic device for medication storage and distribution) for Patient 32 on 8/8/09 at 12:18 p.m.. On 8/9/09 (at 10:10 a.m., less than 24 hours after the previous ADC removal), two more fentanyl 50 mcg/hr patches were removed from the same ADC by a second licensed nurse.

According to Institute of Safe Medication Practices (ISMP), a nationally recognized organization that promotes the safe use of medication in healthcare facilities, fentanyl is considered a high-risk, high alert medication in its 2008 comprehensive list due to the heightened potential for significant patient harm. ISMP recommends healthcare facilities utilize special safeguards to reduce the risk of fentanyl adverse effects.

Lexi-Comp ONLINE, a nationally recognized indicates in its monograph (essay) regarding fentanyl (narcotic pain medication), under "Chronic Administration, Frequency of Application," that frequency of application is usually every 72 hours.

Review of Patient 32's "Patient Medication Profile" (dated 8/7/09) indicated that she had an admission order for two fentanyl 75 mcg/hr patches (total of 150 mcg) every 72 hours.

Review of Patient 32's Physician Orders indicated an order (dated 8/8/09) to "Replace fentanyl patch 50 mcg/hr q 72 [hours] x 3 patches per dose."

Review of Patient 32's 8/8/09 MAR indicated that three 50 mcg/hr fentanyl patches were charted as administered by a licensed nurse at 12:30 p.m.

Review of Patient 32's 8/9/09 Physician Orders revealed no additional orders for fentanyl patches.

Review of Patient 32's 8/9/09 MAR indicated that a second licensed nurse charted two fentanyl 50 mcg/hr patches were applied on 10:15 a.m; the nurse indicated "pt. [patient] had only 1 patch on."

Review of Patient 32's nurses' notes revealed no additional information regarding the discovery of only one fentanyl patch observed the morning of 8/9/09 or the re-application of two patches.

During an interview on 1/25/10 beginning at 1:55 p.m. the DOP indicated that ADC override reports are not run daily, and therefore he was unable to go back to determine why (based on every 72 hour dosing) two 50 mcg/hr fentanyl patches were removed from the ADC for Patient 32 on 8/9/09 (less than 24 hours after the previous ADC removal). The DOP stated, since 3 [patches] were removed on 8/8/09, the [ADC brand name] should have blocked the nurse." The DOP was unable to explain why Patient 32 was discovered to only have one fentanyl patch the morning of 8/9/09, as three were applied on 8/8/09. No further information was provided regarding facility action taken pursuant to this discovery.

Review of the facility policy, "Medication Distribution - [ADC brand name]," dated 10/02, revised 3/09, indicated under N. Controlled Substances, item 2: "This health care facility has the overall responsibility for controlled substances. The Director of Pharmacy, acting as the facility's agent, shall ensure that the distribution and administration of controlled substances are documented adequately by the pharmacy, nursing and other services in accordance with Federal laws and the laws of the State of California. They shall ensure that adequate security of controlled substances shall be provided."

During an interview on 1/26/10 at 11:35 a.m. the DOP explained that he was made aware of the 8/9/09 ADC withdrawal of two 50 mcg fentanyl patches for Patient 32 by way of a medication error report RN 10 had generated on 8/9/09 related to this incident. The DOP then indicated that the two fentanyl patches would not have shown up on an override report based on the default "After remove/admin same Med, wait for" on the ADC being pre-programmed to zero (meaning the ADC does not restrict medication removal by licensed nurses to fixed dosing intervals based on prescribed medication orders). The DOP, who acknowledged that he is responsible for pre-programming the ADC settings, added, "Therefore, the nurse could go back in 10 minutes and withdraw more fentanyl patches. I need to fix that. "

The DOP acknowledged that he did not have a system in place for performing random audits to evaluate appropriateness of use, rule out medication errors, or identify the possibility of misuse of controlled substances.

Based on observation, interview, clinical record and facility document review, the hospital failed to ensure delivery of drugs were controlled and distributed in accordance with acceptable standards of practice. The facility's pharmacist, in consultation with appropriate staff, failed to develop and/or implement guidelines, protocols and policies and procedures for provision of pharmaceutical services that ensured safe administration of medications when:

1. The facility failed to promote safe use of insulin (high risk medication) which resulted in an episode of dangerous low blood sugar for 1 of 31 sampled patients (34). Nursing and pharmacy staff did not clarify and evaluate a physician's order for insulin. Patient 34 experienced a blood sugar of 37 mg/dl.(critically low, normal = 70-120mg/dl.) and required rescue interventions of orange juice and intravenous injection of a 50% sugar solution (D50) to stabilize her blood sugar. The P&Ps for medication reconciliation, clarifying of illegible medication orders and medication administration were not followed. The hospital failed to develop and/or implement policies and procedures regarding care planning and dietary considerations.

The above failures constituted an Immediate Jeopardy by placing patients and others at risk for harm. The Immediate Jeopardy was called on 1/27/10 at 2:30 p.m. with the CEO and other administrative staff members present. The facility presented an acceptable POC and the IJ was abated on 1/29/10 at 2:30 p.m., prior to the exit conference, with the VP of Nursing, the VP of Operations and other administrative staff present.

2. The facility failed to provide patient safety by following facility policy regarding narcotic administration for Patient 33.

3. The facility failed to provide patient safety by ensuring that standards of practice were adhered to regarding safe administration of Dantrium (a medication indicated for malignant hyperthermia, a medical emergency) in the OR (operating room).

Findings:

1. Review on 1/27/10 at 9:45 a.m. of the medical record for Patient 34 with RN 10 (a nursing administrative staff member) indicated that Patient 34 was 71 years old and was admitted to the hospital on 1/25/10 at approximately 5:15 p.m. from the emergency room (ED). Patient 34's diagnoses included leg pain and crush injury, congestive heart failure, insulin-dependent diabetes, and chronic kidney failure. Home insulin doses were not recorded or reconciled by physician, nursing, or pharmacy staff at the time of admission nor during the preceding ED care. An admission history and physical exam was not documented in the patient record within 24 hours of admission. A faxed medication order for insulin, written by the admitting physician on 1/25/10 at 3:30 p.m., documented that a combination rapid acting and intermediate acting insulin product was to be administered twice daily. The evening dose appeared to read as 46 units of 70/30 Novolin with dinner, and an illegible amount to be administered with breakfast. 70/30 Novolin insulin is an intermediate-acting combination insulin product containing both insulin regular and insulin NPH with a more rapid onset than that of insulin NPH alone; onset of action is 0.5 hours, peak effect 2-12 hours, duration of action 18-24 hours according to Lexi-comp Online (a nationally recognized drug reference, retrieved at http://online.lexi.com/crlsql/servlet/crlonline on 2/3/10 at 5 p.m.).

According to concurrent interviews with RN 2 on 1/28/10 at 2:40 p.m. and Registered Pharmacist (RPh 2) on 1/26/10 at 12:25 p.m., the illegible morning insulin dose was not clarified by RN 2 or RPh 2 with the ordering physician. Instead, RN 2 asked the Patient 34 what her usual dose of insulin was at home, and transcribed the order as 60 units of 70/30 Novolin for the morning dose.

Patient 34's blood sugars were documented as 297 mg/dl and 364 mg/dl (the lab normal range was 70-100 mg/dl) in the emergency department on 1/25/10 with no documented insulin administration. The record documented that Patient 34 was admitted to the inpatient unit at 5:15 p.m. and consumed 80% of dinner at 6:52 p.m. At 9:05 p.m. a fingerstick blood sugar was recorded as 360 mg/dl. Ten units of rapid acting insulin was administered. At 9:30 p.m., the "dinner" dose of intermediate acting combination insulin, 46 units, was administered. No additional food intake was recorded and the nurse did not notify the physician of the late administration of insulin (per interview with RN 3 on 1/29/10 at 10 a.m.).

At 7 a.m. on 1/26/10, the diabetic flow sheet documented a blood sugar of 83 mg/dl (low). Breakfast consumption was recorded as 80% at 8:53 a.m.

