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Based on staff interview and document review, the hospital failed to submit reports to the Center for Medicaid/Medicare Services (CMS) Regional Office in a timely manner related to patient deaths for three of three (Ps 7, 8, 9) when restraints had been utilized during the patients' care.

Findings include:

During review of the reports of patient deaths with associated restraint use from 4/6/11 to 2/7/12, it was learned that no reports had been submitted to CMS since April 2011.

An interview was conducted with the director of clinical practice at 2:30 p.m. on 4/24/12. The director of clinical practice stated the process of reporting deaths associated with restraint use was not clearly defined for reporting any deaths potentially associated with the use of restraints, no later than the close of the next business day following the day in which the hospital knows of the patient's death. The director of clinical practice verified the policy identified reporting deaths associated with restraint use to CMS; however, this had not been done since February 2011. The director of clinical practice stated a system was not in place for reporting deaths associated with restraint use to CMS.
The hospital's Restraint Policy (revised January 2010), was reviewed. The policy identified that the hospital would report to CMS any death associated with the use of restraint or seclusion no later than the close of the next business day following knowledge of the patient's death.

Based on document review and interview, the facility failed to ensure nursing services was carried over from the emergency department to the acute care for 1 of 1 patient (P10) who was admitted that needed insulin.

Findings included:

The incident and accident occurrences were reviewed from January 2012 going forward. P10 was transferred to the intensive care unit (ICU) due to the insulin medication regime not being followed.

According to the Fairview patient Incidents and Concerns form dated 2/24/12, P10 was seen in the emergency department (ED) on 2/21/12. The ED compiled a list of medications P10 utilized at home and the list included Novolog insulin (a medication used to treat diabetes) and Lantus insulin (a medication used to treat diabetes). P10 received the prescribed Lantus insulin (BS was 183) and did not receive the prescribed Novolog insulin while at the ED department on 2/21/12.

P10 was admitted to the hospital at 2:49 a.m. on 2/22/12. At 12 noon on 2/22/12, P10's blood sugar (BS) was 466 and at 4:00 p.m. on 2/22/12, the BS was 450. The patient was transferred to ICU. The son-in-law did notify the hospital and, P10 would not have been admitted to ICU. P10 was discharged from the hospital shortly thereafter with no adverse effects. None of the admitting nursing staff reviewed the PTA list to assess P10's elevated BS and the need for Novolog insulin.

The director of ED and inpatient services was interviewed at 12:30 p.m. on 2/24/12. The director indicated the process was to obtain a prior to admission (PTA) list of medications. The PTA medication list would be done at the time the patient presented to the ED either by the pharmacist on duty or by the physician if the pharmacist was not available. When the director of ED was questioned as to why P10 did not receive the prescribed insulin, she indicated she would have to review the chart.

The director of ED and inpatient services was interviewed at 2:45 p.m. on 2/24/12. The director of ED and inpatient services indicated the insulin was overlooked. The son-in-law was gotten back to regarding the incident and accepted the facility's apology. When questioned if the incident had been reviewed by a physician, the director indicated the physician was still reviewing the case. When questioned as to how long the physician was to review the case as the incident had happened in February 2012, the director indicated the physician had two weeks after an incident to review the occurrence report.

The Occurrence Reporting policy revised March 2012, noted "F. Managers/supervisors review and investigate occurrence reports routed to their attention to identify contributing or causal factors that could have been prevented. Ordinarily, this should be completed within 14 days."

Based on document review and interview the facility to follow up on a recommendation from a annual preventative maintenance check for 1 of 4 x-ray machines in the radiology department.

Findings include:

The radiology department was observed at 1:00 p.m. on 4/25/12. A request to see the preventative maintenance information for the x-ray machine in room number 3 was made.
At 2:50 p.m. on 4/24/12, the facility provided the Work Order Form dated 10/26/11, for the number 3 x-ray machine. The form noted that during the preventative maintenance check, the Unfors QA view software (new software made for a simple and uniform way of producing reports from routine preventive maintenance and quality assurance work) crashed and the radiation output information was lost. The recommendation was to schedule a return visit to collect those numbers form the number three x-ray machine. A request was made to review the follow-up visit information and the facility could not produce any information as the follow-up visit had not been scheduled.
The imaging engineering-A in charge of the preventative maintenance for the x-ray machine number 3 was interviewed at 2:50 p.m. on 4/24/12. He acknowledged the follow-up for the recommendation of retrieving the crashed data should have taken place within two days of the recommendation. When questioned if the lack of follow through could impact patient care, he indicated, "Yes." Per the website for Unfors (http://www.unfors.com), the data that was lost included inspection items, calibrations, preventative maintenance checks, and what services were needed on the x-ray machine. The measurements for the Unfors QA that were lost, determined if the machine passed or failed the preventative maintenance check.

