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Iowa Administrative Code Chapter 51.24(3): "Health examinations for all personnel shall be required at the commencement of employment and thereafter at least every four years...."

Based on review of Hospital policy, personnel files and staff interviews the Administrative staff failed to assure the employees were free from communicable disease every 4 years. Review of 24 employee files showed, 19 employees (A, B, C, D, E, F, G, H, I, J, K, L, M, N, O, P, Q, R and S) and 12 of 12 Volunteers (T, U, V, W, X, Y, Z, AA, BB, CC, and DD) lacked a follow-up health exam after hire.

The administrative staff reported a census of 88 in-patients.

The hospital administration failed to provide a health exam for staff and volunteers to identify health issues that could potentially compromise the healing process of patients the staff and volunteers have contact with at the Spencer Hospital.

Findings included

1. Review of employee personnel files confirmed a health exam had occurred prior to employment, but failed to show documented evidence that follow-up health exams occurred for 19 employees (A, B, C, D, E, F, G, H, I, J, K, L, M, N, O, P, Q, R and S) and 12 Volunteers (T, U, V, W, X, Y, Z, AA, BB, CC, and DD).

2. Review of the hospital policy "Health Assessments"showed that facility staff failed to include a requirement for a 4-year follow-up health exam for employees and/or volunteers in their policies and procedures in accordance with Iowa Administrative Code chapter 51.24(3).

3. During an interview on 12/1/10 at 9:30 AM, the Chief Nursing Officer (CNO) stated the hospital does not require employee and/or volunteers routine follow up health exam after the initial exam prior to hire. The CNO reviewed the "Health Assessments" policy and confirmed the policy did not address a routine 4 year follow up health exam. At 2:20, the CNO provided information stating a scheduled meeting for 12/3/10 to address this issue.

Based on review of documents, personnel files for Contracted Services A, and staff interview, the hospital failed to ensure employees working for Contracted Services A completed the required hospital training in accordance with the Acute Dialysis Agreement (contract).

Failure to complete the required hospital training courses could prevent staff from having knowledge needed to work safely, effectively, and proficiently at the hospital.

The hospital reported an inpatient hemodialysis census of 2 at the time of the survey. Findings for 1 of 1 dialysis contracts reviewed and for 4 of 5 personnel files reviewed (Contracted Services A Staff A, C, I, and M) include:

1. Review of a document titled "ACUTE DIALYSIS AGREEMENT", dated 1/22/10, stated in part, "...Require Personnel to complete an orientation...shall include but is not limited to: (i) Welcome to Alegent; (ii) Corporate Integrity for New Employees; (iii) Annual Safety Review; (iv) National Patient Safety Goals for 2009 for Hospitals; and (v) HIPPA training..."

2. Review of a document titled "Alegent Health Transcript" for Contracted Services A Staff RN (Registered Nurse) A showed a list of computer courses taken for the years 2009 and 2010. Further review of the transcript failed to show documentation of completion of the Annual Safety Review or the National Patient Safety Goals, as required in the Acute Dialysis Agreement.

3. Review of a document titled "Alegent Health Transcript" for Contracted Services A Staff RN C showed a list of computer courses taken for the years 2009 and 2010. Further review of the transcript failed to show documentation of completion of the Annual Safety Review or the National Patient Safety Goals, as required in the Acute Dialysis Agreement.

4. Review of a document titled "Alegent Health Transcript" for Contracted Services A Staff RN I showed a list of computer courses taken for the years 2009 and 2010. Further review of the transcript failed to show documentation of completion of the Annual Safety Review or the National Patient Safety Goals, as required in the Acute Dialysis Agreement.

5. Review of a document titled "Alegent Health Transcript" for Contracted Services A Staff RN M showed a list of computer courses taken for the years 2009 and 2010. Further review of the transcript failed to show documentation of completion of the Annual Safety Review or the National Patient Safety Goals, as required in the Acute Dialysis Agreement.

6. During an interview on 12/1/10 at 1:42 PM, the Operations Director of Critical Care and the Registrations Manager acknowledged the requirements outlined in the Acute Dialysis Agreement and agreed staff employed by Contracted Services A failed to complete the required hospital training.

