Crosspoint Medical Clinic

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the CMS (Center for Medicare Services) national database and verified with the proficiency testing company, American Proficiency Institute (API). The facility was found to be out of compliance with the conditions of participation of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 493.803 successful participation in a proficiency testing program 493.1403 laboratories performing moderate complexity testing; laboratory director 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: 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 -- Based on a desk review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the proficiency testing company, American Proficiency Institute (API), it was determined the laboratory had not successfully participated in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory did not successfully participate in the specialty of chemistry for the analyte Calcium, Total. (refer to D2096) D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of CMS Form 155 and American Proficiency Institute (API) records found that the laboratory failed to attain a satisfactory score of at least 80% of acceptable responses for each analyte in the subspecialty of chemistry for the analyte of Total Calcium. The findings were: 1. API 2019 - 3rd event the laboratory received an unsatisfactory score of 60% for Total Calcium. 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: Review of the CMS report 155 and API proficiency testing records found that the laboratory failed to participate in the 2020-1st Testing Event resulting in a score of 0% for the all analytes in the specialty of Chemistry, constituting unsatisfactory performance. Findings: 1. API 2020 - 1st test event reported No Data Received resulting in the following unsatisfactory scores: Alanine aminotransferase ALT 0% Albumin 0% Alkaline Phosphatase 0% Aspartate aminotransferase AST 0% Bilirubin Total 0% Calcium 0% Chloride 0% Total Cholesterol 0% Cholesterol HDL 0% Creatinine 0% Glucose 0% Potassium 0% Sodium 0% Total Protein 0% Triglycerides 0% Blood Urea Nitrogen BUN 0% D2093 ROUTINE CHEMISTRY CFR(s): 493.841(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a -- 2 of 3 -- score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on a review of proficiency testing records it was revealed that the laboratory failed to return all proficiency testing results to the proficiency testing program within the time frame specified by the program for the specialty of chemistry. Findings were: 1. API 2020 1st event - the laboratory received an unsatisfactory result of 0% for the chemistry testing 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 laboratory proficiency testing performance it was revealed that the laboratory director failed to provide overall management and direction of the laboratory services. (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 results it was revealed that the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in a HHS approved proficiency testing program. (refer to D2096) -- 3 of 3 --

Summary Statement of Deficiencies D3001 FACILITIES CFR(s): 493.1101(a)(1) The laboratory must be constructed, arranged, and maintained to ensure the space, ventilation, and utilities necessary for conducting all phases of the testing process. This STANDARD is not met as evidenced by: Based on surveyor observation and confirmed in interview of facility personnel, the laboratory failed to ensure a stable electrical source is maintained in the laboratory for the refrigerator. The findings were: 1. Surveyor observation made on June 10, 2019 at 10:10 hours revealed that the facility stored CLINIQA quality control materials used for Vitamin D, PSA, and TSH testing. The quality control materials were stored in the laboratory refrigerator. 2. Surveyor observation made on June 10, 2019 at 10:28 hours revealed the facility experienced a complete power outage. The electrical power was off from 10:28 hours to 10:33 hours, for a total of five minutes. 3. Interview with the laboratory director on June 10, 2019 at 10:30 hours during the power outage, when asked how frequently this occurs, he stated, "No more than once a year." 4. Interview with the technical consultant on June 10, 2019 at 10:30 hours at 10:30 hours after the power outage, when asked if the facility has a power outage contingency policy, she stated, "No." She went on to say that the facility needs a min/max thermometer for the refrigerator. Key: PSA - prostate specific antigen TSH - thyroid stimulating hormone D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT 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. 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: NEW STANDARD DEFICIENCY: Based on surveyor observation, review of manufacturer's instructions,, and confirmed in interview the laboratory failed to ensure expired items were not available for use in preparation of quality control materials for 1 of 1 box of reagent grade water. The findings were 1. Surveyor observation on June 10, 2019 at 10:15 hours in the laboratory revealed the following 1 of 1 boxes of EKI High Purity Reagent Grade water was expired. The box was opened with an open date of 05-30-2019. As of July 10, 2019, the date of the unannounced follow-up visit revealed the reagent had been opened for 41 days. 2. Review of the manufacturer's instruction located on the package labeling stated, "To prevent microbial contamination, use entire contents within 30 days." The container was in use 11 days after its revised expiration date. 3. An interview with the primary testing person on June 10, 2019 at 10:15 hours confirmed the findings. She confirmed that she had not revised the expiration date after opening the box. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted 02/01/2019. This facility was found NOT in compliance with the CLIA conditions for specialties/subspecialties surveyed for 42 CFR 493.1250 Analytic systems 493.1403 Moderate complexity laboratory director D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions, review of patient final reports, and confirmed in interview of facility personnel, the laboratory failed to follow the manufacturer's instructions for resulting Precision DX Drugs of Abuse Integrated Strip /Card Device/Cup (Urine). The findings were: 1. Review of the manufacturer's instructions for the Precision DX Drugs of Abuse Integrated Strip/Card/Device/Cup (Urine) (ML 20000.89 REV A) under, "Limitations of the Test" it stated, "2. This assay provides a preliminary analytical test result only. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/Mass spectrometry (GC/MS) has been established as the preferred confirmatory method by the National Institute on Drug Abuse (NIDA). Clinical consideration and professional judgement should be applied to any test result, particularly when preliminary positive results are indicated." 2. Random review of patient charts revealed the following patient reports were resulted as "Positive." The results had not been documented as preliminary or sent out for confirmation. Patient 1 (see patient alias list) Date: 03-09-2018 COC (Cocaine): Positive Patient 2 (see patient alias list) Date: 08-30-2018 THC (Marijuana): Positive COC (Cocaine): Positive Patient 3 (see patient alias list) Date: 03-07-2018 THC (Marijuana): Positive COC (Cocaine): Positive Patient 4 (see patient alias list) Date: 04-26-2018 THC Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 12 -- (Marijuana): Positive BZO (Benzodiazepines): Positive COC (Cocaine): Positive 3. The above findings were confirmed in interview of the technical consultant on February 1, 2019 at 14:00 hours in the office. D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on manufacturer's instructions, surveyor observations, review of laboratory policy, and confirmed in interview of facility personnel, the laboratory failed to follow its own policy for laboratory safety. The findings were: 1. Review of the manufacturer's instructions for the MEDICA EasyQC Chemistry reagent, Levels A and B (lot 15265) stated, "2. Carefully reconstitute each vial of lyophilized serum with exactly 5.0 mL of ambient temperature reagent-grade water using a volumetric pipet." 2. Surveyor observation on February 1, 2019 at 13:30 hours in the laboratory revealed the primary testing person demonstrate how quality control reagent is made up for the Medica EasyRA chemistry analyzer. She obtained a sealed 5.0 mL volumetric pipette, but no bulb was present. Once she opened the volumetric pipette and was asked how she would draw up the reagent-grade water used to reconstitute the reagent, she stated, "With my mouth." She went on to say that the service representative had demonstrated the pipetting technique to her when she was trained. 3. Review of the laboratory's policy titled, "Laboratory Safety" (no approval date), stated under the 6th bullet, "Never pipette reagents or specimens by mouth. Use a bulb or mechanical pipette." 4. An interview with the technical consultant on February 1, 2019 at 13:45 hours in the office confirmed the findings. She stated she was unaware of the primary testing person's practice of pipetting by mouth. Key: mL - milliliter 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 review of laboratory policy, review of the laboratory's American Proficiency Institute (API) proficiency testing records, and confirmed in interview of facility personnel, the laboratory failed to verify the accuracy of proficiency testing (PT) scores when the laboratory received an artificial 100%. The findings were: 1. Review of the laboratory's policy titled, "Proficiency Testing" signed and approved by the laboratory director on December 2, 2014, stated, "...PT samples shall be tested and results reported on a timely basis..." 2. Review of the laboratory's proficiency testing records from 2017 (events 1, 2, and 3) and 2018 (events 1, 2, and 3) revealed the laboratory failed to return the following events within the established timeframe: Chemistry 2017 (Event 3) Chemistry 2018 (Event 3) Hematology 2018 (Event 3) 3. -- 2 of 12 -- Further review of the records for event 2018 Chemistry (Event 1) on the Performance Evaluation page the technical consultant documented, "Perform all samples - unable to perform by due date. Analyzer was down." The laboratory did not perform or score the event as instructed. 4. An interview with the technical consultant on February 1, 2019 at 15:00 hours in the office confirmed the findings. 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 review of laboratory policy, review of patient test records from 2017 and 2018, and confirmed in interview of facility personnel, the laboratory failed to have documentation of performing twice annual accuracy assessments for Vitamin D and PSA (Prostate Specific Antigen) in 2017 and 2018. The findings were: 1. A review of the laboratory's policy titled, "Quality Assurance Plan" under, "Comparison of Results" it stated, [SIC] "Our laboratory will verify the accuracy of any test that is not enrolled in a proficiency testing program. We will do so by running at least 2 split specimens (a specimen that is divided into 2 parts after collection; the laboratory analyzes one portion and the other portion is sent to a reference laboratory for analysis) and comparing our results to those of the reference laboratory. Twice a year we will perform this verification on the methods or tests for which we are not enrolled in PT." 2. A random review of 5 patient chart records from 2017 and 2018 found the laboratory performed PSA (prostate specific antigen) testing on 1 of 5 patients in 2017. Patient ID: see patient alias report Date: 11-22-2017 Result: PSA = 0.32 ng/mL 3. A random review of 5 patient chart records from 2017 and 2018 found the laboratory performed Vitamin D testing on 1 of 5 patients in 2018. Patient ID: see patient alias report Date: 01-16-2018 Result: Vitamin D = 29.8 ng/mL 4. At 15:00 hours in the office on February 1, 2019, the laboratory was asked to provide documentation of being enrolled in proficiency testing or of performing twice annual accuracy assessments for PSA in 2017 and Vitamin D in 2018. No documentation was provided. 