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Based on observation, interview, medical record and document review, the hospital's governing body and medical staff failed to ensure patient safety. It was determined:

1. The hospital failed to ensure services performed under contracts for pharmaceutical services and food services contracts are provided in a safe and effective manner. (Refer to A 83)

2. The hospital failed to ensure pharmaceutical services which meet the needs of patients were organized, furnished, and supervised. (Refer to A 83, A 490, A 491, A 500)

3. The hospital failed to develop, implement and maintain an effective quality assurance performance improvement program. (Refer to A 265, A 276, A 283)

4. The hospital failed to ensure insulin injection, a high alert / high risk medication, was administered to Patient 11 in accordance with hospital policies, physicians orders and accepted standards of practice. The hospital's failure placed Patient 11 at risk for adverse outcomes including hypoglycemia (low blood sugar can be potentially fatal) and hyperglycemia (high blood sugar can cause kidney, eye and tissue damage). (Refer to A 404, A 405, A 500)

The cumulative effects of these systemic problems resulted in the hospital's inability to ensure safe provision of services for patients.

Based on staff interviews and document reviews, the governing body failed to ensure that a pharmacist provided pharmaceutical services and a Registered Dietitian provided food services to ensure that oversight of the departments' processes were executed in a manner that complied with conditions of participation for Pharmaceutical Services, Food and Dietetic Services, Quality Assurance / Performance Improvement; and Infection Control. The hospital's failure had the potential to cause harm to patients related to food and medication management and loss of control of the drug supply.

Findings:

1. On 8/1/11 the hospital provided, Consultant Agreement Pharmacist in Charge (effective 1/1/11) for Pharmacist B as the source for how pharmaceutical services were provided.

A review of the contract showed a requirement for the Pharmacist in Charge to be conversant with all federal and state laws and codes related to pharmacy services.

On 8/2/11 at 10:19 a.m. in an interview, the surveyor and Pharmacist B discussed the purpose of the survey. Pharmacist B indicated he did not know about the federal regulations Condition of Participation for Pharmaceutical Services, the Standard for Pharmacy Management and Administration, or the Standard for Delivery of Services.

A review of the contract showed provisions for the Pharmacist in Charge to serve on the Quality Assurance and Improvement Committee (QAPI) and make recommendations regarding performance improvement. On 8/3/11 at 3:40 in an interview, Pharmacist B was provided a list of the hospital's QAPI which included five defined pharmacy QAPI activities. He was asked to describe his role.Pharmacist B said of the hospital's written QAPI plan, "I've never seen this before."

A review of the contract required the Pharmacist in Charge (Pharmacist B) to submit written reports to the Administrator at least quarterly. On 8/2/11 at 2:35 p.m. in an interview, Administrative Staff A verified that the reports of unit inspections were not conducted or provided.

A review of the contract showed provisions for the Pharmacist in Charge to maintain a log of all visits and activities in the facility.

On 8/2/11 at 9:30 a.m. in an interview, Pharmacist B said he kept a log of his visits but logs were not provided during the survey. On 8/4/11 at 11:00 a.m. in an interview, Administrative Staff A explained that Pharmacist B came more than 8 hours a month because he attended meetings and checked crash carts but she did not keep records of his visits or activities.

On 8/2/11 at 4:00 p.m. in an interview, Administrative Staff A explained that [Administrative Nurse E] was assigned oversight of the monthly drug storage inspections by Pharmacist B in policy but that had not been well communicated to her.

A review of the contract showed provisions for the Pharmacist in Charge to review the drug regimen of 10 percent of inpatients and at 10 records of outpatients monthly and to report irregularities.

On 8/3/11 at 3:40 in an interview, Pharmacist B was provided 10 samples of DUEs (Drug Usage Evaluation) he performed and was asked to provide an example of how his recommendations from the DUEs contributed to performance improvement. Pharmacist B did not provide an example.





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2. Review of the hospitals' contract for the consultant Registered Dietitian (RD) was reviewed on 8/2/11 beginning at approximately 9 am. The contract was initially entered into on 1/27/09 which described the roles and responsibilities of the RD. According to this document the contracted service was responsible for clinical nutrition services and to assure that dietetic services meet all applicable regulations.

In an interview on 8/3/11 at 10:45 am, with Administrative Staff A she was asked to describe the scope of the contracted food service. She confirmed that the RD was responsible for the oversight of food services as well as providing clinical nutrition care. AS A also stated that it was the responsibility of the department manager to evaluate the effectiveness of the contract. Concurrent review of the hospital document titled "Annual Contract Service Evaluation" dated 5/1/11 for the consultant RD revealed that the document was completed by the dietary services supervisor (DSS), whose training included community college certificate as a Chef. Similarly the RD's employee performance report was also completed by the DSS; however instead of completing the evaluation utilizing the RD's position description, the evaluation was completed using a cooks' position descriptions.

Administrative Staff A also acknowledged that review of the contract by the dietary service supervisor, a position who would not have the expertise to assess the qualifications of the Registered Dietitian, was likely not an effective mechanism for evaluation of this health professional. She also stated she was unable to explain how the evaluation for the RD, completed using a cook' s job description, was approved and placed in the employees' personnel file.

Comprehensive review of the hospital position description for the RD and contracted vendor agreements revealed that the hospital did not implement an effective mechanism for day to day guidance, by an RD, for food service activities (Cross Reference A621).

Review of food handling practices revealed that staff practices including lack of cooldown monitoring of potentially hazardous foods and food storage practices were not in compliance with good food safety guidelines (Cross Reference A749).

The governing body failed to ensure that the dietary department developed and participated in a hospital wide QAPI program that focused on the identification of quality and performance indicators (Cross Reference A264)

Staff knowledge was inadequate in terms of safe food handling practices as evidenced by utilization of bare hands during food production activities (Cross Reference A622).

Based on interview and record review, the hospital failed to ensure that a contracted service had a delineation of contractor responsibility when the contract for the director of radiology services did not include the responsibilities for "Radiation Safety Officer." This failure could result in contracted staff not performing necessary and essential duties.

Findings:

On 8/2/11, the contract for the "Director/Consultant agreement Radiology Services" was reviewed. The contract did not include the duties of the Radiation Safety Officer (RSO) at the facility.

On 8/3/11 at 2:45 pm, Administrative Staff A stated that the Director of Radiology Services, a contracted position at the facility, had been performing duties of the RSO. Admin Staff A acknowledged that the above contract did not include the responsibilities of the RSO and that the contract was incomplete.

Based on interview and record review, the facility failed to maintain an effective, ongoing, hospital-wide quality assessment and performance improvement program as evidenced by the following:

1. The facility failed to show it had an ongoing program to identify and reduce medical errors. (See A 266, A 276, A 404 and A 405)

2. The facility failed to set priorities for performance improvement that focus on high-risk problem prone areas in pharmaceutical services and did not utilize hospital-wide data on drug regimen reviews in a manner to reduce medication errors. (See A 276 and A 490)

3. The facility failed to collect enough data from the past 12 months to be able to analyze any of its quality indicators (identified areas of concern) for its medical surgical department. (See A 267)

4. The facility failed to ensure that pharmaceutical services met the need of each patient and was administered in accordance with state and federal standards of professional practice. (See A 490)

5. The hospital's 2011 quality indicators identified the use of flash sterilization (a modification of conventional steam sterilization intended to prepare surgical instruments for emergent and immediate use, using un-wrapped method), as a problem but failed to implement a successful corrective action plan. (See A 756)

6. The hospital failed to identify as a quality indicator that one of three surgical procedure rooms were not maintained in accordance with hospital policy and procedures, and national standards of practice. (See 951)

7. The hospital failed to have an ongoing quality appraisal and performance improvement program that addressed the complexity and scope of Food and Dietetic Services. (See A 267)

The cumulative effect of these systemic problem resulted in the facility's inability to identify areas of concern to improve health outcomes and to comply with the statutorily mandated Condition of Participation: Quality Assessment Performance Improvement.

Based on interview and document review, the hospital failed to have an ongoing quality appraisal and performance improvement program that addressed the complexity and scope of Food and Dietetic Services which resulted in failure to identify issues in safe food handling practices as well as food storage and sanitation all of which could result in foodborne illness. Additionally the Registered Dietitian failed to recognize inadequacies in services that could lead to unmet patient nutritional needs. Failure to develop a comprehensive performance improvement program that reflects the operational processes within the foodservice department may further compromise the clinical status of inpatients.

Findings:

1. In an interview on 8/3/11 beginning at 2:10 pm, with Quality Improvement (QI) Staff T she was asked to describe how the performance improvement (PI) committee determined indicators that would be evaluated. She stated that the indicators were selected by the PI committee, Administration and the Department Manager. Review of performance indicators beginning in 2009 revealed that the dietary department was submitting data on 1) patient instruction of drug/nutrient interactions; 2) diet delivered per MD order; and 3) proper infection control with respect to isolation precautions. It was also noted that for these parameters the data revealed that the facility met the parameters between 95-100% of the time. QI Staff T was asked if there were any PI activities relative to the nature and scope of food services. She replied that there were not. QI Staff T also acknowledged that the activities presented to the committee did not appear to provide any opportunities for improvement, rather were more reflective of departmental monitoring activities.

In an interview on 8/10/11 beginning at 4:10 pm, with the Registered Dietitian (RD) she was asked to describe the dietary departments' performance improvement activities. She stated that on a quarterly basis she completed a chart review of closed records. She stated that she reviewed their diet and whether or not the diet was appropriate for their diagnosis. Review of hospital document titled "Registered Dietitian's Quarterly Review" from 3/24-5/05/11 revealed that the RD completed a retrospective study of 42 charts, the majority of which were on a regular diet. It was also noted that in 5 of the 42 charts the RD indicated that a diabetic diet may have been more appropriate for the patients' clinical condition. The RD also stated that while she gathered the information she had not evaluated the relevance of the data and whether or not a performance improvement activity would be beneficial. She also stated the data was not incorporated into the hospital-wide performance improvement plan. She also acknowledged there were no performance improvement activities related to food service and that she did not actively participate in any intra or interdepartmental performance improvement activities. She additionally acknowledged that she did not identify that nursing staff was changing the physician ordered diets likely making the data gathered on physician diet orders inaccurate as the study was a retrospective chart audit rather than observations of meal deliveries (Cross Reference A629).

Based on interview and document review, the facility failed to show it had an ongoing quality improvement program to identify and reduce medical errors. As a result, the facility was unable to demonstrate any improvement in the reduction of medication related errors. (Cross Reference A404).

Findings:

The facility's quality management indicators (identified areas for improvement) for 2010-2011 were reviewed. The indicators for the medical surgical (med surg) department that related to medications were identical for both years. The indicators included the following: "Medication reconciliation process followed (MSN 53)," Medication and Medication Administration Record (MAR) Transcription (MSN 64)," and "Pediatric Patient Sedation (MSN 56)."

The data to be collected for MSN 64 included: were the orders for medications transcribed to the MAR exactly as the physician ordered, was the medication and dosage, frequency and route correct, and were the orders checked and verified by a licensed nurse. The frequency of the data to be collected was 10% of admissions monthly. The data was missing for seven months from 9/10 to 3/11, and the months of 5/11 to 6/11.

During an interview on 8/4/11 at 10:10 am, Quality Improvement Staff T stated that there had been no quality improvement reports completed for the med surg department for the months of 1/11 to 3/11 and 5/11 to 6/11 because there had been no department manager for that period of time.

During an interview on 8/4/11 at 10:25 am, Admin Staff A confirmed the missing reports from 9/10 to 12/10 and acknowledged that they had been unable to evaluate the indicators because of the lack of reports and missing data.

Based on interview and document review, the facility failed to collect enough data to be able to analyze any of the quality indicators (identified area for improvement) chosen for its medical surgical (med surg) department. As a result, the facility was unable to evaluate the effectiveness of its quality improvement program.

Findings:

The facility's quality management indicators for the med surg department for 2010-2011 were reviewed. The indicators were identical for both years. The information for all the med surg department indicators was missing for the ten months from 9/10 to 3/11 and from 5/11 to 6/11. There was one indicator for pediatric patient sedation that remained at 100% or not applicable for all months in 2010 and 2011 for which there was information recorded.

During an interview on 8/4/11 at 9:45 am, Administrative (Admin) Staff A stated that the facility made a decision to continue with the same quality indicators as last year because so many of their management staff were new and did not have knowledge of the facility's needs. Admin Staff A acknowledged that there was no process for how long an indicator remained at 100% before it was retired and some indicators had been carried over from year to year when they should not have been.

During an interview on 8/4/11 at 10:10 am, Quality Improvement Staff T stated that there had been no quality improvement reports completed for the med surg department for the months of 1/11 to 3/11 and 5/11 to 6/11 because there had been no manager to prepare the reports for that period of time.

During an interview on 8/4/11 at 10:25 am, Admin Staff A confirmed the missing reports from the months of 9/10 to 12/10 and acknowledged that they had been unable to evaluate the indicators because of the lack of reports and missing data.

Based on interview and record review, the hospital failed to ensure that QAPI (Quality Assurance Performance Improvement) activities focused on high-risk problem prone areas in pharmaceutical services . The hospital failed to measure the success of Drug Usage Evaluation (DUE) activities after implementation, due in part, because they assigned a Licensed Vocational Nurse to review the consultant pharmacist's evaluations without follow-up. DUE reports were not routinely presented to the medical staff or analyzed and did not include a review of medication orders in the Operating Room or Recovery Rooms. Of 2800 cases reported performed annually, three medication errors were reported for a seven month period without interventions to increase surveillance. The hospital's failure places patients at risk for adverse consequences from medication errors as a result of these system failures.

Findings:
On 8/3/11 at 3:40 in an interview, Pharmacist B was provided a list of the hospital's QAPI which included the following five pharmacy QAPI activities: "Acetaminophen [a mild pain reliever] given in 24 hours does not exceed allowable dose"; "Drug Tracking"; "Nursing unit drug storage areas have BBW (Black Box Warning) drugs labeled"; "Allergies documented in appropriate area of chart" and "Web-based med info access/nursing use".

Pharmacist B read the first activity and said, "I had nothing to do with that but I think they're doing that." Regarding "Drug Tracking " he said, "Yes, we do that - the DUEs." He elaborated that he did not perform DUEs on Operating Room Orders or Recovery Room Orders because, "They don't send me those." He said storage areas have Black Box Warning drugs labeled and allergies were documented in appropriate area of chart. Of the Web-based medication information activity he said, "Yes, I checked some freebie websites and set it up for the nurses." Pharmacist B could not recall the name of the web-based information provided to nurses or inservice materials.

In the same interview, Pharmacist B was asked to elaborate on the hospital's pharmacy-related QAPI activities. Pharmacist B held the hospital's written QAPI plan and said, "I've never seen this before."

He was asked to show how his activities potentially identified or reduced medication errors in the hospital. He said, "We've only had three this year." He elaborated that one was with an antibiotic wasn't given at the right time and one was a Darvocet got on the MAR (Medication Administration Report). Administrative Staff A said later that the DUE with the Darvocet was an old form which had been updated.

The hospital did not have a system to identify or track medication errors. On 8/4/11 at 10:00 a.m. in an interview, Administrative Staff A confirmed that the hospital does approximately 2800 surgical and procedural cases annually. Between January 1, 2011 and August 2, 2011, three medication errors were reported.

The pharmacy service did not utilize hospital-wide data on retrospective drug regimen reviews to analyze ways to reduce medication errors. The review of DUE (Drug Usage Evaluations) was missed as an opportunity for improvement. Unidentified medication errors occurred when a pharmacist did not review all new medication orders before nurses removed drugs from distribution and administered them to patients. The DUE process did not include any process for routine review of operative and recovery room orders by the pharmacist. The need for Physicians Orders clarifications was not identified as a problem prone area.
Pharmacist B did not effectively contribute recommendations or alternative strategies at a Quality Assurance meeting when the medical staff committee approved the continued stocking of expired Levophed (a medication used to maintain blood pressure in emergencies) in crash carts. An effective retrospective drug review process protects patient safety by having the pharmacist review all new medication orders.

Based on document review, staff interview and medical record review the medical staff failed to ensure that their bylaws, rules and regulations contained a requirement that an updated examination of the patient, including any changes in the patient's condition, be completed and documented within 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services, when the medical history and physical examination are completed within 30 days before admission or registration. The updated examination of the patient, including any changes in the patient's condition, must be completed and documented by a physician. For 4 of 40 medical records reviewed (Patients 26, 28, 29 and 30), this lacking requirement in the bylaws resulted in patients undergoing surgical procedures under anesthesia without the benefit of a documented updated examination.

Findings:

On 8/2/11 the medical staff bylaws, rules and regulations were reviewed. The bylaws do not include any requirements related to the pre-surgical medical history and physical examination (H&P). The Rules and Regulations has a section titled "15-Medical Records:" beginning on page 9. Subsection 15-b does have a requirement for an admission H&P to be done at no more than 30 days prior to admission and surgery, but it goes on to give an exception for surgical procedures done under "local anesthesia or moderate sedation/analgesia." The second paragraph of subsection 15-b is related to the required update to the physical examination within 24-hours prior to the surgical procedure, but it goes on to allow for updates that do not actually record any part of the physical examination.