At 11:45 a.m. the diabetic flow sheet documented a blood sugar of 70 mg/dl. Lunch consumption was documented as 10% at 1:50 p.m. The diabetic flow sheet documented a blood sugar of 37 mg/dl (extremely low) at 1:45 p.m. Nursing notes described Patient 34 as "sweating, feeling faint, weakness. Patient mumbling and unable to keep eyes open. Fingerstick checked and is 37. OJ (orange juice) 240 mls (8 ounces) given."

Subsequent blood sugar measurements were documented between 2:15 p.m. and 2:35 p.m. as 57, 59, and 64 mg/dl. At 2:35 p.m. "D50 1/2 amp" (an intravenous sugar solution to rescue the patient from low blood sugar) was administered. At 2:50 p.m. the blood sugar was recorded as 184 mg/dl with the patient feeling better, no sweating, still some fatigue." A physician progress note dated 1/26/10 at 2:25 p.m. documented "70/30 Insulin. Hypoglycemia (low blood sugar) due to [upward pointing arrow] dose than patient normally takes."

According to Institute of Safe Medication Practices (ISMP), a nationally recognized organization that promotes the safe use of medication in healthcare facilities, insulin is considered a high-risk, high alert medication in its 2008 comprehensive list due to the heightened potential for significant patient harm. ISMP recommends healthcare facilities utilize special safeguards to reduce the risk of insulin adverse effects.

Lexi-Comp ONLINE, a nationally recognized drug reference, indicates that insulin should be used with caution in patients with renal impairment/insufficiency, and recommends close monitoring of blood sugars. The most common adverse effect of insulin is hypoglycemia. Profound and prolonged episodes of hypoglycemia may result in convulsions, unconsciousness, temporary or permanent brain damage, or even death.

The following are details of the multiple failures to follow pharmacy related P&Ps to ensure safe use of insulin:

On 1/26/10, at 8:45 a.m., during an observation of medication administration, RN 1 was observed to draw up 60 units of Novolin 70/30 insulin into an insulin syringe, verify the dose with another licensed nurse, and administer the dose subcutaneously (beneath the skin) to Patient 34. Novolin 70/30 insulin (also know as Insulin 70/30) is a mixture of 70% NPH insulin (an intermediate-acting insulin, indicated for the treatment of diabetes mellitus, which peaks in 6 to 12 hours) and 30% regular insulin (a short-acting insulin, indicated for the treatment of diabetes mellitus, which peaks in 0.8 to 2 hours). There was no breakfast tray present in Patient 34's room.

At 9:30 a.m., a reconciliation of observations made during the medication pass with Patient 34's current Physician Orders revealed a FAX 'd admission order (handwritten by Patient 34's physician), dated 1/25/09 (and timed 3:25 p.m.), for Insulin 70/30 [illegible] units at breakfast and 46 units at dinner.

Further clinical record review revealed that Patient 34's Patient Medication Form (which reflected her medications taken at home, was dated 1/25/10, and had not yet been dated or signed by her physician), did not specify the dose of Insulin 70/30 to be administered. Review of Patient 34's Nurse's Notes and Physician Documentation (from her ED assessment date of 1/25/10), under "Home Meds," revealed that the dose of Insulin 70/30 was not specified, nor did the document indicate the last dose received.

Review of the facility policy, "Medication Reconciliation," dated 9/1/05, indicated under Purpose, "To obtain, update and retain and accurate list of medications according to the physician's pre-hospital, admission, transfer, and/or discharge orders to increase patient safety and decrease potential and actual medication adverse drug events (ADEs)." Item 1, Hospital Procedure, indicated "The medication history may be obtained from the patient and/or family members who are present at the time of admission. The nurse should determine if they are reliable historians. If the patient or family is able to provide accurate data, no additional source of information is required." Under item 1a., "In those cases when a patient and family are not considered to be a reliable source of information alternative sources must be located."

During an interview on 1/26/10 at 9:45 a.m. RN 10 confirmed that the morning dose of Novolin 70/30 insulin on Patient 34's FAX'd admission Physician Orders was not legible, and that her Medication Form and ED Nurse's Notes and Physician Documentation did not specify the insulin doses that Patient 34 received at home. RN 10 further confirmed that Patient 34's nursing assessment notes on admission did not indicate that her physician had been contacted to clarify the intended morning dose of Novolin 70/30 insulin, but that the admitting nurse (RN 2) had obtained the information from Patient 34. RN 10 confirmed that Patient 34's admission medication orders had been scanned to the inpatient pharmacy on 1/25/10 at 5:20 p.m.

During an interview on 1/26/10 at 10 a.m. RN 1 indicated that Patient 34 was "probably not a good historian" regarding the insulin doses that she had received at home.

During an interview on 1/26/10 at 10:55 a.m. Patient 34 indicated that she usually self-administered her insulin twice daily at home according to her blood sugar readings, and kept a book at her home; she further indicated that if her blood sugar readings were "OK," she did not administer any insulin. Some days, she did not take insulin at all. She could not state what a typical dose of insulin was in the week prior to admission.

Review of the facility policy, "Medication Distribution - Inpatient," dated 5/03, revised 8/09, indicated under item 7a. Clarification of Unclear Orders, "Any prescriber's order that is not legible or clear in intent or rationality as applied to standard practices and literature will be clarified with the prescriber. The Physician will review any illegible orders with the Primary Nurse prior to leaving the nursing unit. Any clarifications will be written on the Physicians Order Sheet as 'Clarification of Order:..' and signed by the physician or the nurse transcribing the clarification. If the order is still unclear to the pharmacist, the pharmacist will contact the physician directly, or as applicable, will contact the transcriber of a verbal or telephone order for clarification."

During an interview on 1/26/10 at 12:25 p.m. the Director of Pharmacy (DOP) and RPh 1 confirmed that the morning dose of Novolin 70/30 insulin on Patient 34's FAX'd admission Physician Orders was not legible. The DOP indicated that Patient 34's admission medication orders were entered into the pharmacy computer by the technician on 1/25/10 at 5:27 p.m. and verified by RPh 2 at 5:37 p.m. During a concurrent interview, RPh 2 stated that, on 1/25/10, she did question the legibility of Patient 34's morning Novolin 70/30 insulin order, and called the nurse, who had verified the insulin dose with the patient. RPh 2 acknowledged that she did not call Patient 34's physician to verify the morning dose of Novolin 70/30 insulin.

Review of the facility policy, "Medication Administration Times," dated 3/17/03, revised 11/06, indicated under item C2, Administration Times, Medication Specific Exceptions, F. Oral Hypoglycemics, Insulin, and Carafate, BID, 0730 and 1730."

Review of the facility policy, "Medication Errors," dated 5/95, revised 1/09, indicated under item B1, "A medication error is defined as a dose administered differently than ordered by the physician as recorded on the patients medical record," and under item B1h, "Wrong time: Administration of a dose more than 60 minutes before or after the scheduled administration time. Additional parameters: Drugs ordered before meals or on an empty stomach should be given before food and within 30 minutes of the scheduled time; drugs ordered with food should be given within 30 minutes of the scheduled time."

During a follow-up interview on 1/27/10 at 9 a.m. the DOP confirmed that Patient 34's Novolin 70/30 insulin was administered after breakfast on 1/25/10 (at 8:50 a.m.), not with breakfast as per the Physician's Order, and therefore was a medication error. The DOP further indicated that Patient 34 had a hypoglycemic episode on 1/26/10 at approximately 2 p.m. requiring the administration of a reversal agent (50% dextrose, a sugar solution) intravenously (injected into the vein). The DOP provided a copy of the automated dispensing cabinet (a computer controlled robotic dispensing device) "Profile Override" report indicating that RN 1 removed a vial of 50% dextrose solution on 1/26/10 at 2:33 p.m.

The above failures constituted an Immediate Jeopardy by placing patients and others at risk for harm. The Immediate Jeopardy was called on 1/27/10 at 2:30 p.m. with the CEO and other administrative staff members present. The facility presented an acceptable POC and the IJ was abated on 1/29/10 at 2:30 p.m., prior to the exit conference, with the VP of Nursing, the VP of Operations and other administrative staff present.

2. Record review on 1/26/10 at 10:15 a.m. revealed that Patient 33 was a 70 year-old admitted to the facility on 1/25/10 with diagnoses including degenerative joint disease (right knee), gout (increased uric acid in the blood which may deposit in the bony joints and result in pain) and a history of hypoxia (low blood oxygen). Patient 33 had a surgical procedure 1/25/10.

