Pediatric Partners Of Memphis

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: The laboratory failed to maintain satisfactory proficiency testing performance for the hematocrit analyte for three of three testing events, resulting in non-initial unsuccessful PT performance. (Refer to D2130) D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. 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 a desk review survey of the Center for Medicare and Medicaid Services Casper Report 155 (CMS 155) and the laboratory's 2021 and 2022 proficiency testing (PT) records, the laboratory failed to maintain satisfactory performance in three of three PT events for the hematocrit analyte, resulting in non-initial unsuccessful PT occurrence. The findings include: 1. Review of the CMS 155 revealed the following unsatisfactory PT scores for the hematocrit analyte: 2021 Event three=60% 2022 Event one=60% 2022 event two=0% 2. Review of the laboratory's American Academy of Family Physicians (AAFP) PT performance evaluation records revealed the following: 2021 event three: sample numbers HD-14 and HD-15 scored as unacceptable for hematocrit analyte resulting in an overall event score of 60%. 2022 event one: sample numbers HD-2 and HD-5 scored as unacceptable for the hematocrit analyte, resulting in an overall event score of 60%. 2022 event two: sample numbers HD-6, HD-7, HD-8, HD-9 and HD-10 scored as "Fail-No results received", resulting in an overall event score of 0%. 3. Phone interview with the laboratory lead and laboratory director on 08/24/2022 at 12:10 pm confirmed the survey findings. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: The laboratory director failed to ensure the laboratory performed proficiency testing in such a manner as to achieve and maintain satisfactory performance with successful proficiency testing for the hematocrit analyte, resulting in non-initial unsuccessful proficiency testing occurrence. (Refer to D6016) D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of the Centers for Medicare and Medicaid Services Casper Report 155 (CMS 155) and the laboratory's 2021 and 2022 proficiency testing (PT) evaluation reports, the laboratory director failed to ensure the laboratory performed proficiency testing in such a manner as to achieve and maintain satisfactory performance, resulting in unsatisfactory performance for three of three consecutive proficiency testing events for the hematocrit analyte, resulting in non-initial unsuccessful proficiency testing occurrence. The findings include: 1. Review of the CMS 155 and the laboratory's American Academy of Family Physicians (AAFP) -- 2 of 3 -- proficiency testing evaluation reports revealed the following unsatisfactory scores for the hematocrit analyte: 2021 Event three=60% 2022 Event one=60% 2022 event two=0% 2. Phone interview with the laboratory lead and laboratory director on 08/24 /2022 at 12:15 pm confirmed the survey findings. The laboratory director further stated that testing for complete blood count was ceased approximately June 2022 when the first proficiency testing failure citations were issued. -- 3 of 3 --

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: The laboratory failed to maintain satisfactory participation in two out of three proficiency testing (PT) events for the red blood cell (RBC), hemoglobin (HGB), white blood cell (WBC), and platelet (PLT) analytes, resulting in the first unsuccessful PT occurrence for the RBC, HGB, WBC, PLT analytes. (Refer to D2130) D2130 HEMATOLOGY CFR(s): 493.851(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 in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of the Centers for Medicare and Medicaid Services Casper Report 155 (CMS 155) and the laboratory's 2021 and 2022 proficiency testing (PT) records, the laboratory failed to maintain satisfactory performance for the red blood cell count (RBC), hemoglobin (HGB), white blood cell count (WBC), and platelet count (PLT) analytes in two out of three PT events, resulting in the first unsuccessful PT occurrence for the RBC, HGB, WBC, and PLT analytes. The findings include: 1. Review of the CMS 155 revealed the following unsatisfactory PT scores: a. 2021 event three: 60% for RBC, HGB, WBC, PLT b. 2022 event two: 0% for RBC, HGB, WBC, PLT 2. Review of the laboratory's PT evaluation report revealed the following: a. 2021 event one: unacceptable scores for sample numbers HD-14 and HD-15 for the RBC, HGB, WBC, and PLT analytes, resulting in a score of 60% for each analyte. b. 2022 event two: no scores for the RBC, HGB, WBC, and PLT analytes for "No Results Received", resulting in an overall score of 0% for each analyte and the first unsuccessful PT occurrence for the RBC, HGB, WBC, and PLT analytes. -- 