Citing serious and recurring deficiencies, the national organization that just last year rated laboratory operations at Maryland General Hospital "Accredited with Distinction" has now suspended its approval for two key testing areas at the 243-bed facility.
The College of American Pathologists revoked the accreditation for chemistry and point-of-service operations at Maryland General for the one-month period ending May 25. The action was based on an inspection conducted April 26. State and federal officials learned of the action yesterday.
Though it represents another setback, the suspension is expected to have no visible effect on the hospital's operations, which are being monitored by state and federal regulators as a result of widespread testing problems made public this year. The irregularities were uncovered after complaints by a former lab technician at the hospital, an affiliate of the University of Maryland Health System.
The chemistry section of the laboratory includes tests conducted for cholesterol levels, drug screening and prostate-specific antigen to detect prostate cancer. Point-of-care services include routine tests for blood sugar levels and urinalysis.
The hospital sent out more than 450 HIV and hepatitis test results to patients over a 14-month period ending in August of last year despite instrument readings that showed the results might be erroneous.
"Following the College's focused re-inspection of the main laboratory at MGH on April 26, 2004 and a review of all pertinent information regarding this laboratory and its compliance with the College's Standards for Laboratory Accreditation, the College has decided to suspend accreditation of the laboratory's chemistry and point-of-care testing services for a 30-day period beginning April 26, 2004," CAP spokesman Anthony Phipps wrote in a statement.
"This decision was based on the seriousness and recurrence of deficiencies identified," Phipps stated, adding that the organization would be conducting an unannounced inspection at the hospital before May 25 to determine if the problems have been corrected.
Nelson J. Sabatini, Maryland's health secretary, said state and federal actions already had the effect of removing the hospital's accredited status.
He said the lack of accreditation would not affect the hospital's ability to continue providing testing services.
Maryland General officials said they are working to correct the deficiencies and noted that nearly all of the originally suspect tests were accurate.
"Maryland General will not be satisfied until all issues in the laboratory have been completely identified and addressed," the hospital said in a written statement.
CAP, the Illinois-based accrediting organization, had given full approval to all of Maryland General's laboratory operations after a routine inspection a little more than a year ago.
The once-confidential 2003 CAP report released recently by state officials showed inspectors from the agency gave the facility generally high marks at the same time they noted the hospital's laboratory had gone for a year without adhering to a quality-assurance plan.
Sabatini said state officials have asked for the detailed inspection notes from the recent CAP inspection to determine if the problems were the same as those already turned up in a series of state inspections.
"Where were they before April 26?" Sabatini asked.
Since the Maryland General problems became public, Sabatini has been highly critical of CAP and the hospital inspection process. The health official contends that state and federal laws unduly limit the ability of state inspectors to review hospital operations.