Claremont Medical Center

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, Sodium (Na), resulting in an "initial" (first) unsuccessful performance. 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, Na, as follows: 2021 Q2 2022 Q1 Na 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, Na. 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, Na, 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 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 the laboratory's American Proficiency Institute (API) proficiency testing (PT) records, and interview with the laboratory testing personnel and the laboratory director, it was determined that the laboratory failed to successfully participate in a PT program approved by CMS for Total Cholesterol (Chol) which was certified under CLIA. The findings included: a. The laboratory failed to achieve satisfactory performance for the same analyte, Chol, in two out of two consecutive testing API PT events in the specialty of Routine Chemistry constituting unsuccessful PT performance. (See D-2096). 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 -- D2087 ROUTINE CHEMISTRY CFR(s): 493.841(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 laboratory's American Proficiency Institute (API) proficiency testing (PT) test results reports, and interview with the testing personnel and the laboratory director, it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event was unsatisfactory analyte performance for the testing event. The findings included: a. The laboratory used Mindray BS200 to perform Routine Chemistry including, but not limited to Glucose (Glu), Chloride (Chl), Sodium (NA), Total Iron (Iron), BUN, Total Protein (TP), Alk Phos, Triglyceride (TG), b. To ensure the accuracy of the Routine Chemistry testing, the laboratory enrolled its PT with API PT program. c. The laboratory failed to attain a score of at least 80 percent of acceptable responses for the following analyte listed in each PT testing event was unsatisfactory analyte performance for the testing event. Test/% = analyte/attained % score PT event Test/% Test/% Test/% Test/% Q1 2019 Na/60 Q1 2021 Glu/40 Iron/60 BUN/40 Alk Phos/0 Q2 2021 Chl/40 Na/40 TP./20 TG/60 d. The laboratory performed routine chemistry including test in approximately 25 patient sample weekly. e. The laboratory testing personnel affirmed (7/16/21 @ 12:15 PM) that the laboratory failed to attain scores of at least 80 percent of acceptable responses for each analyte in Q2 2021 PT events which were unsatisfactory analyte performance. 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 review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) test results reports, and interview with the testing personnel and the laboratory director, it was determined that the laboratory failed to achieve satisfactory performance for Total Cholesterol (Chol) in two consecutive PT testing events was unsuccessful performance. The findings included: a. The laboratory used Mindray BS200 to perform Routine Chemistry including, but not limited to Chol. b. To ensure the accuracy of the Routine Chemistry testing, the laboratory enrolled a CMS approved PT program with API. c. The laboratory attained scores of 60 % for Chol in both Q3 2020 and Q1 2021 PT events which was unsuccessful performance. d. The laboratory performed Routine Chemistry including Chol test in approximately 25 patient sample weekly. e. The laboratory personnel affirmed (7/16/21 @ 12:15 PM) that the laboratory attained scores of 60 % for Chol in both Q3 2020 and Q1 2021 PT events was unsuccessful performance. D2121 HEMATOLOGY CFR(s): 493.851(a) -- 2 of 5 -- 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 laboratory's American Proficiency Institute (API) proficiency testing (PT) test results reports, and interview with the testing personnel and the laboratory director, it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for hematology testing in each testing event was unsatisfactory analyte performance for the testing event. The findings included: a. The laboratory used Horiba ABX Micro60 with 3-part differentials to perform CBC (Complete Blood Cell Count) including, but not limited to Hemoglobin (Hgb), and WBC with cell differentials (Cell). b. To ensure the accuracy of the CBC testing, the laboratory enrolled its PT program with API. c. The laboratory failed to attain a score of at least 80 percent of acceptable responses for the following analyte listed in each testing event was unsatisfactory analyte performance for the testing event. Test/% = analyte/attained % score PT event Test/% Test/% Q3 2020 Hgb/60 Cell/53 53% = Granulocyte 60%, Lymphocytes 60% Monocyte 40%) d. The laboratory had stopped performing CBC since January 2021. