Pharmacy Case Study Examples
Giorgina Makara
A staff member of a medical practice discussed HIV testing procedures with a patient in the waiting room, thereby disclosing PHI to several other individuals. Also, computer screens displaying patient information were easily visible to patients. Among other corrective actions to resolve the specific issues in the case, OCR required the provider to develop and implement policies and procedures regarding appropriate administrative and physical safeguards related to the communication of PHI. The practice trained all staff on the newly developed policies and procedures. In addition, OCR required the practice to reposition its computer monitors to prevent patients from viewing information on the screens, and the practice installed computer monitor privacy screens to prevent impermissible disclosures.
A grocery store based pharmacy chain maintained pseudoephedrine log books containing protected health information in a manner so that individual protected health information was visible to the public at the pharmacy counter. Initially, the pharmacy chain refused to acknowledge that the log books contained protected health information. OCR issued a written analysis and a demand for compliance. Among other corrective actions to resolve the specific issues in the case, OCR required that the pharmacy chain implement national policies and procedures to safeguard the log books. Moreover, the entity was required to train of all staff on the revised policy. The chain acknowledged that log books contained protected health information and implemented the required changes.
A chain pharmacy disclosed protected health information to municipal law enforcement officials in a manner that did not conform to the provisions of the Privacy Rule. Among other corrective actions to resolve the specific issues in the case, OCR required this chain to revise its national policy regarding law enforcement's access to patient protected health information to comply with the Privacy Rule requirements, including that disclosures of protected health information to law enforcement only be made in response to written requests from law enforcement officials, unless state law requires otherwise. The revised policy was implemented in the chains' stores nationwide.
A municipal social service agency disclosed protected health information while processing Medicaid applications by sending consolidated data to computer vendors that were not business associates. Among other corrective actions to resolve the specific issues in the case, OCR required that the social service agency develop procedures for properly disclosing protected health information only to its valid business associates and to train its staff on the new processes. The new procedures were instituted in Medicaid offices and independent health care programs under the jurisdiction of the municipal social service agency.
A national health maintenance organization sent explanation of benefits (EOB) by mail to a complainant's unauthorized family member. OCR's investigation determined that a flaw in the health plan's computer system put the protected health information of approximately 2,000 families at risk of disclosure in violation of the Rule. Among the corrective actions required to resolve this case, OCR required the insurer to correct the flaw in its computer system, review all transactions for a six month period and correct all corrupted patient information.
A state health sciences center disclosed protected health information to a complainant's employer without authorization. Among other corrective actions to resolve the specific issues in the case, including mitigation of harm to the complainant, OCR required the Center to revise its procedures regarding patient authorization prior to release of protected health information to an employer. All staff was trained on the revised procedures.
A pharmacy employee placed a customer's insurance card in another customer's prescription bag. The pharmacy did not consider the customer's insurance card to be protected health information (PHI). OCR clarified that an individual's health insurance card meets the statutory definition of PHI and, as such, needs to be safeguarded. Among other corrective actions to resolve the specific issues in the case, the pharmacy revised its policies regarding PHI and retrained its staff. The revised policies are applicable to all individual stores in the pharmacy chain.
An employee of a major health insurer impermissibly disclosed the protected health information of one of its members without following the insurer's authorization and verification procedures. Among other corrective actions to resolve the specific issues in the case, OCR required the health insurer to train its staff on the applicable policies and procedures and to mitigate the harm to the individual. In addition, the employee who made the disclosure was counseled and given a written warning.
A private practice failed to honor an individual's request for a complete copy of her minor son's medical record. OCR's investigation determined that the private practice had relied on state regulations that permit a covered entity to provide a summary of the record. OCR provided technical assistance to the covered entity, explaining that the Privacy Rule permits a covered entity to provide a summary of patient records rather than the full record only if the requesting individual agrees in advance to such a summary or explanation. Among other corrective actions to resolve the specific issues in the case, OCR required the covered entity to revise its policy. In addition, the covered entity forwarded the complainant a complete copy of the medical record.
At the direction of an insurance company that had requested an independent medical exam of an individual, a private medical practice denied the individual a copy of the medical records. OCR determined that the private practice denied the individual access to records to which she was entitled by the Privacy Rule. Among other corrective actions to resolve the specific issues in the case, OCR required that the private practice revise its policies and procedures regarding access requests to reflect the individual's right of access regardless of payment source.
A public hospital, in response to a subpoena (not accompanied by a court order), impermissibly disclosed the protected health information (PHI) of one of its patients. Contrary to the Privacy Rule protections for information sought for administrative or judicial proceedings, the hospital failed to determine that reasonable efforts had been made to insure that the individual whose PHI was being sought received notice of the request and/or failed to receive satisfactory assurance that the party seeking the information made reasonable efforts to secure a qualified protective order. Among other corrective actions to remedy this situation, OCR required that the hospital revise its subpoena processing procedures. Under the revised process, if a subpoena is received that does not meet the requirements of the Privacy Rule, the information is not disclosed; instead, the hospital contacts the party seeking the subpoena and the requirements of the Privacy Rule are explained. The hospital also trained relevant staff members on the new procedures.
An outpatient surgical facility disclosed a patient's protected health information (PHI) to a research entity for recruitment purposes without the patient's authorization or an Institutional Review Board (IRB) or privacy-board-approved waiver of authorization. The outpatient facility reportedly believed that such disclosures were permitted by the Privacy Rule. OCR provided technical assistance to the covered entity regarding the requirement that covered entities seeking to disclose PHI for research recruitment purposes must obtain either a valid patient authorization or an Institutional Review Board (IRB) or privacy-board-approved alteration to or waiver of authorization. Among other corrective actions to resolve the specific issues in the case, OCR required the outpatient facility to: revise its written policies and procedures regarding disclosures of PHI for research recruitment purposes to require valid written authorizations; retrain its entire staff on the new policies and procedures; log the disclosure of the patient's PHI for accounting purposes; and send the patient a letter apologizing for the impermissible disclosure.
A hospital employee's supervisor accessed, examined, and disclosed an employee's medical record. OCR's investigation confirmed that the use and disclosure of protected health information by the supervisor was not authorized by the employee and was not otherwise permitted by the Privacy Rule. An employee's medical record is protected by the Privacy Rule, even though employment records held by a covered entity in its role as employer are not. Among other corrective actions to resolve the specific issues in the case, a letter of reprimand was placed in the supervisor's personnel file and the supervisor received additional training about the Privacy Rule. Further, the covered entity counseled the supervisor about appropriate use of the medical information of a subordinate.
A private practice denied an individual access to his records on the basis that a portion of the individual's record was created by a physician not associated with the practice. While the amendment provisions of the Privacy Rule permit a covered entity to deny an individual's request for an amendment when the covered entity did not create that the portion of the record subject to the request for amendment, no similar provision limits individuals' rights to access their protected health information. Among other steps to resolve the specific issue in this case, OCR required the private practice to revise its access policy and procedures to affirm that, consistent with the Privacy Rule standards, patients have access to their record regardless of whether another entity created information contained within it.
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