practice of Medicine
Orthopedic Surgery Toolkit
Gaps in documentation & lab tracking hamper defensibility of orthopedic claim
The patient had a past history of bilateral hip avascular necrosis treated by a bilateral hip core decompression. A hip arthroplasty was performed by the orthopedic surgeon. Five days after the procedure, the patient was experiencing pain, having developed a large, superficial hematoma. She was admitted to the hospital where labs were performed and the physician’s partner performed an incision and drainage (I & D). Wound cultures were negative, white count was 9 , there was no purulence, the packing was removed, the area looked clean, the patient was discharged home on Bactrim by mouth, and instructed to follow-up with her orthopedic surgeon. Six days later, at the follow up visit, the surgeon noted there was a 3-4 cm of wound dehiscence with serous fluid draining. The surgeon documented in error the patient had been on Cipro, and performed another I & D. His medical record dictation was incomplete. He had erroneously documented the patient’s cultures were negative when, one culture was MSSA positive. Nine weeks after the total hip arthroplasty, the patient continued to complain of pain on range of motion. On physical examination, the incision was well-healed, and no fluid or pus was withdrawn at aspiration. Three months after the surgery, the patient continued to complain of significant pain, and had developed a leg inequality. The surgeon performed a total hip arthroplasty revision with exchange of femoral component. The surgeon’s operative note read, “There were no signs of infection. There was no hematoma. There was no pus.” The surgeon further documented that he examined the prosthesis and did not see any infection around it at the time. He did document that because the prosthesis was loose, he put in a larger prosthesis.
The patient continued to complain of pain, reporting that she was now confined to the bed in excruciating pain, unable to work. She was managing her pain with antispasmodics, muscle relaxers and pain relievers. Several consultants were unable to identify the source of the patient’s pain and hip muscle spasms. Her hip was painful to flexion and external rotation. Six months after the original surgery, the orthopedic surgeon removed the hip. The femur was broken in the process. The patient had an elevated CRP and a positive aspirate for MSSA. A bone scan showed no infection around the prosthesis. The plan was to put the patient on IV antibiotics with hopes of doing a revision of the prosthesis.
The patient sought care from a second orthopedic surgeon. That surgeon’s impression was “osteomyelitis of the right ileum and proximal 50% of the right femur; peri-prosthetic infection and chronic sepsis on the right hip joint”. He planned a two-stage revision. The first surgery took over seven hours and included radical soft tissue resection in the pelvis and thigh, debridement of the pelvis and proximal femur, removal of hardware, and total hip replacement using custom antibiotic-loaded articulated antibiotic beads. Almost 1 year later, the second stage of the hip replacement was performed. Four months after the second stage of the surgery, the patient was ambulating with a normal gait, her incision was well healed, and there were no signs of infection or swelling. The patient required long-term IV antibiotic treatment for chronic infection with MSSA.
The plaintiff alleged that the defendant surgeon failed to review the results of a culture report resulting in a staph infection that remained unrecognized and untreated.
Despite expert support for the medical care the orthopedic surgeon provided, the documentation gaps in his dictation, clinic notes, and his failure to show that he had reviewed all lab results, posed a defense challenge. The physician consented to settlement of this case for a moderate amount of money.
Patient Safety Suggestions:
An analysis of the medical record from the time of the patient’s first surgery revealed several reports from I & D admissions that indicate the cultures were negative. Review of cultures over the last two years indicated there had been positive cultures from wound or fluid since the time of the initial first post-operative visit, continuing for the next two years. The expert reviewer’s opinion was that the surgical team remained unaware of some of the final culture reports which caused treatment delay.
The orthopedic surgeon acknowledged the gaps in documentation, but testified in deposition that he was aware of the lab result of the culture that grew out a rare staph infection and was concerned about a deep infection during the time he treated the patient. He believed that if the patient had been given antibiotics at the time, this may have masked the problem.
There are two key themes in this case that commonly hamper the defensibility of an otherwise defensible medical liability claim: failure to document the decision-making process and failure to maintain a reliable clinical tracking system in the medical office.
