Roosevelt Co Hospital District

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory's testing menu, lack of documentation, and interview with the Technical Supervisor (TS), the laboratory failed to perform twice annual evaluation of accuracy of non-regulated test analyte Carboxyhemoglobin (COHb) during 2024 and 2025. Findings include: 1. Review of the laboratory's test menu revealed the laboratory performs COHb testing. 2. A request was made for documentation of twice annual evaluation of accuracy of COHb testing for 2024 and 2025, none was provided. 3. During interview with the TS on 08/05/2025 at 1025 am, the TS indicated the laboratory has not performed twice annual evaluation of accuracy of analyte COHb. This confirms the above findings. 4. The laboratory reported 8 COHb tests in 2024, and 2 COHb tests in 2025. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D0000 An offsite paper revist conducted on August 9, 2024 , for Roosevelt General Hospital found the laboratory to be in compliance with the CLIA regulations found at 42 CFR, Part 493 Laboratory Requirements. 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 review of the Clinical Laboratory Improvement Amendments (CLIA) 116 application for certification, laboratory policy, patient reports, Quality Control (QC) data logs, and interview with Technical Supervisor #2 and General Supervisor #2, the laboratory failed to follow their polices for repeating quality control when analytes were out of range for urinalysis for 4 of 122 days reviewed in 2023 Findings included: 1. A review of the CLIA 116 form listed the laboratory performing urine dipsticks on the Siemens Clinitek Novus, serial number: 19291. The following analytes are being tested and resulted by the laboratory: - Bilirubin - Blood - Clarity - Color - Glucose - Ketones - Leukocytes - Nitrite - pH - Protein - Urobilinogen 2. A review of laboratory policy titled "Quality Control Program", under section 14.1 stated:

Summary Statement of Deficiencies D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D0000 During a Recertification survey completed on 11/07/19 for 42 CFR part 493 Laboratory Requirements, the facility was found out of compliance with the following conditions: 42 CFR Part 493.803 Proficiency Testing, Successful Participation 42 CFR Part 493.1403 Laboratory Director, Moderate Complexity 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 the review of 2019 proficiency test records from the proficiency testing agency, Centers for Medicare & Medicaid Services (CMS) proficiency database, laboratory proficiency testing records, laboratory policy, patient records, and interview with laboratory staff, the laboratory failed to successfully participate in Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- proficiency testing for APTT (Activated Partial Prothrombin Time). The laboratory reported performing 2,208 APTT tests in a 12 month period. Findings are: A. Review of CASPER Report 153 and 96 from the CMS proficiency database revealed the laboratory received failing scores for the analyte APTT for two (2) consecutive test events in 2019. B. Review of proficiency test records from the proficiency testing agency also indicated the laboratory received failing scores for the analyte APTT for two (2) consecutive test events in 2019. See D2121 and D2130 D2121 HEMATOLOGY CFR(s): 493.851(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 the review of 2019 proficiency test records from the proficiency testing agency, Centers for Medicare & Medicaid Services (CMS) proficiency database, laboratory proficiency testing records, laboratory policy, patient records, and interview with laboratory staff, the laboratory received failing scores for the analyte APTT (Activated Partial Prothrombin Time) for two consecutive events in 2019. The laboratory reported performing 2,208 APTT tests in a 12 month period. Findings are: A. Review of CASPER Reports 153 and 96 from the CMS proficiency database revealed the laboratory received failing scores for the analyte APTT for two (2) consecutive test events in 2019. 1. 2019 - 1, the score was reported as 20%. 2. 2019 - 2, the score was reported as 60% B. Review of proficiency test records from the proficiency testing agency also indicated the laboratory received failing scores for the analyte APTT for two (2) consecutive test events in 2019. 1. Event 2019 - 1, 5 of 5 results were low (greater than 2 SDI or Standard Deviation Interval,) when compared to participating laboratories according to the 04/18/19 report. 