American Health Mw, Llc

Summary Statement of Deficiencies 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 observation of hematology microscope and interview with the laboratory manager, the laboratory failed to ensure maintenance was performed on the hematology microscope in 2019. Findings: 1. Observation of hematology microscope showed a tag that stated maintenance "Due 2/2019". 2. Interview with the laboratory manager on March 3, 2020 at 9:30 AM confirmed the laboratory failed to ensure maintenance was performed on the microscope in 2019. 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 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 -- 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 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 two Beckman Coulter DXH 800 hematology analyzer calibrations and interview with the laboratory manager, the laboratory failed to perform calibration at least every six months in 2018 and 2019. Findings: 1. Review of two Beckman Coulter DXH 800 hematology analyzers showed a lack of calibration documentation every six months for WBC, RBC, HGB, MCV, PLT and MPV in 2018 and 2019. 2. Interview with the laboratory manager on March 3, 2020 at 10:30 AM confirmed the laboratory failed to perform hematology calibration at least every six months on two analyzers. D6141 GENERAL SUPERVISOR CFR(s): 493.1459 The laboratory must have one or more general supervisors who are qualified under 493.1461 of this subpart to provide general supervision in accordance with 493.1463 of this subpart. This CONDITION is not met as evidenced by: Based on review of the CMS 209 personnel report, the laboratory failed to have a general supervisor who meets the qualification requirements of 493.1461 (refer to D6143). D6143 GENERAL SUPERVISOR QUALIFICATIONS CFR(s): 493.1461 (a) The general supervisor must possess a current license issued by the State in which the laboratory is located, if such licensing is required; and (b) The general supervisor must be qualified as a-- (b)(1) Laboratory director under 493.1443; or (b)(2) Technical supervisor under 493.1449. (c) If the requirements of paragraph (b)(1) or paragraph (b)(2) of this section are not met, the individual functioning as the general supervisor must-- (c)(1)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; and (c)(1)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing; or (c)(2)(i) Qualify as testing personnel under 493.1489(b)(2); and (c)(2)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing; or (c)(3)(i) -- 2 of 3 -- Except as specified in paragraph (3)(ii) of this section, have previously qualified as a general supervisor under 493.1462 on or before February 28, 1992. (c)(3)(ii) Exception. An individual who achieved a satisfactory grade in a proficiency examination for technologist given by HHS between March 1, 1986 and December 31, 1987, qualifies as a general supervisor if he or she meets the requirements of 493. 1462 on or before January 1, 1994. (c)(4) On or before September 1, 1992, have served as a general supervisor of high complexity testing and as of April 24, 1995-- (c) (4)(i) Meet one of the following requirements: (c)(4)(i)(A) Have graduated from a medical laboratory or clinical laboratory training program approved or accredited by the Accrediting Bureau of Health Education Schools (ABHES), the Commission on Allied Health Education Accreditation (CAHEA), or other organization approved by HHS. (c)(4)(i)(B) Be a high school graduate or equivalent and have successfully completed an official U.S. military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician). (c)(4)(ii) Have at least 2 years of clinical laboratory training, or experience, or both, in high complexity testing; or (c) (5) On or before September 1, 1992, have served as a general supervisor of high complexity testing and-- (c)(5)(i) Be a high school graduate or equivalent; and (c)(5) (ii) Have had at least 10 years of laboratory training or experience, or both, in high complexity testing, including at least 6 years of supervisory experience between September 1, 1982 and September 1, 1992. (d) For blood gas analysis, the individual providing general supervision must-- (d)(1) Be qualified under 493.1461(b)(1) or (2), or 493.1461(c); or (d)(2)(i) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; and (d)(2)(ii) Have at least one year of laboratory training or experience, or both, in blood gas analysis; or (d)(3) (i) Have earned an associate degree related to pulmonary function from an accredited institution; and (d)(3)(ii) Have at least two years of training or experience, or both in blood gas analysis. (e) The general supervisor requirement is met in histopathology, oral pathology, dermatopathology, and ophthalmic pathology because all tests and examinations, must be performed: (e)(1) In histopathology, by an individual who is qualified as a technical supervisor under 493.1449(b) or 493.1449(l)(1); (e)(2) In dermatopathology, by an individual who is qualified as a technical supervisor under 493.1449(b) or 493.1449(l) or (2); (e)(3) In ophthalmic pathology, by an individual who is qualified as a technical supervisor under 493.1449(b) or 493.1449(1)(3); and (e)(4) In oral pathology, by an individual who is qualified as a technical supervisor under 493.1449(b) or 493.1449(m). This STANDARD is not met as evidenced by: Based on review of the CMS 209 personnel report and interview with the laboratory manager, the laboratory failed to provide evidence of an individual for the position of general supervisor. Findings: 1. Review of the CMS 209 personnel report showed no evidence of an individual serving as general supervisor. 2. Interview with the laboratory manager on March 3, 2020 at 10:30 AM confirmed, the laboratory failed to have one or more general supervisors to provide day-to-day supervision of testing personnel. -- 3 of 3 --