Review of Patient 33's "Patient Medication List," dated 1/25/10, revealed that he was receiving no opiate-type medications, indicating that Patient 33 was opiate naive.

Review of Patient 33's nursing assessment, entered 1/26/10 at 9:40 a.m., indicated that he was a "definite fall risk." A nursing note entered 1/25/10 at 11:30 a.m. indicated that he had a history of falls.

Review of Patient 33's Physician Orders revealed an order, dated 1/26/10 at 7:25 a.m., for hydrocodone 10 mg with acetaminophen 325 mg (an opiate containing pain medication indicated for moderate to severe pain), one to two tablets every 4 to 6 hours as needed for pain.

During a concurrent interview, RN 10 indicated that the nursing staff would select the administration of one tablet (containing 10 mg hydrocodone) or two tablets (containing 20 mg hydrocodone) based on whether or not a patient is opiate naive.

According to Institute of Safe Medication Practices (ISMP), a nationally recognized organization that promotes the safe use of medication in healthcare facilities, hydrocodone is considered a high-risk, high alert medication in its 2008 comprehensive list due to the heightened potential for significant patient harm.

Lexi-Comp ONLINE, a nationally recognized drug reference, indicated in its monograph regarding hydrocodone with acetaminophen, under "Geriatric Considerations," that the elderly may be particularly sensitive to the sedating effects of the medication. Under "Dosing: Geriatric" it recommends dosing of 2.5 to 5 mg hydrocodone every 4 hours. Under "Disease-related Concerns," it recommends using hydrocodone with extreme caution in patients with pre-existing respiratory compromise such as hypoxia, as critical respiratory depression may occur.

Review of Patient 33's 1/26/10 MAR revealed that RN 4 administered two hydrocodone 10 mg with acetaminophen 325 mg tablets at 9:40 a.m. (a total of 20 mg hydrocodone, four to eight times that recommended by Lexi-Comp) for a documented pain level of 5.

Continued review of Patient 33's clinical record revealed that on 1/26/10, at 9:40 a.m., RN 4 assessed an oxygen saturation of 87% on room air (normal range is 95 to 100%). Oxygen saturation is determined with a pulse oximeter (a medical device used to measure the oxygenation of the blood by clamping to the finger) and indicates the percentage of hemoglobin (a component of the red blood cell) saturated with oxygen at the time of the measurement. RN 4 provided Patient 33 oxygen via nasal cannula at a rate of 2 liters per minute. At 9:45 a.m., RN 4 obtained a Physician Order for a chest x-ray for the clinical indication of "postop hypoxia."

Review of the facility policy, "Medication, 'As Needed,' or PRN Range Orders," dated 10/05, under Procedure item 5: "Assess patient for need of PRN medication. When initiating new PRN range order, RN will start with the lowest dose in range to establish patient response to medication. Further dosing will be based on individual patient response."

During an interview on 1/28/10 at 4:40 p.m. the DOP acknowledged RN 4's non-adherence to the facility policy with regard to Patient 33's new PRN pain medication order for hydrocodone 10 mg with acetaminophen 325 mg.

3. On 1/26/10 at 2:35 p.m. (accompanied by RPh 2, Tech 1 and an OR licensed nurse) an inspection of medication storage in the locked Anesthesia Room in the OR (operating room) area revealed a grey plastic tub containing 36 glass vials of dantrolene sodium 20 mg (in dry powder form), six 250 mL I.V. (intravenous) bags of sterile water for injection (total of 1500 mL), cardiac medications and supplies for mixing the dantrolene.

Malignant Hyperthermia Association of the United States (MHAUS), a not-for-profit association dedicated to the control of malignant hyperthermia (MH), indicated in its website (MHAUS.org) that MH is a rare but life-threatening genetic disorder (characterized by an increase in body temperature and muscle rigidity caused by certain general anesthetic medications). It further indicated that dantrolene should be kept in or close to the OR so that it is immediately available if MH occurs. A supply of sterile water for injection (without a bacteriostatic agent, or preservative) should be kept nearby to mix with dantrolene before injection (60 mL/vial). In its 1/27/10 updated guidelines, MHAUS recommended the use of 100 mL glass sterile water vials, not I.V. bags, to avoid the accidental administration of a hypotonic (lower salt concentration than in normal body cells or blood) solution.

According to manufacturer guidelines, each dantrolene sodium 20 mg vial should be mixed with 60 mL preservative-free sterile water for injection.

Based on the need for 60 mL of sterile water per vial, the amount of water needed to reconstitute (mix) 36 vials of dantrolene sodium 20 mg totaled 2160 mL (660 mL more than the 1500 mL the facility had readily available). Therefore, the facility had 30% less sterile water than was needed to reconstitute the 36 vials of dantrolene sodium.

During a concurrent interview, RPh 2 acknowledged that the facility did not have a sufficient volume of sterile water readily available to reconstitute the dantrolene sodium according to manufacturer and MHAUS guidelines.

Tech 1 stated "I need 750 mL more [3 bags of 250 mL)."

During an interview on 1/28/10 at 10:15 a.m. the DOP acknowledged that the facility did not have a sufficient volume of sterile water readily available to reconstitute 36 vials of dantrolene sodium when the supply was evaluated the afternoon of 1/26/10.

Based on interview and facility document review, the facility failed to develop effective reporting systems for the identification of medication errors and adverse drug reactions (ADRs) when:
1. The facility failed to evaluate possible adverse drug events for Patient 32 when 2 doses of a reversal agent (Narcan) were administered and there was no evidence that an ADR was evaluated or reported.

2. The facility failed to have a system in place for performing random audits to evaluate appropriateness of use, rule out medication errors, or identify the possibility of misuse of controlled substances.

Findings:

On 1/25/10, beginning at 10:35 a.m., during a discussion of medication errors and adverse drug reactions, the DOP (Director of Pharmacy) presented the 2009 Quarterly Pharmacy Workload Statistics for ADR/Med Error Reporting: 9.8 (first quarter); 15 (second quarter); 11 (third quarter) and 17 (4th quarter). The DOP explained that the current reporting system (implemented the middle of 2009) combines the data for all types of medication incidents.

The DOP further explained that adverse drug reactions are identified by an automated drug cabinet (a computer controlled robotic dispensing device) override for selected rescue drugs (medications used to reverse the effects of other medications). The DOP indicated that override reports for rescue drugs are reviewed daily by a pharmacist. The DOP further indicated that use of rescue medications is not monitored when patients have current orders including these medications.

Review of the facility policy titled "Adverse Drug Reactions," revised 6/06, indicated under Procedure: A. Definition of an Adverse Drug Reaction: A response to a medication that is undesired, unintended, or unexpected in doses recognized in accepted medical practice, that may require treatment with additional medication and resulting in one or a combination of the following: 1. Changing the drug; 2. Stopping the drug; 3. Reducing the drug; 4. Prolonging hospital stay; 5. Administration of another drug; 6. An effect complicating the diagnosed disease state (i.e., any untoward side effect, injury, toxicity, sensitivity reaction or significant failure of expected pharmacological action)." Under D. Pharmacy/Nursing Committee, the policy indicated "The committee will meet periodically to identify reactions that are significant and assist in identifying system problems, trends and possible solutions.

Record review on 1/25/10 revealed that Patient 32 was a 65 year-old admitted for observation on 8/7/09 at 7:02 p.m. with diagnoses including encephalopathy and chronic pain. Review of Patient 32's Physician Orders revealed admission orders for the following opiate medications fentanyl transdermal patch 150mg/hr every 72 hours, Percocet 10/325mg (an opiate medication containing 10mg oxycodone and 325mg acetaminophen) orally every 4 hours routinely and morphine sulfate 1mg intravenously (injected into the vein) every 3 hours as needed for pain. Patient 32 also had an order (dated 8/7/09) for Narcan 0.4mg intravenously every 15 minutes as needed for hypoxia (low blood oxygen), decreased alertness. Narcan is indicated for the reversal of opiate toxicity.

Review of Patient 32's Patient Medication Profile indicated that the following Narcan doses were signed out of the ADC on 8/7/09: Narcan 1mg at 7:07 p.m. and Narcan 0.4mg at 10:05 p.m. The DOP confirmed the administration of the Narcan doses. There was no evidence provided by the DOP that any of the Narcan doses administered were evaluated to rule out an adverse drug reaction.