Based on observation, review of policies, documentation, and staff interviews, the hospital staff failed to secure and maintain the confidentiality of patien's medical records in 1 of 3 off-site clinics (Behavioral Health Unit), 1 (of 1) radiology film library, and the 1 (of 1) ground level archives room. The Hospital had a census of 88 patients.

Failure to secure and maintain the confidentiality of the medical records could potentially result in unauthorized use of patient's personal and medical information.

Findings include:

1. Observation and interview, during the environmental tour of the offsite behavioral health unit, on 12/1/2010 at 8:20 AM revealed a medical record storage room behind the reception desk of the behavioral health unit. The medical record room had a key lock entry door. The room contained 4 medical record cabinets (3 movable and 1 stationary). The medical record cabinets had 6 rows on each of them. The medical record room contained approximately 7 to 8,000 patient medical records.

During an interview, at the time of the observation, the Clinical Supervisor for the behavioral health unit said housekeeping staff enter the medical record room after 5:00 PM to clean and vacuum. The housekeeping staff had access to the medical record room and patient medical records without supervision from clinic staff.

2. Observation and interview, during a tour of the radiology department, on 12/01/10 at 10:36 AM, revealed an unlocked film library. The film library contained office equipment and approximately 75-100 x-ray films with patient names, addresses, and date of birth. At the time of the observation, the film library was unattended. The door to the film library lacked a locking mechanism to secure the door when the library was unattended and after business hours.

a. During an interview, at the time of the tour, the Film Librarian and the Operations Director for the Diagnostic Center verified housekeeping staff cleaned the library after business hours and the door was always open.

b. An additional observation, during the tour of the radiology department, revealed a ground level archives room. The archives room measured approximately 81 x 45 feet and contained 92-3 foot sections of shelving with 4 shelves per each section. Each section contained x-ray films with patient names, addresses, and date of birth. An unlocked card file contained approximately 3000 file cards with similar patient information. Also stored in the archives room, was a patient cart, and a medication cart that did not belong to the radiology department. A badge access device allowed individuals from 9 departments ' access to the archives room.

3. During an interview on 12/01/10 at 4:19 PM, the Operations Director for Ancillary Services presented a document (untitled) dated 12/01/10, that verified 9 various departments were granted access to the archives room. One department identified as "MCB" (Mercy Council Bluffs) Master, this department included outside electrical contractors and Siemens technician (installer of the badge access device). Additional documentation (untitled and undated) showed approximately 489 individuals had access to the archives room. A Document for November 2010 showed 40 of 56 entries to the archives room were from outside electrical contractors and the Siemens technician.

During a phone interview on 12/01/10 at 4:19 PM, the Operations Director for Security and the Lead Security Officer reported that security staff grants badge access to individuals according to job code. The outside contractors had security clearance that allowed them to go anywhere in the hospital. Security staff does not accompany the outside contractors in the secure areas.

Unauthorized individuals do not have a need to know confidential patient information. Outside contractors and the Siemens technician are unauthorized individuals.

Review of a policy titled, "Confidentiality of Information" dated 5/09, on 12/02/10, stated in part ....It is the philosophy of Alegent Health to protect all confidential information in all of its forms, including, but not limited to, private information and PHI (patient health information), from inappropriate access and unauthorized disclosure ....Access to confidential information will be granted to enable maximum control with minimum restrictions.





22898

Based on review of policies and procedures, medical record review, and staff interview, the hospital failed to ensure physicians obtained informed consent from patients prior to the patient receiving in-patient acute hemodialysis treatments provided by Contracted Service A.

Failure to obtain informed consent from the patient prevented the patients from understanding the anticipated benefits, material risks, and/or any alternative therapies available. Additionally, hospital staff failed to inform patients that a contracted service provided the in-patient acute dialysis treatments and the contracted staff were not employees of the hospital.

