Mercy Bella Vista

Summary Statement of Deficiencies 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: Through a review of the IQCP (Individualized Quality Control Plan) for Arterial Blood Gas (ABG) testing performed on the Istat analyzer it was determined the IQCP was missing the required element of frequency of external quality control performance. Survey findings include: A. The laboratory performs moderate complexity ABG analysis using the Istat analyzer . B. The laboratory developed an IQCP for the tests performed on the Istat analyzer in order to perform quality control at a less frequent interval than required by CLIA regulation. A review of the IQCP revealed that it was missing the frequency of external quality control testing. C. In an interview, at 09:15 a.m. on 4/29/22, laboratory employee #1 (as listed on the form CMS-209) confirmed the IQCP did not specify the frequency of external QC performance. D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is 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 -- regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Through review of the Blood bank refrigerator and fresh frozen plasma freezer temperature recording charts, lack of documentation and interview it was determined that the laboratory could not document proper storage temperature requirements were maintained on 17 of 17 occasions when the storage temperature for blood and blood components could not be confirmed on the temperature recording charts. Findings follow: A) Review thirty-five ( August 1, 2021 to April 1, 2022) weeks of the temperature recording charts for the blood storage refrigerator and the fresh frozen plasma storage freezer revealed that temperature records were not recorded on three occasions when the recording pen failed on the blood storage refrigerator and four occasions on the blood plasma storage freezer and that temperatures were recorded on ten occasions with unacceptable readings (reading 0 degrees C.) when the pen was inapropriately calibrated on the blood storage refrigerator . B) Upon request, the laboratory was unable to provide documentation of actual temperature readings on the occasions identified above. C) In an interview on 4/28/22 at 03:35 PM the laboratory staff members, identified as numbers one and two on the CMS 209 form , confirmed that the laboratory could not document proper storage temperatures for the blood storage refrigerator and the fresh frozen plasma freezer for the periods identified above. D5783

Summary Statement of Deficiencies 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: Through review of the data used to determine the Normal Patient Mean value (MNPT) for prothrombin time assays, review of the package insert for STA Neoplastine Plus reagent , and interview it was determined that the laboratory failed to determine the normal patient mean value for the laboratory's patient population used in the calculation of INR values in accordance with manufacturer's instruction. Findings follow: A: Review of the package insert for STA neoplastine revealed that in determining the MNPT donors should be healthy and have no pathological condition, donors should not be taking any medication affecting coagulation, donors should span the adult age range, pediatric range should be established separately, and donors should be equally devided between males and females. B: Review of the documentation presented to establish the MNPT with the change to a new lot number of reagent, STA Neoplastine lot # 253049, revealed that the donors were identified as "Norm-1 .... Norm 20". C. In an interview on 10/17/19 at approximately 08:45 AM , the general supervisor, identified as number 3 on the CMS 209 form, stated that when establishing the MNPT that extra tubes are drawn on patients with no history of medication or pathologies that can affect coagulation and there are no records kept that can be used to evaluate the donors age, sex, medication history or possible pathologies.. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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 3 -- 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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Through review of manufacturer package insert, quality control results for erythrocyte sedimentation rate (ESR) assays for November 2018, March 2019 and July 2019, and interview, it was determined that the laboratory failed to establish its own control limits and to verify the criteria for acceptability of quality control results for the ESR assay for three of three months reviewed. Findings follow: A) The package insert for HemaTechnologies SedRite Plus ESR control material revealed that the individual laboratory should "establish its own mean and acceptable range" and the control means established by the laboratory should fall within the expected range specified for the control. B) Review of quality control results for ESR assay for November 2018, March 2019 and July 2019 revealed that the mean and acceptable range in three of the three months reviewed exactly matched the mean and expected range as listed on the HemaTechnologies SedRite Plus ESR control material package insert. C) In an interview on 10/17/19 at approximately 08:45 AM the laboratory staff member, identified as number 3 on the CMS 209 form stated that "we use the manufacturer's mean and ranges for the ESR controls". Through review of manufacturer package insert, quality control results for coagulation (prothrombin time (PT), and partial thromboplastin time (PTT) assays for November 2018, March 2019 and July 2019, and interview, it was determined that the laboratory failed to establish its own control limits and to verify the criteria for acceptability of quality control results for the coagulation assays for three of three months reviewed. Findings follow: A) The package insert for STA-Plus (N) and (ABN) coagulation controls stated "control ranges given are intended as only guidelines and it is recommended that each laboratory establish its own target and ranges". B) Review of quality control results for coagulation assays for November 2018, March 2019 and July 2019 revealed that the mean and acceptable range in 3 of the 3 months reviewed exactly matched the mean and expected range as listed on the STA- Plus package insert. C) In an interview on 10/17/19 at approximately 09:30 AM the laboratory staff member, identified as number 3 on the CMS 209 form stated that the laboratory used the manufacturer's mean and ranges for the coagulation controls. D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the -- 2 of 3 -- alarm system must be documented. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Through review of the policy and procedure Document ID: BV3 Blood Bank "Component Storage and Transportation", blood bank refrigerator and fresh frozen plasma freezer temperature recording charts, lack of documentation and interview it was determined that the laboratory could not document proper storage temperature requirements were maintained on one of one occasions when the storage temperature for blood and blood components could not be confirmed on the temperature recording charts. Findings follow: A) Review of the policy and procedure Document ID: BV3 Blood Bank "Component Storage and Transportation" revealed " action to be taken if all refrigerators are out due to power failure: use the CBC Blood/Component Emergency Storage Record to monitor and record the blood temperature hourly". B) Review of the temperature recording charts for the blood storage refrigerator and the fresh frozen plasma storage freezer revealed that temperature records were not recorded on 5/29/19 12:00 PM until 5/29/19 08:00 PM with a hand-written notation stating "power off". C) Upon request, the laboratory was unable to provide documentation of hourly temperature recordings on the CBC Blood/Component Emergency Storage Record for 5/29/19 at 12:00 PM until 5/29/19 at 08:00 PM. D) In an interview on 10/17/19 at approximately 03:45 PM the laboratory staff members, identified as numbers one and two on the CMS 209 form , confirmed that the laboratory could not document proper storage temperatures for the blood storage refrigerator and the fresh frozen plasma freezer for the eight hour period identified above. D5783

