So Big Horn Co Hospital

Summary Statement of Deficiencies D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of proficiency testing records, lack of documentation, and staff interview, the laboratory failed to have a system in place for reviewing proficiency testing results that received an artificial score of 100% for 8 of 29 American Proficiency Institute (API) proficiency testing events reviewed from September 2022 through August 2024. The findings were: 1. Review of the 2022 API Microbiology Event #3 proficiency testing evaluation showed sample UR-11 (urine culture MIC /zone diameter value) was not graded and the laboratory was directed to view the data summary. There was no evidence the non-graded proficiency testing sample had been evaluated. 2. Review of the 2023 API Chemistry Core Event #1 proficiency testing evaluation showed the laboratory received an artificial score of 100% on sample CH- 01 (alanine transaminase) due to a lack of consensus. There was no evidence the non- graded proficiency testing sample had been evaluated. 3. Review of the 2023 API Microbiology Event #1 proficiency testing evaluation showed sample UR-01 (urine culture MIC/zone diameter and susceptibility interpretation for ceftazidime) was not graded and the laboratory was directed to view the data summary. There was no evidence the non-graded proficiency testing sample had been evaluated. 4. Review of the 2023 API Microbiology Event #2 proficiency testing evaluation showed sample BL-01 (blood culture MIC/zone diameter value) and sample UR-06 (urine culture MIC /zone diameter value) were not graded and the laboratory was directed to view the data summary. There was no evidence the non-graded proficiency testing sample had 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 -- been evaluated. 5. Review of the 2023 API Microbiology Event #3 proficiency testing evaluation showed sample UR-11 (urine culture MIC/zone diameter value) was not graded and the laboratory was directed to view the data summary. There was no evidence the non-graded proficiency testing sample had been evaluated. 6. Review of the 2024 API Chemistry Core Event #1 proficiency testing evaluation showed samples CH-02, CH-03, and CH-05 (total bilirubin) were not graded due to "results variance". Samples CH-01, CH-02, CH-03, CH-04, and CH-05 (lipase) were not graded and the laboratory was directed to view the data summary. There was no evidence the non-graded proficiency testing samples had been evaluated. 7. Review of the 2024 API Microbiology Event #1 proficiency testing evaluation showed sample SF-01 (cerebrospinal fluid MIC/zone diameter) was not graded and the laboratory was directed to view the data summary. Sample GS-02 (gram stain morphology) and sample UR-01 (urine culture MIC/zone diameter value and susceptibility interpretation for trimethoprim/sulfamethoxazole) were not graded. There was no evidence the non-graded proficiency testing sample had been evaluated. 8. Review of the 2024 Microbiology Event #2 proficiency testing evaluation showed sample UR-06 (urine culture MIC/zone diameter and susceptibility interpretation for ciprofloxacin and gentamicin) were not graded. There was no evidence the non-graded proficiency testing sample had been evaluated. 9. Interview with the general supervisor on 9/26/24 at 10:02 AM revealed he reviewed the non-graded proficiency testing samples; however, he did not document the results of his evaluation. 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 proficiency testing records, policy and procedure review, and staff interview, the laboratory failed to at least twice annually verify the accuracy of ammonia for 1 of 2 years (2023) reviewed. The laboratory performed approximately 14 ammonia patient tests per year. The findings were: 1. Review of the American Proficiency Institute proficiency testing records showed the laboratory scored a 100% on the 2023 Chemistry Miscellaneous Event #1 for ammonia. Further review showed the laboratory scored 67% on ammonia on Event #2 of 2023. A

