The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

REGIONS HOSPITAL 640 JACKSON STREET SAINT PAUL, MN 55101 May 2, 2013
VIOLATION: CONTRACTED SERVICES Tag No: A0083
Based on interviews and documentation review, the hospital failed to ensure the contractor of laundry services complied with applicable conditions of participation and standards for the contracted services when 1 of 1 fetal remains (fetal remains-1) was found at the outside contract laundry service. Fetal remains-1 was identified with arm and ankle bands with the mother's name.

Findings include:

Fetal remains-1 was delivered on 4/3/13, and the Infant Disposition of Remains notes the family released the remains to the hospital for disposition on 4/4/13. The Morgue Information log dated 4/4/13, indicated the fetal remains were logged into the morgue.

An interview was conducted on 4/19/13, at 4:23 p.m. with Employee K/director of safety and security who stated the hospital received a telephone call on 4/16/13, from the contract laundry service that fetal remains-1 was found while sorting linen that morning at approximately 9:05 a.m. Contract laundry staff photographed fetal remains-1 on their personal cell phone and other staff saw the photo. The phone was later retrieved by the police. The hospital sent staff to pick up fetal remains-1 that morning and return it to the hospital morgue.

Police reports were reviewed and verified contracted laundry staff found fetal remains-1 in hospital linens while sorting the linens and reported it to the supervisor on duty. Police reports also verified a laundry staff member photographed fetal remains-1 with a cell phone camera and the photo was forwarded to other people and seen by other staff. The photo showed fetal remains-1 to be wearing a diaper and a bracelet on the right wrist and right ankle. Police report documentation revealed the laundry staff stated the laundry service practice is no cell phone or camera use is allowed while on the work floor and photos of fetal remains-1 should have not been taken.

Review of the Textile Service Agreement Customer Owned Goods signed and dated 2/8/13 noted, "7.1 The parties agree to strictly confidential at all times during the term of this Agreement and thereafter, all non-public business information...." and "7.2 The parties agree not to reveal, divulge, make known, sell, exchange, lease or in any other way disclose any Confidential Information to any third party."

On 4/23/13, at 11:20 a.m. an interview was conducted with Employee-AA/administration who stated no follow up quality assurance was completed regarding the linen service and confidentiality following the incident related to fetal remains-1.
VIOLATION: QAPI Tag No: A0263
Based on observation, interview and document review, the hospital failed to ensure the hospital had quality assurance processes in place to minimize and/or prevent medical errors for 2 of 8 fetal remains (fetal remains-1, fetal remains-2) who were missing from the morgue and the hospital failed to ensure the hospital had quality assurance processes in place to register fetal deaths to the State agency in a timely manner for 4 of 8 fetal deaths (fetal remains-3, fetal remains-4, fetal remains-5, fetal remains-1). The seriousness of these system failures placed the condition of quality assurance and performance improvement plan (QAPI) out of compliance. Refer to the findings in tag A-0266.
VIOLATION: PATIENT SAFETY Tag No: A0286
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview and document review, the hospital failed to ensure the hospital had quality assurance processes in place to minimize and/or prevent medical errors for 2 of 8 fetal remains (fetal remains-1, fetal remains-2) who were missing from the morgue and the hospital failed to ensure the hospital had quality assurance processes in place to register fetal deaths to the State agency in a timely manner for 4 of 8 fetal deaths (fetal remains-3, fetal remains-4, fetal remains-1, fetal remains-5).

Findings include:

Morgue:
On 4/19/13, at 10:00 a.m. the hospital morgue was observed. During the tour of the morgue on 4/19/13, at 10:00 a.m. employee-E verbalized that fetal remains-1 was sent out of the hospital to the laundry. Also during the tour, employee-B acknowledged there was one other fetal remain unaccounted for (fetal remains-2) and missing from the morgue.

On 4/19/13, at 2:00 p.m. the Morgue Information log from 11/30/12 forward to 4/19/13, was reviewed. At the top of the morgue log staff were directed to "Please complete all sections as designated below at Time of Delivery/Pick-up" and "All information MUST be filled in thoroughly and accurately." The morgue log was filled out in an inconsistent manner and examples of the lack of documentation included: pick-up time and date along with initials, shelf numbers where fetal remains were placed, time in morgue, nurse signature, paper chart, date delivered to the morgue, cart numbers to identify the body, mortuary pick-up, and security release. Morgue personnel were to fill in "Autopsy, Yes (Y), No (N), and Pending(P) and Autopsy date/time. Donor services were to complete the same information as the morgue personnel with the addition of Donation date/time out and in. These areas were inconsistently not being completed.

