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Based on review of the hospital's Seclusion and Restraint policy and the records of patient #2, the hospital failed to ensure that restraints for violent/self-destructive patients are discontinued at the earliest possible time in one of six behavioral health patients reviewed as evidenced by :

Page 10, Para 4(d) of the hospital's Seclusion and Restraint policy states " ...A decision to remove a restraint or discontinue seclusion is based on the following: For violent or self-destructive patients - the patient is verbally able to contract for safety and to identify appropriate alternative behaviors. " Since federal regulations call for restraints to end when the patient's violent/self-destructive behavior ends, a facility may not require a patient to contract for safety or to identify appropriate alternative behaviors in order to be released from restraints.

Additionally, based on review of the medical record of Patient #2, the hospital failed to ensure that Patient #2 was removed from seclusion at the earliest possible time as evidenced by the following:

Patient #2 was a 23-year-old male placed into seclusion on 3/23/10 from 7:20 pm until 8:00 pm. His Care and Observation Record documents that between 7:30 pm and 8:00 pm Patient #2 was either "resting on mattress" or "sitting on mattress" behaviors which do not justify keeping a patient in seclusion.

Based on a review of medical records, the hospital failed to implement restraints in accordance with hospital policy and/or state law in one of six behavioral health patients reviewed as evidenced by the following:

Patient #1 was a 55-year-old male placed into 4-point restraints from 8:00 pm on 5/20/10 until thirty minutes after midnight on 5/21/10. There is no documentation on Patient #1's Care and Observation Record that the RN assessment was performed every hour; that circulation checks was done every hour; that ranger of motion was performed every two hours; or that limb realignment/massage was done every hour.

Based on review of the records of six behavioral health patients, the hospital failed to provide the face-to-face evaluation within one hour of the initiation of restraints in one of the 6 patients reviewed as evidenced by :

Patient #1 was a 55-year-old male placed into 4-point restraints from 8:00 pm on 5/20/10 until thirty minutes after midnight on 5/21/10. The record documents that the on-call hospitalist evaluated Patient #1 in a face-to-face at 11:20 pm, more than three hours after he was placed into restraints.

Based on review of six medical records for six behavioral health patients, the hospital failed to document in one record (Patient #1) the behavior that warranted the use of behavioral restraints as evidenced by the following:

Patient #1's record documents that a physician's order was obtained to place him in 4-point restraints on 5/20/10 from 8:00 pm until midnight, and then on 5/21/10 from midnight until 4:00 am. Patient #1's nursing note states only that he became "...increasingly agitated, combative and assaultive with staff ..." but does not document the specific behavior that warranted the restraints.

Additionally, Patient #1's Patient Safety Documentation Record contains boxes for staff to check off with only generic statements attached such as "agitated," "assaultive," and "combative".

Based on observation, staff interviews, and review of pertinent documentation, hospital leadership failed to ensure that the hospital-wide quality assurance program addressed infection control problems in the hospital and failed to implement successful corrective action plans in affected problem areas for most of 2009 and part of 2010 as evidenced by:

As detailed further in Federal Tag A0747, the hospital's infection control program failed to monitor quality related indicators and data through 2009 and part of 2010. When questioned by the surveyor, the current ICP was unable to articulate knowledge of the scope of the hospital's 2010 plan. Interviews further revealed that rather than continuing with the current plan the hospital leadership has decided to focus on developing a plan for 2011. The hospital elected to not to revise the 2010 infection prevention plan, which was not based on a risk assessment and failed to prioritize goals and instead focus on 2011. As part of its active surveillance program the hospital failed to collect, analyze, and monitor data on hand hygiene, which was the only individualized objective identified in the hospital's FY10 plan.

Review of QAPI minutes revealed no discussions in the prior 6 months regarding the failure of units to report infection control Quality Assurance data to the ICP, the failure of the hospital to aggregate the IC data appropriately, or the failure to have valid and reliable data on which to based substantive analysis or decision-making.

