INML (National Institute of Legal Medicine) investigation: In the CF2 Hospital (Hospital of the Railway Authority), where soprano Amelia Antoniu and Alice Preda went into a coma, the utilized disinfectants were so diluted that Pyocyanin was found even in the tank where the scalpels were “sterilized”

The recent medical documents that present into detail the flip side of the nosocomial infections - people and their suffering.

UPDATE: ”There were not four, but five cases of patients who were infected with the same germ! The fifth woman was traveling to the CF2 Hospital all the way from Pitești and came to us directly from Pitești”, says one of the doctors who attended the cases back in 2010 at the Emergency University Hospital in Bucharest. At the end of the text, you will find the response of the current management of the CF2 Hospital.

UPDATE: We publish at the end of the text the full document presenting the INML investigation.

UPDATE: The financial Viennese daily Wirtscafts Blatt, the Al Jazeera TV station and the Forbes magazine report about the diluted disinfectants in Romania. Dan Suciu provides an interesting statement for Al Jazeera regarding the new minister of health. The Government has two requirements for the minister: ”To know the system very well but to be outside the system, if you know what I mean...”. 

• Unbelievable story: what is the outcome of the error denying practice in our hospitals.
• How did two young women get into profound coma, one of them losing her child.
• In an examination requested by the Prosecutor’s Office, INML makes an unsparing presentation of the way the CF2 Hospital made use of the disinfectants, bringing their patients on the verge of death. 
• With this document, Amelia Antoniu and Alice Preda will go to court in a few days.
• The inspectors from the Ministry of Health were appalled when they found Pyocyanin even in the tank where the medical instruments were sterilized.
• The hospital had recently signed a large contract with Hexi Pharma, worth 376,000 lei. 
• But the board of the Ministry of Transports and Infrastructure, to which the CF2 Hospital is subordinated, claims that different disinfectants were utilized.
• One of the companies indicated by CF2, via the Ministry of Transports, denies having provided the sterilizer for the operating room.
• And the union leader sends forth a totally surprising version: ”I haven’t seen any of the Hexi products arriving in the hospital”.
• One thing is certain: a long trial is about to begin, where the patients will relive their emotional ordeal and the doctors will defend themselves by saying they had no knowledge about the state of the disinfectants.

Investigation by Mirela Neag, Răzvan Luțac and Cătălin Tolontan

In the warm evening of April 19, 2010, Amelia and Alice, two women who had undergone surgery at the CF2 Hospital, developed fever and vomiting and the following day they would get into a coma.

They had undergone minor surgery, one after the other, in the same operating room.

For a "minor cervical dysplasia", Amelia stays in the operating room between 02:00 and 02:30 PM.

Alice is brought into the operating room immediately after. Between 02:45 and 03:15 PM she undergoes an intervention of "prophylactic cerclage for preventing a 13/14-week pregnancy loss".

Shortly after, the condition of both women gets worse. The laboratory stays closed overnight.

The doctors cannot run real-time tests.

On April 20, around noon, the doctors admit defeat and their decision ultimately saves the life of their patients.

Alice loses her child

Amelia and Alice are transported with sepsis to the Emergency University Hospital.

Alice leaves first, on April 20, at 06:00 PM. Amelia follows, at 01:15 AM. They get to the Emergency University Hospital, where they are "excellently diagnosed and attended", as stated in a later report drawn by a group of Austrian doctors.

After two weeks of agony, both women survive. 

But Alice loses her child and the possibility of having another ever again.

The cause of sepsis for Alice and Amelia: nosocomial infections contracted in the operating room at the CF2 Hospital.

"Amelia can consider herself lucky"

Quote from the medical report of the Medical University Clinic in Vienna, from June 11, 2010: "Taking into account that the sepsis with gram negative bacteria induces the loss of vital function for several organs and jeopardizes life itself, patient Amelia Antoniu may consider herself lucky to have survived without permanent damage generated by this hospital acquired infection.

Diagnosis: the hospital acquired sepsis that induced loss of several vital functions was generated by the Burkholderia cepacia bacterium".

Burkholderia cepacia is related to Pyocyanin.

The disposable valve was reused!

Note done by the Investigation Commission from the Ministry of Health on April 26, 2010: "At the CF 2 Hospital the vaginal sanitization was done with disinfecting solutions that had been inappropriately stored and a disposable vaginal valve was reused after a chemical ‘sterilization’ with a questionable efficiency".

