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KRIS HUNDLEYPrivate cord blood banks have been growing over the past 10 years, and one company in Land O'Lakes remains a "down-home" mom-and-pop operation.
LAND O'LAKES - Jon and Tracey Suits' lakeside home here has a dock and kiddy swings out back and an umbilical cord blood freezer in front.
The Suitses own and operate Newborn Blood Banking Inc., which stores infants' cord blood for customers for possible future medical use.
The company is housed in a building attached to the Suitses' carport, a few steps from their front door.
The couple market their private cord blood bank on the Internet with a Tampa post office box and a promise of 24-hour staffing, "either in-house or on call." They also advertise Newborn Blood Banking in big white letters on the rear window of their blue 1999 Dodge Caravan, parked next to the lab.
Private cord blood banks, which are virtually unregulated, have been started over the past decade by scientists, sperm bank operators and struggling entrepreneurs. Even so, the Suitses' 7-year-old mom-and-pop operation is somewhat unique.
Their company is not publicly traded, like Cryo-Cell International in Clearwater, so its finances are not open to public scrutiny. Nor is it affiliated with a heavily regulated general blood bank, like four competitors who use the Bergen Community Regional Blood Center in New Jersey.
Instead, it is just Suits, 52, a former Gaither High School math teacher, and his wife, a 43-year-old librarian with Hernando County Schools, who tend frozen bags of cord blood while caring for their 7-year-old daughter and 4-year-old son. Part-time help comes in as needed.
The company has fewer than 1,000 customers, and nearly half of them learned about Newborn through the Internet, Suits said. Newborn charges customers an initial processing and registration fee of $846, with a $100 discount for early registration. Newborn's annual storage fee is $149 a year; the industry average is about $100 a year.
"As far as I know, we've never had a customer complain," Suits said. "Just because other banks are big doesn't mean they're doing it good and just because we're small doesn't mean we're doing it bad."
Jerlyn Shaw, a Tampa teacher who worked with Jon Suits, stored her son's cord blood with Newborn after his birth in December 2001.
"If it had been a big company, I would have been leery about it," she said. "But because it was a smaller company, I figured they'd take more care of it. And with them (the Suitses) both being teachers, I knew it was not just the money thing with them."
As potential medical uses for cord blood stem cells have increased, so has demand for private storage. Such stem cells have been used successfully in transplants for individuals with various types of leukemias and anemias. Most recently researchers at Duke University have proven that these stem cells, considered blank slates, can differentiate themselves into brain, heart, liver and bone cells, repairing damaged cells.
Stem cells in cord blood also are free of the controversy surrounding embryonic stem cells because they are discarded as medical waste after birth if not stored.
Parents can donate their newborn's stem cells to a handful of public cord banks at no cost. If their child ever needs a transplant, they can receive stem cells for free, though the samples would not be their own. Many transplant experts think there are enough stem cells in public banks to provide suitable matches for unrelated patients and meet medical demand.
But thousands of parents each year opt to save their baby's cord blood in a private bank to ensure a perfect match for their child, or a close match for a sibling, should it ever be needed.
Government regulators have not kept up with the proliferation of companies offering private storage. Only New Jersey and New York require these banks to register, but even these states don't have the resources to conduct many inspections.
In January, the Food and Drug Administration began requiring private banks to register with the agency. But there are no guidelines for operation, and routine inspections do not take place.
Private cord banks' most rigorous certification has been given by an industry group, the American Association of Blood Banks. For a fee of $4,400, the AABB visits a private bank and certifies that its procedures meet a certain set of guidelines.
To date, Newborn Blood Banking has not complied with the minimal requirements now in place. The company is not registered with the FDA, though Suits said he's looking into it.
Suits has not licensed his bank with either New York or New Jersey because he said the requirements are not clear. "We don't draw blood in those states, so I don't think we have to register there," he said.
Spokeswomen for licensing agencies in both states said Suits is incorrect: If he stores samples from residents of New York and New Jersey, he must be licensed in those states. Suits said he has stored samples from both New York and New Jersey.