2. Event 2019 - 2, 4 of 5 results were low in comparison with participating laboratories according to the 08/15 /19 report. C. Review of the laboratory's proficiency testing records revealed: 1. The laboratory ordered and tested a new set of samples (same test event samples) in response to the 2019 - 1 failure on 04/29/19. The laboratory performed a self evaluation of the results since the ranges were previously provided by the proficiency agency and all results were acceptable. The original test date was 03/18/19. 2. The laboratory tested the 2019 - 2 samples on 07/11/19. The laboratory was unable to repeat testing for this event because the STAGO analyzer was replaced on 08/05/19 with a Sysmex CS-2500 coagulation analyzer. D. During interview on 11/05/19 at 9: 00 am, the Laboratory Supervisor stated she believed the failures were due to pipetting or reconstitution errors. She also stated the lower APTT results did not affect patients because the hospital did not use heparin therapy. D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. -- 2 of 8 -- This STANDARD is not met as evidenced by: Based on the review of 2019 proficiency test records from the proficiency testing agency, Centers for Medicare & Medicaid Services (CMS) proficiency database, laboratory proficiency testing records, laboratory policy, patient records, and interview with laboratory staff, the laboratory must undertake training and technical assistance for APTT (Activated Partial Prothrombin Time) proficiency testing failures. The laboratory reported performing 2,208 APTT tests in a 12 month period. Findings are: A. Review of CASPER Reports 153 and 96 from the CMS proficiency database and proficiency testing agency reports revealed the laboratory received failing scores for the analyte APTT for two (2) consecutive test events in 2019. See D2021 1. 2019 - 1, the score was reported as 20%. 2. 2019 - 2, the score was reported as 60% B. Review of the laboratory's proficiency testing records revealed: 1. The laboratory ordered and tested a new set of samples (same test event samples) in response to the 2019 - 1 failure on 04/29/19. The laboratory performed a self evaluation of the results and all results were acceptable. The original test date was 03 /18/19. The laboratory reviewed the test records, the previous 3 surveys, and quality control. The laboratory's conclusion: "Probable sample reconstitution error that was more manifested with the greater times of the PTT's. Technologist will be retrained on proper pipetting and reconstitution techniques." 2. The laboratory tested the 2019 - 2 samples on 07/11/19. The laboratory was unable to repeat testing for this event because the STAGO analyzer was replaced on 08/05/19 with a Sysmex CS-2500 coagulation analyzer. The laboratory reviewed the test records, results for 602 patients tested 04/29/19-08/05/19, maintenance and quality control records. The laboratory's conclusion: 'All patient PTT's review from 4/29/19-8/5/19 have been reviewed and it is felt that no remediation is needed." C. During interview on 11/05/19 at 9 am, the Laboratory Supervisor stated she believed the failures were due to pipetting or reconstitution errors. She also stated the lower APTT results did not affect patients because the hospital did not use heparin therapy. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on the review of 2019 proficiency test records from the proficiency testing agency, Centers for Medicare & Medicaid Services (CMS) proficiency database, laboratory proficiency testing records, laboratory policy, patient records, and interview with laboratory staff, the laboratory received failing scores for the analyte APTT (Activated Partial Prothrombin Time) for two consecutive events in 2019 resulting in unsuccessful participation in proficiency testing. The laboratory reported performing 2,208 APTT tests in a 12 month period. Findings are: A. Review of CASPER Reports 153 and 96 from the CMS proficiency database revealed the laboratory received failing scores for the analyte APTT for two (2) consecutive test events in 2019. 1. 2019 - 1, the score was reported as 20%. 2. 2019 - 2, the score was reported as 60% B. Review of proficiency test records from the proficiency testing agency also indicated the laboratory received failing scores for the analyte APTT for two (2) consecutive test events in 2019. 1. Event 2019 - 1, 5 of 5 results were low (greater than 2 SDI or Standard Deviation Index) when compared to participating -- 3 of 8 -- laboratories according to the 04/18/19 report. 2. Event 2019 - 2, 4 of 5 results were low in comparison with participating laboratories according to the 08/15/19 report. C. Review of the laboratory's proficiency testing records revealed: 1. The laboratory ordered and tested a new set of samples (from the same test event) in response to the 2019 - 1 failure on 04/29/19. The laboratory performed a self evaluation of the results since the ranges were previously provided by the proficiency agency and all results were acceptable. The original test date was 03/18/19. 