Lake Pointe Medical Center

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and from the proficiency testing provider. The laboratory was found out of compliance with the following CLIA Conditions: 493.803; D2016: Successful Participation 493.1407; D6000: 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 a desk review of proficiency testing scores obtained from the Casper 0155D report and proficiency testing Comparative Evaluation obtained from the laboratory for the second 2022 and first 2023 events, the laboratory failed to successfully 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 -- participate in a proficiency testing program for the specialty of Hematology. Findings include: (1) The laboratory failed to achieve satisfactory performance for two of three consecutive testing events for the analyte Platelets. Refer to D2130. 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 a desk review of proficiency testing scores obtained from the Casper 0155D report and the proficiency testing graded evaluations obtained from the laboratory, the laboratory failed to achieve successful performance for Platelets for two of three consecutive testing events. Findings include: (1) The laboratory received a score of 0% on the second 2022 AAFP (American Association of Family Physicians) event and a score of 0% on the first 2023 WSLH (Wisconsin State Laboratory of Hygiene) event. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the Casper 0155D report and the proficiency testing graded evaluations obtained from the laboratory, the laboratory failed to achieve satisfactory performance for the analyte Platelets in two of three consecutive events. The laboratory failed to achieve a passing score of 80% for the second 2022 event and first 2023 event. Refer to D6016. 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 a desk review of proficiency testing scores obtained from the Casper 0155D report and the proficiency testing graded evaluations obtained from the laboratory, the laboratory failed to achieve satisfactory performance for the analyte Platelets in two of three consecutive events. The laboratory failed to achieve a passing score of 80% for the second 2022 event and first 2023 event. Refer to D2130. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 04/11/2022. The findings were reviewed with the medical assistant at the conclusion of the survey. The laboratory was found in compliance with standard-level deficiencies cited. 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 a review of records and interview with the medical assistant, the laboratory failed to verify the accuracy of Wet Prep testing at least twice annually. Findings include: (1) On 04/11/2022 at 10:00 am, the medical assistant stated: (a) The laboratory performed Wet Prep testing. (2) A review of 2021 records revealed the testing had not been verified for accuracy twice annually during the review period; (3) The records were reviewed with the medical assistant. The medical assistant stated on 04/11/2022 at 11:00 am, the laboratory had not verified the accuracy twice annually as indicated above. 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. 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 -- This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's storage instructions, and interview with the medical assistant, the laboratory manager failed to ensure the humidity was monitored where the testing equipment was maintained for 15 of 15 months. Findings include: (1) On 04/11/2022 at 10:00 am the medical assistant stated: (a) CBC (Complete Blood Count) testing was performed on the Beckman Coulter AcT2 Diff analyzer. (2) A review of the manufacturer's environmental requirements for the analyzer identified the manufacturer required the relative humidity be maintained between 20%-85%. (3) A review of laboratory records from January 2021 through March 2022 revealed there was no evidence the humidity of the laboratory had been monitored during the review period; (4) The records were reviewed with the medical assistant. The medical assistant stated on 04/11/2022 at 10:55 am the laboratory had not documented the humidity as indicated above. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on a review of records, policies and procedures, and interview with the medical assistant, the laboratory failed to follow their written function check protocol to ensure the urine centrifuge was functioning properly for one of one function checks. Findings include: (1) On 04/11/2022 at 10:00, the medical assistant stated: (a) The laboratory performed urine microscopic testing; (b) The urine specimens were processed at a speed of 1500-1900 rpm (revolutions per minute) for 5 minutes using the Ultra Select centrifuge. (2) A review of the laboratory's written procedures titled, "policy and procedure manual" under the procedure titled, "CENTRIFUGE POLICY PROCEDURE" stated: (a) THE CENTRIFUGE WILL BE INSPECTED AND A FUNCTION CHECK TEST WILL BE PERFORMED ANNUALLY AND DOCUMENTED IN THE POLICY AND PROCEDURE MANUAL AFTER BEING REVIEWED AND SIGNED BY THE LABORATORY DIRECTOR"; (3) A review of the 2021 function check records revealed there was no documentation to prove the laboratory had performed an annual function check; (4) The findings were reviewed with the medical assistant who stated on 04/11/2022 at 11:05 am that the laboratory did not follow their written function check protocol for the urine centrifuge. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed 02/10/2020. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with testing person #1 at the conclusion of the survey. 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 records and interview with testing person #1, the laboratory failed to thoroughly review the results of proficiency testing performed in 2 of 6 Hematology events to identify the cause of failures. Findings include: (1) At the beginning of the survey, testing person #1 stated to the surveyor, the laboratory performed Hemogram testing, which included the analytes, RBC (Red Blood Count), Hct (Hematocrit), etc., using the Beckman Coulter AcT diff 2 analyzer; (2) The surveyor reviewed 2018 and 2019 proficiency testing records and identified the following: (i) First 2018 event: (a) RBC: Sample HD-4: The laboratory failed the result and obtained a score of 80%; (b) Hct: Sample HD-4: The laboratory failed the result and obtained a score of 80%. (ii) Second 2018 event: (a) RBC: Sample HD-11: The laboratory failed the result and obtained a score of 80%; (b) Hct: Sample HD-11: The laboratory failed the result and obtained a score of 80%. (3) There was no documentation the laboratory investigated (i.e., reviewed quality control, maintenance records, testing technique, etc.) the failures to determine the cause of the failures, or to determine if a systematic failure had occurred; (4) The surveyor reviewed the findings with testing person #1 who stated to the surveyor, the failures had not been thoroughly reviewed to determine the cause, or to ensure a systematic failure had not occurred. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT 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 -- CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on a review of records and interview with testing person #1, the laboratory failed to ensure quality control materials were not used beyond the expiration date for 3 of 27 lot numbers. Findings include: (1) At the beginning of the survey, testing person #1 stated the following to the surveyor: (a) The laboratory performed Hemogram testing (WBC-White Blood Count, RBC-Red Blood Count, Hemoglobin, Hematocrit, MCV (Mean Corpuscular Volume), MCH (Mean Corpuscular Hemoglobin), MCHC (Mean Corpuscular Hemoglobin Concentration), RDW (Red Cell Distribution Width), and Platelet Count) using the Beckman Coulter AcT diff 2 analyzer; (b) Three levels (Low, Normal, High) of Coulter 4C-ES Cell Control QC (Quality Control) materials were tested each day of patient testing. (2) The surveyor reviewed QC records from 03/01/18 through 01/31/20 and identified the laboratory utilized 27 lot numbers of QC materials. Of the 27 lot numbers utilized, 3 lot numbers (in use from 09/24/19 through 12/20/19), with the expiration date of 12/16/19, had been used on 12/17/19, 12/18/19, and 12/19/19, as follows: (a) Low Level - Lot #068300 (b) Normal Level - Lot #078300 (c) High Level - Lot #088300 (3) The surveyor reviewed the records with testing person #1 who stated the 3 lot number of QC materials listed above, had been used beyond the expiration date; (4) The following were examples of patient