Summary Statement of Deficiencies D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of proficiency testing records, lack of documentation, review of personnel files, review of the CMS (Centers for Medicare and Medicaid Services) 209 Laboratory Personnel report, policy and procedure review, and staff interview, the laboratory failed to ensure proficiency test results with a score of less than 100% were evaluated for 2 consecutive survey cycles 6/3/21 and 8/11/22. (D5211). In addition the laboratory failed to ensure competency assessments were completed as required (D5209) and an ongoing quality assessment program was in place (D5291). D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of personnel files, review of the CMS (Centers for Medicare and Medicaid Services) 209 Laboratory Personnel Report, lack of documentation, policy Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- and procedure review, and staff interview, the technical supervisor (TS) failed to complete an initial competency assessment for 2 of 6 (TP #1, TP #2) new testing personnel prior to patient testing on the ABBOTT iSTAT instrument. In addition, an annual competency assessment had not been completed for 1 of 4 testing personnel (TP #3) operating the ABBOTT iSTAT instrument for 1 of 2 years reviewed (2021). The findings were: 1. Review of the personnel file for TP #1 showed he was hired on 6 /27/22 and a "6 month" competency assessment had been completed on 8/7/22 (2 months post-hire date). There was no evidence the TS had completed an initial competency assessment prior to TP #1 independently testing patient samples. 2. Review of the personnel file for TP #2 showed she was hired on 5/12/22 and a "6 month" competency assessment had been completed on 8/5/22 (3 months post-hire date). There was no evidence the TS had completed an initial competency assessment prior to TP #2 independently testing patient samples. Interview with TP #2 on 8/10/22 at 8:07 PM revealed the TS had provided training when she was hired and then the TS had given her a "refresher last week". 3. Review of the personnel file for TP #3 showed no evidence an annual competency assessment was completed in 2021. 4. Interview with the TS on 8/11/22 at 11:36 AM confirmed the laboratory did not have documentation of the initial competency assessments for TP #1 and TP #2 or the annual competency assessment for TP #3. 5. Review of the "Competency assessments" policy and procedure, last reviewed 6/9/21, showed "All testing personnel for the laboratory will be assessed upon hire, at 3 months, 6 months and 1 year for competency. Annual assessments will be conducted thereafter...Non Laboratory testing personnel 1. Proficiency i. Emergency room and Critical Access Hospital nurses are trained to perform dipstick urinalysis, waived diagnostic tests and the use of the IStat. Training will be documented...The Laboratory Director will review all competency assessment forms for all employees to ensure proper training is complete." D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of proficiency testing records, lack of documentation, and staff interview, the laboratory failed to review and evaluate proficiency testing results for 4 of 17 proficiency testing events reviewed from May 2021 to August 2022. The findings were: 1. Review of the American Proficiency Institute (API) proficiency testing (PT) report failed to include documentation the laboratory had evaluated test scores of less than 100%. The following concerns were identified: a. Review of the 2021 API Microbiology Event #3 PT results showed the laboratory scored an 80% on gram stain morphology. There was no documentation the laboratory had evaluated the test results. b. Review of the 2022 API Microbiology Event #1 PT results showed the laboratory scored an 80% on gram stain morphology and an 80% on the gram stain. There was no documentation the laboratory had evaluated the test results. c. Review of the 2022 API Microbiology Event #2 PT results showed the laboratory scored an 80% on gram stain morphology. There was no documentation the laboratory had evaluated the test results. d. Review of the 2022 API Chemistry Event #1 PT results showed the laboratory scored an 80% on pH and an 80% on blood alcohol. There was no documentation the laboratory had evaluated the test results. 2. Interview with the technical supervisor on 8/11/22 at 11:33 AM confirmed the PT scores of less than -- 2 of 7 -- 100% had not been investigated. THIS IS A REPEAT DEFICIENCY, last cited on 6/3 /21. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on policy and procedure review, lack of documentation, and staff interview, the laboratory failed to follow written procedures to monitor, assess, and correct problems in the general laboratory system for 2 of 2 years reviewed (2021, 2022). The findings were: 1. Review of the laboratory's documentation showed no evidence an ongoing quality assessment program was in place. 2. Review of the policy and procedure titled "QA/PI (Quality Assurance/Performance Improvement), last revised on 1/23/13, had not been signed and approved by the current laboratory director. 3. Interview with the technical supervisor on 8/11/22 at 11:33 AM revealed she participated in the hospital's quality assurance program, however she did not have a system in place to monitor, assess, and when indicated, correct identified problems within the laboratory. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on observation and staff interview, the laboratory failed to ensure written procedures were readily available to laboratory personnel for 4 of 6 IQCPs [individual quality control plan] (Microbiology using the Microscan, Microalbumin using the DCA Vantage instrument, Troponin I testing on the Abbott iSTAT instrument, BNP (B-type Natriuretic Peptide) testing on the Abbott iSTAT instrument). The findings were: 1. Interview with testing personnel #4 on 8/11/22 at 9 AM revealed she was unaware of where a written quality control procedure was located for the ABBOTT iSTAT instrument. Further, TP #4 stated the technical supervisor (TS) used a monthly planner to keep track of when quality control was due and then transferred the information to a dry erase calendar on the wall. 2. Observation on 8/11/22 at 11:15 AM showed the TS retrieved a flash drive from her desk drawer and printed out the IQCP for Microbiology, Microalbumin, Troponin I, and BNP. 3. Interview with the TS on 8/11/22 at 11:30 AM revealed she kept the procedures on the flash drive because the hospital would change her computer without notice. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test -- 3 of 7 -- procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

