Brett J Gerstenhaber Md, Llc

Summary Statement of Deficiencies D0000 A proficiency testing desk review of the Brett J. Gerstenhaber, MD, Laboratory was conducted pursuant to 42CFR Part 493 of the Clinical Laboratory Improvement Amendments (CLIA) of 1988. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on proficiency testing (PT) record review, the laboratory failed to obtain a score of 80% in two out of three consecutive testing events in the specialty of chemistry for the regulated analyte PO2 blood gas (0325) leading to an unsuccessful PT performance. Refer to tag D2096. 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 -- D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on record review and staff interview the laboratory failed to achieve successful performance score for the same analyte in two out of three consecutive testing Proficiency Testing (PT) events in the specialty of Chemistry. Findings include: 1. Record review of the American Association of Bioanalysts (AAB) PT results on 8/12 /19 revealed the laboratory failed to obtain a score of at least 80% for the regulated analyte PO2 blood gas leading to unsatisfactory performance in 2 out of 3 PT events as evidenced below. Year/Event # PT score 2018 - Event -3 60% 2019 - Event -2 0% 2. Telephone interview with the laboratory director (LD) on 8/15/19 at 2:15 PM confirmed the laboratory did not obtain a score of at least 80% in 2 out of 3 PT events for the regulated analyte PO2 blood gas. LD further stated PT samples were not tested during the 2019 event 2 because the testing personnel was on vacation. 3. The laboratory performs 50 blood gas tests annually. -- 2 of 2 --

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 staff interview, the laboratory failed to have a policy in place to assess the competency of all laboratory personnel. Findings include: 1. Review of the laboratory's policies and procedure manual on 6/3/19 revealed the following: a. The laboratory did not have a policy in place to assess the competency of the clinical consultant (CC) and technical consultant (TC). b. Competency documentation for the above laboratory personnel was not available for 2017 and 2018. 2. Staff interview with the TC on 6/3/19 at 11:15 AM confirmed the laboratory did not have a policy in place to assess the competency of the above laboratory personnel and they were not assessed in 2017 and 2018. 3. The laboratory performs 50 pH, PCO2 and PO2 tests annually. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the 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 record review and staff interview, the laboratory failed to establish a policy 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 -- for documenting daily quality control (QC) for blood gas testing in the specialty of chemistry. Findings include: 1. Record review of the laboratory's QC /maintenance logs on 6/3/19 revealed the OPTI Check control is run prior to patient testing and documented on the maintenance log. 2. Record review of the laboratory's patient test logs on 6/3/19 revealed patient samples tested for pH, PO2 and PCO2 are recorded in a log book with their name, date test was performed and results. 3. Record review comparison of the above logs on 6/3/19 revealed the following Opti Check control was not always documented in the maintenance log for the days patient samples were tested. Specifically for 2/5, 216, 2/20, 3/19 in 2018 and 1/28, 2/19 in 2019. 4. Record review of the laboratory's procedures on 6/3/19 revealed the laboratory failed to provide evidence or documentation of a policy for documenting the Opti check QC. 5. Staff interview with TP on 6/3/19 at 11:00 AM confirmed the above findings. 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 staff interview, the laboratory failed to document all quality control (QC) procedures performed or have a procedure in place to monitor QC shifts and trends in the subspecialty of routine chemistry. Findings include: 1. Record review on 6/3/19 of the laboratory's QC records revealed: a) The laboratory does not monitor QC results over time to monitor shifts and trends. b) The laboratory does not document