Documentation of the Decision-making Process
Doctors are strongly encouraged to document decision-making in a manner clearly understood by others who are involved in the patient’s care. Failure to document the medical thought process may hamper the defensibility of a case, as we’ve seen in this case. Additionally, other physicians involved in the care of the patient, such as the physician rendering the second opinion, may disparage the care provided because they are unable to determine the physician’s rationale for the treatment decisions made at the time.
Clinical Tracking Processes
Almost 27% of medical liability claims arise from care provided in the medical office. Diagnosis-related error or delays in diagnosis are cited as the main reason for paid claims. According to one study, 14% of the diagnostic errors can be attributed to follow-up and tracking of diagnostic tests. Many of these claims relate to inadequate clinic tracking systems within the office.
Most electronic health record (EHR) systems have a built-in tracking feature. Some EHR systems facilitate the ordering of tests, but may not have an interface that automatically reconciles the test results. With some systems, a manual system of reconciliation or a follow-up report system should be incorporated. Whether your practice has an EHR with tracking capability or a manual system, you are encouraged to maintain a reliable process for ensuring receipt, acknowledgment, and follow up of labs and diagnostic test results.
The case report presented is a composite drawn from MagMutual’s case files. Any similarity to a specific case is both coincidental and unintended. The risk and patient safety advice presented in this Claim Lesson is intended as general information of interest to physicians and other healthcare professionals. The recommendations and advice published herein do not reflect a legal opinion, establish a standard of care, and do not establish rules for the practice of medicine. Successful outcomes are not guaranteed. The publication of this information is not intended as an offer to insure such conditions or exposures, or to indicate that MagMutual Insurance Company will underwrite risks for the reader. Our liability is limited to the specific written terms and conditions of the actual insurance policies issued.
 Physician Insurers Association of America. Risk management review: Combined specialties; January 1, 2003 - December 31, 2012.Rockville, MD: Physician Insurers Association of America, 2013.
 Bishop, Tara. "Paid malpractice claims for adverse events in the inpatient and outpatient setting." Journal of the American Medical Association, 2011: 2427-2431.
Failure to conduct pre-procedure verification has been cited as a root cause of serious surgical adverse events. The Joint Commission (TJC) has emphasized this important process as one of its National Patient Safety Goals.
TJC has published the Universal Protocol for preventing wrong site, wrong procedure, and wrong person surgery™ which we outline in this Advisory.
Verify the correct procedure, for the correct patient, at the correct site.
- When possible, involve the patient in the verification process.
- Identify the items that must be available for the procedure.
- Use a standardized list to verify the availability of items for the procedure. (It is not necessary to document that the list was used for each patient.) At a minimum, these items include:
- Relevant documentation:Examples: history and physical, signed consent form(s), pre-anesthesia assessment
- Labeled diagnostic and radiology test results that are properly displayed:Examples: radiology images and scans, pathology reports, biopsy reports
- Any required blood products, implants, devices, special equipment
- Match and then double check each of the items that are to be available in the procedure area to the patient.
Mark the procedure site
The site does not need to be marked for bilateral structures.
Examples: tonsils, ovaries
For spinal procedures: Mark the general spinal region on the skin. Special intra-operative imaging techniques may be used to locate and mark the exact vertebral level.
Mark the site before the procedure is commenced.
If possible, involve the patient in the site marking process.
The site is marked by a licensed independent practitioner who is ultimately accountable for the procedure, and will be present when the procedure is performed.
Ultimately, the licensed independent practitioner is accountable for the procedure – even when delegating site marking.
- The mark should be unambiguous and used consistently throughout the organization.
- The mark is made at or near the procedure site.
- The mark shall be sufficiently permanent to be visible after skin preparation and draping.
- Adhesive markers are not the sole means of marking the site.
- For patients who refuse site marking or when it is technically or anatomically impossible or impractical to mark the site, use your organization’s written, alternative process to ensure that the correct site is operated on.
