Multicare Rockwood Post Falls Specialty Laboratory

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 a Proficiency Testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D) and graded results from the American Proficiency Institute (API), the laboratory failed to successfully participate and achieve an overall satisfactory score for two (2) of three (3) testing events in 2021 and 2022 for the specialty of hematology. D2130 HEMATOLOGY CFR(s): 493.851(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 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 a Proficiency Testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D), graded PT results from the American Proficiency Institute (API) and telephone interview with the technical supervisor on 10 /18/2022, the laboratory failed to successfully participate and achieve an overall satisfactory score for two (2) of three (3) testing events in 2021 and 2022 for the specialty of hematology for the analyte white blood cell (WBC) differential. The findings include: 1. A PT desk review of Report 155D and graded PT results from API identified that the laboratory failed to achieve overall satisfactory scores for event three (3) in 2021 and event two (2) in 2022 for the specialty of hematology for the analyte WBC differential. Analyte Year Event Score WBC Differential 2021 3 32% WBC Differential 2022 2 4% 2. A telephone interview with the technical supervisor on 10/18/2022 at 2:43pm confirmed the above findings. 3. The laboratory reports performing 9,771 Complete Blood Cell Count Tests annually. -- 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 a review of proficiency testing (PT) documents from American Proficiency Institute (API), and an interview with the technical supervisor (TS) on 8/25/2022, the laboratory failed to enroll in PT for serum human chorionic gonadotropin (hCG). The findings include: 1. A review of PT documents from API identified that the laboratory failed to enroll or perform PT for serum hCG testing for 2021 and 2022. 2. An interview with the TS on 8/25/2022 at 9:00 am confirmed that the laboratory failed to perform PT for serum hCG testing in 2021 and 2022. 3. The facility reports performing 10 serum hCG tests annually. 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. 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 -- This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, training and competency assessment records and an interview with the technical supervisor (TS) on 8/25/2022, the laboratory failed to follow written policies and procedures to assess testing personnel training and competency in 2021. The findings include: 1. A review of training and competency assessment records identified one testing personnel hired in February 2021 failed to have documentation of initial training. 2. A review of training and competency assessment records identified one testing personnel hired in February 2021 failed to have documentation of six month competency. 3. A review of training and competency assessment records identified two testing personnel failed to have an annual competency assessment for 2021. 4. An interview with the TS on 8/25/2022 at 8:15 am confirmed the above findings. 5. The laboratory reports performing 148,883 tests annually. 6. This is a repeat deficiency from the previous inspection on 1/4/2021. 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 a review of proficiency testing (PT) documents from American Proficiency Institute (API) and an interview with the technical supervisor (TS) on 8/25/2022, the laboratory failed to review and evaluate PT scores that were less than 100% in 2021 and 2022. The findings include: 1. A review of PT documents from API for the specialty of chemistry for 2021 identified that the laboratory failed to evaluate results for lipase for event one with a score of 80%. 2. A review of PT documents from API for the specialty of chemistry for 2022 identified that the laboratory failed to evaluate results for lipase for event one with a score of 80%. 3. An interview with the TS on 8 /25/2022 at 9:02 am confirmed that the laboratory failed to evaluate PT scores that were less than 100% in 2021 and 2022. 4. The facility reports performing 292 lipase tests annually. 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 a review of proficiency testing (PT) documents from American Proficiency Institute (API), and an interview with the technical supervisor (TS) on 8/25/2022, the laboratory failed to review and evaluate PT scores that were given an artificial 100% in 2021 and 2022. The findings include: 1. A review of PT documents from API for the specialty of chemistry for 2021 identified that the laboratory failed to evaluate results for myoglobin for events one and two that were given an artificial scores of 100% due to lack of participants. 2. A review of PT documents from API for the -- 2 of 7 -- specialty of chemistry for 2022 identified that the laboratory failed to evaluate results for myoglobin and creatine kinase-MB for events one and two that were given an artificial scores of 100% due to lack of participants. 3. An interview with the TS on 8 /25/2022 at 8:58 am confirmed that the laboratory failed to evaluate PT results with artificial scores in 2021 and 2022. 4. The facility reports performing 11 myoglobin and 37 creatine kinase-MB tests annually. 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 the prothrombin time (PT) new reagent lot studies, the Dade Innovin Reagent package insert, a direct observation and an interview with the technical supervisor (TS) on 8/25/2022, the laboratory failed to use the correct international sensitivity index (ISI) for patient International Normalized Ratio (INR) calculations. The findings include: 1. A review of the PT new reagent lot studies for the current reagent in use performed in June 2021 identified an Innovin lot number of 549780 with an ISI of 1.07. 2. A review of the Innovin package insert for lot 549780 confirmed the ISI of 1.07. 3. A direct observation of the ISI in harvest, the laboratory information system (LIS), identified an ISI of 1.02. The laboratory failed to have the correct ISI in the LIS system to calculate the INR for patient reporting. 4. An interview with the TS on 8/25/2022 at 11:52 am confirmed that the laboratory was using the incorrect ISI to calculate patient INR since the new reagents were put in use on 6/29/2022. 