During an interview on 1/28/10 beginning at 4:40 p.m. the DOP acknowledged that he is missing opportunities to evaluate ADR's because of solely evaluating ADC overrides, not patients with physician orders for rescue medications.

The DOP was evaluating rescue medications removed from the ADC by override. But there was no documented evidence that the facility had a system in place to evaluate use of rescue medications when they were associated with routine patient orders.

On 1/25/10 1:55 p.m. a review of the 2009 fentanyl (an opiate medication classified as a Schedule II controlled substance under the Federal Comprehensive Drug Abuse Prevention and Control Act of 1970) transdermal (applied to the skin) patch usage with the DOP revealed that a licensed nurse removed three fentanyl 50 mcg patches from the automated dispensing cabinet (ADC, a computer controlled robotic device) for Patient 32 on 8/8/09 at 12:18 p.m.. On 8/9/09 (at 10:10 a.m.), two more fentanyl 50 mcg/hr patches were removed from the same ADC by a second licensed nurse.

Review of Patient 32's Physician Orders indicated an order (dated 8/8/09) to "Replace fentanyl patch 50 mcg/hr q 72 [hours] x 3 patches per dose."

Review of Patient 32's 8/8/09 MAR indicated that three 50 mcg/hr fentanyl patches were charted as administered by a licensed nurse at 12:30 p.m.

Review of Patient 32's 8/9/09 Physician Orders revealed no additional orders for fentanyl patches.

During an interview on 1/25/10 beginning at 1:55 p.m. the DOP explained that the ADC override report for 1/09 - 12/09 did not reflect the early (based on every 72 hour dosing) removal of two 50 mcg/hr fentanyl patches for Patient 32. The DOP stated, "Since 3 [patches] were removed on 8/8/09, the [ADC brand name] should have blocked the nurse" from accessing the addiitional patches.

During an interview on 1/26/10 at 11:35 a.m. the DOP explained that he was made aware of the 8/9/09 ADC withdrawal of two 50 mcg fentanyl patches for Patient 32 by way of medication error report RN 10 had generated on 8/9/09 related to this incident. The DOP then indicated that the two fentanyl patches would not have shown up on an override report based on the default "lock-out setting" on the ADC being pre-programmed to zero (meaning the ADC does not restrict medication removal to fixed dosing intervals based on prescribed medication orders). The DOP, who acknowledged that he is responsible for pre-programming the ADC settings, added, "Therefore, the nurse could go back in 10 minutes and withdraw more fentanyl patches. I need to fix that."

During an interview on 1/28/10 beginning at 4:40 p.m. the DOP acknowledged that he is missing opportunities to evaluate medication errors due to inability to track medications given at the incorrect time as ordered by the physician.

The DOP acknowledged that he did not have a system in place for performing random audits to evaluate appropriateness of use, rule out medication errors, or identify the possibility of misuse of controlled substances.

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

A. Provide organized dietetic services as evidenced by findings of unsafe food handling practices. (Cross reference A-0620)

B. Ensure the activities of registered dieticians complied with medical staff bylaws and standards of practice (American Dietetic Association). (Cross Reference A-0620)

C. Ensure safe and effective food production practices were evaluated in the hospital wide infection control program. (Cross Reference A-0749)

The cumulative effect of these systemic problems resulted in the inability of the hospital's food and nutrition services to direct and staff in such a manner to ensure that the nutritional needs of the patients' were met in accordance with practitioner's orders and acceptable standards of practice and comply with the statutorily-mandated Condition of Participation for Dietary Services.

Based on observations, dietary staff interview, and document review, the hospital failed to ensure an organized department as evidenced by:
1. failure to ensure registered dietitians (RD) were performing their duties in accordance with Medical Staff bylaws and standards of practice (American Dietetic Association) when the hospital RD's were permitted to write and accept telephone orders for TPN (total parenteral nutrition) for 2 of 31 sampled residents (41, 42),
2. lack of accurate documentation of cool down,
3. lack of following manufacturer's directions for sanitizing kitchen bin ice machine,
4. sanitary storage of dry goods,
5. lack of staff practice (2 of 2 staff observed) for handwashing when changing disposable gloves and,
6. no QAPI program to address the dietary Department contracted services.

Findings:

1. Review on 1/25/10 at 2:15 p.m., and 3:30 p.m., of two patients (Patients 41 and 42) medical records showed TPN (total parenteral nutrition, intravenous administration of nutrients) orders written by the RD as a TO (telephone order).

Also, review of the policy (on 1/25/10) titled "Nutrition support -TF/TPN" showed "Tube feedings (TF) and TPN are ordered by the physician or by the registered dietitian (RD) by written, telephone order from the physician."

In an interview on 1/25/10 at 3:30 p.m., the Director of Nutrition Services (DNS) stated that the hospital RDs can order the TPN and do this with the TO order. The DNS stated that she was responsible for the organization of the Nutrition Services Department that included the writing and reviewing all department policies and the oversight of the policy implementation.

Review of the hospital 2/22/07 Medical Staff Rules and Regulations on 1/26/10 showed Section B(1)(m) listed the requirements for treatment/medication orders: "a verbal order shall be considered to be in writing if dictated to a fully authorized person functioning within his/her sphere of competence." The Rules further documented, "Duly authorized persons who may receive verbal orders for treatments/medications are licensed vocational and registered nurses, physician's assistants, nurse practitioners, lab technicians, respiratory care practitioners, physical therapists, occupational therapists, medical imaging technicians and pharmacists." The Rules did not list registered dieticians as duly authorized persons who may accept verbal orders for treatments/medications.

In a review on 2/4/10 at 10 a.m. of the American Dietetic Association (ADA) website at url
a registered dietician was defined as a food and nutrition expert who has met academic and professional requirements including a bachelor's degree with course work in food and nutrition sciences, foodservice systems management, business, economics, computer science, sociology, biochemistry, physiology, microbiology and chemistry. Pharmacology, anatomy, pathophysiology, and medicine were not included in the requirements for a registered dietician. Although the ADA listed diseases and conditions including "parenteral" nutritional support as situations that benefit by RD services, the ADA defined "Medical Nutrition Therapy" as 1. performing a comprehensive nutrition assessment determining the nutrition diagnosis, 2. planning and implementing a nutrition intervention using evidence-based nutrition practice guidelines, and 3. monitoring and evaluating an individual's progress over subsequent visits with the RD. "During an MNT intervention, RDs counsel clients on behavioral and lifestyle changes required to impact long-term eating habits and health." The ADA did not include the management or prescribing of total parenteral nutrition as a task within the scope of an RD. The ADA list of position papers included no position for RDs to prescribe, adjust, or select the composition of TPN. A position paper dated October 2003 and titled "Integration of Medical Nutrition Therapy and Pharmacotherapy" discussed the interactions of RDs with other members of the health care team for patients with chronic health conditions amenable to lifestyle changes to minimize the need for prescription medications. The paper did not address any role for an RD to manage intravenous treatments and medications. A position paper dated December 2009 and titled "Nutrient Supplmentation" identified RDs as knowledgeable about nutrient supplements but referred only to oral vitamin and mineral products, not intravenous treatments and medications.

Registered Dieticians are not allowed under standards of practice to write orders for TPN, a treatment considered a medication and not in the scope of the allowed medical nutrition therapy.

In an interview with the Director of Pharmacy (DOP) on 1/26/10 at 1:45 p.m., the DOP was asked who had the authority to prescribe TPN. The DOP indicated that the Registered Dietician (RD) was responsible to select the macronutrients (proteins, fats, sugar concentrations) portion of the TPN, and the pharmacist (RPh) selected other additives (electrolytes, insulin, etc.). He said that there is a protocol and a hospital policy regarding who can take verbal orders which must be countersigned by a physician. The DOP indicated that he was very comfortable with the RD ordering macronutrients, stating "They are very good at it." He further indicated that the RD should not be selecting electrolytes/additives, as "Pharmacy does that part." He then stated, "The form is not that good; we are working on it." The DOP did not produce what he considered to be a TPN protocol during the survey.