Based on observation, interview, and document review the hospital failed to ensure employees wore personal radiation monitoring devices for 1 of 4 radiology technicians (RT)-B who was observed without a monitoring badge.

Findings include:

A tour of the radiology service area was completed at 1:35 p.m. on 4/24/12, and RT-B was observed without a radiation badge. When questioned about the missing badge, RT-B went over the employee coat section of the radiology department, took the badge out of the coat pocket and placed the device on his shirt. RT-B also revealed he had been at work since 6:30 a.m. and had completed four to five x-rays. One of which, he had assisted in the holding of a patient while the x-ray was taken. RT-B verified he should have had the badge on.

The hospital radiation exposure record was reviewed for RT-B. The record indicated the radiation level for RT-B was within normal range for the past year.

The director of radiology was interviewed at 1:40 p.m. on 4/24/12, the director acknowledged personal radiation badges were to be worn at all times.

The policy for Radiation Safety dated 11/92, read, "Appropriate personnel monitoring equipment will be provided and required for use by: A. Each individual associated with the operation of an x-ray system and B. Each individual who enters a high radiation area".

The hospital was found out of compliance with the Condition of Participation, Physical Environment (42 CFR 482.41), as evidenced by deficiencies issued as a result of a Life Safety Code inspection completed 4/26/12 during a complaint validation survey.

Findings include:

Refer to Life Safety Code deficiencies - K29, K38, K48, K50 and K72 for additional information.

Based on interview and document review, the facility failed to ensure infection control practices were adhered to for 2 of 4 ultrasound procedures in the radiology department.
Findings include:
A tour of the radiology service area was completed at 1:45 p.m. on 4/24/12, and radiology technician (RT)-A had was interviewed. When RT-A was questioned as to how the ultrasound tables were cleaned/disinfected between patients, she indicated she only cleaned them if there were noticeable body fluids. She indicated she had completed four ultrasounds so far on 4/25/12, and further remarked she disinfected two of four tables between patients.
The director of radiology was interviewed at 1:50 p.m. on 4/24/12, the director acknowledged the tables had to be disinfected between each patient.
The policy for Guideline for disinfection and Sterilization of Patient Care Medical Devices Attachment A printed on April 24, 2012, indicated the ultrasound tables were non-critical and if the patient had intact skin the "items must be cleaned between patients with detergent and water. If disinfection is required, follow with appropriate disinfectant."


25482

The hospital failed to ensure that appropriate infection control practices related to hand hygiene were consistently implemented after direct contact with a patient (P11) who was admitted to the obstetrics unit.

At 9:50 a.m. on 4/25/12, the registered nurse (RN-A) was observed to assess the abdomen and perineum of P11. RN-A donned gloves and proceeded to press on the patient's abdomen to assess the height of the uterine fundus. RN-A then proceeded to assess the patient's perineum for the presence of swelling, bruising and bleeding. RN-A removed her contaminated gloves following her assessment. RN-A then poured a glass of water for the patient, handled the blood pressure equipment, the locked wall unit outside of the patient's room and sat down to document her findings at the computer station outside of the patient's room all without washing her hands. Immediately following the observation RN-A was asked when she should be washing her hands. RN-A immediately grabbed the can of foam hand sanitizer that was sitting on the desk next to her and applied it to her hands. RN-A stated she usually cleanses her hands using the foam hand sanitizer after providing patient cares and what threw her off was that the patient's room does not have a foam hand dispenser right outside the door.

At 1:25 p.m. on 4/25/12, the hospital's infection control officer (ICO) stated all staff receive education regarding appropriate hand hygiene. The ICO stated the facility utilizes a "foam in foam out" procedure to prevent the transmission of infection.

