Towner County Medical Center

Summary Statement of Deficiencies D0000 A proficiency testing desk review conducted on August 19, 2024 found the laboratory out of compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 493.1780. The following condition level deficiencies were cited: D2016 - 42 CFR 493.803 Condition: Successful Participation D6076 - 42 CFR 193.1441 Condition: Laboratory Director 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 Certification and Survey Provider Enhanced Reports review, American Association of Bioanalysts-Medical Laboratory Evaluation proficiency testing record review, and staff interview, the laboratory failed to achieve satisfactory performance Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- in proficiency testing for the sub-specialty of bacteriology for three of four consecutive events in 2023-2024 (Event 2-2023, Event 3-2023, and Event 2-2024), resulting in subsequent unsuccessful performance (refer to D2028). D2028 BACTERIOLOGY CFR(s): 493.823(e) 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 Certification and Survey Provider Enhanced Reports (CASPER) review, American Association of Bioanalysts-Medical Laboratory Evaluation proficiency testing record review, and staff interview, the laboratory failed to achieve satisfactory performance in proficiency testing for the sub-specialty of bacteriology in three of four consecutive events in 2023-2024 (Event 2-2023, Event 3-2023, and Event 2- 2024), resulting in subsequent unsuccessful performance. Findings include: 1. Review of CASPER Report 155D (individual laboratory proficiency testing scores) on 08/19 /24 indicated the laboratory scored the following for the sub-specialty of bacteriology in 2023-2024: Event 2-2023 - 72% Event 3-2023 - 77% Event 2-2024 - 57% 2. Review of 2023-2024 American Association of Bioanalysts-Medical Laboratory Evaluation proficiency testing reports on 09/18/24 for the sub-specialty of bacteriology revealed the following results: Event 2-2023 - 74.3% Antimicrobial susceptibility - 20% Culture ID (identification): Urine Culture - 0% Event 3-2023 - 69.0% Culture ID: Misc (miscellaneous) Cultures - 67% Culture ID: Genital Culture - 0% Event 2-2024 - 57.1% Culture ID: Misc Cultures - 33% Culture ID: Genital Culture - 0% The sub-specialty of bacteriology requires a score of 80% or greater for satisfactory performance. 3. During a telephone interview at 1:10 p.m. on 08/19/24, the laboratory supervisor (#1) confirmed the laboratory had scored less than eighty percent in the sub-specialty of bacteriology for Event 2-2023, Event 3-2023, and Event 2-2024. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 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 Certification and Survey Provider Enhanced Reports review, American Association of Bioanalysts-Medical Laboratory Evaluation proficiency testing record review, and staff interview, the laboratory director failed to fulfill the responsibility for overall management of the laboratory by failing to ensure successful proficiency testing performance for the sub-specialty of bacteriology in three of four consecutive events in 2023-2024 (Event 2-2023, Event 3-2023, and Event 2-2024) resulting in subsequent unsuccessful participation in proficiency testing (refer to D6089). D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) -- 2 of 3 -- 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 Certification and Survey Provider Enhanced Reports review, American Association of Bioanalysts-Medical Laboratory Evaluation proficiency testing record review, and staff interview, the laboratory director failed to ensure successful participation in proficiency testing for the sub-specialty of bacteriology in three of four consecutive events in 2023-2024 (Event 2-2023, Event 3-2023, and Event 2- 2024), resulting in subsequent unsuccessful performance (refer to D2028). -- 3 of 3 --

