Drs Ahern And Galban

Summary Statement of Deficiencies D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on surveyor observation and staff interview, the laboratory failed to ensure positive identification of a patient's specimen from the time of collection through completion of testing. Findings include: 1. Surveyor observation on 6/1/22 at 12:00 PM of the laboratory work bench area revealed the following: a. Four urinalysis samples were kept in a tray at the work bench. b. Two urinalysis samples were marked with patient initials and date of birth. One sample was marked as "MC" and other one was marked as "MN". 2. Record review of the laboratory's individualized quality control plan (IQCP) documents for "microscopic observations-urine sediments" on 6/1/22 revealed "Urine samples obtained by patient in cup labeled with patient's full name and DOB." 3. Staff interview on 3/21/19 at 12:05 PM with the technical consultant confirmed two urinalysis samples were not labeled with two unique patient identifier as listed in item 2 above and one of the staff usually put the initials on the cup. 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 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 -- 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 record review and staff interview, the laboratory failed to document function checks per establish laboratory procedure to ensure proper functioning of the laboratory equipment prior to patient testing. Findings include: 1. Record review on 6 /1/22 of the laboratory's incubator temperature log for incubating throat culture specimens revealed the laboratory did not monitor and document incubator temperatures as follows: (a) 20 of 31 days in March 2022. (b) 17 of 30 days in April 2022. 2. Record review on 6/1/22 of the laboratory's selective Strep select agar (SSA) individualized quality control plan (IQCP) documents revealed "Incubator temperatures are documented AM and PM, Monday through Friday and AM on Saturday." 3. Staff interview with testing personnel #3 on 6/1/22 at 12:30 PM confirmed: (a) Incubator temperature recording were missing as listed in item 1 above. (b) The laboratory was recording incubator temperature only once per day and not following their approved IQCP listed in item 2 above. 4. The laboratory performs 43 throat cultures annually. 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 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 record review and staff interview, the laboratory failed to follow and monitor the accuracy and precision of the complete analytic process for the selective Strep select agar (SSA) quality control plan (QCP) section of the individualized quality control plan (IQCP). Findings include: 1. Record review on 6/1/22 of the laboratory's QCP for SSA IQCP revealed: (a) The quality control (QC) data to be reviewed and monitored quarterly for accuracy and precision. (b) A certificate of analysis generated by the manufacturer is obtained for each lot of SSA media. 2. Record review of the SSA QC logs on 6/1/22 revealed: (a) Lack of documentation of quarterly review of QC data. (b) Lack of documentation of certificate of analysis for each lot number of the SSA media in use. 3. Staff interview with the laboratory technical consultant on 6/1/22 at 11:05 AM confirmed the laboratory's SSA QCP was not followed as indicated in item 1 above. 4. The laboratory performs 43 throat cultures annually. D5477 CONTROL PROCEDURES -- 2 of 3 -- CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and staff interview the laboratory failed to document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer in the specialty of Bacteriology. Findings include: 1. Record review on 6/1/22 of the laboratory's quality control (QC) logs for selective Strep agar (SSA) revealed documentation for the physical characteristics of the SSA media were not recorded since 1/15/21. 2. Staff interview with testing personnel #3 on 6/1/22 at 10:30 AM confirmed the following: a. He/She is unaware why the physical characteristics were not documented when new SSA media were received since 1/15 /21. b. He/She did not have have documentation how many SSA media were arrived since 1/15/21. c. He/She further stated some of the receiving staff members were new and needs retraining. 3. The laboratory performs 43 throat cultures annually. D6054 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 annually, after the first year. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to document annual competency of testing personnel (TP) to assess their knowledge and skills necessary to perform moderate complexity testing. Findings include: 1. Record review of TP competency records on 6/1/22 revealed the laboratory did not have annual competency documentation for 3 of 3 TP performing throat cultures and urine microscopic studies in 2020 and 2021. 2. Staff interview with the technical consultant on 6/1/22 at 11:15 AM confirmed the laboratory failed to perform and document annual competency for throat cultures and urine microscopic studies in 2020 and 2021. 3. The laboratory performs 123 moderate complexity tests annually. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review of the Drs. Ahern and Galban Laboratory was conducted pursuant to 42CFR Part 493 of the Clinical Laboratory Improvement Amendments (CLIA) of 1988. 