Eastern Shore Children's Clinic

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of the CAP (College of American Pathologists) proficiency testing (PT) records and an interview with Testing Personnel #1, the laboratory failed to ensure attestation statements for four out of four 2021 - 2022 surveys were physically signed by the Laboratory Director and Testing Personnel. The findings include: 1. A review of the CAP Hematology PT records revealed attestation statements did not include the physical signatures of the Laboratory Director and Testing Personnel on the three surveys performed, or the first survey in 2022. 2. A review of the instructions on the CAP electronic attestation statements revealed, "Retain a signed ["signed" is underlined] copy of this page in your laboratory for your records and inspection purposes.". 3. In an interview on 4/27/2022 at 11:05 AM, the surveyor reviewed the instructions on the CAP attestation statements with Testing Personnel #1, who confirmed the Laboratory Director and Testing Personnel had failed to physically sign the attestation. . . D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. 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 -- This STANDARD is not met as evidenced by: Based on a review of the testing personnel records and an interview with Testing Personnel #1, the Technical Consultant failed to evaluate the performance of testing personnel at least semiannually during the first year of moderate-complexity patient testing. This was noted on two out of nineteen testing personnel listed on the Form CMS-209 Laboratory Personnel Report (CLIA). The findings include: 1. A review of the testing personnel records revealed no semiannual evaluation was documented for Testing Personnel #9 (due September 2021), and Testing Personnel #12 (due December 2021). 2. During an interview on 04/27/20221 at 11:30 AM, Testing Personnel #1 confirmed the semiannual evaluations were not documented for Testing Personnel #9, and Testing Personnel #12. . D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on a review of the testing personnel records and an interview with Testing Personnel (TP) #1, the Technical Consultant failed to evaluate the performance of testing personnel performing moderate complexity testing at least annually for five out of nineteen testing personnel listed on the Form CMS-209 Laboratory Personnel Report (CLIA). The findings include: 1. A review of the testing personnel records revealed the annual performance was not evaluated or documented for testing personnel as follows: A) TP #2: No annual evaluations in 2020 or 2021 B) TP #3: No annual evaluations in 2021 or 2022 C) TP #4: No annual evaluations in 2020, 2021 or 2022 D) TP #5: No annual evaluations in 2021 E) TP #6: No annual evaluations in 2021 2. During an interview on 04/27/20221 at 11:30 AM, Testing Personnel #1 confirmed the above noted findings. SURVEYOR ID#32558 Licensure and Certification Surveyor -- 2 of 2 --

Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on a review of the personnel records, including training checklists and competency assessments, a review of the policy for personnel assessments, and interviews with the Clinic Manager (also Testing Personnel #9) and the Laboratory Director, the surveyor determined the laboratory failed to ensure testing personnel were trained, prior to assessing the competency (semiannually). This affected four of seventeen testing personnel, who perform moderate complexity testing in Hematology and Bacteriology. The findings include: 1. A review of the personnel records revealed the semiannual competency assessments for Testing Personnel (TP) #10, #12, #14, and #16 were done prior to the personnel being trained, according to the dates indicated on the training records/checklists. 2. According to TP #10's laboratory training checklist, the employee completed training on September 24, 2019. However the semiannual competency assessment was dated as performed on September 23, one day prior to the employee completing laboratory training. 3. TP #12 completed training on July 15, 2018; however had her "semiannual" competency assessed on July 2, 2018. 4. TP #14's "semiannual" competency was documented as being assessed on July 2, 2018; however the laboratory training was not completed until January 1, 2019, according to the personnel's laboratory training checklist. 5. TP #16's "semiannual" competency assessment was documented as being done on May 6, 2019; however the employee's laboratory training was not documented as being complete until September 23, 2019. 6. At 9:54 AM on October 2, 2019, the surveyor discussed with the Clinic Manager, the training and competency assessments of the 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 -- testing personnel, specifically inquiring why the competency of the laboratory personnel was assessed, prior to the employee completing training. The Clinic Manager stated the personnel sometimes needed remedial training, prior to completion of initial training. A review of the training checklists revealed only one completion date for all tests performed by the laboratory personnel. There was no indication of what or which testing procedures the re-training was needed and which tests the personnel were assessed as being competent, not requiring remediation. The Clinic Manager stated the Laboratory Director performed the semiannual competency assessment from date-of-hire, regardless if training was completed or not. 7. At 1:00 PM On October 2, the surveyor explained to the Clinic Manager and the Laboratory Director the need to complete the training, prior to assessing the competency of an individual; and not expect an employee to be competent prior to being trained. D5781