Summary Statement of Deficiencies D5551 IMMUNOHEMATOLOGY CFR(s): 493.1271(a)(f) (a) Patient testing. (a)(1) The laboratory must perform ABO grouping, D (Rho) typing, unexpected antibody detection, antibody identification, and compatibility testing by following the manufacturer's instructions, if provided, and as applicable, 21 CFR 606.151(a) through (e). (a)(2) The laboratory must determine ABO group by concurrently testing unknown red cells with, at a minimum, anti-A and anti-B grouping reagents. For confirmation of ABO group, the unknown serum must be tested with known A1 and B red cells. (a)(3) The laboratory must determine the D (Rho) type by testing unknown red cells with anti-D (anti-Rho) blood typing reagent. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on record review, staff interview, and policy/procedure manual review, the laboratory failed to test patients for Immunoglobin (Ig) M compatibility for 23 of 23 patient compatibility testing days (07/23/23, 08/10/23, 08/30/23, 09/02/23, 09/15/23, 10/10/23, 11/04/23, 11/29/23, 12/18/23, 01/12/24, 01/16/24, 02/01/24, 02/15/24, 03/01 /24, 03/16/24, 03/22/24, 07/04/24, 07/10/24, 07/23/24, 07/24/24, 08/02/24, 08/25/24, 09/04/24) from July 23, 2023 through September 4, 2024 since the laboratory started a new method for compatibility testing. The laboratory performed 44 patient compatibility tests with no IgM compatibility testing during this timeframe. Findings include: 1. Reviewed at 07:50 a.m. on 09/11/24, the July 6, 2023 through September 10, 2024 immunohematology patient logbook failed to include evidence the laboratory performed immediate spin compatibility testing for IgM antibodies for the following: 07/23/23 Patient #599569 - two tests, 08/10/23 Patient #1242318 - one test, 08/30/23 Patient #685145 - two tests, 09/02/23 Patient #1261031 - two tests, 09/15/23 Patient #630410 - two tests, 10/10/23 Patient #685189 - two tests, 11/04/23 Patient #195910 - two tests, 11/29/23 Patient #336918 - two tests, 12/18/23 Patient #714655 - 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 -- two tests, 01/12/24 Patient #714655 - two tests, 01/16/24 Patient #406201 - two tests, 02/01/24 Patient #676133 - two tests, 02/15/24 Patient #105207 - two tests, 03/01/24 Patient #105207 - two tests, 03/16/24 Patient #356908 - two tests, 03/22/24 Patient #1240085 - two tests, 07/04/24 Patient #150908 - two tests, 07/10/24 Patient #105207 - two tests, 07/23/24 Patient #1268173 - two tests, 07/24/24 Patient #1268173 - one test, 08/02/24 Patient #131339 - two tests, 08/25/24 Patient #525402 - two tests, and 09/04/24 Patient #105207 - two tests. 2. During interview at 8:25 a.m. on 09/11/24, a technical supervisor (#1) stated the following: the laboratory began using a new method for immunohematology patient testing on 07/06/23; the laboratory was unaware they should perform immediate spin crossmatch tests for IgM antibodies for all patient compatibility testing; and the laboratory did not perform immediate spin crossmatches for the above listed patient tests. 3. Upon review on 09/11/24, the immunohematology policy/procedure manual failed to include a policy/procedure for performing immediate spin crossmatch tests for IgM antibodies for patient compatibility testing using the new test method. -- 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 Certification and Survey Provider Enhanced Reports review, American Association of Bioanalysts proficiency testing record review, and staff interview, the laboratory failed to achieve satisfactory performance in proficiency testing for the sub- specialty of bacteriology for two of three consecutive events in 2023 (Event 2 and Event 3), resulting in unsuccessful performance. (Refer to D2028) D2028 BACTERIOLOGY CFR(s): 493.823(e) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Failure to achieve 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 Certification and Survey Provider Enhanced Reports (CASPER) review, proficiency testing record review, and staff interview, the laboratory failed to achieve satisfactory performance in proficiency testing for the sub-specialty of bacteriology in two of three consecutive events in 2023 (Event 2 and Event 3), resulting in unsuccessful performance. Findings include: 1. Review of CASPER Report 155D (individual laboratory proficiency testing scores) on 01/10/24 indicated the laboratory scored the following for the sub-specialty of bacteriology in 2023: Event 2 - 72% Event 3 - 77% 2. Review of 2023 American Association of Bioanalysts proficiency testing reports on 01/10/24 for the sub-specialty of bacteriology revealed the following results: Event 2-2023 - 74.3% Antimicrobial susceptibility - 20% Culture ID (identification): Misc (miscellaneous) Cultures - 100% Culture ID: Genital culture - 100% Culture ID: Throat Culture - 100% Culture ID: Urine Culture - 0% Event 3- 2023 - 76.6% Antimicrobial susceptibility - 83% Culture ID: Misc Cultures - 100% Culture ID: Genital culture - 0% Culture ID: Throat Culture - 100% Culture ID: Urine Culture - 100% The sub-specialty of bacteriology requires a score of 80% or greater for satisfactory performance. 