Md Tox Laboratory

Summary Statement of Deficiencies D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) (a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) proficiency testing records, and interview with the Technical Supervisor (TS), the Technical Supervisor (TS), it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for the Routine Chemistry analytes Bilirubin and Lactate Dehydrogenase (LDH). The finding included: 1.The laboratory enrolled in the American Proficiency Institute (API) proficiency testing program for routine chemistry testing using Beckman Coulter AU680 instrument. According to the API evaluation, the laboratory attained the following unsatisfactory scores: Q3- 2023: Bilirubin= 0% Q1- 2025: LD/LDH= 0% 2. On May 28th, 2025, at approximately 11: 30 am the Technical Supervisor affirmed that the laboratory received the above unsatisfactory proficiency scores. 3. The laboratory's testing declaration form, signed by the laboratory director May 15, 2025, stated that the laboratory performed approximately 1,179 Lactate Dehydrogenase (LDH) tests and 9,246 Bilirubin tests annually. Thus, the accuracy and reliability of patient test reports cannot be determined. D2098 ENDOCRINOLOGY CFR(s): 493.843(a) (a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. 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 review of the American Proficiency Institute (API) proficiency testing records, and interview with the Technical Supervisor (TS), the Technical Supervisor (TS), it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for the Endocrinology analytes Prolactin and Thyroxine (T4). The finding included: 1.The laboratory enrolled in the American Proficiency Institute (API) proficiency testing program for endocrinology testing using Beckman Unicel Dxi 800 instrument. According to the API evaluation, the laboratory attained the following unsatisfactory scores: Q3- 2024: Prolactin= 0% Q1- 2025: T4= 60% 2. On May 28th, 2025, at approximately 11:30 am the Technical Supervisor affirmed that the laboratory received the above unsatisfactory proficiency scores. 3. The laboratory's testing declaration form, signed by the laboratory director May 15, 2025, stated that the laboratory performed approximately 4,186 Prolactin tests and 37,553 T4 tests annually. Thus, the accuracy and reliability of patient test reports cannot be determined. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. This STANDARD is not met as evidenced by: Based on review of policies and procedures manuals, laboratory records and interview with the Technical Supervisor (TS) on May 28th, 2025, at approximately 2:00 pm, the laboratory failed to review monthly quality management summary to verify that the laboratory has a system in place to ensure continuous improvement. The findings include: 1. It was practice of the laboratory to perform routine chemistry, urinalysis and toxicology testing using Beckman Coulter AU680 instrument. 2. On May 28th, 2025, at approximately 2:00 pm, the Technical Supervisor (TS) affirmed the laboratory did not review monthly quality management summary for all tests perform using AU680 analyzer. 3. The laboratory's testing declaration form, signed by the laboratory director on May 15, 2025, stated that the laboratory performed approximately 425,860 tests using AU680 analyzer annually. D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(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, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 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. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on interview with Laboratory Director (LD) and Technical Consultant (TC), review of Proficiency Testing and Quality Assessment records on May 28th, 2025, the laboratory Director failed to provide overall management and direction in accordance with 493.1445 of this subpart. The findings included: 1-The LD failed to ensure the proficiency testing samples were tested as required under subpart H of 42 CFR 493. See D2087, D2098 2- The LD failed to ensure that quality assessment programs were maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. See D5791 D6080 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(c) (c) The laboratory director must: (c)(1) Be onsite at least once every 6 months, with at least 4 months between the minimum two on-site visits. Laboratory directors may elect to be on-site more frequently and must continue to be accessible to the laboratory to provide telephone or electronic consultation as needed; and (c)(2) Provide documentation of these visits, including evidence of performing activities that are part of the laboratory director responsibilities. This STANDARD is not met as evidenced by: Based on review of the laboratory's records and interview with the laboratory Director (LD) and Technical Supervisor (TS), the laboratory director failed to determine any specific type or process of documentation required as evidence of conducting an on- site visit by the LD. The findings include: 1. It was the practice of the laboratory to perform high complexity testing. The laboratory director must be onsite at least once every 6 months, with at least 4 months between the minimum two on-site visits. 2. On May 28th, 2025, at approximately 12:00 pm, the TS and LD confirmed that the laboratory did not maintain any evidence of performing on-site visits by the LD for 2 of 2 years. 3. The laboratory's testing declaration form, signed by the laboratory director on May 15, 2025, stated that the laboratory performed approximately 1,246,362 tests annually. -- 3 of 3 --