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 record review of the CASPER Proficiency Testing (PT) data report 0155D and graded results from American Proficiency Institute (API) the laboratory failed to successfully participate for the regulated analyte 0005 Bacteriology. The laboratory received unsatisfactory scores for the 2nd and 3rd events of 2021. Refer to D2021 and D2028. 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 -- D2021 BACTERIOLOGY CFR(s): 493.823(b) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on record review, interview with the American Proficiency Institute (API) proficiency program and staff interview, the laboratory failed to participate in an approved PT program for Bacteriology. Findings include: 1. Record review on 12/20 /2021 of the CASPER 0155D report revealed scores of 0% for the regulated analyte 0005 Bacteriology for 2021 Events 2 and 3. 2. Record review on 12/22/2021 of a letter received by email from the laboratory on 12/21/2021 at 8:42 PM confirmed the laboratory failed to participate in the above referenced PT events. 3. Record review of American Proficiency Institute (API) PT records received from the laboratory via email on 12/23/2021 at 9:25 AM revealed: a. API PT Performance Evaluation for 2021 Microbiology Event 1 listed a "next shipment reminder" of 6/14/2021 for Microbiology 2021 Event 2. b. API PT Performance Evaluation for 2021 Microbiology Event 2 listed a "next shipment reminder" of 9/20/2021 for Microbiology 2021 Event 3. c. API PT Performance Summary for 2021 Microbiology 2nd event listed a score of 0% for the regulated analyte Bacteriology with the remark, "failure to participate." d. API PT Performance Summary for 2021 Microbiology 3rd Event listed a score of 0% for the regulated analyte Bacteriology for 2021 Events 2 and 3 with the remarks, "unsuccessful" and "failure to participate." 4. Telephone Interview with API representative on 12/23/2021 at 2:21 PM revealed: a. 2021 Event 2 Throat Culture was delivered on 6/17/2021 at 1:05 PM and signed for by the laboratory director (LD). b. 2021 Event 3 Throat Culture was delivered on 9/23/2021 at 10:18 AM and signed for by the LD. 5. Staff interview via telephone with Physician #1 (P1) on 12/21/2021 at 1:33 PM: a. P1 stated it was P1's understanding that Event 2 was backordered by the PT program and Event 3 was not received. b. Confirmed the laboratory failed to participate in PT for 2021 Events 2 and 3 for the regulated analyte 005 Bacteriology. D2028 BACTERIOLOGY CFR(s): 493.823(e) 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 proficiency testing (PT) record review and staff interview, the laboratory failed to successfully achieve satisfactory performance for two consecutive testing events for 2021 for the subspecialty of bacteriology. Findings include: 1. Record -- 2 of 3 -- review on 12/20/2021 of the Center for Medicare & Medicaid Services CASPER 0155D report revealed scores of 0% for the regulated analyte 0005 Bacteriology for 2021 Events 2 and 3. 2. Record review of American Proficiency Institute (API) PT records received from the laboratory via email on 12/23/2021 at 9:25 AM revealed: a. API PT Performance Summary for 2021 Microbiology 2nd event listed a score of 0% for the regulated analyte Bacteriology with the remark, "failure to participate." b. API PT Performance Summary for 2021 Microbiology 3rd Event listed a score of 0% for the regulated analyte Bacteriology for 2021 Events 2 and 3 with the remarks, "unsuccessful" and "failure to participate." 3. Staff interview via telephone with Physician #1 (P1) on 12/21/2021 at 1:33 PM: a. P1 stated it was P1's understanding that Event 2 was backordered by the PT program and Event 3 was not received. b. Confirmed the laboratory failed to participate in PT for 2021 Events 2 and 3 for the regulated analyte 0005 Bacteriology. -- 3 of 3 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on record review and staff interview the laboratory failed to enroll in proficiency testing (PT) for the specialty of chemistry and failed to test PT samples in the same manner it tests patient samples. Refer to 2006. Findings include: 1. Record review of the Clinical Laboratory Improvement Amendments (CLIA) CMS116 application test menu on 9/11/19 revealed the laboratory performs microscopic urinalysis testing 2. Record review of the laboratory's PT enrollment forms on 9/11/19 revealed the laboratory failed to provide evidence or documentation of PT enrollment for microscopic urinalysis in 2017, 2018 and 2019. 3. Staff interview with the laboratory director on 9/11/19 at 12:30 PM confirmed the above findings. 4. The laboratory performs 160 chemistry tests annually. D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to ensure proficiency testing (PT) samples were processed in the same manner as patient samples for microbiology PT testing. Findings include: 1. Record review of the laboratory's patient log book on 9/11/19 at 10:00 AM revealed PT samples were not being recorded in the laboratory's patient log, which resulted in the laboratory being unable to identify the mix up of PT samples for the American Proficiency Institute PT events 3 in 2018 and event 2 in 2019. 2. Interview with Technical Consultant#1 on 9/11/19 at 10:00 AM confirmed that PT samples were not being logged into the patient log book like patient samples in 2017, 2018 and 2019. 3. The laboratory performs 235 throat culture tests annually. 