Barry J Klyde Md Pc

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on direct observation, lack of standard operating procedures (SOPs), quality control (QC), calibration, and preventative maintenance (PM) records, as well as interview with the medical assistant (MA), the laboratory failed to maintain and retain Horiba Micros 60 analyzer documentation. FINDINGS: 1. There was no documentation of Horiba Micros 60 analyzer quality control and calibration, daily functions checks, and preventative maintenance. 2. The current, approved SOPs did not include instructions for performing such activity. 3. Findings were confirmed by interview with the MA on October 31, 2024, at approximately 4:00 P.M. D3039 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(5) Quality system assessment records. Retain all laboratory quality system assessment records for at least 2 years. This STANDARD is not met as evidenced by: Based on direct observation, lack of SOPs and Quality Assurance (QA) records, as well as interview with the MA, the laboratory failed to maintain and retain quality system assessment records. FINDINGS: 1. There was no documentation of current, approved procedure manual, QC and calibration records, personnel training and competency assessments, as well as quality assessment review for 2022, 2023, and 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 -- 2024. 2. Findings were confirmed by interview with the MA on October 31, 2024, at approximately 4:00 P.M. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of Centers for Medicare & Medicaid Services (CMS) Proficiency Testing (PT) Certification and Survey Provider Enhanced Reporting system (CASPER 0155D) and College of American Pathologists (CAP) Proficiency Testing (PT) records, as well as interview with the testing personnel (TP), the laboratory failed perform and document remedial action for PT scores less than 100%. FINDINGS: 1. A review of the CASPER 155 report revealed the following unsatisfactory scores: Hematology Specialty: 2022 First Event = 0% 2022 Second Event = 73% 2023 First Event = 23% Cell ID or WBC (White Blood Cell) Diff Test Analyte: 2022 First Event = 0% 2022 Second Event = 40% 2022 Third Event = 73% 2023 First Event = 60% RBC (Red Blood Cell) Test Analyte: 2022 First Event = 0% 2022 Second Event = 60% 2023 First Event = 0% HCT (Hematocrit) (Non-Waived) Test Analyte: 2022 First Event = 0% 2022 Second Event = 60% 2023 First Event = 0% HGB (Hemoglobin) (Non-Waived) Test Analyte: 2022 First Event = 0% 2023 First Event = 40% WBC Count Test Analyte: 2022 First Event = 0% 2023 First Event = 20% Platelets Test Analyte: 2022 First Event = 0% 2023 First Event = 20% 2. A review of the proficiency testing scores from CAP (2022 and 2023) confirmed the above findings. 3. There was no documentation of remedial action or

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 Proficiency Test (PT) desk review of the Center for Medicaid & Medicare Services (CMS) PT data reports and PT summary reports from American Proficiency Institute (API) PT program, the laboratory failed to participate successfully in CMS approved proficiency testing program, for the speciality Hematology and the test analyte's Cell Identification (Cell I.D.)/White Blood Cell Differential (WBC Diff.), Red Blood Cell Count (RBC) and Hematocrit (Hct). The following scores were assigned: speciality Hematology 2022 second event = 73% 2022 third event =95% 2023 first event = 23% RBC 2022 second event = 60% 2022 third event =100% 2023 first event = 0% Hct 2022 second event = 60% 2022 third event =100% 2023 first 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 -- event = 0% This is considered unsuccessful PT performance. Cell I.D/WBC Diff. 2022 second event = 40% 2022 third event =73% 2023 first event = 60% This is considered repeatedly unsuccessful PT performance. Refer to D2130 and D2131 D2121 HEMATOLOGY CFR(s): 493.851(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 PT desk review of the CMS PT data reports and PT records from the API PT program, the laboratory failed to participate successfully in proficiency testing for the test analyte's Hemoglobin (Hgb) White Blood Count (WBC) and Platelet The following scores were assigned: Hgb 2023 first event = 40% WBC 2023 first event = 20% Platelet 2023 fist event = 20% This is considered unsatisfactory PT performance. 