On 8/2/11 at 4:50 p.m. Medical Staff Coordinator Z acknowledged that the "rules and regulations do not clearly state that a 24-hour update is required for procedures with moderate sedation."

On 8/3/11 and 8/4/11 review of patients medical records revealed the following:

1. Patient 26 had a surgical procedure done on 5/25/11. The H&P conducted on 5/16/11 was incomplete. The H&P update done on 5/25/11 did not document any elements of an examination.

2. Patient 28 had a surgical procedure done on 7/7/11. The H&P conducted on 6/13/11 was incomplete. The H&P update done on 7/7/11 did not document any elements of an examination.

3. Patient 29 had a surgical procedure done on 6/2/11. The H&P was done on 5/27/11 and the H&P update done on 6/2/11 did not document any elements of an examination.

4. Patient 30 had a surgical procedure done on 5/2/11. The H&P conducted on 4/29/11 was incomplete. The H&P update done on 5/2/11 did not document any elements of an examination.

Based on interview and document review, the facility failed to ensure that all its nurses were trained in Pediatric Advanced Life Support (PALS) as required in their job description for four of five employee files reviewed. This had the potential to result in nurses not responding effectively in the event of an emergency involving a pediatric patient.

Findings:

The job descriptions for the following RN positions were reviewed: Post Anesthesia Recovery, last revised 6/97, Operating Room, last revised 5/08, Charge Nurse - Med Surg, last revised 3/09, and RN - Staff/Relief Charge, last revised 3/09. PALS was listed under, "required certifications" for all the above job descriptions. All the job descriptions also read as follows, "This position has the responsibility for the assessment, treatment, and or care of patients in the following age groups: Pediatric (18 mos to 11 years) 5%, Adolescent (12/16) 10%".

A review of four RN employee files for the above listed positions disclosed that none had their PALS certifications.

During an interview on 8/4/11 at 2:30 pm, Administrative Staff A confirmed that the nurses did not have their PALS certification and that it was a requirement according to their job description.

Based on medical record review and document review the hospital failed to ensure the development of a diabetes care plan for two of eight patients reviewed for nutritional care. Failure to fully assess the effects of diabetes in a post-surgical (post op) patient may result in elevated blood sugars which may hinder the healing of surgical wounds. (Patients 11 and 36)

Findings:

1. Patient 11 was admitted for foot surgery with a secondary diagnosis of diabetes. Post op surgical diet dated 6/17/11 was clear liquid, with an advance to regular diet. It was also noted that Patient 11 had an insulin pump (an automated insulin delivery system); however there was no physicians' order for the amount of insulin that would be delivered via the pump (Cross Reference A405). Review of diabetes flow sheet beginning 6/17-6/18/11 revealed that Patient 11's blood sugars ranged from a low of 64 to a high of 289 milligrams/deciliter (mg/dl). It was also noted that on 6/17/11 nursing staff recorded that the patient self-administered 7 units of insulin for a blood glucose of 172 mg/dl and on 6/18/11 at 0120, Patient 11 administered 4.2 units for a blood sugar of 265 mg/dl, similarly on 6/18/11at 0315 Patient 11 administered 3 units for a blood glucose of 289 mg/dl.

Review of Patient 11's nursing care plan revealed that there was no developed care plan for patient self-administration of insulin. Hospital policy titled "Care Plans Care Decisions" dated 9/09 revealed that "The RN will assume responsibility of developing a written plan of care."

A care plan was initiated upon admission for a risk of hypo/hyper glycemia (low or high blood sugar ). The interventions included "monitor blood glucose as ordered, notify physician as indicated." However, there were no orders for how often blood glucoses were to be checked or when to notify the physician if a blood glucose result was abnormal.

During an interview on 8/4/11 at 12pm, Administrative Nurse E stated that the nurses should have clarified the insulin order and the parameters for monitoring Patient 11's blood glucoses.

2. Similarly Patient 36 was also admitted with a secondary diagnosis of diabetes for which there was no diabetes care plan developed.

Based on interview and record review the hospital failed to ensure Licensed Nurse W administered doses of insulin (a blood sugar- lowering hormone) to Patient 11 with a valid order in a manner that was consistent with accepted standards of acceptable professional practice and hospital policy. The hospital's failure placed Patient 11 at risk for hypoglycemia and hyperglycemia as a result of loss of control of blood sugar. Hypoglycemia is a condition associated with abnormally low blood sugar which can cause confusion, dizziness, fainting or coma. Hyperglycemia is a condition associated with abnormally high blood sugar which can cause eye disease, kidney disease, nerve disease, and damage blood vessels.

Findings:
1.The Institute for Safe Medication Practices (ISMP) includes insulin, a protein to lower sugar levels, among its list of drugs which have a heightened risk of causing significant patient harm when used in error (Reference: www.ismp.org ). A review of the hospital's policy, High Alert Medication (revised 11/10) showed insulin listed as a high alert medication requiring special precautions. These included an independent double check of insulin by two nurses for patient safety, and a "High Alert" stamp on the patient's Medication Administration Record (MAR).

A review of medical records showed Patient 11 was a 67 year old man admitted to the hospital on 6/17/11 for surgery to his left foot. Medical Doctor Y (a podiatrist) was listed as his admitting physician. Physicians Orders dated 6/17/11 at 3:00 p.m. signed by Medical Doctor Y showed, "Okay to use and administer own insulin via pt insulin pump. " The order was signed by the Medical Doctor Y and Licensed Nurse W.

On 8/2/11 at 12:05 p.m. in a concurrent record review and interview, Administrative Nurse E acknowledged that Patient 11's insulin orders did not list the type of insulin, basal rate, bolus, or frequency of monitoring or coverage as required by policy. She said, "These are prescription errors."

A review of Patient 11's Diabetes Flow Sheet record dated 6/17/11 showed blood glucose readings under the heading, "Medication Insulin/Oral" that "7 units insulin were administered via pump" on 6/17/11 at 7:00 p.m. The entry was signed by Licensed Nurse W.

It is a standard of nursing professional practice to check the dose of a medication before administering it to the patient. Reference: Nursing 2012 Drug Handbook. (2012). Lippincott Williams & Wilkins: Philadelphia, Pennsylvania.

Other entries on the same insulin Flow Sheet record dated 6/18/11 signed by nurses showed, 4.2 units were administered on 6/18/11 at 1:20 a.m.; 3.0 units were administered on 6/18/11 at 3:15 a.m. and 9 units were administered on 6/18 at 8:00 a.m.
Administrative Nurse E acknowledged there were no orders to administer bolus insulin doses. Administrative Nurse E acknowledged that nurses made actual administration errors (wrong dose administration) of insulin on the above dates as a result of failure to clarify incomplete orders. She acknowledged any amount of drug was the wrong dose if it was administered. The nurses were not available for interview during the survey.

In the margin of the same Diabetes Flow Sheet there were undated, unsigned handwritten notes which showed, "9:00 a.m. 2 units per hour" ; " 8:00 p.m. 0.575 units per hour" and "2:00 a.m. 0.65 units per hour". Administrative Nurse E acknowledged there were no orders to administer basal insulin doses. She acknowledged that all of the entries "appeared to be medication administration errors" because, "The nurses never clarified the insulin order as required by the policy." She elaborated that it was contrary to the hospital's policy to allow self-administration of insulin by a patient.

A review of the hospital's policy, "Medication Administration" (revised1/11) showed, "Patients shall not be allowed to self-administer any medication from home."
The record did not show monitoring parameters or a target blood glucose range listed in the medical record; however, The American Diabetic Association ADA) describes, "Tight control means getting as close to a normal (nondiabetic) blood glucose level as you safely can. Ideally, this means levels between 70 and 130 mg/dl before meals and less than 180 two hours after starting a meal." The ADA describes hypoglycemia as a condition associated with abnormally low blood sugar which can cause confusion, dizziness, fainting or coma. They describe hyperglycemia as condition associated with abnormally high blood sugar which can cause eye disease, kidney disease, nerve disease, and damage blood vessels. Reference: www.diabetes.org

Based on interview and record review the hospital failed to ensure that nursing policies regarding Personal Insulin pumps for one patient (Patient 11) were implemented, that the emergency drug supply was maintained in the Recovery Room, or that that Medication Administration policies were implemented to ensure medication orders were clarified for 10 additional patients (Patient 39, Patient 2, Patient 12, Patient 22, Patient 23, Patient 25, Patient 38, Patient 40, Patient 3, Patient 13). The hospital's failure placed these patients at risk for preventable adverse outcomes as a result of medication errors and treatment delay in emergencies.
Findings:
1. A review of medical records showed Patient 11 was a 67 year old man admitted to the hospital on 6/17/11 for surgery to his left foot. Medical Doctor Y (a podiatrist) was listed as his admitting physician. Physicians Orders dated 6/17/11 at 3:00 p.m. signed by Medical Doctor Y showed, "Okay to use and administer own insulin via patient insulin pump."

A review of the hospital's general nursing policy, Personal Insulin Pumps (revised 9/06) showed the purpose of the policy was, "To provide guidelines to establish safe practices regarding the use of personal insulin pumps during hospitalizations." The policy showed, "The physician shall write an order stating that the patient may use their personal insulin pump. The physician's order for the personal insulin pump shall include: type of insulin, basal rate, bolus doses, frequency of blood glucose monitoring, and additional insulin coverage if required."

A review of the hospital's nursing policy, Medication Administration (revised 1/11) showed conflicting instructions, "Patients shall not be allowed to self-administer any medication brought from home." It also showed guidelines for nurses, "When there is any question about the drug, dose, administration or route the nurse is to take a "time out" and consult with another nurse to verify the subject in question. If another nurse is not available or there is still a question after consulting with the second nurse, the physician is to be called to clarify their order."

The same record review showed a telephone order dated 6/17/11 at 4:30 p.m. from Medical Doctor Y to Licensed Nurse W regarding the insulin pump order, "Clarification...Insulin pump instruction." Both the original order and the clarification order were signed by the Medical Doctor Y and Licensed Nurse W. The nurse had an opportunity to clarify the insulin order during the telephone conversation with the attending physician but did not. There was no explanation in the nursing notes or from staff as to why the order was not clarified in order to meet the safety needs of the patient.

2. On 8/2/11 at 10:40 a.m. during an inspection of the crash cart and emergency supplies in PAR I (Recovery Room) with Pharmacist B and Administrative Nurse E, the crash cart seal number (84462) did not match the crash cart log seal number (84459). During that inspection, Pharmacist B said, "The lock has been changed, it's not my initial." He explained, "I applied lock number 84452 on 7/7/11." In the same interview, Administrative Nurse E said, "I changed it myself on 7/9/11 in order to perform an annual cart comparison." Pharmacist B said he expected nurses to call him to verify the medications and reseal the cart whenever the seal is broken.

On 8/2/11 at 10:50 a.m. during an inspection of the crash cart and emergency supplies in PAR II (Recovery Room) with Pharmacist B and Administrative Nurse E (Registered Nurse), the crash cart seal number (46814) did not match the crash cart log seal number (84526). During the inspections, Pharmacist B said, "I applied lock number 84452 on 7/7/11." In the same interview, Administrative Nurse E said, "I changed it from 84526 to 46814 for inventory to verify ACLS drugs and check airways." ACLS stands for Advanced Cardiac Life Support.

On 8/3/11 at 3:40 p.m. during an inspection of the crash cart in PAR 1 with Pharmacist B and Operating Room Supervisor Nurse P, Pharmacist B looked at the seal of the crash cart and said, "I didn't seal this 0099847." In the same interview, Operating Room Supervisor Nurse P said, "This morning there was a lock here. It was not intact. I replaced it. I failed to notify pharmacy."

A review of the hospital's nursing policy "Checking/Auditing the Crash Carts and Emergency PAR II Drug Supply (revised12/10) instructed nurses to, "Check to ensure that red tamper evident seal is intact and note serial number on checklist. If seal has been broken, check inventory contents of crash cart and replace any missing items and complete R.A.Q. Form. Report any missing medications or IV's to the pharmacist who will then replace the missing medications or IV's." A R.A.Q report is the hospital's incident reporting form.

3. A review of medical records showed Patient 39 was a 45 year old female admitted to the hospital on 4/19/11 for foot surgery. Medical Doctor Y was listed as her admitting physician. Physicians Orders dated 6/17/11 at 3:00 p.m. signed by Medical Doctor Y showed, "Demerol 10 milligrams every 5 minutes for mild to moderate pain (1-6); 20 milligrams every 5 minutes for severe pain (7-10); maximum dose not to exceed [the number "2" followed by illegible overlapping circular marks with a pen]. Demerol is a potent opiate analgesic. The orders were signed by Medical Doctor Y and Operating Room Supervisor P (Registered Nurse). The nurse did not clarify the Demerol order. On 8/2/11 at 2:30 a.m. in an interview, Administrative Nurse E said the orders for Patient 39 should have been clarified because, "You can't tell how much to give and it's a narcotic."

A review of medical records showed Patient 2 was a 39 year old female admitted 10/13/11 for surgery to treat vaginal bleeding caused by uterine tumors. Physicians Orders dated 10/13/10 at 5:05 p.m. signed by the physician showed, "Hydrocodone/APAP 10/325 milligrams 1 tablet by mouth every 4 hours as needed for mild pain" and "Hydrocodone/APAP 10/325 milligrams 2 tablets by mouth every 4 hours as needed for moderate to severe pain." Physicians Orders dated 10/14/10 at 2:00 p.m. signed by the physician showed, "Hydrocodone/APAP 10/325 milligrams 1 tablet by mouth every 4 hours as needed for mild pain" and "Hydrocodone/APAP 10/325 milligrams 2 tablets by mouth every 4 hours as needed for moderate to severe pain."

On 8/2/11 at 2:30 a.m. in an interview, Administrative Nurse E said the orders for Patient 2 should have been clarified because it was impossible for the nurse to consistently choose when to give one tablet of pain medicine or two tablets. Administrative Nurse E elaborated, "There is no way for the nurse to know what constitutes mild pain versus moderate or severe pain if the doctor doesn't write it. It is not on the preprinted order."

A review of medical records showed Patient 12 was a 63 year old male admitted for hip arthritis. Physicians Orders dated 1/25/11 showed incomplete orders for Zofran and Decadron (missing frequency and maximum dose) that were signed by the physician and the nurse but not clarified.

A review of medical records showed Patient 22 was a 59 year old male admitted with a displaced lumbar disc in his back. Physicians Orders dated 3/8/11 showed incomplete orders (missing frequency and maximum dose) for Zofran and Reglan. The orders were signed by Medical Director C on 3/8/11 at 7:30 a.m. and by Licensed Nurse U at 11:15 a.m. The nurse did not clarify the Zofran and Reglan orders.

A review of medical records showed Patient 23 was a 58 year old female admitted with a frozen knee. Physicians Orders dated 7/19/11 showed incomplete orders (missing frequency and maximum dose) for Zofran and Reglan. The orders were signed 7/19/11 at 11:37 a.m. by Medical Director C and by Licensed Nurse U at 11:55 a.m. The nurse did not clarify the Zofran and Reglan orders.

A review of medical records showed Patient 25 was a 62 year old female admitted for surgery. Physicians Orders dated 6/1/11 showed incomplete orders (missing frequency and maximum dose) for Zofran and Reglan. The orders were signed 6/1/11 at 7:30 a.m. by Medical Director C and by Licensed Nurse U at 8:35 a.m. The nurse did not clarify the Zofran and Reglan orders.

A review of medical records showed Patient 38 was a 62 year old male admitted for eye surgery. Physicians Orders dated 5/12/11 showed incomplete orders (missing frequency and maximum dose) for Zofran and Reglan. The orders were signed 5/12/11 at 3:20 p.m. by Medical Director C and by Licensed Nurse U at 4:25 p.m. The nurse did not clarify the Zofran and Reglan orders.

A review of medical records showed Patient 40 was a 40 year old female admitted for bladder cancer surgery. Physicians Orders dated 5/19/11 showed ambiguous orders (the reason the patient needed the medication was not clear) for Tylenol with codeine (a controlled substance pain reliever).The order showed, Tylenol with Codeine 30/325 milligrams 1 to 2 tablets every 6 hours "as needed" . The orders were signed by the nurse and the physician. The nurse did not clarify the indication (reason needed) for the Tylenol with codeine.

A review of medical records showed Patient 3 was an 80 year old male admitted for foot surgery. Physicians Orders dated 5/20/11 showed ambiguous orders (order of choice not clear) for different antiemetics. The orders indicated Reglan was to be administered first, and Decadron was to be administered eighth. The orders were signed 5/20/11 at 4:43 p.m. by Physician G and by Licensed Nurse U at 4:48 p.m. The nurse did not clarify the Zofran and Reglan orders. On 8/2/11 at 10:20 a.m. in an interview, Physician G acknowledged that he, "...intended that to be a two not an eight."

A review of medical records showed Patient 13 was an 83 year old male admitted 4/7/11 with a diagnosis of "Internal Derangement." An incomplete handwritten order (missing dose, route, and duration) showed, "Lovenox post-op." Lovenox prevents deep vein clots. The nurse and physician signed the order but the nurse did not clarify the order.

Based on document review and staff interview, the facility failed to ensure that one of three staff had a current performance evaluation; a complete job description for one of three staff ; and evidence of continuing education maintanence in one of three Human Resources files.

Findings:

The Human Resources (HR) files of the three medial records department employees were reviewed on 8/2/11 beginning at 3:05 p.m. Concurrently, HR Staff K reviewed and confirmed the following findings:

In one file, the most recent performance evaluation was done in May, 2009. HR Staff K stated that they should be done on an annual basis; she checked further with Medical Records Manager J, who did not have a more recent one.

The second file contained a position description for a 0.5 FTE (full-time equivalent) Coder. During an earlier interview with Medical Records Manager J on 8/1/11, she stated this employee worked full-time and also performed appointment scheduling for an outpatient service. An additional position description was not included in her HR file, nor was it in the Medical Records Department Policy and Procedure Manual.

The third file did not contain evidence of the employee's maintainance of continuing education, which is required for her credential. The position description qualifications state that a current credential is required.

Lastly, the Confidentiality Statements for each of these three employees were different versions and two did not include the requirement to keep the computer password/access code confidential. These employees do have access to the facility's computer system containing protected patient information, per interview with Medical Records Manager J on 8/3/11.

Based on interview and record review, the facility failed to ensure that all records were promptly completed when the physician failed to complete the required transfer forms for one of 40 sampled patients. (Patient 4)

Findings:

A review of Patient 4's record disclosed that she was admitted on 3/30/11 for a surgical procedure. Patient 4 developed complications and was transferred to another facility on 4/2/11. The physician failed to complete certain portions of the facility's transfer form that included an updated status of the patient's condition and summary of risks and benefits.

A review of the facility's policy titled, "Transferring Patients", last revised 09/09, required the physician certification "form 9-5" to be completed by the physician.

During an interview on 8/1/11 at 3:15 pm, Administrative Staff A and Licensed Nurse D both confirmed that the physician's certification "form 9-5" had not been completed and was missing the updated patient's condition and a summary of the risks and benefits.

Based on medical record and document review and staff interview, the facility failed to ensure that medical record entries were legible because abbreviations were used that were not included in the approved abbreviation list; and that pre-printed orders for influenza vaccine and transfusion information and consent forms were not authenticated by the physician in 5 of 6 records.

Findings:

Medical records were reviewed on 8/2/11. The following findings were discussed with and confirmed by Medical Records Manager J on 8/3/11 beginning at 10:50 a.m.

1. Abbreviations (SSF, MUA, and VB) were used in entries in Records 20, 23, and 25, respectively. The abbreviations were not on the approved abbreviation list, last revised 6/11.

2. The Transfusion Information and Consent form was not signed by the physician in the pre-printed space (Records 20, 21, 22, 23). The forms were signed by the patients. The policy and procedure on Transfusion Information & Consent, last revised 7/08 states: "...This discussion should be documented, either by means of the physician's signed chart note in the patient's medical record, the History and Physical, or, if preferred, by a consent form signed by the patient."

3. The Standing Physician Order-Influenza Vaccination Adult was not signed by the physician in Record 20.

Based on interview and record review, the facility failed to ensure that all verbal orders by the physician were signed within 48 hours for one of 40 sampled patients. This had the potential to result in an incorrect or unclear order. (Patient 4)

Findings:

A review of Patient 4's record disclosed that two sets of verbal orders by the physician, including orders for intravenous fluids, were given on 4/2/11 and not signed until four days later on 4/6/11.

During an interview on 8/1/11 at 3:25 pm, Medical Record Manager J confirmed that the orders on 4/2/11 had not been signed by the physician until 4/6/11.

The facility policy titled "Medication," last revised 1/11, read as follows, "Telephone and verbal orders shall be verified and authenticated by either the attending or covering physician or another practitioner responsible for the care of the patient within 48 hours".

Based on interview and record review the hospital failed to ensure for one of 40 sampled patients that all radiology reports necessary to monitor the patient's condition were complete when a record did not contain a copy of an x-ray as indicated in the physician's report. (Patient 30) This failure could result in incomplete patient information that could jeopardize patient treatment.

Findings:

On 8/3/11 Patient 30's record was reviewed. Patient 30 was admitted for an outpatient procedure on 5/2/11. The physician's procedure report, dated 5/2/11, documented that Patient 30 had an injection in the shoulder and that "an image of the needle placement would be placed in record." The record did not contain evidence that an image of the 5/2/11 needle placement had been placed in the record.

On 8/3/11 at 3:45 pm, Medical Records Manager J acknowledged the above finding.

Based on document and medical record review and staff interview, the facility failed to ensure that all records documented a discharge summary/final progress note in 2 of 6 records.

Findings:

On 8/2/11, records were reviewed. In Record 21, the latest physician progress note was made right after surgery at 10 a.m.; however, the patient was not discharged until 1:30 p.m. In Record 23, the latest physician progress note was made at 1 p.m.; the patient stayed for 23-hour observation and was discharged the next day at 9 a.m. Both records contained a Post Operative Progress Note form, which has a statement pre-printed at the bottom, saying: "Final Progress Note: Condition on discharge & instructions to patient should be noted."

On the morning of 8/3/11, Medical Records Manager J confirmed that both records lacked a complete final progress note.

Based on observation, interview and document review, the hospital failed to ensure pharmaceutical services meet the needs of patients as evidenced by:

1. The pharmacy service did not utilize hospital-wide data on retrospective drug regimen reviews to analyze ways to reduce medication errors. The review of DUE (Drug Usage Evaluations) was missed as an opportunity for improvement. The need for Physicians Orders clarifications was not identified as a problem prone area. (Refer to A263)

2. Expired lidocaine and Levophed (life-saving medications used in conjunction with cardiopulmonary resuscitation) was available for patient use in 2 of 2 Operating Rooms contrary to the manufacturers' specifications and state requirements. (Refer to A491)

3. Monthly inspections of the drug storage areas were not conducted for 3 of 7 months reviewed in 4 medication storage areas (Medical Surgical unit, Operating Room 1, Operating Room 2, and PAR 1 (Recovery Room) in accordance with state requirements and accepted standards of practice. (Refer to A491)

4. Access to medication storage areas was not limited to authorized personnel in accordance with hospital policy, state, and federal requirements. (Refer to A491 and A504)

5. Emergency Crash Carts were not sealed by a pharmacist with tamperproof seals in accordance with the hospital's policy for "Checking/Auditing the Crash Carts and the Emergency PAR II Drug Supply and in accordance with state requirements. (Refer to A491)

6. Insulin, a hormone medication used to lower blood sugar levels, identified by the hospital as a High Alert/High Risk medication, was prescribed and administered to Patient 11 contrary to the hospital's policies for High Alert Medication, Medication Administration; and Personal Insulin Pumps. (Refer to A500)

7. Incomplete Physicians Orders were not clarified by the pharmacist for 9 patients (Patient 11, Patient 2, Patient 22, Patient 23, Patient 25, Patient 38, Patient 40, Patient 3, and Patient 13) in accordance with the hospital's policy, Medication Administration or DUE (Drug Usage Evaluation) process. (Refer to A500)

8. The pharmacy service did not ensure that medical staff predetermined a time to automatically stop drugs from being used for patients whenever the drugs were not specifically prescribed as to number of doses or days (duration of therapy). (Refer to A507)

9. The Pharmacist in Charge (Pharmacist B) did not effectively supervise and coordinate all of the activities of the pharmacy services to ensure patient safety in the administration of medications. (Refer to A492)

The cumulative effects of these systemic problems resulted in the hospital's inability to ensure the provision of safe and effective drugs to meet the needs of the hospital's patients.

Based on observation, interview and record review, the pharmacy storage area was not administered in accordance with accepted professional principles as evidenced by the following:

1. Expired lidocaine (a medication used to decrease irregular cardiac heartbeats) was available in the drug distribution system for patient use in 2 of 2 Operating Rooms contrary to the manufacturers' specifications and professional principles.

2. Monthly inspections of the drug storage areas were not conducted for 3 of 7 months reviewed in 4 medication storage areas (Medical Surgical unit, Operating Room 1, Operating Room 2, and PAR 1 [Recovery Room] in accordance with accepted standards of practice and hospital policies.

3. Access to medication storage areas was not limited to authorized personnel in accordance with professional principles.

4. Emergency Crash Carts were not sealed by a pharmacist with tamperproof seals in accordance with the hospital's policy for "Checking/Auditing the Crash Carts and the Emergency PAR II Drug Supply and in accordance with state requirements.

The hospital's failure to control drug distribution in accordance with their policies had the potential to result in serious patient harm from treatment delay during administration of emergency medications and from loss of control of the drug supply.

Findings:

1. On 8/2/11 at 4:35 p.m. during an inspection of Operating Room 2, Operating Room Supervisor Nurse P (Registered Nurse) opened the anesthesia cart. The cart contained a syringe of lidocaine 2 percent, 100 milligrams per 5 milliliters, with a manufacturer's expiration date of 8/1/11. On 8/2/11 at 4:40 p.m. during an inspection of Operating Room 1, Operating Room Supervisor Nurse P (Registered Nurse) opened the anesthesia cart. The cart contained a syringe of lidocaine 2 percent, 100 milligrams per 5 milliliters, with a manufacturer's expiration date of 8/1/11.

A review of the hospital's policy, Drug Storage (revised 3/10) indicated, "Drugs shall not be kept in stock after the expiration date on the label, and no contaminated or deteriorated drugs shall be available."

2. On 8/2/11 Administrative Staff A provided records of Monthly Inspection of Drug Storage Areas by Consultant Pharmacist between 4/7/11 and 7/31/11. Documentation for monthly inspections was missing from the following areas: Medical Surgical unit (February); Operating Room 1 (February and March); Operating Room 2 (March and April); PAR 1 (Recovery Room) (February); and PAR 2 (February).

A review of the hospital's policy, Pharmacist Monthly Inspection (revised 3/11) showed records were maintained in the Administrator's office and that, "Records of these inspections must be kept on file for at least three years." The policy showed, "Drugs and drug storage areas maintained in this hospital are inspected at least monthly by the Pharmacist in Charge ...Reports of these inspections are submitted monthly by the Pharmacist in Charge."

On 8/2/11 at 10:45 a.m. in an interview, Pharmacist B was asked to describe his process for inspecting the drug supply in the Operating Room. He said, "I don't check the Operating Room - it's sterile." Pharmacist B did not demonstrate his competency with regard to performing monthly inspections as he was unaware that Operating Rooms are not sterile or off limits between surgical cases.

On 8/2/11 at 5:00 p.m. in an interview, Administrative Staff A was unable to account for the missing monthly inspections. She explained that oversight of those inspections had been recently reassigned to a new employee Administrative Nurse E (Registered Nurse Administrator) but had not been well communicated. In the same interview, Administrative Nurse E said, "I just found out about it." When asked who was assigned prior to Administrative Nurse E to ensure the pharmacist performed the monthly inspections, Administrative Staff A said, [Licensed Nurse X] (Licensed Vocational Nurse). Administrative Staff A made this assignment on 12/14/10 as a part of a Plan of Correction subsequent to a state survey where a plan of correction was required which involved the emergency drug supply. Administrative Staff A explained that, at the time, she did not have a Nurse Administrator, and staffing had been extremely difficult for a prolonged period. She said the Licensed Vocational Nurse (Licensed Nurse X) was conscientious and the best qualified person to monitor the inspections. She acknowledged that Licensed Nurse X wore many hats - Licensed Vocational Nurse, Pharmacy Assistant, and Clinical Care Coordinator.

3. On 8/2/11 at 9:30 a.m. during an inspection of the hospital's drug supply in the Drug Room located in the Medical Surgical unit, Pharmacist B borrowed keys from a nurse in order to perform a physical inventory of medications.

On 8/3/11 at 11:05 a.m. during an inspection of the hospital's drug supply in the Overflow Drug Storage Area located across the street from the main hospital, Pharmacist B borrowed keys from Licensed Nurse X.

On 8/3/11 at 1:05 p.m. Pharmacist B borrowed keys from Licensed Nurse X to access Vicodin stock in an Overflow Drug Storage cabinet in Administrative Staff A's office. In an interview at that time, the surveyor asked Pharmacist B why he had to borrow keys to access the medication storage areas. Pharmacist B said, "I refuse to carry keys because of loss. It's a liability issue."

A review of the hospital's policy, Access to Drug Storage and Keys, indicated pharmacists were not authorized to have access to the Drug Room or the Overflow Drug Storage Area but a Licensed Vocational Nurse was authorized. According to the hospital's policy, a pharmacist was authorized to access to the drug supply for the crash carts and malignant hyperthermia cart, but not the Operating Room Mobile Carts, PAR I and PAR II (Recovery Rooms), Diabetic Kit or the Medication Refrigerator in PAR II. The policy did not address which categories of personnel were authorized to access the drug supply in the cabinet in the administrator's office. The policy further showed, "Drug storage keys will only be given to personnel authorized to use them."

On 8/3/11 at 1:10 p.m. in an interview, Administrative Staff A was unable to provide a policy which allowed Pharmacist B access to the Drug Room, the Overflow Storage Room across the street, or the Overflow drug storage cabinet in her office. She said, "The policies don't show where he is allowed access to those areas."

4. On 8/2/11 at 10:40 a.m. during an inspection of the crash cart and emergency supplies in PAR I (Recovery Room) with Pharmacist B and Administrative Nurse E, the crash cart seal number (84462) did not match the crash cart log seal number (84459). During that inspection, Pharmacist B said, "The lock has been changed, it's not my initial. He explained, "I applied lock number 84452 on 7/7/11." In the same interview, Administrative Nurse E said, "I changed it myself on 7/9/11" in order to perform an annual cart comparison." Pharmacist B said he expected nurses to call him to verify the medications and reseal the cart whenever the seal is broken.

On 8/2/11 at 10:50 a.m. during an inspection of the crash cart and emergency supplies in PAR II (Recovery Room) with Pharmacist B and Administrative Nurse E (Registered Nurse), the crash cart seal number (46814) did not match the crash cart log seal number (84526). During the inspections, Pharmacist B said, "I applied lock number 84452 on 7/7/11." In the same interview, Administrative Nurse E said, "I changed it from 84526 to 46814 for inventory to verify ACLS drugs and check airways." ACLS stands for Advanced Cardiac Life Support.

On 8/3/11 at 3:40 p.m. during an inspection of the crash cart in PAR 1 with Pharmacist B and Operating Room Supervisor Nurse P, Pharmacist B looked at the seal of the crash cart and said, " I didn't seal this 0099847." In the same interview, Operating Room Supervisor Nurse P said, "This morning there was a lock here. It was not intact. I replaced it. I failed to notify pharmacy."

A review of the hospital's nursing policy Checking/Auditing the Crash Carts and Emergency PAR II Drug Supply (revised12/10) showed, "The emergency drug supplies shall be stored in clearly marked portable containers which are sealed by the pharmacist in such a manner that a seal must be broken to gain access to the drugs."

California Code of Regulations Division 5, section 70263(f)(2) requires, "The emergency drug supply shall be stored in a clearly marked portable container which is sealed by the pharmacist in such a manner that a seal must be broken to gain access to the drugs."

Based on observation, interview and record review, between 5/3/10 and 8/2/11, Pharmacist B did not effectively coordinate activities of the pharmacy services. These services related to: the hospital's quality assurance and performance improvement plan (QAPI); provision of recommendations to hospital leadership, competency to identify and prevent medication errors; access to drug storage areas, maintenance of drug storage areas; maintenance of the emergency drug supply; recordkeeping requirements for drugs including controlled substances; implementation of pharmacy-related policies and procedures; maintenance of preprinted medication orders; and performance of duties required by the pharmaceutical services agreement with the hospital. The hospital's failure had the potential to expose all patients to adverse outcomes and preventable medication errors throughout the hospital.

Findings:

On 8/3/11 at 3:40 in an interview, Pharmacist B was provided a list of the hospital's QAPI which included five defined pharmacy QAPI activities. Pharmacist B held the hospital's written QAPI plan and said, "I've never seen this before." Pharmacist B was provided 10 samples of DUEs (Drug Usage Evaluation) he performed and was asked to provide an example of how his recommendations from the DUEs contributed to reducing the potential for medication errors. Pharmacist B was unable to provide an example.