The facilities Hand Hygiene (Hand Washing) policy printed April 9, 2012 indicated healthcare workers are expected to perform hand hygiene using soap and water or alcohol rubs: before touching a patient, after contact with a patient, when removing gloves and when changing from dirty to clean procedures, including procedures within the same patient.

Based on observation, interview and document review, the hospital was found not to be in compliance with the Condition of Participation for Surgical Services (CFR 482.51) due to failure to follow acceptable standards of practice related to the use of electrocautery devices for 1 of 2 operative patients (P1).

Findings include:

Refer to findings at A-0951 regarding the use of electrocautery equipment in the surgical suite.


The L Hook Electrode was not holstered during surgery.

Review of the Fairview Lakes Medical Center Perioperative Services policy with the subject title of: Patient Fire Safety: Oxygen Enriched Environment date effective 3/2012, the following was specified under the procedure section #2: Place ESU (Electrosurigical equipment use) active electrode in holster when not in use.

P1 had a laparoscopic cholecystectomy on 4/24/12. P1 was taken to operating room # 4 at 10:50 A.M. During this procedure an instrument identified as an L Hook Electrode was utilized. Multiple observations during the surgery were made by the surveyor looking for the holster for the L Hook Electrode, but no holster was identified. Immediately following removal of the L Hook Electrode from the abdomen of P1, Medical Doctor (MD)-B placed the L Hook Electrode on the drape of P1 at 11:50 A.M. which was located on P1's upper abdominal area.

The Director of Perioperative Services and the Birthplace was present at the above date and time and verified that the L Hook Electrode was not holstered and was laying on the drape of P1, which was located on her upper abdomen. In addition Surgical Scrub Technician (Scrub Tech)-A verified at the same date and time that no holster had been made available for the L Hook Electrode to be holstered during the case. Even though both the Director of Perioperative Services and the Birthplace and Scrub Tech-A indicated they were aware that the L Hook Electrode was laying on the surgical drape of P1, no one removed it or asked MD-B or Physician Assistant (PA)-C to remove it.

On 4/24/12 at 11:55 A.M. the onsite Team Lead Fire Marshall was interviewed and verified that the surgical drape was combustible.

ON 4/24/12 at 12:45 A.M. the Director of Perioperative Services and the Birthplace was notified that the condition of Surgical Services would remain as being out of compliance.

Based on observation, interview and document review the facility failed to follow their policy to assure surgical services were provided consistent with needs and resources in accordance with acceptable standards of practice related to the fire hazards for 1 of 2 (P1) operative patients reviewed.
Findings include:

The Patient Fire Safety:Oxygen Enriched Environment Policy was not followed during a procedure in the operating room.

Review of the Fairview Lakes Medical Center Perioperative Services policy with the subject title of: Patient Fire Safety: Oxygen Enriched Environment date effective 3/2012, the following was specified under the procedure section #2: Place ESU (Electrosurigical equipment use) active electrode in holster when not in use.

During observation at 11:50 A.M. on 4/24/12 in operating room #4 it was identified that the long cautery wand was not holstered immediately following use, but was placed on the surgical drape of P1 which was located on her upper abdomen by Medical Doctor (MD)-B.

The Director of Perioperative Services and the Birthplace was present at the above date and time and verified that the long cuatery wand was not holstered and was laying on the drape of P1, which was located on her upper abdomen. In addition Surgical Scrub Technician (Scrub Tech)-A verified at the same date and time that no holster had been made available for the long cautery wand to be placed in during the case. Even though both the Director of Perioperative Services and the Birthplace and Scrub Tech-A indicated they were aware that the long cautery wand was laying on the surgical drape of P1, no one removed it or asked MD-B or Physician Assistant (PA)-C to remove it.

Based on observation, document review and staff interview, the facility failed to ensure that 1 of 1 surgical in-patients (P3) was evaluated for proper anesthesia recovery following surgery.

Findings include:

One surgical patient record lacked documentation to support the patient had been evaluated for proper anesthesia recovery.

