The medical errors that killed a young cancer patient in December were not isolated events, state investigators say, but part of a wider pattern of safety lapses at a Johns Hopkins-run residential care group that included drug mix-ups and the hiring of unqualified staff.
"When we got there, we saw enough that made us want to expand the survey and take a look at other patients," said Carol Benner, director of the state's Office of Health Care Quality.
Benner's office launched an investigation into the Johns Hopkins Home Care Group last month after the death of 2 1/2 -year-old Brianna Cohen, who died Dec. 4 after being supplied with an intravenous solution that contained an overdose of potassium.
As it examined other patients' records, the state found that the Home Care Group had, for example, delivered the wrong medication to another child who later suffered "protein intoxication," and failed to provide supplies - including an oxygen refill - on time.
The Hopkins group, which treats 5,000 area outpatients, also hired respiratory therapists who did not have the required bachelor of science degrees.
In addition, state investigators said that the home care group kept inconsistent and incomplete patient records and lacked an effective system for catching and addressing mistakes.
"We found a failure [by home care group staff] to adhere to their own policies and procedures," said Benner. "Certainly there was a problem with their record keeping. We also found a pattern of incorrect medications. The biggest concern that I had was related to medication."
Steven A. Johnson, the home care group's president, declined through a Hopkins spokeswoman to be interviewed yesterday.
The state investigation targeted the home care group's Pediatrics at Home and Pharmaquip operations, which are considered "residential service agencies." Maryland has about 350 such agencies.
Unlike home health agencies, residential service agencies are not federally regulated or subject to annual inspections. State inspections are done only periodically. Benner said "very few" such surveys are done each year.
State officials reviewed the records of 11 patients, both children and adults, in addition to Brianna's. In some cases, they found no problems. But in others, they found many - some of which potentially put patients in harm's way.
A pregnant woman who became a home care patient in October had a clotting disorder that required an injection of the anticoagulant heparin twice a day. Though the home care pharmacist was required to contact the woman's physician to determine whether the drug should be stopped before her scheduled Caesarean delivery this month, the pharmacist never did so, until the state stepped in last month.
"The failure of the pharmacist to coordinate care with the physician and clarify the anti-coagulant order placed the patient at risk for possible bleeding," the state's report said.
In the case of the child who was mistakenly given a high-protein formula - sending the 7-month-old to the hospital in a coma - the home care group's records showed, despite the error, that the correct medication had been delivered.
Hopkins released a statement Monday in response to the state's findings, but it has since declined to elaborate. It said that many of the problems - some of which Hopkins called "major" and some of which it called "relatively minor" - have been addressed. The statement also said that Hopkins is taking steps to improve safety and provide oversight at the home care group. Hopkins must provide a detailed corrective plan to the state.
After reviewing the home care group's internal incident reports, which documented 14 medication errors and six "delivery incidents" last year, the state found that the home care group didn't do enough to address errors.
For instance, the home care group found that two patients had been given syringes of Heparin labeled with the other's name. The incident report stated that "both patients agreed to destroy the labels but are keeping the syringes."
"Prudent action would have been to provide new syringes as it could not be determined that the medication and dose were accurate," the state report said. In one case, an oxygen refill was not delivered on the day it was promised because no drivers were available. Among other problems, the state found:
The home care group could provide no documentation for the pharmacy audits it claimed were done between April and June of last year.
The required "sterility" testing of total parenteral nutrition solutions - which are used by patients like Brianna who can't eat normally - was not performed between July and October of last year. The pharmacy supervisor told investigators that the necessary supplies were on back order and that "there was no backup system ... to ensure that the required testing was performed."
On-call logs for after-hours service were not kept consistently - or, in some cases, at all. The pharmacy supervisor said she had never received training for the on-call process.
Daily records verifying the correct temperatures for the freezer, incubator, refrigerator and "clean room" were not kept for 20 of the 30 days in November. That same month, records showed that the chemotherapy hood, which was to be cleaned weekly, was cleaned just once.