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing (PT) test result reports, and interview with the laboratory's personnel, it was determined that the laboratory failed to verify, at least twice annually, the accuracy of any test or procedure it performed which are not listed in subpart I of 42 CFR part 493. The findings included: a. The laboratory failed to verify and ensure, at least twice annually, the accuracy of the test procedures it performed, which are not listerd in the subpart I of 42 CFR part 493. b. The laboratory performed routine chemistry and general immunology including, but are not limited to the following test procedures of CA-125, Folate, TIBC and Urine Creatinine, which are not listed in the subpart I of 42 CFR part 493. c. The laboratory enrolled with American Proficiency Institute (API) PT programs to verify and ensure the accuracy of the test procedures it performed. d. The laboratory failed to attain scores of at least 80% for the following analyte in the API PT events: Score in %; U = Urine; Vol = estimated monthly patient test volume. PT event Analyte Score Vol Q2 2022 CA 125 50 60 Q2 2022 Folate 50 100 Q1 2022 TIBC 60 42 Q2 2021 U Creatinine 33 2 Q1 2022 U Creatinine 0 2 e. The laboratory personnel affirmed ( 4/19 /2023 @ 12:40 PM) that the laboratory failed to verify and ensure the accuracy of the tests for the listed on (c) above. 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 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 -- 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 review of the laboratory's proficiency testing (PT) result reports, and interview with the laboratory personnel, it was determined that the laboratory director failed to ensure that the proficiency testing samples were tested as required and failed to attain scores of at least 80% to verify and ensure the accuracy of test procedures. The findings included: a. The laboratory director failed to ensure the accuracy of API PT samples that the laboratory performed and attained scores of at least 80% for the analyte of CA-125, Folate, TIBC and Urine Creatinine, see D-5217 -- 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 with the laboratory's American Proficiency Institute (API) proficiency testing (PT) result reports for Hematology from Q3 2018 thru Q3 2020 shown unsuccessful (2 of 2) failure to attain scores of at least 80% of acceptable responses for Blood Cell Identification in Q2 and Q3 2020 Hematology PT events, and interview with the testing personnel and the laboratory director, it was determined that the laboratory failed to successfully participate in a PT program approved by CMS for Hematology in which the laboratory is certified under CLIA regulations. The findings included: The laboratory failed to achieve satisfactory performance for the Blood Cell Identification in two out of two consecutive testing Q2 and Q3 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- Hematology PT 2020 events in the specialty of Hematology constituting unsuccessful PT performance. (See D2130) D2020 BACTERIOLOGY CFR(s): 493.823(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review with the laboratory's American Proficiency Institute (API) proficiency testing (PT) for a specialty of Bacteriology from Q3 2018 thru Q3 2020 PT events, and interview with the laboratory testing personnel (TP), it was determined that the laboratory failed to attain an overall testing event score of at least 80 percent for Bacteriology testing event is unsatisfactory analyte performance for the testing event. The findings included: a. The laboratory performed Bacteriology testing including but is not limited to C. trachomatis and N. gonorrhoeae. b. The laboratory enrolled with API PT program in order to be following CLIA's "Evaluation of proficiency testing performance" 42 CFR part 493.1236. c. The laboratory attained a score of 0 % for C. trachomatis and N. gonorrhoeae Q2 2020 API Bacteriology PT event, which was unsatisfactory analyte performance for the testing event. d. The laboratory performed C. trachomatis and N. gonorrhoeae in approximately 110 patient samples monthly. e. The TP affirmed (1/25/2021 @ 111:35 am) that the laboratory attained a score of 60 % for C. trachomatis and N. gonorrhoeae in Q2 2020 API Bacteriology PT event, which was unsatisfactory analyte performance for the testing event. D2098 ENDOCRINOLOGY CFR(s): 493.843(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review with the laboratory's American Proficiency Institute (API) proficiency testing (PT) for endocrinology from Q3 2018 thru Q3 2020 PT events, and interview with the laboratory testing personnel (TP), it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for each analyte in a subspecialty of Endocrinology testing event is unsatisfactory analyte performance for the testing event. The findings included: a. The laboratory performed Endocrinology testing including but is not limited to Thyroxine. b. The laboratory enrolled with API PT program in order to be following CLIA's "Evaluation of proficiency testing performance" 42 CFR part 493.1236. c. The laboratory attained a score of 60 % for Thyroxin in Q1 2019 API PT event, which was unsatisfactory analyte performance for the testing event. d. The laboratory performed Thyroxin in approximately 1913 patient samples monthly. e. The TP affirmed (1/25/2021 @ 111: 35 am) that the laboratory attained a score of 60 % for Thyroxin in Q1 2019 API PT event, which was unsatisfactory analyte performance for the testing event. D2130 HEMATOLOGY CFR(s): 493.851(f) -- 2 of 4 -- 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 review with the laboratory's American Proficiency Institute (API) proficiency testing (PT) for the specialty of Hematology from Q3 2018 thru Q3 2020 PT events, and interview with the laboratory testing personnel (TP), it was determined that the laboratory failed to achieve satisfactory performance for Blood Cell Identification (BCI) in two consecutive Q2 and Q3 PT 2020 testing events, was unsuccessful performance. The findings included: a. The laboratory performed Hematology testing including but is not limited to Blood Cell Identification (BCI). b. The laboratory enrolled with API PT program in order to be in complaint with CLIA "Evaluation of proficiency testing performance" 42 CFR part 493.1236. c. The laboratory attained scores of 40 % and 60 % for BCI in Q2 2020 and Q3 2020, respectively for API Hematology PT events, which was unsuccessful performance. d. The failures of BCI PT results are shown as follows: Q2 2020 (40 %) PT event, FAIL Sample # Result Target BCI-07 Lymph Plasmacytoid, Lymphocyte normal BCI-09 Neutrophil band (stab), Neutrophil segmented BCI-10 Schistocyte, Sickle Cell (drepanocyte) Q3 2020 (60%) PT event, FAIL Sample # Result Target BCI-12 Neutrophil band (stab), Neutrophil segmented BCI-13 Neutrophil with toxic gran, Neutrophil band (stab) e. The TP affirmed (1/25/2021 @ 11:35 am) that the laboratory attained scores of 40 % and 60 % for BCI in Q2 2020 and Q3 2020, respectively for Hematology API PT events, in two consecutive events was unsuccessful performance. 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 review with the laboratory's American Proficiency Institute (API) proficiency testing (PT) from Q3 2018 thru Q3 2020 PT events, and interview with the laboratory testing personnel (TP), it was determined that the laboratory director failed to ensure that the proficiency testing samples were tested as required under Subpart H of 42 CFR part 493. The findings included: a. The laboratory enrolled with API PT program for the testing systems including but are not limited to Bacteriology, Endocrinology, and Hematology, in order to be following CLIA "Evaluation of proficiency testing performance" 42 CFR part 493.1236. b. The laboratory failed to attain an overall testing event score of at least 80 percent for Bacteriology PT testing event is unsatisfactory performance, see D-2020. c. The laboratory failed to attain a score of at least 80 percent of acceptable responses for Endocrinology PT testing event is unsatisfactory analyte performance, see D-2098 D6076 LABORATORY DIRECTOR CFR(s): 493.1441 -- 3 of 4 -- The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review with the laboratory's American Proficiency Institute (API) proficiency testing (PT) from Q3 2018 thru Q3 2020 events, and interview with the laboratory testing personnel (TP), it was determined that the laboratory director failed to provide and fulfill the overall management and direction. The findings included: a. The laboratory performed the high complexity testing including but is not limited to Hematology with Blood Cell Identification (BCI). b. The laboratory enrolled with API PT program for the specialty of Hematology and failed to meet the compliance with CLIA "Evaluation of proficiency testing performance" 42 CFR part 493.1236. c. The laboratory attained scores of 40 % and 60 % for BCI in Q2 2020 and Q3 2020, respectively, for the same analyte in two consecutive events, was unsuccessful performance, see D-2130 See D-2016 and D-6089 D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on review with the laboratory's American Proficiency Institute (API) proficiency testing (PT) from Q3 2018 thru Q3 2020 events, and interview with the laboratory testing personnel (TP), it was determined that the laboratory director failed to ensure the proficiency testing samples were tested as required under subpart H of 42 CFR part 493. The findings included: a. The laboratory performed Hematology testing including but is not limited to Blood Cell Identification (BCI), which is a high complexity testing. b. The laboratory attained scores of 40 % and 60 % for BCI in Q2 2020 and Q3 2020, respectively for Hematology API PT events, which was unsuccessful performance, see D-2130. -- 4 of 4 --

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 desk review of CMS proficiency testing (PT) records (i.e. CMS CASPER Reports 0155D entitled, "Individual Laboratory Profile" and CMS CASPER Report 0153D entitled, "Unsuccessful (2 of 3) Report"), it was determined that the laboratory failed to successfully participate in a PT program approved by CMS for each analyte or test in which the laboratory is certified under CLIA. The findings included: The laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events in the specialty of Endocrinology constituting unsuccessful PT performance. (See D2107) 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 -- 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 unsuccessful performance. This STANDARD is not met as evidenced by: Based on desk review of CMS PT records (CMS CASPER Report 0155D and 0153D, it was determined that the laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT events for the analyte, thyroxine (T4), resulting in an "initial" (first) unsuccessful performances. The findings include: a. The laboratory failed to maintain successful performance with the PT program by failing to obtain a score of 80% of acceptable responses in two out of three consecutive PT events for the analyte, T4, as follows: 2018 Q2 2019 Q1 T4 40% 40% Q1 = First Testing Event Q2 = Second Testing Event b. Failure to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT resulted in an initial unsuccessful performance for the analyte, T4. 