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.

WOMEN & INFANTS HOSPITAL OF RHODE ISLAND 101 DUDLEY STREET PROVIDENCE, RI 02905 Dec. 11, 2012
VIOLATION: PATIENT RIGHTS: CONFIDENTIALITY OF RECORDS Tag No: A0147
Based on staff interview, it was determined that the hospital failed to ensure that that the patient has the right to confidentiality of his or her medical records.

Findings are as follows:

Review of the facilities investigation of missing back up media, and interview with the Risk Manager on 12/10/2012 at approximately 9:30 AM, revealed that in September of 2012 the hospital learned that unencrypted tapes were missing from two locations. These backup tapes contained ultrasound studies and patient names, dates of birth, dates of exam, physicians' names and ultrasound images. There were 14,004 patient affected.

Although the hospital believed the tapes were destroyed, they were unable to produce evidence that could confirm that the confidentiality of the tapes had been maintained.

Refer to F 439.
VIOLATION: FIVE-YEAR RETENTION OF RECORDS Tag No: A0439
Based upon record review and staff interview it was determined that the hospital failed to maintain medical records in their original or legally reproduced form for a period of at least 5 years.

Findings are as follows:

Section 27.10.1 of the RI Rules and Regulations for Licensing of Hospitals (R23-17-HOSP) April 2009 states:

" Records of minors shall be kept for at least five (5) years after such minor shall have reached the age of 18. "

Interview with the Risk Manager on 12/10/2012 at approximately 9:30 AM revealed that, during a hospital investigation to determine the whereabouts of missing back up tapes (of fetal ultrasound images), it was concluded that the tapes may have inadvertently been destroyed by a contracted disposal company in 2011. However, there was no inventory of what, specifically, was destroyed.

As the tapes were created 1993-2007 and included fetal ultrasound images and personal identifying information, the hospital had intended to save them for 23 years (18 years plus 5 years) in accordance with State law according to the Risk Manager.

Review of the hospital policy entitled "Media Reuse and Disposal" (effective 4/27/2005 and revised 5/9/2011) states:

"For any media that is sent offsite to an approved third party vendor for destruction, appropriate documentation must be maintained on the destruction status."

Review of the disposal company's service agreement dated 4/1/2011 revealed that it failed to identify what should be documented relative to the destruction.

Interview with the Information Services Director on 12/11/2012 at approximately 9:45 AM, revealed that although the tapes were likely destroyed, the documentation by the disposal contractor in 2011 had only documented the number of pounds of material destroyed. This was insufficient to determine what specific records were destroyed.

The hospital has no evidence that medical records were preserved in accordance with State law.
VIOLATION: CONFIDENTIALITY OF MEDICAL RECORDS Tag No: A0441
Based upon record review and staff interview it was determined that the hospital failed to ensure the confidentiality of patient records, specifically, related to electronic records at dispersed sites.

Findings are as follows:

Record review revealed that on 9/13/2012 the hospital discovered unencrypted back up tapes containing fetal ultrasound images and personal information (name, date of birth, date of exam, and patient identification number) were missing. This affected 14,004 patients, of which the majority used the social security number as the patient identification number.

Interview with the Risk Manager on 12/11/2012 revealed that, although it had been three months since this breech was discovered, the hospital had not audited all of the off site locations relative to security measures of patient records.
VIOLATION: WRITTEN PROTOCOL FOR TISSUE SPECIMENS Tag No: A0585
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record review, staff interview, and review of the hospital policies entitled "Investigation of Specimen Discrepancy" and "Maintaining Anatomical Pathology Specimen Identity", it was determined that the hospital failed to ensure compliance with these policies related to reporting of tissue specimen results for 2 of 6 relevant sample patients (ID #'s 1 and 2).

Findings are as follows:

A review of the hospital policy entitled "Investigation of Specimen Discrepancy" states:

"This policy is to facilitate investigation of tissue specimen discrepancy in Department of Pathology when there is a mismatch/discrepancy between the requisition and the actual specimen received".

Item #3 states: "Notify the pathologist on service to direct the investigation".

A review of the hospital policy entitled "Maintaining Anatomic Pathology Specimen Identity" states under "Purpose":

"To assure the proper identification of all tissues submitted to the Department of Pathology from registration through microscopic examination".

Under "Procedure", item # 5 states:

"The PA (or pathologist) dictates one case at a time and places the tissue into the correct cassettes".