2. On 1/25/10 at 10:00 a.m., the "Food Cooling Log" dated from 11/12 to 12/26/09, was reviewed and showed the cooling time documented was approximately 4 hours from start to 37 to 38 degrees Fahrenheit (F) for soup items. The log directions stated "to ensure potentially hazardous foods are cooled from 140 degrees F to 70 degrees F in two hours, then to 40 degrees F in an additional two hours. Review of the policy, "Food Cooling Log," showed the initial safe cooling process was to be completed in a two hour time frame.

In an interview on 1/16/10 at approximately 8:30 a.m., the Dietary manager (DM), and written documentation of his review stated the staff used a blast chiller (device that rapidly cools food) to cool food items from 140 degrees to 34 degrees F in an average of 2 hours depending on the volume and the staff was logging the time the product remained in the blast chiller and not the actual cooling time. He acknowledged that the staff documentation of the cooling temperatures for 4 hours did not reflect safe control of temperatures.

Review of the policy "Food Cooling Log" revised 12/28/08 showed "the potentially hazardous food are cooled from a temperature of 140 degrees to 70 degree F within 2 hours and then from 70 degrees F to 40 degrees F or below in an additional 2 hours."

Neither the food cooling log policy nor the food cooling log directions reflected the staff practice of using the blast chiller to cool the food. The documentation did not show the food was cooled within the two hours as specified for safe food handling.

The documented temperatures for cooling food did not reflect the safe practice and policy that demonstrated the food was cooled in the required initial 2 hours. The food cooling policy did not reflect the practice of the blast chiller.

3. On 1/25/10 at 10 a.m., the cleaning and sanitizing procedure for the kitchen bin ice machine was reviewed. The DM stated food service staff using a quaternary ammonia product cleaned the ice machine bin.

Review of the ice machine manufacturers directions on 1/26/10 at 8:30 a.m., showed the manufacturer brand "sanitizer and cleaner are the only products approved for " for use in their brand ice machine. Manufacturer's directions were not followed to ensure sanitation and use of specifies products. The manufacturer did not specify the use of a quaternary ammonia in the cleaning or sanitizing of their ice machine.

4. On 1/25/10 during kitchen tour starting at 9 a.m., there were two open boxes of dried barely and peas observed on storeroom shelf. The lids were loosely covering the product but did not securely seal the top to prevent access from pests or vermin.

The DM indicated the packages could be taped shut to ensure the safety of the product form cross contamination.

The FDA (Food and Drug Administration) Food Code 2005 states "packaged food shall be protected from cross contamination.

5. On 1/27/10 at starting 11:30 a.m., two trayline staff engaged in serving food on the lunch trayline, were observed to change disposable gloves without washing hands.

The DM confirmed that the staff, although the gloves may not have been soiled, should wash hands any time the gloves are changed per department policy.

The FDA Food Code 2005 specifies food employees shall clean their hands and exposed portions of their arms: Before donning gloves for working with food.

6. During interview with the DNS on 1/27/10 at 2:30 p.m., contracts for dietary computer services, food purchases and vending contract were reviewed. The DNS stated that she did not know how the contracted services were evaluated in the QAPI program and she did not provide any information on the contract services to the department responsible for maintaining the contracts and hospital equipment.

Based on observation, staff interview, and document review the hospital failed to develop a hospital wide infection control program, when:

A. The hospital failed to develop a hospital wide infection control program for the maintenance of food sanitation policies and procedures and staff compliance with policies that prevented the potential for cross contamination and food borne illness. (Cross-reference to A-0749 and A-0620 #2)

B. The hospital failed to provide surgical services in accordance with acceptable standards of practice as related to infection control (cross reference to A-0940):

C. The hospital failed to ensure infection control measures were implemented for prevention of infections, when:
1. The hospital failed to develop effective Mycobacterium Tuberculosis (an organism of a specific bacteria family) surveillance program. The two-step TB (tuberculosis) testing was not performed for 2 of 2 traveler nurses used periodically in the hospital's ICU, and
2. The hospital failed to ensure flash sterilization was not used routinely.

D. The hospital failed to ensure that infection control policies were developed and implemented by the infection control officer to effectively control infections and communicable diseases in accordance with nationally recognized standards when medical staff members were exempt from complying with infection control training or health screening review. (cross reference to A 0748)

The cumulative effect of these systemic practices resulted in the failure of the hospital to deliver statutorily mandated compliance with the Condition of Participation for Infection Control, CFR?482.42 and placed all patients at risk for infections.

Findings:

C-1. According to the Communicable Disease Center (CDC) Guidelines for Preventing the Transmission of Mycobacterium tuberculosis (a in Health-Care Setting, 2005, page 10, "the classification of medium risk should be applied to settings in which the risk assessment has determined that health care workers (HCW) will or will possibly be exposed to persons with TB disease or to clinical specimens that might contain M. tuberculosis." Low risk applied to settings where exposure to TB was not expected to be encountered. If there was uncertainty about whether the risk was low or medium, medium should be adopted. The recommendations for medium risk included, "All HCWs should receive baseline TB screening (checked to identify presence of the disease) upon hire, using two-step TST (skin test) or a single BAMT (alternate test) to test for infection," and "After baseline testing for infection, HCWs should receive TB screening annually."

Further addressed in the CDC TB guidelines on page 83 was clarification related to persons previously vaccinated with BCG (a vaccine against TB): "Some persons who received BCG never have a positive TST result. For others, the positive reaction wanes after 5 years. U.S. guidelines state that a positive TST result in a person who received BCG should be interpreted as indicating LTBI (latent TB infection)," and "BCG is the most commonly used vaccine in the world. BCG might cause a positive TST (i.e., false-positive) result initially; however, tuberculin reactivity caused by BCG vaccination typically wanes after 5 years but can be boosted by subsequent TST. No reliable skin test method has been developed to distinguish tuberculin reactions caused by vaccination with BCG from reactions caused by natural mycobacterial infections, although TST reactions of >20 mm of induration are not usually caused by BCG."

According to the CDC in a document titled, "Tuberculin Skin Testing" dated May 2007, a 2 -Step TST is useful for adults who will be retested periodically such as HCWs. This 2-Step approach can reduce the likelihood of a boosted reaction to a subsequent TST which will be misinterpreted as a recent infection.

The 1/29/10 review of the hospital P&P titled "Tuberculosis Surveillance Program" (rev 7/2003) showed the P&P applied only to employees and volunteers and did not apply to all healthcare workers (did not include contracted staff) for tuberculosis screening. The P&P indicated in section B.1. a. "Two step methods used for: 1. Foreign born (not born in the USA). 2. Post BCG (after being vaccinated with BCG) and never had PPD (skin test for TB) since. 3. No documentation of PPD within the last year prior to employment." In section B.2., it indicated annual update required for all employees and volunteers with a previously documented negative test.

The personnel health files review on 1/29/10 at 10 a.m. with the VP of HR showed no 2 step TB testing was performed, with only one TB test results in their files, for 2 of 2 traveler registered nurses periodically used to work in the hospital's ICU.

C-2. During the facility tour of sterile processing on 1/25/10 at 10:45 a.m., the Instrument Processing Technician stated that the facility had no eye trays for the eye surgeries performed in the hospital. He stated that the contracted services staff brought in the eye trays for the days that the eye surgeries were performed. The technician stated that he did not perform sterilization of the eye trays.

The 1/27/10 review of surgery logs showed that 24 eye surgeries were performed on 10/22/09 by one surgeon. Review of intraoperative records for the second case of the day (Patient 6) showed that on 10/22/09 the patient had left eye cataract (disease of the eye lens)extraction with intraocular (within the eyeball) implantation performed and that flash sterilization was used for the eye instruments used during the procedure. Review of additional 10 of 24 cases showed that flash sterilization was used to sterilize the eye instruments.

Review of the Sterilization record with the Director of Surgery on 1/27/10 at 12 p.m. showed that on 10/21/09 two eye trays were sterilized, with one indicated as a backup tray. The Director explained that only one tray was used for all surgeries for the day. The first case was done with the tray sterilized by using the regular sterilization cycle (wrapped method). The subsequent cases were done with the same eye tray, using flash sterilization, starting with the second case. She stated that on 10/22/09 all 23 cases, starting with case two at 8:35 a.m. and the last case starting at 3:11 p.m. (per the OR log), were performed with the same eye instruments, sterilized by flash sterilization. The second eye tray was not used but it was kept as a backup.