3. During a telephone interview at 10:58 a.m. on 01/10 /24, the laboratory supervisor (#1) confirmed the laboratory had scored less than eighty percent in the sub-specialty of bacteriology for Event 2 and Event 3 in 2023. -- 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 American Proficiency Institute proficiency testing record review and staff interview, the laboratory failed to achieve satisfactory performance in proficiency testing for the analyte total bilirubin for two of three consecutive events in 2023 (Event 2 and Event 3), resulting in unsuccessful performance. (Refer to D2096) D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- 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 record review and staff interview, the laboratory failed to achieve satisfactory performance in proficiency testing for the analyte total bilirubin in two of three consecutive events in 2023 (Event 2 and Event 3), resulting in unsuccessful performance. Findings include: 1. Review of 2023 American Proficiency Institute (API) proficiency testing reports on 10-09-23 for the analyte total bilirubin revealed the following results: Event 2-2023 - 60% Sample Lab Results Acceptable Range #06 1.6 0.7 - 1.6 #07 4.0 2.5 - 3.9 #08 0.5 0.0 - 0.9 #09 5.2 3.4 - 5.2 #10 3.5 2.1 - 3.2 Event 3-2023 - 40% Sample Lab Results Acceptable Range #11 5.4 3.3 - 5.1 #12 1.4 0.6 - 1.5 #13 4.5 2.7 - 4.2 #14 3.4 2.2 - 3.4 Sample Lab Results Acceptable Range #15 2.8 1.7 - 2.7 The specialty of chemistry requires a score of 80% or greater for satisfactory performance. 2. During a telephone interview at 10:15 a.m. on 10/09/23, the laboratory supervisor (#1) confirmed the laboratory had scored 60% in Event 2 and 40% in Event 3 in 2023 for total bilirubin. -- 2 of 2 --

Summary Statement of Deficiencies D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on record review, staff interview, and policy review, the laboratory failed to verify the accuracy for 1 of 1 new immunology test method (qualitative rheumatoid factor) in 2021 before reporting patient results. The laboratory performed approximately twenty patient tests with the new test kit since implementation. Findings include: 1. Reviewed at 5:20 p.m. on 10/04/22, the laboratory's 2021 records for a new qualitative rheumatoid factor test kit started 11/15/21 lacked evidence the laboratory verified the accuracy performance specifications. Upon request the laboratory failed to provide evidence of accuracy verification for the new qualitative rheumatoid factor test kit. 2. During interview at 8:00 a.m. on 10/05/22, the laboratory supervisor (#1) confirmed the laboratory began patient testing using a new qualitative rheumatoid factor test kit (Cardinal Health RF [rheumatoid factor]) on 11/15/21, and the laboratory did not verify the performance specification for accuracy. 3. Reviewed at 11:45 a.m. on 10/05/22, the policy "Adopting New Test Procedure," dated 09/2014, stated, ". . . Purpose: To provide guidelines to follow when adopting a new test procedure. . . . Procedure: . . . 11. . . . the following studies need to be performed: A. Analytical accuracy is established by comparing results to a definitive or reference method, or may be verified by comparing results to an established comparative method. . . . 12. Review the above data with the pathologist responsible for the 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 -- section. When all required preliminary testing has been completed and no additional studies are felt to be needed, proceed with preparation of test procedure and personnel training. . . ." 4. Reviewed at 11:45 a.m. on 10/05/22, the policy "Test Implementation for Towner County Medical Center," dated 11/2015, stated, ". . . New Method Data: . . . Qualitative Testing . . .: 1) Approximately 5 patient correlations between testing methods. 2) Approximately 5 control correlations between new and old lots. . . ." -- 2 of 2 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on record review, staff interview, and policy review, the laboratory failed to enroll in proficiency testing for 2 of 2 regulated chemistry tests (magnesium and lactate dehygrogenase [LD]) started in May 2019. The laboratory performed approximately 200 magnesium and LD patient tests in May 2019 through April 21, 2021. Findings include: 1. Reviewed at 1:00 p.m. on 04/20/21, the laboratory's test menu listed magnesium and LD available for patient testing. 