The hospital reported an inpatient hemodialysis census of 2 at the time of the survey. Findings for 2 of 2 inpatients (Patient #'s 1 and 8) and 6 of 6 closed medical records reviewed (Patient #'s 2, 3, 4, 5, 6, and 7) include:

1. The hospital had a policy titled "Informed Consent", effective date 8/08, which stated in part, "...Informed consent is a process, not a form, in which the physician and patient discuss the risks, benefits, alternatives, and consequences of a course of therapy, medical treatment, or a procedure, and this collaborative decision is based on the patient's knowledge and understanding of the diagnosis and prognosis, nature and purpose of the intervention, the likely risks and complications, benefits, probability of successful outcomes, feasible alternatives, and the prognosis if the treatment is not given...the responsibility of obtaining informed consent relies with the treating physician..."

2. Review of the medical record for Patient #1 showed the patient admitted to the hospital on 11/26/10 and received hemodialysis on 11/30/10. However, further review of the medical record failed to show documentation of informed consent to receive hemodialysis and failed to show documentation of discussion regarding the risks, benefits, alternatives, and consequences regarding hemodialysis.

3. Review of the closed medical record for Patient #2 showed the patient admitted to the hospital in June 2010 and again in July 2010, and received hemodialysis treatments during each admission. However, further review of the medical record failed to show documentation of informed consent to receive hemodialysis and failed to show documentation of discussion regarding the risks, benefits, alternatives, and consequences regarding hemodialysis for either admission.

4. Review of the closed medical record for Patient #3 showed the patient admitted to the hospital in June 2010 and again in August 2010, and received hemodialysis treatments during each admission. However, further review of the medical record failed to show documentation of informed consent to receive hemodialysis and failed to show documentation of discussion regarding the risks, benefits, alternatives, and consequences regarding hemodialysis for either admission.

5. Review of the closed medical record for Patient #4 showed the patient admitted to the hospital twice in August 2010, and received hemodialysis treatments during each admission. However, further review of the medical record failed to show documentation of informed consent to receive hemodialysis and failed to show documentation of discussion regarding the risks, benefits, alternatives, and consequences regarding hemodialysis for either admission.

6. Review of the closed medical record for Patient #5 showed the patient admitted to the hospital in July 2010 and again in October 2010, and received hemodialysis treatments during each admission. However, further review of the medical record failed to show documentation of informed consent to receive hemodialysis and failed to show documentation of discussion regarding the risks, benefits, alternatives, and consequences regarding hemodialysis for either admission.

7. Review of the closed medical record for Patient #6 showed the patient admitted to the hospital in September 2010, and received hemodialysis treatments during that admission. However, further review of the medical record failed to show documentation of informed consent to receive hemodialysis and failed to show documentation of discussion regarding the risks, benefits, alternatives, and consequences regarding hemodialysis.

8. Review of the closed medical record for Patient #7 showed the patient admitted to the hospital in October 2010, and received hemodialysis treatments during that admission. However, further review of the medical record failed to show documentation of informed consent to receive hemodialysis and failed to show documentation of discussion regarding the risks, benefits, alternatives, and consequences regarding hemodialysis.

9. Review of the medical record for Patient #8 showed the patient admitted to the hospital on 11/25/10 and received hemodialysis on 12/2/10. However, further review of the medical record failed to show documentation of informed consent to receive hemodialysis and failed to show documentation of discussion regarding the risks, benefits, alternatives, and consequences regarding hemodialysis.

10. During an interview on 12/1/10 at 9:50 AM, the Nurse Manager for Contracted Services A reported that the hospital used the general "Consent To Treatment" form signed by patients on admission, which replaced the need for a hemodialysis consent form.

11. During an interview on 12/1/10 at 1:42 PM, the Operational Director of Critical Care and the Registrations Manager acknowledged and agreed that hemodialysis is a special procedure and required a specific consent form.

Based on review of medication error reports, hospital policies and staff interviews, the hospital staff failed to assure staff immediately notified physicians of medication errors for 4 of 7 medication error reports reviewed (Patients #1, #2, #3 and #4). The hospital had a census of 88 in-patients.

Failure to notify the attending Physician of medication errors could delay necessary patient evaluation and treatment related to the medication error, potentially resulting in serious harm or death.

Findings include:

1. Review of 5 medication error reports for Patients #1, #2, #3 and #4 with an event severity of A, B, C or D revealed the hospital staff failed to notify the attending physician of the medication error. Review of 2 of 2 medication error reports for Patients #5 and #6 with an event severity of E or above showed hospital staff did notify the attending physician of the medication error.

2. Review of the hospital policy "Occurrence (Incident) Reporting and Routing" dated 5/10 showed employees complete "all sections via SARA". SARA reports are used by hospital staff to report medication errors.

Review of the hospital policy "Disclosure of Unexpected Clinical Outcomes" dated 6/08 revealed the following, in part. Upon discovery of A, B, C or D; report the occurrence to your manager/ direct supervisor and enter event into SARA. Upon discovery of a significant/ serious occurrence (category E), the patient's attending physician will be notified.

3. During an interview on 11/30/10 at 4:10 PM, the Quality Improvement and Safety Registered Nurse (QIS) said staff fills out all mandatory fields of the SARA report. The Quality Improvement and Safety Registered Nurse was not sure if it was mandatory for the staff to complete the physician notification field.

a. During an interview on 12/1/10 at 1:30 PM, the QIS Nurse stated, according to hospital policy, staff were not notifying the attending physician when medication errors categorized A, B, C or D occurred. The category of medication errors were identified by the staff identifying the medication error and filling out the SARA report. The QIS nurse reviewed the SARA report for accuracy of categorizing the medication error.

b. During an interview on 12/1/10 at 2:10 PM, the QIS nurse verified hospital staff do not report medication errors to the attending physician when categorized A, B, C or D.

Based on observation, document review, and staff interview, the hospital surgical services administrative staff failed to ensure surgical staff wore dosimetry badges for 4 of 5 staff observed in the operating room during a surgical procedure involving fluoroscopy. The Operations Director for Surgical Services identified an average of 650 procedures involving fluoroscopy per year.

Failure to provide dosimetry badges to all staff potentially exposed to ionizing radiation could potentially result in hospital staff receiving an unknown and unrecognized quantity of ionizing radiation, potentially resulting in cancer or death.

Findings include:

1. Observations during a tour on 11/30/10 at 10:22 AM revealed a C-Arm fluoroscope used during an operative procedure. Observations revealed 5 staff members, including: a surgeon; anesthesia provider; scrub technician; circulator nurse; and radiation technologist. The only staff member wearing a dosimetry badge was the radiation technologist.

2. During an interview on 11/30/10 at the time of the tour, the Operations Lead for Surgical Services stated the surgical services staff did not wear dosimetry badges during surgical procedures involving fluoroscopy. The surgical services staff stopped wearing dosimetry badges about 5 years ago.

3. During an interview on 12/1/10 at 2:15 PM, the Lead Nuclear Medicine Technician stated surgical staff only received a dosimetry badge if the surgical staff member requested a dosimetry badge.

4. Review of the policy "Radiology Safety", effective 12/09, revealed in part, "The option to wear a radiation detection badge will be offered to any Surgical Services employee who feels their assignment, on a consistent basis, places them in danger of receiving excess exposure to radiation.

5. During an interview on 12/1/10 at 11:00 AM, the Operations Director for Diagnostic Imaging stated they monitored the radiation technologists' dosimetry badges for radiation exposure. They relied on the radiation technologist's dosimetry badges to show if radiation technologists received excessive doses of radiation. If the radiation technologist's badges were below the limits for radiation exposure, the Operations Director for Diagnostic Imaging assumed the surgical services staff had not received excessive doses of radiation. The Operations Director for Diagnostic Imaging did not specifically monitor surgical services staff for exposure to radiation.

Based on review of manufacturer's information, documents, observation, and staff interview, the hospital failed to ensure Contracted Services A (CSA) staff verified the TDS (total dissolved solids) and percent rejection for the portable reverse osmosis (RO) in accordance with the manufacturer's recommendations.

