Summary:
Summary Statement of Deficiencies D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) (e)(13) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on personnel record review and review of laboratory policies and procedures on 10/09/25 at 12:50 PM, the laboratory director failed to establish policies and procedures for monitoring the competency of 1 out of 1 testing personnel who conducts testing in the subspecialty of histopathology. Findings include: 1. The laboratory employs one testing personnel who performs the gross examination of dermatopathology specimens. 2. The laboratory director failed to establish policies and procedures to monitor individuals who perform the gross examination of dermatopathology specimens, to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. 3. The facility personnel interviewed on 10/09/25 at 12:50 PM acknowledged the laboratory director failed to establish policies and procedures as indicated above. 4. The laboratory performs 10,000 tests annually in the specialty of Histopathology. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (b)(7) Identifying training needs and assuring that each individual performing tests Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of semiannual competency evaluation documentation from September 15, 2025 and interview with the facility personnel on 10/09/25 at 12:46 PM, the technical supervisor failed to evaluate the competency of one out of one testing personnel who performs testing in the subspecialty of Histopathology. Findings include: 1. The CMS-209, Laboratory Personnel Form presented for review during the survey listed 1 Technical Supervisor, and listed 1 testing personnel (TP-1) who performs the gross examination of dermatopathology specimens. 2. The semiannual competency documentation reviewed for TP-1 dated 9/15/25 revealed the competency evaluation was not performed by the Technical Supervisor, and instead performed by a facilty employee who was not listed on the CMS-209 form. 3. The facility personnel interviewed on 10/9/2025 at 12:46 PM confirmed that the competency evaluation indicated above was not performed by the Technical Supervisor. 4. The laboratory performs testing in the subspecialty of Histopathology with a reported annual test volume of 10,000. -- 2 of 2 --