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on touring the facility and observation of the storage areas of the laboratory supplies, and interview with the laboratory testing personnel and the laboratory director it was determined that the Urine Drug Screen calibrators found in the refrigerator, they have exceeded their expiration date. The findings included: a. The laboratory performed Urine Drug Screen qualitatively using Thermo Fisher calibrators. b. The UDS calibrators with Lot # 73893546 for level I, II, and III were found in a refrigerator with expiration date on 3/31/2021, . c. The laboratory testing personnel affirmed (7/16/2021 @ 11:45 AM) that the UDS calibrators level I, II and III were expired on 3/31/2021. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: -- 3 of 5 -- Based on review of the laboratory's patient test results reports, interview with the laboratory testing personnel and the laboratory director, it was determined that the laboratory failed to include the report date and provide proper information in the patient test results reports. The findings included: a. To ensure the accuracy, reliability and timely, the patient test report must indicate and include but not limited to the followings: (1) The test report date. (2) The test performed. (3) The test result and, if applicable, the units of measurement or interpretation, or both. b. Review of the laboratory's patient test result reports found that the laboratory failed to include the report date in the report. c. A test name of TSH3 is improperly used to represent a test name of TSH, Thyroid Stimulating Hormone. d. The unit of measurement for a test of TSH was "uLu/ML", instead of uIU/mL (where "u" is micro, IU is international Unit). e. The laboratory testing personnel affirmed (7/16/2021 @ noon) that the laboratory's patient test result reports missing the report date and having inaccurate test name of TSH with its measurement unit. 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 D-6016 and D-2016) 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 of the laboratory's American Proficiency Institute (API) proficiency testing (PT) test results reports, and interview with the testing personnel and the laboratory director, it was determined that the laboratory director failed to ensure that the proficiency testing samples were tested as required. The findings included: a. The laboratory used Mindray BS200 to perform Routine Chemistry including, but not limited to Chol. b. To ensure the accuracy of the Routine Chemistry testing, the laboratory enrolled a CMS approved PT program with API. c. The laboratory attained scores of 60 % for Chol in both Q3 2020 and Q1 2021 PT events which was unsuccessful performance see D-2096. D6023 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(6) -- 4 of 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)(6) Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system; This STANDARD is not met as evidenced by: Based on touring and observation of the facility, review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) test results reports, review of the patient test result reports, and interview with the testing personnel and the laboratory director, it was determined that the laboratory director failed to ensure the establishment and maintenance of acceptable levels of analytical performance for each test system. The findings included: a. The laboratory used Mindray BS200 to perform Routine Chemistry and Horiba ABX Micro 60 to perform hematology testing. b. To ensure the accuracy of the Routine Chemistry testing, the laboratory enrolled a CMS approved PT program with API for Routine Chemistry and Hematology testing systems. c. The laboratory failed to attain at least 80 percent of acceptable responses for each analyte in each testing event was unsatisfactory analyte performance for the testing event, see D-2087, and D-2121. d. The laboratory failed to achieve satisfactory performance for the same analyte in two consecutive testing events consecutive testing events was unsuccessful performance, see D-2096 e. The laboratory was found to use expired UDS calibrators, See D-5417 f. The laboratory's patient test result reports did not include the information required by CLIA's rules and regulations, see D-5805 -- 5 of 5 --

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, Ca, 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 analyte, Ca, Total, as follows: 2020 Q2 2021 Q1 Ca, Total 40% 0% 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, Ca, 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, Ca, 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 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, Cholesterol, HDL, as follows: 2020 Q2 2020 Q3 Cholesterol, HDL 0% 20% Q2 = Second testing event Q3 = Third testing event b. Failure to achieve satisfactory performance for the same analyte or test in two of three consecutive PT resulted in an initial unsuccessful performance for the analyte, Cholesterol, HDL. 