On 8/3/11 at 3:40 p.m. in an interview, Pharmacist B discussed how a physician requested expired Levophed be left on the carts "as it would still be effective." Pharmacist B said he was not aware of patient safety and compliance issues of stocking expired Levophed. He said he did not discuss or provide advice to medical staff that stocking Levophed was contrary to hospital policy, manufacturer's guidelines, and state requirements. A review of Quality Assurance Interdisciplinary Committee minutes (dated 5/12/11) showed a discussion that the medical staff approved using expired Levophed vials in crash carts. Pharmacist B said expired Levophed vials were maintained in the drug distribution system for about three weeks before he replaced them. MD 1 (Physician) confirmed in an interview on 8/3/11 at 4:00 p.m. that he attended the meeting and Pharmacist B did not have input.

On 8/3/11 at 3:40 in an interview, Pharmacist B was asked to show how his activities potentially identified or reduced medication errors in the hospital. He said, "We've only had three this year." The surveyor confirmed the hospital performs approximately 2800 surgical cases annually. He was unable to recall whether the hospital increased their surveillance measures in response to the number of errors reported.

Pharmacist B did not identify medication errors or report irregularities during a retrospective drug review when a patient's own insulin pump was prescribed and administered to Patient 11 contrary to the hospital's policies for High Alert Medication, Medication Administration; and Personal Insulin Pumps. Pharmacist B did not demonstrate competency to clarify incomplete or ambiguous Physicians Orders for 8 patients (Patient 2, Patient 22, Patient 23, Patient 25, Patient 38, Patient 40, Patient 3, and Patient 13) when he had opportunities to do so. (Refer to A500)

On 8/3/11 at 11:05 a.m. during an inspection of the hospital's drug supply Pharmacist B was unable to access medication stock and disposition records stored without borrowing keys. The hospital's policy Access to Drug Storage and Keys showed that Pharmacist B was not authorized to have keys to drug storage areas. Pharmacist B did not coordinate with hospital administration to ensure access to medication storage areas was limited to authorized personnel in accordance with hospital policy, state, and federal requirements.

On 8/2/11 at 9:30 a.m. in an interview, Administrator 1 verified that the following monthly inspections from 2011 were not conducted: Medical Surgical unit (February); Operating Room 1 (February and March ); Operating Room 2 (March and April); PAR 1 (Recovery Room) (February); and PAR 2 (February). A review of the pharmacist contract showed the inspections were to be maintained for 3 years. Pharmacist B and Administrator A did not provide the missing monthly inspections during the survey.

On 8/2/11 at 4:35 p.m. during an inspection of Operating Room 2, Operating Room Supervisor Nurse P (Registered Nurse) opened the anesthesia cart. The cart contained a syringe of lidocaine 2 percent, 100 milligrams per 5 milliliters, with a manufacturer's expiration date of 8/1/11. On 8/2/11 at 4:40 p.m. during an inspection of Operating Room 1, Operating Room Supervisor Nurse P (Registered Nurse) opened the anesthesia cart. The cart contained a syringe of lidocaine 2 percent, 100 milligrams per 5 milliliters, with a manufacturer's expiration date of 8/1/11.

Pharmacist B did not coordinate activities to maintain a system for ensure Emergency Crash Carts were sealed by a pharmacist with tamperproof seals in accordance with the hospital's policy for a period of eight months in accordance with hospital policy and state requirements. (Refer to A491)

Pharmacist B did not ensure a monitoring system was in place to ensure: portable emergency containers with medications were sealed by a pharmacist; that nurses reported to the pharmacist whenever tamper-evident seals were broken; and that serial numbers on crash cart logs matched seals on crash carts. (Refer to A500)

On 8/2/11 a physical inventory of Vicodin 5/500 milligrams and Vicoprofen (both controlled substance painkiller) was conducted in the drug room in the Medical Surgical unit. There were 24 tablets of Vicodin and 34 tablets of Vicoprofen on hand in the physical inventory. Pharmacist B was asked to demonstrate control of the drug supply for the two items between the date of the last federally mandated biennial inventory (5/12/10) and the present day (8/2/11). Biennial refers to "every other year". A review of the biennial inventory dated 5/12/10 showed the hospital had a beginning inventory of 202 Vicodin 5/500 milligram tablets and a beginning inventory of 40 Vicoprofen tablets. The hospital was unable to account for the control of the two items from receipt to final distribution during the survey.

The hospital was unable to demonstrate they had an ongoing recordkeeping system to account for 42 tablets of Vicodin using wholesaler, disposition, and destruction/return records during the survey. On 8/3/11 at 1:05 p.m. in an interview, Pharmacist B said, "Licensed Nurse X found them" [referring to the Vicodin tablets] but he did not provide the documents to the surveyor. At the exit conference, a request was made for the records from Administrative Nurse E. On 8/9/11, Administrative Nurse E provided summary documents via facsimile supporting the hospital's position that the hospital verified a complete accounting of Vicodin 5/500 milligrams. In a telephone interview on 8/9/11 at 10:00 a.m. Administrative Nurse E explained that the faxed documents showed where the additional 42 tables of Vicodin 5/500 milligrams were dispensed to the Drug Room on the following dates: 5/13/10 (22 tablets), 8/23/10 (10 tablets), and on 12/13/10 (10 tablets).

On 8/3/11 at 9:45 a.m. in an interview, Pharmacist B indicated the current Automatic Stop Order policy did not cover all the drug categories of the medications administered in the hospital. He acknowledged that he never discussed the hospital's policy with hospital leadership and/or administration. He elaborated, "Nobody asked me to." (Refer to A507)

When he reviewed an insulin order for Patient 11, Pharmacist B did not implement the hospital's policies for High Alert Medication, Medication Administration; and Personal Insulin Pumps. Insulin is a hormone medication used to lower blood sugar levels. During DUEs, (another type of retrospective drug review), Pharmacist B did not clarify incomplete and ambiguous preprinted and handwritten Physicians Orders for 9 patients (Patient 39, Patient 2, Patient 22, Patient 23, Patient 25, Patient 38, Patient 40, Patient 3, and Patient 13) in accordance with the hospital's policy, Medication Administration or Drug Usage Evaluation (DUE) process.

On 8/2/11 at 9:30 a.m. in an interview, Pharmacist B was asked to provide logs of his visits and activities as required by his contract. Pharmacist B said he kept a log of his visits but that they only included dates, not activities or times. Logs were not provided during the survey.

On 8/2/11 at 10:19 a.m. in an interview, Pharmacist B said, "I don't know about the condition or standards on federal surveys." (Refer to A0083)

Based on observation, interview and record review, the hospital failed to keep current and accurate records of the receipt through disposition of Vicodin 5/500 milligrams (a controlled substance painkiller). The hospital's failure to maintain readily retrievable systems of recordkeeping prevented them from accounting for a stock of 42 tablets of a controlled substance for 7 days.

Findings:

On 8/2/11at 9:30 a.m. a physical inventory of Vicodin 5/500 milligrams and Vicoprofen 7.5/200 milligrams (a controlled substance painkiller) was conducted in the drug room in the Medical Surgical unit. There were 24 tablets of Vicodin and 34 tablets of Vicoprofen on hand in the physical inventory. Pharmacist B was asked to demonstrate control of the drug supply for the two items between the date of the last biennial inventory (5/12/10) and the present day (8/2/11). A review of the biennial inventory dated 5/12/10 showed the hospital had a beginning inventory of 202 Vicodin 5/500 milligram tablets and a beginning inventory of 40 Vicoprofen tablets. The hospital was unable to account for the control of the two items from receipt to final distribution during the survey.

On 8/3/11 at 1:05 p.m. in an interview, Pharmacist B said, "Licensed Nurse X found them" but the hospital did not provide records to demonstrate where they were found. At the exit conference, the records were requested from Administrative Nurse E. On 8/9/11 Administrative Nurse E provided summary documents via facsimile supporting the hospital's position that a complete accounting of Vicodin 5/500 milligrams had been verified. In a telephone interview on 8/9/11 at 10:00 a.m. Administrative Nurse E indicated that an additional 42 tables of Vicodin 5/500 milligrams had been dispensed to the Drug Room on the following dates: 5/13/10 (22 tablets), 8/23/10 (10 tablets), and on 12/13/10 (10 tablets).

Based on interview and record review, the hospital failed to ensure patient safety as they failed to ensure medications were prescribed and clarified in accordance with the hospital's policy and according to standards of practice between 3/8/11 and 10/3/11 for 9 sampled patients (Patient 11, Patient 2, Patient 22, Patient 23, Patient 25, Patient 38, Patient 40, Patient 3, and Patient 13). The hospital's census was 1. The hospital's failure to ensure that all mediation orders were complete had the potential to result in adverse outcomes for these patients as a result of preventable medicaiton errors.

Definition: A "complete" order refers to one which has all the necessesary components as required by regulations or the facility policy (e.g. medication name, strength, dose, route, instructions, and authorized prescriber).

Findings:

A review of medical records showed Patient 11 was a 67 year old man admitted to the hospital on 6/17/11 for surgery to his left foot. Medical Doctor Y (a podiatrist) was listed as his admitting physician. Physicians Orders dated 6/17/11 at 3:00 p.m. signed by Medical Doctor Y showed, "Okay to use and administer own insulin via patient insulin pump." The order was signed by Medical Doctor Y and Licensed Nurse W and was initialed by Pharmacist B.

A review of the hospital's policy, High Alert Medication (revised 10/09) showed insulin was identified by the hospital as a High Alert medication. The hospital defined, "High alert drugs are those that require special handling due to a narrow therapeutic index, multiple drug/disease state interactions, severe life-threatening side effects, psychotherapeutic drugs, or require special monitoring before, during or after the administration of the drug." The policy also indicated, "All medication orders should be reviewed for appropriateness and safety before the first dose is administered ...."

A review of the hospital's policy, Medication Administration (revised 1/11) indicated, "All drugs will be administered.... in accordance with the approved medical staff policies and procedures." The policy indicated, "Patients shall not be allowed to self-administer any medication brought from home."

A review of the hospital's policy, Personal Insulin Pumps (dated 9/06) indicated the physician's order for the personal insulin pump shall include: type of insulin, basal rate, bolus doses (one time dose), frequency of monitoring, and additional insulin coverage if required.


On 8/3/11 at 1:05 p.m. in an interview, Pharmacist B verified that he received and reviewed the insulin order for Patient 11, "because those are my initials." Pharmacist B could not recall what time or day he reviewed the order, explaining, "I don't keep a log." The order had a preprinted stamp which indicated, "Faxed to pharmacy" but there was no date or time associated with the pharmacist's review. Pharmacist B acknowledged that Patient 11's insulin orders were for self-administration through a device provided by the patient. Pharmacist B acknowledged the order did not list the type of insulin, basal rate, bolus, or frequency of monitoring or coverage as required by policy. Pharmacist B did not demonstrate competency with regard to his responsibility for ensuring medication errors related to policy failures with self-administered medications were addressed to prevent similar events in the future.

A review of medical records showed Patient 2 was a 39 year old female admitted 10/13/11 for surgery to treat vaginal bleeding caused by uterine tumors. Physicians Orders dated 10/13/10 at 5:05 p.m. signed by the physician showed, "Hydrocodone/APAP 10/325 milligrams 1 tablet by mouth every 4 hours as needed for mild pain" and "Hydrocodone/APAP 10/325 milligrams 2 tablets by mouth every 4 hours as needed for moderate to severe pain." Physicians Orders dated 10/14/10 at 2:00 p.m. signed by the physician showed, "Hydrocodone/APAP 10/325 milligrams 1 tablet by mouth every 4 hours as needed for mild pain" and "Hydrocodone/APAP 10/325 milligrams 2 tablets by mouth every 4 hours as needed for moderate to severe pain." A preprinted stamp showed, "Faxed to Pharmacy Initials" and were initialed by Pharmacist B.
On 8/3/11 at 1:05 p.m. in an interview, Pharmacist B indicated he had an opportunity to clarify the order but did not. A review of Medication Administration Records showed Patient 2 received four doses of Hydrocodone/APAP 10/325 milligrams on 10/13/10.

On 8/2/11 at 2:30 a.m. Administrative Nurse E said the orders for Patient 2 should have been clarified because it was impossible for the nurse to consistently choose when to give one tablet of pain medicine or two tablets. Administrative Nurse E elaborated, "There is no way for the nurse to know what constitutes mild pain versus moderate or severe pain if the doctor doesn't write it. It is not on the preprinted order."

A review of medical records showed Patient 22 was a 59 year old male admitted with a displaced disc in his back. Physicians Orders dated 3/8/11 showed incomplete orders (missing frequency and maximum dose) for Zofran and Reglan. The orders were signed by Medical Director C on 3/8/11 at 7:30 a.m. and by Licensed Nurse U at 11:15 a.m. The nurse did not clarify the Zofran and Reglan orders. Pharmacist B did not review the order.

A review of medical records showed Patient 23 was a 58 year old female admitted with a frozen knee. Physicians Orders dated 7/19/11 showed incomplete orders (missing frequency and maximum dose) for Zofran and Reglan. The orders were signed 7/19/11 at 11:37 a.m. by Medical Director C and by Licensed Nurse U at 11:55 a.m. The nurse did not clarify the Zofran and Reglan orders.

A review of medical records showed Patient 25 was a 62 year old female admitted for surgery. Physicians Orders dated 6/1/11 showed incomplete orders (missing frequency and maximum dose) for Zofran and Reglan. The orders were signed 6/1/11 at 7:30 a.m. by Medical Director C and by Licensed Nurse U at 8:35 a.m. The nurse did not clarify the Zofran and Reglan orders.

A review of medical records showed Patient 38 was a 62 year old female admitted for eye surgery. Physicians Orders dated 5/12/11 showed incomplete orders (missing frequency and maximum dose) for Zofran and Reglan. The orders were signed 5/12/11 at 3:20 p.m. by Medical Director C and by Licensed Nurse U at 4:25 p.m. The nurse did not clarify the Zofran and Reglan orders.

A review of a Drug Usage Evaluation (DUE) dated 6/2/11 showed the results of a focused review of Patient 38's medication orders by Pharmacist B. The evaluation showed there were no "...variations from hospital, pharmacy or manufacturer criteria for use" and that, "medication orders are written properly". Pharmacist B documented that there were no nursing or medical staff related issues with the review.

On 8/3/11 at 1:05 p.m. in an interview, Pharmacist B said, "I don't review anesthesia or recovery orders. They don't send me those." When shown Patient 38's Zofran and Reglan orders and DUE, Pharmacist B said, "Yes, those should have been clarified." The DUE was reviewed and signed 6/2/11 by Licensed Nurse X (Licensed Vocational Nurse/Clinical Care Coordinator) who did not document that "appropriate follow-up was completed" or comment one way or the other on Pharmacist B's reviews.

A review of medical records showed Patient 40 was a 40 year old female admitted for bladder cancer surgery. Physicians Orders dated 5/19/11 showed ambiguous orders (the reason the patient needed the medication was not clear) for Tylenol with codeine (a controlled substance pain reliever). The order showed, Tylenol with Codeine 30/325 milligrams 1 to 2 tablets every 6 hours "as needed." The orders were signed by the nurse and the physician. The nurse did not clarify the indication (reason needed) for the Tylenol with codeine. A preprinted stamp showed, "Faxed to Pharmacy Initials" signed by Pharmacist B. On 8/3/11 at 1:05 p.m. in an interview, Pharmacist B indicated he had an opportunity to clarify the order but did not.

A review of the hospital's policy, Medication Administration (revised 1/11) showed, "PRN orders must include dosage parameters and the indications for the medication, i.e., "q 4 hours prn nausea." note: PRN (pro re nata) is Latin shorthand used in medical prescriptions which means, "as needed."

A review of a DUE dated 6/2/11 showed the results of a focused review of Patient 40's medication orders by Pharmacist B. The evaluation showed there were no "...variations from hospital, pharmacy or manufacturer criteria for use" and that, "medication orders are written properly. Pharmacist B documented that there were no nursing or medical staff related issues with the review. It was signed by Licensed Nurse X.

A review of medical records showed Patient 3 was an 80 year old male admitted for foot surgery. Physicians Orders dated 5/20/11 showed ambiguous orders (order of choice not clear) for different antiemetics. The orders indicated Reglan was to be administered first, and Decadron was to be administered eighth. The orders were signed 5/20/11 at 4:43 p.m. by Physician G and by Licensed Nurse U at 4:48 p.m. The nurse did not clarify the Zofran and Reglan orders. On 8/2/11 at 10:20 a.m. in an interview, Physician G acknowledged that he, "...intended that to be a two not an eight."

A review of medical records showed Patient 13 was an 83 year old male admitted 4/7/11 with a diagnosis of "Internal Derangement." An incomplete handwritten order (missing dose, route, and duration) showed, "Lovenox post-op." Lovenox is a medication used to prevent deep vein clots. The nurse and the pharmacist did not clarify the order.