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 Centers for Medicare and Medicaid Casper 155 report and staff interview, the laboratory failed to successfully participate in 3 out of 5 American Proficiency Institute chemistry core proficiency testing events for chloride (2020 event #2, 2021 event #1, 2021 event #3). 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 review of the Centers for Medicare and Medicaid (CMS) Casper 155 report and staff interview, the laboratory failed to successfully participate in 3 out of 5 American Proficiency Institute (API) chemistry core proficiency testing events for chloride (2020 event #2, 2021 event #1, 2021 event #3). The findings were: 1. Review of the CMS Casper 155 report showed the laboratory failed to sucessfully obtain a passing score for the analyte of chloride for the following API proficiency testing events: a. 2020 event #2 showed the laboratory scored a 40%. b. 2021 event #1 showed the laboratory scored a 60%. c. 2021 event #3 showed the laboratory scored a 60%. 2. Telephone interview on 10/26/21 at 11:04 AM with the technical supervisor verified chloride had failed on 3 of the last 5 proficiency testing events. 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 review of the Centers for Medicare and Medicaid Casper 155 report and staff interview, the laboratory director failed to ensure an effective

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 review of the human chorionic gonadotropin (hCG) test records, review of the proficiency test records, and staff interview, the laboratory failed to enroll in an approved proficiency testing program for the regulated hCG analyte for 2 of 2 years of proficiency testing reviewed (May 2019 to May 2021). The laboratory performed approximately 38 serum pregnancy tests (hCG) per year. The findings were: Review of the proficiency test records from May 2019 through May 2021 showed no evidence the hCG analyte had been included in the endocrinology proficiency testing program. Interview with the general supervisor on 6/3/21 at 1:10 PM confirmed the laboratory did not perform proficiency testing for the hCG analyte. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. 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 -- This STANDARD is not met as evidenced by: Based on review of proficiency testing records, lack of documentation, and staff interview, the laboratory failed to review and evaluate proficiency testing results for 12 of 21 proficiency testing events reviewed from May 2019 to May 2021. The findings were: 1. Review of the American Proficiency Institute (API) proficiency testing (PT) report failed to include documentation the laboratory had evaluated test scores of less than 100%. The following concerns were identified: a. Review of the 2019 microbiology Event 1 PT results showed the laboratory scored an 80% for gram stains. There was no documentation the laboratory had evaluated the test results. b. Review of the 2019 hematology Event 1 PT results showed the laboratory scored an 80% for neutrophils. Review of the evaluation form showed it was signed by the general supervisor (GS) on 5/13/19 and signed by the laboratory director (LD) on 10 /22/19. There was no documentation the laboratory had evaluated the test results. c. Review of the 2019 chemistry Event 2 PT results showed the laboratory scored a 60% for gamma-glutamyl transferase (GGT). There was no documentation the laboratory had evaluated the test results. d. Review of the 2019 microbiology Event 2 PT results showed the laboratory scored a 60% for gram stains. There was no documentation the laboratory had evaluated the test results. e. Review of the 2019 Event 2 chemistry PT results showed the laboratory scored a 67% on urine toxicology. The evaluation form was signed by the GS on 12/11/19 and the LD on 12/12/19 with no investigative or

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 (API) report review, Centers for Medicare and Medicaid Services, (CMS) Casper 155 report review, and telephone interview conducted on 02/26/2021, the laboratory failed to successfully participate in proficiency testing for Chloride (CL) in two out of three events (the 2nd event of 2020 and the 1st event of 2021). (See 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 American Proficiency Institute (API) report review, CMS CASPER 155 report review, and telephone confirmation of test results, the laboratory failed to successfully participate in 2 out of 3 API Chemistry core proficiency testing events for Chloride, (CL). Findings include: 1. API summary evaluation reports review for the second Chemistry event of 2020 and the first Chemistry event of 2021 included summary scores of 40% Chloride scores for the 2nd event of 2020 and 60% for the 1st API Chemistry testing event of 2021. 2. Casper 155 report for the 2nd event of 2020 review included Chloride scores of 40% for the 2nd event of 2020. 3. In a telephone interview on 02/26/2021, the laboratory technical supervisor verified failure of the 2nd event of 2020 and the 1st event of 2021 making 2 out of 3 Chloride proficiency failures. -- 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 (API) report review, Centers for Medicare and Medicaid Services, (CMS) Casper 153 and 155 reports review, and E-Mail interview concluded on 10/16/2019, the laboratory failed to successfully participate in proficiency testing for Chloride (CL) in two consecutive testing events and a subsequent failure (the 2nd and the 3rd events of 2018 and the second event of 2019). (See 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 American Proficinecy Institute (API) report review, CMS CASPER 153 and 155 reports review, and E-mail confirmation of test results, the laboratory failed to successfully participate in 2 consecutive proficiency testing events for Chloride, (CL) (API events 2 and 3 of 2018 and the 2nd event of 2019). Findings include: 1. API summary evaluation reports review for the second and third Chemistry events of 2018 included summary scores of 60% Chloride scores for the for the 2nd and 3rd API events of 2018 and a score of 20% for the 2nd API event of 2019. 2. Casper reports for 3 out of 4 events reviewed included Chloride scores of 60% for the 2nd and 3rd events of 2018, and 20% for the 2nd event of 2019. 3. In an E-mail interview begun on 10/03/2019 and continued to 10/16/2019, the laboratory technical supervisor confirmed the laboratory failed the 2nd API event of 2019 making 3 out of 4 Chloride failures. 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 American Proficiency Institute (API) proficinecy testing reports review, CASPER 153 and 155 reports review, and confirmation by the laboratory staff, the laboratory director failed to ensure