2. Reviewed at 1:10 p.m. on 04/20/21, the third event 2019, first-third events 2020, and first event 2021 proficiency testing records indicated the laboratory did not participate in proficiency testing for magnesium and LD. 4. During interview at 9:30 a.m. on 04/21/21, the laboratory supervisor (Personnel #1) confirmed the laboratory started performing magnesium and LD patient testing in May 2019 when the laboratory began using a new chemistry analyzer and did not enroll in proficiency testing since the start of magnesium and LD testing. 5. Reviewed at 10:00 a.m. on 04/21/21, the policy "Laboratory Proficiency Testing Policy," dated 11/2015, stated, ". . . Standards: 1. Proficiency testing must be performed for all regulated laboratory tests. . . ." D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- 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 record review, staff interview, and policy review, the laboratory failed to twice annually verify the accuracy of 4 of 19 non-regulated analytes (phosphorus, sperm absence/presence, direct bilirubin, and potassium hydroxide preparation [KOH prep]) in 2020. The laboratory performed approximately 40 phosphorus, one sperm absence/presence, 90 direct bilirubin, and 30 KOH prep patient tests in 2020. Findings include: 1. Reviewed at 1:00 p.m. on 04/20/21, the laboratory's test menu listed phosphorus, sperm absence/presence, direct bilirubin, and KOH prep available for patient testing. 2. Reviewed at 1:10 p.m. on 04/20/21, the 2020 proficiency testing records indicated the laboratory did not participate in proficiency testing for phosphorus, sperm absence/presence, direct bilirubin, and KOH prep. 3. Reviewed at 9:20 a.m. on 04/21/21, the laboratory's 2020 twice annual comparison records failed to provide evidence of twice annual accuracy verification for phosphorus and sperm absence/presence in 2020. These records indicated the laboratory verified the accuracy of direct bilirubin and KOH prep once in 2020. 4. During interview at 9:30 a. m. on 04/21/21, the laboratory supervisor (Personnel #1) confirmed the laboratory performed phosphorus, sperm absence/presence, direct bilirubin, and KOH prep patient testing in 2020 and did not twice annually verify the accuracy of these tests in 2020. 5. Reviewed at 10:00 a.m. on 04/21/21, the policy "Laboratory Proficiency Testing Policy," dated 11/2015, stated, ". . . Standards: 1. . . . Unregulated analytes must have one of the following: Proficiency Testing, Biannual in house comparison testing or Biannual comparison testing with another approved laboratory. . . ." D6087 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(iii) The laboratory director must ensure that laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on record review, manufacturer's instructions review, observation, staff interview, and procedure review, the laboratory failed to use the correct ISI (International Sensitivity Index) and mean normal protime (PT) value for calculating International Normalized Ratios (INRs) for 20 of 20 weeks (December 1, 2020 through April 20, 2021) since the laboratory began using a new lot number of Innovin (thromboplastin) reagent on their coagulation analyzer. The laboratory performed approximately 200 tests during this timeframe. Findings include: 1. Reviewed at 10: 55 a.m. on 04/21/21, the 2018-2020 coagulation lot number change records failed to include data to determine the mean normal PT for Innovin lot number 549730. 2. Reviewed at 11:00 a.m. on 04/21/21, the Siemens Dade Innovin package insert for lot number 549730, dated 07/2018, stated the BFTII analyzer ISI as 0.89. 3. Observation of the BFT II coagulation analyzer at 11:30 a.m. on 04/21/21 revealed an ISI of 0.88 and a mean normal PT value of 9.5 used to calculate patient INRs. 4. During interview at 11:45 a.m. on 04/21/21, the laboratory supervisor (Personnel #1) confirmed the laboratory did not calculate a new mean normal PT using the new lot number of Innovin and confirmed the laboratory should use an ISI value of 0.89 for Innovin lot -- 2 of 3 -- number 549730. The laboratory supervisor (#1) stated she did not know the exact date the laboratory started using the new lot number of Innovin, but the old lot number expired on 11/30/20. 