The morgue log also identified two fetal remains on one shelf. On 3/4/13, at 11:24 am fetal remain-6 was placed on shelf number 3 with disposal date of 4/18/13. On 4/7/13, at 6:11 a.m. fetal remains-2 was placed on shelf number 3 and fetal remains-2's mortuary pick-up date was left blank. The morgue log identified two fetal remains in the same shelf on 4/7/13 through 4/18/13, fetal remains-6 was disposed by the hospital on [DATE] and fetal remains-2's information remained blank for the disposition.

The Morgue Information log noted 2 of 2 fetal remains on 4/4/13 (fetal remains-1) and 4/7/13 (fetal remains-2), were not disposed of by the hospital as both family's had requested.

Medical record review indicated that fetal remains-1 was delivered on 4/3/13, and the Perinatal Loss-Stillbirth checklist dated 4/4/13, indicated the family had wanted the hospital to dispose of the fetal remains by cremation. An All Progress Note dated 4/4/13, at 10:25 a.m. documented the hospital was to dispose of the fetal remains. The Morgue Information log dated 4/4/13, indicated the fetal remains were in the morgue. However, fetal remains-1 was found at the hospital's laundry service on 4/16/13, at approximately 9:05 a.m. The laundry staff telephoned the hospital to inform them of the found fetal remains in the linens. The hospital then documented on the Morgue Information sheet that fetal remains-1 was sent to the medical examiner's office on 4/16/13, at 7:10 p.m.

Medical record review indicated that fetal remains-2 was delivered on 4/7/13, and the Perinatal Loss-Stillbirth checklist dated 4/7/13, indicated the family had wanted the hospital to dispose of the fetal remains by cremation. An All Progress Note dated 4/7/13, at 4:57 a.m. documented the hospital was to dispose of the fetal remains. The Morgue Information log dated 4/7/13, indicated the fetal remains were not sent to a funeral home for disposal. The section for mortuary address, license, signature, and time and date were left blank. fetal remains--2 was unaccounted for and missing according to the Morgue Log.

An interview was conducted on 4/22/13, at 10:15 a.m. with Employee-E and Employee-F. They verified the hospital did not have a system to reconcile remains in the morgue on a regular, consistent basis. They also verified the morgue log provided and contained incomplete information.

The policy for disposal of Fetal Tissue with an effective date of 1/1/07, noted "All POC [products of conception]/fetal tissue is collected separately from other human tissue and periodically sent to Forest Lawn Cemetery for cremation."


Birth Registrar:
On 4/23/13, at 9:00 a.m. the Fetal Death Log was reviewed. The log noted at least four of eight fetal deaths were not reported to the State agency within five days.

Fetal remains-3 was delivered on 1/4/13, and the report was filed with State agency on 1/10/13.
Fetal remains-4 was delivered on 1/23/13, and the report was filed with State agency on 2/5/13.
Fetal remains-1 was delivered on 4/3/13, and the report was filed with State agency on 4/17/13.
Fetal remains-5 was delivered on 4/11/13, and the report was filed with State agency on 4/18/13.

On 4/23/13, at 9:45 a.m. the employee-G was interviewed. Employee-G revealed there had been a problem with registering the live births and fetal deaths identified back in October 2012. Employee-G indicated Employee-B noted the report from the State was low in reporting births and fetal deaths and that it was unacceptable. The birth registrar position was moved to the labor and delivery unit in February 2013 so the information of the births could be reported within time frames. Even though the birth registrar department moved to the labor and delivery unit, employee-G indicated she was still having problems of obtaining the medical information and family demographics so she could fill out the information and submit the report to the State agency within the required five five days.
VIOLATION: COMPLIANCE WITH LAWS Tag No: A0020
Based on interview and document review, the hospital was found out of compliance with the Condition of Participation for Compliance with Federal, State and Local Laws CFR 482.11. The hospital failed to have systems in place to ensure the hospital complied with State laws for 2 of 2 fetal remains (fetal remains-1 and fetal remains-2) when the fetal remains were missing; 5 of 8 stillbirths reviewed were not registered per State statute (stillbirth-3, stillbirth-4, stillbirth-1, stillbirth-5, stillbirth-2). The hospital failed to ensure 9 of 10 employees received the Right-to-Know information at intervals of not greater than one year according to State law. This system failure resulted in a condition level deficiency. Refer to deficiency issued at A-0022.
VIOLATION: LICENSURE OF HOSPITAL Tag No: A0022
Based on interview and document review, the hospital failed to ensure the hospital met standards required by State laws for 2 of 2 fetal remains (fetal remains-1 and fetal remains-2); 5 of 8 fetal deaths (fetal remains-3, fetal remains-4, fetal remains-1, fetal remains-5, fetal remains-2) who were not registered with the State, and for 9 of 10 employees regarding Right-to-Know training.

