The Legal Side of Clinical Laboratories
An incorrect diagnostic resulted in a liability against a medical professional.
Medical checkups are important. I routinely have an annual medical checkup to know the status of my health. During my medical examination this year, I had the opportunity to observe how doctors ran their clinics. I must say that I was satisfied and even impressed at how clinics were run by the doctors in Medical City Pasig City.
While doing my observation, I was thinking of a case where an incorrect diagnostic resulted in a liability against a medical professional. It was supposed to be a routine checkup for employment purposes. Unfortunately, it did not end well for the patient who lost her job due to a mistaken analysis of her results.
This was the case. I am lifting this excerpt from my book Legal Aspects of Business.
Garcia v. Salvador
G.R. No. 168512, 20 March 2007
As part of the requirement for regular employment in a company, trainee Salvador underwent a medical checkup with a clinic wherein Garcia worked as a medical technologist. Garcia conducted HBs Ag blood tests on Salvador. The clinic released the results showing she had Hepatitis B, a liver disease. When she submitted the result to the company doctor, she lost her job for failing the physical examination. After informing her father, he suffered a heart attack resulting in his confinement. Meanwhile, she went to a hospital and twice had a checkup and another with the same clinic to confirm her condition. This time all results showed negative. She was rehired. She sued Garcia for damages.
HELD: Garcia was liable. He was negligent for failing to follow the laws relative to running a clinic. In sum, the clinic failed to comply with the Sec. 2 of R.A. 4688 (The Clinic Laboratory Law) requiring the following: (1) that a licensed physician should supervise it; (2) that HBs Ag test be conducted with supervision by a licensed physician; and (3) that the test result be released with authorization from the supervisor. The clinic did not have a licensed physician who supervised it.
“In fine, violation of a statutory duty is negligence. Where the law imposes upon a person the duty to do something, his omission or non-performance will render him liable for whoever he may be injured thereby.”
The elements of an actionable conduct are as follows: (a) duty on the part of the defendant; (b) breach of such duty by the defendant; (c) injury caused to the plaintiff due to such breach; and (d) proximate cause of the injury is the breach of duty. All were present in this case. Defendant had the duty to comply with the law which he breached directly resulting in the plaintiff’s injury.
Garcia was made liable to pay Salvador the judgment awarded as follows: P50,000.00 for moral damages, P50,000.00 for exemplary damages, and P25,000.00 for attorney’s fees (amounting to a total of P125,000.00).
In the Garcia case, it was made clear and categorical that a violation of a duty imposed by law is negligence. For this reason, the medical professional who failed to comply with the law on clinical laboratories was made liable for the damages suffered by the patient.
R.A. 4688 or the Clinical Laboratory Law
Republic Act No. 4688, otherwise known as the Clinical Laboratory Law, is the special law that regulates clinical laboratories. Interestingly, the law dates back to 1966 with no amendments made thus far.
In the said law, the following are required to be observed of clinical laboratories:
- Clinical laboratories are required to annually register and secure a license from the Office of the Secretary of Health (exempted: government hospital laboratories doing routine or minimum laboratory examinations if their services are extensions of government regional or central laboratories; Sec. 1).
- Only a licensed physician duly qualified in laboratory medicine and authorized by the Secretary of Health may be professionally in-charge of a registered clinical laboratory (Par. 1, Sec. 2).
- The authority of the said licensed physician has to be renewed annually (Ibid.).
- The license to operate a clinical laboratory may only be issued if it is under the administration, direction and supervision of the said authorized physician (Par. 2, Sec. 2).
In line with Sec. 3 of the law where the Secretary of Health is authorized to issue implementing rules and regulations (IRR), the Department of Health (DOH) issued DOH Administrative Order No. 2007-0027 (Re: Revised Rules and Regulations Governing the Licensure and Regulation of Clinical Laboratories in the Philippines) last 22 August 2007. Citing R.A. 4688, DOH confirmed the law’s mandate on it “to look after the public welfare by effectively enforcing and updating the current regulations to improve laboratory performance.”