A review of a DUE dated 4/7/11 showed the results of a focused review of Patient 13's medication orders by Pharmacist B. The evaluation showed there were no "...variations from hospital, pharmacy or manufacturer criteria for use" and that, "medication orders are written properly. Pharmacist B documented that there were no nursing or medical staff related issues with the review. It was signed by Licensed Nurse X. Pharmacist B and Licensed Nurse X did not demonstrate competency with regard to their responsibility for ensuring medication errors were identified and addressed to prevent similar events in the future.

Based on observation, interview and record review the hospital failed to ensure that only authorized personnel may have access to locked areas in the hospital where medications are stored. The hospital's failure to develop policies and procedures which prevent unauthorized access placed patients at risk for adverse events from loss of control of the drug supply.

Findings:

On 8/2/11 at 9:30 a.m. during an inspection of the hospital's drug supply in the Drug Room located in the Medical Surgical unit, Pharmacist B was unable to access medication stored there areas because he said he didn't have keys. Pharmacist borrowed keys from a nurse in order to perform a physical inventory of Vicodin and Vicoprofen 7.5/200 milligrams (controlled substance opiate analgesic pain relievers).

On 8/3/11 at 11:05 a.m. during an inspection of the hospital's drug supply in the Overflow Drug Storage Area located across the street from the main hospital, Pharmacist B borrowed keys from Licensed Nurse X (Licensed Vocational Nurse). When asked if the area contained a log for expired meds, Pharmacist B said, "I don't know where she keeps it." Pharmacist B explained, "I know it's locked up but I don't have control. I don't have a key."

8/3/11 at 1:05 p.m. Licensed Nurse X was observed opening the cabinet containing controlled substances for Pharmacist B.

A review of the hospital's policy, Access to Drug Storage and Keys, indicated pharmacists were not authorized to have access to the Drug Room or the Overflow Drug Storage Area. According to the hospital's policy, a pharmacist was authorized to access to the drug supply for the crash cart and malignant hyperthermia cart, but not the Operating Room Mobile Carts, PAR I and PAR II (Recovery Rooms), Diabetic Kit or the Medication Refrigerator in PAR II. The policy did not address which categories of personnel who were authorized to access the drug supply in the cabinet in the administrator's office. The policy further showed, " Drug storage keys will only be given to personnel authorized to use them."

Based on observation, interview, and record review, the facility failed to ensure that expired lidocaine, a life-saving medication used in conjunction with cardiopulmonary resuscitation, was not available for patient emergencies in 2 of 2 Operating Rooms. The hospital's failure to remove expired medications from patient care areas in accordance with facility policies and procedures placed patients receiving surgical services at risk for treatment delay or death resulting from fatal heart rhythms (e.g. ventricular fibrillation or pulseless ventricular tachycardia).

Findings:

On 8/2/11 at 4:35 p.m. during an inspection of Operating Room 2, Operating Room Supervisor Nurse P (Registered Nurse) opened the anesthesia cart. The cart contained a syringe of lidocaine 2 percent, 100 milligrams per 5 milliliters, with a manufacturer's expiration date of 8/1/11. In an interview at that time, Operating Room Supervisor Nurse P said, "This is expired." She indicated that a pharmacist checks the drug supply in the Anesthesia Carts "every month".

On 8/2/11 at 4:40 p.m. during an inspection of Operating Room 1, Operating Room Supervisor Nurse P (Registered Nurse) opened the anesthesia cart. The cart contained a syringe of lidocaine 2 percent, 100 milligrams per 5 milliliters, with a manufacturer's expiration date of 8/1/11.

A review of the hospital's policy, Drug Storage (revised 3/10) indicated, Drugs shall not be kept in stock after the expiration date on the label, and no contaminated or deteriorated drugs shall be available."

Based on interview and record review the hospital failed to ensure the medical staff predetermined a reasonable time to automatically stop drugs from being used for patients whenever the drugs were not specifically prescribed as to number of doses or days (duration of therapy). The hospital's failure placed patients at risk for adverse consequences from medication errors resulting from administration of unnecessary medications.

Findings:

On 8/2/11 at 10:20 Administrative Nurse E provided the hospital's policy, Automatic Stop Orders (revised 10/06), it showed, "Automatic stop order for certain classes of medications have been established by the Medical Staff." The categories listed included: controlled substances, antibiotics, hypnotics (sleeping medicines), anticoagulants (blood thinners), barbiturates (sedatives and anesthetics), oxytoxics (hormones), steroids (anti-inflammatories), and antineoplastics (chemotherapy).

A review of the hospital's policy, High Alert Medication (revised 10/09) listed, among others, insulin, antipsychotics, pediatric medications, total parenteral nutrition (TPN), calcium chloride, magnesium sulfate, potassium chloride, and intravenous promethazine. Staff could not recall the last time they had a surgical patient requiring TPN, antipsychotics or intravenous promethazine.

Classes of therapeutic or pharmacologic medications have been developed by professional associations which reflect the Food and Drug Administration's required package labeling. The American Hospital Formulary System (AHFS) lists 275 separate therapeutic categories (www.lexicomp.com ). For example, insulin is a blood sugar level lowering medication which is listed in the AHFS classification "insulin" therapeutic category. Antipsychotics are medications used to treat schizophrenia which are listed in the AHFS classification "antipsychotics-miscellaneous" category. Lexicomp, a drug monograph publication, lists calcium chloride, magnesium sulfate and potassium chloride in the pharmacologic category, "parenteral electrolyte supplements".

On 8/3/11 at 9:45 a.m. in an interview, Pharmacist B indicated the current Automatic Stop Order policy did not cover all the drug categories of the medications administered in the hospital. He acknowledged that he never discussed the hospital's policy with hospital leadership and/or administration. He elaborated, "Nobody asked me to."

Based on observation, interview, and record review, the hospital failed to ensure that all hospital employees who may be regularly exposed to radiation (five staff that worked in operation rooms) were checked for exposure to radiation by use of exposure meters or radiation detection badge tests (monitoring cumulative exposure to ionizing radiation. The badge consists of two parts: picture film and a holder. The film is removed and developed to measure exposure.) This failure could result in employees being exposed to unknown amounts of radiation which could adversely impact the health of individuals.

Findings:

The operation room (OR) staff (scrub technicians, nurses and surgeons) was observed multiple times during the survey between 8/1 and 8/4/11. None of the OR staff was observed to be wearing a radiation detection badge. It was observed that OR 1 and 2, and Rooms 9 and 10 had radiation detection badges clipped to clocks that hung on the wall.

On 8/3/11 at 10 am, OR Supervisor Nurse (ORSN) P stated that x-rays were taken in the OR for knee surgeries and spinal testing and that fluoroscopy (shows a continuous x-ray image on a monitor, like an x-ray movie) was also performed in the OR for injections and spinal surgery. She stated that when x-ray or fluoroscopy was used in the OR, that staff was instructed to move behind a shield (wall with lead) or wear a lead apron to protect themselves from radiation expose. ORSN P stated that it was not always possible to move away from the patient during surgery and that it was unknown how many procedures were done in the OR that included taking an x-ray or using fluoroscopy.

ORSN P stated that three anesthesiologists and one nurse who worked in a special injection clinic were assigned a radiation detection badge and that both OR's had a detection badge on the wall, hanging on the clock. She stated that each OR procedure at a minimum had present: a nurse, scrub tech, surgeon and anesthesiologist. She stated that only the anesthesiologist would have a radiation detection badge and that the other staff did not have a way to know their exposure to radiation.

On 8/4/11 at 10 am, Plant Manager I stated that the radiation detection badges, a total of eight, were sent for testing every other month.

Based on interview and record review, the hospital failed to ensure that all radiology personnel requirements were met when an x-ray technician did not have current cardiopulmonary resuscitation (CPR) certificate. This failure could potentially result in unqualified staff providing emergency care to patients.

Findings:

On 8/2/11 at 2:30 pm, Radiology Staff (RS) S's personnel record was reviewed. The record contained an evaluation, dated 10/1/10, that indicated that radiology staff was required to have a current CPR certificate. RS S's record did not contain evidence of a current CPR certificate.

On 8/3/11 at 11:50 am, Human Resource Manager K acknowledged the above finding.

Based on interview and record review, the hospital failed to ensure a Clinical Laboratory Improvement Amendments (CLIA) waiver certificate for blood glucose monitoring (a test to measure blood sugar) by nursing for single patient testing, was obtained. This failure had the potential to result in inaccurate testing which could adversely affect patient treatment.

Findings:

On 8/3/11 at 10:30 am, an interview and concurrent review of the hospital's CLIA certificate was conducted with Laboratory Staff (LS) Q. LS Q stated that the nurses perform blood glucose testing using a device that required the nurse to obtain blood from a patient's finger.

The CLIA certificate did not indicate that blood glucose monitoring using a device (accuchek or glucometer) had been approved by the Center for Medicare and Medicaid Services.

LS Q acknowledged that the hospital did not have a CLIA waiver for the nurses to perform single patient testing for blood glucose monitoring.

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

1. Provide organized dietetic services as evidenced by findings of unsafe food handling practices and supervision of the dietary department (Cross Reference A620).
2. Provide a comprehensive therapeutic diet manual that reflected the diets offered in the hospital (Cross Reference A629).
3. Develop performance improvement activities that reflected the scope and nature of the services (Cross Reference A265).
4. Ensure safe and effective food storage/production practices (Cross Reference A749).
5. Ensure the development of comprehensive policies and procedures that reflected the scope and nature of services (Cross Reference A 619, A621, A749).
6. Ensure the development of an effective in-service training program for dietetic services staff (Cross Reference A622).

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

Based on food services observations, dietary staff interview and dietary document review the hospital failed to ensure effective food and nutrition services dietary systems as evidenced by the lack implementation of foodservice systems relative to the scope and nature of the departments' activities. Failure to ensure implementation of effective food handling procedures may result in unsafe food handling practices putting all inpatients at risk for foodborne illness, further compromising medical and nutritional status.

Findings:

1. During review of food production practices at the offsite kitchen on 8/1/11 beginning at 10:30 am, it was noted there were unsafe food handling practices as evidenced by lack of cooldown monitoring of potentially hazardous foods (PHF) (Cross Reference A749). The standard of practice for cooked PHFs, which are held for later use, would be to monitor for time/temperature control for food safety (Food Code, 2009).

In an interview on 8/1/11 at 2:30 pm, with Dietary Staff L he stated that at one point there was a system to monitor time/temperature control for cooldown. He also stated that the system was discontinued approximately 1 year ago when the previous dietary services supervisor decided that monitoring the cooldown of foods was not necessary.

Time/Temperature control for food safety would be to ensure that the PHF's are cooled from 135 to 70?F within 2 hours and to 41?F or below within an additional 4 hours (Food Code, 2009). Review of hospital policy titled "Temperature Cooling Label" dated 6/08 revealed that while a policy existed; the policy did not meet the standard of practice. The policy guided staff that if the food did not cool to 70? within 2 hours staff should implement remedies that would allow it to cool to 41?F within an additional 4 hours. The remedy would be to either discard or reheat the item (Food Code, 2009). It was also noted that this policy did not have a referenced standard of practice as a basis for the policy.

In an interview on 8/10/11 at 4:10 pm, with the Registered Dietician (RD) she was asked how she ensured safe food handling practices. She stated that she did a monthly safety and sanitation check. She also stated that the hospital cooked items as needed. The surveyor described the leftover foods after which the RD stated that she was aware that these items were cooked in larger batches. She acknowledged that she had not effectively evaluated this practice and also stated that she had not realized that these items may require cooldown monitoring.

2. During review of dietary departmental policies and procedures on 8/3/11 beginning at 8 am, it was noted that a sampling of polices were not reflective of the standard for safe food handling practices, nor did any of the policies have a referenced standards of practice. The following policies were noted to have unclear/inaccurate guidance: 1) Food Preparation Service/Inventories - the policy does not accurately reflect holding temperatures for cold foods. The policy guides that colds cannot be held for more than 2 hours in a refrigerated unit if the temperature is 40?F or below. Similarly this policy guided that small servings were considered "half size" and large portions were "1-1/2 size" ; however there was no nutritional analysis, in particular of the half size portion to ensure the nutritional needs of patients would be met; 2) Receiving and Storage - the policy did not reflect the current standard of practice for food holding temperatures. The policy utilized an upper range of 45?F for cold food storage rather than the standard of practice of 41? (Food Code, 2009). Similarly this policy guided staff that meats can be thawed under potable running water; however did not include any of the time/temperature control parameters when utilizing this method of thawing; 3) Dietary Employee Personal Appearance, Hygiene and Habits - did not include parameters for the use of beard restraints in food production. The policy also included the use of hand based sanitizers in place of handwashing . This policy did not indicate any authoritative references relative to safe food handling practices; 4) Infection Control, Kitchen Cleaning & Sanitizing - this policy did not reflect the current standard of practice for sanitizing work counters and equipment nor did it reflect manufacturers' guidance for chemical sanitizers or equipment, in particular the ice machine and the slicer. The standard of practice would be to allow chemical sanitizers to air dry per manufacturers' guidance (Food Code, 2009). The policy did not reference any authoritative references relative to safe food handling practices.

In an interview on 8/10/11 beginning at 4:10 pm, with the RD she was asked to describe her duties as the consultant RD. She stated that one of her duties was to review and revise policies/procedures. The surveyor asked her to describe the references she utilized as a standard of practice. She replied that she would use documents such as California Code of Regulations, Title 22. The California Code of Regulations, Title 22, Social Security Division, Chapter 5 are regulatory requirements that govern facilities. They do not delineate operating policies and/or procedures (California Department of Public Health, 2011). Hospital policy titled "Registered Dietitian Responsibilities" dated 11/09 noted this position was responsible for the participation in development of policies and procedures.

3. On 8/1/11 at 10:30 am, in an interview, at the offsite kitchen, with Dietary Staff (DS) L he was asked to describe the diets that were offered. He presented a diet list that included a sampling of the most commonly ordered patient diets. Review of the diets that were offered included regular, 1800/2000 calorie diabetic diets as well as a 2 gram sodium diet, light and modified light diets. DS L was also asked if there was a nutritional analysis of these diets. He stated that to his knowledge the only nutritional analysis that was available for the commonly ordered diets was the calorie level of calorie restricted diets and sodium level of the 2 gram sodium restriction. It was also noted that the hospital did not have a pediatric menu. Review of hospital policy titled "Registered Dietitian Responsibilities" dated 11/09 noted this position was responsible for the participation in approval and development of menus.

4. During initial tour of the nourishment station on 8/1/11 beginning at 9 am and an observation on 8/1/11 beginning at 10:30 am, at the offsite kitchen, it was noted that the hospital was not monitoring the cooldown of PHF's (Cross Reference A749). It would be the standard of practice to monitor time/temperature control for PHF's held for use at a later time (Food Code, 2009). Review of hospital recipes dated 6/09, titled chicken consomme, chicken noodle soup and lasagna Bolognese revealed that while the hospital had recipes there was no guidance for monitoring of cooldown, nor was there any standardization in terms of the number of servings that would be obtained from the recipes. In an interview on 8/10/11 beginning at 4:10 pm, with the RD the surveyor presented the information regarding lack of guidance for cooldown monitoring and lack of standardization with respect to recipe yield. She acknowledged she had not identified these issues.

5. The hospitals' contract for consultant Registered Dietitian was reviewed on 8/2/11 beginning at approximately 9 am. In an interview on 8/3/11 at 10:45 am, Administrative Staff A stated that it was the responsibility of the department manager to evaluate the effectiveness of the contract. Concurrent review of the hospital document titled "Annual Contract Service Evaluation" dated 5/1/11 for the consultant RD revealed that the evaluation was completed by the DSS, whose training included a community college certificate as a Chef. Similarly the RD's employee performance report was also completed by the dietary services supervisor; however instead of completing the evaluation utilizing the RD's position description, the evaluation was completed using a cooks' position description.

Administrative Staff A also acknowledged that review of the contract by the dietary service supervisor, a position who would not have the expertise to assess the qualifications of the Registered Dietitian, was likely not an effective mechanism for evaluation of this contract or the RD as a health professional. She also stated she was unable to explain how the evaluation for the RD which was completed using a cook's job description, was placed in the employees' personnel file.

Review of the hospitals' organizational chart revised 8/08 revealed that the Foodservice Manager and the RD had a peer relationship; rather than a supervisory relationship. It was also noted that the organizational chart did not delineate any oversight into food production activities. It was also noted that the position description for the RD dated 8/3/10 noted the reporting that the Foodservice Manager had supervisory responsibility of the RD.

6. During general food production observations at the offsite kitchen on 8/2/11 beginning at 10:30 am, it was noted that dietary staff was storing greater than 10 plastic containers of spices on the ledge directly above the stove hood/fire suppression system. It was also noted that some of the containers were beginning to melt from the heat directly above the food production area. In a concurrent interview with DS L he stated he had not been advised to remove the spices from the hood. Review of hospital document titled "Dietary Sanitation Checklist" for May and June 2011 failed to identify the storage of spices on the exhaust hood.

