Lakeway Complete Care Llc

Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, and recertification is recommended. D5781

Summary Statement of Deficiencies 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 review of manufacturer's instructions, humidity charts, EMR query, interview, and pre-survey paperwork, the laboratory failed to monitor the humidity within the Sysmex XP-300 manufacturer's specifications for performing CBC testing for 26 of 115 days reviewed. Findings follow. A. Review of the Sysmex XP-300 Instructions for Use, AU553517 November 2017, at 14. Technical Information, 14.1 Specifications, stated, "Operating Environment... Relative humidity: 30% to 85%". B. Review of the laboratory's Temperature and Humidity Log had an acceptable humidity of 23-80%. Review of logs from May 2022 - February 2022 showed the laboratory exceeded the manufacturer's range on 26 of 115 days reviewed. The dates were then compared to a EMR query from 04/09/2022 - 02/04/2022 showing patient testing by date: Date % Humidity # patients tested 04/07/2022 27 4 04/08/2022 26 10 04/09/2022 25 4 03/01/2022 25 4 03/02/2022 26 5 03/08/2022 27 7 03/09/2022 29 2 03/10/2022 27 3 03/12/2022 25 4 03/13/2022 25 4 03/15/2022 29 4 03/19/2022 28 5 03/20/2022 28 0 03/24/2022 26 2 03/26/2022 28 8 02/04/2022 25 5 02/05/2022 25 2 02/06/2022 25 2 02/07/2022 28 3 02/08/2022 28 8 02/09/2022 26 7 02/10/2022 27 2 02/11/2022 26 4 02/18/2022 27 1 02/19/2022 25 6 02/22/2022 29 6 C. Interview with Technical Consultant #1 on the CMS form 209, on June 15, 2022 at 1700 hours in the 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 -- break room acknowledged Sysmex had a letter stating labs could establish their own humidity range but had not performed that study in this laboratory. D. Review of the pre-survey paperwork showed an annual test volume of 12,000. KEY: EMR = Electronic Medial Record CBC = Complete Blood Count D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedure, observation, interview, and pre-survey paperwork, the laboratory failed to label their 5% bleach solution used to maintain their Sysmex XP-300 for performing CBC testing to include prepared date and expiration date. Findings follow. A. Review of the laboratory's policy and procedure titled CBC Sysmex XP-300 on page 22 under Maintenance stated, "IMPORTANT NOTE FOR ALL MAINTENANCE Clorox bleach is available with different concentrations of sodium hypochlorite. Refer to the label of the product in use for the sodium hypochlorite concentrations. The Sysmex XP-300 Instructions for Use recommends using a 5% sodium hypochlorite solution. Clorox must be diluted to the appropriate concentration of sodium hypochlorite prior to use. The example below describes how to make a liter of 5% sodium hypochlorite solution from Clorox (6% sodium hypochlorite concentration). Store prepared 5% bleach in a dark place for up to one week to prevent solution degradation from exposure to light." B. Surveyor observed on June 15, 2022 at 1530 hours in the laboratory a specimen cup labeled "Cell Clean", and a second specimen cup labeled "5% bleach solution" in the cabinet near the Sysmex XP-300. C. Interview with Technical Consultant #1, as listed on the CMS form 209, on June 15, 2022 at 1530 hours in the laboratory confirmed the 5% sodium hypochlorite was used to clean the Sysmex XP-300 daily and was missing the prepared and expiration dates. She checked with testing personnel #11, on the CMS form 209, and added he normally makes it up fresh each week but didn't make any this week. D. Review of the pre-survey paperwork showed an annual test volume of 12,000. KEY: CBC = Complete Blood Count D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the -- 2 of 3 -- range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on review of the laboratory records, and interview, the laboratory failed to perform calibration verification every six months for CKMB, Troponin I, and D- Dimer performed on the Alere Triage for three of three events for 18 months reviewed. Findings follow. A. Review of laboratory records showed no calibration verifications. Calibration verifications were requested on June 15, 2022 at 1730 hours but not provided. B. Interview with Technical Consultant #1 on June 15, 2022 at 1730 hours in the break room confirmed they did not perform calibration verifications on the Triage. KEY: CKMB = Creatinine kinase MB fraction D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of the laboratory test reports, interview, and pre-survey paperwork, the laboratory failed to include the name and address of the laboratory for three of 15 test reports reviewed. Findings follow. A. Review of 7 patients' test reports with an aggregate of 15 moderately complex tests, showed three Biofire RP 2.1 (respiratory panel) test reports did not have the name and address of the laboratory: Account Date of Service 1. 28783 May 12, 2022 2. 29435 June 3, 2022 3. 29463 June 4, 2022 B. Interview with Technical Consultant #1, as listed on the CMS form 209, on June 15, 2022 at 1800 hours in the break room confirmed the findings. C. Review of the pre- survey paperwork showed an annual test volume of 12,000. -- 3 of 3 --

