HospitalInspections.org

Based on hospital policy review, laboratory documentation review, incident report review, and staff interviews the laboratory staff failed to follow the hospital's policy for event reporting for 1 of 6 outpatient laboratory records reviewed (Patient #1), to ensure an effective Periodic Evaluation and Quality Assurance Review program.

The findings include:

Review of current hospital policy "EVENT REPORTING" (effective: 10/20/2011) revealed "...Definitions: ...Reportable Event: 'Reportable Event' shall mean, but shall not necessarily be limited to, the following: 1) Medical Error: 'Medical Error' shall mean an unintended but significant act or omission that does not achieve its intended clinical outcome... Policy: An Event Report is to be completed whenever an individual determines that a reportable event has occurred. Procedure: A. An (name) Facility MUST generate an event report in the following four types of occurrences....1. ERROR - an unintended act, either of omission or commission, or an act that does not achieve its intended outcome. ...B. An Event Report must be filed under the following circumstances and given to the facility's Risk Manger. ...2. An undesirable event occurs which is inconsistent with normal patient care. ...4. An unusual event occurs which does, or may, result in personal injury. ...C. Once an event requiring an Event Report occurs, the facility member most directly involved in the event will complete and submit the Event Report form as required. ..."

Review on 05/30/2012 of a "COC (chain of custody) Collections Log" revealed Patient #1 was entered into the log on 01/06/2012. Review revealed "Company Name/Account" was "(name) County DSS (Department of Social Services)."

Closed outpatient laboratory record review on 05/30/2012 for Patient #1 revealed a 28 year old female presented to the hospital's emergency department registration on 01/06/2012 at 1620 for outpatient laboratory tests. Review revealed the patient was sent to the hospital by the local county DSS for a quantitative urine drug screen and diagnostic ethanol (alcohol) level.

Review of the "Laboratory Requisition" form (completed by DSS personnel) revealed a requisition to perform a "Urine Drug Screen, Quantitative" and "Ethanol, Diagnostic." Review of the form revealed a pound symbol (#) next to Urine Drug Screen (UDS), Quantitative and a asterisk symbol (*) next to Ethanol (ETOH), Diagnostic. Review of the form revealed under "ADDITIONAL INFORMATION/TESTS" the asterisk symbol (*) indicated "In House" (test to be completed by hospital lab) and the pound symbol (#) indicated "Reference Testing" (test to be completed by outside reference lab).

Review of a "...Testing Custody and Control Form" dated 01/06/2012 revealed a urine specimen was collected by Medical Technologist (MT) #1 at 1635. Review revealed "...G. Drug Tests to be Performed: 5840N ALCOHOL, ETHYL (U)....8937N SAP 9-50 #3S...." were checked. Review revealed "...STEP 5: COMPLETED BY DONOR I certify that I provided my specimen to the collector, that I have not adulterated it in any manner; each specimen bottle used was sealed with a tamper-evident seal in my presence; and that the information and numbers provided on this form and on the label affixed to each specimen bottle is correct." Review revealed a hand written signature and printed name of Patient #1 on the line "Signature of Donor" dated 01/06/2012.

Review of a "FAX LABORATORY REPORT" form, from the outside reference lab transmitted to the hospital's Lab Supervisor on 01/10/2012 at 0845 revealed a urine specimen was received by the outside reference lab on 01/07/2012. Review revealed the results of a urine drug screen and urine alcohol level were documented on the report. Further review revealed "...Test in Question SPECIMEN SUBMITTED BLOOD/SERUM TESTS(S) ORDERED NONE NO TEST(S) ARE INDICATED ON THE CUSTODY & CONTROL FORM FOR THE SPECIMEN SUBMITTED. PLEASE CLARIFY THE TESTING REQUIRED AND FAX TO....PLEASE BE ADVISED THAT THE SPECIMEN WILL BE DISCARDED IF NO REPLY IS RECEIVED WITHIN SEVEN (7) DAYS. ..."

