M D Express Urgent Care- Hampton

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at MD Express Urgent Care-Hampton on July 26, 2023 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiencies cited are as follows: D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a tour, review of procedures, daily temperature/environment logs, lack of documentation, and an interview, the laboratory failed to retain documentation of monitoring daily relative humidity percent (%) and refrigerator/freezer temperatures according to their procedures for one of twenty-one months reviewed (review timeframe: October 2021 to the date of the inspection, 7/26/23). Findings include: 1. During a tour of the laboratory at approximately 10:00 AM on 7/26/23, the inspector noted: Freezer A - sign stated "Chemistry Biosite and Piccolo Controls are to be stored in this freezer"; Freezer B - sign stated "Patient Send out COVID-19 test swabs are to be stored in this freezer"; Refrigerator A - sign stated "CBC Controls, Cardiac Marker Controls are to be stored in this refrigerator"; Refrigerator B - sign stated "Piccolo, BNP, Cardiac, D-Dimer Reagents are to be stored in this refrigerator". 2. Review of the laboratory's procedures revealed Quality Assurance protocols that outlined daily monitoring of environmental conditions that included laboratory room 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 -- temperature/humidity and refrigerator/freezer temperatures. The QA procedure stated, "Record daily and maintain logs of room, refrigerators and freezers' temperatures and humidity." 3. Review of the available laboratory temperature log records for October 2021 up to the date of the inspection revealed no record of laboratory room temperature/humidity or refrigerator/freezer temperature monitoring during the month of November in calendar year 2021. The inspector requested to review documentation of humidity and temperature monitoring in November 2021. No records were available for review. 4. An exit interview with the lab coordinator at approximately 1 PM on 7/26/23 confirmed the above findings. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of hematology analyzer quality control (QC) records, policies, and interviews, the laboratory failed to follow their QC protocol to verify two (2) levels of acceptable QC for Complete Blood Count (CBC) on 2 days with five (5) patients tested/reported during the twenty-one (21) months reviewed (October 2021 to the date of the inspection on 7/26/23). Findings include: 1. Review of the Medonic hematology analyzer QC records from October 2021 to 7/26/23 revealed that the laboratory failed to verify 2 levels of acceptable hematology QC on the following dates with patient accession numbers (#) tested/reported: 05/30/23 - #848229, #848232; 06/10/23 - #848632, #848636, #848653. The inspector noted that one level of CBC QC (High) was verified on the dates outlined above. The inspector noted that the Low and Normal QC failed on both dates outlined above. The inspector inquired regarding the laboratory's protocol for hematology QC verification. The lab coordinator stated at approximately 11:30 AM on 7/26/23, "Our protocol is to run three levels of hematology QC and at least two of three levels have to be acceptable before we run patients. I will need to look into why the procedures were not followed before CBC testing was done." 2. Review of the laboratory policies revealed a QC protocol that stated, "At a minimum, the lab will run two control specimens every 24 hour period when patient testing is performed. Do not report any patient test result unless the test system has produced adequate control results on the day the patient test has been performed." 3. An exit interview with the lab coordinator at approximately 1 PM on 7 /26/23 confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at MD Express Urgent Care-Hampton on September 1, 2021 by the Virginia Department of Health's Office of Licensure and Certification. The inspector noted that the laboratory performs SARS-CoV-2 (COVID-19) testing and was in compliance with the applicable COVID- 19 reporting requirements. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiencies cited are as follows: D2122 HEMATOLOGY CFR(s): 493.851(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on a review of Centers for Medicare and Medicaid Services CASPER 0096D report form (CMS CASPER 96), proficiency testing (PT) records, and an interview, the laboratory failed to attain an overall score of at least eighty (80) percent of acceptable responses for Hematology in one (1) out of three (3) 2020 PT testing events. Findings include: 1. During pre-survey duties, the inspector noted that the CMS CASPER 96 report included an overall unsatisfactory PT score for the speciality of Hematology. The pre-survey review revealed the laboratory received 58 % score for 2020 Event 3. 2. During the onsite survey on 09/01/21, the inspector reviewed the laboratory's American Academy of Family Physicians (AAFP) PT records (2020 Events 1-3, 2021 Events 1-2). The review revealed the following unsatisfactory scores: 2020 Event 3: Hematology overall scored at 58% - module breakdown of Cell Identification scored 73%, Red Blood Cell scored 80%, Hematocrit scored 0%, and Platelets scored 0%. 3. An exit interview with the lab/nurse coordinator at approximately 2:30 PM confirmed the above findings. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE 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 -- 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 a review of proficiency testing (PT) records, lack of documentation, and an interview, the laboratory failed to record evaluation of fifteen (15) of 15 unsatisfactory scores for Lymphocyte (LYMP), Monocyte (MONO), Granulocyte (GRAN), Red Blood Cell (RBC), Hematocrit (HCT) and Platelet (PLT) challenges reported on the 2020 Hematology PT Event 3 report. Findings include: 1. Review of the laboratory's American Academy of Family Physicians (AAFP) PT records (2020 Events 1-3, 2021 Events 1-2) revealed no evidence of evaluation for each of the following failed analyte challenge samples: 2020 AAFP Event 3: LYMP % (HD-12, HD-13), MONO % (HD-13), GRAN % (HD-13), RBC (HD-12), HCT (HD-11, 12, 13, 14, 15), and PLT (HD-11, 12, 13, 14, 15). The inspector requested to review documentation that the laboratory evaluated the 15 unacceptable challenge results outlined above. Documentation was not available for review. The lab/nurse coordinator stated at approximately 1 PM: "I have been unable to find the documentation of the review by our previous coordinator or director at the time of this report. I cannot comment on the matter because I was not the coordinator at that time but going forward we will review in a timely manner". 2. An exit interview with the lab/nurse coordinator at approximately 2:30 PM confirmed the above findings D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on a review of the laboratory's Centers for Medicare and Medicaid Services (CMS) 116 form, patient test logs, two (2) randomly selected patient reports, and interviews, the laboratory failed to ensure that five hundred twenty (520) patient Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (Tv) polymerase chain reaction (PCR) test reports included the performing laboratory address and specimen type during the timeframe of February 3, 2021 to the date of the inspection on September 1, 2021. Findings include: 1. Review of the laboratory's CMS 116 form revealed a laboratory name and physical facility location as follows: MD Express Urgent Care-Hampton 3321 West Mercury Boulevard Hampton, Virginia 23666 and non waived PCR testing for CT, NG, and Tv utilizing Cepheid GeneXpert was added to the test menu on 2/3/21. 2. Review of the patient GeneXpert CT/NG and Tv PCR test logs revealed three hundred six (306) CT/NG and two hundred fourteen (214) Tv patient results were reported from 2/3/21 to 8/31/21 from the Cepheid Serial Number 843965. 3. The inspector requested to review 2 random patient results from the patient test logs. The following selected medical record -- 2 of 3 -- number results (MRN #) were printed from the EPIC laboratory information system: MRN # 005962942 (dated 3/17/21) and MRN # 005916263 (dated 9/1/21). The inspector noted that the reports outlined above did not entail the performing laboratory's address or patient specimen type. The inspector inquired regarding the the missing report information. The lab/nurse coordinator stated, on 9/1/21 at approximately 1:30 PM: "We can run urine, endocervical and vaginal swabs but typically only collect urine for male and endocervical for females. I can reach out to our EPIC report builder to add both the source and this site's address information to our reports." 4. An exit interview with the lab/nurse coordinator at approximately 2:30 PM confirmed the above findings -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at MD Express-Hampton on May 7, 2019 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of the laboratory's hematology and chemistry proficiency testing (PT) records and an interview, the laboratory failed to retain attestations by the personnel performing the PT testing on seven (7) of the 7 events reviewed from calendar year 2017 up to the date of the inspection on 5/7/19. Findings include: 1. Review of the laboratory's 2017 (three events), 2018 (three events), and year to date 2019 (one event) American Proficiency Institute (API) PT documentation revealed no testing personnel (TP) signed attestations for the hematology and chemistry PT modules. The inspector requested to review the TP attestations. The primary testing personnel stated, "We have the lab director sign but did not have the personnel sign the attestations at this location". 2. In an interview with the clincal coordinator, at approximately 12:30 PM, the above findings were confirmed. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. 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 a tour, review of analyzer maintenance records, policies and procedures, and an interview, the laboratory director (LD) failed to document approval and review of procedures for Complete Blood Count (CBC) patient testing on the Medonic M Series analyzer from the date of installation on March 22, 2018 and up to the date of the inspection on May 7, 2019. Findings include: 1. During a tour of the laboratory, the inspector noted a Medonic M Series hematology analyzer in use for patient CBC testing. The primary testing personnel stated, "We replaced our Abbott Cell Dyn with the Medonic instrument in 2018". 2. Review of the laboratory's hematology analyzer maintenance documentation revealed that a field service representative installed the Medonic M Series analyzer on March 22, 2018. 3. Review of the laboratory's policy and procedure manual revealed a procedure for Abbott Cell Dyn 1800 Operation, Quality Control, Maintenance, Troubleshooting and CBC testing. The policies were approved by the LD on 6/2/15. The laboratory inspector requested to review approved procedures for the Medonic hematology analyzer. The primary testing personnel stated, "We have not updated all of our procedure manuals yet". 4. In an interview with the clinical coordinator, at approximately 12:30 PM, the above findings were confirmed. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a tour, a review of manufacturer's analyzer user guides, daily temperature logs, and an interview, the laboratory failed to monitor the daily relative humidity percent (RH%) for two (2) analyzers (Alere Biosite Meter and Medonic M Series) to ensure manufacturer's operating requirements were followed from June 2017 to April 2019. Findings include: 1. During a tour of the laboratory, the inspector noted a Medonic M Series hematology analyzer in use for patient hematology Complete Blood Count (CBC) testing and an Alere Biosite Meter in use for patient chemistry Creatine Phosphokinase MB (CK-MB), Troponin, Myoglobin, D-dimer, and B Type natriuretic peptide (BNP) testing. 2. Review of the manufacturer's users guides for ambient operating requirements revealed: Medonic M Series humidity requirement less than or equal to 80%, Biosite humidity requirement 10-85%. Review of the 2 manufacturers users guides also revealed maintenance instructions with daily humidity listed as "record daily". 3. Review of the daily temperature logs from June 2017 to April 2019 revealed no record of laboratory humidity monitoring. 4. In an exit interview with the clinical coordinator at approximately 12:30 PM, the above findings were confirmed. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) -- 2 of 4 -- Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on a review of hematology analyzer performance verification documentation, manufacturer's user guide instructions, patient test logs, and an interview, the laboratory director failed to evaluate and verify the normal values (reference ranges) for Complete Blood Count (CBC) testing prior to reporting eight hundred ninety-one (891) patient CBC panels from March 22, 2018 to the date of the survey, May 7, 2019. Findings include: 1. Review of the laboratory's instrument validation records revealed a new hematology analyzer installation, by a Medonic field service technical specialist, occurred on 3/22/18. The inspector noted that no validation, by the lab director, of the CBC patient normal values for the new Medonic M Series (Serial Number 29666) was documented. The inspector requested to review documentation that the laboratory director validated the Medonic's patient normal value ranges prior to patient testing. No documentation was available for review. 2. Review of the Medonic M Series Users Guide for new instrument installation revealed instructions: "The patient Reference Range must be validated by the Lab Director". 3. Review of the patient test logs revealed that the lab reported 891 CBC reports from 3/22/18 to the date of the survey on 5/7/19. 4. In an interview with the clinical coordinator at approximately 12:30 PM, the above findings were confirmed. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of hematology instrument maintenance logs, manufacturer's operations manual, and an interview, the laboratory failed to document required monthly Medonic M Series hematology analyzer preventative maintenance procedures for three (3) of thirteen (13) months reviewed from March 2018 to April 2019. Findings include: 1. Review of the laboratory's Medonic M Series hematology analyzer maintenance logs and manufacturer's Clinical Diagnostic Solutions User Manual revealed the following two (2) required preventative maintenance procedures listed as "perform monthly": Monthly Cleaning with Hypochlorite, Clot Prevention (Enzymatic Cleaning). 2. Review of the laboratory's Medonic instrument maintenance logs from 3/22/18 to 4/30/19 revealed that the laboratory failed to document performance of the 2 monthly maintenance procedures listed above in: August 2018, October 2018, February 2019. 3. In an exit interview with the clinical coordinator at approximately 12:30 PM, the above findings were confirmed. D6055 TECHNICAL CONSULTANT RESPONSIBILITIES -- 3 of 4 -- CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing whenever test methodology or instrumentation changes. The individual's performance must be reevaluated to include the use of the new test methodology or instrumentation prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on a review of Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), new analyzer installation validation records, manufacturer's users guide, laboratory personnel files, and an interview, the technical consultant (TC) failed to document training and competency evaluations for thirty-two (32) of thirty-four (34) testing personnel after a hematology instrument change occurred in the laboratory on March 22, 2018. Findings include: 1. Review of the CMS 209 form revealed that the laboratory director (LD) also performs the duties of TC and that there are thirty-four (34) testing personnel. 2. Review of the laboratory's instrument validation records revealed a new hematology analyzer installation (Medonic M Series - Serial Number 29682) was performed by a Medonic field service technical specialist on 3/22/18. 3. Review of the Medonic M Series User's Guide revealed an M Series Training Checklist to be completed prior to patient testing. 4. Review of the laboratory personnel files and installation records revealed that testing personnel # 1 through # 32 lacked a Medonic M Series Training Competency checklist and evaluation. The inspector requested the training competency evaluations. No documentation was available for review. The clinical coordinator stated, "the field service representative trained two of us in March 2018 and we have trained the other personnel. I do not have those records at this time". (See Personnel Code Sheet) 5. In an exit interview with the clinical coordinator at approximately 12: 30 PM, the above findings were confirmed. -- 4 of 4 --