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 testing (PT) record review, the laboratory failed to successfully achieve a score of 80 percent (%) in two of three testing events for 2018 and 2019 for the subspecialty of bacteriology, specifically event 3: 40% and event 2: 40%. Refer to D2028. D2028 BACTERIOLOGY CFR(s): 493.823(e) 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. -- 2 of 7 -- This STANDARD is not met as evidenced by: Based on proficiency testing (PT) data summary reports the laboratory failed to successfully achieve a score of 80 percent (%) in two of three testing events for 2018 and 2019 for the subspecialty of bacteriology. Findings include: 1. Record review of the Center for Medicare & Medicaid Services (CMS) PT Data Report on 9/11/19 revealed the laboratory obtained unsatisfactory scores for two of three PT events for analyte #005 Bacteriology as follows: Year/Event # PT Score 2018 - Event - 3 40% 2019 - Event - 1 100% 2019 - Event - 2 40% 2. Record review of the American Proficiency Institute PT program results for the Microbiology survey on 9/11/19 revealed the laboratory obtained unsatisfactory scores in two of three PT events as evidenced below. Year/Event # PT Score 2018 - Event -3 40% 2019- Event -1 100% 2019 - Event- 2 40% 3. The laboratory performs 235 throat cultures annually in the subspecialty of bacteriology. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to have a policy in place to assess the competency of all laboratory personnel. Findings include: 1. Review of the laboratory's personnel competency records on 9/11/19 revealed the following: a. The laboratory did not have policy in place to assess the competency of the technical consultant and clinical consultant. b. Competency documentation for the above laboratory personnel was not available. 2. Staff interview with the technical consultant on 9/11/19 at 11:15 AM confirmed the laboratory did not have a policy in place to assess the competency of the above laboratory personnel and they were not assessed in 2017 and 2018. 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 record review and staff interview, the laboratory failed to verify the accuracy bi-annually for microscopic KOH testing in the specialty of microbiology. Findings include: 1. Record review of the laboratory's Proficiency testing on 9/11/19 revealed that biannual verification for accuracy was not performed in 2017 and 2018 for 4 of 4 testing personnel. 2. Staff interview with laboratory director on 9/11/19 at 12:30 PM confirmed the above findings. 3. The laboratory performs 6 microscopic KOH tests annually. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 -- 3 of 7 -- 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 documentation and interview with the technical consultant, the laboratory director failed to enroll in proficiency testing (PT), process PT samples in the same manner as patient samples, ensure remedial actions taken for unsuccessful PT failures, investigate or document unsuccessful PT scores and ensure training and competency of all testing personnel. Findings include: 1. The laboratory director failed to enroll in PT testing for microscopic urinalysis testing (See D6015) 2. The laboratory director failed to ensure PT samples were processed in the same manner as patient samples (See D6016) 3. The laboratory director failed to ensure remedial actions were taken for unsuccessful PT failures for bacteriology (See D6018) 4. The laboratory director failed to investigate or document unsuccessful PT scores (See D6019) 5. The laboratory director failed to ensure training/competency for new testing personnel. (See D6029) D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) 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) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on record review and staff interview the laboratory failed to enroll in proficiency testing (PT) for the specialty of chemistry. Findings include: 1. Record review of the Clinical Laboratory Improvement Amendments (CLIA) CMS116 application test menu on 9/11/19 revealed the laboratory performs microscopic urinalysis testing. 2. Record review of the laboratory's PT enrollment forms on 9/11 /19 revealed the laboratory failed to provide evidence or documentation of PT enrollment for microscopic urinalysis in 2017, 2018 and 2019. 3. Staff interview with the laboratory director on 9/11/19 at 12:30 PM confirmed the above findings. 4. The laboratory performs 160 microscopic urinalysis tests annually. 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: -- 4 of 7 -- Based on record review and staff interview, the laboratory failed to ensure proficiency testing (PT) samples were processed in the same manner as patient samples for microbiology PT testing. Findings include: 1. Record review of the laboratory's patient log book on 9/11/19 at 10:00 AM revealed PT samples were not being recorded in the laboratory's patient log, which resulted in the laboratory being unable to identify the mix up of PT samples for the American Proficiency Institute PT events 3 in 2018 and event 2 in 2019. 2. Interview with Technical Consultant#1 on 9/11/19 at 10:00 AM confirmed that PT samples were not being logged into the patient log book like patient samples in 2017, 2018 and 2019. 3. The laboratory performs 235 throat culture tests annually. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies No Tags No deficiency details available. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --