Summit Health City Md +

Summary Statement of Deficiencies D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on review of the approved reference ranges for Chemistry and Hematology in the laboratory procedure manual, review of two (2) patient reports, and interview with the Technical Supervisor (TS), the laboratory failed to ensure the test report included current approved reference ranges as determined by the laboratory. Four (4) out of sixteen (16) chemistry normal values and one (1) out of seven (7) hematology normal values listed on the laboratory information system (LIS) report differed from the reference ranges in the current approved procedure manual. Findings include: 1. Review of patient reports 6856708 for Hematology and 6856355 for Chemistry from the LIS system provided by the TS when requested, revealed the following: LIS Patient Report Procedure Manual Chemistry: BUN 8-23 mg/dL 6-20 mg/dL Creatinine, BLD 0.50-1.10 mg/dL 0.7-1.2 mg/dL AST 0-32 IU/L 0-41 IU/L ALT 0-33 IU/L 0-38 IU/L Hematology: RBC 4.20-5.30 M/uL 4.30-6.0 M/uL 2. Interview with the TS on 04/09/2024 at 1430 pm confirmed the laboratory failed to ensure the correct reference ranges approved in the procedure manual were the same as those in the LIS and on the patient report. 3. The laboratory reports performing 209,916 chemistry tests and 50,561 hematology tests annually. D6115 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(2) The technical supervisor is responsible for verification of the test procedures performed and establishment of the laboratory's test performance characteristics, 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 -- including the precision and accuracy of each test and test system. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedure manual, review of two (2) patient reports for Chemistry and Hematology and interview with the Technical Supervisor (TS), the TS failed to ensure the reference ranges for Chemistry and Hematology on patient reports reflected the current reference ranges in the procedure manual. See D5807 -- 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 proficiency testing (PT) desk review of the American Proficiency Institute (API) proficiency testing comparative evaluation results, review of the CASPER Report 0155D, and phone conversation with the technical supervisor (TS) revealed the laboratory had unsuccessful participation for three (3) out of four (4) testing events for the specialty toxicology for the analyte digoxin. Refer to D2118. D2118 TOXICOLOGY CFR(s): 493.845(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 3 -- 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 proficiency testing (PT) desk review of the American Proficiency Institute (API) proficiency testing comparative evaluation results, review of the CASPER Report 0155D, and phone conversation with the technical supervisor (TS) revealed the laboratory had unsuccessful participation for three (3) out of four (4) testing events for the analyte digoxin. Findings include. 1. Review of the API comparative evaluation results revealed a) 1st event 2023 digoxin 60% , b) 3rd event 2023 digoxin 60% c) 1st event 2024 digoxin 60% 2. Review of the Casper Report 0155D a) 1st event 2023 digoxin 60% b) 3rd event 2023 digoxin 60% c) 1st event 2024 digoxin 60% 3. Phone conversation with the TS confirmed these findings on 03/07/2024 at 3:13 PM. 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: Based on proficiency testing (PT) desk review of the American Proficiency Institute (API) proficiency testing comparative evaluation results, review of the CASPER Report 0155D, and phone conversation with the technical supervisor (TS), the laboratory director (LD) failed to provide overall management and direction to the laboratory which resulted to three (3) out four (4) PT event failures. Refer to D6019 D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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)(iv) Ensure that an approved

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 Proficiency Testing (PT) desk review of the American Proficiency Institute (API) proficiency testing and CASPER Report 0155D, and phone conversation with the Technical Supervisor (TS) revealed the laboratory had unsuccessful participation for two (2) out of three (3) testing events for the analyte Digoxin in the specialty Toxicology in 2023. Findings include. 1. API 1st event 2023 = Digoxin 60% 2. API 1st event 2023 = Toxicology 60% 3. API 3rd event 2023 = Digoxin 60% 4. API 3rd event 2023 = Toxicology 60% 5. Phone conversation with the TS confirmed these findings on 10/16/2023 @ 11:30 AM. 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 -- D2118 TOXICOLOGY CFR(s): 493.845(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 Proficiency Testing (PT) desk review of the American Proficiency Institute (API) proficiency testing and CASPER Report 0155D, and phone conversation with the Technical Supervisor (TS) revealed the laboratory had unsuccessful participation for two (2) out of three (3) testing events for the analyte Digoxin in 2023. Findings include. 1. API 1st event 2023 = Digoxin 60% 2. API 3rd event 2023 = Digoxin 60% 3. Phone conversation with the TS confirmed these findings on 10/16/2023 @ 11:30 AM. D2119 TOXICOLOGY CFR(s): 493.845(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 Proficiency Testing (PT) desk review of the American Proficiency Institute (API) proficiency testing and CASPER Report 0155D, and phone conversation with the Technical Supervisor (TS) revealed the laboratory had unsuccessful participation for two (2) out of three (3) testing events for specialty Toxicology in 2023. Findings include. 1. API 1st event 2023 = Toxicology 60% 2. API 3rd event 2023 = Toxicology 60% 5. Phone conversation with the TS confirmed these findings on 10/16 /2023 @ 11:30 AM. -- 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: Record review of the American Proficiency Institute (API) proficiency testing reveals that your laboratory has unsuccessful proficiency testing for Endocrinology. Refer to D2107. D2107 ENDOCRINOLOGY CFR(s): 493.843(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 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 -- unsuccessful performance. This STANDARD is not met as evidenced by: Review of the American Proficiency Institute (API) proficiency testing (PT) shows unsatisfactory performance for the same analyte in two consecutive testing events. Findings include: 1. 3rd Event 2017 - Human chronic gonadotropin (HCG) - 0% 2. 1st Event 2018 - HCG - 40% -- 2 of 2 --