7. During initial tour, of the offsite kitchen, on 8/1/11beginning at 10:25 am, the following was noted:
a. in the dry storage area the following items were opened and undated-vinegar, Worchester sauce, red wine vinegar, teriyaki sauce, sesame oil, liquid smoke, and corn syrup. It was also noted that there was ground mustard with a receipt dated of 2/4/10; pumpkin spice received on 3/17/10; nutmeg received on 3/1/07. Additionally there was allspice with a use by date of 9/27/06 and white pepper with a use by date of 1/26/11. There was also thyme leaves, chili powder, ground cumin, garlic powder and cinnamon that were opened, no date. In the walk-in freezer there was a box of baguettes that were undated and open to air.

In concurrent interview with DS L he stated he was unsure of the policy of dating shelf stable opened items. He also acknowledged that there were expired spices.

Based on food production observations, administrative and dietary staff interview and dietary document review the hospital failed to ensure the consultant Registered Dietitian (RD) provided effective oversight into dietetic services. Failure to provide comprehensive and integrated departmental oversight may compromise the clinical condition of patients.

Findings:

1. During hospital survey from 8/1-8/3/11 numerous issues surrounding lack of effective implementation of a food and nutrition program was identified (Cross Reference A619, A 620, A 622, A628, A630, A631, A701 and A749). Issues identified included 1) lack of nutritional analysis of patient menus, 2) lack of a pediatric menu; 3) lack of a comprehensive diet manual relative to the scope of dietetic services; 4) lack of a performance improvement program relative to the scope and nature of the department; 5) lack of effective oversight into food production activities resulting in unsafe food handling practices; lack of overall kitchen cleanliness, equipment that was not cleaned/maintained per manufacturers' guidance and lack of implementation for time/temperature control of potentially hazardous foods; 6) lack of an effective preventative maintenance program for hospital equipment; 7) lack of an effective training/orientation program for dietetic staff.

Review of hospital documents titled "Registered Dietitians Dietary Sanitation Checklist" from May-July 2011 revealed that with the exception of noting the lack of cleanliness in the dry storage area in 5/11 the RD had not identified any other issues.

In an interview on 8/3/11 at 10 am, Administrative Staff (AS) A was asked to describe the amount of time the hospital expected the RD to be present at the facility. She stated the RD's contract was to execute the responsibilities of the contract and there were no minimum or maximum hours that were delineated and since the RD was a contractor there were no timesheets. Review of the hospital document titled "Clinical Services Agreement" revealed she was to be on call 7-days/week between the hours of 8 am and 5 pm; she was responsible for on-site assessment and treatment of patients; provide hospital PI performance improvement data; orientation/reorientation of employees and to ensure that all services provided comply with regulatory requirements. Similarly the position description titled "Clinical Dietitian" dated 8/3/10 noted that this position was responsible for providing in-service programs; collaborates with the foodservice manager to continually assess, modify and improve the department and participate in committees to modify and improve the continuum of care. Hospital policy titled "Registered Dietitian Responsibilities" dated 11/09 place the responsibility of collaboration with other hospital services such as medical staff, nursing and pharmacy to plan and implement the nutritional needs of patients. There was no documentation that the RD fulfilled these responsibilities.

In an interview on 8/10/11 at 4:10 pm, with the consultant RD the surveyor asked her to describe her training relative to dietetic services, in particular safe food handling practices. She stated that as a RD she had coursework in food services. She also stated that several years earlier she attended a safe food handling course. She further stated that she utilized California Code of Regulations, Title 22. The California Code of Regulations, Title 22, Social Security Division, Chapter 5 are regulatory requirements that govern facilities. They do not delineate operating policies and procedures (California Department of Public Health, 2011).

The surveyor also asked the consultant RD to describe the activities she completed when on-site. She stated that she visited monthly and spent approximately 1 hour providing foodservice oversight at the offsite kitchen. She also stated that she did not provide any in-service activities for the staff at the off-site production kitchen. She also stated that the previous supervisor had little interest in training staff. The surveyor asked if she discussed the lack of staff training with AS A. She stated she had; however had not documented it. The surveyor also provided the RD with a sampling of the identified issues. She acknowledged that she had not previously identified any of the issues. She also stated that she did not participate in any of the hospital committees and provided collaboration only when asked to do so.

Based on food storage observations, dietary staff interview and dietary document review the hospital failed to ensure staff was competent in their assigned duties as evidenced by lack of glove use when handling ready to eat foods. Failure to ensure staff is provided comprehensive training/orientation in their assigned duties may result in practices that place patients at risk for food borne illness. Food borne illness may result in compromise of clinical condition and in severe instances may result in death.


Findings:

1. During general food production observations at the offsite kitchen of Dietary Staff (DS) L and DS LL from 8/1-8/2/11 there were issues identified with respect to safe food handling practices (Cross Reference A749). During food production observations on 8/1/11 beginning at 10 am, DS L was observed handling ready to eat foods with bare hands. On 8/2/11 beginning at 11 am, DS LL was observed to use ready to eat foods without washing as well as handling them with bare hands.

In an interview on 8/2/11 at 3:30 pm, with DS L he was asked to describe staff training upon hire. He stated that until 2 weeks ago he was a cook at which time he was assigned to act at the DSS after. Concurrently DS LL stated that he received a general hospital orientation; however had no training on his current supervisory position.

Review on 8/3/11 at 9 am, DS L's and DS LL's personnel files revealed that with the exception of general hospital orientation that included fire safety, hazardous materials, risk management and corporate compliance there was no documentation that either staff member received training and orientation relative to the scope of their positions. Review of the dietary departments' training records from 2/10-7/11 revealed the only in-services presented were on receiving/storage, handwashing, and injury prevention. There was no evidence that the hospital developed a comprehensive training, orientation program or competency evaluation of dietetic staff relative to the scope and nature of food services.

In an interview on 8/2/11 at 2 pm, with Administrative Nurse (AN) E she stated that the hospital provided competency training of staff at the time of orientation. She also stated she would rely on the Registered Dietitian (RD) for department specific orientation. Review of the competency packet titled "Diet Aide Competency" dated 7/09 revealed that this competency was specific to a position that did not have any food production responsibilities, rather was the competency for the Diet Aide that delivered meals within the hospital. Undated hospital policy titled "Continuing Education" noted that continuing education required a minimum of four in-service programs/year, one of which was specific to infection control. The hospital failed to provide documentation that the policy was followed.

Based on dietary staff interview and dietary document review the hospital failed to ensure that the patient diets met nutritional needs as evidenced by the lack of a nutritional analysis for offered diets. Diets that do not meet patient nutritional needs may further complicate clinical status.

Findings:

On 8/1/11 at 10:30 am, in an interview at the offsite kitchen with Dietary Staff (DS) L he was asked to describe the diets that were offered. He presented a diet list that included a sampling of the most commonly ordered patient diets. Review of the diets that were offered included regular, 1800/2000 calorie diabetic diets as well as a 2 gram sodium diet and facility titled diets that included light and modified light diets. DS L was also asked if there was a nutritional analysis of these diets. He stated that to his knowledge the only nutritional analysis that was available for the commonly ordered diets was the calorie level of calorie restricted diets and sodium level of the 2 gram sodium restriction. It was also noted that the hospital did not have a pediatric menu.

In an interview on 8/3/11 at 10:30 am, with Administrative Staff (AS) A she confirmed that the hospital routinely performed outpatient surgeries on pediatric patients. She also stated that if there were minor post-surgical complications with pediatric patients, that may require admission, the patient would not be admitted to the hospital; rather be transferred to another general acute care hospital. Review of the hospitals rules and regulations dated 3/29/10 as well as medical staff bylaws dated 3/2/11 revealed that there were no provisions that stated the hospital would transfer post-surgical patients that may require hospital admission.

Based on medical record review, nursing and dietary staff interview the hospital failed to ensure therapeutic diets were ordered by the physician for 1 of 4 patients' (Patient 3) reviewed for clinical nutrition care. Failure to obtain a physicians' order for diets may further compromise patients' clinical status.

Findings:

Patient 3 was admitted for an orthopedic surgical procedure. Medical record review was conducted on 8/2/11 beginning at 9 am. Admission diet order dated 5/20/11 was a clear liquid diet with an advance to a regular diet as tolerated. A follow up diet order dated 5/3/11 was for a mechanical soft diet. Review of the diets that were delivered noted that on 5/20/11 the meal was a no added sugar- modified light diet. It was also noted that from 5/21-5/24/11 the meal that was delivered to Patient 3 was documented as a no added sugar or a diabetic diet. There was no physicians' order for a diabetic diet. There was no documentation that the physician ordered the diet that was implemented.

In an interview on 8/3/11 at 3:30 pm, with Licensed Nurse (LN) D she was asked to describe the process for physician ordered diets. She stated that at the time of admission a diet was ordered. She also stated that generally the post-surgical diet was a clear liquid diet to advance, usually to a regular diet. She also stated that nursing staff had the ability to "downgrade" the diet as necessary. She also stated that nursing staff would use one of the modified diets that were available. She also stated that nursing may alter the texture depending on the patients' chewing ability. LN D also acknowledged that this was a regular practice within the hospital.

In an interview on 8/10/11 at 4:10 pm, with the Registered Dietitian she was asked how she ensured that physician diet orders were implemented. She stated that as part of the quality assurance program she performed a retrospective chart review in an effort to determine if the physician ordered diet was appropriate for the patients' medical condition. She also stated that while on occasion she observed meal delivery she had not identified that nursing staff were altering the physician ordered diets.

Based on medical record review the hospital failed to ensure a therapeutic diet was ordered for 1 of 8 patients reviewed for nutrition care (Patient 11) who may have benefitted with a diabetic diet. Failure to provide therapeutic diets when there is a necessity may result in compromising clinical status.

Findings:

Patient 11 was admitted with for foot surgery with a secondary diagnosis of diabetes. Post op surgical diet dated 6/17/11 was a clear liquid, with an advance to regular diet. It was also noted that Patient 11 had an insulin pump (an automated insulin delivery system); however there was no physicians' order for the amount of insulin that would be delivered via the pump. Review of diabetes flow sheet beginning 6/17-6/18/11 revealed that Patient 11's blood sugars ranged from a low of 64 to a high of 289. For non-critically ill patients, there is no clear evidence for specific blood glucose goals; however data suggest that outcomes are better in hospitalized patients with fasting glucose <126 mg/dl and all random glucoses <180-200 (Standards of Medical Care In Diabetes, 2009)

It was also noted that on 6/17/11 nursing staff recorded that Patient 11 administered 7 units of insulin for a blood glucose of 172 and on 6/18/11 at 0120, Patient 11 administered 4.2 units for a blood sugar of 265, similarly on 6/18/11 at 0315 Patient 11 administered 3 units for a blood glucose of 289. There was no indication that the Registered Dietitian was contacted despite post-surgical elevation of blood sugars or the lack of a physician ordered therapeutic diet for Patient 11. Review of Patient 11's nursing care plan revealed that there was no developed care plan for nutrition care or for Patient 11 with specialized nutritional needs.

Based on dietary and administrative staff interview and dietary document review the hospital failed to ensure the hospital diet manual accurately reflected the diets that were routinely ordered. Failure to provide accurate reference documents may result in diet orders that do not meet the nutritional needs of patients resulting in a compromised clinical status.

Findings:

On 8/1/11 at 10:30 am, in an interview at the offsite kitchen with Dietary Staff (DS) L he was asked to describe the diets that were offered. He presented a diet list that included a sampling of the most commonly ordered patient diets. Review of the diets that were offered included regular, 1800/2000 calorie diabetic diets as well as a 2 gram sodium diet, light, modified and modified light diets. DS L was also asked if there was a nutritional analysis of these diets. He stated that he was unsure. On 8/2/11 beginning at 3 pm, the hospitals' diet manual was reviewed. It was noted that the hospital purchased a diet manual that had a wide variety and complexity of diets that included diets such as a neutropenic diet, diets for renal and liver failure, bland and diabetic diets. It was also noted that the diet manual did not include diets that were offered by the facility. The diet manual did not include specific patterns for the routinely physician ordered light , modified and modified light diet nor was there a pattern for the various caloric level of diabetic diets or a pediatric diet pattern.

In an interview and concurrent review of the diet manual on 8/3/11 beginning at 10 am, with Administrative Staff (AS) A she was asked to describe the implementation of the diet manual. She stated that the previous administrator guided staff on the implementation of the diet manual. The surveyor asked her to describe the scope of services the hospital offered. She replied that the scope of the hospital was primarily healthy surgical patients who stayed 2-3 days. She also acknowledged that some of the diets offered were not part of the diet manual and that the majority of the diets in the diet manual were designed for a greater complexity of medical service than the hospital offered. In an interview with the Registered Dietitian on 8/10/11 beginning at 4:10 pm, she stated she was involved in putting together the diet manual and acknowledged that there was not a description or nutritional analysis for the light, modified or modified light diets.

Based on dishwashing observations, dietary staff interview and administrative document review the hospital failed to ensure a preventive maintenance program for the dish machine.

Findings:

During review of dishwashing on 8/1/11 beginning at 1:20 pm, the surveyor asked Dietary Staff (DS) L to describe the operation of the dishwasher and how he knew the equipment was working properly. He stated that he would check the temperature and level of sanitizer of the machine. DS L concurrently demonstrated the process for testing the sanitizer. It was noted that the resulting sanitizer concentration was less than 50 ppm. DS L stated that he worked on 7/30 and 7/31/11 and that sanitizer concentration was a problem. The surveyor asked if the machine was part of a preventive maintenance program. He stated that during his 2 years of employment the only time the chemical vendor came was if there was a problem. He also stated that he had not notified anyone of the problem. He did however state that if there was a maintenance problem he would contact the hospitals' maintenance department. Concurrent review of the hospital document titled "Temperature Log Sheet" for the dish machine for July and August 2011 noted that despite identification of a problem with the concentration of the sanitizer, DS L recorded the concentration as ranging between 142-145 parts/million (ppm). DS L was unable to explain why the concentration recorded was different that that observed.

Review on 8/3/11 of hospital document titled "PHR Contracted Services List" dated 8/1/11 confirmed that the hospital did not have a preventative maintenance contract for the dish machine.

Based on observation, interview, and document review, the hospital failed to provide a sanitary environment that avoided sources and transmission of communicable diseases as evidenced by:

1. The hospital failed to implement their policy and procedure ensuring that all Health Care Workers (HCW) were annually screened for tuberculosis (TB) (Refer to A749).
2. That 1 of 3 three surgical procedure rooms were cleaned and disinfected, and traffic patterns were maintained in accordance with hospital approved policy and procedure, and national standards of practice (Refer to A951, item 1 a).
3. Surgical attire was worn in 1 of 3 surgical procedure rooms as directed in policy and procedure, and national standards of practice (Refer to A951, item 1 b).
4. That 1 of 3 surgical procedure rooms had positive air pressure (pressure gradient in the operating room should be positive to outer corridors reducing the risk of surgical site infections), the total air exchange rate, and temperature and humidity were monitored and maintained according policy and procedure and national standards of practice (Refer to A951, item 1 c).
5. Failure to ensure that flash sterilization (a modification of conventional steam sterilization intended to prepare surgical instruments for emergent and immediate using un-wrapped method), of surgical instruments was done only in an emergency, and not as routine practice (Refer to A951, item 2).

6. Failure to ensure that padded devices used to position patients had intact surfaces allowing for appropriate cleaning and disinfection between each patient for 2 of 2 areas where surgery was performed (Refer to A951, item 3).

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure a sanitary environment and placed all patients and staff at risk of exposure to or developing infections and communicable diseases.

Based on food production observations, dietary staff interview and dietary document review the hospital failed to ensure that dietetic services were implemented in a safe and effective manner as evidenced 1) lack of effective time/temperature monitoring system for potentially hazardous; 2) bare hand contact with ready to eat foods; 3) lack of effective sanitation of ice machines; 4) multiple use of dry wiping cloths; 5) presence of pests in the kitchen; 6) lack of temperature monitoring of foods during transit; 7) overall kitchen cleanliness; 8)lack of beard restraints for 1 employee during food production activities; 9) retention of cracked plastic ware; 10) storage of raw and ready to eat foods next to each other.

Failure to ensure effective systems to prevent the transmission of hospital acquired infections, such as foodborne illness, may result in further compromising acutely ill patients' clinical condition and in severe instances may result in death.

Findings:

1. During initial tour of the nourishment station on 8/1/11 beginning at 9 am, it was noted that in the freezer there were individual containers of cream of rice, chicken noodle and beef barley soup. All of these items were potentially hazardous foods (PHF's) which are capable of supporting bacterial growth associated with foodborne illness. The standard of practice for cooked PHF's, which are held for later use, would be to monitor for time/temperature control for food safety. Time/Temperature control for food safety would be to ensure that the PHF's are cooled from 135 to 70?F within 2 hours and to 41?F or below within an additional 4 hours (Food Code, 20099). Review of hospital policy titled "Temperature Cooling Label" dated 6/08 revealed that while a policy existed; the policy did not meet the standard of practice (Cross Reference A620).