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 PT desk review of the CMS PT data reports and PT summary reports from API PT program, the laboratory failed to participate successfully in CMS approved proficiency testing program, for the test analyte's Cell I.D./WBC Diff., RBC and Hct. The following scores were assigned: RBC 2022 second event = 60% 2022 third event =100% 2023 first event = 0% Hct 2022 second event = 60% 2022 third event =100% 2023 first event = 0% This is considered unsuccessful PT performance. Cell I.D/WBC Diff. 2022 second event = 40% 2022 third event =73% 2023 first event = 60% This is considered repeatedly unsuccessful PT performance. D2131 HEMATOLOGY CFR(s): 493.851(g) Failure to achieve an overall testing event score of satisfactory performance for 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 PT desk review of the CMS PT data reports and PT summary reports from API PT program, the laboratory failed to participate successfully in CMS approved proficiency testing program, for the speciality Hematology. The following scores were assigned: speciality Hematology 2022 second event = 73% 2022 third event =95% 2023 first event = 23% This is considered unsuccessful PT performance D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 -- 2 of 3 -- 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 PT desk review of the CMS PT and API PT program records, the laboratory director failed to fulfill the laboratory director's responsibilities and ensure that the laboratory achieved a satisfactory performance and successfully participate in a PT program, approved by CMS, for the speciality Hematology and the test analyte's Cell I. D./WBC Diff., RBC,Hct, Hgb, WBC, Platelet. 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 PT desk review of the CMS PT and API PT program records, the laboratory director failed to fulfill the laboratory director's responsibilities and ensure that the laboratory achieved a satisfactory performance and successfully participate in a PT program, approved by CMS, for the speciality Hematology and the test analyte's Cell I. D./WBC Diff., RBC,Hct, Hgb, WBC, Platelet. The following scores were assigned: speciality Hematology 2022 second event = 73% 2022 third event =95% 2023 first event = 23% RBC 2022 second event = 60% 2022 third event =100% 2023 first event = 0% Hct 2022 second event = 60% 2022 third event =100% 2023 first event = 0% This is considered unsuccessful PT performance. Cell I.D/WBC Diff. 2022 second event = 40% 2022 third event =73% 2023 first event = 60% This is considered repeatedly unsuccessful PT performance. Hgb 2023 first event = 40% WBC 2023 first event = 20% Platelet 2023 fist event = 20% This is considered unsatisfactory PT performance. -- 3 of 3 --

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 Proficiency Test (PT) desk review of the Center for Medicaid & Medicare Services (CMS) PT data reports and PT summary reports from American Proficiency Institute (API) PT program, the laboratory failed to participate successfully in CMS approved proficiency testing program, for the speciality Hematology and the test analyte's Cell Identification (Cell I.D.)/White Blood Cell Differential (WBC Diff.), Red Blood Cell Count (RBC), and Hematocrit (Hct). The following scores were assigned: speciality Hematology 2021 third event = 0% (failure to participate) 2022 first event = 0% (failure to participate) 2022 second event = 73% WBC Diff 2021 third event = 0% (failure to participate) 2022 first event = 0% (failure to participate) 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 -- 2022 second event = 40% RBC and Hct 2021 third event = 0% (failure to participate) 2022 first event = 0% (failure to participate) 2022 second event = 0% This is considered repeatedly unsuccessful PT performance. Refer to D2130 and D2131 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 PT desk review of the CMS PT data reports and PT summary reports from API PT program, the laboratory failed to participate successfully in CMS approved proficiency testing program, for the test analyte's Cell I.D./WBC Diff., RBC and Hct. The following scores were assigned: RBC, WBC, Hct 2021 third event = 0% (failure to participate) 2022 first event = 0% (failure to participate) 2022 second event = 60% Cell I.D./WBC Diff 2021 third event = 0% (failure to participate) 2022 first event = 0% (failure to participate) 2022 second event = 40% This is considered repeatedly unsuccessful PT performance. D2131 HEMATOLOGY CFR(s): 493.851(g) Failure to achieve an overall testing event score of satisfactory performance for 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 PT desk review of the CMS PT data reports and PT summary reports from API PT program, the laboratory failed to participate successfully in CMS approved proficiency testing program, for the speciality Hematology. The following scores were assigned: 2021 third event = 0% (failure to participate) 2022 first event = 0% (failure to participate) 2022 second event = 73% This is considered repeatedly unsuccessful PT performance. 