Cornerstone Specialty Hospital Of Muskogee

Summary Statement of Deficiencies D0000 The recertification survey was performed on 04/15/2021. The findings were reviewed with the laboratory lead, technical consultant, and the chief clinical officer during an exit conference performed at the conclusion of the survey. The laboratory was found in compliance with standard-level deficiencies cited. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the laboratory lead and technical consultant, the laboratory failed to follow the manufacturer's instructions for test timing for a blood gas cartridge for 1 of 6 patients. Findings include: (1) On 04/15/2021 at 09:50 am, the laboratory lead stated to the surveyor Arterial Blood Gas testing was performed in the laboratory using the G3+ cartridge and the iSTAT1 analyzer; (2) The surveyor reviewed the manufacturer's instructions under the section titled, "Mixing and Test Timing (time from collection to cartridge fill) for Chemistry and Blood Gas Cartridge". For test timing, the instructions stated, "Samples for pH, PCO2, PO2, TCO3 and ionized calcium should be tested within 10 minutes."; (3) The surveyor randomly reviewed 6 patient records from blood gas testing performed between 10/09/2019 through 02/13/2020. For 1 of 6 records, there was no evidence the laboratory followed the manufacturer's instructions for testing the patient within 10 minutes as follows: (a) Patient testing was performed on 10/24/2019. Although the result time was 01:23 pm, the time of specimen collection was not documented. (4) The surveyor reviewed the record with the technical consultant who stated on 04/15/2021 at 02:00 pm the laboratory could not 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 -- prove the specimen was collected and tested within 10 minutes as required by the manufacturer. 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 a review of records, written procedure, and interview with the laboratory lead and technical consultant, the laboratory failed to ensure the demonstrated reportable ranges were utilized for 1 of 1 new test method. Findings include: (1) On 04 /15/2021 at 11:50 am, the laboratory lead stated to the surveyor, the laboratory began using the replacement iSTAT1 analyzer (Serial #317723) to perform Arterial Blood Gas testing on 01/31/2020; (2) The surveyor reviewed the performance specification records for test system and identified the laboratory had demonstrated a PCO2 reportable range of 18.6 - 98.4 mm Hg; (3) The surveyor then reviewed patient testing records and identified PCO2 results greater than 98.4 mm Hg (the highest value demonstrated by the laboratory) had been reported for 2 of 33 records reviewed: (a) Patient tested on 02/16/2020 - Reported as 101.0 mm Hg (b) Patient tested on 02/17 /2020 - Reported as 99.7 mm Hg (4) The surveyor reviewed the records with the technical consultant who stated on 04/15/2021 at 02:05 pm, the laboratory was not utilizing the reportable range that had been demonstrated by the laboratory. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records, written policies, and interview with the laboratory lead and the technical consultant, the laboratory failed to follow written quality control policies for 2 of 16 months. Findings include: (1) On 04/15/2021 at 09:50 am, the laboratory lead stated the following to the surveyor: (a) Arterial Blood Gas testing was performed in the laboratory using the G3+ cartridge and the iSTAT1 analyzer (serial number 317723); (b) An IQCP (Individualized Quality Control Plan) had been developed for the test system. (2) The surveyor reviewed the IQCP that had been developed for the test system. The QCP (Quality Control Plan) portion of the IQCP -- 2 of 3 -- required 2 levels of external quality control materials be tested once every 30 days; (3) The surveyor then reviewed QC (quality control) records for 16 months (January 2020 through April 2021) and identified the laboratory failed to follow the written QCP of performing quality control testing every 30 days. Quality control testing had not been performed as follows: (a) Between 07/23/2020 and 09/29/2020 (b) Between 09/29 /2020 and 11/28/2020 (4) The findings were reviewed with the technical consultant who stated on 04/15/2021 at 01:15 pm, the laboratory had not performed quality control testing as required by the QCP. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory lead and the technical consultant, the technical consultant failed to evaluate personnel performing moderate complexity testing at least annually for 2 of 4 testing persons. Findings include: (1) On 04/15/2021 at 09:50 am, the laboratory lead stated to the surveyor Arterial Blood Gas testing was performed in the laboratory using the G3+ cartridge and the iSTAT1 analyzer; (2) The surveyor then reviewed personnel records for 4 persons performing Arterial Blood Gas Testing in the laboratory in 2019, 2020, and 2021. The records showed that annual evaluations had been not been performed as follows: (a) Testing Person #4 - Between 02/18/2018 and 02/14/2020 (b) Testing Person #14 - Between 12 /10/2019 and 02/04/2021 (3) The surveyor reviewed the findings with the technical consultant, who stated on 04/15/2021 at 10:30 am, annual evaluations had not been performed as shown above. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 12/06/18. The laboratory was found to be in compliance with standard-level deficiencies cited. The findings were reviewed with the CEO, the CCO/director of nursing, the lead respiratory therapist, and the RML support/technical consultant #2 during an exit conference at the conclusion of the survey. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records, quality control policy, and interview with the CCO /director of nursing and the RML laboratory support/technical consultant #2, the laboratory failed to follow its written quality control plan. Findings include: (1) At the beginning of the survey, the CCO/director of nursing stated to the surveyor the laboratory performed patient arterial and venous blood gas testing (i.e. pH, pO2, and pCO2) using the i-STAT1 analyzer and G3+ test cartridges; (2) Later in the survey, the CCO/director of nursing and the RML laboratory support/technical consultant #2 explained the laboratory utilized an IQCP (Individualized Quality Control Plan) for the testing; (3) The surveyor reviewed the IQCP and identified the QCP (Quality Control Plan) included the following: (a) The electronic simulator check will be performed each week; (b) Two levels of external liquid control materials will be 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 -- tested once per month and when a new lot number of test cartridges is received. (4) The surveyor then reviewed QC (Quality Control) records from 05/01/17 through 11 /30/18 and identified instances when the laboratory failed to follow its QCP for performance of the electronic simulator checks and testing of the external liquid control materials. The specific findings follow: (a) Weekly electronic simulator checks had not been performed: (i) Between 10/17/17 and 11/01/17 (ii) Between 12/24 /17 and 01/02/18 (iii) Between 06/27/18 and 07/20/18 (iv) Between 08/30/18 and 09 /13/18 (b) Monthly testing of 2 levels of external liquid control materials had not been performed during October 2018. (5) The surveyor asked the CCO/director of nursing and the RML laboratory support/technical consultant #2 if patient blood gas testing had been performed during the time periods listed above. The CCO/director of nursing and the RML laboratory support/technical consultant #2 searched the testing records and identified the following examples of patient blood gas testing performed when the laboratory failed to follow its QCP for the i-STAT1 analyzer and G3+ test cartridges: (a) Patient #1: Testing performed on 10/17/17 (b) Patient #2: Testing performed on 10/25/17 (c) Patient #3: Testing performed on 10/29/17 (d) Patient #4: Testing performed on 11/01/17 (e) Patient #5: Testing performed on 06/28/18 (f) Patient #6: Testing performed on 06/29/18 (g) Patient #7: Testing performed on 07/08 /18 (h) Patient #8: Testing performed on 07/11/18 (i) Patient #9: Testing performed on 07/13/18 (j) Patient #10: Testing performed on 07/20/18 (k) Patient #11: Testing performed on 08/30/18 (l) Patient #12: Testing performed on 08/31/18 (m) Patient #13: Testing performed on 09/02/18 (n) Patient #14: Testing performed on 09/07/18 (o) Patient #15: Testing performed on 09/13/18 (p) Patient #16: Testing performed on 10/29/18 (q) Patient #17: Testing performed on 10/30/18 NOTE: D5445 was cited at the previous recertification survey performed 04/26/17. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on a review of records and interview with the CCO/director of nursing and the RML laboratory support/technical consultant #2, the technical consultant failed to ensure that testing persons performing moderate complexity testing had been evaluated semiannually during the first year of testing. Findings include: (1) At the beginning of the survey, the surveyor reviewed personnel records for the 13 individuals who performed the moderate complexity arterial and venous blood gas testing (i.e. pH, pO2, and pCO2) using the i-STAT1 analyzer and the G3+ test cartridges. The surveyor identified the following: (a) Testing Person #7 - The initial training for this person was completed on 04/28/18. There was no evidence a semiannual evaluation had been performed (due 10/18). (2) The surveyor reviewed the records with the CCO/director of nursing and the RML laboratory support /technical consultant #2 who both stated there were no records available to prove testing person #7 had been evaluated semiannually. -- 2 of 2 --