And though Newborn pays a fee to be a member of the AABB, there are no requirements for membership. Certification by the organization is a separate process. Newborn has not requested accreditation by the AABB.
Newborn recently signed a license agreement with PharmaStem Therapeutics, a Larchmont, N.Y., company that has successfully defended its patent for cord blood collection and processing against other private banks. The license did not involve an on-site inspection of Newborn's facilities.
"Being licensed under the PharmaStem patent is not necessarily a label of quality processing," said Nicholas Didier, president of PharmaStem. "It is just proof the company is in compliance with U.S. patent law. It's up to federal and state health regulators to determine whether or not to regulate and supervise the cord blood industry."
Getting into private cord blood banking was a very personal decision for the Suites. Tracey had battled lung cancer in 1992 and when she was pregnant in 1996, the couple started looking for places to store their first child's stem cells. With only a handful of companies then offering the service, the Suitses decided to do it themselves.
"Some people in our prenatal class got wind of our plan and wanted to do a co-op," Suits said. "But we contacted an attorney who advised us to incorporate. So we started a business."
The Suitses turned to Dr. Yen Hui Chang, a clinical director at All Children's Hospital in St. Petersburg, for advice. Chang said she helped the couple set up a lab in their home, which was then on Davis Islands in Tampa.
"I showed them how to make a sterile technique," said Chang, who said she has not seen the Suitses' current facility in Land O'Lakes. "They were using the same technique the New York Blood Bank was using at the time."
Carol Wells of Davis Islands was an early Newborn customer, banking her child's cord blood with the company in September 1997. She had visited the facility in their Davis Islands home and felt comfortable with the couple.
"They had a good reputation as individuals in the community," Wells said of the Suits. "What appealed to me was that this was a local company and it was a fairly low-cost investment. If we were paying $5,000 a year (to store the blood), maybe I would have looked a little further into it."
Wells has since recommended Newborn Blood Banking to pregnant friends. "It's an insurance policy," she said. "You just hope you never have to find out if you have a viable sample."
Newborn is unusual because it stores the whole cord blood. Most competitors remove the red cells and plasma and store just the stem cells.
"We tried to choose the path of saving the greatest number of stem cells," Suits said. "We save the blood in bags, not vials. And it's stored in the liquid phase of liquid nitrogen, not vapor."
The Suitses offer pickup service at hospitals close to their Land O'Lakes home, though most samples arrive by FedEx usually within 24 hours of the baby's delivery.
According to Suits, after he adds a cryo-preservative to the blood, the bag is submerged in a cold water bath, then put in a controlled-rate freezer that slowly lowers its temperature. The sample is then placed in liquid nitrogen in a cryogenic freezer.
Suits said his freezers are the same models used by All Children's Hospital and Moffitt Cancer Center in Tampa. The company purchased one freezer, manufactured by Custom Bio Genics Systems, about six months ago for approximately $30,000, he said.
Unlike most competitors, Newborn does not test the cord blood for disease or bacteria. Suits said the maternal blood is tested for infectious disease prior to the birth, and he thinks testing cord blood just adds unnecessary cost.
"We'll send it out to be tested if the parent wants," he said. "But I've found that even when you get bad results, the parents say they still want to save the sample. So ultimately, it just adds costs."
Suits said Newborn's prices are high because of the expense of storing blood in bags, rather than tiny cryo-vials, as well as the cost of liquid nitrogen and equipment.
"I think I spent $10,000 last year on liquid nitrogen," said Suits, who gets weekly deliveries of the cryogenic liquid to his home. "I've spent tens of thousands of dollars on the freezer and equipment that goes into it."
According to Pasco County records, Newborn pays tangible tax on equipment appraised at about $10,000.
Though the Suitses started their business with their first child's welfare in mind, they were not able to store her blood. "We just didn't get everything together in time," he said of his daughter's birth in November 1997. "But we put our son's cord blood in there when he was born in 1999."