The following are the recommended practices for Sterilization in the Perioperative Practice Setting by the AORN (2008 Edition):

Recommendation IV
Use of flash sterilization (a fast method) should be kept to minimum. Flash sterilization should be used only in selected clinical situations and in a controlled manner. Flash sterilization may be associated with increased risk of infection to patients because of pressure on personnel to eliminate one or more steps in the cleaning and sterilization process.

IV.a. Flash sterilization should be used only when there is insufficient time to process by the preferred wrapped or container method. Flash sterilization should not be used as a substitute for sufficient instrument inventory. Proper decontamination is essential in removing bioburden and preparing an item for sterilization by any method. Failures in instrument cleaning have resulted in transmission of infectious agents.

Items to be flash sterilized should be subjected to the same decontamination processes as described in AORN's "Recommended practices for cleaning and caring for surgical instruments and powered equipment."

Flash sterilization should be performed only if all of the following conditions are met: The device manufacturer's written instructions on cycle type, exposure times, temperature device manufacturer's written instructions on cycle type, exposure times, temperature settings, and drying times (if recommended) are available and followed. Items are disassembled and thoroughly cleaned with detergent and water to remove soil, blood, body fats, and other substances. Lumens are brushed and flushed with a cleaning solution and rinsed thoroughly. Items are placed in a closed sterilization container or tray, validated for flash sterilization, in a manner that allows steam to contact all instrument surfaces. Measures are taken to prevent contamination during transfer to the sterile field. Flash-sterilized items are to be used immediately and not stored for later use.

In an interview with the Director of Infection Control on 1/28/10 at 12:30 p.m., the Director stated that as to date, she was not involved in monitoring of environment and general operations in the Surgery Services other than monitoring of hand hygiene and surgical sites infections, which showed a slight increase. The Director stated that the causes for the slight increase was evaluated, but the OR environment was not considered.

Based on staff interview and document review, the hospital failed to ensure that infection control policies were developed and implemented by the infection control officer to effectively control infections and communicable diseases in accordance with nationally recognized standards when medical staff members (176 total members) were exempt from complying with infection control training or health screening review.

Findings:

In an interview with Administrative Staff (AS) 8 (the medical staff coordinator), AS 2 (the medical director) and AS 3 (the chief of the medical staff) on 1/26/10 at 9:40 a.m., all leadership representatives agreed that members of the medical staff were not required to attend or participate in infection control trainings. Formal verifications or certifications of infection control training was not collected or filed in the staff credentials or occupational health files for medical staff members. Medical staff members were not included in hand hygiene observations for quality data analysis to evaluate the effectiveness of the infection control program. Influenza vaccine and tuberculosis immunity status was tracked by an occupational health department, but there was no required screening for immunity to hepatitis B, hepatitis C, or other communicable diseases. The leadership representatives acknowledged that medical staff members performed procedures and were exposed to blood-borne pathogens similar to other healthcare workers (direct care staff).

Review of the hospital online infection control course, presented as the current hospital infection control plan, on 1/27/10 at 6 p.m. indicated that the course objective was to identify and reduce risks of healthcare-associated infections. Page 4 of 35 documented, "Transmissible infections are a major concern among healthcare workers ... that can affect patient safety." Page 6 of 35 documented, "This facility monitors infections among staff and patients." Page 34 of 35 listed references to support the training. The most current reference was dated 2004.

In a review of the Association of Practitioners for Infection Control (APIC) Position Paper: Safe Injection, Infusion and Medication Vial Practices in Healthcare, dated 7/30/09, the following infection control standards and practices for healthcare workers (including medical staff exposed to blood and body fluids) to prevent outbreaks of serious infections in health facilities were outlined:

Provide the hepatitis B vaccination series to all previously-unvaccinated healthcare personnel.
Ensure staff preparing or administering injections or other parenteral medications are competent to aseptically perform these tasks.
Periodically assess compliance with safe injection practices by observing and evaluating personnel performing these procedures.

The APIC position paper concluded that "healthcare workers and their managers must understand, practice, and promote safe injection, infusion and medication vial practices." Administrators of medical facilities must support safe injection practices and provide resources for training and equipment. The role of the "Infection Preventionist" is to assess procedures for safety, develop programs, train, and implement safe practices. "The health and safety of our patients require adherence to infection prevention practices by all healthcare workers."

To address safe practices related to the use of blood sugar devices and percutaneous procedures that were performed by healthcare workers, the Center for Disease Control (CDC) issued standards similar to APIC in the March 11, 2005 / Vol. 54 / No. 9 edition of the CDC Morbidity and Mortality Weekly Report. Some of the practice standards to minimize the risk for cross-contamination of potentially contagious infections included:

a. Provide a full hepatitis B vaccination series to all previously unvaccinated staff members with exposure to blood or body fluids. Check and document postvaccination titers 1-2 months after completion of the vaccination series. Require staff members to know standard precautions and demonstrate proficiency in taking these precautions with procedures involving potential blood or body fluid exposures.

b. Provide staff members who perform percutaneous procedures with infection-control training that includes practical demonstration of aseptic techniques and instruction regarding reporting exposures or breaches. Conduct annual retraining of all staff members who perform procedures with exposure to blood or body fluids.

c. Assess compliance with infection-control recommendations (e.g., hand hygiene or glove changes) by periodic observation of staff and tracking use of supplies.

Based on observation, staff interview, and document review the hospital failed to develop a hospital wide infection control program for the maintenance of food sanitation policies and procedures and staff compliance with policies that prevented the potential for cross contamination and food borne illness.

Findings:

1. Inspection of Medical/Surgical and ICU shoot ice machines on 1/26/10 starting at 9:30 a.m., showed the shoot ice machine in Medical/Surgical Unit had significant buildup of white on the out side of the black shoot and white and yellow colored scale on the inside of the shoot. The shoot ice machine on ICU was also coated with white colored build up on the exterior and the interior of the shoot. The Director of Nutrition Services DNS) confirmed that the buildup of white scale was a potential hazard for growth of microorganisms and contamination of patient ice from these ice machines.

Interview on 1/26/10 at 4:30 p.m., the Director of Facilities (DF) stated that the approximately 11 ice machines were on a quarterly preventative maintenance program (PM) but because of the hard water there was significant accumulation of calcium and the ice machine shoots would need more frequent cleaning. Review of the ice machine PM reports showed the quarterly maintenance.

2. On 1/25/10 at 10 a.m., the cleaning and sanitizing procedure for the kitchen bin ice machine was reviewed. The DM stated food service staff using a quaternary ammonia product cleaned the ice machine bin.

Review of the ice machine manufacturers directions on 1/26/10 at 8:30 a.m., showed the manufacturer brand "sanitizer and cleaner are the only products approved for " for use in their brand ice machine. Manufacturer's directions were not followed to ensure sanitation.

3. On 1/25/10 during kitchen tour starting at 9 a.m., there were open two boxes of dried barely and peas on storeroom shelf. The lids were loosely covering the product but did not securely seal the top to prevent access from pests or vermin.

The DNS indicated the packages could be taped shut to ensure the safety of the product.

4. On 1/27/10 at starting 11:30 a.m., two trayline staff engaged in serving food on the lunch trayline, were observed to change disposable gloves without washing hands.

The dietary manager (DM) confirmed that the staff, although the gloves may not have been soiled, should wash hands any time the gloves are changed per department policy.

Interview on 1/27/10 at 4:30 p.m., with the infection control manager, stated that she was new to the manager job and was unaware of the hospital wide aspects of the job. She stated that she was involved with the environmental rounds to observe physical plant including the kitchen, but had not been involved with the ice machines for the kitchen and patient units to ensure policies and practice to ensure hospital compliance with the sanitation and following manufacturer's directions. She was not involved in the review of the dietary department policies and procedures for infection control or oversight of safe food storage practices, and dietary staff compliance with hand washing practices. Further she stated she was not knowledgeable in the food service aspects of infection control including the food safety standards for FDA Food Code and HACCP (Hazard Analysis Critical Control Point Program) developed to ensure food safety and sanitation standards based on scientific standards that would be standard of practice for the oversight of infection control in the food service and patient food delivery systems.