In 1 of 37 medical records reviewed, the hospital failed to ensure that drugs and biologicals were prepared and administered in accordance with Federal and State laws, the orders of the practitioner or practitioners responsible for the patient's care as specified under 482.12-c, and accepted standards of practice as evidenced by:

In 1 of 37 records reviewed (patient #2) the surveyor noted an incomplete order for TPN (Total Parenteral Nutrition) and nursing had reviewed and relied on this incomplete order during administration of TPN as evidenced by:

Based on review of the medical records of patient #2 an incomplete order dated 5/24/10 for TPN (Total Parenteral Nutrition) was noted. As written, the order indicated that it was written and signed by the RN. There were no notation on the order to identify it as verbal order or telephone order and there was no authorizing physician indicated with the RN signature.

Review of the personnel folder for the RN who documented that she wrote the order revealed that she was not a Licensed Independent Practitioner and was not credentialed to write orders. The order form had a space for a physician signature, which was blank.

Further, the order form was also incomplete because it lacked the patient's height, weight, and allergy information, as well as the TPN infusion rate. Nonetheless, the order was faxed to pharmacy and pharmacy both accepted and filled the order. The bottom of the same form then indicated that at time of administration, 2 RNs signed off that they too checked the order at the time of administration. Thus, TPN was ordered, approved, dispensed, and administered to patient #2 without any indication that the physician had ordered it.

The hospital later reported that the order was a telephone order, but there was no notation on the order that it was a telephone order in the record. The order was not noted as a telephone order, "read back " was not indicated on the order, and the nurse had not noted what physician had authorized it as a telephone order. Nonetheless, after review of the order by 2 RNs, and without any clarifications noted in the record, the TPN was administered by nursing.

Based on review of the medical records and interview with staff it was determined that the hospital failed to ensure that pharmaceutical services safely met the needs of the patients in one of 37 medical records reviewed as evidenced by:

In 1 of 37 open records reviewed (patient #2) on 5/25/2010, the surveyor noted an incomplete 5/24 order for TPN (Total Parenteral Nutrition). Patient #2 was a 78 year-old male admitted on 5/11/2010. Patient #2's TPN order indicated that it was written by an RN but review of the personnel folder for the RN who documented that she wrote the order revealed that she was not a Licensed Independent Practitioner and was not credentialed to write orders. The order form had a space for a physician signature, which was blank. The order form was not complete as it lacked the patient's height, weight, and allergy information, as well as the TPN infusion rate. Lacking a physician signature, any notation demonstrating it was a telephone order, height, weight, allergy data, and any infusion rate, this was not a complete order.

Nonetheless, the order was faxed to pharmacy, and pharmacy both accepted and filled the order. The bottom of the same form then indicated that at time of administration, 2 RNs checked the order and signed off that the TPN was administered. Thus, TPN was ordered , approved, dispensed, and administered to patient #2 with an order that, as written, was both incomplete.

Based on kitchen observations and staff interview, it was determined that the facility staff failed to: 1) follow safe food handling precautions when storing food; and 2) maintain an effective sanitizer concentration in the 3-compartment sink. The findings include:

1) The facility staff failed to follow safe food handling precautions when storing food.

On 05/25/10 at 9:30AM, an unannounced kitchen inspection was conducted. During this time, the following concerns were identified:

a) Three undated packages of thawed flank steak were observed in the walk-in refrigerator (two of which were not wrapped in the original aseptic packaging). Staff were unable to identify when these steaks had been pulled from the freezer. Two opened tubes of undated whipped topping, in addition to 6 unopened and undated tubes, were observed in the dairy walk-in refrigerator. These products have a limited shelf life and must be dated upon thawing to ensure freshness.

b) A 5-pound container of light sour cream with an expiration date of 05/19/10 was observed in the walk-in refrigerator. After surveyor intervention, this expired product was discarded.

c) Observation of the walk-in freezer revealed that the floor was unswept. Food and debris (including frozen carrots, pepperoni slices, and ice cream cups) were observed on the floor throughout the walk-in area.

2) The facility staff failed to maintain an effective sanitizater concentration in the 3-compartment sink.