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 PT desk review of the CMS PT data reports and API PT program records, the laboratory director failed to fulfill the laboratory director's responsibilities and ensure that the laboratory achieved a satisfactory performance and successfully participate in a PT program, approved by CMS, for the speciality Hematology and the test analyte's Cell I.D./WBC Diff., RBC, Hct and Platelets. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES -- 2 of 3 -- 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 PT desk review of the CMS PT data reports and API PT program records, the laboratory director failed to fulfill the laboratory director's responsibilities and ensure that the laboratory achieved a satisfactory performance and successfully participate in a PT program, approved by CMS, for the speciality Hematology and the test analyte's Cell I.D./WBC Diff., RBC and Hct. The following scores were assigned: speciality Hematology 2021 third event = 0% (failure to participate) 2022 first event = 0% (failure to participate) 2022 seond event= 73% Cell I.D./WBC Diff., 2021 third event = 0% (failure to participate) 2022 first event = 0% (failure to participate) 2022 seond event= 40% RBC and Hct. 2021 third event = 0% (failure to participate) 2022 first event = 0% (failure to participate) 2022 seond event= 60% This is considered repeatedly unsuccessful PT performance. -- 3 of 3 --

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 Proficiency Test (PT) desk review of the Center for Medicaid & Medicare Services (CMS) PT data reports and PT summary reports from American Proficiency Institute (API) PT program, the laboratory failed to participate successfully in CMS approved proficiency testing program, for the speciality Hematology and the test analyte's Cell Identification (Cell I.D.)/White Blood Cell Differential (WBC Diff.), Red Blood Cell Count (RBC), White Blood Cell Count (WBC), Hemoglobin (Hgb), Hematocrit (Hct) and Platelet Count The following scores were assigned: 2021 third event = 0% (failure to participate) 2022 first event = 0% (failure to participate) This is considered unsuccessful PT performance. Refer to D2130 and D2131 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 -- 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 PT desk review of the CMS PT data reports and PT summary reports from API PT program, the laboratory failed to participate successfully in CMS approved proficiency testing program, for the test analyte's Cell I.D./WBC Diff., RBC, WBC, Hgb, Hct and Platelet Count The following scores were assigned: 2021 third event = 0% (failure to participate) 2022 first event = 0% (failure to participate) This is considered unsuccessful PT performance. D2131 HEMATOLOGY CFR(s): 493.851(g) Failure to achieve an overall testing event score of satisfactory performance for 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 PT desk review of the CMS PT data reports and PT summary reports from API PT program, the laboratory failed to participate successfully in CMS approved proficiency testing program, for the speciality Hematology. The following scores were assigned: 2021 third event = 0% (failure to participate) 2022 first event = 0% (failure to participate) This is considered unsuccessful PT performance. 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 PT desk review of the CMS PT data reports and API PT program records, the laboratory director failed to fulfill the laboratory director's responsibilities and ensure that the laboratory achieved a satisfactory performance and successfully participate in a PT program, approved by CMS, for the speciality Hematology and the test analyte's Cell I.D./WBC Diff., RBC,Hct, HgB, WBC and Platelets. 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 -- 2 of 3 -- 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 PT desk review of the CMS PT data reports and API PT program records, the laboratory director failed to fulfill the laboratory director's responsibilities and ensure that the laboratory achieved a satisfactory performance and successfully participate in a PT program, approved by CMS, for the speciality Hematology and the test analyte's Cell I.D./WBC Diff., RBC,Hct, HgB, WBC and Platelets. The following scores were assigned: 2021 third event = 0% (failure to participate) 2022 first event = 0% (failure to participate) This is considered unsuccessful PT performance. -- 3 of 3 --

