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Shelby County vaccine investigation findings released by Tennessee Department of Health

Update Monday concluded nearly 55,000 doses administered by SCHD between late December and late February were all found to be stable and effective.

MEMPHIS, Tenn. — UPDATE: Here is a statement from the Shelby County Health Department that Local 24 received Monday afternoon:

"The Shelby County Health Department has worked collaboratively with the Tennessee Department of Health and the Centers for Disease Control and Prevention to identify all factors that may have contributed to the loss or waste of vaccine. We welcome the announcement that vaccine remained stable from the storage in the pharmacy to administration in the community. The Shelby County Health Department remains committed to continuously improving our services to meet the public health needs of Shelby County. "

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"It was incredibly important to know that Shelby Countians got effective doses," Tennessee Health Commissioner Dr. Lisa Piercey said. "It's a huge population center and a lot of vulnerable individuals it was well worth every hour spent."

Monday, Dr. Piercey concluded that Monday - following a weekslong state and federal investigation - that nearly 55,000 COVID-19 vaccine doses monitored administered by the Shelby County Health Department between late December and late February.

"We can confidently reassure all recipients of vaccine at Shelby County sites that the doses received were stable and effective," Dr. Piercey said.

With the city of Memphis now in control of vaccine distribution indefinitely, Dr. Piercey pointed to lessons learned - and corrected - from the Shelby County Health Department's previous oversight.

"The bottom line is there was poor record keeping, there was a lack of standing operating procedure that could be followed consistently and that was what was the root cause of the mismanagement," Dr. Piercey said.

Dr. Piercey Monday was unable to shed any light on two incidents - both February 3rd - of the reported theft of vaccines at the Pipkin Building site or identifying the two children reportedly vaccinated at the Appling site.

"There's been no reports that they were harmed by that and so I suppose they received vaccine dose and did OK, I just don't have any information on that," Dr. Piecey said.

Here's the full release Monday from the TN Department of Health: 

The Tennessee Department of Health, with the assistance of the Centers for Disease Control and Prevention is nearing completion of a month-long investigation into the COVID-19 vaccine handling procedures at the Shelby County Health Department.

TDH recognized staffing and operational challenges in SCHD field sites in late January and provided additional support, including deploying FEMA resources, in early February. TDH was made aware of over 1,000 expired doses on February 19, prompting deployment of TDH staff and resources to SCHD.

TDH staff identified multiple contributing factors resulting in vaccine mismanagement including suboptimal and unusual pharmacy operations, a lack of standard operating procedures for storage and handling of vaccine, insufficient and disorganized recordkeeping and a deficient process for management of soon-to-expire vaccine doses resulting in multiple wastage events.

This investigation was a herculean effort involving multiple state and federal agencies including TDH, the CDC, HHS, Operation Warp Speed and the FDA, as well as notification of the White House. Additionally, scientists and executives from both vaccine manufacturers, Pfizer and Moderna, were frequently integrated into discussions of the Shelby County situation to provide expertise into vaccine stability of their specific products.

RELATED: State health department investigates SCHD after over 2400 vaccine doses were wasted

The first phase of this response focused on inventory assessment, management and ultimately the transfer of all physical inventory and vaccine operations to the City of Memphis, as well as a detailed accounting for all expired doses. In total, there were 2,510 vaccine doses that were expired or wasted at SCHD, dating back to February 3. Other critical issues which were quickly resolved included movement of soon-to-expire excess inventory and other previously unreported vaccine handling and administration issues.

Following successful transition of vaccine operations in the first phase, TDH and CDC worked closely with SCHD officials to comprehensively assess cold chain management and administration of vaccine doses given at SCHD sites between the dates of December 28 through February 24. Due to the previously described deficiencies in record keeping, this was an extensive and painstaking analysis. Information was gathered from vaccine storage units, digital data loggers, all available handwritten temperature logs and hours of personnel interviews. Between TDH and CDC, it is estimated that over 1,000 hours of public sector manpower over the last 25 days was dedicated to this massive undertaking, which sought to ensure the effectiveness of almost 55,000 doses given during this date range.

Following a review of all findings with both Pfizer and Moderna scientific teams, the final determination by TDH, SCHD, FDA and CDC is that vaccine stability remained intact for the dates in question. CDC has finalized its report confirming vaccine stability and has provided that to both TDH and Shelby County leadership, as of this morning. Because of the exhaustive assessment by local, state, federal and industry partners, we can confidently reassure all recipients of vaccine at Shelby County sites that the doses received were stable and effective.

Going forward, TDH will conclude its work and demobilize from the SCHD site. An after-action review and a full written report will be forthcoming in the next few weeks and will be presented to Mayor Harris and the SCHD leadership, in an effort to continuously improve its public health services. TDH and SCHD collaborate on public health activities including other critically important vaccine work such as the Vaccines for Children Program, which is currently under CDC review. In its report provided this morning, CDC officials were clear that the report provided today did not include an analysis of the other issues surfaced during their visit, including recordkeeping, program oversight and inventory management, and that the CDC’s Immunization Services Division would continue to be engaged in this review.

