Center For Advanced Medicine South

Summary Statement of Deficiencies 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 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: Review of 2019 calibration records for the Gem 4000 blood gas analyzer for pH, pCO2, pO2 and interview with the testing personnel (TP), the laboratory failed to perform calibration verification procedures at least once every six months that included at least a minimal value, a mid-point value and a maximum value near the upper limit to verify the laboratory's reportable range. Findings: 1. No 2019 calibration records for the Gem 4000 blood gas analyzer were available for pH, pCO2, 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 -- pO2. 2. Interview with the TP confirmed the laboratory failed to include a minimal, mid-point, and maximum calibrator in the calibration verification procedure for pH, pCO2, pO2 at least once every six months. -- 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 review of 2018 and 2019 routine chemistry proficiency testing (PT) results reported to the CLIA database by the PT provider and phone interview with the testing personnel, the laboratory failed to successfully participate in PT. See D-tags 2096 and 2097 failure to successfully participate in three of four consecutive PT challenges. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- 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 review of chemistry proficiency testing (PT) results for 2018, 2019 and phone interview with the testing personnel, the laboratory failed to achieve satisfactory performance for the analytes pH, pCO2, pO2 in three of four PT events. Findings: 1. Review of the chemistry PT results for the third event of 2018 revealed the laboratory obtained an unsatisfactory score of 0 percent for the analytes, pH, pCO2, pO2. 2. Review of the chemistry PT results for the first event of 2019 revealed the laboratory obtained an unsatisfactory score of 0 percent for the analytes, pH, pCO2, pO2. 3. Review of the chemistry PT results for the third event of 2019 revealed the laboratory obtained an unsatisfactory score of 0 percent for the analytes, pH pCO2, pO2. 4. Phone interview with the testing personnel on February 19, 2020 at 1: 30 PM confirmed the laboratory failed to achieve satisfactory performance for pH, pCO2, pO2 testing in three of four events for 2018 and 2019. D2097 ROUTINE CHEMISTRY CFR(s): 493.841(g) Failure to achieve an overall testing event score of satisfactory performance for 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 review of chemistry proficiency testing (PT) results for 2018, 2019 and phone interview with the testing personnel, the laboratory failed to achieve satisfactory performance for the specialty of routine chemistry in three of four PT events. Findings: 1. Review of the chemistry PT results for the third event of 2018 revealed the laboratory obtained an unsatisfactory score of 0 percent for routine chemistry. 2. Review of the chemistry PT results for the first event of 2019 revealed the laboratory obtained an unsatisfactory score of 0 percent for routine chemistry. 3. Review of the chemistry PT results for the third event of 2019 revealed the laboratory obtained an unsatisfactory score of 0 percent for routine chemistry. 4. Phone interview with the testing personnel on February 19, 2020 at 1:30 PM confirmed the laboratory failed to achieve an overall satisfactory performance for routine chemistry in three of four events for 2018 and 2019. -- 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 review of 2018, 2019 routine chemistry proficiency testing (PT) results reported to the CLIA database by the PT provider and phone interview with the testing personnel, the laboratory failed to participate in PT. See D-tag 2089, failure to participate in two consecutive PT challenges. D2089 ROUTINE CHEMISTRY CFR(s): 493.841(c) Failure to participate in a testing event is unsatisfactory performance and results in a 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 -- score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3)The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on review of proficiency test records for the third event of 2018 and the first event of 2019 and interview with testing personnel, the laboratory failed to participate in chemistry proficiency testing for blood gas analysis, resulting in unsatisfactory performance with a score of zero for the testing events. Findings: 1. Review of the third event of 2018 for routine chemistry proficiency test results showed a score of zero percent for pH, pO2, pCO2. 2. Review of the first event of 2019 for routine chemistry proficiency test results showed a score of zero percent for pH, pO2, pCO2. 3. Interview with the testing personnel on June 21, 2019 at 12:00 PM confirmed the laboratory failed to participate in the third event of 2018 and first event of 2019 for arterial blood gas testing and scored an unsatisfactory performance of zero percent. -- 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 review of patient reports, proficiency testing records revealed and interview with the laboratory director on March 28, 2018 at 11:00 PM confirmed, the laboratory failed to enroll in proficiency testing during 2016, 2017 and to date March 28, 2018 for the analyte of total hemoglobin for blood gas testing. D2003 ENROLLMENT CFR(s): 493.801(a)(2)(ii) For those tests performed by the laboratory that are not included in subpart I of this part, a laboratory must establish and maintain the accuracy of its testing procedures, in accordance with 493.1236(c)(1) This STANDARD is not met as evidenced by: Based on review of proficiency records for 2016, 2017 and to date March 28, 2018, review of patient reports and interview with the laboratory director, the laboratory failed to establish a means to verify the accuracy of four of four non-regulated 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 -- analytes for arterial blood gas testing twice a year. Findings: 1. Review of proficiency records for the third event of 2016, all three events for 2017, and to date March 28, 2018, revealed the laboratory failed to enroll to prove accuracy on the non-regulated analytes of oxyhemoglobin, methemoglobin, carboxyhemoglobin and deoxyhemoglobin. 2. Review of the patient test report showed results for oxyhemoblobin, methemoglobin, carboxyhemoglobin, and deoxyhemoglobin. 3. Interview with the laboratory director on March 28, 2018 at 11:00 AM confirmed the laboratory resulted four of four non-regulated analytes on the patient report and failed to verify the accuracy of the non-regulated analytes of methhemoglobin, oyxhemoglobin, deoxyhemoglobin, and carboxyhemoglobin for blood gas testing twice annually for 2016 and 2017. -- 2 of 2 --