Summary Statement of Deficiencies D2089 ROUTINE CHEMISTRY CFR(s): 493.841(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3)The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on a review of the the CMS-155 individual Profile report, the American Proficiency Institute (API) proficiency testing records for 2019 and 2020, Quality control records, patient test records and interview of facility personnel, the laboratory failed to participate in 2 of three consecutive testing events ( 3 events annually) for the analytes Lactic Acid, Magnesium and Phosphorous. The findings included: 1. Review of the Casper 155 individual proficiency testing report found: a. The laboratory received a score of 0% for 16 of 16 analytes Albumin, BNP, Calcium, Chloride, CO2, Creatine Kinase Isoenzyme, Creatinine, D-dimer Glucose, Lactic Acid, Magnesium, Phosphorus, Potassium, Sodium, Troponin I and Urea Nitrogen in the 2019 Chemistry Core 3rd event. b. The laboratory received a score of 100% for 15 of 16 analytes ( 80% for Creatine Kinase Isoenzyme in the 2020 Chemistry Core 2nd Testing event. 2. Based on review of the (API) proficiency testing records found: a. The laboratory failed to test and submit results for the 2019 Chemistry Core 3rd testing event to the proficiency testing agency for grading prior to the final submission date of September 13, 2019 resulting in an unacceptable score of 0% for 16 of 16 analytes. Further 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 -- review found the laboratory failed to test proficiency specimens CH 11- CH15 until September 16, 2019 and performed a self evaluation of the results obtained on November 6, 2019. b. Review of the 2020 Chemistry Core 2nd testing event, found: I. The laboratory tested proficiency specimens CH06, CH 07 and CH10 on May 26, 2020 using the CMP discs and the Liver panel discs. Specimen CH09 was tested on May 27, 2020 using the CMP discs and the Liver panel discs. Specimen CH08 was tested May 28, 2020 using the CMP discs and the Liver panel discs. The laboratory reported a test problem for specimens CH06 - CH10 (five specimens) for the analytes Lactic Acid, Magnesium, and Phosphorus and submitted the results to the proficiency testing agency on June 9, 2020 at 5:16 PM. c. Review of the Comparative Evaluation for the 2020 Chemistry Core 2nd Testing event found the laboratory received a score of 100% for 15 of 16 analytes ( 80% for Creatine Kinase Isoenzyme). 3. Review of the Met Lac 12 quality control records found that the laboratory tested quality control specimens using Met Lac 12 lot 9463BC2 on February 22, 2020, with the next quality control procedures performed on May 29, 2020 using Met Lac 12 Panel lot 0185AC1. Documentation found the Met Lac 12 panels were on back order after January 1, 2020. 4. Review of patient test records found the laboratory tested 3 patient specimens using the Met Lac 12 discs between May 29, 2020 ( date of receipt) and June 9, 2020 (date of proficiency testing results submission). 5. Interview of the Technical Consultant conducted on January 13, 2021 at 10:42 AM confirmed the laboratory failed to test the 2019 Chemistry Core proficiency testing specimens for the 3rd testing event prior to the final submission date. She also stated that the laboratory was notified in January 2020 that Met Lac 12 panels were on back order. The laboratory had no Met Lac 12 disks ( for use on the Abaxis Piccolo analyzer) on May 26, 2020 to test the five specimens received in the 2020 2nd Chemistry Core testing event, so testing personnel used the CMP and Liver Panel discs to complete as many of the analytes that were to be reported. She stated that the Panels were received and quality control procedures were performed on May 29, 2020. She stated she suggested to the laboratory to test the proficiency specimens on the correct discs to report to the proficiency testing agency, but the lab did not want to repeat the testing. They were able to complete testing for all analytes except the Lactic Acid, Magnesium and Phosphorous. They reported an instrument problem to API that they did not have the discs to perform these tests. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing records for 2019 and 2020, the CMS-155 proficiency testing report, and confirmed in staff interview, the laboratory director failed to ensure proficiency testing samples were tested as required to achieve successful scores.( Refer to D 2089) D6017 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(ii) -- 2 of 3 -- The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(ii) Ensure that results are returned within the timeframes established by the proficiency testing program. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing records from 2019 and 2020 and staff interview the laboratory director failed to ensure proficiency test results were returned prior to the submission deadline in one of sixChemistry testing events. (refer to D2089). -- 3 of 3 --