On 05/25/10 at 9:45AM, an employee was observed utilizing the 3-compartment sink. The surveyor returned after the employee set up the sanitizer compartment. A 3-compartment sink is used to wash, rinse and sanitize pots, pans, and serving utensils. No test strips were available to the employee until the supervisor retrieved them from storage. The test strip revealed that the sanitizer concentration was approximatley 0-50 ppm (part per million). This is below the required level of 150-200 ppm for effective sanitization. After surveyor intervention, a technician was contacted and it was determined that the automatic sanitizer dispenser was in need of resetting. At 3:45PM on 05/25/10, this concern was corrected.

Based on meal service observations, record review and staff interview, it was determined that the facility staff failed to ensure that proper portion sizes were utilized. The findings include:

On 05/25/10 at 10:55AM, a trayline observation was conducted at lunch. During this time, staff were seen using #16 scoops (equivalent to 2 ounces) of mashed potatoes, whipped sweet potatoes, and spinach. Review of the menus and interview of the FSD (Foodservice Director) revealed that a 4-ounce serving was supposed to be provided for these food items.

Facility staff must follow menus as planned to ensure that patients receive meals that are nutritionally adequate.

Based on the deficiencies cited as part of the life safety code survey conducted on May 26, 2010 it was determined that the hospital failed to comply with all requirements of the Life Safety Code as evidenced by:

During the tour of the hospital, the staff of the State Fire Marshall noted that the hospital failed to patch spray applied fire proofing in mechanical room 2050 as cited at K012; failed to provide approved astragals to seal the cross corridor doors and fire barrier doors in the new cardiac pulmonary services area as cited at K027; failed to provide vision panels in the same sets of doors as cited at K028; failed to remove a magnetic lock from a door with panic hardware in the cafeteria area as noted at K 038; allowed work stations to occupy an exit access corridor in human resources as noted in K038; ; allowed storage in an exit access corridor on the ground floor near plant maintenance as noted in K038; failed to have documentation of the quarterly sprinkler testing and maintenance including drain tests as noted in K062; failed to identify and correct the sprinkler system violations noted in K056; failed to remove unused fire extinguishers cabinets in the psychiatric unit as noted in K064 and failed to provide " No Smoking or Open Flames" signage in oxygen storage and holding areas as identified in K141.

Based on observations, staff interviews, and review of pertinent documentation, the hospital's infection control officer failed to fulfill the requirements to maintain an active program for the prevention, control, and investigation of infections and communicable diseases as evidenced by:

Interview with administrative staff revealed that in August 2009 the hospital had determined that the former Infection Control Practitioner was not performing her duties and was subsequently terminated 01/12/2010. The former ICP had failed to collect and aggregate any meaningful data in order to track and trend infection control concerns hospital-wide. An interim ICP replaced her and a new ICP was working in the role for 8 weeks prior to this survey.

As a result the hospital did not have documentation to indicate that the hospital's program included a process to identify risk of infection and communicable diseases throughout the hospital. For example, the hospital was not able to produce data including baselines, regarding central line infections, MRSA infections, or ventilator associated pneumonia when requested by the surveyors. Review of the hospital's infection control records revealed that:

1. In November to December 2009 the hospital was not tracking data on central lines including culture results to determine if the patient met the criteria for central line infection.

2. In January 2010 it was noted that the on-going surgical site infection project data was not available to be presented to Infection Prevention and Control meeting and that the partially completed surgical site action plan and process had not been communicated to the OR. This became evident during the 1/26/10 Infection Prevention and Control (IPAC) meeting.

3. As of January 2010 there were 10 infection control policies that had not been updated.

4. Review of the core measures for 2008 revealed no data collected for urinary catheter removal and peri-operative temperature management.

5. As of January 2010 no data had been collected for the hospital's special project surviving sepsis.

6. No hand hygiene data was collected for 7 out of 13 hospital units from July to August 2009, 6 out of 13 units for September 2009 with no improvement noted between October to November 2009, and from December 2009 to March 2010 , 4 of 9 units did not report data. Some of the units not reporting included ED, Joint, Cardiopulmonary, Laboratory, PACU, OR and Rehabilitation.