5. The laboratory reports performing 1321 PT/INR tests annually. 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 a random review of laboratory temperature logs, a direct observation and an interview with the technical supervisor (TS) on 8/25/2022, the laboratory failed to establish and maintain the correct storage temperature of reagents in the freezer. The findings include: 1. A review of the laboratory temperature logs identified the freezer temperature range was set at -10 to -20 C. 2. A direct observation of reagents and quality controls (QC) in the freezer identified that the Ortho Vitros reagents and calibrators had a storage requirement of -18 C or below and the Biorad Liquichek Immunology QC had a storage requirement of -20 to -80 C. 3. A random review of the laboratory's freezer temperature logs identified that the laboratory failed to have -- 3 of 7 -- temperatures at or below -20 C for 25 of 29 days in March 2021, 26 of 28 days in April of 2021, 24 of 28 days in May 2021, 23 of 28 days in June 2021 and 25 of 27 days in July 2021 as required by manufacturers. 4. An interview with the TS on 8/25 /2022 at 1:29 pm confirmed that the laboratory failed to maintain reagents, calibrators and QC at the proper temperature. 5. The laboratory reports performing 148,883 tests annually. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of the laboratory maintenance logs, instrument manuals and an interview with the technical supervisor (TS) on 8/25/2022, the laboratory failed to perform maintenance as required by the instrument manufacturers. The findings include: 1. A review of Sysmex CA660 maintenance logs identified that the laboratory failed to perform quarterly LED calibration in March 22 and June 22 as required by the manufacturer. 2. A review of the Stratus CS operators manual identified maintenance as monthly replace and clean air filter, clean sample door area, clean lower cannula chamber seal, clean waste container area, clean tip chute and clean the pak shield. A review of Stratus SS maintenance logs identified that the laboratory failed to perform maintenance in 2021 and 2022. 3. A review of the laboratory maintenance logs identified that the laboratory failed to document maintenance on the Vitros 350, Sysmex XS-1000i, and the Sysmex CA-660 in December 2021. 4. An interview with the TS on 8/25/2022 at 11:42 am confirmed the above findings. 5. The laboratory reports performing 148,883 tests annually. 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 the laboratory's policies and procedures, quality control (QC) records for the Stratus CS and the iStat and an interview with the technical supervisor (TS) on 8/25/2022, the laboratory failed to perform QC once each day of patient testing. The findings include: 1. A review of the laboratory's policies and procedures identified that the laboratory failed to have an Individualized Quality Control Plan (IQCP) for testing performed on the Stratus CS and the iStat. 2. A review of QC for blood gas testing on the iStat and cardiac testing on the Stratus CS identified that the laboratory failed to test QC each day of patient testing. 3. An interview with the TS on -- 4 of 7 -- 8/25/2022 at 12:41 pm confirmed that the laboratory did not have an IQCP for the Stratus CS and the iStat and only performed QC once per week. 4. The laboratory reports performing 192 tests on the Stratus CS and the iStat annually. 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 a review of proficiency testing (PT) documents from American Proficiency Institute (API), the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, training and competency assessment records, the prothrombin time (PT) new reagent lot studies, the Dade Innovin Reagent package insert, laboratory temperature logs, laboratory maintenance logs, quality control (QC) records and direct observations on 8/25/2022, the laboratory director failed to provide direction and management to the laboratory. See D6088, D6091, D6093, D6095 and D6103. D6088 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4) The laboratory director must ensure that the laboratory is enrolled in an HHS- approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) documents from American Proficiency Institute (API), and an interview with the technical supervisor (TS) on 8/25/2022, the laboratory director failed to ensure PT enrollment for serum human chorionic gonadotropin (hCG). The findings include: 1. A review of PT documents from API identified that the laboratory failed to enroll or perform PT for serum hCG testing for 2021 and 2022. 2. An interview with the TS on 8/25/22 at 9:00 am confirmed that the laboratory failed to perform PT for serum hCG testing in 2021 and 2022. 3. The facility reports performing 10 serum hCG tests annually. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies 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 record review of personnel training and competency assessments, the CMS- 209 personnel form, and an interview with the laboratory manager on 01/04/21, the laboratory failed to follow written policies and procedures to assess competency for the technical supervisor/consultant and testing personnel. The findings include: 1. The Technical Supervisor/Technical Consultant (TS/TC) listed on the CMS-209 did not have documentation of competency assessments available at the time of survey for 2019 and 2020. 2. Three of four testing personnel listed on the CMS-209 did not have documentation of initial training available at the time of survey. 3. Two of four testing personnel listed on the CMS-209 did not have documentation of 6-month competency assessment available at the time of survey. 4. The laboratory manager confirmed the above findings on 01/04/2021 at 1:30 PM. 5. The laboratory reports performing 60,130 Hematology and 72,600 Routine Chemistry patient specimens annually. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(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 preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: 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 -- Based on a review of the laboratory's policies and records, the laboratory failed to establish and follow their own written policies and procedures for monitoring and assessing quality indicators and for implementing