In a concurrent interview at the hospital nourishment center with Dietary Staff (DS) LL he stated that these items were part of the regular patient stock of food that was prepared at the offsite kitchen. In an observation on 8/1/11 beginning at 10:30 am, in the offsite kitchen walk in refrigerator it was noted there was a bag of previously cooked pasta as well as a bowl of hard boiled eggs. Additionally in the freezer there were additional cups of all three soups as well as cooked veal dated 7/2/11 and lasagna dated 5/21/11.

In an interview, at the offsite kitchen, on 8/1/11 at 2:30 pm, with DS L he stated that the items in the refrigerator were intended to be used for meals during the next three days. He also stated the items in the freezer were items that were cooked in bulk to be held for use at a later time for the patient menu. He also stated that once the items were cooked they would be packaged, labeled and dated and placed in the freezer. The surveyor also asked if there was a system that monitored time/temperature control for PHF's. He stated that at one point there was an existing system to monitor time/temperature control for cooldown. He also stated that the system was discontinued approximately 1 year ago when the previous dietary services supervisor decided that monitoring the cooldown of foods was not necessary.

In an interview on 8/2/11 at 1:40 pm, with Infection Control Nurse (ICN) H she was asked to describe her oversight in the dietary department. She stated that every 3 months environmental rounds were completed that included evaluation of cleaning/sanitizing of the kitchen, food storage/preparation per policy, outdated foods, refrigerator/freezer temps, dishwashing temperatures as well as availability of handwashing supplies. She also stated that this evaluation would take 30-40 minutes quarterly which may or may not include observation of food production. She also stated, that as a nurse, she would not necessarily have the expertise to fully ensure safe food handling practices and would rely on the Registered Dietitian (RD) and departmental supervisory staff to identify poor food handling practices.

In an interview on 8/10/11 at 4:10 pm, with the RD she was asked how she ensured safe food handling practices. She stated that she did a monthly safety and sanitation check. She also stated that the hospital cooked items as needed. The surveyor described the leftover foods after which the RD stated that she was aware that these items were cooked in larger batches. She also stated that she had not realized that these items may require cooldown monitoring.


2. In a general food production observation, at the offsite kitchen, on 8/1/11 beginning at 11:10 am, it was noted that DS L was handling ready to eat foods with bare hands. In a concurrent interview DS L stated that he used gloves to touch patient foods but did not use gloves to touch staff foods. In a follow up observation on 8/2/11 beginning at 11:15 am, it was noted that DS M pulled fresh herbs from the refrigerator and proceeded to cut them without prior washing as well as handling them with bare hands. In a concurrent interview with DS M he stated he was recently hired to fill in as a cook. He also stated that his primary orientation with respect to food services was guidance given by DS L.

Review of hospital policy titled "Facility-Wide Hand Hygiene Program" dated 9/10 revealed that while a hand hygiene policy existed it was specific to patient care activities. There were no elements within the policy that guided staff on handwashing/glove use in food production settings.

3. On 8/1/11 at 3:05 pm, review of ice machine sanitation in the offsite kitchen was reviewed with DS L. He stated that while the ice machine was currently broken; however he was the person that performed the task. He stated that he melted the ice using hot water after which he sprayed a sanitizer in the ice holding bin. The surveyor asked if there was any cleaning or preventive maintenance of the ice production mechanism; to which he replied "no." In a follow up interview on 8/3/11 at 1:30 pm, with Plant Operation Staff (POS) O he was asked to describe the preventive maintenance for the hospitals' ice machine. He described that he removed the panel of the unit and utilized a descaling chemical. He also stated that that was the only chemical used in the ice machine preventive maintenance. There was no sanitation of the ice producing mechanism of the machine.

Hospital policy titled "Ice Machine Sanitation" dated 1/10 guided staff to complete the sanitation of ice machines on monthly basis. It was also noted that the process was limited to sanitation of the bin and exterior surfaces of the machine. There was no process to descale and sanitize the ice producing mechanism. Ice is considered hazardous as it is capable of supporting bacterial growth associated with foodborne illness. It would be the standard of practice to ensure that ice production is conducted in a sanitary manner (Centers for Disease Control, 2003). Review of manufacturers' guidance revealed that the manufacturer recommended comprehensive sanitizing of the ice machine with a bleach solution.

4. During general food production observations, at the offsite kitchen, on 8/2/11 beginning at 11 am, it was noted that during food production activities dietary staff was using a single dry wiping cloth to wipe food particles during several food production tasks. In a concurrent interview with DS LL the surveyor asked if this was his usual practice. He stated that he would use a dry cloth and at a later time would use a cloth that was immersed in sanitizer. Review of hospital policy titled "Safety & Sanitation Prep Towels" dated 3/09 guided staff that "All prep towels must be rinsed in ...sanitizer between each use." In an interview on 8/2/11 at 11:30 am, with DS LL he stated that he was recently hired as a relief cook and that his orientation was being provided by DS L, the full time cook.

Review of hospital document titled "Employee Orientation Attendance Record" dated 6/27/11 for DS LL it was noted that he received an administrative orientation on 6/27/11 that included elements such as personnel policies, safety videos and corporate compliance videos. It was also noted that on 7/7/11 DS LL completed a general orientation. There was no documentation that the hospital provided DS LL training and orientation specific to dietetic services.

5. During general food production observations at the offsite kitchen on 8/2/11 at 11:35 am, it was noted that there were flies in the kitchen. Previous observations on 8/1/11 beginning at 10:30 am, revealed that there was a door from the dry storage area leading directly to the alley. It was also noted that dietary staff would use this door to enter and exit the building. It was also noted that this door was regularly used to load the meals that were transported to the hospital. There was no deterrent to insects at either door.

6. On 8/2/11 beginning at 11:30 am, food transportation from the offsite kitchen to the hospital was observed. It was noted that the food was plated at the offsite kitchen, placed into a food holding compartment on a vehicle and transported to the hospital. Observation on 8/2/11 beginning at 11:50 am, revealed that the food items were brought in through a side door of the hospital, placed on a meal cart after which the meal was delivered to the patient. In an interview on 8/2/11 beginning at 11:15 am, DS L stated that he did not monitor food temperatures, rather monitored the ambient air temperature of the hot and cold food compartments of the truck. In an interview on 8/10/11 at 4:10 pm, with the consultant RD she stated that on occasion she did a test tray of the meals that were given to patients and acknowledged that she had not evaluated temperatures during the delivery of the meals.

Review on 8/3/11 of hospital documents dated 3/17/10, 10/26/10, 8/11/10, 12/15/10, 1/4/11 and 5/13/11 titled "Food Service Weekly Test Tray Evaluation" revealed that in 5 of 6 of the evaluations patients were served food that was within the food danger zone defined as temperatures between 41 and 135?F (Food Code, 2009). It was also noted that in the evaluation dated 5/13/11 the patient requested that the entree be served undercooked. While the RD completed the test tray evaluation there was no indication that the RD provided follow up investigation on the temperatures. Serving undercooked food to a highly susceptible population, defined as hospitalized patients, are more likely to be affected by a foodborne illness (Food Code, 2009).

In an interview on 8/10/11 at 4:10 pm, with the RD she stated she did complete the test trays; however was unaware that the temperatures being taken were not food temperatures; rather were temperatures of the transport truck.

7. During general kitchen observations, at the offsite kitchen, on 8/1/11 beginning at 10 am, and 8/2/11 beginning at 11am, it was noted that there were issues with respect to overall kitchen cleanliness. It was noted that there was a buildup of black tar-like substance as well as dried on food particles on the grill; the front of the oven including the knobs were covered with food particles as well as a clear grease-type substance; the waffle maker was covered with dried on food particles as well as a buildup of an oily substance; a rack that was next to the stove as well as a rack adjacent to the trayline, both of which held cleaned and sanitized dishes were covered with a grey dust-like matter, it was also noted that there were several plastic lids that were covered with a yellow oily substance and measuring cups and a funnel with dried on food particles; the air vent directly above the center food assembly area was covered with a grey dust-like matter; baking dishes stored under the work table adjacent to the walk-in freezer were covered with unidentified food particles; the knife holder was covered with food particles; there were cob webs under the food production sink as well as the window in the dry storage area. It was also noted the window sill in the dry storage area was covered with greater than 20 dead insects.

In an interview on 8/1/11 at 3:30 pm, with DS L he was asked to describe the cleaning schedule. DS L presented the cleaning schedule dated 7/11. It was noted that the schedule was divided into daily, weekly, monthly and bi-monthly tasks. It was noted that with the exception of the bakers rack and the ceilings, none of the other identified areas/equipment were listed on the cleaning schedule. It was also noted that equipment such as the microwave and trashcans were limited to weekly cleaning. Similarly the oven, racks and grills were limited to cleaning twice/month. The standard of practice would be to develop a cleaning schedule that would maintain kitchen cleanliness at an appropriate frequency to prevent cross contamination and to ensure the functionality of equipment (Food Code, 2009).

Review of hospital policy titled "Infection Control, Kitchen Cleaning & Sanitizing" dated 10/09 guided the staff to clean the range top and grill as needed, ovens bimonthly, trash cans and microwave weekly and ceilings monthly. While the hospital developed a cleaning schedule, the frequency of cleaning did not ensure that all kitchen areas remained clean and free of potential contaminants.

8. During general food production observations, at the offsite kitchen, on 8/2/11 beginning at 11 am, it was noted that DS LL was completing food production activities. It was also noted that DS LL had a full facial beard without the benefit of a beard restraint. In an interview on 8/2/11 at 1 pm, with Administrative Staff (AS) the surveyor requested to speak with the consultant Registered Dietitian. In an interview on 8/10/11 at 4 pm, with the RD she stated that she was aware that the department hired a new cook; however she had not seen him nor provided any training/orientation in dietetic services for his new position.

Review of the dietary departments' policy and procedure manual revised in 2010 revealed there was no policy that guided the use of beard restraints. The standard of practice would be that food employees wear beard restraints (Food Code, 2009). Review of hospital document titled "Clinical Services Agreement" executed on 3/27/10 revealed that it was the responsibility of the RD to "assure that all employees assigned to hospital will complete orientation ..." The contract also delineated that it was the responsibility of the RD to "...assure that all services provided comply with applicable regulations ..."

9. During general kitchen observation, at the offsite kitchen, on 8/1/11 beginning at 10:30 am, it was noted that the plastic food holding container and top of the Robocoup (a blender) was cracked. In a concurrent interview with DS L he stated he was unsure of how long the item was cracked. He also acknowledged he did not bring it to the attention of anyone. It would be the standard of practice that food contact surfaces remain free of breaks, seams or cracks (Food Code, 2009).

Review of hospital policy titled "Safety Guidelines" dated 1/02 guided staff that "Plasticware ...that is ...hazardous because of cracks ...shall be discarded." In an interview on 8/2/11 at 11 am, with DS L he acknowledged the existence of a policy and procedure manual for the department; however was not familiar with the content.

10. During general food storage observations on 8/2/11 at 10:30 am, it was noted that in the walk in refrigerator dietary staff was storing unpasteurized raw eggs directly adjacent to ready to eat fruits. In a concurrent interview with DS L he stated that he was unaware that it would be problematic to store raw and ready to eat foods in close proximity. It would be the standard of practice to store raw, potentially hazardous foods on a different shelf than ready to eat or previously cooked foods (Serve Safe, 2007). Review of the departments' policy and procedure manual revealed that while there was a policy titled "Food Storage" dated 8/07 it failed to provide comprehensive guidance for food storage practices to prevent potential cross contamination of patient foods.


16501

11. The hospital failed to implement their policy and procedure ensuring that all HCW (Healthcare workers) were annually screened for TB (tuberculosis).

On 8/2/11 at 9:15 am, a request was made for the hospital's policy and procedure for screening HCW for TB.

On 8/2/11 at 11 am, the hospital's policy and procedure titled, "Employee Health - Tuberculin Skin Test" dated 2/09, was provided and reviewed. Under the policy section, direction was given that, "Annual tuberculin testing will be required of all employees, physician, and patient care contract employees and vendors."

On 8/2/11 at 3 pm, a request was made for for a list of physicians whose TB were due or past due. The physician TB skin test due list was provided, reviewed, and revealed that Physician Z TB skin test was due on 6/1/11. The physician's TB skin test due list also showed that Physician's AA, BB, CC, and DD, TB skin tests were due on 8/1/11.

On 8/2/11 at 4 pm, an interview was conducted with the Medical Staff Coordinator. During the interview, the Medical Staff Coordinator stated that the hospital did not have a process in place ensuring that physicians complied with the hospital's TB screening policy and procedure.

According to the Communicable Disease Center (CDC) Guidelines for Preventing the Transmission of Mycobacterium tuberculosis (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 HCW will or will possibly be exposed to persons with TB disease or to clinical specimens that might contain M.(mycobacterium) tuberculosis. The recommendations for medium risk included, "All HCWs should receive baseline TB screening (checked to identify presence of the disease) upon hire, using two-step TST (TB skin test) or a single BAMT (blood assay alternate test) to test for infection," and "After baseline testing for infection, HCWs should receive TB screening annually."

Based on interview and document review, the hospital's senior management failed to implement a successful corrective action plan after flash sterilization (a modification of conventional steam sterilization intended to prepare surgical instruments for emergent and immediate using un-wrapped method), was identified as a problem area.

Findings:

The hospital failed to ensure that a successful action plan was implemented after management identified that flash sterilization was not in accordance with facility policy or national standards of practice.

On 8/1/11 at 9:30 am, a tour was conducted of the surgical services area. During the tour, Administrative Nurse E was asked if she was aware how frequent flash sterilization was used to sterilize surgical instruments? Administrative Nurse E stated that the hospital flash sterilized almost 100 percent of the instruments used during surgical procedures. Administrative Nurse E stated that she recently told central sterile staff that they needed to decrease the use of flash sterilization in the hospital. When asked if the use of flash sterilization had decreased, Administrative Nurse E replied, "Not, yet." When asked if a high rate of flash sterilization was in accordance with hospital policy/procedure or national standards of practice, Administrative Nurse E replied, "No, isn't."

On 8/2/11 at 4 pm, the hospital's 2011, "Department Quality Indicator Reporting" log was reviewed. Under the section titled, central sterile, item 4, the quality indicator report directed that, "Flash Sterilization per AORN" (Association of periOperative Registered Nurses - AORN).

On 8/2/11 at 4:30 pm, Administrative Staff A, could provide no documentation showing the hospital implemented a successful corrective action plan decreasing the use of flash sterilization after it was identified as a problem area.

Based on staff interview and document review the hospital failed to ensure that requirements were met for the condition of participation: Organ, Tissue and Eye Procurement as evidenced by:

The hospital did not develop or implement written protocols or training procedures to ensure that hospital staff members were encouraged to be discreet and sensitive with respect to the circumstances, views and beliefs of families of potential organ tissue donors. (Refer to A890)

The cumulative effect of this systemic problem resulted in the hospital's inability to ensure their employed staff did use discretion and sensitivity with respect to the circumstances, views, and beliefs of the families of potential organ and tissue donors.

Based on staff interview and document review, for the single provided document, the hospital failed develop or implement written protocols to ensure that hospital staff members were trained and encouraged to use discretion and sensitivity with respect to the circumstances, views, and beliefs of the families of potential organ and tissue donors.

Findings:

On 8/1/11 at 8:20 a.m. during the entrance conference, the hospital's policies & procedures related to organ, tissue and eye procurement were requested. That same afternoon, a single document was provided by being set out on a table, delivery time unknown. The provided document was a printed policy & procedures statement from a hospital's computer under the "Subject: General Nursing -- Section: Patient Services -- Sub-Section: Organ/Tissue Donation" and it was titled "Anatomical Donations for Transplantation." The document was undated other a line on the last page that records it was last revised in "5/11." This document delineates the responsibilities of the OPO (Organ Procurement Organization) coordinators (employees of the OPO) and directs the hospital staff to cooperate with the OPO coordinators. This document does state "The (OPO) will assure that all representatives (of the OPO) will encourage discretion and sensitivity in there training plan for all (OPO employed) coordinators." However it does not address how the hospital nursing staff or other hospital staff members are to be trained or otherwise encouraged to interact with discretion and sensitivity when caring for the patient and interacting with the families.

On 8/2/11 at 10:00 a.m. Administrative Staff A verified that there were no other policy & procedures related to "Organ/Tissue Donation." She also acknowledged the hospital did not have an established training or other protocols to ensure the hospital staff were sensitive and discrete when working with families of potential donors. She stated that other than cooperating with the OPO coordinators "we do not train our staff relative to organ and tissue procurement."

Based on observation, interview, and document review, the hospital failed to provide surgical services in accordance with national standards of practice as evidenced by:

1. Failure to ensure that all rooms where surgical procedures were performed, were positive pressure (pressure gradient in the operating room should be positive to outer corridors reducing the risk of surgical site infections), that minimum total air exchanges (the total number of air exchanges within the operating room per hour), and that the temperature and humidity levels were monitored and maintained (Refer to A941, item 1 a).