COVID-19 vaccine delivery has been a fast moving and complex response effort. Future implications for resuming COVID-19 vaccine activities at SCHD will require improved vaccine inventory management, timely reporting of issues identified and a renewed emphasis on the importance of record keeping. SCHD has expressed their ongoing commitment to the administration of COVID vaccines to Shelby County residents through movement of state-funded vaccine strike teams and discussions around further integration of SCHD nursing staff into the currently vaccine delivery mechanism.

Shelby County Health Department Timeline

The following outline describes events discovered during the Tennessee Department of Health’s investigation of COVID-19 vaccine mismanagement by the Shelby County Health Department. All times are Central time.

Wednesday, Jan. 27 – TEMA requests 26 FEMA staff members for Memphis

Monday, Feb. 1 – TDH and Shelby County Health Department schedule strategic planning session for Feb. 5.

Tuesday, Feb. 2 – FEMA team lead onsite in Shelby County to support staffing

Wednesday, Feb. 3 – FEMA staff on site

Wednesday, Feb. 3 Thursday, Feb. 4 – FEMA site visit including Region 4 FEMA Administrator Gracia Szczech at vaccine site

Friday, Feb. 5 – TDH and SCHD Strategic Planning Session held

Friday, Feb. 19, 10 a.m. – SCHD Director Alisa Haushalter notified TDH Chief Medical Officer Tim Jones of 1,315 (1,578*) expired doses of vaccine

Friday, Feb. 19, 7:30 p.m. – TDH/Unified Command Group team arrives onsite at SCHD

Friday, Feb. 19, 9 p.m. – TDH confirms 1,578 expired vaccine doses and counts 51,480 doses in inventory

Saturday, Feb. 20, 11 a.m. – State team departs SCHD after two-hour meeting

Sunday, Feb. 21 – Tennessee Health Commissioner Lisa Piercey requests onsite assistance from Centers for Disease Control and Prevention vaccine team

Monday, Feb. 22, 1 p.m. – Embedded TDH team arrives onsite. This team remains at SCHD.

Monday, Feb. 22 – Onsite inventory physically managed by TDH pharmacist

Monday, Feb. 22 – TDH team learns of additional 840 expired doses not disclosed by SCHD on Feb. 19

Tuesday, Feb. 23 – Onsite inventory physically managed by TDH pharmacist

Tuesday, Feb. 23 – TDH team finds 64** unused doses and 12 unaccounted doses wasted after Feb. 23 vaccination event

Wednesday, Feb. 24 – Onsite inventory physically managed by TDH pharmacist

Wednesday, Feb. 24, 10 a.m. – Transfer of authority for all vaccine management assigned to City of Memphis

Wednesday, Feb. 24 – Onsite inventory moved by TDH to Regional One (Pfizer) and Poplar Healthcare (Moderna)

Wednesday, Feb. 24 – Digital data loggers and transport coolers for vaccine tracking and storage flown from Smyrna and Chattanooga to Memphis

Thursday, Feb. 25, 8 a.m. – City of Memphis begins assignment and transport of vaccine to Points of Dispensing countywide

Thursday, Feb. 25 – Purchased/installed refrigeration unit in Regional One pharmacy exclusively for vaccine storage

Thursday, Feb. 25 – Onsite inventory moved by TDH to Regional One (Pfizer) and Poplar Healthcare (Moderna)

Thursday, Feb. 25 – TDH team finds 18 unused doses wasted after vaccination event, unknown date (possibly Feb. 22)

Thursday, Feb. 25 – Shelby County Mayor Lee Harris notifies Piercey of Appling site incident of children being vaccinated on Feb. 3

Thursday, Feb. 25 – Harris notifies Piercey of Pipkin site incident of potential vaccine theft on Feb. 3

Thursday, Feb. 25 – TDH general counsel notifies Federal Bureau of Investigation regarding potential theft

Sunday, Feb. 28 – A three-person team from the CDC is deployed to SCHD

Monday, Mar. 1Friday, Mar. 12 – Detailed analysis of all available data sources is conducted to ensure vaccine stability for approximately 54,700 vaccinations given at SCHD sites from Dec. 28, 2020 through Feb. 24, 2021

Wednesday, Mar. 3 – Piercey and TDH Vaccine-Preventable Diseases and Immunization Program Medical Director Michelle Fiscus travel to Atlanta, Ga. to meet with top CDC officials including Director of the National Center for Immunization and Respiratory Diseases Director Nancy Messonnier

Monday, Mar. 15 – CDC issues report confirming vaccine stability of all doses administered by SCHD Dec. 28 – Feb. 24

Ongoing – CDC Immunization Services Division work with SCHD on all vaccine management practices, including the Vaccines for Children program.

TBD – TDH final report/after-action review to be presented to Mayor Harris and SCHD leadership

Timeline of notable events of mismanagement

February 3 - Expiration of 1,056 doses

February 3 - Two children inappropriately vaccinated at Appling site; no report to state or federal partners

February 3 - Volunteer suspected of stealing multiple doses at Pipkin site; no report to state or federal partners or authorities

February 9 - Expiration of 198 doses

February 10 - Expiration of 72 doses

February 12 - Expiration of 84 doses

February 14 - Expiration of 90 doses

Unknown date - Expiration of 78 doses

February 15 - Expiration of 840 doses

Unknown date - Wastage of 18 unused doses

February 23 - Wastage of 64 (plus 12) unused doses