Oakleaf Surgical Hospital Llc

Summary Statement of Deficiencies D3041 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(6) Test reports. Retain or be able to retrieve a copy of the original report (including final, preliminary, and corrected reports) at least 2 years after the date of reporting. (i) In addition, retain immunohematology reports as specified in 21 CFR 606.160(d) (ii) and pathology test reports for at least 10 years after the date of reporting. This STANDARD is not met as evidenced by: Based on surveyor review of patient test reports and interview with the technical consultant, the laboratory was not able to retrieve a copy of the original preliminary frozen section report for one of three patients reviewed. Findings include: 1. Review of pathology and frozen section patient reports showed the laboratory utilizes two forms, one for the preliminary frozen section report to include the time the specimen is received and time the diagnosis is reported to the surgeon from the pathologist. Further review showed the frozen section diagnosis is part of the final pathology report but does not include the time the specimen is received and the time the diagnosis was reported to the surgeon from the pathologist. 2. Review of pathology patient reports showed patient 1 had a frozen section procedure on August 5, 2021. Further review showed no evidence of the preliminary report from the frozen section to include the time the specimen was received and time the diagnosis was reported to the surgeon by the pathologist. 3. Interview with the technical consultant on July 21, 2022 at 2:03 PM confirmed the laboratory was not able to retrieve a copy of the original preliminary frozen section report for one of three patients reviewed. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification 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 -- procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on surveyor review of calibration verification records and interview with the technical consultant, the laboratory did not perform calibration verification every six months for the CHEM8+ test cartridge on the Abbott i-STAT chemistry analyzer in 2021. Findings include: 1. Review of the calibration verification records for the Abbott i-STAT chemistry analyzer showed calibration verification performed on the CHEM8+ test cartridge on June 2, 2021 and June 8, 2022. Further review showed no additional documentation of calibration verification between those dates. 2. Interview with the technical consultant on July 21, 2022 at 2:55 PM confirmed the laboratory did not perform calibration verification every six months for the CHEM8+ test cartridge on the Abbott i-STAT chemistry analyzer in 2021. -- 2 of 2 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on surveyor review of the federal Certification and Survey Provider Enhanced Reports (CASPER), proficiency testing (PT) records, laboratory records, and interview with the technical consultant, the laboratory did not enroll in PT for blood gas testing in 2019. Findings include: 1. Review of CASPER report 155 'Individual Laboratory Profile' for OakLeaf Surgical Hospital LLC, CLIA number 52D0929354 showed no results for blood gas testing, including the regulated analytes pH (a measure of the hydrogen ion concentration in blood), pO2 (partial pressure of oxygen), and pCO2 (partial pressure of carbon dioxide) in 2019. 2. Review of the American Proficiency Institute (API) 'Comparative Evaluation Forms' for the three Chemistry Core events in 2019 showed no evidence of Blood Gas results submitted to or graded by API for this laboratory. 3. Review of the OakLeaf Surgical Hospital 'Lab Resulted Test Counts' report for January 1, 2019 - December 31, 2019 showed the laboratory reported blood gas results for six patients during 2019. 4. Interview with the technical consultant on November 18, 2020 at 8:15 AM confirmed the laboratory did not enroll in PT for blood gas testing in 2019 and confirmed the laboratory performed patient blood gas testing during 2019. 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 -- D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory procedures and interview with the technical consultant, the current laboratory director has not approved, signed, and dated the procedures and Individualized Quality Control Plan (IQCP) in use in the laboratory. Findings include: 1. Review of the laboratory procedure manuals and IQCP for the iSTAT analyzer show no evidence of review or approval of the procedures by the current laboratory director. 2. Interview with the technical consultant on November 18, 2020 at 1:25 PM confirmed the current laboratory director has not signed and dated the laboratory procedures or IQCP since taking the role of laboratory director in July 2020. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on surveyor review of test reports for frozen sections and interview with the laboratory manager, the 'Frozen Section Report' for three of three patients reviewed does not include the time the laboratory received the specimen or reported the test result. Findings include: 1. Review of "Frozen Section Report" forms for patients one, two, and three, showed the form includes space to record the time the laboratory received the specimen and reported the results. Two of the three reports (patients two and three) show the laboratory sequentially received and reported three specimens for each patient. The three reports reviewed do not show receipt or report times. 2. Interview with the laboratory manager, staff A, on November 18, 2020 at 2:15 PM confirmed the testing personnel performing the frozen sections did not complete the reports to include the time the laboratory received the specimen or reported results. -- 2 of 2 --

Summary Statement of Deficiencies 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 surveyor review of the federal Certification and Survey Provider Enhanced Reports (CASPER) Proficiency Testing (PT) and American Proficiency Institute (API) Proficiency Testing (PT) records, the laboratory failed to successfully participate in PT for the Chloride analyte in the Specialty of Routine Chemistry for events 2017-3, and 2018-1. Findings include: 1. Review of PT records in the federal CASPER reporting system shows that the laboratory failed two consecutive PT events for the Chloride analyte within the Specialty of Routine Chemistry- Event 2017-3, score 40% and Event 2018-1, score 60%. 2. Surveyor review of the API PT evaluation reports confirmed the failed 2017 and 2018 PT scores which results in a failure to 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 -- successfully participate in Chloride testing for the Specialty of Routine Chemistry. Refer to D2096. 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 surveyor review of the federal Certification and Survey Provider Enhanced Reports (CASPER) Proficiency Testing (PT) and American Proficiency Institute (API) PT records, the laboratory failed to have successful performance in PT for the Chloride analyte in the Specialty of Routine Chemistry for events 2017-3, and 2018-1. Findings include: 1. Review of PT records in the federal CASPER reporting system shows that the laboratory failed two consecutive PT events for Chloride in the Specialty of Routine Chemistry - Event 2017-3, score 40% and Event 2018-1, score 60%. 2. Surveyor review of the API PT evaluation reports confirmed the failed 2017 and 2018 PT scores. This results in a failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events which is unsuccessful PT performance. -- 2 of 2 --