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: The laboratory failed to maintain satisfactory participation for two consecutive proficiency testing events for the Hematocrit (HCT) analyte in 2021 event three and 2022 event one, resulting in the first unsuccessful proficiency testing (PT) occurrence for the HCT analyte. (Refer to D2130) D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 -- events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of the Centers for Medicare and Medicaid Casper Report 155 (CMS 155) and the laboratory's 2021 and 2022 proficiency testing (PT) evaluation reports, the laboratory failed to maintain satisfactory performance for two consecutive test events for the Hematocrit (HCT) analyte. The findings include: 1. Review of the CMS 155 report revealed the following unsatisfactory HCT scores: a. 2021 event two 60%. b. 2022 event one 60%. 2. Review of the 2021 PT event three evaluation report revealed failed scores for sample numbers HD-14 and HD-15, resulting in an overall score of 60% for the HCT analyte. 3. Review of the 2022 PT event one evaluation report revealed failed scores for sample numbers HD-02 and HD-05, resulting in an overall score of 60% for the HCT analyte and the first unsuccessful PT occurrence. -- 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 review of the laboratory's quality assurance policy/procedure, employee personnel records for 2018 and 2019, and interview with the lead testing personnel, the laboratory failed to have a procedure to include all six criteria for assessing personnel competency. The findings include: 1) Review of the laboratory's quality assurance policy/procedure revealed the laboratory's policy did not specify the methods to be used when assessing testing personnel competency. The following six criteria were not included in the procedure and competency documentation: direct observation of routine patient test performance; monitoring the recording and reporting of test results; review of intermediate test results or worksheets, quality control records, proficiency testing results and preventative maintenance records; direct observation of performance of instrument maintenance and function checks; assessment of test performance through previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and assessment of problem solving skills. 2) Review of the 2018 and 2019 employee personnel records revealed no documentation of competency assessment that included all six required criteria. 3) Interview on November 26, 2019 at 12:30 p.m. with the lead testing personnel confirmed the testing personnel competency procedure and documentation did not include the six criteria for testing personnel competency assessment required by the Centers for Medicare and Medicaid Services (CMS). D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) 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 -- 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)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the Verification of Performance Specifications (VoPS) studies for the Beckman Coulter AcT Diff 2 Complete Blood Count (CBC) instrument and interview with the lead testing personnel, the laboratory director failed to review and approve the VoPS studies for the Beckman Coulter AcT Diff CBC instrument in 2019. The findings include: 1) Observation of the laboratory on November 26, 2019 at 8:30 am revealed the Beckman Coulter AcT Diff 2 CBC instrument (serial number 59394676) on the counter in use for patient testing. 2) Review of the VoPS studies for the Beckman Coulter AcT Diff 2 CBC instrument, performed March 21, 2019, revealed no review or approval by the laboratory director. 2) Interview with the lead testing personnel on November 26, 2019 at 10:30 am confirmed the laboratory director failed to review and approve the VoPS for the Beckman Coulter AcT diff 2 instrument in 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: The laboratory failed to maintain satisfactory proficiency testing (PT) performance for the hematocrit analyte in 2017 event two, 2017 event three, and 2018 event two, resulting in the second unsuccessful PT occurrence for the hematocrit analyte. (Refer to D2130) D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 -- events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of the Centers for Medicare and Medicaid Casper Report 155 (CMS 155) and the laboratory's 2017 and 2018 proficiency testing (PT) evaluation reports, the laboratory failed to maintain satisfactory performance for three out of four proficiency testing events for the hematocrit analyte resulting in the second unsuccessful PT occurrence for hematocrit. The findings include: 1. Review of the CMS 155 report revealed the following unsatisfactory hematocrit scores: 2017 event two 60%, 2017 event three 0%, 2018 event two 40%. 