Summary Statement of Deficiencies D0000 The laboratory was surveyed and failed to meet the following conditions of the CLIA regulations found at CFR 42 493.1 through 493.1780: 493.801 Condition: Enrollment and testing of samples 493.1403 Condition: Laboratories Performing Moderate Complexity Testing; laboratory director 493.1409 Condition: Laboratories Performing Moderate Complexity Testing; technical consultant 493.1421 Condition: Laboratories Performing Moderate Complexity Testing; testing personnel 493.1250 Condition: Analytic Systems 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: Observations, review of the laboratory proficiency testing records, review of the CMS report 155 Individual Laboraotry Profile and interview of facility personnel found that the laboratory failed to enroll in a proficiency testing program for all analytes tested in the specialty of Chemistry. Findings included: 1. Observations made during the tour of the facility found that the laboratory used the MetLac 12 Panel (Abaxis Piccolo) and the One Step Drug Screen Test Card (moderately complex procedures) for testing patient specimens. 2. Review of the American Proficiency Institute (API) proficiency testing records from 2016 third event through the 2018 first event ( three events per 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 -- year) found that the laboratory did not enroll and participate in an appropriate proficiency testing program for non waived Chemistry and Toxicology analytes as follows: a. Chemistry - The laboratory failed to enroll in a nonwaived proficiency testing program for testing performed using the moderately complex Abaxis Piccolo MetLac12 Panel Reagent Disc. The MetLac Panel 12 Reagent Disc includes Albumin, Calcium, Chloride, Creatinine, Glucose, Lactate, Magnesium, Phosphorous, Sodium. Carbon Dioxide and Blood urea nitrogen. b. Toxicology - The laboratory failed to enroll in a nonwaived proficiency testing program for testing performed using the moderately complex One Step Drug Screen Test Card for urine drug screens. 3. Review of the CMS Report 155 Laboratory Individual Profile found no results reported for regulated analytes included in the moderately complex Abaxis MetLac 12 Panel. 4. Interview of Technical Consultant 2 on the CMS Report 209 conducted on May 16, 2018 at 11:21 confirmed that the laboratory did not participate in a nonwaived Chemistry proficiency testing program for MetLac 12 Panel Reagent Disc. She stated that" the laboratory started using the MetLac 12 Panel Reagent Disc in July, 2016 but did not enroll in a nonwaived Chemistry proficiency testing program until 2018, and they did not report Phosphorous and Magnesium." At 11:54 AM, Technical Consultant 2 went on to say that it was the laboratory's practice to" report analytes from the CMP disc and add the non common analytes from the liver panel" to complete the Chemistry proficiency testing results submitted to the Proficiency testing agency. The Technical Consultant also confirmed that the laboratory did not enroll in a proficiency testing program for urine drug screens because they were not supposed to be using the OneStep Drug Screen Test card for testing patients. 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: Observations, review of the laboratory proficiency testing records, review of the CMS report 155 Individual Laboratory Profile and interview of facility personnel found that the laboratory quality assessment program failed to identify that the laboratory was enrolled in an appropriate proficiency testing program for nonwaived analytes tested in the specialty of Chemistry. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, 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 analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Review of laboratory records and interview of facility personnel found that the -- 2 of 8 -- laboratory failed to ensure that quality control procedures were tested each day when the non waived Multi Drug Screen Test Panel urine drug screen test kits were used for patient testing. (see D5449) D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test 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)