The portable RO removes harmful contaminants to provide dialysis quality water used for the dialysis treatments. Each RO should have acceptable parameter limits regarding the amount of contaminants (TDS) allowed and the percent rejections necessary to provide the dialysis quality water. If the RO has an increased TDS, the dialysis patients' exposure to harmful contaminants could occur. In addition, if the percent rejection or the amount of contaminants rejected to the drain to ensure the dialysis water quality falls below an acceptable limit, dialysis patients' exposure to unsafe water could occur. During the dialysis treatment, the exposure to massive amounts of water could cause severe illness and/or death if the water does not meet the standards for dialysis quality water.

Failure to follow the manufacturer's recommendations and verify the TDS and percent rejection results with an independent meter every 3 months could potentially cause the portable RO to show acceptable limits for both the TDS and percent rejection readings. Dialysis staff could not ensure the RO readings as accurate without the completion of the secondary verification for these limits.

If the acceptable limits for the TDS and percent rejection on the portable ROs falls within the acceptable parameters and the readings are inaccurate, the dialysis staff could unknowingly expose the dialysis patients to unsafe water.

The hospital contracted with CSA to provide the acute or inpatient dialysis treatments.

Findings for 2 of 2 portable ROs include:

1. Observation during a tour of the room identified by the hospital as the storeroom CSA used to store the supplies and equipment used to provide the inpatient dialysis treatments on 11/29/10 at 11:30 AM showed an RO labeled "Millenium".

2. Review of the manufacturer's information for the "Millenium" RO titled "MAR COR PURIFICATION" showed the information included maintenance instructions. The maintenance instructions included a recommendation to verify the TDS and percent rejection readings with an independent meter on a quarterly basis. Review of the documents provided by CSA showed no documentation that reflected the TDS or percent rejection verification with an independent meter.

3. During an interview on 11/30/10 at 10:45 AM, CSA's Technical Manager acknowledged the preventative maintenance did not include independent reading verifications for the TDS or percent rejection readings. The Technical Manager went on to report this would occur in the future.

4. During an interview on 12/1/10 at 10:00 AM, CSA's Nurse Manager acknowledged the importance of following the manufacturer's recommendations for all the equipment maintenance and agreed CSA staff should complete the independent meter verification for the TDS and percent rejection readings on a quarterly basis.

Based on review of policies, procedures, manufacturer's information, documents and staff interview, the hospital failed to ensure Contracted Services A (CSA) staff:

1. Collected the water cultures and LALs (limulus amebocyte lysate) endotoxin specimens without disinfecting the culture and LAL sites.

2. Collected the water cultures and LAL endotoxin specimens while wearing full PPE (personal protective equipment) that included protective gown, mask and gloves in accordance with the policy and procedure.

3. Disinfected the portable reverse osmosis (RO) in accordance with the manufacturer's recommendations.

Failure to collect the water and LAL endotoxin results without disinfecting the culture and/or LAL endotoxin site could potentially cause the RO water cultures and/or LAL endotoxin results to fall within the acceptable limits, when in fact the culture and/or LAL endotoxin results could be above the acceptable limits. If bacterial growth is present in the water used for the dialysis treatments, the patients exposed to that bacteria could develop adverse symptoms that could include severe illness and/or death.

Failure to collect the water culture and/or LAL endotoxin specimens in accordance with the policy and procedure and to wear the appropriate PPE could potentially cause the staff that collect the specimens to contaminate those specimens with bacteria. The results would not reflect the true quality of the water. If the water culture and LAL endotoxin results showed bacterial growth and the dialysis staff withheld equipment for patient treatments, a delay for the patient treatments could occur. Dialysis is a life sustaining treatment and delay could potentially cause severe illness and/or death.

Failure to disinfect the ROs in accordance with the manufacturer's recommendations could potentially cause exposure of the dialysis patients to bacterial growth. The RO should provide dialysis quality water for the dialysis treatments. Any bacteria present in the dialysis quality water should measure at or below the acceptable limits. Exposure to bacterial contaminants above acceptable limits could potentially cause the immunosuppressed dialysis patient to experience severe illness and/or death.

1. Review of CSA's policies and procedures titled "Bacteriology Corrective Action Plan (cultures)" POLICY NO[number]: ATO-26b, with a revision date of 7/04 and "Bacteriology Corrective Action Plan (Pyrogen)" POLICY NO: ATO-26a, with a revision dated of 7/04 showed staff should collect the water cultures and LAL endotoxin specimens after flushing the collection site. Further review failed to show staff should disinfect the collection site prior to obtaining the cultures.