2. Review of the 2017 PT event two evaluation report revealed unacceptable scores for hematocrit for sample numbers HD-6, HD-7. 3. Review of the 2017 PT event three evaluation report revealed unacceptable scores for hematocrit for sample numbers HD-11, HD-12, HD-13, HD- 14, HD-15. 4. Review of the 2018 PT event two evaluation report revealed unacceptable scores for hematocrit for sample numbers HD-6, HD-7, HD-8; resulting in the second unsuccessful PT occurrence for the hematocrit analyte. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: The laboratory director failed to maintain compliance with successful hematocrit analyte proficiency testing (PT) for three out of four events and failed to follow the approved allegation of compliance (AOC) for the hematocrit analyte, resulting in the second unsuccessful PT occurrence for the hematocrit analyte. (Refer to D6004) D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) 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. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on a desk review of the Centers for Medicare and Medicare Services Casper report 155 (CMS 155), the laboratory's 2017 event two, 2017 event three, and 2018 event two proficiency testing (PT) evaluation reports and the laboratory's December 20, 2017 Allegation of Compliance (AOC), the laboratory director failed to follow the approved AOC for the hematocrit analyte, resulting in the second unsuccessful PT occurrence for the hematocrit analyte. The findings include: 1. Review of the CMS -- 2 of 3 -- 155 report and the laboratory's 2017 events two and three, and 2018 event two PT evaluation reports revealed the hematocrit scores as follows: 2017 event two = 60%, 2017 event three = 0%, 2018 event two = 40%. 2. Review of the laboratory's AOC dated December 20, 2017, in reference to a previous failure to maintain compliance with successful PT, signed by the laboratory director on January 18, 2018 revealed the following statements: "Beckman Coulter has been notified and are look at Q&A of control/start ups to determine the problem." "All staff will be inserviced again on Hematology." "Service on instrument." -- 3 of 3 --

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 a desk review of the Centers for Medicare and Medicaid Services Casper report 155 (CMS 155) and the laboratory's 2017 and 2018 proficiency testing (PT) records the laboratory failed to maintain satisfactory performance for the red blood cell (RBC) analyte for 2017 event three and 2018 event two resulting in the first unsuccessful occurrence. (Refer to D2130) D2130 HEMATOLOGY CFR(s): 493.851(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 in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of the Centers for Medicare and Medicaid Casper Report 155 (CMS 155) and the laboratory's 2017 and 2018 proficiency testing records, the laboratory failed to maintain satisfactory performance for the red blood cell (RBC) analyte for two out of three proficiency testing events (2017 event three and 2018 event two), resulting in the first unsuccessful occurrence. The findings include: 1. Review of the CMS155 report revealed failing scores for the RBC analyte as follows: 2017 event three = 40%, 2018 event two = 40%. 2. Review of the 2017 event three results revealed RBC sample numbers HD-11, HD-13 and HD-15 scored as Fail, resulting in a score of 40%. 3. Review of the 2018 event two results revealed RBC sample numbers HD-6, HD-7, and HD-8 scored as Fail, resulting in a score of 40%. -- 2 of 2 --

Summary Statement of Deficiencies D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the laboratory records and interview with testing personnel number one, the laboratory director failed to ensure the quality assessment (QA) was maintained for the complete blood count (CBC) quality control (QC), CBC proficiency testing (PT), and testing personnel training/competency, in 2017. The findings include: 1) Observation of the laboratory on January 25, 2018 at 1: 30 p.m. revealed the Beckman Coulter AcT diff 2 instrument in use for CBC patient testing. 2) Review of the 2017 laboratory records revealed the CBC QC summary reports were not signed for review, the 2017 CBC PT attestation statements were not available for review, the 2017 testing personnel training/competency records were not available for review. 3) Interview on January 25, 2017 at 3:30 p.m. with testing personnel number one confirmed the laboratory director did not review the 2017 CBC QC summary records and that the 2017 CBC PT and 2017 testing personnel records were not available for review. 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 --