Findings include:

Minnesota Statute 145.1621 Subdivision 3. Regulation of disposal noted, "Remains of a human fetus resulting from an abortion or miscarriage, induced or occurring accidentally or spontaneously at a hospital, clinic, or medical hospital must be deposited or disposed of in this state only at the place and in the manner provided by this section or, if not possible, as directed by the commissioner of health."

On 4/19/13, at 2:00 p.m. the hospital's Morgue Information log was reviewed. The log noted two of two human fetus remains from 4/4/13 and 4/7/13, were not disposed of in a manner that was in accordance to the State statute.

Medical record review established fetal remain-1 was delivered on 4/3/13, and the Perinatal Loss-Stillbirth checklist dated 4/4/13, indicated the family wanted the hospital to dispose of the fetal remains by cremation. An All Progress Note dated 4/4/13, at 10:25 a.m. documented the hospital was to dispose of the fetal remains. The Morgue Information log dated 4/4/13, indicated the fetal remains were in the morgue. On 4/16/13, at 7:10 p.m. fetal remains-1 were sent to the medical examiner's office. On 4/19/13, at 4:23 p.m. Employee-K stated hospital staff were contacted by the offsite laundry service on 4/16/13, at approximately 9:30 a.m. and informed the staff fetal remains-1 was found in the linens at approximately 9:05 a.m.

fetal remains-2 was delivered on 4/7/13, and the Perinatal Loss-Stillbirth checklist dated 4/7/13, indicated the family wanted the hospital to dispose of the fetal remains by cremation. An All Progress Note dated 4/7/13, at 4:57 a.m. documented the hospital was to dispose of the fetal remains. The Morgue Information log dated 4/7/13, indicated the fetal remains were not sent to any funeral home for disposal. The section for mortuary address, license, signature, time and date were left blank. The Morgue Information log lacked evidence that fetal remains-2 were accounted for.

During the tour of the morgue on 4/19/13, at 10:00 a.m. employee-E stated fetal remains-1 was found at an outside laundry service. Also during the tour, employee-B acknowledged one other fetal remains (fetal remains-2) were unaccounted for and missing from the morgue.

The policy for disposal of Fetal Tissue dated as effective on 1/1/07, noted, "All POC [products of conception]/fetal tissue is collected separately from other human tissue and periodically sent to Forest Lawn Cemetery for cremation."


Minnesota Statute 145.1621 Disposition of aborted or miscarried fetuses. Subdivision 1. Purpose: noted, "The purpose of this section is to protect the public health and welfare by providing for the dignified and sanitary disposition of the remains of aborted or miscarried human fetuses in a uniform manner and to declare violations of this section to be a public nuisance." fetal remains-1 and fetal remains-2 were not disposed of in a dignified and sanitary manner.

On 4/19/13, at 2:00 p.m. the Morgue Information log was reviewed. The log noted two of two human fetus remains from 4/4/13 and 4/7/13, were not disposed of in accordance with State statute.

Fetal remains-1 was delivered on 4/3/13. The Morgue Information log dated 4/4/13, indicated the remains were sent to the Medical Examiner on 4/16/13, at 7:10 p.m. However, the fetal remains were found at the hospital's off site laundry service on 4/16/13, at approximately 9:05 a.m. On 4/19/13, at 4:23 p.m. Employee K stated hospital staff were contacted by the offsite laundry service on 4/16/13, at approximately 9:30 a.m. and informed the hospital staff fetal remains-1 was found in the linens at approximately 9:05 a.m.

Fetal remains-2 was delivered on 4/7/13, and the Morgue Information log dated 4/7/13, indicated the human fetus remains was not sent to any funeral home for disposal. The section for mortuary address, license, signature, time and date were left blank.

During the tour of the morgue on 4/19/13, at 10:00 a.m. employee-E verbalized fetal remains-1 was sent out of the hospital to the laundry. Also during the tour, employee-B acknowledged there was one other fetal remains (fetal remains-2) unaccounted for and missing from the morgue.

The policy for disposal of Fetal Tissue dated as effective on 1/1/07, noted, "All POC [products of conception]/fetal tissue is collected separately from other human tissue and periodically sent to Forest Lawn Cemetery for cremation."