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the bacteriology procedure manual and interview with the general supervisor, the laboratory failed to follow the Inoculum Density policy for 2017 and to date 2018. Findings: 1. The Determination of Inoculum Density procedure 12-231.1 M states, the "procedure (prompt inoculum check) allows you to verify inoculums densities in colony forming units/ml (CFU/ml) for aerobic and facultatively anaerobic bacteria in the laboratory. This will ensure that proper technique is being followed by technical staff and panels are not over or under inoculated which could lead to erroneous results." The procedure effective date was March 14, 2016. 2. The laboratory did not have documentation to show it performed this procedure in 2017 or 2018, to date. 3. Interview with the general supervisor on March 20, 2018 at 1:30 PM confirmed, the laboratory failed to follow the policy during 2017 and to date March 20, 2018. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- This STANDARD is not met as evidenced by: Based on review of instrument test result comparisons and interview with the general supervisor the laboratory failed to define a relationship between erythrocyte sedimentation rate (ESR) methodologies for 2016 and 2017. Findings: 1. Review of test result comparisons on the Excyte 20 ESR instrument and the back up Excyte mini ESR instrument showed no relationship between test results using the two instruments for 2016 or 2017. 2. Interview with the general supervisor on March 29, 2018 at 1:00 PM confirmed the laboratory failed to ensure ESR test result comparisons on both instruments were performed. D5800 POSTANALYTIC SYSTEMS CFR(s): 493.1290 Each laboratory that performs nonwaived testing must meet the applicable postanalytic systems requirements in 493.1291 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 postanalytic systems and correct identified problems as specified in 493. 1299 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of four of four patient test reports, laboratory policy and interview with the general supervisor, the laboratory failed to monitor and evaluate the quality of the postanalytic system for reporting positive blood culture results. (Refer to # D5813) D5813 TEST REPORT CFR(s): 493.1291(g) The laboratory must immediately alert the individual or entity requesting the test and, if applicable, the individual responsible for using the test results when any test result indicates an imminently life-threatening condition, or panic or alert values. This STANDARD is not met as evidenced by: Based on review of four of four selected blood culture test reports from 2017, laboratory policy, hours of operation, and interview with the general supervisor, the laboratory failed to immediately alert individual(s) responsible for clinical use of positive blood culture (panic value) results reported from the VersaTREK blood culture instrument. Findings: 1. Review of four patient test reports revealed the laboratory failed to immediately alert pertinent individual(s) for the following positive blood cultures: a) On October 9, 2017 at 11:30 PM VersaTREK instrument reported a positive blood culture result on patient "A". On October 10, 2017 at 10:11 AM the positive blood culture result was called to the responsible entity. b) On September 24, 2017 at 5:44 AM VersaTREK instrument reported a positive blood culture result on patient "B". On September 24, 2017 at 7:56 AM the blood culture result was called to the responsible entity. c) On September 30, 2017 at 12:20 AM the VersaTREK instrument reported a positive blood culture result on patient "C". On September 30, 2017 at 7:40 AM the blood culture result was called to the responsible entity. d) On June 29, 2017 at 6:36 AM the VersaTREK instrument reported a positive blood -- 2 of 4 -- culture result on patient "D". The laboratory did not have documentation to show the result was called to the responsible entity. 2. Review of AHA Panic Values policy number 3-201M (attachment B ) revealed the laboratory defined a positive blood culture result as a panic value. Attachment E of policy 3-201M states," a panic value defined by AHA policy may require immediate intervention. Therefore, these test values are called to ordering provider as soon as they are finalized twenty-four hours a day seven days a week. A panic value may be called to the ordering provider during the middle of the night." 3. Review of the the laboratory's hours of operation revealed the laboratory is closed from 8:00 PM to 7:00 AM Monday through Friday. On Saturdays the laboratory closes at 6:00 PM and reopens on Monday at 7:00 AM. The laboratory did not have a system to monitor positive blood culture results reported from the instrument when the laboratory is closed and unattended. 4. Interview with the general supervisor on March 20, 2018 at 1:30 PM confirmed the laboratory failed to immediately contact responsible entities for positive patient blood culture results. 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 review of the laboratory's quality management plan (quality assessment) and interview with the general supervisor the director failed to provide overall management and direction by failing to maintain the written quality assessment program. (Refer to # 6094) D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of the laboratory's quality management plan (quality assessment), patient blood culture and MRSA (Methicillin Resistant Staph Aureus) culture procedures, and interview with the general supervisor, the laboratory director failed to ensure the quality assessment programs were followed and to identify failures in quality as they occur. Findings: 1. The laboratory's quality management plan (policy number 6-101.6M #5 ) Panic (Critical) Value Notification and Documentation states, " Used to monitor certain result values which have been deemed to be panic values requiring immediate notification to the individual utilizing such results. See procedure 3-201M Critical and STAT Results Notification, Call, Read-Back and Documentation." 2.Review of policy 3-201M (AHA Panic Values) revealed the policy deemed positive blood culture results and positive MRSA cultures as panic values. 3. Policy number 3-201.11 M (Critical and STAT Results Notification, Call, Read-Back and Documentation) states, "critical laboratory results are test values that warrant immediate action by medical personnel to avoid possible harm to the patient." 4. Review of patient blood culture procedures revealed the laboratory did not have a -- 3 of 4 -- system to detect positive blood culture results reported from the blood culture instrument when the laboratory is closed. The laboratory is closed for 11 of 24 hours each day Monday through Friday, closed for 13 of 24 hours on Saturday and closed on Sunday. The laboratory is closed for 37 consecutive hours from Saturday 6:00 PM to 7:00 AM Monday. The blood culture instrument continuously monitors patient culture bottles for growth twenty-four hours a day, seven days a week. Testing personnel do not work-up positive blood cultures when the laboratory is closed. 5. Review of the MRSA culture procedure revealed the laboratory did not have a system to monitor positive MRSA culture results when laboratory is closed from Saturday 6:00 PM to 7: 00 AM Monday. 6. Interview with the general supervisor on March 20, 2018 at 1:30 PM confirmed, the director failed to ensure the laboratory followed the written quality management plan for blood culture and MRSA culture panic values. -- 4 of 4 --