Review of the manufacturer's information for the "Millenium" RO titled "MAR COR PURIFICATION" showed the information included in part, "...Product Water Culture Procedure ... Obtain the samples wearing long sleeves and a mask to prevent contamination of samples, use a "mid-stream" "clean catch" type procedure ... "

During an interview on 11/30/10 at 10:05 AM, CSA Biomed Tech N showed the surveyor the procedure to collect the water culture and LAL endotoxin specimens. Biomed N reported collecting the culture and LAL specimens after disinfecting the end of the product water (dialysis quality) culture site with either the disinfectant used by staff to disinfect the equipment following the dialysis treatments or an alcohol wipe. Biomed Tech N demonstrated disinfecting both the outside and the interior portion of the hose where the product water exited.

During an interview on 11/30/10 at 3:00 PM, CSA's Nurse Manager acknowledged Biomed Tech N had failed to collect the water cultures and LAL endotoxin specimens in accordance with the policy and procedure. CSA's Nurse Manager went on to acknowledge the disinfection of the culture site prior to the collection of the water cultures and LAL endotoxin specimens could alter the results. In addition, CSA's Nurse Manager agreed staff should wear the full PPE as directed in the policy and procedure to prevent contamination of the collected specimens.

2. Review of CSA's policies and procedures titled "Bacteriology Corrective Action Plan (cultures)" POLICY NO[number]: ATO-26b, with a revision date of 7/04 and "Bacteriology Corrective Action Plan (Pyrogen)" POLICY NO: ATO-26a, with a revision dated of 7/04 showed staff should collect the water cultures and LAL endotoxin specimens while wearing a protective gown, gloves and mask.

Review of the manufacturer's information for the "Millenium" RO titled "MAR COR PURIFICATION" showed the information included in part, "...Product Water Culture Procedure ... Obtain the samples wearing long sleeves and a mask to prevent contamination of samples, use a "mid-stream" "clean catch" type procedure ... Follow facility protocols (gloves, mask, etc. ) for collection of samples... "

During an interview on 11/30/10 at 10:05 AM, CSA Biomed Tech N showed the surveyor the procedure to collect the water culture and LAL endotoxin specimens. Biomed N reported the only PPE worn during these specimen collections were gloves.

During an interview on 11/30/10 at 3:00 PM, CSA's Nurse Manager acknowledged staff should wear the full PPE as directed in the policy and procedure to prevent any bacterial contamination to the collected specimens.

3. On 11/30/10 at 8:10 AM, CSA's Nurse Manager reported 2 ROs were available to provide the dialysis quality water for the acute dialysis treatments.

Review of the manufacturer's information for the "Millenium" RO titled "MAR COR PURIFICATION" showed the information included in part, "... System Storage...It is not recommended that a unit be dormant longer than 24 hours without disinfectant. ROs that have been left unused for more than 24 hours risk the possibility of colonizing bacteria and exceeding acceptable limits...."

Review of CSA's RO disinfection logs, RO hours of use logs, dialysis machine disinfection logs and an inpatient dialysis log from 10/1/10 through 11/30/10 showed 2 of 2 ROs labeled M 9 and M 21 were stored greater than 24 hours on 10/16/10, 11/6/10 and 11/27/10. In addition, the RO labeled M 9 was stored for greater than 24 hours on 11/20/10. Further review of the disinfection logs failed to show the ROs received any disinfection prior to patient use.

During an interview on 12/1/10 at 10:00 AM, CSA's Nurse Manager acknowledged the importance of following manufacturer's recommendations for dialysis equipment.

During an interview on 12/1/10 at 3:00 PM, CSA's Nurse Manager reported after reviewing the manufacturer's information, the Nurse Manager did not think it was necessary to disinfect the ROs before patient use if the storage time exceeded 24 hours. When the surveyor questioned why the staff would not follow the manufacturer's recommendations, the Nurse Manager provided no additional information.