Further, the DOH sees the need to keep up with modern advancements in the field of medicine. “Advances in technology necessitate the need to update the minimum standards and technical requirements for clinical laboratories. Current regulatory issuances on this matter may no longer be relevant.”
In DOH Administrative Order No. 2007-0027, these following General Guidelines were set:
- The License to Operate (LTO) will be issued only to clinical laboratories that have complied with the standards and technical requirements by the Bureau of Health Facilities and Services (BHFS).
- While clinical laboratories that are operated and maintained exclusively for research and teaching purposes are exempted from the licensing requirement, they are still required to register with the BHFS.
- Special clinics that are covered by other administrative orders (i.e. Assisted Reproduction Technology Laboratories, Molecular and Cellular Technology, Molecular Biology, Molecular Pathology, Forensic Pathology, Anatomic Pathology Laboratories, etc.) and operating independent of a clinical laboratory are required to register with BHFS without being licensed. The head for these special clinics must be a pathologist or a licensed physician who is trained in the management, principles and methodology of these specialized services.
- The DOH-designated National Reference Laboratory (NRL) is covered by the license of the clinical laboratory of the hospital where they are respectively assigned. (Note: The said NRL which is separate and physically independent from the said hospital may be allowed to register with the BHFL so long as they are duly accredited or certified by an international accrediting or certifying body, including but not limited to, the Center for Disease Control of the U.S.A. and the World Health Organization (WHO) and/or local accrediting or certifying body recognized by DOH.
- A Physician’s Office Laboratory (POL) is required to obtain a clinical laboratory license when it undertakes any or all of the activities: (a) issue official laboratory results; (b) perform more than monitoring examinations; and (c) cater not only to the physician’s own patients. (NOTE: POL-performed monitoring examinations are permitted only if they are used for monitoring patients.)
- A hospital-based Point of Care Testing (POCT) is required to be under the management and supervision of the licensed clinical laboratory of the respective hospital.
Meanwhile, there are specific guidelines also stated such as the standards to be observed in running a clinic, qualifications on human resource or staff, equipment, glassware, reagents and supplies, administrative policies and procedures, technical problems, quality assurance program, communication and records, physical activities and work environment, and referrals of examinations outside of the Clinic Laboratory. (Click Herefor more information)
Violations of the Clinical Laboratory Law, including its IRR, may result in these penalties: (a) imprisonment for not less than 1 month but not more than 1 year, or (b) a fine of not less than P1,000.00 but not more than P5,000.00, or (c) both imprisonment or fine, at the court’s discretion (Sec. 4).
Best Legal Practices
In view of the Garcia case, and what I had observed in clinics, the following are best legal practices that may be observed in running a clinical laboratory:
1) Observe the required standard of care
For every industry or profession, there is the standard of care that should be observed. These should be followed in running clinical laboratories from sterilizing medical equipment to following medical procedures.
2) Document as much as possible
When a patient comes in, he/she should fill up a form to obtain the necessary information. If a patient has a record already, his/her files should be located and updated. At this point, the patient’s contact numbers should be a priority in the event that he/she needs to be contacted after the examination.
3) Check for healthcare coverage
Patients who have healthcare coverage will be entitled to their benefits depending on the provider. This particular information should be obtained so as to inform the patient of his/her rights and privileges.
4) Take a photo of the patient
It is a good practice to take a photo of the patient. This documents his/her physical condition and status prior to the checkup. In case a situation develops during or after the examination, this is a good documentary evidence that can establish what the patient looked like when he/she visited. It will also provide additional information later on.
5) Sterilize tools and equipment
For medical and legal reasons, tools and equipment should be sterilized. This avoids any charge of negligence later on.
6) Have a staff handle payments
As doctors will be handling tools and equipment which will be used on the patient, it is a good practice to delegate the payment transactions with a staff.