Robyn Jacobson Pediatrics Pllc

Summary Statement of Deficiencies D0000 An announced recertification survey was conducted on 5/18/2023 to 6/19/2023 at Robyn Jacobson Pediatrics, PLLC, clinical laboratory in Tampa, Florida. The laboratory was not in compliance with 42 CFR 493, Requirements for Clinical Laboratories. Based on the survey findings, an Immediate Jeopardy situation was identified and the laboratory was notified at 4:14 PM on 6/19/2023. The following Conditions were not met: D5400- Analytic Systems 493.1250 D6000- Moderate Complexity Laboratory Director 493.1403 D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the Laboratory Personnel Report (Form CMS-209), the policy manual, personnel records, and staff interview, the laboratory failed to document an annual competency assessment for 1 Testing Person (#A) out of 2 Testing Persons for 1 (2021) of 2 years reviewed. Findings included: Review of the CMS-209, signed by the Laboratory Director on 5/16/23, revealed the Laboratory Director was also the Technical Consultant and there were two (#A, #B) Testing Personnel. Review of the laboratory's policy, Staff Orientation, Training, and Competency Assessment, stated, "After initial competency assessment at the completion of orientation and training, competency assessment will occur at 6 months, 12 months, and annually thereafter." Review of personnel records for Testing Person #A, with a hire date of 10/2016 revealed no annual competency assessment was performed in 2021. Interview with Testing Person #A on 5/18/23 at 12:15 PM confirmed she performed complete blood count (CBC) testing in Hematology and had no annual competency assessment completed in 2021. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on observation, policy review, and interview, the laboratory failed to follow their policy for labeling specimens for complete blood count (CBC) testing for 2 out of 2 patient samples observed on 6/12/2023. Findings included: Observation of the laboratory on 6/12/2023 at approximately 1:45 PM revealed two pediatric lavender top blood collection tubes, with blood in them, in a rack on the countertop. The first tube was labeled with three letters and the second tube did not have any patient identifiers on it. Review of the laboratory's policy titled "Specimen Collection, Handling and Transport; Patient Test Management" revealed: "3. Specimen collection personnel will:...Label specimens with patients name and one other unique identifier... Requirements for acceptable specimens: Testing will ONLY be performed when the minimum identification criteria is met. Specimens must be accessioned, (identified and logged); properly labeled with the patient's complete name and secondary identifier, date and time of collection, and initials of the phlebotomist." Review of the laboratory policy titled "BLOOD COLLECTION: CAPILLARY PUNCTURE 13. Match the specimens to the patient and label all of the tubes immediately AFTER completion of the filling of the collection tubes. All tubes are labeled with a minimum of two unique identifiers. Information to be included on the label is: a. Patient's first and last names b. Patient's secondary identifier (determined by the facility) c. Date and time of collection d. Initials of the phlebotomist NOTE: The small size of these tubes limits the amount of information that can be included. Minimally include the patient's name and date." During an interview on 6/12/2023 at 2:00 PM, Testing Person #A confirmed the blood collection tubes were not labeled properly per their policy. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of manufacturers' package inserts, Levey Jennings reports, Quality Control (QC) printouts, patient printouts and interview, the Laboratory failed to ensure expired QC material was not used prior to patient testing (See D5417), failed to follow their QC Policy running three levels (Low, Normal, High) of QC for complete blood counts (CBCs) before patient testing (See D5441), failed to ensure -- 2 of 9 -- QC material for Complete Blood Counts (CBCs) met the laboratory's acceptable criteria before reporting patient test results.(See D5481), failed to take

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Robyn Jacobson Pediatrics PLLC on 01/26/21. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on record review and interview with the Office Manager, the laboratory failed to have 1 (#B) of 2 testing personnel (#A and #B) rotate through the testing of proficiency testing samples for 2 of 2 years reviewed (2019 1st, 2nd, and 3rd Events and 2020 1st, 2nd and 3rd Events). Findings Included: 1. Review of the CMS 209 form titled Laboratory Personnel Report (signed and dated by the Laboratory Director 01/25/21) revealed 2 testing personnel (#A and #B). 2. Review of the undated "Proficiency Testing" procedure revealed the following statement "Testing of proficiency samples should be rotated among all laboratory staff performing patient testing." 3. Review of American Proficiency Institute (API) proficiency testing found that Testing Personnel #A performed all of the proficiency testing in 2019-2020 (2019 1st, 2nd, and 3rd Events and 2020 1st, 2nd, and 3rd Events). 4. Interview on 01/26/21 at approximately 11:30 AM with the Office Manager revealed that he was responsible for proficiency testing not being rotated between Testing Personnel #A and #B. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and interview with the Office Manager, the laboratory failed to perform competency assessments on 2 (#A and #B) out of 2 Testing Personnel. Findings Included: Review of the policy and procedure (last reviewed by the Laboratory Director on 09/21/15) states that "After initial competency assessment at the completion of orientation and training, competency assessments will occur at 6 months, 12 months and annually thereafter." Review of Testing Personnel #A and #B revealed no competency assessment in their personnel files. During an interview on 12 /06/18 at 11:30 AM the Office Manager confirmed that there was no documentation of competency assessments on Testing Personnel #A and #B. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- This STANDARD is not met as evidenced by: Based on record review and interview with Testing Person #A the laboratory failed to document the temperature of the refrigerator that the controls are kept in and the room humidity for 2 (2017-2018) out of 2 years reviewed. Findings Included: Review of the manufacturers instructions for the hematology analyzer revealed that the controls should be between 2-8 degrees Celsius and the humidity of the room where the hematology analyzer is should be between 30%- 85%. Review of temperature charts revealed no temperature chart for the refrigerator that the controls were kept in and no humidity charts. During an interview on 12/06/18 at 12:20 PM Testing Personnel confirmed that it was not documented. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview with Testing Person #A the laboratory failed to monitor their quality control over time for shifts and trends for 2 (2017-2018) out of 2 years reviewed. Findings Included: Review of the policy and procedures (last reviewed by the Laboratory Director on 09/21/15) stated under Quality Control Graphs and Shifts and Trends that "These graphs illustrate a method's accuracy and precision over time." It also states "it is necessary to evaluate a trend to eliminate the possibility of reporting erroneous result." During an interview on 12/06/18 at 12:30 PM Testing Person #A revealed that even though it is looked at daily, quality control is not looked at over time for shifts and trends. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on record review and interview with Testing Person #A the laboratory failed to verify new lot numbers of quality control material when in use for 2 (2017-2018) out of 2 years reviewed. Findings Included: Review of policy and procedure (last reviewed by the Laboratory Director 09/21/2015) states that when changing lot numbers of quality controls "The established means must be verified and adjusted to facility specific data, as necessary: Each level of the new control material must be evaluated 5 times, with alternating personnel and on multiple days when possible, to verify that control results fall within manufacturer stated 2SD ranges. Results may be compared against those found with in the package insert and filed in the quality control binder, or documented on the chart template, to show acceptability of new lot control material." During an interview on 12/06/18 at 12:30 PM Testing Person#A confirmed that this procedure was not being performed. -- 3 of 3 --