5. An interview with the technical consultant on February 1, 2019 at 13:45 hours in the office confirmed the findings. She stated she didn't know the facility had tested patients using the FREND analyzer. She went on to say the validation was not done because the facility notified her that they would not be using the FREND analyzer. She agreed twice annual accuracy assessments had not been performed. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the CMS (Center for Medicare Services) national database and verified with the proficiency testing company, American Proficiency Institute (API). The facility was found to be out of compliance with the conditions of participation of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 493.803 successful participation in a proficiency testing program 493.1403 laboratories performing moderate complexity testing; laboratory director 493.807 (a) reinstatement after failure 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: 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 -- Based on a desk review of proficiency testing records, it was determined that the laboratory has not successfully participated in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory did not successfully participate in the specialty of general immunology for the analyte Antinuclear Antibody - ANA (refer to D2084). D2017 REINSTATEMENT OF NONWAIVED LABORATORIES CFR(s): 493.807(a)(b) (a) If a laboratory's certificate is suspended or limited or its Medicare or Medicaid approval is cancelled or its Medicare or Medicaid payments are suspended because it fails to participate successfully in proficiency testing for one or more specialties, subspecialties, analyte or test, or voluntarily withdraws its certification under CLIA for the failed specialty, subspecialty, or analyte, the laboratory must then demonstrate sustained satisfactory performance on two consecutive proficiency testing events, one of which may be on site, before CMS will consider it for reinstatement for certification and Medicare or Medicaid approval in that specialty, subspecialty, analyte or test. (b) The cancellation period for Medicare and Medicaid approval or period for suspension of Medicare or Medicaid payments or suspension or limitation of certification under CLIA for the failed specialty, subspecialty, or analyte or test is for a period of not less than six months from the date of cancellation, limitation or suspension of the CLIA certificate. This CONDITION is not met as evidenced by: Based on a desk review of laboratory proficiency testing performance the laboratory failed to participate successfully in proficiency testing for the satisfactory performance in a specialty of general immunology for the analyte ANA for two of three consecutive testing events and has not demonstrated sustained satisfactory performance on two consecutive proficiency events since the unsuccessful scores. Findings: 1. API 2017 - 1st event the laboratory received an unsatisfactory score of 60 % for ANA. 2. API 2017 - 2nd event the laboratory received an unsatisfactory score of 60 % for ANA. 3. API 2017 - 3rd event the laboratory received an unsatisfactory score of 60 % for ANA. D2075 GENERAL IMMUNOLOGY CFR(s): 493.837(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of CMS form 155 and API records found the laboratory failed to attain a score of at least 80% acceptable responses for each analyte in the subspecialty of Immunology for the analyte antinuclear antibodies (ANA). Findings: 1. API 2017 - 1st event the laboratory received an unsatisfactory score of 60 % for ANA. 2. API 2017 - 2nd event the laboratory received an unsatisfactory score of 60 % for ANA. 3. API 2017 - 3rd event the laboratory received an unsatisfactory score of 60 % for ANA. D2084 GENERAL IMMUNOLOGY CFR(s): 493.837(f) -- 2 of 3 -- Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on desk review of proficiency testing records, it was determined the laboratory failed to achieve satisfactory performance (80 % or greater) for the same analyte in the specialty of immunology in two consecutive testing events or two out of three consecutive testing events. Two out of three unsatisfactory scores results in unsuccessful PT performance. Findings: 1. API 2017 - 1st event the laboratory received an unsatisfactory score of 60 % for ANA. 2. API 2017 - 2nd event the laboratory received an unsatisfactory score of 60 % for ANA. 3. API 2017 - 3rd event the laboratory received an unsatisfactory score of 60 % for ANA. 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 laboratory proficiency testing performance it was revealed that the laboratory director failed to provide overall management and direction of the laboratory services. 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 results it was revealed that the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in a HHS approved proficiency testing program (refer to D2084). -- 3 of 3 --