P3 had a surgical procedure under general anesthesia on 4/24/12. The surgery end time based on interview at 8:57 A.M. on 4/25/12 with the Director of the Perioperative Services and the Birthplace was identified as being 2:55 P.M. The CRNA documented the post-anesthesia evaluation at 3:01 p.m., just 6 minutes following the end of surgery.

The Director of Perioperative Services and the Birthplace, interviewed at 9:03 A.M. on 4/25/12, verified that following general anesthesia, the post-anesthesia evaluation was being completed too quickly to allow for proper and adequate evaluation of the status of the surgical patient.

Interview at 8:30 A.M. on 4/26/12 with the Lead CRNA verified that the post anesthesia evaluation was completed very soon following transfer to the Recovery Room and agreed that patients might not be able to assess their pain level during this short time frame. He further added that the CRNA's do go back later and check on the patients to further evaluate how they are doing, however, he stated that we don't document this.

Based on observation, document review and staff interview, the facility failed to ensure that 4 of 5 surgical out-patients (P1, P2, P5 and P6) were evaluated for proper anesthesia recovery following surgery.

Findings include:

Four surgical patient records lacked documentation to support the patients had been evaluated for proper anesthesia recovery.

P1 had a surgical procedure under general anesthesia on 4/24/12. The surgery end time based on interview at 8:55 A.M. on 4/25/12 with the Director of the Perioperative Services and the Birthplace was identified as being 12:19 P.M. The CRNA (certified registered nurse anesthetist) documented the post-anesthesia note at the same time of 12:19 P.M..

P2 had a surgical procedure under general anesthesia on 4/24/12. The surgery end time based on interview at 8:56 A.M. on 4/25/12 with the Director of the Perioperative Services and the Birthplace was identified as being 12:07 P.M. The CRNA documented the post-anesthesia note at 12:12 P.M, just 5 minutes following the end of surgery.

P5 had a surgical procedure under general anesthesia on 4/24/12. The surgery end time based on interview at 8:59 A.M. on 4/25/12 with the Director of the Perioperative Services and the the Birthplace was identified as being 4:25 P.M The post-anesthesia evaluation was documented at 4:30 P.M., just 5 minutes following the end of surgery.

P6 had a surgical procedure under general anesthesia on 4/24/12. The surgery end time based on interview at 9:00 A.M. on 4/25/12 with the Director of the Perioperative Services and the Birthplace was identified as 3:25 P.M. The post-anesthesia evaluation was documented at 3:33 P.M., just 8 minutes following the end of surgery.

During interview with the Director of Perioperative Services and the Birthplace at 9:03 A.M. on 4/25/12 verified that following general anesthesia, the post-anesthesia evaluation was being completed too quickly to allow for proper and adequate evaluation of the status of the surgical patients.

Interview at 8:30 A.M. on 4/26/12, with the Lead Certified Registered Nurse Anesthetist (CRNA), verified that the post anesthesia evaluation is completed very soon following transfer to the Recovery Room and agreed that patients might not be able to assess their pain level during this short time frame. He further added that the CRNA's do go back later and check on the patients to further evaluate how they are doing, however, he stated that we don't document this.

Based on review of the organizational chart of outpatient services and interview, the hospital failed to ensure that there was one single person responsible for the 11 outpatient services. This had the potential to affect any patients receiving outpatient services.

Findings include:

On 4/23/2012 at 1:25 p.m., the locations of the outpatient services were reviewed and the hospital organizational chart indicated they had outpatient off-sites that included cardiac rehab, lymphedema clinic, Coumadin clinics, nutrition clinics, occupational , physical and speech therapy clinics, pulmonary rehab, respiratory therapy and a sleep lab. The facility also had outpatient services which included urgent care, cardiac rehab, Coumadin clinic, nutrition, occupational therapy, physical therapy, speech therapy, radiology services and laboratory services. .

The facility's undated organizational chart was reviewed. The organizational chart indicated that there was not a single person designated to direct the overall operation of the outpatient services.

On 4/25/2012 at 11:15 a.m., the Senior Director of Ancillary Services was interviewed and stated that the outpatient services were assigned to himself and one other staff person.

On 4/25/2012 at 1:30 p.m., the Administrator and Vice president of Quality Services was interviewed. Both verified that two of their staff were responsible for the outpatient services. The duties had been disseminated throughout the system.