Newborn's first customer, in June 1997, was Tracey Suits' obstetrician, Dr. Steven Greenberg.
"One of the reasons I elected to store with Newborn is because they were my patients and very reputable people," said Greenberg, who practices in Tampa. "I have a comfort level with them and I think if they get to the point where they're not able to manage, they won't throw the blood in the trash, they'll sell it to a bigger company."
Greenberg said he has never visited Newborn's lab and doesn't feel the need to do so.
"I could walk through and it would look gorgeous and it may give me a false sense of security," he said. "But there are big fancy companies that look pretty good yet they lie and cheat."
In fact, Suits discourages clients from visiting Newborn's facilities, saying his insurance policy does not allow such visits. He also is reluctant to publicize his address, which is in an area zoned for residential use only. Suits said he is not in violation of zoning regulations because his business has a low impact on the neighborhood.
"We rarely get a question about our location and when we do, we tell them we're near Routes 54 and 41," he said. "Maybe some people would be surprised to find out this is our house, but I think people are looking for security. The way I look at it, the most valuable things you have, you keep in your home. And because this is a 24/7 job, it's ideal for us to have the lab where it is convenient."
Though Suits allowed a reporter to visit his lab, he declined to allow a Times photographer to take pictures of his operations.
The 14- by 40-foot space, with bright white walls and linoleum floor, has a window looking out onto Suits' front yard and an air-conditioning unit in the wall. There's a sink and countertop for processing incoming cord blood samples, which Suits said arrive at the rate of three or four a week. A controlled-rate freezer and graphing monitor, which tracks a sample's temperature, are at one end of the counter. A baby monitor sits on top of the control unit; Suits said the freezer's alarm alerts him when the initial cooling process is complete.
Suits' lab has two cryogenic storage freezers, each with its own liquid nitrogen tank. Promotional brochures and lab supplies fill shelves on the opposite side of the room. By the door is a framed copy of the company's occupational license, along with a photo of the couple's two children.
Suits said he looks forward to building Newborn's business and has room in his lab for more than 10 times as many samples. He is considering storing just stem cells, like most of his competitors. Such a change would require more processing upfront but less storage space. And he'd like to store the cord blood of a child with a family member in immediate need of a transplant, to prove his lab is up to the task.
So far, no Newborn samples have been used for transplant.
Roger Mrowiec is director of a public cord blood program housed at the Bergen Community Regional Blood Center in Paramus, N.J. The program also contracts with four private cord blood banks to process and freeze their samples. So far, Mrowiec's program has provided stem cells for 26 transplants.
"When we started our program, we decided to apply all the regulations from whole blood banking to cord blood banking," Mrowiec said of the guidelines followed by his program. "We happened to be correct."
Mrowiec said when the FDA begins regulating private cord blood banks, as he expects they will do soon, he thinks Newborn will be required to perform certain tests on the cord blood prior to freezing. In the meantime, the quality of a cord bank's service can be determined only when and if a sample is needed for transplant.
"That's what's scary," Mrowiec said. "I imagine there are some organizations in this business purely for the money and they don't care about quality and when the time comes for a transplant, it will be a disappointment for the people who stored and paid. It's not about the money, it's about the person needing the transplant. If the sample is not processed and stored correctly, the patient may die."
Though Newborn has developed in a regulatory vacuum, Suits insists he wouldn't mind some official oversight.
"To be honest, I'm kind of surprised somebody hasn't stepped up and done it," he said. "But what happens is the FDA kind of uses a sledgehammer. And they could shut us down if they overburdened us too much with regulations."
Suits said neither he nor his wife has drawn a salary from the business. And he said government inspections couldn't make him any more vigilant than he is today about the safety and security of his customers' cord blood samples.
"My own son's cord blood is in here," he said. "Personally, I probably have the greatest vested interest of any operator in making sure my freezer is maintained properly and correctly. The health and welfare of my wife and son are most important to me."
- Kris Hundley can be reached at hundley@sptimes.com or 727 892-2996.