2. The laboratory tested the 2019 - 2 samples on 07/11/19. The laboratory was unable to repeat testing for this event because the STAGO analyzer was replaced on 08/05/19 with a Sysmex CS- 2500 coagulation analyzer. D. During interview on 11/05/19 at 9:00 am, the Laboratory Supervisor stated she believed the failures were due to pipetting or reconstitution errors. She also stated the lower APTT results did not affect patients because the hospital did not use heparin therapy. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on the review of turn-around-time reports, patient test records, laboratory policies, manufacturer instructions, and interviews with laboratory staff, the laboratory failed to ensure 29 of 163 patient samples for lactate (or lactic acid) were received, spun, and tested as required by the manufacturer in December 2018 and October 2019. Findings are: A. Review of the Siemens Dimension clinical chemistry instructions for Lactic Acid, dated 01/30/2015, indicated "Blood is best collected without stasis in a container of sodium fluoride/potassium oxalate followed by immediate chilling of the specimen and separation of the cells within 15 minutes... Keep sample on ice and analyze promptly. If testing cannot be performed immediately, refrigerate the separated plasma sample for up to 24 hours or freeze it for up to 1 month.' B. Review of the laboratory's CHE-160 Lactic Acid R2 policy, dated 01/09/18, met the manufacturer's requirements listed above. C. Review of laboratory procedures revealed no reference to the speed or time required to spin the samples. See D5403 1. During interview on 11/06/19 at 09:44 am, Phlebotomist #1 stated that if the samples are not drawn by the lab and if there are no orders, the samples are spun in the Drucker 614B in the phlebotomy area and the plasma stored in the refrigerator. 2. During interview on 11/06/19 at 09:52 am, TP (Testing Person) #1 stated the phlebotomists brought laboratory collected samples directly to chemistry and the samples are spun for 5 minutes in the EBA 21 Centrifuge at 6,000 RPM (Revolutions Per Minute). D. Review of patient records and the laboratory Turnaround Time Reports for December 2018 and October 2019 revealed the laboratory failed to ensure the collection and receipt times were documented accurately and met the manufacturer's requirements. 1. The laboratory failed to document the collection and receipt times for lactic acid in the LIS (Laboratory Information System). See D5787 2. The collection to receipt (into the laboratory) time exceeded 10 minutes (allowing 5 minutes for centrifugation and placement on the analyzer) for 15 of 100 patients in December 2018. 6 of the 15 patients had physician -- 4 of 8 -- orders after the collection of the sample. 2 samples, LA 72 and LA 59, did not have documentation in the LIS indicating the laboratory had spun and refrigerated the plasma until the samples could be tested. Orders received prior to collection LA54, collected on 12/07/18 at 06:30 am, was received by the laboratory at 06:44 am, 14 minutes after collection. LA69, collected on 12/27/18 at 11:45 pm, was received by the laboratory at 12:02 pm, 17 minutes after collection. LA72, collected on 12/07/18 at 13:29 pm, was received by the laboratory at 13:36 pm, 235 minutes after collection. LA84, collected on 12/05/18 at 17:04 pm, was received by the laboratory at 17:53 pm, 49 minutes after collection. LA86, collected on 12/11/18 at 17:45 pm, was received by the laboratory at 17:57 pm, 12 minutes after collection. LA87, collected on 12/27/18 at 20:15 pm, was received by the laboratory at 20:43 pm, 28 minutes after collection. LA88, collected on 12/27/18 at 21:56 pm, was received by the laboratory at 22:00 pm, 50 minutes after collection. LA92, collected on 12/19/18 at 15:05 pm, was received by the laboratory at 15:18 pm, 50 minutes after collection. LA88, collected on 12/27/18 at 21:56 pm, was received by the laboratory at 22:00 pm, 50 minutes after collection. Orders received after collection LA43, collected on 12/26/18 at 04:30 am, was received by the laboratory at 05:48 am, 78 minutes after collection. LA59, collected on 12/18/18 at 09:45 am, was received by the laboratory at 10:54 am, 69 minutes after collection. LA70, collected on 12/28/18 at 11:58 am, was received by the laboratory at 12:27 pm, 29 minutes after collection. LA77, collected on 12/30/18 at 18:40 pm, was received by the laboratory at 18:52 pm, 12 minutes after collection. LA94, collected on 12/11/18 at 18:06 pm, was received by the laboratory at 19:09 pm, 50 minutes after collection. LA95, collected on 12/03/18 at 16:40 pm, was received by the laboratory at 16:52 pm, 12 minutes after collection. 