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 the severity of the deficiencies cited herein, the Condition: Laboratories Performing Moderate Complexity Testing: Laboratory director was not met. The laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under Subpart H of this part. (See 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 CMS PT records, it was determined the laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under subpart H. of this part. The findings included: For the analyte, T4, the laboratory repeatedly failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events, resulting in unsuccessful PT performance. (See D2016 and D2107) -- 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 desk review of CMS proficiency testing (PT) records (i.e. CMS CASPER Reports 0155D entitled, "Individual Laboratory Profile" and CMS CASPER Report 0153D entitled, "Unsuccessful (2 of 3) Report"), it was determined that the laboratory failed to successfully participate in a PT program approved by CMS for each analyte or test in which the laboratory is certified under CLIA. The findings included: The laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events in the specialty of Routine Chemistry constituting unsuccessful PT performance. (See 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 desk review of CMS PT records (CMS CASPER Report 0155D and 0153D, it was determined that the laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT events for the analyte, Bilirubin, total, resulting in an "initial" (first) unsuccessful performances. The findings include: a. The laboratory failed to maintain successful performance with the PT program by failing to obtain a score of 80% of acceptable responses in two out of three consecutive PT events for the analytes, Bilirubin, total, as follows: 2018 Q2 2018 Q3 Bilirubin, total 0% 20% Q2 = Second Testing Event Q3 = Third Testing Event b. Failure to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT resulted in an initial unsuccessful performance for the analyte, Bilirubin, total. 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 the severity of the deficiencies cited herein, the Condition: Laboratories Performing Moderate Complexity Testing: Laboratory director was not met. The laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under Subpart H of this part. (See 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 CMS PT records, it was determined the laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under subpart H. of this part. The findings included: For the analyte, Bilirubin, total, the laboratory repeatedly failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events, resulting in unsuccessful PT performance. (See D2016 and D2096) -- 2 of 2 --

Summary Statement of Deficiencies D3033 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3)(i) In addition, the laboratory must retain records of test system performance specifications that the laboratory establishes or verifies under 493.1253 for the period of time the laboratory uses the test system but no less than 2 years. This STANDARD is not met as evidenced by: Based review of the laboratory's records, and interview with the laboratory testing personnel, it was determined that the laboratory failed to retain records including validation of new procedures, calibrations and or calibration verification of test system performance specifications. The findings included: a. The laboratory implemented the new procedures to perform ABO type and Rh (D) type. b. The laboratory claimed that the laboratory had performed and validated the new procedures for ABO type and Rh (D) type. c. At the time of the survey (7/24/2018), there were no ABO type and Rh (D) type validation records available. d. At the time of the survey (7/24/2018), there were no 2017 calibration verification records for Olympus AU 400 chemistry instruments available either. 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 observation of the laboratory temperature records and interview with the laboratory personnel, it was determined that the laboratory failed to follow written Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- policies and procedures to assess employee and, if applicable, consultant competency. The findings included: a. The laboratory used many digital thermometers for the purpose of storage of the laboratory supplies and reagents. b. Observe and interview with the laboratory personnel about how are the features of the digital thermometers work. c. The digital thermometers display three numbers/information to indicate that the current temperature, "Min" and "Max" in the past, some time ago, plus other mode to set the acceptable ranges. d. The laboratory monitor temperature person and other laboratory personnel did not present well that they were competent in monitoring or understand the temperature monitoring. e. An inconsistent acceptable temperature range was set for the freezer # 1005 to between -15 oC and -30 oC on the chart, but on the freezer door was set at -15 oC to -25oC. f. The digital thermometer for freezer # 1005 reading at the time of the survey (7/24/2018 @ 11 am) had indicated the "Min" at -28 oC while the "Max" at 24, which were out of the acceptable range of -15 oC to -25 oC. g. The digital thermometer for freezer # 1001 reading at the time of the survey (7/24/2018 @ 11 am) had indicated the "Max" at 5, which was out of the acceptable range of -15 oC to -25 oC. h. The digital thermometer for refrigerator # 1004 reading at the time of the survey (7/24/2018 @ 11 am) had indicated the "Min" at 1 oC while the "Max" at 24, which were out of the acceptable range of 2 oC to 8 oC. 