5. Reviewed on 04/21/21, the Siemens Dade Innovin package insert, dated 05/2008, stated, ". . . Determination of INR (International Normalized Ratio) . . . 1. . . . the PT results for patients on oral anticoagulants should be recorded as INR values. . . The INR is determined according to the following equation: INR = R [powered to the ISI value] where R = Patient PT [divided by] Mean normal PT** ISI is the International Sensitivity Index of the reagent/instrument combination. . . . ** The mean normal PT is defined as the mean value of the normal range. It must be determined specifically for each thromboplastin lot using the method used to analyze the patient samples . . ." 6. Reviewed on 04/21/21, the procedure "Dade - Innovin BFT II Prothrombin Time (PT)," dated 09/2014, failed to include a procedure to use when changing lot numbers of Innovin. -- 3 of 3 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on American Proficiency Institute proficiency testing record review and staff interview, the laboratory failed to achieve satisfactory performance in proficiency testing for the analyte alanine transaminase for two consecutive events in 2019-2020 (Event 3-2019 and Event 1-2020), resulting in unsuccessful performance. (Refer to D2096) D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on proficiency testing record review and staff interview, the laboratory failed to achieve satisfactory performance in proficiency testing for the analyte alanine transaminase (ALT) in two consecutive events in 2019-2020 (Event 3-2019 and Event 1-2020), resulting in unsuccessful performance. Findings include: 1. Review of 2019- 2020 American Proficiency Institute (API) proficiency testing reports on 08/24/20 for the analyte ALT revealed the following results: Event 3-2019 - 60% Sample Lab Results Acceptable Range #11 36 49 - 74 #12 60 68 - 103 #13 128 123 - 186 #14 148 141 - 212 #15 192 176 - 266 Event 1-2020 - 60% Sample Lab Results Acceptable Range #01 16 20 - 31 #02 84 81 - 123 #03 14 30 - 46 Sample Lab Results Acceptable Range #04 248 200 - 302 #05 157 135 - 203 The specialty of chemistry requires a score of 80% or greater for satisfactory performance. 2. During a telephone interview at 10:00 a.m. on 08/24/20, the laboratory manager (#1) confirmed the laboratory had scored 60% in Event 3 in 2019 and Event 1 in 2020 for ALT. He stated the laboratory had changed instruments and had failed to change the method code with the proficiency testing company. -- 2 of 2 --

Summary Statement of Deficiencies D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on quality control (QC) record review, staff interview, patient record review, and policy review, the laboratory failed to perform two levels of QC for thirteen chemistry analytes on the Vitros 350 analyzer on 1 of 26 patient testing days (from 11: 30 a.m. on 05/17/18 until 1:00 p.m. on 05/18/18) in May 2018. The laboratory tested and reported results for thirteen Vitros 350 analytes for approximately 13 patients during this timeframe. Findings include: 1. Reviewed at approximately 9:30 a.m. on 08 /22/18, the May 2018 Vitros 350 chemistry QC records lacked evidence the laboratory performed two levels of QC from 11:30 a.m. on 05/17/18 until 1:00 p.m. on 05/18/18. Upon request, the laboratory failed to provide evidence of QC performance for this timeframe. 2. During interview at approximately 10:45 a.m. on 08/22/18, a technical supervisor (#1) stated the laboratory should perform QC every 24 hours of patient testing on the Vitros 350. A technical supervisor (#1) confirmed the laboratory did not have evidence of QC performance from 11:30 a.m. on 05/17/18 until 1:00 p.m. on 05 /18/18 for thirteen analytes on the Vitros 350, and the laboratory reported patient results during this timeframe. 3. Reviewed at 10:50 a.m. on 08/22/18, the patient test records indicated the laboratory reported Vitros 350 chemistry results from 11:30 a.m. on 05/17/18 until 1:00 p.m. on 05/18/18 for the following patient samples: #374251, #374505, #374726, #374829, #376264, #375297, #375411, #375417, #375419, #375489, #376186, #376593, and #376736. 4. Reviewed at 1:40 p.m. on 08/22/18, the policy "General Laboratory Policy & Laboratory Operation," dated 11/2015, stated, ". 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 -- . . Quality Control runs and re-runs are as follows: . . . Vitros/Chemistry 2 levels (Level 1 & Level 2). Good for 24 hours. . . ." -- 2 of 2 --