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 Cholesterol, HDL, 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 D2087 ROUTINE CHEMISTRY CFR(s): 493.841(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 laboratory's proficiency testing (PT) result reports, and interview with the technical consultant (TC) and the 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 each testing event was unsatisfactory analyte performance for the testing event. The findings included: a The laboratory performed and reported routine chemistry including, but are not limited to the following: Alk Phos, AST, Na, CA, for its patient test result reports.. b. The laboratory enrolled its PT with American Proficiency Institute (API) to evaluate to ensure the ace proficiency testing performance to ensure the curacy of the testing systems. c. The laboratory attained a score of 60 % for analyte of Alk Phos in the 1st 2017 PT event which was unsatisfactory analyte performance for the testing event. d. The laboratory attained scores of 60 % for analyte of AST and Na in the 3rd 2017 PT event which were unsatisfactory analyte performance for the testing event. e. The laboratory attained scores of 40 % for analyte of CA in the 3rd 2017 PT event which was unsatisfactory analyte performance for the testing event. f. The laboratory performed the analyte mentioned above in approximately 82 patient samples monthly for each analyte. g. The laboratory affirmed (11/2/18 @ 11:35) that the laboratory failed to attain a score of at least 80 percent of acceptable responses for those analyte mentioned above in each testing event were unsatisfactory analyte performance for the testing event. D2121 HEMATOLOGY CFR(s): 493.851(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 6 -- 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 laboratory's proficiency testing (PT) result reports, and interview with the technical consultant (TC) and the 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 each testing event was unsatisfactory analyte performance for the testing event. The findings included: a The laboratory used ABX Micro 60, a hematology analyzer, and performed hematology and reported results including, but is not limited to the following: Hematocrit (Hct), for its patient samples. b. The laboratory enrolled its PT with American Proficiency Institute (API) to evaluate the proficiency testing performance and to ensure the accuracy of the testing systems. c. The laboratory attained a score of 60 % for analyte of Hct in the 2nd 2018 PT event which was unsatisfactory analyte performance for the testing event. d. The laboratory performed the analyte Hct in approximately 340 patient samples monthly g. The laboratory affirmed (11/2/18 @ 11:35) that the laboratory failed to attain a score of at least 80 percent of acceptable responses for Hct the 2nd 2018 PT event was unsatisfactory analyte performance for the testing event. 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 on review of the laboratory documents and records, and interview with the technical consultant (TC), and the testing personnel (TP), it was determined that the laboratory failed to 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. The findings included: a. The laboratory failed to retain the manufacturer's inserts and/or the assay quality control target values inserts for at least two years. b. At the time of the survey (11/2/18 @ 13:15), the laboratory failed to provide manufacturer's insert to verify the current assay quality control target data for the period of time the laboratory. c. Where the laboratory can provide the inserts, the laboratory failed to date and retain the manufacturer's instructions of test system performance specifications for at least two years. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: -- 2 of 6 -- Based on observation of the storage areas, interview with the testing personnel (TP), it was determined that the laboratory failed to label and date when the reagents and the expiration date once the reagents opened . The findings included: a. Observed the refrigerator reagent storage areas and noted that the routine chemistry reagent bottles in use were not labeled and dated for expiration date when opened . b. The reagent bottles in use inside the instrument reagent carousel were not labeled with date. c. The TP affirmed (11/2/18 @ 13:50) that the laboratory failed to label and date the reagent once it opened to indicate the expiration date. D5419 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(e) Components of reagent kits of different lot numbers must not be interchanged unless otherwise specified by the manufacturer. This STANDARD is not met as evidenced by: Based on observation of the reagent storage areas and the instrument, interview with the testing personnel (TP), it was determined that the laboratory failed to follow the manufacture's instructions that the reagent kits of different lot numbers must not be interchanged unless otherwise specified by the manufacturer. The findings included: a. Interview with the TP, the laboratory bought bulk reagents and refill the reagent bottles in the instrument chamber when the reagents in use is low. b. Observed the routine chemistry analyzer, Mindray BS200, the reagent bottle barcode with a lot number of D. Bili (direct Bilirubin) R2 (lot #701602-032) in use was different from the one lot in stock in the refrigerator (lot # 701602-026) when the TP refill the bottle.. c. The TP mixed D. Bili (R2) reagent lot 701602-032 with 701602-026 to its reagent bottle in the instrument chambers, d. The TP affirmed (11/2/18 @ 13:45) that the laboratory mixed different lot of D. Bili (R2) reagent. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory quality control documents and interview with the technical consultant (TC), and the testing personnel (TP), it was determined that the laboratory failed to update and follow the written quality control policy to detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance and monitor over time the accuracy and precision of test performance that may be influenced by changes in test system. The findings included: a. Based on interview with the TP, when the QC out of the -- 3 of 6 -- acceptable ranges, the TP first would repeat the failed QC sample once more and go further, if failed again. b. No repeated noted for the day a QC indicated that the QC run on 01/15/18 @07:44, a normal QC level result of RBC (lot # MX 409 Expiry of 03 /05/18 ) was 4.45 L, which was out of the acceptable range between 4.54 and 4.90. c. Review of the laboratory's written "QUALITY CONTROL DECISIONS" procedure, with subtitle of "USING A TWO OR THREE CONTROL SYSTEM", no written procedures or instruction to instruct the TP what to do when the QC out in the first run. d. The verbiage in the "ACCEPT RUN IF:" on the third paragraph of "QUALITY CONTROL DECISIONS" , "the laboratory MUST ONLY RUN 2 LEVELS of controls,..." not consistent with the laboratory daily operations, for hematology the laboratory regularly performs "three levels" control material, namely. Abn low, Norm, and Abn Hi. e. The TC affirmed (11/2/18 @ 12:35) that the QC policies and procedures need to be updated and revised. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on review of the laboratory instrument print-out documents and the final patient test result reports, and interview with the technical consultant (TC), the testing personnel (TP), it was determined that the laboratory failed to ensure the patient test results and other patient-specific data were accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination. The findings included: a. The laboratory failed to ensure the patient test results and patient- specific data electronically reported to network or interfaced systems. b. Review of the patient test result reports and its instrument print-out data, the laboratory's patient tests final reports provided inconsistent between sample collection date and reported date. c. A patient ID #7299, the instrument print-out sheet indicated a collected (draw) date of 10/18/2018 , while the final report indicated a report date of 10/17/18. c. The collected date was one day AFTER the patient final test results reported date. d. The laboratory used Medcom, an LIS (laboratory information system) to generate their patient final test results. e. The laboratory was aware of the problems and notified the LIS vendor long ago, but failed to correct it. f. The laboratory affirmed (11/2/18 @ 13: 45) that the laboratory failed to correct the LIS system. 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 -- 4 of 6 -- 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 of the facility and laboratory operations, the laboratory documents, and interview with the technical consultant (TC) and the testing personnel (TP), it was determined that the laboratory director failed to be responsible for the overall operation and administration of the laboratory to assure compliance with the applicable regulations. The findings included: See D-6016, D-6020, and D-6021 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 of the laboratory's proficiency testing (PT) result reports, and interview with the technical consultant (TC) and the 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: See D-2087 and D-2121 D6020 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 the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on review of the laboratory quality control (QC) documents, and interview with the technical consultant (TC), the testing personnel (TP) and the owner, it was determined that the laboratory director failed to ensure that the quality control program was established, revised and maintained to assure the quality of laboratory services provided. The findings included: See D-3033, D-5415, D-5419, and D-5441 D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of -- 5 of 6 -- 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 review of the laboratory documents, and interview with the technical consultant, the testing personnel and the owner, 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. The findings included: See D-5801 -- 6 of 6 --