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: Based on review of the laboratory's records, and interview with the laboratory testing personnel, it was determined that the laboratory failed to follow the manufacturer's calibration verification (CV) instructions and to perform CV for its chemistry instruments. The findings included: a. The laboratory performed routine chemistry using Olympus AU 400 instrument, the test system provided less than three (3) calibrators for the most of the enzyme test procedures. b. The laboratory must perform and document calibration verification (CV) following the manufacturer's CV instructions, at least once every 6 month and including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to -- 2 of 5 -- verify the reportable range of the test results for the test system. c. At the time of survey (7/24/2018 @ 13:15), no CV records available for 2017. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on review of the laboratory records, interview with the laboratory testing personnel, it was determined that the laboratory failed to perform and document all test result comparison activities twice a year to evaluate and define the relationship between test results using the different methodologies, or instruments. The findings included; a . The laboratory used Pentra Excel 80 to perform CBC (complete blood cell counts) including but are not limited to WBC (white blood cell) and automated WBC cell differentials. b. The laboratory also provided and reported with manual WBC cell differentials when the automated cell differentials meet the laboratory established specific criteria to verify for the accuracy of automated results. c. The laboratory failed to document twice annually all test result comparison activities. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on review of the laboratory reports, and interview with the testing personnel, it was determined that the laboratory failed to follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems. The findings included: a. Sample randomly 5 patient test results reports, including its requisition form, quality control records for the tests ordered and performed on the dates to support and verify the accuracy of the testing systems and the accuracy for the patient test reports (Patient Test Result Reports Quality Assessment). b. One health provider has authorized and ordered for its patient, ID #1046 for the following tests: CBC, TSH (3rd IS); T4, Free; T3, Free; PSA, total (Hybrietech); and Magnesium. c. The blood was collected on 07/16/2017 10:34 AM and a final reported was generated on 7/17/2018 5:53 PM. d the laboratory requisition accession# 82164 for that patient #1046 was provided along with its final report on 7/24/2018 for the surveyor to quality assess the laboratory operation, which still showed "pending" to all the tests ordered mentioned above item (b). e. The laboratory personnel could not explain why the laboratory requisition still showed "pending" to all the tests ordered, but the final report has been generated and released to the health provider. D6004 LABORATORY DIRECTOR RESPONSIBILITIES -- 3 of 5 -- 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 observation, review of the laboratory's records, and interview with the laboratory personnel, it was determined that the laboratory director failed to be 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. The findings included: See D-5209, D- 6013, D-6021, and D-6045, D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) 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 review of the laboratory records, interview with the laboratory testing personnel, it was determined that the laboratory director failed to ensure that verification procedures used were adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method. The findings included: See D-5439 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: -- 4 of 5 -- Based on review of the laboratory records, interview with the laboratory testing personnel, it was determined that the laboratory director failed to ensure that quality assessment programs were established and maintained to assure the quality of laboratory services provided. See D-5439, D-5775, and D-5891 D6045 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(7) (b) The technical consultant is responsible for-- (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; This STANDARD is not met as evidenced by: Based on review of the laboratory records, interview with the laboratory testing personnel, it was determined that the laboratory director failed to delegate the technical consultant to provide and identify training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed. The findings included: See D-5209 -- 5 of 5 --