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Based on review of facility documents, observation and interview with staff (EMP), it was determined that the facility failed to store medical records in a manner that would protect them from damage.

Findings include:

Review on March 11, 2014, of facility document "Filing and Storage of Medical Record reviewed March 2013," revealed no policy to safeguard patient medical records from damage.

Observation on March 11, 2014, at 10:00 AM of the third floor medical record storage room revealed a secured room with seven sets of uncovered metal bookcases. The metal bookcases contained seven shelves. Each shelf stored patient paper medical records. A smoke alarm and an automated water sprinkler was noted on the ceiling above the bookcases.

Observation on March 11, 2014, at 10:15 AM of the second floor medical record storage room revealed a secured room with seven sets of open metal bookcases. The metal bookcases contained seven shelves. Each shelf stored patient paper medical records. A smoke alarm and an automated water sprinkler was noted on the ceiling above the bookcases.

Interview on March 11, 2014, at 11:00 AM, with EMP1 confirmed the medical records stored in the second and third floor medical record storage rooms would not be protected from water damage in the event the automatic sprinkler system was activated.

Based on review of facility documents and interview with staff (EMP), it was determined that the facility failed to ensure the agreement with the laboratory supplying the hospital with blood contained the following elements of notification to the hospital if the blood later tested reacted for HIV or HCV.

Findings include:

Review on March 11, 2014, of facility document "Reference Laboratory Services Agreement," revealed the following documentation was missing from the agreement : "... The agreement must require that the blood collecting establishment notify the hospital-- (i) Within 3 calendar days if the blood collecting establishment supplied blood and blood components collected from a donor who tested negative at the time of donation but tests reactive for evidence of HIV ( Human Immunodeficiency Virus) or HCV (Hepatitis C Virus) infection on a later donation or who is determined to be at increased risk for transmitting HIV or HCV infection; (ii) Within 45 days of the test, of the results of the supplemental (additional, more specific) test for HIV or HCV, as relevant, or other follow-up testing required by FDA; (iii) Within 3 calendar days after the blood collecting establishment supplied blood and blood components collected from an infectious donor, whenever records are available, as set forth at 21 CFR 610.48(b)(3).

Interview on March 11, 2014, at 2:15 PM, with EMP2 confirmed the above items were not contained in the agreement with the laboratory supplying the hospital with blood.