Hemogram testing performed when the laboratory used expired QC materials to assess the acceptable performance of the analyzer: (a) 12 /17/19: (i) Patient #4014: Testing performed at 09:02 AM (ii) Patient #5492: Testing performed at 09:13 AM (iii) Patient #14884: Testing performed at 10:21 AM (iv) Patient #16365: Testing performed at 10:23 AM (v) Patient #12200: Testing performed at 10:42 AM (vi) Patient #3427: Testing performed at 10:52 AM (vii) Patient #14878: Testing performed at 11:41 AM (viii) Patient #6858: Testing performed at 01:35 PM (b) 12/18/19: (i) Patient #6844: Testing performed at 10:11 AM (ii) Patient #11886: Testing performed at 10:13 AM (iii) Patient #12536: Testing performed at 10:15 AM (iv) Patient #16622: Testing performed at 10:16 AM (v) Patient #14672: Testing performed at 10:18 AM (vi) Patient #8256: Testing performed at 10:50 AM (vii) Patient #12378: Testing performed at 10:54 AM (viii) Patient #6349: Testing performed at 10:56 AM (ix) Patient #9089: Testing performed at 3:02 PM (c) 12/19/19: (i) Patient #4446: Testing performed at 09:52 AM (ii) Patient #5435: Testing performed at 09:54 AM (iii) Patient #15458: Testing performed at 09: 55 AM D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system -- 2 of 5 -- performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records and interview with testing person #1, the laboratory failed to have control procedures that monitored over time the accuracy and precision of test performance that may be influenced by changes in test system performance, environmental conditions, and variance in operator performance. Findings include: (1) At the beginning of the survey, testing person #1 stated the following to the surveyor: (a) The laboratory performed Hemogram testing (WBC-White Blood Count, RBC- Red Blood Count, Hemoglobin, Hematocrit, MCV (Mean Corpuscular Volume), MCH (Mean Corpuscular Hemoglobin), MCHC (Mean Corpuscular Hemoglobin Concentration), RDW (Red Cell Distribution Width), and Platelet Count) using the Beckman Coulter AcT diff 2 analyzer; (b) Three levels (Low, Normal, High) of Coulter 4C-ES Cell Control QC (Quality Control) materials were tested each day of patient testing. (3) The surveyor reviewed QC (Quality Control) records from 03/01 /18 through 01/31/20 and identified the laboratory used 27 lot numbers of QC materials during the review period, as follows: (a) Used from 03/01/18-03/31/18: (i) Low Control: Lot #068800 (ii) Normal Control: Lot #078800 (iii) High Control: Lot #08800 (b) Used from 04/02/18-07/02/18: (i) Low Control: Lot #0694000 (ii) Normal Control: Lot #079400 (iii) High Control: Lot #089400 (c) Used from 07/03/18-09/21 /18 (i) Low Control: Lot #067500 (ii) Normal Control: Lot #077500 (iii) High Control: Lot #087500 (d) Used from 09/24/18-12/31/18: (i) Low Control: Lot #068200 (ii) Normal Control: Lot #0782000 (iii) High Control: Lot #088200 (e) Used from 01/02/19-03/29/19: (i) Low Control: Lot #068900 (ii) Normal Control: Lot #078900 (iii) High Control: Lot #088900 (f) Used from 04/0/19-06/28/19: (i) Low Control: Lot #069500 (ii) Normal Control: Lot #079500 (iii) High Control: Lot #089500 (g) Used from 07/01/19-09/19/19: (i) Low Control: Lot #067700 (ii) Normal Control: Lot #077700 (iii) High Control: Lot #087700 (h) Used from 09/24/19-12/20 /19: (i) Low Control: Lot #068300 (ii) Normal Control: Lot #078300 (iii) High Control: Lot #088300 (i) Used from 12/20/19 and in use on the day of the survey: (i) Low Control: Lot #069000 (ii) Normal Control: Lot #079000 (iii) High Control: Lot #089000 (4) For 27 of the 27 lot numbers listed above, there were no records (i.e., Levey-Jennings data, statistical data, etc.) proving the control results had been monitored for variances; (5) The surveyor asked testing person #1 to explain how the lot numbers listed above had been monitored for variances. Testing person #1 explained each day the results of the three levels of QC were printed and reviewed for acceptability, but QC results were not reviewed for variances over time; (6) The surveyor reviewed the findings with testing person #1 and explained the laboratory must have a method to review QC results to monitor over time the accuracy and precision of testing that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: -- 3 of 5 -- Based on a review of records, and