3. The collection to receipt (into the laboratory) time exceeded 10 minutes (allowing 5 minutes for centrifugation and placement on the analyzer) for 14 of 63 patients in October 2019. 11 of the 14 patients had physician orders after the collection of the sample. Orders received prior to collection LA111, collected on 10/08/19 at 13:10 pm, was received by the laboratory at 13:22 am, 12 minutes after collection. LA125, collected on 10/14/19 at 06:30 am, was received by the laboratory at 07:22 am, 52 minutes after collection. LA126, collected on 10/14/19 at 12:30 pm, was received by the laboratory at 12:43 pm, 13 minutes after collection. Orders received after collection LA104, collected on 10/03 /19 at 00:39 am, was received by the laboratory at 00:58 am, 19 minutes after collection. LA105, collected on 10/03/19 at 11:07 am, was received by the laboratory at 12:26 am, 79 minutes after collection. LA106, collected on 10/04/19 at 19:25 pm, was received by the laboratory at 19:25 am, 117 minutes after collection. LA112, collected on 10/08/19 at 14:46 pm, was received by the laboratory at 15:58 pm, 22 minutes after collection. LA114, collected on 10/08/19 at 21:06 pm, was received by the laboratory at 23:33 pm, 147 minutes after collection. LA127, collected on 10/14 /19 at 15:37 pm, was received by the laboratory at 15:55 pm, 18 minutes after collection. LA128, collected on 10/14/19 at 19:50 pm, was received by the laboratory at 20:26 pm, 36 minutes after collection. LA137, collected on 10/19/19 at 14:03 pm, was received by the laboratory at 15:18 pm, 75 minutes after collection. LA138, collected on 10/19/19 at 18:45 pm, was received by the laboratory at 20:02 pm, 77 minutes after collection. LA139, collected on 10/19/19 at 15:48 pm, was received by the laboratory at 20:03 pm, 255 minutes after collection. LA140, collected on 10/20 /19 at 23:25 pm, was received by the laboratory at 23:55 pm, 30 minutes after collection. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test -- 5 of 8 -- 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 D0000 The following deficiencies were cited during a recertification survey completed on 02 /15/2018 for the federal requirements of 42 CFR Part 493 for Laboratories. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on observation, the review of manufacturer's instructions, temperature records and interviews with laboratory staff, the laboratory failed to ensure the environmental conditions in the laboratory met the manufacturer's requirements for the TOSOH G8 immunochemistry analyzer and the Clinitek Advantus urine analyzer. Findings are: Observation of the laboratory on 2/15/18 at 2:40 pm revealed one vent blowing air directly on the TOSOH immunochemistry analyzer. The air flow from the vent was strong enough to cause the instrument tape to visibly move in the breeze. The vent was located approximately 3 feet from the open doorway to the phlebotomy room and 6-8 feet from the Advantus urine analyzer. 1. The manufacturer of the TOSOH analyzer stated in the Operator's Manual to not install the unit in the path of direct air currents. 2. Review of the Advantus manufacturer's instructions indicated the ambient operating temperature should be 18 - 30 degrees Celsius. The instructions also indicate "At temperatures under 22 degrees Celsius, urobilinogen and leukocyte results may be decreased, and at temperatures above 26 degrees Celsius, increased." 3. Review of the Siemens Multistix 10 SG package insert indicated the following 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 -- limitations for Urobilinogen, "Strip reactivity increases with temperature; the optimum temperature is 22-26 degrees Celsius." 4. Review of room temperature records for the phlebotomy room (connected through an open doorway near the vent) and the blood bank/serology area (closest to the Advantus) revealed the laboratory did not have the correct acceptable range for the operation of the Clinitek Advantus urine analyzer. The laboratory's temperature logs indicated the acceptable range was 15 - 25 degrees Celsius. The laboratory recorded the temperature twice per day. 5. Review of the temperature records indicated that the temperature was less than 18 degrees Celsius for the initial temperature recorded for each day. a. Blood Bank Serology area 8 of 31 days in July 2017 3 of 30 days in November 2017 23 of 31 days in December 2017 b. Phlebotomy area 8 of 30 days in June 2017 13 of 31 days in July 2017 2 of 31 days in August 2017 6 of 30 days in September 2017 15 of 31 days in October 2017 28 of 30 days in November 2017 14 of 31 days in December 2017 6. During the exit conference on 2/15/18 at 4:30 pm, the laboratory director, laboratory manager and the clinic administrator acknowledged these findings. -- 2 of 2 --