Although they had the possibility of pressure moist heat sterilization (autoclaving procedure), the medical staff from CF2 chose to sterilize using only disinfectants. As this is an exclusively chemical sterilization.

It is efficient only if the disinfectants are really powerful.

Pyocyanin in the sterilization tank

Two weeks after the events that set chaos in the hospital, the Ministry of Health collects new samples. They are tested at the Cantacuzino Institute.

The inspectors are appalled. Because although the medical staff of the hospital is supposedly under sanitary alert, aggressive germs are found in the operating rooms! And that is not all. Some germs resilient to antibiotics are detected even in the tank where the disinfectants are inserted and then, through immersion, the operating medical instruments are chemically sterilized.

In theory, bacteria cannot survive in that tank filled with highly disinfecting biocides.

But the biocides are what is written on the label.

”The decontamination in the operating room is non-compliant: it is done inconsistently (the use of disinfecting substances is quantitatively insufficient) with low-efficiency substances” - THE REPORT OF THE MINISTRY OF HEALTH COMMISSION FROM APRIL 2010 ON THE CASE OF THE TWO INFECTED PATIENTS

"Late epidemiological investigation"

The Prosecutor’s Office takes over the case.

Amelia Antoniu and Alice Preda intend to sue the CF2 Hospital. They have several official reports to support their case.

The most recent is the one done by the National Legal Medicine Institute (INML) in February 2016 in the case of Amelia Antoniu, but it refers also to her partner of suffering.

INML examines all the data included in the medical file. The investigation also considers the research undergone by the Ministry of Health Commission.

Quote: "The epidemiological investigation was initiated late compared to the onset of the postoperative pathological state and the transfer of the patients, due to the failure in communicating by the CF2 Hospital of a suspicion of sepsis through nosocomial infection".

The hospital lied to the very last moment.

The Ministry of Health further states: "The concentrations and the timings were not respected".

Another quote: "The proper stages, concentration and timings for decontamination with biocides were not respected, there were discrepancies with the products’ brochures and there was no protocol enforced for this type of sterilization".

Even if the biocides had the concentration from the label, and there was no reason for doubt in 2010, when the Ministry of Health reached these conclusions after investigation, they claimed that the disinfecting itself was being done by ear.

Two drops of kindred suffering 

INML cannot accurately indicate the source of the Pyocyanin.

The forensic specialists indicate the probability, in that inaccurately disinfected operating room, for the very substance used for anesthesia, Propofol, to have been contaminated.

Yet INML does something else. He confronts the two cases.

The table does not require any further explanation.

Amelia is 36, Alice, 35. They are both in good physical condition.

They are admitted in the morning, 20 minutes one after the other. And they undergo surgery 15 minutes apart from each other.

Amelia has cervical dysplasia and Alice is getting a prophylactic cervical cerclage for safely carrying out her pregnancy.

After the intervention, their state identically deteriorates, like two drops of black water.

Shivering... Deterioration of the general condition... Comatose state... Severe sepsis with septic shock...

What are the conclusions of the forensic specialists?

"The table shows that the two patients:

- from different environments,

- from different families,

- young,

- with good general condition,

- without immunodeficient states,

- without pre-existing infections,

- admitted at the same time,

- for different diagnostics,

- undergoing, approximately at the same time, minor but different surgical interventions,

- in both cases under endovenous anesthesia administered through a catheter,

- present during an early postoperative phase, approximately at the same time,

- the same type of symptoms, with rapid deterioration and occurring of severe sepsis state".

The germ was detected in total in the case of four patients

The cases of two more patients are discovered, Huțan, undergoing surgery on April 15 and Geanina Igna, undergoing surgery on April 19, infected with the same germ: Burkholderia Cepacia.

Back to the present.

At present, May 2016, with the latest report received from INML, Amelia and Alice are taking steps to sue the hospital. The trial is about to begin.

But it will be influenced by what is yet to follow.

Two weeks ago Gazeta paid a visit to CF2.

"What if the Hexi products never reached the hospital?"

"I was not director at that time, I was appointed immediately after", says Adrian Pop, the hospital’s care manager and the one in charge with fighting nosocomial infections.

On December 31, 2009, the CF2 Hospital signed a contract with Hexi Pharma worth 376,000 lei.