interview with testing person #1, the laboratory failed to ensure normal reference intervals appropriate for the patient population serviced by the laboratory, were made available to the provider responsible for using the test results. Findings include: GENDER SPECIFIC NORMAL REFERENCE INTERVALS (1) At the beginning of the survey, testing person #1 stated to the surveyor the laboratory performed Hemogram testing (i.e., WBC-White Blood Count; RBC-Red Blood Count; Hgb-Hemoglobin, Hct-Hematocrit, MCV-Mean Corpuscular Volume, MCH-Mean Corpuscular Hemoglobin; MCHC-Mean Corpuscular Hemoglobin Concentration; Platelet Count, and RDW-Red Cell Distribution Width) using the Beckman Coulter AcT Diff 2 analyzer; (2) The surveyor reviewed 2 patient test reports as follows: (a) Patient #312: Adult female. Testing performed on 03/29/19 (b) Patient #802: Adult male. Testing performed 01/08/20 (3) The two test reports included the same reference intervals for the following analytes: (a) WBC: 4.1-10.9 (b) RBC: 4.2-6.3 (c) Hgb: 12.0-18.0 (d) Hct: 37.0-51.0 (e) MCV: 80-97 (f) MCH: 26- 32 (g) MCHC: 31-36 (h) RDW: 11.6-14.8 (4) The surveyor reviewed the findings with testing person #1 and asked if the laboratory had gender specific normal Hemogram reference intervals. The laboratory manager stated to the surveyor, the laboratory had gender specific reference intervals for the Hemogram analytes listed above but the ranges had not been included on the patient test reports. NOTE: Routinely, female reference intervals for analytes RBC, Hemoglobin, and Hematocrit are lower than male reference intervals. PEDIATRIC NORMAL REFERENCE INTERVALS (1) At the beginning of the survey, the surveyor asked testing person #1 if the laboratory performed Hemogram testing on pediatric patients (less than 18 years of age). Testing person #1 stated to the surveyor on a rare occasion, the laboratory had performed Hemogram testing on pediatric patients when requested by the provider; (2) The surveyor asked testing person #1 for a Hemogram test result report for a pediatric patient (Patient #10351: Hemogram testing performed on a 9 year old female patient on 09/09/19). The surveyor reviewed the test report and identified the normal reference ranges on the pediatric patient's test report were the same reference ranges as provided for adult female and male patients: (a) WBC: 4.1-10.9 (b) RBC: 4.2-6.3 (c) Hgb: 12.0-18.0 (d) Hct: 37.0-51.0 (e) MCV: 80-97 (f) MCH: 26-32 (g) MCHC: 31- 36 (h) RDW: 11.6-14.8 (3) The surveyor asked testing person #1 if the laboratory had normal reference intervals specific for pediatric patients. Testing person #1 stated to the surveyor the laboratory did not have normal reference intervals specific for pediatric patients. 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 testing person #1, the technical consultant failed to ensure a testing person performing moderate complexity testing had been evaluated semiannually during the first year of testing. Findings include: (1) At the beginning of the survey, testing person #1 stated to the surveyor the laboratory performed Hemogram testing (i.e., WBC-White Blood Count; RBC-Red Blood Count; Hemoglobin, Hematocrit, Mean Corpuscular Volume, Mean Corpuscular Hemoglobin; Mean Corpuscular Hemoglobin Concentration; Platelet Count, and Red Cell Distribution Width) using the Beckman Coulter AcT Diff 2 analyzer; (2) The -- 4 of 5 -- surveyor reviewed personnel records for the 2 individuals (testing person #1 and testing person #2) who performed the moderate complexity testing. The surveyor identified the semiannual competency assessment had not been performed for testing person #2, hired after the previous recertification survey performed on 02/20/18: (a) The initial training had been completed on 02/01/19; (b) The annual competency assessment had been completed on 01/02/20; (c) There was no evidence a semiannual evaluation had been performed. (3) The surveyor reviewed the records with testing person #1, who stated there was no documentation a competency assessment had been performed for testing person #2 during the first year of testing. -- 5 of 5 --

Summary Statement of Deficiencies D0000 The findings were reviewed with testing person #1 at the conclusion of the survey. 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