Based on observations, staff interview and document review the hospital failed to provide surgical services in accordance with acceptable standards of practice, when:

A. The hospital failed to ensure that Registered Nurses administering moderate sedation had demonstrated competencies specific to the nursing management of patients receiving conscious sedation documented. (cross-reference to A0405).

B. RNs performing administration and monitoring of moderate (conscious) sedation did not provide continuous monitoring for patients receiving moderate sedation. (refer finding number 1)

C. The surgical technologists in the GI lab performed procedures outside their scope of practice. (cross-reference to A0945).

D. Staff in the OR and in the GI procedure rooms did not wear attire suitable for the kind of surgical cases performed. (refer to findings number 2).

E. Humidity and temperatures in the surgery suites were not monitored daily and were not kept in the ranges recommended in accordance with acceptable standards of practice. (Refer to number 3 finding).

The cumulative effect of these systemic problems resulted in the inability of the hospital to comply with the statutorily-mandated Condition of Participation for Surgical Services.

Findings:

1. On 1/25/10 at 2:10 p.m. RN A was observed administering conscious sedation and monitoring to Patient #1 in the OR room while a physician performed a pain procedure. No circulating nurse (RN who manages nursing care of patient during surgery) was present during the procedure. RN A was observed performing conscious sedation (IV anesthesia)administration and monitoring role as well as circulating duties, to include assisting the physician with drawing up medications for procedural injections and cleaning the surgical site, and applying dressing following the procedure. The Director of Surgical Services was also present during observations of the procedure.

In concurrent interview with the Director of Surgical Services she acknowledged that no specific circulating nurse was assigned to the case. She stated that typically no circulating nurse was assigned to pain procedures and that the sedation nurse routinely performed duties of the circulator as well as conscious sedation monitoring.

The position statement titled Conscious Sedation from the California Board of Registered Nursing (BRN) retrieved at www.brn.ca.gov indicated: "The registered nurse administering agents to render conscious sedation would conduct a nursing assessment to determine that administration of the drug is in the patient's best interest. The RN would also ensure that all safety measures are in force, including back-up personnel skilled and trained in airway management, resuscitation (revival after death), and emergency intubation (inserting a tube into the lungs), should complications occur. RNs managing the care of patients receiving conscious sedation shall not leave the patient unattended or engage in tasks that would compromise continuous monitoring of the patient by the registered nurse."

Similarly, the 2008 edition of the AORN Moderate Sedation/Analgesia Recommendation IV, indicated, "...the peri-operative (time before, during and after surgery) registered nurse monitoring the patient receiving moderate sedation/analgesia should have no other responsibilities that would require leaving the patient unattended or would compromise continuous monitoring during the procedure. A designated peri-operative registered nurse should continually monitor the patient during administration of moderate sedation/analgesia. An additional peri-operative registered nurse should be assigned to the circulation role during the administration of moderate sedation."

Review of the P&P titled "Moderate and Deep sedation" (rev 08/09) indicated in section 5. Personnel Requirements: " i. If a procedure is being performed with the administration of moderate or deep sedation, a sufficient number of qualified personnel shall participate in sedation in addition to the practitioner performing the procedure ...The registered nurse assigned to monitoring the patient during moderate sedation shall not also act as an assistant to the practitioner performing the procedure."

2. Staff in the OR and in the GI procedure rooms did not wear attire suitable for the kind of surgical cases performed.

a) During observations on 1/25/10 between 2:40 p.m. and 3:30 p.m. three OR nurses (RN A and two random nurses) were observed wearing multicolored cloth head coverings. During observations it was also noted that the head covering worn by OR staff (nursing and physicians) did not fully contain their hair.

In an interview on 1/25/10 at 3:30 p.m. RN A stated, that the cloth head covering was her own and that she took it home to wash it. She would only wear a disposable head covering for patients with MRSA (methicillin-resistant staphylococcus aureus) infections .

In concurrent interview with the Surgical Services Director, the Director stated that staff in the OR was allowed to wear their own head coverings as long as they took it home in a plastic bag to wash them every day. She stated there was no system to ensure that this part of the OR attire was adequately and routinely washed at home.

Review of the facility P&P "Personnel attire-dress code" (rev10/08) indicated in section P that the above practice was allowed per Surgery Unit policy: "P) Home -made caps will be acceptable if laundered daily at home and brought in plastic wraps."

The 2008 perioperative standards and recommended practices published by the Association of periOperative Registered Nurses (AORN) on page 285 recommended that: "All individuals who enter the semirestricted and restricted areas of the surgical suite should wear freshly laundered surgical attire intended for use only within the surgical suite." In the next paragraph AORN recommended, "If scrubs are worn into the institution from outside, they should be changed before entering the semirestricted or restricted areas to minimize the potential for contamination (e.g., animal hair, cross contamination from other uncontrolled environments)." Under item 7 on page 285, the AORN recommended, "Home laundering of surgical attire is not recommended. Without clear evidence about safety for patients, health care workers, and their families, AORN does not support the practice of home laundering of surgical attire."

AORN addressed the hair not fully contained and the use of cloth hair coverings under "Recommendation II" on page 287, "Personnel should cover head and facial hair, including sideburns, and necklines, when in the semirestricted and restricted areas of the surgical suite...2. The head cover or hood should be designed to minimize microbial dispersal. Hair acts as a filter when left uncovered and collects bacteria in proportion to its length, curliness, and oiliness. Shedding from hair has been shown to effect surgical wound infection; therefore, complete coverage is necessary. Disposable bouffant and hood-style covers are preferred...3. Single use headgear should be removed and discarded in a designated receptacle as soon as possible after daily use. Reusable hats or hoods should be laundered in a commercial laundry after each use."

b) GI procedure room surgical attire not used.

During observations of GI surgical procedure on 1/26/10 at 1:30 p.m. staff presenting for GI surgeries were wearing clothing/scrubs from home or wore street clothes with a disposable gown over the top. The physician performing the surgery (MD 10) was wearing street clothes (dress shirt and tie) without wearing a gown over the top. The physician made a comment that he was not wearing a gown because rules did not apply to him.

In an interview following the surgery MD 10 stated that the GI procedure rooms (seperate location from the OR suites) were not considered surgical suites because sterile environment was not required for endoscopic procedures. The surgery attire dress code was not applicable and therefore was not used in the GI procedure rooms.

The CMS guidelines use the following definition of surgery, developed by the American College of Surgeons, to determine whether or not a procedure constitutes surgery and is subject to surgical services Condition of Participation: " Surgery is performed for the purpose of structurally altering the human body by the incision or destruction of tissues and is part of the practice of medicine. Surgery also is the diagnostic or therapeutic treatment of conditions or disease processes by any instruments causing localized alteration or transposition of live human tissue which include lasers, ultrasound, ionizing radiation, scalpels, probes, and needles. The tissue can be cut, burned, vaporized, frozen, sutured, probed, or manipulated by closed reductions for major dislocations or fractures, or otherwise altered by mechanical, thermal, light-based, electromagnetic, or chemical means. Injection of diagnostic or therapeutic substances into body cavities, internal organs, joints, sensory organs, and the central nervous system also is considered to be surgery (this does not include the administration by nursing personnel of some injections, subcutaneous, intramuscular, and intravenous, when ordered by a physician)."

Review of the system wide Surgical Services P&P titled "Scope of Service" (rev 1/09) indicated that major and minor surgeries included General (including laparoscopic Endoscopy) and GI/Pulmonary Endoscopy. In section "Standards of Practice" it was in part indicated "The standards of practice in California and the recommended practices of the AORN are also taken into consideration in determining our standards of practice."

The 2008 Perioperative standards and recommended practices published by the Association of Perioperative Registered Nurses (AORN) on page 285 recommended that, "All individuals who enter the semi restricted and restricted areas of the surgical suite should wear freshly laundered surgical attire intended for use only within the surgical suite."

3. During OR tour on 1/25/10 at 9:30 a.m. with the Surgical Services Director, the Director was asked about monitoring of humidity and temperatures in the OR and sterile processing areas. The Director stated that staff in the OR did not keep logs or monitor either humidity or temperatures. The monitoring was done remotely by engineering department and unless there was a problem identified by the engineering she would not know if temperature and humidity were within any recommended ranges. The Director was not aware of any P&P pertaining to the acceptable ranges or monitoring.