Were the Hexi Pharma products bought three months before being used in April 2010? It was impossible they had already run out.

"In all honesty, I don’t even know if these products actually reached the hospital!", says Denisa Popovici, the union leader at CF2. How come they never reached the hospital?! "I don’t recall ever seeing them here", she replies, further adding: "But former director Constantin Tănase and his acquisitions man, Ovidiu Vasile, dragged the hospital into this whole scandal. We all pay the price for their deeds!".

In 2010, Evenimentul Zilei would describe the situation at CF2 as "gothic".

"Novospray and Steril C were used"

In that case, what substances were used in the hospital?

"According to the consumption receipts, the Fefrom products were used in April 2010: 15 liters of Novospray and 6 containers of Steril C", comes the official statement of the Ministry of Transports.

The ministry further indicates that agreements were closed in 2010 with several companies: Hexi Pharma (5 products), Fefrom (3 products), Intercoop (1 product) and Sante International (1 product).

But that is not all. The Ministry of Transports is missing the big picture.

According to the public acquisitions site, in February and April 2010, CF2 directly purchased from Romexterra Grup SRL two disinfectants, Dizethol and Biosept.

Six years after

We contacted Fefrom, the company the Ministry of Transports describes as the provider of Novospray and Steril C. "We delivered only Novospray to CF2, which is a product for surfaces and air microflora, not a high-level disinfectant. Steril C, used in the operating rooms, was not delivered by us", stated a Fefrom representative.

Steril C, an Italian brand, widely commercialized in Romania as a hospital sterilizer, even for the cold sterilization, was brought to the hospital by somebody else.

"Most probably there was a miscommunication with the Ministry of Transports. In any case, it is extremely implausible for an investigation to find pyocyanin in the tank after being treated with Steril C", further added the same person from Fefrom.

We addressed another question to the board of the Ministry of Transports, that governs over the CF2 Hospital: what happened with the auction worth 376,000 lei won by Hexi Pharma? Where did the products go? And who provided the hospital with Steril C? The Ministry of Transports continue to get their information from the hospital.

On April 19 in the morning Amelia Antoniu and Alice Preda were admitted in the CF2 Hospital for two minor surgical interventions.

6 years have gone by.

Alice tried to adopt a child. She has given up.

Right of Reply of the CF2 Hospital in Bucharest:

Regarding the information presented in the mentioned article, the current management of the Clinical CF2 Hospital specifies the following:

* It is out of the question for the infections to have been surgically induced, as the scalpel was not used. In April 2010 the following interventions were undergone: for one case LEEP -  loop electrosurgical excision procedure (bactericide effect through loop diathermy) and for the other case prophylactic cervical cerclage. The cause of the claimed infection (severe sepsis) is a totally different one according to the investigations that were undergone at that moment, which invalidates the public statement of Mr. Cătălin Tolontan. The patients were subsequently transferred to another hospital that has been extensively using the Hexi Pharma products, then and up to the present.

* We emphasize that the Clinical CF 2 Hospital ceased purchasing products from the Hexi Pharma company in January 2015, in contradiction with the statements of the journalistic investigation.

* The amount of 396,000 lei, mentioned by Mr. Tolontan in his article, paid to Hexi Pharma on December 31, 2009, is not real, as it represents the value stipulated in the framework agreement and does not reflect the value actually invested in these products by the hospital. This fact is clearly illustrated by the subsequently closed contracts. During January 2009 - January 2015 the hospital purchased disinfectants from Hexi Pharma with a total value of only 113,293 lei (and during 2009-⁠2010 of 55,000 lei).

* We want to point out that since 2014, in addition to the well-known disinfectants, we have at our disposal the nebulization treatment (peroxide vapors) for the operating rooms, wards and surgical dressing units which is undergone on an as-needed basis and which operates on all surfaces (furniture, medical equipment, walls, ceiling, pavement). The control of the disinfecting procedure is achieved both through our internal service (CSCIN) as well as through the company providing disinfection services at the laboratory of the Public Health Department in Bucharest.

We therefore consider that at this moment there is no hazard for the patients who require the services provided by our hospital, a state that was acknowledged also by the recent inspections.

* Regarding the case of the two patients, there is a trial under development and that is why we consider that the further disclosure of information by the press is not opportune for the time being.