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Based on review of facility's Type and Crossmatch Log, review of facility's Adverse Reaction Log, medical record review, review of employee and credential files, staff interview, and, review of Constitution and By-Laws, and facility policies, the Early County Hospital Authority failed to provide effective hospital oversight, resulting in potential harm to patients who received packed red blood cells tested using an expired reagent, and resulting in identification of an Immediate Jeopardy (I.J.) situation on 7/5/2016.

Cross reference:

241- Governing Body or Responsible Individual, as it relates to assuring laboratory services were provided in a safe manner, and assuring their staff's competency.

Clinical Laboratory Improvement Amendments (CLIA) I.J. investigation #GA00164174

Based on review of facility's Type and Crossmatch Log, review of facility's Adverse Reaction Log, medical record review, review of employee and credential files, staff interview, and, review of Constitution and By-Laws and facility policies, the facility failed to assure that Laboratory services were provided in a safe manner to the patients treated therein, and to assure that laboratory employees received orientation to their current position, including skills demonstrations.

Findings include:

Review of laboratory control records and direct observation revealed the ORTHO Confidence Cell 1, Cell 2, and Antibody expired 5/10/2016.
Review of the Type and Crossmatch Log revealed documentation that the expired reagents had been used to test blood from 5/12/2016-7/1/2016.

Review of laboratory records revealed A1 Cells and B cells expired 5/24/2016.
Review of the Type and Crossmatch Log revealed documentation that the expired reagents had been used to test blood from 5/26/2016-7/1/2016.

Interview on 7/5/2016 at 2:20 PM in the conference room with the laboratory manager confirmed the above findings.

Request for Adverse Blood Reaction Log for the previous twelve (12) months yielded one result (patient #10). The situation had been investigated, and determined not to have been a blood reaction, and the patient continued to receive packed red blood cells (PRBC) without difficulty.

Review of ten (10) electronic patient medical records (#s 1-10) revealed:
All records were complete
All had received PRBC
All units of PRBC had been verified by two (2) nurses prior to administration.
All patients had vital signs monitored during administration
None of the patients had experienced an adverse reaction

Review of four (4) employee files (#s 2, 3, 4, and 8) revealed:
Three (3- #s 2, 3, and 4) did not contain evidence of orientation or skills observation to current position.
All contained initial applications with references, job descriptions, and had received initial/annual trainings which included infection control.

Review of four (4) credential files (#1, 5, 6, and 7) revealed:
All had current licenses, DEAs, privileges, appointments, and malpractice insurance.
Two (2-#s 5 and 6) contained evidence that quality reviews had been conducted.

Interview with the Administrator on 7/5/2016 at 3:00 PM confirmed the absence of documentation that laboratory employees had received orientation to their positions, and had undergone skills checks.

Interview with the Administrator on 7/7/2016 at 9:05 AM revealed that he/she became aware that the laboratory had been using expired reagents approximately three (3) weeks ago. The administrator continued to explain that the laboratory manager had informed him/her that the hospital could not do standing orders (auto-shipment) with their contracted vender due to the hospital being in bankruptcy. He/she went on stating the the corporate office informed the hospital that the vender supplies hospitals with standing orders before those without standing orders; and their facility had been receiving items close to their expiration dates. The administrator also stated that he/she had phoned the corporate office to request re- instatement of standing orders, but had been declined. He/she had suggested changing vendors. The administrator stated due to the hospital being in bankruptcy, all transactions had to go to the bankruptcy court in Jackson, MS (location of corporate office). The laboratory manager had suggested borrowing reagents from other hospitals in the meanwhile, but had never informed him/her that they were using expired reagents. The administrator explained that he/she had obtained an agreement with a new vendor the prior Wednesday, and had informed the laboratory manager that he/she could place an order for next day delivery, and instructed the manager not to use the expired reagent, or the new reagents, until correlations had been performed. The manager had agreed, and placed an order. The order was received, and the manager had used the new reagents without correlating first, as instructed. The Administrator became aware that correlations had not been performed prior to using the new reagent when the State Laboratory Surveyors had arrived on 7/5/2016. He/she continued to explain that the correlations had still not been performed because of the inability to obtain the necessary controls from their prior vendor, to whom he/she had requested such for the third or fourth time on 7/6/2016. The Administrator confirmed that on 7/5/2016, he/she had provided the State Laboratory Surveyors with a letter stating that the hospital would be providing emergency release blood only until the issue was resolved.

Interview with the laboratory manager on 7/7/2016 at 9:25 AM revealed that he/she had been a medical laboratory technician (MLT) for approximately eight (8) years, employed in the hospital's laboratory for approximately two (2) years, and laboratory manager for two (2) months. The manager stated that he/she was aware that the reagent was expired, and had continued to use it because they had been unable to obtain more due to the hospital bankruptcy. The manager explained that the vendor had been sending supplies that expired within days of receiving them. He/she added that in hindsight, he/she should have shut the blood bank down. The manager went on stating that the necessary controls and antibody screening cells had been ordered from their previous vendor the day before, and expected the next day. He/she explained that he/she had the new reagent, but could not perform correlations. He/she had used the new reagent anyway in an attempt to get the job done, and meet the needs of the patients. The manager stated that he/she was not aware of any patients who experienced adverse effects from receiving PRBCs that had been tested with the expired reagents.

Review of facility's Constitution and By-Laws of the Early County Hospital Authority, adopted March 21, 1975, revealed that Early County Hospital Authority was charged with full responsibility of operating and maintaining the Early Memorial Hospital and related activities, the equipment therein, the personnel therein employed, providing rules and regulations for such maintenance and operation in conformity with good hospital practice and supervision.
Article 1. The Governing Board would be known as the Early County Hospital Authority

Review of facility's Quality Improvement Projects revealed that performance indicators included areas of Administration, Laboratory services, and Physician services.

Review of facility policies failed to reveal a policy which addressed laboratory staff orientation.