Primary Care Associates (PCA) is a three-clinician practice located in a suburban area. PCA has an office manager and four additional full-time staff members. One person is dedicated to the front desk operations, and three of the staff members are medical assistants.

Staff of Primary Care Associates:
     Senior Physician, David Smith
     Nurse Practitioner, Kesari Singh
     Physician Partner, Nicholas Swanepoel
     Medical Assistant, Tracy Hoover
     Medical Assistant, Rosa Sanchez
     Medical Assistant, Meghan Meade
     Front Desk, Mary Reed
     Office Manager, Kim Machenski
     Kim Machenski’s mother, Mrs. Eva Machenski – a patient of the practice

Through this case study we will illustrate the challenges, the potential solutions and outcomes of several issues that frequently arise in laboratory testing in a practice setting.

Mrs. Machenski has been receiving warfarin for two months after developing deep vein thrombosis. She is regularly seen at the practice where, using a waived point of care instrument, her prothrombin time and INR are monitored. On her most recent visit, her INR is found to be 2.3 and deemed acceptable. She is instructed to maintain her current dosage of warfarin and to return for her next INR in one month. On the drive home, she is involved in an automobile accident and is transported to the emergency room of the community hospital. The emergency room physician orders multiple laboratory studies including a prothombin time/INR. The INR is found to be 5.3. Repeat testing confirms this result. Since no significant injuries are found, Mrs. Machenski is instructed to return to her physician so that the warfarin dosage can be adjusted. Mrs. Machenski and her daughter, Kim, are understandably upset about this and that afternoon Kim speaks with Dr. Smith, who immediately begins an investigation.

The first finding reveals the cartridges currently in use for the office prothrombin testing expired two months age. Further investigation shows in the log of results, two patients recorded only with initials “KM” had INR testing performed within a 5 – 10 minute period on the day that Mrs. Machenski is tested. No full names or other identifying information are recorded. Results are transcribed in batch into the electronic medical record so both “KM” are recorded at the same time. One “KM” has an INR result of 5.2 and the other has an INR results of 2.3. Dr. Smith immediately calls the second “KM” and requests she go to the outpatient drawing station at the hospital to have an INR repeated ASAP. INR re-testing reveals the result to be 2.2. Dr. Smith re-adjusts the warfarin dosage on the second “KM”.

Dr. Smith concludes that a patient mix-up occurred due to the inadequate recording of patient identification associated with the laboratory results when placed in the log book and a lack of immediate recording of results into the electronic medical record. In this case no adverse patient outcomes resulted from the error, but Dr. Smith is worried. He has identified three problems that could lead to more errors:

  1. Patients are not adequately identified on the patient result log;
  2. The results are not immediately entered into the EMR; and
  3. Outdated cartridges are being used for testing.

Dr. Smith had directed the laboratory in his practice for many years. Originally he performed waived and moderate complexity testing in-house, but after the practice had been acquired by the community hospital three years prior to this incident, the policy had been reviewed and led to the discontinuation of in house testing using chemistry and hematology analyzers. These tests were infrequently needed for immediate patient decisions. Subsequently, patients visited the outpatient laboratory service center at the hospital in the days prior to office visit for chemistry and hematology testing, with the results transmitted to the practice EMR prior to the patient visit. Only waived testing was performed on site for those instances where the test results were used immediately for patient care decisions. When chemistry and hematology tests were needed for immediate patient disposition, a specimen was drawn in the office and immediately couriered to the adjacent hospital laboratory, run STAT and reported electronically to the practice. While this proved satisfactory, Dr. Smith was now very concerned about the quality of the waived testing. The investigation of Mrs. Machenski’s erroneous result uncovered several other instances in which lab results had been flawed.

Dr. Smith had discontinued his laboratory accreditation since it was not a requirement of waived testing. As a consequence of this decision, there was no external oversight of the office laboratory. In addition, proficiency testing had been discontinued since only waived testing was being performed. Fifteen years before his current problem, he attended a COLA Laboratory Symposium to obtain the 20 CME credits needed to become a laboratory director of a moderately complex laboratory. Although he was only performing a limited waived testing menu, he concluded that was in the interest of his patients to again attend this program to refresh his knowledge on current laboratory practice.

Following his return from the Symposium, Dr. Smith used a self-assessment tool provided at the Symposium and held several noon hour meetings with his staff reviewing all the processes in his laboratory. Dr. Smith was surprised and chagrined. He immediately recognized that, to him, “waived testing” translated into a waiver of his oversight of laboratory quality. He had assumed tests granted waived status by the FDA indicated that the testing was error free. Among some of the problems he uncovered were:

  • There was no longer any quality assessment of any laboratory function.
  • The laboratory lacked a procedure manual containing information on patient identification, requisition and specimen labeling, patient preparation, procedure performance and reporting of results.
  • The job descriptions in the practice lacked any reference to laboratory duties.
  • There was no evidence of any of the employees having been trained in performing the waived laboratory procedures.
  • No procedures for entering the laboratory results into the practice medical record existed.
  • Many outdated reagents were found and some were still in use.
  • Some of the kits were not being stored as defined by the manufacturers.
  • External quality control was not being performed according to manufacturer specifications, and results of internal and external quality controls were not being recorded.

By not subscribing to proficiency testing for his waived testing, Dr. Smith and his patients were not benefiting from the level of confidence in laboratory results that external review can impart. Dr. Smith and his staff recognized they had a problem and, by working as a team, they developed a plan of action.

Each individual was assigned a specific problematic area and instructed to provide the corrective action necessary to comply with good laboratory practice. After one month, there was general discussion of all that had been corrected and the remedies put in place to correct these deficiencies in laboratory practice. This was a major education session for all employees. The employees then developed a quality assessment plan utilizing the COLA quality assessment manual. In addition, the staff decided that it was imperative to subscribe MLE, the ACP proficiency testing program, so that there was external peer review of their testing and results. They also made the decision that while the testing performed was waived and did not require external accreditation, it was important for there to be external review from an accreditation agency so that they would be in a position to inform their patients and their payers that they had gone the extra mile to assure laboratory quality. Dr. Smith resolved that on a monthly basis he would be in the laboratory reviewing all the documents, using a modified self-survey form to evaluate several key areas of the laboratory. In addition, as part of one of the monthly practice meetings, the findings of the laboratory quality assessment were to be presented so all needed corrective action could be taken. In addition, the laboratory was going to undergo a biennial survey from an accreditation agency.

Nine months later, the employees had a greater sense of responsibility in their laboratory work. All the proficiency testing had been successful. The monthly quality assessment reports uncovered several problems which were resolved in a timely manner and follow up had revealed that the actions taken for resolution were successful. The laboratory had undergone a COLA survey and experienced a perfect result, resulting in a Laboratory Excellence Aware which was proudly displayed in the patient waiting area. Mrs. Machenski had sent a letter to Dr. Smith and stated that, while she had been very upset at the error in her laboratory testing, the actions Dr. Smith had taken and shared with her actually made her happy that the error had been made. In her case, it had not caused a significant health problem, and it triggered corrective actions which had potentially saved another patient from a more serious issue due to faulty laboratory testing.