Minnesota Statutes, section 144.222 subdivision 1, "Require that each fetal death be reported within five days to the state registrar as prescribed by rule." The hospital failed to report all fetal deaths within five days to the State agency.
On 4/23/13, at 9:00 a.m. the Fetal Death Log was reviewed. The log noted four of eight fetal deaths were not reported to the State agency within the required five days.

fetal remains-3 was delivered on 1/4/13, the report was filed with the State agency on 1/10/13.
fetal remains-4 was delivered on 1/23/13, the report was filed with the State agency on 2/5/13.
fetal remains-1 was delivered on 4/3/13, the report was filed with the State agency on 4/17/13.
fetal remains-5 was delivered on 4/11/13, the report was filed with the State agency on 4/18/13.

On 4/22/13, at 1:30 p.m. employee-L was interviewed. Employee-L was asked if she knew who to contact at the hospital to notify the State agency for fetal deaths. Employee-L stated, "No."

On 4/23/13, at 9:45 a.m. the employee-G was interviewed. Employee-G revealed there had been a problem with registering the live births and fetal deaths back in October 2012. The birth registrar position was moved to the labor and delivery unit in February 2013 so the information of the births could be reported in a timelier manner. Even though the birth registrar department moved to the labor and delivery unit, employee-G stated she was still having problems of obtaining the medical information and family demographics so she could fill out the information and submit the report to the State agency within five days.

The hospital submitted a Fetal Process Flowsheet as the policy, however, there was no date and nor did the flowsheet reference a policy. The hospital policy for reporting fetal deaths to the State agency was requested again on 5/2/13, and no policy was received and the hospital referred to the Flowsheet as the policy.


Minnesota Rule 5206.0700, Subpart 1. Right-to-Know Training
According to Occupational Safety and Health Administration (OSHA), Right-to-Know "requires employers to establish hazard communication programs to transmit information on the hazards of chemicals to their employees by means of labels on containers, material safety data sheets, and training programs. Implementation of these hazard communication programs will ensure all employees have the 'right-to-know' the hazards and identities of the chemicals they work with, and will reduce the incidence of chemically - related occupational illnesses and injuries."

According to Minnesota Rule 5206.0700 TRAINING.
Subpart 1. In general. The requirements in items A to J apply to training programs provided to employees concerning hazardous substances, harmful physical agents, and infectious agents.

G. Frequency of training:
(4) Training updates must be repeated at intervals of not greater than one year. Training updates may be brief summaries of information included in previous training sessions.

On 4/22/13, the Online Training Status Report was reviewed for housekeeping. The following was noted:
- Employee-Q was hired on 3/19/00. Employee-Q last had the Right-to-Know training on 4/5/12. Employee-Q has gone over 382 days without receiving the annual Right-to-Know training.
- Employee-BB was hired on 8/25/04. Employee-BB last had the Right-to-Know training on 4/5/12. Employee-BB has gone over 382 days without receiving the annual Right-to-Know training.
- Employee-CC was hired on 6/17/11. Employee-CC last had the Right-to-Know training on 4/4/12. Employee-CC has gone over 383 days without receiving the annual Right-to-Know training.
- Employee-DD was hired on 3/11/11. Employee-DD last had the Right-to-Know training on 4/4/12. Employee-DD has gone over 383 days without receiving the annual Right-to-Know training.
- Employee-EE was hired on 11/4/11. Employee-EE last had the Right-to-Know training on 4/4/12. Employee-EE has gone over 383 days without receiving the annual Right-to-Know training.
- Employee-FF was hired on 10/24/08. Employee-FF last had the Right-to-Know training on 4/10/12. Employee-FF has gone over 376 days without receiving the annual Right-to-Know training.
- Employee-GG was hired on 10/10/94. Employee-GG last had the Right-to-Know training on 4/4/12. Employee-GG has gone over 383 days without receiving the annual Right-to-Know training.
- Employee-HH was hired on 2/24/08. Employee-HH last had the Right-to-Know training on 4/10/12. Employee-HH has gone over 376 days without receiving the annual Right-to-Know training.
- Employee-II was hired on 3/23/07. Employee-II last had the Right-to-Know training on 4/4/12. Employee-II has gone over 383 days without receiving the annual Right-to-Know training.

Employee-K was interviewed on 5/3/13, at 9:38 a.m. Employee-K indicated the hospital provided employee training for Right-to-Know every year usually in December when the new updates came. New updates were provided in April of 2012 and the employees were provided training in April 2012. Employee-K read Minnesota Rule 5206.0700 out loud and confirmed the rule stated, "training updates must be repeated at intervals of not greater than one year."