2. Failure to ensure that surgical attire, laundered by a hospital accredited laundry was worn in all areas where surgical procedures were performed (Refer to A941, item 1 b).

3. Failure to ensure all rooms where surgical procedures were performed were cleaned and disinfected according to policy and procedure (Refer to A941, item 1 c).

4. Failure to ensure that flash sterilization (a modification of conventional steam sterilization intended to prepare surgical instruments for emergent and immediate using un-wrapped method), was used only in an emergency (Refer to A941, item 2).

5. Failure to ensure that devices used to position multiple patients during surgical procedures had intact surfaces allowing the device to be appropriately cleaned and disinfected between patients (Refer to A941, item 3).

The cumulative effect of these systemic problems resulted in the hospital's inability to provide surgical services in accordance with national standards of practice, and places all surgical patients at risk of developing surgical site infections.

Based on observation, interview, and document review, the hospital failed to provide surgical services in accordance with approved policies and procedures, and in accordance with national standards of practice, placing all surgical patients at risk of developing surgical site infections.
* The hospital failed to ensure that rooms where surgical procedures were performed, had positive pressure (positive pressure inside the surgical suite compared to outside the surgical suite), that the temperature, humidity (moisture in the air), total number of air exchanges (total number of air exchanges within the operating room per hour), were monitored and maintained, that surgical attire (clothing only worn in areas where surgery is performed), was worn during all surgical procedures, and all rooms were cleaned and disinfected (process to remove bacteria and communicable diseases), according to policy and procedure, and in accordance with national standards of practice for 1 of 3 surgical procedure rooms.

* The hospital failed to ensure that flash sterilization (a modification of conventional steam sterilization intended to prepare surgical instruments for emergent and immediate using un-wrapped method), of surgical instruments was done only in an emergency.

* The hospital failed to ensure that padded devices used to position patients during surgery had intact surfaces allowing for appropriate cleaning and disinfection between each patient for 2 of 2 areas where surgery was performed.

Findings:

1. a. The hospital failed to ensure that 1 of 3 surgical procedure rooms had positive air pressure gradient (positive gradient to outer areas and corridors that reduce the risk of surgical site infections), that the total air exchange rate, and temperature and humidity were monitored and maintained according policy and procedure, and in accordance with national standards of practice.

On 8/1/11 at 10 am, Staff O was asked for the air flow/air exchange report (report documenting air flow patterns, and, the total number of air exchanges within an hour), and the temperature and humidity (moisture) monitoring for room 110. Staff O stated that he did not have a report showing the total number of air exchanges in room 110. When asked if room 110 was a positive pressure room Staff O replied, "No, it isn't."

On 8/2/11 at 3 pm, the hospital's policy and procedure dated 5/11, titled, "Infection Control in the OR / PAR / CS area" was reviewed. (CS - central sterile). On page three under item 8, direction in the policy and procedure was, "Temperature, humidity and air exchange rates in the OR suite: Temperature is to be maintained at 68 to 73 degrees Fahrenheit. Humidity is to be 20 % to 60 %. Air exchange rate is to be 15 exchanges per hour. Temperature and humidity is checked daily and any variances are reported to Bio-med...."

On 8/1/11 at 4 pm, the Perioperative Standards and Recommended Practices, published by Association of periOperative Registered Nurses (AORN) in 2011, was reviewed. On page 218, under Recommendation V, AORN recommended that, "Air in the perioperative environment contains microbial-laden dust, lint, skin squames, and respiratory droplets. The number of microorganisms in the air in an operating room is directly proportional to the number of personnel moving in and around the room. Outbreaks of surgical-site infections have been traced to airborne contamination from colonized health care workers. Heating, ventilation, and air conditioning systems dilute and remove contaminants from the air and control airflow patterns...."

On page 218, under Recommendation V.b., AORN recommended that, "Relative humidity should be maintained between 30 % and 60 % within the perioperative suite, including the operating rooms....High humidity increases the risk of microbial growth in areas where sterile supplies are stored and procedures are performed." Under item V.c.1., AORN recommended that, "Temperature should be maintained between 68 degrees F. to 73 degrees F...." (F- Farenheit).

On page 219, under item V.d.1., AORN recommended that, "The minimum rate of total air exchanges per hour should be maintained at a constant level as follows. Operating room: minimum of 15 air exchanges per hour with a recommended range of 20 to 25 air exchanges...."

On 8/2/11 at 2 pm, an interview was conducted with Administrative Staff A and Administrative Nurse E. Both staff were asked if pain management procedures were surgical procedures. Both staff responded that they did not consider pain management procedures surgery. Administrative Nurse E was then asked if all pain management procedures performed at the hospital were performed in room 110. Administrative Nurse E stated that one physician performed pain management in surgery and another physician performed pain management procedures in room 110. When asked for clarification as to why one physician performed pain management procedures in the operating room, and a second physician performed pain management procedures in room 110. Administrative Staff A, stated the physician who performed pain management procedures room 110, was for physician scheduling convenience.

Administrative Staff A and Administrative Nurse E were then provided a copy of what CMS (Centers for Medicare and Medicaid Services), considers to be surgery. The CMS definition of surgery, developed by the American College of Surgeons, specifies that, "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). All of these surgical procedures are invasive, including those that are performed with lasers, and the risks of any surgical procedure are not eliminated by using a light knife or laser in place of a metal knife, or scalpel. Patient safety and quality of care are paramount and, therefore, patients should be assured that individuals who perform these types of surgery are licensed physicians (physicians as defined in 482.12(c)(1)) who are working within their scope of practice, hospital privileges, and who meet appropriate professional standards."

After review of CMS surgery definition, Administrative Staff A and Administrative Nurse E, confirmed that pain management procedures were surgical procedures.

b. The hospital failed to ensure that hospital provided surgical attire was worn in 1 of 3 surgical procedure rooms as directed in policy and procedure, and in accordance with national standards of practice.

On 8/1/11 at 10:30 am, Administrative Nurse E was asked if hospital staff working in the main operating room and in room 110 wore surgical attire that was laundered by the hospital's commercial laundry? Administrative Nurse E stated that the hospital staff working in the main operating room wore hospital provided surgical attire. Administrative Nurse E added that hospital staff working in room 110, wore personal uniforms or scrubs that they laundered at home. When asked if all pain management procedures were performed in room 110? Administrative Nurse E replied that one physician performed pain management procedures in room 110, and that a second physician did them in surgery. When asked if sterile supplies were opened and used during pain management procedures, Administrative Nurse E replied, "Yes."

On 8/1/11 at 3 pm, the hospital's policy and procedure dated, 6/11, titled, "OR / PAR Dress Code" was reviewed. (OR - operating room, PAR - post anesthesia recovery). On page 1 under item A, direction in the policy was that, "Scrub Clothes: Clean scrub attire is provided by the hospital. Personnel scrub clothes are not acceptable..."

On 8/1/11 at 4 pm, the Perioperative Standards and Recommended Practices, published by Association of periOperative Registered Nurses (AORN) in 2011, was reviewed. On page 61, under Recommendation III, AORN recommended that, "All individuals who enter the semirestricted and restricted areas should wear freshly laundered surgical attire at a health care-accredited laundry facility or disposable surgical attire provided by the facility and intended for use within the perioperative setting." (Perioperative setting - area where surgery is performed).

c. The hospital failed to ensure that 1 of 3 surgical procedure rooms were cleaned and disinfected, and, traffic patterns were maintained in accordance with approved policy and procedure, and, in accordance with national standards of practice.

On 8/1/11 at 8:45 am, a tour was conducted of the hospital's in-patient rooms. It was noted the door leading into room 110 was closed.

During a concurrent interview, Administrative Nurse E stated the door to room 110 was closed because a patient was having a pain management procedure. When asked if pain management procedures were routinely performed in room 110, Administrative Nurse E replied, "Yes."

On 8/1/11 at 1 pm, room 110 was inspected. It was noted that the floor in room 110 was carpeted. It was also noted that equipment in room 110, included a fluoroscopy (X-Ray), table, fluoroscopy machine and video monitoring equipment. Inspection inside cabinets in room 110, revealed that sterile trays and other sterile supplies were stored inside. It was also noted that the traffic pattern in room 110, went from an unrestricted area directly into the restricted area (a traffic flow pattern designed to facilitate movement of patients and personnel into, through, and out of defined areas within the surgical suite. Unrestricted - street clothes are permitted. Semirestricted - surgical attire required. Restricted - Surgical attire and hair covering required. Surgical mask required when sterile equipment and supplies are open).

During an interview on 8/2/11 at 1:30 pm, Nurse H was asked about the process for cleaning and disinfecting room 110. Nurse H stated that the horizontal surfaces in room 110, were cleaned and disinfected after each pain management procedure, and at the end of the day. Nurse H was asked if there was a system ensuring that carpet was cleaned daily in room 110. Nurse H stated that carpet in room 110 was cleaned when needed. When asked if she considered room 110 a surgical suite, Nurse H replied that she didn't consider room 110 a surgical suite.

On 8/2/11 at 3 pm, the hospital's policy and procedure (undated), titled, "Environment of Care" was reviewed. On page two, direction in the policy and procedure under cleaning and disinfection requirements, was, "Carpeting in patient care areas will be vacuumed daily and spot cleaned as needed....Shampooing of carpet in patient care areas will be done every quarter as needed..." The policy and procedure provided no direction on how carpeted floors were to be cleaned in rooms where surgical procedures were performed.

On 8/2/11 at 3:15 pm, the hospital's policy and procedure dated 5/11, titled, "Infection Control in the OR / PAR / CS area" was reviewed. (CS - central sterile). On page one, under item 4, direction in the policy and procedure was, "Classification of areas: Unrestricted - where the hazards of contamination are minimum...This applies to reception desk and locker room... Semi-restricted - where substantial care should be taken to prevent cross contamination...These areas include: corridors.. storage areas.. and recovery areas..Restricted - where the hazard is greatest and maximum precautions should be taken to prevent cross contamination. Persons entering these areas are expected to wear protective clothing or strict operating room attire: All OR major rooms.. hall immediately adjacent to major rooms..."

On 8/2/11 at 3:30 pm, the Perioperative Standards and Recommended Practices, published by Association of periOperative Registered Nurses (AORN) in 2011, was reviewed. On page 241, under Recommendation IV, AORN recommended that, "Surgical and invasive procedure rooms and scrub / utility areas should be terminally cleaned daily. Terminal cleaning and disinfection of the perioperative environment decreases the number of pathogens, dust, and debris that is created during the day. Under Recommendation IV.a., AORN recommended that, "Terminal cleaning and disinfection of operating and invasive procedure rooms should be done when the scheduled procedures are completed for the day, and each 24-hour period during the regular work week." Under Recommendation IV.a.2., AORN, recommended that, "Floors should be wet-vacuumed with an EPA-registered disinfectant after scheduled cases are completed." (EPA - Environmental Protection Agency).

2. The hospital failed to implement their policy and procedure ensuring that surgical instruments were sterilized according to current standards of practice and that flash sterilization was only used in an emergency and when instruments were to be used immediately.

On 8/1/11 at 9:30 am, a tour was conducted of the surgical services area. During the tour, Administrative Nurse E was asked if she was aware how frequent flash sterilization was used to sterilize surgical instruments. Administrative Nurse E stated that the hospital flash sterilized almost 100 percent of the instruments used during surgical procedures. Administrative Nurse E stated that she was aware that sterile processing staff (individuals responsible for cleaning and sterilizing surgical instruments), routinely flash sterilized surgical instruments. Administrative Nurse A also stated that she was aware that the hospital needed to reduce flash sterilization of instruments.

On 8/1/11 at 2 pm, documents titled, "Flash sterilization log" was provided and reviewed. Documentation on the "Flash sterilization log" revealed that from 9/1/10 to 7/28/11, all of the instruments used for surgical procedures were sterilized using flash sterilization. It was noted that the reason frequently listed for using flash sterilization was, "Turn over." A second review of the sterilization logs disclosed there was no documentation showing that surgical instruments were sterilized using conventional steam sterilization.

On 8/1/11 at 3 pm, the hospital's 8/11, policy and procedure titled, "Assembly of instrument trays and wrapping of instruments" was reviewed. On page one, under the section titled, "Steam sterilization" hospital staff were directed, "Items sterilized for immediate use in the operating room must be run in transport pans or transported through the common corridor in a covered fashion. This will be used for emergencies and not as a routine practice."

On 8/2/11 at 10 am, Nurse P was interviewed. During the interview, Nurse P was asked about the hospital's practice of flash sterilizing instruments. During the interview, Nurse P verified that the hospital flash sterilized all sterilized surgical instruments. In addition, Nurse P stated for the months of April, May and June 2011, the hospital flash sterilized 146 of 146 loads of surgical instruments.

On 8/1/11 at 4 pm, the Perioperative Standards and Recommended Practices, published by Association of periOperative Registered Nurses (AORN) in 2011, was reviewed. On page 466, under Recommendation IV, AORN recommended that, "Use of flash sterilization should be kept to a minimum. Flash sterilization should be used only in selected 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." Under IV.a., AORN recommended that, "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 used as a substitute for sufficient instrument inventory."

3. The hospital failed to develop and implement policies and procedures ensuring that devices used to position multiple patients, had intact surfaces allowing the devices to be appropriately cleaned and disinfected between patients.

On 8/2/11 at 1 pm, a tour was conducted of the surgical services area. During the tour, padded devices (four different devices), used to position patient's legs and arms while on the surgical table were observed stored on wire racks outside operating room 1. Inspection of the four devices revealed that the outer vinyl covering was cracked and that the inside foam was exposed.

During a concurrent interview, Nurse P was asked to explain how the positioning devices were cleaned and disinfected between patients. Nurse P stated that the positioning devices were cleaned and disinfected after each patient. When asked how the positioning devices could be cleaned and disinfected with non intact surfaces, Nurse P replied, that it would be difficult to ensure that the padded positioning devices were cleaned and appropriately disinfected after each patient. When asked if the hospital had developed a system ensuring the surfaces of equipment used for multiple patients was intact, Nurse P replied, "No."

On 8/2/11 at 2 pm, room 110, where surgical pain management procedures were performed was toured. Three padded devices used to position patients during pain management procedures were observed sitting on a table. It was noted that the outer surfaces of the three devices were cracked and did not have intact surfaces.

On 8/2/11 at 2:15 pm, an interview was conducted with Staff R. Staff R was asked about the process for cleaning the positioning devices used in room 110. Staff R stated that the positioning devices were cleaned and disinfected between patients. When asked if he felt that the positioning devices with non intact surfaces could be appropriately cleaned and disinfected. Staff R replied, "No," and added that several times he requested that the positioning devices be replaced, but was told there wasn't money in the budget.

On 8/1/11 at 4 pm, the Perioperative Standards and Recommended Practices, published by Association of periOperative Registered Nurses (AORN) in 2011, was reviewed. On page 339, under Recommendation III, under item III.b., AORN recommended that, "Surfaces of positioning and transporting equipment, should be smooth and intact. Loss of equipment surface integrity can result in bacterial growth. Surfaces that hold moisture or wrinkle contribute to skin breakdown."

Based on document review and staff interview, the hospital failed to ensure that the operating room register was complete, up-to-date and contained dates concerning all surgical procedures performed. As a result, critical operative data was not collected for 818 surgical procedures performed at the hospital from 2/1/11 through 7/31/11.

Findings:

On 8/1/11 at 8:20 a.m. during the entrance conference, the surgical registration log was requested and a post bound book of log sheets was presented for review. These log sheets contained data about surgical procedures performed in the operating suite identifying date and time of the surgical procedure, the patient's name, the surgical procedure performed and all other demographics required by California Code of Regulations section 70223. On 8/2/11 surgical procedures consisting of injections of medications into the spinal canal for analgesia (for relief of pain and commonly referred to as "block" procedures) were being performed in Room 101, a patient care room adjacent to the surgical suite. On 8/3/11 at 9:30 a.m. the surgical registration log was again reviewed and it was noted that the log did not contain any surgical procedures outside of the two rooms in the operating suite. On 8/2/11 at 9:50 a.m., during an interview, Administrative Staff A stated: "The operating room log does not include any of the 'block' procedures done in the "procedure room." "It is what it is; we have not been recording a log of these procedures."

In response to this interview, Administrative Staff A arranged for a special computer report to be generated form the financial data maintained in the hospital's computer system. This report was run at 10:37 a.m. on 8/3/11. The report contained only the procedure numbers, financial class numbers, patient names, patient record numbers, and admission dates. This report documented that from 2/1/11 until 7/31/11 there were a total of 818 "block" procedures performed on patients in the procedure room.

On 8/4/11 at 10:30 during an interview with the Medical Director C, it was again acknowledged that the hospital did not keep a log or the surgical "block" procedures done in the "procedure room."