HospitalInspections.org

Bringing transparency to federal inspections

1555 LONG POND ROAD

ROCHESTER, NY 14626

ORDERS FOR DRUGS AND BIOLOGICALS

Tag No.: A0409

Based on policy review, medical record review and interview, the facility did not ensure the administration of blood products was conducted in accordance with facility policy for 5 of 20 Patients (Patient # 1, 5, 17, 19 and 20). Failure to follow established standards of practice could result in adverse patient outcomes.

Findings include:

Review on 01/26/18 of the facility's policy "Blood and Blood Product Administration," last reviewed 07/31/17 indicates that all blood components must be infused within 4 hours from the start of the infusion and vital signs are to be obtained within 30 minutes following the completion of the transfusion.

Medical record review on 01/26/18 revealed blood products were not infused within 4 hours of initiation for the following patients:
- On 01/05/18: The 1st unit of packed red blood cells was started at 01:30 PM for Patient #1. The transfusion was completed in 4 hours and 15 minutes at 05:55 PM.
- On 01/21/18: One unit of packed red blood cells was started at 05:17 PM for Patient #17. The transfusion was completed in 4 hours and 7 minutes at 08:22 PM.

Medical record review on 01/26/18 revealed post transfusion vital signs were not obtained within 30 minutes of the blood transfusion completion for the following patients:
- On 01/24/18: Post transfusion vital signs for Patient #5 were taken at 04:19 PM, 1 hour and 13 minutes after the transfusion was completed at 03:06 PM.
- On 01/20/18: Post transfusion vital signs for Patient #19 were taken at 06:00 PM, 1 hour after the transfusion was completed at 05:00 PM.
- On 01/12/18: Post transfusion vital signs for Patient #20 were taken at 11:43 PM, 43 minutes after the transfusion was completed at 11:00 PM.

Interview on 01/26/18 at 09:45 AM with Staff (E), Senior Director for Clinical Regulatory Compliance, Staff (Q), Director of Clinical Practice and Staff (CC), Clinical Regulatory Compliance Specialist, verified these findings.

LABORATORY SERVICES

Tag No.: A0576

Based on medical record review, policy review and interview, the facility did not provide laboratory services in accordance with their policy & procedures. Failure to follow established standards of practice could result in inaccurate results, inadequate treatment and potential adverse patient outcomes.

See Tag # 582.

ADEQUACY OF LABORATORY SERVICES

Tag No.: A0582

Based on medical record review, policy review and interview, the facility did not provide laboratory services in accordance with their policy & procedures for Patient #1. Failure to follow established standards of practice could result in inaccurate results, inadequate treatment and potential adverse patient outcomes.

Findings include:

Medical record review on 01/24/18 revealed Patient #1 presented to the emergency department (ED) on 01/05/18 with the complaint of frank rectal bleeding. A blood sample was obtained for type & cross matching, which indicated a B+ blood type. Patient #1 received 4 units of B+ blood. On 01/10/18, Patient #1 required additional blood transfusion. A type & cross match blood sample was obtained which indicated an O+ blood type, not B+ as previous laboratory results indicated. Patient #1 had received the wrong blood type on 01/05/18.

Review on 01/24/18 of the facility's policy "Specimen Labeling," dated 10/1/17 indicates if a specimen has been collected and has a label other than a laboratory barcode order label:
- Query patient name, date of birth (DOB), medical record number (MRN) to find associated orders.
- Print the associated barcode label.
- Affix the laboratory barcode order label to the specimen.
- Labels must be applied with an accession (unique identifier) number at the top of the tube.
- Label must be straight with no crease/rips
- Affix label so original patient name can still be seen.
- Check the name and DOB of the laboratory barcode order label to the original label.
- Verify both names and DOB match prior to bringing the specimen to the testing location.

Review on 01/24/18 of the facility's policy "Blood Bank Specimen Labeling," dated 10/31/17 indicates sample labels must be reviewed for accuracy and completeness every time a sample is used for testing. When multiple labels are on the tube, it is the responsibility of the technologist to compare all labels for agreement of patient information (name, DOB, MRN if applicable). Initial both labels near patient name to verify that this has been done. Initialing should be done in a place on the label that does not obscure any demographic information.

Interview on 01/24/18 at 10:00 AM with Staff (C), Medical Director of the Blood Bank revealed Patient #1's blood sample arrived in the lab on 01/05/18 and was mislabeled by processing technicians. The labels were not double checked by the medical technologist in the blood bank prior to processing the specimen for the type and cross match.

Interview on 01/25/18 at 09:00 AM with Staff (X), Supervisor of Phlebotomy & Customer Service revealed that at the time of the incident (01/05/18), blood sample tubes/specimens from the ICU and ED were labeled with addressograph (patient demographic) style labels. Once the blood tubes/specimens arrived at the laboratory, a laboratory processing technician accesses the lab barcoding system to print and affix a 2nd label to the blood tube/specimen. The 2nd label is affixed so that the demographic information on both labels can be seen. A laboratory processing technician then delivers the blood tube/specimen to other areas of the lab in which it is to be processed. Medical technologists perform testing on all specimens. Blood bank processing and storage is in its own contained area of the lab. Staff (X) indicated that all blood tube/specimens that come into the blood bank with 2 labels (addressograph and lab barcode) must be initialed by the medical technologist. This is to verify a double check has been performed of the demographic information on both labels.

Interview on 01/25/18 at 10:30 AM with Staff (F), Laboratory Processing Technician revealed that she had a trainee working with her on the day of the incident (01/05/18), who pulled the blood tubes from a refrigerator storage area and applied the labels to the them. She did not check his work prior to the blood tubes being taken to the blood bank for further processing.

Interview on 01/25/18 at 12:30 PM with Staff (H), Medical Technician revealed she did not check the blood sample name/demographic information of both labels brought to the blood bank, prior to performing the type & cross match for Patient #1.

Interview on 01/25/18 at 02:30 PM with Staff (AA), Laboratory Processing Technician revealed he was a trainee on 01/05/18. He had the bar code label in his hand and thought the other technician was handing him the correct tube in which to affix the 2nd label. He did not check to make sure that both labels had matching patient demographic information.

Interview on 01/26/18 at 09:00 AM with Staff (E), Senior Director of Clinical Regulatory Compliance, verified these findings.