When reviewed, the hospital's infection control plan had no individualized goals and objectives except a hand-washing initiative. Even though the only individualized initiative identified in the hospital's infection control plan for 2010 was hand-washing, based on observations in 3 of 13 units, dirty utility rooms hand washing stations were unavailable for use and no sanitizing gel dispensers were available in these same areas.

Pertinent documentation revealed that unit observations of hand-washing (12 of 13 units) were frequently not reported to the ICP, and thus there was no evidence that hand-washing observations needed to collect the data were completed on the units.

Review of minutes from Quality, Medical Staff and Governing Body revealed that concerns with the infection control program, though known, were not discussed or reported up through the committees.

Based on the review there was a failure to track central line infections, sepsis, surgical site infections, and hand washing data consistently during 2009 and part of 2010 until the interim and new ICP were put in place. While the hiring of the new ICP may address the previous lapses in the program insufficient time has passed to determine if this will address the inadequacies in the infection control program.

Based on observation, staff interviews, and review of pertinent documentation, hospital leadership failed to ensure that the hospital-wide quality assurance program addressed infection control problems in the hospital and failed to implement successful corrective action plans in affected problem areas in a timely manner as evidenced by:

As detailed further in Federal Tag A0747, the hospital's infection control program failed to monitor quality related indicators and data through 2009 and part of 2010. When questioned by the surveyor, the current ICP was unable to articulate knowledge of the scope of the hospital's 2010 plan. Interviews further revealed that rather than continuing with the current plan the hospital leadership has decided to focus on developing a plan for 2011. The hospital elected to not to revise the 2010 infection prevention plan, which was not based on a risk assessment and failed to prioritize goals and instead focus on 2011. As part of its active surveillance program the hospital failed to collect, analyze, and monitor data on hand hygiene, which was the only individualized objective identified in the hospital's FY10 plan.

Review of QAPI minutes revealed no discussions in the prior 6 months regarding the failure of units to report infection control Quality Assurance data to the ICP, the failure of the hospital to aggregate the IC data appropriately, or the failure to have valid and reliable data on which to based substantive analysis or decision-making. Further this same information that was absent in QAPI minutes was also not found reported up to Medical Staff subcommittees and/or the Governing Body. Thus, hospital leadership failed to ensure that the hospital-wide quality assurance program monitored the infection prevention and control goals and corrective action plans in affected problem areas.

Based on a review of 5 inpatient medical records on the Maternal Child Health Unit, 3 of those patients received epidural anesthesia during delivery. (An epidural is a regional anesthesia that blocks pain in particular region of the body. Epidurals block nerve impulses from the lower spinal segments resulting in decreased sensation to the lower half of the body.) Three out of 3 epidural records reviewed did not have post anesthesia evaluations within 48 hours. In fact, none of the patients, who received epidural anesthesia, received post operative evaluations or were discharged from anesthesia. Post procedure, the anesthesiologist documented the time that the epidural catheter was removed "with tip intact." There were no followup progress notes written to support post-operative assessment within the required 48 hours. It was determined the post anesthesia evaluation was not being completed on patients who received epidural anesthesia. Those patients were never discharged from anesthesia.

In a discussion with the Chief of Anesthesiology, he admitted that the post anesthesia evaluation for patients receiving epidurals was not being completed. He discussed the time necessary for recovery from epidural anesthesia presented documentation issues for surgical/anesthesiology services. It was determined in discussion with the surveyor that progress notes written within 48 hours post-op that covered the required parameters would meet the requirement.

Post anesthesia care is an important aspect of patient care and safety. Vital signs (blood pressure, pulse and respiratory rate, temperature), mental status, pain level, other discomforts like nausea and vomiting, and return of movement and sensation all need to be part of the post anesthesia assessment and monitoring. The patient needs to be fully assessed by practitioners who are qualified to administer anesthesia post procedure and discharged by the service in stable condition.






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