Steven Unkel Md

Summary Statement of Deficiencies D0000 A Certification survey was performed on December 27, 2023 at Steven Unkel MD, CLIA ID # 19D0464339. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of laboratory proficiency testing records and interview with personnel, the laboratory failed to ensure the appropriate personnel signed the attestation forms for four (4) of six (6) proficiency testing events reviewed. Findings: 1. Review of the laboratory's American Association of Bioanalysts (AAB) proficiency testing records revealed the laboratory director and testing personnel did not sign the attestation statement for the following four (4) of six (6) proficiency testing events reviewed in 2022 and 2023: a) NonChemistry Q1 2022 - Testing Personnel signature on attestation statement b) NonChemistry Q2 2022 - Laboratory Director and Testing Personnel signature on attestation statement c) NonChemistry M1 2023 - Laboratory Director signature on attestation statement d) NonChemistry M2 2023 - Laboratory Director and Testing Personnel signature on attestation statement 2. In interview on 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 -- December 27, 2023 at 11:21 am, Personnel 1 confirmed the attestation statement was not signed for the identified proficiency testing events. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on observation by surveyor, review of maintenance records and interview with personnel, the laboratory failed to ensure the monthly maintenance on the Sysmex XP- 300 analyzer was performed as required by the manufacturer. Findings: 1. Observation by surveyor during the laboratory tour on December 27, 2023 at 10:30 am revealed the laboratory utlizes a Sysmex XP-300 analyzer for Complete Blood Count (CBC) testing in the specialty of Hematology. 2. Review of the laboratory's Sysmex XP-300 maintenance log revealed the laboratory performs the following monthly maintenance: a) Clean RBC and WBC Transducer b) Clean Waste Chamber 3. Further review of the maintenance logs from May 2022 through December 2023 revealed the laboratory did not perform the monthly maintenance for the following four (4) of twenty (20) months reviewed: a) May 2022 b) June 2022 c) January 2023 d) June 2023 4. In interview on December 27, 2023 at 11:21 am, Testing Personnel 1 confirmed the monthly maintenance was not performed for the identified months above. D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(iii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(3) Ensure that-- (e)(3)(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on review of laboratory maintenance records and interview with personnel, the Laboratory Director failed to ensure the laboratory personnel performed test methods as required. Refer to D5429. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D0000 A Recertification survey was performed on January 14, 2022 at Steven Unkel, MD, CLIA ID # 19D0464339. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on observation by surveyor, review of manufacturer's instructions, test menu, and interview with personnel, the laboratory failed to include "Fact Sheets" to patients for Emergency Use Authorization (EUA) SARS COV-2 testing. Findings: 1. Observation by surveyor during laboratory tour on January 14, 2022 at 9:10 am revealed the laboratory utilizes the Quidel Sofia SARS-CoV-2 test system for SARS CoV-2 patient testing. 2. Review of the manufacturer's instructions for use under the "Conditions of Authorization for the Laboratory" section revealed "Authorized laboratories using your product must include with test result reports, all authorized Fact Sheets. Under extingent circumstances, other appropriate methods for disseminating these Fact Sheets may be used, which may include mass media." 3. In interview on January 14, 2022 at 10:23 am, Personnel 1 stated that she was unaware that a fact sheet must be provided to patients with waived testing. Personnel 1 confirmed the laboratory does not include fact sheets upon patient testing. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by 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 3 -- laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures and interview with personnel, the laboratory failed to have a complete policy and procedure manual. Findings: 1. Review of the laboratory's policies and procedures revealed the laboratory did not include a policy stating written, detailed instructions for the reporting of SARS CoV-2 test results to the state public health agency, to include but not limited to who is responsible for reporting test results and the frequency at which reporting is performed. 2. In interview on January 14, 2022 at 10:23 am, Personnel 1 stated she was unaware the laboratory needed a policy for SARS CoV-2 reporting of test results to state agency. Personnel 1 confirmed the laboratory did not have the above identified policy. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on direct observation by surveyor, review of laboratory policy and procedure and interview with personnel, the laboratory failed to ensure supplies did not exceed their expiration date. Findings: 1. Direct observation by surveyor during the laboratory tour on January 14, 2022 at 9:10 am revealed the following expired supplies located on a phlebotomy tray: a) BD vacutainer SST 8.5 mL tubes: Lot 0301417, Expiration 10/31/2021, Quantity: nine (9) 2. Review of the laboratory's policy "Expired Lab Supplies" revealed "When and if any supplies expire we have made a box to put it in and give to the schools that are in need of supplies". 