Perform a time-out
Conduct a time-out immediately before starting the invasive procedure or making the incision.
- A designated member of the team starts the time-out.
- The time-out is standardized.
- The time-out involves all of the immediate members of the procedure team: the individual performing the procedure, anesthesia providers, circulating nurse, operating room technician, and others who are participating in the procedure from the beginning.
- All relevant members of the procedure team actively communicate during the time-out.
- During the time-out, the team members agree, at a minimum, on (1) correct patient identity; (2) correct site; and (3) procedure to be performed.
- When the same patient has two or more procedures, another time-out needs to be performed before starting each procedure.
- Document the completion of the time-out. The organization determines the amount and type of documentation.
Address missing information or discrepancies before starting the procedure. At a minimum, mark the site when there is more than one possible location for the procedure and when performing the procedure in a different location could harm the patient. The procedure is not started until all questions or concerns are resolved.
Ultimately, it is up to each organization to decide when this pre-procedure information is collected and by which team member. It is always best to involve the patient directly in the process.
MagMutual Risk Management and Patient Safety Consultants invite our policyholders’ questions. If you wish to discuss issues related to this article, or have other questions please call us at 1-800-282-4882, and ask for Risk Management.
This document has been adapted with TJC’s permission from the full Universal Protocol. For specific requirements of the Universal Protocol see The Joint Commission standards.
The Joint Commission Ambulatory Health Care: 2014 National Patient Safety Goals. UP.01.01.01, www.jointcommission.org/assets/1/6/AHC_NPSG_Chapter_2014.pdf page 8 of 12.
Documenting verbal, e-mail or texting communications in the medical record
The medical record serves many purposes, but its primary purpose is to support and coordinate the medical care of a patient. It is important to think of the medical record first and foremost as clinical communication. Good documentation is critical to support patient care. More specifically, the medical record’s primary purposes are:
- To document the course of a patient’s illness and the treatment that the patient receives or to facilitate the flow of information
- To protect the patient by preserving information that may be needed for future care
- To serve as the main communication tool between all members of the healthcare team
Office procedures should specify documentation requirements for telephone-based, email or texting patient encounters. All communication, either during or after office hours, should be documented in the medical record when one of the following occurs:
- Prescribing or changing medication
- Making a diagnosis
- Directing treatment
- Directing patient to another provider or facility
It is important to include the time and date of the telephone conversation, email or text. The message, along with any advice or instruction given to the patient should be documented in the medical record. Communication with other healthcare providers, such as hospital staff, consultants or testing facilities should also be consistently documented.
The importance of documenting after-hours communications with patients is sometimes overlooked. After-hours calls often deal with what patients perceive to be acute problems, and may lead to litigation if they result in poor outcomes or hospitalization. It is suggested that a system be implemented to ensure prompt documentation of telephone calls and other communications in the medical records. Consider use of secure direct remote entry if available, a reminder notepad or use of voice-messaging.
Sample patient information booklet
XYZ MEDICAL GROUP INFORMATION BOOKLET
Practice location; address(es) and phone number(s)
We are a group of medical specialists with nurses, technicians and support personnel treating diseases and injuries to the musculoskeletal system.
Orthopedics is a specialty within medicine concerned with diagnosis and treatment of diseases and injuries to bones, joints, ligaments, nerves and muscles. After our orthopedic evaluation, we will seek consultation with another medical doctor if we feel it is appropriate.
Our goals are to provide you with excellent orthopedic care and treat you with compassion and courtesy. We thank you for your trust and confidence.
Why We Practice As Associates
We feel that a group practice is beneficial to you and us. In this way we can:
- Provide orthopedic coverage to you 24 hours a day.
- Have the opportunity to discuss unusual or complicated cases among ourselves to provide you with the advantage of group consultation.
- Assure you that if your doctor is away, the other doctors have access to your records. The on-call doctor is as interested in your well-being as your own personal orthopedic doctor.
- Take the necessary time off for continued postgraduate medical education to keep up with the latest developments in the diagnosis and treatment of problems in our field.