Interview with Medical Laboratory Technician (MLT) #1 was attempted on 05/31/2012 during survey. Administrative management staff revealed MLT #1 was no longer an employee of the hospital.

Interview on 05/31/2012 at 1055 with MT #1 revealed she collected the COC urine specimen from Patient #1 on 01/06/2012 at 1635 and completed the COC form. Interview revealed patients generally present to the ED and register as an outpatient and then are sent to the lab to have the specimen collected. Interview revealed the patient generally will have an order for the UDS from a physician, their employer, or DSS. Interview revealed if the patient does not have a lab requisition form then one is completed at the lab. Interview revealed patients are explained the procedure for collecting the urine specimen. Interview revealed the patient's identification is confirmed with photo identification. Interview revealed the patient is escorted to the restroom (located in the lab draw station area), blue dye is placed into the toilet. Interview revealed the restroom does not have hot water and the patient's are instructed not to turn the cold water on. Interview revealed the patient is instructed to urinate into the container and not to wash their hands until after the specimen is given to the MT. Interview revealed once the specimen is collected the temperature is recorded. Interview revealed the patient is allowed to wash their hands at that time. Interview revealed once the patient washes their hands they sign and date the COC form. Interview revealed the patient is present and observes the MT pour the urine specimen into the specimen containers. Interview revealed the patient then is asked to date, time, and initial the seals. Interview revealed the seals are placed on the specimen containers and the specimens are placed into a plastic bag and sealed again. Interview confirmed the patient observes the specimen and specimen bag being sealed by the MT. Interview revealed the patient is then given a copy of the COC form. Further interview revealed (after MT #1's review of the outpatient lab requisition form for Patient #1) the form appeared to have been completed by DSS personnel. Interview revealed DSS personnel selected the UDS under reference testing (to be sent out to a reference lab) and the ethanol level under chemistry (to be done by the in-house hospital lab). Interview revealed the form does not have an ethanol level listed under reference testing. Interview revealed when a patient presents with an outpatient order from DSS for a COC UDS with an ethanol level, the technologist "knows it is not for a serum (blood) alcohol level, it is for urine only." Interview revealed only a urine specimen is needed for a COC UDS and ethanol level. Interview revealed serum ethanol levels are only ordered for patients in the emergency department. Interview revealed "I am aware of only one instance that (MLT #1 name) drew blood on a patient (Patient #1) in error for a COC UDS and ethanol level. Interview revealed the specimen collected should have been urine only because the order was from DSS. Interview revealed MT #1 did not witness the blood draw on Patient #1. Interview revealed "(MLT #1 name) may have drawn the blood first then I did the COC." Interview revealed the patient's husband was not present when the COC UDS was collected. Interview revealed she remembers being told "the husband came back and complained, he was upset because he felt his wife had blood drawn needlessly." Interview revealed "(MLT #1 name) drew (a serum ethanol level) in error because he was confused over the order." Interview revealed MLT #1 had been hired in October 2011 for the second shift and was still on orientation. Interview revealed she did not complete an incident report and did not know if MLT #1 had completed an incident report on 01/06/2012 related to Patient #1 and the blood draw error.

Telephone interview on 05/31/2012 at 1315 with corporate administrative management staff revealed no documented evidence of an incident report involving Patient #1 being submitted by laboratory staff on 01/06/2012 or thereafter as of May 31, 2012 regarding a blood draw error on 01/06/2012.

Interview on 05/30/2012 with the laboratory manager revealed he contacted the reference lab (where Patient #1's COC UDS and blood sample was sent on 01/06/2012) and confirmed only a urine specimen was needed for the COC UDS and ethanol level. Interview confirmed no blood sample was necessary to perform the diagnostic test ordered for Patient #1.

Follow-up interview on 05/31/2012 at 1335 with the laboratory manager revealed "I would expect an incident report to have been completed." Interview revealed unnecessary venipuncture procedures on a patient would be considered an "error." Interview revealed not completing an incident report would "look like a cover up..." Interview confirmed the laboratory staff failed to follow the hospital policy for event reporting.

NC00077844