3. In interview on January 14, 2022 at 9:53 am, Personnel 1 stated that she was unaware some of the tubes on the phlebotomy tray were expired. Personnel 1 confirmed the above identified supplies were expired. D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(iii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(3) Ensure that-- (e)(3)(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on observation during laboratory tour, review of laboratory records and -- 2 of 3 -- interview with personnel, the Laboratory Director failed to ensure the laboratory personnel performed test methods as required. Findings: 1. The laboratory failed to ensure supplies did not exceed their expiration date. Refer to D5417. D6031 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(13) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(13) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; This STANDARD is not met as evidenced by: Based on review of laboratory policy and procedure manual and interview with laboratory personnel, the Laboratory Director failed to ensure that an approved procedure manual was available to all personnel. Findings: 1. The laboratory failed to establish a complete policy and procedure manual. Refer to D5401. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An Offsite revisit survey was conducted at Steven Unkel MD - CLIA ID # 19D0464339 on August 28, 2019. laboratory was found in compliance with 42 CFR 493 Requirement for Laboratories. No deficiencies were ci ________________________________________________________________________________________ A Recertification survey was conducted at Steven Unkel MD - CLIA ID # 19D0464339 on July 23, 2019. Th laboratory was found in compliance with 42 CFR 493 Requirement for Laboratories; however, standard defic were cited. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be avai and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written pr for testing or examining specimens. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to have a complete policy and pro manual. Findings: 1. Review of the laboratory's policy and procedure manuals revealed the laboratory did not detailed policies for the following: Performance specifications: detailed policy of how the laboratory will ver accuracy, complete precision, reportable range and reference range of new instrumentation prior to use and ac criteria of each. 2. In interview on July 23, 2019 at 11:07 am, Personnel 1 stated she was unaware of the polic required. Personnel 1 confirmed the above areas were not included in the current policies. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following b reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to t established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i)(B) P 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 -- (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference in (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on observation, record review and interview with personnel, the laboratory failed to have complete performance specification verification studies for the Sysmex XP-300 Hematology analyzer. Findings: 1. Ob by surveyor during the laboratory tour on July 23, 2019 revealed the laboratory utilizes the Sysmex XP-300 hematology analyzer for Complete Blood Counts (CBC) testing. 2. Review of the laboratory's records reveale laboratory did not have a policy for performance verification studies for new instruments. 3. Review of the laboratory's performance verification studies revealed the laboratory did have studies to include accuracy, pre (run-to-run, within run, and operator variance), reportable range, and reference range;however, the laboratory include the day-to-day precision studies and the raw data to support these studies. 4. In interview on July 23, 11:07 am, Testing Personnel 1 confirmed the installation studies did not include the day-to-day data for comp precision. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) The laboratory director is responsible for the overall operation and administration of the laboratory, including employment of personnel who are competent to perform test procedures, and record and report test results pro accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory dire must-- (e)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, pre and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based on observation, record review, and interview with personnel, the Laboratory Director failed to ensure t complete verification procedures were performed. Refer to D5421. D6031 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(13) The laboratory director is responsible for the overall operation and administration of the laboratory, including employment of personnel who are competent to perform test procedures, and record and report test results pro accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory dire must-- (e)(13) Ensure that an approved procedure manual is available to all personnel responsible for any asp testing process; This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel, the Laboratory Director failed to ensure tha approved procedure manual was available to all personnel responsible for any aspect of the testing process. R D5401. -- 2 of 2 --