On 1/28/10 at 10:15 a.m. the Director of Engineering was interviewed regarding monitoring of temperatures and humidity levels in the OR suites and sterile processing areas. He stated that OR temperatures were adjusted based on requests from surgeons and/or other surgical staff to ensure their comfort and preference. There were no specific ranges that the facility maintained. There was no system in place for monitoring of the levels of humidity and/or temperatures in those areas on the days when surgeries were performed. There was no record or monitoring of humidity and temperatures in GI procedure rooms or the rooms where sterile equipment and supplies were maintained. The Engineering department routinely printed a snapshot record of the temperatures and humidity in the ORs on monthly bases but there were no parameters set or monitored.

During the above interview the Director of Engineering stated that there was no P&P for maintaining or monitoring of humidity and temperatures in the OR/Sterile processing areas until 1/26/10. After the surveyor asked for it, the Director presented a P&P, dated 1/26/10, titled "Temperature & Humidity Control." The Director stated that the P&P did not go through the facility's appropriate approving process. The P&P in part indicated "Operating Room Suite temperatures are adjusted per comfort level of varying medical staff. Humidity higher than 60% can promote the growth of airborne fungi and bacteria mold and other allergens." The P&P indicated that the engineering will attempt to lower humidity if higher then 60% but did not speak to any recommended ranges and did not address process for monitoring.

The Director of Engineering presented binder with monthly picture records of what he described as snapshots of the humidity and temperature controls on the days the pictures were taken. Review of the binder content "Humidity level readings" showed pictures of the controls taken monthly. The most current dated 1/2/10, showed the following readings of humidity and temperatures, respectively, for OR 1-5: OR 1, 23%, 64F; OR 2, 24%, 66F; OR 3, 29.9%, 64F; OR 4, 21.5%, 67F; OR 5, 22.5%, 64.5F. The Director of Engineering stated that no one monitored the controls but he stated that he thought he could print a log of humidity and temperatures from the system if necessary.

The 2008 edition of Perioperative Standards and Recommended Practices published by the Association of periOperative Registered Nurses (AORN) made the following recommendations related to Safe Environment of Care: "V.b. Relative humidity should be maintained between 30% and 60% within the perioperative suite, including operating rooms, recovery area, cardiac catheterization rooms, endoscopy rooms, instrument processing areas, and sterilizing areas and be maintained below 70% in sterile storage areas. Low humidity increases the risk of electrostatic charges, which pose a fire hazard in an oxygen-enriched environment or when flammable agents are in use and increases the potential for dust. High humidity increases the risk of microbial growth in areas where sterile supplies are stored or procedures are performed."

Section V.b.2. indicated "Humidity should be monitored and recorded daily using a log format or documentation provided by the HVAC system. Section V.c. indicated "Temperature should be monitored and recorded daily using a log format or documentation provided by the HVAC system.V.c.1. Temperature should be maintained between 68 F to 73 F (20 C to 23 C) within the operating room suite and general work areas in sterile processing."

The 1/28/09 review of the temperature and humidity logs for the past 11 days printed and presented by Director of Engineering showed that the humidity and temperatures were not maintained in accordance with acceptable standards of practice. The humidity was below 30% ranges on all 11 days reviewed and reached below 20 for 4 of the 11 days reviewed. The logs showed the temperatures in the OR suites were below 68 F for all 11 days reviewed.

Based on staff interviews and document reviews, the hospital failed to ensure that surgical privileges were delineated for all practitioners performing surgery in accordance with the competencies of each practitioner. The hospital failed to specify the surgical privileges and ensure competencies for each practitioner that performs surgical tasks. Unlicensed staff (GI technicians) were permitted to perform surgical tasks without surgical privileges and beyond their scope of practice.

Findings:

Review of the P&P titled "Colonoscopy with Polypectomy, Assisting with," dated 02/09, in part indicated, under the Procedure section: "Place the snare down the biopsy channel. The assistant will open and close the loop slowly as the physician directs." This policy did not indicate which discipline (GI tech, nurse, etc) was to perform the assistant duties.

The 1/29/10 review of the P&P for Surgical Services titled "Scope of Services" (rev 1/08) indicated (in the availability of necessary staffing section): "One RN and one GI tech per procedure to cover endoscopy, one GI tech for scope processing, and one RN for post GI procedures."

In an interview on 1/26/10 at 10:30 a.m., two GI technicians (GI Tech C and GI Tech D, unlicensed surgery staff members) stated that their duties in the GI procedure rooms included assisting the physician during endoscopic procedures. Their duties included inserting and manipulating portions of an endoscope (flexible tube inserted into a body part), assisting with the set-up of equipment and obtaining and handling of specimens. The two GI technicians assigned to GI lab assisted the physician in the endoscopic procedures, switching their roles: one of the technician was "driving" the scope as the other GI technician threaded instruments through the endoscope and obtained biopsy (cutting of tissue) when directed by the physician. The task was accomplished by the endoscope control switches which were handled by the GI technician. The technicians stated that there was a RN assigned to the procedure room during the endoscopic procedures to administer or monitor conscious sedation. No other assistants or circulating nurse (or other licensed personnel) were present during the procedure assigned to either assisting or circulating duties.

In concurrent interview with the Surgical Services Director, the Director stated that no privileging or competencies were completed for GI technicians for surgical tasks and there were no annual or ongoing competency assessments for the technical skills described above.

Review of the Bylaws of Medical Staff (revised January 2007) indicated in Article V, titled "Clinical Privileges," section 5.1: A practitioner shall be entitled to exercise only those Clinical Privileges or Practice Prerogatives must be location (i.e., Hospital and/or clinic) specific and within the scope of the person's license, certificate or other legal credential authorizing practice in the appropriate State ..." Section 5.2-2 indicated: "Requests for Clinical Privileges shall be evaluated on the basis of the Member's education, training, experience, demonstrated professional competence and judgment, clinical performance, health status, and the documented results of patient care and other quality review and monitoring which the Medical Staff deems appropriate."

The American College of Surgeons has defined surgery as structurally altering the human body by the incision or destruction of tissues and is part of the practice of medicine. Surgery is also the diagnostic or therapeutic treatment of conditions or disease processes by any instruments causing localized alteration or transposition of live human tissue which includes lasers, ultrasound, ionizing radiation, scalpels, probes and needles. The tissue can be cut, burned, vaporized, frozen, sutured, probed or manipulated by closed reductions...(reference CMS State Operations Manual, Appendix L, effective 5/18/09).

California Business and Professions Code Section 2051 authorized the holder of a physician's and surgeon's certificate (license) to sever or penetrate the tissues of human beings. Section 2052 stated, "Any person who practices or attempts to practice, ... who diagnoses, treats, operates for, or prescribes for any ailment, blemish, deformity, disease, disfigurement, disorder, injury...without having at the time of so doing a valid, unrevoked, or unsuspended certificate as provided in this chapter, or without being authorized to perform such act pursuant to a certificate obtained in accordance with some other provision of law, is guilty of a misdemeanor." California State laws (AB3 filed 10/10/07 for physician assistants, B&P 2725 for licensed nurse categories) permit delegation of physician tasks only to a few licensing categories. There is no state licensure category for surgical tech, scrub tech, or operating room tech, and therefore no scope of practice.

Surgical tasks as performed by the GI technicians require specific education and training and by the above definitions are considered surgery and the practice of medicine.

Personnel files reviewed on 1/27/10 at 4 p.m. with the HR personnel showed that GI Tech C and D had no competencies formally evaluated for the GI duties that included surgical assist. The surgical technicians had not been granted any surgical tasks privileges. Surgical technicians had no documented state licensure, certifications, or primary verification of education and training to indicate any qualifications to perform the surgical procedures which they performed.

Based on personnel file review and staff interview the facility failed to ensure that the staff performing duties and procedures related to nuclear medicine had appropriate training for 1 of 1 files reviewed.

Findings:

Personnel files reviewed on 1/29/10 at 10 a.m. with the VP of HR showed that randomly selected file of Nuclear Medicine Technologist (Technologist 3) had no formally evaluated competencies for performing duties specific to nuclear medicine procedures. The VP of HR confirmed that there were no competencies in the file as above and stated that competency tools and policies for nuclear medicine staff were in process of being developed.