Patient ID #1 was admitted on [DATE] for elective laparoscopic assisted vaginal hysterectomy with bilateral salpingo-oophorectomy. The Operative Report revealed that "ultimately the uterus was delivered without difficulty through the vagina with the bilateral tubes and ovaries intact". The Pathology Report revealed that the specimen was received "unfixed in one part labeled with the patient's name", and designated "uterus, cervix, BSO". The report also noted "ovaries are not identified".

During an interview on 12/11/12 at 10:30 AM with the patient's surgeon, it was reported that at an office postoperative visit approximately 3 weeks after the surgery, the pathology report was reviewed with the patient. At this time it was determined that the pathology report did not include an ovary gross exam. The surgeon became concerned, as a dissection of the ovaries had taken place per patient request, and had been removed with a bulky fibroid uterus. The surgeon had assured the patient that the ovaries looked normal. The surgeon notified pathology, and looked at the dissected tissue which included no ovaries. On 11/17/12, the patient underwent a diagnostic procedure, which revealed/confirmed that the ovaries had indeed been removed.

During an interview on 12/11/12 at 8:30 AM with the Risk Manager, it was reported that during a chart review on 12/3/12 for patient ID #2 (who had a robotically assisted total hysterectomy, bilateral salpingectomy and cystocopy on 10/12/12 for uterine fibroids), it was determined that this patient's operative report and pathology report did not match. The pathology report had identified a right and left ovary, with a gross examination. Since this patient did not have ovaries removed, it was suspected that the specimens from patient ID #1 and patient ID #2 "had somehow been switched".

During an interview on 12/11/12 at 8:30 AM with the surgical scrub nurse, it was reported that the specimen for patient ID #1 had been received by the surgeon "all in one", with a verbal verification identifying the specimen. This specimen was wrapped in a white towel and handed off to the circulating nurse, who placed the specimen in a clear biohazard specimen bag and placed a label on the outside of the bag that included patient demographics and what the tissue sample was, in accordance with hospital protocol. In addition, a four copy "Patient Test Requisition" slip was completed that included clinical diagnosis, clinical procedure, and organ or tissue for pathology. This was initialed by the circulating nurse with RBV (read back verified) noted. The requisition was placed in the "pocket" of the specimen bag. The specimen was then placed in the pathology refrigerator for pick-up.

Review of the Patient Test Requisition slip for patient ID #1 revealed "uterus, cervix, bso" under "Organ or Tissue". The Patient Test Requisition slip for patient ID #2 revealed "uterus, cervix, bilateral adnexa" under "Organ or Tissue".

During an interview on 12/10/12 at 11:30 AM with the Director of Clinical Pathology, it was reported that both tissue specimen gross exams had been performed by a second year pathology resident. The specimens had been transported from a refrigerator in the OR, by a Histology Technician, to the lab and "by accession" assigned a surgical number in the computer. These numbers had been assigned in succession (i.e., patient ID #2's number was one digit greater that patient ID #1's number), and written on the specimen bags and on the pathology requisition slip in accordance with hospital protocol. The specimens were then placed on a cart for the pathology resident to perform the gross exam.

The Director of Clinical Pathology further reported that when the pathology resident reviewed the pathology requisition and then performed the gross exam for patient ID #1 and identified no ovaries, the resident pathologist should have notified the pathologist on service to direct an investigation. The requisition slip did not match the specimen.

There was no evidence that an investigation of tissue specimen discrepancies took place when a mismatch/discrepancy between the requisition and the actual specimen received was determined, in accordance with hospital policy.

Further interview with the Director of Pathology revealed that gross examinations with dictation are always done one case at a time. "The hospital performs 19,000 gross exams yearly and has never had a problem with tissue identity". Although the pathology resident had reported to the Director of Pathology, and in an interview on 12/10/10 at 12:00 PM, that hospital protocol related to dictating one case a a time and placing the tissue into the correct cassettes had been done, there was no evidence that anatomic pathology specimen identity had been accomplished in accordance with hospital policy.

In addition, it was confirmed with the Director of Pathology that the pathology resident did receive an "Incoming Pathology Resident Orientation" with a checklist completed. This checklist does include the "Investigation of Specimen Discrepancy" policy.

Although it was noted that both pathology reports had normal findings, and that the hospital did make both patients aware of the discrepancies suspected, and identified opportunities for improvement, these have not yet been fully implemented.