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Through a review of proficiency test documentation for 2017 it was determined the laboratory director failed to sign attestation statements for three of eleven testing events in 2017. Survey findings follow: A. A review of the Attestation Statement for 1st Chemistry Core Proficiency Testing Event of 2017 revealed that the laboratory director failed to sign the Attestation Statement. B. A review of the Attestation Statement for 2nd Chemistry Miscellaneous Proficiency Testing Event of 2017 revealed that the laboratory director failed to sign the Attestation Statement. C. A review of the Attestation Statement for 3rd Hematology / Coagulation Proficiency Testing Event of 2017 revealed that the laboratory director failed to sign the Attestation Statement. D. In an interview at 13:36 on 1/10/2018, laboratory employee #4 (as listed on the form CMS-209) confirmed that the laboratory director failed to sign Attestation Statements for three proficiency testing events in 2017. D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) 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 -- The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Through a review of personnel records for 17 randomly selected testing personnel, lack of documentation, and interviews with laboratory staff, it was determined the laboratory director failed to give written authorization for testing personnel to perform testing without direct supervision. Survey findings follow: A. Through a review of 17 randomly selected personnel files it was determined that 11 of 17 personnel files failed to include a written authorization to perform testing, signed by the laboratory director. Personnel files without written authorization are those for laboratory personnel #8, #11, #12, #13, #14, #17, #22, #27, #33, #35, and #39 (as listed on the form CMS-209). B. In an interview, at 13:26 on 1/10/2018, employee #4 (as listed on the form CMS-209) confirmed that the laboratory director failed to sign written authorizations to test for 11 of 17 personnel reviewed by the surveyor. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Through a review of personnel files for 17 randomly selected testing personnel, lack of documentation, and interviews with laboratory staff, it was determined the technical supervisor failed to evaluate the performance for 2 of 17 testing personnel twice in the first year of testing. Survey findings follow: A. Through a review of personnel records for laboratory employee #9 it was determined that she was authorized to perform testing on 10/26/2016. During the 14 months that personnel has performed testing since the original authorization there is only one documented competency evaluation which is dated 3/14/2017. B. Through a review of personnel records for laboratory employee #5 it was determined that he was authorized to perform testing on 11/1/2016. During the 14 months that personnel has performed testing since the original authorization there is only one documented competency evaluation which is dated 3/14/2017. C. During an interview at 13:26 on 1/10/2018, laboratory employee #4 confirmed the lack of documented competency assessments twice during the first year of testing. -- 2 of 2 --