According to the undated hospital documentation on Right-to-Know training, "Housekeeping conducts annual Right-to-Know training with staff. Training includes, but not limited to, review of the law, review of hazardous chemicals, MSDS [material safety data sheets], watching videos on isolation, standard cleaning practices, and infection control. Employees take a Post Test after completing the training." The documentation further indicated "training needs to be completed 1 time during the calendar year." The hospital on-line training information did not match the Minnesota Rule which read, "Training updates must be repeated at intervals of not greater than one year." The hospital failed to have the employees receive Right-to-Know training in a timely manner.
VIOLATION: GOVERNING BODY Tag No: A0043
Based on interview and document review, the hospital failed to have an effective governing body to ensure the hospital had an adequate system in place for tracking and security of human remains when 2 of 2 fetal remains (fetal remains 1 and fetal remains 2) were missing from the hospital morgue. The hospital was unaware of the missing fetal remains until the outside contracted laundry service informed the hospital staff that the remains of a fetal remain-1 was found in the laundry. Upon searching the morgue, the hospital staff identified that the remains of one other fetal remains (fetal remains-2) were missing. The seriousness of the hospital failure to keep track of these remains places the Condition of Participation of Governing Body out of compliance.

Findings include:

Medical record review established that fetal remains-1 was delivered on 4/3/13 and the Infant Disposition of Remains noted the family released the remains to the hospital for disposition on 4/4/13. Review of the Morgue Information log indicated that on 4/4/13 at 11:26 a.m. a nurse signed the fetal remains into the morgue. There was no further information on the log until the medical examiner's office retrieved the remains on 4/16/13 at 7:07 p.m. Hospital documentation indicated that on 4/16/13 the hospital was informed by the offsite laundry service that the fetal remains-1 was found in the linens. According to the documentation, hospital staff went to the laundry to retrieve fetal remains-1.

An interview was conducted on 4/19/13 at 12:56 p.m. with Employee E/manager who stated there was no reason for fetal remains to be out of the morgue unless the family changed their minds regarding disposition or disposition had already taken place. Employee E verified disposition for fetal remains 1 had been released by the family to the hospital after the birth. The fetal remains should have continued to be located in the morgue.An interview was conducted on 4/19/13 at 4:23 p.m. with Employee K/director who stated hospital staff were contacted by the offsite laundry service on 4/16/13 at approximately 9:30 a.m. and informed fetal remains-1 was found in the linens at approximately 9:05 a.m. Hospital staff were sent to the laundry to retrieve fetal remains-1 and returned them to the morgue. The remains were retrieved by the medical examiner's office on 4/16/13 and returned back to the hospital morgue on 4/17/13. During the onsite visit on 4/19/13, fetal remains-1 was in a locked refrigerator in the Pathology laboratory.
Medical record review revealed fetal remains-2 was delivered on 4/7/13. The Infant Disposition of Remains form noted the family released the remains to the hospital for disposition on 4/7/13.
Review of hospital documentation established the Morgue Information log indicated the fetal remains-2 were logged into the morgue by a nurse on 4/7/13 at 6:11 a.m. There was no noted date or time of disposition of the fetal remains. The section for mortuary address, license, signature, time and date were blank.

Review of the hospital Morgue Information Log, which indicated, "ALL information MUST be filled in thoroughly and accurately", revealed the log was incomplete for 178 of 232 remains listed on the log for the period of time from 1/1/13-4/19/13.
On 4/19/13 at 10:00 a.m. a tour of the hospital morgue was conducted. Employee B/administration joined the tour and stated one other fetal remains (fetal remains-2) was missing from the morgue. Hospital staff have been unable to locate fetal remains-2.

On 4/19/13, at 5:10 p.m. an interview was conducted with Employee B/administration who stated fetal remains-2 was still missing from the morgue.

On 4/22/13 at 10:15 a.m. an interview was conducted with Employee E/laboratory manager and Employee F/ administration. They verified the hospital did not have a system to reconcile fetal or human remains in the morgue on a regular, consistent basis. They also verified the morgue log provided to the surveyor contained incomplete information.

The hospital also failed to ensure the contracted laundry services complied with all applicable conditions of participation and standards for contracted services when 1 of 7 fetal remains (fetal remains-1) was found in linens offsite at the laundry and laundry staff took photos of fetal remains-1. Fetal remains-1 was identified by the identification tag with it's mother's name. Refer to documentation of tag A-0083.