Summary Statement of Deficiencies 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 observation of beverage and food in the laboratory refrigerator which contained Horiba control & calibration materials, Quantimetrix Dipper urine control the laboratory failed to follow the laboratory's Safety and Universal procedures. FINDINGS: 1. The laboratory's Safety & Universal procedures states, "that no food, beverages, smoking is permitted in the laboratory." 2. The surveyor observed a beverage an salad at 9:30 AM in the laboratory refrigerator which contained Horiba control & calibration materials, and Quantimetrix Dipper urine controls. 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: Based on review of the Quality Assessment (QA) policy, lack of the 2020 & 2021 QA documentation and an interview with the laboratory testing personnel, the laboratory failed to follow the establish QA policy and perform an annual review, as required. FINDINGS: 1. The laboratory's QA policy requires an annual review to identify 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 -- problems, perform a corrective/remedial action and monitor the remedial action to ensure the problem was corrected. 2. The laboratory failed to perform and document an annual QA review in the calendar year 2020 and 2021. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records and interview with the testing personnel, the laboratory failed to establish written policies and procedures for specimen collection, labeling, storage, transportation, acceptability and rejection. FINDINGS: 1. The laboratory failed to provide written policies and procedures for specimen collection. 2. The laboratory failed to provide written policies and procedures for specimen labeling. 3. The laboratory failed to provide written policies and procedures for specimen storage. 4. The laboratory failed to provide written policies and procedures for specimen transportation. 5. The laboratory failed to provide written policies and procedures for specimen acceptability and rejection. 6. The testing personnel confirmed on February 8, 2022 at approximately 10: 00 AM, the laboratory failed to establish written procedures and policies for urine and blood specimens. 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. This STANDARD is not met as evidenced by: Based on observation of the Horiba calibration material stored in the laboratory's refrigerator Siemens Multistix 10SG urine test strips interview with the laboratory testing personnel, the laboratory failed to review calibration materials and reagent test strips for expired dates. FINDINGS: 1. The surveyor observed 3 boxes of Horiba Minocal calibration material at 9:45AM in the laboratory refrigerator and urine test strips on the counter. Minocal Lot # CX450 expiration date 6-5-21 (1 box) Minocal Lot# CX460 expiration date 2-5-22 (2 boxes) Siemens Multistix 10SG urine test strips Lot# 802037 expiration 8/31/19 (100 strips in the vial- not used for patient testing) 2. The laboratory testing personnel confirmed on February 8, 2022 at approximately 9: 45AM, the surveyor's findings of the expired calibration material was not used for calibration of the Horiba Micros 60 hematology analyzer and the urine test strips were not used for patient testing. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 -- 2 of 3 -- 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 review of the laboratory standard operating procedure (SOP), lack of QA records and an interview with the laboratory testing personnel, the laboratory director failed to provide overall management of the laboratory. The laboratory director failed to implement and maintain the: 1. laboratory's Quality Assessment program was maintained, Refer to D6021; 2. laboratory's corrective/remedial action, Refer to D6024 D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on of review of the laboratory's QA procedures, lack of the

Summary Statement of Deficiencies D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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: No deficiency details available. D6010 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(2) 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)(2) Ensure that the physical plant and environmental conditions of the laboratory are appropriate for the testing performed. This STANDARD is not met as evidenced by: No deficiency details available. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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 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 -- and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: No deficiency details available. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: No deficiency details available. D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy 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; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official 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); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: No deficiency details available. -- 2 of 2 --