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 (API) report review, Centers for Medicare and Medicaid Services (CMS), CMS Casper 155 report review, E-Mail interview conducted on 10/08/2018, and telephone interview on 10/15/2018, the laboratory failed to successfully participate in proficiency testing for Chloride (CL) in two consecutive testing events (the 2nd and the 3rd events of 2018). (See 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 American Proficiency Institute (API) report review, CMS CASPER 153 and 155 reports review, and E-mail confirmation of test results, the laboratory failed to successfully participate in 2 consecutive proficiency testing events for Chloride (CL) (API events 2 and 3 of 2018). Findings include: 1. API summary evaluation reports review for the second and third Chemistry events of 2018 included summary scores of 60% Chloride scores for the 2nd and 3rd American Proficiency testing agency events of 2018. 2. Casper reports for 2 out of 3 events reviewed included Chloride scores of 60% for the 2nd and 3rd events of 2018. 3. In an E-mail interview begun on 10/08 /2018 and concluded on 10/16/2018 the laboratory technical supervisor verified the laboratory failed the 3rd 2018 event making 2 consecutive Chloride failures. -- 2 of 2 --

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on bacteriology procedure manual review, lack of documentation, and interview with staff, the current laboratory bacteriology procedure manual lacked documentation the current director signed and dated the manual as approved. Findings include: 1. The bacteriology procedure manual including Gram's stain, urine, blood, and sputum cultures, and susceptibility testing failed to include the current director's signature and date of approval. 2. In an interview with staff on 08/02/2018 at approximately 5:00 P.M., staff stated the director had most likely not been given the bacteriology procedure manual to sign along with the other procedures resulting in the lack of signature and date of approval. Based on instrument manufacturer's operators manual review, lack of documentation, and confirmation by staff, the director failed to sign and date the Pentra 400 chemistry analyzer as the approved laboratory testing method for routine chemistry testing for 20 tests reported. The laboratory performed approximately 1500 tests per year using the Pentra 400. Findings include: 1. The operator's manual review cover page included the statement, "This manual has been accepted as the procedure manual for this instrument." The signature of the technical supervisor followed with the date of 04/25/2017. 2. In an interview conducted on 08 /02/2018 at approximately 3:30 P.M., the technical supervisor confirmed the Pentra 400 instrument operator's manual had not been signed and dated as approved by the current laboratory director. D5471 CONTROL PROCEDURES CFR(s): 493.1256(e)(1)(g) 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 -- (e) For reagent, media, and supply checks, the laboratory must do the following: (e)(i) Check each batch (prepared in-house), lot number (commercially prepared) and shipment of reagents, disks, stains, antisera, (except those specifically referenced in 493.1261 (a)(3)) and identification systems (systems using two or more substrates or two or more reagents, or a combination) when prepared or opened for positive and negative reactivity, as well as graded reactivity, if applicable. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on quality control record review, lack of documentation and interview with staff, the laboratory failed to check each new lot number of blood culture media for the ability to support growth for 2 of 2 years of testing reviewed, (August 2016 to August 2018). The laboratory performed approximately 100 blood cultures per year. Findings include: 1. Quality control records reviewed failed to include documentation the media was checked for it's ability to support bacterial aerobic and anaerobic growth for each shipment or lot number of media received from August 2016 to August 2018. 2. In an interview conducted on 08/02/2018 at approximately 3:00 P.M., staff stated the laboratory did not verify the blood culture media's ability to support bacterial growth for the past 2 years or develop an Individualized Quality Control Plan. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on bacteriology test records review, lack of documentation and interview with staff, the laboratory failed to document the primary isolation media used for 4 of 5 patient culture sources (urine, sputum, throat, and wound), and the resulting colonial growth description or lack of growth for each media type used for specimen culture for two years of culture records reviewed. The laboratory performed approximately 150 cultures per year. Findings include: 1. The laboratory test records failed to include the culture test results for each media type used to culture for the presence or absence of bacterial growth and the description of the colonies present for urine, sputum, throat and wound cultures. 2. In an interview with staff on 08/02/2018 at approximately 4:00 P.M., staff stated they did not record growth or no growth and description of colonial morphology for each type of media inoculated. -- 2 of 2 --