Ensuring competency: are fundamentals of laparoscopic surgery training and certification necessary for practicing surgeons and operating room personnel?

BACKGROUND: Certification in fundamentals of laparoscopic surgery (FLS) is required by the American board of surgery for graduating residents. This study aimed to evaluate the feasibility and need for certifying practicing surgeons and to assess proficiency of operating room (OR) personnel. METHODS: Through a patient safety and health care delivery effectiveness grant, investigators at four state medical schools received funding for FLS certification of all attending surgeons and OR personnel credentialed in laparoscopy. Data were voluntarily collected under an institutional review board-approved protocol. Surgeons performed a single repetition of the FLS tasks oriented to the FLS proficiency-based curriculum and online cognitive materials and were encouraged to self-practice. The FLS certification examination was administered 2 months later under standard conditions. Operating room nurses and scrub technicians were enrolled in a curriculum with cognitive materials and a multistation skills practicum. Baseline and completion questionnaires were administered. Performance was assessed using signed-rank and χ(2) analysis. RESULTS: The study aimed to enroll 99 surgeons. Subsequently, 87 surgeons completed at least one portion of the curriculum, 72 completed the entire curriculum (73% compliance), 83 completed the baseline skills assessment, and 27 (33%) failed. The self-reported practice time was 3.7 ± 2.5 h. At certification (n = 76), skills performance had improved from 317 ± 102.9 to 402 ± 54.2 (p < 0.0001). One surgeon (1.3%) failed the skills certification, and nine (11.8%) failed the cognitive exam. Remediation was completed by six surgeons. Of the 64 enrolled OR personnel, 22 completed the curriculum (34% compliance). All achieved proficiency at skills, and 60% passed the cognitive exam. CONCLUSIONS: This study demonstrated that FLS certification for practicing surgeons and proficiency verification for OR personnel are feasible. A baseline skills failure rate of 33% and a certification failure rate of 13% suggest that FLS certification may be necessary to ensure surgeon competency. Fortunately, with only moderate practice, significant improvement can be achieved.

Prediction of crossmatch outcome of highly sensitized patients by single and/or multiple antigen bead luminex assay.

BACKGROUND: We used a solid-phase assay to identify human leukocyte antigen (HLA) Class I and II specificities in highly reactive sera, and applied this information to predict crossmatch outcome with greater than 90% accuracy. METHODS: Sera from 20 highly sensitized end-stage renal disease patients reactive to 70-100% of HLA Class I and II antigen panel were analyzed by single and/or multiple antigen flow microparticle bead assay using Luminex platform (Luminex assay). These sera contained antibodies directed against high frequency public HLA class I and/or II epitopes accounting for 70-100% of serum's total reactivity. More than 2,000 complement dependent cytotoxicity (CDC) and 200 flow crossmatches (FLXM) were performed using sera from these patients and deceased donor T and B lymphocytes. RESULTS: Luminex serum analysis was able to correctly predict outcomes of 95% of T and B cell FLXM. In contrast, predictive values for the CDC T and B cell crossmatches by Luminex serum analysis were only 77% and 75%, respectively. The use of serum analysis in donor selection would have reduced the total number of required FLXM by more than 50%. The frequency of negative T cell FLXM was 56% when donors were selected randomly; however, if serum antibody analysis had been used to preselect the donors by excluding donors that were likely to be positive, the frequency of corresponding negative crossmatches would have increased up to 93%. CONCLUSION: This approach to donor selection may allow wider geographic sharing of cadaver donor organs without actually performing the crossmatch.

Pretransplant soluble CD30 is a better predictor of posttransplant development of donor-specific antibodies and acute vascular rejection than panel reactive antibodies.

BACKGROUND: This study tests a hypothesis that pretransplant concentration of soluble CD30 (sCD30) is a better predictor of posttransplant development of donor-specific HLA antibodies (DSA) and acute vascular rejection (AVR) than panel reactive HLA antibodies (PRA). METHODS: Pretransplant sera from 115 patients were evaluated for their PRA and sCD30 concentrations. All patients received calcineurin-inhibitor based immunosuppressive therapy. Objective measurements for rejection were biopsy-proven AVR episodes within first 6 months of the transplant. Posttransplant sera of patients with or without AVR were tested for the presence of DSA. RESULTS: AVR rate was 16% (18/115). Patients positive for PRA and sCD30 tests were at significantly higher risk for AVR compared to those patients negative for both tests (36% versus 5%, p = 0.01). Among negative PRA patients risk for AR was significantly elevated if they were also tested positive for sCD30 concentrations (21% versus 5%, p = 0.04). Of the 18 patients with AVR, 14 were positive for sCD30, and 13 of them (93%) developed DSA posttransplant (p = 0.001) Nineteen patients without AVR were tested for DSA and sCD30 concentrations. Only two of these 19 patients were positive for sCD30 and DSA. AVR was strongly associated with the patients tested positive for both the tests: DSA and sCD30 (p = 0.00007). Furthermore, patients with AVR are more likely to produce DSA than those without AVR (p = 0.02). CONCLUSION: These data support our hypothesis that patients positive for sCD30 contents are at high risk the development of DSA and AVR posttransplant regardless of their pretransplant PRA.

Efficacy of anticoagulation therapy in end-stage renal disease patients with antiphospholipid antibody syndrome.

BACKGROUND: End-stage renal disease (ESRD) patients with antiphospholipid antibody syndrome (APAS) remain at high risk for the development of renal thrombosis without the benefit of anticoagulation therapy. This study examines the efficacy of anticoagulation therapy in this high-risk patient population. METHOD: Of nine APAS renal-transplant patients, seven were treated with coumadin, whereas two were treated with heparin. RESULTS: Of the two patients treated with heparin, one had early allograft loss, whereas the other patient is doing fine at 5 years posttransplant. Of the seven 7 patients treated with coumadin, two patients are doing well at 2 and 3 years posttransplant, two had early allograft loss, the remaining three patients returned to dialysis after they were taken off of the coumadin at 6, 12, and 20 months posttransplant because of bleeding complications. CONCLUSIONS: Anticoagulation therapy is beneficial to some but not all APAS patients. In addition, bleeding complications are a serious side effect of this therapy.