- Have time to be with our families.
If applicable, we are all board certified. To be board certified, an orthopedist must have completed college, four years of medical school, five years of postgraduate study (internship and residency), practiced as an orthopedic surgeon for two years and passed a certifying exam given by the American Board of Orthopedic Surgeons. A complete professional as well as personal history on each associate is available on request.
The physician who referred you will promptly receive a letter outlining the results of your evaluation and treatment plan.
When making an appointment, you may request the doctor of your choice. Your appointment will be an approximate time. Every effort is made to keep your waiting time to a minimum. Emergencies do occur and operations may take longer than anticipated; hence, delays are unpreventable. When this happens, your patience is appreciated. Your appointment time is approximately 20 minutes before you are scheduled to see the doctor. This is to allow for necessary administrative time.
Appointments for Minors
Patients under the age of 18 who are not married or emancipated and who seek medical treatment for problems unrelated to pregnancy, contraception or sexually transmitted disease must have consent of a parent, guardian or custodian. It is best if the parent, guardian or custodian accompanies the minor patient to the appointment.
If you are unable to keep an appointment, call as far in advance as possible.
Because of emergencies, we may reschedule your appointment. We regret that this may happen without advance notice.
If you become acutely ill, we will work you into our routine schedule; however, if your illness is of chronic (long-standing) nature, it is expected that you will make an appointment.
After-Hours Telephone Calls
Calls will be answered 24 hours a day by the staff or the answering service. If a return call is not received within 45 minutes, please notify the answering service.
For emergencies occurring during regular office hours, 7:30 a.m. to 5:00 p.m., phone ahead if possible for instructions or go directly to our office at (address). During the hours of 5:00 p.m. to 7:30 a.m., go to the emergency room at ABC Medical Center and request that we be called. One of us will either come to the emergency room to see you or, in some cases, ask the emergency room doctor to examine you, take the necessary x-rays and contact us regarding treatment.
New medications will not be prescribed over the telephone. The best method of having a prescription refilled is to have your pharmacist call our office. Normally, refills are issued only when you have been seen by your doctor within the last three (3) months. If you call, please have the pharmacy telephone number, the name, dosage and dosage schedule of the medication available when you call.
Fees are based on reasonable and customary charges for this area. The fee for the first visit or a new problem is higher than a routine follow-up visit, because more time is required.
An estimated fee for any procedure will be given on request by our business office. If you are unable to pay in full at the time of service, you should pay your balance within 30 days. If your account is covered by insurance, payment in full is expected within 60 days.
If you have a financial problem, we will understand. Contact our Accounts Control or Collection Clerks. Time will be extended for payment which is fair to you and the clinic. If you do not make these arrangements, your account is past due ninety (90) days after service.
When your medical treatment is the result of an injury involving a third party, any delayed liability action between you and the third party is not a valid reason for delaying payment.
All patients receiving treatment under Workers’ Compensation must have employer verification. We will provide your employer with the necessary medical and financial information.
Hospital and Major Medical Insurance
You or your insurance company will be provided with the medical and financial information necessary to process your claim(s). There is no charge for this service.
Disability Insurance Forms
There is no charge for this service.
Medicare or CHAMPUS
Assignment of benefits is accepted from Medicare or CHAMPUS recipients. You pay the deductible and coinsurance balance.
We work with the state of Georgia to provide medical treatment for crippled children, cerebral palsy patients and government programs monitored by the Social Security Administration, including Medicaid.
We are on the staff of ABC Medical Center. This excellent hospital is located near our office.
We strive to give you the best medical care, while at the same time treating you with human kindness. Our ultimate goal is to treat you as we would want to be treated.
If you feel that we have failed you in any way, please let your doctor or our Clinic Director know about it immediately.
We are honored that you have chosen us. Again, thank you for your trust and confidence.
The information provided in this resource does not constitute legal, medical or any other professional advice, nor does it establish a standard of care. This resource has been created as an aid to you in your practice. The ultimate decision on how to use the information provided rests solely with you, the PolicyOwner.